STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, PETITIONER, CASE NO. 2017-06013
V.
KATHERINE NIELSEN, R.Ph., RESPONDENT.
ADMINISTRATIVE COMPLAINT COMES NOW, Petitioner, Department of Health, by and through its undersigned counsel, and files this Administrative Complaint before the Board of Pharmacy against Respondent, Katherine Nielsen, R.Ph., and in support thereof alleges: 1.
Petitioner is the state agency charged with regulating the
practice of pharmacy pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 465, Florida Statutes. 2.
At all times material to this Administrative Complaint,
Respondent was a licensed pharmacist within the state of Florida, having been issued license number PS22116.
3.
Respondent's address of record is 805 Jacaranda Drive, Largo,
Florida 33770. 4.
At all times material to this Administrative Complaint,
Respondent was the Prescription Department Manager (PDM) at Lincourt Compounding Center (the Permittee) located in Clearwater, Florida. 5.
On or about March 21, 2017, the Department conducted an
inspection of the Permittee's physical location. 6.
From the inspection on or about March 21, 2017, the following
deficiencies were found: a. The Department's inspection revealed that Respondent failed to ensure the Permittee had written documentation for specific load items or patterns for the dry heat depyrogenation oven. b. The Department's inspection revealed that Respondent failed to ensure the Permittee had the external surface of the light fixture smooth side down. c. The Department's inspection revealed that Respondent failed to ensure that the Permittee had the previous two months
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(January and February 2017) documentation list the agent used for disinfectant. d. The Department's inspection revealed that Respondent failed to ensure the Permittee had documented observations of cleaning for personnel in charge of cleaning the cleanroom. e. The Department's inspection revealed that Respondent failed to ensure that the Permittee had nail cleansers in the IV room. f. The Department's inspection revealed that Respondent failed to ensure the Permittee's compounding personnel did not repeatedly enter the anteroom (ISO Class 8 environment) without performing the full hand hygiene and garbing process. g. The Department's inspection revealed that Respondent failed to ensure that the Permittee's pharmacist who supervises technicians and signs off on compounded products completed a low/medium risk media fill test with the year preceding the inspection. h. The Department's inspection revealed that Respondent failed to ensure that all of the Permittee's compounding personnel who engage in high-risk sterile compounding completed a DOH v. Katherine Nielsen, R.Ph. DOH Case No. 2017-06013
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high risk media fill test within the 6 months preceding the inspection. i. The Department's inspection revealed that Respondent failed to ensure that all of the Permittee's compounding personnel completed didactic training on aseptic technique. j. The Department's inspection revealed that Respondent failed to ensure that the Permittee's compounding personnel completed didactic training semi-annually for high-risk products. k. The Department's inspection revealed that Respondent failed to ensure that the Permittee had documentation showing that all compounding personnel completed gloved fingertip testing. I. The Department's inspection revealed that Respondent failed to ensure that the Permittee had documentation showing completion of a visual inspection of compounded sterile products.
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7.
Section 456.072(1)(k), Florida Statutes (2016) provides that
failing to perform any statutory or legal obligation placed upon a licensee constitutes grounds for disciplinary action. 8.
Section 465.022(11)(a), Florida Statutes (2016) provides the
prescription department manager must ensure the permittee's compliance with all rules adopted under those chapters as they relate to the practice of the profession of pharmacy and the sale of prescription drugs. 9.
Rule 64616-27.797(1)(a), Florida Administrative Code, provides
in relevant part, that all sterile compounding shall be performed in accordance with the minimum practice and quality standards of the following chapters of the United States Pharmacopeia ("USP"), 36th revision, Second Supplement, incorporated and adopted by reference with the effective chapter dates of December 1, 2013: Chapter 797, Pharmaceutical Compounding-Sterile Preparations. 10.
USP Chapter 797 provides that the description of the dry heat
depyrogenation cycle and duration for specific load items shall be included in written documentation in the compounding facility. 11.
USP Chapter 797 provides that surfaces of ceilings, walls, floors,
fixtures, shelving, counters, and cabinets in the buffer area shall be smooth, DOH v. Katherine Nielsen, R.Ph. DOH Case No. 2017-06013
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impervious, free from cracks and crevices, and nonshedding, thereby promoting cleanability, and minimizing spaces in which microorganisms and other contaminants may accumulate. 12.
USP Chapter 797 provides that cleaning and disinfecting agents,
their schedules of use and methods of application shall be in accordance with written SOPs and followed by custodial and/or compounding personnel. 13.
USP Chapter 797 provides that mopping shall be performed by
trained personnel using approved agents and procedures described in the written $0Ps. 14.
USP Chapter 797 provides that the order of compounding garb
and cleansing in ante-area shall be: shoes or shoe covers, head and facial hair covers, face mask, fingernail cleansing, hand and forearm washing and drying, non-shedding gown. 15.
USP Chapter 797 provides that personnel shall repeat proper
procedures after they are exposed to direct contact contamination or worse than ISO Class 8 air. 16.
USP Chapter 797 provides that for medium risk level
compounded sterile products compounding personnel shall complete mediafill tests annually. DOH v. Katherine Nielsen, R.Ph. DOH Case No. 2017-06013
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17.
USP Chapter 797 provides that compounding personnel for high-
risk level compounded sterile products shall complete a media-fill test semiannually. 18.
USP Chapter 797 provides that compounding personnel shall
complete didactic training, pass written competence assessments, undergo skill assessment using observational audit tools, and media-fill testing. 19.
USP Chapter 797 provides that compounding personnel must
demonstrate proficiency of proper hand hygiene, garbing, and consistent cleaning procedures in addition to didactic evaluation and aseptic media fill. 20.
USP Chapter 797 provides that all employees shall successfully
complete an initial competency evaluation and gloved fingertip/thumb sampling procedure (0 cfu) no less than three times before initially being allowed to compound CSPs for human use. 21.
USP Chapter 797 provides that there shall be a visual inspection
for abnormal particulate matter and color and intact containers and seals. 22.
Based on the foregoing, Respondent has violated Section
456.072(1)(k), Florida Statutes (2016), by and through a violation of Section 465.022(11)(a), Florida Statutes (2016), by failing to ensure the Permittee's compliance with Rule 64616-27.797(1)(a), Florida Administrative Code, DOH v. Katherine Nielsen, R.Ph. DOH Case No. 2017-06013
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which provides in relevant part, that all sterile compounding shall be performed in accordance with the minimum practice and quality standards of the following chapters of the United States Pharmacopeia (CUSP"), 36th revision, Second Supplement, incorporated and adopted by reference with the effective chapter dates of December 1, 2013: Chapter 797, Pharmaceutical Compounding-Sterile Preparations. [remainder of page left intentionally blank]
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WHEREFORE, the Petitioner respectfully requests that the Board of Pharmacy enter an order imposing one or more of the following penalties: permanent revocation or suspension of Respondent's license, restriction of practice, imposition of an administrative fine, issuance of a reprimand, placement of the Respondent on probation, corrective action, refund of fees billed or collected, remedial education and/or any other relief that the Board deems appropriate. SIGNED this 2nd day of
November
2017.
Celeste Philip, M.D., M.P.H. Surgeon General and Secretary
FILED DEPARTMENT OF HEALTH DEPUTY CLERK CLERK:
zgytyd ceders
DATE: NOv Q 3 2017
/5/ Christopher Jurich CHRISTOPHER A. JURICH Assistant General Counsel Fla. Bar No. 0099014 Florida Department of Health Office of the General Counsel 4052 Bald Cypress Way, Bin C-65 Tallahassee, FL 32399-3265 Telephone: (850) 558-9861 Facsimile: (850) 245-4662 Email:
[email protected]
PCP Meeting: November 2, 2017 PCP Members: Michele Weizer, David Bisaillon
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NOTICE OF RIGHTS Respondent has the right to request a hearing to be conducted in accordance with Section 120.569 and 120.57, Florida Statutes, to be represented by counsel or other qualified representative, to present evidence and argument, to call and cross-examine witnesses and to have subpoena and subpoena duces tecum issued on his or her behalf if a hearing is requested. A request or petition for an administrative hearing must be in writing and must be received by the Department within 21 days from the day Respondent received the Administrative Complaint, pursuant to Rule 28-106.111(2), Florida Administrative Code. If Respondent fails to request a hearing within 21 days of receipt of this Ac4ninistrative Complaint, Respondent waives the right to request a hearing on the facts alleged in this Administrative Complaint pursuant to Rule 28-106.111(4), Florida Administrative Code. Any request for an administrative proceeding to challenge or contest the material facts or charges contained in the Administrative Complaint must conform to Rule 28-106.2015(5), Florida Administrative Code. Please note that mediation under Section 120.573, Florida Statutes, is not available to resolve this Administrative Complaint. NOTICE REGARDING ASSESSMENT OF COSTS Respondent is placed on notice that Petitioner has incurred costs related to the investigation and prosecution of this matter. Pursuant to Section 456.072(4), Florida Statutes, the Board shall assess costs related to the investigation and prosecution of a disciplinary matter, which may include attorney hours and costs, on the Respondent in addition to any other discipline imposed.
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