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DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT Health Facilities Regulation Division STANDARDS FOR HOSPITALS AND HEALTH FACILITIES 6 CCR 1011-1 [Editor’s Notes follow the text of the rules at the end of this CCR Document.]

Chapter II General Licensure Standards Copies of these regulations may be obtained at cost by contacting: Division Director Colorado Department of Public Health And Environment Health Facilities Division 4300 Cherry Creek Drive South Denver, Colorado 80222-1530 Main switchboard: (303) 692-2800 These chapters of regulation incorporate by reference (as indicated within) material originally published elsewhere. Such incorporation, however, excludes later amendments to or editions of the referenced material. Pursuant to 24-4-103 (12.5), C.R.S., the Health Facilities Division of the Colorado Department of Public Health And Environment maintains copies of the incorporated texts in their entirety which shall be available for public inspection during regular business hours at: Division DirectorColorado Department of Public Health And EnvironmentHealth Facilities Division4300 Cherry Creek Drive SouthDenver, Colorado 80222-1530Main switchboard:(303) 692-2000 Certified copies of material shall be provided by the division, at cost, upon request. Additionally, any material that has been incorporated by reference after July 1, 1994 may be examined in any state publications depository library. Copies of the incorporated materials have been sent to the state publications depository and distribution center, and are available for interlibrary loan. Part 1 - REVIEW OF BUILDING PLANS AND SPECIFICATIONS 1.1 SUBMISSION OF BUILDING PLANS. Plans and drawings for all facilities to be built, added to, or altered that are presently or may be licensed by the Department shall be submitted to the department for review in the following sequence prior to the start of construction: 1.1.1 A written program describing the objectives of the sponsoring organization, and the type and size of service or services to be provided in the proposed facility. 1.1.2 Preliminary drawings showing the proposed general location, boundaries, approaches to and physical features of the site, other buildings on the site, means of water supply, sewage disposal, and other utilities to the site. The preliminary drawings shall also show the proposed layout of each floor of the facility with each room labeled as to its use, and a general cross section of the structure indicating type of construction.

1.1.3 Outline specifications indicating important electrical, mechanical and other features not shown on drawings. 1.1.4 Final working drawings and specifications. These must be approved before construction is begun. 1.2 COMPLIANCE RESPONSIBILITY. It is the responsibility of the health facility to insure that any construction project complies with the applicable standards and codes. 1.3 Materials submitted for review shall be in the format and/or on forms prescribed by the department. Part 2 - Application for License 2.1 LICENSE REQUIRED. No person or entity shall establish, maintain, or operate a health facility without first having obtained a license therefor or, in the case of governmental facilities, a certificate of compliance from the Department. For purposes of these rules, the holder of a certificate of compliance shall be considered a licensee. 2.2 BED CAPACITY. Each license shall state the maximum bed capacity for which it is issued. No person shall admit a patient or resident to a health facility if such admission would exceed the facility's licensed capacity. If the facility has the physical and staff capacity to meet an extra patient's or resident's needs, the Department may allow admission above the licensed capacity for a period up to one month if the patient or resident requires immediate admission and there is no convenient alternative source of admission, as determined by the Department. 2.3 APPLICATION. Any person or entity that opens, conducts, or maintains a health facility shall obtain a license or certificate of compliance as required in the regulations before accepting patients or residents for care or treatment. Each facility providing such care or treatment shall obtain a separate license. Each facility located upon a separate physical location shall obtain a separate license, except that facilities so located but which provide services as part of a single licensed facility type, taking into consideration boards of directors or applicable governing boards, medical staffs, administration, by-laws and articles of incorporation or governing documents, and are located within reasonable geographic proximity as determined by the Department; based upon such factors as, but not limited to, geographical barriers, usual and customary service areas, political boundaries, and standard metropolitan statistical areas, may operate under a single license. The burden of proving this exception shall be upon the applicant or facility. Applicants shall state on the application, the services provided and the locations of the services that are subject to the Department's authority to license and inspect health facilities. 2.3.1 Initial or renewal application shall be made on forms prescribed by and available from the Department. No license shall be issued until the applicant conforms to all applicable statutes and regulations. 2.3.2 Each application shall be signed under penalty of perjury by an authorized corporate officer, general partner, or sole proprietor of the applicant, as appropriate. 2.3.3 By-laws and Articles of Incorporation or Partnership Agreement, as appropriate, shall accompany the initial application. 2.3.4 The license fee established by law for operation of a health facility shall accompany the application. 2.3.5 An application for an initial license shall include the following information, updates as required by 2.4: (1) The name, address, and respective ownership

(a) The operator of the health facility, including administrators and management contractors; (b) Any person who, directly or indirectly, owns or controls five percent or more of the applicant; (c) Any person who, directly or indirectly, owns or controls five percent or more of the land on which the services are provided; (d) Any person who, directly or indirectly, owns or controls a five percent or more interest in the building in which the facility is located; (e) Any person who, directly or indirectly, owns five percent or more of any mortgage, note, deed of trust, or other obligation secured in whole or in part by the facility or any of the property or assets thereof; (f) Any person who, directly or indirectly, has any interest as lessor or lessee in any lease or sublease of the land on which or the building in which the facility is located; (2) The applicant's legal name and any other names under which it does business; (3) The following information, depending on the type of business entity applying: (a) If a partnership, the name, address, ownership share (expressed as a percentage), and legal status (general or limited) of each partner; (b) If a corporation, the address and ownership share of each shareholder who directly or indirectly owns or controls five percent or more of the shares of the corporation, and the name, address, and corporate title of each officer and director. In addition, the applicant shall file with the Department copies of all documents of incorporation filed with the Colorado Secretary of State; (c) If a sole proprietorship or any other form of business entity, the name, address, title, and ownership share (expressed as a percentage) of each person with a financial interest therein, and the name, address, and title of every person who controls, directs, or operates the business entity; (d) If the applicant is the lessee of the health facility, it shall furnish the information required in (a) through (c) for itself and the lessor. It shall also submit a copy of the relevant lease. (e) For purposes of these regulations, “indirect” ownership means any ownership interest in an entity that has an ownership interest in the applicant, including an ownership interest in any entity that has an indirect ownership interest in the applicant. (4) Each applicant shall furnish to the Department a signed statement at the time of application describing and dating every known proceeding in the United States within five years of the date of the application, in which the applicant, or any of its present shareholders owning an interest of five percent or more, officers, directors, partners, or other controlling or managing persons, was involved, the result of which was a limitation upon or a suspension, revocation, or refusal to grant or renew a health facility license, certification for Medicaid or Medicare or

other public health or social services payment program, or contract for participation in Medicaid or Medicare. (a) For purposes of these regulations, reportable proceedings include final agency action, whether or not such action has been stayed in a judicial appeal. (b) For purposes of these regulations, “known proceedings” means proceedings of which the applicant know or reasonably should have known. (c) For purposes of these regulations, “controlling or managing person” means a person or organization that exercises operational or managerial control over or who directly or indirectly conducts day-to-day operation of the entire facility. (5) Each applicant shall furnish a signed statement to the Department at the time of application, describing every known civil and criminal proceeding within five years of the date of the application in which the applicant or any of its present shareholders owning an interest of five percent or more, officers, directors, partners, or other controlling or managing persons, has sustained a civil judgment, or criminal conviction, or in which a guilty plea or nolo contendere plea has been accepted, involving conduct or an offense in the operation, management, or ownership of a health facility related to patient or resident care or fraud in a public health or social services payment program. (6) Each applicant shall furnish to the Department the information required in sections (3) through (5) with respect to any management company with which it contracts for management services for the facility. 2.4 CURRENT INFORMATION REQUIRED. Each licensee shall keep current all information required in sections 2.3.5(1) through (6) and shall report changes in the required information to the Department within thirty (30) days of the occurrence or of UK-date upon which the licensee reasonably should have known of the occurrence. 2.5 FITNESS INVESTIGATION. Upon receipt of a completed application for new license, renewal of license, or modification or change of licensure, the Department shall review the applicant's fitness (as defined in this subsection) and shall determine by on-site inspection or other appropriate investigation the applicant's compliance with applicable statutes and regulations. 2.5.1 The Department shall not approve an application for a new, renewed, modified, or changed license unless it has conducted an investigation of the fitness of the applicant. In determining fitness, the Department shall consider the following: (1) Whether the applicant has legal capacity demonstrated by such documents as articles of incorporation to provide the services for which the license is sought; (2) Whether the financial resources and sources of revenue for the specific facility of the applicant appear adequate to provide staff, services, and the physical environment sufficient to comply with state law and regulations; (3) Whether the applicant, its incorporators, officers, directors, partners;, owners or shareholders who, directly or indirectly, own or control five percent or more of the applicant, and any controlling or managing persons, including any management company or individual manager that manages the applicant, have the competence to establish, maintain, or operate a health facility. In so determining,

the Department may consider other pertinent evidence of competence and shall consider the following: (a) Compliance with all applicable standards such as state licensing and federal Medicare and Medicaid certification standards; (b) Health facility-related civil judgements, criminal convictions, or guilty or nolo contendere pleas, as specified in 2.3.5(5); (c) Adverse action, as specified in 2.3.5(4); and (d) Whether any person described in 2.5.1(3) has violated any provisions of state health law or the Departments's health and licensure regulations in any health facility within five years prior to the date of application. 2.6 LICENSEE NAME. Each health facility applying for a license shall be designated by a distinctive name and identified or held out to the public by one of the health facility categories requiring licensure. Each facility, regardless of the number of locations, when such locations conform to section 2.3 of these regulations, shall be identified by this distinctive name, using clearly visible signage at the location and on stationery and billing materials that identify the licensed facility name. In the case of common support services shared by more than one licensee, the name of the legal owner of the health facility licensees so supported shall be used to identify the service. Any facility shall notify the Department of any proposed name change. If the Department determines that such change would create confusion or misrepresentation to the public regarding the type of licensed facility or services it can provide or regarding the fitness of the licensee to conduct and maintain such facility, it may disapprove such name change. 2.7 MEETING LICENSURE DEFINITIONS. No facility shall create the impression that it is a health facility at any location unless it meets the legal definition of the health facility which it purports to be and is so licensed by the Department, or is part of a licensed health facility and conforms to the provisions of sections 2.3 and 2.6 of these regulations. 2.8 DISPLAY AND USE OF LICENSE. The license must be displayed in a conspicuous public place. Each license or certificate of compliance shall be valid only in the hands of the person to whom it is issued and shall not be subject to sale, assignment or other transfer, voluntary or involuntary, nor shall a license be valid for any premises other than those for which originally issued. 2.9 NOTICE OF CHANGES. At least thirty (30) days in advance of any of the following changes the holder of a license or certificate of compliance shall notify the Department and the new applicant shall file an application for a new license or certificate of compliance: 2.9.1 Change of ownership. (1) In the case of a partnership, transfer of ownership shall include dissolution of the partnership and conversion thereof into any other entity or the substitution or attempted substitution of one or more of the partners. But change of ownership docs not include dissolution of the partnership to form a corporation with the same persons retaining the same shares of ownership in the new corporation. For purposes of this subsection, “substitution” means any arrangement whereby a partner can participate in the management or administration of the partnership business or affairs. (2) Transfer of ownership of a sole proprietorship (any business owned by a single individual) shall include transfer of title to the business, whether or not title to real property is transferred to another person. But change of ownership docs not

include forming a corporation from the sole proprietorship with the proprietor as the sole shareholder. (3) Transfer of ownership of a corporation shall not, in itself, include transfer of corporate stock or merger of one or more corporations with the licensee surviving. Transfer of ownership of a corporation shall include consolidation of two or more corporations resulting in the creation of a new corporate entity, and except as provided in subsections (1) and (2) formation of a corportion from a partnership or a sole proprietorship. (4) Transfer of ownership of a licensee shall include a management contract, lease or any other arrangement where the current licensee retains no control of the operation or management of the facility or where the licensee is paid by the manager or lessee. 2.9.2 Change in name or address of the health facility; 2.9.3 Increase or decrease in licensed bed capacity; or 2.9.4 Change in licensure category. 2.10 PROVISIONAL LICENSE. If an facility fails to conform to the requirements of the law and regulations, the Department may refuse to issue a license but may issue a provisional license to allow the facility to comply with licensing requirements, if the applicant or licensee is making a substantial good faith attempt to comply with such requirements and requires such time to effect compliance. 2.10.1 The provisional license shall be valid for ninety (90) days. 2.10.2 The provisional license may be renewed once, if the applicant demonstrates to the Department that it has made further substantial progress toward compliance and can effect compliance within the following ninety (90) days. 2.10.3 The applicant shall pay the provisional license fee established by law. 2.10.4 Before determining whether to issue a permanent license to a provisionally licensed facility, the Department shall conduct a survey or such other investigation it deems necessary and shall find that the facility meets the requirements for licensure. 2.11 LICENSE TERM. Each license or certificate of compliance issued for the operation of a health facility shall expire after a period not longer than one year from the date issued unless earlier suspended or revoked, as provided by law and these licensure regulations or unless voluntarily surrendered by the licensee. 2.12 LICENSE RENEWAL APPLICATION.Each application for renewal of a license shall be submitted not less than sixty (60) days prior to expiration of the license and shall conform to all requirements in these regulations for applications for initial licenses except for the filing of duplicate information not amended during the applicable period. The applicant's failure to file timely its renewal application shall result in expiration of the current license on its last effective date. In such cases, the late renewal application shall in all respects be treated as an application for a new license. 2.13 INFORMATION REQUIREMENTS.Licensees shall provide upon request access to such patient or resident medical records as the Department shall reasonably require for the performance of its licensure and grievance functions. Licensees shall provide upon request access to or copies of reports and information required by the Department, including but not limited to, staffing reports, census data, statistical information, and such business records as the Department shall reasonably require for the

performance of its licensure and grievance functions. The Department shall not release to any unauthorized person any information defined as confidential under state law. 2.14 SURRENDER OF LICENSE.The holder of each license or certificate of compliance issued by the Department shall surrender the license or certificate immediately upon suspension, revocation, refusal to renew, or discontinuance of the operation of the health facility. 2.15 SUMMARY LICENSE SUSPENSION.Notwithstanding any other remedies available under state law, the Department may summarily suspend a license pending proceedings for revocation of or refusal to renew a license in cases of deliberate or willful violation of applicable statutes and regulations or where the public health, safety, or welfare imperatively requires emergency action. The summary suspension of any license shall be by order of the Executive Director of the Department or his authorized designee and shall comply with the requirements of C.R.S., 24-4-104, as amended. For purposes of this chapter, deliberate and willful conduct may be shown by either the existence of a pattern or practice of repeated, identical or similar violations or by intentional conduct. 2.16 FITNESS REVIEW.At any time upon reasonable cause, the Department may investigate an applicant's fitness to maintain or operate a facility and take appropriate action. 2.17 INFORMATION PROVIDED TO OTHER AGENCIES.If the Department has information about an applicant or licensee or its employees or managers gathered in the context of a department investigation and provides such information to any state or federal agency that is investigating the applicant or licensee, the Department shall also forward to such other agency any responses the licensee or applicant has made to allegations or charges that are contained in the information provided to such other agency. 2.18 DEPARTMENT INSPECTION.The Department and any duly authorized representatives thereof shall have the right to enter upon and into the premises of any licensee or applicant for a license in order to determine the state of compliance with the law and regulations, and shall initially identify themselves to the person in charge of the facility at the time. 2.19 HOURS OF INSPECTION.The Department shall perform its routine unannounced on-site surveys between 7:00 A.M. and 7:00 P.M. 2.20 LICENSURE FEES. Unless otherwise specified in either 6 CCR 1011-1 or the Colorado Revised Statutes, fees shall be assessed as follows:

Initial license Renewal license Conditional license Provisional license Change of ownership Change of facility name Change of address Change of beds

$360 $360 $360 $360 $360 $360 $360 $360

Part 3 - Quality Management 3.1 QUALITY MANAGEMENT PROGRAM.Every licensed or certified facility, except personal care boarding homes of nineteen beds or fewer and except, community residential homes for persons with developmental disabilities shall establish a quality management program appropriate to the size and type of facility that evaluates the quality of patient or resident care and safety, and that complies with this part 3.

3.1.1 Within 90 days of the effective date of this regulation for facilities licensed on the effective date of this regulation and within 90 days of the issuance of a license to a new facility, every facility defined in section 3.1 shall submit to the Department for its approval a plan for a quality management system that includes the following elements: (1) a general description of the types of cases, problems, or risks to be reviewed and criteria for identifying potential risks, including without limitation any incidents that may be required by Department regulations to be reported to the Department; (2) identification of the personnel or committees responsible for coordinating quality management activities and the means of reporting to the administrator or governing body of the facility. (3) a description of the method for systematically reporting information to a person designated by the facility within a prescribed time; (4) a description of the method for investigating and analyzing the frequency and causes of individual problems and patterns of problems; (5) a description of the methods for taking corrective action to address the problems, including prevention and minimizing problems or risks; (6) a description of the method for the follow-up of corrective action to determine the effectiveness of such action; (7) a description of the method for coordinating all pertinent case, problem, or risk review information with other applicable quality assurance and/or risk management activities, such as procedures for granting staff or clinical privileges; review of patient or resident care; review of staff or employee conduct; the patient grievance system; and education and training programs; (8) documentation of required quality management activities, including cases, problems, or risks identified for review; findings of investigations; and any actions taken to address problems or risks; and (9) a schedule for plan implementation not to exceed 90 days after the date the facility receives written notice of the Department's approval of the plan. 3.1.2 If upon review of the facility's plan, the Department finds that it does not meet the requirements of these regulations, the Department shall return it to the facility along with the specific reasons for disapproval and establish a reasonable date for resubmittal of a revised plan meeting the requirements of these regulations. 3.1.3 In lieu of requiring the submission of an entire plan for a quality management program as required under section 3.1.1, the Department may accept documented evidence of compliance with any or all applicable standards of the Joint Commission on Accreditation of Health Care Organizations, Medicare conditions of participation, or other acceptable standards regarding risk management and quality assurance functions. The Department may accept submission of all or part of a plan or appropriate documentation regarding any or all elements required in section 3.1.1. 3.1.4 Any facility that makes a permanent and substantive change in its quality management plan shall submit a description of the change to the Department prior to implementation. The Department shall notify the facility if it determines that such change does not meet the requirements of these regulations along with the specific reasons therefor.

3.1.5 The Department may audit the quality management program to determine its compliance with the approved plan. (1) If the Department determines that an investigation of any incident or patient or resident outcome is necessary, it may, unless otherwise prohibited by law, investigate and review relevant documents to determine actions taken by the facility. (2) This section shall be effective June 1, 1988. 3.2 Reporting.Notwithstanding any other reporting required by state law or regulation, each health facility shall report to the Department the occurrences specified at 25-1-124 (2) C.R.S. 3.2.1 The following occurrences shall be reported to the department by telephone by the next business day after the occurrence or the facility becomes aware of the occurrence: (1) Any occurrence that results in the death of a patient or resident of the facility and is required to be reported to the coroner pursuant to section 3-10-606, C.R.S., as arising from an unexplained cause or under suspicious circumstances; (2) Any occurrence that results in any of the following serious injuries to a patient or resident: (a) Brain or spinal cord injuries; (b) Life-threatening complications of anesthesia or life-threatening transfusion errors or reactions; (c) Second or third degree burns involving twenty percent or more the body surface area of an adult patient or resident or fifteen percent or more of the body surface area of a child patient or resident; (3) Any time that a resident or patient of the facility cannot be located following a search of the facility, the facility grounds, and the area surrounding the facility and there are circumstances that place the resident's health, safety, or welfare at risk or, regardless of whether such circumstances exist, the patient or resident has been missing for eight hours; (4) Any occurrence involving physical, sexual, or verbal abuse of a patient or resident, as described in section 18-3-202, 18-3-203, 18-3-204, 18-3-206, 18-3-402, 18-3403, 18-3-404, or 18-3-405, C.R.S., by another patient or resident, an employee of the facility or a visitor to the facility, (5) Any occurrence involving neglect of a patient or resident, as described in section 263.1-101 (4)(b) C.R.S.; (6) Any occurrence involving misappropriation of a patient's or resident's property. For purposes of this paragraph (f), “misappropriation of a patient's or resident's property” means a pattern of or deliberately misplacing, exploiting, or wrongfully using, either temporarily or permanently, a patient's or resident's belongings or money without the patient's or resident's consent. (7) Any occurrence in which drugs intended for use by patients or residents are diverted to use by other persons; and

(8) Any occurrence involving the malfunction or intentional or accidental misuse of patient or resident care equipment that occurs during treatment or diagnosis of a patient or resident and that significantly adversely affects or if not averted would have significantly adversely affected a patient or resident of the facility. 3.2.2 Any reports submitted shall be strictly confidential in accordance with and pursuant to 25-1124 (4),(5), and (6) C.R.S. 3.2.3 (not used) 3.2.4 The department may request further oral reports or a written report of the occurrence if it determines a report is necessary for the department's further investigation. 3.2.5 Every health facility shall have a policy that defines the deaths reportable to the local county coroner under 30-10-606(1), C.R.S. (1977) and that is consistent with the local coroner's reporting policy. 3.2.6 Every health facility shall have a policy for requiring its employees to report occurrences to it. 3.2.7 No health facility or officer or employee thereof shall discharge or in any manner discriminate or retaliate against any patient or resident of a facility, relative or sponsor thereof, employee of the facility, or any other person because such person, relative, legal representative, sponsor, or employee has made in good faith or is about to make in good faith, a report pursuant to this section 3.2 or has provided in good faith or is about to provide in good faith evidence in any proceeding or investigation relating to any occurrence required to be reported by a health facility. 3.2.9 The department shall investigate all reports made to it under this part, and make a summary report. (1) Such report shall include: (a) a summary of finding(s) including the department's conclusion(s); (b) whether any violation of licensing standards was noted or whether a deficiency notice was issued; (c) whether the facility acted appropriately in response to the occurrence, and (d) if the investigation was not conducted on site, how the investigation was conducted. (2) A summary report shall not identify a patient, resident or health care professional. (3) In response to an inquiry, the department may confirm that it has obtained a report concerning the occurrence and that an investigation is pending. (4) Prior to releasing a summary report that identifies a health facility, the department shall notify the facility and provide to it a copy of the summary report. The facility shall be allowed seven days to review, comment, and verify such information. If immediate release of information is necessary and the department cannot provide at least prior oral notice to the facility identified, it shall provide notice as soon as reasonably possible and shall explain why it could not provide prior notice. 3.2.10 Nothing in this part 3 shall be construed to limit or modify any statutory or common law right, privilege, confidentiality or immunity. 3.2.11 Nothing in this part shall affect a person's access to his or her medical record as provided in section 25-1-801, nor shall it affect the right of a family member or any other person to obtain

medical record information upon the consent of the patient or his/her authorized representative. PART 4 - WAIVER OF REGULATIONS FOR HEALTH FACILITIES 4.101 Statutory Authority, Applicability and Scope (l) This Part 4 is promulgated by the State Board of Health pursuant to Section 25-1-108(l)(c), C.R.S., in accordance with the general licensing authority of the Department as set forth in Section 25-l-107(l)(l)(I), C.R.S. (2) This Part 4 applies to health facilities licensed by the Department and establishes procedures with respect to waiver of regulations relating to state licensing and federal certification of health facilities. (3) Nothing contained in these provisions abrogates the Applicant's obligation to meet minimum requirements under local safety, fire, electrical, building, zoning, and similar codes. (4) Nothing herein shall be deemed to authorize a waiver of any statutory requirement under state or federal law, except to the extent permitted therein. (5) It is the policy of the State Board of Health and the Department that every licensed health facility complies in all respects with applicable regulations. Upon application to the Department, a waiver may be granted in accordance with this Part 4, generally for a limited term. Absent the existence of a current waiver issued pursuant to this part, facilities are expected to comply at all times with all applicable regulations. 4.102 Definitions For This Part 4 (1) “Applicant” means a current health facility licensee, or an applicant for federal certification or for an initial license to operate a health facility in the state of Colorado. (2) “Board” means the State Board of Health. (3) “Department” means the Colorado Department of Public Health and Environment. (4) “Facility” means a health facility licensed pursuant to Sections 25-1-107 (1)(1)(I) and 25-3102, C.R.S., and/or certified pursuant to federal regulations to participate in a federally funded health care program. (5) “Regulation(s)” means: (a) Any state regulation promulgated by the Board relating to standards for operation or licensure of a Facility, or (b) Any federal regulation pertaining to certification of a Facility, but only when final authority for waiver of such federal regulation is vested in the Department. “Regulation(s)” includes the terms “standard(s)” and “rule(s).” 4.103 Application Procedure (1) General Waiver applications shall be submitted to the Department on the form and in the manner required by the Department. (a) Only one Regulation per waiver application will be considered.

(b) The Applicant shall provide the Department such information and documentation as the Department may require to validate the conditions under which the waiver is being sought. (c) The application must include the Applicant's name and specify' the Regulation that is the subject of the application, identified by its citation. (d) The application must be signed by an authorized representative of the Applicant, who shall be the primary contact person for the Department and the individual responsible for ensuring that accurate and complete information is provided to the Department. (2) At a minimum, each waiver application shall include the following: (a) A copy of the notice required to be posted pursuant to Section 4.103(4); (b) If the waiver application pertains to building requirements, schematic drawings of the areas affected and a description of the effect of the requested waiver on the total Facility; (c) A description of the programs or services offered by the Facility that are anticipated to be affected by the waiver; (d) A description of the number of residents or patients in the Facility and the level of care they require; (e) A description of the nature and extent of the Applicant's efforts to comply with the Regulation; (f) An explanation of the Applicant's proposed alternative(s) to meet the intent of the Regulation that is the subject of the waiver application; (g) An explanation of why granting the waiver would not adversely affect the health, safety or welfare of the Facility's residents or patients; (h) If the waiver is being sought for state Regulation, a description of how any applicable federal Regulation similar to the state Regulation for which the waiver is sought (if any) is being met. (3) A waiver application shall address the following matters, to the extent applicable or relevant: (a) Staffing considerations, such as staff/resident or patient ratios, staffing patterns, scope of staff training, and cost of extra or alternate staffing; (b) The location and number of ambulatory and non-ambulatory residents or patients; (c) The decision-making capacity of the residents or patients; (d) Recommendations of attending physicians and other care-givers; (e) The extent and duration of the disruption of normal use of resident or patient areas to bring the Facility into compliance with the Regulation; (f) Life safety code factors, including but not limited to:

(i) The availability and adequacy of areas safe from fire and smoke to hold residents or patients during a fire emergency; (ii) Smoking regulations; (iii) Fire emergency plan; (iv) The availability, extent and types of automatic fire detection and fire extinguishment systems provided in the Facility; (v) The ability to promptly notify, and availability of. the fire department; (g) Financial factors, including but not limited to: (i) The estimated cost of complying with the Regulation, including capital expenditures and any other associated costs, such as moving residents or patients; (ii) How application of the Regulation would create a demonstrated financial hardship on the Facility that would jeopardize its ability to deliver necessary health care services to residents or patients; (iii) The availability of financing to implement the Regulation, including financing costs, repayment requirements, if any, and any financing or operating restrictions that may impede delivery of health care to residents or patients; and (iv) The potential increase in the cost of care to residents or patients as a result of implementation of the Regulation. (h) Why waiver of the Regulation is necessary for specific Facility programs to meet specific patient or resident needs, and why other patient or resident needs are not thereby jeopardized. (4) Notice and Opportunity to Comment on Application (a) No later than the date of submitting the waiver application to the Department, the Applicant shall post notice of the application and a meaningful description of the substance of the waiver request at all public entrances to the Facility, as well as in at least one area commonly used by patients or residents, such as a waiting room, lounge, or dining room. The notice must reflect the date of posting, and indicate that an application for a waiver has been made and that a copy of the waiver application shall be provided by the Facility upon request. (b) The notice must also indicate that any person interested in commenting on the waiver application may forward written comments directly to the Department at the following address: CDPHE - HFD, A2 - Waiver Program4300 Cherry Creek Drive SouthDenver, CO 80246. (c) The notice must specify that written comments from interested persons must be submitted to the Department within thirty (30) calendar days of the date the notice is posted by the Applicant, and that persons wishing to be notified of the Department's action on the waiver application may submit to the Department at the above address a written request for notification and a self-addressed

stamped envelope. 4.104 Department Action Regarding Waiver Application (1) General Upon an Applicant's submission of a completed waiver application to the Department, a waiver of a particular Regulation with respect to a Facility may be granted in accordance with this Part 4. (2) Decision on Waiver Application (a) In acting on a waiver application, the Department shall consider: (i) The information submitted by the Applicant; (ii) The information timely submitted by interested persons, pursuant to Section 4.103 (4); and (iii) Whether granting the waiver would adversely affect the health. safety or welfare of the Facility's residents or patients. (b) In making its determination, the Department may also consider any other information it deems relevant, including but not limited to occurrence and complaint investigation reports, and licensure or certification survey reports and findings related to the Facility and/or the operator or owner thereof. (c) The Department shall act on a waiver application within ninety (90) calendar days of receipt of the completed application. An application shall not be deemed complete until such time as the Applicant has provided all information and documentation requested by the Department. (3) Terms and conditions of the waiver.The Department may specify' terms and conditions under which any waiver is granted, which terms and conditions must be met in order for the waiver to remain effective. 4.105 Termination, Expiration and Revocation of Waiver (1) General.The term for which each waiver granted will remain effective shall be specified at the time of issuance. (a) The term of any waiver shall not exceed any time limit set forth in applicable state or federal law. (b) At any time, upon reasonable cause, the Department may review any existing waiver to ensure that the terms and conditions of the waiver arc being observed, and/or that the continued existence of the waiver is otherwise appropriate. (c) Within thirty (30) calendar days of the termination, expiration or revocation of a waiver, the Applicant shall submit to the Department an attestation, in the form required by the Department, of compliance with the Regulation to which the waiver pertained. (2) Termination (a) Change of Ownership. A waiver shall automatically terminate upon a change of ownership of the Facility, as defined in Section 2.9.1 of Pan 2, Chapter II of these

Regulations. However, to prevent such automatic termination, the prospective new owner may submit a waiver application to the Department prior to the effective date of the change of ownership. Provided the Department receives the new application by this date, the waiver will be deemed to remain effective until such time as the Department acts on the application. (3) Expiration (a) Except as otherwise provided in this Part 4, no waiver shall be granted for a term that exceeds one year from the date of issuance. (b) A waiver with a term in excess of one year may be granted for Regulations pertaining to state building or fire safety Regulations, or in other specific cases where it is determined a longer term is appropriate. (c) If an Applicant wishes to maintain a waiver beyond the stated term, it must submit a new waiver application to the Department not less than ninety (90) calendar days prior to the expiration of the current term of the waiver. (4) Revocation (a) Notwithstanding anything in this Pan 4 to the contrary, the Department may revoke a waiver if it determines that: (i) The waiver's continuation jeopardizes the health, safety, or welfare of residents or patients; (ii) The Applicant has provided false or misleading information in the waiver application; (iii) The Applicant has failed to comply with the terms and conditions of the waiver; (iv) The conditions under which a waiver was granted no longer exist or have changed materially; or (v) A change in a federal or state law or Regulation prohibits, or is inconsistent with, the continuation of the waiver. (b) Notice of the revocation of a waiver shall be provided to the Applicant in accordance with the Colorado Administrative Procedures Act, Section 24-4-101 et seq., C.R.S. 4.106 Waiver of Building and Fire Safety Regulations for Skilled and Intermediate Health Facilities (1) Notwithstanding anything in this Part 4 to the contrary, an application for waiver of building or fire safety Regulations promulgated by the Board that is submitted with respect to a Facility that is a skilled or intermediate health care Facility shall be reviewed and acted upon in accordance with this Section 4.106. To the extent they do not conflict with the express provisions of this Section 4.106, the remaining provisions of this Part 4 shall also apply to this type of waiver application. (2) A waiver application described in Section 4.106(1) shall be submitted to the Department and notice thereof shall be posted in accordance with Section 4.103. The application must address those matters set forth in Section 4.103(2) and Sections 4.103(3) (f) and (g).

Other matters described in Section 4.103(3) may also be addressed, as appropriate. (3) The Department shall review the application in accordance with Section 4.104(2), and shall make a recommendation to the Board within ninety (90) calendar days of receipt of the complete application as to whether or not the requested waiver should be granted. (a) The Department may recommend granting a waiver only upon finding that: (i) Rigid application of the Regulation would result in demonstrated financial hardship to the Facility, and (ii) Granting the requested waiver would not adversely affect the health and safety of the Facility's residents or patients. (b) The Department's recommendation shall include the term of the waiver and any terms and conditions for issuance thereof. (4) The Department's recommendation to the Board on any waiver application subject to this Section 4.106 shall be in writing and shall include the following: (a) A statement of the Department's recommendation, including the required findings described in Section 4.106(3)(a) and a general statement of the basis for the recommendation; and (b) A list of the documents and other information reviewed by the Department in preparing its recommendation, which documents shall be made available to the Board for review upon request. (5) The Board shall review and act upon the Department's recommendation at its next regularly scheduled meeting, or as soon as reasonably possible thereafter. The Department shall provide the Applicant notice of the Board's action, and if the waiver is approved, shall issue the waiver in accordance with the direction of the Board. (6) The Department shall be responsible for monitoring any waiver approved by the Board pursuant to this Section 4.106 and, at the Board's request, shall provide periodic reports to the Board concerning the status thereof. Such waivers shall be subject to the provisions of Section 4.105 concerning termination, expiration and revocation; provided, however, that the Department's action to revoke a waiver pursuant to Section 4.105(4)(a) shall be subject to the Board's prior approval. 4.107 Appeal Rights (1) An Applicant may appeal the decision of the Department or the Board regarding a waiver application or revocation as provided in the Colorado Administrative Procedures Act, Section 24-4-101 et seq., C.R.S. STANDARDS 5 ACCESS TO PATIENT MEDICAL RECORDS 5.0 It is the intent of the legislature and these regulations that persons who have been treated by health care facilities or individual providers have access to their medical records in order to take more complete responsibility for their own health and to improve their communication with health care providers. 5.1 DEFINITIONS 5.1.1 PATIENT - A patient is any individual admitted to or treated in a health facility defined in 5.2

or treated by any of the providers defined in 5.3. 5.1.2 PATIENT RECORD - A patient record is a documentation of services pertaining to medical and health care that are performed at the direction of a physician or other licensed health care provider on behalf of the patient by physicians/dentists, nurses, technicians and other health care personnel. Patient records include such diagnostic documentation as X-rays and EKG's. Patient records do not include doctors' office notes, which are the notes by-a physician of observations about the patient made while the patient is in a non-hospital setting and maintained in the physician's office 5.1.3 ATTENDING HEALTH CARE PROVIDER - An attending health care provider is the physician currently or most recently responsible for coordinating the patient's care in a facility, or in the case of outpatient services, is the custodian of the record of the outpatient service. If the attending health care provider is deceased or unavailable, the current custodian of the record shall designate a substitute attending health care provider for purposes of compliance with these regulations. 5.1.4 DESIGNATED REPRESENTATIVE - A designated representative of a patient or attending health care provider is a person so authorized in writing or by court order to act on behalf of the patient or attending health care provider. In the case of a deceased patient, the personal representative or, if none has been appointed, heirs shall be deemed to be designated representatives of the patient. 5.2 FACILITY RECORDS. 5.2.1 Except as hereinafter provided, patient records in the custody of health facilities required to be certified under section 25-l-107(l)(I),(II) or licensed under Part 1 of Article 3 of Title 25 of the C.R.S. shall be available to a patient or his/her designated representative through the attending health care provider or his/her designated representative at reasonable times and upon reasonable notice. 5.2.2 Inpatient Records 5.2.2.1 While an inpatient in a facility described in 5.2.1, a person may inspect his/her patient record within a reasonable time, which should normally not exceed 24 hours of request (excluding weekends and holidays). The patient or designated representative shall sign and date the request. The attending health care provider or his/her designated representative shall acknowledge in writing the patient's or representative's request. After inspection, the patient or designated representative shall sign and date the patient record to acknowledge inspection. 5.2.2.2 The patient or designated representative shall not be charged for inspection. 5.2.2.3 If the attending health care provider feels that any portion of the patient record pertaining to psychiatric or psychological problems or any doctor's notes would have a significant negative psychological impact upon the patient, the attending health care provider shall so indicate on his/her acknowledgment of the patient's or representative's request to inspect the patient record. The attending health care provider or his/her designated representative shall so inform the patient or representative within a reasonable time, normally not to exceed 24 hours, excluding holidays and weekends. The facility shall permit inspection of the remaining portions or the patient record. The portion of the patient record pertaining to psychiatric or psychological problems or doctor's notes may then be withheld from the patient or representative until completion of the treatment program, if in the opinion of an independent third party who is a licensed physician practicing psychiatry, the portion of the record would have a significant negative

psychological impact upon the patient. The Department of Public Health and Environment, upon request of either the patient or the attending health care provider, shall identify an independent third party psychiatrist to review the record and render a final decision. If the record or a portion thereof pertaining to psychiatric or psychological problems or doctor's note having a significant negative psychological impact is withheld from the patient, a summary thereof prepared by the attending health care provider may be available following termination of the treatment program, upon written, signed and dated request by the patient or his/her designated representative, without the necessity of further consultation with an independent third party. 5.2.2.4 A statement setting forth the requirements of 5.2 of these regulations, the facility's procedures for obtaining records, and the right to appeal grievances regarding access to records to the Department of Public Health and Environment shall be posted in conspicuous public places on the premises and made available to each patient upon admission to the facility. 5.2.3 Discharged Inpatient Record 5.2.3.1 A discharged inpatient or his/her designated representative may inspect or obtain a copy of his/her record after submitting a signed and dated request to the facility. The attending health care provider or his/her designated representative shall acknowledge in writing the patient's or representative's request. After inspection, the patient or designated representative shall sign and date the record to acknowledge inspection. 5.2.3.2 The facility shall make a copy of the record available or make the record available for inspection within a reasonable time, from the date of the signed request, normally not to exceed ten days, excluding weekends and holidays, unless the attending health care provider or designated representative is unavailable to acknowledge the request, in which case the facility shall so inform the patient and provide the patient record as soon as possible. 5.2.3.3 Discharged patients or their representatives shall not be charged for inspection of patient records. 5.2.3.4 Unless otherwise prohibited by law, a representative of the patient, other than a “personal representative” as defined in the Federal Health Insurance Portability and Accountability Act (HIPAA) § 164.502(g), with the patient’s written authorization, shall pay for the reasonable cost of obtaining a copy of the patient’s record, which shall be $16.50 for the first ten or fewer pages, $.75 per page for pages 11-40, and $.50 per page for every additional page. The discharged patient or personal representative (as defined under HIPAA § 164.502(g)) shall pay for the reasonable cost of obtaining a copy of his/her patient record, not to exceed $14.00 for the first ten or fewer pages, $.50 per page for pages 11-40, and $.33 per page for every additional page. Actual postage or shipping costs and applicable sales tax, if any, also may be charged. The per-page fee for records copied from microfilm shall be $1.50 per page. No fees shall be charged by a health care provider of patient records for requests for medical records received from another health care provider or to an individual regulated pursuant to Section 25-1-802(1) solely for the purpose of providing continuing medical care to a patient. For one or more specific classes of records or services, institutions may charge additional sums upon presenting a justification therefor acceptable to the Department.

5.2.3.5 If the patient or the patient's designated representative so approves, the facility may supply a written interpretation by the attending health care provider or his/her designated representative of records, such as X-rays, which cannot be reproduced without special equipment. If the requestor prefers to obtain a copy of such records, he/she must pay the actual cost of such reproduction. 5.2.3.6 If the attending health care provider feels that any portion of the patient record pertaining to psychiatric or psychological problems or any doctor's notes would have a significant negative psychological impact upon the patient, the attending health care provider shall so indicate on his/her acknowledgment of the patient's or representative's request to inspect or obtain a copy of the patient's record. The attending health care provider or his/her designated representative shall so inform the patient or representative within a reasonable time of the date of the request, normally not to exceed five days, excluding weekends and holidays. The facility shall permit inspection or provide a copy of the remaining portion of the record within that time. The portion of the patient record pertaining to psychiatric or psychological problems may then be withheld from the patient or representative until completion of the treatment program if, in the opinion of an independent third party who is a licensed physician practicing psychiatry, the portion of the patient record would have a significant negative psychological impact upon the patient. The Department of Public Health and Environment, upon request of either the patient or the attending health care provider, shall identify an independent third party psychiatrist to review the record and render a final decision. If the patient record or a portion thereof pertaining to psychiatric or psychological problems or doctor's note having a significant negative psychological impact is withheld from the patient, a summary thereof prepared by the attending health care provider may be available following termination of the treatment program, upon written, signed and dated request by the patient or his/her designated representative, without the necessity of further consultation with an independent third party. 5.2.4 Nothing in this section shall apply to any nursing facility conducted by or for the adherents of any well-recognized church or religious denomination for the purpose of providing facilities for the care and treatment of the sick who depend exclusively upon spiritual means through prayer for healing and the practice of the religion of such church or denomination. 5.2.5 Facilities licensed by the Department of Public Health and Environment shall submit to the Department a copy of their policy and procedure to comply with this regulation and all forms used to implement it, and shall promptly submit to the Department any future amendments to such policies and procedures. 5.2.6 EMERGENCY ROOM RECORDS. Patient records in the custody of emergency rooms of facilities described in 5.2.1 shall be available to patients or their designated representatives as provided in 5.2. 5.2.7 If any changes/corrections, deletions, or other modifications are made to any portion of a patient record, the person must note in the record the date, time, nature, reason, correction, deletion, or other modification, his/her name and the name of a witness, to the change, correction, deletion or other modification. 5.4 EFFECT OF THIS PART 5 ON SIMILAR RIGHTS OF A PATIENT 5.4.1 Nothing in this Part 5 shall be construed so as to limit the right of a patient or his designated representative to inspect the patient's medical or psychological data pursuant to section 24-72-204 (3)(1), C.R.S. 1973.

5.4.2 Nothing in this Part 5 shall be construed as to limit a right to inspect patient records which is otherwise granted by state statute to the patient or his designated representative. 5.4.3 Nothing in this Part 5 shall be construed to require aperson responsible for the diagnosis or treatment of venereal diseases or addiction to or use of drugs in the case of minors/pursuant to sections 25-4-402 (4) and 13-22-102, C.P.S. 1973, to release patient records of such diagnosis or treatment to a parent, guardian, or person other than the minor or his designated representative. 5.4.4 Nothing in this Part 5 shall be construed to waive the responsibility of a custodian of medical records in facilities to maintain confidentiality of those records in its possession. 6 PATIENT GRIEVANCE MECHANISM AND FACILITY'S OBLIGATIONS TO THE PATIENT 6.1 APPLICABILITY.(This section is applicable to general hospitals, psychiatric hospitals, rehabilitation hospitals, chiropractic centers, maternity hospitals and related facilities having in excess of fifty beds except for nursing -facilities conducted by or for the adherents of any well-recognized church or religious denominations for the purpose of providing for the care and treatment of the sick who depend exclusively upon spiritual means through prayer for healing in the practice of the religion of such church or denomination, nursing care facilities, and intermediate health care facilities which are subject to the provisions of C.R.S. 25-1-120 as amended.) 6.2 PLAN SUBMISSION.Each facility meeting the above applicability clause shall submit to the Health Facilities-Division, Colorado Department of Public Health and Environment, for approval, a plan for a grievance mechanism and a policy statement with respect to the obligations of the facility to patients using the facilities of such facility. 6.3 DEFINITIONS 6.3.1 Admission: The acceptance of a person as a patient and for whom a record of treatment is instituted, whether on an inpatient or outpatient basis. 6.3.2 Grievance Mechanism: The established procedure whereby complaints by patients nay be initiated and resolved. 6.3.3 Patient: A person accepted on either an inpatient or outpatient: basis. Where a patient is incompetent or unable to act or. his or her own behalf, such interest devolves on the next of kin or legal guardian, if possible. 6.3.4 Patient Representative: The person or persons designated by each facility to function as the primary contact to receive complaints from patients regarding facility services. 6.3.5 Chief Executive Officer: The person appointed by the governing body who is responsible for the continuous management of the facility. The chief executive officer shall authorize an individual to act for him in an absence which would preclude ful-fillment of the regulations in a timely manner. 6.4 The patient grievance mechanism plan shall include but not be limited to the following: 6.4.1 A provision for a patient representative to serve as a liaison between the patient and the facility. 6.4.2 A description, of the qualifications of the patient representative. 6.4.3 An outline of the job description of the patient representative.

6.4.4 A description of the amount of decision-making authority given to the patient representative. 6.4.5 A method by which each patient will be made aware of the patient representative program and how the representative of the program may be contacted. 6.4.6 Provision for informing patients that every effort will be made to translate the grievance procedure into the language of the patient if the patient does not understand or is unable to read English. 6.4.7 A means to inform the patient that the facility encourages patients to speak out and to present grievances without fear of retribution. 6.4.8 Provision for inclusion in new employee orientation programs of a briefing on the facility's grievance procedure and at least annually transmission of information to all staff members who have direct patient contact covering the grievance mechanism. 6.5 GRIEVANCE PROCEDURE 6.5.1 The facility grievance mechanism will be so designed as to provide for the submission of grievances by patients, orally and in writing, to the patient representative. 6.5.2 To insure prompt action, the grievance mechanism will provide that a grievance may be submitted to a staff member at any time, 24 hours per day, and that the grievance will be submitted to the patient representative by the next working day. 6.5.3 Complaints that cannot be resolved by the patient representative shall be referred to the facility chief executive officer or his designee immediately, but in any event no later than three days after receipt of the report of the patient representative to the patient. The chief executive officer or his designee shall cause an additional investigation to be made and provide results of his investigation to the complainant within seven days. 6.5.4 If the complainant is dissatisfied with the report of the facility chief executive officer, the complainant shall be informed that the problem may be referred in writing to the Executive Director, Colorado Department of Health, by the patient representative if requested by complainant. The complainant shall also be notified by the patient representative that the complainant may refer the matter to the Executive Director as well. 6.5.5 Upon receipt of the complaint, the Colorado Department of Public Health and Environment shall, within seven days, notify the complaint and the facility that an investigation has been initiated and a report in writing will be made to the complainant and to the facility as to its findings and/or recommendations within fourteen days after notification. 6.6 Policy Statement (A) In addition to any posting requirements under this part of the regulations, each facility shall make available, upon admission, a disclosure of its policy statement on patient rights pursuant to 25-1-121(4), C.R.S. And this part 6 of the regulations. The disclosure shall be made available through the use of an appropriate communication medium and in a manner understood by the patient, or the patient's legal representative. For any patient care or treatment course requiring multiple patient encounters, disclosure provided at the beginning of such care or treatment course shall meet the intent of the regulations. 6.6.1 The policy statement shall include, at least, the following explanations: 6.6.6.1 The physician's, dentist's, or podiatrist's duty to obtain informed consent.

(A) The explanation of the physician's, dentist's, or podiatrist's duty in the policy statement shall include at a minimum the following information: (1) the right of the patient or the patient's legal representative to give informed consent for all treatment and procedures consistent with other state and federal statutes. (B) For the purposes of this regulation, the term, “informed consent,” shall include, but not be limited to, the following: (1) an explanation of the recommended treatment or procedure in layman's terms and in a form of communication understood by the patient or the patient's legal representative; (2) an explanation of the risks and benefits of a treatment or procedure; the probability of success, mortality risks, and serious side effects; (3) an explanation of the alternatives with the risks and benefits of these alternatives; (4) an explanation of the probable or likely consequences if no treatment is pursued; (5) an explanation of the recuperative period which includes a discussion of anticipated problems and the anticipated length of the recuperative period; (6) an explanation that the patient, or the patient's legal representative, is free to withdraw his or her consent and to discontinue participation in the treatment regimen; and (7) an explanation to the patient, or patient's legal representative, if the patient's physician, dentist, or podiatrist is participating in teaching programs and/or in research, and experimental or educational projects relating to the patient's own case. 6.6.1.2 Admission procedures. (A) The explanation of admission procedures shall include disclosure to each patient or patient's legal representative, regarding the facility's policy statement on patient rights upon admission for care or treatment consistent with paragraph 6.6.(A). (B) The policy statement providing the explanation of a patient's rights shall, in addition to patient rights in the other subsections of this part 6, include, but not be limited to, the following: (1) the right to participate in all decisions involving the patient's care or treatment consistent with other state and federal statutes; (2) the right to refuse any drug, test, procedure, or treatment consistent with other state and federal statutes; and to be informed of the probable or likely medical consequences of this action;

(3) the right to be informed of the facility's rules and regulations as they apply to the patient; (4) the right to be informed of the facility's grievance procedure. 6.6.1.3 Staff identification (how different staff members are identified; i.e., uniforms, badges, etc.) (A) The policy statement shall also inform the patient or the patient's legal representative of the right to know the names, professional status, and experience of the staff that are providing care or treatment to the patient. 6.6.1.4 Privacy concerning medical treatment and care. (A) The policy statement shall also inform the patient or the patient's legal representative of the right to care or treatment that is respectful, recognizes a person's dignity, and provides for personal privacy to the extent possible during the course of treatment. 6.6.1.5 Medical records will be maintained in confidence and in accordance with medical staff bylaws, rules and regulations. The right of patient access will be specified pursuant to 25-1-801, C.R.S., et. seq. And consistent with part 5 of this chapter II of the regulations. 6.6.1.6 Billing procedures. (A) The patient, or the patient's legal representative, has the right to be informed upon request, prior to the initiation of care or treatment, that is nonemergent of the charge(s) for service(s) that is routine, usual, and customary; or the estimated charge(s) for service(s) based upon an average patient with a diagnosis similar to the tentative or preliminary admission diagnosis of the patient being admitted; and, based upon insurance information supplied by the patient, to be given assistance on obtaining an estimate of any co-payment, deductible, or other charges that will not be covered by a third party payer and must be paid by the patient. The patient, or the patient's legal representative, has the right to be informed prior to the initiation of care or treatment, of the facility's general billing procedures. A facility may include a disclaimer with the disclosure of any charges. Such disclaimer may include further information on variables which may alter any disclosed charge. If charges to the patient are prohibited by law or by third party payer contract, then a disclaimer of no charge shall meet the requirements of this paragraph. 6.6.1.7 The facility shall provide information to the patient, or the patient's legal representative, if the facility or the patient's physician, dentist, or podiatrist is participating in teaching programs and/or in research, experimental, or educational projects relating to the patient's own case. 6.6.2 The policy statement, with respect to the obligations of the facility to patients, shall be conspicuously posted in a public place on the premises of the facility preferably in, but not limited to, the admissions area. 6.6.3 Each facility shall adhere to, treat, and provide services to patients in accordance with, the provisions of the facility's policy statement.

6.7 The grievance plan and performance of the facility thereunder shall be approved by the Colorado Department of Public Health and Environment prior to certification of compliance or issuance or renewal of a license. The Department shall notify the facility as to the acceptance or rejection of its plan within fourteen days of receipt. If unacceptable, the Department shall provide a detailed written statement of the reasons for the plan's unacceptability and suggested changes. 6.8 Each facility shall post notice, in a conspicuous place in the facility, of the existence of its internal grievance procedure. The notice shall also inform patients, or their legal representatives, that if still dissatisfied with physician, dental, or podiatric patient care services, excluding fee disputes, a complaint may be filed with the Colorado State Board of Medical Examiners, the State Board of Dental Examiners, and the Colorado Podiatry Board. Upon request, the facility shall provide the patient, or the patient's legal representative, with the address of the appropriate board and inform such person that these boards are prohibited from arbitrating or adjudicating fee disputes between licensees or between a licensee and -any other party, pursuant to sections 12-36-104.5, 12-35-107.5, and 12-32-104.5, C.R.S. (A) A facility may post such notice in a manner that is conducive to a positive customer relations approach as long as the above provisions are incorporated in a manner that is consistent with the intent of the regulation. 7 SINGLE USE DISPOSABLE MEDICAL DEVICES 7.1 Applicability. This section is applicable to all health facilities licensed by the Department. 7.2 Basis and Purpose. Statutory authority for adoption of these regulations is C.R.S. 1973, 25-1-107(1) (1)(I) and 25-1-108(1)(c)(I). The regualtions are proposed to control the re-use of single-use or disposable medical devices. Without such regulations, the public health safety may be jeopardized. 7.3 Definitions: 7.3.1 A medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in-vitro reagent or other similar or related article intended for use in the diagnosis of disease or in the cure, mitigation, treatment or prevention of disease.” Examples are cardiac pacemakers, glass clinical thermometers, catheters, cardiac guidewires, renal dialyzers, etc. 7.3.2 A single-use or disposable medical device is one labeled as such by the manufacturer, or one in which a caution is included in the accompanying literature or catalogue recommending one time only usage. 7.3.3 Dialyzer Regeneration means the preparation for reuse of a single-use dialyzer in accordance with this Section 7 of Chapter II. 7.4 Policy Statement. 7.4.1 The re-use of medical devices labeled as single-use or disposable shall be prohibited with the following exceptions: 1. Dialyzers for the same patient. 2. Ballon-assist catheters (opening but not inserted). 3. Devices not requiring maintenance of sterility (irrigation and other patient devices). 7.4.2 Prior to re-use of any items except dialyzers list in 7.4.1 (reuse of which is subject to the provisions of 7.5, 7.6, 7.7), the facility shall submit the the Department for approval written processing procedures which shall meet the following guidelines based on F.D.A. standards:

1. The device can be adequately cleaned prior to disinfection and reuse. 2. The physical characteristics of the device material will not be adversely affected by cleaning, disinfection, or re-use. 3. The packaging material will allow effective penetration of the disinfecting agent and will prevent recontamination of the device under the storage conditions to which the devices will be subjected. 4. If disinfecting process is effective. 5. If the treated device is used parenterally, the process will not evoke pyrogenic response. 6. The device, after gas or chemical disinfection, will not contain toxic residues. 7.5 Dialyzer Regeneration. 7.5.1 Regeneration shall not be permitted on dialyzers used for hepatitis antigen positive patients. 7.5.2 Prior to individual dialyzer regeneration, each patient shall be provided by the physician with a presentation of possible complications and hazards and possible benefits of such regeneration. This shall be incorporated into the consent for dialysis form and shall become a part of the patient's dialysis record. Patients shall have access to the number of times their dialyzer has been reused. 7.5.3 No person shall be denied access to dialysis in the facility as a result of that patient's refusal to permit regeneration of his or her dialyzer. Refusal to permit regeneration shall be documented. 7.5.4 The facility shall document the qualifications of and the protocols for training personnel responsible for the regeneration process. 7.5.5 The facility shall provide training for all personnel in the protocols and procedures for regeneration at the time of employment and no less than annually. 7.5.6 The facility shall establish policies and procedures to ensure the safety of employees in regard to the use of disinfecting agents and procedures to deal with accidents and spillage of disinfectants. 7.6 Quality Control for Dialyzer Regeneration. Procedures shall be established and documented in the facility procedure manual which shall include but not be limited to:? 7.6.1 Each dialyzer to be resued shall be indelibly and clearly labeled with the patient's name and other unique identifying information before the initial use. 7.6.2 At each subsequent use, the label shall be checked by two separate individuals, the dialysis staff member and the patient, if feasible. 7.6.3 The number of the uses shall be recorded both in a reuse record maintained for each dialyzer, and in the patient's permanent dialysis record. 7.6.4 Water used to formulate cleaning solution and to rinse dialyzers shall be passed through a reverse osmosis membrane, ultrafiltration membrane or a submicron filter (0.45 micron) which is

appropriately maintained. This water shall contain less than 200 bacteria per ml, which shall be documented by bacteriologic sampling of the source water outlet in the reprocessing area monthly. Where such sampling reveals bacterial counts that periodically approach or exceed this limit, corrective measures and weekly sampling shall be accomplished. Results of such samples shall be recorded. 7.6.5 Disinfection shall be achieved with an effective agent, the addition of which to each dialyzer shall be documented and recorded. If formaldehyde is used as the disinfecting agent, a mimimum concentration of 21 in both the blood and dialysate compartments, and minimum exposure time of 24 hours if required. 7.6.6 Disinfection shall be monitored epidemiologically of all febrile reactions during dialysis with new or used dialyzers and shall be documented in the patients record. 7.6.7 Blood and dialysate cultures shall be done on all patients during febrile reactions. Reports of cultures shall be recorded in the dialysis record. 7.6.8 Documentation and recording of the addition of effective disinfectant concentrations in the dialyzer to be reused shall be done. 7.6.9 Documentation and recording of effective disinfectant removal from each dialyzer immediately prior to reapplication shall be done. Validation tests of methodologic achievement shall be made monthly. 7.6.10 Removal of any other potentially toxic substances added as any part of the reprocessing procedure shall be documented and recorded by routine testing and/or validation studies as appropriate. 7.6.11 The effectiveness of the reprocessing procedure must be documented before each subsequent use of each dialyzer. 1. For hollow fiber dialyzers, a hollow fiber bundle volume (HFBV) of not less than 80% of the initial HFBV, measured at 0+10 MM of HG transmembrane pressure, shall be maintained. 2. For parallel plate or coil dialyzers, small molecular clearance tests shall be performed during or after each use, performance less than 90% of original capacity will not be permitted. 7.6.12 Blood leaks during use of both new and reprocessed dialyzers shall be documented and recorded. If the blood-leak, rate of used dialyzers exceeds that of new dialyzers, each dialyzer must be pressure tested for possible blood compartment leak, before reuse. 7.6.13 Dialyzers shall be discarded unless the following criteria are met at the time the dialyzer is to be used on the patient: 1. The dialyyer has no cracked or broken parts. 2. The dialyzer appears clear and free of dissolved or residual blood manifest by a brownish or pinkish tinge. 3. Headers are visibly free of all but small peripheral clots. 7.6.14 A clean storage space for disinfected dialyzers will be provided.

7.6.15 Where such committee exists, all quality control procedures shall be approved by the Infection Control Committee. 7.7 Dialyzer Regeneration Facilities.A separate room shall be provided. 7.7.1 Unless the room is equipped with an appropriate flushing system, the room shall be equipped with a counter and counter sink. 7.7.2 The room shall have approved hand-washing facilities and storage cabinets. 7.7.3 The room shall be separated in clean and soiled areas. Regeneration dialyzers shall be maintained only in the clean area. 7.7.4 The room shall be ventilated with fresh air at a minimum rate of six air changes per hour or locally exhausted. Air shall not be recirculated through the ventilating system except at those times when processing is not taking place. If general exhaustion of the room is selected, as opposed to local exhaustion, the site of exhaustion must be, at a maximum, six inches from floor level. (NOTE: Formeldehyde gas is heavier than air,) 7.7.5 The rooms shall be lighted to a level of 50 foot candles throughout. Light levels shall be 100 foot candles at the work surfaces. 7.7.6 Storage space shall be provided for supplies and for regenerated dialyzers proportional to the number of patients in the unit. PART 8. PROTECTION OF PERSONS FROM INVOLUNTARY RESTRAINT 8.101 Statutory Authority and Applicability. This part is promulgated pursuant to Sections 26-20-106 and 26-20-108, C.R.S. This part applies to the use of involuntary restraint in all licensed health care facilities, except under the circumstances described: (1) for hospitals as provided for in Section 8.103 (l)(a); and (2) for Medicare/Medicaid certified nursing homes as provided for in Section 8.103 (3). 8.102 Definitions (1) “Chemical restraint” means giving an individual medication involuntarily for the purpose of restraining that individual; except that “chemical restraint” does not include the involuntary administration of medication pursuant to Section 27-10-111 (4.5), C.R.S., or administration of medication for voluntary or life-saving medical procedures. (2) “Emergency” means a serious, probable, imminent threat of bodily harm to self or others where there is the present ability to effect such bodily harm. (3) “Mechanical restraint” means a physical device used to involuntarily restrict the movement of an individual or the movement or normal function of a portion of his or her body. (4) “Physical restraint” means the use of bodily, physical force to involuntarily limit an individual's freedom of movement; except that “physical restraint” does not include the holding of a child by one adult for the purposes of calming or comforting the child. (5) “Restraint” means any method or device used to involuntarily limit freedom of movement, including but not limited to bodily physical force, mechanical devices, or chemicals. “Restraint” includes a chemical restraint, a mechanical restraint, a physical restraint, and

seclusion. (6) “Seclusion” means the placement of a person alone in a room from which egress is involuntarily prevented. 8.103 Exemptions (1) “Restraint” does not include: (a) The use of any form of restraint in a licensed or certified hospital when such use: (I) Is in the context of providing medical or dental services that are provided with the consent of the individual or the individual's guardian. For the purposes of this Section (1)(a) the term “medical services” means the provision of care in a hospital where the primary goal of treatment is treatment of a medical condition as opposed to treatment of a psychiatric disorder, and (II) Is in compliance with industry standards adopted by a nationally recognized accrediting body or the conditions of participation adopted for federal Medicare and Medicaid programs; (b) The use of protective devices or adaptive devices for providing physical support, prevention of injury, or voluntary or life-saving medical procedures; (c) The holding of an individual for less than five minutes by a staff person for protection of the individual or other persons; (d) Placement of an inpatient or resident in his or her room for the night; (e) The use of time-out as may be defined by written policies, rules, or procedures of a facility; or (f) Restraints used while the facility is engaged in transporting a person from one facility or location to another facility or location when it is within the scope of that facility's powers and authority to effect such transportation. (2) “ A facility, as defined in Section 27-10-102 (4.5), C.R.S., that is designated by the Executive Director of the Department of Human Services to provide treatment pursuant to Sections 27-10-105,27-10-106,27-10-107, or 27-10-109, C.R.S., to any mentally ill person, as defined in Section 27-10-102 (7), C.R.S., may use seclusion to restrain a mentally ill person when such seclusion is necessary to eliminate a continuous and serious disruption of the treatment environment. (3) If the use of restraint in skilled nursing and nursing care facilities licensed under state law is in accordance with the federal statutes and regulations governing the Medicare program set forth in 42 U.S.C. sec. 1395i-3(c) and 42 C.F.R. part 483, subpart B and the Medicaid program set forth in 42 U.S.C. sec. 1396r(c) and 42 C.F.R. part 483, subpart B and with chapter V, Long Term Care Facilities, there shall be a conclusive presumption that such use of restraint is in accordance with this Part 8. (4) If any provision of this Part 8 concerning the use of restraint conflicts with any provision concerning the use of restraint stated in Article 10.5 of Title 27, C.R.S., or any regulation adopted pursuant thereto, the provision of Article 10.5 of Title 27, C.R.S., or the regulation adopted pursuant thereto shall prevail.

8.104 Basis for use of restraint (1) A facility may only use restraint: (a) In cases of emergency; and (I) After the failure of less restrictive alternatives; or (II) After a determination that such alternatives would be inappropriate or ineffective under the circumstances. (2) A facility that uses restraint pursuant to the provisions of subsection (1) of this; section shall use such restraint: (a) For the purpose of preventing the continuation or renewal of an emergency; (b) For the period of time necessary to accomplish its purpose; and (c) In the case of physical restraint, using no more force than is necessary to limit the individual's freedom of movement. 8.105 Duties relating to use of restraint (1) Notwithstanding the following provisions - Section 8.103, subsections (1 )(f), (2), (3)* and (4) and Section 8.104 - a facility that uses restraint shall ensure that: (a) At least every fifteen minutes, staff shall monitor any individual held in mechanical restraints to assure that the individual is properly positioned, that the individual's blood circulation is not restricted, that the individual's airway is not obstructed, and that the individual's other physical needs are met; (b) No physical or mechanical restraint of an individual shall place excess pressure on the chest or back of that individual or inhibit or impede the individual's ability to breathe; (c) During physical restraint of an individual, an agent or employee of the facility shall check to ensure that the breathing of the individual in such physical restraint is not compromised; (d) A chemical restraint shall be given only on the order of a physician who has determined, either while present during the course of the emergency justifying the use of the chemical restraint or after telephone consultation with a registered nurse, certified physician assistant, or other authorized staff person who is present at the time and site of the emergency and who has participated in the evaluation of the individual, that such form of restraint is the least restrictive, most appropriate alternative available; (e) An order for a chemical restraint, along with the reasons for its issuance, shall be recorded in writing at the time of its issuance; (f) An order for a chemical restraint shall be signed at the time of its issuance by such physician if present at the time of the emergency; (g) An order for a chemical restraint, if authorized by telephone, shall be transcribed and signed at the time of its issuance by an individual with the authority to accept

telephone medication orders who is present at the time of the emergency; (h) Staff trained in the administration of medication shall make notations in the record of the individual as to the effect of the chemical restraint and the individual's response to the chemical restraint. (2) For individuals in mechanical restraints, facility staff shall provide relief periods, except when the individual is sleeping, of at least ten minutes as often as every two hours, so long as relief from the mechanical restraint is determined to be safe. During such relief periods, the staff shall ensure proper positioning of the individual and provide movement of limbs, as necessary. In addition, during such relief periods, staff shall provide assistance for use of appropriate toiletting methods, as necessary. The individual's dignity and safety shall be maintained during relief periods. Staff shall note in the record of the individual being restrained the relief periods granted. (3) Relief periods from seclusion shall be provided for reasonable access to toilet facilities. (4) An individual in physical restraint shall be released from such restraint within fifteen minutes after the initiation of physical restraint, except when precluded for safety reasons. 8.106 Staff training (1) All agencies shall ensure that staff utilizing restraint in facilities or programs are trained in the appropriate use of restraint. (2) All agencies shall ensure that staff are trained to explain, where possible, the use of restraint to the individual who is to be restrained and to the individual's family if appropriate. 8.107 Documentation requirements. Each facility shall ensure that an appropriate notation of the use of restraint is documented in the record of the individual restrained. Each facility shall document the following in the patient record: (1) type of restraint and length of time in the restraint;. (2) identification of staff involved in the initiation and application of the restraint; (3) care provided while in the restraint, including monitoring conducted and relief periods granted; and (4) the effect of the restraint on the individual. 8.108 Review of the use of restraint. Each facility that allows for the use of restraint under this Part 8 shall ensure that a review process is established for the appropriate use of the restraints. Part 9 PATIENT RIGHTS 9.1 Any facility licensed by the department, unless exempted under section 9.4, shall make available, upon admission for care or treatment, a disclosure of its policy on patient rights. The disclosure shall be made available through.the use of an appropriate communication medium, and in a manner understood by the patient, or the patient's legal representative. For any patientcare or treatment course requiring multiple patient encounters, disclosure provided at the beginning of such care or treatment course shall meet the intent of the regulations. A facility shall treat patients in accordance with the provisions of the patient rights statement. 9.2 The patient rights statement shall include but not be limited to the following:

(a) the right to participate in all decisions involving the patient's care or treatment; (b) the right to know the names, professional status, and experience of the staff that are providing care or treatment to the patient; (c) the right to know if the facility is participating in teaching programs, research, and/or experimental programs; (d) the right to refuse any drug, test, procedure, or treatment; (e) the right to care or treatment that is respectful, recognizes a person's dignity, and provides for “ personal privacy to the extent possible during the course of treatment; (f) the right to be informed of the facility's rules and regulations as they apply to the patient; and (g) The right to be informed, upon request, prior to the initiation of care or treatment that is nonemergent/of the charge(s) for service(s) that is routine, usual, and customary; or the estimated charge(s) for service (s) based upon an average patient with a diagnosis similar to the tentative or preliminary admission diagnosis of the patient being admitted; and, based upon insurance information supplied by the patient, to be given assistance obtaining an estimate of any co-payment, deductible, or other charges that will not be covered by a third party payer and must be paid by the patient; and, the right to be informed prior to the initiation of care or treatment of the facility's general billing procedures. A facility may - include a disclaimer with the disclosure of any charges. Such disclaimer may include further information on variables which may alter any disclosed charge. If charges to the patient are prohibited by law, or by third party payer contract, then a disclaimer of no charge shall meet the requirements of this paragraph; (h) the right to give informed consent for all treatment and procedures. (i) The right to be informed of the facility's grievance procedure. 9.3 For the purposes of this regulation, the term, “informed consent”, shall include, but not be limited to, the following: (a) an explanation of the recommended treatment or procedure in layman's terms and in a form of communication understood by the patient, or the patient's legal representative; (b) an explanation of the risks and benefits of a treatment or procedure; the probability of success, mortality risks, and serious side effects; (c) an explanation of the alternatives with the risks and benefits of these alternatives; (d) an explanation of the consequences if no treatment is pursued; (e) an explanation of the recuperative period which includes a discussion of anticipated problems and the anticipated length of the recuperative period; and (f) an explanation that the patient, or the patient's legal representative, is free to withdraw his or her consent and to discontinue participation in the treatment regimen. 9.4 Applicability. The provisions of 9.1 And 9.2 shall not apply to any facility currently covered under section 25-1-121 and the regulations promulgated pursuant to said section in Chapter II, Part 6 of the regulations. The provisions of 9.1 and 9.2 shall not apply to long term care facilities, personal care boarding homes, residential facilities for the developmentally disabled, and hospice that are regulated

pursuant to section 25-1-120 and 6 CCR 1011-1, chapter V, chapter VI I, chapter VI II, Part 5, and Chapter XXI respectively. 9.5 Each facility shall post notice, in a conspicuous place in the facility, of the existence of its internal grievance procedure. The notice shall also inform patients, or their legal representatives, that if still dissatisfied with physician, dental, or podiatric patient care services, excluding fee disputes, a complaint may be filed with the Colorado State Board of Medical Examiners, the State Board of Dental Examiners, and the Colorado Podiatry Board. Upon request, the facility shall provide the patient, or the patient's legal representative, with the address of the appropriate board and inform such person that these boards are prohibited from arbitrating or adjudicating fee disputes between licensees or between a licensee and any other party, pursuant to sections 12-36-104.5, 12-35-107.5, and 12-32-104.5, C.R.S. (A) A facility may post such notice in a manner that is conducive to a positive customer relations approach as long as the above provisions are incorporated in a manner that is consistent with the intent of the regulation. CHAPTER III GENERAL BUILDING AND FIRE SAFETY 1. CONSTRUCTION STANDARDS. All buildings housing health facilities licensed by the Colorado Department of Public Health and Environment shall conform to the standards listed herein. 2. SITE. All weather roads and walks shall be provided within the lot lines to the main, service, and ambulance entrances.The site of any health facility should be reasonably accessible to the population served. Public transportation should be available, especially if an outpatient service is to be maintained.The site should not be near insect breeding areas, industrial developments, airports, railways, or highways producing noise, nuisance or air pollution, or other objectional facilities or businesses. 3. PARKING. Parking space shall be conveniently available for staff, visitors, and service vehicles. A ratio of two parking spaces per patient bed is recommended. 4. CODES AND REGULATIONS.The following codes and regulations (on file at the address listed on page i of these regulations) must be observed insofar as they are not in conflict with the other sections of these standards: 1) National Fire Protection Association. BuildingExitCode 1963, excluding paragraphs 2350 to 2376. 2) International Conference of Building Officials, UniformBuilding Code. Vol. 1, 1964. 3.) USPHS, PublicHealthServiceRegulations. Part53. Pertaining to the Construction and Modernization of Hospitals and Medical Facilities, “Sub-part N” (Appendix A), Dec. 29, 1964; 4) National Fire Protective Association:

Bulletin No. 10 14 30 31 37 55 56 -

PortableExtinguishers. 1962 Standpipe-HoseSystems. 1952 FlammableLiquidsCode. 1963 OilBurningEquipment. 1964 CombustionEngines. 1963 Gas Shut-off. 1924. Flammable Anesthetics.

565 -

1962 Nonflammable Medical Gases. 1962 L. P. Gas Storage. Use. 1963 National Electrical Code. 1962 Central Station Signal. 1962 Proprietary Signal System. 1962 Remote Station Systems. 1962 Hospital Electrical Service. 1962 Incinerators. 1960 Rubbish. 1948 Air Conditioning System. 1962 Ventilation Restaurant Cooking Equipment. 1964 Building Construction Operation. 1958 Flamespread Tests. 1961

58 70 71 72 72C 76 82 82A 90A 96 241 255 -

5) Colorado Department of Health: Technical Plumbing Code, amended 1961, Restaurant Sanitation Code, amended 1959 6) Colorado State Industrial Commission Boiler Code, amended 1961. 7) National Bureau of Standards: Handbook 73, Protection Against Radiations from Sealed Gamma Sources, 1960; Handbook 76, Medical X-ray Protection Up to Three Million Volts. 1961. 8) All other applicable local codes and regulations. 5. NEW CONSTRUCTION, ADDITIONS, CONVERSIONS. 5.1 Buildings erected after the adoption date of these standards, and additions thereto, shall comply with all requirements for new buildings. 5.2 Each addition to anew or an existing building converted to health facility use, shall be such that the entire resulting building conforms to all requirements of these standards. 5.3 No building shall be converted to a health facility unless it complies with all requirements for new buildings and meets specified standards for patient services to be rendered. 6. OCCUPANCY. Occupancies not essential to the functions of a health facility are prohibited therein, with the exception of residence facilities for personnel required to live in the building. 7. LOCATION OH PROPERTY. Fire protection requirements for exterior walls and wall openings, based on the location on the property, shall be as specified in Section 504 of the Uniform Building Code.

8. AREAS OF BUILDINGS.Floor areas of buildings for fire separation shall be specified in Sections 505 and 506 of the Uniform Building Code. 9. FOUNDATIONS.Foundations shall rest on natural solid ground and shall be carried to a depth of not less than one foot below the estimated frost line or shall rest on leveled rock or load-bearing piles, when solid ground is not encountered.* Footings, piers, and foundation walls shall be adequately protected against deterioration from the action of ground water. Proper bearing values for the soil shall be established in accordance with recognized standards. 10. DESIGN. 10.1 General. The buildings and all parts thereof shall be of sufficient strength to support all dead, live, and lateral loads without exceeding the working stresses permitted for the materials of their construction in the applicable code. 10.2 Special. Special provision shall be made for machine or apparatus loads which would cause a greater stress than that produced by the specified minimum live load, with due consideration of vibration or impact resulting from operation of such equipment (e.g., some portable x-ray machines weigh as much as 1,000 pounds). Consideration shall be given to structural members and connections of structures which may be subject to hurricanes, tornadoes, and earthquakes. Suitable allowance shall be made for future partition changes. 10.3 Live Loads. The following unit live loads shall be taken as the minimum uniformly distributed live loads for the occupancies *Not required for existing facilities listed: 1) Patient bedrooms and all adjoining service” rooms which comprise a typical patient care unit (except solaria and corridors) - 40 p.s.f.; 2) Solaria, corridors above the first floor, operating suites, examination and treatment rooms, laboratories, toilets and locker rooms 60 p.s.f.; 3) Corridors on first floor, waiting rooms and similar public areas, offices, conference room, library, kitchen and radiographic room - 80 p.s.f.; 4) Stairways, laundry, large rooms used for dining, recreation or assembly purposes, work shops - 100 p.s.f.; 5) Records, file room, storage, supply - 125 p.s.f.; 6) Mechanical equipment room (unless actual equipment loads are accurately determined) 150 p.s.f.; 7) Roofs (except use increased value where snow and ice may occur) - 20 p.s.f.; 8) Wind -as required by local conditions, but not less than 15 p.s.f. 11. FIRE RESISTIVE CONSTRUCTION. 11.1 Where one-hour fire resistive construction throughout is required by these standards, an approved automatic fire-extinguishing system may not be substituted. 11.2 One-story buildings shall be constructed of not less than one-hour fire resistive construction throughout, except that if used to house or treat mentally retarded or mentally ill patients, onestory buildings shall in addition be constructed of noncombustible materials. 11.3 Buildings more than one-story in height shall be constructed of noncombustible materials, using a structural framework of rein-forced concrete or structural steel except that load-bearing masonry walls and piers may be used in buildings up to and including three stories. Basements shall be counted a story if the finished floor level directly above a basement or cellar is more than six feet above grade. Grade (ground level) is the average of the finished ground level at the center of all walls of a building. If walls are parallel to and within five (5) feet of a sidewalk, alley or other public way, the above ground levels shall be measured at the elevation of the sidewalk, alley or public way. 11.4 Interior non-load-bearinq partitions, other than those enclosing corridors and vertical shafts, may be of noncombustible construction without a fire-resistive rating.

11.5 All walls enclosing stairways, elevators, laundry and trash chutes, and other vertical shafts, in buildings of more than one-story, and all boiler rooms and rooms used for the storage of combustible materials shall be of two-hour fire resistive non-combustible construction. 12. EXITS. 12.1 All exit facilities shall be in accordance with the Building Exits Code. (Except paragraphs 2350 to 2376 inclusive, Existing Hospitals and Nursing Homes). 12.2 In new construction, only the following types of exits will be permitted: 1) Doors; 2) Stairs and smokeproof towers; 3) Ramps; 4) Horizontal exits. In existing buildings, fire escape stairs, Class A or B, in addition to the above types of exits, will be permitted. 12.3 At least two exits of the above type, remote from each other, shall be provided for each floor or fire section of the building. At least one exit in each floor or fire section shall be of type 1 or 2 as listed above. In new buildings, stairs must be Class A. In existing buildings, stairs must be Class A or B. (See Building Exits Code, par. 3311). Class A stairways must be forty-four (44) inches wide. The width shall be measured between handrails when handrails project more than 31/2 inches. 12.4 Basements used only for service to the building, and every boiler room and every room containing an incinerator or L.P. gas or liquid fuel-fired equipment, shall have at least two means of egress, one of which may be a ladder. 12.5 Basement exits for patients shall discharge directly outdoors without the necessity for use of interior stairs connecting with the story above. 12.6 Elevators, if for patient use, must have a platform size of 5'4”x8'. Door openings must be 3' 10” wide. 12.7 Every patient room shall have a doorway opening directly to a patient corridor. 12.8 Corridors and passageways to be used as a means of exit, or part of a means of exit, shall be unobstructed and shall not lead through any room or space used for a purpose that may obstruct free passage. 12.9 Exits shall be so placed that the entrance door of every patient room, day rooms, dormitories, dining rooms and other areas shall be not more than one hundred (100) feet (along line of travel) from the nearest exit. In buildings completely protected by a standard automatic sprinkler system, the distance may be one hundred and fifty (150) feet. 12.10 Corridor widths. 12.10.1 Corridors located in areas housing bed patients, and providing egress therefrom, shall be eight (8) feet in clear width. This width may be narrowed to 7'6” by corridor railings or other projections. A greater width should be provided at elevator entrances. 12.10.2 Horizontal exits and smoke stop doors at least forty-four (44) inches in width are permitted in corridors. 12.10.3 New buildings shall be so designed that all patient beds can be rolled to exits. 12.10.4 In existing buildings, corridors in areas housing bedridden patients, and providing egress therefrom, shall be at least five (5) feet wide.

12.11 Dead Ends. Exits shall be so arranged that there are no pockets or dead ends exceeding thirty (30) feet in which occupants may be trapped. 12.12 No door shall swing into a corridor except closet doors. 12.13 Door widths shall be 3'8” clear widths (4'0” preferable) at all: 1) Bedrooms; 2) Treatment rooms; 3) Operating rooms; 4) X-ray therapy rooms; 5) Delivery rooms; 6) Solariums; 7) X-ray rooms; 8) Physical therapy rooms; 9) Labor rooms. In existing buildings exit doorways and doorways to the above areas shall be at least thirty-two (32) inches in clear width. Exit doors so located as not to be subject to use by patients may not be less than twentyeight (28) inches wide. 12.14 Horizontal Exits. Horizontal exits shall be in accordance with Section 30 of the Building Exits Code and shall be at least forty-four (44) inches in clear width. Doors need not swing with exit travel. In existing buildings, wall of one-hour fire-resistive construction may be used in connection with horizontal exits. 13. PROTECTION 13.1 Each floor used for sleeping rooms for more than thirty (30) patients, unless provided with a horizontal exit, shall be divided into at least two fire sections by a smoke stop partition having at least a one-hour fire-resistance rating. (A one-half hour fire resistance rating is permitted for existing buildings.) Such a partition shall be continuous through any concealed space such as between the ceiling and the floor or roof above. 13.2 Openings in smoke stop partitions shall have three-quarter hour fire doors (metal, metal covered, or approved treated wood construction). Smoke stop doors shall be so installed that they may be left in open position but will close automatically in case of fire by arrangements which are in accordance with Section 3209 of the Building Exits Code or by heat sensitive releases, and may be released manually to self-closing action. Such doors need not swing with exit travel. 13.3 Any openings in smoke stop partitions or doors shall be protected by fixed wire glass panels, or by rated louvers. 13.4 In unsprinkled buildings, no more than one hundred and fifty (150) feet of corridor without horizontal exit or smoke stop doors shall be permitted. 13.5 Glass on corridors, except directly to the outside, must be one-fourth inch wire glass set. in approved metal stops. 13.6 Doors opening on corridors must be wood solid core, or better. 13.7 Protection of Vertical Openings. All stairways, elevator shafts, chutes and other openings between different stories or floor levels shall be enclosed or protected to prevent the spread of fire or smoke (See Section 11.5). 13.8 Doors in stairway enclosures shall be one and one-half hour B label, fire rated doors, and shall be self-closing and shall be kept in closed position except as otherwise permitted by Section 3209 of the Building Exits Code. 13.9 No laundry, trash, or other chute, or incinerator flue shall open directly on any exit, or corridor to an exit. A separate room or closet separated from the exit or corridor by an approved self-closing fire door shall be used.* Laundry chutes, where used, must be 2'0” minimum diameter.* *

Not required in existing facilities

13.10 All incinerator flues, rubbish chutes, and linen or laundry chutes shall be of standard type properly designed and maintained for fire safety according to N.F.P.A. Standard No. 82, Incinerators. 1960. (This standard applies to rubbish, linen and laundry chutes). 13.11 In new construction, all chutes other than incinerator chutes shall be provided with automatic sprinkler protection. 14. X-RAY PROTECTION. 14.1 X-ray rooms, surgeries, cystoscopic rooms and other areas containing x-ray producing equipment, other than mobile equipment, shall have ray protection as recommended by Handbooks No. 73 and 76 of the National Bureau of Standards. 14.2 All Radioisotopes. Rooms or areas where radioisotopes are used or stored, shall have the ray protection necessary to limit the radiation in occupied areas to those levels required by the Atomic Energy Commission. The methods for determining radiation barriers shall be those established in the applicable handbook of the National Bureau of Standards. 14.3 X-ray Equipment. X-ray equipment and installation shall comply with recommendations contained in the National Electrical Code and Handbooks, Nos. 73 and 76 of the National Bureau of Standards. 15. WINDOWS. 15.1 All rooms customarily used by patients or personnel shall have windows or be supplied by mechanical ventilation as required by Section 19.4, chapter IV of these standards. 15.2 For patient room windows see Section 19.4, chapter IV of these standards. 15.3 For purposes of evacuation, the window sills of one-story buildings constructed of other than noncombustible materials shall be not more than six feet above the adjacent ground level. 16. INTERIOR FINISHES. 16.1 Floors. The floors of the following areas shall have smooth, waterproof surfaces which are wear resistant: 1) Toilets; 2) Baths; 3) Bedpan rooms; 4) Floor pantries; 5) Utility rooms; 6) Treatment rooms; 7) Sterilizing rooms; 8) Janitor's closets; 9) Elevators; 10) Chute anterooms; 11) Central supply rooms; 12) Clean or soiled linen storage rooms; 13) Storage in patient areas; 14) Lobbies; 15) Waiting rooms; 16) Corridors; 17) Nurses' station; 18) Patient rooms; 19) Medicine preparation room; 20) X-ray suite; 21) Operating suite; 22) Delivery suite; 23.) Emergency suite; 24) Nursery suite; 25) Dining rooms; 26) meeting rooms. 16.2 Carpeting may be used in administrative areas and other areas as approved by the State Health Department. 16.3 The floors of the following areas shall be waterproof, grease-proof, smooth and resistant to heavy wear: 1) kitchens; 2) Butcher rooms; 3) Food preparation; 4) Formula rooms; 5) Dishwashing rooms. 16.4 Floors in anesthetizing areas and in rooms used for storage of flammable anesthetic agents in surgical suites and floors within ten feet of the door to these areas shall be conductive as required by the N.F.P.A. No. 56, Code for Use of Flammable Anesthetics, 1962. 16.5 The walls of the following areas shall have a smooth or smooth textured surface with painted or equal washable finish. At: the base they shall be waterproof and free from spaces

which may harbor insects or dirt: 1) Patient rooms; 2) Corridors; 3) Nurses' station; 4) X-ray room; 5) Clean storage areas. 16.6 The walls of the following areas shall have waterproof pairted, glazed or similar finishes. At the base they shall be free from spaces which may harbor insects or dirt: 1) Kitchens; 2) Pantries; 3) Utility rooms; 4) Toilets; 5) Baths; 6) Showers; 7) Dishwashing rooms; 8) Janitor's closets; 9) Sterilizing rooms; 10) Spaces with sinks; 11) Treatment rooms; 12) Delivery suite; 13) Operating suite; 14) Nursery suite; 15) Emergency suite; 16) Dark rooms; 17) Chute anterooms; 18) Central supply rooms; 19) Medicine preparation rooms; 20) Soiled linen holding rooms; 21) Laboratories; 22) Autopsy rooms. 16.7 Ceilings. The ceilings of the following areas shall be painted with waterproof paint. The first three shall have a surface that is unbroken except for lighting, ventilation, or other necessary services: 1) Operating rooms; 2) Delivery rooms; 3) Emergency rooms; 4) All rooms where food and drink is prepared; 5) Dishwash room; 6) Toilets; 7) Baths; 8) Showers; 9) Janitor closets; 10) Patient rooms; 11) Central medicine-surgical supply rooms; 12) Clinical examination and treatment rooms; 13) Nursery suite; 14) Medicine preparation area; 15) Darkrooms; 16) Radiological suite; 17) Chute anterooms; 18) Clean holding areas; 19) Soiled holding areas; 20) Laboratories; 21) Autopsy rooms; 22) Clean storage areas; 23) Surgical suite; 24) Delivery suite; 25) Emergency suite; 26) Laundry rooms. 16.8 The ceilings of the following areas shall be acoustically treated: 1) Corridors in patient areas; 2) Nurses stations; 3) Labor rooms; 4) Floor pantries. 17. FLAME SPREAD. 17.1 Interior finish of all exit ways, storage rooms and all areas of unusual fire hazard shall have a flame spread rating of less than 20. 17.2 Interior finish of patient rooms, patient day rooms and other areas occupied by patients shall have a flame spread rating of less than 75. 17.3 Interior finish of other areas shall have a flame spread rating of less than 75 except that ten percent of the aggregate wall and ceiling areas of any space may have a flame spread rating up to 200. 17.4 Interior finish materials shall be classified in accordance with their average flame spread rating on the basis of tests conducted in accordance with ASTM Standard No. E84. 18. CEILING HEIGHTS AND CEILING INSULATION. 18.1 Ceiling heights and ceiling insulation for all health facilities shall be as specified in the Public Health Service Regulations. Sub-part N. Par. 53.160 with the following exceptions: a. Ceiling heights as specified above for boiler rooms, laundry rooms, and kitchens, are required only in new hospitals. b. Boiler room ceilings must be at least 5 feet higher than the top of any boiler unit, c. Kitchen ceiling heights may be no less than 9'0”. 19. UTILITIES. 19.1 Requirements for the following categories shall be as specified in the Public Health Service Regulations, Sub-part N, Par. 53.163 or elsewhere in these standards: 1)Heating; 2) Ventilation;

3) Plumbing; 4) Plumbing fixtures and fittings; 5) Hater supply; 6) Drainage; 7) Gas piping and appliances; 8) Oxygen systems; 9) Sterilizers; 10) Electrical installations; 11) Elevators and Dumbwaiters; 12) Refrigerators; 13) Kitchen equipment; 14) Laundry. 19.2 Ventilation. Exhaust air shall be discharged from the building remote from fresh air intakes. 19.3 Water Supply. The water supply system shall be from a municipal water supply system or other system approved by the State Health Department as meeting the Standards for the Quality of Water Supplied to the Public, published by the Colorado Department of Health. 19.4 Chemical properties of the water should be such as to prevent caking of deposits in and corrosion of the plumbing system and undesirable depositing of salts from water evaporation. 19.5 Electrical Service. The provisions of N.F.P.A. Standard No. 76, Essential Hospital Electrical Service, shall be complied with as follows: a. The Emergency Electrical System shall be Type I as defined in the Building Exits Code No. 101, Sec. 52. b. The Critical Electrical System I (Automatic Restoration) shall include the recommended areas and functions, c. Critical Electrical System II (Delayed Automatic Restoration) shall include the recommended areas and functions and partial use of elevators and vertical conveyors. 20. FIRE PREVENTION AND DRILLS. There shall be a written program of Fire Prevention, Fire Exit Drill, and Evacuation for all Health Facilities. The program shall define policies, procedures, and the responsibilities and duties of personnel. All personnel shall be instructed and trained concerning their duties under the program. Fire Exit Drills shall be conducted at regular intervals. 21. SUBMISSION AND APPROVAL OF BUILDING PLANS AND SPECIFICATIONS. Plans and drawings for all buildings to be built, added to, or altered, to house-facilities licensed by the Department of Public Health And Environment shall be submitted to the department for approval in the following sequence prior to the start of construction: 21.1 A written program describing the objectives of the sponsoring organization, and the type and size of service or services to be provided in the proposed facility. 21.2 Preliminary drawings showing the proposed general location, boundaries, approaches to and physical features of the site, other buildings on the site, means of water supply, sewage disposal, and other utilities to the site. The preliminary drawings shall also show the proposed layout of each floor of the facility with each room labeled as to its use, and a general cross section of the structure indicating type of construction. 21.3 Outline specifications indicating important electrical, mechanical and other features not shown on drawings. 21.4 Final working drawings and specifications. These must be approved before construction is begun, and should not be commenced before preliminary drawings are approved, to avoid redrawing of detail plans. CHAPTER IV GENERAL HOSPITALS Part 1. STATUTORY AUTHORITY AND APPLICABILITY

1.100 1.101 STATUTORY AUTHORITY (1) Authority to establish minimum standards through regulation and to administer and enforce such regulations is provided by Sections 25-1.5-103 and 25-3-101, C.R.S., et seq. 1.102 APPLICABILITY (1) All hospitals shall meet applicable federal and state statutes and regulations, including but not limited to: (a) 6 CCR 1011-1, Chapter II. (b) This Chapter IV, except as noted in subparagraphs (i) and (ii), below: (i) facilities that are federally certified or are undergoing federal certification under 42 CFR 482 et seq. as long term hospitals shall meet the requirements of this chapter, except that they shall not be required to have an emergency department, obstetric services or anesthesia services. (ii) Facilities that have 25 inpatient beds or less and are federally certified or undergoing federal certification under 42 CFR 485.600, et seq., as critical access hospitals shall meet the requirements of this chapter, except that the level of staffing, hours of operation, and quality management requirements shall not exceed the requirements established in the aforementioned federal regulations. (2) Contracted services shall meet the standards established herein. Part 2. GENERAL PROVISIONS 2.100 DEFINITIONS 2.101 GENERAL DEFINITIONS (1) “Department” means the Department of Public Health and Environment. (2) “General hospital” means a health facility that, under an organized medical staff, offers and provides twenty-four hours per day, seven days per week, inpatient services, emergency medical and surgical care, continuous nursing services, and necessary ancillary services, to individuals for the diagnosis or treatment of injury, illness, pregnancy, or disability. (a) A general hospital may offer and provide, but is not limited to, outpatient, preventive, therapeutic, surgical, diagnostic, rehabilitative, or any other supportive services for periods of less than twenty-four hours per day. (b) Services offered or provided by a general hospital may be provided directly or by contractual agreement in compliance with the regulations. (c) A general hospital may provide services through the use of more than one physical location pursuant to the provisions of Chapter II, sections 2.3, 2.6, and 2.7 of these regulations. (3) “Critical care unit” means a designated area of the hospital containing a grouping of single bedrooms or enclosures accommodating not more than 6 beds each, and providing particularized facilities and services to care for patients who require continuing, acute observation and concentrated,

highly proficient care. (4) “Governing board” means the board of trustees, directors, or other governing body in whom the ultimate authority and responsibility for the conduct of the hospital is vested. (5) “Patient care unit” means a designated area of the hospital that provides a bedroom or a grouping of bedrooms with respective supporting facilities and services to provide adequate nursing care and clinical management of inpatients; and that is thereby planned, organized, operated, and maintained to function as a separate and distinct unit. (6) “Plan review” means the review by the Department, or its designee, of new construction or remodeling plans to ensure compliance by the facility with the National Fire Protection Association (NFPA) Life Safety Code and with this Chapter IV. Plan review consists of the examination of new construction or remodeling plans and onsite inspections, where warranted. In reference to the National Fire Protection Association requirements, the Department is the authority having jurisdiction for state licensure. (7) “Respiratory care” is that service which is organized to provide facilities, equipment, and personnel who are qualified by training, experience and ability to treat conditions caused by deficiencies or abnormalities associated with respiration. (8) “Surgical recovery room” means designated room(s) designed, equipped, staffed, and operated to provide close, individual surveillance of patients recovering from acute affects of anesthesia, surgery, and diagnostic procedures. 2.200 DEPARTMENT OVERSIGHT 2.201 GENERAL. Reserved. 2.202 LICENSURE FEES. Fees shall be submitted to the Department as specified below. (1) Initial license (when such initial licensure is not a change of ownership). A license applicant shall submit a nonrefundable fee with an application for licensure as follows: (a) See table below.

Number of Beds 1 - 25 beds 26 - 50 beds 51 - 100 beds 101 + beds . .

Fee $8,000 $10,000 $12,500 Base: $9,800 Per bed: $50 Cap: $20,000

(b) Notwithstanding the provisions of Section 2.202 (1)(a), the initial fee for facilities to be licensed as general hospitals but certified as long term hospitals pursuant to 42 CFR 482 et seq. shall submit: a base fee of $5,700 and a per bed fee of $50. The initial licensure fee for long term hospitals shall not exceed $10,500. (2) Renewal license . A license applicant shall submit a nonrefundable fee with an application for licensure as shown in the following table. The renewal fee shall not exceed $8,000.

Number of Beds

Fee

1 - 50 beds . 51 - 150 beds . 151 + beds .

Base: $900 Per bed: $ 12 Base: $1,400 Per bed: $12 Base: $2,000 Per bed: $12

(3) Change of ownership . A license applicant shall submit a nonrefundable fee of $2,500 with an application for licensure. (4) Provisional License . The license applicant may be issued a provisional license upon submittal of a nonrefundable fee of $2,500. If a provisional license is issued, the provisional license fee shall be in addition to the initial license fee. (5) Conditional License . A facility that is issued a conditional license by the Department shall submit a nonrefundable fee ranging from 10 to 25 percent of its applicable renewal fee. The percentage shall be determined by the Department. If the conditional license is issued concurrent with the initial or renewal license, the conditional license fee shall be in addition to the initial or renewal license fee. (6) Other regulatory Functions . If a facility requests an onsite inspection for a regulatory oversight function other than those listed in Sections 2.202 (1) through (3) and Section 2.203 Plan Review, the Department may conduct such onsite inspection upon notification to the facility of the fee in advance and payment thereof. The fee shall be calculated solely on the basis of the cost of conducting such survey. A detailed justification of the basis of the fee shall be provided to the facility upon request. 2.203 PLAN REVIEW AND PLAN REVIEW FEES. Plan review and plan review fees are required as listed below in sections (1) through (5), below. Fees are nonrefundable and shall be submitted prior to the Department initiating a plan review for a facility. (1) Initial licensure . Applicable to applications for an initial license, when such initial license is not a change of ownership. This includes new facility construction and existing structures. The requirement for plan review and the fee applies to initial license applications submitted on or after January 1, 2008. Fee : see table below.

Square Footage 0-35,000 sq ft

Cost per square foot $0.37

35,001-200,000

$0.03

200,001+

$0.01

Explanatory Note This is the cost for the first 35,000 sq ft of any plan submitted. This cost is applicable to the additional square footage over 35,000 and up to 200,000 sq ft. This cost is applicable to the additional square footage over 200,000 sq ft.

(2) New Construction . Applicable to new construction including replacement facilities, structural additions of any size and prefabricated structures. The requirement for plan review and the fee applies to construction for which the application for the building permit from the local authority having jurisdiction is dated on or after January 1, 2008. However, facilities for which the application for the building permit from the local authority having jurisdiction is dated prior to January 1, 2008 may request a partial plan review. The partial plan review is subject to a ten (10) to twenty-five (25) percent reduction of the fee, as determined by the Department, dependent on the phase of facility construction; except that the fee shall not be below the minimum fee established by this subsection. Fee : see table below. Minimum fee: $2,000.

Square Footage 0-35,000

Cost per square foot $0.37

35,001-200,000

$0.03

200,001+

$0.01

Explanatory Note This is the cost for the first 35,000 sq ft of any plan submitted. This cost is applicable to the additional square footage over 35,000 and up to 200,000 sq ft. This cost is applicable to the additional square footage over 200,000 sq ft.

(3) Remodeling – General . Applicable to relocation, removal or installation of walls resulting in 50% or more of a smoke compartment being reconfigured. The cost per square footage listed in the table below is to be assessed for the entire smoke compartment(s) being reconfigured. The requirement for plan review and the fee applies to construction for which the application for the building permit from the local authority having jurisdiction is dated on or after January 1, 2008. Fee : see table below. Minimum fee: $2,000.

Square Footage 0-35,000

Cost per square foot $0.25

35,001-200,000

$0.03

200,001+

$0.01

Explanatory note This is cost for the first 35,000 sq ft of any plan submitted. This cost is applicable to the additional square footage over 35,000 and up to 200,000 sq ft. This cost is applicable to the additional square footage over 200,000 sq ft.

(4) Remodeling – Egress Components . Applicable to the relocation, removal, or addition of any egress component, including but not limited to corridors, stairwells, exit enclosures, or points of refuge. (Widening of an egress component is not relocation.) The requirement for plan review and the fee applies to construction for which the application for the building permit from the local authority having jurisdiction is dated on or after January 1, 2008. Fee : $2,000. However, if these renovations are part of the smoke compartment reconfiguration subject to the fee listed in Section 2.203 (3), the fee in this Section 2.203 (4) shall not apply.

(5) Remodeling – Specific Systems . Applicable to significant modifications to the following systems: fire sprinkler, fire alarm, medical gas, kitchen exhaust/suppression system, and essential electrical system. The requirement for plan review and the fee applies to significant modifications where construction is initiated on or after July 1, 2008. For the purposes of this subsection 32.2.5, construction of significant modifications is deemed initiated when there is an alteration associated with the remodeling to an existing structure that results in a physical change. Fee : $2,000 for up to four smoke compartments, plus $500 for each additional compartment. However, if these renovations are part of the smoke compartment reconfiguration subject to the fee listed in Section 2.203 (3), the fee in this Section 2.203 (5) shall not apply. Significant modifications include: (a) Fire sprinkler: 100 or more sprinklers. Notwithstanding the other provisions in this Section 2.203 (5), the extension of a sprinkler system involving the installation of 25 to 99 sprinkler heads for an area previously unsprinklered is subject to a partial plan review consisting of the review of the remodeling plans and a fee of $500. (b) Fire alarm: any modification to the fire alarm system that involves the replacement of the main fire alarm control unit (panel). (c) Medical gas: modifications that affect 50% or more of a smoke compartment. (d) Kitchen exhaust/suppression system: replacement of the suppression or hood exhaust/duct system. (e) Essential electrical system: replacement or addition of a generator or transfer switch. Part 3. GOVERNING BOARD 3.100 3.101 ORGANIZATION & STAFFING (1) The governing board shall be organized formally with written constitution or articles of incorporation and by-laws, have meetings at regularly stated intervals, and maintain records of these meetings. (2) The governing board shall appoint an administrative officer who is qualified by training and experience in hospital administration and delegate to him or her the executive authority and responsibility for the administration of the hospital. (3) The governing board shall appoint the medical staff. Appointments shall be made following consideration of the recommendations by the medical staff. The governing board shall establish formal liaison with; and approve the by-laws, rules, and regulations of the medical staff. (4) The governing board shall provide personnel necessary for the welfare and safety of patients. 3.102 PROGRAMMATIC FUNCTIONS. The governing board shall: (1) provide services and hospital departments necessary for the welfare and safety of patients. The scope of care shall be defined in writing. (2) be responsible for all the functions performed within the hospital. (3) ensure that training programs in the safe management of patients are conducted. (4) adopt a written emergency management plan.

(a) at minimum, the plan shall address the following emergency situations: (i) loss of heat or air conditioning. (ii) unanticipated interruption of serve of utilities, including water, gas, and electricity either within the facility or within a local widespread area. (iii) fire, explosion, or other physical damage to the hospital. (iv) local and widespread weather emergencies or natural disaster. (v) pandemics or other situations where the community’s need for services exceeds the availability of beds and services regularly offered by the hospital. The hospital response for emergency epidemics shall be directed by 6 CCR 1009-5, Regulation 2 – Preparations by General or Critical Access Hospitals for an Emergency Epidemic. (b) at minimum, the plan shall address the following components of the facility response: (i) the responsibilities of those involved in the emergency management activities within the facility, including authority to activate the plan. (ii) patient triage, care, and discharge. (iii) staff education and training. 3.103 EQUIPMENT AND SUPPLIES (1) The governing board shall provide equipment and supplies necessary for the welfare and safety of patients. 3.104 FACILITIES (1) The governing board shall provide facilities necessary for the welfare and safety of patients. Part 4. ADMINISTRATIVE OFFICER 4.100 4.101 ORGANIZATION AND STAFFING (1) The facility shall have an administrative officer who shall be responsible for the onsite administration of the hospital and shall maintain liaison between the governing board and the medical staff. (2) The hospital shall be organized formally to carry out its responsibilities. The administrative officer shall be responsible for developing and implementing a written plan of organization defining the authority, responsibility, and functions of each category of personnel. 4.102 PROGRAMMATIC FUNCTIONS (1) The administrative officer shall be responsible for the development of hospital policies and procedures for employee and medical staff use. 4.103 EQUIPMENT AND SUPPLIES. Reserved.

4.104 FACILITIES. Reserved. Part 5. MEDICAL STAFF 5.100 5.101 ORGANIZATION AND STAFFING (1) All hospitals shall have an organized medical staff with written rules, regulations, and by-laws. The bylaws shall make provision for application, appointment, privileges, discipline, control, right of appeal, attendance at medical staff meetings, committees, and professional conduct in the hospital. (2) A physician from the organized medical staff shall be appointed or elected as chief of staff. (3) The medical staff shall meet regularly and maintain written records of these meetings. 5.102 PROGRAMMATIC FUNCTIONS (1) There shall be a medical committee composed of physicians to review systematically the work of the medical staff with respect to quality of medical care. (2) Medical records shall include final diagnosis with completion of medical records within 30 days following discharge. (3) The admitting diagnosis, history, and physical examination shall be completed no more than seven (7) days prior to admission or within twenty-four (24) hours after the patient's admission to the hospital. (4) All persons admitted as patients to a hospital shall have benefit of continuing daily care of a medical staff member. Policies shall be provided for coordinating and designating responsibility when more than one member of the medical staff is treating a patient. 5.103 EQUIPMENT AND SUPPLIES. Reserved. 5.104 FACILITIES. Reserved. Part 6. NURSING DEPARTMENT 6.100 6.101 ORGANIZATION AND STAFFING (1) There shall be a nursing department. The nursing department shall be organized formally to provide complete, effective care to each patient. (2) The nursing service department shall be under the direction of a registered nurse qualified by education and experience to direct effective nursing care. (3) There shall be a master plan of nurse staffing for providing continuous registered nurse coverage, for distribution of nursing personnel, for replacement of nursing personnel, and for forecasting future needs. The nursing care required by different types of patients shall be the major consideration in determining the number, quality, and category of nursing personnel that are needed in any given situation.

(4) The authority and responsibility of each nurse and nursing personnel shall be defined clearly in written policies. Licensed practical nurses and auxiliary nursing personnel shall be assigned only those duties for which they are qualified and shall be under the supervision of a registered nurse. 6.102 PROGRAMMATIC FUNCTIONS (1) There shall be written nursing procedures that establish the standards of performance for safe, effective nursing care of patients. These procedures shall be reviewed periodically and revised as necessary. (2) There should be a plan for continuous evaluation of nursing care including that of private duty nurses. The nursing department should periodically evaluate the adequacy of facilities in terms of patient and nursing needs, and participate in planning facilities and services. 6.103 EQUIPMENT. Reserved. 6.104 FACILITIES. Reserved. Part 7. PERSONNEL 7.100 7.101 ORGANIZATION AND STAFFING (1) Each hospital department or service shall have written organizational policies and procedures that identify the scope of the services to be provided, the lines of authority and accountability and the qualifications of the personnel performing the services. Such policies and procedures shall be made available to employees. (2) Each department or service of the hospital shall be under the direction of a person qualified by training, experience, and ability to direct the department or service. (3) There shall be sufficient qualified personnel in each department or service to properly operate the department or service. (4) Facility staff shall be licensed or registered in accordance with applicable state laws and regulations. (5) All persons assigned to the direct care of or service to patients shall be prepared through formal education, as applicable, and on-the-job training in the principles, the policies, the procedures, and the techniques involved so that the welfare of patients will be safeguarded. 7.102 PROGRAMMATIC FUNCTIONS (1) There shall be personnel records on each person of the hospital staff including employment application and verification of licensure, competencies and credentials for medical staff. (2) All personnel shall have a pre-employment physical examination and such interim examinations as may be required by the hospital administration or the health service physician. (3) There shall be library services available to meet the needs of the medical staff and other professional personnel. 7.103 EQUIPMENT AND SUPPLIES. Reserved. 7.104 FACILITIES. Reserved.

Part 8. MEDICAL RECORDS DEPARTMENT 8.100 8.101 ORGANIZATION AND STAFFING (1) A complete medical record shall be maintained on every patient from the time of admission through discharge. In addition, complete medical records shall be maintained for patients receiving emergency and outpatient services. (2) A registered record administrator or other trained medical record practitioner shall be responsible for the administration and functions of the medical record department. (3) There shall be a sufficient number of regular full-time and part-time employees so that medical record services may be provided as needed. 8.102 PROGRAMMATIC FUNCTIONS (1) Medical records shall be stored safely to provide protection from loss, damage, and unauthorized use. (2) Medical records shall be preserved as original records, on microfilm or electronically: (a) for minors, for the period of minority plus 10 years (i.e., until the patient is age 28) or 10 years after the most recent patient usage, whichever is later. (b) for adults, for 10 years after the most recent patient care usage of the medical record. (3) After the required time of record preservation, records may be destroyed at the discretion of the facility. Facilities shall establish procedures for notification to patients whose records are to be destroyed prior to the destruction of such records. (4) If a facility ceases operation, the facility shall make provision for secure, safe storage, and prompt retrieval of all medical records for the period specified in 8.102 (2). The hospital shall publicize in a widely circulated newspaper(s) in the facility’s service area a notice indicating where medical records can be retrieved. (5) All orders for diagnostic procedures, treatments, and medications shall be signed by the physician or other licensed practitioner as authorized by law submitting them and entered in the medical record in ink or in type. The prompt completion of a medical record shall be the responsibility of the attending physician or other practitioner authorized by law. Authentication may be by written signature, identifiable initials or computer key. The use of rubber stamp signatures is acceptable under the following strict conditions: (a) The physician or other practitioner authorized by law whose signature the rubber stamp represents is the only one who has possession of the stamp and is the only one who uses it; and (b) The physician or other practitioner authorized by law places in the administrative offices of the hospital a signed statement to the effect that he or she is the only one who has the stamp and is the only one who will use it. (6) The content of patient records shall be as follows. (a) All patient records shall include the following:

(i) Adequate identification - sociological data (including hospital number assigned to patient.) (ii) Chief complaint and present illness. (iii) History of disease or injury. (iv) Past, family, and personal history. (v) Physical examination reports. (vi) Reports of any special examinations, including clinical and pathological laboratory findings. Original copies of all pathology test results shall be posted in the patient's medical record, to include reports of tests referred to another laboratory. (vii) A written report of the findings and evaluation of each diagnostic imaging examination signed by the physician or other practitioner authorized by law responsible for the procedure, as applicable. (viii) Reports of consultations by consulting physicians, when applicable. (ix) Treatment and progress notes signed by the attending physician or other practitioner authorized by law. (x) Findings of clinical or other staff involved in the care of the patient. (xi) Nursing notes. (xii) All medications administered including the name, strength, dosage, mode of administration of the medication; date, time, and signature of the person administering. (xiii) Signed informed consent forms. (xiv) Final diagnosis, secondary diagnosis, complications. (xv) Disposition of the case and instructions for follow-up care. (xvi) Autopsy protocol, if any. (xvii) As applicable, physical therapy/occupational therapy treatment records to include a prescription and/or order for treatment signed by the physician, progress notes of the physical/occupational therapist, and results of special tests and measurements. (b) Inpatient records shall include the following: (i) Date and time of admission and discharge. (ii) Admission diagnosis. (iii) Discharge summary, with outcome of hospitalization. If the patient is discharged in less than 24 hours, the discharge summary may be included in the physician’s progress notes.

(c) Records of all patients undergoing surgery shall include the following: (i) History, physical, special examinations, and diagnosis recorded prior to operation. (ii) Anesthesia record, including post-anesthetic condition signed by the anesthetist, anesthesiologist, surgeon or licensed practitioner authorized by law to sign the record. (iii) Complete description of operative procedures and findings including the provisional diagnosis prior to the operative procedure, and post-operative diagnosis recorded and signed by the attending surgeon promptly following the operation. (iv) The pathologist's report on all tissues removed at the operation. (d) Records of all obstetric patients shall include the following: (i) Record of previous obstetric history and pre-natal care including blood serology, and RH factor determination. (ii) Admission obstetrical examination report describing conditions of mother and fetus. (iii) Complete description of progress of labor and delivery, including reasons for induction and operative procedures. (iv) Records of anesthesia, analgesia, and medications given in the course of labor and delivery. (v) Records of fetal heart rate and vital signs. (vi) Signed report of consultants when such services have been obtained. (vii) Names of assistants present during delivery. (viii) Progress notes including descriptions of involution of uterus, type of lochia, condition of breast and nipples, and report of condition of infant following delivery. (e) Records of newborn infants shall be maintained as separate records and shall contain the following: (i) Date and time of birth, birth weight and length, period of gestation, sex. (ii) Parents' names and addresses. (iii) Type of identification placed on infant in delivery room. (iv) Description of complications of pregnancy or delivery including premature rupture of membranes; condition at birth including color, quality of cry, method and duration of resuscitation. (v) Record of prophylactic instillation into each eye at delivery. (vi) Results of newborn screening required by law and regulation. (vii) Report of initial physical examination, including any abnormalities, signed by the attending physician.

(viii) Progress notes including temperature, weight, and feeding charts; number, consistency, and color of stools; condition of eyes and umbilical cord; condition and color of skin; and motor behavior. (f) The following hospital records shall be maintained: (i) Daily census (ii) Admissions and discharges analysis record. (iii) Chronological register of all deliveries including live and stillbirths. (iv) Register of all surgeries performed (entered daily) (v) Diagnostic index. (vi) Physician index. (vii) Death register. (viii) Register of out-patient and emergency room admissions and visits. 8.103 EQUIPMENT AND SUPPLIES (1) Each facility shall provide adequate supplies and equipment for the safe storage and prompt retrieval of medical records. 8.104 FACILITIES (1) Each hospital shall provide a medical record room or other suitable medical record facilities. (2) In the case of new hospital construction or modification of an existing hospital facility the hospital shall have a medical record department with administrative responsibility for medical records and the following shall apply: (a) Each hospital shall provide a medical record department and other medical record facilities with supplies and equipment for medical record functions and services. This department shall include: (i) Active Record Storage Area. (ii) Record Review and Dictating Room for physicians. (iii) Work area for sorting, recording, typing, filing and other assigned medical record functions shall be separate from the record review and dictating room. Consideration should be given to isolation of noisy equipment. Accommodations should be provided for conducting medical record business with hospital paramedical personnel or public individuals for legitimate access to medical records. (iv) Medical record storage area within the department. (v) Inactive medical record storage area. (May be omitted if microfilming used.) Medical record department shall be located in an area of the hospital that is convenient to most of the professional staff.

(b) Security measures shall be maintained by mechanical means in the absence of medical record supervision, to preserve confidentiality and to provide protection from loss, damage and unauthorized use of the medical records. Part 9. ANESTHESIA SERVICES 9.100 9.101 ORGANIZATION AND STAFFING (1) The hospital shall provide anesthesia services commensurate with the services provided by the hospital. (2) General or regional anesthesia or analgesia shall be administered only by a physician qualified by training, experience, and ability in anesthesiology; or a registered nurse anesthetist graduated from a certified school. In case of dental treatment, dentists may administer local anesthetics. 9.102 PROGRAMMATIC FUNCTIONS (1) Patients recovering from anesthesia shall remain under continuous care of a registered nurse. Nurses shall have been instructed in the care of post-anesthetic patients, shall have no other duties during the time they are caring for such patients and shall have facilities for immediate communication with the attending surgeon, anesthesiologist, or qualified substitute present in the hospital. 9.103 EQUIPMENT (1) There shall be equipment for the administration of anesthesia that is commensurate with the clinical procedures and programs conducted within the hospital. (2) Anesthesia equipment shall be cleaned properly and sterilized after each use excepting multi-use heat sensitive equipment may be disinfected using a process that is bactericidal, tuberculocidal and virucidal. Hypodermic needles, syringes, and allied equipment shall be sterilized, unless disposed of after use. Written procedures shall be developed for these processes. 9.104 FACILITIES (1) There shall be facilities for the administration of anesthesia that are commensurate with the clinical procedures and programs conducted within the hospital. (2) Areas used to care for post-anesthetic patients shall have facilities for immediate communication with the attending surgeon, anesthesiologist, or qualified substitute present in the hospital. Part 10 LABORATORY SERVICES 10.100 CLINICAL PATHOLOGY 10.101 ORGANIZATION AND STAFFING (1) Clinical pathology services shall be made available as required by the needs of the medical staff. Emergency laboratory services shall be made available whenever needed. (2) The laboratory shall be under the supervision of a physician, certified in clinical pathology, either on a full-time, part-time, or consulting basis. The pathologist shall provide, at a minimum, monthly consultative visits.

(3) There shall be a sufficient number of clinical laboratory technologists, qualified by training and experience, to promptly and proficiently perform the laboratory tests and examinations required of them. 10.102 PROGRAMMATIC FUNCTIONS (1) All clinical pathology services shall be ordered by a physician or a person authorized by law to use the results of such findings. (2) Clinical pathology services shall comply with the requirements set forth in the Clinical Laboratory Improvement Amendments (CLIA). (3) Policies and procedures (a) A manual outlining all procedures performed in the laboratory shall be complete and readily available for reference. (b) The conditions and procedures for referring specimens to another laboratory be in writing and available in the laboratory. (c) Procedures for the adequate precautions for discarding specimens shall be in use -sterilization, incineration, or both. (4) Records (a) A record system shall be established which ensures that specimens are adequately identified, properly processed, and permanently recorded. (b) Duplicate copies of all reports shall be kept in the laboratory in a manner which permits ready identification and accessibility for two years. 10.103 EQUIPMENT AND SUPPLIES (1) All equipment shall be in good working order, be routinely checked and be precise in terms of calibration. (2) If tests are performed in the specialties of mycobacteriology, mycology, and/or virology, the laboratory shall be equipped with a microbiological safety cabinet, with an adequately filtered exhaust system. (3) Vacuum breakers must be present on sinks where specimens are handled or discarded to ensure that the water supply is not contaminated. 10.104 FACILITIES. Reserved. 10.200 BLOOD BANKING 10.201 ORGANIZATION AND STAFFING (1) The hospital shall provide for the procurement, storage, and transfusion of blood as needed for routine and emergency cases. 10.202 PROGRAMMATIC FUNCTIONS (1) Standards of the American Association of Blood Banks shall be used; or the administrative staff of the

hospital must substitute, in writing, alternate standards which are safe and adequate for the collection and administration of blood and blood products. (2) Blood and blood products shall only be administered upon order of a physician or other practitioner authorized by law. (3) Before administering a blood transfusion, the following shall be identified accurately and verified by a registered nurse and a licensed health care professional acting within his or her standard of practice: 1) Patient; 2) Patient's blood specimen; 3) Type, crossmatch, and expiration date of donor blood. (4) Records must be kept which show the complete receipt and disposition of blood. (5) Each unit of blood typed and cross-matched for transfusion must be adequately identified by an attached tag which cannot be removed from the unit accidentally. 10.203 EQUIPMENT AND SUPPLIES (1) Equipment shall be available which ensures safe storage and transfusion of blood. (2) Refrigerators used to store blood overnight shall have a recording thermometer and an adequate alarm system. The refrigerator shall be on the emergency power source. 10.204 FACILITIES (1) Facilities shall be available to ensure safe storage and transfusion of blood. Part 11. PREGNANCY, LABOR AND DELIVERY 11.100 LABOR AND DELIVERY 11.101 ORGANIZATION AND STAFFING (1) To the extent the facility provides non-emergent labor and delivery services, the facility shall provide labor and delivery in accordance with the scope of care established pursuant to Section 3.102 (1). The requirements set forth in this Subpart 11.100 are in addition to those specified in Part 19, General Patient Care Services. (2) If a delivery suite is provided, the nursing service of the delivery suite shall be under the supervision of a registered nurse qualified by training and experience to direct obstetric nursing. 11.102 PROGRAMMATIC FUNCTIONS (1) Nursing (a) A registered nurse qualified by training and experience in delivery room nursing shall be present as a circulating nurse during each delivery. Additional registered and licensed practical nurses, or auxiliary nursing personnel shall be available as necessary. (b) Patients shall be provided with continuous direct care by a registered nurse, either in the delivery room or in an obstetric recovery room, until vital signs are established, shock and hemorrhage are not evidenced, and the patient is awake. (2) Policies for the administration of oxytocic drugs, analgesics, and anesthetics shall be written.

(3) Security measures shall be instituted to safeguard against unauthorized entry and to protect the safety of newborns. (4) Newborn Care (a) Identification shall be placed securely on each infant before removal from the delivery room. (b) Prophylaxis shall be administered to the eyes of all newborn infants. (c) Newborn screening shall be conducted in accordance with 5 CCR 1005-4 Newborn Screening and Second Newborn Screening. (5) If an obstetric recovery room is provided, it shall be restricted to obstetric patients only. 11.103 EQUIPMENT AND SUPPLIES (1) Each delivery room shall be equipped with the following: 1) Incubator approved by the Underwriters Laboratories; 2) Suction and resuscitation equipment for adults and infants; 3) Anesthesia machines and supplies for inhalation, spinal, and saddle-block anesthesia; 4) Instruments and supplies for management of normal delivery, obstetric emergencies; 5) Emergency drugs, solutions, and supplies; 6) Infant identification. 11.104 FACILITIES (1) The obstetric (maternity) patient care unit in the hospital should be isolated from other patient care units, both architecturally and nursing-wise. However, if necessary, under specific controls, the presence of clean gynecological and surgical cases may be admitted on the obstetric patient care unit. (2) The delivery suite and labor room(s) shall be located so as to minimize traffic to patients, visitors, and personnel from other areas of the hospital. (3) The design of and equipment in labor room(s) shall meet the requirements for a private bedroom specified in Part 19, General Patient Care Services except that windows need not be provided if mechanical ventilation is installed. (4) The delivery suite shall be provided with at least one delivery room should be equipped for major obstetrical operative procedures, including caesarian section. In case of new hospital construction, or modification of an existing hospital facility the following shall apply: (a) In hospitals of 30 beds or less, one operating suite may be used for surgical or delivery procedures, providing there is a labor room equipped for emergency delivery adjacent and accessible to the suite and with a minimum area of 180 sq. ft., no dimension to be less than 12'0" except ceiling height. Ventilation of the emergency delivery room must be either a separate system from that in the operating suite, allowing recirculation in each area, or if connected to the same system as the operating Suite, the system must provide 100% exhaust with no recirculation. (b) Sub-sterilizing room adjacent; to delivery room(s) will not be required unless major gynecological surgical procedures are performed in the delivery room. (5) The requirements specified in Part 23, Surgical and Recovery Services, Section 23.104, with the exception of the requirements for the operating room shall be met. (6) In hospitals under 50 beds, separate nurses and doctors locker rooms with toilets and showers for

each suite are desirable but not mandatory. 11.200 NURSERY SERVICES 11.201 ORGANIZATION AND STAFFING (1) The hospital may provide nursery services. The standards in this subpart shall only apply if the hospital provides such services. The following requirements are in addition to those specified in Part 19, General Patient Care Services. (2) Nursery services shall be under the supervision of a qualified physician. (3) A registered nurse shall supervise at all times the nursing care of newborn infants. At no time shall an infant be left unattended in the nursery. Nursing personnel assigned to the care of newborn infants should not care for other patients. 11.202 PROGRAMMATIC FUNCTIONS (1) Written policies and procedures shall be established for nursery personnel. (2) Personnel shall wash their hands before and after handling each infant. (3) Security measures shall be instituted to safeguard against unauthorized entry and to protect the safety of newborns. (4) Infants shall be held for feedings. Propping bottles is prohibited. (5) A common conveyor shall not be used to transport infants to mothers. (6) Each infant shall be examined upon admission to the nursery and daily until discharge. (7) Isolation of infectious disease cases shall be conducted in accordance with written neonatal standards of practice. If an infant is isolated with his mother, both shall be isolated in a private room. 11.203 EQUIPMENT AND SUPPLIES (1) The following equipment shall be provided in each nursery: 1) Easily cleaned bassinet for each infant, with storage space for the individual infant supplies in a compartment in bassinet or on individual table; 2) Incubator or warmer; 3) Infant emergency equipment and supplies essential to resuscitation; 4) Diaper waste receptacles with foot controls and disposable impervious liners, 5) Soiled linen waste receptacles with foot controls and disposable impervious liners, 6) Accurate easily cleaned scales. 11.204 FACILITIES (1) The nursery should be located in the maternity patient care unit as close to the mothers as possible and away from the line of traffic of others than maternity services. The nursery(ies) shall be separated physically and functionally from other hospital services. (2) A minimum of twenty-four (24) square feet per infant shall be provided within the nursery. Thirty square feet are recommended. (3) A control area shall be provided to serve as a work space and nursery entry for security.

(4) A fixed view window shall be provided between nursery(ies) and control area or between two nursery(ies). Fixed view windows between the nurseries and corridor shall be wire glass set in steel frames. In the case of new hospital construction or modification of an existing hospital facility, the view windows shall be 1/4 inch thick welded wire glass set in steel frames. Curtains or drapes when used in nurseries shall be laundered frequently and maintained flame-retardant. (5) All electrical outlets must have a common ground. One electrical outlet shall be provided for every two bassinets. Some of the outlets shall be connected to an emergency source of power. In the case of new hospital construction, or modification of an existing hospital facility fifty (50) percent of the outlets shall be connected to an emergency source of power. The use of adapters, extension cords, and junction boxes should be discouraged. (6) The nursery(ies) shall be well lighted to permit optimal observation and for easy detection of jaundice or cyanosis. In the case of new hospital construction, or modification of an existing hospital facility, shadow-free illumination with at least 100 ft. candle intensity at the infants' level is required and is best provided by fluorescent lamps. A suggested fluorescent tube for illuminations is General Electric's fluorescent tubes F-40-CWX(deluxe cool white) or equal. Light fixtures should be provided with lenses to reduce glare. The number and exact location of fixtures cannot be recommended because ceiling height and windows influence the intensity of the illumination. Spot illumination can be provided by a portable lamp containing two 15 watt fluorescent bulbs which, when held 12” from the infant, will produce about 100 ft. candle intensity of light. (7) Wall surfaces shall be washable and non-glare. Acoustical ceiling tile is permissible if it is incombustible and washable. (8) A minimum ventilation rate of 12 room volumes of out-door air per hour with no recirculation shall be provided by mechanical supply and exhaust air systems. Filters with a minimum efficiency of 9099 percent in the retention of particles shall be provided. Positive air pressure relative to the air pressure of adjoining areas should be maintained. A temperature of 75-82° F. and a relative humidity of less than 50% is recommended. In the case of new hospital construction, or modification of an existing hospital facility, access openings in ducts for cleaning purposes shall be provided. (9) Facilities shall be available for the immediate isolation of all newborn infants who have or are suspected of having an infectious disease (e.g., infants whose possible infection constitutes a risk or danger to other newborns, including those born outside the delivery suite.) (10) The following shall be provided in each nursery: 1) Lavatory with mixing faucet, knee, foot or automatically operated, soap and sanitary hand-drying accommodations; 2) Piped oxygen with outlets, one for every four bassinets; 3) In the case of new hospital construction, or modification of an existing hospital facility, a nurse call shall be provided. Part 12. DIETARY SERVICES 12.100 12.101 ORGANIZATION AND STAFFING (1) There shall be an organized food service planned, equipped, and staffed to serve adequate meals to patients according to physicians' orders. (2) A dietitian or person qualified by training and experience in food service shall direct the dietary services. 12.102 PROGRAMMATIC FUNCTIONS

(1) Policies and procedures for dietary practices shall be written. (2) Therapeutic Diets (a) All diets and nourishments shall be served as prescribed by the attending physician. (b) A diet manual shall be available to medical staff and personnel for fulfilling dietary prescriptions. (3) Menus (a) Menus shall be varied to meet patient needs. Personal tastes, desires, and cultural patterns of patients shall be considered and reasonable menu adjustments made. (b) Rotating menus are recommended. (4) All food served shall be from approved sources and shall meet the standards of quality as established by applicable laws and regulations. Food prepared outside the hospital shall be from sources that comply with applicable laws and regulations. (5) Personal Hygiene (a) Employees shall wash their hands thoroughly in an approved hand washing facility before starting work and as often as may be necessary to remove soil and contamination. Each employee shall wash his hands before resuming work after visiting the toilet room. (b) All dietary employees shall wear hair nets, head-bands, caps, or other effective hair restraints. (c) Employees shall not use tobacco in any form while engaged in food preparation, service, or equipment washing areas. (6) Food Storage and Handling (a) Unwrapped food on display for service shall be protected against contamination by counterprotector devices. Food being conveyed should be covered, completely wrapped or packaged to protect from contamination. (b) Potentially perishable foods shall be maintained at a temperature of 45° F. or below, or 140° F. or above. Other foods should be stored at approximately 50° F. (c) Convenient and suitable utensils, including self-service, such as forks, knives, tongs, and spoons shall be used to handle food at all points where food is prepared and served. (7) Poisonous and toxic materials shall be labeled, stored separately from food, and used only in such ways that they will neither contaminate food nor be hazardous to employees. (8) Storage and Handling of Utensils (a) Clean cups and glasses shall be handled so that fingers do not contact inside or lip-contact surfaces. (b) Portable equipment and utensils shall be cleaned, disinfected, and stored above the floor in a clean, dry location. Utensils shall be air-dried before storing. Stored containers and utensils shall be covered or inverted.

(c) Disposable serving utensils shall be stored, handled, and dispensed to prevent contamination; and shall be used only once. (9) Food served to patients in isolation, because of infectious diseases, shall be in disposable utensils or in utensils that shall be sterilized. (10) Ware Washing and Storage (a) If washable dishes are used, commercial-type mechanical dishwashing equipment shall be provided equipped with an easily readable thermometer in each tank. In case of new hospital construction, or modification of an existing hospital facility this equipment shall be physically separated from food preparation and service areas. Equipment and utensils shall be prescraped and, when necessary, presoaked to remove soil. A suitable detergent in effective concentration shall be used. Wash water shall be kept reasonably clean, and washing cycle properly timed. The wash water temperature shall be compatible with the detergent used. The final rinse water shall be unused water at temperature not less than 180° F. manifold temperature, 170° F. on the surface of the dishes. Rinsing cycles shall be timed accurately. In case of new hospital construction, or modification of an existing hospital facility, the dishwash room must be arranged such that clean dishes are discharged from the dish machine onto a clean dish table outside of the dishwash room. Only air drying shall be employed after washing and rinsing. All dishes and utensils shall be stored in clean, dry areas free of contamination. (b) Utility ware, pots, pans, and similar utensils shall be cleaned in an area separated from the dishwashing operation. (c) Separate drainboards shall be used for soiled utensils prior to washing and for clean utensils following disinfecting. (11) Garbage and refuse shall be placed in impervious containers equipped with tightly fitting covers. Containers shall be stored in a safe area or refrigerated space pending removal and shall be removed from the premises and cleaned at frequent intervals. (12) Storage rooms, loading docks, and premises shall be free from rodent and insect infestation, odors, dust, and other sources of contamination. 12.103 EQUIPMENT AND SUPPLIES (1) A minimum of two units of refrigeration shall be provided to protect foods kept on hand. Refrigerators and storerooms used for perishable foods shall be equipped with reliable thermometers. (2) Walk-in refrigerators and freezers shall have inside lighting and inside lock releases, or an audiovisual signal system as a suitable safety device. (3) Adequate equipment shall be provided for efficient preparation of meals. Equipment and utensils should be resistant to denting, pitting, chipping, and excessive wear; should withstand repeated scrubbing, scouring, and corrosive action of cleaning and disinfecting agents; and should be in good repair. (4) Food-contact surfaces of equipment and utensils shall be smooth; free from breaks, open seams, cracks, chips, and similar imperfections; and free of difficult-to-clean internal corners and crevices. (5) Cutting blocks, boards, and table tops should be of hard material which is non-toxic; smooth; and free of cracks, crevices, and open seams.

(6) Equipment on tables or counters, unless readily movable, shall be installed so as to facilitate cleaning and safety. (7) Floor-mounted equipment, unless readily movable shall be sealed to the floor to prevent liquids or debris from settling under the equipment. Lubricated bearings and gears shall be constructed so that lubricants cannot get into the food. (8) Food waste grinders shall be installed in compliance with applicable laws and regulations. 12.104 FACILITIES (1) Adequate space shall be provided to allow for fixed and movable equipment and employee functions for receiving and storage, refrigeration, food preparation, and dishwashing and scullery. (2) Clean, well ventilated food storerooms shall be provided. Food when being stored, prepared, displayed, served, or sold shall be protected from contamination. (3) Containers of food shall be stored above the floor on clean racks, dollies, or other clean surfaces to protect them from contamination. (4) Facilities and systems for storage of silverware shall be designed and maintained to prevent contamination. (5) Areas for preparing food, and storing and cleaning utensils shall be adequately lighted. (6) Rooms for preparing and serving food and washing utensils shall be well ventilated. Filters shall be readily removable for cleaning or replacement. (7) Adequate, clean toilet facilities shall be provided. (8) Approved handwashing facilities with soap and sanitary hand-drying accommodations shall be conveniently provided. In the case of new hospital construction, or modification of an existing hospital facility, this must be provided within the kitchen area. (9) In case of new hospital construction, or modification of an existing hospital facility, this area the area for the manual washing of utility ware, pots, pans and similar utensils must be physically separated from the dishwashing operation. Separate two-compartment sinks are required for manual washing operations, and they shall be of such length, width, and depth to permit complete immersion of equipment and utensils. In the case of new hospital construction, or modification of an existing hospital facility, each compartment shall be supplied with hot and cold water under pressure through a mixing faucet. (10) In the case of new hospital construction, or modification of an existing hospital facility, the following shall apply: (a) Cart washing space must be provided, preferably in the dishwashing area. Hot water and a floor drain must be provided in this area. (b) A lounge, complete with lockers and toilet facilities for the dietary staff shall be provided near the kitchen. (c) Dining area(s) must be provided for staff, visitors and patients. Part 13. EMERGENCY SERVICES

13.100 13.101 ORGANIZATION AND STAFFING (1) Each general hospital shall be organized and equipped to provide emergency treatment at any hour to persons presenting or presented for this purpose. Such treatment shall be rendered in an area specifically designated for this service, and hereafter referred to as the “emergency department” . (2) Each hospital shall have a well defined plan for the provision of emergency care. This plan shall relate to community need and the capability of the hospital. If the hospital elects to transfer patients, the referring hospital shall institute essential life saving measures and provide emergency procedures. (3) The emergency department shall be organized formally as a department or service of the organized medical staff. (4) Provision shall be made for medical staff coverage at any hour. (5) A registered nurse qualified by training and experience in emergency procedures shall be available at all times to supervise nursing care in the emergency unit. Nursing staff shall be available to cover average utilization. Provision shall be made for additional nursing personnel during unusual circumstances. 13.102 PROGRAMMATIC FUNCTIONS (1) Emergency patient care shall be guided by written policies, and shall be supported by appropriate procedure manuals and reference material. (2) Each patient shall be discharged from the emergency department only upon a physician’s recorded authorization including instructions given to the patient for follow-up care. (3) A poison control chart and the location and telephone number of the nearest poison control center shall be posted prominently in the emergency department. 13.103 EQUIPMENT AND SUPPLIES (1) Equipment, supplies and drugs shall be provided commensurate with the scope of operation. (2) The equipment and supplies shall include but not be limited to the administration of blood, plasma, plasma expanders, parenteral solutions; the administration of oxygen; tracheotomy; the control of bleeding; emergency splinting of fractures; and gastric lavage. X-Ray permeable stretchers intended for use as examining tables should be provided. 13.104 FACILITIES (1) Emergency facilities should be conveniently located with respect to radiological and laboratory services. Emergency facilities shall be separate and removed from surgical and obstetrical suites and shall consist, as a minimum of the following: (a) A well-marked ENTRANCE, separate from the main hospital entrance, at grade level and sheltered from the weather with provisions for ambulance and pedestrian service. (b) A RECEPTION AND CONTROL AREA with visual control of the entrance, waiting room and treatment area. (Required for hospitals of 50 beds or more).*

(c) COMMUNICATIONS with appropriate nursing stations outside the emergency unit and connected to emergency power source. (d) PUBLIC WAITING SPACE with toilet facilities, telephone, drinking fountain, stretcher and wheelchair storage.* (e) EMERGENCY ROOM equipped with clinical sink and handwashing facilities.* (f) NURSES STATION which may be combined with reception and control area, or it may be within the emergency room.* (g) STORAGE FOR CLEAN SUPPLIES.* * Required only in case of new hospital construction, or modification of an existing hospital facility.

(2) If provided, operating rooms located within the emergency unit shall meet the requirements specified in Part 23 surgical suite and recovery room(s). (3) The following physically separated areas must be provided: 1) An adequate waiting room, 2) public toilet facilities, 3) public phone, 4) drinking fountain, 5) patient preparation area with adjacent toilet room, handwashing and provision for storing patient's clothing, 6) provisions within the patient preparation area for medication storage and preparation, 7) recovery room equipped as specified in Part 33, Section 11. Part 14. OUTPATIENT SERVICES 14.100 14.101 ORGANIZATION AND STAFFING (1) Hospitals shall provide outpatient services. (2) There shall be specific written policies for admissions and discharge of patients, physician responsibility, staffing, and procedures for individual patient care, and equipment and supplies. (3) The nursing service shall be under the supervision of a registered nurse qualified by training, experience and ability. There shall be such professional and non-professional personnel as required for efficient operation. 14.102 PROGRAMMATIC FUNCTIONS. Reserved. 14.103 EQUIPMENT AND SUPPLIES. Reserved. 14.104 FACILITIES (1) The following physically separated areas shall be provided: 1) An adequate waiting room, 2) public toilet facilities, 3) public phone, 4) drinking fountain, 5) patient preparation area with adjacent toilet room, handwashing and provision for storing patient's clothing, 6) ' provisions within the patient preparation area for medication storage and preparation, 7) recovery room equipped as specified in Part 23, Surgical and Recovery Services. Part 15. INFECTION CONTROL SERVICES 15.100 15.101 ORGANIZATION AND STAFFING

(1) The facility shall have an infection control program responsible for reducing the risk of acquiring and transmitting nosocomial infections and infectious diseases in the facility. (2) There shall be a multi-disciplinary infection control committee charged with: (a) developing written policies and procedures regarding prevention, surveillance and control of nosocomial infections and infectious diseases. (b) making findings and recommendations to prevent and control nosocomial infections and infectious diseases. (3) Infection control officer(s) shall implement the policies and procedures and the recommendations of the infection control committee. 15.102 PROGRAMMATIC FUNCTIONS (1) There shall be written policies and procedures regarding infection control consistent with the following guidelines of the Centers for Disease Control and Prevention (CDC): Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings, 2007 and Guidelines for Environmental Infection Control in Health-Care Facilities, 2003. Policies and procedures shall include, but not be limited to: (a) the admission and isolation of patients with specific infectious diseases; (b) the control of routine use of antibiotics and adrenocorticosteroids; (c) the inservice education programs on the control of nosocomial and infectious diseases, including but not limited to universal precautions; (d) standards for sterilization of equipment used for direct patient care; (e) standards for cleaning and disinfecting all areas of the hospital; (f) standards for linen and laundry services; (g) the implementation of infection control measures during hospital renovations; (h) the reporting of diseases as required by laws and regulations pertaining to disease control. (2) The committee shall make findings and recommendations available promptly to the infection control officer for action. (3) The committee shall meet at least monthly and maintain minutes of the meetings. 15.103 EQUIPMENT AND SUPPLIES. Reserved. 15.104 FACILITIES (1) Rooms used for isolation of patients with infectious diseases should be: 1) Equipped with private toilet facilities; 2) Provided with an air supply and exhaust system that neither recirculates nor redistributes air from a central air system; 3) Designed to provide a negative or positive pressure in relation to adjacent areas. In the case of new hospital construction, or modification of an existing hospital facility isolation room(s) shall be provided on the basis of one for each thirty (30) beds or major fraction thereof, if

the hospital does not have a separate contagious disease unit. Each isolation room shall have: (a) Handwashing facilities as required in Part 19 General Patient Care Services. (b) Separate toilet room with bath or shower (c) Mechanical ventilation shall be provided at the rate of six air changes per hour with no recirculation. Supply air shall be filtered using 80% efficient filters. Rooms to be of negative pressure relative to adjacent areas. (d) An anteroom with lavatory should be provided (One anteroom may serve more than one isolation room.) Part 16. RESPIRATORY CARE SERVICES 16.100 16.101 ORGANIZATION AND STAFFING (1) The hospital may provide respiratory care services. The following standards shall apply only if the hospital provides such services. (2) The respiratory care service should be under the direct supervision of a committee of the organized medical staff or a physician who has had special training in respiratory diseases and therapy. 16.102 PROGRAMMATIC FUNCTIONS (1) Respiratory care services shall be administered only by persons qualified by training, experience, and ability in respiratory therapy. 16.103 EQUIPMENT AND SUPPLIES (1) The equipment for respiratory care services shall be commensurate with the clinical procedures and programs of the hospital. (2) Respiratory care equipment shall be cleaned properly and disinfected after each use in accordance with written procedures. The disinfection process shall be bactericidal, tuberculocidal, and virucidal. 16.104 FACILITIES (1) The facilities for respiratory care services shall be commensurate with the clinical procedures and programs of the hospital. Part 17. CRITICAL CARE SERVICES 17.100 17.101 ORGANIZATION AND STAFFING (1) The hospital may provide critical care services in a critical care unit. The following standards shall apply only if the hospital provides such services. 17.102 PROGRAMMATIC FUNCTIONS

(1) There shall be specific written policies for admission and discharge of patients, physician responsibility, staffing, and procedures for individual patient care. (2) The nursing service shall be under the supervision of a registered nurse qualified by training, experience, and ability. At least a minimum of one registered nurse shall be on duty at all times to give direct patient care. Additional nursing personnel shall be available, consistent with the nursing care required by the different types of patients. 17.103 EQUIPMENT AND SUPPLIES (1) There shall be written policies regarding equipment and supplies. (2) The equipment shall include: 1) Variable height beds with safety sides; 2) Bedside cabinets; 3) Sphygnomannometers; 4) Resuscitation apparatus; 5) Additional equipment as oxygen tents, pacemaker, defibrillator, and electrocaridiography apparatus. 17.104 FACILITIES (1) A system shall be established for calling selected emergency personnel to the unit. (2) The critical unit shall have: 1) Intravenous rods installed in ceilings or walls, or attached to beds; 2) Piped oxygen; 3) Suction outlets; 4) Emergency signal system at each bed and nurses station, 5) In case of new hospital construction or modification of an existing hospital facility, an emergency call from unit to outside the unit where additional personnel are available shall be provided. (3) The area shall be sufficient in size to allow movable equipment to be placed on either side of the bed(s) and provide-at least 80 square feet per bed in multiple bedrooms and 100 square feet in single bedrooms. Space for storage of commonly used equipment and supplies shall be provided. (Storage carts are recommended). A patient care control center (nurses station), medicine preparation area, clean and soiled holding areas, and janitor's closet conforming to the requirements of Section 19, Patient Care Unit, shall be provided in proximity to the bedrooms or within the enclosures. When more than one enclosure is provided within room, the size of these areas should be increased. (4) A toilet complete with flushing attachments shall be provided in each room. In case of new hospital construction or modification of an existing hospital facility the door to the toilet room shall be 2'8” wide, 3'0” recommended. (5) A lavatory complete with mixing faucet, blade controls, soap, and sanitary hand-drying accommodations shall be provided within each room. (6) Two duplex convenience outlets shall be installed in proximity to the head of each bed. General lighting shall be uniform throughout the room and controlled by a dimmer. The electrical system shall be connected to the emergency power system. In the case of new hospital construction, or modification of an existing hospital facility, four duplex convenience outlets shall be installed in proximity to the head of each bed. (7) A waiting room shall be provided. This may be shared with as adjacent patient care unit. Part 18. OCCUPATIONAL AND PHYSICAL THERAPY SERVICES 18.100 OCCUPATIONAL THERAPY 18.100 ORGANIZATION AND STAFFING

(1) The hospital may provide occupational therapy services. The following standards shall apply only if the hospital provides such services. (2) Occupational therapy services shall be rendered only by individuals qualified by training and experience. 18.101 PROGRAMMATIC FUNCTIONS (1) There shall be written policies identifying the organization, administration, performance standards, and direction and supervision of patient care rendered. 18.102 EQUIPMENT AND SUPPLIES (1) There shall be appropriate equipment as determined by the professional staff to be essential to the requirements of care and treatment of referred patients. 18.103 FACILITIES (1) There shall be adequate facilities, space, and storage areas as determined by the professional staff to be essential to the requirements of care and treatment of referred patients. 18.200 PHYSICAL THERAPY 18.201 ORGANIZATION AND STAFFING (1) The hospital may provide physical therapy services. The following standards shall apply only if the hospital provides such services. (2) The physical therapy services shall be under medical direction. This may be 1) A committee of the organized medical staff, or 2) A designated physician qualified by training and experience. (3) Physical therapy shall be rendered only by a physical therapist licensed to practice in the State of Colorado. All personnel assisting with the physical therapy of patients must be under the direct supervision of a licensed physical therapist. 18.202 PROGRAMMATIC FUNCTIONS (1) There shall be written policies governing physical therapy services. 18.203 EQUIPMENT AND SUPPLIES (1) There shall be appropriate equipment as determined by the professional staff, to be essential to the requirements of care and treatment of referred patients. 18.204 FACILITIES (1) The physical therapy services shall be located in an area convenient for in and out patients. (2) There shall be adequate facilities, space, appropriate equipment, and storage areas as determined by the professional staff to be essential to the requirements of care and treatment of referred patients. Part 19. GENERAL PATIENT CARE SERVICES 19.100

19.101 ORGANIZATION AND STAFFING (1) There shall be patient care services commensurate with the services provided by the facility. (2) The nursing care required by different types of patients shall be the major consideration in determining the number, quality, and category of nursing personnel that are needed in any given situation. 19.102 PROGRAMMATIC FUNCTIONS (1) Admissions (a) Each patient admitted to the hospital shall have a visible means of identification placed on his person. (b) No patient shall be admitted for inpatient care to any room or area other than one regularly designated as a patient bedroom. There shall be no more patients admitted to a patient bedroom than the number for which the room is designed and equipped. Emergencies are exceptions. (2) Patient Care Unit (a) At least one registered nurse shall be on duty at all times in each patient care unit. One registered nurse shall be designated in charge and shall be delegated the authority and responsibility for the nursing services on that patient care unit. Additional registered nurses, licensed practical nurses, or other auxiliary personnel shall be available. (b) Written policies for patient care shall be established. (3) A nursing care plan shall be prepared for each patient. The plan shall be reviewed and revised as needed. (4) Medications (a) Medications shall be identified with at least the name, strength, dosage, and frequency and mode of administration of the medication; and the name of the patient for whom the medication is prescribed. This identification shall be verified not only when the medicine is prepared but also when it is administered. (5) Orders (a) Medications and treatments shall be given only on the order of a physician or other practitioner authorized by law. (b) Orders shall be received by a house physician or registered nurse; shall be written; and shall include the date, time, and specifications of the order. (c) Physician orders for treatment may be received by members of the appropriate discipline as specified and approved by the medical staff, nursing services, and the governing board. (d) Orders shall be transferred to the medical record by a member of the specific discipline responsible for implementing the order. (e) Orders prescribing dangerous drugs, i.e., narcotics, sedatives, anticoagulants, antibiotics, etc., shall include a time limit. Such time limit shall be agreed upon by the medical staff

and shall be so recorded in the rules and regulations of the organized medical staff. 19.103 EQUIPMENT/FURNITURE AND SUPPLIES (1) The following shall be readily available at all times: 1) Oxygen; 2) Suction; 3) Portable emergency equipment, supplies and medications; 4) Compatible supplies and equipment for immediate intravenous therapy. (2) Patient bedrooms shall be equipped with movable furniture and equipment with the following for each patient: 1) Adjustable, washable bed with side rails; 2) Cabinet or bedside table; 3) Overbed table; 4) Complete personal care equipment that is sterile including water carafe, mouth wash cups, emesis basin, wash basin, bedpan and urinal (when necessary). 19.104 FACILITIES (1) Patient Rooms (a) There shall be provisions for private and multiple bedrooms to meet the needs of patients and programs of the hospital. There shall be no more than four beds per patient bedroom. There should be no more than approximately 40 patient beds in a patient care unit. (b) Each one-bed room shall contain a minimum floor area of 100 square feet. Each multiple-bed room shall contain a minimum floor area of 80 square feet per bed. This minimum floor area, may include built-ins not exceeding four feet in height. (c) Privacy shall be provided for each patient in a multiple-bed room by the installation of approved cubicle curtains or partitions. (d) Each patient bedroom shall have a minimum window area equal to 1/8 of the floor area. The ground level shall be maintained at or below the window sill for a distance of at least 8 feet measured perpendicular to the window. Privacy for the patient and control of light shall be provided at each window. (e) Each patient bedroom shall have direct entry from a corridor. In the case of new hospital construction, or modification of an existing hospital facility, the door to each patient room may be no more than 120 feet from the nursing station or from the clean or soiled holding rooms. (f) Artificial light shall be provided and include: 1) General illumination; 2) Other sources of sufficient illumination for reading, observations, examinations, and treatments; 3) Night light controlled at the door of the bedroom; 4) Quiet operating switches (not required in existing buildings.) (g) A lavatory complete with mixing faucet, blade controls, soap and sanitary hand drying accommodations shall be provided in each patient bedroom, except that the lavatory may be installed within the toilet room in private bedrooms. (h) Toilet facilities shall be provided immediately adjacent to private or multiple-bed rooms in the ratio of one facility for not more than four patient beds and shall include: 1) Toilet with bedpan flushing equipment; 2) Incombustible waste paper receptacle, either seamless or with removable impervious liner; 3) Approved grab bars convenient for the safety of patients; 4) Nurse-call signal system. In new construction the door to the toilet shall be at least 2'8” in width and shall not swing into the toilet room unless provided with rescue hardware. Recommend 3'0” door.

(i) Each patient shall be provided with separate closet space or locker. In the case of new hospital construction or modification of an existing hospital facility, the closet space or locker must open into the patient room. (j) Each patient shall be furnished with a nurse-call signal system that registers a signal from the patient, at the corridor bedroom door, at the patient care control center (nurses station), and in service areas of the patient care unit. A duplex unit may be used for 2 patients in multi-bed rooms, but a light should be provided to indicate the patient placing the call. (2) Service Areas (a) The following service areas shall be provided and located conveniently for patient care: 1) Patient care control center (nurses station) accommodating a nurse call signal system from patients, a communication system with other hospital departments, and the outside; 2) Medical record recording facilities; 3) Medicine preparation area; 4) Clean holding area: 5) Soiled holding area; 6) Janitor's closet; 7) Stretcher and wheelchair storage area, 8) Nourishment station shall be provided in the case of new hospital construction, or modification of an existing hospital facility; 9) Clinical examination and treatment room: 10) Bathing facilities. (b) The patient care control center (nurses station)** shall be adequately designed and equipped. (c) The medication preparation area** shall be equipped with: 1) Cabinets with suitable locking devices to protect drugs stored therein; 2) Refrigerator equipped with thermometer and used exclusively for pharmaceutical storage; 3) Counter work space; 4) Sink with approved handwashing facilities; 5) Antidote, incompatibility, and metri-apothecary conversion charts. Only medications, equipment, and supplies for their preparation and administration shall be stored in the medication preparation area. Test reagents, general disinfectants, cleaning agents, and other similar products shall not be stored in the medication area. ** Other approved facilities for patient services may be substituted to meet the requirements specified in 19.13 through 19.18

(3) Linen and Laundry (a) (Not required in hospitals of 25 beds or less if the CSR is conveniently located on the same floor). The clean supply holding room*** shall be equipped with: 1) Suitable counter sink with mixing faucet, blade controls, soap, and sanitary band drying facility; 2) Waste container with cover (foot controlled recommended), and impervious, disposable liner; 3) Cupboards or carts for supplies. In the case of new hospital construction, or modification of an existing hospital facility, 4) Mechanical fresh air supply to maintain positive pressure; and 5) Nurse call utility station must also be provided. (b) There shall be a separate closed area in the clean supply holding room, on a cart, or in a separate closet for clean linen supplies.*** (c) (Not required in hospitals of 25 beds or less if there is a CSR, and a soiled linen holding room or soiled linen chute conveniently located on the same floor). The soiled holding room*** shall be equipped with: 1) Suitable counter sink with mixing faucet, blade controls, soap, and sanitary hand-drying facility. In the case of new hospital construction, or modification of an existing hospital facility the sink must be 2-compartment. 2) Waste container with cover (foot controlled recommended) and impervious, disposable liner; 3) Soiled linen cart or hamper with impervious liner; 4) Accommodations and provisions for enclosed soiled articles; 5) Space for short-time holding of specimens awaiting delivery to laboratory; 6) Adequate shelf and counter space; and in the case of new hospital construction, or modification of an existing hospital facility, 7) Nurse call utility station; 8) A

clinical flushing sink; and 9) Continuous mechanical exhaust ventilation to the outside. (4) The janitor's closet*** shall be equipped with: 1) Sink, preferably a floor receptor, with mixing faucets; 2) Hook strip for mop handles from which soiled mopheads have been removed; 3) Shelving for cleaning materials; 4) Approved handwashing facilities, in the case of new hospital construction, or modification of an existing hospital facility, the handwashing facility must be separate if a floor receptor is used; 5) Waste receptacle with impervious liner. The floor area should be adequate to store mop buckets on a roller carriage, wet and dry vacuum machine, and floor scrubbing machine. (5) In new construction, recessed storage space or rooms shall be provided for extra equipment, stretchers, and wheelchairs. (6) In new construction, the nourishment station shall contain a sink equipped for handwashing, equipment for serving nourishments between scheduled meals, refrigerator, and storage cabinets. Ice for patient service and treatment shall be provided only by ice maker - dispenser units. *** Other approved facilities for patient services may be substituted to meet the requirements specified in 19.13 through 19.18.

(7) Patient bathing facilities shall be provided in the ratio of one tub or shower for each ten patients. Approved grab bars, and in the case of new hospital construction, or modification of an existing hospital facility, a nurse call, shall be installed at each tub or shower convenient for the safety of patients using the tub or shower. The room shall be sufficiently large to provide space for wheelchair movement and provision for privacy. In the case of new hospital construction or modification of an existing hospital facility, on each patient floor at least one shower shall be provided which will accommodate a wheelchair. There should be toilet and lavatory facilities in the bathroom with mixing faucet, blade controls, soap, and sanitary hand-drying accommodations. (8) Toilet facilities shall be provided for personnel on each patient care unit. Part 20. PEDIATRIC PATIENT CARE SERVICES 20.100 20.101 ORGANIZATION AND STAFFING (1) The hospital shall provide pediatric patient care in accordance with the scope of care established pursuant to Section 3.102 (1). The following requirements are in addition to those specified in Part 19, General Patient Care Services. (2) A medical staff member with special training in pediatrics should be appointed chief of pediatric service. (3) Pediatric nursing care shall be under the direction of a registered nurse qualified by training, experience, and ability to direct effective pediatric nursing. All nursing personnel, assigned to care for children, shall be oriented to the special care of children. 20.102 PROGRAMMATIC FUNCTIONS (1) The hospital shall not routinely admit children to patient bedrooms where accommodations are shared with adults.

20.103 EQUIPMENT AND SUPPLIES (1) When a pediatric patient care unit is established it shall provide: 1) equipment and supplies appropriate for the care of children; 2) Cubicle partitions, when used, that permit visibility of patients by nurses and by patients in the same room and that are of shatterproof materials; 3) washable tables and chairs of various sizes, and appropriate entertainment materials. 20.104 FACILITIES (1) A separate pediatric patient care unit is recommended when the annual average pediatric daily census requires 10-14 beds. The unit should contain no more than 24 beds. (2) When a pediatric patient care unit is established it shall provide; 1) A playroom with washable tables and chairs of various sizes, storage for equipment and supplies, and appropriate entertainment materials; 2) An examination and treatment room with equipment and supplies appropriate for the care of children; 3) Rooms designed and furnished to facilitate grouping patients according to condition and age groups; 4) Cubicle partitions, when used, that permit visibility of patients by nurses and by patients in the same room and that are of shatterproof materials; 5) Space with adequate facilities for safe storing and warming of food. (3) Nursery facilities shall be provided for sick newborn infants transferred from the newborn nursery and admitted from outside. The facility shall include: 1) A minimum of 30 square feet of space for each bassinet or incubator; 2) At least one incubator approved by the Underwriters Laboratories; 3) Diaper containers with foot-controlled covers and impervious, disposable liners; 4) Baby scales and stand. (4) Reasonable privacy, without limiting necessary observation, shall be available for adolescents. Part 21. PHARMACEUTICAL SERVICES 21.100 21.101 ORGANIZATION AND STAFFING (1) The pharmaceutical services of the hospital shall be organized and maintained primarily for the benefit of the hospital patients, and shall be operated in accordance with federal and state laws and regulations. (2) The pharmacy service shall be under the direction or supervision of a pharmacist licensed to practice pharmacy in the State of Colorado. 21.102 PROGRAMMATIC FUNCTIONS (1) Written policies shall be developed by the hospital and the supervising pharmacist to indicate the pharmacist’s responsibility for periodic inspection of medications, dispensing, inventory control, and establishment of necessary records. (2) The pharmacist shall initiate and develop policies of the service. There should be a hospital pharmacy and therapeutic committee to assist in the formulation of broad professional policies regarding the evaluation, selection, procurement, distribution, use, safety procedures, and other matters relating to drugs in hospitals. It is recommended that a formulary be adopted and operations be under the formulary system. (3) Unused prepared medications shall be disposed of in accordance with documented procedures.

(4) A pharmacist's responsibilities shall include: 1) Preparation of pharmaceuticals; 2) Filling and labeling of all drug containers from which medications are to be administered; 3) Dispensing of drugs, antibiotics, biological, and pharmaceutical preparations which shall meet the standards established by the United States Pharmacopeia , National Formulary , or New and Non-official Drugs : 4) Dispensing of narcotics, hypnotics, amphetamines, alcohol preparations, and the maintenance of a perpetual inventory of them; 5) Maintenance of an approved stock of antidotes and emergency drugs; 6) Periodic inspection of all pharmaceuticals and biological supplies on all services; 7) Distribution of information concerning medications to physicians, dentists, and nurses; 8) Preparation, sterilization, and analysis of injectable medications when compounded in the pharmacy; 9) Establishment and maintenance of a system of records and accounting in accordance with hospital policies. (5) Only physicians, who are so authorized under the laws of the State of Colorado, and are registered with the Director of Internal Revenue, shall prescribe narcotics. 21.103 EQUIPMENT. Reserved. 21.104 FACILITIES (1) Facilities shall be provided for the storage, safe-guarding, preparation, and dispensing of drugs with proper lighting, temperature control, ventilation, and sanitation facilities. In addition to adequate safeguards for all drugs, special safety precautions should be given to the storage of alcohol. (2) A refrigerator with thermometer and freezing compartment shall be provided for the proper storage of thermolabile products. Part 22. PSYCHIATRIC PATIENT CARE SERVICES 22.100 22.101 ORGANIZATION AND STAFFING (1) The hospital may provide psychiatric patient care services. The standards in this subpart shall apply only if the hospital provides such services. The following requirements are in addition to those specified in Part 19, General Patient Care Services. (2) A medical staff member with special training in psychiatry, preferably a Diplomate of the American Board of Psychiatry and Neurology, should be appointed chief of the psychiatric service. (3) A qualified psychiatric staff shall provide diagnostic and consultation services for the care and treatment of patients admitted for psychiatric disorders and for those patients who in the course of hospitalization experience a psychiatric illness. (4) The nursing care shall be under the direction of a registered nurse qualified by training, experience, and ability to direct effective psychiatric nursing. 22.102 PROGRAMMATIC FUNCTIONS (1) Confinement of patients in psychiatrically secure rooms and physical restraints shall be used only when necessary to prevent injury to the patient or others, and only when other measures are not sufficient to accomplish the purpose. Written policies shall be established relative to the use of psychiatrically secure rooms and restraints. 22.103 EQUIPMENT. Reserved.

22.104 FACILITIES (1) When a psychiatric patient care unit is established, the unit shall provide; 1) A day-room or solarium; 2) A dining room; 3) An occupational therapy and recreation room with storage facilities; 4) A conference and interview room; 5) two or more psychiatrically secure rooms. Part 23. SURGICAL AND RECOVERY SERVICES 23.100 23.101 ORGANIZATION AND STAFFING (1) The hospital shall provide emergency surgical care in accordance with the scope of care established pursuant to Section 3.102 (1), and may provide other surgical services. (2) The nursing service of the surgical suite shall be under the supervision of a registered nurse qualified by training and experience to direct operating room nursing. (3) A registered nurse qualified by training and experience in operating room nursing shall be present as a circulating nurse during operative procedures. (4) At least one registered nurse shall be on duty at all times in the surgical recovery room when patients are present. Nurses shall have been instructed in the care of post-anesthetic and post-surgical patients, shall have no other duties during the time they are caring for such patients. Additional registered and licensed practical nurses, and auxiliary nursing personnel shall be available. The nursing care required by different types of patients shall be the major consideration in determining the number, quality, and category of nursing personnel that are needed in any given situation. 23.102 PROGRAMMATIC FUNCTIONS (1) Policies related to the surgical suite shall be written and available for staff use. Policies shall include the admission of patients, personnel, and visitors. (2) Policies governing the authority and responsibilities of nursing personnel and the admission and length of stay of patients in the surgical recovery room shall be written. 23.103 EQUIPMENT (1) Equipment in anesthetizing areas shall be constructed of metal or other electrically conductive material and equipped with rubber pads, leg tips, casters, or equivalent devices which are conductive. (2) Only approved portable X-ray equipment shall be used in anesthetizing locations. (3) At least one pressurized steam sterilizer or equivalent shall be installed in the sub-sterilizing room, and provided with indirect waste connections and recording thermometer that indicates temperature in discharge line of sterilizer. In the case of new hospital construction, or modification of an existing hospital facility pressurized steam sterilizer or equivalent, shall be installed in each sub-sterilizing facility, and provided with an indirect waste connection and a recording thermometer that indicates temperature in the discharge line of the sterilizer. 23.104 FACILITIES (1) Signs identifying the surgical suite shall be posted at each entrance to the suite.

(2) Interior finishes in the surgical suite shall be smooth, unbroken, and shall facilitate and withstand frequent cleaning and disinfecting. (3) The surgical suite shall be located so that traffic will not pass through the suite to any other part of the hospital and shall be separated physically from the delivery suite and emergency department. However, in hospitals of 30 beds or less, one operating suite may be used for surgical and delivery procedures, providing there is a labor room equipped for emergency delivery adjacent and accessible to the suite and with a minimum area of 180 sq. ft. See Section 9.3.1. (4) Operating Room (a) The surgical suite shall be provided with at least one operating room. There should be one operating room for each 50 beds or major fraction thereof up to and including 200 beds. Above 200 beds the number of operating rooms will be based on the expected average of daily operations. (b) The operating room design, equipment, and functional layout should be commensurate to the surgical procedures performed. (c) Each operating room should not be less than 18 feet in any one dimension. (d) Operating room(s) shall be provided with an approved electrical nurse call system. In the case of new hospital construction, or modification of an existing hospital facility, this system must be to the operations and control station or nurses station where additional help is available. (e) General and spot illumination shall be provided in each operating room. (f) The ceiling height shall not be less than 9 feet in operating rooms.**** (g) Each operating room shall be provided with piped oxygen. Nitrous oxide and vacuum are recommended. In addition to operating room(s) the following physically separated areas shall be provided within the suite. In the case of new hospital construction or modification of an existing hospital facility these areas shall be separated by doors and/or walls: 1) Sub-sterilizing facilities; 2) Scrubup area; 3) Cleanup room: 4) Instrument and supply storage; 5) Anesthesia storage; 6) Janitor's facilities: 7) Doctors' locker and dressing room; 8) Nurses' locker and dressing room; 9) Stretcher alcove. In the case of new hospital construction, or modification of an existing hospital facility, an anesthesia workroom must also be provided. Stretcher space must also be provided in the surgery suite. **** Not required in existing buildings.

(5) The sub-sterilizing room shall be physically separated from but adjacent to the operating room for service to the room without passing through contaminated areas. In the case of new hospital construction, or modification of an existing hospital facility, sub-sterilizing facilities shall be located to serve each operating room conveniently. More than one sub-sterilizing facility shall be provided if a suite of operating rooms is not compactly arranged (6) The scrubup area shall be adjacent to the operating room to permit immediate access to the room after scrubbing. Surgeon scrub sink(s) with knee or foot controls shall be installed in the scrubup area. (7) A clinical sink with an integral fresh water trap seal, and a sink with wrist-blade or foot-action valves shall be installed in each cleanup room.

(8) Toilet, shower, and lavatory facilities shall be provided in the doctors' locker rooms and in the nurses' locker rooms. (9) In the case of new hospital construction, or modification of an existing hospital facility, at least one anesthesia equipment workroom for the cleaning, testing and storage of anesthesia equipment shall be provided. It shall contain a work counter and sink. In hospitals of 30 beds or less, the anesthesia workroom may be combined with other spaces provided that the resulting plan will not compromise the best standards of safety and of medical and nursing practices. (10) Ventilation (a) Operating rooms shall be provided with a minimum ventilation rate of 8 room volumes of outdoor air per hour with no recirculation, except when not in use, by mechanical supply and exhaust air systems. In the case of new hospital construction or modification of an existing hospital facility, operating rooms shall be provided with a minimum ventilation rate of twenty-five room volumes of air per hour by mechanical supply and exhaust air systems. (a) Outdoor air intakes shall be located as far as practical but not less than 25 feet from the exhausts from any ventilating system, combustion equipment, medicalsurgical vacuum system, or plumbing vent or areas which may collect noxious fumes. The bottom of outdoor air intakes shall be located as high as practical but not less than three feet above ground level, or if installed through the roof, 3 feet above the roof level. (b) All air supplied to sensitive areas such as operating and delivery rooms and nurseries shall be delivered at or near the ceiling of the area served. (b) Filters shall be installed down draft from blower and provide a minimum efficiency of 90% of 1-5 micron size particles. In the case of new hospital construction, or modification of an existing hospital facility: 1) All ventilation or air conditioning systems serving surgery and delivery suites shall have a minimum of two filter beds. Filter Bed No. 1 shall be located upstream of the air conditioning equipment and shall have a minimum efficiency of 25%. 2) Filter Bed No. 2 shall be downstream of the supply fan and air conditioning equipment and humidifying equipment. Filter Bed No. 2 shall have a minimum efficiency of 90% of 15 micron size particles. 3) Each filter bed serving sensitive areas shall have a manometer installed across each filter bed. (c) Exhaust outlets, at least two (2), shall be provided, not less than 4 inches above the floor. In the case of new hospital construction, or modification of an existing hospital facility, exhaust outlets, at least two (2), shall be provided in each operating room, not less than 4 inches above the floor. (d) The entire surgical suite shall have a balanced air pressure. The surgical suite shall be maintained at a positive air pressure relative to the air pressures of adjacent areas within the hospital. In the case of new hospital construction, or modification of an existing hospital facility, operating rooms shall have a positive air pressure relative to the air pressures of adjacent rooms within the suite. The surgical suite shall be maintained at a positive air pressure relative to the air pressures of adjacent areas within the hospital. (11) Surgical Recovery Room (a) The design and equipment shall conform generally to the critical care unit. In the case of new hospital construction, or modification of an existing hospital facility, the surgical recovery room must provide for the visual observation of all patients, medicine dispensing facilities, charting facilities, clinical sink with a bedpan washer attachment, and storage space for supplies and equipment. (b) The surgical recovery room(s) shall be located in the surgical suite or adjacent thereto.

(c) The surgical recovery room shall have facilities for immediate communications with the attending surgeon, anesthesiologist, or qualified substitute present in the hospital. Part 24. DIAGNOSTIC IMAGING SERVICES 24.100 24.101 ORGANIZATION AND STAFFING (1) The hospital shall provide diagnostic radiology services in accordance with the scope of care established pursuant to Section 3.102 (1). Radiological imaging shall be available at all times. The hospital may provide other diagnostic imaging services, such as ultrasound and magnetic resonance imaging. (2) Imaging services shall be under the direction of a qualified physician. Radiology services shall be under the supervision of a full-time or consulting radiologist whose professional competence has been determined by the organized medical staff. 24.102 PROGRAMMATIC FUNCTIONS (1) Radiological services involving the use of machines that produce ionizing radiation or the use of radioactive materials for diagnostic purposes shall be in compliance with 6 CCR 1007-1, Rules and Regulations Pertaining to Radiation Control. (2) The hospital shall be responsible for the formulation, implementation and periodic review of written policies and procedures governing the services offered and in addition include the management of patients with infectious diseases, critical care patients, and patients who experience medical emergencies. (3) Diagnostic imaging services shall be ordered by a physician or other practitioner authorized by law. The order shall include the name of the patient, the name of the ordering individual, and the radiological procedure ordered. Services shall be provided in accordance with the order. 24.103 EQUIPMENT AND SUPPLIES. Reserved. 24.104 FACILITIES (1) The facilities used to provide diagnostic imaging services shall have adequate space, storage (including storage for radiological images), lighting and ventilation. Part 25. NUCLEAR MEDICINE SERVICES 25.100 25.101 ORGANIZATION AND STAFFING (1) The hospital may provide nuclear medicine services. The following standards shall apply only if the hospital provides such services. (2) Nuclear medicine services shall be under the direction of a qualified physician. 25.102 PROGRAMMATIC FUNCTIONS (1) Nuclear medicine services shall be in compliance with 6 CCR 1007-1, Rules and Regulations Pertaining to Radiation Control.

(2) There shall be written policies and procedures for all services offered which shall additionally include: (a) steps to take in the event of an adverse reaction. (b) protection from non-therapeutic radiation exposure for patients and visitors while in the hospital. (c) information to be provided to patients who receive nuclear medicine therapy and still have radioactive particles in their bodies regarding how to prevent/minimize radiation exposure of others. 25.103 EQUIPMENT. Reserved. 25.104 FACILITIES. Reserved. Part 26. CENTRAL MEDICAL-SURGICAL SUPPLY SERVICES 26.100 26.101 ORGANIZATION AND STAFFING (1) All hospitals shall provide central medical-surgical supply services with facilities for processing, sterilizing, storing, and dispensing supplies and equipment for all departments/services of the hospital. (2) The central medical-surgical supply services shall be organized as a service under the immediate supervision of a person who is competent in management, asepsis, supply processing, and control methods. (3) Sufficient supporting personnel shall be assigned to the service and properly trained in central medical-surgical supply services. 26.102 PROGRAMMATIC FUNCTIONS (1) Continuous supervision shall be maintained throughout receiving, cleaning, processing, sterilizing, and storing. A combination of controls or indicators shall be used to determine THE effectiveness of the sterilization process. Bacteriological methods shall be used to evaluate the effectiveness of sterilization, by at least monthly cultures with records maintained. (2) Written policies and procedures shall be established for all functions of central medical-surgical supply services. Such written procedures shall include, but not be limited to, obtaining, cleaning, processing, sterilizing, storing and issuing supplies. These policies and procedures shall be periodically reviewed by the Infection Control Committee, as applicable. (3) Policies shall be established to provide supervision and training programs for all personnel involved in central medical-surgical supply operations and services. (4) Water used for sterile solutions shall be distilled and sterilized in flasks which are resistant to heat, chemical, and electrical action. (5) Dry heat and special chemical methods are available and acceptable for sterilization of materials which would be damaged by pressurized steam. 26.103 EQUIPMENT

(1) Pressurized steam sterilizers, or equivalent, and water stills, of approved type and necessary capacity for adequate sterilization, shall be provided and maintained. Pressurized steam sterilizers shall be installed and provided with arecording thermometer that indicates temperature in discharge line of the sterilizer. 26.104 FACILITIES (1) This service shall be separated physically from other areas of the hospital and shall include areas designated for the following: 1) Receiving; 2) Cleaning and processing; 3) Sterilizing; 4) Storing clean and sterile supplies; 5) Storing bulk supplies and equipment. (2) A two-compartment sink, with counter or drainboard and knee-or-wrist action valves, shall be provided in the cleaning area. (3) Adequate cabinets, cupboards, and other suitable equipment shall be provided for the processing of materials and for the storage of equipment and supplies in a clean and orderly manner. (4) Pressurized steam sterilizers shall be installed and provided with indirect waste connections. Vents used for sterilizers that emit steam exhaust shall be installed in such a manner as to avoid recirculation. (5) Ventilation (a) Ventilation to this area may be supplied from the general ventilation system, if properly filtered. (b) The flow of air should be from the clean areas toward the exhaust in the soiled area. In the case of new hospital construction or the modification of a hospital facility, the flow of air shall be from the clean areas toward the exhaust in the soiled area. (c) Exhausts shall be installed over sterilizers to prevent condensation on walls and ceilings. Part 27. HOUSEKEEPING SERVICES 27.100 27.101 ORGANIZATION AND STAFFING (1) Each hospital shall establish organized housekeeping services. The hospital environment shall be clean and sanitary. (2) The services shall be under the supervision of a person competent in environmental sanitation and management. 27.102 PROGRAMMATIC FUNCTIONS (1) Written policies and procedures shall be established and implemented for cleaning the physical plant and equipment. The policies and procedures shall be designed to prevent and control infection. At minimum, the policies and procedures shall address: cleaning schedules, cleaning methods, the proper use and storage of cleaning supplies, hand washing, and the supervision and training of housekeeping personnel. These policies and procedures shall be periodically reviewed by the Infection Control Committee, as applicable. (2) Dry dusting and sweeping are prohibited.

(3) All personnel shall wash their hands thoroughly after handling waste products. (4) Accumulated waste material shall be removed at least daily. 27.103 EQUIPMENT AND SUPPLIES (1) Suitable equipment and supplies shall be provided for cleaning of all surfaces. Such equipment shall be maintained in a safe, sanitary condition. (2) Selection of germicides shall be under the supervision of competent individual(s). (3) Solutions, cleaning compounds, and hazardous substances shall be labeled properly and stored in safe places. Paper towels, tissues, and other supplies shall be stored in a manner to prevent their contamination prior to use. (4) All rubbish and refuse containers shall be impervious and tightly covered. (5) Carts used to transport rubbish and refuse shall be constructed of impervious materials, shall be enclosed, and shall be used solely for this purpose. 27.104 FACILITIES. Reserved. Part 28. LINEN AND LAUNDRY SERVICES 28.100 28.101 ORGANIZATION AND STAFFING (1) The hospital shall provide linen and laundry services. There shall be proper laundering of washable goods and a sufficient supply of clean linen. (2) Linen and laundry services shall be under the supervision of a person qualified by education, training or experience. 28.102 PROGRAMMATIC FUNCTIONS (1) There shall be written policies and procedures for the collection, processing, distribution and storage of linen. These policies and procedures shall be reviewed periodically by the infection control committee, as applicable. (2) Clean linen shall be stored and distributed to the point of use in a way that minimizes microbial contamination from surface contact or airborne particles. (3) Soiled linen shall be collected at the point of use and transported to the soiled linen holding room in a manner that minimizes microbial dissemination. 28.103 EQUIPMENT (1) The hospital shall use only commercial laundry equipment to process hospital linen and laundry. 28.104 FACILITIES (1) Laundry Area. Handwashing facilities and a toilet should be available in the laundry area. The general air movement shall be from the cleanest areas to the most contaminated areas. A minimum ventilation rate of ten room volumes of outside air per hour with no recirculation is recommended

for the laundry proper. Laundry exhaust should be carried to a point above the roof or 50 feet away from any window and shall not discharge near any fresh air inlet. (2) Soiled Linen Storage and Sorting Area (a) If a laundry is not provided in the hospital, a soiled linen storage room shall be provided. (b) Soiled linen storage room shall be enclosed, designed and used solely for that purpose, and provided with exhaust ventilation direct to the outside. Recirculation of air from this room shall not be permitted. The room shall have negative pressures relative to adjacent areas. Eight room volumes of outside air per hour is recommended for the sorting area. In the case of new hospital construction, or modification of an existing hospital facility, the room shall also be mechanically ventilated to the outside air. (3) Clean Linen Storage (a) A clean linen storage and sewing room shall be provided separate from the laundry room. (b) Clean linen stored on patient care units shall be in closets, shelves, conveyances, or rooms used only for clean linen storage. Part 29. MAINTENANCE SERVICES 29.100 29.101 ORGANIZATION AND STAFFING (1) The hospital shall provide facility maintenance services which shall be responsible for the upkeep of the hospital’s grounds, physical plant, equipment and furnishings. The grounds, physical plant, equipment and furnishings shall be hazard free and in good repair. (2) The building and mechanical programs shall be under the direction of a qualified person informed in the operations of the facility and in the building structures, their component parts and facilities. (3) Only properly trained responsible personnel shall be allowed to apply insecticides and rodentcides. 29.102 PROGRAMMATIC FUNCTIONS (1) The hospital shall implement written policies and procedures to keep the entire facility in good repair and to provide for the safety, welfare, and comfort of the occupants of the building(s). (2) Physical Plant Maintenance (a) Inspections and maintenance shall be conducted, in accordance with written maintenance schedules, of physical plant systems including but not limited to the electrical system, emergency power generators, water supply, and ventilation. (b) Records shall be maintained showing the date of maintenance and action taken to correct any deficiencies. (3) Equipment Maintenance (a) Inspections and preventive maintenance shall be conducted in accordance with written maintenance schedules of equipment, including equipment used for direct patient care, to ensure that it is in good working order. Preventive maintenance includes, but is not

limited to, routine inspections, cleaning, testing and calibrating in accordance with manufacturer’s instructions or if there are not manufacturers’ instructions, as specified by the hospital’s written policies and procedures. (b) Records shall be maintained showing the date of maintenance and action taken to correct any deficiencies. (4) Insect, Pest, and Rodent Control (a) The facility shall develop and implement written policies and procedures for the effective control and eradication of insects, pests, and rodents. (b) Pesticides shall not be stored in patient or food areas and shall be kept under lock. 29.103 EQUIPMENT. Reserved. 29.104 FACILITIES (1) Screens or other effective methods shall be provided on all exterior openings and the structure so maintained as to prevent entry of rats or mice through cracks in foundations, holes in walls, around service pipes, etc. Part 30. WASTE DISPOSAL SERVICES 30.100 30.101 ORGANIZATION AND STAFFING (1) The hospital shall provide for the safe disposal of all types of waste products. (2) Infectious waste disposal shall be directed by a person qualified by education, training, or experience in the principles of infectious waste management. 30.102 PROGRAMMATIC FUNCTIONS (1) The hospital shall implement written policies and procedures to ensure the safe disposal of waste products. The policies and procedures shall address: (a) sewage. All sewage shall be discharged into a public sewer system. (b) garbage and refuse. All garbage and refuse, not treated as sewage, shall be collected in and stored in covered containers and shall be removed from the hospital premises as frequently as necessary to prevent nuisance or health hazards or incinerated once a day. (c) infectious waste. Infectious waste shall be handled and disposed of in accordance with the requirements of C.R.S. 25-15-401, et seq. (d) biological non-infectious waste. (2) Refuse or garbage shall not be burned on the premises except in an incinerator. Incinerators shall comply with federal, state and local air pollution regulations. 30.103 EQUIPMENT (1) Incinerators shall be so constructed as to prevent insect and rodent breeding and harborage.

(2) A sufficient number of sound water-tight containers with tight fitting lids, to hold all refuse that accumulates between collections, shall be provided. Lids must be kept on the containers. Garbage containers shall be cleaned each time emptied. (Single service container liners are recommended). 30.104 FACILITIES (1) No exposed sewer line shall be located directly above working, storing, or eating surfaces in kitchens, dining rooms, pantries, or food storage rooms, or where medical or surgical supplies are prepared, processed, or stored. (2) Racks or stands for garbage containers shall be kept in good repair. A paved storage area for the containers should be provided. Part 31. PHYSICAL PLANT 31.100 31.101 COMPLIANCE WITH THE LIFE SAFETY CODE (1) Facilities shall be compliant with the National Fire Protection Association (NFPA) 101, Life Safety Code (2000). (a) Facilities licensed on or before September 30, 2003 shall meet Chapter 19, Existing Health Care Occupancies, NFPA 101 (2000). (b) Facilities licensed on or after October 1, 2003 or portions of facilities that undergo remodeling on or after October 1, 2003 shall meet Chapter 18, New Health Care Occupancies, NFPA 101 (2000). In addition, if the remodel represents a modification of more than 50 percent, or more than 4,500 square feet of the smoke compartment, the entire smoke compartment shall be renovated to meet Chapter 18, New Health Care Occupancies, NFPA 101 (2000). CHAPTER V LONG TERM CARE FACILITIES Part 1 - Governing Body Definition LONG-TERM CARE FACILITY. A long-term care facility is a health facility that holds itself out as a nursing home, nursing facility, nursing care facility or intermediate care facility or a health facility that is planned, organized, operated, and maintained to provide supportive, restorative, and preventive services to persons who, due to physical and/or mental disability, require continuous or regular inpatient care. (a) a long-term care facility is a nursing care facility, or a nursing facility serving residents who require continuous medical and nursing care and supervision. (b) a long-term care facility is an intermediate care facility serving residents who require regular, but not continuous nursing care and supervision. 1.1 GOVERNING BODY. The governing body is the individual, group of individuals, or corporate entity that has ultimate authority and legal responsibility for the operation of the long-term care facility. 1.1.1 The governing body shall provide the necessary facilities, qualified personnel, and services to meet the total needs of the facility's residents.

1.1.2 The governing body shall appoint for the facility a full-time administrator, qualified as provided in Section 2.1, and delegate to that officer the executive authority and full responsibility for day-to-day administration of the facility. 1.1.3 The governing body is responsible for the performance of all persons providing services within the facility. 1.2 STRUCTURE.If the governing body includes more than one individual, the group shall be formally organized with written constitution or articles of incorporation and by-laws; hold regular, periodic meetings; and maintain meeting records. 1.2.1 The facility shall disclose its ownership as required in Part 2, chapter II of these regulations. 1.2.2 The governing body shall provide a formal means of obtaining local community involvement and opportunity to communicate with the administrator on issues of residents' rights. The means of community input shall provide opportunity for regular input and such input shall be documented. (a) The input may come through a formally organized community advisory committee that is given the opportunity to comment and advise the governing body on matters of facility policy; is composed of members, a majority of whom reside in the facility's service area, and none of whom are owners or employees of or consultants to the facility. (b) The input may come through membership of at least 25% of the governing body representing citizens in the facility's service area, none of whom are owners or employees of or consultant? to the facility. (c) The facility may request Department approval of an alternative means of obtaining community input on residents' rights. 1.3 QUALITY ASSURANCE. The governing body shall assure that there is an effective quality assurance program to evaluate the availability, appropriateness, effectiveness, and efficiency of resident care, including without limitation, a continuous program of evaluating medical, nursing care, social services, activities, dietary, housekeeping, maintenance, infection control, and pharmacy services. 1.3.1 The quality assurance plan shall be in writing and shall include objectives; personnel involved; responsibility for reviewing critical incidents; methods for monitoring and evaluating care; and methods for monitoring effectiveness of actions taken to improve quality of resident care. 1.3.2 The facility shall maintain evidence of actions taken in response to quality assurance activity and their effectiveness and shall report annually to the governing body. 1.4 EXCEPTIONS TO RULES. The requirements of these regulations do not prohibit the use of alternate concepts, methods, procedures, techniques, equipment, or personnel qualifications or conducting pilot projects. A facility may request waivers or exceptions to these regulations under provisions of Part 4 of Chapter 2. 1.5 POSTING DEFICIENCIES. The facility shall post conspicuously in public view either the statement of deficiencies following its most

recent survey or a notice stating the location and times at which the statement can be reviewed. Part 2 - Administration 2.1 ADMINISTRATOR. The administrator is responsible to the governing body for planning, organizing, developing, and controlling the operations of the facility. 2.1.1 The administrator shall be licensed in the State of Colorado. 2.1.2 The administrator's responsibilities: 1) liaison among the governing body, medical staff, and physicians whose patients reside in. the facility, 2) financial and personnel management, 3) providing for appropriate resident care; and 4) maintaining relationships with the community and with other health care facilities, organizations, and services; 5) assuring facility and staff compliance with all regulations; and 6) any responsibilities prescribed by facility policy. 2.2 ORGANIZATION. The facility shall be organized formally to carry out its responsibilities with a plan of organization clearly defining the authority, responsibilities, and functions of each category of personnel. 2.3 POLICIES. In consultation with the Medical Advisor and one or more registered nurses and other related health care professionals, the administrator shall develop and at least annually review written resident care policies and procedures that govern resident care in the following areas: nursing, housekeeping, maintenance sanitation, medical, dental, dietary, diagnostic, emergency, and pharmaceutical care; social services; activities; rehabilitation; physical, occupational, and speech therapy; resident admission, transfer, and discharge; notification of physician and family or other responsible party of resident's incidents, accidents and changes of status; disasters; and health records and any other policies the department determines the facility needs based on its characteristics of its resident population. 2.4 FACILITY STAFFING PLAN. The facility shall have a master staffing plan for providing staffing in compliance with these regulations, distribution of personnel, replacement of personnel, and forecasting future personnel needs. Part 3 - Admissions 3.1 RESTRICTIONS. The facility shall admit only those persons whose needs it can meet within the accommodations and services it provides. 3.1.1 No resident shall be admitted for inpatient care to any room or area other than one regularly designated and equipped as a resident bedroom. 3.1.2 There shall be no more residents admitted to a bedroom than the number for which the room is designed and equipped. 3.2 BED HOLD POLICIES. The facility shall develop policies for holding beds available for residents who are temporarily absent therefrom, provide a copy of the policy upon admission, and explain these policies to residents upon

admission and before each temporary absence. 3.3 RESIDENT IDENTIFICATION. Upon admission, each resident shall have a visable means of identification placed and maintained on his or her person and property. Part 4 - Personnel 4.1 POLICIES. The facility shall maintain written approved personnel policies, job descriptions, and rules prescribing the conditions of employment, management of employees, and quality and quantity of resident care to be provided. 4.1.1 The facility shall provide job-specific orientation to all new employees within 90 days of employment. 4.1.2 All personnel shall be informed of the purpose and objectives of the facility. 4.1.3 All personnel shall be provided access to the facility's personnel policies and the facility shall provide evidence that each employee has reviewed them. 4.2 DEPARTMENTS. Each department of the facility shall be under the direction of a person qualified by training, experience, and ability to direct effective services. 4.2.1 The facility shall provide a sufficient number of qualified personnel in each department to operate the department. 4.2.2 All persons assigned to direct resident care shall be prepared through formal education or on-the-job training in the principles, policies, procedures, and appropriate techniques of resident care. The facility shall provide educational programs for employees to be informed of new methods and techniques. 4.3 STAFF DEVELOPMENT COORDINATOR. The long-term care facility shall employ a staff development coordinator who shall be responsible for coordinating orientation, inservice, on-the-job training, and continuing education programs and for determining that staff have been properly trained and are implementing results of their training. The objective of this standard is that staff be appropriately trained in necessary aspects of resident care to carry out their job responsibilities. 4.3.1 The coordinator shall have experience in and ability to prepare and coordinate inservice education and training programs for adult learners in the area of geriatrics. 4.3.2 The facility shall employ a staff development coordinator for a sufficient amount of time to meet inservice, orientation, training, and supervision needs of staff. The facility shall provide for appropriate staff follow-up. 4.3.3 The facility shall provide annual inservice education for staff in at least the following areas: infection control, fire prevention and safety, accident prevention, confidentiality of resident information, rehabilitative nursing, resident rights, dietary, pharmacy, dental, behavior management, disaster preparedness, and, if it has developmentally disabled residents,

developmental disabilities, residents with Alzheimer's conditions, those conditions, or mentally ill residents, mental illness. 4.3.4 The facility shall maintain attendance records with original signatures on inservice programs and course materials or outlines that staff who are unable to attend the program may review. 4.4 RECORDS. The facility shall maintain personnel records on each employee, including an employment application, that includes training and past experience, verification of credentials, references of past work experience, orientation, and evidence that health status is appropriate to perform duties in the employee's job description. 4.5 REFERENCE MATERIALS. The facility shall provide current reference material related to the care that is provided in the facility for use by all personnel. 4.6 STAFF IDENTIFICATION. All facility staff shall wear name and title badges while on duty, except where they may pose a danger to staff or residents due to the nature of resident conditions. Part 5 - Resident Care 5.1 RESIDENT CARE. Residents shall receive the care necessary to meet individual physical, psycho-social, and rehabilitative needs and assistance to achieve and maintain their highest possible level of independence, self-care, and self-worth and well-being. Provision of care shall be documented in the health record. 5.1.1 QUALITY OF LIFE. Residents shall be provided: a safe, supportive, comfortable, homelike environment; freedom and encouragement to exercise choice over their surroundings, schedules, health care, and life activities; the opportunity to be involved with the members of their community inside and outside the nursing home; and treatment with dignity and respect. 5.1.2 DECUBITUS PREVENTION AND CARE. (See also 7.7) (1) For residents whose decubitus ulcers developed while the resident was in the facility, the facility shall have (a) assessed the potential for skin breakdown and (b) provided preventive measures before the ulcer developed to residents identified in the assessment required in Section 5.2 as at risk of decubiti (i.e. a resident exhibiting three or more of the following symptoms: underweight, incontinence, dehydration, disorientation or unconsciousness, or limited mobility). (2) For all residents with decubitus ulcers, the facility shall: (a) have developed an individualized treatment plan (as prescribed by Section 5.7) designed to alleviate the condition;

(b) be providing active treatment to improve the condition in accordance with the treatment plan; (c) be evaluating the resident's progress and treatment at least weekly and revising the treatment plan as needed and required by Section 5.7; (d) be providing proper nutrition and hydration to promote healing and prevent further breakdown. 5.1.3 ACCIDENT PREVENTION AND ATTENTION. (1) The facility shall: (a) investigate causes of accidents; (b) monitor the resident's response to the accident, and obtain physician's or mental health evaluation, if needed; (c) have developed and implemented an individualized plan as part of the care plan prescribed by Section 5.7 for prevention of future accidents; (d) evaluate and revise the plan as needed. (2) For residents at high risk for accidents, the facility shall have identified the risk in the care plan and taken reasonable precautions to prevent common accidents before the accident occurred. Residents at high risk of accidents include the blind, the deaf, those with seizure disorders, those with accidents in the last 6 months, the totally confused but ambulatory, new amputees, and residents on psychoactive drugs. 5.1.4 BEHAVIOR PROBLEM CARE. (1) For residents with behavior problems the facility shall: (a) have noted the behavioral problem and evaluated it in the initial assessment required by Section 5.2; (b) develop and implement an individualized treatment plan as part of the care plan prescribed by Section 5.7; (c) develop and implement a behavior management plan as part of the care plan prescribed by Section 5.7; (d) obtain a mental health evaluation in appropriate cases; (e) evaluate the resident's progress and revise the plan, as needed and required by Section 5.7; (2) For residents receiving behavior modification drugs, the facility shall indicate in nurses' notes both positive and/or negative effects of the drug and that alternatives or adjuncts to the drugs in care planning were considered. These evaluations shall meet requirements of Section 7.10.8. 5.1.5 CONTRACTURE CARE. (See also 7.7)

(1) For residents with contractures upon admission, the facility shall have noted the problem, evaluated it, and undertaken restorative nursing intervention. (2) For residents with contractures that occurred while in the facility, the facility shall have documented that range of motion and/or repositioning was performed before the contracture developed; if the resident refused treatment or preventive measures, the. facility shall have documented that such measures and the consequences of the refusal were explained to the resident. (3) For all other residents with the potential for contracture, the facility shall have developed and be implementing an individualized treatment plan as part of the care plan prescribed in Section 5.7 to prevent or manage contractures and be periodically evaluating the progress. The plan shall be reviewed and revised at least annually as needed. 5.1.6 PROMOTION OF MOBILITY. (See also 7.7) (1) For all residents, the facility shall have assessed each resident's ambulation potential and capability at least monthly, designed a plan of care as part of the care plan prescribed in Section 5.7 to encourage mobility, be implementing the plan, regularly evaluate progress and revise the plan as needed. (2) For residents requiring devices and/or personal assistance to ambulate, the facility shall provide and maintain devices in good repair, assist the resident to obtain appropriate footwear, and provide assistance to residents to move and transfer. (3) For residents physically limited from walking, the medical record shall contain evidence of a monthly review of the need for restraints and evidence that restraints are removed in accordance with Sections 7.11 and 7.12. 5.1.7 INDWELLING CATHETER CARE. (1) For residents with any indwelling catheter, the facility shall have: (a) evaluated appropriateness of continued use at least monthly; (b) assessed the reason for the incontinence; (c) evaluated the potential of bladder retraining, implementing it, if indicated, or documenting reasons if retraining was not indicated; (d) implemented any physician order for irrigation or catheter replacement. (2) For residents exhibiting signs or symptoms of urinary tract infection, the facility shall have notified the physician, obtained orders for treatment and implemented such treatment plan. 5.1.8 WEIGHT CHANGES. The facility shall: (1) evaluate the resident to determine the cause of the weight change; (2) develop and implement an individualized plan of care as part of the care plan prescribed by Section 5.7 (including appropriate intervention by other appropriate disciplines); evaluate resident progress as required by Section 5.7, and revise the plan, as needed;

(3) observe food and fluid intake and provide encouragement to residents with eating problems; (4) provide reasonable choices of foods to meet personal preferences and religious needs; (5) if nourishments are provided as part of the care plan, between meals and at bedtime, document the nourishments provided and whether they are consumed; (6) provide assistance in eating or adaptive eating devices and assist residents in obtaining dentures, or dental care, as appropriate to the individual resident; (7) for residents with mouth or gum problems, meet the requirements of part 10. 5.1.9 GROOMING. (1) The facility shall assist the resident to obtain appropriate materials for personal care for the resident, provide personal care in a manner that preserves resident dignity and privacy, and provide social services intervention, if needed. (2) For residents with inappropriate, unclean, or poorly maintained clothing and/or assistive devices, the facility shall assist the residents to obtain clothing, shoes and devices. Such clothing, shoes and devices shall fit properly, be clean, and be in good repair. (3) For residents with poor oral hygiene, the facility shall meet the requirements of Part 10. 5.1.10 EXCORIATION PREVENTION AND CARE. (See also 7.7) (1) For all residents who are incontinent or immobile, have impaired sensation, compromised nutritional or fluid status, or inadequate hygiene, the facility shall: (a) have completed an initial skin evaluation upon admission and re-evaluated the condition at least weekly; (b) be providing measures to prevent the excoriation, including: (1) maintenance of clean, dry well lubricated skin; (2) taking incontinent residents to the bathroom on a regular individualized schedule; (3) evaluating the need for daily baths; (4) determining potential trouble spots where microbial growth may occur (breasts, gluteal folds, skin folds). (2) For residents with excoriations, the facility shall: (a) develop and be implementing an individualized treatment plan as part of the care plan prescribed by Section 5.7 for the excoriation; (b) evaluate the resident's progress at least daily and review and revise the treatment plan as needed;

(c) enter a progress note at least weekly in the health record. 5.1.11 FLUID MANAGEMENT. The facility shall provide fluid in quantities needed to maintain hydration and body weight and shall: (1) assess each resident's hydration needs; (2) observe and evaluate food and fluid intake daily and record and report deviations from sufficient food and fluid intake; (3) provide assistance and encouragement to residents requiring assistance to meet their food and fluid requirements; (4) provide self-help adaptive devices and encourage their use. 5.1.12 PERSONAL ENVIRONMENT. The facility shall allow for personalization of rooms through the use of residents' personal furniture, appliances, decorations, plants, and memorabilia. The facility may limit the number of furniture items in resident rooms if to do so is necessary to accommodate roommate preferences, fire codes, housekeeping, or safe movement in the room. 5.1.13 PERSONAL CHOICE. The facility shall: (1) make reasonable efforts to accommodate preferences of roommate, including the right of each resident so requesting to be assigned to a room with non-smokers; (2) allow residents flexibility in times to eat main meals, consistent with requirements of Section 11.2 and with its own reasonable staffing and scheduling requirements; (3) allow residents flexibility in times to bathe, rise and retire, consistent with its own reasonable staffing and scheduling requirements; (4) provide at least one alternative menu choice for each meal of similar nutritive value. The same alternative shall not be used for two consecutive meals. 5.1.14 PROBLEM RESOLUTION. The facility shall inform residents of the resident council and grievance procedures, the name, address, and phone number of the Long-Term Care Ombudsman, and the phone number and address of the Departments of Health and Social Services and the Colorado Foundation for Medical Care. Staff shall assist residents in raising problems to the facility's administration or appropriate outside agencies. 5.2 RESIDENT ASSESSMENT. Within twenty-four hours of admission to the long-term care facility, a licensed nurse shall assess each resident's physical, mental, and functional status, including strengths, impairments, rehabilitative needs, special treatments, capability for self-administration of medications, and dependence and independence in activities of daily living. The initial assessment shall form the basis of the preliminary care plan. Within seven days of admission, the nurse shall also collaborate with social services staff in assessing discharge potential and shall coordinate assessments with social services, dietetic, and activity staff. These assessments shall form the basis of the interdisciplinary care plan prescribed by Section 5.7. 5.2.1 The continuing assessment shall at all times reflect resident status. 5.2.2 The assessment shall be updated at least at three month intervals, but in any event whenever a significant change of resident condition occurs.

5.2.3 The current resident assessment shall be a part of the resident's health record and available for all direct care staff to use. 5.3 NURSING CARE PLANNING. A licensed nurse shall prepare an individualized nursing care plan for each resident based on the resident assessment prescribed by Section 5.2 and applicable physician treatment orders. The purpose of the care plan is to create an individualized tool for carrying out preventive, therapeutic, and rehabilitative nursing care. 5.3.1 Within 24 hours of admission, nursing staff shall prepare and implement a preliminary nursing care plan to meet each resident's immediate needs. 5.3.2 Within one week of admission, nursing staff shall prepare and implement a comprehensive nursing care plan for each resident. 5.3.3 The plan shall meet each resident's unique needs, problems, and strengths by identifying resident strengths, needs, and problems; specifying care interventions to capitalize on the strengths and meet those needs or problems; and defining the frequency of each intervention. 5.3.4 The nursing care plan shall be current and evaluated and revised following each assessment and whenever the resident's condition changes. 5.4 SOCIAL SERVICES CARE PLANNING. Social services staff shall assess social services needs within one week of admission and develop a social services care plan to meet each resident's needs. 5.5 ACTIVITIES CARE PLANNING. Activities staff shall assess activities needs within one week of admission and shall develop an activities care plan to meet each resident's needs. 5.6 NUTRITIONAL CARE PLANNING. (a) The Dietary supervisor or consultant shall prepare an initial nutritional history and assessment for each resident within two weeks of admission that includes special needs, likes and dislikes, nutritional status, and need for adaptive cutlery and dishes and develop a plan of care to meet these needs. (b) In the event the facility elects to utilize paid feeding assistants or feeding assistant volunteers pursuant to Part 11.001 of this Chapter V, as part of the history and assessment conducted pursuant to paragraph (a) of this 5.6, the interdisciplinary team shall evaluate each resident regarding the suitability of the resident to be fed and hydrated by a feeding assistant. Such evaluation shall include, but need not be limited to each resident’s level of care, functional status concerning feeding and hydration, and, the resident’s ability to cooperate and communicate with staff. 5.7 INTERDISCIPLINARY CARE PLANNING. Within two weeks of admission, an interdisciplinary long-term care facility staff team shall develop a personalized overall care plan for each resident based on the resident assessments and applicable physician orders. 5.7.1 The overall care plan shall contain a list of resident problems and the discipline that will

address each problem in its own more detailed plan of care. 5.7.2 The overall care plan shall be evaluated according to the goals set out in the plan, following each assessment and whenever the resident's condition changes. 5.7.3 The interdisciplinary team shall consist of representatives of resident services inside and outside the facility, as appropriate, including at least nursing, social services, activities, and dietetic staff. Other persons, such as medical, pharmacy, and special therapies, shall be included as appropriate. Residents and their representatives shall be invited to participate in care planning. Refusal to participate shall be documented. Part 6 - Medical Care Services 6.1 PHYSICIAN CARE. Each facility resident shall be admitted to the facility by a physician and have the benefit of continuing health care under supervision of a physician. The facility shall have written policies developed by the medical advisor to coordinate and designate responsibility when more than one physician is treating a resident. [See Part 26 exceptions] 6.1.1 The facility shall take all necessary steps to assure that upon admission, the physician provides to the facility sufficient information to validate the admission and identify the resident and a medical plan of therapy to include diet, medications, treatments, special procedures, activities, specialized rehabilitative services, if applicable, and potential for discharge. 6.1.2 The facility shall take all necessary steps to assure that the admitting physician provides to the facility on admission the anticipated schedule of visits to meet resident needs, which shall be no less often than every 6 months. Acknowledgement of the visit schedule by the resident or authorized representative shall be documented in the health record. 6.1.3 The facility shall take all necessary steps to assure that telephone orders are received by a physician, licensed nurse or other appropriate disciplines as authorized by their professional licensure and are countersigned by the attending physician or dentist and entered in the record within 2 weeks. 6.1.4 The facility shall take all necessary steps to assure that the attending physician authenticates medical histories and physical examinations completed by other authorized personnel. 6.1.5 The facility shall take all necessary steps to assure that a licensed dentist authenticates dental examinations and dental histories completed by other authorized personnel and signs dental treatment records. 6.1.6 The facility shall take all necessary steps to assure that the attending physician writes a progress note following each visit, and at least once per year provides a written evaluation of the resident's current medical status compared to the previous year's status. 6.1.7 The facility shall take all necessary steps to assure that all drugs and therapies ordered by the physician are supported by diagnoses indicating the use of those drugs and therapies. 6.2 MEDICAL ADVISOR. The facility shall retain by written agreement a physician or medical practice group to serve as medical advisor to the facility.

6.2.1 The medical advisor is responsible for overall coordination of medical care in the facility and for systematic review of the quality of the health care provided by the facility and the medical services provided by the physicians in the facility. The medical advisor shall develop policies and procedures for medical care and for the physicians admitting residents to the facility. 6.2.5 The medical advisor is responsible to: (1) be a liaison between the facility and admitting physicians on matters related to attendance on residents, prompt writing of orders, and responding to requests by facility staff; (2) advise in developing and reviewing resident care policies; (3) establish rules governing conduct of physicians admitting residents to the facility; (4) develop a procedure to provide care in emergencies when a resident's physician is unavailable; (5) review accidents and hazards; and (6) participate in pharmacy advisory committee deliberations. Part 7 - Nursing Services 7.1 ORGANIZATION. The facility shall have a department of nursing services that is formally organized to provide complete, effective care to each resident. The facility shall clearly define qualifications, authority, and responsibility of nursing personnel in written job descriptions. 7.2 DIRECTOR OF NURSING. Except as provided in Section 7.6, a nursing care facility shall employ a full-time (40 hours/week) Director of Nursing, who is a registered nurse, qualified by education and experience to direct facility nursing care. 7.3 24-HOUR NURSING COVERAGE. The facility shall be staffed with qualified nursing personnel, awake and on duty, who are familiar with the residents and their needs in a number sufficient to meet resident functional dependency, medical, and nursing needs. 7.3.1 Staff shall be sufficient in number to provide prompt assistance to persons needing or potentially needing assistance, considering individual needs such as the risk of accidents, hazards, or other untoward events. Staff shall provide such assistance. 7.3.2 Except as provided in Section 7.6, a nursing care facility shall be staffed at all times with at least one registered nurse who is on duty on the premises. Each resident care unit shall be staffed with at least a licensed nurse. 7.3.3 Except as provided in Section 7.6, an intermediate care facility shall be staffed with at least one full-time licensed registered nurse or licensed practical nurse who is on duty on the premises on the day shift seven days per week. A facility using a licensed practical nurse as a director of nursing shall provide at least 4 hours per week of consultation by a licensed registered nurse. 7.3.4 A nursing care facility shall provide nurse staffing sufficient in number to provide at least 2.0

hours of nursing time per resident per day. In facilities of 60 residents or more, the time of the Director of Nursing, Staff Development Coordinator, and other supervisory personnel who are not providing direct resident care shall not be used in computing this ratio. 7.3.5 Nursing personnel shall be trained in nursing procedures and responsibilities and shall be familiar with any equipment necessary for care on the unit. 7.3.6 All nursing assistants and other nursing personnel shall function under the direction of a registered nurse. 7.3.7 If a long-term care facility operates out of more than one building, it shall have staff on duty 24 hours per day in each building in a number sufficient to meet resident care needs. 7.4 WRITTEN PROCEDURES. The facility shall have written nursing procedures establishing the standards of performance for safe, effective nursing care of residents and shall assure that they are followed by all nursing staff. 7.4.1 Procedures shall include the requirement that medications be administered in compliance with applicable Colorado law. 7.4.2 The nursing procedures shall be evaluated and revised as necessary, but no less often than annually. 7.5 NURSE STAFF RESPONSIBILITIES. Nursing staff shall participate in resident assessment, resident care planning, and resident nursing care, as prescribed by this Part and Part 5. 7.6 EXCEPTIONS. Nothing contained in this Part shall require any rural long-term care facility certified as a Skilled Nursing Facility or an Intermediate Care Facility under Medicaid to employ nursing staff beyond current federal certification requirements. Since federal standards require that nurse staffing be sufficient to meet the total nursing needs of all residents, resident conditions will in all events determine the specific numbers and qualifications of staff that each facility must provide. 7.6.1 A rural facility is one that is located in: (1) a county of fewer than fifteen thousand population; or (2) a municipality of fewer than fifteen thousand population that is located ten miles or more from a municipality of fifteen thousand population or over; or (3) the unincorporated part of a county ten miles or more from a municipality of fifteen thousand population or more. 7.6.2 To the extent that these regulations require any facility to employ a registered nurse more than 40 hours per week, the Department may waive such requirements for such periods as it deems appropriate if, based on findings consistent with Part 4 of chapter II of these regulations it determines that: (1) The facility is located in a rural area as defined in Subsection 7.6.1; (2) The facility has at least one full-time registered nurse who is regularly on duty 40

hours per week; (3) The facility has only residents whose attending physicians have indicated in orders or admission notes that each resident does not require the services of a registered nurse for a 48-hour period or the facility has made arrangements for a professional nurse or physician to spend such time at the facility as is determined necessary by the resident's attending physician to provide needed services on days when the regular full-time registered nurse is not on duty; and (4) The facility has made and continues to make a good faith effort to comply with the more than 40-hour registered nurse requirement, but registered nurses are unavailable in the area. 7.7 SUPPLIES AND EQUIPMENT. The facility shall provide the supplies and equipment necessary to conduct the preventive, therapeutic, and rehabilitative nursing program. Equipment includes devices to assist residents to perform activities of daily living. 7.7.1 Equipment shall be maintained in clean and proper functioning condition. 7.7.2 The facility shall provide or assist residents to obtain walkers, crutches, canes, and wheelchairs (with appropriate padding), all of which shall fit residents properly. 7.7.3 Nursing staff shall be trained in rehabilitative nursing procedures, including preventive nursing care measures, and in the proper use of prosthetic devices and equipment. 7.8 CARE POLICIES. The facility shall have written resident care policies approved by the governing body, which staff shall follow. 7.9 RESIDENT SOCIALIZATION. Except where contraindicated by physician order or resident preference, residents shall be dressed, encouraged to be active, be out of bed for reasonable periods of time each day, and encouraged to eat in a dining room. 7.10 MEDICATION ADMINISTRATION. Medications shall be identified as provided in Subsection 16.3.2. Staff shall verify identification of the medication when the medication is prepared as well as when it is administered. 7.10.1 Medications and treatments shall be given only as ordered by a physician. 7.10.2 Medication shall be administered in a form that can be most easily tolerated by, the resident. Staff shall not mask the medication or alter its form, through crushing or dissolving or other means, if to do so would be hazardous and not without first informing the resident or responsible party. 7.10.3 Medications that are prepared but unused shall be disposed of in accordance with state law and the facility's written procedures. 7.10.4 All administered medications shall be recorded in the resident's health record, indicating the name, strength, dosage, and mode of administration of the medication, the date and time of

administration, and the signature of the person administering the medication. 7.10.5 To encourage independence and prepare residents for discharge, the facility shall permit self-administration of medications in appropriate cases upon the order of the attending physician and under the guidance of a registered or a licensed practical nurse. 7.10.6 If facility policy permits medications to be kept at the bedside, the pharmaceutical advisory committee shall approve such types of medications. The facility shall assure that each such medication is ordered by the physician to be kept at the bedside, it is used properly, use is documented, and it is stored in a secure manner that protects all residents. 7.10.7 Drug reactions and significant medication errors shall be reported within thirty minutes to the resident's physician. A call to the office or answering service does not meet the facility's responsibility to provide emergency care. The resident's condition shall be monitored for 72 hours and observations documented in the health record. 7.10.8 If a resident is administered psychoactive medications, he or she snail be evaluated for symptoms of tardive dyskinesia at least every three months. 7.11 RESTRAINTS. A) A PHYSICAL RESTRAINT is a device or application of force that is designed to modify behavior detrimental to the resident, others or the facility. Physical restraints include without limitation, straight jackets, hard leather cuffs, or locking devices. B) A CHEMICAL RESTRAINT is a medication applied, ingested, or injected for the purpose of altering or controlling behavior. Any medication that can be used both to treat a medical condition and to alter or control behavior shall be evaluated to determine its use for the resident. If a medication is used solely or primarily to treat a medical condition, it is not a chemical restraint. 7.11.1 Linen shall not be used as restraints. 7.11.2 The facility shall establish written policies and procedures governing the use of physical and chemical restraints and shall assure that they are followed by all staff members. 7.11.3 Physical and chemical restraints shall only be used upon the order of a physician and only when necessary to prevent injury to the resident or others, based on a physical, functional, emotional and medication assessment. 7.11.4 Restraints shall not be used for disciplinary purposes, for staff convenience or to reduce the need for care of residents during periods of understaffing. 7.11.5 Whenever restraints are used, a call signal switch or similar device within reach or other appropriate method of communication shall be provided to the resident. 7.11.6 In an emergency in which there is documented danger of injury to self or others, a registered nurse or licensed practical nurse may order a physical restraint. The nature of the emergency shall be documented in the health record and a physician's order for the restraint shall be obtained as soon as practicable but in no event later than 24 hours after the restraint is first used. 7.11.7 Residents in physical restraints shall be monitored at least every 15 minutes to assure that the resident is properly positioned, blood circulation is not restricted, and other resident needs are met.

7.11.8 At least every two hours during waking hours, residents shall have the physical restraint removed and shall have the opportunity to: drink fluids, be toileted, and be exercised, moved, or repositioned, which activity shall be documented in the health record. 7.12 SAFETY DEVICES. A safety device is used to protect the resident from injury to self, maintain body alignment, or facilitate comfort. Safety devices include without limitation bed side rails, wheel or geri-chair tray tables, soft cloth vest, waist, or pelvic devices, roll bars, hand mittens, or helmets. 7.12.1 Linen shall not be used as safety devices. 7.12.2 Safety devices shall not be used for disciplinary purposes, for the convenience of staff, or to reduce the need for care of residents during periods of understaffing. 7.12.3 The facility shall establish written policies and procedures governing the use of safety devices and shall assure that they are followed by all staff members. 7.12.4 A registered nurse may order a safety device after assessing the need therefor. If the nurse applies a device (other than bedrails or helmets) for more than a 24 hour period, the nurse shall perform a comprehensive, documented physical and functional assessment of the resident's need for the device no less often than after the first 24 hours, at the end of the week, and monthly thereafter. 7.12.5 At least every two hours during waking hours, residents with safety devices shall be given the opportunity to: drink fluids, be toileted, and be exercised, moved or repositioned, which activity shall be documented in the health record. 7.12.6 Residents with safety devices shall have either a call signal switch or similar device within reach or some other appropriate means of communication provided. 7.13 PHYSICIAN NOTIFICATION. Facility staff shall notify the attending physician promptly in cases of significant change in resident status and any incident or accident involving the resident. Part 8 - Social Services 8.1 SOCIAL SERVICES. The facility shall identify, plan care for, and meet the identified emotional and social needs of each resident to enhance resident psycho-social health and well-being. 8.1.1 Social services staff shall be involved in the pre-admission process, providing input as to appropriateness of placement from a psycho-social perspective, except in emergency admissions. Such involvement may include contact with the prospective resident or family member, or interdisciplinary conferences that consider psycho-social issues as well as medical/nursing criteria. 8.1.2 Social services staff shall provide for addressing needs of individuals or groups, either directly by staff or by referral to community agencies. 8.1.3 Social services staff shall assist residents and families in coping with the medical and psycho-social aspects of the resident's illness and disability and the stay in the facility.

8.1.4 Social services staff shall assist residents in planning, for discharge by coordinating service delivery with the nursing staff and by assessing availability and facilitating use of financial and social support services in the community. 8.1.5 When services, such as community mental health services, are available in the community to meet special residents' social and emotional needs, social services staff shall provide appropriate referrals to community services. 8.1.6 Social services staff shall coordinate transfers (other than medical transfers) within and out of the facility and assist residents in adjusting to intra-facility. transfers. 8.1.7 Social services staff shall participate in resident assessment and care planning as prescribed by 5.2, 5.4, and 5.7, and shall provide social services to residents. Staff shall review and update the assessment and care plan at least every six months. 8.1.8 Social services staff shall record information on social history in the health record and review it at least annually. 8.1.9 Social services staff shall record progress notes in the resident's health record at least quarterly for the first six months that a resident is in a long-term care facility and at least semiannually thereafter. 8.1.10 Social services staff shall participate in developing policies and procedures pertaining to social services in the facility. 8.1.11 Social services staff shall provide orientation to new residents and their families (including explanation of residents' rights) and assistance to residents and families in raising concerns about resident care. 8.2 STAFFING. The facility shall employ social services staff qualified as provided in Subsections 8.2.1 and 8.2.2 and sufficient in number to meet the social and emotional needs of the residents. 8.2.1 A qualified social work staff member of a public or private non-profit facility* is a person who is either: (1) A social worker licensed or authorized expressly by state law to practice under supervision of a licensed social worker; or (2) a person with a Master's or Bachelor's Degree in social work; or (3) a person with a Master's orBachelor's Degree in a related human services field who has monthly consultation from a person meeting the qualifications in subsections 1, or 2. The consultation shall be sufficient in amount to assist the social work staff to meet resident needs. 8.2.2 A qualified social work staff member of a for-profit facility* is a person who is either a social worker licensed or authorized expressly by state law to practice under supervision of a licensed social worker or a person with a Master's or Bachelor's Degree in social work or other human services field who has monthly consultation from a person so licensed or authorized; the consultation shall be sufficient in amount to assist the social work staff to meet resident needs. 8.2.3 Any facility that on the effective date of these regulations employed a person with a high school degree or GED as social services staff may continue to employ that individual with

prescribed consultation. 8.2.4 Any facility located in a rural area as defined by subsection 7.6.1 may apply for a waiver under Part 4 of chapter II of the qualifications for a social services staff member under this section if it demonstrates that it has made a good faith effort to hire staff with the required qualifications, but that qualified social services staff are unavailable in the area. 8.3 FACILITIES AND EQUIPMENT. The facility shall provide for social services staff suitable space, equipped with a telephone, for confidential interviews with residents and families. The space shall provide visual and auditory privacy and locked storage for confidential records and be accessible to non-ambulatory persons. Part 9 - Resident Activities 9.1 ACTIVITIES PROGRAM. The facility shall offer a program of organized activities that promotes residents' physical, social, mental, and intellectual well-being, encourages resident independence and pursuit of interests, maintains an optimal level of psycho-social functioning, and retains in residents a sense of continuing usefulness to themselves and the community. 9.1.1 Activities shall be broad enough in scope to stimulate participation of all residents, including residents with mental and emotional impairments, but no resident shall be compelled to participate in any activity. Each month, activities shall include at least one from each of the following categories: social/recreational, intellectual, physical, spiritual, and creative. 9.1.2 The facility shall provide individual and group activities designed to meet each resident's individual needs. 9.1.3 Activities staff shall participate in resident assessment and care planning as prescribed by 5.2, 5.5, and 5.7, and shall implement activity programs. 9.1.4 The facility shall develop programs to encourage community contact, including use of community volunteers inside the facility and activities for residents outside the facility. The facility shall make reasonable arrangements for transportation for residents to such activities. 9.1.5 The facility shall provide activities daily, including at least one evening per week. Activities in addition to religious services shall be provided on weekends each week. 9.1.6 The facility shall post a monthly activities schedule where it is visible to all residents and families indicating date and time of each activity that is open to all residents. 9.1.7 The facility shall retain activity attendance records, maintained in a location other than the health record. 9.2 STAFFING. The facility shall employ activities staff sufficient in number to meet resident needs and qualified as either: (1) an activity professional certified by the National Certification Council for Activity Professionals as an Activity Director Certified or Activity Consultant Certified; (2) an occupational therapist or occupational therapy assistant meeting the requirements for certification by the American Occupational Therapy Association and having at

least one year of experience in providing activity programming in a long term care facility; (3) a therapeutic recreation specialist (registered by the National Therapeutic Recreation Society) having at least one year of experience in providing activity programming in a long term care facility; (4) a person with a Master's or Bachelor's degree in the social or behavioral sciences who has at least one year of experience in providing activity programming in a long term care facility; (5) a person who has completed, within a year of employment, a training course for activity professionals in an accredited state facility [if available] and who has at least two years experience in social or recreational program work, at least one year of which was full-time in an activities program in a health care setting; or (6) a person with monthly consultation from a person meeting the qualifications set forth in subsections (1) through (5). The consultation shall be sufficient in amount to assist the activity staff members to meet resident needs. 9.3 RELIGIOUS SERVICES. The facility shall assist residents who are able and wish to do so to attend religious services of their choice. The facility shall honor resident requests to see their clergy and provide private space for such visits. 9.4 SPACE AND EQUIPMENT. The facility shall make available the supplies, space, and equipment to provide an activities program that meets each resident's individual needs. The facility shall provide an activities and recreation area and provide at least: books, current newspapers, games, stationery, radio, and television. Part 10 - Dental Services 10.1 DENTAL EXAMINATION. Upon admission, each resident of a facility upon his/her consent or upon the consent of a responsible person, shall have an oral examination by a licensed dentist or an initial oral inspection by a licensed dental hygienist designated by a dentist. 10.1.1 The facility shall take all necessary steps to assure that the dental examination is conducted according to current dental practice. 10.1.2 The facility is not responsible to pay for such services. 10.1.3 If the local dental society provides a list of dentists who are willing to participate, the facility shall make the list available to the residents. 10.1.4 In lieu of the admission examination, the resident may present written results, for entry into his/her medical record, of an oral examination administered during a period not to exceed six months prior to admission. 10.2 DENTAL RECORDS. The dentist or the designated dental hygienist is responsible for the dental record. For residents agreeing

to participate in the program, the facility shall take all necessary steps to assure that there are complete, accurate dental records that include the following: 10.2.1 Results of all current dental examinations and plans for treatment. 10.2.2 One of the following to document provision of planned treatment: (1) Record of treatment provided pursuant to a plan for treatment. (2) A document signed by each resident of a nursing care facility or responsible party that states that the resident or responsible party is aware of any and all specific oral pathology identified during an oral examination of the resident, but elects not to obtain treatment because of cost or other reasons. (3) In the event that the resident or responsible party elects not to obtain the initial oral examination, a signed statement to that effect in the resident's permanent medical record, which substitutes for the dental record requirement. 10.3 ORAL APPLIANCES. Upon consent, all residents' removable oral appliance and personal hygiene appliances (including without limitation, full dentures, partial dentures, and toothbrushes) shall be clearly identified and marked in a permanent manner with the user's name, as recommended by the dentist designated as advisory dentist to the facility. 10.4 DENTAL HYGIENE. Each facility shall implement policies for an oral hygiene for its residents, in consultation with the advisory dentist or the designated dental hygienist. 10.4.1 Direct care staff from each facility shall have at least annual inservice training course in preventive dentistry and oral hygiene, conducted by a dentist, dental hygienist, or preventive dental aide. Part 11 - Dietary Services 11.1 DIETARY SERVICES. The facility shall provide meals that are nutritious, attractive, well balanced, in conformity withphysician orders, and served at the appropriate temperature in order to enhance residents' health and well being. It shall also offer nourishing snacks. 11.2 ORGANIZATION. The facility shall have an organized food service, appropriately planned, equipped, and staffed to prepare and serve the number of meals created in the kitchen. The facility shall offer at least three meals or their equivalent per day, at regular times, with not more than 14 hour between the beginning of the evening meal and breakfast. Routine seatings shall be no later than 8 A.M. for breakfast and no earlier than 5 P.M. for the evening meal. Timing of meals shall generally comport with cultural practices in the community, unless inconsistent with these regulations. 11.3 PERSONNEL. The administrator shall designate a dietician or person qualified by training and experience to be responsible for the dietary services.

11.3.1 If not a professional dietician, the designee shall obtain frequent regularly scheduled consultation from a registered dietician or a person eligible for registration who meets the American Dietetic Association's qualifications standards or a graduate from a baccalaureate degree program with major studies in food and nutrition. 11.3.2 The number of trained food service personnel shall be sufficient to provide food service to the residents in the facility over a period of 12 hours or more per day. 11.4 POLICIES. The facility shall have written policies and procedures approved by the governing body for dietary practices and shall assure that they are followed by staff members. 11.5 ORDERS. All diets and nourishments shall be provided and served as by the attending physician. 11.6 NUTRITIONAL ASSESSMENT AND PROGRESS NOTES. The dietary supervisor consultant shall participate, in resident, assessment and care planning as prescribed by 5.2, 5.6, and 5.7. 11.6.1 The supervisor or consultant shall write progress notes on each resident at least at six month intervals. 11.6.2 The facility shall reasonably accommodate individual resident references in meals by offering appropriate and nutritionally adequate substitutes. (See Section 5.1.13(4).) 11.7 DIET MANUAL. The facility shall maintain a current diet manual conveniently available to the dietary and nursing staffs. For purposes of this section, current means initially published or revised within five years. 11.8 MENUS. Menus shall be written as approved by a dietician and planned at least one week in advance, considering residents' personal tastes, desires, and cultural patterns. Menus shall be posted in the kitchen area and maintained in the facility at least four weeks. If menus are changed, all changes shall be posted as served. Menus shall meet the requirements of the “Recommended Dietary Allowances for Food and Nutrition Board,” National Research Council, 1980. Recipes appropriate to the menus and needs of the facility shall be available to the cooks. 11.9 SPACE. The facility shall provide adequate space to accommodate fixed and movable equipment and employee functions; receive, store, refrigerate, and prepare food; assemble trays; store carts; and clean dishes, pots, and pans. 11.10 REGULATIONS. “Rules and Regulations Governing the Sanitation of Food Service Establishments in the State of Colorado,” Colorado Department of Health, July 1, 1978 is hereby adopted by reference and made applicable to long-term care facilities under these regulations except as follows: Section 2-502 is not adopted; Section 4-208 applies as of the effective date of these regulations; the first sentence of Section 5-103(a) applies to new construction only; provisions of Section 6-401 pertaining to toilets for patrons are

not adopted; Section 7-806 is adopted as applying to prohibit animals from only kitchen areas of facilities and from dining areas when food is being served; Chapters 8 and 9 are not adopted; Sections 10-101 through 10-205 and 10-501 are not adopted. This adoption of the Restaurant regulations does not include later amendments or editions. 11.11 REFRIGERATOR SAFETY. Walk-in refrigerators and freezers shall have inside lighting and inside lock releases. In facilities constructed after the effective date of these regulations, there shall be an alarm system that is clearly audible throughout the food preparation and storage areas of the facility and that may be readily activated by staff members from within walk-in refrigerators or freezers. 11.12 EQUIPMENT. The facility shall provide equipment sufficient in amount, adequate in type for efficient and timely preparation of meals. 11.13 STORAGE OF DISHES AND GLASSES. Clean glasses, cups, and other dishes shall not be stored in such a manner as to entrap moisture. 11.14 ISOLATION. Dishes and utensils with which food is served to residents in isolation because of infectious diseases shall be sanitized if they are contaminated with infectious material such as blood drainage or secretions or shall be disposable. 11.15 MILK. Milk for drinking shall be provided to consumers in an unopened, commercially filled container not exceeding a one pint capacity, or drawn from a commercially filled container stored in a mechanically refrigerated bulk milk dispenser, or poured directly into the drinking vessel from a commercially filled halfgallon or gallon container that has been refrigerated until served to maintain atemperature of 45 degrees F or less. 11.16 NAIL POLISH AND FALSE NAILS. Staff involved in preparing and serving food shall not wear nail polish or false nails. 11.17 DINING AND RECREATIONAL FACILITIES. Dining and recreation areas shall be readily accessible to all residents, and shall not be in a hallway or lane of traffic in or out of the facility. Such space shall be sufficient to accommodate activities conducted there, consistent with resident comfort and safety. The dining and recreation areas may be separate or combined. Part 11.001 – Feeding Assistants 11.001.1 Definitions. Unless otherwise indicated, as used in Part 11.001: (1) (a) “Feeding assistant” means an individual who assists residents by performing feeding

assistant tasks, meets the requirements of Section 11.001.2 and 11.001.3; and, is paid as an employee of a facility; used by a facility under arrangement with another agency or organization; or, who is an unpaid volunteer. (b) The following individuals may provide feeding assistance to residents without meeting the requirements of section 11.001.2 and 11.001.3: (i) Registered or licensed nurses; (ii) Certified nurse aides; (iii) Registered dietitians; (iv) Licensed health care practitioners with appropriate experience in feeding and hydrating residents; (v) Private duty aides and students in nursing education programs and other allied health programs who utilize facilities as clinical practice sites; or, (vi) Resident family members. (2) “Employing facility” means a facility that employs paid feeding assistants or utilizes the services of volunteer feeding assistants. (3) “Feeding assistant tasks” include and are limited to the provision of feeding and hydration services provided in accordance with this Section 11.001. A feeding assistant may not perform or be assigned to perform any task that constitutes: the practice of professional nursing as defined in §12-38-103 (10), C.R.S.; the practice of practical nursing as defined in §12-38-103 (9), C.R.S.; or the practice of a nurse aide as defined in §12-38.1-102 (5), C.R.S. (4) “Training program provider” means, an employing facility or other training entity approved by the department pursuant to 11.001.6 to administer a feeding assistant training program. 11.001.2 Authorization; Qualifications (1) A facility may employ or use an individual as a volunteer feeding assistant if: the individual meets all applicable requirements of this Chapter V; and, the facility first verifies that the individual: (a) Has successfully completed a feeding assistant training program in accordance with 11.001.5; and, (b) Is at least sixteen 16 years of age. (2) (a) An employing facility must screen prospective feeding assistants to ensure individuals have no history that would preclude their interaction with residents. (b) In addition to applicable facility pre-employment screening procedures, an employing facility shall obtain from each prospective paid and volunteer feeding assistant a copy of the recognition of completion document evidencing successful completion of the feeding

assistant training program issued in accordance with 11.001.5 (1)(b)(II). Additionally, an employing facility shall verify the following: (I) In the case of an individual who has not previously been employed or volunteered as a feeding assistant and who has received feeding assistant training administered by an entity other than the employing facility, successful completion of the feeding assistant training program with the training entity that provided such training; (II) In the case of an individual who has been previously employed as a feeding assistant, feeding assistant employment history with the prospective employee’s previous long-term care facility employer; (III) In the case of an individual who has previously volunteered as a feeding assistant, feeding assistant volunteer history with the long-term care facility that previously utilized the services of that individual. (3) Feeding assistants may not be counted toward meeting or complying with any requirement for nursing care staff and functions of a facility, including minimum nurse staffing requirements. 11.001.3 Supervision; emergencies (1) A feeding assistant shall work under the supervision of and shall report to a registered or licensed practical nurse. Each feeding assistant shall be given instruction by a registered nurse, licensed practical nurse or registered dietitian concerning the specific feeding and hydration needs of each resident the feeding assistant will be assigned to assist. (2) (a) Feeding assistants may perform feeding assistant tasks in congregate dining areas. A nurse shall be immediately available in case of an emergency during meals. (b) Upon a determination by the charge nurse pursuant to 11.001.4 that it is safe to do so, based on assessments conducted pursuant to 11.001.4(1), a feeding assistant may perform feeding assistant tasks in a resident room for a resident who is unable or unwilling to dine in a congregate dining area. (3) In an emergency, a feeding assistant must immediately secure the assistance of a supervisory nurse or physician. Feeding assistants shall know how to use resident call systems. This includes use of call light systems and other methods of immediately securing the assistance of supervisory nurses and physicians. 11.001.4 Resident Selection (1) The facility must base resident selection on the charge nurse’s assessment of the resident’s present condition and the following provisions of this Chapter V: (a) Most recent resident assessment performed pursuant to Section 5.2; (b) Nutritional care plan developed pursuant to Section 5.6; and, (c) Plan of care developed pursuant to Section 5.7. (2) A feeding assistant may perform feeding assistant tasks for those residents who require assistance or encouragement with feeding and hydration. Consistent with the assessments and care plans

specified in (1) of this section 11.001.4, a facility must ensure that a feeding assistant feeds only residents who do not have a complicated feeding problem. Such problems include, but are not limited to, difficulty with swallowing, recurrent lung aspirations, and tube or parenteral/ intravenous feedings. 11.001.5 Feeding Assistant Training Program (1) (a) The feeding assistant training program shall be administered by a training program provider approved in accordance with 11.001.6 and shall consist of not less than twelve (12) actual clock hours of classroom instruction. Class size shall be limited to twenty (20) enrollees. Classroom instruction shall be conducted in accordance with current standards of practice and shall conform to the “Feeding Assistant Curriculum Specifications and Program Requirements” available from the department. Curriculum subjects shall include, but need not be limited to, the following: (I) Feeding techniques; (II) Assistance with feeding and hydration; (III) Communication and interpersonal skills; (IV) Appropriate responses to resident behavior; (V) Safety and emergency procedures, including the Heimlich maneuver; (VI) Infection control; (VII) Resident rights; and, (VIII) Recognizing changes in residents that are inconsistent with their normal behavior and the importance of reporting those changes to the supervisory nurse. (b) (I) Successful completion of the feeding assistant training program requires each individual enrolled to obtain a score of eighty (80) percent or greater in a written examination provided at the conclusion of classroom instruction. Written examination questions shall be of an appropriate level of difficulty to reflect proficiency in each module of the “Feeding Assistant Curriculum Specifications and Program Requirements” and, at the discretion of the training program provider, may include ancillary feeding assistant-related curriculum subjects. Written examination questions shall not be disclosed to candidates in advance and shall be varied in format and content from test-to-test. (II) Within ten (10) calendar days from successful completion of a feeding assistant training program, a training program provider approved in accordance with 11.001.6 shall furnish each individual who successfully completes the program with a uniform recognition of completion document. Said document shall be in the format designated by and available from the department to be used by the individual to whom it is issued for the purpose of establishing successful completion of the training program. The document shall bear the notarized signature of an authorized representative of the training program provider.

(III) An individual who successfully completes a feeding assistant training program is not required to repeat the program upon employment or upon providing volunteer feeding assistant services at another facility unless the individual has not worked or volunteered in a long term care facility as a feeding assistant for a period of twenty-four (24) consecutive months. In such case, the individual shall not be employed or used as a volunteer feeding assistant by a facility as a paid feeding assistant until the person successfully repeats the feeding assistant training program. (c) An individual who fails to score eighty (80) percent or greater in the written knowledge test may be retested one time by a training program provider. An individual who fails to pass on the second attempt shall not be retested without the individual first repeating the twelve (12) actual clock hours of classroom instruction specified in subparagraph (1) (a) of this section. 11.001.6 Feeding Assistant Training Program Provider Approval (1) A feeding assistant training program may be administered by an employing facility or other training entity approved pursuant to this 11.001.6. As used in this 11.001.6, “other training entity” includes: an accredited college, university or vocational school; or, a program, seminar or inservice training sponsored by an organization, association, corporation, group or agency with specific expertise concerning the provision of feeding and hydration services. (2) Feeding assistant training programs shall use as instructors only individuals who have appropriate experience in feeding and hydrating residents and who hold: a valid Colorado license to practice as a registered or practical nurse; a certificate of registered dietitian through the commission on dietetic registration; a certificate of speech-language pathologist through the American speechlanguage-hearing association; or, a certificate of registered occupational therapist through the national board for certification in occupational therapy. (3) (a) An employing facility or other training entity seeking approval to administer a feeding assistant training program shall complete and submit to the department an initial attestation in the format designated by the department certifying that the feeding assistant training program conforms to the “Feeding Assistant Curriculum Specifications and Program Requirements.” Program approval may be granted, for a period not to exceed one year to those programs that meet minimum requirements. Department approval is required prior to initiating feeding assistant training. (b) A training program provider approved to administer a feeding assistant training program pursuant to this section shall submit annual renewal attestation forms in the format designated by the department in the following manner: (I) For employing facilities, annually with the facility’s annual license renewal application. (II) For other training entities, not less than sixty (60) days in advance of the date department approval expires. (4) Training program providers approved to administer a feeding assistant training program shall maintain the training record of each individual who attends the feeding assistant training program for a period of not less than three (3) years. Based on such records, training program providers shall verify successful completion of the feeding assistant training program pursuant to a request by an employing facility in accordance with 11.001.2 (2)(b) (I). (5) The department may deny, suspend, or withdraw approval granted under this 11.001.6 upon a determination by the department that good cause exists to do so. Good cause may include, but is

not limited to, a determination that a feeding assistant training program is not operated in compliance with applicable regulations. 11.001.7 Policies and Procedures An employing facility shall develop and implement policies and procedures concerning the use of paid feeding assistants developed in accordance with this section. 11.001.8 Records Maintenance (1) (a) An employing facility shall maintain a record of all individuals employed as feeding assistants and all individuals who serve as volunteer feeding assistants, including but not limited to records evidencing successful training program completion. Such records shall be maintained for not less than three (3) years from the date of separation or completion of volunteer service. (b) Based on such records, a facility shall verify previous feeding assistant employment and volunteer history pursuant to a request by an employing facility in accordance with 11.001.2 (2)(b) (II). 11.001.9 Reporting Requirements (1) Periodically, facilities and training program providers may be required to submit information regarding their feeding assistant program and feeding assistant training program. Such reports may include, but not be limited to: (a) The number of feeding assistants routinely utilized by the facility to assist residents; (b) The number of residents identified as benefiting from the feeding assistant program; and, (c) Information concerning the feeding assistant training program administered by the training program provider. Part 12- Residents' Rights 12.1 RESIDENTS' RIGHTS. The facility shall adopt a statement of the rights and responsibilities of their residents, post it conspicuously in apublic place, and provide a copy to each resident or guardian before admission. The facility and staff shall observe these rights in the care, treatment, and supervision of the residents. Rights shall include at least: 12.1.1 The right to receive adequate and appropriate health care consistent with established and recognized practice standards within the community and with long-term care facility rules issued by the Department; 12.1.2 The right to civil and religious liberties, including: (1) Knowledge of available choices and the right to independent personal decisions, which will not be infringed upon; (2) The right to encouragement and assistance from the staff of the facility in the fullest possible exercise of these rights;

(3) The right to vote; (4) The right to participate in activities of the community both inside and outside the facility; 12.1.3 The right to present grievances on behalf of him/herself or others to the facility's staff or administrator, to governmental officials, or to any other person, without fear of reprisal, and to join with other patients or individuals within or outside of the facility to work for improvements in resident care, including: (1) The right to participate in the resident council; (2) The right to be informed of the address and telephone number for the Department and the state and local Nursing Home Ombudsman; the facility shall post these numbers conspicuously; 12.1.4 The right to manage his or her own financial affairs or to have a quarterly accounting of any financial transactions made in his or her behalf, should the resident delegate such responsibility to the facility for any period of time; 12.1.5 The right to be fully informed, in writing, prior to or at the time of admission and during his or her stay, of services available in the facility and of related charges, including charges for services not covered under Medicare or Medicaid or not covered by the basic per diem rate; 12.1.6 The right to be adequately informed of his or her medical condition and proposed treatment unless otherwise indicated by his or her physician, and to participate in the planning of all medical treatment, including: (1) The right to refuse medication and treatment, unless otherwise indicated by his or her physician, and to know the consequences of such actions; (2) The right to participate in discharge planning; and (3) The right to review and obtain copies of his or her medical records in accordance with Part 5of chapter II of these regulations. (4) For residents whose primary language is other than English, the facility shall arrange for persons speaking the resident's language to facilitate daily communications and to attend assessment and care planning conferences in order to allow the resident to participate in those activities. This section does not require a translator to be present daily as long as the resident is enabled to engage in necessary daily communication within the facility. (5) For residents with sensory impairments that inhibit daily communication, the facility shall provide assistance so that they may participate in care and activities of daily living. 12.1.7 The right to have private and unrestricted communications with any person of his or her choice; including (1) The right to privacy for telephone calls. (2) The right to receive mail unopened; (3) The right to private consensual sexual activity;

12.1.8 The. right to be free from mental and physical abuse and from physical and chemical restraints, except those restraints initiated through the. judgment of professional staff for a specified and limited period of time or on the written authorization of a physician; 12.1.9 The right to freedom of choice in selecting a health care facility; 12.1.10 The right of copies of the facility's rules and regulations, including a copy of these rights, and an explanation of his or her rights and responsibility to obey all reasonable rules and regulations of the facility and to respect the personal rights and private property of the other patients; (1) If the resident does not speak English, the right to an explanation of rights and responsibilities in a language the resident can understand; and (2) The right to see facility policies, upon request, and state survey reports on the facility; 12.1.11 The right to be transferred or discharged only for medical reasons or his or her welfare, or that of other residents, or for nonpayment for his or her stay, not for raising concerns or complaints, and the right to be given reasonable advance notice of any transfer or discharge, except in the case of an emergency as determined by professional staff, in accordance with the transfer procedures prescribed by Section 12.6; 12.1.12 The right to have privacy in treatment and in caring for personal needs, confidentiality in the treatment of personal and medical records, and security in storing and using personal possessions; 12.1. . The right to be treated courteously, fairly, and with the fullest measure of dignity and to receive a written statement of the services provided by the facility, including those required to be offered on an as-needed basis; 12.1.14 The right of any person eligible to receive Medicaid to select any long-term care facility certified for participation in Medicaid where space is available. 12.2 DEVOLUTION OF RIGHTS. The rights of a Long-term care resident who is adjudicated incompetent under state Law devolve to the resident's legal guardian or sponsoring agency, who are responsible to assure that the resident is provided with adequate, appropriate, and respectful health care and that his or her rights are observed. In the case of devolution, the facility shall observe these rights with respect to the guardian or sponsoring agency. 12.3 STAFF TRAINING IN RESIDENTS' RIGHTS. The facility shall provide a copy of the facility's statement of residents' rights at new employee orientation. Current employees shall be provided a copy of the rights no later than the first pay period after receipt of these rules. The facility shall train all staff in the observation and protection of residents' rights. Social services staff shall assist in residents' rights orientation for new employees. 12.4 GRIEVANCE PROCEDURE. The facility shall develop a grievance procedure, which it shall post conspicuously in a public place, for presentation of grievances by residents, the resident council, or members of the resident's family regarding any conditions, treatment, or violations of rights of any resident by the facility or staff (regardless of the consent of the victim of the alleged improper conduct).

12.4.1 The facility shall designate a full-time staff member (“staff designee”) to receive all grievances. 12.4.2 The facility shall establish a grievance committee consisting of the chief administrator or his or her designee, a resident selected by the facility's residents, and a third person agreed upon by the administrator and the resident representative. 12.4.3 Any resident or legal representative, or member of a resident's family or the resident council may present a grievance to the facility staff designee orally or in writing within 14 days of the incident giving rise to the grievance. 12.4.4 The staff designee shall confer with persons involved in the incident and other relevant persons and within 3 days of receiving the grievance shall provide a written explanation of findings and proposed remedies to the complainant and the aggrieved party, if other than the complainant, and legal representative, if any. Where appropriate due to the mental or physical condition of the complainant or aggrieved party, an oral explanation shall accompany the written one. 12.4.5 If the complainant or aggrieved party is dissatisfied with the findings and remedies of the staff designee or their implementation, within 10 days of receiving the designee's explanation, the complainant or aggrieved party may file the grievance orally or in writing along with any additional information it wishes to the grievance committee. 12.4.6 The committee shall confer with persons involved in the incident and other relevant persons, including the complainant, and within 10 days of the date of the appeal shall provide a written explanation of its findings and proposed remedies to the complainant and the aggrieved party, if other than the complainant, and to the legal representative, if any. Where appropriate due to the mental or physical condition of the complainant, or aggrieved party, an oral explanation shall accompany the written one. 12.4.7 If the complainant or aggrieved party is dissatisfied with the findings and remedies of the grievance committee or their implementation (except for grievances regarding physician or physician-prescribed treatment), the person may file the grievance in writing with the Executive Director of the Department within 10 days of receipt of the written findings of the grievance committee. The Department shall then investigate the facts and circumstances of the grievance and make written findings of fact, conclusions, and recommendations and provide them to the complainant, aggrieved party, legal representative, if any and the facility administrator. 12.4.8 If the complainant or facility administrator is aggrieved by the Department's findings and recommendations, he or she may request, within 30 days of receipt of the findings and recommendations, a hearing to be conducted by the Department pursuant to C.R.S. 24-4-105. 12.5 RESIDENT ADVISORY COUNCIL. Each facility shall establish a resident advisory council consisting of no less than five members selected from the facility's residents. 12.5.1 The council shall be conducted by residents. It shall have the opportunity to meet without staff present and shall meet at least monthly with the administrator and a staff representative to make recommendations concerning facility policies. Staff shall respond to these suggestions in writing by the next meeting. Minutes of council meetings shall be maintained and posted or otherwise available to residents. 12.5.2 The council may present grievances to the grievance committee on behalf of residents.

12.5.3 The council shall elect its officers and establish a process for obtaining views of all facility residents. 12.6 TRANSFER, DISCHARGE, AND. ROOM CHANGE PROCEDURES AND APPEALS. 12.6.1 Definitions: (1) “Discharge” means movement of a resident from a nursing facility to a noninstitutional setting when the discharging facility ceases to be legally responsible for the care of the resident. (2) “Transfer” means -movement of a resident from a nursing facility to another institutional setting when the legal responsibility for the care of the resident changes from the transferring facility to the receiving facility. (3) “Room change” refers to the movement of a resident from one room to another. 12.6.2 A resident shall not be transferred or discharged unless: (1) The transfer or discharge is necessary for the resident's welfare. Facilities that are certified to participate in the Medicaid and/or Medicare reimbursement program must also demonstrate that the resident's needs cannot be met in the facility; (2) the transfer or discharge is only for medical reasons. Facilities that are certified to participate in the Medicaid and/or Medicare reimbursement program must also demonstrate that the resident's needs cannot be met in the facility; (3) the transfer or discharge is necessary to preserve the welfare of other residents; or (4) the resident has failed to pay for (or to have paid under Medicaid or Medicare) a stay at the facility. Facilities that are certified to participate in the Medicaid and/or Medicare reimbursement program must also provide reasonable and appropriate notice of non-payment and its consequences to the resident prior to initiating a transfer or discharge of a resident for reasons of non-payment. 12.6.3 When the facility transfers or discharges a resident under any of the circumstances specified in 12.6.2, the resident's clinical record must be documented. The documentation must be made by: (1) the resident's' physician when the transfer or discharge is necessary under 12.6.2 (1) and (2); and (2) a physician when transfer or discharge is necessary under 12.6.2 (3). 12.6.4 Whenever a resident is transferred or discharged for the reasons in 12.6.2 (1), 12.6.2 (2) or 12.6.2 (3), the facility must provide assessment and reasonable intervention prior to determining the need for the transfer or discharge. The assessment, attempted intervention and reason for the discharge or transfer shall be documented in the clinical record. 12.6.5 The facility shall provide reasonable advance notice to the resident and the family member or legal representative of the resident of its intent to transfer or discharge a resident. Reasonable advance notice means notice in writing at least thirty (30) days before the transfer or discharge except in the following circumstances in which the professional staff determines there is an emergency, in which case the notice must be made as soon as practicable before the transfer or discharge:

(1) the safety of residents in the facility is endangered; (2) the health of residents in the facility is endangered; or (3) an immediate transfer or discharge is required by the resident's urgent medical needs. 12.6.6 The written notice shall be in a language and manner understandable to the resident and the resident's legal representative, if applicable, and shall include: (1) The reason for the transfer or discharge; (2) The effective date of the transfer or discharge; (3) The location to which the resident is transferred or discharged; (4) The grievance procedure; and (5) the following text: “You have a right to appeal the nursing care facility's decision to transfer or discharge you. If you think you should not be transferred or discharged, you may appeal to _________ (staff designee). If you do not wish to handle the appeal yourself, youmay use an attorney, relative, or friend. If your appeal is not resolved to your satisfaction by the staff designee, you can continue your appeal to the nursing care facility's grievance committee and, if necessary, the Colorado Department of Public Health and Environment. You may direct questions regarding this notice to the Department of Public Health and Environment at____________________(division name, address and phone number).” (a) Nursing care facilities that are certified for Medicaid and/or Medicare reimbursement, must also add the following statement: “In addition, if you have questions or complaints about the transfer or discharge or would like help to appeal, call or write the State or Local Long Term Care Ombudsman at ___________(phone numbers/addresses).” (b) If the resident who is being involuntarily transferred is a person with a developmental disability for whom an agency has been authorized by law as the agency responsible for advocacy and protection of the rights of persons with developmental disabilities, the nursing care facility must also furnish to resident and the resident's family member or legal representative, the following statement: “In addition, if you have questions or complaints about the transfer or discharge or would like help to appeal, call or write the _____________, (name, phone number and address of the agency.)” (c) If the resident who is being transferred is a person with mental illness for whom an agency has been authorized by law as the agency responsible for the advocacy and protection of persons with mental illness, the nursing care facility must also furnish to the resident and the resident's family member or legal representative the following statement: “In addition, if you have questions or complaints about the transfer or discharge or would like help to appeal, call or write the _____.________, (name, phone number and address of the agency.)”

12.6.7 In cases where a resident is being involuntarily transferred or discharged from a nursing care facility that is certified to participate in the Medicaid and/or Medicare reimbursement program, a copy of the written notice (including the grievance and appeal rights, and the name, address and telephone number of the State and Local Long Term Care Ombudsman) shall also be sent the State or Local Long Term Care Ombudsman at the same time it is sent to the resident or as soon as the determination is made that the transfer or discharge is involuntary. 12.6.8 A facility must provide sufficient preparation and orientation to residents to ensure safe and orderly transfer and discharge from the facility. 12.6.9 When the facility intends to move a resident to another room in the facility without the resident's consent, the facility shall provide the resident and a family member or legal representative with written notice of such intent to be received at least 5 days before such move, including an explanation on their right to appeal. 12.6.10 A resident shall not be involuntarily transferred, discharged, or moved to another room within the facility until: (1) The expiration of the notice period, or (2) The time for any further administrative appeals has expired, or (3) The grievance or appeal has been resolved. 12.7 RESIDENT RELOCATION. If a facility intends to close or change bed classification, it shall notify the Department of Public Health and Environment and the Colorado Department of Health Care Policy And Financing, if it has Medicaid residents, at least 60 days before it expects to cease or change operations and at least 7 days before it notifies residents and families. 12.7.1 The facility shall appoint one staff person to coordinate resident relocation activities. 12.7.2 If the facility has Medicaid residents, it shall review its relocation plan with the Department of Health Care Policy And Financing. 12.7.3 Any facility certified for participation in Medicaid shall follow the relocation procedures prescribed by regulations of the Department of Social Services. Other facilities shall provide for an orderly relocation of residents, designed to minimize risks and ensure optimal placement of all residents, in coordination with the Department of Health, the Nursing Home Ombudsman, and local public and private social services agencies. Part 13 - Emergency Services 13.1 EMERGENCY CARE POLICIES. The facility shall have and follow written policies for the care of residents in an emergency available for staff use, including: 1) arrangements for necessary medical care when a resident's physician is unavailable (developed by persons described in Section 6.2); 2) procedures and training programs that cover immediate care of residents; and 3) persons to be notified in an emergency. 13.2 FIRE AND INTERNAL DISASTER PLAN. With the assistance of qualified fire and safety experts, the facility shall develop written policies and procedures for protection of persons within the building in case of fire, explosion, flood, staff shortage,

food shortage, termination of vital services, or other emergency in the building. Policies shall include: 1) brief, written instructions, posted at each nurses' station, that include persons to be notified and other immediate steps to be taken before the fire department or other assistance arrives; 2) a schematic plan of the building or portions thereof posted at each nurses' station, showing evacuation routes, smoke stop and fire doors, exit doors, and the location of fire extinguishers and fire alarm boxes; 3) procedures for evacuating helpless residents; A) assignment of specific tasks and responsibilities to the personnel on each shift; 5) provision for at least annual training and instruction to keep employees informed of their duties; and 6) provisions for conducting simulated fire drills at least three times per year. 13.3 MASS CASUALTY PLAN. Each facility shall develop a written mass casualty plan for managing residents and treating casualties in an external or community disaster. The program shall be developed in cooperation with other health facilities in the area and with official and other community agencies. Part 14 - Facility Records 14.1 HEALTH RECORDS. The facility shall maintain on its premises a health record for each resident. The record and the resident for which it is maintained shall be identified by a separate, unique number. The record shall contain sufficient information to identify the resident; provide and support resident diagnoses; include orders for medications, treatments, restorative services, diet, special procedures, and activities. It shall include a care plan and discharge plan and indicate in progress notes the resident's progress at appropriate intervals. The components of the record may be kept separately as long as they are readily retrievable. 14.1.1 Only physicians, dentists or persons operating under their supervision shall write or dictate medical histories and physical examinations in the medical record, and only dentists shall write dental histories. 14.1.2 Telephone orders shall be taken by licensed nurses or members of other appropriate disciplines as authorized by their professional licensure and as approved in facility policy. They shall be countersigned by the physician or dentist and entered into the record within two weeks. 14.1.3 All orders for diagnostic procedures, treatments, and medications shall be entered into the health record and authenticated and signed by the physician, except that orders for dental procedures shall be authenticated and signed by a dentist. All reports of x-ray, laboratory, EKG, and other diagnostic tests shall be authenticated by the person submitting them and incorporated into the health record within two weeks after receipt by the facility. 14.1.4 All entries in the health record shall be the original ink or typed copy of valid copies, kept current, dated, and signed or authenticated. The responsibility for completing the health record rests with the attending physician and the facility administrator. A physician may authenticate the health record by written signature, identifiable initials, computer key, or, under the following conditions, facsimile stamp: (1) The physician whose signature the facsimile stamp represents is the only one who has possession of the stamp and is the only one who uses it; and (2) The physician places in the medical record office a signed statement to the effect that the physician is the only one who has the stamp and the only one who will use it. 14.1.5 A completed health record shall be maintained on every resident from the time of admission through the time of discharge. All health records shall contain:

(1) Identification and summary sheet that includes: (a) resident's name, health record number, social security number, marital status, age, race, home address, date of birth, place of birth, religion, occupation, name of informant and other available identifying sociological data (country of citizenship, father's name, mother's maiden name, military service, if any, and dates), (b) name, address, and telephone number of referral source, (c) name, address, and telephone number of attending physician and dentist, (d) name of next of kin or other responsible person, (e) date and time of admission and discharge, (f) admitting diagnosis, final diagnosis(es), condition on discharge, and disposition, and (g) attending physician's signature. (2) Medical data that includes: (a) medical history, (b) medical evaluation reports on admission and thereafter as needed and at least annually, (c) reports of any special examinations, including laboratory and x-ray reports, (d) reports of consultations by consulting physicians, if any, (e) reports from all consulting persons and agencies, if any, (f) reports of special treatments, such as physical or occupational therapy, (g) dental reports, if any, (h) treatment and progress notes written and signed by the attending physician at the time of each visit, (i) authentication of hospital diagnosis(es) in a hospital summary sheet or transfer form when applicable, and a summary of the course of treatment followed in the hospital if the resident is hospitalized, (j) physician orders for all medications, treatments, diet, and restorative and special procedures, (k) autopsy protocol, if any, and authorization for autopsy, and (3) plans and notes of the social service and activities service, including social history, social services assessment/plan, progress notes, activities assessment/plan and activities progress notes; (4) nutritional assessments and progress notes of the dietary service; and

(5) reports or accidents or incidents experienced by the resident, (6) Nursing records, dated and signed by nursing personnel, which include the resident assessment required by Section 5.2, all medications and treatments administered, special procedures performed, notes of observations, and the time and circumstances of death. 14.2 FACILITIES. The facility shall provide a health record room or other health record accommodation and supplies and equipment adequate for health record functions. Health records shall be maintained and stored safely for confidentiality and protection from loss, damage, and unauthorized use. 14.3 PRESERVATION. All health records shall be completed promptly, not later than 30 days following resident discharge, filed, and retained for a period of time consistent with the applicable statute of limitations and the facility's written policies. 14.4 STAFFING. A Registered Record Administrator (RRA), Accredited Record Technician (ART), or other employee who is trained in medical records and who has consultation from a registered record administrator or accredited record technician shall be responsible for the custody, supervision, filing, and indexing of completed health records of all residents and for allied health records services. 14.5 LONG-TERM CARE FACILITY RECORDS. The facility shall maintain current the following records: 1) daily census including current resident problems and room numbers, 2) admission and discharge analysis records, 3) master resident file, 4) resident number index, and 5) disease index and (6) file of all accident and incident reports, including without limitation, those required by Part 3 of Chapter II. Part 15 - Occupational, and Physical and Speech Therapy 15.1 OCCUPATIONAL THERAPY. The facility shall provide or make arrangements for referral to occupational therapy services for all residents whom a physician refers to such therapy. If the facility provides occupational therapy services directly, it shall comply with the following requirements: 15.1.1 The facility shall have written policies approved by the governing body identifying the organization, administration, performance standards, direction, and supervision of resident care. 15.1.2 Only a qualified occupational therapist, who is a graduate of an occupational therapy curriculum accredited jointly by the Council on Medical Education of the American Medical Association and the American Occupational Therapy Association or is eligible for certification by the AOTA, shall provide occupational therapy. All personnel assisting residents with occupational therapy shall be under supervision of a qualified occupational therapist. 15.1.3 Records of occupational therapy shall include the physician's referral for treatment, resident progress notes, and results of special tests and measurements. 15.1.4 The facility shall take all necessary steps to assure that therapist communicates to the facility the resident's condition and response to treatment within two weeks of initiation of

treatment and every thirty days thereafter while treatment continues. 15.1.5 The facility shall provide space, appropriate equipment, and storage areas adequate for occupational therapy on all referred residents. Services shall be provided in an area readily accessible to residents. Equipment shall be properly maintained to ensure safety of residents and staff. 15.2 PHYSICAL THERAPY. The facility shall provide or make arrangements for referral to physical therapy services for all residents whom a physician refers to such therapy. If the facility provides physical therapy services directly or holds itself out through advertisement or door sign to provide such care, it shall comply with the following requirements: 15.2.1 The facility shall have written policies approved by the governing body identifying the organization, administration, performance standards, direction, and supervision of resident care. 15.2.2 Only a physical therapist who is registered by Physical Therapy Registration (Department of Regulatory Agencies) shall provide physical therapy. All personnel assisting residents with physical therapy shall be under supervision of a qualified physical therapist. 15.2.3 Records of physical therapy shall include the physician's order for treatment, resident progress notes, and results of special tests and measurements. 15.2.4 The facility shall take all necessary steps to assure that therapist communicates to the facility the resident's condition and response to treatment within two weeks of initiation of treatment and every thirty days thereafter while treatment continues. 15.2.5 The facility shall provide space, appropriate equipment, and storage areas adequate for physical therapy on all referred residents. Services shall be provided in an area readily accessible to residents. Equipment shall be properly maintained to ensure safety of residents and staff. 15.3 SPEECH THERAPY. The facility shall provide or make arrangements for referral to speech therapy services for all residents whom a physician refers to such therapy. If the facility provides speech therapy services directly or holds itself out through advertisement or door sign to provide such care, it shall comply with the following requirements: 15.3.1 The facility shall have written policies approved by the governing body identifying the organization, administration, performance standards, direction, and supervision of resident care. 15.3.2 Only a speech pathologist who is eligible for certification by the American Speech and Hearing Association or meets educational requirements thereof and is obtaining the supervised experience required for certification shall provide speech therapy. All personnel assisting residents with speech therapy shall be under supervision of a qualified speech pathologist. 15.3.3 Records of speech therapy shall include the physician's order for treatment, resident progress notes, and results of special tests and measurements. 15.3.4 The facility shall take all necessary steps to assure that the therapist communicates to the facility the resident's condition and response to treatment within two weeks of initiation of treatment and every thirty days thereafter while treatment continues. 15.3.5 The facility shall provide space, appropriate equipment, and storage areas adequate for

speech therapy on all referred residents. Services shall be provided in an area readily accessible to residents. Equipment shall be properly maintained to ensure safety of residents and staff. Part 16 - Pharmaceutical Services 16.1 ORGANIZATION. The pharmaceutical services of the facility shall be organized and maintained exclusively for the benefit of the facility's residents. 16.1.1 The pharmaceutical service shall be supervised by a consultant pharmacist licensed to practice pharmacy in the State of Colorado. 16.1.2 All compounding and dispensing shall be from a pharmacy licensed by the Colorado Board of Pharmacy in accordance with all pharmacy laws and regulations. 16.2 ADVISORY COMMITTEE. The facility shall establish a pharmaceutical advisory committee, including a registered nurse, the consulting pharmacist and the medical advisor, to assist in the formulation of broad professional policies and procedures relating to pharmaceutical service in the facility. 16.3 DRUG REQUISITION AND STORAGE POLICIES. The facility shall designate in written policies approved by the governing body the person authorized to requisition, receive, control, and manage drugs. 16.3.1 Resident drugs shall be obtained from a licensed pharmacy on an individual prescription basis for each resident. 16.3.2 Unless the facility uses a unit dose system, each resident drug shall be stored in individual, originally received containers or “blister” or “bubble” cards that are clearly and legibly labeled with the name, strength, dosage, frequency and mode of administration, date of issue and expiration of the drug; physician's name; name, address, and telephone number of the dispensing pharmacy; and the full name of the resident for whom the drug is prescribed. 16.3.3 The facility shall protect each resident's drugs from use by other residents, visitors, and staff. 16.4 CONSULTING PHARMACIST. The facility shall contract in writing with a licensed pharmacist to be responsible for all pharmaceutical matters in the facility. The contract shall set forth the fees to be paid for services and the pharmacist's responsibilities, including at least the following: (1) Legal compounding; (2) Prompt dispensing of properly labeled individual resident prescriptions; (3) Inventory control; establishment of necessary records; (4) Periodic inspection of all pharmaceutical supplies and drugs on all resident care units; (5) Provision of an emergency medical kit, which remains the property of a licensed pharmacy approved by the pharmaceutical advisory committee and the Colorado State Board of Pharmacy; (6) Regularly scheduled visits and consultations and at least annual in-service training to staff; (7) Inspection of preseriptions all drugs for proper labeling, proper storage, and drug deterioration or expiration of shelf life;

(8) Determination of proper procurement and maintenance of all prescriptions and other drugs; (9) Development of proper accounting procedures for controlled substances and legend drugs; (10) Evaluation of the rule 01 policies of the pharmaceutical advisory committee; and (11) Quarterly reports to the Pharmacy Advisory Committee on the status of pharmacy services. 16.5 CONTROLLED SUBSTANCES. Only practitioners authorized under the laws of the State of Colorado and properly registered with the federal government shall prescribe controlled substances, The facility shall comply with all federal and state laws and regulations relating to procurement, storage, administration, and disposal of scheduled drugs. Unless the facility uses a unit dose system, it shall maintain a record on a separate sheet for each resident receiving a scheduled drug, which contains the name of the drug, strength, date, time administered, resident name, dose, physician's name, signature of person administering, and the quantity of the drug remaining. 16.6 DISPOSITION OF MEDICATIONS 16.6.1 If controlled substances (Schedules 2 through 5) are being held by a facility on behalf of a resident and the controlled substances are no longer needed, the facility shall conduct on-site destruction of the controlled substances as follows: (1) The facility shall properly inventory the destruction and keep the inventory copy on file for at least two years. (2) At least the administrator or designee, the supervisory nurse, and the consultingpharmacist shall witness each destruction and sign the destruction inventory. (3) The destruction shall be performed in a manner that renders the controlled substances totally unretrievable. 16.6.2 Except as provided herein, all prescriptions and other drugs (except controlled substances) remaining upon death or discharge shall be destroyed by the administrator, a registered nurse, and a pharmacist who shall record the quantity of the drugs destroyed. In accordance with state law, including Section 12-22-133, C.R.S. (2005), the facility may return unused medications to a pharmacist for redispensing if those medications were donated to the facility by the resident or the resident’s next of kin. For purposes of this paragraph, unused medications means prescription medications that are not controlled substances. If a facility accepts donated medications for redispensing by a pharmacist, it shall implement a written policy that addresses inventory control and prevents the diversion of such medications. 16.7 MEDICATION RELEASE. The facility staff shall release medications to a resident only upon written physician authorization. 16.8 RESIDENT DRUG PROFILE RECORD. The dispensing pharmacist shall maintain drug profile records on each resident for whom he or she dispenses medications. Part 17 - Diagnostic Services 17.1 POLICIES. The facility shall establish and follow policies for obtaining clinical laboratory, x-ray, and other diagnostic services.

17.2 PHYSICIAN ORDERS. Diagnostic services shall be provided only on the order of the attending physician or dentist. 17.3 TRANSPORTATION. The facility shall assist residents to make arrangements for transportation of residents and/or laboratory specimens to and from the source of diagnostic services. 17.4 REPORTS. All diagnostic reports shall be included in the resident's health record within thirty days of the time the facility receives them. Part 18 - Resident Care Unit 18.1 RESIDENT CARE UNIT. A resident care unit means a designated area of a long-term care facility consisting of a bedroom or a grouping of bedrooms with supporting facilities and services that are planned, organized, operated, and maintained to provide adequate nursing and supportive care of not more than sixty residents. 18.2 PRIVATE AND MULTIPLE BEDROOMS. The long-term care facility shall provide private and multiple bedrooms to meet resident needs. There shall be no more than four beds per room. 18.2.1 *Minimum room area, exclusive of closets, lockers, wardrobes of any type, vestibules and toilet rooms, shall be 100 sq. ft. for one-bed rooms and 80 sq. ft. per bed in multi-bed rooms. 18.2.2 *Privacy shall be provided for each resident in a multiple bedroom by the installation of opaque flame retardant cubicle curtains or movable screening. 18.2.3 *Each bedroom shall have an exterior window with area not less than 1/8 of the floor area. The sills of such windows shall not be located below the finished ground level and shall not be more than 32 inches above the floor level. The ground level shall be maintained at or below the window sill for a distance of at least eight feet measured perpendicular to the window. One-half of the required window area shall be openable without the use of tools. 18.2.4 *Each bedroom shall have direct entry from a corridor. Such entry shall have a door at least equal in fire resistance to 1-3/4 inches thick solid core wood door. The door shall be at least 3'8” in width (4' width is recommended) and shall not swing into the corridor. 18.2.5 *Artificial light shall be provided and include: 1) General illumination; 2) Other sources of illumination for reading, observation, examinations, and treatments; 3) Night light controlled at the door of the bedroom; 4) Quiet-operating switches. 18.2.6 *A lavatory complete with mixing faucet, blade controls, soap and sanitary hand-drying accommodations shall be provided in each bedroom. The lavatory may be installed within the toilet room in private bedrooms. Mirrors should be arranged for convenient use by residents in wheelchairs as well as by residents in a standing position. 18.2.7 *A toilet room, directly accessible from each bedroom, without going through a general corridor, shall be provided. One toilet may serve two resident rooms but not more than four beds. The minimum dimensions for any room containing only one water closet 18.2.8 Comfortable bedrooms shall be equipped with movable furniture and equipment with the following for each resident: 1) Adjustable, washable bed (roll away type beds, cots and folding beds shall not be used) equipped with side rails when appropriate to the safety of the resident, mattress protected by water-proof material, mattress pad, and a comfortable pillow; 2) Cabinet or bedside table; 3) Overbed table as applicable; 4) Waste paper receptacle with impervious,

disposable liner or disposable waste receptacle; 5) Complete personal care equipment including water carafe, mouth wash cup, emesis basin, wash basin, bedpan and, when necessary, a urinal; 6) Comfortable chair; 7) Storage facilities adequate for residents' personal articles and grooming. 18.2.9 *Each bedroom shall be provided with a separate closet or locker for each resident. The minimum size of closet or locker in a nursing care facility shall be - 1'8′ wide by 1'10′ deep with full length hanging space, clothes rod and shelf. 18.2.10 *Each resident shall be furnished with a nurse call signal system that registers a visual signal from the resident at the corridor bedroom door and at the clean and soiled holding areas and a visual and audible signal at the Nurse's Station. Calling stations shall be located at the resident's bed, toilet room and at each tub and shower. The nurses call in toilet, tub or shower shall be an emergency call. 0ther approved facilities for resident services may be substituted to meet the requirements specified in 18.2.1 through 18.2.7, 18.2.9 through 18.2.10, 18.3.1 through 18.3.10 and 18.4. *

18.3 SERVICE FACILITIES. The following service areas shall be provided on each floor housing residents and located conveniently for patient care. 18.3.1 *The Nurses Station shall be designed and equipped for medical record recording, communications, and storage for supplies and nurses' personal effects. 18.3.2 *The medication preparation area shall be equipped with: 1) Cabinets with suitable locking devices to protect drugs stored therein; 2) Refrigerator equipped with thermometer and used exclusively for pharmaceutical storage; 3) Counter work space; 4) sink with approved handwashing facilities; 5) Antidote, incompatibility, and metriapothecary conversion charts. Only medications, equipment, and supplies for their preparation and administration shall be stored in the medication preparation area. Test reagents, general disinfectants, cleaning agents, and other similar products shall not be stored in the medication area. 18.3.3 *The clean supply holding room shall be equipped with: 1) Counter, sink with mixing faucet, blade controls, soap, and sanitary hand-drying facility; 2) Waste container with cover (foot controlled recommended) and impervious, disposable liner; 3) Cupboards or carts for supplies. 18.3.4 *There shall be a separate closed area in the clean supply holding room, on a cart, or in a separate closet for clean linen supplies. 18.3.5 *The soiled holding room shall be equipped with: 1) Suitable counter, double-sink with mixing faucet, blade controls, soap, and sanitary hand-drying facility; 2) Waste container with cover (foot controlled recommended) and impervious, disposable liner; 3) Soiled linen cart or hamper with impervious liner; 4) Accommodations and provisions for enclosed soiled articles; 5) Space for short-time holding of specimens awaiting delivery to laboratory; 6) Adequate shelf and counter space; and in nursing care facilities 7) Clinical flushing sink. 18.3.6 *The janitor's closet shall be equipped with: 1) Sink, preferably depressed or floor mounted, with mixing faucets; 2) Hook strip for mop handles from which soiled mopheads have been removed; 3) Shelving for cleaning materials; 4) Approved handwashing facilities; 5) Waste receptacles with impervious liner. The floor area should be adequate to store mop buckets on a roller carriage, wet and dry vacuum machine, and floor scrubbing machine. 18.3.7 *A storage room should be provided on the Resident Care Unit. Storage space for stretchers and wheelchairs should be recessed off the corridor. 18.3.8 *BATHING FACILITIES. Resident bathing facilities shall be provided in the ratio of one tub or one shower for each fifteen residents. Approved grab bars shall be installed at each tub or

shower and tubs shall be of non-slip surface. The room shall provide privacy and be sufficiently large to provide space for wheelchair movement. The entry door shall be at least 36” in width. Curbs should be omitted from showers. There shall be toilet and lavatory facilities in the bathroom with mixing faucet, blade controls, soap, and sanitary hand-drying accommodations. 18.3.9 *Nourishment stations shall be provided with storage space and sink for serving betweenmeal nourishments. 18.3.10 *An examination and treatment room shall be provided on at least one Resident Care Unit and shall be equipped with a treatment table, storage cabinet for supplies and instruments; and a lavatory complete with blade controls. 0ther approved facilities for resident services may be substituted to meet the requirements specified in 18.2.1 through 18.2.7, 18.2.9 through 18.2.10, 18.3.1 through 18.3.10 and 18.4. *

18.4 *PERSONNEL TOILET FACILITIES. Toilet facilities shall be provided for personnel on each Resident Care Unit. 0ther approved facilities for resident services may be substituted to meet the requirements specified in 18.2.1 through 18.2.7, 18.2.9 through 18.2.10, 18.3.1 through 18.3.10 and 18.4. *

18.5 EMERGENCY EQUIPMENT AND SUPPLIES. The following shall be readily available at all times: 1) Oxygen; 2) Suction; 3) Portable emergency equipment, supplies and medications; and in nursing care facilities 4) Compatible supplies and equipment for immediate intravenous therapy to be administered only in accordance with applicable Colorado laws. 18.6 THERMOMETER. A disinfected thermometer shall be used each time a resident's temperature is taken. 18.7 DRESSINGS. There shall be individual resident equipment and supplies for changing dressings. 18.8 MODIFICATIONS. If the facility was licensed as a Nursing Home prior to August 10, 1959, and was not in compliance with the 1958 Uniform Building Code requirements, the facility shall comply with standards as specified in Section 18, except as modified herein. The modifications are as follows: 18.2.1 See Part 25. 18.2.3 Exterior window, 50% openable, is required. 18.2.4 Each occupied room shall have at least one doorway opening directly to the outside or to a corridor leading directly or by a stairway or ramp to the outside or to an adjacent room not subject to locking, which has such access to the outside. Doors shall be at least 30” in width. 18.2.5 Artificial lighting shall be provided for general illumination, reading lamps, and night lights (plug-in types approved). 18.2.6 One lavatory shall be provided for each 10 residents. 18.2.7 One toilet shall be provided for each eight residents of each sex. 18.2.10 A call signal is required at each resident bed. Signals shall register at the nursing station. If the facility was licensed as a Nursing Home or a Basic Nursing Home after August 10, 1959, and before the effective date of these Standards, the facility shall comply with the Standards specified in Section 18 and the 1958 Uniform Building Code requirements, except as modified herein. The modifications are as follows:

18.2.1 Minimum room area shall be 100 sq. ft. for one-bed room and 80 sq. ft. per bed in multiple-bed rooms. 18.2.4 Door width may be 3'6”. 18.2.5 Artificial lighting shall be provided for general illumination, reading lamps, and night lights (plug-in types approved). 18.2.6 Handwashing facilities may be installed in a toilet room adjacent to the bedroom. 18.2.7 If centralized toilet facilities are provided, one toilet shall be provided for each eight residents of each sex. If toilet facilities are provided between adjacent bedrooms, the ratio shall be one facility for not more than four beds. 18.2.10 The resident call signal is not required to register at clean or soiled areas. Calling stations are not required at toilets, tubs, or showers. Part 19 - Secure Units 19.1 COMPLIANCE. Any facility that has one or more units that are secured to prohibit free egress of residents within the facility shall comply with the standards in this Part in addition to all other applicable requirements of this chapter. 19.2 MENTAL HEALTH FACILITIES. Any facility that is a “designated” or “placement” facility under 2710-101 C.R.S., et seq, shall comply with the regulations or the Department of Human Services. In the case of conflicting regulations, the stricter shall apply. 19.3 ADMISSIONS. 19.3.1 Residents on a secure unit shall be placed so as to insure that those placed in the unit because they are dangerous to self or wander out of the building and are unable to return on their own are protected from harm by residents who are a danger to others or whose behavior seriously disrupts the rights of other residents. 19.3.2 Placement on a secure unit shall not be used for the punishment of a resident or the convenience of the staff and shall be the least restrictive alternative available. 19.3.3 A facility shall have written programs to treat residents whom it admits, as required by 19.7. 19.3.4 Residents of a secure unit shall be allowed to have visitors on the unit. Residents of the facility may participate in organized activities on the unit. 19.4 PRE-ADMISSION SCREENING AND PLACEMENT. The-facility shall not place a resident into a secure unit unless the requirements of this section are met: 19.4.1 An evaluation team finds, based on available evidence, that: (1) the resident is a serious danger to self or others, or (2) the resident habitually wanders or would wander out of buildings and is unable to find the way back, or (3) the resident has a significant behavior problem that seriously disrupts the rights of other residents; and in all cases

(4) less restrictive alternatives have been unsuccessful in preventing harm to self or others; and (5) legal authority for such restrictive authority has been established. 19.4.2 The evaluation team shall consist of at least the Director of Nursing, Social Services staff member, member of the facility's utilization control committee, if any, and a person with mental health or social work training (as appropriate to the needs of the unit's residents) who is not a facility staff member. Such non-staff member need not participate in prior review of admissions. A facility that is a mental health “placement facility” under 27-10-101, C.R.S., et seq. shall have a person from its contracting “designated facility” on the evaluation team for evaluations of clients referred by the designated facility. 19.4.3 Written findings and their factual basis shall be documented in the health record. 19.4.4 The resident or his/her legally responsible and authorized representative gives informed, written consent, and 19.4.5 A physician has authenticated the placement. 19.5 PLACEMENT EVALUATION. A resident's placement in or restriction to a secure unit shall terminate when the condition or behavior justifying the placement have diminished to the extent that the criteria in 19.4.1 are no longer met or when consent is terminated or withdrawn or if the facility and physician determine that such continued placement would adversely affect resident health or safety. 19.5.1 The facility shall provide the same notice and appeal rights required by Section 12.6 before moving a resident out of a secure unit. 19.5.2 The evaluation team described in Subsection 19.4.2 shall re-evaluate the placement of each resident 30 days after initial placement and no less often than every 180 days thereafter. Persons under involuntary mental health placement under 27-10-101, C.R.S., et seq, shall be evaluated as prescribed in rules of the Department of Human Services. 19.5.3 For residents with Alzheimer's disease whose conditions have stabilized, the evaluation team may recommend continued placement on the unit if it finds that placement is necessary to avoid a likely recurrence of the condition that was the purpose of the initial placement on the unit. 19.6 STAFFING. The facility shall provide a sufficient number of qualified staff to meet fully the needs of residents in the secure unit, which may require a higher staffing ratio than in other units in the facility, particularly on the night shift. 19.6.1 Staff in the special secure unit shall be experienced and trained in the particular needs and care of the types of residents in the unit. 19.6. . For residents in the secure unit, the facility shall provide additional social work and activities staff to meet the social, emotional, and recreational needs of the residents and the social and emotional needs of their families in coping with the resident's illness. 19.6.3 For residents with mental illness, the facility shall provide staff who have demonstrated knowledge and skill in caring for residents with mental illness. 19.7 PROGRAMS. In addition to meeting the special medical and nursing needs of each resident in the secure unit, the facility shall provide social services and activity programs especially designed for the residents of the secure unit to avoid programmatic isolation.

19.7.1 Activities and social services programs shall include the opportunity for regular interaction with non-confused residents of the facility and regular interaction with the community outside the facility. 19.7.2 Residents of the secure unit may not be locked into or out of their rooms, except that facilities that are “designated” or “placement” facilities under 27-10-101, C.R.S. et seq, may use seclusion under procedures prescribed by Department of Human Services' regulations. 19.8 PHYSICAL FACILITIES. In addition to the physical plant requirements of these regulations, the facility shall provide at least 10 square feet per resident (excluding hallways) of common areas within the secure unit. 19.8.1 The facility shall identify its method for securing the unit and establish and implement procedures for monitoring the effectiveness of the security system. 19.8.2 Any facility that has an outside area or yard that residents in the non-secure areas of the facility may use shall establish a secure outside area for residents of the secure unit. 19.8.3 Secure units shall meet fire safety standards of Section 12-2.11.1 through 12-2.11.4 of the N.F.P.A. Life Safety Code (1985), which is herein incorporated by reference. Adoption of these provisions of the 1985 Life Safety Code does not include later amendments or editions. 19.8.4 A facility may seek a waiver under the procedures and standards provided in Part A of chapter II of these regulations from standards required in Part 18 of this chapter that may be detrimental to resident needs, safety, or health. 19.9 REVIEW OF PLANS. A facility wishing to open a secure unit shall submit its plans for physical plant, staffing, and program to the Department for prior review of conformity with these standards. Part 20 - Housekeeping Services 20.1 ORGANIZATION. Each facility shall establish an organized housekeeping service that keeps the facility clean and orderly and free from odor resulting from poor housekeeping practices. 20.1.1 The facility shall provide a sufficient number of housekeeping personnel and adequate equipment. 20.1.2 Deodorizers shall not be used to cover up odors caused by unsanitary conditions, poor nursing care, or housekeeping practices. 20.2 EQUIPMENT AND SUPPLIES. Suitable equipment and supplies shall be provided for cleaning of all surfaces. Such equipment shall be maintained in a safe, sanitary condition. 20.3 DISINFECTANTS. Disinfectants shall be only those registered by the manufacturer with the United States Environmental Protection Agency and shall be stored in a manner approved by the Department. 20.4 STORAGE, Storage areas, attics, and cellars shall be kept safe and free from accumulations of extraneous materials such as refuse, discarded furniture, and old newspapers. 20.4.1 Combustibles such as cleaning rags and compounds shall be kept in closed metal containers. 20.4.2 Cleaning compounds and other hazardous substances (including products labeled “Keep out of reach of children” on their original containers) shall be clearly labeled to indicate contents and (except when a staff member is present) shall be stored in a location sufficiently secure to

deny access to confused residents. Janitors' rooms used for storing disinfectants and detergent concentrates, caustic bowl and tile cleaners, and insecticides shall be locked. 20.4.3 Paper towels, tissues, and other absorbent paper goods shall be stored in a manner that prevents their contamination prior to use. 20.5 CLEANING METHODS. Cleaning shall be performed in a manner to minimize the spread of pathogenic organisms. Floors shall be cleaned regularly. 20.6 FLOOR SURFACES. Uncarpeted floors and adjacent base coving shall be maintained to provide a smooth, continuous, washable surface that is free of discoloration or staining. Polishes applied to uncarpeted floors shall provide a nonslip surface; throw or scatter rugs shall not be used except for nonslip entrance mats. 20.7 HANDWASHING. All personnel shall wash their hands thoroughly after handling waste products. 20.8 TRAINING AND SUPERVISION. Housekeeping personnel shall receive adequate supervision. Frequent in-service training programs shall be provided for housekeeping personnel. 20.9 POISON CONTROL. The facility shall maintain at each nurses' station a current list of potentially hazardous substances in regular use by housekeeping and other staff and the name, manufacturer, EPA registration number, notation of where used and by whom, where stored, cautionary information, antidote if any, and phone number of the poison control center. Part 21 - Linen and Laundry 21.1 LAUNDRY FACILITIES. Laundry facilities and/or contract with commercial laundry shall be provided with the necessary washing, drying, and ironing equipment having sufficient capacity to process a continuous seven-day supply based on ten pounds of dry laundry per bed per day. Laundry equipment shall meet all safety and sanitary requirements. The equipment shall be designed and installed to comply with all state and local laws. Laundry equipment, processing, and procedures shall render soiled linen and patient clothing clean and free from detergent, soap, and other chemical residues. 21.1.1 Laundry facilities and operations shall be located in an area separated from Resident Care Units. 21.1.2 In facilities constructed after the effective date of these regulations, there shall be proper spacing and placing of the equipment to minimize material transportation and operation, to avoid all cross traffic between clean and soiled linen, to provide balance of operations, and to provide storage between operations. The general air movement shall be from the cleanest areas to the most contaminated areas. Soiled laundry shall be processed frequently enough to prevent excessive unsanitary accumulations. 21.2 WASHING TEMPERATURE. The temperature of water during the washing and hot rinsing process shall be a minimum of 130 degrees F and for a combined period of time of at least 25 minutes, and the detergent shall be compatible with the wash cycle and temperature (as evidenced by purveyor statement or literature kept for inspection). Washers shall not be overloaded so as to limit adequate movement of contents and flow of water through the fabrics. 21.3 COMMERCIAL LAUNDRY SERVICES. If laundry facilities are not provided entirely within the facility there shall be a written contract between the facility and a commercial laundry service that provides for compliance with Section 21.2. 21.4 RESIDENT LINEN SUPPLY. Linen supply (top and bottom sheets, pillowcases, washcloths, bath and face towels) shall be at least three complete changes times the number of licensed beds. All linens

shall be maintained clean, in good repair. 21.5 SOILED LINEN HANDLING. In removing and handling soiled linen from a bed, there shall be minimal shaking of the linen. Soiled linen, including blankets, shall be placed in bags tightly closed before removal from a bedroom. The bags shall remain closed, shall be removed from the Resident Care Unit at least every eight hours. 21.6 INFECTIOUS DISEASE LINEN. All linens and blankets from residents with infectious disease shall be placed in special bags identified “contaminated” and transported in these closed bags. Special measures shall be taken to insure the disinfection of contaminated laundry and protection of persons doing laundry. 21.7 SORTING AND PRE-RINSING. Pre-rinsing shall be permitted only in a designated room where approved facilities are provided. Sorting and all other linen and laundry operations shall be confined to the laundry facility and shall not be permitted in the resident's room, bathtub, shower, lavatory or janitor's closets. 21.8 LINEN CHUTES. If linen chutes are used, all soiled linen, clothing, and other items deposited in them shall first be enclosed in bags before placing then in chute. Linen chutes shall be cleaned regularly by methods approved by the Department. 21.9 SOILED LINEN CARTS. Carts and hampers used to transport soiled linen shall be constructed of or lined with impervious materials, cleaned and disinfected after use, and used only for transporting soiled linen. 21.10 SOILED LINEN STORAGE. The facility shall provide a separate soiled linen storage and sorting area, mechanically ventilated to the outside atmosphere. No re-circulation of air from this area is permitted. 21.11 HANDWASHING EQUIPMENT. Handwashing facilities shall be provided in the laundry facility. 21.12 HANDWASHING. All personnel shall wash their hands thoroughly after handling anysoiled linen. 21.13 RESIDENT CLOTHING. Resident clothing and other laundry shall be processed and stored in a manner approved by the Department. 21.14 CLEAN LINEN STORAGE. A clean linen folding/storage room shall be provided as part of the laundry area, located adjacent to the drying equipment. Positive pressure shall be maintained in this area. Storage for clean linen for current use shall be provided on each Resident Care Unit. 21.15 CLEAN LINEN HANDLING. Clean linen shall be transported in a manner that preserves its clean condition so that it is clean at the site of its use. Part 22 - Infection Control 22.1 INFECTION CONTROL PROGRAM. The facility shall have an infection control program that provides in-service training on infection control and shall have current infection control policies and procedures available to all staff members. 22.2 POLICIES. The facility shall have and follow the following written policies approved by the governing body 1) a policy prohibiting admission of residents who have a communicable disease with a significant risk of transmission to other persons, as determined by the Department; 2) a policy for preventing transmission of disease in the facility that is applicable to any resident who is discovered to have a communicable disease after admission or to any employee with a communicable disease; and 3) a policy of reporting diseases to the state of local health department, pursuant to regulations promulgated by the

Board of Health pertaining to control of communicable diseases. 22.2.1 By itself the fact that a resident or employee has a communicable infection that is primarily transmitted either sexually or by blood products shall not prevent admission to or employment by the facility. Decisions concerning the admission or employment of such individuals should be made by the individual's personal physician in conjunction with the professional staff of the facility. Upon order of a physician, residents with such infectious diseases may be admitted to facilities. The facility shall observe the following precautions for residents with such conditions: (1) Staff shall wash hands before and after working with such residents. (2) Staff shall exercise caution when handling sharp objects such as needles around such residents. Needles shall not be recapped, broken off, or disposed of in other than puncture-proof containers. (3) Linen and clothing of such residents shall be washed in water of at least 140 degree temperature. (5) Staff shall wear disposable gloves when handling items soiled with blood or body fluids, but gowns and masks are not necessary except where staff performs a procedure requiring extensive contact with blood or body fluids. (6) If resuscitation appears necessary, equipment shall be immediately at hand to minimize the need for mouth-to-mouth resuscitation. (7) Wearing disposable gloves, staff shall immediately clean up spills of blood or bodily fluid from such residents. Staff shall then disinfect the contaminated area using an appropriate concentration of a disinfectant certified by the manufacturer to be effective as used. Appropriate concentrations of phenol disinfectant or chlorine bleach may be used. (8) All disposable equipment containing infective waste shall be disposed of in the room where it is used in sturdy plastic bags and then rebagged outside the room. It shall either be autoclaved or incinerated prior to disposal in a sanitary landfill. (9) A private room is indicated if resident hygiene is poor (e.g., the resident does not wash hands after touching infective material, contaminates the environment with infective material, or shares contaminated material with other residents). In general, residents infected with the same organism may share a room. The resident shall be permitted to eat with other residents and be encouraged to participate in activities inside and outside the facility. (10) Health care workers with colds or other communicable diseases shall not be assigned to care for such residents, since the residents are highly vulnerable to infection. Health care workers with HIV infection or other immunosuppresive disorders should not be required to work with residents with communicable diseases. 22.3 RESIDENT ISOLATION. Facilities shall provide for the isolation of residents with communicable diseases, as determined by the Department. Facilities shall provide well-ventilated single-bed rooms and separate toilet facilities for residents, when indicated. 22.4 SANITATION OF NURSING AND RESIDENT CARE EQUIPMENT. Nursing and resident care equipment shall be properly cleaned, sanitized, disinfected or sterilized, and stored. Nursing care

equipment that is to be used internally shall be properly cleaned, sterilized and stored after each use; thermometers shall be properly disinfected. 22.5 DISPOSABLE EQUIPMENT AND SUPPLIES. Single service disposable nursing care equipment shall be used only once and shall be disposed of in an approved manner. Other disposable nursing care equipment shall be used only for the resident to which assigned. Disposable sterile equipment shall be certified by the distributor as sterile and be destroyed after initial use. 22.6 PRESSURIZED STEAM. When pressurized steam sterilizers or equivalents are used, they shall be of approved type and necessary capacity for adequate sterilization and all sterilization equipment shall be maintained in good operating condition. Bacteriological methods shall be used to evaluate the effectiveness of pressurized steam sterilization, by at least monthly testing with records maintained. 22.7 STERILE SOLUTIONS. Water used for sterile solutions shall be distilled and sterilized in flasks that are resistant to heat, chemical and electrical action and are properly sealed, labeled, and stored. 22.8 HANDWASHING. Personnel shall wash their hands after contact with a resident or with a contaminated object and observe the following techniques: 1) Remove watches and rings, and roll sleeves of clothing above elbows; 2) Wash hands and forearms with soap or detergent with friction, not a brush, and rinse under running water; 3) Repeat the washing procedure two or three times; 4) Dry hands with a disposable towel. 22.9 SANITATION OF AIR. Design, installation, and operation of heating/cooling/ventilation system shall insure adequate microbial control of the air. 22.10 PETS. If the facility allows pets, it shall be responsible for their proper care and feeding and shall have them vaccinated and licensed, as appropriate. Part 23 - Pest Control 23.1 INSECT, PEST AND RODENT CONTROL. The facility shall be maintained free of infestations of insects, arachnids, rodents, and other vermin. 23.1.1 The facility shall have a pest control program provided by maintenance personnel or by contract with a pest control company using the least toxic and least flammable effective pesticides. The pesticides shall not be stored in patient or food areas and shall be kept under lock and only properly trained responsible personnel shall be allowed to apply them. The application of pesticides shall conform to applicable State of Colorado Pesticide Applicators' Act, 35-10-101, C.R.S. 23.1.2 Screens or screen doors shall be provided on all exterior openings except where prohibited by fire regulations. Facility doors, door screens, and window screens shall fit with sufficient tightness at their perimeters to exclude vermin. Part 24 - Waste Disposal 24.1 SEWAGE AND SEWER SYSTEMS. All sewage shall be discharged into a public sewer system, or if such is not available, disposed of in a manner approved by the State and local health authorities and the Colorado State Water Pollution Control Commission. 24.1.1 When private sewage disposal systems are in use, records of maintenance and the system design plans shall be kept on the premises. 24.1.2 No unprotected exposed sewer line shall be located directly above working, storage or eating surfaces in kitchens, dining rooms, pantries, or food storage rooms, or where medical or

nursing supplies are prepared, processed, or stored. 24.2 REFUSE. All garbage and rubbish that is not disposed of as sewage shall be collected in impervious containers in such manner as not to become a nuisance or a health hazard and shall be removed to an outside approved storage area at least once a day. 24.2.1 The refuse storage area shall be kept clean, and free from nuisance. 24.2.2 A sufficient number of impervious containers with tight fitting lids shall be provided and kept clean and in good repair. 24.3 REFUSE CART. Carts used to transport refuse shall be constructed of impervious materials, enclosed, used solely for refuse, and maintained in a sanitary manner. 24.4 PLUMBING. All plumbing in the facility shall be installed and maintained in accordance with the 1986 Colorado Model Plumbing Code and local plumbing codes All plumbing shall be maintained so that it is free of the possibility of backflow and backsiphonage, through the use of vacuum breakers and fixed air gaps, in accordance with state and local codes. The adoption of the Model Plumbing Code does not include later amendments or editions. 24.5 INCINERATORS. Incinerators shall comply with state and local air pollution regulations and be soconstructed as to prevent insect and rodent breeding and harborage. The facility shall obtain a permit to operate an incinerator from the State Air Pollution Control Division and maintain the permit on file. Part 25 - General Building and Fire Safety 25.2 GENERAL BUILDING AND FIRE SAFETY. The long-term care facility shall be constructed in accordance with the requirements of Group D occupancy, 1958 Uniform Building Code, Volume No. 1,Second Printing; or the standards imposed by any city, city and county, town, county or other political subdivision in which the facility is located, whichever is the highest, and all other applicable state laws, rules and regulations. 25.3 STRUCTURAL AND FIRE SAFETY REQUIREMENTS FOR EXISTING HEALTH FACILITIES. Longterm care facilities in existence as of August 10, 1959 shall conform with the requirements of the Building Exits Code, Fourteenth Edition, National Fire Protection Association 101-1957 except that in respect to space requirements for multiple sleeping rooms, the rooms shall have a minimum of 75 square feet per person for at least 60 percent of the residents housed in the facility and 65 square feet per person for the remaining 40 percent of the residents housed in the facility. For single occupant rooms the minimum area requirement shall be 75 square feet. 25.4 OCCUPANCY RESTRICTIONS. No building used as a health facility shall be occupied beyond the limits as specified herewith:

Type of Construction Less than 2 hour construction 2 hour construction or more, or any building equipped with an approved automatic sprinkler system.

Equipment Needed For Permitted Occupancy Approved Automatic Fire Detection System None.

Occupancy Restrictions No non-ambulatory person above second floor. No residents above third floor. No limit.

In resident areas an approved fire detection system shall be installed with 135 degree head with rate of rise and fixed temperature. Part 26 - Religious Treatment Exclusions 26.1 EXCEPTION OF CERTAIN FACILITIES. Nothing in this Part applies to any nursing facility conducted by or for the adherents of any well-recognized church or religious denomination for the purpose of providing facilities for the care and treatment of the sick who depend exclusively upon spiritual means through prayer for healing in the practice of the religion of such church or denomination 26.2 EXCEPTION FOR RELIGIOUS BELIEFS. Nothing in this chapter authorizes the Department to impose on a resident any mode of treatment inconsistent with the resident's religious belief. Part 27 - Medicaid Certification Standards 27.1 For the purpose of fulfilling its facility certification responsibilities as the State Survey Agency pursuant to the requirements of Title XIX (Medicaid) of the Social Security Act (42 U.S.C. Section 1396(a) et seq.) and the Colorado Medical Assistance Act (C.R.S. 1973, Section 26-4-101. et seq. as amended), the Department shall apply and enforce the Skilled Nursing Facility and Intermediate Care Facility certification standards of the U.S. Department of Health and Human Services as those standards presently exist pursuant to Title XIX. (These standards are presently contained in 42 C.F.R.) Part 28 - Legal Requirements 28.1 The basis and purpose for this rule is on file at the Department of Health, Division of Health Facilities Regulation, and is open to public inspection. 28.2 “Rules and Regulations Governing the Sanitation of Food Service Establishments in the stat of Colorado,” July 1, 1978 are available from the Consumer Protection Division of the Colorado Department of Health at the address listed on page 65 of these regulations. 28.3 The 1958 Uniform Building Code, Volume 1,2d printing, the Building Exits code, 14th edition, N.F.P.A. 101-1957, and Sections 12-2.11.1 through 12-2.11.4 of the N.F.P.A. Life Safety Code (1958) are available for inspection at the Health Facilities Division of the Colorado Department of Public Health and Environment at the address listed on page I of these regulations. 28.4 The 1986 Colorado Model Plumbing Code is available from the Examining Board of Plumbers, Department of Regulatory agencies, 1390 Logan Street, #400, Denver, Colorado 80203. 28.5 The effective date of this rule is July 1, 1988. Part 29 - Enforcement Remedies 29.1 Authority for the Department of Public Health and Environment to recommend the assessment, enforcement, and collection of a civil money penalty, and the amount of such money penalty to the Department of Health Care Policy And Financing for imposition against a nursing facility which violates federal regulations for participation in the Medicaid program as enumerated in the federal Omnibus Budget Reconciliation Act of 1987, 1989, and 1990,42 USC 1396r (h), is provided by sections 25-1-107, 25-1-107.5, and 24-34-105(5)(b), C.R.S. 29.2 Collection, enforcement, and assessment of a civil money penalty pursuant to this chapter and the denial of Medicaid payments, shall be the responsibility of the Department of the Health Care Policy And Financing and shall be made upon recommendation of the Department of Public Health and Environment

pursuant to 26-4-122(1) (a), C.R.S. 29.3 Definitions: For purposes of this part, the following definitions shall apply: (a) “Deficiency” or “violation” means any failure to comply with a requirement of participation for which the facility is required to take some form of corrective action. (b) “Department” means the department of health. (c) “Enforcement remedy or remedies” means any remedy or combination of remedies, in accordance with 42 USC 1396r (h) and 25-1-107.5 and 26-4-122, Colorado Revised Statutes, which may be imposed by the department or recommended by the department for imposition by the Department of Health Care Policy And Financing against any nursing facility which fails to meet any one of the enumerated requirements for participation in the Medicaid program. Remedies include, but are not limited to: (1) a plan of correction, (2) a directed plan of correction, (3) monitoring of a facility by the state survey agency, (4) full or partial bans on admissions, (5) denial of payment under the state Medicaid plan with respect to any individual admitted to the nursing facility involved after such notice to the public and the facility as may be provided for by law, (6) civil money penalties, (7) temporary management, (8) termination of the facility's participation under the state plan, and (9) receivership as provided by section 25-3-108, C.R.S. (d) “Nursing facility” means any skilled or intermediate nursing care facility which receives federal and state funds under the Title XIX of the federal Social Security Act. (e) “Nursing Home Penalty Cash Fund” means the fund created pursuant to section 264-122. C.R.S. (f) “Plan of correction” means a written plan prepared by the facility and approved by the department that describes the actions the facility will take to correct noted deficiencies and specifically sets the date the corrective action will be accomplished. (g) “Requirements of participation” means those requirements of participation in the medicaid program as enumerated in 42 USC 1396r (h) of the federal Omnibus Budget Reconciliation Act of 1987, 1989, and 1990, regulations promulgated pursuant to those acts, and section 25-1-107.5, C.R.S.

(h) “Secretary” means the secretary of the federal department of Health and Human Services. (i) “Scope” means the frequency of the occurrence of the deficiency in one of the following levels: (1) Level 1. The deficiency exists in only one or a limited number of cases. (2) Level 2. The deficiency exists in more than a limited number of cases, but no pattern can be identified. (3) Level 3. The deficiency exists in more than a limited number of cases and indicates a pattern. (4) Level 4. The deficiency occurs in sufficient number among residents or staff or with sufficient regularity that it can be considered systemic/pervasive. (j) “Severity” means the seriousness of the deficiency in one of the following levels: (1) Level 1. Any deficiency not meeting the criteria for Levels 2, 3, or 4. (2) Level 2. Any deficiency which may result in a negative outcome to the resident or residents. (3) Level 3. Any deficiency which has resulted in a negative outcome to the resident or residents. (4) Level 4. Any deficiency which has a high probability that serious harm or serious injury to residents could occur at any time, or already has occurred and may well occur again if residents are not protected effectively from the harm, or the threat is not removed. (k) “Temporary management” means the temporary utilization of a substitute manager pursuant to either an agreement between the licensee and the department or pursuant to section 25-3-108, et seq., C.R.S. (1) “Negative outcome” means that the impact of the facility's deficient practice on the resident or residents is: (1) The physical, mental or psychosocial deterioration of the resident or residents, or (2) The ability of the resident or residents to achieve the highest practicable physical, mental, or psychosocial well-being has been compromised. (m) “Repeat deficiency” means a subsequent deficiency with comparable circumstances or the same tag number, unless the department determines that the circumstances of the previous deficiency are so dissimilar that it would not be proper to consider the deficiency to be a repeat. 29.4.1 If the department, as a result of a standard survey, extended survey, or verified complaint or other investigation by the department at any time upon reasonable cause, determines that a facility fails to meet the requirements of participation as defined herein and further determines that such failure places the health or safety of the facility's residents in serious and immediate jeopardy, the department shall take immediate action to remove such jeopardy and correct the

deficiency, by either: (a) temporary management, or (b) termination of the facility's participation in the state plan. 29.4.2 In addition to the action taken pursuant to 29.4.1 the department may apply any other remedy as provided by law or regulation. 29.4.3 If the department, as a result of a standard survey, extended survey, or verified complaint or other investigation by the department at any time upon reasonable cause, determines that a facility fails to meet the requirements of participation and further determines that such failure does not place the health or safety of the facility's residents in serious and immediate jeopardy, the department may take action to correct the deficiency including the application of any remedy designed to minimize the length of time between the identification of a deficiency indicating failure to meet a requirement of participation and the correction of that deficiency. Such a remedy shall not be limited to those remedies enumerated in 29.3 (c). 29.5 In determining which remedies to apply, the department shall consider the severity of the deficiency and shall, in addition to any other remedies provided by law or regulation, impose the remedies provided by 29.3(C) as follows: (a) For a deficiency of severity Level 1, the department shall impose the remedy specified in 29.3(C)(1) and may impose the remedies specified in 29.3(C)(2). For a repeat deficiency within a fifteen (15) month period, the department shall impose the remedy specified in 29.3 (C)(1), or (2), and may impose the remedy specified in 29.3(C)(6). (b) For a deficiency of severity Level 2, the department shall impose the remedies specified in 29.3(C)(1), or (2), and may impose the remedies specified in 29.3(C) (3) and/or (6). For a repeat deficiency within a fifteen (15) month period, the department shall impose the remedies specified in 29.3(C)(1) or (2) and may impose the remedies specified in 29.3(C)(3) and/or (6). (c) For a deficiency of severity Level 3, the department shall impose the remedies specified in 29.3(C)(1) or (2), and if the scope of the deficiency is Level 4, shall impose the remedies specified in 29.3(C)(3)* or (4) or (5) or (6), and may impose any available remedies. For a repeat deficiency within a fifteen (15) month period, the department shall impose the remedies specified in 29.3(C)(1) or (2), and (3)*, or (4), or (5), or (6) and may impose any available remedy. (*The remedy specified at 29.3(C) (3) for Level 3 shall only be available as a mandatory choice for six (6) months from the effective date of these revisions.) (D) For a deficiency of severity Level 4, the department shall impose the remedies specified in 29.3(C)(1) or (2), and (6) and (7) or (8). In addition, the department may impose any other available remedy. For a repeat deficiency within a fifteen (15) month period, the department shall impose the remedies specified in 29.3(C) (2) and (6) and (7) or (8). In addition, the department may impose any available remedy. 29.6.1 The department shall make a recommendation in a timely manner to the Department of Health Care Policy And Financing that a civil money penalty be assessed against a facility for failure to comply with a requirement of participation if the department determines that a civil money penalty is an appropriate remedy.

29.6.2 The department shall consider all mitigating factors including but not limited to a change of ownership of the facility subject to the approval of the department as provided in chapter II of 6 OCR 1011-1. 29.6.3 A civil money penalty shall not be recommended under circumstances where the relevant deficiency occurred for reasons outside the nursing facility's reasonable control or despite reasonable, good faith efforts to avoid the deficiency. 29.7.1 Upon a determination by the department that the recommendation of a civil money penalty is appropriate, the department shall apply the criteria set forth in section 25-l-107.5(2)(b) (II)(A) through (H), C.R.S. to determine the amount of the penalty to be recommended for imposition by the Department of Health Care Policy And Financing. To determine the amount per day of the civil money penalty, the department will utilize the criteria set forth at section 25-1107.5(2)(b)(II), C.R.S. as follows: (a) The period of time over which the violation occurred. The length of time that the violation existed. The longer a violation has existed, the higher the amount per day. (b) The frequency of the violation. (c) The nursing facility's history concerning the type of violation for which the penalty is assessed. The number of times the same type of deficiency has been cited in the past. (d) The nursing facility's intent or reason for the violation. Did the facility have prior knowledge of the violation, what control did it have, what efforts were taken to prevent the deficiency, are there any extenuating circumstances. (e) The effect, if any, of the violation on residents' health, safety, security, or welfare, i.e., Severity. (f) The existence of other violations, in combination with the violation for which the penalty is assessed, which increase the threat to residents' health, safety, security, or welfare. Are there other violations, which when combined with the violation, increase the actual or potential harm to the residents. (g) The accuracy and extent of the nursing facility's legally required records regarding the violation and the availability of such records to the department. How did the facility's record-keeping affect the existence of the violation and the department's ability to discover the existence and extent of the violation. (h) The number of additional related violations occurring within the same time span as the violation in question. How many similar violations, which do not meet the criteria of F, occurred within the same time period. In determining the amount of a civil money penalty, multiple violations of different requirements of participation resulting from a single act shall be considered as one violation. However, this shall not preclude their consideration under criteria (f) or (h) above. 29.7.2 A civil money penalty which is recommended to the Department of Health Care Policy And Financing for imposition by that department shall be for the amount of not less than $100 per day nor more than $10,000 per day for each day the facility is found to have been in violation and shall provide for the assessment of the legal rate of interest.

29.7.3 Any such civil money penalty shall accrue from the date the facility receives written notice from the Department of Public Health and Environment of its recommendation for a civil money penalty unless the Department of Public Health and Environment determines the violation to be life threatening to residents or one creating a direct threat of a serious adverse effect on the health, safety, security, rights or welfare of a resident or residents, in which case the penalty shall run for each day in which the facility is or was out of compliance. The period of time during which the civil money penalty accrues shall be as follows: (a) No longer than six (6) months in the case of non-serious or non-immediate threat. (b) Until the department verifies the deficiency is corrected or the facility notifies the department that the deficiency is corrected whichever is earlier. (1 If the facility acts in a timely and diligent manner to correct the violation in accordance with a plan of correction as agreed to by the department, the department shall recommend to the Department of Health Care Policy And Financing that the penalty be suspended or reduced for the period of the plan of correction. (2 In the event the facility has not corrected the violation, pursuant to the notice provided by the facility, the penalty shall be reinstated at an increased amount retroactive to the date the penalty was tolled. (3 For the purposes of this provision, the plan of correction must contain a reasonable and appropriate plan of action and timetable to completely correct the deficiency. This provision (plan of correction) shall not apply in cases of repeat deficiencies or those with a severity level of 4. 29.8.1 The department shall notify the facility, by personal service, first class mail, or electronic transmission (“fax”), of its recommendation of the imposition of a civil money penalty and the amount of any such penalty not later than the fifth day following the last day of the inspection or survey on which the deficiencies which constitute the violation were found. The notice shall explain the deficiencies that are the basis for the recommendation and shall provide instructions for responding to the notice, including that the facility submit a written plan of correction. 29.8.2 After notice pursuant to 29.8.1 above, a facility may notify the department of the correction of the deficiency for which the civil money penalty is being recommended. Such initial notice to the department may be given by telephone, electronic transmission (“fax”), or in person but shall be documented by a writing postmarked within five (5) business days of the initial notification to the department. 29.8.3 It shall be the responsibility of the Department of Health Care Policy And Financing, pursuant to section 26-4-122(l)(b), C.R.S. to provide for an appeal process for any facility which has a civil money penalty assessed against it for failure to meet a requirement of participation. 29.9 If a facility fails to correct a deficiency or deficiencies within three (3) months after the date the facility is found by the Department of Health Care Policy And Financing pursuant to 25-1-107.5(2) (a),C.R.S. to be out of compliance with a requirement of participation, the department shall recommend to the Department of Health Care Policy And Financing denial of payment under the state plan with respect to any individual admitted to the facility involved after such notice to the public and the facility as is provided for by the state. 29.10 If a facility has provided a substandard quality of care to the residents as evidenced by three consecutive standard surveys, the department shall take action pursuant to (a) and (b) below and may take any such additional action as provided for by law or regulation, including the recommendation of a

civil money penalty to the Department of Health Care Policy And Financing; (a recommend to the Department of Health Care Policy And Financing that payment be denied under the state plan with regard to any individual admitted to the facility involved after such notice to the public and to the facility as may be provided for by the state; and (b) monitor the facility until such time as it has demonstrated to the satisfaction of the department that it is in compliance with the requirements and that it has the management capacity to remain in compliance. 29.11.1 Nothing in this section shall preclude the department from recommending alternative remedies as provided by law so long as the secretary deems such remedy or remedies to be at least as effective in correcting the violation and deterring future violations as those remedies enumerated in the federal Omnibus Budget Reconciliation Act of 1987, 1989, and 1990. 29.11.2 Nothing in this section shall be construed as limiting, negating, or superseding any other remedy available for use by the Department of Public Health and Environment to correct a deficiency or deficiencies. In recommending or selecting a particular remedy, the primary consideration shall be the selection of the remedy or remedies most likely to achieve correction of the relevant deficiency and long-term compliance. 29.12.1 The department shall, in conjunction with the Department of Health Care Policy and Financing establish circumstances under which the funds of the Nursing Home Penalty Cash Fund may be disbursed in order to protect the health or property of residents. 29.12.2 Those circumstances shall include, but not be limited to: (a) relocating residents to other facilities if necessary; (b) maintaining the operation of a facility pending completion of a plan of correction or directed plan of correction; (c) maintaining the operation of a facility pending closure; and (d) reimbursing residents for personal funds lost. 29.12.3 Neither the department nor the Department of Health Care Policy And Financing may use money from the fund to pay the costs of administration of those departments. 29.12.4 At the end of the fiscal year, all unexpended and unencumbered moneys remaining in the fund must remain in the fund and may not be transferred or credited to the general fund. CHAPTER VI ACUTE TREATMENT UNITS 1.101 Statutory Authority and Applicability (1) Authority to establish minimum standards through regulation and to administer and enforce such regulations is provided by Section 25-1.5-103, C.R.S. (2) Acute treatment units, as defined herein, shall be in compliance with all applicable federal and state statutes and regulations, including but not limited to, the following: (a) This Chapter VI.

(b) The following parts of 6 CCR 1011-1, Chapter II, General Licensure Standards: (i) Parts 1, Review of Building Plans and Specifications (ii) Part 2, Application for License (iii) Part 3.2, Occurrence Reporting (iv) Part 4, Waiver of Regulations for Health Facilities (3) This chapter applies to services provided by acute treatment units, including services provided through contracts. 1.102 Definitions. For purposes of this chapter, the following definitions shall apply, unless the context requires otherwise: (1) “Acute treatment unit” means a facility or a distinct part of a facility for short-term psychiatric care, which may include substance abuse treatment, and which provides a total, twenty-four-hour therapeutically planned and professionally staffed environment for persons who do not require inpatient hospitalization but need more intense and individual services than are available on an outpatient basis, such as crisis management and stabilization services. (2) “Auxiliary aid” means any device used by persons to overcome a physical disability and includes but is not limited to a wheelchair, walker or orthopedic appliance. (3) “Client” means an individual who is age 18 and over in need of short-term psychiatric care. (4) “Construction on-site review” means on-site inspection by the Department, or its designee, of new construction or substantial remodeling to determine compliance by the facility with the National Fire Protection Association (NFPA) Life Safety Code and with this Chapter VI. (5) “Construction plan review” means the review by the Department, or its designee, of new construction or remodeling plans to determine compliance by the facility with the National Fire Protection Association (NFPA) Life Safety Code and with this Chapter VI. (6) “Deficiency” means a violation of regulatory and/or statutory requirements governing acute treatment units, as cited by the Department. (7) “Deficiency list” means a listing of deficiency citations which contains: (a) a statement of the statute or regulation violated; and (b) a statement of the findings, with evidence to support the deficiency. (8) “Department” means the Colorado Department of Public Health and Environment or its designee. (9) “Director” means a person who is responsible for the overall operation, daily administration, management and maintenance of the facility. (10) “Distinct part” means a contiguous section of a building dedicated to serving as an acute treatment unit. (11) “Facility” means an acute treatment unit. (12) “Governing body” means the board of trustees, directors or other governing body in whom the

ultimate authority for the conduct of the facility is vested. (13) “Licensee” means the person or entity to whom: (a) a license is issued by the Department pursuant to Section 25-1.5-103 (1) (a), C.R.S., to operate a facility within the definition herein provided, and (b) a “27-10” designation has been granted by the Department of Human Services pursuant to Section 27-10-101, et. seq. and 2 CCR 502-1. (14) “Occurrences” means information reported to the Department in accordance with 25-1-124, C.R.S. and Chapter II, General Licensure, Part 3.2 occurrence Reporting. (15) “NFPA” means the National Fire Protection Association. (16) “Owner” means the entity in whose name the license is issued. The entity is responsible for the financial and contractual obligations of the facility. Entity means any corporation, limited liability corporation, firm, partnership, or other legally formed body, however organized. For the purposes of this regulation, the term “owner” is used interchangeably with the terms “applicant” and “licensee.” (17) “Plan of correction” means a written plan to be submitted by facilities to the Department for approval, detailing the measures that shall be taken to correct all cited deficiencies. (18) “Seclusion room” means a room where a client is placed alone and from where egress is involuntarily prevented. (19) “Short-term psychiatric care” means services provided to treat persons with mental illness for an average of 3-7 days, but generally no longer than 30 days. (20) “Staff” means employees; and contract staff intended to substitute for, or supplement staff who provide client care services. (21) “Therapeutic diet” means a diet ordered by a physician as part of a treatment of disease or clinical condition, or to eliminate, decrease, or increase specific nutrients in the diet. Examples include, but are not limited to: a calorie counted diet, a specific sodium gram diet, and a cardiac diet. (22) “Unit” means a locked treatment setting that serves a maximum of sixteen persons. (23) “Warewashing” means the cleaning and sanitizing of equipment and utensils. For the purposes of this definition, equipment includes but is not limited to kitchen appliances and tables with which food normally comes into contact. For the purposes of this definition, utensils are implements used to prepare, store, transport or serve food. 1.103 (1)

Department Oversight

General (a) Facility Compliance. The governing body shall be responsible for the operation of the facility and for compliance with these regulations. The governing body shall delegate the responsibility for day-to-day operations to the director. (b) Issuing Licenses. The Department shall issue or renew a license after it is satisfied that the license applicant or licensee is in compliance with the requirements set forth in this Chapter VI and the requirements established by the Division of Mental Health,

Department of Human Services. Such license issued or renewed pursuant to this section, other than a provisional license, shall expire one year from the date of issuance or renewal. (2) Licensure Fees. Licensure fees are specified in Section 25-3-105 (1)(c), C.R.S. (3) Construction Plan Review. In reference to the National Fire Protection Association requirements, the Department is the authority having jurisdiction for state licensure. (a) When Plan Review is Required (i) Application for an initial license, when such initial license is not a change of ownership. This includes new facility construction and existing structures. (ii) Substantial remodeling which includes, but is not limited to: (A) Structural additions, of any size or type (including pre-fabricated structures) to or adjacent to the structure and on the property controlled by the facility. (B) Alteration of an existing space, room, structure, or area of the facility not previously used for providing client services to space used for the delivery of services to clients. (C) Any structural alteration that affects 25% or more of the square footage of the existing habitable 1 floor space, as determined by the Department. (D) Installation or substantial alteration 2 of the following systems: fire alarm, sprinkler, kitchen-hood fire-suppression and security. 1 Areas, such as unfinished basements and garages, not used for habitable space shall not be included in the calculation of habitable existing building area. 2 Substantial alteration does not include repairs, replacement in kind, or additions of a single device to a required Life Safety Code system. Substantial alteration does include permanent de-activation of a system.

(b) Process for Submission and Approval of Building Plans (i) General. The building plans and plans for the security system, fire alarm system and automatic fire suppression system, subject to plan review under this Chapter VI, shall be submitted in accordance with 6 CCR 1011-1, Chapter II, Part 1, Review of Building Plans and Specifications, Sections 1.1.1, 1.1.4, and 1.3. (ii) Locked areas. The following shall also be submitted as part of the plan review: (A) Locking devices for egress doors, egress access doors, and seclusion room doors. (B) Location of locked egress and locked egress access doors. (C) Drawings and information detailing how the facility will install or construct fencing or other enclosures around all secured outdoor areas, to prevent elopement and maintain the safety of the clients. (D) Location, size, and distance from the structure(s) of any secured exterior point of safety used for emergency evacuation purposes.

(4) Citing Deficiencies (a) The Department is authorized to cite deficiencies. (b) The facility shall respond to a life or limb-threatening deficiency by immediately removing the cause of the life or limb threatening risk and provide evidence, either verbal or written as required by the Department, that the risk has been removed. (5) Plans of Correction (POCs). The Department shall require and the facility shall submit a plan of correction in response to cited deficiencies. (a) General (i) The facility shall develop a POC, in the format required by the Department, for every deficiency cited by the Department in the deficiency list. (ii) The POC shall be typed or printed legibly in ink. (iii) The date of correction for deficiencies shall be no longer than 30 calendar days from the date of the mailing of the deficiency list to the facility, unless otherwise required or approved by the Department. (b) Process for Submission and Approval of POC (i) A facility shall submit a POC to the Department no later than ten (10) working days of the date of the deficiency list letter sent by the Department. (ii) If an extension of time is needed to complete the POC, the facility shall request an extension in writing from the Department prior to the POC due date. An extension of time may be granted by the Department not to exceed seven (7) calendar days. (iii) The POC is subject to Department approval. (6) Facility Reporting Requirements. The facility shall develop and implement policies and procedures for complying with the following reporting requirements. (a) Occurrences (i) Reporting. The facility shall be in compliance with occurrence reporting requirements pursuant to 6 CCR 1011, Chapter II, Section 3.2. (ii) Facility investigation of occurrences (A) Occurrences shall be investigated to determine the circumstances of the event and institute appropriate measures to prevent similar future situations. (B) Documentation regarding investigation, including the appropriate measures to be instituted, shall be made available to the Department, upon request. (C) A report with the investigation findings will be available for review by the Department within five working days of the occurrence.

(D) Nothing in this Section 1.103 (6)(a) shall be construed to limit or modify any statutory or common-law right, privilege, confidentiality or immunity. (b) Notification Regarding Relocations. The facility shall notify the Department within 48 hours of the relocation of one or more clients occurs due to any portion of the facility becoming uninhabitable as a result of fire or other disaster. (c) Facility Closure. If the closure of a facility by a licensee is pending, the licensee shall notify the Department in writing at least 30 days prior to such closure. 1.104

Facility Operations

(1) Medications. Medications shall be stored in a manner that prevents unauthorized access and drug diversion. (2) Staffing Requirements: Communicable Diseases (a) General. All staff and volunteers shall be free of communicable disease that can be readily transmitted in the workplace. (b) Tuberculosis (i) All staff shall be required to have a tuberculin skin test prior to direct contact with the clients. In the event of a positive reaction to the skin test, evidence of a chest xray and other appropriate follow-up shall be required in accordance with community standards of practice. (ii) The facility personnel files for staff members as well as for volunteers who have direct contact with clients shall include documentation evidencing TB testing and results. (3) Emergency Preparedness (a) The facility shall develop, update as necessary, and implement a plan for emergency preparedness that addresses the facility response to the following emergencies: (i) Severe weather, including but not limited to floods, blizzards, and tornados. (ii) Fire. (iii) Bomb threats. (iv) Explosions. (v) Hazardous material spills. (vi) Internal system failures, such as electrical outages. (vii) Communicable disease outbreaks. (b) Staff shall receive training regarding their responsibilities under the plan. (i) Within three (3) working days of date of hire or commencement of volunteer service, the facility shall provide training in emergency preparedness.

(ii) Every two (2) months, there shall be a review of all components of the emergency preparedness plan, including each individual employee’s responsibilities under the plan, with the staff of each shift. (4) Infection Control. The facility shall adopt and implement policies and procedures regarding infection control that shall address, at minimum: (a) housekeeping, (b) dietary services, and (c) linen and laundry services. (5) Unit Safety Checks. The facility shall conduct unit safety checks every shift to identify and remedy hazards that could be used by clients to harm themselves or others. There shall be documentation of these safety checks. 1.105 Dietary Services (1) Supervision. The governing body shall appoint an individual to be in charge of dietary services. Such individual shall have knowledge of foodbourne disease prevention, including but not limited to hygienic practices and food safety techniques pertaining to preparation, food storage and warewashing. (2) Sanitary Conditions. Food shall be prepared, handled and stored in a sanitary manner, so that it is free from spoilage, filth or other contamination, and shall be safe for human consumption. (3) Dishwashing. Warewashing shall be conducted in a safe and sanitary manner. Unless commercial grade dishwashers are used, a two-compartment sink or a single-compartment sink shall be used in conjunction with a domestic dishwashing machine. Dishwashing machines shall be used in accordance with manufacturer's instructions. (4) Meals and Snacks (a) Meals (i) Menus shall vary daily and shall be adjusted for seasonal changes and holidays. (ii) At least three nutritionally balanced meals in adequate portions, using a variety of foods shall be made available at regular times daily. (iii) In the event the meal provided is unpalatable, a nutritionally balanced substitute shall be available. (b) Snacks. Between meal snacks of nourishing quality shall be available, to the extent that such availability does not conflict with a client’s service plan. (c) Therapeutic Diets. This provision is only applicable to facilities that admit clients who require therapeutic diets. If the facility admits such clients, the following requirements shall apply. (i) Therapeutic diets shall be prescribed by a physician. (ii) The facility shall implement a system in order to ensure that the proper diet is provided.

(5) Food Supply. There shall be enough food and water on hand to prepare three nutritionally balanced meals for four days. 1.106 Linen and Laundry Services (1) Provision of Laundry Services. The facility shall make laundry services available for clients’ personal laundry in one of the following ways, and in accordance with these regulations: (a) Providing laundry service for clients’ personal items. (b) Providing a designated laundry room for use by clients. Clients may do their personal laundry as part of their treatment plan. (2) Clean Linen Supply. The facility shall maintain a sufficient supply of clean linen, including sheets and towels. (3) Sanitary Conditions (a) Linen and laundry services shall be conducted in a manner designed to prevent contamination of patients and personnel. (b) Staff shall wash their hands after handling soiled linen and before handling clean linen. (c) Storage (i) Soiled linen shall be stored separately from clean linen. Soiled linen and clean linen shall be stored in separate enclosed areas. (ii) Laundry room(s) shall not be used for storage of soiled or clean laundry unless the laundry room is over 100 square foot in area and meets the requirements of NFPA 101, Chapter 18, Section 18.3.2. 1.107 Interior and Exterior Environment (1) Interior Environment (a) General. The facility shall provide a clean, sanitary interior environment, free of hazards to health and safety. The facility shall have a layout, finishes, and furnishings that minimize the opportunity for residents to injure themselves or others. (b) Maintenance. Interior areas shall be in good repair. (c) Finishes (i) All finishes shall promote maintenance of sanitary conditions. (ii) Floor surfaces and coverings shall promote mobility in areas used by individuals and shall promote maintenance of sanitary conditions. (d) Furnishings. The furnishings shall be clean, dry, free of foul orders, safe and well-maintained. (e) Windows. Windows that can be accessed by clients shall have security glazing or other appropriate security features to reduce the possibility of patient injury or escape. (f) Potential Infection/Injury Hazards

(i) Sharps. Sharp knives and other objects that could be used for self-harm or harm to others shall be secured in a manner inaccessible to clients. (ii) Insect/rodent infestations. The facility shall be maintained free of infestations of insects and rodents and all openings to the outside shall be screened. (iii) Storage of hazardous substances. Solutions, cleaning compounds and hazardous substances shall be labeled and stored in a safe manner, in an area inaccessible to the clients. (g) Heating, Lighting, Ventilation (i) Each room in the facility shall be installed with heat, lighting and ventilation sufficient to accommodate its use and the needs of the clients. (ii) All interior and exterior steps and interior hallways and corridors shall be adequately illuminated. (h) Water (i) Potable water. There shall be an adequate supply of safe, potable water available for domestic purposes. (ii) Hot water (A) Hot water shall not measure more than 120 degrees Fahrenheit at taps which are accessible by clients. (B) There shall be a sufficient supply of hot water during peak usage demands. (i) Telephone. There shall be a telephone available for use by residents and staff. (2) Exterior Environment (a) General. The facility shall provide a clean, sanitary, and secure, exterior environment, free of hazards to health and safety. (b) Potential Hazards. Exterior areas shall be well maintained. (i) Maintenance of the grounds. Exterior premises shall be kept free of high weeds and grass, garbage and rubbish. Grounds shall be maintained to prevent hazardous slopes, holes, or other potential hazards. (ii) Staircases. Exterior staircases of three (3) or more steps and porches shall have handrails. Staircases and porches shall be kept in good repair. 1.108

Physical Plant

(1) Compliance with State and Local Laws/Codes. Facilities shall be in compliance with all applicable: (a) Local zoning, housing, fire and sanitary codes and ordinances of the city, city and county, or county where the facility is situated to the extent that such codes are consistent with the federal "Fair Housing Amendment Act of 1988", as amended, 42 U.S.C., sec. 3601, et seq.

(b) State and local plumbing laws and regulations. Plumbing shall be maintained in good repair, free of the possibility of backflow and backsiphonage, through the use of vacuum breakers and fixed air gaps, in accordance with state and local codes. (c) Sewage disposal requirements. Sewage shall be discharged into a public sewer system or disposed of in a manner approved by the local health department, or local laws if no local health department exists, and the Colorado Water Quality Control Commission. (2) Common Areas (a) Common areas sufficient to reasonably accommodate all clients shall be provided. (b) All common areas and dining areas shall be accessible to clients utilizing an auxiliary aid without requiring transfer from a wheelchair to walker or from a wheelchair to a regular chair for use in the dining area. All doors to those rooms requiring access shall be at least 32 inches wide. (c) A minimum of two entryways shall be provided for access and egress from the building by clients utilizing a wheelchair. (3) Dining Areas. A designated dining area accessible by all clients shall be provided in a separate area or areas capable of comfortably seating all clients. (4) Bedrooms (a) Bedroom Assignment. No client shall be assigned to any room other than a regularly designated bedroom. (b) Occupancy Ratios. No more than two (2) clients shall occupy a bedroom. (c) Square Footage Requirements (i) Each designated bedroom shall have at least 100 square feet for single occupancy bedrooms and 60 square feet per person for double occupancy bedrooms. Bathroom areas and closets shall not be included in the determination of square footage. (d) Storage Space. Each client shall have within his or her room separate storage facilities adequate for clothing and personal articles such as a closet or a locker. When the treatment program indicates, shelves for folded garments shall be used instead of hanging garments. (e) Windows. Each bedroom shall have at least one window of eight (8) square feet with a sill height not to exceed 36 inches. (f) Furnishings (i) Each client bedroom shall be equipped as follows for each client: (A) A comfortable, standard-sized bed equipped with a comfortable, clean mattress, mattress protector, and pillow. Rollaway type beds, cots, folding beds or bunk beds shall not be permitted. (B) A standard-sized chair in good condition.

(C) A safe and sanitary method to store the client’s towel, such as a breakaway towel rack. (g) Electrical Hazards. Extension cords and multiple use electrical sockets shall be prohibited in client bedrooms. (5) Bathrooms (a) Number of Bathrooms Per Client. There shall be at least one full bathroom for every six (6) clients. A full bathroom shall consist of at least the following fixtures: toilet, handwashing sink, toilet paper dispenser, mirror, tub or shower, and towel rack. Bathrooms shall be equipped with soap dispensers or the facility shall have a procedure in place that prevents clients from sharing soap. (b) Bathroom Accessibility. There shall be a bathroom on each floor having client bedrooms which is accessible without requiring access through an adjacent bedroom. (c) Bathrooms for Clients using Auxiliary Aids. The facility shall provide at least one full bathroom as defined herein with fixtures positioned so as to be fully accessible to any client utilizing an auxiliary aid. Grab bars shall be properly installed at each tub and shower, and adjacent to each toilet. (d) Fixtures (i) Non-skid surfaces. Bathtubs and shower floors shall have non-skid surfaces. (ii) Toilet seats. Toilet seats shall be constructed of non-absorbent material and free of cracks. (e) Supplies (i) Individualized supplies. The use of common personal care articles, including soap and towels, is prohibited. (ii) Toilet paper. Toilet paper in a dispenser shall be available at all times in each bathroom of the facility. (iii) Liquid soap and paper towels. Liquid soap and paper towels shall be available at all times in the common bathrooms of the facility. (6) Seclusion rooms (a) Client Safety (i) The seclusion room shall be constructed to prevent patient hiding, escape, injury, or suicide. (ii) The seclusion room shall be free of all protrusions, sharp corners, hardware, fixtures or other devices, and furnishings which may cause injury to the occupant. (b) Temperature. The seclusion room shall maintain temperatures appropriate for the season. (c) Location. The room shall be located in a manner affording direct observation of the patient by the nursing staff.

(d) Square Footage. The seclusion room shall have an area of at least 100 square feet. (e) Windows. The seclusion room shall have a window that allows someone outside to see into all of the corners of the room. Windows in the seclusion room shall be constructed to prevent breakage and otherwise prevent the occupant from harming himself. (f) Doors. Doors to the seclusion room shall be at least 32 inches wide, shall open outward. (g) Electrical Outlets (i) Light fixtures and other electrical outlets in the seclusion room shall be limited to those required and necessary, shall be recessed, and shall be constructed as to prevent the occupant from harming himself. (ii) All electrical outlets, devices, and circuits accessible from inside the seclusion room shall be controlled by on/off switches located outside the seclusion room, in a secure location that is within the line of vision of the seclusion room. The switches shall be durably labeled as to their function. (h) Fire Detection and Suppression Equipment. Any sprinkler head in a seclusion room shall be tamper proof, either by being recessed and covered at all times with the manufacturer’s recommended cover or institutional style (7) Linen and Laundry (a) The facility may have laundry room(s) no larger than 100 square feet in area equipped with residential style washer(s) and one residential style dryer without such laundry rooms being classified as a hazardous area. These laundry rooms shall not be used for storage of soiled or clean linen. (b) Facilities shall have a separate enclosed area for receiving and holding soiled linen until ready for pickup or processing in addition to a separate enclosed area for clean linen storage. Enclosed areas located inside the structure or attached to the structure, used for soiled linen, shall meet the requirements of NFPA 101, Chapter 18, Section 18.3.2 for hazardous areas. Enclosed areas located inside the structure or attached to the structure, that are over 50 square feet and used for clean linen, shall meet the requirements of NFPA 101, Chapter 18, Section 18.3.2. (c) There shall be hand-washing facilities in each area where un-bagged, soiled linen is handled. 1.109 Fire Safety These regulations incorporate by reference the National Fire Protection Association’s NFPA 101, Life Safety Code, 2006 Edition. Such incorporation does not include later amendments to or editions of the referenced material. The Department of Public Health and Environment maintains copies of the complete text of the incorporated materials for public inspection during regular business hours, and shall provide certified copies of the incorporated material at cost upon request. Information regarding how the incorporated material may be obtained or examined is available from: Division Director Health Facilities and Emergency Medical Services Division Colorado Department of Public Health and Environment

4300 Cherry Creek Drive South Denver, CO 80246 Phone: 303-692-2800 Copies of the incorporated materials have been provided to the State Publications Depository and Distribution Center, and are available for interlibrary loan. Any incorporated material may be examined at any state publications depository library. (1) General (a) Multiple Buildings Under One License. Any facility operating under one license but comprised of multiple buildings shall have the Life Safety Code requirements determined for each building on an individual basis. (2) Compliance with NFPA 101, Life Safety Code Requirements (a) Except as noted in Section 109 (2) (b), facilities shall meet the requirements of Chapter 18 “New Health Care Occupancies” of NFPA 101, Life Safety Code. In addition, facilities shall meet the requirements referenced in NFPA 101, Chapter 2 “Referenced Publications.” (b) Exceptions. Facilities that have the exceptions listed under subsections (i) Smoke Barriers and (ii) Minimum Construction Requirements, below, shall have a minimum staffing ratio of 1:6 to ensure timely evacuation in case of fire. (i) Smoke Barriers. A facility is exempted from the requirements of NFPA 101, Chapter 18, Section 18.3.7.1 (smoke barriers) if: (A) The facility is equipped with a complete fire alarm system that includes smoke detectors in all corridors, sleeping rooms, and habitable spaces, and (B) The facility maintains a travel distance of 200 feet or less from any point in the facility to the exterior of the structure, through a required exit, and the required exits lead to an approved, secured exterior point of safety. (ii) Minimum Construction Requirements. In addition to the acceptable types of building construction listed in NFPA 101, Chapter 18, Table 18.1.6.4, facilities may be type V (000) construction if: (A) The structure is one-story in height, and (B) The facility is equipped with a complete fire alarm system that includes smoke detectors in all corridors, sleeping rooms, and habitable spaces. (3) Locking devices (a) Egress and egress access doors. Locking devices, used to secure facility egress doors and egress access doors, shall be in compliance with the following: (i) NFPA 101, Chapter 7, Section 7.2.1.6.1, Delayed Egress Locks, or (ii) NFPA 101, Chapter 7, Section 7.2.1.6.2, Access Controlled Egress Doors, or

(iii) Doors in the required means of egress may have locking arrangements without delayed egress provided that all staff can readily unlock such doors at all times. (iv) Facilities may use electric or electronic locking devices if: (A) All staff can readily unlock such doors at all times. (B) For emergency purposes, the facility evacuates clients to an approved, secured, exterior, point of safety, OR, the facility is equipped with smoke barriers as required by NFPA 101, Chapter 18, Section 18.3.7.1 of. (v) Doors in the required means of egress that are equipped with electronic or electrical locking devices must: (A) Unlock upon loss of power controlling the lock or locking mechanism, and (B) Unlock upon actuation of the approved supervised automatic sprinkler system, and (C) Unlock upon activation of no more than two smoke detectors of the approved automatic fire detection system. (b) Seclusion Rooms. Seclusion rooms are permitted to have door-locking arrangements, provided that at all times keys are carried by the staff, responsible for client care and treatment. These keys shall have a distinct color and feel. (c) Secure Outdoor Area (i) In addition to the interior common areas required by this regulation, the facility shall provide a safe and secure outdoor area for the use of clients year round. (ii) Fencing or other enclosures (A) Fencing or other enclosures, that prevent elopement and protect the safety and security of the clients, shall be installed around secure outdoor areas. (B) Where a locked outdoor fence gate restricts access to the public way, all staff must carry gate lock keys on their person at all times while on duty, unless the gate is locked using electronic or electrical devices authorized under Section 1.109 (3)(a)(v). (4) Fire Drills (a) During the first year of operation, fire drills shall be conducted once per shift per month. (b) After the first year of operation, fire drills shall be conducted once per shift per quarter. (c) Fire drills conducted during normal sleeping hours do not require the activation of the fire alarm system. All other fire drills shall include the activation of the fire alarm system. (d) Clients should, whenever possible, participate in daytime fire drills. Client participation in fire drills conducted during normal sleeping hours is not required. (5) Equipment

(a) First Aid. First aid equipment shall be maintained on the premises in a readily available location and staff shall be instructed in its use. (b) Telephone (i) There shall be at least one telephone, not powered by the facility’s electrical system, for use by the staff for emergencies. (ii) Current phone number and location of the nearest hospital, and current phone numbers of ambulance service, poison control center, fire station and the police shall be shall be readily accessible to staff. (6) Fire Suppression or Detection Equipment. Any fire suppression or detection equipment shall be operational and functional. The facility must fully document all inspections for fire alarm and smoke detection systems, automatic fire sprinkler systems and fixed kitchen systems with written records maintained at the facility for review. All inspections and documentation shall be per NFPA requirements. (a) Fire alarm and smoke detection systems must be inspected by trained and qualified personnel at least annually. (b) Automatic fire sprinkler systems must be inspected annually, by a sprinkler contractor currently registered with the State of Colorado – Division of Fire Safety to perform inspection and maintenance services. The facility shall perform and document, main drain tests and flow tests on a quarterly basis. (c) Fixed kitchen extinguishing systems must be inspected by trained and qualified personnel on a semi-annual basis. (d) Portable fire extinguisher. The facility shall have a portable fire extinguisher of the ABC type and of at least 3-pound capacity 3 , located in the kitchen area, common area, and at least one on every level of the facility. Fire extinguishers shall be checked monthly to ensure that they are mounted in a location that is easily accessible and that the pressure gauge is within the safe zone. Portable fire extinguishers shall be inspected annually, and tagged by a qualified fire extinguisher maintenance contractor. 3 Capacity is defined as the capacity of the extinguishment agents.

Chapter VII - Assisted Living Residences 1.101

Statutory Authority and Applicability

1.101(1) Authority to establish minimum standards through regulation and to administer and enforce such regulations is provided by sections 25-1.5-103, et seq., C.R.S., 25-27-101, and 25-27-104, C.R.S. 1.101(2) Assisted living residences, as defined herein, shall be in compliance with all applicable federal and state statutes and regulations, including but not limited to, the following: 101 (2)(a)

This Chapter VII.

101 (2)(b)

6 CCR 1011-1, Chapter II, pertaining to general licensure requirements.

101 (2)(c) 6 CCR 1011-1, Chapter XXIV and Section 25-1.5-301, et seq., C.R.S, pertaining to medication administration.

1.102

Definitions.

For purposes of this chapter, the following definitions shall apply, unless the context requires otherwise: 1.102(1)

"Abuse" means emotional, physical and sexual abuse, as defined herein.

1.102(2) "Administrator" means a person who is responsible for the overall operation, and daily administration, management and maintenance of the facility. "Administrator" also refers to "operator" as that term is used in Title 25, Section 27, Part 1. 1.102(3)

"Activities of daily living" include but are not limited to the following:

102(3)(a)

Assisting resident or providing reminders for the following:

(i)

bathing, shaving, dental hygiene, caring for hair;

(ii)

dressing;

(iii)

eating;

(iv)

getting in or out of bed.

102(3)(b) Making available, either directly or indirectly through the resident agreement, at least the following: (i)

meals;

(ii)

laundry;

(iii)

cleaning of all common areas, bedrooms, and bathrooms;

(iv)

managing money, as necessary and by agreement;

(v)

making telephone calls;

(vi)

arranging appointments and schedules;

(vii)

shopping;

(viii)

writing letters;

(ix)

recreational and leisure activities.

1.102(4) "Alternative care facility" means an assisted living residence certified by the Colorado Department of Health Care Policy and Financing to receive Medicaid reimbursement for the services provided by the facility. 1.102(5) "Assess or assessment" as used herein means recognizing a significant change in the resident's condition. It does not mean making clinical judgments unless the person conducting such assessment is licensed to make such judgments. 1.102(6)

"Assisted living residence" means any of the following:

102(6)(a) A residential facility that makes available to three or more adults not related to the owner of such facility, either directly or indirectly through a resident agreement with the

resident, room and board and at least the following services: personal services; protective oversight; social care due to impaired capacity to live independently; and regular supervision that shall be available on a twenty-four-hour basis, but not to the extent that regular twenty-four hour medical or nursing care is required. 102(6)(b) A residential treatment facility for the mentally ill which is an assisted living residence similar to the definition under Section 1.102 (6)(a), except that the facility is operated and maintained for no more than sixteen (16) mentally ill individuals who are not related to the licensee and are provided treatment commensurate to the individuals' psychiatric needs which has received program approval from the Department of Human Services. 102(6)(c)

The term "assisted living residence" does not include:

(i)

Any facility licensed in this state by the Department of Human Services as a residential care facility for individuals with developmental disabilities pursuant to Section 27-10.5-101, C.R.S., et seq.; or

(ii)

Any individual residential support services for individuals with developmental disabilities provided in accordance with Section 27-10.5-101, C.R.S., et seq., unless specifically authorized to be an assisted living residence by the Department of Human Services.

1.102(7) "Auxiliary aid" means any device used by persons to overcome a physical disability and includes but is not limited to a wheelchair, walker or orthopedic appliance. 1.102(8) "Bedridden" means a resident who is unable to ambulate or move about, independently or with the assistance of an auxiliary aid, who also requires assistance in turning and repositioning in bed. 1.102(9) "Care plan" means a written description in lay terminology of the functional capabilities of an individual, the individual's need for personal assistance, and the services to be provided by the facility in order to meet the individual's needs and may also mean a service plan for those facilities which are licensed to provide services specifically for the mentally ill. 1.102(10) "Deficiency" means a violation of regulatory and/or statutory requirements governing assisted living residences, as cited by the Department. 1.102(11)

"Deficiency list" means a listing of deficiency citations which contains:

102(11)(a)

a statement of the statute or regulation violated; and

102(11)(b)

a statement of the findings, with evidence to support the deficiency.

1.102(12) "Department" means the Colorado Department of Public Health and Environment or its designee. 1.102(13) "Discharge" means termination of the resident agreement and the resident's permanent departure from the facility. 1.102(14) "Emergency contact" means one of the individuals identified on the face sheet of the resident record to be contacted in the case of an emergency. 1.102(15) "Emotional abuse" means harassment; threats of punishment, harm, or deprivation directed toward the resident.

1.102(16) "External services" means personal services and protective oversight services provided to a resident by family members or by professionals who are not employees, contractors, or volunteers of the facility. External services providers include, but are not limited to, home health, hospice, private pay caregivers and family members. 1.102(17)

"Facility" means an assisted living residence.

1.102(18) "High Medicaid Utilization facility" means an assisted living residence that is certified as an alternative care facility and is eligible for a modified fee schedule. 1.102(19)

"Individualized social supervision" means social care, as defined below.

1.102(20) "Licensee" means the person or entity to whom a license is issued by the Department pursuant to Section 25-1.5-103 (1) (a), C.R.S., to operate a facility within the definition herein provided. For the purposes of this Chapter VII, the term "licensee" shall be the same as the term "owner." 1.102(21) "Medical or nursing care" means care provided under the direction of a physician and maintained by on-site nursing personnel. 1.102(22) "Medication administration" means assisting a resident in the use of medication in accordance with state law. 1.102(23) "Monitoring" with respect to medications means involvement with a resident's use of medication in accordance with state law. 1.102(24)

"Neglect" means failure to fulfill a caretaking responsibility that leads to physical harm.

1.102(25)

"NFPA" means the National Fire Protection Association.

1.102(26)

"Ombudsman" means, unless otherwise specified, long term care ombudsman.

1.102(27) "Owner" means the entity in whose name the license is issued. The entity is responsible for the financial and contractual obligations of the facility. Entity means any individual, corporation, limited liability corporation, firm, partnership, or other legally formed body, however organized. For the purposes of the background check required pursuant to Section 1.104 (3) of the owner, if the owner is an entity other than an individual, one person with legal liability for the facility shall be designated to undergo fingerprinting, in accordance with Department requirements. 1.102(28) "Personal services" means those services which the administrator and employees of an assisted living residence provide for each resident, including, but not limited to: 102(28)(a)

an environment that is sanitary and safe from physical harm;

102(28)(b)

individualized social supervision;

102(28)(c) assistance with transportation whether by providing transportation or assisting in making arrangements for the resident to obtain transportation; and 102(28)(d)

assistance with activities of daily living, as herein defined.

1.102(29) "Physical abuse" means causing physical harm in a situation other than an accident. Physical abuse means behavior, including but not limited to, hitting, slapping, kicking or pinching. 1.102(30)

"Plan of correction" means a written plan to be submitted by facilities to the Department for

approval, detailing the measures that shall be taken to correct all cited deficiencies. 1.102(31) "Plan review" means the review by the Department, or its designee, of new construction or remodeling plans to ensure compliance by the facility with the National Fire Protection Association (NFPA) Life Safety Code and with this Chapter VII. Plan review consists, as appropriate, of: 102(31)(a)

the examination of new construction or remodeling plans; and

102(31)(b)

onsite inspections.

1.102(32) "Protective oversight" means guidance of a resident as required by the needs of the resident or as reasonably requested by the resident including the following: 102(32)(a) being aware of a resident's general whereabouts, although the resident may travel independently in the community; and 102(32)(b) monitoring the activities of the resident while on the premises to ensure the resident's health, safety, and well-being, including monitoring the resident's needs and ensuring that the resident receives the services and care necessary to protect the resident's health, safety, and well-being. 1.102(33)

"Resident's legal representative" means one of the following:

102(33)(a) the legal guardian of the resident, where proof is offered that such guardian has been duly appointed by a court of law, acting within the scope of such guardianship; 102(33)(b) an individual named as the agent in a power of attorney (POA) that authorizes the individual to act on the resident's behalf, as enumerated in the POA; 102(33)(c) an individual selected as a proxy decision-maker pursuant to Section 15-18.5-101, C.R.S., et seq., to make medical treatment decisions. For the purposes of this regulation, the proxy decision-maker serves as the resident's legal representative for the purposes of medical treatment decisions only; or 102(33)(d) a conservator, where proof is offered that such conservator has been duly appointed by a court of law, acting within the scope of such conservatorship. 1.102(34) "Restraints" means any involuntary restraint as defined in 26-20-102 (6) C.R.S. and 6 CCR 1011-1, Chapter II, Part 8, Section 102 (5). For the purposes of this chapter, restraint also includes voluntary restraints. A secured environment that meets the requirements in Section 1.108 of these regulations shall not be considered a restraint. 1.102(35) "Restrictive egress alert device" means a device used to prevent the elopement of a resident who is at risk if he or she leaves the facility unsupervised. This includes any device used with residents who have confusion or dementia and is used to prohibit their egress or to immediately redirect them after they exit the facility. Egress alert devices are not considered restrictive when used only to alert staff regarding the ingress and egress of residents, visitors, and others. Restrictive egress alert devices shall not lock any door in a means of egress, including access to a means of egress. 1.102(36) "Secured environment" means, unless the context requires otherwise, any grounds, building or part thereof, method or device, other than restrictive egress alert devices used consistent with Section 1.104 (5)(k), that prohibits free egress of residents. An environment is secured when the right of any resident thereof to move outside the environment during any hours is limited.

1.102(37) "Sexual abuse" means non-consensual sexual contact as defined in Section 18-3-401 (4), C.R.S and sexual contact with any person incapable of giving consent. Sexual abuse includes, but is not limited to, sexual harassment, sexual coercion, or sexual assault. 1.102(38) "Social care" means the organization, planning, coordination, and conducting of a resident's activity program in conjunction with the resident's care plan. 1.102(39) "Staff" means employees; and contract staff intended to substitute for, or supplement staff who provide resident care services. This does not include individuals providing external services, as defined herein. 1.102(40) "Therapeutic diet" means a diet ordered by a physician as part of a treatment of disease or clinical condition, or to eliminate, decrease, or increase specific nutrients in the diet. Examples include, but are not limited to: a calorie counted diet, a specific sodium gram diet, and a cardiac diet. 1.103

Department Oversight

1.103(1)

General

103(1)(a)

Issuing Licenses

(i)

The Department shall issue or renew a license when it is satisfied that the applicant or licensee is in compliance with the requirements set out in these regulations. Such license issued or renewed pursuant to this section, other than a provisional license, shall expire one year from the date of issuance or renewal.

(ii)

No license shall be issued or renewed by the Department if the owner, applicant, or licensee of the assisted living residence has been convicted of a felony or of a misdemeanor, which felony or misdemeanor involves moral turpitude, as defined by law, or involves conduct that the Department determines could pose a risk to the health, safety, and welfare of residents of the assisted living residence.

103(1)(b)

Provisional Licenses

(i)

The Department may issue a provisional license to an applicant for the purpose of operating an assisted living residence for a period of ninety days if the applicant is temporarily unable to conform to all the minimum standards required under these regulations, except no license shall be issued to an applicant if the operation of the applicant's facility will adversely affect the health, safety, and welfare of the residents of such facility.

(ii)

As a condition of obtaining a provisional license, the applicant shall show proof to the Department that attempts are being made to conform and comply with applicable standards. No provisional license shall be granted prior to the submission of a criminal background check in accordance with 25-27-105 (2.5), C.R.S.

(iii)

A provisional license shall not be renewed.

103(1)(c) (i)

Action Against a License General . The Department may suspend, revoke, or not renew the license of any facility which is out of compliance with the requirements of these regulations in conformance with the provisions and procedures specified in article 4 of title 24,

C.R.S. (ii)

1.103(2)

Denials . When an application for an original license has been denied by the Department, the Department shall notify the applicant in writing of the denial by mailing a notice to the applicant at the address shown on the application. Any applicant aggrieved by such a denial may pursue the remedy for review provided in article 4 of title 24, C.R.S., by petitioning the Department, within thirty days after receiving such notice.

Licensure Fees .

With the exception of the fees addressed below, licensure fees are specified in Section 25-27-107, C.R.S. 103(2)(a) (i)

Fee . High Medicaid utilization facilities shall pay a modified licensure fee schedule, as established in statute.

(ii)

Eligible facilities . Facilities identified as High Medicaid Utilization are those that have:

103(2)(b)

1.103(3)

High Medicaid Utilization Facilities

(A)

no less than 35 percent of the licensed beds occupied by Medicaid enrollees as indicated by complete and accurate fiscal year claims data; and

(B)

served Medicaid clients and submitted claims data for a minimum of nine (9) months of the relevant fiscal year.

Facilities Serving a Disproportionate Share of Low Income Residents

(i)

Fee . Facilities serving a disproportionate share of low income residents shall pay a reduced initial licensure fee of $2,500.

(ii)

Eligible facilities . Facilities eligible for the reduced initial licensure fee shall: (A)

have qualified for federal or state low income housing assistance;

(B)

plan to serve low income residents with incomes at or below 80 percent of the area median income; and

(C)

submit evidence of such qualification, as required by the Department.

Plan Review .

In reference to the National Fire Protection Association requirements, the Department is the authority having jurisdiction for state licensure. 103(3)(a)

When Plan Review is Required

(i)

Application for an initial license, when such initial license is not a change of ownership. This includes new facility construction and existing structures;

(ii)

Remodeling, commencing on or after November 1, 2002, not limited to:

1

which includes, but is

1 Instances where remodeling shall be deemed to have commenced before November 1, 2002 are: a) when the local jurisdiction

issued a building permit for such remodeling on or before October 31, 2002; or b) if a building permit is not required by the local jurisdiction, where architectural and engineering plans have been drafted and/or onsite construction began on or before October 31, 2002 and completed by May 31, 2004.

(A)

Additions to the facility of any size, where such additions are to be used for the delivery of services to residents.

(B)

Creation or structural alteration of resident sleeping area.

(C)

Alteration of an existing area of the facility into space for a secured environment.

(D)

Any structural alteration that affects 25% or more of the square footage of the existing habitable 2 floor space, as determined by the Department.

2 Areas such as unfinished basements and garages that have not been used as habitable space shall not be include in the calculation of habitable existing building area.

103(3)(b)

(E)

Conversion of existing space not previously used for providing resident services, including storage space, to space used for the delivery of services to residents.

(F)

Any change that alters the path of ingress or egress and impacts the residents' ability to exit the building.

(G)

Installation or renovation of fire alarms, sprinkler systems, and kitchen hood systems. Plan review regarding sprinkler systems shall be limited to the extent of sprinkler coverage and the water supply.

Process for Submission and Approval of Building Plans

(i)

General . The building plans subject to plan review under this Chapter VII shall be submitted in accordance with 6 CCR 1011, Chapter II, Part 1, Review of Building Plans and Specifications, Sections 1.1.1, 1.1.4, and 1.3.

(ii)

Secured Environments . If the addition, remodeling or new construction involves areas to be used for secured environments, information about the following shall also be submitted as part of the plan review:

103(3)(c) (i)

(A)

locking devices for egress and egress access doors.

(B)

location of locked egress and egress access doors.

(C)

how the fencing or other enclosure around the secured outdoor area will be installed such that it prevents elopement and protects the safety and security of the residents.

What is Subject to the Plan Review Fees Application for an initial license, when such initial license is not a change of ownership . An application for an initial license is subject to the initial licensure fee. 3 Such applications are not subject to additional plan review fees outlined under Section 1.103 (3)(d).

3 Plan review for prospective licensees is conducted as part of the $5,000 initial licensure fee, pursuant to Section 25-27-107 (1)(b) (I), C.R.S. Section 1.103 (2)(b) reduces the initial licensure fee to $2,500 for facilities serving a disproportionate share of low income residents.

(ii)

Remodeling . Remodeling is subject to plan review fees, except for remodeling associated with the creation of a new secured environment. 4

4 Plan review for a new secured environment is conducted as part of the $1,150 fee established pursuant to Section 25-27-107 (1) (b)(III), C.R.S.

103(3)(d) Plan Review Fees . Fees shall not exceed $2,000. Subject to this cap, fees shall be billed as follows:

1.103(4)

(i)

New construction or remodeling of 2,000 square feet or less: $500.

(ii)

New construction or remodeling of more than 2,000 square feet: $500 plus $0.25 per additional square foot over 2,000 square feet.

(iii)

If remodeling is limited to the installation or renovation of fire suppression systems: (A)

facilities with 3 to 16 licensed beds: $500.

(B)

facilities with 17 to 40 licensed beds: $750.

(C)

facilities with 41 to 60 licensed beds: $1,000.

(D)

facilities with 61 or more licensed beds: $1,250.

Citing Deficiencies

103(4)(a) The level of the deficiency shall be based upon the number of sample residents affected and the level of harm, as follows:

Deficiency level Level A

Number of Sample 5 Isolated 6

Level B

Pattern 7

Level C

Isolated

Level D

Pattern

Level E

Isolated or Pattern

Level of Harm Potential harm to the resident(s) Potential harm to the resident(s) Actual harm to the resident(s) Actual harm to the resident(s) Life threatening to the resident(s)

5 Sample may consist of residents, rooms, staff, etc. 6 One or a limited number of the sample is affected. 7 More than a limited number of the sample is affected.

103(4)(b) When a Level E deficiency is cited, the facility shall immediately remove the cause of the life-threatening risk and provide evidence, either verbal or written as required by the Department, that the risk has been removed. 1.103(5)

Plans of Correction (POCs)

The Department shall require a plan of correction by facilities pursuant to Section 25-27-105 (2), C.R.S. 103(5)(a)

General

(i)

The facility shall develop a POC, in the format required by the Department, for every deficiency cited by the Department in the deficiency list.

(ii)

The POC shall be typed or printed legibly in ink.

(iii)

The date of correction shall be no longer than 30 calendar days from the date of the mailing of the deficiency to the facility, unless otherwise required or approved by the Department.

103(5)(b)

1.103(6)

Process for Submission and Approval of POC

(i)

A facility shall submit a POC to the Department no later than ten (10) working days of the date of the deficiency list letter sent by the Department.

(ii)

If an extension of time is needed to complete the POC, the facility shall request an extension in writing from the Department prior to the POC due date. An extension of time may be granted by the Department not to exceed seven (7) calendar days.

(iii)

The POC is subject to Department approval.

Intermediate Restrictions or Conditions .

The Department may impose intermediate restrictions or conditions on a licensee as provided in Section 25-27-106, C.R.S. 103(6)(a) General . The Department may impose intermediate restrictions or conditions on a licensee that may include at least one of the following: (i)

Retaining a consultant to address corrective measures. The consultant shall not be affiliated with the corporation or the facility on which the intermediate restriction/condition is required; 8

8 A facility may be required to retain a consultant in order to address deficient practice resulting from systemic failure. Systemic failure involves violations regarding a facility system, where such violations resulted or could have resulted in physical or emotional harm to residents. It will be the responsibility of the facility to select the consultant and the consultant's services. An example of a facility system is the facility's medication administration program.

(ii)

Monitoring by the Department for a specific period;

(iii)

Providing additional training to employees, owners, or operators of the residence;

(iv)

Complying with a directed written plan, to correct the violation; or

(v)

Paying a civil fine not to exceed two thousand dollars ($2,000) in a calendar year.

103(6)(b) (i)

Imposition of Restrictions/Conditions General . Intermediate restrictions or conditions may be imposed when the Department finds the facility has violated statutory or regulatory requirements. The factors that may be considered include, but are not limited to, the following: (A)

level of actual or potential harm to a resident(s);

(B)

the number of residents affected;

(C)

whether the behaviors leading to the imposition of the restriction are isolated or a pattern;

(D)

the licensee's prior history of noncompliance in general, and specifically with reference to the cited deficiencies.

(ii)

Optional . Intermediate restrictions or conditions may be imposed for Levels A, B and C deficiencies.

(iii)

Mandatory Imposition

103(6)(c) (i)

(A)

A minimum of one intermediate restriction or condition shall be imposed for all cases where the deficiency list includes Levels D or E deficiencies.

(B)

For all Level E deficiencies, the Department shall impose a minimum civil fine of $500, not to exceed the $2,000 cap established by statute; shall require the immediate correction of the circumstances that give rise to the life threatening situation; and may impose other restrictions or conditions as the Department finds necessary.

Submission of the Written Plan Non-life threatening situations other than fines and Department monitoring . No later than ten (10) working days after the date the notice is received from the Department, unless otherwise extended, the licensee shall submit a written plan, as part of the plan of correction, regarding the implementation of the restriction or condition. This plan shall be subject to Department approval. The plan shall include: (A)

how the restriction or condition will be implemented; and

(B)

the timeframe for implementing the restriction or condition.

103(6)(d) Appealing the Imposition of Intermediate Restrictions/Conditions . A licensee may appeal the imposition of an intermediate restriction or condition pursuant to procedures established by the Department and as provided by Section 25-27-106, C.R.S. (i)

(ii)

Informal review . Informal review is an administrative review process conducted by the Department that does not include an evidentiary hearing. (A)

A licensee may submit a written request for informal review of the imposition of an intermediate restriction no later than ten (10) working days after the date notice is received from the Department of the restriction or condition. If an extension of time is needed, the facility shall request an extension in writing from the Department prior to the submittal due date. An extension of time may be granted by the Department not to exceed seven (7) calendar days. Informal review may be conducted after the plan of correction has been approved.

(B)

Civil fines . For civil fines, the licensee may request in writing that the informal review be conducted in person, which would allow the licensee to orally address the informal reviewer(s).

Administrative Procedures Act (APA) . A licensee may appeal the imposition of an intermediate restriction or condition in accordance with Section 24-4-105, C.R.S.

of the APA. A licensee is not required to submit to the Department's informal review before appealing pursuant to the APA. (iii)

Implementation of Restrictions/Conditions (A)

(iv)

1.103(7)

Life-threatening situations . The licensee shall implement the restriction or condition immediately upon receiving notice of the restriction or condition.

Non life-threatening situations. The restriction or condition shall be implemented: (A)

for restriction/conditions other than fines, immediately upon the expiration of the opportunity for appeal or from the date that the Department's decision is upheld after all administrative appeals have been exhausted.

(B)

for fines, within 30 calendar days from the date the Department's decision is upheld after all administrative appeals have been exhausted.

Facility Reporting Requirements

103(7)(a)

Occurrences

(i)

Reporting . The facility shall be in compliance with occurrence reporting requirements pursuant to 6 CCR 1011, Chapter II, Section 3.2.

(ii)

Facility investigation of occurrences (A)

Occurrences shall be investigated to determine the circumstances of the event and institute appropriate measures to prevent similar future situations.

(B)

Documentation regarding investigation, including the appropriate measures to be instituted, shall be made available to the Department, upon request.

(C)

A report with the investigation findings will be available for review by the Department within five working days of the occurrence.

(D)

Nothing in this Section 1.103 (7)(a) shall be construed to limit or modify any statutory or common law right, privilege, confidentiality or immunity.

103(7)(b) Mistreatment of Residents/Mishandling of Resident Property . The declaration required in Section 2.3.5 (4), Chapter II of 6 CCR 1011-1, shall also include any action related to the treatment of residents or the handling of their property. 103(7)(c) Notification Regarding Relocations . The facility shall notify the Department within 48 hours of the relocation of one or more residents occurs due to any portion of the facility becoming uninhabitable as a result of fire or other disaster. 103(7)(d) Proof of Fire Suppression or Detection Equipment Testing . Written proof that such fire suppression or detection equipment has been tested and approved as fully functional and operational, shall be submitted with the application prior to the issuance of a new license or license renewal. 1.103(8)

Certification of Administrator Training .

A program of certification shall be approved by the Department if all of the following requirements are met: 103(8)(a)

The program or program components are conducted by:

(i)

an accredited college, university, or vocational school, or

(ii)

an organization, association, corporation, group, or agency with specific expertise in that area; and

(iii)

the curriculum includes at least thirty (30) actual hours.

103(8)(b)

At least fifteen (15) hours shall comprise a discussion of each the following topics:

(i)

resident rights;

(ii)

environment and fire safety, including emergency procedures and first-aid;

(iii)

assessment skills;

(iv)

identifying and dealing with difficult situations and behaviors; and

(v)

nutrition.

103(8)(c) The remaining fifteen (15) hours shall provide emphasis on meeting the personal, social and emotional care needs of the resident population served, for example, the elderly, Alzheimers, or the severely and persistently mentally ill. 1.104

Organization and Staffing

1.104(1)

Owner

104(1)(a) Regulatory Compliance . the owner shall be responsible for meeting the requirements in these regulations. 104(1)(b) Oversight of Staff . The owner is responsible for assuring that there is adequate training and supervision for staff. 1.104(2)

Administrator

104(2)(a)

Minimum Age Requirement . The administrator shall be at least 21 years of age.

104(2)(b)

Minimum Education, Training and Experience Requirements

(i)

Any person commencing service as an administrator July 1, 1993, shall meet the minimum education, training, and experience requirements in one of the following ways: (A)

successful completion of a program approved by the Department pursuant to Section 1.103 (6); or

(B)

documented previous job related experience or related education equivalent to successful completion of such program. The Department may require additional training to ensure that all the required components of the training curriculum are met.

(ii)

(iii) 1.104(3)

Any person already serving as an administrator on July 1, 1993, shall either meet subparagraph (i) above or meet the minimum education, training, and experience requirements in one of the following ways: (A)

successful completion of a program approved by the Department, pursuant to Section 1.103 (4) , if completed within a period of eighteen (18) months following July 1, 1993;

(B)

submission of evidence of successful completion of such a program within the five (5) years immediately prior to July 1, 1993; or

(C)

previous job related experience equivalent to successful completion of such a program.

The administrator shall be familiar with all applicable federal and state laws and regulations concerning licensure and certification.

Personnel

104(3)(a) (i)

General Communicable diseases (A)

All staff and volunteers, shall be free of communicable disease that can be readily transmitted in the workplace.

(B)

All staff shall be required to have a tuberculin skin test prior to direct contact with the residents. In the event of a positive reaction to the skin test, evidence of a chest x-ray and other appropriate follow-up shall be required in accordance with community standards of practice.

(ii)

Physical/mental impairment . Any person who is physically or mentally unable to adequately and safely perform duties that are essential functions, may not be approved as a licensee, or employed as staff member, or used as a volunteer.

(iii)

Alcohol or substance abuse . The facility shall not employ any person or use a volunteer who is under the influence of a controlled substance, as defined in C.R.S. Sections 18-18-203, 18-18-204, 18-18-205, 18-18-206, and 18-18-207, or who is under the influence of alcohol in the worksite. This does not apply to employees or volunteers using controlled substances under the direction of a physician, and in accordance with their health care provider's instructions.

(iv)

Access to policies and procedures . All staff and all volunteers shall have access to the facility's policies, procedure manuals, and other information necessary to perform their duties and to carry out their responsibilities.

104(3)(b) Personnel Files . The facility shall maintain personnel files for staff members as well as for volunteers performing personal services and protective oversight under the auspices of the facility. Files of current employees and volunteers shall be available onsite for Department review. (i)

General . Files shall include documentation required in these Chapter VII regulations, evidencing: (A)

training;

104(3)(c)

(B)

TB testing, if applicable;

(C)

background checks;

(D)

date of hire;

(E)

If a Qualified Medication Administration Person (QMAP), also: (I)

a copy of the certificate of completion of the medication training course required by these regulations for QMAPs, and

(II)

for those QMAPs filling medication reminder boxes, a signed disclosure that they have not had a professional medical, nursing, or pharmacy license revoked.

Background Checks - Owner and Administrator

(i)

The owner and administrator of a facility shall be of good, moral, and responsible character. As part of this determination, the owner and the administrator shall undergo a state fingerprint check with notification of future arrests from a criminal justice agency designated by the Department. The information, upon such request and subject to any restrictions imposed by such agency, shall be forwarded by the criminal justice agency directly to the Department.

(ii)

Background checks shall be conducted for all of the following: (A)

owners and administrators for initial licensure, as part of the application process.

(B)

existing owners and administrators who have not undergone a state fingerprint check with notification of future arrests.

(C)

new owners in a change a ownership, as part of the application process.

(D)

new administrators in a change of administrators.

(iii)

No license shall be issued or renewed by the Department if the owner of the assisted living facility has been convicted of a felony or of a misdemeanor, which felony or misdemeanor involves moral turpitude, as defined by law, or involves conduct that the Department determines could pose a risk to the health, safety, and welfare of residents of the assisted living residence.

(iv)

The owner shall ascertain whether the administrator has been convicted of a felony or a misdemeanor that could pose a risk to the health, safety, and welfare of the residents, when making employment decisions.

(v)

Cost of background checks . All costs of obtaining a criminal history record pursuant to this requirement shall be borne by the facility, the contract staff agency, or the individual who is the subject of the criminal history record, as appropriate.

104(3)(d) (i)

Background Checks - Other Staff and Volunteers When a background check shall be conducted . The staff who has direct personal contact with the residents of a facility and any volunteer performing personal

services or protective oversight, under the auspices of the facility for residents of such facility, shall be of good, moral, and responsible character. In making such a determination, the owner or licensee of a facility shall obtain, prior to such staff or volunteer performing duties, any criminal history record information from a criminal agency, subject to any restrictions imposed by such agency, for any person responsible for the care and welfare or residents of such facility. If the individual is contract staff, the facility shall ensure that a background check has been conducted on such individual within 12 months prior to the date of hire by the facility. The facility shall have documentation of such background checks. (ii)

Use of information by the facility . The facility shall ascertain whether prospective staff or volunteers have been convicted of a felony or a misdemeanor that could pose a risk to the health, safety, and welfare of the residents, when making employment decisions.

(iii)

Costs of background checks . All costs of obtaining a criminal history record from a criminal justice agency shall be borne by the facility, the contract staff agency, or the individual who is the subject of the criminal history record, as appropriate.

104(3)(e)

Qualifications

(i)

General . All staff and all volunteers shall have sufficient skill and ability to perform their respective duties, services, and functions.

(ii)

Licensed and certified staff . Licensed or certified staff shall perform duties in accordance with applicable statutes and regulations. Staff and volunteers shall not perform duties that they are not licensed or certified to provide.

(iii)

Qualified Medication Administration Persons (A)

To be a qualified medication administration person, an individual shall have completed a medication training course given by a licensed nurse, physician, physician's assistant, or pharmacist, and approved by the Department and/or shall have passed an approved Department competency test for assisting with medications in accordance with 251.5-301, et seq. and the regulations promulgated thereto.

(B)

Every qualified medication administration staff member who administers medications, whether prescribed or non-prescribed, shall be able to read and understand the information and directions printed or written on the label.

104(3)(f) Training . The facility shall document the evaluation of previous related experience for volunteers, as applicable, and for staff and that these personnel have all of the training, including on-the-job training, required in this section. (i)

On-the-job training/Evaluation of experience . All staff and all volunteers shall be given on-the-job training or have related experience in the job assigned to them and shall be supervised until they have completed on-the-job training appropriate to their duties and responsibilities or had previous related experience evaluated.

(ii)

Training requirements . Staff shall receive the following training, as appropriate. Volunteers providing direct care shall receive training appropriate to their duties and responsibilities.

(A)

(B)

(C)

1.104(4)

Prior to providing direct care, the facility shall provide an orientation of the physical plant and adequate training on each of the following topics: (I)

training specific to the particular needs of the populations served (e.g., residents in secured environments, mentally ill, frail elderly, AIDS, Alzheimer's, diabetics, dietary restrictions and bedfast);

(II)

resident rights;

(III)

first aid and injury response;

(IV)

the care and services for the current residents; and

(V)

the facility's medication administration program.

Emergency and Fire Escape Plan (I)

Within three (3) days of date of hire or commencement of volunteer service, the facility shall provide adequate training in emergency and fire escape plan procedures.

(II)

Every two (2) months, there shall be a review of all components of the emergency plan, including each individual employee's responsibilities under the plan, with the staff of each shift.

Within one month of the date of hire, the facility shall provide adequate training for staff on each of the following topics: (I)

assessment skills;

(II)

infection control;

(III)

identifying and dealing with difficult situations and behaviors;

(IV)

residents rights, unless previously covered through other training; and

(V)

health emergency response, unless previously covered through other training.

Staffing Requirements

104(4)(a)

Staffing

(i)

General . The owner shall employ sufficient staff to ensure the provision of services necessary to meet the needs of the residents.

(ii)

Staffing levels . In determining staffing, the facility shall give consideration to factors including but not limited to: (A)

services to meet the residents' needs,

(B)

services to be provided under the care plan, and

(C)

services to be provided under the resident agreement.

(iii)

Minimum Staffing . Each facility shall ensure that at least one staff member who has the qualifications and training listed under Sections 1.104 (3)(e) and (f), and who shall be at least 18 years of age, is present in the facility when one or more residents is present.

104(4)(b) Use of Residents . Residents may participate voluntarily in performing housekeeping duties and other tasks suited to the resident's needs and abilities. However, residents who provide services for the facility on a regular basis, or on an exchange or fee-forservice basis may not be included in the facility's staffing plan in lieu of facility employees except for trained, tested, and supervised residents in those facilities which are licensed to provide services specifically for the mentally ill. 104(4)(c) Use of Volunteers . Volunteers may be utilized in the facility but may not be included in the facility's staffing plan in lieu of facility employees. 1.104 (5) Policies and Procedures. Unless otherwise indicated in this Section 1.104 (5), all facilities shall develop, adopt, and follow written policies and procedures that include the requirements listed below and shall comply with all applicable state and federal statutes and regulations. Required disclosures to residents or their legal representatives, as appropriate, regarding the policies and procedures shall be documented in the resident record. [Eff 07/30/2006] 104(5)(a) Admissions . The facility's criteria for admission shall be based upon its ability to meet all the identified care needs of residents. The facility shall consider at least all of the following in making its admission decision: the facility's physical plant, financial resources, and availability of adequately trained staff. 104(5)(b)

Emergency Plan and Fire Escape Procedures

(i)

Emergency plan . The emergency plan shall include planned responses to fire, gas explosion, bomb threat, power outages, and tornado. Such plan shall include provisions for alternate housing in the event evacuation is necessary.

(ii)

Fire escape procedures . The fire escape procedures shall include a diagram developed with local fire department officials which shall be posted in a conspicuous place.

(iii)

Disclosure to residents . Within three (3) days of admission, the plan and diagram shall be explained to each resident or legal representative, as appropriate.

104(5)(c)

Serious Illness, Serious Injury, or Death of the Resident

(i)

The policy shall describe the procedures to be followed by the facility in the event of serious illness, serious injury, or death of a resident.

(ii)

The policy shall include a requirement that the facility notify an emergency contact when the resident's injury or illness warrants medical treatment or face-to-face medical evaluation. In the case of an emergency room visit or unscheduled hospitalization, a facility must notify an emergency contact immediately, or as soon as practicable.

104(5)(d) Physician Assessment . The facility shall identify when a physician's assessment will be required, based upon at least the following indicators: (i)

a significant change in the resident's condition;

(ii)

evidence of possible infection (open sores, etc.);

(iii)

injury or accident sustained by the resident which might cause a change in the resident's condition;

(iv)

known exposure of the resident to a communicable disease;

(v)

development of any condition which would have initially precluded admission to the facility.

104(5)(e)

Resident Rights

(i)

General . The policy shall incorporate the provisions under Section 1.106 (1). This policy shall not exclude, take precedence over, or in any way abrogate legal and constitutional rights enjoyed by all adult citizens.

(ii)

Posting . The policy on resident's rights shall be posted in a conspicuous place.

(iii)

Disclosure to residents . Upon admission, the facility shall document the resident or legal representative, as appropriate, has read or had explained the policy on residents' rights.

104(5)(f)

Smoking

(i)

General . The policy shall address residents, staff, volunteers and visitors.

(ii)

Disclosure to residents/staff . Prior to admission or employment, residents and staff shall be informed of any prohibitions.

104(5)(g) (i)

(ii)

Discharge General . The policy shall include all of the following: (A)

circumstances and conditions under which the facility may require the resident to be involuntarily transferred, discharged or evicted;

(B)

an explanation of the notice requirements;

(C)

a description of the relocation assistance offered by the facility; and

(D)

the right to call advocates, such as the state ombudsman or the designated local ombudsman and the adult protection services of the appropriate county Department of Social Services, for assistance.

Disclosure to residents . Upon admission, the facility shall document that the resident or legal representative, as appropriate, has read or had explained the policy on discharge.

104(5)(h) Management of Resident Funds/Property . The policy shall address the procedures for managing resident funds or property, if the facility provides this service to residents. 104(5)(i) (i)

Internal Grievance Process General . The policy shall establish a process for routine and prompt handling of grievances brought by residents and their families. Such policy shall also

indicate that residents and their families may contact any of the following agencies and shall provide the telephone number and address of each of the following: (A)

The state and local Long Term Care Ombudsman;

(B)

The Adult Protection Services of the appropriate county Departments of Social Services;

(C)

The Advocacy Services of the Area's Agency on Aging;

(D)

The Colorado Department of Public Health and Environment; and

(E)

The Colorado Department of Human Services in those cases where the facility is licensed to provide services specifically for the mentally ill.

(ii)

Posting . The internal grievance policy and procedure shall be posted in a conspicuous place.

(iii)

Disclosure to residents . Upon admission, the facility shall document that the resident or the resident's representative, as appropriate, has read or had the policy for the internal grievance process explained.

104(5)(j) Investigation of Abuse and Neglect Allegations . The facility shall investigate all allegations of abuse and neglect involving residents in accordance with its written policy, which shall include but not be limited to: (i)

reporting requirements to the appropriate agencies such as the adult protection services of the appropriate county Department of Social Services and to the facility administrator;

(ii)

a requirement that the facility notify an emergency contact about the allegation within 24 hours of the facility becoming aware of the allegation;

(iii)

the process for investigating such allegations;

(iv)

how the facility will document the investigation process to evidence the required reporting and that a thorough investigation was conducted;

(v)

a requirement that the resident shall be protected from potential future abuse and neglect while the investigation is being conducted;

(vi)

a requirement that if the alleged neglect or abuse is verified, the facility shall take appropriate corrective action; and

(vii)

a requirement that a report with the investigation findings will be available for review by the Department not later than five working days of the allegation being lodged with a staff member of the facility.

104(5)(k) Restrictive Egress Alert Devices . Facilities that use restrictive egress alert devices, shall have policy addressing at minimum, the following: (i)

How the device will be used to protect the resident from elopement, including but not limited to, which door alarms will be triggered by the device.

(ii)

(iii)

Evidence in the resident's record that the facility has: (A)

established the legal authority by guardianship, court order, medical durable power of attorney, health care proxy, or other means allowed by Colorado law, for the use of such device;

(B)

conducted an assessment, prior to use, that evaluates the appropriateness of the device and reassessment(s) within 3 calendar days of a significant change in the resident's condition that warrants intervention or different care needs. The assessment and reassessment shall include written findings and their basis. The assessment and reassessment(s) shall be completed by a qualified professional, such as the resident's physician, a social worker, physician's assistant or nurse practitioner. If the qualified professional is a member of the facility staff or has been hired by the facility to conduct the evaluation, the qualified professional shall consult with the resident's physician or other independent person qualified to review the care needs of the resident.

How the facility will respond to prevent elopement when an alarm is triggered, including but not limited to: (A)

the system that will be used to alert staff regarding which door(s) have been breached;

(B)

the staff member(s) responsible for responding to the alarm and for conducting the behavior management intervention; and

(C)

how staff will continue providing protective oversight for other residents while the behavior management intervention, such as redirection, is taking place.

(iv)

How the facility will provide access to a secure outdoor area, consistent with Section 108 (9)(c) (i) and (ii).

(v)

Monthly testing to ensure that the devices are functioning properly and written evidence of such testing.

104 (5) (l) Accepting Donated Medications for Redispensing by a Pharmacist. A policy under this subsection (l) is required only if the facility accepts unused donated medications in accordance with state law, including section 12-22-133, C.R.S. (2005). The policy shall address at minimum the following: [Eff 07/30/2006] (i) documented evidence that the resident or the resident’s next of kin donated the medications; (ii)

the name(s) and contact information of the pharmacist(s) who have agreed to accept donated medications from the facility and the types of medication that such pharmacist(s) will accept; [Eff 07/30/2006 ]

(iii)

inventory control, including but not limited to, documentation of the date the medication was donated, type and quantity of medication, and the date the pharmacist received the medication evidenced by signature of the pharmacist or his/her representative; [Eff 07/30/2006 ]

(iv)

secure storage of the medication, including but not limited to ensuring that donated

medications will not be intermingled with other medications, and prevention of diversion; and [Eff 07/30/2006 ] (v)

1.105

adequate disposal of donated medications either not accepted by the pharmacist or in the facility inventory for longer than 90 days after the date of the donation. [Eff 07/30/2006 ]

Administrative Functions

1.105 (1)

Admissions

105 (1)(a) Who May be Admitted to the Facility . Only residents whose needs can be met by the facility within its licensure category shall be admitted. The facility's ability to meet resident needs shall be based upon a comprehensive pre-admission assessment of the resident's physical, health and social needs; preferences; and capacity for self care. 105 (1)(b) Who May Not be Admitted to the Facility . A facility shall not admit or keep any resident requiring a level of care or type of service which the facility does not provide or is unable to provide, and in no event shall a facility admit or keep a resident who: (i)

Is consistently, uncontrollably incontinent unless the resident or staff is capable of preventing such incontinence from becoming a health hazard.

(ii)

Is totally bedridden with limited potential for improvement. A facility may keep a resident who becomes bedridden after admission if there is documented evidence of each of the following: (A)

an order by a physician describing the services required to meet the health needs of the resident, including but not limited to, the frequency of assessment and monitoring by the physician or by other licensed medical professionals.

(B)

ongoing assessment and monitoring by a licensed or Medicare/Medicaid certified home health agency or hospice service. The assessment and monitoring shall ensure that resident's physical, mental, and psychosocial needs are being met. The frequency of the assessment and monitoring shall be in accordance with resident needs, but shall be conducted no less frequently than weekly.

(C)

adequate staffing, with staff who are trained in the provision of caring for bedridden residents, and provision of services to meet the needs of the resident.

(iii)

Needs medical or nursing services, as defined herein, on a twenty-four hour basis, except for care provided by a psychiatric nurse in those facilities which are licensed to provide services specifically for the mentally ill.

(iv)

Needs restraints, as defined herein, of any kind except as otherwise provided in 2710-101, et seq. C.R.S. for those facilities which are licensed to provide services specifically for the mentally ill. The placement of residents in his or her room for the night and the use of time-out, as provided for in Section 26-20,102 (6), C.R.S., shall be conducted only as part of a treatment plan developed in consultation with a physician board certified in psychiatry or an advance practice nurse with a specialty in psychiatry. The appropriateness of these provisions in the treatment plan shall be reassessed by either one of these psychiatric

clinicians every three months. (v)

Has a communicable disease or infection that is: 1) reportable under 6 CCR 1009 Regulation 1 and 2) potentially transmissible in a facility, unless the resident is receiving medical or drug treatment for the condition and the admission is approved by a physician; or

(vi)

Has a substance abuse problem, unless the substance abuse is no longer acute and a physician determines it to be manageable.

1.105 (2) Resident Agreement A written agreement shall be executed between the facility and the resident or the resident's legal representative at the time of admission. The parties may amend the agreement provided such amendment is evidenced by the written consent of both parties. No agreement shall be construed to relieve the facility of any requirement or obligation imposed by law or regulation. 105 (2)(a) Content . The written agreement shall specify the understanding between the parties regarding, at a minimum the following: (i)

charges, refunds and deposit policies;

(ii)

services included in the rates and charges, including optional services for which there will be an additional, specified charge;

(iii)

types of services provided by the facility, those services which are not provided, and those which the facility will assist the resident in obtaining;

(iv)

the amount of any fee to hold a place for the resident in the facility while the resident is absent from the facility and the circumstances under which it will be charged;

(v)

transportation services;

(vi)

therapeutic diets;

(vii)

whether the facility or the resident will be responsible for providing bed and bath linens, as outlined in Section 110 (3)(a) or furnishings and supplies, as outlined in Section 112(3)(f); and

(viii)

a provision that if the facility closes without giving residents thirty days notice of such closure, that security deposits shall be reimbursed.

105 (2)(b)

Addenda . The written agreement shall have as addenda:

(i)

the care plan outlining functional capability and needs; and

(ii)

house rules, established pursuant to Section 1.105 (4).

105 (2)(c) Disclosures . There shall be written evidence that the following have been disclosed, upon admission unless otherwise specified, to the resident or the resident's legal representative, as appropriate: (i)

the facility policies and procedures listed under Section 1.104 (5).

(ii)

the method for determining staffing levels based on resident needs; and the extent

to which certified or licensed health care professionals are available onsite. (iii)

types of daily activities, including examples of such activities, that will be provided for the residents.

(iv)

whether or not the facility has automatic fire sprinkler systems.

(v)

if the facility uses restrictive egress alert devices, the types of individuals exhibited by persons that need such devices.

1.105 (3) Management of Resident Funds/Property . A facility may enter into a written agreement with the resident or resident's legal representative for the management of a resident's funds or property. However, there shall be no requirement for the facility to handle resident funds or property. 105 (3)(a) Written Agreement . A resident or the resident's legal representative may authorize the owner to handle the resident's personal funds or property. Such authorization shall be in writing and witnessed and shall specify the financial management services to be performed. 105 (3)(b) Fiduciary Responsibility . In the event that a written agreement for financial management services is entered into, the facility shall exercise fiduciary responsibility for these funds and property, including, but not limited to, maintaining any funds over the amount of five hundred dollars ($500) in an interest bearing account, separate from the general operating fund of the facility, which interest shall accrue to the resident. 105 (3)(c) Surety Bond . Facilities which accept responsibility for residents' personal funds shall post a surety bond in an amount sufficient to protect the residents' personal funds. 105 (3)(d)

Accounting

(i)

A running account, dated and in ink, shall be maintained of all financial transactions. There shall be at least a quarterly accounting provided to the resident or legal representative itemizing in writing all transactions including at least the following: the date on which any money was received from or disbursed to the resident; any and all deductions for room and board and other expenses; any advancements to the resident; and the balance.

(ii)

An account shall begin with the date of the first handling of the personal funds of the resident and shall be kept on file for at least three years following termination of the resident's stay in the facility. Such record shall be available for inspection by the Department.

105 (3)(e) Receipts . Residents shall receive a receipt for and sign to acknowledge disbursed funds. 1.105 (4)

House Rules The facility shall establish written house rules.

105 (4)(a) Content . House rules shall list all possible actions which may be taken by the facility if any rule is knowingly violated by a resident. House rules may not violate or contravene any regulation herein, or in any way discourage or hinder a resident's exercise of those rights guaranteed herein. Such rules shall address at least the following: (i)

smoking.

(ii)

cooking.

(iii)

protection of valuables on premises.

(iv)

visitors.

(v)

telephone usage including frequency and duration of calls.

(vi)

use of common areas, including the use of television, radio, etc.

(vii)

consumption of alcohol.

(viii)

dress.

(ix)

pets. A facility may keep household pets including dogs, cats, birds, fish, and other animals as permitted by local ordinance, with evidence of compliance with state and local vaccination and inoculation requirements and in accordance with house rules. In no event shall such rules prohibit service or guide animals.

105 (4)(b) Posting . The facility shall prominently post written house rules which shall be available at all times to residents. 105 (4)(c) Disclosure to Residents . There shall be documentation in the resident's record that a copy of the rules was provided to the resident or the legal representative, as appropriate, prior to admission. 1.105 (5) Resident Record A confidential record shall be maintained for each resident. Records shall be dated and legibly recorded in ink or in electronic format. 105 (5)(a) Content of Resident Record . Resident records shall contain at least, but not be limited to, the following: (i)

Demographic and medical information (A)

(B)

Face sheet . The face sheet shall contain the following information: (I)

resident's full name, including maiden name if applicable;

(II)

resident's sex, date of birth, marital status and social security number, where needed for medicaid or employment purposes;

(III)

date of admission;

(IV)

name, address and telephone number of relatives or legal representative(s), or other person to be notified in an emergency;

(V)

name, address and telephone number of resident's primary physician, and case manager if applicable, and an indication of religious preference, if any, for use in emergency;

(VI)

resident's diagnoses, at the time of admission;

(VII)

current record of the resident's allergies.

Progress notes of any significant change in physical, behavioral, cognitive

and functional condition and action taken by staff to address the resident's changing needs; (C)

Medication administration record;

(D)

Documentation of on-going services provided by external services providers, such as physical therapy and home health services;

(E)

Advance directives, if applicable;

(F)

Physician's orders;

(ii)

The resident agreement;

(iii)

The care plan, as that term is defined herein;

(iv)

Resident's most recent former address of residence.

105 (5)(b) Who May Access Resident Records . Records shall be available for inspection by and release to: (i)

the resident or the resident's legal representative, if so authorized ,

(ii)

the resident's attorney of record;

(iii)

the state or local Long Term Care ombudsman with the permission of the resident and in accordance with Section 25-1-801, C.R.S.;

(iv)

the Department; and

(v)

those otherwise authorized by law.

105 (5)(c)

Resident Record Storage and Retention

(i)

Records shall be maintained and stored in such a manner as to be protected from loss, damage or unauthorized use.

(ii)

Records shall be maintained in the facility or in a central administrative location readily available to facility staff and the department. Records necessary to respond to the current care needs of the resident shall be maintained onsite at the facility.

(iii)

Records for discharged residents shall be complete and maintained for a period of three years following the termination of the resident's stay in the facility.

105 (5)(d) Confidentiality . The confidentiality of the resident record including all medical, psychological and sociological information shall be protected at all times, in accordance with all applicable state and federal laws and regulations. 1.105 (6)

Discharge

105 (6)(a) (i)

A resident shall be discharged only for one or more of the following reasons: When the facility cannot protect the resident from harming him or herself or others.

(ii) 105 (6)(b)

When the facility is no longer able to meet the resident's identified needs, based on the facility's discharge policy. A resident may be discharged for one or more of the following reasons:

(i)

Nonpayment for basic services, including rent, in accordance with the resident agreement; or

(ii)

Failure of the resident to comply with the resident agreement which contains notice that discharge may result from violation of the agreement.

105 (6)(c) Written notice of discharge shall be provided to the resident or resident's legal representative as follows: (i)

thirty (30) days in advance of discharge for discharge in accordance with Sections 1.105 (6)(a)(ii), 1.105 (6)(b)(i) and 1.105 (6)(b)(ii);

(ii)

in cases of medical emergency, or in accordance with Section 1.105 (6)(a)(i), the responsible party shall be notified as soon as possible.

105 (6)(d) A copy of the 30 day written notice shall be sent to the state or local ombudsman, within 5 calendar days of the date that it is provided to the resident or the resident's legal representative. 105 (6)(e) Discharge shall be coordinated with the resident, the resident's family or resident's legal representative , or the appropriate agency. 1.106

Resident Rights

1.106 (1)

General . Residents shall have the following rights:

106 (1)(a)

The right to be treated with respect and dignity.

106 (1)(b)

The right to privacy.

106 (1)(c)

The right not to be isolated or kept apart from other residents.

106 (1)(d) The right not to be sexually, verbally, physically or emotionally abused, humiliated, intimidated, or punished. 106 (1)(e)

The right to be free from neglect.

106 (1)(f) The right to live free from involuntary confinement, or financial exploitation and to be free from physical or chemical restraints as defined within these regulations except as otherwise provided in Section 27-10-101, et seq. C.R.S. for those facilities which are licensed to provide services specifically for the mentally ill. 106 (1)(g) The right to full use of the facility common areas, in compliance with the documented house rules. 106 (1)(h)

The right to voice grievances and recommend changes in policies and services.

106 (1)(i) The right to communicate privately including but not limited to communicating by mail or telephone with anyone.

106 (1)(j) The right to reasonable use of the telephone, in accordance with house rules, which includes access to operator assistance for placing collect telephone calls. At least one telephone accessible to residents utilizing an auxiliary aid shall be available if the facility is occupied by one or more residents utilizing such an aid. 106 (1)(k) The right to have visitors, in accordance with house rules, including the right to privacy during such visits. 106 (1)(l) The right to make visits outside the facility in which case the administrator and the resident shall share responsibility for communicating with respect to scheduling. 106 (1)(m) The right to make decisions and choices regarding their care and treatment, in the management of personal affairs, funds, and property in accordance with their abilities. 106 (1)(n) The right to expect the cooperation of the facility in achieving the maximum degree of benefit from those services which are made available by the facility. 106 (1)(o)

The right to exercise choice in attending and participating in religious activities.

106 (1)(p) The right to be reimbursed at an appropriate rate for work performed on the premises for the benefit of the administrator, staff, or other residents, in accordance with the resident's care plan. 106 (1)(q) The right to 30 days written notice of changes in services provided by the facility, including but not limited to changes in charges for any or all services. Exceptions to this notice are: (i)

changes in the resident's medical acuity that result in a documented decline in condition and that constitute an increase in care necessary to protect the health and safety of the resident; and

(ii)

requests by the resident or the family for additional services to be added to the care plan.

106 (1)(r) The right to have advocates, including members of community organizations whose purposes include rendering assistance to the residents. 106 (1)(s) The right to wear clothing of choice unless otherwise indicated in the resident's care plan and in accordance with reasonable house rules. 106 (1)(t) The right to choose to participate in social activities, in accordance with the care plan. 106 (1)(u) The right to receive services in accordance with the resident agreement and the care plan. 1.106 (2) Ombudsman Access . A facility shall permit access during reasonable hours to the premises and residents by the State Ombudsman and the designated local long-term care ombudsman in accordance with the federal "Older Americans Act of 1965", pursuant to Section 25-27-104 (2) (d), C.R.S. 1.106 (3) Restraints . Restraints as defined within these regulations are prohibited except as otherwise provided in 27-10-101, et seq. C.R.S. for those facilities which are licensed to provide services specifically for the mentally ill. The measures in Section 26-20-102 (6)(d) and 26-10102 (6)(e), C.R.S., may only be used in accordance with a treatment plan developed in

consultation with and based on a written order by a physician board certified in psychiatry or a psychiatric clinical nurse specialist listed on the advance practice registry. The treatment plan, which shall document that less restrictive measures were unsuccessful, shall be evaluated by a clinician with such credentials every three months. 1.106 (4)

Mechanisms to Address Resident/Resident Family Concerns

106 (4)(a) Internal Grievance Process . The facility shall implement an internal process for the routine and prompt handling of grievances brought by residents and their families. 106 (4)(b)

Facilities with Less than 17 Beds - House Meetings

(i)

House meetings shall be held in addition to implementing the internal grievance process pursuant to Subsection (4)(a), above.

(ii)

In facilities with less than seventeen (17) beds, house meetings shall be held at least quarterly with residents, the appropriate staff, family and friends of residents in order that residents have the opportunity to voice concerns and make recommendations concerning facility policies.

(iii)

Written minutes of such meetings shall be maintained for review by residents at any time.

106 (4)(c)

1.107

Facilities with 17 Beds or More - Residents' Council

(i)

Resident council meetings shall be held in addition to implementing the internal grievance process pursuant to Subsection (4)(a), above.

(ii)

In facilities with seventeen (17) or more beds, a residents' council shall be established.

(iii)

The residents' council shall have full opportunity to meet without the presence of staff.

(iv)

The council shall meet at least monthly with the administrator and a staff representative to voice concerns and make recommendations concerning facility policies. Staff shall respond to these suggestions in writing prior to the next regularly scheduled meeting.

(v)

Written minutes of council meetings shall be maintained for review by residents.

Resident Care Services

1.107 (1)

General

107 (1)(a) Facility Census . The facility shall maintain a current list of residents and their assigned room or apartment. 107 (1)(b) Minimum Services . The facility shall make available, either directly or indirectly through a resident agreement, the following services, sufficient to meet the needs of the residents: (i)

a physically safe and sanitary environment;

(ii)

room and board;

1.107 (2)

(iii)

personal services;

(iv)

protective oversight; and

(v)

social care.

Social and Recreational Activities

107 (2)(a) The facility, in consultation with the residents, shall provide opportunities for social and recreational activities both within and outside the facility and shall coordinate community resources and promote resident participation in activities both in and away from the residence. 107 (2)(b) The facility shall encourage resident participation in planning, organizing, and conducting the residents' activity program, taking into consideration the individual interests and wishes of the residents. 107 (2)(c) In determining the types of activities offered, the facility shall take into account the physical, social and mental stimulation needs of the residents as well as their personal and religious preferences. 1.107 (3) Care Planning The facility shall develop and implement a written care plan for each resident to monitor and oversee the resident's care needs. 107 (3)(a) Care Plan . A written care plan for each resident shall be completed at the time of admission and shall include at least the following: (i)

(ii)

a comprehensive assessment of the resident's physical health, behavioral, and social needs; preferences; and capacity for self care. The assessment shall include, but not be limited to: (A)

whether medication is self-administered or whether assistance is required from staff;

(B)

special dietary instructions, if any; and ;

(C)

any physical or mental limitations.

a description of the services which the facility will provide to meet the needs identified in the comprehensive assessment.

107 (3)(b) Care Plan Modifications . The resident may request a modification of the services identified in the care plan at any time. 107 (3)(c) Reassessments . The resident shall be reassessed yearly or more frequently, if necessary, to address significant changes in the resident's physical, behavioral, cognitive and functional condition and identify the services that the facility shall provide to address the resident's changing needs. The care plan shall be updated to reflect the results of the reassessment. 107 (3)(d) External Services . If the resident is receiving personal care and/or protective oversight services from external services provider(s), the facility shall coordinate and document in the care plan the services that are to be provided by the external services provider(s) as well as the services to be provided by the facility to ensure that the resident needs are met.

1.107 (4)

Medication

107 (4)(a)

Personal Medication

(i)

All personal medication is the property of the resident and no resident shall be required to surrender the right to possess or self-administer any personal medication, except as otherwise specified in the care plan of a resident of a facility which is licensed to provide services specifically for the mentally ill or if a physician or other authorized medical practitioner has determined that the resident lacks the decisional capacity to possess or administer such medication safely.

(ii)

Personal medication shall be returned to the resident or resident's legal representative, upon discharge or death, except that return of medication to the resident may be withheld if specified in the care plan of a resident of a facility which is licensed to provide services specifically for the mentally ill or if a physician or other authorized medical practitioner has determined that the resident lacks the decisional capacity to possess or administer such medication safely. The return of medication shall be documented by the facility.

(iii) Notwithstanding the provisions of Section 107 (4)(a)(ii), if donated by the resident or the resident’s next of kin, the facility may return to a pharmacist unused medications in accordance with state laws, including Section 12-22-133, C.R.S (2005). For purposes of this paragraph, unused medications means prescription medications that are not controlled substances. 107 (4)(b)

Misuse of Medication

(i)

Misuse or inappropriate use of known medications for persons who are selfadministering shall be reported to the resident's physician or other authorized practitioner.

(ii)

No resident shall be allowed to take another's medication nor shall staff be allowed to give one resident's medication to another resident.

(iii)

Medication which has a specific expiration date shall not be administered after that date and shall be disposed of appropriately.

107 (4)(c)

Labeling

(i)

Medications shall be labeled with the resident's full name and pursuant to Article 22 of Title 12. This does not apply to medications that are self-administered by and in the possession of the resident.

(ii)

Any medication container which has a detached, excessively soiled or damaged label, shall be returned to the issuing pharmacy for relabeling or disposed of appropriately.

107 (4)(d) Storage . All medication shall be stored in a manner that ensures the safety of the residents. (i)

Central location (A)

Medication which is kept in a central location, including refrigerators, shall be kept under lock and shall be stored in separate or compartmentalized

packages, containers, or shelves, for each resident in order to prevent intermingling of medication. (B)

1.107 (5)

Residents shall not have access to medication which is kept in a central location.

(ii)

Refrigeration . Medications which require refrigeration shall be stored separately in locked containers in the refrigerator. If medication is stored in a refrigerator dedicated to that purpose, and the refrigerator is in a locked room, then the medications do not need to be stored in locked containers.

(iii)

Bulk Quantities . Prescription and over-the-counter medication shall not be kept in stock or bulk quantities, unless such medication is administered by a licensed medical practitioner.

Administration of Medication and Treatment

107 (5)(a) Qualified Medication Administration Staff . Qualified medication administration staff members may administer or assist the resident in administration of medication. 107 (5)(b)

Medication Administration Record

(i)

For residents whose medications are monitored or administered by the facility staff, a current record shall be maintained of the resident's medications including name of drug, dosage, route of administration of medication and directions for administration of medication.

(ii)

The administration of medication shall be documented at the time of administration.

107 (5)(c)

Written Orders

(i)

The facility shall only administer medications upon the written order of a licensed physician or other authorized practitioner.

(ii)

If the facility assists the resident with the administration of one or more medications and the resident also self-administers the same or other medication, the written order shall specify that such self-administration is authorized.

107 (5)(d)

Telephone Orders

(i)

Only a licensed nurse may accept telephone orders for medication from a physician or other authorized practitioner.

(ii)

All telephone orders shall be evidenced by a written and signed order within fourteen (14) days and documented in resident's record and the facility's medical administration record.

107 (5)(e)

Compliance with Physician Orders

(i)

This applies to medications and treatment which do not conflict with state law and regulations pertaining to assisted living residences and which are within the scope of services provided by the facility, as outlined in the resident agreement or the house rules.

(ii)

The facility shall be responsible for complying with physician orders, associated with

the administration of medication or treatment, unless the resident selfadministers such medication or treatment. The facility shall implement a system that: (A)

107 (5)(f) (i)

Obtains clarification from the physician, as necessary and documents that the physician: (I)

has been asked whether refusal of the medication or treatment should result in physician notification.

(II)

has been notified, where such notification is appropriate. Documentation of such notification shall be made in the medication administration record or in the progress notes.

(B)

Coordinates care with external providers or accepts responsibility to perform the care using facility staff.

(C)

Trains staff regarding the parameters of the ordered care as appropriate.

(D)

documents delivery of the care, including refusal by the resident of the medication or treatment.

Drugs Used to Affect or Modify Behavior Any drugs used to affect or modify behavior, including psychotropic drugs may not be administered by unlicensed persons as a "PRN" or "as needed" medication, except: (A)

in those residential treatment facilities which are licensed to provide services for the mentally ill, or

(B)

where a resident understands the purpose of the medication, is capable of requesting the drug of his or her own volition and the facility has documentation from a licensed medical professional that the use of such drug in this manner is appropriate.

107 (5)(g) Oxygen . Residents may administer oxygen, and staff shall assist with the administration as needed, when prescribed by a physician and if the facility follows appropriate safety requirements regarding oxygen herein. (i)

General (A)

Oxygen tanks shall be secured upright at all times to prevent falling over and secured in a manner to prevent tanks from being dropped or from striking violently against each other.

(B)

Tank valves shall be closed except when in use.

(C)

Transferring oxygen from one container to another shall be conducted in a well-ventilated room with the door shut. Transfer shall be conducted by a trained staff member or by the resident for whom the oxygen is being transferred, if the resident is capable of performing this task safely. When the transfer is being conducted, no resident, except for a resident conducting such transfer, shall be present in the room. Tanks and other oxygen containers shall not be exposed to electrical sparks, cigarettes or

open flames. (D) (ii)

(iii)

1.108

Tanks shall not be placed against electrical panels or live electrical cords where the cylinder can become part of an electric circuit.

Handling (A)

Tanks shall not be rolled on their side or dragged.

(B)

Smoking shall be prohibited in rooms where oxygen is used. Rooms in which oxygen is used shall be posted with a conspicuous "No Smoking" sign.

Storage (A)

Smoking shall be prohibited in rooms where oxygen is stored and such rooms shall be posted with a conspicuous "No Smoking" sign.

(B)

Tanks shall not be stored near radiators or other heat sources. If stored outdoors, tanks shall be protected from weather extremes and damp ground to prevent corrosion.

Secured Environment

Facilities choosing to operate a secured environment must comply with the regulations contained in this section as well as the other provisions within these regulations. 1.108 (1) Disclosure to Residents . A facility that operates a secured environment shall disclose to the resident and the resident's legal representative, if applicable, prior to the resident's admission to the facility, that the facility operates a secured environment. The disclosure shall include information about the types of resident diagnoses or behaviors that the facility serves and for which staff of the secured environment is trained to provide services. 1.108 (2) Resident Rights . The resident who believes that he or she has been inappropriately admitted to the secured environment may request the assistance of the facility in contacting the state and local ombudsman and the resident's legal representative. Upon such request the facility shall assist the resident in making such contact. 1.108 (3)

Who May be Admitted to the Secured Environment

108 (3)(a) Needs Can be Met . Only those residents who need a secured environment placement and whose needs can be met by the facility, as determined by an assessment, may be admitted. Upon completion of the assessment, a resident who has been determined to be a danger to self or others shall not be admitted to the secured environment. 108 (3)(b) Legal Authority/Voluntary Admission . A resident shall not be admitted to a secured environment unless legal authority for admitting the resident has been established by guardianship, court order, medical durable power of attorney, health care proxy or other means allowed by Colorado law. However, a resident may voluntarily be admitted or may remain in a secured environment if his or her egress is not restricted. 108 (3)(c) Mentally Ill . Facilities that serve residents who are mentally ill shall not admit such residents into a secured environment unless there is no less restrictive alternative and unless they are otherwise in compliance with the requirements of Article 10 of Title 27,

Colorado Revised Statutes. 108 (3)(d) Developmentally Disabled . Facilities that serve residents with developmental disabilities as defined in Article 10.5 of Title 27, Colorado Revised Statutes shall not admit such residents into a secured environment, unless the facility is in compliance with the requirements of such article. 1.108 (4)

Secured Environment Assessments and Reassessments

108 (4)(a) Prior to admission, there shall be an assessment of the resident that evaluates the appropriateness of placement in a secured environment. The assessment shall include written findings and their basis regarding admission to the secured environment and an evaluation of less restrictive alternatives. 108 (4)(b) Reassessments must be completed within 10 days of a significant change in the medical or physical condition of the resident that warrants intervention or different care needs, or when the resident becomes a danger to self or others, to determine whether the resident's stay in the secured environment is still appropriate. 108 (4)(c) The assessment and reassessment shall be completed by a qualified professional such as the resident's physician, a social worker, physician's assistant or nurse practitioner. If the qualified professional is a member of the facility staff or has been hired by the facility to conduct the evaluation, the qualified professional shall consult with the resident's physician or other independent person qualified to review the care needs of resident. 1.108 (5) Documentation in the Resident Record . The following shall be documented in the resident's record : 108 (5)(a)

The legal authority for admission.

108 (5)(b)

The assessment.

108 (5)(c)

The reassessment(s).

1.108 (6)

Staffing

108 (6)(a) The facility shall provide a sufficient number of trained staff members to meet the needs of the residents in the secured environment. In addition to the requirements set forth in Section 1.104 (4)(a) (iii) there shall always be at least one trained staff member in attendance in the secured environment at all times. 1.108 (7)

Family Council

108 (7)(a) Facilities with secured environments shall establish a forum for family members of residents in secured environments to voice suggestions, concerns and grievances. 108 (7)(b) The forum shall allow families to meet with the administrator and a staff representative to make recommendations concerning facility policies, grievances, incidents, and other matters of concern to the residents. Staff shall respond to these suggestions in writing prior to the next regularly scheduled meeting. 108 (7)(c) The forum shall be offered at least quarterly and may be held in conjunction with resident house or council meetings. Families shall be given the opportunity to meet with facility staff without residents present, upon request. The forum shall be scheduled at a

time that reasonably accommodates family participation and schedules. 1.108 (8)

Discharge

108 (8)(a) A facility must give at least 30 days written notice to the resident and the resident's legal representative when moving a resident out of a secured environment, unless the move is made at the request of, or voluntarily by, the person who is legally responsible for the resident or in accordance with the requirements of Section 1.105(6)(b) of these regulations. 1.108 (9)

Building Requirements, Grounds and Fire Safety

108 (9)(a) (i)

(ii)

Locking devices General . Locking devices, used to secure facility egress doors and egress access doors, shall be in compliance with one of the following: (A)

NFPA Life Safety Code (2003) Section 7.2.1.6.1, Delayed Egress Locks.

(B)

NFPA Life Safety Code (2003) Section 7.2.1.6.2, Access Controlled Egress Doors.

(C)

In buildings protected throughout by either an approved supervised automatic fire detection system in accordance with NFPA Life Safety Code (2003) Section 9.6 or an approved supervised automatic sprinkler system in accordance with NFPA Life Safety Code (2003) Section 9.7, the doors may be arranged as follows: (I)

the doors unlock upon actuation of the building fire-protective signaling system. The fire-protective signaling system shall be activated by each of the following systems if installed: the approved supervised automatic sprinkler system, the approved supervised fire detection system or an approved manual fire alarm system. The doors shall remain unlocked until the fireprotective signaling system has been manually reset; and

(II)

the doors unlock upon loss of power controlling the locking mechanism; and

(III)

there shall be an override device, such as a digital keypad, pushbutton release or key locks. If key locks are used, all staff must carry keys on their person at all times. The override device shall be readily accessible and located within five (5) feet of the locked door.

Prior approvals . Special locking arrangements approved by the Department prior to June 1, 2004 may remain in use.

108 (9)(b) Egress Alert Systems and Devices . Egress alert systems and devices (such as Wanderguard), shall be arranged to sound a proximity alarm only, and shall not lock any door within a means of egress, unless the alarm is in accordance with Section 1.108 (9) (a)(i)(C). 108 (9)(c)

Secure Outdoor Area

(i)

In addition to the interior common areas required by this regulation, the facility shall provide a safe and secure outdoor area for the use of residents year round.

(ii)

Fencing or other enclosures

(iii) 1.109

(A)

Fencing or other enclosures that prevent elopement and protect the safety and security of the residents shall be installed around secure outdoor areas.

(B)

Where a locked outdoor fence gate restricts access to the public way, all staff must carry gate lock keys on their person at all times while on duty.

In facilities establishing a secured environment on or after June 1, 2004, residents shall be able to access the secure outdoor area independently.

Dietary and Dining Services

1.109 (1)

General . Reserved.

1.109 (2)

Food Service Sanitation

109 (2)(a)

Facilities with Less than 20 Beds

(i)

Food shall be prepared, handled and stored in a sanitary manner, so that it is free from spoilage, filth, or other contamination, and shall be safe for human consumption.

(ii)

Hazardous materials shall not be stored with food supplies.

109 (2)(b) Facilities with 20 Beds or More . Facilities licensed for 20 beds or more shall comply with "Colorado Retail Food Establishment Rules and Regulations" Colorado Department of Public Health and Environment, 1999. 1.109 (3)

Meals and Snacks

109 (3)(a) (i)

At least three nutritionally balanced meals in adequate portions, using a variety of foods shall be made available, either directly or indirectly through the resident agreement, at regular times daily.

(ii)

In the event the meal provided is unpalatable, a substitute shall be provided.

109 (3)(b) (i) 1.109 (4)

Meals

Snacks Between meal snacks of nourishing quality shall be available.

Menus

109 (4)(a)

Menus shall vary daily and shall be adjusted for seasonal changes and holidays.

109 (4)(b) Weekly menus shall be available for review by residents in advance of the day of preparation. 109 (4)(c)

Residents shall be encouraged to participate in planning and in making

suggestions as to menus and the facility shall make reasonable efforts to accommodate such suggestions. 1.109 (5)

Food Supply

109 (5)(a) There shall be enough food on hand to prepare three nutritionally balanced meals for three days. 1.109 (6) Therapeutic Diets . A facility may provide therapeutic diets to residents. However, there shall be no requirement that facilities provide this service. If the facility provides therapeutic diets, the following requirements shall apply. 109 (6)(a)

Therapeutic diets shall be prescribed by a physician.

109 (6)(b) If the facility provides therapeutic diets, the facility shall implement a system in order to ensure that the proper diet is provided. 1.109 (7)

Dining Area/Services

109 (7)(a) Dining Area . A designated dining area accessible by all residents shall be provided in a separate area or areas capable of comfortably seating all residents. 109 (7)(b)

Exclusion from Dining Area

(i)

No resident or group of residents shall be excluded from the designated dining area during meal time unless otherwise indicated in the resident's care plan.

(ii)

Meals shall not be routinely served in resident rooms unless otherwise indicated in the resident's care plan.

1.109 (8) Dishwashing Dishwashing shall be conducted in a safe and sanitary manner. A twocompartment sink or a single-compartment sink used in conjunction with a domestic dishwashing machine shall be required. Dish-washing machines shall be used in accordance with manufacturer's instructions . 1.110

Laundry Services

1.110 (1) Provision of Laundry Services . The facility shall make laundry services available in one of the following ways, and in accordance with these regulations: 110 (1)(a)

providing laundry service for the residents;

110 (1)(b) providing access to laundry equipment so that the residents may do their own laundry; or 110 (1)(c)

by making arrangements with a commercial laundry.

1.110 (2) Separation of Clean/Soiled Laundry . Separate storage for soiled linen and clothing shall be provided. 1.110 (3)

Supply of Clean Bed and Bath Linens

110 (3)(a) Facilities which provide bed and bath linens, shall provide such linens at least weekly or more frequently in accordance with residents' needs. Clean blankets shall also be provided as necessary.

1.111

Interior and Exterior Environment.

The facility shall provide a clean, sanitary environment, free of hazards to health and safety. 1.111 (1) Interior Environment All interior areas including attics, basements, and garages shall be safely maintained. 111 (1)(a)

Potential Fire Hazards

(i)

Cooking. Cooking shall not be allowed in bedrooms. Residents may have access to an alternative area where minimal food preparation such as heating or reheating food or making hot beverages is allowed. In those facilities which make housing available to residents through apartments rather than resident bedrooms, cooking may be allowed in accordance with house rules. Only residents who are capable of cooking safely shall be allowed to do so. The facility shall document such assessment.

(ii)

Electrical equipment (A)

Extension cords. Extension cords and multiple use electrical sockets, shall be prohibited in resident bedrooms.

(B)

Power strips. Power strips are permitted throughout the facility with the following limitations:

(C)

(D)

(I)

The power strip must be provided with overcurrent protection in the form of a circuit breaker or fuse.

(II)

The power strip must have a UL (underwriters laboratories) label.

(III)

The power strips cannot be linked together when used.

(IV)

Extension cords cannot be plugged into the power strip.

(V)

Power strips can have no more than six receptacles.

(VI)

The use will be restricted to one power strip per resident per bedroom.

Personal appliances. Personal appliances shall be allowed in resident bedrooms only under the following circumstances: (I)

such appliances are not used for cooking;

(II)

such appliances do not require use of an extension cord or multiple use electrical sockets;

(III)

such appliance is in good repair as evaluated by the administrator; and

(IV)

such appliance is used by a resident who the administrator believes to be capable of appropriate and safe use. The facility shall document such assessment.

Electric blanket/Heating pad. In no event shall a heating pad or electric

blanket be used in a resident room without either staff supervision or documentation that the administrator believes the resident to be capable of appropriate and safe use. (iii)

Accumulation of refuse . All interior areas including attics, basements, and garages shall be free from accumulations of extraneous materials such as refuse, discarded furniture, and old newspapers.

(iv)

Combustibles . Combustibles such as cleaning rags and compounds shall be kept in closed metal containers.

(v)

Portable Heaters . Kerosene (fuel fired) heaters shall not be permitted within the facility. Electric or space heaters shall not be permitted within resident bedrooms and may only be used in common areas of the facility if owned, provided, and maintained by the facility.

(vi)

Fire resistant wastebaskets . Enclosed areas on the premises where smoking is allowed shall be equipped with fire resistant wastebaskets. In addition, bedrooms occupied by smokers, even when house rules prohibit smoking in bedrooms, shall have fire resistant wastebaskets.

111 (1)(b) (i)

Insect/rodent infestations . The facility shall be maintained free of infestations of insects and rodents and all openings to the outside shall be screened.

(ii)

Storage of hazardous substances . Solutions, cleaning compounds and hazardous substances shall be labeled and stored in a safe manner

111 (1)(c)

Heating, Lighting, Ventilation

(i)

Each room in the facility shall be installed with heat, lighting and ventilation sufficient to accommodate its use and the needs of the residents.

(ii)

All interior and exterior steps and interior hallways and corridors shall be adequately illuminated.

111 (1)(d)

Water

(i)

Potable water . There shall be an adequate supply of safe, potable water available for domestic purposes.

(ii)

Hot water.

111 (1)(e) (i) 1.111 (2)

Potential Infection/Injury Hazards

(A)

Hot water shall not measure more than 120 degrees Fahrenheit at taps which are accessible by residents.

(B)

There shall be a sufficient supply of hot water during peak usage demands.

Telephone There shall be a telephone available for regular telephone usage by residents and staff.

Exterior Environment

111 (2)(a)

1.112

Potential Hazards

(i)

Maintenance of the grounds . Exterior premises shall be kept free of high weeds and grass, garbage and rubbish. Grounds shall be maintained to prevent hazardous slopes, holes, or other potential hazards.

(ii)

Staircases . Exterior staircases of three (3) or more steps and porches shall have handrails. Staircases and porches shall be kept in good repair.

Physical Plant, Furnishings, Equipment and Supplies

1.112 (1) Compliance with State and Local Laws/Codes . Facilities shall be in compliance with all applicable: 112 (1)(a) Local zoning, housing, fire and sanitary codes and ordinances of the city, city and county, or county where the facility is situated to the extent that such codes are consistent with the federal "Fair Housing Amendment Act of 1988", as amended, 42 U.S.C., sec. 3601, et seq. 112 (1)(b) State and local plumbing laws and regulations. Plumbing shall be maintained in good repair, free of the possibility of backflow and backsiphonage, through the use of vacuum breakers and fixed air gaps, in accordance with state and local codes. 112 (1)(c) Sewage disposal requirements. Sewage shall be discharged into a public sewer system or disposed of in a manner approved by the local health department, or local laws if no local health department exists, and the Colorado Water Quality Control Commission. 1.112 (2)

Common Areas

112 (2)(a) Common areas sufficient to reasonably accommodate all residents shall be provided. 112 (2)(b) All common areas and dining areas shall be accessible to residents utilizing an auxiliary aid without requiring transfer from a wheelchair to walker or from a wheelchair to a regular chair for use in dining area. All doors to those rooms requiring access be at least 32 inches wide. 112 (2)(c) A minimum of two entryways shall be provided for access and egress from the building by residents utilizing a wheelchair if the facility is occupied by one or more residents utilizing a wheelchair. 1.112 (3)

Bedrooms and Occupancy Ratios

112 (3)(a) Bedroom Assignment . No resident shall be assigned to any room other than a regularly designated bedroom. 112 (3)(b) Occupancy Ratios . No more than two (2) residents shall occupy a bedroom. However, facilities licensed prior to July 1, 1986 may have up to four (4) residents per room until either a substantial remodeling or a change of ownership occurs. 112 (3)(c) (i)

Square Footage Requirements On or after June 1, 2004, facilities applying for initial licensure, when such initial license is not a change of ownership, shall have at least 100 square feet for single occupancy bedrooms and 60 square feet per person for double occupancy

bedrooms. Bathroom areas and closets shall not be included in the determination of square footage. (ii)

Single occupancy bedrooms shall have at least 100 square feet; double occupancy bedrooms shall have at least 60 square feet per person. However, any facility licensed prior to January 1, 1992 may have bedrooms of not less than 80 square feet for one occupant until either substantial remodeling or a change of ownership occurs. Bathroom areas shall not be included in the determination of square footage.

112 (3)(d) Storage Space . Each resident shall have storage facilities adequate for clothing and personal articles such as a closet. 112 (3)(e) Windows . Each bedroom shall have at least one window of eight (8) square feet which shall have opening capability. Any facility licensed prior to January 1, 1992 may have a window of smaller dimensions until either a substantial remodeling or a change of ownership occurs. 112 (3)(f) (i)

1.112 (4)

Furnishings and Supplies In facilities which provide furnishings for resident bedrooms pursuant to a resident agreement, each resident bedroom shall be equipped as follows for each resident: (A)

a comfortable, standard-sized bed equipped with a comfortable, clean mattress, mattress protector and pad, and pillow. Rollaway type beds, cots, folding beds or bunk beds shall not be permitted.

(B)

a standard-sized chair in good condition.

(C)

a towel rack.

Bathrooms

112 (4)(a) Number of Bathrooms Per Resident . There shall be at least one full bathroom for every six (6) residents. A full bathroom shall consist of at least the following fixtures: toilet, handwashing sink, toilet paper dispenser, mirror, tub or shower, and towel rack. However, any facility licensed to provide services specifically for the mentally ill prior to January 1, 1992 may have one bathroom for every eight (8) residents until either a substantial remodeling or a change of ownership occurs. 112 (4)(b)

Bathroom Accessibility

(i)

General . There shall be a bathroom on each floor having resident bedrooms which is accessible without requiring access through an adjacent bedroom.

(ii)

Residents using auxiliary aids . In any facility which is occupied by one or more residents utilizing an auxiliary aid, the facility shall provide at least one full bathroom as defined herein with fixtures positioned so as to be fully accessible to any resident utilizing an auxiliary aid.

112 (4)(c) (i)

Fixtures Non-skid surfaces . Bathtubs and shower floors shall have non-skid surfaces.

(ii)

Grab bars . Grab bars shall be properly installed at each tub and shower, and adjacent to each toilet in any facility which is occupied by one or more residents utilizing an auxiliary aid or as otherwise indicated by the needs of the resident population.

(iii)

Toilet seats . Toilet seats shall be constructed of non-absorbent material and free of cracks.

112 (4)(d)

1.113

Supplies

(i)

Individualized supplies . The use of common personal care articles, including soap and towels, is prohibited.

(ii)

Toilet paper . Toilet paper in a dispenser shall be available at all times in each bathroom of the facility.

(iii)

Liquid soap and paper towels . Liquid soap and paper towels shall be available at all times in the common bathrooms of the facility.

Fire Safety

These regulations incorporate by reference National Fire Protection Association (NFPA) Life Safety Code 2003 and Guide on Alternative Approaches to Life Safety 2004. Such incorporation does not include later amendments to or editions of the referenced material. The Department of Public Health and Environment maintains copies of the complete text of the incorporated materials for public inspection during regular business hours, and shall provide certified copies of the incorporated material at cost upon request. Information regarding how the incorporated material may be obtained or examined is available from: Division DirectorHealth Facilities and Emergency Medical Services Division Colorado Department of Public Health and Environment4300 Cherry Creek Drive SouthDenver, CO 80246Phone: 303692-2800 Copies of the incorporated materials have been provided to the State Publications Depository and Distribution Center, and are available for interlibrary loan. Any incorporated material may be examined at any state publications depository library. 1.113 (1)

General

113 (1)(a) Multiple Buildings Under One License . Any facility operating under one license but comprised of multiple buildings shall have the Life Safety Code requirements determined for each building on an individual basis. 113 (1)(b) Chair Glides . Chair glides (powered resident movement equipment) cannot be installed within any required means of egress or required access to a means of egress if the installation reduces the egress width below the required minimum. Chair glides that reduce the required minimum width of a means of egress, or access thereto, will result in the egress route not being credited. Under no circumstance can a chair glide be installed on a stairway that is the primary means of escape from any level or story used by residents. 113 (1)(c) Resident Evacuation Capability . In any facility where the evacuation capability of the resident population is required to be rated, the "Procedure for Determining Evacuation Capability" published by NFPA is to be used by the facility whether the facility is evaluated utilizing the NFPA 101A, Guide on Alternative Approaches to Life Safety

(2004), or NFPA Standard 101, Life Safety Code (2003). The Level of Evacuation Difficulty for each facility will be determined by the scores developed in the Worksheet for Rating Residents completed by responsible staff for each resident and the level of staffing maintained at the facility. It is the responsibility of the owner or administrator to insure that the abilities of the residents are accurately rated in accordance with the published instructions. Each new resident shall be rated utilizing the Worksheet for Rating Residents within two (2) weeks of their admission to the facility. All resident rating scores shall be reviewed at least annually, or when there are significant changes in a resident's physical or cognitive abilities. 1.113 (2) Compliance with National Fire Protection Association (NFPA) Life Safety Code Requirements 113 (2)(a) Chapter 32, NFPA 101 (2003) . The following facilities shall meet the requirements of Chapter 32, New Residential Board and Care Occupancies, NFPA 101 (2003): (i)

facilities which apply for licensure on or after June 1, 2004.

(ii)

Facilities with nine or more licensed beds which apply for a change of ownership, on or after June 1, 2004. However, the new owner in a change of ownership transaction shall have three years from the date that the initial license was issued to comply with the requirements of Life Safety Code sections 32.2.3.5 or 32.3.3.5, as applicable.

(iii)

Facilities required to submit building plans for plan review, pursuant to Section 1.103, for additions or remodeling of more than 25 percent of the habitable floor space on or after June 1, 2004.

(iv)

Facilities licensed on or after June 1, 2004, that met the automatic sprinkler exception requirements of Section 32.2.3.5.2 that subsequently apply for a change of ownership shall meet the requirements of 32.2.3.5.1 upon change of ownership.

113 (2)(b) Chapter 33, NFPA 101 (2003) . The following facilities shall meet the requirements of Chapter 33, Existing Residential Board and Care Occupancies, NFPA 101 (2003): (i)

Facilities that were constructed and that obtained a building permit for such construction on or between January 1, 1993 to May 31, 2004. Existing life safety features that met the requirements for new buildings at the time of licensure shall be maintained and not diminished.

(ii)

Facilities that underwent addition, remodeling or renovation to 50 percent or more of its floor area, and obtained a permit for such remodeling on or between January 1, 1993 to May 31, 2004. Such remodeling or renovation may have been completed as part of a single project or through a series of projects over a period of time. Existing life safety features that met the requirements for new buildings at the time of licensure shall be maintained and not diminished.

(iii)

However, facilities with less than 17 beds that were approved by the Department for prompt and slow evacuation levels prior to June 1, 2004 based on the installation of the automatic NFPA Standard 13D or 13R, for automatic fire suppression systems may remain in compliance with this standard, without necessitating the extension of sprinkler coverage in small closets of 24 square feet or less.

113 (2)(c)

Chapter 33, NFPA 101 (2003) or NFPA 101-A Guide on Alternative Approaches to

Life Safety (2004) . The following facilities shall meet the requirements of either Chapter 33, Existing Residential Board and Care Occupancies, NFPA 101 (2003) or NFPA 101-A Guide on Alternative Approaches to Life Safety (2004). 9 9 For those facilities complying with NFPA 101-A, Guide on Alternative Approaches to Life Safety (2004), the requirements for existing facilities shall apply.

1.113 (3)

(i)

Facilities with eight or less licensed beds that apply for a change of ownership, on or after June 1, 2004. These facilities, licensed on or before June 1, 2004, are allowed one change of ownership prior to having to meet the requirements set forth in 1.113 (2) (a) (NFPA Life Safety Code Chapter 32, Small Facility).

(ii)

Any other currently licensed facility not described under Subsections (a) or (b) above.

Fire Drills

113 (3)(a) Drills shall be designed to provide residents with experience in exiting through all exits required by the Life Safety Code, although exiting through egress windows shall not be required. Exits not used in any fire drill shall not be credited in meeting the requirements of the Life Safety Code. 113 (3)(b) Drills may be announced in advance to the residents. However, such advance notice shall not be construed to be prompting of residents immediately prior to sounding the building's fire alarm. 113 (3)(c) For those facilities for which the evacuation of residents is part of the emergency plan, the drills shall involve the actual evacuation of all residents to a predetermined assembly point outside the building or the relocation to a point of safety, as defined by the Life Safety Code. If the facility fire emergency plan, developed in conjunction with the local fire authority, outlines a "defend in place" strategy (which typically requires residents to remain in their rooms), an impractical level of evacuation capability shall apply. Existing large facilities that are determined to be impractical level of evacuation capability will be allowed to meet the equivalency requirements through application of the NFPA Standard 101A, Guide on Alternative Approaches to Life Safety (2004) Chapter 4, Fire Safety Evaluation System for Health Care Facilities, Worksheet 4.7.8A for an Existing Facility. 113 (3)(d) During the first year of operation, fire drills shall be conducted monthly. After the first year of operation, fire drills shall be conducted every other month. There shall be at least two (2) fire drills annually conducted during the overnight hours when residents are sleeping. 1.113 (4)

Equipment

113 (4)(a) First Aid . First aid equipment shall be maintained on the premises in a readily available location and staff shall be instructed in its use. 113 (4)(b) Telephone . There shall be at least one telephone, not powered by household electrical current, in the facility which may be used by staff, residents, and visitors at all times for use in emergencies. The telephone numbers of police, fire, ambulance [9-1-1, if applicable] and poison control center telephone numbers shall be readily accessible to staff. 113 (4)(c) Fire Suppression or Detection Equipment . Any fire suppression or detection equipment shall be fully operational and functional. All inspections for fire alarm and

smoke detection systems, automatic fire sprinkler systems and fixed kitchen systems must fully documented with written records maintained on premises for review. (i)

Fire alarm and smoke detection systems . Any fire alarm or supervised smoke detection system, installed for life safety purposes, must be inspected by trained and qualified personnel at least annually. Inspection and personnel requirements are defined in NFPA Standard 72, National Fire Alarm Code.

(ii)

Automatic fire sprinkler systems . Automatic fire sprinkler systems must be inspected annually by a sprinkler contractor that is currently registered to perform inspection and maintenance services with the State of Colorado - Division of Fire Safety.

(iii)

Fixed kitchen extinguishing systems . Fixed kitchen extinguishing systems must be inspected by trained and qualified personnel on a semi-annual basis in accordance with NFPA Standard 96, Ventilation Control and Fire Protection of Commercial Cooking Operations.

(iv)

Portable fire extinguisher . The facility shall have a portable fire extinguisher of the ABC type of at least 3 pound capacity located in the kitchen area, common area, and at least one on each floor of the facility. Fire extinguishers shall be checked monthly, by staff, to ensure that they are mounted in a location that is easily accessible and that the pressure gauge is within the safe zone. Portable fire extinguishers shall be inspected annually and tagged by a qualified fire extinguisher maintenance contractor.

CHAPTER VIII- PART 1-4 FACILITY FOR THE MENTALLY RETARDED The regulations promulgated below incorporate by reference (as indicated within) material originally published elsewhere. Such incorporation, however, excludes later amendments to or editions of the referenced material. Pursuant to section 24-4-103 (12.5), C.R.S., 1988 Repl. Vol. 10A, the Health Facilities; Division of the Colorado Department of Health maintains copies of the incorporated texts in their entirety which shall be available for public inspection during regular business hours - at: Colorado Department of HealthHealth Facilities Division4300 Cherry Creek Drive SouthDenver, Colorado 80222-1530 Main Switchboard:(303) 692-2000 Certified copies of incorporated material shall be provided by the Division, at cost, upon request. LICENSE. All facilities specifically for the mentally retarded shall be licensed in accordance with the requirements specified in Chapter II, Licensure. License applications shall be submitted to the appropriate local health department for review and recommendations prior to licensure. The Department of Health shall not issue a license unless approval shall first have been received from the Director of the Department of Institutions on the proposed program of the facility, rogether with his recommendations as to licensure. Such approval and recommendations shall be an annual requirement for reissuance of the license. CHAPTER VIII (2) FACILITIES FOR PERSONS WITH DEVELOPMENTAL DISABILITIES

DEFINITION Facility for Persons with Developmental Disabilities means a facility specifically designed for the active treatment and habilitation of persons with developmental disabilities. 1 GOVERNING BODY DEFINITION. Governing body means the individual(s) or group in whom the ultimate authority and legal responsibility is vested for the conduct of the facility for persons with developmental disabilities. 1.1 ORGANIZATION. When the Governing Body includes more than one individual, the group shall be organized formally with written constitution or articles of incorporation and by-laws, have meetings at regularly stated intervals, and maintain records of these meetings. The facility's for persons with developmental disabilities ownership shall be disclosed fully on file with the Department. In the case of corporation, the corporate officers shall be disclosed fully on file with the Department. 1.2 ADMINISTRATIVE OFFICER. The Governing Body shall appoint an Administrative officer, duly licensed in the State of Colorado, who shall be responsible on a full-time basis to the Governing Body and who by training, at least one year's experience, and continuing education is qualified in health care administration; and delegate to him the executive authority and responsibility for the administration of the facility for persons with developmental disabilities. 1.3 FACILITIES.The governing body shall provide the necessary facilities, qualified personnel, and services for the welfare and safety of patients and in compliance with these standards. The Governing Body has a responsibility for the program of all groups performing functions within the facility for persons with developmental disabilities. 1.4 EVALUATION COMMITTEE. The Facility shall have an Evaluation Committee which is a standing committee composed of representatives of all professional and program departments. This committee shall be responsible for the acquiring of comprehensive social, medical, and psychological data for optimum program planning for each individual. 2 ADMINISTRATIVE OFFICER 2.1 RESPONSIBILITY. The Administrative Officer shall be responsible on a full-time basis to the Governing Body for planning, organizing, developing, and controlling the operations of the facility for persons with developmental disabilities. 2.2 ORGANIZATION. The facility for persons with developmental disabilities shall be organized formally to carry out its responsibilities. The plan of organization with the authority, responsibility, and functions of each category of all personnel shall be clearly in writing. 2.3 POLICIES. The Administrative Officer, in consultation with one or more physicians and one or more registered professional nurses and other related professional health care personnel, shall develop and at least annually review appropriate written policies and procedures for the care of residents, i.e. admission and transfer of residents; dental, diagnostic, dietary, medical and emergency care, nursing, pharmaceutical, physical and occupational therapy, training, and social services as applicable. 2.4 ACCOUNTING. A recognized system of accounting shall be used to accurately reflect the details of the business. A fiscal audit shall be performed at least annually by a qualified auditor independent of the facility for persons with developmental disabilities. 3 PHYSICIAN SERVICES

3.1 SUPERVISION BY PHYSICIAN, Each resident shall have benefit of initial evaluation and at least quarterly reevaluation by a physician and benefit of continuing health care under the supervision of a physician. 3.2 MEDICAL CARE IN CASE OF EMERGENCY, There shall be written policies for provision of necessary medical care in case of emergency when a resident's physician is not available immediately. The management of the facility should consult with an appropriate medical society or hospital staff for guidance in establishing these policies. 3.3 MEDICAL RECORDS. 1) The medical record shall contain sufficient information to properly identify the resident; to provide and support the diagnosis(es); to cover orders for medications, treatments, restorative services, diet, special procedures, activities, plans for continuing care and discharge; and to indicate the resident's progress at appropriate intervals as specified in the written policies of the facility; 2) Only physicians shall write or dictate medical histories and physical examinations, dentists the dental histories; 3) Telephone orders written by the licensed nurse receiving them, shall be countersigned by the physician within 48 hours; 4) Each record shall be authenticated and signed by a licensed physician. Those on dental treatment shall be signed by a licensed dentist. 3.4 DIAGNOSTIC SERVICES. Written policies shall provide for obtaining necessary diagnostic services for the resident when prescribed by a physician or dentist. Arrangements shall be made for the transportation of the resident to and from the source of diagnostic services. 4 MEDICAL RECORDS 4.1 FACILITIES. As a responsibility of administration, with periodic consultation from a medical record librarian, the facility for persons with developmental disabilities shall provide a medical record room or other medical record accommodations, supplies, and equipment adequate for medical record functions. 4.2 ENTRIES. All orders for diagnostic procedures, treatments, and medications shall be entered into the medical record and shall be signed by the physician. All reports, X-ray, laboratory, EKG, etc., shall be incorporated into the medical record and authenticated by the individual submitting such reports. All entries in the medical record shall be the original ink or typed copy of valid copies thereof, kept current, dated and signed or authenticated. The completion of a medical record shall be the responsibility of the attending physician and the administration of the facility. Authentication may be by written signature, identifiable initials or computer key. The use of rubber stamp signatures is acceptable under the following strict conditions: 1. The physician whose signature the rubber stamp represents is the only one who has possession of the stamp and is the only one who uses it; and 2. The physician places in the administrative offices of the facility a signed statement to the effect that he is the only one who has the stamp and is the only one who will use it. 4.3 CONTENT. A complete medical record shall be maintained on every resident from the time of admission through discharge. All resident records shall contain: 1. Identification and Summary Sheet that includes: 1) Resident's name, social security number, marital status, age, race, sex, home address, date of birth, place of birth, religion, occupation, name of informant and other available identifying sociological data, e.g. citizen of what country, Father's name, Mother's maiden name, U.S. Armed Forces (if yes, give dates). 2) Name, address and telephone number of referral source.

3) Name, address and telephone number of attending physician and dentist. 4) Name of next of kin or other responsible person. 5) Date and time of admission and discharge. 6) Admitting diagnosis, final diagnosis(es), condition on discharge and disposition, 7) Signature of attending physician. 2. Medical Data when applicable, e.g: 1) Medical history. 2) Medical evaluation reports on admission and at least quarterly thereafter, 3) Reports of any special examinations, including laboratory reports, X-ray reports, etc. 4) Reports of consultations by consulting physicians, when applicable. 5} Reports of special treatments; physical therapy, occupational therapy, etc. 6) Dental reports, when applicable. 7) Treatment and progress notes written and signed by the attending physician at the time of each visit. 8) Authentication of hospital diagnosis(es) in a hospital summary sheet or transfer form when applicable, and a summary of the course of treatment followed in the hospital if resident hospitalized. 9) Physician orders for all medications, treatments, diet, restorative and special procedures. 10) Autopsy protocol, if any, and authorization for autopsy, 11) Social service notes, 3. Nursing records that Include: All medications and treatments administered, special procedures performed, notes of observations, time and circumstance of death. All such entries shall be recorded, dated and properly signed by nursing personnel. 4. Accidents and incidents resulting in possible resident injury shall be reported on special report forms. The report shall include date, time and place of incident; circumstances of the occurrence, signature of witness; time doctor was notified; physician's report; signature of person making the report, A copy of report shall be filed in the resident's medical record. 4.4 FACILITY'S FOR PERSONS WITH DEVELOPMENTAL DISABILITIES RECORDS. The following facility for persons with developmental disabilities records shall be maintained; 1. Daily census.

2. Admission and discharge records. 3. Resident master card file. 5 PERSONNEL 5.1 OBJECTIVES. The purpose and objectives of the facility for persons with developmental disabilities shall be explained to all personnel. There shall be written personnel policies; job descriptions that clarify the type of functions to be preformed; and rules and regulations that govern the conditions of employment, the management of employees, and the quality and quantity of resident services to be maintained. Following approval by the Governing Body copies should be distributed to all employees. 5.2 DEPARTMENTAL. Each department of the facility for persons with developmental disabilities shall be under the direction of a person qualified by training, experience, and ability to direct effective services. Sufficient qualified personnel shall be available in each department to properly operate the department. All personnel shall have an appropriate annual screening test for tuberculosis and should have a preemployment physical examination and such interim examinations as may be required by the facility for persons with developmental disabilities administration. The examining physician should certify that the employee, before returning from illness to duty, is free from infectious disease. Employment health policies should be arranged so personnel are free to report their illness without fear of income loss. There shall be an education program for all personnel to keep all employees abreast of changing methods and new techniques. All personnel shall have an appropriate annual screening test for tuberculosis and should have a preemployment physical examination and such interim examinations as may be required by the facility's administration. The examining physician should certify that the employee, before returning from illness to duty, is free of infectious disease. Employment health policies should be arranged so personnel are free to report their illness without fear of income loss. 5.3 RECORDS. There shall be personnel records on each person of the facility persons with developmental disabilities staff including employment application with resume of employee's training and experience, verification of credentials, and evidence of adequate health supervision. 6 ADMISSIONS 6.1 POLICIES. The facility's written policies shall specify that only those individuals are admitted for care whose needs can be met within the accommodations and services the facility provides. 6.2 RESIDENT INFORMATION. When a resident is admitted, prior to or upon admission, essential information, including medical evaluation report, pertinent to the care of the resident, shall be made available to the facility by the referring agent, 6.3 IDENTIFICATION. Upon admission, adequate measures shall be taker to insure proper identification. 6.4 RESIDENT BEDROOM. No resident shall be admitted for care to any room or area other than one regularly designated as a bedroom. There shall be no more residents admitted to a bedroom than the number for which the room is designed and equipped.

7 DIETARY SERVICES 7.1 ORGANIZATION. There shall be an organized food service planned, equipped, and staffed to serve adequate meals to residents according to physician's orders when applicable to an Individual resident. At least three meals or their equivalent are served daily, at regular times, with not more than an approximate 14-hour span between the evening and breadfast meals. Between-meal snacks of nourishing quality are offered. When the “four or five meal a day” plan is in effect, meals and snacks provide nutritional value equivalent to the daily food guide. 7.2 PERSONNEL. A person qualified by training and experience shall be designated by the administrator to be responsible for the dietary services. When this person is not a professional dietitian, frequent regularly scheduled consultation should be obtained from a professional dietitian who meets the American Dietetic Association's qualifications standards or from a person graduated from a baccalaureate degree program with major studies in foods and nutrition. A sufficient number of trained food service personnel shall provide services over a period of 12 hours or more per day, 7.3 POLICIES. Policies and procedures for dietary practices shall be written. 7.4 ORDERS. All diets and nourishments shall be provided and served as prescribed by the attending physician, when applicable. 7.5 DIET MANUAL. A diet manual should be maintained by the facility for fulfilling dietary prescriptions. 7.6 MENUS. Menus shall be planned at least one week in advance. Personal tastes, desires, and cultural patterns of residents shall be considered and reasonable menu adjustments made. The menus shall be posted in the kitchen area, and after use shall be filed and maintained for at least four weeks. Menus should meet the requirements of the Recommended Dietary Allowances For Food and Nutrition Board, National Research Council, 1968. Rotating menus are recommended. Recipes appropriate to the needs of the facility shall be available to the cook. 7.7 SPACE. Adequate space shall be provided to allow for fixed and movable equipment and employee functions; for receiving, storage, refrigeration, food preparation, tray assembly, cart storage when applicable; and for dishwashing and scullery. 7.8 REGULATIONS. Food Service design, equipment, and practices and dishwashing shall be in accordance with the Rules and Regulations Governing the Maintenance and Operation of Restaurants In the State of Colorado, Colorado Department of Health, May 1964,See Section 10, Infectious Disease Control. 7.9 FOOD SUPPLIES. All food in nursing care facilities shall be from sources approved or considered satisfactory by the health authority, and shall be clean, wholesome, free from spoilage, free from adulteration and misbranding, and safe for human consumption. No hermetically sealed, nonacid and lowacid food which has been processed in a place other than a commercial food-processing establishment shall be used. 7.10 STORAGE. Adequate, clean, well ventilated food storage space shall be provided. Containers of food shall be stored above the floor on clean shelves, dollies, or other clean surfaces to protect them from contamination.

7.11 REFRIGERATION. A minimum of two units of refrigeration shall be provided to protect foods kept on hand. Refrigerators and walk-in boxes used for perishable foods shall be equipped with reliable thermometers. 7.12 REFRIGERATOR SAFETY. Walk-in refrigerators and freezers shall have inside lighting and inside lock releases, and should have audio-visual signal system as a secondary safety device. 7.13 PERISHABLE FOODS. Potentially hazardous foods including eggs, shall be maintained at a temperature of 45°F or below, or 140°F. or above, except when being prepared or served. Home canned vegetables and home canned meats shall not be served. 7.14 TOXIC MATERIALS. Poisonous and toxic materials' shall be labeled, stored separately from food, and used only in such ways that they will neither contaminate food nor be hazardous to employees. 7.15 UTENSILS. Convenient and suitable utensils, including self-service, such as forks, knives, tongs, and spoons shall be used to handle food at all points where food is prepared and served. 7.16 DISPLAYED FOOD. Unwrapped food on display for service shall be protected against contamination by counter-protector devices. Food being conveyed should be covered, completely wrapped or packaged to protect from contamination. Appropriate precautionary measures shall be taken to protect food from contamination when feeding patients. 7.17 HANDWASHING. Employees shall wash their hands thoroughly in an approved handwashing facility before starting work and as often as may be necessary to remove soil and contamination. Each employee shall wash his hands before resuming work after visiting the toilet room. Handwashing facilities shall be provided in the kitchen areas. 7.18 HEAD PROTECTION. All dietary employees shall wear hair nets, caps, or other effective hair restraints. 7.19 TOBACCO. Employees shall not use tobacco in any form while engaged in food preparation, service, or equipment washing. 7.20 EQUIPMENT. Adeauate equipment shall be provided for efficient preparation of meals. Food contact surfaces of equipment and utensils shall be non-toxic, smooth, free from breaks, open seams, cracks, chips, and similar imperfections; and free of difficult-to-clean. internal corners and crevices. Cutting blocks, boards, and table tops shall be of impervious material which is non-toxic, smooth, and free of cracks, crevices, and open seams. 7.21 COUNTER EQUIPMENT. Equipment on tables or counters, unless readily movable, shall be installed so as to facilitate cleaning and. safety. 7.22 FLOOR-MOUNTED EQUIPMENT. Floor-mounted equipment, unless readily movable, shall be sealed to the floor to prevent liquids or debris from settling under the equipment. Lubricated bearings and gears shall be constructed so that lubricants cannot get into the food. 7.23 SILVERWARE. Facilities and systems for storage of silverware shall be designed and maintained to prevent contamination. 7.24 CUPS AND GLASSES. Clean cups and glasses shall not be stored with entrapped moisture. 7.25 EQUIPMENT AND UTENSIL SANITIZATION. Portable equipment and utensils shall be cleaned,

sanitized, and stored above the floor in a clean, dry location. Utensils shall be air-dried before storing. Stored containers and utensils shall be covered or inverted. 7.26 ISOLATION. Food served to patients in isolation, because of infectious diseases, shall be served in disposable utensils or in utensils that shall be sterilized. 7.27 MECHANICAL WASHING. Commercial-type mechanical dishwashing equipment shall be provided separate from food preparation and serving areas, and equipped with an easily readable thermometer in each tank. Equipment and utensils shall be preflushed or prescraped and, when necessary, presoaked to remove soil. A suitable detergent in effective concentration shall be used. Wash water shall be kept reasonably clean, and washing cycle properly timed. The wash water temperature shall be compatible with the detergent used. The final rinse water shall be unused water at temperature not less than 180°F manifold temperature, 170.F on surface of the dishes. Rinsing cycles shall be timed accurately. The use of automatic dishwashing machines using chemical sanitization is acceptable if properly Installed and maintained; the chemical sanitizer applied in such concentration and for such a period of time as to provide effective bactericidal treatment of the equipment and utensils. Only air drying shall be employed after washing and rinsing, All dishes and utensils shall be stored 1n clean, dry areas free of contamination, 7.28 MANUAL WASHING, Utility ware, pots, pans, and similar utensils shall be cleaned 1n an area separated from the dishwashing operation. Separate two-compartment sinks are required for manual washing operations, and they shall be of such length, width, and depth to permit complete immersion of equipment and utensils. Each compartment shall be supplied with hot-cold mixing faucet. 7.29 DRAINBOARDS. Separate drainboards shall be used for soiled utensils prior to washing, and for clean utensils following disinfecting, 7.30 LIGHTING, Areas for preparing food, and storing and cleaning utensils shall be adequately lighted. 7.31 VENTILATION. Rooms for preparing and serving food and washing utensils shall be well ventilated. Ventilation hood, ducts, and devices shall be designed to comply with, or equal to, NFPA Bulletin No. 96, 1964. Filters shall be readily removable for cleaning or replacement. 7.32 TOILET FACILITIES. Adequate, clean toilet facilities shall be provided, 7.33 HANDWASHING FACILITIES. Approved handwashing facilities with soap and sanitary hand-drying accommodations shall be conveniently provided. 7.34 HASTE. Garbage and refuse shall be placed in impervious containers equipped with tightly fitting covers when filled or stored, or not in continuous use, Containers shall be stored in a safe area or refrigerated space pending removal and shall be removed from the premises and cleaned at frequent intervals. 7.35 WASTE GRINDERS. Food waste grinders shall, be installed in compliance with applicable laws and regulations. 7.36 INFESTATIONS. Storage rooms, loading docks, and premises shall be reee from rodent and insect infestation, odors, dust, and other sources of contamination. 7.37 MILK. Milk may be served in the containers to the resident if the container is no larger than an individual serving. 7.38 DINING AND RECREATION FACILITIES. Dining and recreation areas shall be provided, shall be readily accessible to all residents, and should not be in a hallway or lane of traffic in or out of the facility.

The dining and recreation areas may be separate or combined. 8 EMERGENCY SERVICES 8.1 EMERGENCY CARE POLICIES. Statements of policies for the care of residents in an emergency shall be developed and incorporated into a manual for staff use. See Section 2.3, 3.1, and 3,7. The manual should include but not be limited to: 1) Arrangements for the necessary medical care when a resident's physician is not available immediately; 2} Procedures and training programs which cover immediate care of the resident; 3) Persons to be notified, 8.2 FIRE AND INTERNAL DISASTER PLAN, Written policies and procedures shall be formulated for the protection of persons within the building in case of fire, explosion,, or other emergency in the building, and shall consist of the following: 8 2.1 Brief, written instructions to be posted at appropriate places, of persons to be notified, and other immediate steps to be taken before the fire department or other assistance arrives. 8.2.2 A schematic plan of the building, or portions thereof, to be posted at approrpiate places showing evacuation routes, smoke stop and fire doors, exit doors, and the location of fire extinguishers and fire alarm pull boxes. 8.2.3 Other policies and procedures that need not be posted but -must include: procedures for evacuating helpless residents, assignment of specific tasks and responsibilities to the personnel of each shift, provision for at least annual training and instruction sessions to keep employees informed of their duties, and provision for conducting simulated fire drills at least three times annually. The above policies, procedures, and plan must be developed with the assistance of qualified fire and safety experts. 8.3 MASS CASUALTY PROGRAM. Each facility for persons with developmental disabilities should develop a written mass casualty plan for the management of residents and the treatment and disposition of casualties in the event of an external or community disaster. This program should be developed in cooperation with other health facilities of the area and with official and non-official agencies concerned. 9 INFECTIOUS DISEASE CONTROL 9.1 CONTROL, The facility shall have an Infection control program which provides for policies, procedures and training programs. 9.2 POLICIES. There shall be written policies Including but not limited to the following: 1) The nonadmission of residents having an Infectious disease and the protective Isolation of residents who, subsequent to admission, are discovered to have an Infectious disease; 2) The reporting of diseases as required by Laws and Regulations, pertaining to Disease Control, Colorado Department of Health. 9.3 RESIDENT ISOLATION. Intermediate Health Care Facilities for the Mentally Retarded shall observe the rules pertaining to isolation as required by Laws and Regulations, pertaining to Disease Control, Colorado Department of Health. 10 RESIDENT SERVICES 10.1 ORGANIZATION. The facility for persons with developmental disabilities shall be organized to provide effective services to each resident. The authority and responsibility of personnel shall be defined clearly in written job descriptions.

10.2 MASTER STAFFING PLAN. There shall be a master staffing plan, including provision for licensed nurses, for providing 24-hour resident services. A registered professional nurse or licensed practical nurse shall be employed full time by the facility and responsible for the residents' needs. Licensed practical nurses and auxiliary nursing personnel shall be assigned only those duties for which they are qualified. Supplemental staff shall be available to assure that treatments, medications, and other services prescribed by the resident's physician are properly carried out and recorded. If the facility utilizes more than one building for the care of residents, there shall be personnel on duty in each building 24 hours daily. The care required by residents shall be the major consideration in determining the number, quality, and category of personnel that are needed in any given situation. 10.3 WRITTEN PROCEDURES. There shall be written procedures that establish the standards of performance for safe, effective care of residents. These procedures shall be reviewed periodically and revised as necessary. There should be a written plan for continuous evaluation of resident services including nursing services. There should be periodic evaluation of the facility in terms of residents' needs. 11 PROGRAMMING 11.1 OCCUPATIONAL THERAPY, When occupational therapy services are provided, the following requirements shall be observed; 11.1.1 MEDICAL DIRECTION, Direct resident care requires a physician's referral, 11.1.2 POLICIES. There shall be written policies identifying the organization, administration, performance standards, and direction and supervision of resident care rendered. 11.1.3 PERSONNEL. Occupational therapy shall be rendered only by a registered occupational therapist. All personnel assisting with the occupational therapy of residents shall be under the direct supervision of a registered occupational therapist. 11.1.4 RECORDS. Occupational therapy records shall include a physician's referral for treatment, resident progress notes, and results of special tests and measurements. 11.1.5 FACILITIES. There shall be adequate facilities, space, appropriate equipment and storage areas for the treatment of referred residents. The occupational therapy services shall be located in an area readily accessible to residents, 11.1.6 EQUIPMENT. Commonly used therapeutic equipment necessary for the occupational therapy service shall be properly maintained to insure the safety of both residents and employees using the equipment. 11.2 PHYSICAL THERAPY. When physical therapy services are offered and when the term “physical therapy” is used in any type of advertisement or as a door sign, the following requirements shall be observed: 11.2.1 MEDICAL DIRECTION. Direct resident care requires a referral from a phusician or dentist. 11.2.2 POLICIES. There shall be written policies governing the services.

11.2.3 PERSONNEL. Physical therapy shall be rendered only by a licensed physical therapist, All personnel assisting with the physical therapy of residents must be under the supervision of a physical therapist. 11.2.4 TREATMENT RECORDS. Treatment records shall include the physician's referral, evaluation and progress notes of the physical therapist and result of special tests and measurements, 11.2.5 FACILITIES, There shall be adequate facilities, space, appropriate equipment and storage area for the care and treatment of referred residents. If a special room is used it shall be located where it is readily accessible for residents. 11.3 RESIDENT ACTIVITIES 11.3.1 GENERAL, the facility involves planning for individual residents in terms of determined abilities and disabilities, potentials for future growth and development, specific services needed, resources available and potentials for release to the community involves homogeneous grouping of the resident population and providing appropriate services for the respective groups. The above programs should be available either in the facility or in the community. 11.3.2 THERAPIES AND ACTIVITIES. Programming should include the following: Volunteer Services, Library Services, Music Therapy, Industrial Therapy, and Recreational Therapies. Physical and Occupational Therapy are included in a separate section. The purpose shall be to plan and administer a comprehensive schedule of activities, suited to the individual and group needs of the residents, and contribute to their maximum growth and development. The purposes of such activities are: Provide Leisure Time Activities.Facilitate the Development of Social Skills.Develop Tension-reducing Activities.Promote Physical Health.Provide Experiences in Avocational Skills.Promote the Development of Motor Skills.Promote Functional Skills.Provide for Normalization. These therapies and activities should be planned in relation to other specialized services, and should play a supporting role to such services and to the total program. 11.3.3 EDUCATION AND TRAINING SERVICES. Education and training programming within the facility should be conceived and conducted as an integral part of the total facility-community effort leading to the mental, emotional, physical, social and vocational growth of each resident. Education and training services should constitute a clearly defined area. Its basic responsibility is to provide education and training services to all residents deemed capable of benefiting from such a program. The education and training should include the following according to the needs of the residents and the scope of the program: Qualified School Administrators.Special Education Teachers at all Levels.Vocational Instructors.Vocational Guidance Counselors.Home Economics Teachers.Music Teachers.Physical Education Teachers.Speech and Hearing Therapists.Special Teachers Proficient in Working With Those Who Have Emotional, Visual and Orthopedic Handicaps. All education and training personnel should meet the certification requirement of the State of Colorado

11.3.4 RECREATION SERVICES. Recreation programming should provide each resident with enjoyable leisure time activities and promote mental and physical health through interesting and worthwhile recreational pursuits, 11.3.5 PSYCHOLOGICAL SERVICES. Programming should include psychological services to the residents of the facility, to the administration, and to other departments whose responsibilities involve the day-to-day care and training of the residents. Responsibility may vary somewhat in facility settings according to the administrative organization of the facility. The professional background of a department of psychological services equips it to fulfill the following responsibilities: Intellectual ClassificationConsultation and ReportingCounseling and Therapy 12 RESIDENT CARE UNIT DEFINITION. Resident care unit means a designated area of an Intermediate Health Care Facility for the Mentally Retarded that consists of a bedroom or grouping of bedrooms with supporting facilities and services that are planned, organized, operated, and maintained to provide adequate resident care and to accommodate no more than 60 residents. 12.1 RESIDENT BEDROOMS. There should be no more than four beds per resident bedroom. 12.1.1 SIZE. Minimum room area (exclusive of closets, lockers, ward-robes of any type, vestibules, and toilet room) shall be 100 sq. ft. for a single bedroom and 80 sq, ft. per bed in multiple bedrooms. 12.1.2 WINDOWS. Each resident bedroom shall have an exterior window with area not less than 1/8 of the floor area. The sills of such windows shall not be located below the finished ground level and shall not be more than 32 inches above the floor level. The ground level shall be maintained at or below the window sill for a distance of at least eight feet measured perpendicular to the window. One-half of the required area shall be openable without the use of tools. If a mechanical ventilation system is provided, a portion of the required window shall be openable without the use of tools. Privacy for the resident and control of light shall be provided at each window. 12.1.3 ENTRIES. Doors to resident bedrooms shall be at least 2'6“ in width (3'0” width is recommended). If residents are non-ambulatory, 3'8” doors are required. 12.1.4 LIGHTING. Artificial light shall be provided and include: 1) General illumination; 2) Other sources of illumination for reading, observations, examinations, and treatments; 3) Night light controlled at the door of the bedroom; 4) Quiet operating switches. 12.1.5 HANDWASHING FACILITIES. A lavatory complete with mixing faucet, blade controls, soap and sanitary hand-drying accommodations shall be provided. If centralized, the handwashing facilities must be in the ratio of 1-10 residents. 12.1.6 TOILET FACILITIES. Toilet rooms may be adjacent to patient bedrooms. If adjacent to bedrooms, one toilet may serve two bedrooms but not more than four beds. If toilet rooms are centralized, the ratio of toilets to residents must be not less than one (1) per eight (8). The toilet room shall be provided with: 1) Toilet; 2) Grab bars convenient for safety of the residents (optional for ambulatory residents), 12.1.7 RESIDENT FURNISHINGS. Resident bedrooms shall be equipped with the following for

each resident: 1) Comfortable bed (roll away type beds, cots, and folding beds shall not be used) equipped with comfortable, clean mattress and pillow and with side rails when appropriate to the safety of the resident; 2) Cabinet or bedside table; 3) Waste paper receptacle with impervious, disposable liner or disposable waste receptacle; 4) Comfortable chair: 5) Storage facilities adequate for residents' personal and grooming articles. 12.1.8 CLOSET. Each bedroom shall be provided with a closet or locker space for each resident. 12.1.9 RESIDENT CALL SIGNAL SYSTEM. Calling stations (that register a visual signal at the clean and soiled holding rooms and a visual and audible signal at the nurses' station) should be located in toilet rooms and at each tub and shower. 12.2 RESIDENT SERVICE FACILITIES. The following service areas shall be provided on each floor housing residents and located conveniently for resident care: 12.2.1 RESIDENT CARE CONTROL CENTER. The Resident Care Control Center shall be designed and equipped for resident record charging, communications, and storage of supplies. 12.2.2 MEDICATION PREPARATION AREA. When provided, the medication preparation area shall be equipped with: 1) Cabinets with suitable locking devices to protect drugs stored therein; 2) Refrigerator equipped with thermometer and used exclusively for pharmaceutical storage; 3) Counter work space; 4) Sink with approve: handwashing facilities; 5) Antidote, incompatibility, and metriapothecary conversion charts. Only medications, equipment, and supplies for their preparation and administration shall be stored in the medication preparation area. Test reagents, general disinfectants, cleaning agents, and other similar products shall not be stored in the medication area. 12.2.3 CLEAN HOLDING ROOM. The clean supply holding room shall be equipped with: 1) Counter sink with mixing faucet, blade controls, soap, and sanitary hand-drying facility; 2) Waste container with cover (foot controlled recommended) and impervious, disposable liner; 3) Cupboards or carts for supplies. 12.2.4 CLEAN LINEN, There shall be a separate closed area (in the clean supply holding room, on a cart, or in a separate closet) for clean linen supplies. 12.2.5 SOILED HOLDING ROOM. The soiled holding room shall be equipped with: 1) Suitable counter double-sink with mixing faucet, blade controls, soap, and sanitary hand-drying facility; 2) Waste container with cover (foot controlled recommended) and impervious, disposable liner; 3} Soiled linen cart or hamper with impervious liner; 4) Accommodations and provisions for enclosed soiled articles; 5) Space for short-time holding of specimens awaiting delivery to laboratory; 6} Adequate shelf and counter space. 12.2.6 JANITOR'S CLOSET. The janitor's closet shall be equipped with: 1) Sink, preferably depressed or floor mounted, with mixing faucets; 2) Hook strip for mop handles from which soiled mopheads have been removed; 3) Shelving for cleaning materials; 4) Approved handwashing facilities; 5} Waste receptacle with impervious liner, The floor area should be adequate to store mop buckets on a roller carriage, wet and dry vacuum machine, and floor scrubbing machine. 12.2.7 STORAGE. A storage room should be provided. Storage space for wheel chairs should be recessed off the corridor,

12.2.8 NOURISHMENT STATION. Nourishment stations should be provided with storage space and sink for serving between-meal nourishments. 12.3 RESIDENT BATHING FACILITIES. Resident bathing facilities shall be provided in the ratio of one tub or one shower for each fifteen (15) residents. Approved grab bars shall be installed at each tub or shower. The tubs are to have non-slip surfaces. The room shall provide privacy and be sufficiently large to provide space for wheelchair movement. The entry door shall be at least 30” in width. Curbs should be omitted from showers. There shall be toilet and lavatory facilities in the bathroom with mixing faucet, blade controls, soap, and sanitary hand-drying accommodations, 12.4 PERSONNEL TOILET FACILITIES. Toilet facilities shall be provided for personnel on each resident unit. 12.5 PHYSICIAN ORDERS. Medications and treatments shall be administered only on the order of a physician. Orders shall be received by a house physician or licensed nurse; shall be written; and shall include the date, time and specifications of the order, Verbal orders shall be designated as such, shall be signed by the person receiving, and shall be countersigned within 48 hours by the ordering physician. 12.6 RESIDENT MEDICATION. Resident medications shall be self-administered and only upon written order of the resident's physician and under guidance of a licensed nurse. However, in those transitory instances when self-administered medication(s) would endanger the health, welfare, and safety of an individual resident, medication(s) may be administered the individual resident, provided, however, that such medication(s) shall be administered only in accordance with applicable Colorado laws and shall be recorded on the resident's medical record and include the name, strength, dosage, mode of administration of the medication; date, time, and signature of the person administering Written policies shall specify the delegated person authorized for the requisition, receipt, control, and management of drugs. Resident drugs shall be obtained from a licensed pharmacy on an individual prescription basis for a specific resident. These drugs shall bear a label affixed in or to the container, which contains at least the following: Name of pharmacy, name of the resident, name of the prescribing physician, date filled and refilled, number of the prescription, and such directions as prescribed by the physician. The label shall be brought into accord with the current directions of the physician each time the prescription is refilled. The facility shall protect each resident's drugs from use by other residents, visitors, and personnel. Resident drugs shall be destroyed in accordance with documented procedures when: 1) The label is mutilated or indistinct; 2} The medicine has deteriorated or gone beyond its safe shelf life: 3} Unused portions remain due to death, discharge, or discontinuance of medication as reflected on the resident's record. 12.7 INCIDENT REPORTS. Medication errors, drug reactions, and resident accidents shall be reported immediately to the resident's physician and an entry thereof recorded in the resident's medical record and on an incident report. 12.8 EMERGENCY EQUIPMENT AND SUPPLIES, The following shall be readily available at all times: 1) Oxygen; 2) Suction; 3) Portable emergency equipment, supplies and medications, 12.9 THERMOMETER, A disinfected thermometer shall be used each time a resident's temperature is taken, 12.10 DRESSING. There shall be individual resident equipment and supplies for changing dressings. 12.11 RESIDENT CARE PLAN. In addition to physician orders, there shall be a written plan of care for

each individual resident, The plan should indicate what care is needed, how it can best be accomplished for the resident, how the resident likes things done; what methods and approaches are most successful with the resident and what modifications are necessary to ensure best results. The resident care plan should be retained as specified by the facility's written policies. 12.12 RESTRAINTS, Confinement of residents to physical restraints shall be used only when necessary to prevent injury to the resident or others, and only when other measures are not sufficient to accomplish the purpose. Written policies shall be established relative to the use of restraints, 12.13 RESTORATIVE CARE, There shall be a continuous program of restorative care directed toward assisting the residents to achieve and maintain their optimum level of independence. 12.14 WRITTEN POLICIES. Written policies for resident care shall be established. 13 SOCIAL SERVICES 13.1 PROVISIONS. The facility for persons with developmental disabilities shall provide appropriate social services to residents and families and consultation to the staff. The social services may be provided by a qualified social worker on the facility staff or by a designated staff member for whom the facility has an effective arrangement for consultation from a qualified social worker of an outside agency. 13.2 RECORDS. Pertinent social information shall be recorded on the resident's record. 14 MICROBIAL CONTROL 14.1 INFECTION CONTROL PROGRAM. The facility for persons with developmental disabilities shall have a microbial and infection control program which provides for policies, procedures and in-service training programs for microbial and infectious disease control. 14.2 SANITATION OF NURSING AND RESIDENT CARE EQUIPMENT. Resident care equipment shall be properly cleaned, stored, sanitized, disinfected or sterilized. Resicent care equipment that Is to be used internally shall be properly cleaned, sterilized and stored after each use; thermometers shall be properly disinfected. 14.3 DISPOSABLE EQUIPMENT AND SUPPLIES. Single service disposable equipment shall be used only once and shall be disposed of in an. approved manner. Other disposable resident care equipment shall be used only for the resident to which assigned. Disposable sterile equipment shall be certified by the distributer as sterile and be destroyed after initial use. 14.4 PRESSURIZED STEAM. When pressurized steam sterilizers or equivalent are used, they shall be of approved type and necessary capacity for adequate sterilization and all sterilization equipment shall be maintained in good operating condition.' Bacteriological methods shall be used to evaluate the effectiveness of sterilization, by at least monthly cultures with records” maintained. 14.5 STERILIZATION METHODS. Boiling water, chemical disinfectants, and dry heat are prohibited as methods of sterilization. 14.6 STERILE SOLUTIONS. Water used for sterile solutions shall be distilled and-sterilized in flasks, These flasks shall be resistant to heat, chemical, and electrical action; and shall be properly sealed, labeled, and stored. Commercially prepared sterile solutions are highly recommended. 14.7 HANDWASHING. Personnel shall wash their hands after contact with a resident or with a contaminated object and observe the following techniques: 1) Remove watches and rings, and roll

sleeves of clothing above elbow; 2) Wash hands and forearms with soap or detergent, with friction, not a brush, and rinse under running water; 3) Repeat the washing procedure two or more times; 4) Dry hands with a disposable towel. 14.8 SANITATION OF AIR. Design, installation, and operation of a ventilation system should insure adequate microbial control of the air. 15 HOUSEKEEPING SERVICES 15.1 ORGANIZATION. Each facility shall establish organized housekeeping services planned, operated, and maintained to provide a pleasant, safe, and sanitary environment. Adequate housekeeping personnel shall be provided. Housekeeping personnel, using accepted practices and procedures, shall keep the facility free from offensive odors, accumulations of dirt, rubbish, dust and safety hazards. Deodorizers shall not be used to cover up odors caused by unsanitary conditions or poor housekeeping practices. 15.2 EQUIPMENT AND SUPPLIES. Suitable equipment and supplies shall be provided for cleaning of all surfaces. Such equipment shall be maintained in a safe, sanitary condition. 15.3 GERMICIDES. Germicides shall be registered with the Colorado Department of Agriculture and stored in an approved manner, 15.4 STORAGE. Storage areas, attics, and cellars shall be kept safe and free from accumulations of extraneous materials such as refuse, discarded furniture, and old newspapers. Combustibles such as cleaning rags and compounds shall be kept in closed metal containers. Solutions, cleaning compounds, and hazardous substances shall be labeled properly and stored in safe places. Paper towels, tissues, and other supplies shall be stored in a manner to prevent their contamination prior to use. 15.5 CLEANING METHODS. Cleaning shall be performed in a manner to minimize the spread of pathogenic organisms. Floors shall be cleaned regularly. Polishes on floors shall provide a non-slip finish; throw or scatter rugs shall not be used except for non-slip entrance mats. 15.6 HANDWASHING. All personnel shall wash their hands thoroughly after handling waste products. 15.7 TRAINING AND SUPERVISION. Housekeeping personnel shall receive adequate supervision. Continuous in-service training programs shall be established for housekeeping personnel. 16 LINEN AND LAUNDRY 16.1 LAUNDRY FACILITIES, Laundry facilities and/or contract with commercial laundry shall be provided with the necessary washing, drying, and ironing equipment having sufficient capacity to process a continuous seven-day supply based on ten pounds of dry laundry per resident bed per day. Laundry equipment shall be provided with all safety applicances and sanitary requirements. The equipment shall be designed and installed to comply with all state and local laws. Laundry equipment, processing and procedures shall render soiled linen and resident clothing clean and free of detergents and soap, Laundry facilities and operations shall be located in areas separated from Resident Care Units. There should be proper spacing and placing of the equipment to minimize material transportation and operation, to avoid all cross traffic between clean and soiled linen, to provide balance of operations, and to provide storage between operations. The general air movement shall be from the cleanest areas to the most contaminated areas and exhausted to the exterior. Soiled laundry shall be processed frequently enough to prevent unsanitary accumulations. 16.2 WASHING TEMPERATURE. The temperature of water during the washing and hot rinsing process shall be a minimum of 165°F and for a combined period of time of at least 25 minutes,

16.3 COMMERCIAL LAUNDRY SERVICES. If laundry facilities are not provided in the facility for persons with developmental disabilities, any contract with a commercial laundry service shall provide for these standards. 16.4 RESIDENT LINEN SUPPLY. Linen supply shall be at least two complete changes times the number of resident beds. All linens shall be maintained in good repair, 16.5 RESIDENT LINEN HANDLING. In removing and handling soiled linen from a resident's bed, there shall be minimum shaking of the linen. Soiled linen, including blankets, shall be placed in bags tightly closed before removal from a resident's room. The bags shall remain closed, shall be removed from the Resident Care Unit at least every eight hours. 16.6 INFECTIOUS DISEASE LINEN. All linens and blankets from residents with infectious disease shall be placed in special bags identified “contaminated” and transported in these closed bags. Special measures shall be taken to insure the disinfection of contaminated laundry. 16.7 SORTING AND PRE-RINSING. Pre-rinsing shall be permitted only in a designated room where approved facilities are provided. Sorting and all other linen and laundry operations shall be confined to the laundry facility and shall not be permitted in the resident's room, bathtub, shower, lavatory or janitor's closets. 16.8 LINEN CHUTES. If linen chutes are used, all soiled linen shall be enclosed in bags before placing them in chute. Laundry chutes shall be cleaned regularly by approved methods. 16.9 SOILED LINEN CARTS, Carts and hampers used to transport soiled linen shall be constructed of or lined with impervious materials, cleaned and disinfected after use, and used only for transporting soiled linen. 16.10 SOILED LINEN STORAGE. The facility shall provide separate storage for soiled linen and clothing. In facilities over ten beds a soiled linen storage and sorting room, mechanically ventilated to the outside atmosphere, shall be provided, Reciruclation of air from this room shall not be permitted. 16.11 HANDWASHING EQUIPMENT, Handwashing facilities shall be provided in or convenient to the laundry facility, 16.12 HANDWASHING, All personnel shall wash their hands thoroughly after handling any soiled linen, 16.13 RESIDENT CLOTHING, Resident clothing and other laundry shall be processed and stored in an approved manner, 16.14 CLEAN LINEN STORAGE, A clean linen storage room shall be provided separate from the laundry room. Storage for clean linen for current use shall be provided on each Resident Care Unit, 17 INSECT, PEST, AND RODENT CONTROL INSECT, PEST AND RODENT CONTROL, The facility shall be maintained free of infestations of insects, pests and rodents. The facility shall have a pest control program provided by maintenance personnel or by contract with a pest control company using the least toxic and least flammable effective pesticides. The pesticides shall not be stored in resident or food areas and shall be kept under lock and only properly trained, responsible personnel shall be allowed to apply insecticides and rodenticides. In the absence of other effective controls, screens shall be provided on all exterior openings, 18 WASTE DISPOSAL 18.1 SLWAGE AND SEWEK SYSTEMS.

1) All sewage shall be discharged into a public sewer system, or if such is not available, shall be disposed of in a manner approved by the State and local health authorities and the Colorado State Water Pollution Control Commission, 2) When private sewage disposal systems are in use, records of maintenance and the system design plans shall be kept on the premises. 3) No exposed sewer line shall be located directly above working, storage, or eating surfaces in kitchens, dining rooms, pantries, or food storage rooms, or where medical or surgical supplies are prepared, processed or stored, 18.2 REFUSE. All garbage and rubbish not as sewage, shall be collected in impervious containers in such manner as not to become a nuisance or a health hazard and shall be removed to an approved storage area at least once a day. The refuse and garbage storage area shall be kept clean and free from nuisance, A sufficient number of impervious containers with tight fitting lids shall be provided and kept clean and in good repair. 18.3 REFUSE CART. Carts used to transport refuse shall be constructed of impervious materials, shall be enclosed, used solely for refuse, and maintained in a sanitary manner. 18.4 PLUMBING. All plumbing in the facility for persons with developmental disabilities shall be installed and maintained in accordance with the Colorado State and local plumbing code. All plumbing shall be maintained so that it is free of the possibility of backflow and backsiphonage, through the use of vacuum breakers and fixed air gaps, as in accordance with state and local codes. 18.5 INCINERATORS. Incinerators shall comply with state and local air pollution regulations and be so constructed to prevent insect and rodent breeding and harborage. 19 GENERAL BUILDING AND FIRE SAFETY The facility for persons with developmental disabilities shall meet the General Building and Fire Safety requirements as follows: 19.1 The facility shall be constructed in accordance with the requirements of Group D occupancy; 1967 Uniform Building Code, or the Standards imposed by any city, city and county, town, county, or other political subdivision in which the facility is located, whichever is the highest, and all other applicable state laws, rules and regulations. CHAPTER VIII (3) RESIDENTIAL CARE FACILITY FOR THE MENTALLY RETARDED Residential Care Facility for the Mentally Retarded of less than 10 residents shall conform to the requirements of chapter VI I, Residential Care Facility. Residential Care Facility for the Mentally Retarded of more than 10 residents shall meet the requirements of Chapter 13 for Group H occupancy, 1967 Uniform Building Code, and the requirements specified in chapter VI I, Residential Care Facility, except Paragraph 17.2. CHAPTER VIII - PART 5 COMMUNITY RESIDENTIAL HOMES FOR PERSONS WITH DEVELOPMENTAL DISABILITIES Division DirectorColorado Department of Public Health And EnvironmentHealth Facilities Division4300 Cherry Creek Drive SouthDenver, Colorado 80222-1530 Main Switchboard:(303) 692-2000

Certified copies of material shall be provided by the Division, at cost, upon request 1 DEFINITION Definition: “Community residential home for persons with developmental disabilities” means a facility housing at least four and no more than eight persons, licensed by the state, where services and supports are provided to persons with developmental disabilities. 1.1 “Developmental disability” means a disability that is manifested before the person reaches twenty-two years of age, which constitutes a substantial disability to the affected individual, and is attributable to mental retardation, or related conditions which include cerebral palsy, epilepsy, autism, or other neurological conditions when such conditions result in the impairment of general intellectual functioning or adaptive behavior similar to that of a person with mental retardation. 2 GOVERNING BODY “Governing body” means the service agency or community centered board when acting as a service agency in which authority and responsibility are vested for the conduct of a community residential home. The governing body shall establish policies and procedures for the operation of such homes. The governing body shall appoint an administrator with the authority and responsibility for the implementation of policies and procedures in, and for the day to day management of, such community residential home. 2.1 LICENSE (a) In addition to meeting the requirements of this chapter VI II - part 5,a community residential home shall be licensed in accordance with the requirements specified in Chapter II. A community residential home shall also meet the requirements of the “Medication Administration Law,” 25-l-107(l)(ee) and the related rules in Chapter XXIV. A community residential home shall also verify to the Department that it has obtained approval from the Department of Human Services to provide services through the “Colorado Medical Assistance Act” governing the home and communitybased services program. Community residential homes shall be licensed biennially. (b) A community residential home shall demonstrate compliance with local codes prior to initial licensure and licensure renewal. In addition to local requirements there shall be a minimum distance between such homes of seven hundred and fifty (750) feet Evidence of such local compliance shall be submitted to the Department in the manner requested. 2.2 ADMISSIONS AND DISCHARGE (a) The governing body shall create policies and procedures for admission and discharge of residents. Such policies and procedures shall be consistent with state statutes governing resident rights, admission, and discharge, pursuant to article 10.5 of tide 27 of the Colorado Revised Statute. 2.3 CLOSURE OF A COMMUNITY RESIDENTIAL HOME (a) In the event of voluntary closure of a community residential home, such home shall notify the Department thirty (30) days prior to closure and submit a plan for resident transfer at that time. Such plan shall provide for transfers that protect the health and safety of the residents. (b) In the event of a denial, suspension, or revocation of the community residential home's license by the Department, the Department shall assist the Department of Human Services and the community residential home in the coordination of the relocation of the

residents. 3 RESIDENT RIGHTS 3.1 GENERAL RESIDENT RIGHTS The community residential home shall adhere to a policy on resident rights consistent with article 10.5 of title 27 and 2CCR 503-1 chapter 6of the Department of Human Services' Developmental Disabilities Services rules and regulations governing the rights of persons receiving services. The community residential home shall demonstrate, during any inspection by the Department, that appropriate measures have been taken to ensure all residents' rights are protected. In addition to the these standards, such policy on rights shall include the following: 3.2 CARE AND TREATMENT RIGHTS (a) The right to medical care and treatment pursuant to section 27-10.5-114 C.R.S. shall also include the right to be administered medications in a manner compliant with Chapter XXIV of the Department's regulations. In addition, each community residential home shall ensure the right of a person with developmental disabilities to be free from excessive medication. (b) A community residential home shall disclose, during any inspection by the Department, the safeguards provided to any resident participating in experimental, hazardous, or research treatment programs, when applicable. 3.3 OTHER RIGHTS (a) Every resident shall be entitled to care that is free from abuse and consistent with section 2710.5-115 C.R.S. (b) Every resident shall be entitled to communications and visits consistent with section 27-10.5117 C.R.S. This shall include the right to receive visitors in the community residential home in accordance with the reasonable rules of the home, and the right to privacy for such visits. (c) Every resident shall be entitled the right to personal property consistent with section 27-10.5121 C.R.S. 4 FIRE SAFETY AND ENVIRONMENTAL REQUIREMENTS 4.1 FIRE SAFETY (a) Existing community residential homes I) “Existing community residential home” means a community residential home licensed prior to the effective date of these regulations and lawfully constructed under local and state regulations governing such structures at the time of initial licensure. II) Existing community residential homes in compliance with existing building and fire safety regulations at the time of initial licensure and during any subsequent inspections may continue to utilize existing approved fire safety systems provided they remain in compliance, and there is ho change in evacuation status of a resident, nor a resident admission or discharge that alters the community residential home's overall fire safety rating, and provided no renovation of 25 percent or greater to the total interior of the physical plant is performed. If such a change, admission, discharge, or renovation occurs, the home shall be required

to meet the applicable standards contained in the references of part (b) of this section. (b) Initial licensure I) Applicants for initial licensure, or any community residential home undergoing a renovation of at least 25 percent or greater to the total interior of the physical plant, shall meet the applicable standards of the National Fire Protection Association 101. Life Safety Code. 1994, or The National Fire Protection Association 101a. Manual on Alternative Approaches to Life Safety. 1995, for board and care occupancies. (c) Portable fire extinguishers in new and existing community residential homes shall be the ABC type, and have a capacity of at least 3 pounds. 4.2 ENVIRONMENT AND MAINTENANCE REQUIREMENTS (a) The community residential home shall maintain a home-like environment. (b) The community residential home shall have furnishings in all living areas, including but not limited to the living room and dining a that meet the needs of the residents. Furnishings throughout the community residential home shall be kept in good repair. (c) Community residential homes admitting residents who use wheelchairs or other assistive technology shall have the necessary modifications to be accessible and safe for all residents. (d) Residents shall be allowed free use of all common living areas within the community residential home, with due regard for privacy, personal possessions, and safety of all residents. (e) Lighting, heat, and ventilation consistent with resident needs shall be provided in all living areas. (f) A sufficient supply of hot water shall be available for the peak demand of resident use. The water shall be kept at a temperature that protects the safety of the residents. (g) The community residential home shall be maintained free of infestations of insects and rodents and all openings to the outside shall be adequately screened. (h) The community residential home shall develop and implement procedures for handling soiled linen and clothing, storing personal care items, and general cleaning which minimize the spread of pathogenic organisms. The community residential home shall be kept free from offensive odors and accumulations of dirt and rubbish. (i) The community residential home shall ensure that each resident is furnished with personal hygiene and care items. (j) The community residential home interior, exterior, and grounds, shall be maintained safely and in good repair. Hazardous substances shall be labeled properly and stored safely. (k) Bed linens shall be changed as often as necessary, but in no case less than once a week Mattresses and pillows shall be of washable material and/or provided with a cover that can be removed and laundered.

(l) There shall be at least one full bathroom, containing shower or-bathtub, for each four residents. In community residential homes of more than one level there shall be no less than one toilet room on each level containing any resident bedroom. Each bathroom shall be equipped with liquid soap and paper towels and other items necessary for staff and resident sanitation. (m) Bathtubs and showers shall be equipped with handrails or handholds as needed. Such equipment shall be installed to meet the needs of all residents. Bathtub and shower floors shall have non-skid surfaces. 4.3 RESIDENT BEDROOMS (a) There shall be no more than two residents occupying a bedroom. Each resident shall occupy a regularly designated bedroom. (b) Bedrooms with two occupants shall be at least 120 square feet exclusive of space occupied by closets, vestibules, and toilet rooms. All bedrooms shall be of a size that accommodates the needs of the resident and any of his/her adaptive equipment. (c) Resident bedrooms shall contain furnishings that meet the needs of the resident. (d) Each bedroom shall contain storage adequate for the resident's clothing and personal articles. (e) The ground level outside of any basement resident bedroom shall be maintained at or below the window sill for a distance of at least eight feet measured out from the window. 5 PERSONNEL 5.1 STAFFING (a) The governing body shall employ staff who are qualified by education, training, and experience. The community residential home shall have staff on duty as necessary to meet the needs of all residents at all times, so that provision of residential services is not dependent upon the use of residents to perform staff functions. Volunteers may be utilized in the community residential home, but shall not be included in the home's staffing plan in lieu of employees. (b) The governing body shall have written personnel policies. Each staff member shall be provided a copy upon employment and the administrator shall explain such - policies during the initial staff orientation period. 5.2 TUBERCULIN TESTING (a) All staff and any volunteer providing direct resident care shall be tested for tuberculosis upon initial employment unless such person produces documentation of a Purified Protein Derivative (PPD) Mantoux test administered and read in the previous twelve (12) months. Such documentation shall give results including the measure of induration and be signed by a licensed physician or other licensed authorized practitioner. I) All staff unable to produce documentation of a test in the previous twelve (12) months shall undergo the 2-step method of PPD Mantoux tuberculin testing. This 2-step process shall be initiated prior to contact with the residents. II) In the event of a positive result of a PPD Mantoux test, evidence of a chest x-ray

and/or other appropriate follow-up shall be required. (b) All staff testing negative and having any contact with the residents or the community residential home shall be retested with the PPD Mantoux test for tuberculosis on an annual basis. The results of such tests, including the measure of induration, shall be maintained in a central registry in the community residential home's or the service agency's main office. 5.3 PERSONNEL TRAINING (a) The governing body shall establish and implement requirements for initial orientation and ongoing staff training of a scope that ensures all duties and responsibilities are carried out competently. Such requirements shall include but not be limited to: I) extent and type of orientation for all new employees prior to unsupervised contact with residents; II) job training specific to the needs of the residents for each staff person. Such training shall be related to the health, safety, and services for the resident Such training shall include, but not be limited to, resident rights, individual resident's care issues, abuse and neglect prevention, and the community residential home's policies and procedures to be completed in the first ninety (90) days of employment. III) all staff training and inservices shall be documented. (b) The administrator shall document that orientation and training in emergency procedures has been provided for each new staff member and each newly admitted resident capable of self-preservation. Training shall occur within seven (7) working days of employment or admission to the community residential home. 6 EMERGENCY PLANS AND PROCEDURES 6.1 EMERGENCY PLANS AND PROCEDURES (a) The governing body shall develop written emergency plans and procedures for fire, serious illness, severe weather, disruption of essential utility services, and missing persons. Such plans shall include but not be limited to: I) assignments of staff and residents to specific tasks and responsibilities; II) instruction relating to the use of alarm systems and signals; III) instruction on appropriate methods of fire containment; IV) plans for the overnight or short-term resettlement or relocation of residents; and V) procedures for notification of appropriate persons in emergencies. (b) Staff and residents shall have training on, and practices of, emergency plans and procedures, in addition to fire drills, at intervals throughout the year. All such practices and training shall be documented. Such documentation shall include any difficulties encountered and any needed adaptations to the plan. Such adaptations shall be implemented immediately upon identification.

6.2 First aid equipment shall be available on the premises in a readily accessible location and staff shall be instructed in its use. 7 DIETARY 7.1 GENERAL (a) All food shall be procured, stored, and prepared safely. At least a three day supply of food shall be available in the community residential home in case of an emergency. (b) Meals shall be planned in advance in a manner which incorporates resident involvement and provides a nutritionally adequate diet for all residents. (c) Meals shall vary daily and shall be adjusted for seasonal changes and holidays. (d) Residents shall have reasonable access to food supplies. (e) Staff support shall be assured to all residents who need assistance during meals. (f) Records of meals prepared including available options shall be kept by community residential home staff and shall be available for review for a period of thirty (30) days. (g) The community residential home shall provide for the special dietary needs of the residents. 7.2 SPECIAL DIETS (a) The prescription of therapeutic diets shall be documented and such information shall be made available to staff preparing meals. (b) The community residential home shall establish procedures for informing all staff, including volunteers and temporary staff, of any resident's food allergies and/or special dietary requirements. 8 MEDICATIONS AND MEDICAL SERVICES 8.1 MEDICATIONS. Unless otherwise specified, medications refers to all non-prescription (over the counter) and prescription drags as defined in 12-22-102 C.R.S. (a) The governing body shall establish, and the administrator shall implement, policies and procedures which ensure the appropriate procurement, storage, and administration of medications to include but not be limited to: I) administration and storage of medications, including the use of locked storage areas and refrigeration; II) documentation of medication administration to residents, including time and dosage given, documentation of staff administering, or medication refusal by resident; III) reporting medication errors and refusals to program or consulting nurse and/or physician; IV) administration and transport of medications to facilitate community integration and other activities such as day programs, vacation, and home visits; and V) the proper disposal and documentation of discontinued, out-dated, or expired

medications. (b) Unless self-administered by residents capable of self-administration, medications shall be administered only by qualified medication administration staff members. I) For residents who are independent in the administration of medications, the community residential home staff shall provide at least quarterly monitoring or review of medications to determine that medications are taken properly. (c) Medications shall be administered only upon the written order of a licensed physician or other licensed authorized practitioner. (d) Prescription medications shall be administered from containers or packages that are lawfully labeled. I) Any drug container or package having a damaged label shall be returned to the issuing pharmacy for relabeling. II) The contents of any drug container or package having no label, or with an illegible label, shall be immediately removed from use and destroyed. (e) Non-prescription (over the counter) medications administered to a resident shall meet the following conditions: I) the medication has been ordered by a physician or other licensed authorized practitioner; II) the medication is maintained in the original container; and III) the medication is labeled with a single resident's full name in a way that does not obscure the original label. (f) Non-prescription (over the counter) medications may be purchased by residents capable of self-administration. (g) Medications shall be reviewed annually or more frequently as necessary by the primary care physician or other licensed authorized practitioner designated to coordinate resident's care. (h) If authorized by the physician or other licensed authorized practitioner, medications belonging to a resident shall be given to his or her legal guardian, or to a qualified medication administration staff at the new residence at the time of discharge or transfer. Such authorization shall be documented in the resident's record 8.2 MEDICAL SERVICES (a) Prescribed medical services shall be provided. (b) Each resident shall have a primary care physician or other licensed authorized practitioner designated to coordinate resident's care. (c) Each resident shall be assisted in obtaining a dental examination at least annually. (d) Other medical, dental, and therapeutic assessments, services, and follow-up shall be obtained as the need for such services is identified by the physician or other authorized

practitioner. (e) The community residential home shall arrange for a medical evaluation by a physician or other licensed authorized practitioner of the resident annually unless a greater or lesser frequency is specified by the primary care physician or other licensed authorized practitioner designated to coordinate resident's care. If it is determined an annual evaluation is not needed, a medical evaluation shall be conducted no less frequently than every two (2) years. Results of such evaluations shall be documented and include any follow-up services required. (f) There shall be a record of any specialized care or treatment therapies prescribed by a physician or other authorized practitioner and carried out by community residential home staff. Such records shall include a list of staff members trained for such care. (g) All therapeutic and health services utilized by residents shall be provided by persons or facilities licensed, certified, or otherwise authorized by law to provide such services. (h) Residents who use wheelchairs or other assistive technology services shall receive professional reviews, at a prescribed or recommended frequency, to ensure the continued applicability and fitness of such devices. (i) Wheelchairs and other assistive technology devices shall be maintained in good repair. (j) Changes in resident's physical condition that could affect his/her health shall be reported to the program or consulting nurse and/or physician, or other licensed authorized practitioner. (k) The governing body shall develop, and the community residential home shall implement, a policy for monitoring each resident's weight, except all residents under 22 years of age shall have height and weight measurements every quarter. 9 RESIDENT RECORDS 9.1 INITIAL RECORD REQUIREMENTS (a) The following minimum information shall be recorded in the resident's program or medical record upon admission to the community residential home: I) name, previous address, and birth date; II) name, address, and phone number of legal guardian (if any), person to contact in an emergency; physician, dentist, and case manager; and III) special needs, allergies, and current medication. If a resident has an allergy to any substance, a notice shall be placed in a conspicuous place on the resident's record. (b) To the extent possible, the following shall also be obtained: I) the results of assessments conducted within the previous 12 months; II) all Individual Service and Support Plans (I.S.S.P.) developed within the previous 12 months; III) record of prescriptions of medications within the previous 12 months;

IV) dates and descriptions of illnesses, accidents, treatments thereof, and immunizations for the previous 12 months; V) summary of hospitalizations for the previous 12 months, to include recommendations for follow-up and treatment; and VI) any other information relevant to the health of the resident. 9.2 CONTINUING RECORD REQUIREMENTS (a) The community residential home shall maintain program and medical records for each resident which also contain the following: I) all information contained in subparagraph (a) and (b) of this section; II) a record of the use of the resident's funds, if such use is supervised by the administrator; III) Current Individualized Plan (I.P.) And Individual Service and Support Plans (I.S.S.P.); IV) current photo of resident; V) general physical characteristics; VI) general description of personality characteristics; VII) quarterly weight and height measurement of residents under twenty-two years of age; VIII) records of prescriptions ordered and medication administered in the previous twelve (12) months; and IX) when applicable, date, time, and circumstances of resident's death. (b) All entries in any resident record shall be dated and authenticated. Acceptable authentication shall be the staffs written signature, identifiable initials, computer key, or other appropriate technological means. (c) All records specifically required by these standards shall be made available to the Colorado Department of Public Health and Environment for purposes of enforcing these regulations. 9.3 MEDICAL RECORD RETENTION. Medical records are those records pertaining to the health status and related medical services and treatments of the resident. Such records do not include documents involving services and programs. (a) All medical records for adults (persons eighteen (18) years of age or older) shall be retained for no less than ten (10) years after the last date of service or discharge from the community residential home. All medical records for minors shall be retained after the last date of service or discharge from the community residential home for the period of minority plus ten (10) years. CHAPTER IX COMMUNITY CLINICS AND COMMUNITY CLINICS AND EMERGENCY CENTERS Policy Statement: The following regulations are the minimum standards necessary, to operate a

community clinic or a community clinic and emergency center. Facilities shall always operate by providing a level of care that meets the needs of the patients being served. This may necessitate standards that exceed the minimum. Patient populations vary widely and the minimum standard may not be enough to meet the needs of patients being served and those needs must still be met. SECTION 1 DEFINITIONS 1.1 Community Clinic or Community Clinic and Emergency Center. A “community clinic” or a “community clinic and emergency center” is defined as a comprehensive community-based medical facility which includes general or primary care services, preventive health services, diagnostic or therapeutic outpatient services, appropriate inpatient services, and/or emergent care services. The emergency center (emergency services available 24 hours) portion of the license shall be an optional component, and a community clinic may be licensed as a “community clinic” or as a “community clinic and emergency center.” A “community clinic” or a “community clinic and emergency center” includes accommodations for inpatient stays, unless otherwise exempted by statutory provisions or by a waiver of the requirement by the Department under section 10.1. A “community clinic” or a “community clinic and emergency center” may include general and primary care providers participating in the medically indigent program pursuant to article 15 of title 26. No waiver of inpatient accommodation requirements as required under section 10.1 of these regulations shall be necessary for medically indigent program providers who provide only primary care and other outpatient services during normal business hours. No waiver of inpatient accommodation requirements as required under section 10.1 Of the regulations shall be necessary for a community clinic or a community clinic and emergency center located within a licensed hospital, but not licensed as part of the hospital, and has an admission or transfer agreement with that hospital. 1.2 Emergency or Emergent Care. Emergency or emergent care is defined as treatment for a medical condition manifesting itself by acute symptoms of a sufficiently severe nature that are life, limb, or disability threats requiring immediate attention, where any delay in treatment could be reasonably expected to place the health of the individual in serious jeopardy, or seriously impair bodily functions, or cause serious dysfunction of any bodily organ or part. 1.3 Inpatient Care. For the purposes in Chapter IX of these regulations, “inpatient care” shall be defined as extended care or stay in the facility beyond the primary care or general services normally rendered which would include an overnight stay or a continuous period of care exceeding twenty-four (24) hours, but not to exceed 72 hours. 1.4 Primary Care. Primary care is defined as a practice that deals with the individual rather than an organ system or an abnormal physiology and provides an array of services covering the preventive, diagnostic, and therapeutic needs of patients, including referral and coordination of care to the services. 1.5 Exclusions. The term community clinic or a community clinic and emergency center does not include the following: (a) A facility that is licensed as part of or a department of a general hospital and is not freestanding; (b) A facility which is used as an office for the private practice of a physician(s) except when: l) it holds itself out to the public or other health care providers as a community clinic or a community clinic and emergency center or as a similar facility with a similar name or variation thereof which creates confusion in the mind of the public, indicating that it is capable of providing the same care as required by these regulations and or in fact provides the same level of care as required by these regulations, and in the case of an emergency center, of providing 24-hour emergency care; 2) it is operated or used by a person or entity different than the physician(s).

3) patients are charged a fee for the use of the facility in addition to the physician(s) professional fee. SECTION 2 LICENSE 2.1 A community clinic or a community clinic and emergency center shall be licensed and meet all of the licensure requirements in chapter II and the requirements of this Chapter IX of the Colorado Department of Public Health and Environment's Standards for Hospitals and Health Facilities. 2.2 A community clinic or a community clinic and emergency center shall be in compliance with all other applicable state, local, and federal laws. SECTION 3 ORGANIZATIONAL STRUCTURE 3.1 Governing Body. The community clinic or a community clinic and emergency center shall have a governing body which shall have responsibility for the oversight of the organization and the provider staff. The governing body shall meet as necessary. The governing body shall adopt the general bylaws or policies by which the community clinic or a community clinic and emergency center operates. These by3.2 Medical Director. The governing body of the community clinic or a community clinic and emergency center shall appoint a medical director for the facility. Such medical director shall be a physician, licensed under the laws of the state of Colorado, who is a member of the facility's staff. 3.3 Provider Staff. The community clinic or a community clinic and emergency center shall have an organized provider staff under the direction of the medical director that shall be responsible for the quality of medical care provided to patients in the facility. 3.4 Administrator. The governing body of the community clinic or a community clinic and emergency center shall appoint an administrator or a designated person who is principally responsible for directing the daily operation of the community clinic or a community clinic and emergency center. The administrator shall develop clear lines of authority and responsibility for the provider staff. The administrator, in conjunction with the provider staff, or a representative committee from the provider staff, shall develop policies and procedures for the operation of the facility. The policies and procedures shall be approved by the governing body and reviewed periodically and revised as needed. 3.5 Government Entities. A community clinic or a community clinic and emergency center wholly owned and operated by the state or any of its political subdivisions shall be governed, directed, administered, and staffed according to the statutory provisions establishing such facilities. 3.6 Corporate Health Care Entities or Health Care Networks. A community clinic or a community clinic and emergency center that is part of a larger, corporate health care system or health care network may fulfill the administrative record requirements, the policies and procedures requirements, and the medical records requirements of this Chapter IX through a central system common to the entire organization, providing that the intent of the requirements of this Chapter is met. SECTION 4 STAFFING 4.1 Provider Staff. There shall be adequate provider staff to meet the preventive, diagnostic, and therapeutic needs of the patient population being served. The provider staff shall participate in the quality management program; and, in coordination with the administrator/participate in the enforcement of policies and procedures or rules and regulations of the facility. If the facility is operating as an emergency center, at least one of the provider staff on duty at all times shall be qualified in basic cardiac life support and advanced cardiac life support. 4.2 Personnel. The administrator shall develop and maintain personnel policies and procedures.

Personnel employed by the community clinic or a community clinic and emergency center shall have qualifications as met by education, training, and experience necessary to meet the medical needs of the patients. Personnel shall be oriented and trained upon employment and kept abreast of new health care services developments and new technology through in-services and other educational programs. SECTION 5 MEDICAL RECORDS 5.1 All community clinics or community clinic and emergency centers shall maintain a clinical medical record system as established by the facility's written patient care policies. A designated member of the staff shall be responsible for maintaining medical records and for ensuring that they are completely and accurately documented. Medical records shall be systematically organized and easily accessible. All necessary precautions shall be taken to protect the confidentiality of the information contained within. 5.2 An individual medical record for each patient that receives services from any community clinic or a community clinic and emergency center shall contain, but not necessarily be limited to, the following: (a) identification and social data, evidence of consent forms, relevant medical history, assessment of the health status and health care needs of the patient, and a brief summary of the episode, disposition, and instructions to the patient per visit; (b) reports of physical examinations, diagnostic and laboratory test results, reports of x-rays, scans, and other radiological imaging studies, and consultative findings; (c) all physician's orders, reports of treatments and medications, and other information necessary to monitor the patient's progress; (d) signatures of the physician or other health care professionals making entries into the medical record. 5.2 Medical records for adults (persons 18 years of age or over) shall be retained for no less than 10 years after the last patient usage. Medical records for minors must be retained for the period of minority plus 10 years after the last patient usage. SECTION 6 SERVICE PROVISION 6.1 Care From Licensed Practitioner. The policies of the community clinic or community clinic and emergency center shall ensure that every patient is under the care of a physician or, if applicable, a physician assistant or advanced practice nurse with appropriate specialization and registered pursuant to 12-38-111.5. 6.2 Patient Care Policy. The facility shall have written patient care policies. The policies shall include but are not limited to the following: (a) a description of the services furnished directly and those furnished through agreements, arrangements with, or referrals to other facilities or other health care service providers; (b) protocols for the medical management of health problems, including the conditions requiring medical consultation and/or patient referral, the maintenance of health care records, and procedures for periodic review and evaluation of the services furnished by the facility; (1) protocols shall include: (A) a description of the scope of medical acts that may be undertaken by the physician assistant, or advanced practice nurse, or other provider staff under the supervision of a physician or other authorized licensed

practitioner; and (B) protocols to be followed for acts of medical diagnosis and treatment that may be undertaken without direct, over the shoulder physician supervision. (2) Protocols are not intended to mandate the development of practice guidelines for physicians or other licensed provider staff practicing in the facility. 6.3 Outpatient Surgery. Outpatient surgical procedures commonly performed in a physician's office may be performed in any community clinic or a community clinic and emergency center if adequate staffing, equipment, and supplies are available. SECTION 7 EMERGENCY SERVICES PROVISIONS 7.1 Services and Equipment. Emergency centers shall provide at a minimum the following services and equipment, both adult and pediatric as applicable: (a) an emergency call system; (b) oxygen; (c) ventilation assistance equipment, including airways, manual breathing bag; (d) continuous electrocardiogram monitoring with cardiac defibrillator; (e) intravenous therapy supplies; (f) laryngoscope and endotracheal tubes; (g) suction equipment; (h) indwelling urinary catheters; and (i) drugs and other emergency medical equipment and supplies, including basic obstetric supplies, necessary for the level of services to stabilize the patient as specified by the provider staff and by the specific needs of the community being served. 7.2 Triage Protocols. A community clinic or a community clinic and emergency center shall have in place emergency medical protocols to provide triage and stabilization procedures to be initiated by on-duty staff; and to provide air or ground transportation with pre-arranged destinations, including transfer agreements with a hospital(s). SECTION 8 ANCILLARY SERVICES 8.1 Obstetrics. A community clinic or a community clinic and emergency center may provide for routine pre-natal care and for necessary emergency obstetrical services according to emergency triage protocols of the facility. However, the facility shall not provide services for the routine delivery of newborn infants and care of obstetrical patients and newborn infants unless the facility can meet the requirements for a birthing center in Chapter XXII of the regulations. 8.2 Laboratory Services. Laboratory services essential to the treatment and diagnosis of the patient (both primary care and emergency patients) shall be available. Laboratory services shall be provided directly or by contract. Services provided directly shall be provided pursuant to the “Clinical Laboratory Improvement Amendments of 1988,” and the corresponding regulations (42 USC 263a and 42 CFR 493).

8.3 Radiological Services. Radiological services essential to the treatment and diagnosis of the patient shall be available. Radiological services shall be provided directly or by contract or plan. X-rays, films, scans, and other imaging records shall be maintained by the facility for a period of five years, if services are provided directly. Services provided directly shall be provided pursuant to the regulations of the Department of Public Health and Environment pertaining to radiation control (6 CCR 1007-1 ). 8.4 Pharmacy. Pharmaceutical methods, procedures, and controls which ensure the appropriation, acquisition, storage, dispensing, administration, and control of pharmaceuticals shall be developed in accordance with applicable state and federal laws regulating the practice of pharmacy. SECTION 9 AVAILABILITY OF SERVICES 9.1 The Community Clinic. The community clinic shall maintain regular hours for services. The community clinic shall provide an emergency referral number and/or a procedure for the provision of medical services when the clinic is not open for regular service. 9.2 The Community Clinic and Emergency Center. The community clinic and emergency center shall maintain operations on a 24-hour basis, every day of the year. If a community clinic and emergency center chooses to temporarily interrupt operations or access to services for any part of the 24-hour period, a means of making services available within 30 minutes or sooner if medically necessary shall be instituted. Any seasonal interruption in services, such as seasonal closures, shall be reported to the Department prior to such closure, and all signage that would indicate that services are available shall be removed. Protocols shall be developed by the medical director to establish appropriate response times for on-call staff for differing emergent situations that would present themselves at the facility. Clear directions at the front and/or emergency entrance to the facility that can be easily understood by persons approaching the emergency center shall be posted in a conspicuous location with an appropriate communications device, such as a “hot phone” or “tip and ring phone”, so that care can be summoned immediately and an appropriate response by the facility can be made. SECTION 10 INPATIENT SERVICES 10.1 Limited Stay. A community clinic or a community clinic and emergency center may provide inpatient services to ill or injured persons where a determination has been made that transportation to a hospital or other appropriate facility when a higher level of care is not immediately necessary provided that the needs of such patients can be met by the facility during a short stay not to exceed 72 hours. “Meeting the needs of patients” shall include appropriate provider staff consistent with the licensure requirements relating to such staff. (a) The Department may waive the requirement for inpatient services after a review of applicant materials for licensure provided that the facility demonstrates that it meets the definition of a facility under this Chapter IX of the regulations, with the exception of the inpatient component, and is not the private practice of an independent, licensed physician. (b) The 72-hour limit on inpatient stays shall not apply to the Department of Corrections providing medical services pursuant to article I of title 17. 10.2 Patient Care Unit. A community clinic or a community clinic and emergency center providing inpatient care shall establish and maintain a patient care unit. Each patient shall have a visible means of identification placed securely on his or her person until discharge. Each patient room shall have adequate space to meet the needs of the patient. In general, the standard shall be 100 square feet for each single patient room or 80 square feet per bed for multiple bedrooms and include sufficient illumination to meet patient needs for treatment. Each patient shall have direct access to a call system which signals the provider staff on duty. The facility shall provide patient bathing facilities for patients staying overnight. 10.3 Admissions. Any community clinic or a community clinic and emergency center providing inpatient

services shall develop admissions policies and procedures, which include but shall not be limited to appropriateness of admissions, and the necessary staffing to provide those services, (a) Necessary staffing includes the licensed staff with the ability to meet the needs of the patient and the regulatory requirements imposed by other state laws on the use of such licensed staff. 10.4 Nutrition. Dietary services shall be provided in the following manner: (a) Dietary or nutrition consultation shall be provided by a qualified person for routine dietary needs and on call consultation available for special dietary needs. (b) All food shall be pre-packaged and require microwave heating only and disposable products for preparation and service shall be used unless the facility meets the requirements of the Rules and Regulations Governing the Sanitation of Food Service Establishments in the State of Colorado, Colorado Department of Health. 1990 or the intent of such regulations as applicable and appropriate. (c) A person shall be assigned the responsibility for food preparation and service and shall have no other assigned duties during such assignment. (d) The food service area shall be an area separate from the employee lounge or other areas used by facility personnel or the public. (e) Food shall, at all times, be prepared, stored, and served properly so as to prevent the development and spread of food borne disease. (f) Catering and alternative methods of meal provision shall be allowed if patient needs and the intent of this part of the regulations are met. (g) There shall be food service available to serve adequate meals to patients “required to stay” in any community clinic or a community clinic and emergency center for more than six hours, if necessary or consistent with medical treatment or evaluation needed. Being “required to stay” is defined as a condition which requires the patient to stay in the facility for extended treatment or until transportation to another facility can be arranged. It does not apply to outpatient visits that may require extensive waiting before receiving services if the patient is able to leave after services are rendered or is able to reschedule a visit if service cannot be provided in a timely manner. 10.5 Discharge Planning. For those community clinics or community clinic and emergency centers that offer inpatient care, documentation of discharge and follow-up shall be included in the patient record to ensure the provision of post-discharge care. SECTION 11 INFECTION CONTROL 11.1 All community clinics or community clinic and emergency centers shall develop a plan for infection control that is adequate to avoid the sources of and prevent the transmission of infections and communicable diseases. The facility shall develop a system for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personnel. Sterilization procedures shall be developed and implemented in necessary service areas. SECTION 12 LIABILITY 12.1 Community clinics or community clinic and emergency centers shall submit evidence to the Colorado Department of Public Health and Environment that they maintain at least $300,000 professional

liability insurance per incident and $900,000 annual aggregate per year in order to demonstrate compliance with the Health Care Availability Act of 1988. SECTION 13 PHYSICAL PLANT AND ENVIRONMENT 13.1 The community clinic or and the community clinic and emergency center shall be constructed and maintained to ensure access to all patients and to ensure the safety of patients. (a) Life Safety Code. All community clinics or community clinics and emergency centers shall comply with the Life Safety Code, National Fire Protection Association 101, 1991 for new and existing ambulatory health care facilities. A community clinic or a community clinic and emergency center that is currently licensed and was lawfully constructed and found to be in compliance at the time of initial licensure and during any subsequent surveys may continue to utilize existing, approved life safety systems provided that they present no hazard to the life, health, and safety of patients. The community clinic or the community clinic and emergency center shall, in the event of any renovation to the facility of 50 percent or greater of the total interior of the physical plant, after the effective date of these regulations, comply with the requirements of the Life Safety Code, National Fire Protection Association 101, 1991. (1) Other Building Requirements. The community clinic or the community clinic and emergency center shall also demonstrate compliance with all other building and fire safety requirements of local governments and other state agencies, including but not limited to structural, mechanical, plumbing, and electrical requirements. (b) Pest Control. Policies shall be developed and procedures implemented for the effective control of insects, rodents, and other pests. (c) Waste disposal. All wastes shall be disposed in compliance with local, state and federal laws. (d) Preventive Maintenance. A preventive maintenance program to ensure that all essential mechanical, electrical and patient care equipment is maintained in safe operating condition shall be provided. Emergency systems, and all essential equipment and supplies shall be inspected and maintained on a frequent or as needed basis. (e) Housekeeping. Housekeeping services to ensure that the premises are clean and orderly at all times shall be provided and maintained. Appropriate janitorial storage shall be maintained. (f) Laundry and Linens. Laundry and linen services shall be provided by in-house staff or by contract. Separate clean and soiled linen areas shall be provided and maintained. Effective Date: August 1, 1994 CHAPTER X. REHABILITATION CENTERS Part 1. STATUTORY AUTHORITY AND APPLICABILITY 1.100 1.101 STATUTORY AUTHORITY (1) Authority to establish minimum standards through regulation and to administer and enforce such regulations is provided by Sections 25-1.5-103 and 25-3-101, C.R.S., et seq. 1.102 APPLICABILITY (1) All hospitals shall meet applicable federal and state statutes and regulations, including but not limited to:

(a) 6 CCR 1011-1, Chapter II. (b) This Chapter X. (c) Provisions of 6 CCR 1011-1, Chapter IV, General Hospitals, as referenced herein. (2) Contracted services shall meet the standards established herein. Part 2. GENERAL PROVISIONS 2.100 DEFINITIONS 2.101 GENERAL DEFINITIONS (1) “Department” means the Department of Public Health and Environment, unless the context dictates otherwise. (2) “Division” means the Health Facilities and Emergency Medical Services Division, unless the context dictates otherwise. (3) “Governing board” means the board of trustees, directors, or other governing body in whom the ultimate authority and responsibility for the conduct of the hospital is vested. (4) “General Hospital” means a hospital licensed pursuant to 6 CCR 1011-1, Chapter IV, General Hospitals. (5) “Occupational therapy” means a rehabilitation procedure guided by a qualified therapist who, under medical supervision, uses any purposeful activity to gain from the patient the desired physical function and/or mental response. (6) “Patient care unit” means a designated area of the hospital that provides a bedroom or a grouping of bedrooms with respective supporting facilities and services to provide adequate nursing care and clinical management of inpatients; and that is thereby planned, organized, operated, and maintained to function as a separate and distinct unit. (7) “Plan review” means the review by the Department, or its designee, of new construction or remodeling plans to ensure compliance by the facility with the National Fire Protection Association (NFPA) Life Safety Code and with this Chapter X. Plan review consists of the examination of new construction or remodeling plans and onsite inspections, where warranted. In reference to the National Fire Protection Association requirements, the Department is the authority having jurisdiction for state licensure. (8) “Rehabilitation center” means a facility that is intended to provide a community with a type of facility, licensed as a hospital, capable of rendering quality service to those patients not acutely ill and not requiring surgical, intensive, maternity, or extensive radiological or clinical laboratory services, on a direct admission thereto or as a secondary referral admission subject to the clinical judgment of attending physicians, and who may, therefore, receive a relatively high level of special medical and nursing care directed primarily to a rehabilitative or restorative process commensurate with the individual clinical diagnosis. In general, but subject to specific conditions governing a particular facility within a given community, it is intended that a Rehabilitation Center offer its services on the basis of a full spectrum of community need without singular identification with any specific age groups or economic status of patients served. (9) “Respiratory care” is that service which is organized to provide facilities, equipment, and personnel who are qualified by training, experience and ability to treat conditions caused by deficiencies or

abnormalities associated with respiration. 2.200 DEPARTMENT OVERSIGHT 2.201 GENERAL. Reserved. 2.202 LICENSURE FEES. Fees shall be submitted to the Department as specified below. (1) Initial License (when such initial licensure is not a change of ownership). A license applicant shall submit a nonrefundable fee with an application for licensure as follows: base fee of $5,700 and a per bed fee of $50. The initial licensure fee shall not exceed $10,500. (2) Renewal License . A license applicant shall submit a nonrefundable fee with an application for licensure as follows: base fee of $1,600 and a per bed fee of $12. The renewal fee shall not exceed $8,000. (3) Change of Ownership . A license applicant shall submit a nonrefundable fee of $2,500 with an application for licensure. (4) Provisional License . The license applicant may be issued a provisional license upon submittal of a nonrefundable fee of $2,500. If a provisional license is issued, the provisional license fee shall be in addition to the initial license fee. (5) Conditional License . A facility that is issued a conditional license by the Department shall submit a nonrefundable fee ranging from 10 to 25 percent of its applicable renewal fee. The percentage shall be determined by the Department. If the conditional license is issued concurrent with the initial or renewal license, the conditional license fee shall be in addition to the initial or renewal license fee. 2.203 PLAN REVIEW AND PLAN REVIEW FEES. Plan review and plan review fees are required as listed below in Sections (1) through (5), below. Fees are nonrefundable and shall be submitted prior to the Department initiating a plan review for a facility. (1) Initial Licensure . Applicable to applications for an initial license, when such initial license is not a change of ownership. This includes new facility construction and existing structures. The requirement for plan review and the fee applies to initial license applications submitted on or after May 15, 2008. Fee : see table below.

Square Footage 0-35,000

Cost per square foot $0.37

35,001-200,000

$0.03

200,001+

$0.01

Explanatory Note This is the cost for the first 35,000 sq ft of any plan submitted. This cost is applicable to the additional square footage over 35,000 and up to 200,000 sq ft. This cost is applicable to the additional square footage over 200,000 sq ft.

(2) New Construction . Applicable to new construction including replacement facilities, structural additions of any size and prefabricated structures. The requirement for plan review and the fee applies to construction for which the application for the building permit from the local authority having jurisdiction is dated on or after May 15, 2008. However, facilities for which the application for the building permit from the local authority having jurisdiction is dated prior to May 15, 2008 may request a partial plan review. The partial plan review is subject to a ten (10) to twenty-five (25) percent reduction of the fee, as determined by the Department, dependent on the phase of facility construction; except that the fee shall not be below the minimum fee established by this subsection. Fee : see table below. Minimum fee: $2,000.

Square Footage 0-35,000

Cost per square foot $0.37

35,001-200,000

$0.03

200,001+

$0.01

Explanatory Note This is the cost for the first 35,000 sq ft of any plan submitted. This cost is applicable to the additional square footage over 35,000 and up to 200,000 sq ft. This cost is applicable to the additional square footage over 200,000 sq ft.

(3) Remodeling – General . Applicable to relocation, removal or installation of walls resulting in 50% or more of a smoke compartment being reconfigured. The cost per square footage listed in the table below is to be assessed for the entire smoke compartment(s) being reconfigured. The requirement for plan review and the fee applies to construction for which the application for the building permit from the local authority having jurisdiction is dated on or after May 15, 2008. Fee : see table below. Minimum fee: $2,000.

Square Footage 0-35,000

Cost per square foot $0.25

35,001-200,000

$0.03

200,001+

$0.01

Explanatory note This is cost for the first 35,000 sq ft of any plan submitted. This cost is applicable to the additional square footage over 35,000 and up to 200,000 sq ft. This cost is applicable to the additional square footage over 200,000 sq ft.

(4) Remodeling – Egress Components . Applicable to the relocation, removal, or addition of any egress component, including but not limited to corridors, stairwells, exit enclosures, or points of refuge. (Widening of an egress component is not relocation.) The requirement for plan review and the fee applies to construction for which the application for the building permit from the local authority having jurisdiction is dated on or after May 15, 2008. Fee : $2,000. However, if these renovations are part of the smoke compartment reconfiguration subject to the fee listed in Section 2.203 (3), the fee in this Section 2.203 (4) shall not apply.

(5) Remodeling – Specific Systems . Applicable to significant modifications to the following systems: fire sprinkler, fire alarm, medical gas, kitchen exhaust/suppression system, and essential electrical system. The requirement for plan review and the fee applies to significant modifications where construction is initiated on or after July 1, 2008. For the purposes of this subsection 2.203 (5), construction of significant modifications is deemed initiated when there is an alteration associated with the remodeling to an existing structure that results in a physical change. Fee : $2,000 for up to four smoke compartments, plus $500 for each additional compartment. However, if these renovations are part of the smoke compartment reconfiguration subject to the fee listed in Section 2.203 (3), the fee in this Section 2.203 (5) shall not apply. Significant modifications include: (a) Fire sprinkler: 100 or more sprinklers. Notwithstanding the other provisions in this Section 2.203 (5), the extension of a sprinkler system involving the installation of 25 to 99 sprinkler heads for an area previously unsprinklered is subject to a partial plan review consisting of the review of the remodeling plans and a fee of $500. (b) Fire alarm: any modification to the fire alarm system that involves the replacement of the main fire alarm control unit (panel). (c) Medical gas: modifications that affect 50% or more of a smoke compartment. (d) Kitchen exhaust/suppression system: replacement of the suppression or hood exhaust/duct system. (e) Essential electrical system: replacement or addition of a generator or transfer switch. Part 3. GOVERNING BOARD. The facility shall have a governing board in conformance with the standards established in Chapter IV, Part 3, Governing Board. Part 4. ADMINISTRATIVE OFFICER. The facility shall have an administrative officer in conformance with the standards established in Chapter IV, Part 4, Administrative Officer. Part 5. MEDICAL STAFF. The facility shall have medical staff in conformance with the standards established in Chapter IV, Part 5, Medical Staff. In addition, the Chief of Staff shall have training and expertise in rehabilitation medicine. The qualifications of the medical staff shall meet the needs of the patients in accordance with the scope of services provided by the facility. Part 6. NURSING DEPARTMENT. The facility shall have a nursing department in conformance with the standards established in Chapter IV, Part 6, Nursing Department. Part 7. PERSONNEL. The facility shall be in conformance with the standards established in Chapter IV, Part 7, Personnel. Part 8. MEDICAL RECORDS DEPARTMENT. The facility shall have a medical records department in conformance with the standards established in Chapter IV, Part 8, Medical Records Department.

Part 9. ANESTHESIA SERVICES. The facility may provide anesthesia services. If such services are provided, they shall be in conformance with the standards established in Chapter IV, Part 9, Anesthesia Services. Part 10.

LABORATORY SERVICES.

The facility shall provide laboratory services in conformance with the standards established in Chapter IV, Part 10, Laboratory Services. Part 11. Reserved. Part 12. DIETARY SERVICES. The facility shall provide services in conformance with the standards established in Chapter IV, Part 12, Dietary Services. Part 13.

EMERGENCY SERVICES

13.100 13.101 ORGANIZATION AND STAFFING (1) Each rehabilitation center shall be organized and equipped to provide emergency treatment to patients who have been admitted to the facility. (2) Provision shall be made for medical staff coverage at any hour. (3) A roster of physicians on call, including physicians on second call, shall be posted, together with methods whereby specialized medical services may be obtained. 13.102 PROGRAMMATIC FUNCTIONS (1) Policies and procedures for staff action in the event of an emergency shall be developed by the medical staff and incorporated in a manual for staff use. (2) The facility shall establish a transfer agreement with a general hospital to provide patients with a higher level of care when needed. 13.103 EQUIPMENT AND SUPPLIES (1) Emergency equipment, supplies and medications shall be provided commensurate with the scope of emergency services as specified in the written policies and procedures. 13.104 FACILITIES. Reserved. Part 14. OUTPATIENT SERVICES 14.100 14.101 ORGANIZATION AND STAFFING (1) The hospital may provide outpatient services. Where outpatient services are provided, the type and quantity of facilities shall be such as to provide safe, prompt service to the number and types of patients served.

(2) The privilege of physicians and dentists in the outpatient service shall be defined in terms of their training and ability, in the same manner as their privilege in the inpatient services. (3) There shall be sufficient qualified registered nurses and other nursing personnel to render adequate nursing service to patients. 14.102 PROGRAMMATIC FUNCTIONS. Reserved. 14.103 EQUIPMENT AND SUPPLIES. Reserved. 14.104 FACILITIES. Reserved. Part 15. INFECTION CONTROL SERVICES. The facility shall provide services in conformance with the standards established in Chapter IV, Part 15, Infection Control Services. Part 16. RESPIRATORY CARE SERVICES. The facility may provide respiratory care services. If such services are provided, they shall be in conformance with the standards established in Chapter IV, Part 16, Respiratory Care Services. Part 17. SOCIAL AND PSYCHOLOGICAL SERVICES 17.100 17.101 ORGANIZATION AND STAFFING (1) Psychological services shall be available, by persons qualified by training, experience and ability, to patients who need this service. (2) Social services shall be provided by persons qualified by training, experience and ability. 17.102 PROGRAMMATIC FUNCTIONS. Reserved. 17.103 EQUIPMENT AND SUPPLIES. Reserved. 17.104 FACILITIES (1) Office and work space for psychological testing, evaluation and counseling shall be provided. (2) Social services office space for private interview and counseling shall be provided. Part 18. REHABILITATION THERAPIES & SERVICES 18.100 OCCUPATIONAL THERAPY 18.101 ORGANIZATION AND STAFFING (1) The occupational therapy services shall be under direction of a physician who is licensed to practice medicine in the State of Colorado, preferably a diplomate of the American Board of Physical Medicine and Rehabilitation. However, nothing in this Section 18.101 (1) shall preclude the facility from having one medical director who is responsible for all rehabilitation therapies and services. 18.102 PROGRAMMATIC FUNCTIONS

(1) There shall be written policies for the occupational therapy services which are determined jointly by the physician and the rehabilitation center administrator. There shall be evidence that these policies are reviewed and revised at regular intervals. 18.103 EQUIPMENT AND SUPPLIES (1) There shall be adequate and appropriate equipment and supplies as determined by the professional staff to meet the requirements for care and treatment of patients. 18.104 FACILITIES (1) The occupational therapy services shall be located in an area convenient for all patients. (2) The occupational therapy area shall have a reception area, an examining room, treatment area, separate toilet and lavatory facilities for patients and staff, and storage areas. (3) There shall be adequate space in the reception area to accommodate ambulatory and wheel chair patients. (4) The following specific evaluation and treatment facilities must be provided by all rehabilitation centers: Occupational Therapy. (1) Office and work space for occupational therapy staff; (2) Therapy area; (3) Storage space for supplies and equipment. (5) Facilities for teaching activities of daily living. 18.200 PHYSICAL THERAPY 18.201 ORGANIZATION AND STAFFING (1) Physical therapy services shall be under the direction of a physician who is licensed to practice medicine in the State of Colorado, who has a particular interest in physical medicine, and who preferably is a diplomate of the American Board of Physical Medicine and Rehabilitation. However, nothing in this Section 18.201 (1) shall preclude the facility from having one medical director who is responsible for all rehabilitation therapies and services. (2) Physical therapy shall be rendered only by a physical therapist licensed to practice in the State of Colorado. All personnel assisting with the physical therapy of patients must be under the direct supervision of physical therapists at all times. 18.202 PROGRAMMATIC FUNCTIONS (1) There shall be written policies for the physical therapy services which are developed jointly by the physician and the chief physical therapist and approved by the rehabilitation center administrator. There shall be evidence that these policies are reviewed and revised at regular intervals. (2) Prosthetic and orthotic services may be provided either within the rehabilitation center or through arrangements with a qualified facility. The program may be worked out in cooperation with other health facilities of the area and with official and nonofficial agencies concerned. This program should include the possibility of disaster involving loss of the rehabilitation center or serious impairment of its facilities. 18.203 EQUIPMENT AND SUPPLIES (1) There shall be adequate and appropriate equipment and supplies as determined by the professional staff to meet the requirements for care and treatment of patients.

18.204 FACILITIES (1) The physical therapy services shall be located in an area convenient for all patients. (2) The physical therapy area shall have a reception area, an examining room, treatment area, separate toilet and lavatory facilities for patients and staff and storage areas. (3) There shall be adequate space in the reception area to accommodate ambulatory, stretcher and wheel chair patients. (4) The following specific evaluation and treatment facilities must be provided by all rehabilitation centers: Physical Therapy. (1) Office and work space for physical therapy staff; (2) Rehabilitation gymnasium; (3) Physical therapy treatment area; (4) Storage for supplies and equipment; (5) Outdoor exercise area (desirable but not mandatory). (5) If orthotic and prosthetic devices are provided within the facility, space shall be provided, for fitting and adjustment services for prosthetic and orthotic devices. 18.300 SPEECH THERAPY 18.301 ORGANIZATION AND STAFFING (1) Speech therapy services shall be provided by persons qualified by training, experience and ability. 18.302 PROGRAMMATIC FUNCTIONS. Reserved. 18.303 EQUIPMENT AND SUPPLIES (1) Suitable equipment and supplies for speech therapy shall be provided either within the facility or through arrangements with existing community services. (2) Suitable equipment for audiometric and other sensory testing and evaluation shall be provided either within the facility or through arrangements with existing community facilities. 18.304 FACILITIES (1) Suitable space for speech therapy shall be provided either within the facility or through arrangements with existing community services. 18.400 VOCATIONAL COUNSELING 18.401 ORGANIZATION AND STAFFING (1) Vocational services shall be provided by persons qualified by training, experience and ability. 18.402 PROGRAMMATIC FUNCTIONS. Reserved. 18.403 EQUIPMENT AND SUPPLIES. Reserved. 18.404 FACILITIES (1) Office space for vocational counseling and evaluations shall be provided. Part 19. GENERAL PATIENT CARE SERVICES.

The facility shall provide services in conformance with the standards established in Chapter IV, Part 19, General Patient Care Services. Part 20. PEDIATRIC PATIENT CARE SERVICES. The facility may provide pediatric patient care services. If such services are provided, they shall be in conformance with the standards established in Chapter IV, Part 20, Pediatric Patient Care Services. Part 21. PHARMACEUTICAL SERVICES. The facility shall provide pharmaceutical services in conformance with the standards established in Chapter IV, Part 21, Pharmaceutical Services. Part 22. Reserved. Part 23. Reserved. Part 24. DIAGNOSTIC IMAGING SERVICES. The facility shall provide diagnostic imaging services in conformance with the standards established in Chapter IV, Part 24, Diagnostic Imaging Services. Part 25. Reserved. Part 26. CENTRAL MEDICAL-SURGICAL SUPPLY SERVICES. The facility shall provide services in conformance with the standards established in Chapter IV, Part 26, Central Medical-Surgical Supply Services. Part 27. HOUSEKEEPING SERVICES. The facility shall provide services in conformance with the standards established in Chapter IV, Part 27, Housekeeping Services. Part 28. LINEN AND LAUNDRY SERVICES. The facility shall provide services in conformance with the standards established in Chapter IV, Part 28, Linen and Laundry Services. Part 29. MAINTENANCE SERVICES. The facility shall provide services in conformance with the standards established in Chapter IV, Part 29, Maintenance Services Part 30. WASTE DISPOSAL SERVICES. The facility shall provide services in conformance with the standards established in Chapter IV, Part 30, Waste Disposal Services. Part 31. PHYSICAL PLANT. The facility shall be in conformance with the standards established in Chapter IV, Part 31, Physical Plant. This Part 31 incorporates by reference, the National Fire Protection Association (NFPA) 101, Life Safety Code (2000). Such incorporation by reference, as provided for in 6 CCR 1011-1, Chapter II, excludes later amendments to or editions of the referenced material. In addition, the architectural design must

provide for easy, independent access to all areas of the facility by handicapped persons. Appropriate ramps, rails, and elevators must be provided. CHAPTER XI CONVALESCENT CENTERS Convalescent Center. Convalescent center means a health facility planned, organized, operated, and maintained to offer facilities and services to inpatients requiring restorative care and treatment, and that is either an integral patient care unit of a general hospital or a facility physically separated from, but maintaining an affiliation with, all services in a general hospital. Convalescence is considered to be period of recovery after injury or illness, either mental or physical, and/or following excessive strain on psychological process which produce exhaustion or fatigue. It is a gradual process which may be interrupted by relapses or for necessary therapy. In some cases the recovery may be only partial, but in any event, important mental and physical improvements in the patient, regardless of the injury or disease, is required criterion of convalescence. Thus a license for a Convalescence Center will be used only when a facility demonstrates that their services and condition of patients are such that there is some promise of full or partial recovery to a former state of well-being and that the facility has arrangements and programs to promote this return. 1.1 LICENSE. All Convalescent Centers shall be licensed in accordance with the requirements specified in Chapter II. 1.2 APPLICABILITY OF OTHER SECTIONS. Convalescent Centers shall conform to all applicable sections of chapter IV, General Hospital, with regard to area and operational requirements, environmental sanitation, physical plant maintenance, safety, food service, and patient care units. 1.3 FACILITIES AND SERVICES. The facilities and services shall include provision for prompt transfer of patients between the General Hospital and the Convalescent Center, utilization of the General Hospital's diagnostic and treatment facilities, and sharing of knowledge and skills between personnel in the General Hospital and Convalescent Center. 1.4 INTEGRATION WITH GENERAL HOSPITAL. When the Convalescent Center and the General Hospital have separate and distinct governing boards or authorities, an integrated affiliation shall be established by written agreement. 1.5 WRITTEN AGREEMENT. The written agreement shall include names of the owner or corporate officers authorized to sign the agreement, and accurate, clear statements which reflect that the operations provide: 1) Continuity and evaluation of patient care; 2) Emergency care of patients; 3) Administrative and medical staff organization and integration; 4) Review and appraisal of the quality and appropriateness of medical care including the frequency with which patients are to be seen by their physicians; and 5) Procedural policies. CHAPTER XII CHIROPRACTIC CENTERS 1. LICENSE. All Chiropractic Centers shall be licensed in accordance with requirements specified in Chapter II. 2. APPLICABILITY OF OTHER SECTIONS. Chiropractic Centers shall conform to all applicable sections of chapter IV, General Hospitals, with regard to area and operational requirements, environmental sanitation, physical plant maintenance, safety, food service and patient care units. 3. SURGERY AND OBSTETRICS. There shall be neither surgical nor delivery suites. Neither surgery nor obstetrics shall be performed. 4. DRUGS AND MEDICATIONS. Neither drugs nor medications shall be administered by persons under

conditions prohibited by law. 5. CHIROPRACTIC STAFF. The chiropractic staff shall consist of chiropractors licensed under the Chiropractic Practice Act in the State of Colorado. 6. PATIENT CARE SERVICES. All patient care services shall be provided by an adequate staff. CHAPTER XIV MATERNITY HOSPITALS Part 1. STATUTORY AUTHORITY AND APPLICABILITY 1.100 1.101 STATUTORY AUTHORITY (1) Authority to establish minimum standards through regulation and to administer and enforce such regulations is provided by Sections 25-1.5-103 and 25-3-101, C.R.S., et seq. 1.102 Applicability (1) All hospitals shall meet applicable federal and state statutes and regulations, including but not limited to: (a) 6 CCR 1011-1, Chapter II. (b) This Chapter XIV. (c) Provisions of 6 CCR 1011-1, Chapter IV, General Hospitals, as referenced herein. (2) Contracted services shall meet the standards established herein. Part 2. GENERAL PROVISIONS 2.100 DEFINITIONS 2.101 GENERAL DEFINITIONS (1) “Department” means the Department of Public Health and Environment, unless the context dictates otherwise. (2) “General hospital” means a hospital licensed pursuant to 6 CCR 1011-1, Chapter IV, General Hospitals. (3) “Governing board” means the board of trustees, directors, or other governing body in whom the ultimate authority and responsibility for the conduct of the hospital is vested. (4) “Patient care unit” means a designated area of the hospital that provides a bedroom or a grouping of bedrooms with respective supporting facilities and services to provide adequate nursing care and clinical management of inpatients; and that is thereby planned, organized, operated, and maintained to function as a separate and distinct unit. (5) “Maternity hospital” means a health facility planned, operated, and maintained to offer medical and nursing facilities, beds, and services over a continuous period exceeding 24 hours to women requiring care before, during, and recovery from obstetric delivery. Provision shall be made, by agreement with a General Hospital, or within the facility, for a clinical laboratory, diagnostic X-ray,

treatment facilities for emergency, surgery, and definitive medical treatment under an organized medical staff. (6) “Plan review” means the review by the Department, or its designee, of new construction or remodeling plans to ensure compliance by the facility with the National Fire Protection Association (NFPA) Life Safety Code and with this Chapter XIV. Plan review consists of the examination of new construction or remodeling plans and onsite inspections, where warranted. In reference to the National Fire Protection Association requirements, the Department is the authority having jurisdiction for state licensure. 2.200 DEPARTMENT OVERSIGHT 2.201 GENERAL. Reserved. 2.202 LICENSURE FEES. Fees shall be submitted to the Department as specified below. (1) Initial License (when such initial licensure is not a change of ownership). A license applicant shall submit a nonrefundable fee with an application for licensure as follows: base fee of $5,700 and a per bed fee of $50. The initial licensure fee shall not exceed $10,500. (2) Renewal License . A license applicant shall submit a nonrefundable fee with an application for licensure as follows: base fee of $1,600 and a per bed fee of $12. The renewal fee shall not exceed $8,000. (3) Change of Ownership . A license applicant shall submit a nonrefundable fee of $2,500 with an application for licensure. (4) Provisional License . The license applicant may be issued a provisional license upon submittal of a nonrefundable fee of $2,500. If a provisional license is issued, the provisional license fee shall be in addition to the initial license fee. (5) Conditional License . A facility that is issued a conditional license by the Department shall submit a nonrefundable fee ranging from 10 to 25 percent of its applicable renewal fee. The percentage shall be determined by the Department. If the conditional license is issued concurrent with the initial or renewal license, the conditional license fee shall be in addition to the initial or renewal license fee. 2.203 PLAN REVIEW AND PLAN REVIEW FEES. Plan review and plan review fees are required as listed below in sections (1) through (5). Fees are nonrefundable and shall be submitted prior to the Department initiating a plan review for a facility. (1) Initial Licensure . Applicable to applications for an initial license, when such initial license is not a change of ownership. This includes new facility construction and existing structures. The requirement for plan review and the fee applies to initial license applications submitted on or after May 15, 2008. Fee : see table below.

Square Footage 0-35,000

Cost per square foot $0.37

35,001-200,000

$0.03

Explanatory Note This is the cost for the first 35,000 sq ft of any plan submitted. This cost is applicable to the additional square footage over 35,000 and up to 200,000 sq ft.

200,001+

$0.01

This cost is applicable to the additional square footage over 200,000 sq ft.

(2) New Construction . Applicable to new construction including replacement facilities, structural additions of any size and prefabricated structures. The requirement for plan review and the fee applies to construction for which the application for the building permit from the local authority having jurisdiction is dated on or after May 15, 2008. However, facilities for which the application for the building permit from the local authority having jurisdiction is dated prior to May 15, 2008 may request a partial plan review. The partial plan review is subject to a ten (10) to twenty-five (25) percent reduction of the fee, as determined by the Department, dependent on the phase of facility construction; except that the fee shall not be below the minimum fee established by this subsection. Fee : see table below. Minimum fee: $2,000.

Square Footage 0-35,000

Cost per square foot $0.37

35,001-200,000

$0.03

200,001+

$0.01

Explanatory Note This is the cost for the first 35,000 sq ft of any plan submitted. This cost is applicable to the additional square footage over 35,000 and up to 200,000 sq ft. This cost is applicable to the additional square footage over 200,000 sq ft.

(3) Remodeling – General . Applicable to relocation, removal or installation of walls resulting in 50% or more of a smoke compartment being reconfigured. The cost per square footage listed in the table below is to be assessed for the entire smoke compartment(s) being reconfigured. The requirement for plan review and the fee applies to construction for which the application for the building permit from the local authority having jurisdiction is dated on or after May 15, 2008. Fee : see table below. Minimum fee: $2,000.

Square Footage 0-35,000

Cost per square foot $0.25

35,001-200,000

$0.03

200,001+

$0.01

Explanatory note This is cost for the first 35,000 sq ft of any plan submitted. This cost is applicable to the additional square footage over 35,000 and up to 200,000 sq ft. This cost is applicable to the additional square footage over 200,000 sq ft.

(4) Remodeling – Egress Components . Applicable to the relocation, removal, or addition of any egress component, including but not limited to corridors, stairwells, exit enclosures, or points of refuge. (Widening of an egress component is not relocation.) The requirement for plan review and the fee applies to construction for which the application for the building permit from the local authority having jurisdiction is dated on or after May 15, 2008. Fee : $2,000. However, if these renovations are part of the smoke compartment reconfiguration subject to the fee listed in Section 2.203 (3), the fee in this Section 2.203 (4) shall not apply. (5) Remodeling – Specific Systems . Applicable to significant modifications to the following systems: fire sprinkler, fire alarm, medical gas, kitchen exhaust/suppression system, and essential electrical system. The requirement for plan review and the fee applies to significant modifications where construction is initiated on or after July 1, 2008. For the purposes of this subsection 2.203 (5), construction of significant modifications is deemed initiated when there is an alteration associated with the remodeling to an existing structure that results in a physical change. Fee : $2,000 for up to four smoke compartments, plus $500 for each additional compartment. However, if these renovations are part of the smoke compartment reconfiguration subject to the fee listed in Section 2.203 (3), the fee in this Section 2.203 (5) shall not apply. Significant modifications include: (a) Fire sprinkler: 100 or more sprinklers. Notwithstanding the other provisions in this Section 2.203 (5), the extension of a sprinkler system involving the installation of 25 to 99 sprinkler heads for an area previously unsprinklered is subject to a partial plan review consisting of the review of the remodeling plans and a fee of $500. (b) Fire alarm: any modification to the fire alarm system that involves the replacement of the main fire alarm control unit (panel). (c) Medical gas: modifications that affect 50% or more of a smoke compartment. (d) Kitchen exhaust/suppression system: replacement of the suppression or hood exhaust/duct system. (e) Essential electrical system: replacement or addition of a generator or transfer switch. Part 3. GOVERNING BOARD. The facility shall have a governing board in conformance with the standards established in Chapter IV, Part 3, Governing Board. Part 4. ADMINISTRATIVE OFFICER. The facility shall have an administrative officer in conformance with the standards established in Chapter IV, Part 4, Administrative Officer. Part 5. MEDICAL STAFF. The facility shall have medical staff in conformance with Chapter IV, Part 5, Medical Staff. In addition, the Chief of Staff shall be board certified in obstetrics and gynecology. The qualifications of the medical staff shall meet the needs of the patients in accordance with the scope of services provided by the facility. Part 6. NURSING DEPARTMENT. The facility shall have nursing staff in conformance with the standards established in Chapter IV, Part 6, Nursing Department. The qualifications of the nursing staff shall meet the needs of the patients in accordance with the scope of services provided by the facility.

Part 7. PERSONNEL. The facility shall be in conformance with Chapter IV, Part 7, Personnel. Part 8. MEDICAL RECORDS DEPARTMENT. The facility shall have a medical records department in conformance with the standards established in Chapter IV, Part 8, Medical Records Department. Part 9. ANESTHESIA SERVICES. The facility shall provide anesthesia services in conformance with the standards established in Chapter IV, Part 9, Anesthesia Services. Part 10. LABORATORY SERVICES. The facility shall provide laboratory services in conformance with the standards established in Chapter IV, Part 10, Laboratory Services. Part 11. PREGNANCY, LABOR AND DELIVERY, AND NURSERY. The facility shall provide pregnancy, labor and delivery, and nursery services. Such services shall be in conformance with the standards established in Chapter IV, Part 11, Pregnancy, Labor and Delivery. Part 12. DIETARY SERVICES. The facility shall provide dietary services in conformance with the standards established in Chapter IV, Part 12, Dietary Services. Part 13. EMERGENCY SERVICES 13.100 13.101 ORGANIZATION AND STAFFING (1) Each facility shall be organized and equipped to provide emergency treatment to patients who have been admitted to the facility. (2) Provision shall be made for medical staff coverage at any hour. (3) A roster of physicians on call, including physicians on second call, shall be posted, together with methods whereby specialized medical services may be obtained. 13.102 PROGRAMMATIC FUNCTIONS (1) Policies and procedures for staff action in the event of an emergency shall be developed by the medical staff and incorporated in a manual for staff use. (2) The facility shall establish a transfer agreement with a general hospital to provide patients with a higher level of care when needed. 13.103 EQUIPMENT AND SUPPLIES (1) Emergency equipment, supplies and medications shall be provided commensurate with the scope of emergency services as specified in the written policies and procedures.

13.104 FACILITIES. Reserved. Part 14. OUTPATIENT SERVICES. The facility may provide outpatient services in conformance with the standards established in Chapter IV, Part 14, Outpatient Services. Part 15. INFECTION CONTROL SERVICES. The facility shall provide infection control services in conformance with the standards established in Chapter IV, Part 15, Infection Control Services. Part 16. SOCIAL SERVICES 16.100 16.101 ORGANIZATION AND STAFFING (1) The facility shall provide appropriate social services to patients and families and consultation to the staff. (2) The social services may be provided by: (a) A qualified social worker employed full or part time by the facility; (b) Contract with a recognized agency for the provision of social services by, or under the supervision of, a qualified social worker to include some combination of direct service to patients and/or families and consultation to personnel of the facility; 16.102 PROGRAMMATIC FUNCTIONS. Reserved. 16.103 EQUIPMENT AND SUPPLIES. Reserved. 16.104 FACILITIES. Reserved. Part 17. CRITICAL CARE SERVICES. The facility may provide critical care services. If the facility provides critical services, such services shall be in conformance with the standards established in Chapter IV, Part 17, Critical Care Services. Part 18. Reserved. Part 19. GENERAL PATIENT CARE SERVICES. The facility shall provide patient care services in conformance with the standards established in Chapter IV, Part 19, General Patient Care Services. Part 20. Reserved. Part 21. PHARMACEUTICAL SERVICES. The facility shall provide pharmaceutical services in conformance with the standards established in Chapter IV, Part 21, Pharmaceutical Services. Part 22. Reserved.

Part 23. SURGICAL AND RECOVERY SERVICES. The facility shall provide surgical and recovery services in conformance with the standards established in Chapter IV, Part 23, Surgical and Recovery Services. Part 24. DIAGNOSTIC IMAGING SERVICES. The facility shall provide diagnostic imaging services in conformance with the standards established in Chapter IV, Part 24, Diagnostic Imaging Services. Part 25. Reserved. Part 26. CENTRAL MEDICAL-SURGICAL SUPPLY SERVICES. The facility shall provide medical-surgical supply services in conformance with the standards established in Chapter IV, Part 26, Central Medical-Surgical Supply Services. Part 27. HOUSEKEEPING SERVICES. The facility shall provide housekeeping services in conformance with the standards established in Chapter IV, Part 27, Housekeeping Services. Part 28. LINEN AND LAUNDRY SERVICES. The facility shall provide linen and laundry services in conformance with the standards established in Chapter IV, Part 28, Linen and Laundry Services. Part 29. MAINTENANCE SERVICES. The facility shall provide maintenance services in conformance with the standards established in Chapter IV, Part 29, Maintenance Services. Part 30. WASTE DISPOSAL SERVICES. The facility shall provide waste disposal services in conformance with the standards established in Chapter IV, Part 30, Waste Disposal Services. Part 31. PHYSICAL PLANT. The facility shall be in conformance with the standards established in Chapter IV, Part 31, Physical Plant. This part incorporates by reference, the National Fire Protection Association (NFPA) 101, Life Safety Code (2000). Such incorporation by reference, as provided for in 6 CCR 1011-1, Chapter II, excludes later amendments to or editions of the referenced material. CHAPTER XV DIALYSIS TREATMENT CLINIC Section 1 – Statutory Authority and Applicability 1.1 The statutory authority for the promulgation of these rules is set forth in Sections 25-1.5-103, 25-1.5108, and 25-3-101, et seq., C.R.S. 1.2 A dialysis treatment clinic, as defined herein, shall comply with all applicable federal and state statutes and regulations, including but not limited to, the following: (A) This Chapter XV.

(B) 6 CCR 1011-1, Chapter II, General Licensure Standards, including Part 7, Single Use Disposable Medical Devices. Section 2 – Definitions 2.1 Department – The Colorado Department of Public Health and Environment, unless the context dictates otherwise. 2.2 Dialysis Treatment Clinic – A health facility or a department or unit of a licensed hospital that is planned, organized, operated and maintained to provide outpatient treatment to, or hemodialysis training for home use of hemodialysis equipment by, end-stage renal disease patients. 2.3 End-Stage Renal Disease – The stage of renal impairment that appears irreversible and permanent and that requires a regular course of dialysis or a kidney transplant to maintain life. 2.4 General Hospital – A facility licensed pursuant to 6 CCR 1011-1, Chapter IV, General Hospitals, that provides 24-hours per day, seven days per week inpatient services, emergency medical and surgical care, continuous nursing services, and necessary ancillary services to individuals for the diagnosis or treatment of injury, illness, pregnancy, or disability. 2.5 Governing Board – The board of trustees, directors, or other governing body in whom the ultimate authority and responsibility for the conduct of the dialysis treatment clinic is vested. 2.6 Hemodialysis Technician – A person who is not a physician or a registered nurse and who provides dialysis care. 2.7 National Credentialing Program – Any national program for credentialing or determining the competency of hemodialysis technicians that is recognized by the National Association of Nephrology Technicians/Technologists (NANT), or a successor association. Section 3 – Fees 3.1 Effective January 1, 2009, each dialysis treatment clinic shall submit with its application for initial licensure or relicensure an annual fee of $200 to cover the department’s administrative costs in implementing these rules. The $200 fee shall be in addition to any licensing fee established pursuant to Section 25-3-105, C.R.S. Section 4 – Hospital Agreement and Public Notice Requirements 4.1 Hospital Agreement 4.1.1 With the exception of general hospitals, any facility that applies for a dialysis treatment clinic license shall also have a written agreement with an affiliating general hospital that includes arrangements for medical audit, utilization review, emergency hospitalization and infectious disease control. The agreement may also provide for an organized medical staff in the affiliating general hospital. Such agreement shall be submitted to and approved by the Department before issuance of any license. 4.1.2 A special medical advisory board composed of physicians specializing in nephrology and/or with clinical experience in dialysis may be appointed by the affiliating hospital for the purpose of medical audit and utilization review. 4.2 Public Notice Requirements 4.2.1 Each dialysis treatment clinic shall post a clear and unambiguous notice in a public location

in the facility specifying that the clinic is licensed, regulated, and subject to inspection by the Department. 4.2.2 Each dialysis treatment clinic shall also inform consumers, either in the public notice described in this section or in written materials provided to consumers, that the consumer has a right to make any comments the consumer has concerning the clinic’s services to either the clinic or the Department for consideration. 4.2.3 The consumer notice shall specify that any comments the consumer has concerning clinic services may be raised either orally or in writing. Section 5 – Organization and Staffing Requirements 5.1 Governing Board 5.1.1 A dialysis treatment clinic shall have a governing board that is formally organized with a written constitution or articles of incorporation and by-laws. 5.1.2 The governing board shall meet at regularly stated intervals, and maintain records of these meetings. 5.1.3 The governing board shall assume responsibility for the services provided by the clinic. 5.1.4 The governing board shall provide facilities, personnel, and services necessary for the welfare and safety of patients. 5.1.5 The governing board shall appoint the medical staff. Such appointments shall be made following consideration of the recommendations by the existing medical staff. 5.1.6 The governing board should appoint an administrative officer who is qualified by training and experience in hospital or clinic administration and delegate to that individual the executive authority and responsibility for the administration of the dialysis treatment clinic. 5.2 Administrative Officer 5.2.1 The administrative officer shall be responsible for the administration of the dialysis treatment center and shall maintain liaison between the governing board and medical staff. 5.2.2 The administrative officer shall ensure that the dialysis treatment clinic is formally organized to carry out its responsibilities. The plan of organization with the authority, responsibility, and functions of each category of all personnel should be defined clearly in writing. 5.2.3 The administrative officer shall be responsible for the development of dialysis treatment clinic policies and procedures for employee and medical staff use. 5.3 Medical Staff 5.3.1 All dialysis treatment clinics shall have an organized medical staff with written rules, regulations, and by-laws. The by-laws shall make provision for application, appointment, privileges, discipline, control, right of appeal, attendance at medical staff meetings, committees, and professional conduct in the clinic. 5.3.2 A physician from the organized medical staff shall be appointed or elected as chief of staff.

5.3.3 The medical staff shall meet regularly and maintain written records of these meetings. 5.3.4 There shall be a medical audit committee to review systematically the work of the medical staff with respect to quality of medical care. 5.3.5 There shall be a medical records committee that supervises and appraises the quality of medical records according to the requirements contained in Section 6.3 of this chapter. 5.4 Nursing 5.4.1 Each clinic shall be under the direct supervision of a registered nurse with administrative capability and experience in hemodialysis. 5.4.2 The supervising nurse shall be responsible for staff assignments, policy and procedure development, records and reports, educational planning and overall patient care. 5.4.3 A registered nurse qualified in hemodialysis shall be on duty during the hours of the clinic’s operation. 5.5 Hemodialysis Technicians 5.5.1 On and after January 1, 2009, a person shall not act as, or perform the duties and functions of, a hemodialysis technician unless that person has been credentialed by a national credentialing program and is under the supervision of a physician or registered nurse experienced or trained in dialysis treatment. 5.5.2 On and after January 1, 2009, a dialysis treatment clinic shall not allow any person to perform the duties and functions of a hemodialysis technician at or for the dialysis treatment clinic if the person has not been credentialed by a national credentialing program. 5.5.3 Nothing in this Section 5.5 shall prohibit a person enrolled in a hemodialysis technician training program from performing the duties and functions of a hemodialysis technician if: (A) The person is under the direct supervision of a physician or a registered nurse experienced or trained in dialysis treatment, who is on the premises and available for prompt consultation or treatment; and (B) The person receives his or her credentials from a national credentialing program within 18 months after the date the person enrolled in the training program. 5.6 All Clinic Personnel 5.6.1 Personnel records shall be kept on each of the clinic staff. These records shall include the employment application and verification of credentials. 5.6.2 On and after January 1, 2009, each dialysis treatment clinic shall confirm and maintain records for hemodialysis technician certification. Facilities shall provide a list to the department at the time of initial licensure, relicensure and upon request, with information including but not limited to the following: (A) The names of all technicians employed by the clinic, (B) The date the technician was credentialed by a national credentialing program or, if not credentialed, the date the technician enrolled in a credentialing training

program, and (C) The name of the credentialing association. 5.6.3 The dialysis treatment clinic shall explain its purposes and objectives to all personnel. There should be written personnel policies and rules that govern the conditions of employment, the management of employees, the types of functions to be performed, and the quality and quantity of clinic service. Following approval by the governing board, copies of such policies and rules should be distributed to all employees. 5.6.4 There should be sufficient qualified personnel in the clinic. 5.6.5 Additional personnel, including hemodialysis technicians, shall be assigned according to the needs of the patient and the clinic. 5.6.6 All persons assigned to the direct care of or service to patients should be prepared through formal education and on-the-job training in the principles, the policies, the procedures, and the techniques involved so that the welfare of patients will be safeguarded. 5.6.7 There should be an education program for all clinic personnel to keep the employees abreast of changing methods and new techniques in dialysis services. 5.6.8 All personnel should have a pre-employment physical examination and such interim examinations as may be required by the clinic administration or health service physician. The examining physician should certify that the employee, before returning from illness to duty, is free from infectious disease. Employment health policies should be arranged so personnel are free to report their illness without fear of income loss. Section 6 – Patient/Clinical Functions 6.1 Hemodialysis Services 6.1.1 Water Supply (A) The clinic’s water supply system shall be from a municipal water supply system or other system that meets the criteria established by the Department in the Colorado Primary Drinking Water Regulations, 5 CCR 1003-1. (B) Water used in hemodialysis procedures shall be further treated before use in dialysis machines. Dialysis treatment clinics shall follow a recognized method of treatment. 6.2 Clinical Laboratory 6.2.1 Clinical laboratory services shall be provided within the facility or by contract. 6.2.2 Contracted services shall meet the standards established herein. 6.2.3 Staffing and Organization (A) The laboratory shall be under the supervision of a physician, certified in clinical pathology, either on a full-time, part-time, or consulting basis. The pathologist shall provide, at a minimum, monthly consultative visits. (B) Emergency laboratory services shall be made available whenever needed.

(C) All laboratory work shall be ordered by a physician or a person authorized by law to use the results of such findings. 6.2.4 Facilities and Equipment (A) There shall be adequate space within the facility for the laboratory. (B) There shall be adequate storage space for supplies. (C) Workbench space shall be ample, well lighted, and convenient to sink, water, and electrical outlets as necessary. (D) All laboratory equipment shall be in good working order, be routinely checked and be precise in terms of calibration. (E) A schedule of preventive maintenance shall be set up for all laboratory equipment. 6.2.5 Policies and Procedures (A) A manual outlining all procedures performed in the laboratory shall be completed and readily available for reference. (B) The conditions and procedures for referring specimens to another laboratory shall be in writing and available in the laboratory. 6.2.6 Clinical Laboratory Records (A) A record of all preventive maintenance, repair, and calibration shall be kept on each item of laboratory equipment. (B) A record system shall be established which ensures that laboratory specimens are adequately identified, properly processed, and permanently recorded. (C) Duplicate copies of all reports shall be kept in the laboratory in a manner that permits ready identification and accessibility, for at least four years plus the current fiscal year. 6.3 Medical Records 6.3.1 Only members of the medical/house staff or other persons authorized by state law or regulation shall write or dictate medical histories and physical examinations. 6.3.2 A complete medical record shall be maintained on every patient registered in the dialysis treatment clinic. Each patient’s record shall include: (A) Sufficient information to properly identify the patient including clinic identification assigned to patient, (B) Date and time of each treatment session, (C) Original copies of any clinical test results including reports of tests referred to another laboratory, (D) Initial diagnosis, and

(E) Secondary diagnosis and complications as necessary. 6.3.3 All orders for diagnostic procedures, treatments, and medications shall be signed by the physician submitting them and entered in the medical record in ink, in type or electronically. The prompt completion of a medical record shall be the responsibility of the attending physician. 6.3.4 Authentication of the order may be by written signature, identifiable initials, computer key, or electronic verification. The use of rubber stamp signatures is acceptable under the following strict conditions: (A) The physician whose signature the rubber stamp represents is the only one who has possession of the stamp, is the only one who uses it, and (B) The physician places in the administrative offices of the clinic a signed statement to the effect that he is the only one who has the stamp and is the only one who uses it. 6.3.5 Each dialysis treatment center shall provide a medical record room or other suitable medical record facility with adequate supplies and equipment. Medical records should be stored safely to provide protection from loss, damage, and unauthorized use. 6.3.6 Medical records for individuals 18 years of age and older shall be preserved as original records, on microfilm or computer disc for no less than ten years from the most recent patient care usage, after which time records may be destroyed at the discretion of the clinic. Medical records for minors under the age of 18 shall be preserved for the period of minority plus ten (10) years. 6.3.7 The clinic shall establish procedures for notifying patients whose records are to be destroyed before the destruction of such records. 6.3.8 The sole responsibility for the destruction of all medical records shall lie with the clinic involved but in no case shall records be destroyed before consultation with legal counsel. 6.3.9 Nothing in this section shall be construed to affect the requirements for the destruction of public records as set forth in Section 24-80-101, et seq., C.R.S. 6.4 Infection Control 6.4.1 The dialysis treatment clinic shall have a multi-disciplinary infection control committee charged with the responsibility of investigation and recommendations for the prevention and control of infection in the clinic. 6.4.2 The multi-disciplinary infection control committee shall be responsible for all clinic policies and procedures related to infection control including the following: (A) The isolation of patients with specific infectious diseases and protective isolation of appropriate patients, (B) The control of routine use of antibiotics and adrenocorticosteroids, (C) The review and revision of policies and procedures for infection surveillance and control, (D) Presentation of in-service education programs on the control of infection, and

(E) The reporting of infectious diseases as required by applicable state and federal laws and regulations. 6.4.3 For the committee to carry out its responsibilities the following are highly recommended standards: (A) Meet at least monthly, and more frequently if the surveillance committee so indicates. (B) Plan an agenda that includes: (1) Review of significant features of the monthly report. (2) Review of one major control policy (and related procedures) area each month in the light of newest available information and the clinic's current practice. Section 7 – Sanitary Environment 7.1 Housekeeping Services 7.1.1 Each dialysis treatment clinic shall establish organized housekeeping services that are planned, operated, and maintained to provide a pleasant, safe and sanitary environment. The services should be under the supervision of a person competent in environmental sanitation and management. 7.1.2 There shall be specific written procedures for appropriate cleaning of the physical plant and equipment, giving special emphasis to procedures that apply to infection control. Policies shall be established to provide supervision and training programs for housekeeping personnel. 7.1.3 Solutions, cleaning compounds, and hazardous substances shall be properly labeled and stored in safe places. Paper towels, tissues, and other supplies shall be stored in a manner to prevent their contamination prior to use. 7.1.4 Dry dusting and sweeping are prohibited. 7.1.5 All rubbish and refuse containers shall be impervious and tightly covered. Carts used to transport rubbish and refuse shall be constructed of impervious materials, shall be enclosed, and shall be used solely for this purpose. Accumulated waste material shall be removed at least daily. 7.2 Insect, Pest and Rodent Control 7.2.1 Written policies and procedures shall provide for effective control and eradication of insects, pests, and rodents. 7.2.2 The clinic shall have a pest control program provided by maintenance personnel or by contract with a pest control company using the least toxic and least flammable effective pesticides. 7.2.3 The pesticides shall not be stored in patient or food areas and shall be kept under lock, and only properly trained responsible personnel shall be allowed to apply insecticides and rodenticides.

7.2.4 Screens or other approved methods shall be provided on all exterior openings and the structure shall be maintained to prevent entry of rats or mice through cracks in foundations, holes in walls, around service pipes, etc. 7.3 Waste Disposal 7.3.1 The clinic shall make provision for proper and safe disposal of all types of waste products. 7.3.2 All personnel shall wash their hands thoroughly after handling medical waste products. 7.3.3 All sewage shall be discharged into a public sewer system, or if such is not available, shall be disposed of in a sanitary manner consistent with applicable state laws and regulations. 7.3.4 No exposed sewer line shall be located directly above working, storing, or eating surfaces in kitchens, food storage rooms, or where medical supplies are prepared, processed or stored. 7.3.5 All garbage, not treated as sewage, shall be collected in watertight containers in a manner that prevents it from becoming a nuisance, and shall be removed from the facility on a scheduled basis per public or contracted service. 7.3.6 A sufficient number of sound watertight containers with tight-fitting lids, to hold all garbage that accumulates between collections, shall be provided. Lids shall be kept on the containers. Any racks or stands shall be kept in good repair. 7.3.7 Garbage containers shall be cleaned each time they are emptied. (Single service container liners are recommended.) A paved storage area for the containers should be provided. Section 8 – Physical Plant and Equipment 8.1 Life Safety Code 8.1.1 All dialysis treatment clinics shall comply with the National Fire Protection Association (NFPA) 101 Life Safety Code (2000) which is incorporated by reference herein. Such incorporation does not include later amendments to or editions of the referenced material. The Health Facilities and Emergency Medical Services Division of the Department of Public Health and Environment maintains copies of the complete text of the incorporated materials for public inspection during regular business hours, and shall provide certified copies of any non-copyrighted material to the public at cost upon request. These materials have also been submitted to the state publications depository and distribution center and are available for interlibrary loans. The incorporated material may be examined at any state publications depository library. 8.1.2 Facilities originally licensed before January 1, 2008 shall meet Chapter 21, Existing Ambulatory Health Care Occupancies, NFPA 101 (2000). 8.1.3 Facilities licensed on or after January 1, 2008 or portions of facilities that undergo remodeling after January 1, 2008 shall meet Chapter 20, New Ambulatory Health Care Occupancies, NFPA 101 (2000). In addition, if the remodel represents a modification of more than 50 percent, or more than 4,500 square feet of the smoke compartment, the entire smoke compartment shall be renovated to meet Chapter 20, New Ambulatory Health Care Occupancies, NFPA 101 (2000). 8.2 Maintenance

8.2.1 The building and mechanical programs shall be under the direction of a qualified person informed in the operations of the clinic and in the building structures, their component parts and facilities. 8.2.2 There shall be written policies and procedures for an organized maintenance program to keep the entire facility, including equipment, in good repair and to provide for the safety, welfare, and comfort of the occupants of the building(s). 8.3 Central Medical Supply 8.3.1 Each dialysis treatment clinic shall provide central supply services with facilities for processing, sterilizing, storing and dispensing supplies and equipment if supplies and equipment are not all sterilized by the manufacturer. 8.3.2 This service shall be separated physically from other areas of the clinic and shall include areas designated for the following: (A) Receiving, (B) Cleaning and processing, (C) Sterilizing, if applicable, (D) Storing clean and sterile supplies, and (E) Storing bulk supplies and equipment. 8.3.3 A two-compartment sink, with counter or drain board and knee-or-wrist action valves, shall be provided in the cleaning area. 8.3.4 Adequate cabinets, cupboards, and other suitable equipment shall be provided for the processing of materials and for the storage of equipment and supplies in a clean and orderly manner. 8.3.5 Ventilation to the central supply area may be supplied from the general ventilation system, if properly filtered. The flow of air should be from the clean areas toward the exhaust in the soiled area. Exhausts shall be installed over sterilizers to prevent condensation on walls and ceilings. In the case of new facility construction, or modification of an existing facility, the flow of air shall be from the clean areas toward the exhaust in the soiled area. 8.3.6 Central medical supply services shall be organized as a unit under the immediate supervision of a person who is competent in management, asepsis, supply processing, and control methods. Sufficient supporting personnel shall be assigned to the unit and properly trained in central medical supply services. CHAPTER XVII REHABILITATIVE NURSING FACILITY In addition to the standards currently in effect in chapter V, Nursing Care Facility, Standards for Hospitals and Health Facilities, Colorado Department of Health, the following standards will apply to facilities furnishing services as a “Rehabilitative Nursing Facility” under provisions of Senate Bill 95 passed by the Fifty-first General Assembly. STATEMENT OF PURPOSE: The purpose of “these regulations is to adopt standards for a new class of health facility known as a

“Rehabilitative Nursing Facility” in order to implement a 12-month pilot project for such facility as required by Senate Bill 95, 1978 General Assembly. PHYSICAL THERAPY SERVICES A. General Physical therapy services are those services ordered by a physician or upon a physician's referral and provided to a patient by or under the supervision of a physical therapist to achieve and maintain the highest level of functional ability. Physical therapy services include, but are not limited to, the following: 1. Assisting the physician in an evaluation of the patient's rehabilitation potential. 2. Applying muscle, nerve, joint and functional ability tests. 3. Treating patients to relieve pain, develop and restore function. 4. Assisting patients to achieve and maintain maximum performance using physical means such as exercise, massage, heat, sound, water, light and electricity. 5. Communicating with the nursing staff in the carryover of physiotherapy programs as appropriate for them to perform. B. Staff The physical therapy service unit shall be under the supervision of a full-time physical therapist licensed by the State of Colorado. Additional licensed physical therapists and physical therapy aides shall be available in sufficient numbers to perform adequately the services designated by the supervisor. The facility shall provide for the consultative services of a physician experienced in rehabilitative medicine to work with the physical therapist(s) and the nursing staff in general program planning and individual resident consultations. C. Duties of Physical Therapist Supervisor The physical therapist supervisor shall be responsible for the following: 1. An evaluation of the patient and the preparation of a physical therapy treatment plan conforming to the attending physician's orders and goals. The plan is to include information on modalities, frequency and duration of treatment. The treatment plan will be modified based upon subsequent reevaluations, will define long term and short term goals, and outline current treatment program. 2. For consultation with ether facility personnel who are providng patient care so that physical therapy treatment is integrated with overall health care plan. 3. Shall be responsible for communicating with nursing personnel as to the administration of selected restorative nursing procedures. 4. Maintenance of health records which shall contain pertinent information on the patient. Notes indicating that physical therapy services have been performed shall be entered into the patient's health record each day the service is needed, and signed by the physical therapist. Progress notes shall be written and signed at least weekly by the physical

therapist during the active treatment stages, thereafter as appropriate but not less than every thirty days. 5. Completion of a discharge summary to include recommendation for any further treatment or followup written within five days of discharge. 6. Development and implementation of written cleaning and culturing techniques of hydrotherapy equipment. D. Policies and Procedures There shall be written policies and procedures governing the provision of physical therapy. The physical therapy supervisor shall be responsible for the development and implementation of physical therapy policies, procedures and job descriptions, with the assistance of the patient care policy committee. E. Equipment and Space Physical therapy equipment and space shall be sufficient to provide an adequate physical therapy service and to meet the needs of the patients accepted for treatment. OCCUPATIONAL THERAPY SERVICES A. General Occupational therapy is a medically prescribed service in which selected purposeful activity is used to restore the functional capacity of those individuals whose ability to cope with tasks of daily living are threatened or impaired by developmental deficit, the aging process, physical illness or injury or psychosocial disabilities. Occupational therapy includes: 1. Assisting physician in his evaluation of a patient's level of function by applying diagnostic and prognostic tests. 2. Reevaluation of the patient as his condition changes and modifying treatment goals consistent with these changes. 3. Increasing or maintaining a patient's capability for independence through the use of professionally selected self-care skills, daily living tasks and tests, and therapeutic exercises to improve function. 4. Enhancing of patient's physical, emotional and social well being by training in the performance of tasks modified to the patient's level of physical and emotional tolerance. 5. Use of tests to determine patient's ability in areas of concentration, attention, thought organization, perception and problem solving. 6. Developing function to a maximum level so that early testing can be applied for future job -raining and employment. B. Staff Occupational therapy shall be under the direct supervision of a full-time registered Occupational Therapist.

C. Duties of Occupational Therapy Supervisor The occupational therapy supervisor will be responsible for: 1. Development of an initial evaluation treatment plan and administration in accordance with physician's prescription and rehabilitation goals. 2. Consultation with other personnel within the facility who are providing patient care and plan with them for integration of a treatment program into the overall health care plan. 3. Entry of patient's chart of procedures performed and then signed by the occupational therapist. Progress notes shall be written at least weekly and signed on each visit. D. Policies and Procedures There shall be written policies and procedures governing the provision of occupational therapy. The occupational therapy supervisor shall be responsible for the development and implementation of occupational therapy policies, procedures and job descriptions, subject to the assistance and approval of the patient care policy committee. E. Equipment and Space Equipment necessary to enable patients to increase their functional capacity or capability shall be provided. This shall include, but not be limited to: 1. Supportive slings, supportive and/or assistive hand splints and materials from which to fabricate these and other assistive devices. 2. Adaptive devices to aid in the performance of daily living skills such as sating, dressing, grooming, writing, with instructions for their use. 3. Means and supplies for adapting equipment for reeducation in activities of daily living. 4. Sufficient space shall be available to implement all treatment plans. ACTIVITIES SERVICE A. General This service shall be staffed and equipped to meet the needs and interests of each patient to encourage self-care and resumption of normal activities. It should be designed to meet the needs and interest of each patient within the limitations set by the patient's physician. An activity program shall have a written planned schedule of social and other purposeful independent or group activities designed to make the patient's life more meaningful, to stimulate and support his desire to use his physical and mental capabilities to their fullest extent, to enable him to maintain his highest attainable social, physical and emotional functioning, his usefulness and self-respect but not necessarily to correct or remedy a disability. The program shall provide a therapeutic milieu facilitating the individual's ability to cope with social, emotional and physical disabilities. The program shall include activities for evenings and weekends. Residents may be vigorously encouraged, but no resident shall be forced to participate. Suitable activities will be made available for patients unable-to leave their rooms. Programs will not be limited to the premises of the facility. Activities and facilities in the community will be

an integral part of the overall activities program. Consultive sources shall be used in the planning and organizing of appropriate programs, incorporating post-planning services intended to enable the patient to function and gain independence. Remedial education programs consistent with the patient's needs and plan of care shall be available through appropriate community school facilities. Skill training programs shall be provided but not limited to techniques of behavior modification training in self-skills, sensory training or the modalities of reality orientation and remotivation therapy. Programs which include the co-mingling of persons with differing disabilities shall be appropriate to the group needs. B. Staff The activity program shall be under the supervision of a full-time director who shall be a trained recreation therapist and who shall have access to the nursing staff and/or special activities staff for assistance as needed. There shall be additional assistants as needed to carry cut a comprehensive activity program as dictated by the needs of -he patients. C. Duties of Activity Director The activity director shall be responsible for: 1. An initial evaluation and assessment of each resident within ten days of admission unless an evaluation has been done by the referring agency within thirty days prior to admission to the facility. 2. Development of an activity plan for each resident which shall be approved by the patient care assessment committee (or some similar group). This plan shall be concerned with social interactions, physical and recreational activity, and shall be reviewed as appropriate but at least semiannually. 3. Development of a program of activities for the institution as a whole, which shall be designed so as to offer residents the opportunity for choice among a variety of activities such as discussion and study groups, reading, games, sports, simple homemaking tasks, exercise classes, musical and other creative activities and religious services. D. Policies and Procedures Written policies and procedures governing the conduct of the activity program shall be developed by the activity director with the assistance and approval of the patient care policy committee, and shall be available for use by the activity director and other personnel assisting in the program. E. Equipment and Space Designated activity areas appropriate to independent and group needs of patients shall be maintained. Such areas shall be: 1. Accessible to wheelchair and ambulatory patients. 2. Of sufficient size to accommodate necessary equipment and permit unobstructed movement of wheelchair and ambulatory patients or personnel responsible for instruction or

supervision. 3. Have adequate space to store equipment and supplies. 4. Activity room(s) shall approach a goal of 10 sq. feet per resident. 5. Equipment and supplies shall include, but not be limited to, leatherwork, weaving, needlework, ceramics, woodworking, painting, and graphic arts. SOCIAL SERVICES A. General Social work services, in addition to the requirements contained in Section 15, chapter V, Colorado Standards for Hospitals and Health Facilities, must also provide the following: 1. The social services supervisor shall ensure that within five days after admission each resident shall be interviewed and a social services assessment completed by a qualified social worker. 2. The social services supervisor shall develop a plan, including goals and treatment, for social work services for each resident, with participation of the resident, his family, and all the treating disciplines. This may be carried out as part of the initial care planning process. The plan will be reviewed at least quarterly. 3. Signed and dated progress reports shall be written in the health record of each patient receiving social services as necessary but not less than monthly by a member of the social services department. 4. The social worker shall participate as a member of the patient care assessment committee. 5. There shall be discharge planning and implementation through liaison with local health and welfare agencies, other community personnel and the patient's family or authorized representative. 6. Orientation and inservice training of other staff members on all shifts shall be coordinated by the social services supervisor and shall be conducted at least monthly, to assist in the recognition and understanding of the emotional problems and social needs of patients and families and to teach how to implement appropriate action to meet such identified needs. 7. The social services supervisor shall ensure that the needs and entitlements of each resident for public benefits and services are identified and satisfied. B. Staff There shall be a social work staff employed a sufficient number ofhours in the facility to meet the social needs of the patients. As a minimum, the staff shall consist of one full-tine LSW II who shall be responsible for organizing, directing and supervising other members of the social work staff. Appropriate job descriptions shall be available for all social work staff personnel. Adequate clinical support services shall be available for the social work staff. C. Policies and Procedures

There shall be written policies and procedures developed and maintained which govern provision of social service within the facility. Policies shall be approved by the patient care policy committeee. D. Equipment and Space Adequate equipment, supplies and space shall beavailable to the staff and patient personnel to assure the proper operation of the service. OTHER SERVICES Depending on the needs of the patients accepted for care, the following services will be furnished on a full or parttime in-house or outside consultant basis. A. Speech Pathology and Audiology Services 1. General Speech pathology and/or audiology services are physician referred services which provide diagnostic screening, preventive and corrective therapy for individuals with speech, hearing and/or language disorders. The person providing such services must be a qualified speech pathologist or audiologist who has a current certificate of clinical compliance in the appropriate area granted by the American Speech and Hearing Association or equivalent. 2. Speech therapy services shall include the following: a. Speech, language, and educational capacity screening for any individual admission who is involved in an educational or turoring program, as required by PL94-102. b. Participation in the development of initial care plans for each admission, including the recommendation of speech, language, and/or hearing evaluations when appropriate. 3. When required, speech therapy services will provide as a minimum: a. Evaluation of patients to determine the type of speech, language and/or hearing disorder. b. Determination and recommendation of the appropriate speech, language, and hearing therapy and institution of such therapy when approved. c. Instruction of other facility personnel and family members in methods of assisting the patient to improve and/or correct speech or hearing disorders. 4. Entries shall be made by the consultant in the health record to include all pertinent information of patient history and background and a signed medical order for the service. Progress notes including patient's reaction to treatment and any changes in condition shall be written at least monthly and be signed by the speech pathologist or audiologist. 5. There shall be written policies and procedures governing speech and hearing approved by the patient care policy committee. 6. There shall be sufficient equipment, tests, materials and supplies to implement the treatment and program required by each patient seen by the speech pathologist and/or audiologist. B. Psychiatric Services 1. The facility shall employ fully-trained psychological therapist(s) or counsellor(s), experienced in the problems of rehabilitative care, as needed to provide inservice training, group and individual counselling to the staff with regard to resident-staff interactions, and group and individual therapy to residents. a. Such services may be coordinated through one of the existing departments in the facility or may be provided as a separate service. b. In either of the above cases, individual resident care needs shall be identified, and provision of

care coordinated through the care planning process. 2. The facility shall provide the consultive services of a psychiatrist on an as-needed basis. C. Resident Care Coordinator One or more individuals on the staff of the facility shall be designated as resident care coordinators whose responsibility it shall be to see that care plans/individual program plans are implemented, and reassessments performed when required. The hours spent as resident care coordinator shall not be counted as part of the staff time of any of the previously mentioned nursing or restorative services. FACILITIES AND EQUIPMENT - GENERAL The pilot project is intended to provide facilities much more varied than those commonly found in a skilled nursing facility. The following should be provided whenever possible as adjunctive aides in promoting a more normal atmosphere for patients being considered for return to independent living outside the facility. 1. A goal of 160 sq. ft. per single bedroom and 240 sq. ft. for a double bedroom with no more than 2 patients per room. 2. Portable screens or furniture arrangement should provide privacy for occupants of double occupancy rooms. 3. Provide for wheelchair access to vanity and storage space, lavatory, and toilet. 4. Provide for wheelchair access to writing surfaces, shelving and display furnishings. 5. A resident kitchen area shall be provided for supervised restorative training, which shall include counter, sink, cabinets, cooktop oven and refrigerator. 6. A resident laundry shall be provided for supervised restorative training which shall include a domestic washer, clothes dryer, laundry tray, handwashing facilities, ironing board, and counter space. SPECIAL NURSING STAFF REQUIREMENTS 1. As stated in current standards, there must be a full-time (8 hours per day, five days per week) director of nursing who is a currently licensed registered professional nurse experienced in rehabilitative nursing care, who devotes full time to supervision and management of the nursing service. 2. In addition, there shall be at least one registered professional nurse, other than the D.O.N., and one licensed practical nurse on each shift to supervise resident care. 3. The individual nursing needs of the residents shall be the major consideration in staffing the nursing service. In all cases the number of nursing staff shall be sufficient to provide at least 3.5 hours of nursing care per resident per 24 hour period exclusive of the hours of the D.O.N. or of the alternate when functioning as the D.O.N. This is also exclusive of staff training or orientation time. 4. Rehabilitative nursing care shall be emphasized to include but not restricted to activities of daily living training, vigorous encouragement to participate in activities, prevention of contractures and decubitus ulcers, and individual bowel and bladder re-training programs. TRANSPORTATION

If patients attend schools in the community, transportation and supervision to and from schools shall be arranged in accordance with the needs and conditions of the patients. Transportation shall also be available for the recreational needs of the patients. CHAPTER XVIII PSYCHIATRIC HOSPITALS Psychiatric Hospital. Psychiatric Hospital means a health facility planned, organized, operated, and maintained to provide facilities, beds, and services over a continuous period exceeding twenty-four (24) hours to individuals requiring early diagnosis and intensive and continued clinical therapy for mental illness, and mental rehabilitation. 1. GOVERNING BOARD DEFINITION. Governing Board means the board of trustees, directors, or other governing body in which the ultimate authority and responsibility for the conduct of the psychiatric hospital is vested. 1.1 ORGANIZATION. The governing board shall be organized formally with written constitution or articles of incorporation and bylaws, have meetings at regularly stated intervals, and maintain records of these meetings. The governing board shall appoint an administrative officer who is qualified by training and experience in health care administration and delegate to him the executive authority and responsibility for the administration of the hospital. 1.2 MEDICAL STAFF. The governing board shall appoint the medical staff. Appointments shall be made following consideration of the recommendations by the medical staff. The governing board shall establish formal liaison with, and approve the by-laws, policies and procedures of the medical staff. 1.3 FACILITIES. The governing board shall provide facilities, personnel, and services necessary for the health, welfare and safety of patients. 1.4 PROGRAM. The governing board has responsibility for all groups performing functions within the hospital including policy for conducting training programs in the safe management of patients. 1.4.1 The governing board of the hospital shall be responsible for defining and promulgating the safety limitations of the environment of various patient locations based on the medical procedures involved, the choice of electric distribution and ground systems, and all electric appliances used in the location. 1.4.2 The governing board shall be responsible for establishing a testing and maintenance program to detect and correct degradation of the safety features of the selected system and equipment used. 2. ADMINISTRATIVE OFFICER 2.1 RESPONSIBILITY. The administrative officer shall be responsible for the administration of the psychiatric hospital and shall maintain liaison between the governing board and the medical staff. 2.2 ORGANIZATION. The psychiatric hospital shall be organized legally to carry out its responsibilities. The plan of organization shall be defined clearly in writing and shall delineate the responsibility, authority, and functions of each category of personnel. 2.3 POLICIES. The administrative officer shall be responsible for the development of psychiatric hospital

and departmental policies and procedures for employee and staff use. 2.4 ACCOUNTING. An audit shall be performed at least annually by a qualified auditor independent of the psychiatric hospital in accordance with a recognized system of hospital accounting. 3. MEDICAL STAFF 3.1 ORGANIZATION. All hospitals shall have a medical staff organized with written by-laws, policies and procedures. The by-laws shall make provision for application, appointment, privileges, discipline, control, right of appeal, attendance at medical staff meetings, committees, and professional conduct in the psychiatric hospital. If the psychiatric hospital permits outside allied health professionals to participate as members of a treatment team (as defined in Section 7.11), administer treatment and record in patients' records, it shall provide for the credentialing of all such persons in the facility. 3.2 CHIEF OF STAFF. A physician from the organized medical staff shall be appointed or elected as chief or president of the staff. 3.3 MEDICAL DIRECTOR. The Governing Board of the psychiatric hospital shall appoint a medical director responsible for medical care in the hospital, and as a liaison between the administration and the medical staff. The Medical Director shall be a medical staff member with special training in psychiatry, preferably Board certified. 3.4 MEETINGS. The medical staff shall meet regularly and maintain written records of these meetings. 3.5 PEER REVIEW. The psychiatric hospital shall maintain an ongoing peer system which regularly examines the quality of care provided to individual patients in the psychiatric hospital. The peer review committee will consist of selected members of the medical staff. 3.6 PSYCHIATRIC-MEDICAL AUDIT. There shall be a Psychiatric-Medical Audit Committee, or its equivalent, to review systematically the work of the medical staff with respect to the quality of psychiatric and medical care, by conducting medical care evaluation studies and/or other psychiatric audits. There shall be a minimum of two such audits completed each year. 3.7 MEDICATIONS POLICIES. The medical staff shall develop policies for the use of psychotropic medications, in conformity with the guidelines contained in C.R.S. 1973, 27-10-116. 4. ADMISSIONS 4.1 CARE BY MEDICAL STAFF. All patients admitted to a hospital shall have benefit of daily care under supervision of a member of the medical staff. Where appropriate, this may be accomplished by a treatment team, (as defined in S 7.11) Policies shall be provided for coordinating and designating responsibility when more than one member of the medical staff is treating a patient. 4.2 INVOLUNTARY DETAINMENT. A psychiatric hospital shall not detain any person involuntarily unless it has been approved as a designated facility by the Department of Human Services pursuant to C.R.S., 27-10-101, et. seq. as amended. 4.3 PATIENT BEDROOM. Patients admitted to psychiatric hospitals shall not be assigned to any room or area other than one regularly designated as a patient bedroom. 4.4 CHILDREN AND ADOLESCENTS. Children and adolescents may be admitted to an adult unit if specifically ordered by the attending physician, but shall not remain there more than two weeks unless the attending physician specifically orders that the child or adolescent remain on the adult unit. 5. OUTPATIENT EMERGENCY PSYCHIATRIC SERVICES

5.1 SERVICE. If a psychiatric hospital chooses to offer outpatient emergency psychiatric services, such treatment shall be available at any hour to persons presenting themselves for this purpose. If the hospital chooses not to offer such emergency psychiatric services, it shall have a written plan for referral of persons making inquiry regarding such services or presenting themselves for such services. 5.2 EMERGENCY UNIT 5.2.1 Emergency psychiatric services, if offered, shall be organized as a service specifically designated for this purpose. 5.2.2 The following public facilities shall be available; 5.2.2.1 An area for conducting interviews with individuals and families; 5.2.2.2 A reception and control area; 5.2.2.3 Communication facilities; 5.2.2.4 A public waiting area with telephone, drinking fountain and toilet facilities. 5.2.3 ORGANIZATION. The emergency unit shall be organized as is deemed appropriate by the medical staff. 5.2.4 POLICIES. Emergency psychiatric services, if offered, shall be guided by written policies and shall be supported by appropriate procedures, Including admissions and treatment procedures, and psychiatric and medical reference materials. Seclusion and restraints shall be used only in emergency situations where a patient is determined by a professional person to be in imminent or immediate danger of hurting him/herself or others, or when treatment of the condition is only possible with the use of seclusion and/or restraints. 5.2.5 PHYSICIAN COVERAGE. Provision shall be made for physician coverage at all hours. 5.2.6 MEDICAL RECORDS. Medical records shall be maintained on all patients presented or presenting themselves for treatment according to written policies of the medical staff. Medical records for patients treated in the emergency service shall be organized by a medical record administrator. 5.3 POISON CONTROL. A poison control chart and information providing the location and telephone number of the nearest poison control center shall be posted prominently in the emergency unit. 5.4 A psychiatric hospital offering emergency services shall not detain any person involuntarily unless approved as a designated facility by the Department of Human Services pursuant to C.R.S. 27-10-101 et. seq., as amended. 6. PSYCHIATRIC PATIENT CARE UNIT 6.1 DEFINITION. A psychiatric patient care unit is a patient area which includes living, treatment, support, sleeping facilities and services designed and organized to provide adequate clinical management of patients. The maximum size of the psychiatric patient care unit shall be determined by program requirements and the functional design of the hospital physical plan. Patient care units shall be designed to maximize home-like appearance by the use of appropriate color, design, and furniture. and services designed and organized to provide adequate clinical management of patients. The maximum size of the psychiatric patient care unit shall be determined by program requirements and the functional design of the hospital physical plan. Patient care units shall be designed to minimize

institutional appearance by the use of appropriate color, design, and furniture. 6.2 PATIENT ROOM. There shall be provision for private or multiplebed bedrooms to meet the needs of patients and the programs of the psychiatric hospital. For new construction there shall not be more than four patients per room. 6.3 BEDROOM SIZE. Each one-bed bedroom shall contain a minimum floor area of 100 square feet. Each multiple-bed bedroom shall contain a minimum floor area of 80 square feet per bed. 6.4 PRIVACY. The psychiatric hospital shall provide for privacy of patients in multiple-bed bedroom, by, for example, the use or arrangement of furnishings. 6.5 SMOKING. The psychiatric hospital shall allow all patients, prior to elective admission, to choose to be in a no-smoking patient room, and, when possible, shall accommodate such request. 6.6 WINDOWS. Each patient bedroom shall have a minimum window area equal to one-eighth of the floor area. The sills of such windows shall not be located below the finished ground level and shall not be more than 36 inches above the floor level. The exterior ground level shall be maintained at or below the window sill for a distance of at least eight feet, measured direct to the window. A portion of the required window shall be openable sufficient to provide adequate ventilation, unless a mechanical ventilation system is provided. A means of privacy and control of light shall be provided at each window. 6.7 ENTRIES. Each patient bedroom shall have access to exit routes sufficient to meet the fire safety requirements of the Life Safety Code. The door openings shall be at least 32 inches in clear width. Doors shall not swing into the exit route unless emergency release hardware is provided. 6.8 LIGHTING. Artifical light shall be provided in each patient bedroom including: 1) general illumination; 2) other sources of sufficient illumination for reading and observations; and 3) silent operating switches. 6.9 TOILET FACILITIES. Toilet facilities shall be provided in one of two ways: 6.9.1 Located immediately adjacent to private or multiple-bed bedrooms in the ratio of one facility for not more than four patient beds which include: 1) toilet; 2) incombustible waste paper receptacle, either seamless or with removable impervious liner, and 3) grab bars in some facilities and of a sufficient number to accommodate disabled patients. In new construction, the door to the toilet shall be at least thirty-two inches in clear width and shall not swing into the toilet room unless provided with rescue hardware or tool-released privacy bath sets. 6.9.2 Separate men's and women's restrooms within the psychiatric patient care unit with toilets in a ratio of one toilet for not more than ten patient beds, providing partitions for privacy, and an incombustible wastepaper receptacle, either seamless or with a removable impervious liner, and grab bars available in some facilities, and of a sufficient number to accommodate disabled patients. 6.10 HANDWASHING FACILITIES. Handwashing facilities shall be provided in one of two ways: 6.10.1 A lavatory complete with soap and sanitary hand-drying accommodations be either provided in each patient bedroom or installed within the toilet room adjacent to bedrooms with no more than four patient beds per lavatory; or 6.10.2 By the provision of separate men's and women's restrooms located in the patient care unit and containing a lavatory complete with soap and sanitary hand-drying accommodations in a ratio of at least one lavatory for each ten patient beds. 6.11 PATIENT EQUIPMENT. Patient bedrooms shall be equipped with furniture and equipment providing

the following for each patient: 6.11.1 Movable washable bed and bedside table (or its equivalent), 6.11.2 Movable or built-in cabinet. 6.11.3 Personal care equipment such as drinking glasses, carafes and utensils, sufficient for the type of treatment provided in the facility. 6.11.4 One noncombustible waste receptacle, either seamless or with a removable impervious liner. 6.12 CLOSET. Each patient bedroom shall be provided with a separate closet space or locker adequate in size for the number of patients assigned to the room. In the case of new psychiatric hospital construction or modification of an existing psychiatric hospital facility, the closet space or locker must open into the patient room. 6.13 STORAGE. Each patient shall be provided with individual locked storage space which is readily accessible to patients at reasonable times. The psychiatric hospital shall establish policies which, if adhered to by patients, will protect patient property against theft or loss. 6.14 PATIENT CARE SUPPORT FACILITIES. A psychiatric patient care unit shall, as a minimum, contain or be reasonably accessible to the following patient care support facilities: 6.14.1 Day-rooms or group-rooms in the ratio of one facility for not more than 25 patient beds. 6.14.2 A dining room sufficient in size to meet the needs of the program. 6.14.3 An occupational therapy and recreation facility. 6.14.4 Conference/interview rooms in the ratio of one facility for not more than 25 patient beds. 6.14.5 Secure rooms equipped with means for direct observation of occupant, protected lighting source, and other features designed to accommodate a psychiatrically agitated patient, in the ratio of one facility for not more than 25 patient beds. Such secure rooms shall be at least 100 square feet, shall be mechanically ventilated quietly, at the rate of four room changes per hour (unlessan outside window is available); air shall be diffused and at a comfortable temperature. The room shall not be equipped with hazardous equipment or devices. 6.14.6 A reasonably accessible telephone closet with a seat or telephone equipment enclosed so as to assure privacy. 6.15 BATHING FACILITIES. Patient bathing facilities with adequate provision for privacy and safety shall be provided in the ratio of one tub or shower for each ten patients. Some bathing facilities shall have grab bars, and there shall be a sufficient number of facilities with grab bars to accommodate disabled patients. Wheelchair accessible facilities shall be available. 6.16 SERVICE FACILITIES. The following service areas shall be provided and located conveniently for patient care: 6.16.1 Patient care center (nursing station) which provides a communication system with other hospital departments. 6.16.2 Medical record recording facilities.

6.16.3 Medicine preparation area. 6.16.4 Clinical supply area. 6.16.5 Soiled linen holding area. 6.16.6 Janitor's closet. 6.16.7 Nourishment station. 6.16.8 Clinical examination and treatment room. 6.16.9 Clean linen area. 6.17 PATIENT CARE CENTER. (Nursing Station.) The patient care center (nursing station) shall be adequately designed and equipped to meet patient care and program needs. 6.18 MEDICATION PREPARATION AREA. 6.18.1 The medication preparation area shall, as a minimum, be equipped with: 1) cabinets with suitable locking devices to protect drugs stored therein; 2) refrigerator equipped with thermometer and used exclusively for pharmaceutical storage and powered from the critical branch of the essential electrical system; 3) counter work space; 4) sink, with approved handwashing facilities; 5) antidote, incompatibility, and metriapothecary conversion charts. 6.18.2 Only medications, equipment, and supplies for their preparation and administration shall be stored in the medication preparation area. Test reagents, general disinfectants, cleaning agents, and other similar products shall not be stored in the medication preparation area. 6.19 CLINICAL SUPPLY AREA. There shall be a clinical supply area adequately designed and equipped to meet supply needs of the psychiatric patient care unit. 6.20 CLEAN LINEN AREA. There shall be a separate closed area with adequately designed supply space or a separate room for clean linen supplies. 6.21 SOILED LINEN HOLDING ROOM. There shall be a soiled holding room equipped with: 1) suitable counter sink, mixing faucet, blade controls, soap and sanitary hand-drying facility. (In case of new hospital construction, or modification of an existing hospital facility, the sink must be two compartments); 2) waste container with cover (foot controlled recommended) and impervious disposable liner; 3) soiled linen cart or hamper with impervious liner; 4) adequate shelf and counter space; 5) a clinical flushing sink; 6) continuous mechanical exhaust ventilation to the outside. 6.22 JANITOR'S CLOSET. There shall be a janitor's closet equipped with: 1) sink, preferably a floor receptor, with mixing faucet; 2) hook-strip for mop handles from which soiled mopheads have been removed; 3) shelving for cleaning materials; 4) approved handwashing facilities (in case of new hospital construction or modification of an existing hospital facility, the floor receptor cannot be considered as a handwashing facility); and 5) waste receptacle with impervious liner. The floor area should be adequate to store mop buckets on a roller carriage and floor cleaning equipment. 6.23 NOURISHMENT STATION.

6.23.1 A nourishment station where food is prepared shall include a sink equipped for handwashing, equipment for serving nourishment between scheduled meals, refrigerator, and provision for adequate storage. 6.23.2 In the case of a patient care unit which includes a dining room conveniently located thereto, the dining room may be equipped to serve as the nourishment station. 6.24 PERSONNEL TOILET FACILITIES. Toilet facilities shall be provided for personnel on each patient care unit. 6.25 EMERGENCY EQUIPMENT AND SUPPLIES. The following shall be readily available at all times: 1) oxygen; 2) suction; 3) portable emergency equipment, supplies and medication; 4) compatible supplies and equipment for intravenous therapy. 6.26 THERMOMETER. A disinfected thermometer shall be used each time a patient's temperature is taken. 7. PATIENT CARE POLICIES 7.1 WRITTEN POLICIES. Written policies and procedures designed to ensure provision of good patient care shall be established, reviewed, and revised as needed, by the medical staff and followed in the course of the daily psychiatric hospital operation. 7.2 MEDICAL CARE. A psychiatric/medical staff qualified according to medical staff written by-laws and policies shall provide diagnostic consultation service for the care and treatment of patients admitted for psychiatric disorders, and for those patients who, in the course of hospitalization, experience a medical illness. 7.3 NURSING. The nursing care shall be under the direction of a registered nurse qualified by training, experience, and ability to direct effective psychiatric nursing. At least one registered nurse so qualified shall be available and on duty at all times for each patient care unit. One registered nurse shall be designated in charge and shall be delegated the authority and responsibility for the nursing -services on the patient care unit. Additional registered nurses, licensed practical nurses, or other auxiliary personnel shall be available as needed. The nursing care required by different types of patients shall be the major consideration in determining the number, quality, and category of the nursing personnel that are needed in any given situation. 7.4 PHYSICIAN ORDERS. Medications and treatment shall be given only on the orders of a physician. 7.4.1 Medication orders shall be received only by a physician, pharmacist or registered nurse. These orders shall be written; shall include the date and specifications of the order; name of the provider of the order; and the name of the person receiving the order. 7.4.2 Physician orders for other types of treatment may be received by members of the appropriate discipline as specified and approved by the medical staff, nursing service, and the governing board. 7.4.3 Orders shall be transferred by a member of the specific discipline responsible for implementing the order to the patient records. 7.5 DANGEROUS DRUGS. Orders prescribing dangerous depressant and hallucenogenic drugs, as defined by C.R.S., 1973, 12-22-403, and narcotics as defined by C.R.S. 1973, 12-22-301 (16) shall include a time limit not to exceed 72 hours unless otherwise specified by the attending physician. Such time limits shall be agreed upon by the medical staff and shall be so recorded in the policies and procedures of the medical staff.

7.6 MEDICATION IDENTIFICATION. 7.6.1 Medication shall be identified with at least the name, strength, dosage, and frequency and mode of administration of the medication, and the name of the patient for whom the medication is prescribed. 7.6.2 This identification shall be verified, not only when the medicine is prepared, but also when it is administered. 7.6.3 Unused prepared medication shall be disposed of in accordance with documented procedures. 7.7 MEDICATION RECORDING. All medication shall be recorded on the patient's medical record and include the name, dosage, mode of administration of medication and the date, time, and signature of the person administering. 7.8 INVESTIGATIONAL DRUGS. When nurses administer investigational drugs, they shall have documented basic information available concerning such drugs including dosage forms, strengths available, actions and uses, side effects, including methods to combat them, symptoms of toxicity, and contra-indications for use. (See Section 20.6) 7.9 SECLUSION AND RESTRAINT. Confinement of patients in secure rooms and physical restraints shall be used only when necessary to prevent injury to the patient or others, and only when other measures are not sufficient to accomplish the purpose. Written policies shall be established relative to the use of secure rooms and restraints and such use shall be documented in the medical record. 7.10 PATIENT CARE PLANS, Patient care plans shall be prepared for each patient. This may be accomplished, when appropriate, at a care planning conference by a treatment team (including the attending physician). The plan shall be reviewed and revised as needed. 7.11 TREATMENT TEAM. When, in the opinion of the attending physician, it is appropriate for a patient's care to utilize other health professionals, a coordinated treatment team may be used. Such a team may be, as appropriate, composed of psychologists, registered nurses, licensed practical nurses, social workers, mental health workers, recreational staff therapists, and psychiatric technicians, and others. The use of this treatment team approach is encouraged. 7.12 POSTING PATIENT RIGHTS POLICIES. The psychiatric hospital shall conspicuously post a patient rights statement as required by Section 30.5.1, as well as the names of responsible persons to whom complaints may be registered. 8. PHYSICAL MEDICINE SERVICE 8.1 PHYSICAL MEDICINE SERVICES. When physical medicine services are provided, there shall be a written plan describing how physical medicine service shall be provided, or arrangement for such services if not provided directly by the hospital, to meet patient needs. 8.2 Physical medicine services shall be provided by an adequate, qualified staff that receives competent medical direction. 8.3 Physical medicine services shall be initiated only upon the written prescription of the responsible physician, shall be under a written plan of care and shall be regularly evaluated. 8.4 A written plan shall be established for the referral of patients for evaluation and treatment for services

not provided. 8.5 When physical medicine services are provided within the psychiatric hospital, there shall be adequate space, equipment and facilities to fulfill the professional, educational and administrative needs of the service. 9. CHILD/ADOLESCENT PSYCHIATRIC PATIENT CARE UNIT 9.1 If the facility admits children or adolescents, it shall comply with the requirements of this section in addition to the other requirements of these regulations. 9.2 Children and adolescents may be admitted to an adult unit if specifically ordered by the attending physician, but shall not remain there more than two weeks unless the attending physician specifically orders that the child or adolescent remain on the adult unit. 9.3 A separate child/adolescent psychiatric patient care unit shall be provided when the annual average child/adolescent patient care daily census requires ten or more beds. A mental health professional with training in child/adolescent psychiatry shall be responsible for the treatment provided by this service. 9.4 If a child/adolescent psychiatric patient care unit is established, it shall provide: 9.4.1 Facilities for organized activities, play, and education programs for all children/adolescents within the limits of their abilities to participate. 9.4.2 A room with washable tables and chairs of various sizes, storage for equipment and supplies, and appropriate entertainment materials. 9.4.3 An examination and treatment room with equipment and supplies appropriate for the care of children. 9.4.4 Rooms designed to facilitate grouping patients according to mental status and age groups. 9.5 NURSING. Child/adolescent psychiatric nursing care shall be under the direction of a registered professional nurse, qualified by training, experience and ability to direct effective child/adolescent psychiatric nursing. All nursing personnel assigned to care for children/adolescents shall be trained in their special characteristics and needs. 10. ACTIVITY THERAPY 10.1 DEFINITION. Activity therapy is that treatment designed to develop personal, occupational and recreational skills and enhance the patient's ability to function independently. Activity therapy includes, but is not limited to: occupational therapy, recreational therapy, dance therapy, music therapy, art therapy, and horticulture therapy. 10.2 ORGANIZATION. Activity therapy services shall be available to all patients. For those activity therapy services provided, there shall be written policies by the medical and nursing staffs identifying the organization, administration, performance standards, records, and direction and supervision of patient care rendered. Activity therapy services, when provided, shall be under the supervision of individuals qualified by training and experience to do so. 10.3 FACILITIES. There shall be adequate facilities, space appropriate equipment and storage areas as determined to be essential to meet the needs of the referred patients for activity therapy services. 11. MEDICAL RECORDS

11.1 FACILITIES. Each psychiatric hospital shall provide a medical record department and other medical record facilities with supplies and equipment for medical record functions and services. This department shall include: 11.1.1 Active record storage area. 11.1.2 A suitable space for record review and dictation by physicians and other appropriate staff. 11.1.3 Work area for sorting, recording, typing, filing, and other assigned medical record functions. This work area shall be separate from the record review and dictating room. Accommodations shall be provided for conducting medical record business with hospital personnel or other individuals with legitimate right of access to medical records. 11.1.4 Medical record storage area within the department, where medical records may be stored safely, providing protection from loss, damage, and unauthorized use. 11.1.5 Inactive medical record storage area including storage of microfilmed records, if any. 11.2 Security measures shall be maintained by mechanical means, in the absence of medical record supervision, to preserve confidentiality and to provide protection from loss, damage, and unauthorized use of the medical records. 11.3 PRESERVATION. With the exception of medical records of minors (individuals under the age of 18 years), medical records shall be preserved as original records or on microfilm for no less than ten years after the most recent patient care usage, after which time records may be destroyed at the discretion of the facility. 11.3.1 Medical records of minors shall be preserved for the period of minority plus ten years (i.e., 28 years less age of minor at time of most recent patient care usage of the medical record). 11.3.2 Facilities shall establish procedures for notifying patients whose records are to be destroyed prior to the destruction of such records. 11.3.3 The sole responsibility for the destruction of all medical records shall be with the psychiatric hospital involved but in no case shall records be destroyed prior to consultation with legal counsel. 11.3.4 Nothing in this section shall be construed to affect the requirements for the destruction of public records as set out in Part I of Article 80 of Title 24, C.R.S., 1973. 11.4 MEDICAL RECORDS COMMITTEE. There shall be a Medical Records Committee that supervises and appraises the quality of medical records. 11.5 PERSONNEL. A registered record administrator or other trained medical record practitioner shall be responsible for the administration and functions of the medical record department. 11.5.1 There shall be a sufficient number of regular full-time and part-time employees so that medical record services may be provided as needed. 11.6 ENTRIES. All orders for diagnostic procedures, treatments, and medications shall be signed by the person submitting them and entered in the medical record in ink or type. The prompt completion of the medical record shall be the responsibility of the attending physician. 11.6.1 Only members of the medical staff, or other members of the treatment team with approval of the medical staff, shall write or dictate psychiatric or medical histories and physical

examinations. 11.6.2 Only members of the dental staff or dental house staff shall write or dictate the dental histories and examinations. 11.6.3 Authentication may be by written signature, identifiable initials or computer key. The use of rubber stamp signatures is acceptable under the following strict conditions: 11.6.3.1 The physician whose signature the rubber stamp represents is the only one who has possession of the stamp and is the only one who uses it; and 11.6.3.2 The physician places in the administrative offices of the hospital a signed statement to the effect that he is the only one who has the stamp and is the only one who will use it. 11.6.4 The admission history shall be completed within 24 hours of the patient's admission. 11.6.5 The admitting diagnosis and physical examination shall be completed within 48 hours after the patient's admission. 11.7 CONTENT. A complete medical record shall be maintained on every patient from the time of admission through the time of discharge, containing sufficient information to justify the diagnosis and treatment and indicate the patient's progress. Patients' records shall include: 11.7.1 ADMISSION AND DISCHARGE RECORD: Date and time of admission and discharge. Adequate identification and sociological data including hospital number assigned to patient; legal status and justification for involuntary commitment (if appropriate) and continued confinement; admitting diagnosis; final diagnosis based on “Diagnostic and Statistical Manual of Mental Disorders,” American Psychiatric Association, Washington, D.C.; secondary diagnosis and complications; operative procedures when applicable; condition on discharge; and signature of attending physician. 11.7.2 PSYCHIATRIC/MEDICAL DATA: Chief complaint and present illness; past, family, social, and personal history; physical examination reports; provisional diagnosis; treatment goals and patient treatment program; progress notes entered not less than once a week; description of experimental and other therapies which may entail a substantial or catastrophic risk; discharge plans and plans for post-discharge treatment, if any, including consideration of placement in other facilities and community settings; reports of any special examinations conducted, including but not limited to clinical and pathological laboratory findings, X-ray findings; psychological testing; vocational aptitude testing; reports of consultations by consulting physicians or other consultants when applicable; treatment and progress notes signed by the person entering the note giving the discipline of the person; complete surgical and dental reports, when applicable; type and amount of restraints used; condition on discharge; final diagnosis; autopsy protocol, if any; discharge summary; and signed permission for any special therapies, when applicable. settings; reports of any special examinations conducted, including but not limited to clinical and pathological laboratory findings, X-ray findings; psychological testing; vocational aptitude testing; reports of consultations by consulting physicians or other consultants when applicable; treatment and progress notes signed by the person entering the note giving the discipline of the person; complete surgical and dental reports, when applicable; type and amount of restraints used; condition on discharge; final diagnosis; autopsy protocol, if any; discharge summary; and signed permission for any special

therapies, when applicable. 11.7.3 NURSING RECORDS. 11.8 TREATMENT IN ANOTHER HOSPITAL. During the course of treatment, efforts should be made to obtain summary records of the treatment provided to the patient in another hospital, if applicable to the admission, and if directed by the attending physician. 11.9 HOSPITAL RECORDS. The following hospital records shall be maintained : Daily census; admissions and discharges analysis records; diagnostic index; physician index; number index; death register; patient master card file; and register of out-patient and emergency room admissions and visits when applicable. 11.10 ACCESS TO PATIENTS' RECORDS. Patients and their designated representatives shall have access to their medical records as prescribed by C.R.S. 1973, 25-1-801 and the regulations issued pursuant thereto in 6 C.C.R. 1011-1, Chapter 5, of the Department of Health's Standards for Hospitals and Health Facilities. 12. NURSING SERVICE 12.1 ORGANIZATION. The nursing service shall be organized formally to provide complete, effective nursing care to each patient. The authority and responsibility of each nurse and nursing personnel shall be defined clearly in written policies. 12.2 DIRECTOR OF NURSING SERVICE. The Nursing Service shall be under the direction of a registered professional nurse, who is a graduate of an accredited school of nursing and who is licensed currently by the Colorado State Board of Nursing. Additionally, the director shall have a minimum of two (2) years experience in psychiatric nursing, supervision, and nursing administration. 12.3 REGISTERED NURSE SUPERVISION. Licensed practical nurses and auxiliary nursing personnel shall be assigned only those duties for which they are qualified and shall be under the direct supervision of a registered nurse. 12.4 WRITTEN PROCEDURES. 12.4.1 There shall be written nursing procedures that establish the standards of performance for safe, effective nursing care of patients. These procedures shall be reviewed periodically and revised as necessary. 12.4.2 There shall be a plan for continuous evaluation of nursing care, including that of private duty personnel. 12.4.3 The Nursing Service shall have an organized method for periodic evaluation of the adequacy of facilities in terms of patient and nursing needs. 12.5 MASTER STAFFING PLAN. There shall be a master plan of nurse staffing for providing continuous registered nurse coverage, for distribution of nursing personnel, for placement of nursing personnel and for forecasting future needs. The nursing care required by different types of patients shall be the major consideration in determining the number, quality and category of nursing personnel that are needed in any given situation. 13. OUTPATIENT SERVICES 13.1 OUTPATIENT SERVICES. Outpatient services shall be organized to provide facilities, equipment,

and personnel who are qualified by training, experience, and ability to care for individuals who come to the psychiatric hospital on an outpatient basis. 13.2 POLICIES. There shall be specific written policies for admissions and discharge of patients, physician responsibility, staffing, procedures for individual patient care treatment plans, and equipment and supplies. 13.3 PERSONNEL. There shall be such professional and non-professional personnel as required for efficient operations 13.4 FACILITIES. In addition to appropriate interview and treatment facilities, the following shall be provided: 1) a waiting area; 2) public toilet facilities; 3) public phone; and 4) drinking fountain. 13.5 MEDICAL RECORDS. Medical records shall be maintained, and maintained together with other hospital records. Information contained in the medical record shall be complete and sufficiently detailed relative to diagnosis and treatment to facilitate continuity of care. 14 COMMUNICABLE DISEASE CONTROL PROGRAM 14.1 COMMUNICABLE DISEASE CONTROL PROGRAM. There shall be a communicable disease program of the nature and extent determined by the medical staff to be appropriate for the hospital. 14.2 INFECTIONS COMMITTEE. There shall be a multidisciplinary infections committee charged with the responsibility of investigation and recommendations for the prevention and control of communicable diseases in the psychiatric hospital. 14.2.1 POLICIES. The committee shall be responsible for all psychiatric hospital policies and procedures related to communicable disease control including the following: 1) the admission and isolation of patients with specific communicable diseases, and protective isolation of appropriate patients; 2) the control of routine use of antibiotics and adrenal cortical steroids; 3) the review and revision of policies and procedures for communicable disease surveillance and control; 4) the inservice education programs on the control of communicable diseases; 5) the reporting of diseases as required by statute and regulations pertaining to disease control of the Colorado Department of Health. 14.2.2 FINDINGS. The committee shall make findings and recommendations available promptly to a designated individual for action. 14.2.3 MEETINGS. It is recommended that the committee meet at least quarterly and that it meet more frequently if it judges this is necessary. 14.3 PATIENT ISOLATION. Psychiatric hospitals shall observe the rules pertaining to isolation of patients as provided in United States Department of Health Education and Welfare, Center for Disease Control, Isolation Techniques for Use in Hospitals (2nd Ed. 1975). 14.4 PATIENTS WITH COMMUNICABLE DISEASES. The medical staff shall judge which patients with communicable disease are within the capacity of the hospital to treat in keeping with the rules referred to in 14.3, above. 14.5 TRANSFER TO A GENERAL HOSPITAL. Patients with serious infectious or communicable diseases shall be transferred to a general hospital for appropriate treatment. 15 DIETARY SERVICES 15.1 ORGANIZATION. There shall be an organized food service, planned, equipped, and staffed to serve

adequate meals to patients according to physicians' orders, or a contractual arrangement that provides its own food service The following standards shall apply: 15.2 PERSONNEL. A dietitian or person qualified by training and experience in food service shall direct the dietary service. 15.3 POLICIES. Policies and procedures for dietary practices shall be written. 15.4 ORDERS. All diets and nourishments shall be served as prescribed by the attending physician. 15.5 DIET MANUAL. A diet manual shall be available to medical staff and personnel for fulfilling dietary prescriptions. 15.6 MENUS. Menus as served shall be planned at least one week in advance. Personal tastes, desires, and cultural patterns of patients shall be considered and reasonable menu adjustments made. The menus should be posted in the kitchen area, and after use should be filed for at least four weeks. Menus should meet requirements of the Recommended Dietary Allowances for Food and Nutrition Board, National Research Council, 1968. 15.7 SPACE. Adequate space shall be provided to allow for fixed and movable equipment, employee functions, receiving and storage, refrigeration, food preparation, and dishwashing and scullery. 15.8 CODES. Food service design, equipment, and practices shall be in accordance with the Rules and Regulations Governing the Sanitation of Food Service Establishments in the State of Colorado, Colorado Department of Health, 1978, 6 C.C.R. 1010-2. 15.9 FOOD SERVICE. All food served shall be from approved sources and shall meet the standards of quality as established by applicable laws and regulations. Food prepared outside the psychiatric hospital shall be from sources that comply with applicable laws and regulations. 15.10 STOREROOMS. Clean, well-ventilated food storerooms shall be provided. Food when being stored, prepared, displayed, served, or sold shall be protected from contamination. 15.11 STORAGE. Containers of food shall be stored above the floor on clean racks, dollies, or other clean surfaces to protect from contamination. 15.12 REFRIGERATION. A minimum of two units of refrigeration shall be provided to protect foods kept on hand. Refrigerators and storerooms used for perishable foods shall be equipped with reliable thermometers. 15.13 REFRIGERATOR SAFETY. Walk-in refrigerators and freezers shall have inside lighting and inside lock releases, or an audio-visual signal system as a suitable safety device. 15.14 PERISHABLE FOODS. Potentially hazardous foods shall be maintained at a temperature of 45°F or below, or 140 F or above. Potentially hazardous foods shall mean any food that consists in whole or in part of milk or milk products, eggs, meat, poultry, fish, shellfish, edible Crustacea, or other ingredients capable of supporting rapid and progressive growth of infectious or toxigenic microorganisms. This term does not include clean, wholly uncracked, odor-free shell eggs. 15.15 TOXIC MATERIALS. Poisonous and toxic materials shall be labeled, stored separately from food, and used only in such ways that they will neither contaminate food nor be hazardous to employees. 15.16 UTENSILS. Convenient and suitable utensils, including self-service, such as forks, knives, tongs, and spoons shall be used to handle food at all points where food is prepared and served.

15.17 DISPLAYED FOOD. Unwrapped food on display for service shall be protected against contamination by counter-protector devices. Food being conveyed should be covered, completely wrapped or packaged to protect from contamination. 15.18 HANDWASHING. Employees shall wash their hands thoroughly in an approved handwashing facility before starting work and as often as may be necessary to remove soil and contamination. 15.18.1. Each employee shall wash his hands before resuming work after visiting the toilet. 15.19 HEAD PROTECTION. All dietary employees shall wear hair nets, headbands, caps, or other effective hair restraints. 15.20 TOBACCO. Employees shall not use tobacco in any form while engated in food preparation, service, or equipment washing areas. 15.21 EQUIPMENT. Adequate equipment shall be provided for efficient preparation of meals. Equipment and utensils should be resistant to denting, pitting, chipping, and excessive wear; should withstand repeated scrubbing, scouring, and corrosive action of cleaning and disinfecting agents; and should be in good repair. 15.22 EQUIPMENT QUALITY. 15.22.1 Food-contact surfaces of equipment and utensils shall be smooth; free from breaks, open seams, cracks, chips, and similar imperfections; and free of difficult-to-clean internal corners and crevices. 15.22.2 Cutting blocks, boards, and table tops should be of hard material which is non-toxic; smooth; and free of cracks, crevices, and open seams. 15.23 COUNTER EQUIPMENT. Equipment on tables or counters, unless readily movable, shall be installed so as to facilitate cleaning and safety. 15.24 FLOOR-MOUNTED EQUIPMENT. Floor-mounted equipment, unless readily movable, shall be installed so as to facilitate cleaning and safety. 15.25 SILVERWARE. Facilities and systems for storage of silverware shall be designed and maintained to prevent contamination. 15.26 CUPS AND GLASSES. Clean cups and glasses shall be handled so as to prevent contamination. 15.27 DISINFECTION. Portable equipment and utensils shall be cleaned, disinfected, and stored above the floor in a clean, dry location. 15.27.1 Utensils shall be air-dried before storing. 15.27.2 Stored containers and utensils shall be covered or inverted. 15.28 SERVING UTENSILS. Disposable serving utensils shall be stored, handled, and dispensed to prevent contamination, and shall be used only once. 15.29 ISOLATION. Food served to patients in isolation, because of infectious diseases, shall be in disposable utensils or in utensils that shall be sterilized. 15.30 MECHANICAL WASHING.

15.30.1 If washable dishes are used, commercial-type mechanical dishwashing equipment shall be provided equipped with an easily readable thermometer in each tank. In case of new hospital construction, or modification of an existing hospital facility, this equipment shall be physically separated from food preparation and service areas. 15.30.2 Equipment and utensils shall be pre-flushed or pre-scraped and, when necessary, presoaked to remove soil. A suitable detergent in effective concentration shall be used. Wash water shall be kept reasonably clean, and washing cycle properly timed. The wash water temperature shall be compatible with the detergent used. 15.30.3 The final rinse water shall be unused water at temperature not less than 180°F manifold temperature, 170 F on the surface of the dishes. Rinsing cycles shall be timed accurately. In case of new psychiatric hospital construction, or modification of an existing psychiatric hospital facility, the dishwash room must be arranged such that clean dishes are discharged from the dish machine onto a clean dish table outside of the dishwash room. Only air drying shall be employed after washing and rinsing. 15.30.4 A All dishes and utensils shall be stored in clean, dry areas, free of contamination. 15.31 MANUAL WASHING 15.31.1 Utility ware, pots, pans, and similar utensils shall be cleaned in an area separated from the dishwashing operation. In case of new psychiatric hospital construction, or modification of an existing psychiatric hospital facility, this area must be physically separated from the dishwashing operation. 15.31.2 Separate two-compartment sinks are required for manual washing operations, and they shall be of such length, width and depth to permit complete immersion of equipment and utensils. In the case of new psychiatric hospital construction, or modification of an existing psychiatric hospital facility, each compartment shall be supplied with hot and cold water under pressure through a mixing faucet. 15.32 DRAINBOARDS. Separate drainboards shall be used for soiled utensils prior to washing and for clean utensils following disinfecting. 15.33 LIGHTING. Areas for preparing food, and storing and cleaning utensils shall be adequately lighted. 15.34 VENTILATION. Rooms for preparing and serving food and washing utensils shall be well ventilated. 15.35 TOILET FACILITIES. Adequate, clean toilet facilities shall be provided. 15.36 HANDWASHING FACILITIES. Approved handwashing facilities with soap and sanitary hand-drying accommodations shall be conveniently provided. In the case of new psychiatric hospital construction, or modification of an existing psychiatric hospital facility, this must be provided within the kitchen area. 15.37 WASTE. Garbage and refuse shall be placed in impervious containers equipped with tightly fitting covers. Containers shall be stored in a safe area or refrigerated space pending removal and shall be removed from the premises and cleaned at frequent intervals. 15.38 WASTE GRINDERS. Food waste grinders shall be installed in compliance with applicable laws and regulations. 15.39 INFESTATION. Storage rooms, loading docks, and premises shall be free from rodent and insect infestation, odors, dust and other sources of contamination.

15.40 NEW HOSPITAL CONSTRUCTION OR MODIFICATION OF AN EXISTING FACILITY. In the case of new psychiatric hospital construction, or modification of an existing psychiatric hospital facility, the following shall apply: 15.40.1 CART WASHING. Cart washing space shall be provided in the dishwashing area. Hot water and a floor drain shall be provided in this area. 15.40.2 LOUNGE. A lounge, complete with clothes storage facilities and toilet facilities for the dietary staff shall be provided near the kitchen. 15.40.3 DINING AREA(s) shall be provided for staff and patients, and a snack facility shall be provided for visitors. 16 DISASTER PLAN 16.1 Each psychiatric hospital shall have a well-defined plan for the provision of services in the event of a disaster. This plan shall account for a disaster occurring in the community as well as in the psychiatric hospital itself. The plan shall relate to community need, community resources, and the capability of the hospital, and shall be coordinated with other community disaster planning programs and resources. 17 ANESTHESIA AND GASES 17.1 In psychiatric hospitals in which anesthetic agents are used in Electro-convulsive Therapy and other psychiatric procedures, practices employed in the administration of anesthesia shall be consistent with the written policies of the medical staff. 17.2 FACILITIES. There shall be facilities and equipment for the administration of anesthesia which are commensurate with the clinical procedures and programs conducted within the hospital. 17.3 STAFF. Anesthesia utilized in Electro-convulsive Therapy or in other psychiatric procedures shall be administered only by a physician qualified by training, experience, and ability to do so, or by a registered nurse anesthetist graduated from a certified school and who is under the supervision of the attending physician. 17.3.1 In the case of dental treatment, a dentist may administer local anesthetics. 17.4 A written plan shall be established for the referral of patient for evaluation and treatment for services requiring anesthesia which are not provided in the facility. 17.5 ANESTHESIA MACHINES. Persons administering anesthesia shall ensure that anesthetic gas cylinders are installed properly on machines that are pin-indexed. 17.6 NURSING. Patients recovering from anesthesia shall remain under continuous care of a registered nurse. Nurses shall have been instructed in the care of post-anesthetic patients, shall have no other duties during the time they are caring for such patients, and shall have facilities for immediate communication with the attending surgeon, anesthesiologist, or qualified substitute person at the hospital. 17.7 EQUIPMENT STERILIZATION. Anesthesia equipment shall be cleaned properly and sterilized after each use, except multi-use heat sensitive equipment may be disinfected using a process that is bactericidal, tuberculocidal and virucidal. Hypodermic needles, syringes and allied equipment shall be sterilized, in accordance with written procedures. 18 CENTRAL MEDICAL SUPPLY 18.1 SERVICES. All psychiatric hospitals shall provide central medical supply services appropriate to the

needs of the patients served in the programs of the hospital. 18.2 SUPPLIES. All medical supplies shall be received, stored, and distributed under conditions adequate to maintain the quality of the supplies for the purpose for which they are intended and appropriate control and availability of the use of the supplies. 18.3 STERILIZATION CONTROLS. Continuous supervision shall be maintained throughout the receiving, cleaning, processing, sterilizing and storing. Boiling water is prohibited as a method of sterilization. A combination of controls or indicators shall be used to determine effectiveness of sterilization process. Bacteriological methods shall be used to evaluate the effectiveness ofsterilization, by at least monthly cultures with records being maintained. 18.4 ORGANIZATION. A central medical supply service shall be organized as a unit under the immediate supervision of a person who is competent in management, asepsis, supply processing, and control methods. 19 CLINICAL PATHOLOGY 19.1 SERVICES. Clinical pathology services shall be made available as required by the needs of the patients as determined by the medical staff. The services shall be provided within the psychiatric hospital or by contract with the pathology department of another hospital or with a private practitioner of pathology and of a quality consistent with standards enumerated below. 19.2 EMERGENCY SERVICE. Emergency laboratory services shall be made available either through facilities of the psychiatric hospital itself or by contract with an appropriate provider. 19.3 IN-HOSPITAL LABORATORY SERVICE. Whenever a psychiatric hospital provides its own laboratory services, the following shall apply: 19.4 SPACE. 19.4.1 The psychiatric hospital shall provide within the hospital adequate space for a laboratory. 19.4.2 Workbench space shall be ample, well lighted, and convenient to sink, water, gas, suction, and electrical outlets as necessary. 19.4.3 There shall be adequate storage space for supplies. 19.5 PERSONNEL. 19.5.1 PATHOLOGIST. The laboratory shall be under the supervision of a physician, certified in clinical pathology, either on a full-time, part-time, or consulting basis. The pathologist shall provide, at a minimum, monthly consultative visits. The pathologist shall coordinate with the administrator in the hiring of laboratory personnel to help ensure all technologists are adequately qualified to carry out the duties required of them. 19.5.2 TECHNOLOGISTS. There shall be a sufficient number of clinical laboratory technologists, qualified by training and experience, to promptly and proficiently perform the laboratory tests and examinations required of them. 19.6 QUALITY CONTROL 19.6.1 INTERNAL QUALITY CONTROL, (a) There shall be an adequate quality control program in effect including the use, where applicable, of reference or control area and other biological samples, concurrent calibrating standards, and records of all standard and control readings, (b)

All reagents, chemicals, and microbiological culture media shall be adequately labeled, to include the date received, opened, and/or prepared. Outdated supplies shall be promptly discarded. 19.6.2 EXTERNAL QUALITY CONTROL, (a) To the extent that the State Health Department provides proficiency testing services in one or more of the laboratory specialties, the laboratory shall either participate in the program in all specialties in which it performs tests or it shall participate in another similar program which has been approved by the State Health Department, (b) Tests shall not be performed in those specialties in which the laboratory fails to achieve a satisfactory performance in the state-operated or state-approved proficiency testing program. 19.7 EQUIPMENT. All equipment shall be in good working order, be routinely checked and be precise in terms of calibration. 19.7.1 A schedule of preventive maintenance shall be set up for all equipment. 19.7.2 A record of all preventive maintenance, repair, and calibration shall be kept on each item of equipment. 19.8 POLICIES AND PROCEDURES. 19.8.1 A manual outlining all procedures performed in the laboratory shall be complete and readily available for reference. 19.8.2 The conditions and procedures for referring specimens to another laboratory shall be in writing and available in the laboratory. 19.9 RECORDS. A record system shall be established which ensures that specimens are adequately identified, properly processed, and permanently recorded. 19.9.1 Original copies of all test results shall be posted in the patient's medical record, to include reports of tests referred to another laboratory. 19.9.2 Duplicate copies of all reports shall be kept in the laboratory, in a manner which permits ready identification and accessibility, for at least four years plus the current fiscal year. 19.9.3 All laboratory work shall be ordered by a physician or a person authorized by law to use the results of such findings. 19.10 FIRE AND SAFETY. There shall be established practices and procedures which will ensure that the patients and employees are protected from unnecessary physical, chemical, and biological hazards. 19.10.1 Fume hoods shall be available where needed. 19.10.2 If tests are performed in the specialties of mycobacteriology, mycology, and/or virology, the laboratory shall be equipped with a microbiological safety cabinet, with an adequately filtered exhaust system. 19.10.3 Vacuum breakers shall be present on sinks where specimens are handled or discarded to ensure that the water supply is not contaminated. 19.10.4 Adequate precautions for discarding specimens shall be in use - sterilization, incineration, or both. 20 PHABMACEUTICAL SERVICES

20.1 ORGANIZATION. The pharmaceutical services of the psychiatric hospital shall be organized and maintained primarily for the benefit of the hospital patients, and shall be operated in accordance with Federal and State laws and regulations. 20.1.1 The pharmacy service shall be under the direction or supervision of a pharmacist registered to practice pharmacy in the State of Colorado. 20.1.2 Written policies shall be developed by the psychiatric hospital and the supervising pharmacist to indicate his responsibility for periodic inspection of medications, dispensing, inventory control, and establishment of necessary records. 20.1.3 The pharmaceutical services for the psychiatric hospital may be contracted. The quality of the contract service shall be consistent with the standards enumerated below for a pharmaceutical service provided by the psychiatric hospital itself. 20.2 POLICIES. The pharmacist shall initiate and develop policies of the department, in conformity with the requirements of the State Board of Pharmacy. 20.3 PHARMACY AND THERAPEUTICS COMMITTEE. There shall be a hospital pharmacy and therapeutic committee to assist in the formulation of broad professional policies regarding the evaluation, selection, procurement, distribution, use, safety procedures, and other matters relating to drugs in hospital. 20.4 PHARMACIST RESPONSIBILITIES. A pharmacist's responsibility shall include: 1) preparation of pharmaceuticals; 2) filling and labeling of all drug containers from which medications are to be administered; 3) dispensing of drugs, antibiotics, biological, and pharmaceutical preparations which shall meet the standards established by the United States Pharmaceopeia, National Formulary, of New and Non-Official Drugs; 4) dispensing of narcotics, hypnotics, amphetamines, alcohol preparations and the maintenance of perpetual inventory of them; 5) maintenance of an approved stock of antidotes and emergency drugs; 6) periodic inspection of all pharmaceuticals and biological supplies on all services; 7) distribution of information concerning medications to physicians, dentists, and nurses; 8) preparation, sterilization, and analysis of injectable medications when compounded in the pharmacy; 9) establishment and maintenance of a system of records and accounting in accordance with psychiatric hospital policies. 20.5 NARCOTICS. Only physicians who are so authorized under the laws, of the State of Colorado and are registered with the Director of Internal Revenue, shall prescribe narcotics. In case of recurring shortages or loss of significant quantities of narcotics, a copy of report of investigation shall be forwarded to the District Supervisor of the Bureau of Narcotics, in accordance with Treasury Regulations No. 5, 1964. 20.6 INVESTIGATIONAL DRUGS. Investigational drugs, as defined by federal law (C.F.R. 21, Subpart A, Part 312.1), shall be used only under direct supervision of the principal investigator and with recorded evidence of full knowledge of and approval of the medical staff, pharmacy and therapeutics committee, and psychiatric hospital administration. 20.6.1 Investigational drugs shall not be administered to any patient until such patient has given informed consent for the use of such Investigational drugs. 20.6.2 The principal investigator shall be a member of the medical staff and shall assume responsibility for securing patient's consent prior to administration of the drug. 20.7 FACILITIES. Facilities shall be provided for the storage, safe-guarding, preparation, and dispensing of drugs with proper lighting, temperature, control, ventilation, and sanitation facilities. 20.7.1 In addition to adequate safeguards for all drugs, special safety precautions shall be taken

for the storage ofalcohol. 20.8 REFRIGERATION. A refrigerator with thermometer and freezing compartment shall be provided for the proper storage of thermolabile products. 20.9 STANDARD REFERENCES. The latest revisions of U.S. Pharmacopeia, National Formulary, New and Non-Official Drugs, and Toxicology and Therapeutics shall be available. 20.10 FIRE EXTINGUISHERS. Adequate fire extinguishers shall be installed in the pharmacy. 21 RADIOLOGICAL SERVICES 21.1 FACILITIES. Psychiatric hospitals shall provide within the facility, or by contracted services, adequate space and fixed equipment for diagnostic X-ray examinations, including facilities or the development and storage of radiographic film. 21.1.2 CONTRACT. When radiological services are provided by contract, the characteristics of the contracted service shall be consistent with the standards enumerated below for a service provided by the psychiatric hospital itself. 21.2 ORGANIZATION. The X-ray department shall be under the supervision of a full-time consulting radiologist whose professional competence has been determined by the organized medical staff. If radiotherapy is provided, the physician in charge shall be qualified appropriately. 21.3 SAFETY. The psychiatric hospital shall ensure that all X-ray equipment is operated under adequate professional supervision by competent personnel trained in the use of X-ray equipment and familiar with safety precautions as set forth by the National Bureau of Standards and Colorado Department of Health. 21.4 MEDICAL RECORD. A written report of the findings and evaluation of each X-ray examination or treatment shall be signed by the physician responsible for the procedure and shall be made a part of the patient's medical record. 21.5 MONITORING. Personnel monitoring shall be maintained for each individual working in the area of radiation where there is a reasonable probability of receiving one-fourth of the maximum permissible dose. 21.6 MONITORING RECORDS. 21.6.1 Personnel monitoring records resulting from the use of film badges or dosimeters shall be maintained. 21.6.2 Readings should be on at least a monthly basis. Permanent records of exposure on all monitored personnel must be maintained. 21.7 RADIOACTIVE ISOTOPES. All radioactive isotopes shall be received, handled, used and disposed of in accordance with the requirement of the Atomic Energy Commission. 22 REFERRALS 22.1 REFERRALS. The psychiatric hospital shall establish a written policy* for referral of patients for evaluation and/or treatment for services not provided within the facility. The circumstances and necessity for referral shall be documented in the referred patient's medical record. 23 PERSONNEL

23.1 PERSONNEL. The hospital shall employ or contract for sufficient personnel of adequate training and skill to meet patient needs. 23.1.1 OBJECTIVES. The purposes and objectives of the psychiatric hospital shall be explained to all personnel. 23.1.2 There shall be written personnel policies and procedures that govern the conditions of employment, the management of employees, types of functions to be performed, and the quality and quantity of psychiatric hospital services to be maintained. 23.1.3 Following approval by the governing body, copies shall be made available to all employees. 23.2 DEPARTMENTAL. Each department of the psychiatric hospital shall be under the direction of a person qualified by training, experience, and ability to direct effective services. 23.2.1 There shall be sufficient qualified personnel in each department to properly operate the department. 23.2.2 All persons assigned to the direct care of or services to patients shall be prepared through formal education and on-the-job training in the principles, the policies, the procedures and the techniques involved so that the welfare of patients will be safeguarded. 23.2.3 There shall be an education program for all psychiatric hospital personnel to keep the employees abreast of changing methods and new techniques in hospital services. 23.2.4 Personnel shall be trained, in applicable laws, including those relating to patients' rights and confidentiality. 23.3 POLICIES. The psychiatric hospital shall develop written policies regarding staff training and development, continuing education and a review of the quality of the services provided by staff personnel. 23.4 PHYSICAL EXAMINATIONS. All personnel shall have a physical examination upon employment and such interim examinations as may be required by the hospital administration or the health service physician. 23.4.1 The examining physician shall certify that the employee, before returning to duty from extended illness, is free from infectious disease. 23.4.2 Employment health policies shall be arranged so personnel are free to report their illness without fear of income loss. 23.5 RECORDS. There shall be personnel records on each person of the psychiatric hospital staff including employment application and verification of credentials. 23.6 LIBRARY. There shall be library services available to meet the needs of the medical staff and other professional personnel. 23.7 STAFF SECURITY. The psychiatric hospital shall adopt a policy designed to ensure protection of staff members on duty at all hours. 24 ENVIRONMENTAL SERVICES 24.1 ORGANIZATION. Each psychiatric hospital shall establish organized environmental services planned, operated, and maintained to provide a pleasant, safe, and sanitary environment.

24.1.1 Services shall be under the supervision of a person competent in environmental sanitation management. 24.1.2 The services may be provided by contract with an outside provider. 24.2 POLICIES. Written policies shall be established for cleaning the physical plant and equipment. 24.3 WRITTEN PROCEDURES. There shall be specific written procedures for appropriate cleaning of all service areas in the psychiatric hospital, giving special emphasis to procedures applying to infection control. 24.4 CLEANING METHODS. Cleaning shall be performed in a manner which will minimize the spread of pathogenic organisms in the hospital atmosphere. 24.5 EQUIPMENT AND SUPPLIES. Suitable equipment and supplies shall be provided for cleaning of all surfaces. Such equipment shall be maintained in a safe, sanitary condition. 24.6 GERMICIDES. Selection of germicides shall be under the supervision of competent individual(s). 24.7 STORAGE. Solutions, cleaning compounds, and hazardous substances shall be labeled properly and stored in safe places. Paper towels, tissues, and other supplies shall be stored in a manner to prevent their contamination prior to use. 24.8 CRITICAL AREAS. Secure rooms shall be maintained at a particularly high level of cleanliness at all times. 24.9 DRY DUSTING AND SWEEPING. Dry dusting and sweeping are prohibited. 24.10 RUBBISH AND REFUSE CONTAINERS. All rubbish and refuse containers shall be impervious and tightly covered. 24.11 RUBBISH AND REFUSE CARTS. Carts used to transport rubbish and refuse shall be-constructed of impervious materials, shall be enclosed, and shall be removed at least daily. 24.12 WASTE DISPOSAL. Psychiatric hospitals shall make provision for proper and safe disposal of all types of waste products. 24.13 HANDWASHING. All personnel shall wash their hands thoroughly after handling waste products. 24.14 TRAINING PROGRAMS. Policies shall be established to provide supervision and training programs for housekeeping personnel. 24.15 PETS. When pets are permitted by hospital policy for therapeutic purposes, adequate provisions for sanitation, cleanliness, and the prevention of infection shall be made. 25 LINEN AND LAUNDRY 25.1 PATIENT LINEN. In removing and handling soiled linen from the patient's bed, there shall be minimum shaking of the linen. Soiled linen, including blankets, shall be placed in bags and enclosed immediately in the patient's room. Clean non-used linen also shall be placed in bags and enclosed before removal from a patient's room. The bags shall remain closed during transportation to soiled linen holding areas and laundry. 25.2 INFECTIOUS DISEASE LINEN. All linens and blankets from patients with infectious diseases shall be placed in special bags identified “contaminated” and transported in these enclosed bags to soiled linen

holding areas and laundry. 25.3 SOILED LINEN. All soiled linen shall be placed in bags and enclosed in the immediate area of contamination, and transported enclosed to soiled linen holding areas in the laundry. 25.4 SORTING AND PRE-RINSING. Soiled linen shall be neither sorted nor prerinsed on patient care units. Bathtubs, showers, and lavatories shall not be used to launder or restore linens. No laundry operation shall be carried out in a psychiatric patient care unit nor in areas where food is prepared, served, or stored. 25.4.1 Personal laundry facilities may be permitted in a psychiatric patient care unit. Only personal laundry may be laundered in those facilities. No facility laundry may be so laundered. 25.5 HANDWASHING. All personnel shall wash their hands thoroughly after handling any soiled linen. 25.6 SOILED LINEN TRANSPORTATION. Soiled linen, enclosed in a hag, shall be removed from patient care units at least daily and transported to a closed storage area designated solely for that purpose. 25.7 SOILED LINEN CARTS. Carts and hampers used to transport soiled linen shall be constructed of impervious materials, and cleaned and disinfected after each use. 25.8 LINEN CHUTE. If linen chutes are used, all soiled linen shall be enclosed in bags before placing it in chutes. Laundry chutes shall be cleaned regularly and by approved methods. 25.9 LINEN PROCESSING. The psychiatric hospital shall provide for proper handling, cleaning, and disinfecting of linen and other washable materials in its own laundry or in a commercial laundry. 25.10 SOILED LINEN STORAGE ROOM. If a laundry is not provided in the hospital, a soiled linen storage room and a clean linen storage room shall be provided. The soiled linen storage room shall be enclosed, designed, and used solely for these purposes, and provided with exhaust ventilation direct to the outside. In case of new psychiatric hospital construction or modification of an existing psychiatric hospital facility, a soiled linen storage and sorting room shall be enclosed, designed, and used solely for that purpose, and shall be mechanically ventilated to the outside air. Recirculation of air from this room shall not be permitted. 25.11 VENTILATION. In the laundry serving the psychiatric hospital, the soiled linen storage and sorting area shall be a separate, well-ventilated room with negative pressure relative to adjacent area. Recirculation of air from this room shall not be permitted. The air in the washing area shall be vented away from the area of extracting, ironing, and finishing. General air movement shall be from the cleanest areas to the most contaminated areas. 25.11.1 A minimum ventilation rate of ten-room volumes of outside air per hour with no recirculation is recommended for the laundry. Eight-room volumes of outside air per hour is recommended for the sorting area. Laundry exhaust should be carried to a point above the roof or 50 feet away from any window and should not discharge near any fresh air inlet. 25.12 LAUNDRY FACILITIES. Where a total laundry service is provided within the hospital, the laundry shall have a capacity sufficient to process a continuous seven-day supply. The laundry equipment shall be provided with all safety appliances and sanitary requirements. The equipment shall be designed and installed to comply with all local and state codes. 25.12.1 There shall be proper spacing and placing of the equipment to minimize material transportation and operation to avoid all cross operations, and to provide storage between operations.

25.12.2 Handwashing facilities and a toilet shall be available to the laundry area. 25.13 SOILED LINEN SORTING. Soiled linen shall be sorted only in the sorting area. 25.14 WASHING TEMPERATURE. The temperature of water during the washing process shall be controlled to provide a minimum temperature of 165°F (74°C) for 25 minutes. 25.15 CLEAN LINEN STORAGE ROOM. A clean linen storage and a sewing room shall be provided separate from the laundry room. 25.16 COMMERCIAL LAUNDRY SERVICES. A contract for laundry services performed by commercial laundries for psychiatric hospitals shall provide for these standards. 25.17 CLEAN LINEN TRANSPORTATION. Clean linen shall be returned to storage area separate from the laundry, in clean enclosed conveyances used only for transporting clean linen. 25.18 CLEAN LINEN STORAGE. Clean linen stored in patient care units shall be in closets, shelves, conveyances, or rooms used only for clean linen storage. 26 MAINTENANCE 26.1 WRITTEN POLICIES AND PROCEDURES. There shall be written policies and procedures for an organized maintenance program to keep the entire facility in good repair and to provide for the safety, welfare, and comfort of the occupants of the building(s). 26.2 SUPERVISION.The building and mechanical programs shall be under the direction of a qualified person informed in the operations of the facility and about building structures, their component parts and facilities. 27 INCINERATOR 27.1 INCINERATOR, PATHOLOGICAL WASTE. An incinerator installed in a hospital to handle pathological waste shall burn completely 60 percent wet garbage without objectionable smoke or odor. In case of new hospital construction or modification of an existing hospital facility, an incinerator shall be provided on-site or by off-site shared services for the complete destruction of pathological wastes. Incinerators shall comply with State and local air pollution regulations and be so constructed as to prevent insect and rodent breeding and harborage. 27.2 INCINERATOR, RUBBISH. Rubbish incinerators shall be designed to completely burn 50 percent wet rubbish without objectionable smoke or odor. In the case of new psychiatric hospital construction or modification of an existing psychiatric hospital facility, incinerators shall comply with State and local air pollution regulations and be so constructed as to prevent insect and rodent breeding and harborage. 27.3 SAFETY. Incinerators with capacities up to 500 pounds shall have the enclosing walls of combustion chambers lined with fire brick not less than four and one-half inches (41/2”) thick, and incinerators of greater capacity shall have not less than nine inch (9”) brick lining or the equivalent. 28 INSECT, PEST AND RODENT CONTROL 28.1 INSECT, PEST, AND RODENT CONTROL. Written policies and procedures shall provide for effective control and eradication of insects, pests, and rodents. 28.1.1 In the case of new psychiatric hospital construction, or modification of an existing psychiatric hospital facility, the facility shall have a pest control program provided by maintenance personnel or by contract with a pest control company using the least toxic and least flammable

effective pesticides. 28.1.2 The pesticides shall not be stored in patient or food areas and shall be kept under lock, and only properly trained responsible personnel shall be allowed to apply insecticides and rodenticides. 28.2 PROTECTION OF OPENINGS. Screens or other approved methods shall be provided on all exterior openings excluding doors and the structure so maintained as to prevent entry of rats or mice through cracks in foundations, holes in walls, around service pipes, etc. 28.3 POLICIES AND PROCEDURES. There shall be written policies and procedures to assure these control measures. 29 WASTE DISPOSAL 29.1 SEWAGE AND SEWER SYSTEMS. All sewage shall be discharged into a public sewer system, or, if such is not available, shall be disposed of in a manner approved by the Colorado Department of Health. 29.1.1 The Colorado Department of Public Health and Environment shall determine the availability of the public sewer system. 29.1.2 No exposed sewer line shall be located directly above working, storing, or eating surfaces in kitchens, dining rooms, pantries, or food storage rooms, or where medical or surgical supplies are prepared, processed, or stored. 29.2 GARBAGE AND REFUSE. All garbage and refuse, not treated as sewage, shall be collected in approved containers in such manner as not to become a nuisance, and shall be removed from the hospital or incinerator once a day. Refuse or garbage shall not be burned on the premises except in an approved incinerator. 29.3 PATHOLOGICAL WASTE. Pathological and bacteriological wastes, dressings, and other contaminated wastes shall be incinerated at the hospital or disposed of by other methods approved by the Colorado Department of Health. 29.4 FACILITIES. A sufficient number of sound, water-tight containers with tight-fitting lids to hold all refuse that accumulates between collections shall be provided. Lids must be kept on containers. Racks or stands shall be provided. 29.4.1 Garbage containers shall be cleaned each time emptied. (Single service container liners are recommended.) 29.4.2 A paved storage area for the containers shall be provided. 30 CONFIDENTIALITY 30.1 CONFIDENTIALITY OF INFORMATION. All information about patients in psychiatric hospitals whether oral or written, shall be maintained confidential by all personnel, staff (including volunteers) and attending providers at the hospital, and shall only be disclosed upon written consent of the patient as herein provided, or in a bona fide medical emergency as herein provided, or by court order. 30.2 ALCOHOL AND DRUG ABUSE FACILITIES. Psychiatric hospitals subject to regulation under the Federal Drug Abuse Office and Treatment Act of 1972, as amended, P.L. 92-255 (21 U.S.C. s1101 et seq.) and/or the Comprehensive Alcohol Abuse and Alcoholism Prevention Treatment and Rehabilitation Act of 1970, as amended, P.L. 91-616 (42 U.S.C. §4551 et seq.) shall comply

with regulations issued pursuant to those acts regarding confidentiality of alcohol and drug abuse patient records. (42 C.F.R. §2). In the case of a conflict between those regulations and the rules herein, the federal alcohol and drug abuse regulations shall govern. 30.3 AUTHORIZED DISCLOSURES. No information about a patient shall be disclosed by the psychiatric hospital unless the patient signs a written, dated authorization for disclosure which specifies the information which is to be disclosed; to what persons (by name or titles) the information may be disclosed, the purpose for which the information is sought and may be used and the duration of the consent. (See Section 11.9 of this chapter.) 30.4 MEDICAL EMERGENCIES. Disclosure to medical personnel is authorized without the written consent of the patient when and to the extent necessary to meet a bona fide medical emergency, which shall be documented in the patient medical record. 30.5 POLICIES. The psychiatric hospital shall develop written policies on protecting the confidentiality of records with respect to third party insurers, governmental programs and investigations, research and minors. 31 PHYSICAL PLANT 31.1 COMPLIANCE WITH THE LIFE SAFETY CODE 31.1.1 Facilities shall be compliant with the National Fire Protection Association (NFPA) 101, Life Safety Code (2000). Such incorporation by reference, as provided for in 6 CCR 1011-1, Chapter II, excludes later amendments to or editions of the referenced material. (a) Facilities licensed on or before September 30, 2003 shall meet Chapter 19, Existing Health Care Occupancies, NFPA 101 (2000). (b) Facilities licensed on or after October 1, 2003 or portions of facilities that undergo remodeling on or after October 1, 2003 shall meet Chapter 18, New Health Care Occupancies, NFPA 101 (2000). In addition, if the remodel represents a modification of more than 50 percent, or more than 4,500 square feet of the smoke compartment, the entire smoke compartment shall be renovated to meet Chapter 18, New Health Care Occupancies, NFPA 101 (2000). 32 DEPARTMENT OVERSIGHT 32.1 GENERAL. Reserved. 32.2 LICENSURE FEES. Nonrefundable fees shall be submitted to the department with an application for licensure as follows: 32.2.1 Initial License : (when such initial licensure is not a change of ownership). A license applicant shall submit a nonrefundable fee with an application for licensure as follows: base fee of $5,700 and a per bed fee of $50. The initial licensure fee shall not exceed $10,500. 32.2.2 Renewal License . A license applicant shall submit a nonrefundable fee with an application for licensure as follows: base fee of $1,600 and a per bed fee of $12. The renewal fee shall not exceed $8,000. 32.2.3 Change of Ownership . A license applicant shall submit a nonrefundable fee of $2,500 with an application for licensure.

32.2.4 Provisional License . The license applicant may be issued a provisional license upon submittal of a nonrefundable fee of $2,500. If a provisional license is issued, the provisional license fee shall be in addition to the initial license fee. 32.2.5 Conditional License . A facility that is issued a conditional license by the Department shall submit a nonrefundable fee ranging from 10 to 25 percent of its applicable renewal fee. The percentage shall be determined by the Department. If the conditional license is issued concurrent with the initial or renewal license, the conditional license fee shall be in addition to the initial or renewal license fee. 32.3 PLAN REVIEW AND PLAN REVIEW FEES. Plan review and plan review fees are required as listed in Sections (1) through (5), below. Fees are nonrefundable and shall be submitted prior to the Department initiating a plan review for a facility. (1) Initial Licensure . Applicable to applications for an initial license, when such initial license is not a change of ownership. This includes new facility construction and existing structures. The requirement for plan review and the fee applies to initial license applications submitted on or after May 15, 2008. Fee : see table below.

Square Footage 0-35,000

Cost per square foot $0.37

35,001-200,000

$0.03

200,001+

$0.01

Explanatory Note This is the cost for the first 35,000 sq ft of any plan submitted. This cost is applicable to the additional square footage over 35,000 and up to 200,000 sq ft. This cost is applicable to the additional square footage over 200,000 sq ft.

(2) New Construction . Applicable to new construction including replacement facilities, structural additions of any size and prefabricated structures. The requirement for plan review and the fee applies to construction for which the application for the building permit from the local authority having jurisdiction is dated on or after May 15, 2008. However, facilities for which the application for the building permit from the local authority having jurisdiction is dated prior to May 15, 2008 may request a partial plan review. The partial plan review is subject to a ten (10) to twenty-five (25) percent reduction of the fee, as determined by the Department, dependent on the phase of facility construction; except that the fee shall not be below the minimum fee established by this subsection. Fee : see table below. Minimum fee: $2,000.

Square Footage 0-35,000

Cost per square foot $0.37

35,001-200,000

$0.03

Explanatory Note This is the cost for the first 35,000 sq ft of any plan submitted. This cost is applicable to the additional square footage over 35,000 and up to 200,000 sq ft.

200,001+

$0.01

This cost is applicable to the additional square footage over 200,000 sq ft.

(3) Remodeling – General . Applicable to relocation, removal or installation of walls resulting in 50% or more of a smoke compartment being reconfigured. The cost per square footage listed in the table below is to be assessed for the entire smoke compartment(s) being reconfigured. The requirement for plan review and the fee applies to construction for which the application for the building permit from the local authority having jurisdiction is dated on or after May 15, 2008. Fee : see table below. Minimum fee: $2,000.

Square Footage 0-35,000

Cost per square foot $0.25

35,001-200,000

$0.03

200,001+

$0.01

Explanatory note This is cost for the first 35,000 sq ft of any plan submitted. This cost is applicable to the additional square footage over 35,000 and up to 200,000 sq ft. This cost is applicable to the additional square footage over 200,000 sq ft.

(4) Remodeling – Egress Components . Applicable to the relocation, removal, or addition of any egress component, including but not limited to corridors, stairwells, exit enclosures, or points of refuge. (Widening of an egress component is not relocation.) The requirement for plan review and the fee applies to construction for which the application for the building permit from the local authority having jurisdiction is dated on or after May 15, 2008. Fee : $2,000. However, if these renovations are part of the smoke compartment reconfiguration subject to the fee listed in Section 32.2.3 (3), the fee in this Section 32.2.3 (4) shall not apply. (5) Remodeling – Specific Systems . Applicable to significant modifications to the following systems: fire sprinkler, fire alarm, medical gas, kitchen exhaust/suppression system, and essential electrical system. The requirement for plan review and the fee applies to significant modifications where construction is initiated on or after July 1, 2008. For the purposes of this subsection 32.2.3 (5), construction of significant modifications is deemed initiated when there is an alteration associated with the remodeling to an existing structure that results in a physical change. Fee : $2,000 for up to four smoke compartments, plus $500 for each additional compartment. However, if these renovations are part of the smoke compartment reconfiguration subject to the fee listed in Section 32.2.3 (3), the fee in this Section 32.2.3 (5) shall not apply. Significant modifications include: (a) Fire sprinkler: 100 or more sprinklers. Notwithstanding the other provisions in this Section 32.2.3 (5), the extension of a sprinkler system involving the

installation of 25 to 99 sprinkler heads for an area previously unsprinklered is subject to a partial plan review consisting of the review of the remodeling plans and a fee of $500. (b) Fire alarm: any modification to the fire alarm system that involves the replacement of the main fire alarm control unit (panel). (c) Medical gas: modifications that affect 50% or more of a smoke compartment. (d) Kitchen exhaust/suppression system: replacement of the suppression or hood exhaust/duct system. (e) Essential electrical system: replacement or addition of a generator or transfer switch. CHAPTER XIX HOSPITAL UNITS Part 1. STATUTORY AUTHORITY AND APPLICABILITY 1.100 1.101 STATUTORY AUTHORITY (1) Authority to establish minimum standards through regulation and to administer and enforce such regulations is provided by Sections 25-1.5-103 and 25-3-101, C.R.S. 1.102 APPLICABILITY (1) All hospitals shall meet applicable federal and state statutes and regulations, including but not limited to: (a) 6 CCR 1011-1, Chapter II. (b) This Chapter XIX. (2) Contracted services shall meet the standards established herein. Part 2. GENERAL PROVISIONS 2.100 DEFINITIONS (1) “Hospital unit” means a physical portion of a licensed or certified general hospital, psychiatric hospital, maternity hospital, or rehabilitation hospital which is leased or otherwise occupied pursuant to a contractual agreement by a person other than the licensee of the host facility for the purpose of providing outpatient or inpatient services. 2.200 DEPARTMENT OVERSIGHT 2.201 GENERAL. Reserved. 2.202 LICENSURE FEES. Reserved. 2.203 PLAN REVIEW AND PLAN REVIEW FEES (1) Initial Licensure . Applications for an initial license, when such initial license is not a change of

ownership. This includes new facility construction and existing structures. The requirement for plan review and the fee applies to initial license applications submitted on or after January 1, 2008. Fee : see table below.

Square Footage 0-35,000

Cost per square foot $0.37

35,001-200,000

$0.03

200,001+

$0.01

Explanatory Note This is the cost for the first 35,000 sq ft of any plan submitted. This cost is applicable to the additional square footage over 35,000 and up to 200,000 sq ft. This cost is applicable to the additional square footage over 200,000 sq ft.

(2) New Construction . New construction including replacement facilities, structural additions of any size and prefabricated structures that are licensed under this Chapter XIX. The requirement for plan review and the fee applies to construction for which the application for the building permit from the local authority having jurisdiction is dated on or after January 1, 2008. However, facilities for which the application for the building permit from the local authority having jurisdiction is dated prior to January 1, 2008 may request a partial plan review. The partial plan review is subject to a ten (10) to twenty-five (25) percent reduction of the fee, as determined by the Department, dependent on the phase of facility construction; except that the fee shall not be below the minimum fee established by this subsection. Fee : see table below. Minimum fee: $2,000.

Square Footage 0-35,000

Cost per square foot $0.37

35,001-200,000

$0.03

200,001+

$0.01

Explanatory Note This is the cost for the first 35,000 sq ft of any plan submitted. This cost is applicable to the additional square footage over 35,000 and up to 200,000 sq ft. This cost is applicable to the additional square footage over 200,000 sq ft.

(3) Remodeling – General . Relocation, removal or installation of walls resulting in 50% or more of a smoke compartment being reconfigured. Fee : See table below. The cost per square footage listed in the table below is to be assessed for the entire smoke compartment(s) being reconfigured. The requirement for plan review and the fee applies to construction for which the application for the building permit from the local authority having jurisdiction is dated on or after January 1, 2008. Minimum fee: $2,000.

Square Footage 0-35,000

Cost per square foot $0.25

Explanatory note This is the cost for the first 35,000 sq ft of any

35,001-200,000

$0.03

200,001+

$0.01

plan submitted. This cost is applicable to the additional square footage over 35,000 and up to 200,000 sq ft. This is the cost applicable to the additional square footage over 200,000 sq ft.

(4) Remodeling – Egress Components . The relocation, removal, or addition of any egress component, including but not limited to corridors, stairwells, exit enclosures, or points of refuge. (Widening of an egress component is not relocation.) The requirement for plan review and the fee applies to construction for which the application for the building permit from the local authority having jurisdiction is dated on or after January 1, 2008. Fee : $2,000. However, if these renovations are part of the smoke compartment reconfiguration subject to the fee listed in 2.203 (3), the fee in this Section 2.203 (4) shall not apply. (5) Remodeling – Specific Systems . Significant modifications to the following systems: fire sprinkler, fire alarm, medical gas, kitchen exhaust/suppression system, and essential electrical system. The requirement for plan review and the fee applies to significant modifications where construction is initiated on or after July 1, 2008. For the purposes of this subsection 2.203 (5), construction of significant modifications is deemed initiated when there is an alteration associated with the remodeling to an existing structure that results in a physical change. Fee : $2,000 for up to four smoke compartments, plus $500 for each additional compartment. However, if these renovations are part of the smoke compartment reconfiguration subject to the fee listed in 2.203 (3), the fee in this Section 2.203 (5) shall not apply. Significant modifications include: (a) Fire sprinkler: 100 or more sprinklers. Notwithstanding the other provisions in this Section 2.203 (5), the extension of a sprinkler system involving the installation of 25 to 99 sprinkler heads for an area previously unsprinklered is subject to a partial plan review consisting of the review of the remodeling plans and a fee of $500. (b) Fire alarm: Any modification to the fire alarm system that involves the replacement of the main fire alarm control unit (panel). (c) Medical gas: modifications that affect 50% or more of a smoke compartment. (d) Kitchen exhaust suppression system: replacement of the suppression or hood exhaust/duct system. (e) Essential electrical system: replacement or addition of a generator or transfer switch. Part 3. GENERAL HOSPITAL SERVICES 3.100 3.101 If the hospital unit is providing general hospital services, the hospital unit shall comply with the following parts of Chapter IV, General Hospitals: (1) Reserved.

(2) PART 2.100. DEFINITIONS (3) Part 3. GOVERNING BOARD (4) PART 4. ADMINISTRATIVE OFFICER. (However, where more than one unit is operated by a licensee, a single administrative officer may be delegated responsibility for all such units.) (5) PART 5. MEDICAL STAFF (6) PART 6. NURSING Department (7) PART 7. PERSONNEL (8) PART 8. MEDICAL RECORDS DEPARTMENT. (Medical records services may be provided by arrangement with the host facility or a related licensed facility; and the records required under Section 8.102(6)(f) shall be as applicable to the services offered by the unit.) (9) PART 9. ANESTHESIA SERVICES. (This part shall apply only if anesthesia services are provided.) (10) PART 10. LABORATORY SERVICES. (However, clinical pathology services may be provided through a contract with a qualified provider.) (11) PART 11. PREGNANCY, LABOR AND DELIVERY. (This PART shall apply only if pregnancy, labor and delivery services are provided by the unit.) (12) PART 12. DIETARY SERVICES. (Dietary services may be provided through A contract with a qualified provider.) (13) PART 13. EMERGENCY SERVICES. (This part shall apply only if emergency services are provided by the unit.) (14) PART 14. OUTPATIENT SERVICES. (This part shall apply only if outpatient services are provided by the unit.) (15) PART 15. INFECTION CONTROL SERVICES. (However, infection control services may be provided only by arrangement with the host facility or related licensed facility.) (16) PART 16. RESPIRATORY CARE SERVICES. (This part applies only if respiratory care service is provided by a unit; and services may be provided through a contract with a qualified provider.) (17) PART 17. CRITICAL CARE SERVICES. (This part applies only if critical care services are provided by a unit.) (18) PART 18. OCCUPATIONAL AND PHYSICAL THERAPY SERVICES. (However, occupational and physical therapy services may be provided through a contract with qualified provider.) (19) PART 19. GENERAL PATIENT CARE SERVICES. (This part applies only if inpatient care is provided by the unit.) (20) PART 20. PEDIATRIC PATIENT CARE SERVICES. (This part applies only if pediatric services are provided by a unit.) (21) PART 21. PHARMACEUTICAL SERVICES. (However, pharmaceutical services may be provided through A contract with qualified provider.)

(22) PART 22. PSYCHIATRIC PATIENT CARE SERVICES. (This part applies only if psychiatric services are provided by a unit.) (23) PART 23. SURGICAL AND RECOVERY SERVICES. (However, surgical suite and recovery room services may be provided only by arrangement with the host facility or related licensed facility.) (24) PART 24. DIAGNOSTIC IMAGING SERVICES. (This part applies only if radiological services are provided by a unit; and services may be provided through a contract with a qualified provider.) (25) PART 25. NUCLEAR MEDICINE SERVICES. (This part applies only if nuclear medicine services are provided by a unit.) (26) PART 26. CENTRAL MEDICAL-SURGICAL SUPPLY SERVICES. (However, central medicalsurgical supply services may be provided through a contract with a qualified provider.) (27) PART 27. HOUSEKEEPING SERVICES. (However, housekeeping services may be provided through a contract with a qualified provider.) (28) PART 28. LINEN AND LAUNDRY SERVICES. (However, linen and laundry services may be provided through a contract with a qualified provider.) (29) PART 29. MAINTENANCE SERVICES. (However, maintenance services may be provided through a contract with a qualified provider.) (30) PART 30. WASTE DISPOSAL SERVICES. (This part shall apply only if the unit has an incinerator; and these services may be provided through a contract with a qualified provider.) (31) PART 31. PHYSICAL PLANT. This Part 31 incorporates by reference, the National Fire Protection Association (NFPA) 101, Life Safety Code (2000). Such incorporation by reference, as provided for in 6 CCR 1011-1, Chapter II, excludes later amendments to or editions of the referenced material. Part 4. REHABILITATION CENTER SERVICES 4.100 4.101 If the hospital unit is providing Rehabilitation Center services, the hospital unit shall comply with the following parts of Chapter X, Rehabilitation Centers: (1) Reserved. (2) PART 2.100. DEFINITIONS (3) PARTS 3 THROUGH 31. Part 31 incorporates by reference, the National Fire Protection Association (NFPA) 101, Life Safety Code (2000). Such incorporation by reference, as provided for in 6 CCR 1011-1, Chapter II, excludes later amendments to or editions of the referenced material. Part 5. MATERNITY HOSPITAL SERVICES 5.100 5.101 If the hospital unit is providing Maternity Hospital services, the hospital unit shall comply with the following parts of Chapter XIV, Maternity Hospitals: (1) Reserved.

(2) Part 2.100. DEFINITIONS (3) PARTS 3 THROUGH 31. Part 31 incorporates by reference, the National Fire Protection Association (NFPA) 101, Life Safety Code (2000). Such incorporation by reference, as provided for in 6 CCR 1011-1, Chapter II, excludes later amendments to or editions of the referenced material. Part 6. PSYCHIATRIC HOSPITAL SERVICES 6.100 6.101 If the hospital unit is providing Psychiatric Hospital services, the hospital unit shall comply with the following parts of Chapter XVIII, Psychiatric Hospitals, and definitions: (1) PART 1. GOVERNING BOARD (2) PART 2. ADMINISTRATIVE OFFICER. (However, where more than one unit is operated by a licensee, a single administrative officer may be delegated responsibility for all such units [2.1], and a single combined audit may be performed [2.4].) (3) PART 3. MEDICAL STAFF (4) PART 4. ADMISSIONS (5) PART 5. OUTPATIENT EMERGENCY PSYCHIATRIC SERVICES. (This section shall apply only if outpatient emergency psychiatric services are provided by the unit.) (6) PART 6. PSYCHIATRIC PATIENT CARE UNIT (7) PART 7. PATIENT CARE POLICIES (8) PART 8. PHYSICAL MEDICINE SERVICE. (This section shall apply only if physical medicine services are provided by the unit.) (9) PART 9. CHILD/ADOLESCENT PSYCHIATRIC PATIENT CARE UNIT. (This section shall apply only if child/adolescent psychiatric services are provided by the unit.) (10) PART 10. ACTIVITY THERAPY. (However, activity therapy services may be provided through a contract with a qualified provider.) (11) PART 11. MEDICAL RECORDS. (However, medical records services may be provided only by arrangement with the host facility or a related licensed facility; the records required under 11.9 shall be as applicable to the services offered by the unit.) (12) PART 12. NURSING SERVICE (13) PART 13. OUTPATIENT SERVICES. (This section shall apply only if outpatient services are provided by a unit.) (14) PART 14. COMMUNICABLE DISEASE CONTROL PROGRAM. (However, communicable disease control services may be provided only by arrangement with the host facility or a related licensed facility.) (15) PART 15. DIETARY SERVICES. (However, dietary services may be provided through a contract with a qualified provider.)

(16) PART 16. DISASTER PLAN (17) PART 17. ANESTHESIA AND GASES. (This section shall apply only if anesthesia services are provided by a unit; may be provided through a contract with a qualified provider.) (18) PART 18. CENTRAL MEDICAL SUPPLY. (However, central medical supply services may be provided through a contract with a qualified provider.) (19) PART 19. CLINICAL PATHOLOGY (20) PART 20. PHARMACEUTICAL SERVICES. (However, pharmaceutical services may be provided through a contract with a qualified provider.) (21) PART 21. RADIOLOGICAL SERVICES. (However, radiological services may be provided through a contract with a qualified provider.) (22) PART 22. REFERRALS (23) PART 23. PERSONNEL (24) PART 24. ENVIRONMENTAL SERVICES. (However, environmental services may be provided through a contract with a qualified provider.) (25) PART 25. LINEN AND LAUNDRY. (However, linen and laundry services may be provided through a contract with a qualified provider.) (26) PART 26. MAINTENANCE. (However, maintenance services may be provided through a contract with a qualified provider.) (27) PART 27. INCINERATOR. (However, incineration may be provided through a contract with a qualified provider.) (28) PART 28. INSECT, PEST AND RODENT CONTROL. (However, insect, pest and rodent control services may be provided through a contract with a qualified provider.) (29) PART 29. WASTE DISPOSAL. (However, waste disposal services may be provided through a contract with a qualified provider.) (30) PART 30. CONFIDENTIALITY (31) PART 31. PHYSICAL PLANT. This Part 31 incorporates by reference, the National Fire Protection Association (NFPA) 101, Life Safety Code (2000). Such incorporation by reference, as provided for in 6 CCR 1011-1, Chapter II, excludes later amendments to or editions of the referenced material. CHAPTER XX AMBULATORY SURGICAL CENTER The regulations promulgated below incorporate by reference (as indicated within) material originally published elsewhere. Such incorporation, however, excludes later amendments to or editions of the referenced material. Pursuant to section 24-4-103 (12.5), C.R.S., 1988 Repl. Vol. 10A, the Health Facilities Division of the Colorado Department of Public Health and Environment maintains copies of the incorporated texts in their entirety which shall be available for public inspection during regular business hours at: Director, Health Facilities Division

Colorado Department of Public Health and Environment HFD-A2 4300 Cherry Creek Drive South Denver, Colorado 80222-1530 Certified copies of incorporated material shall be provided by the Division, at cost, upon request, and may be examined at any state publications depository library. DEFINITIONS: A. Ambulatory Surgical Center (ASC) means a facility which operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization. 1. Offering multiple health services in the same building does not preclude or exempt a facility from meeting the requirements of Chapter XX. The building space constituting the ambulatory surgical center must be used exclusively for ambulatory surgery and its directly related services. The other health services being offered in the same building must be physically separated from the ambulatory surgical center. 2. The term “ambulatory surgical center” does not include: A. a facility that is licensed as part of a hospital, or; B. a facility which is used as an office or clinic for the private practice of a physician(s), podiatrist(s), or dentist(s) except when: 1) it holds itself out to the public or other health care providers as an ambulatory surgical center, surgical center, surgicenter or similar facility using a similar name or variation thereof, or; 2) it is operated or used by a person or entity different than the physician(s), podiatrists(s), or dentist(s), or; 3) patients are charged a fee for use of the facility in addition to the physician(s), podiatrist(s), or dentist(s) professional services; unless such fees are an integrated part of the office-based surgery program incentive allowance of a licensed sickness and accident insurer, a non-profit hospital, medical-surgical and health service corporation, or a health maintenance organization and the program incentive occurs in a setting that does not require licensure. 3. A licensed hospital provider of ambulatory surgical services may use the term “ambulatory surgery” or a similar term to indicate that ambulatory surgical services or an ambulatory surgery or surgical department is available or housed within the hospital as part of the facility's services. Such hospital shall not indicate to the public nor hold itself out to the public as an ambulatory surgical center (free standing or otherwise) unless the hospital entity actually possesses such a license. B. “Plan Review” means the review by the Department, or its designee, of new construction or remodeling plans to ensure compliance by the facility with the National Fire Protection Association (NFPA) Life Safety Code and with this Chapter XX. Plan review consists of the examination of new construction or remodeling plans and onsite inspections, where warranted. In reference to the National Fire Protection Association requirements, the Department is the authority having jurisdiction for state licensure.

I. LICENSE An ambulatory surgical center shall meet all of the requirements specified in chapter II and this Chapter XX of the Colorado Department of Public Health and Environment Standards for Hospitals and Health Facilities. A. An ambulatory surgical center shall be in compliance with all other applicable state, local, and federal laws. II. GOVERNING BODY A. Responsibility; The Governing Body shall provide facilities, personnel, and services necessary for the welfare and safety of the patients. B. Duties: The Governing Body shall: 1. adopt by-laws in accordance with legal requirements; 2. meet regularly and maintain accurate records of such meetings; 3. appoint committees consistent with the needs of surgical center; 4. appoint and delineate clinical and surgical privileges of practitioners based upon recommendations by the provider staff and other appropriate indicators of physician and other licensed practitioner competence; 5. establish a formal means of liaison with the provider staff; 6. approve by-laws, rules and regulations of the provider staff; 7. adopt appropriate policies on admissions, surgical procedures, and the timely completion of medical records; 8. conduct, with the active participation of the provider staff, an ongoing, comprehensive saltassessment of the quality of care provided, including the medical necessity of procedures performed, the appropriateness of care, and the appropriateness of utilization. This information shall provide a basis for the revision of facility policies and the granting or continuation of clinical privileges; 9. require that the facility's Quality Assurance Program ensure the adequate investigation, control and prevention of infections; III. ADMINISTRATOR A. Responsibility: The administrator shall be the official representative of the governing body and the chief executive officer of the surgical center. The administrator shall be delegated responsibility and authority in writing by the governing body for the management of the surgical center end shall provide liaison among the governing body, provider staff and other departments of the surgical center. B. Duties: The administrator shall be responsible for the development of surgical center policies and procedures for employee and provider staff use. All policies and procedures shall be reviewed and/or updated as necessary but at least annually. IV. PROVIDER STAFF

A. Organization: The ambulatory surgical center shall have an organized provider staff. 1. The governing body shall appoint a member of the provider staff to act as medical director for the ambulatory surgical center. The medical director shall have the responsibility for directing the provision of services and for monitoring the quality of all medical care and services provided patients in the facility. B. Duties: The provider staff or a delegated committee shall: 1. be responsible for the quality of all medical care provided patients in the facility; 2. hold meetings regularly and maintain accurate records of such meetings; 3. formulate, adopt, and enforce by-laws, rules, regulations and policies for the proper conduct of its activities and credentialing of its members; 4. recommend staff privileges to the Governing Body; 5. insure professionally ethical conduct on the part of all members of the provider staff and initiate corrective measures as required; 6. establish a formal liaison with the governing body; 7. participate actively in the quality assurance program; 8. recommend admission and surgical procedure policies to the Governing Body; V. MEDICAL RECORDS A. Facilities: The center shall provide sufficient space and equipment for the processing and the safe storage of records. The facility shall maintain an individual record for each patient admitted. B. Personnel: A person knowledgeable in the management of Medical Records shall be responsible for the proper administration and functioning of the medical records section. C. Security: Medical records shall be protected from loss, damage and unauthorized use. D. Preservation: With the exception of medical records of minors (individuals under the age of 18 years) medical records shall be preserved as original records, on microfilm, or other technologically appropriate medium as administratively determined by the department for no less than ten years after the most recent patient care usage, after which time records may be destroyed at the discretion of the facility. Accessibility of records to the department to assure compliance and to patients or their legal representatives shall be maintained. 1. Medical records of minors shall be preserved for the period of minority plus 10 years (i.e., 28 years less age of minor at time of most recent patient care usage of the medical record); 2. Facilities shall establish procedures for notification to patients whose records are to be destroyed prior to the destruction of such records; 3. The sole responsibility for the destruction of all medical records shall be in the facility involved but in no case shall records be destroyed prior to consultation with legal counsel; 4. Nothing in this section shall be construed to affect the requirements for the destruction of public records as set out in Part 1 of Article 80 of Title 24, C.R.S. 1973.

5. Actual x-ray films, scans, and other imaging records shall be maintained by the facility for a period of five years, if services are provided directly. E. Content: The medical records shall contain sufficient accurate information to justify the diagnosis and warrant the treatment and end results including, but not limited to: 1. complete patient identification and a unique identification number; 2. admission and discharge dates; 3. chief complaint and admission diagnosis; 4. medical history and physical examination completed prior to surgery; 5. diagnostic tests, laboratory, x-ray, scans, and other radiological imaging reports and consultative findings when appropriate; 6. physician progress notes if appropriate; 7. properly executed informed consent; 8. a pre-anesthesia examination by a physician prior to surgery, a proper anesthesia record and a post-anesthesia follow-up; 9. e complete detailed description of operative procedures, findings and post-operative diagnosis recorded and signed by the attending surgeon; 10. a pathology report of tissue removed during surgery in accordance with facility policies; 11. all medication and treatment orders in writing and signed by the authorizing party. Telephone and verbal orders are designated as such, signed and dated by a legally designated person, and countersigned by the attending provider within a clearly designated time period established by the medical director; and 12. patient's condition on discharge, final diagnosis, and instructions given patient for follow-up care; F. Other records: The facility shall maintain: 1. a register of all operations performed (entered daily); 2. statistical information concerning all admissions, discharges, deaths and other information such as blood usage, surgery complications, etc, required for the effective administration of the facility 3. master patient index file. G. Nursing Records: Standard nursing practice and procedure shall be followed in the recording of medications and treatments, including operative and post-operative notes. Nursing notes shall include notation of the instructions given patients preoperatively and at the time of discharge. All nursing notes shall be entered as part of the patient's medical record. Entries shall be appropriately signed, including name and identifying title. H. Entries: All orders for diagnostic procedures, treatments, and medications shall be signed by the physician submitting them and entered in the medical record by technologically appropriate

medium as administratively determined by the department. Authentication may be by written signature, identifiable initials or computer key. The use of rubber stamp signatures is acceptable under the following strict conditions: 1. the physician whose signature the rubber stamp represents is the only one who has possession of the stamp and is the only one who uses it; and 2. the physician places in the administrative offices of the hospital a signed statement to the effect that he is the only one who has the stamp and is the only one who will use it. VI. PERSONNEL A. Orientation: The purpose and objectives of the surgical canter shall be explained to all personnel as part of an overall orientation program. B. Policies: There shall be appropriate written personnel policies, rules and regulations governing the conditions of employment, the management of employees and the types of functions to be performed. C. Job Description: There shall be written job descriptions for each position in the facility including at least the title, authority, specific responsibilities and minimum qualifications. Each employee shall be provided a copy of his or her job description. D. Staffing: Each service department of the center shall be under the direction of a person qualified by training, experience, and ability. Staffing levels shall be commensurate with the needs of the patients and facility clientele and the facility. E. Inservice: There shall be an in-service program which keeps all employees abreast of changing methods and new techniques. Records including attendance and subject matter of each inservice shall be maintained. F. Disease: Any personnel with communicable disease as defined by the Department shall return to work only after complying with the facility's infection control policy. G. Records: Personnel records shall be maintained for each person employed in the facility which include at least: 1. an employment application; 2. verification of references and/or credentials as required; 3. incident and/or accident reports; 4. results of medical examinations required as a part of employment. VII. ADMISSIONS A. Admissions: All persons admitted to the ambulatory surgical center shall be under the direct care of a member of the provider staff. The provider staff shall ensure the continuity of care for each patient including pre-operative, intra-operative, and post-operative care. Each patient shall be provided prior to admission all necessary instruction and education for pre and post-surgical care. B. Restrictions: Surgical procedures shall be limited to the following: 1. those that do not exceed twenty-three (23) hours combined operating and recovery and/or

convalescent time, and; 2. those that do not generally result in extensive blood loss, require major or prolonged invasion of body cavities, directly involve major blood vessels, or constitute an emergency or life threatening procedure. C. Identification: Each patient admitted to the center shall have a visible means of identification placed and maintained on his/her person until discharge. In cases of off-site pre-planned transfer such means of identification shall be maintained throughout the period of transfer and until such time as the patient becomes a patient of another licensed facility. D. Admission Requirements: All admissions shall be in accordance with appropriate written policies and procedures which reflect the admission requirements established in this section, recommended by the provider staff and adopted by the governing body, specific to the ambulatory surgical center operations, that includes at least the following: 1. The patient must be in good health or have mild systemic disease which is under good control and does not require special management. Patient status shall be documented by the admitting physician. 2. The patient or a responsible person acting on behalf of the patient must be able to strictly follow instructions related to ingestion of fluids or solids within the specified time frame prior to the surgery. 3. If the patient is to receive sedation or anesthetic which will result in impaired mental status following surgery, the patient must be accompanied upon discharge by a responsible adult. 4. Patients who may require post-operative ventilation following surgery, either because of the procedure to be performed or because of a pre-existing condition, shall not be admitted for surgery. 5. Surgery which requires the presence of special equipment, personnel, and/or facilities due to the risk of the operation involved shall not be performed in the center unless such equipment, personnel, and/or facilities are available in the ambulatory surgical center. 6. When overnight care is provided, appropriate services shall be rendered within the defined capabilities of the organization. If overnight care is to be provided by the facility, notice of such shall be sent to the Health Facilities Division. 7. The governing body of the facility shall have an organizationwide policy on the use of smoking materials in the facility which shall be posted and disclosed to the patient upon admission. E. OFF-SITE PRE-PLANNED TRANSFERS: Off-site pre-planned transfers of patients include those transfers of patients to other licensed health facilities, that are physically located off-site or offcampus, where it is known in advance that further post-surgical patient care will be needed. Offsite pre-planned transfers do not include discharges to the patient's place of residence where further care will be provided by home health or home care providers. Ambulatory surgical centers providing off-site pre-planned transfer service options shall adhere to the following requirements. 1. DISCLOSURE. Facilities offering surgical services which include an off-site pre-planned transfer to another licensed facility following post-operative recovery shall disclose in written form to the patient all the details of the transfer prior to admission to the facility. Disclosure includes, but is not limited to, the cost of the transfer, whether or not such

costs shall be covered by insurance or other third party payer, and the details of the actual transfer, including, but not limited to, the mode of transport. Disclosure shall be made to the patient prior to the time for admission to the facility. The patient shall acknowledge such disclosure in writing, and the date thereof. Such disclosures on facility policies regarding off-site pre-planned transfers shall be in addition to the requirements for informed consent. 2. Off-site pre-planned transfers shall be made only to other licensed facilities that can provide the level of care necessary to meet the needs of the patient. The ambulatory surgical center shall have a written agreement with any and each licensed facility that admits patients for post-surgical care from an ambulatory surgical center. The ambulatory surgical center shall provide written discharge instructions, including patient progress information, to the receiving facility. a. An ambulatory surgical center shall allow preplanned transfers only with the written consent of the patient and the written authorization of the attending or operating surgeon or physician. The attending or operating surgeon or physician shall approve such a transfer if there are assurances that the continuity of care for the patient shall be maintained and contact with the patient's attending physician is continuous. 3. All pre-planned transfers shall be by licensed ambulance. The ambulatory surgical center shall have a written agreement with the provider(s) of ambulance services. Such transfer agreements shall include the provision for an appropriate level of care commensurate with the needs of a post-surgical recovering patient. If necessary, as determined by the attending or operating physician, licensed provider staff from the ambulatory surgical center shall accompany the patient on the ambulance to provide continuity of care and a level of care that meets the peri-operative needs of the patient. 4. Ambulatory surgical centers engaging in pre-planned transfers shall provide space at the entrance to the building to facilitate transfer. The facility shall provide close-in parking that shall be accessible at all times and shall not be obstructed by other parked vehicles or any other architectural barriers. The space provided for ambulance access shall also contain adequate height clearance to accommodate a type I or a type 3 ambulance. 5. An ambulatory surgical center located above the ground level of the building that admits patients for which a pre-planned transfer is anticipated shall have elevators available for the transport of such patients. Elevators shall be large enough to accommodate an ambulance cot in horizontal position and a minimum of two attendants. F. ON-SITE PRE-PLANNED TRANSFERS: On-site pre-planned transfers of patients are also authorized where it is known in advance that further post-surgical patient care will be needed. Such transfers are limited to those transfers of patients to other licensed health facilities, located on-site or on campus and are physically connected to the ambulatory surgical center. a. The provisions of paragraph (e)(1) and (2) shall apply to on-site pre-planned transfers. The provisions of paragraph (e)(3), (4), and (5) shall not apply to on-site preplanned transfers. VIII. LABORATORY AND RADIOLOGY A. Services: Clinical laboratory services shall be available as required by the needs of the patients as determined by the provider staff. Whether provided on-site or by contract, the laboratory shall meet the requirements of the “Clinical Laboratory Improvement Amendments of 1988,” and the corresponding regulations (42 USC 263a and 42 CFR 493).

B. RADIOLOGY SERVICES: Radiological services shall be provided as required by the needs of the patients as determined by the provider staff. Whether provided on-site or by contract, the radiological service shall meet “Colorado Rules and Regulations Pertaining to Radiation Control,” 6 CCR 1007-1. IX. ANESTHESIA A. The use of flammable anesthetics in ambulatory surgical centers is prohibited. X. EMERGENCY SERVICES A. The center shall have policies and procedures which provide for adequate care of the facility's patients in the event of an emergency. B. There shall be a policy and procedure for obtaining ambulance services to an emergency center/hospital including notification of next of kin or responsible party. C. There shall be a written transfer agreement with an emergency center/hospital, or all physicians performing surgery in the ASC shall have admitting privileges at the hospital. D. Emergency equipment and supplies shall be readily available on the premises. E. An ambulatory surgical center transferring a patient to a hospital on an emergency basis, shall submit to the receiving hospital at the time of transfer a copy of all medical records related to the patient's condition, including observations of the patient's signs and symptoms, preliminary diagnosis, treatment provided, results of any tests, and a copy of the informed written consent. XI. NURSING SERVICES A. Nursing Administration: The facility shall have an organized nursing department under the supervision of a Director of Nursing who is currently licensed by the State of Colorado as a professional registered nurse and who has responsibility and accountability for all nursing services. B. The Director of Nursing, shall be responsible for: 1. delivery of appropriate nursing services to patients; 2. development and maintenance of appropriate nursing service objectives, standards of nursing practice, nursing policy and procedure manuals, and written job descriptions for all levels of nursing personnel; 3. coordination of nursing services with other patient services; 4. establishment of a means of adequately assessing and planning the nursing care needs of patients and staffing to meet those needs; 5. staff development including orientation, inservice and continuing education which includes provisions for CPR certification or review. C. Nursing Personnel: There shall be sufficient licensed and auxiliary nursing personnel on duty to meet the total nursing needs of patients: 1. at least one registered nurse shall be in the facility at all times when a patient is in the facility;

2. nursing personnel shall be assigned duties consistent with their education and experience. D. Medications and Treatments: Medications and treatments shall be administered in accordance with all applicable laws and acceptable standards of practice. E. Staff Meetings: Meetings of the nursing staff shall be held regularly to discuss, review and evaluate nursing care. Written minutes of these meetings shall be maintained and distributed to staff. F. Inservice Education: All nursing personnel shall receive inservice education at least semi-annually which shall include, but not be limited to, infection control, fire and safety procedures. G. Evaluation: There shall be an adequate plan of continuous evaluation of nursing care. The Director of Nursing shell periodically evaluate the adequacy of the facility to meet the nursing needs of its patients and shall participate in planning for needed improvements or revisions of facilities and services. H. Circulating Nurse: A registered nurse, qualified by education and experience in operating room nursing, shall be present as a circulating nurse in each operating room during operative procedures. XII. PHARMACEUTICAL SERVICES A. There shall be methods, procedures and controls which ensure the appropriation, acquisition, storage, dispensing and administration of drugs and biologicals in accordance with acceptable pharmaceutical practice and applicable state and federal laws and regulations, whether it provides its own pharmaceutical services or makes other legal and appropriate arrangements for obtaining necessary pharmaceuticals. XIII. SURGICAL SERVICES A. Location: The ambulatory surgical center shall have at least one operating room that has the capability of administering general anesthesia to patients and is located in a sterile environment within the facility. The operating room(s) and accessory areas shall be located so that in and out traffic is properly controlled. The ambulatory surgical center may have additional, appropriately equipped treatment and/or procedures rooms for surgical procedures not requiring general anesthesia. 1. If an ambulatory surgical center generally provides only surgical services that do not require general anesthesia, the facility may make application to the department for an appropriate modification of the requirements for a surgical suite provided that the facility can demonstrate the ability to implement a functional, sterile operating room whenever such use would be necessitated by patient needs. 2. The provisions of paragraph A.1. Shall not apply to ambulatory surgical centers licensed prior to the January 30, 1995. B. Patient Preparation Area: A patient preparation area with adjacent toilet facilities must be provided near the surgical suite. This area must provide for the privacy and comfort of the patients and for storage of patient's clothing. C. Surgical Privileges Roster: An up-to-date roster of staff providers specifying the approved surgical privileges of each shall be kept on file and available to the nursing staff. D. Doorways and Corridors: The-minimum width of doors for patients and equipment shall be 3'0” . Doors to accommodate stretchers must be a least 3'8” wide. The minimum width of corridors

serving surgery suites and recovery and patient preparation areas from these areas must be at least 8 feet. E. Operating Room(s)/surgical suites and treatment and procedures rooms: Each room shall be large enough to accommodate equipment and personnel for surgical procedures to be performed. If general anesthesia is to be administered during the surgery, the room shall contain a minimum of 225 square feet and; adequate provisions shall be made for an emergency communication system connecting the surgical suite to a control station. F. Equipment: The following minimum equipment must be available in the surgical suite: 1) cardiac monitor, 2) resuscitator, 3) defibrillator, 4) aspirator, 5) tracheotomy set and equipment for airway maintenance, and 6) pediatric-sized equipment, if pediatric patients are served. G. Medical Gases and Medical Gas Systems: A supply of oxygen shall be available and stored in accordance with the National Fire Protection Association 99-1999 Standards for Health Care Facilities, Chapter 4, Gas and Vacuum Systems. Piped medical gas systems shall meet the requirements of NPFA 99-1999 Chapter 4, Gas and Vacuum Systems. H. Ancillary Areas: In addition to operating room(s), the following physically separated areas shall be provided within the suite and shall be separated by doors and/or walls: 1) scrub area, 2) cleanup room, 3) instrument and supply storage, 4) janitor's facilities. I. Scrub Area: The scrub area shall be adjacent to the operating room to permit immediate access to the room after scrubbing. Scrub sink(s) with knee or foot controls shall be installed in the scrub area. J. Clean-up Facilities: Clean and soiled utility rooms shall be arranged and provided with equipment necessary for proper patient care and for the processing of soiled equipment, including a pressurized steam sterilizer or equivalent, or a sterilizer or sterilization system that is appropriate to the procedures being performed, and storage cabinets and work counters with sinks. K. Staff Dressing Rooms: Shall be provided for both men and women, each containing a toilet, handsink, and provisions for storage of clothing. L. Ventilation: Operating rooms or surgical suites shall be provided with a minimum ventilation rate as required in Section XXII by mechanical supply and exhaust system. The air may be recirculated, provided the recirculated air passes through the final filters. The mechanical ventilation system may be shut down during off hours: 1. outdoor air intakes shall be located as far away as practical, but not less than 25 feet from the exhausts from any ventilating systems, combustion equipment, medical-surgical vacuum system or plumbing vent or areas which may collect noxious fumes, the bottom of all outdoor air intakes shall be located as high as practical but not less than 3 feet above grade level, or if installed through the roof, 3 feet above the roof level; 2. all air supplied to operating rooms and recovery rooms shall be delivered at or near the ceiling of the area served. M. Filters: All ventilation or air-conditioning systems serving surgery suites shall have a minimum of two filter beds. Filter bed No. 1 shall be located upstream of the air conditioning equipment and shall have a minimum efficiency of 25 percent. Filter bed No. 2 shall be downstream of the supply fan and air-conditioning equipment and humidifying equipment. If a steam humidifying system is provided, it may be downstream of the final filter. Filter bed No. 2 shall have a minimum efficiency of 90 percent of 1-5 micron size particles. Each filter bed serving sensitive areas shall have a manometer installed across each filter bed.

N. Exhaust: At least two (2) exhaust outlets shall be provided in each operating room, with the lower perimeter of the outlet situated between three to four inches off the floor. O. Lighting: General and spot illumination shall be provided in each operating room. P. Anesthetizing Locations: Anesthetizing locations shall meet the requirements of NFPA 99-1999, Chapter 3, Electrical Systems. Q. Janitors Room: A separate janitors' room or equivalent shall be provided exclusively for the surgical suite. It shall be equipped with shelves for supplies, mop clip boards, and a wall or floor-mounted mop sink. A hand-washing sink with soap and sanitary handwashing facilities will be available nearby. There shall be room also for a waste container, drum of disinfectant detergent, mop carts and buckets, etc. XIV RECOVERY ROOM A. Recovery Room(s): Recovery room(s) for post-anesthesia recovery that meet the needs of surgical patients shall be provided. B. Recovery Area and Equipment: The surgical recovery rooms must provide for: 1) direct visual observation of all patients, 2) medicine administration facilities, 3) charting facilities, 4) toilet facilities, 5) storage space for supplies and equipment, 6) oxygen, 7) emergency call system, and 8) hand washing facilities. C. Bed Space: There must be at least 3’ 0” on each side or between recovery beds and space at the foot of the bed for work. and/or circulation. XIV-A PATIENT CARE UNIT A. An ambulatory surgical center shall maintain a distinct patient care area if the ambulatory surgical center provides surgical services for persons needing longer periods of care and/or observation beyond the recovery period and prior to discharge, but not to exceed 23 hours. Patient rooms shall have direct exit to the corridor or exit way or discharge and shall have a maximum of two beds per room. B. Each patient room shall be 100 square feet for a one-bed occupancy and 80 square feet per bed for a two-bed occupancy, exclusive of closets or lockers. A patient room shall not contain more than two beds. In a two-bed patient room, privacy shall be provided by cubicle curtains or other appropriate partitions. C. Each patient room shall contain at least one, appropriately sized patient bed equipped with a mattress protected by waterproof material and a pillow. D. Each patient room shall be in an area that is visible to the staff at the nurses station and shall be equipped with a nurse call system. E. A patient bathroom, with toilet and bathing or showering facilities shall be provided in the immediate vicinity of the patient bedroom(s). Immediate vicinity means in the patient bedroom or adjacent to the patient bedroom or directly across the corridor from the patient bedroom. F. Patient rooms shall be equipped with medical and personal care equipment that is necessary to meet the needs of the patient. XV SUPPLIES

A. Storage. Maintenance and Distribution: There shall be safe and sanitary storage, maintenance and distribution of sterile supplies and equipment, in accordance with adequate written policies and procedures which also govern shelf life. B. Segregation: Sterile supplies and equipment shall not be mixed with unsterile supplies, shall be stored in dust proof and moisture free units, and shall be properly labeled. C. Sterilizing Equipment: Sterilizing equipment of appropriate type shall be available and of sufficient capacity to adequately sterilize instruments and operating room materials as well as laboratory equipment and supplies. The sterilizing equipment shall have an approved recording thermometer and safety features. The accuracy of such instrumentation and equipment shall be checked and calibrated periodically, preventive maintenance shall be provided as necessary and a log maintained. XVI HOUSEKEEPING SERVICES A. Organization: Each facility shall provide housekeeping services which ensure a pleasant, safe and sanitary environment. The facility shall be kept clean and orderly. B. Written Policies and Procedures: Appropriate written policies and procedures shall be established and followed which ensure adequate cleaning and/or disinfection of the physical plant and equipment. C. Storage: All cleaning materials, solutions, cleaning compounds, and hazardous substances, shall be properly identified and stored in a safe place. D. Critical Areas: Surgical and recovery areas shall be maintained at a high level of cleanliness at all times. E. Dry Dusting and Sweeping: Dry dusting and sweeping shall be prohibited in clean/sterile areas. F. Rubbish and Refuse Containers: All rubbish and refuse containers in treatment areas shall be impervious, lined and clean. G. Handwashing: All personnel shall wash their hands after handling refuse. XVII LAUNDRY AND LINENS Written provisions shall be made for the proper handling of linens and washable goods. A. Outside Laundry: Laundry that is sent out shall be sent to a commercial or hospital laundry. A contract for laundry services performed by commercial laundries for ambulatory surgical centers shall include these standards. B. Storage: If soiled linen is not processed on a daily basis, a separate, properly ventilated storage area shall be provided. C. Processing: The laundry processing area shall be arranged to allow for an orderly progressive flow of work from the soiled to the clean area. D. Washing Temperatures: The temperatures of water during water process shall be controlled to provide a minimum temperature 165 F. (74 C) for at least 25 minutes. E. Packaging: The linens to be returned from the outside laundry to the facility shall be completely wrapped or covered to protect against contamination.

F. Soiled Linen Transportation: Soiled linen shall be enclosed in an impervious bag and removed from surgery units after each procedure. G. Soiled Linen Carts; Carts, if used to transport soiled linen, shall be constructed of impervious materials, cleaned and disinfected after each use. H. Clean Linen Storage Room; Adequate provisions shall be made for storage of clean linen. I. Contaminated Linens: Contaminated linens shall be afforded appropriate special treatment by the laundry. J. Procedures: Adequate procedures for the handling of all laundry and for the positive indentification and proper packaging and storage of sterile linens must be developed and followed. XVIII MAINTENANCE A. Written Policies and Procedures: There shall be written policies and procedures for a preventive maintenance program which is implemented to keep the entire facility and equipment in good repair and to provide for the safety, welfare and comfort of the occupants of the building(s). XIX INCINERATION A. Agreement: If there is no pathological incinerator on the premises, the facility must have an agreement with another facility that has an approved pathological incinerator for the proper disposal of pathological waste. B. Incinerator for Pathological Waste: Any pathological waste incinerator must meet the appropriate clean air act of the state. C. Refuse Incinerators: Refuse incincerators are prohibited. XX PEST CONTROL A. Pest Control; Adequate written policies and procedures shall be developed and implemented to provide for effective control and eradication of insects and rodents. B. Outer Air Openings: All openings to the outer air shall be effectively protected against the entrance of insects and rodents, etc., by self-closing doors, closed windows, screens, controlled air currents or other effective means. XXI WASTE STORAGE AND DISPOSAL A. Sewage and Sewer Systems: All sewage shall be discharged into a public sewer system, or if such is not available, shall be disposed of in a manner approved by the Colorado State Department of Health. B. Refuse and Rubbish: All garbage and refuse not treated as sewage shall be collected in approved containers with liners in such manner as not to become a nuisance, and shall be removed from the facility once a day. A paved outside storage area for the containers must be provided. XXII BUILDING AND FIRE SAFETY A. Facilities shall be compliant with the following National Fire Protection Association (NFPA) 101 Life Safety Code requirements:

1. Facilities licensed on or after October 1, 2003 or portions of facilities that undergo remodeling shall meet NFPA 101, Life Safety Code (2000), Chapter 20, New Ambulatory Health Care Occupancies. 2. Facilities licensed on or before September 30, 2003 shall meet NFPA 101, Life Safety Code (2000), Chapter 21, Existing Ambulatory Health Care Occupancies. 3. Facilities licensed on or before April 29, 1994 shall meet either Section XXII, A.2 above or NFPA 101 Life Safety Code (1981), Section 12-6 “New Ambulatory Health Care Centers.” The facility may meet the NFPA 101 Life Safety Code (1981) if such facilities were lawfully constructed and in compliance with the regulations at the time of initial licensure and found to be in continuing compliance during any subsequent inspections, they may continue to utilize existing, approved life safety systems provided that they present no hazard to life, health, or property and that there are no changes in the scope of services and utilization patterns in the ambulatory surgical center. The ambulatory surgical center shall, in the event of any renovation to the facility of 25 percent or greater of the total interior of the physical plant on or after April 30, 1994 comply with the requirements established in Section XXII, A.1 above. B. Facilities licensed on or after April 30, 1994 shall also be compliant with NFPA 99, Health Care Facilities (1999 Edition), Chapter 13, “Other” Health Care Occupancies. C. Ambulatory surgical centers shall also demonstrate compliance with all other building and fire safety requirements of local governments and other state agencies, including but not limited to structural, mechanical, plumbing, and electrical requirements. D. The publication “Guidelines for Construction and Equipment of Hospitals and Medical Facilities, 19921993” from the American Institute of Architects and the U.S. Department of Health and Human Services may be used by the Department in resolving building and fire safety issues that relate to the services provided or systems installed on or before February 29, 2008 and are necessary to protect patient health, safety, and welfare. On or after March 1, 2008, the American Institute of Architects “Guidelines for Design and Construction for Health Care Facilities,” (2006 Edition) may be used by the Department in resolving building and fire safety issues that relate to the services provided or systems installed on or after March 1, 2008, and are necessary to protect patient health, safety, and welfare. XXIII DEPARTMENT OVERSIGHT A. LICENSURE FEES. Fees shall be submitted to the Department as specified below. 1. Initial license (when such initial licensure is not a change of ownership). A license applicant shall submit with an application for licensure a nonrefundable fee of $6,600. 2. Renewal license. A license applicant shall submit with an application for licensure a nonrefundable fee as follows: Base: $1,440; Per Operating or Procedure Room: $200. The renewal fee shall not exceed $3,000. 3. Change of Ownership. A license applicant shall submit with an application for licensure a nonrefundable fee of $4,100. 4. Provisional License. The license applicant may be issued a provisional license upon submittal of a nonrefundable fee of $2,500. If a provisional license is issued, the provisional license fee shall be in addition to the initial or renewal license fee. 5. Conditional License. A facility that is issued a conditional license by the Department shall

submit a nonrefundable fee ranging from 10 to 25 percent of its applicable renewal fee. The percentage shall be determined by the Department. If the conditional license is issued concurrent with the initial or renewal license, the conditional license fee shall be in addition to the initial or renewal license fee. B. PLAN REVIEW AND PLAN REVIEW FEE. Fees shall be submitted to the Department as specified below. Fees are nonrefundable and shall be submitted prior to the Department initiating a plan review for a facility. 1. Initial license (when such initial licensure is not a change of ownership). A license applicant shall submit with construction plans a nonrefundable fee of: $2,500 for facilities with two or less operating and/or procedure rooms and $5,000 for facilities with three or more operating and/or procedure rooms. 2. Remodeling. Plan review for remodeling is applicable to significant modifications where construction is initiated on or after July 1, 2008 or if a permit is required where the permit from the local authority having jurisdiction is dated on or after July 1, 2008. Significant modifications include: new construction; relocation of walls of any operating or procedure room; addition of one or more operating or procedure rooms; changes to the fire alarm system that involve the replacement of the main fire alarm control unit (panel); and modifications to the medical gas system that affects 50% or more of the facility. A facility shall submit the following nonrefundable fees upon submission of plans: A. Desk review only: $500 B. Desk and onsite review: $1,500 for review of up to two procedure or operating rooms. Significant modifications that impact more than two procedure or operating rooms are subject to an additional fee of $250 per additional procedure or operating room. 3. Replacement Building or New Location. A facility shall submit a nonrefundable fee of $3,100 for facilities with two or less operating or procedure rooms and $5,600 for facilities with three or more operating or procedure rooms. CHAPTER XXI HOSPICE 1. DEFINITIONS 1.1 A hospice is a centrally administrated program of palliative, supportive and interdisciplinary team services providing physical, psychological, spiritual and sociological care for terminally ill individuals and their families within a continuum of inpatient and home care available 24 hours, 7 days a week. Hospice services shall be provided in the home, residential facility, and/or licensed health care facility. Hospice services include but shall not necessarily be limited to the following: nursing, physician, home health aide, homemaker, physical therapy, pastoral counseling, trained volunteer and social services. 1.2 A patient is an individual in the terminal stage of illness who has an anticipated life expectancy of days, weeks or months and who, alone or in conjunction with a family member or members, has voluntarily requested admission and been accepted into a hospice. 1.3 A patient/family is one unit of care consisting of those individuals who are closely linked with the patient including the immediate family, the primary care giver and individuals with significant personal ties. 1.4 Palliative Services are those services and/or interventions which are not curative but which produce the greatest degree of relief from symptoms of the terminal illness.

1.5 The interdisciplinary team is a group of qualified individuals, consisting of at least a physician, registered nurse, clergy/counselors, volunteer director and/or trained volunteers, and appropriate staff who collectively have expertise in meeting the special needs of hospice patient/families. 1.6 Core Services are physician service's, nursing services, pastoral counseling, trained volunteers, and social/counseling services routinely provided by hospice employees. 1.7 Bereavement is that period of time during which survivors mourn a death and experience grief. Bereavement services means support services to be offered during the bereavement period. 1.8 Social/counseling services are those services provided by an individual who possesses a baccalaureate degree in social work, psychology or counseling or the documented equivalent in a combination of education, training and experience. 1.9 The governing body is the group in which ultimate authority and legal responsibility is vested for the conduct of the hospice. 1.10 Informed consent requires that the patient/family giving consent has been informed of the type of care and services which may be provided as part of hospice care and has been given: 1) an explanation of the procedures to be followed. 2) a description of the benefits to be expected. 3) a disclosure of alternative services that could be advantageous to the patient. 4) an offer to answer any inquiries concerning procedures. 5) instruction that the patient or other person giving consent is free to withdraw his consent and to discontinue participation in the program. 1.11 Personal care means services provided to a patient in his or her home to meet the patient's physical requirements and/or to accommodate a patient's maintenance or supportive needs. 1.12 Homemaker services means services provided the patient which include: 1) general household activities including the preparation of meals and routine household care, and 2) teaching, demonstrating and providing patient/family with household management techniques that promote self-care, independent living and good nutrition. 1.13 Respite care means hospice services provided in a patient's home or in a licensed health care facility to relieve temporarily the patient's family or other care providers for unforeseen emergencies or the daily demands of care for the patient. 1.14 Hospice staff shall consist of paid or unpaid persons and shall include volunteers. 1.15 Evaluation means an objective, formal and cyclical assessment of the functioning of the organization and of the provision of hospice care. 1.16 Home care services are hospice services which are provided in the place the patient designates as his/her primary residence. 1.17 Inpatient services are hospice services provided to patient/families who require 24-hour nursing

supervision in a licensed health care facility. The hospice shall maintain administrative control of and responsibility for the provision of all services. 1.18 Hospice day care means health and social services provided on a regularly scheduled basis in a day care center governed by the licensed hospice to insure the overall continuum of patient care. 1.19 A hospice residential facility is an optional part of the home care or respite services provided by the hospice. The facility is one which houses no more than eight hospice patients and is located in a residential area. The facility shall approximate a normal home and directly provides 24 hour home care services. 1.20 An inpatient hospice facility is one which shall directly provide inpatient services and may provide any or all of the continuum of hospice services. These services are provided 24 hours a day and, to the extent possible, in a homelike setting. 2. GOVERNING BODY 2.1 The Governing Body shall be organized formally with written by-laws, shall meet no less often than quarterly and shall maintain records in the hospice available for review. 2.2 The Governing Body shall consist of no fewer than seven members, at least two-thirds of whom shall have no financial interest in the hospice and who shall be representative of the geographic area in which the hospice is located. 2.3 The Governing Body shall appoint an administrator qualified by training and/or experience in hospice administration and to whom the responsibility for the management of the hospice on a day-to-day basis shall be delegated. 2.4 The Governing Body shall promulgate a written philosophy and objectives for the hospice. 2.5 The Governing Body shall provide for medical direction by a licensed physician. 2.6 The Governing Body shall provide for qualified nursing personnel in sufficient quantity to ensure nursing care 24 hours a day, 7 days a week. 2.7 The Governing Body shall ensure the provision of both home care and in-patient services. 3. ADMINISTRATION 3.1 The hospice shall have an administrator who: 1) is a physician licensed in Colorado, or 2) is a registered nurse, or 3) has training and experience in health service administration and at least 1 year of supervisory or administrative experience in related health programs. 3.2 The administrator shall be responsible for the management of the hospice and shall maintain liaison between the Governing Body and the hospice staff. If the administrator delegates specific duties, the person responsible shall be clearly identified. 3.3 The duties of the administrator shall include but not be limited to: 1) directing the hospice and ensuring implementation of policies and procedures regarding all

activities and patient/family care services provided in the hospice, whether provided through staff employed directly by the hospice, by volunteers or through contract arrangement. 2) designation an alternate to act in his or her absence. 3) implementing administrative policies and procedures which include personnel policies and which are applicable to all hospice staff. 4) implementing financial policies and procedures, approved by the Governing Body, according to sound business practice. Such policies and procedures shall include at least the following: a) payroll (if applicable). b) accepting and accounting for gifts and donations. c) keeping and submitting such reports and records as required by the Department in these regulations and other authorized agencies. 4. QUALITY MANAGEMENT 4. 1 The hospice shall have a quality management program to evaluate and report to the governing body on the 1) organization or method of operations and 2) patient care services. A summary of the outcomes of this program shall be available to the public on an annual basis. 4.1.1 The hospice shall evaluate its: 1) Goals and objectives. 2) Patient care policies and procedures. 3) Administrative policies and procedures. 4) Staff and volunteer performance. 5) On-going education and training. 6) Financial reporting. 7) Board performance. 4.1.2 There shall be a quality assurance program to guide evaluation of the care provided and include at least: 1) The desired outcomes of hospice care. 2) Criteria for determining appropriate length of stay. 3) Criteria for determining level, location, and intensity of care for continuing, respite, and bereavement care, and for discharge. 4) Provision for responding to consumer complaints. 5) Provision for review of service providers. 6) A patient care plan which directly relates to the identified physical and psychosocial needs of the patient and family. 7) A determination that the services, medications and treatments prescribed were in

accordance with the current hospice plan of care. 8) A determination that the hospice program of care appropriately utilized inpatient hospice care. 9) A determination the R.N. staffing ratios are consistent with quality hospice care. 4.1.3 The hospice shall appoint a clinical record review committee, composed of appropriately selected members, including at least one member not affiliated with the hospice. The committee shall meet at least twice yearly. Dated and signed minutes of these meetings shall be maintained. 1) The committee's function shall be to provide ongoing evaluation and review of hospice utilization and to make recommendations to the administrator. 2) The administrator shall report such findings and recommendations to the governing body and staff. 3) All incident reports shall be reviewed by this committee. 5. PATIENT RIGHTS AND RESPONSIBILITIES 5.1 Each hospice patient/family shall receive a copy of the Hospice Patient's Bill of Rights and Responsibilities. 5.1.1 There shall be written documentation of receipt of the copy of the patient rights and responsibilities. 5.1.2 By written declaration the hospice shall affirm the following patient rights and responsibilities: 1) the right to be informed of the hospice concept, admission criteria, services to be provided, options available, and any charges which may be incurred. 2) the right to participate in developing the patient plan of care. 3) the right to expect that all records be confidential. 4) the right to refuse service or withdraw from the program at any time. 5) the responsibility to provide accurate information which may be useful to the hospice in delivering appropriate care. 6) The right to express a grievance without fear of reprisal. 5.1.3 Hospice responsibilities shall include but not be limited to: 1) the responsibility to provide quality care to individuals regardless of race, religion, sex, age, and/or physical or mental disabilities or ability to pay. 2) the responsibility to train all professional staff and volunteers adequately for the level of service they provide. 3) the responsibility to provide care which is ethical, is in the best interest of the patient, and is respectful of the patient/family life values, religious preference, dignity, individuality, privacy in treatment and personal needs.

4) special attention, in regard to their right to privacy, choice and dignity shall be given to infants, small children and adolescents. 6. POLICIES AND PROCEDURES 6.1 Under the supervision and direction of the Governing Body, the hospice shall develop and implement written policies to coordinate a program for home and inpatient hospice care services. 6.1.1 These policies and procedures shall be reviewed and approved by the Governing Body annually. 6.1.2 The policies and procedures shall include but not be limited to: 1) medical direction. 2) admission and termination of care. 3) physician services. 4) nursing services. 5) nutrition services. 6) pharmacy services. 7) bereavement services. 8) social services. 9) volunteer services. 10) spiritual services. 11) special needs of infants, children and adolescents. 12) management of: a) pain and other symptoms. b) physical components of care. c) financial needs. d) contractual services. 13) patient/family education. 14) death at home and in facilities. 15) coordination and communication between all agencies serving the patient/family. 16) referral to hospice, response to requests and referral to other appropriate agencies. 17) community education. 6.1.3 Prior to admission to the hospice the patient/family shall be apprised of all options provided by the hospice to meet their needs. 6.1.4 There shall be an admission agreement which includes but is not limited to: 1) information regarding charges for services, materials and equipment available to the patient/family.

2) a statement of patient/family financial responsibility. 3) any existing pre-payment, refund and sliding scale fee policies. 4) a copy of the patient's rights and responsibilities. 6.1.5 Admission policies shall indicate that admission to a hospice shall be limited to the following: 1) patients in the terminal stage of illness whose survival is defined in terms of days, weeks or months. 2) the patient/family and attending physician agree that palliative care is appropriate. 3) persons shall not be admitted without a signed parent/guardian consent. 4) a patient/family must be under the care of a physician who shall be responsible for medical care. 6.1.6 Admission to a home care hospice program may be limited to those patients who have a primary care giver. 6.1.7 The hospice shall have a written policy regarding the admission of patients who do not have a primary care giver. 6.2 Transfers: To facilitate continuity of care, when transferring within the hospice, to another hospice, or to another provider, the patient/family plan of care shall be immediately forwarded to the receiving provider of care. 6.3 Termination of Care: The hospice shall establish specific criteria for termination of care. 6.3.1 There shall be policies and procedures related to termination of care and/or referral. 6.3.2 The patient/family record shall contain documentation of the reason care has been terminated. 6.4 There shall be policies and procedures related to provision of bereavement services for individuals who have not previously received hospice services. 7. PATIENT CARE SERVICES 7.1 The hospice shall establish an interdisciplinary team whose responsibility shall include but not be limited to: 1) establishment of a plan of care. 2) provision and/or supervision of hospice care and services. 3) review and/or revision, at least twice monthly, of the plan of care for each patient/family receiving hospice care. 4) implementation of written policies governing the day-to-day provision of hospice care and services. 7.1.1 On admission to the hospice there shall be an assessment of the patient/family physical,

emotional, psychosocial and spiritual needs, including any environmental or financial considerations and an initial plan of care developed by the physician and one member of the interdisciplinary team. 7.1.2 Based upon the assessment and admission findings, there shall be prepared, within 5 working days of admission, an interdisciplinary team plan of care which shall include but not be limited to: 1) plans to meet the identified needs. 2) a mechanism for initial and on-going liaison with the patient's attending physician. 3) designation of the primary care giver or alternate plan. 4) identification of the team members who will provide care. 5) identification of the anticipated frequency of services needed. 6) plans instructing the patient/family in patient care. 7) when applicable, plans to meet the special needs of infants, children and adolescents. 7.1.3 The hospice shall designate a registered nurse to coordinate the overall plan of care for each patient. 7.1.4 Progress notes shall demonstrate the implementation and evaluation of the plan of care. 7.1.5 There shall be on-going assessment of patient/family needs, and revision of plan of care as appropriate. 7.1.6 There shall be documentation of coordination and continuity of care to include: 1) on-going liaison with the primary or attending physician. 2) communication among team members. 3) communication between inpatient and home care teams. 4) instruction of patient/family in care needed. 7.1.7 The interdisciplinary team shall ensure that the patient/family shall be actively involved in hospice care including but not limited to: 1) participating in designating the primary care giver or alternate plan. 2) assisting the interdisciplinary team to identify and meet needs. 3) receiving instruction and participating in care. 4) participating in care and care decisions. 7.1.8 The interdisciplinary team shall make use of consultants and community resources as necessary. 7.1.9 Any unusual change in the patient's physical, mental, spiritual or emotional status shall be

reported to the interdisciplinary team and next of kin or significant other. 7.2 Medical Direction: The hospice shall have a physician who shall act as medical director who is currently licensed to practice in the State of Colorado. 7.2.1 The medical director shall be a member of the interdisciplinary care team and shall be responsible for the direction and quality of the medical care rendered to the patient/family by the interdisciplinary team. 7.2.2 The responsibility of the medical director shall include but not be limited to: 1) reviewing appropriate clinical material from the referring physician to validate the prognosis as anticipated by the patient's attending physician. 2) assisting in developing and medically validating the interdisciplinary plan of care for each patient/family with the coordination of the patient's primary or attending physician. 3) rendering, as necessary, or supervising active medical care in the patient's home, in the inpatient hospice unit or outpatient hospice service; and maintaining a record of such care. 4) maintaining a regular schedule of participation in all components of the hospice care program. 5) being readily available to the hospice program personally or naming a qualified physician designee. 6) acting as a consultant to and maintaining liaison with the attending physicians and other members of the interdisciplinary care team. 7) helping to develop and review patient/family care policies and procedures. 8) serving on appropriate committees. 9) reporting regularly to the administrator regarding medical care delivered to the hospice patients. 10) approving written protocols for symptom control, i.e., pain, nausea, vomiting, or other symptoms. 7.3 Physician Services: The hospice shall ensure that each patient has a primary physician. If a patient has no primary physician, there shall be a mechanism for assuring the availability of one. 7.3.1 The primary and/or attending physician shall: 1) approve and sign the plan of care for the patient/family. 2) be available to the interdisciplinary team as necessary. 3) provide information to the interdisciplinary team in developing the plan of care. 4) review the plan of care at least every 60 days. 7.4 Nursing Services: The hospice shall have an organized nursing service under the direction and

supervision of a registered nurse qualified by training and experience to direct hospice nursing care. 7.4.1 The responsibilities of the aforementioned registered nurse shall include but not be limited to: 1) developing and implementing nursing objectives, policies and procedures. 2) developing job descriptions for all nursing personnel. 3) establishing staffing schedules to meet patient/family needs. 4) developing and implementing orientation and training programs. 5) developing and implementing a program of performance evaluation. 7.4.2 A registered nurse shall assess the patient/family and identify nursing needs. 7.4.3 A registered nurse shall plan, supervise and evaluate the nursing care for each patient/family. 7.4.4 Nursing care of each patient/family shall be provided in accord with the needs of the patient. 7.4.5 All nursing personnel shall be assigned duties consistent with their education and experience. 7.4.6 All nursing personnel caring for infants, children, and adolescents shall have training appropriate to the care including pediatric pharmacology, normal growth and development, and the special psychological needs of the dying child. 7.4.7 There shall be documentation of nursing care given which shall include observations which contribute to the continuity of patient care and treatment goals. 7.4.8 Each nursing visit shall be documented in the clinical record. 7.4.9 Nursing service shall be ensured 24 hours a day, 7 days a week. 7.4.10 There shall be periodic meetings of the professional nursing staff to enhance the nursing care provided in the hospice. Written documentation of such meetings must be maintained. 7.5 Social/counseling services: The hospice shall provide, either directly or by arrangement, social/counseling services to the patient/family before and after the patient's death. 7.5.1 Social/counseling services shall be available 7 days a week. 7.5.2 Social/counseling services shall provide support to enable an individual to adjust to experiences associated with death. 7.5.3 Social/counseling services shall be delivered consistent with the patient care plan. 7.6 Volunteer Services: The hospice shall utilize trained volunteer services to promote the availability of care, meet the broadest range of patient/family unit needs, and effect financial economy in the operation of the hospice. 7.6.1 The hospice shall designate a volunteer services director.

7.6.2 A hospice shall develop, implement and document a program which meets the operational needs of the volunteer program, coordinates orientation and education of volunteers, defines the role and responsibilities of volunteers, recruits volunteers, and coordinates the utilization of volunteers with other program directors. 7.6.3 The volunteer services director shall be a member of the interdisciplinary team. 7.6.4 Volunteer service staff shall be aware of a patient's condition and treatment as indicated on the written plan of care. 7.6.5 Services provided by volunteers shall be in accord with the written plan of care and shall be documented in the clinical record. 7.7 Bereavement Services: The hospice shall provide services to the family to assist them in coping with the death of the family member. Bereavement services shall be provided under the supervision of an individual who has documented evidence of training and experience in dealing with bereavement. 7.7.1 Bereavement services shall be available to families/significant others before and after the patient's death. 7.7.2 Bereavement services shall be available 7 days a week and shall be available to the family for a period not less than 12 months following the death of the patient. 7.7.3 Bereavement services shall be delivered consistent with the written plan of care with criteria for termination and/or referral. 7.8 Spiritual Services: The hospice shall provide the services of at least one clergy-person or spiritual advisor. 7.8.1 There shall be defined policies regarding the delivery of spiritual services. 7.8.2 The hospice program of spiritual care shall not impose upon the patient/family the dictates of any value or belief system. 7.8.3 All spiritual services provided shall be documented in the patient/family record. 7.9 Personal Care and Home-Maker Services 7.9.1 The hospice shall provide documented supervision according to agency policy of personal care/homemaker services. 7.9.2 The hospice shall assure that personal care givers shall have received forty (40) hours of training prior to service delivery in: 1) hospice philosophy and orientation. 2) basic personal care procedures including grooming. 3) bowel and bladder care. 4) food, nutrition, diet planning, etc. 5) methods of making patients comfortable. 6) assisting patient mobility including transfer.

7) basic needs of the frail elderly and/or the physical disabled persons. 8) first aid and handling emergencies. 9) health oriented record keeping including time/employment records. 10) basic techniques in observation of patient's mental and physical health. 11) basic techniques of identifying and correcting potential safety hazards in the home. 12) techniques in lifting. 7.9.3 The hospice shall ensure that homemakers have received eight (8) hours of training in providing the following care: 1) basic techniques in cleaning including floor care, appliances, supplies inventory, sanitation, vacuuming, etc. 2) basic household appliance maintenance. 3) basic nutritional requirements, shopping, food preparation and storage. 4) basic techniques in observation of patient's mental and physical health. 5) basic techniques of identifying and correcting potential safety hazards in the home. 6) techniques in lifting. 7) first aid and emergency procedures. 8) basic needs of frail elderly and/or physically disabled persons. 7.9.4 The hospice shall ensure that the training provided the homemaker/personal care giver is specific to the unique needs of the patient. 7.9.5 The personal care giver/homemaker shall meet all personnel requirements of Section 10. 8. DAY CARE 8.1 Day care services shall include but not be limited to: 1) daily monitoring to assure that patients are maintaining personal hygiene and participating in appropriate social and recreational activities prescribed; and assisting with activities of daily living (e.g., eating, dressing). 2) emergency services including written procedures to meet medical crises. 3) assistance in the development of self-care capabilities, personal hygiene, and social support services. 4) provision of nourishments appropriate to the hours in which the patient is served. 5) nursing services provided to monitor patient's health status, supervise medications and carry out the plan of care.

6) social and recreational services as prescribed to meet the patient's needs. 8.2 Day care centers shall meet the following standards: 1) the center shall operate in full compliance with all applicable federal, state and local fire, health, safety, sanitation and other standards prescribed in law or regulations. 2) the center shall provide a clean environment, free of obstacles that could pose a hazard to client health and safety. 3) the center shall provide lockers or a safe place for patient's personal items. 4) the center shall provide recreational areas and activities appropriate to the number and needs of the patients. 5) drinking facilities shall be located within easy access to patients. 6) the center shall provide eating and resting areas consistent with the number and needs of the patients being served. 7) the center shall provide easily accessible toilet facilities, hand-washing facilities and paper towel dispensers. 8) the center shall be accessible to patients with supportive devices for ambulation or in wheelchairs. 8.3 The center shall maintain such records and information necessary to document services provided the patient. Records shall include but not be limited to: 1) medications the patient is taking and whether they are being self-administered. 2) special dietary needs, if any. 3) restrictions on outside-of-center activities identified in the plan of care. 8.4 The day care center shall be staffed with qualified personnel in numbers sufficient to provide: 1) daily nursing services. 2) therapies as prescribed in the Plan of Care. 3) volunteer services. 4) supervision of patients at all times during operating hours. 5) immediate response to emergency situations. 6) prescribed recreational and social activities. 7) monitoring of the on-going medical needs. 8) administrative, recreational, and supportive functions of the center. 8.5 The center shall have written policies and procedures relevant to the operation of the day care center.

Such policies and procedures shall include but not be limited to: 1) admission criteria that qualify patients to be appropriately served in the center. 2) an assessment procedure conducted for qualified patients and/or family members prior to admission to the center. 3) meals and nourishments including special diets that will be provided. 4) hours that the patients will be served in the center and days of the week services will be available. 5) personal items that the patients may bring with them to the center. 8.6 A written, signed contract shall be drawn up between the patient or responsible party and the center outlining rules and responsibilities of the facility and of the patient. Each party to the contract shall have a copy. 9. RESPITE CARE 9.1 Respite services shall be hospice services provided in a patient's home or in a distinct part of a health care facility licensed as a general hospital, skilled nursing facility, residential hospice facility or inpatient hospice facility. 9.2 Respite services may vary according to individual patient needs and support systems but shall be provided under the direction of the hospice. 9.3 Respite providers shall meet all standards contained in these regulations. 9.4 Normal procedures for admission to in-patient facilities shall be waived except for requiring the plan of care. 10. PERSONNEL 10.1 The hospice shall employ, or have available through volunteers, at least the following services: 1) physician services. 2) registered professional nursing services. 3) a social worker or counselor services. 4) pastoral counseling services. 5) trained volunteers services. 10.1.1 The hospice shall provide clerical staff sufficient in quantity to provide administrative services. 10.1.2 There shall be written personnel policies, approved by the governing body that govern the conditions of employment. 10.1.3 There shall be a written program of orientation for all personnel that includes but is not limited to:

1) personnel screening for suitability for hospice service. 2) history, philosophy and structure of the hospice concept. 3) current hospice concepts. 4) the interdisciplinary approach. 5) communication skills. 6) hospice services offered. 7) agency organizational structure. 8) agency policies and procedures. 9) personnel policies. 10) continuing educational requirements. 11) infection control. 10.1.4 There shall be a mechanism to ensure an ongoing staff education program for all personnel which offers, at a minimum, 20 hours of education/training annually to enhance hospice related skills. 10.1.5 There shall be personnel records on each employee including application, documentation of orientation, documentation of staff education, verification of credentials, and evaluations. 10.1.6 The hospice shall have a written policy regarding on-the-job injuries. 10.1.7 There shall be a mechanism to ensure that the governing body and administrator provide the hospice staff with the means and opportunity for psychological support. 11. PHARMACEUTICAL SERVICES 11.1 The hospice shall develop and maintain written policies and procedures for the administration and provision of pharmaceutical services that are consistent with the drug therapy needs of the patient as determined by the medical director and patient's primary physician. 11.1.1 Medications ordered shall be consistent with the hospice philosophy which focuses on palliation, i.e., controlling pain and other symptoms which are manifested during the dying process and are consistent with professional practice and regulations of the Colorado Board of Pharmacy. 11.2 Medication Labeling and Disposition of Medications. 11.2.1 Unless the pharmacy provides a unit dose system, all prescription drugs (to include “bubble” or “blister” cards) shall be labeled and shall include: 1) name of pharmacy. 2) name of patient. 3) name of prescribing physician.

4) date prescription filled. 5) prescription number. 6) name of medication. 7) directions and dosage. 8) expiration date. 9) quantity dispensed. 11.2.2 Medications shall be destroyed when: 1) the label is mutilated or indistinct. 2) the medication is beyond the expiration or shelf life date. 3) unused portions remain due to discontinuance, death, or discharge. Notwithstanding the provisions of this subsection 11.2.2 (3), in accordance with state law, including Section 12-22-133, C.R.S. (2005), the hospice may return unused medications to a pharmacist for redispensing if those medications were donated to the hospice by the patient or the patient’s next of kin. For purposes of this paragraph, unused medications means prescription medications that are not controlled substances. If a hospice accepts donated medications for redispensing by a pharmacist it shall implement a written policy that addresses inventory control and prevents the diversion of such medications. 11.3 Pharmaceutical Services: Home Program 11.3.1 All prescription medications shall be ordered in writing by a licensed physician or dentist, dispensed by a licensed pharmacy, received by the patient/family and maintained in the home. 11.3.2 The hospice shall maintain current documentation of all prescription medications being administered. 11.3.3 The hospice shall have a written procedure for destruction of drugs according to acceptable standards. The procedure to be used for destruction of controlled substances depends upon the ownership of the drugs. If the controlled substances have been obtained by prescription, they are the property of the patient and either the patient or relatives should be encouraged by the attending physician or nurse to destroy the drugs. 11.4 Pharmaceutical Services: In-Patient Facilities 11.4.1 The in-patient facilities shall meet all standards for pharmaceutical services in chapter IV, General Hospitals, or chapter V, Nursing Care Facility, or chapter VI, Intermediate Care Facility, if maintained as a distinct part of such a licensed facility. 11.4.2 Pharmacy services shall be under the supervision of a registered pharmacist. 11.4.3 All medications shall be obtained from a licensed pharmacy. 11.4.4 All medications shall be prescribed by a licensed physician and, unless self-administered, be administered by a licensed nurse.

11.4.5 A pharmacist and one other responsible individual shall destroy medications (except scheduled drugs). 11.4.6 Medication destruction shall be accomplished by incineration or by disposal in a sewer system. 11.4.7 If the controlled substances involved have been furnished to the patient from a physician's “bag stock” or a hospital or pharmacy stock, not pursuant to a prescription, the drugs should be returned to the physician, hospital or pharmacy in compliance with the Colorado Board of Pharmacy regulations on such procedures. 11.4.8 If the controlled drugs (scheduled 2-5) are being held by the hospice on behalf of a patient and the medications are no longer needed, the hospice is authorized to conduct on-site destruction of the controlled substances. The following procedures must be adhered to in the destruction process of schedule 2-5 drugs: 1) all destructions must be properly inventoried and a copy of the inventory must be kept on file for a minimum of two (2) years. DBA Form 41 is not required for the inventory. 2) each destruction must be witnessed by the facility administrator or designee, the supervisory nurse and the consulting pharmacist. Each must actually witness the destruction inventory. 3) the destruction must be performed in such a manner, as to render the drugs totally unretrievable. 11.4.9 Non-prescription medications may be maintained in and administered in the hospice providing the following conditions are met: 1) the physician has authorized the medication. 2) the medication is brought to the hospice unopened and in its original carton. 3) the medication is labeled with tape containing the patient's full name. 4) the tape is place upon the container in such a manner as not to obscure the original label. 11.4.10 Medications shall be self-administered only upon written authorization of a physician. 11.4.11 Medications shall not be left at the bedside unless authorized by a physician. When authorized, provision shall be made for storage of medications in a safe and sanitary manner. 11.4.12 All medication administration shall be documented in the patient's record. 11.4.13 Medications not stored at the bedside shall be maintained in locked storage in a centralized location. 12. RECORDS 12.1 In accordance with accepted principles of medical record practice, the hospice shall maintain a centralized and complete record on every individual receiving service. 12.2 All entries shall be permanent and legible and signed with name and title of individual making the

entries. 12.3 The record shall include documentation of all services provided whether furnished directly or by arrangement. 12.4 Each record shall include but not be limited to: 1) identification and demographic data. 2) initial and subsequent assessments. 3) the plan of care. 4) medical history. 5) documentation of all services and events. 6) consent and authorization forms. 7) physicians' orders. 8) medication and records. 9) discharge/transfer records. 12.5 The hospice shall ensure the safety of the records against loss, destruction or unauthorized use. 12.6 All records shall be maintained for a period of 5 years after death or discharge. In the case of a minor, the record shall be maintained for a period of 5 years after death or, if a minor attains majority, for a five-year period thereafter. 13. CONTRACTUAL SERVICES 13.1 A hospice may contract as defined by law with other health care providers for the provision of all but core services. 13.1.1 Contracts shall be written and shall clearly delineate the authority and responsibility of each of the contracting parties. 13.1.2 The hospice shall maintain responsibility for coordinating and administering the hospice program. 13.1.3 All contracts shall specify that services provided shall be as specified in the Plan of Care. 13.1.4 All contracts shall specify financial arrangements including arrangements for donated services. 13.2 All contracts shall be dated and signed by an authorized agent of the hospice and the contracting agency. 13.3 All contracts shall be reviewed and/or revised by the hospice on an annual basis. 13.4 Individuals providing contract services shall be credentialed as applicable. The hospice shall maintain documentation of such credentials.

13.5 Contracting for a service shall not absolve the hospice form legal responsibility for the provision of that service. 13.6 The hospice shall ensure that employees of an agency providing a contractual service shall not seek or accept reimbursement in addition to that due the agency for the actual service delivered. 13.7 If contract services are utilized, the contractor shall meet all applicable provisions of hospice regulations. 14. IN-PATIENT AND RESIDENTIAL FACILITIES 14.1 The hospice shall ensure that in-patient services are available to meet the needs of the patient as determined by the hospice. 14.2 The hospice shall maintain administrative control of and responsibility for the provision of all services. 14.3 There shall be written policies and procedures to meet medical emergencies. 14.4 The hospice shall provide areas that ensure private patient/family visiting. 14.5 The hospice shall provide or arrange for accommodations for family members to remain with the patient overnight. 14.6 The hospice shall provide accommodations for family privacy after a patient's death. 14.7 The hospice visiting hours shall be flexible and shall not exclude children or pets. 14.8 The hospice shall provide a Patient Care Control Areas, designed and equipped for record recording, communications and storage of supplies and staff personal effects. 14.9 A separate handicapped accessible telephone shall be provided for resident use. 14.10 The facility shall meet all state and local laws and regulations pertaining to health and safety, and where applicable, zoning regulations. 14.11 There will be a disaster plan to cover evacuation of patients. 14.12 Sewage shall be discharged into a public sewer system, or if such is not available, it shall be disposed of in a manner approved by the state and local health authorities and the Colorado State Water Pollution Control Commission. 14.13 Garbage and rubbish not as sewage shall be stored in impervious containers in such a manner as not to become a nuisance or a health hazard. A sufficient number of impervious containers with tightfitting lids shall be provided and kept clean and in good repair. Refuse shall be removed from the outside storage area at least once a week (preferably twice) to a disposal site approved by the local health department. Open burning on the premises is prohibited. 14.14 The water supply shall be designed, constructed and protected so as to assure that a safe, potable and adequate water supply is available for domestic purposes in compliance with state and local laws and regulations. 14.15 All plumbing shall be installed and maintained in accordance with the Colorado Plumbing Code and local plumbing codes. All plumbing shall be maintained in good repair and free of the possibility of backflow and backsiphonage, through the use of vacuum breakers and fixed air gaps, in accordance with

state and local codes. 14.16 Inpatient or residential facilities with 8 or more patients must have a water heater with a capacity of 75 gallons or more. 14.17 The facility shall be maintained free of infestations of insects and rodents and all openings to the outside shall be adequately screened. A pest control inspection is required annually by an approved pest control company. 14.18 Furnishings shall be of a home-like variety and include lounge furniture as well as that contained in patient rooms. Accessories such as wallpaper, bedspreads, carpets, lamps, etc. shall be selected to create such an atmosphere. Provision shall be made for each patient to bring items from home to place about his/her room to the extent of space available, and as long as item will not jeopardize patient safety. 14.19 There may be single and/or double bedrooms to meet the needs of the patients. There shall be no more than two beds per patient room. Each patient room shall be located at or above ground level, have a window, and have direct entry from the corridor. 14.20 Patient rooms shall be 100-sq feet for one-bed rooms and 80-sq feet per bed in multi-bedrooms, exclusive of closets, lockers. 14.21 Artificial lighting shall be provided as consistent with a home-like decor and illumination to meet treatment needs. 14.22 Each patient room shall contain a comfortable, appropriately sized bed, equipped with a mattress protected by waterproof material, mattress pad and comfortable pillow; a comfortable chair and other furniture as appropriate to the decor and patient needs. 14.23 Infants and small children shall not be placed in a room with an adult patient. All equipment and supplies shall be age appropriate. 14.24 Housekeeping practices and procedures shall be employed to keep the facility free from offensive odors, accumulation of dirt, rubbish and dust. 14.25 Each facility shall provide storage for housekeeping equipment. 14.26 Cleaning shall be performed in a manner to minimize the spread of pathogenic organisms. Floors shall be cleaned regularly. Polishes on floors shall provide a non-slip finish; throw or scatter rugs shall not be used except for non-slip entrance mats. 14.27 Test reagents, general disinfectants, cleaning agents, etc., shall not be stored in the medication area and shall be maintained in a safe, secure manner. 14.28 The hospice shall provide a separate area for storage of clean linen. 14.29 The shared use of linens and other personal care articles is prohibited. 14.30 The hospice shall ensure supplies of clean bed linen, towels, and washcloths in quantities appropriate to the proper care of patients. 14.31 Laundry facilities and/or arrangements with commercial laundry shall provide for the necessary washing, drying and ironing equipment to adequately serve the needs of the facility. 14.32 Separate storage for soiled linen and clothing shall be provided. Such storage may consist of individual plastic bags or hampers or a soiled linen room.

14.33 The hospice shall provide a ventilated area for medication preparation. The area shall include a refrigerator used primarily for storage of medications. Specimens and food may be stored in the refrigerator, in separately labeled areas. The area shall include counter-space with illumination providing 100 foot-candles at the work surface, a sink with handwashing facilities and, if applicable, cabinets with locking devices to protect drugs stored therein. 14.34 Patient Care Areas (inpatient facilities) 14.34.1 Inpatient care may be provided in a distinct part of a health care facility licensed as a general hospital, skilled nursing facility, or inpatient hospice facility. 14.34.2 There shall be a registered nurse on duty in each patient care unit 24 hours a day. 14.34.3 Hospice in-patient care units shall have a identifiable and appropriately trained staff. 14.34.4 Hospice nursing care staff (RN'S, LPN'S, CNA'S, and personal care givers) shall be in ratios no fewer than 1:6 during the 12 hour day and early evening hours and 1:8 during the 12 hour late evening and night hours. 14.34.5 Licensed health care facilities, in which inpatient hospice services are provided, shall meet the building and life safety codes currently being required for licensure and certification. Inpatient hospice facilities must meet the provisions of Chapter 10 requirements for Group 1occupancies, Uniform Building Code, 1982 Edition, except delete the following sentence in Section 3305(h) Openings 1. Doors shall be maintained self-closing or shall be automatic closing by activation of a smoke detector in accordance with Section 4306 (b). (Exception: Hazardous areas) inpatient hospices shall meet all provisions of Chapter 12, New Health Care Occupancies, Life Safety Code, NFPA 101-1985. 14.34.6 There shall be a storage room on each patient care unit for storage of patient care equipment. 14.34.7 The medication preparation area shall be ventilated and the room temperature shall not exceed 72 degrees F. 14.34.8 Each patient care unit shall have a separate clean holding area equipped with 1) counter, 2) sink with mixing faucet, 3) blade controls, 4) soap, 5) hand-drying equipment, 6) waste container and cupboards for supplies. 14.34.9 In facilities with more than 8 patients, each patient care unit shall have a separate soiled holding area equipped with 1) counter, 2) double sink with mixing faucet, 3) blade controls, 4) soap and hand-drying equipment, 5) covered waste container, 6) soiled linen hamper with impervious liner, 7) clinical flushing sink and shelf space. 14.34.10 In facilities with more than 8 patients, each patient care unit shall have a janitor's closet equipped with 1) floor-mounted sink with mixing faucets, 2) hook strips for mop handles, 3) shelves, 4) soap and hand-washing facilities, 5) waste receptacles and floor area adequate to store mop buckets on roller carriages. 14.34.11 Each patient room shall be furnished with a call system that registers a visual signal from the patient. It shall register in the corridor outside the patient's room and at the Patient Care Control Center. Call stations shall be located at the patient's I bed, the toilet rooms and each tub and shower. Call stations at I toilet rooms and bathing areas shall be emergency calls. 14.34.12 Each patient room shall have closet space for each patient for clothing and personal belongings.

14.34.13 Bed linens shall be changed as often as necessary, but no less than twice each week. 14.34.14 Toilet facilities shall be easily accessible from each patient room. One toilet may service two patient rooms but not more than four beds. Minimum dimensions of any toilet room shall be 18 square feet. The door to the toilet room shall be at least 32 inches wide and swing out. The toilet room shall be furnished with the following: (1) toilet with grab bars; (2) lavatory with wrist blade controls and mixing faucet; (3) mirror; (4) soap and hand drying facilities, waste paper receptacle with a removable impervious liner. 14.34.15 There shall be bathing facilities in the ratio of one tub or shower for each fifteen patients. Approved grab bars shall be installed at each tub or shower and tubs shall have a nonslip surface. There shall be toilet and lavatory facilities in the bathroom with mixing faucet, blade controls, soap and hand-drying accommodations. 14.35 Patient Care Areas - Residential Facility 14.35.1 Hospices maintained as residential facilities shall provide documentation of approval from local zoning commissions fire departments, code enforcement and building departments. Additional fire safety requirements are: 1) if the residential facility houses 1-3 residents (and no one resident is determined to have an evacuation capability more than 12 - see NFPA-101, 1985 - appendix F), the facility shall meet the requirements of Chapter 22, NFPA-101, 1985 - one and two family dwellings. 2) if any resident is determined to have an evacuation capability of 12 or more or if the residential facility houses 4-16 residents, the facility shall meet the requirements of Chapter 21, NFPA-101, 1985 - Residential Board and Care Occupancies, Section 21-2, Small Facilities. 14.35.2 There shall be an audible and accessible call system furnished in each patient, toilet, or tub room. 14.35.3 There shall be an area provided for charting, storage of supplies and personal effects of staff. 14.35.4 Provisions shall be made for the storage of patient care equipment. 14.35.5 There shall be bathing facilities in the ratio of one tub or shower for each eight residents. Approved grab bars shall be installed at each tub or shower and tubs shall have a non-slip surface. 14.35.6 There shall be toilet and lavatory facilities in the ration of one for each four residents. These shall be equipped with blade controls, mixing faucet, soap and hand-drying accommodations and waste basket. or locker 14.35.7 Each resident shall be provided with a closet or locker space and a towel rack in the bedroom. 14.35.8 Dining space shall be provided in an area capable of comfortably seating all residents at the same time. 14.35.9 A two compartment sink or domestic dishwashing machine shall be required. 14.35.10 Bed linens shall be changed as often asnecessary, but no less than once each week.

15. DIETARY SERVICES FOR INPATIENT AND RESIDENTIAL FACILITIES 15.1 The hospice shall develop and maintain written policies and procedures for dietary services. 15.2 The hospice shall provide a practical freedom-of-choice diet to patients and shall assure that patients' favorite foods are included in their diets whenever possible. 15.3 The hospice shall appoint a staff member trained or experienced in food management to: 1) plan menus to meet the nutritional needs of the patients. 2) supervise meal preparation and service. 3) provide therapeutic diets as prescribed by the physician. 15.4 The food service shall be planned and staffed to adequately serve three balanced meals at regular intervals or at a variety of times depending upon the needs of the residents. Between-meal snacks of nourishing quality shall be offered and be available on a 24 hour basis. 15.5 The hospice shall provide one or more areas for dining, recreation and/or social activities. These areas may not be used for corridor traffic. 15.6 The food service shall meet acceptable standards relative to food sources, refrigeration, refuse handling, pest control, storage, preparation, procuring, serving and handling. 16. INFECTION CONTROL 16.1 The hospice shall develop and implement an infection control program. 16.2 There shall be written policies and procedures governing the infection control program developed by the hospice administrator and medical director and approved by the governing body. 16.3 A procedure shall be developed whereby the implementation of the infection control program is monitored on A monthly basis. 16.4 All employees shall wear clean outer garments and/or protective clothing at all times and shall practice good personal hygiene and cleanliness. 16.5 The inpatient hospice shall isolate only those patients with diseases with a high risk of transmission. 16.6 The inpatient hospice shall be responsible for ensuring that residents maintain an acceptable level of personal hygiene at all times. 17. REFERENCES 17.1 The following referenced codes in the regulations do not include later amendments to or editions of the incorporated material: Chapter 10, Group 1 Occupancies, Uniform Building Code, 1982 Edition, International Conference of Building Officials Chapter 12, New Health Care Occupancies, Life Safety Code, NFPA-101, 1985, National Fire Protection Association NFPA 101-1985 Appendix F, National Fire Protection Association

Chapter 22, NFPA-101. 1985 One and Two Family Dwellings, National Fire Protection Association Chapter 21, NFPA-101, 1985 Residential Board and Care Occupancies, Section 21-2, Small Facilities, National Fire Protection Association Certified copies of the above codes are available for inspection during regular business hours. Copies of the materials shall be provided at cost and may be obtained at the address listed on page 255 of these regulations upon request. CHAPTER XXII BIRTH CENTER DEFINITION: Birth Center means any public or private health facility or institution which is not licensed as a hospital or as part of a hospital and provides care during delivery and immediately after delivery for generally less than twenty-four hours. I. LICENSE A. Birth Center shall meet all the requirements specified in chapter II and this Chapter XXII of the Colorado Department of Health Standards for Hospitals and Health Facilities. II. GOVERNING BODY A. Responsibility: A Governing Body shall provide facilities, personnel and services necessary for the welfare and safety of the patients. B. Duties: The Governing Body shall: 1. adopt by-laws in accordance with legal requirements; 2. meet regularly and maintain accurate records of such meetings; 3. appoint a credentials committee, composed of clinical staff, which shall have the authority and responsibility for appointments and reappointments of clinical staff and ensure that only members of the clinical staff shall admit patients to the birth center; 4. appoint and delineate clinical privileges of practitioners based upon recommendations by the clinical staff and other appropriate indicators of physicians and certified nurse mid-wife competence; 5. establish a formal means of liaison with the clinical staff; 6. approve by-laws, rules and regulations of the clinical staff; 7. appoint committees consistent with the needs of the birth center. C. Quality of Care: 1. Conduct, with the active participation of the clinical staff, an ongoing, comprehensive selfassessment of the quality of care provided, including the medical necessity of procedures performed, the appropriateness of care, and the appropriateness of utilization. This information shall provide a basis for the revision of facility policies and the granting or continuation of clinical privileges. 2. Require that the facility's Quality Assurance Program ensures the adequate investigation, control and prevention of infections.

3. Provide that there shall be on file in the center an agreement with an ambulance service (air or ground) for emergency transfer of patients to hospital. III. ADMINISTRATOR A. Responsibility; The administrator shall be the official representative of the governing body and the chief executive officer of the birth center. The administrator shall be delegated responsibility and authority in writing by the governing body for the management of the birth center and shall provide liaison among the governing body, clinical staff and other departments of the birth center. B. Duties: The administrator shall be responsible for the development of Birth Center policies and procedures for employee and clinical staff use. All policies and procedures shall be reviewed and/or updated as necessary but at least annually. IV. CLINICAL STAFF A. Organization: The birth center shall have an organized clinical staff restricted to physicians and certified nurse-midwives. B. Definition: Certified Nurse-Midwife (CNM) - a professional nurse licensed in the state of Colorado who is educated in the two disciplines of nursing and midwifery, who possesses evidence of certification according to the requirements of the American College of Nurse-Midwives. C. Duties: The clinical staff or a delegated committee shall: 1. be responsible for the quality of all medical care provided patients in the facility; 2. bold meetings regularly and maintain accurate records of such meetings; 3. formulate, adopt and enforce by-laws, rules, regulations and policies for the proper conduct of its members; 4. recommend staff privileges to the governing body; 5. establish formal liaison with the governing body; 6. participate actively in the quality assurance program; 7. recommend admission and procedure policies to the governing body. D. Clinical Staff Requirements; 1. Each staff physician shall be licensed to practice medicine in the state of Colorado and provide proof. 2. Each certified nurse-midwife shall be licensed as a professional nurse and show proof. 3. Any physician applying for privileges at the birthing center must demonstrate hospital admitting privileges for patients who develop complications. 4. Any certified nurse-midwife applying for privileges must provide proof of a back-up agreement with a physician who will accept consultation calls and referrals from the CNM 24 hours a day. Proof of hospital admitting privileges of the back-up physicians must be submitted. 5. A physician or certified nurse mid-wife shall be present at each birth and until the woman and

newborn are stable postpartum. A second person in addition to the above, who is a registered nurse with adult and infant resuscitation skills, shall be present during the delivery. 6. A certified nurse-midwife or registered nurse with adult and infant resuscitation skills shall be present at the birthing center at all times when a patient is present. Additional and sufficient personnel shall be provided when more than one woman is in active labor. V. MEDICAL RECORDS A. Facilities: The center shall provide sufficient space and equipment for the processing and the safe storage of records. B. Personnel: A person knowledgeable in the management of Medical Records shall be responsible for the proper administration and functioning of the medical records section. C. Security: Medical records shall be protected from loss, damage and unauthorized use. D. Preservation: With the exception of medical records of minors (individuals under the age of 18 years) medical records shall be preserved as original records or on microfilm for no less than ten years after the most recent patient care usage, after which time records may be destroyed at the discretion of the facility. 1. Medical records of minors shall be preserved for the period of minority plus 10 years. 2. Facilities shall establish procedures for notification to patients whose records are to be destroyed prior to the destruction of such records. 3. The sole responsibility for the destruction of all medical records shall be in the facility involved. 4. Nothing in this section shall be construed to affect the requirements for the destruction of public records as set out in Part 1 of Article 80 of Title 24, C.R.S. E. Content: The medical records shall contain sufficient accurate information to justify the diagnosis and warrant the treatment and end results including, but not limited to: 1. complete patient identification and a unique identification number; 2. admission and discharge dates; 3. chief complaint and admission diagnosis; 4. medical history and physical examination completed prior to birth; 5. diagnostic tests, laboratory and x-ray reports when appropriate; 6. progress notes if appropriate; 7. properly executed informed consent which shall be obtained prior to the onset of labor and shall include evidence of an explanation by personnel of the birth services offered and the potential risks; 8. patient's condition on discharge, final diagnosis and instructions given patient for follow-up care of patient and child;

9. obstetrical records shall include in addition to the requirements for medical records the following: a. prenatal care record containing at least a hemoglobin or hematocrit, urine screening, prenatal blood serology, RH factor determination, rubella titre, past obstetrical history and physical examination; b. labor and delivery record, including reasons for induction and operative procedures if any; c. records of anesthesia and analgesia and medication given in the course of labor, delivery and postpartum. 10. Records of newborn infants shall be maintained as separate records and shall include in addition to the requirements for medical records the following information: a. date and hour of birth, birth weight and length, period of gestation, sex and condition of infant on delivery (including Apgar and any resuscitative measures taken); b. mother's name and facility number, and/or similar identification. Type of ID placed on infant in delivery room; c. record of ophthalmic prophylaxis; d. record of administration of Rh immune globulin if any; e. appropriate physical examination at birth and at discharge; f. genetic screening, PKU or other metabolic disorders report; g. fetal monitoring record; h. copy of birth certificate. F. Nursing Records: Standard nursing practice and procedure shall be followed in the recording of medications and treatments, including operative and post-operative notes. Nursing notes shall include notation of the instructions given patients pre-operatively and at the time of discharge. All recordings shall be in ink and properly signed, including name and identifying title. G. Entries: All orders for diagnostic procedures, treatments and medications will conform to the requirements of Chapter IV, section 4.4, of Standards for Hospitals and Health Facilities. VI. NURSING SERVICES A. Nursing Personnel; There shall be sufficient Registered Professional Nurses and auxiliary nursing personnel on duty to meet the total nursing needs of the patients. VII. PERSONNEL A. Orientation; The purpose and objectives of the birth center shall be explained to all personnel as part of an overall orientation program. B. Policies: There shall be appropriate written personnel policies, rules and regulations governing the conditions of employment, the management of employees and the types of functions to be performed.

VIII. ADMISSIONS A. Admissions: All persons admitted to a birth center shall be under the direct care of a member of the provider staff and agree to remain at the center not less than four hours postpartum. B. Disclosure Document: As a condition of acceptance for birth center care all persons shall sign prior to the onset of labor a disclosure document which shall contain: 1. an explanation of the services available; 2. an explanation of the services not available, including types of anesthesia; 3. a statement of the time to and location of the nearest hospital facilities for care of mother and child; 4. a statement of the additional risk involved in having a child at a birth center instead of a hospital; 5. a statement of cost. C. Prohibitions from Birth Center Delivery: 1. Medical limitations: a. current drug or alcohol addiction; b. paraplegia, quadraplegics; c. hypertensives on medications; d. hypertension over 140/90; e. diabetes (insulin dependent or gestational); f. history of significant deep vein thrombophlebitis or any thrombophlebitis with this pregnancy; g. severe anemia (hct. below 30 at admission); h. epileptics on medication; i. mental impairment that would interfere with the ability to follow directions; j. morbid obesity (100% over ideal body weight). 2. Obstetrical Limitations: a. grand multiparity (over five births); b. previous birth of a baby with serious congenital anomaly of a probably repeating type that cannot be excluded through antenatal evaluation; c. suspected congenital anomaly; d. previous Cesarean delivery;

e. preeclampsia; f. multiple gestation; g. intrauterine growth retardation or macrosomia; h. documented oligohydramnios or polyhdramnios; i. abnormal fetal surveillance studies; j. fetal presentation other than vertex; k. rising antibody titre of any type that is known to affect fetal well-being; l. all RH sensitizations; m. significant third trimester bleeding of unexplained cause; n. need for induction of labor (no induction allowed); o. need for general or conduction anesthesia; p. need for C-section (no C-sections allowed); q. placental abnormalities (previa or abruptio) which might threaten the neonate; r. known or suspected active genital herpes at the time of admission; s. premature labor (before 37 weeks) or postmaturity (after 42 weeks); t. any other condition or need which will adversely affect the health of the mother or infant during pregnancy, labor, birth, or the immediate postpartum period. D. Conditions Requiring Intrapartum Transfer from Birth Center to a Hospital: 1. a desire for transfer from birth center care; 2. patient inadvertently admitted with any of the listed conditions which preclude birth center delivery; 3. excessive need for analgesia during labor, or for anesthesia other than pudendal or local; 4. failure of progressive cervical dilation or descent after trial of therapeutic steps capable of being applied at the center; 5. fetal distress without delivery imminent; 6. passage of any meconium when delivery is not imminent; 7. development of hypertension or preeclampsia; 8. intrapartum hemorrhage (placenta previa or abruptio placentae); 9. prolapsed cord;

10. change to non-vertex presentation; 11. evidence of amnionitis; 12. development of other severe medical or surgical problems. E. Conditions Requiring for Post-partum Transfer from Birth Center to a Hospital 1. Maternal: a. hemorrhage not responding to treatment; b. need for transfusion; c. retained placenta greater than 30 minutes; d. need for extended observation that prevents discharge home; e. any other significant morbidity. 2. Infant: a. Apgar less than 7 at 5 minutes; b. need for oxygen beyond 5 minutes; c. signs of prematurity; d. signs of respiratory distress; e. jaundice, anemia, polycythemia, or hypoglycemia; f. persistent hypothermia (less than 97° at 2 hours of life); g. persistent hypotonia; h. exaggerated tremors, seizures or irritability; i. any significant congenital anomaly, seen or suspected; j. sign of significant birth trauma; k. feeding difficulty; l. any other significant morbidity. IX EQUIPMENT AND SUPPLIES A. There shall be appropriate equipment and supplies maintained for the mother and newborn to include, but not be limited to: 1. a bed suitable for labor, birth and recovery; 2. oxygen with flow meters and masks or equivalent;

3. mechanical suction and bulb suction (immediately available); 4. resuscitation equipment to include resuscitation bags, endotracheal tubes and oral airways for the mother and newborn; 5. firm surfaces suitable for resuscitation; 6. emergency medications, intravenous fluids, and related supplies and equipment for both mother and newborn; 7. fetoscope and doptone for fetal monitoring; 8. a means for monitoring and maintaining the optimum body temperature of the newborn; 9. infant scale; 10. a clock with a sweep second hand; 11. sterile suturing equipment and supplies; 12. adjustable examination light; 13. containers for soiled linen and waste materials which shall be closed or covered; 14. autoclave; 15. log book, for registration of birth which shall contain at least the following: a. mother's name b. mother's facility number c. date of delivery d. time of delivery e. mother's age f. Gravida, Para, g. newborn weight h. newborn sex i. gestational age j. transport: (1) mother (2) baby (3) where (4) when

(5) by whom k. indication for hospital delivery l. maternal outcome after transfer m. indication for newborn transfer n. newborn outcome after transfer o. death: (1) neonatal (2) maternal (3) stillbirth p. type of delivery q. condition of newborn at delivery/congenital anomalies r. delivering person s. Apgar t. any required resuscitation. X. LABORATORY A. Services: Clinical pathology services shall be available as required by the needs of the patients as determined by the provider staff. 1. Quality Control: Internal quality control shall be established to insure compliance with generally accepted standards of laboratory practice and procedure. XI. PHARMACEUTICAL SERVICES A. There shall be methods, procedures and controls which ensure the appropriation, acquisition, storage, dispensing and administration of drugs and biologicals in accordance with acceptable pharmaceutical practice and applicable state and federal laws and regulations. B. When the facility maintains its own pharmaceutical services, it shall comply with applicable regulations of the Colorado State Board of Pharmacy. XII. HOUSEKEEPING SERVICES A. Organization: Each facility shall provide housekeeping services which ensure a pleasant, safe and sanitary environment. The facility shall be kept clean and orderly. B. Written Policies and Procedures: Appropriate written policies and procedures shall be established and followed which ensure adequate cleaning and/or disinfection of the physical plant and equipment. C. Storage: All cleaning materials, solutions, cleaning compounds and hazardous substances shall be properly identified and stored in a safe place. D. Rubbish and Refuse Containers: All rubbish and refuse containers in treatment areas shall be impervious, lined and clean.

E. Handwashing: All personnel shall wash their hands immediately after handling refuse. XIII. LAUNDRY AND LINENS Written provisions shall be made for the proper handling of linens and washable goods. A. Outside Laundry: Laundry that is sent out shall be sent to a commercial or hospital laundry. A contract for laundry services performed by commercial laundries for birth centers shall include these standards. B. Storage: If soiled linen is not processed on a daily basis, a separate, properly ventilated storage area shall be provided. C. Processing: The laundry processing area shall be arranged to allow for an orderly progressive flow of work from the soiled to the clean area. D. Washing Temperatures: The temperature of water during the washing process shall be controlled to provide a minimum temperature of 165° F. for 25 minutes or 130° F. if the soap/detergent supplier will verify that their products will work effectively at that lower temperature. A label indicating same shall be affixed to the laundry machine. E. Packaging: The linens to be returned from the outside laundry to the facility shall be completely wrapped or covered to protect against contamination. F. Soiled Linen Transportation; Soiled linen shall be enclosed in an impervious bag and removed from surgery units after each procedure. G. Soiled Linen Carts; Carts, if used to transport soiled linen, shall be constructed of impervious materials, cleaned and disinfected after each use. H. Clean Linen Storage: Adequate provisions shall be made for storage of clean linen. I. Contaminated Linens: Contaminated linens shall be afforded appropriate special treatment by the laundry. J. Procedures: Adequate procedures for the handling of all laundry and for the positive identification and proper packaging and storage of sterile linens must be developed and followed. XIV. MAINTENANCE A. Written Policies and Procedures: There shall be written policies and procedures for a preventive maintenance program which is implemented to keep the entire facility and equipment in good repair and to provide for the safety, welfare and comfort of the occupants of the building(s). XV. PEST CONTROL A. Pest Control: Adequate written policies and procedures shall be developed and implemented to provide for effective control and eradication of insects and rodents. B. Outer Air Openings: All openings to the outer air shall be effectively protected against the entrance of insects and rodents, etc., by self-closing doors, closed windows, screens, controlled air currents or other effective means. XVI. WASTE STORAGE AND DISPOSAL

A. Sewage and Sewer Systems: All sewage shall be discharged into a public sewer system, or if such is not available, shall be disposed of in a manner approved by the Colorado State Department of Health. XVII. GENERAL BUILDING AND FIRE SAFETY A. The Birth Center shall be maintained to provide a safe, clean sanitary environment and meet the National Fire Protection Association 1985 Life Safety Code, Section 12-6 - New Ambulatory Health Care Centers (does not include later editions or amendments of the code). B. Each birthing room shall be maintained in a condition which is adequate and appropriate to provide for the equipment, staff, supplies and emergency procedures required for the physical and emotional care of a mother, her support person(s), and the newborn during birth, labor and the recovery period. 1. Birthing rooms shall have at least 120 square feet with a minimum room dimension of 10 feet. 2. Birthing rooms shall be located to provide unimpeded, rapid access to an exit of the building which will accommodate emergency transportation vehicles and equipment. C. Patient toilet and bathing facilities. 1. A toilet and lavatory shall be maintained in or adjacent to the vicinity of the birthing room. 2. A shower shall be available for mother's use. 3. All wall, ceiling, floor surfaces, toilets, lavatories, tubs and showers shall be kept clean and in good repair. D. Hallways and doors providing entry/exit and access into the birthing center and birth room(s) shall be of adequate width and/or configuration to accommodate maneuvering of ambulance stretchers and wheelchairs and other emergency equipment. E. Water Supply: There shall be an adequate supply of hot and cold running water under pressure for human consumption and other purposes which shall be approved by the Colorado Department of Health as meeting the Colorado Primary Drinking Water Regulations, 1981. F. Heating and Ventilation: 1. A safe and adequate source of heat capable of maintaning a room temperature of at least 72°F. shall be provided and maintained. 2. Ventilation shall remove objectionable odors, excessive heat and condensations. 3. Mechanically operated systems shall be used to supply air to and/or exhaust air from soiled workrooms or soiled holding rooms, janitor's closets, soiled storage areas, toilet rooms, and from spaces which are not provided with openable windows or outside doors. All fans serving exhaust systems shall be located at the discharge end of the system. G. Food Services: 1. When birth center policy provides for allowing the preparation and/or storage of personal food brought in by the patient or families of patients for consumption of that family, there shall be an adequate electric or gas refrigerator and dishwashing facilities.

H. Fire Safety and Accident Prevention: 1. Emergency numbers shall be located near the telephone. 2. There shall be a written evacuation and fire plan for the removal of patients in case of fire and other emergencies. The plan shall be posted in a conspicuous place in the building. 3. A simulated drill shall be performed every quarter per work shift. A written record of each drill shall be kept on file. I. Every bathroom door lock shall be designed to permit the opening of the locked door from the outside in an emergency. J. There shall be no pets on the premises. K. Each birthing room shall be equipped with a nurse call system. L. Grab bars and a nurse call system shall be installed in each patient bathing and toilet area. M. Automatic regulation of water supply temperature not to exceed 110 F. at shower, bathing and handwashing facilities. Control devices shall be inaccessible to unauthorized personnel.EFFECTIVE: November 30, 1985 SPECIFIC STATUTORY AUTHORITY These Standards were developed under the statutory authority found at 25-1-107(1)(L)I and II and 25-3101 which requires the Department of Health to annually license and to establish and enforce standards for the operation of hospitals and other institutions of a like nature. Chapter XXIV MEDICATION ADMINISTRATION REGULATIONS I. POLICY A. All licensed facilities shall maintain and follow written policies and procedures for the administration of medication. Policies must be consistent with the regimen taught in the medication administration course. B. Unlicensed, qualified medication administration staff members and their employing facilities shall administer medication according to the regimen taught in the medication administration course. II. QUALIFIED MEDICATION ADMINISTRATION STAFF MEMBERS A. Pursuant to section 25-1-107(1)(ee)(I)(A), regarding the administration of medication in residential facilities, the term qualified medication administration staff member will be defined as follows: (1) A person who is trained and employed by the licensed facility on a full or part-time basis to provide direct care services, which includes medication administration services to the resident. Evidence which establishes employment by the facility may be payment records or other employment documents; or (2) A person employed by a licensed facility on a contractual, full or part-time basis to provide direct care services, which includes medication administration services to the resident. Evidence which establishes contractual employment by the facility will include the actual contract naming the specific employee who is trained in medication administration and will be providing service on that basis; provisions in the contract that indicate that this

employee will be serving only the residents of the facility with regard to direct care and medication administration; and provisions which demonstrate that the facility is paying for this person's services. (3) A person employed by a home health agency who functions as permanent direct care staff to licensed facilities and is trained in medication administration shall be considered a qualified medication administration staff member and administer medication only to the residents of the licensed facility. The home health agency must meet the conditions of contractual employment. Evidence which establishes the condition of contractual employment shall include the conditions established in paragraph (2). B. The term qualified medication administration staff member does not apply to intermittent, temporary, pool staffing services provided by agencies offering such services. III. MONITORING A. The term “lawfully labelled”, as provided in 25-1-107(1)(ee)(III)(A), means labelled pursuant article 22 of title 12 (pharmacy practice law) and the regulations promulgated thereto. IV. ADMINISTRATION OF MEDICATION A. Prescription and non-prescription medications shall be administered only by qualified medication administration staff members and only upon written order of a licensed physician or other licensed authorized practitioner. Such orders must be current for all medications. B. Non-prescription medications must be labelled with resident's full name. C. No resident shall be allowed to take another's medication nor shall staff be allowed to give one resident's medication to another resident. D. The contents of any medication container having no label or with an illegible label shall be destroyed immediately. E. Medication which has a specific expiration date shall not be administered after that date. F. Each facility shall document the disposal of discontinued, out-dated, or expired medications. V. MEDICATION REMINDER BOXES OR SYSTEMS A. A medication reminder box or system (“med minder”) or customized patient medication package is a device which is compartmentalized and designed to house medications_ according to some time element (day or week or portions thereof). Medication reminder boxes or systems will also be referred to in this part IV of the regulations as medication reminder(s). B. Medication reminder boxes or systems may be used by residents who are self-administering. Facilities using medication reminders for persons who are not self-administering must have qualified medication administration staff member available to assist with or administer from the medication reminder. C. Only qualified medication administration staff members may assist residents with medication reminders. D. The facility's qualified medication administration staff members assisting with or administering from medication reminders shall record each assist or administration on medication record forms developed or acquired and maintained by the facility.

E. A licensed pharmacist shall prepare medications for the medication reminder in a registered prescription drug outlet or other outlet and in accordance with 12-22-121(4) and 12-22-123. After a physician or other authorized practitioner orders a change in medications for the resident, the facility shall discontinue use of the medication reminder until the pharmacist has refilled the medication reminder according to the change so ordered. The facility will be responsible for administering the correct medications to the residents in a manner consistent with the provisions of 25-1-107(1) (ee). F. The facility shall ensure that if a licensed nurse fills the medication reminder or a family member or friend gratuitously fills the medication reminder, a label shall be attached to the medication reminder box. If the medication reminder box has a labelling system, such labelling system may be used. The label shall include the name of the resident, each medication, the dosage, the quantity, the route of administration, and the time that each medication is to be administered. Each medication reminder shall have a medication record or sheet where all administrations will be recorded. After a physician or other authorized practitioner orders a change in medications for the resident, the facility shall discontinue use of the medication reminder until the nurse or family member or friend has refilled the medication reminder according to the change so ordered. The facility will be responsible for administering the correct medications to the residents in a manner consistent with the provisions of 25-1-107(1) (ee). G. If medications in the medication reminder are not consistent with the labelling, administration or assistance to the resident shall not proceed and the qualified medication administration staff member shall immediately notify the proper persons as outlined in the policies and procedures of the facility. For purposes of this paragraph, the proper persons will be the licensed nurse or pharmacist who filled the medication reminder, the family member or friend who gratuitously filled the medication reminder, or the resident's physician or other licensed practitioner who prescribed the medication(s). Once the problem with the medications is resolved and the medications are correctly assigned to the various compartments of the medication reminder, the qualified medication administration staff member may resume the administration or assistance to the resident from the medication reminder. H. All medication problems must be resolved prior to the next administration. I. PRN or “as needed” medications of any kind shall not be placed in medication reminders. Only medications intended for oral ingestion shall be placed in the medication reminder. Medications that must be administered according to special instructions, including but not limited to such instructions as “30 minutes or an hour before meals”, rather than administered routinely (unspecified--one, two, three, or four times a day, etc.), may not be placed in a medication reminder. J. Medications in the medication reminder box may only be used at the time specified on the box. Medication reminder boxes may not be filled for more than two weeks at a time. K. Any medication reminder day packs or individual trip packs must be filled pursuant to the requirements of this Part V of the regulations. VI. STORAGE OF MEDICATIONS A. All prescription and non-prescription medication shall be maintained and stored in a manner that ensures the safety of all residents. B. Medication shall not be stored with disinfectants, insecticides, bleaches, household cleaning solutions, or poisons. VII. CONTRACT INSTRUCTORS

A. The medication administration curriculum may be taught by a person who contracts with the Department of Health or is otherwise approved by the Department of Health to teach an approved curriculum and holds a valid license in good standing as a physician, nurse, or pharmacist or holds a valid certification in good standing as a physician assistant. Chapter XXV repealed effective 11/01/2004 Repealed effective 11/01/2004 _____________________________________________________ Editor’s Notes History Chapter II Section 2.20 eff. 5/21/2007. Chapter II Section 2.20; Chapter IV Sections 7, 9.3, 10.34, 14.8, 19.3, 19.4, 19.5, 19.9, 23. Delete Sections 14.9; 29.3. Add Section 32. Chapter XIX Add Section 6 eff. 8/30/2007. Chapters IV-33, X-14, XIV-7, XV, XVIII-31 eff. 01/30/2008. Chapter II Section 5.2 and Chapter XX eff. 3/1/2008. Chapters IV; X; XIV; XVIII, Parts 6, 15, 17, 19, 31; XIX eff. 5/15/2008.

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