Idea Transcript
EXHIBIT 2: CHICAGO DEPARTMENT OF PUBLIC HEALTH SAMPLE FORMS
Bid Line 1: Form Number NS-18: Adult Immunization Form
Bid Line 2: Form Number FLU-01: Influenza Service Form
/
Birth
Over 65? Yes
Age
/
Medicare No.
No Black /African American Caucasia
Zip Code
Phone Number
Hispanic Asian/Pacific Islander Native American Other
I have received a copy and have read or had explained to me the information from the vaccine information statements about the vaccine that will be given today. I have had a chance to ask questions and they were answered to my satisfaction. I believe I understand the benefits and risks of the vaccine that will be given today and ask that the vaccine be given to me or the person named on this form for whom I am authorized to make this request. My signature indicates that I fully understand the above information. I certify that to the best of my knowledge and belief, the information I have provided is true, correct and complete.
X ___________________________________________________________
Date___________________________________
Signature of Recipient, Parent or Guardian
Patient refused to sign acknowledgement box. X ________________________________________________
_______________________________________________
(Date)
(Staff Signature)
DOSE:
0.25 mL
0.5 mL
DOSE Number:
#1
#2
ROUTE: IM
Intranasal
Vaccinator Signature________________________________________Title____________________________
10/2012
(Date)
History of receiving nasal spray, MMR or varicella vaccine in the past 4 weeks Long-term health care problems with: -heart disease -kidney disease or liver disease -lung disease -metabolic disease -asthma -anemia, and other blood disorders Weakened immune system Age 50 years or older Age younger than 2 years Age younger than 5 years with one or more episodes of wheezing within the past year Long-term aspirin treatment Pregnancy Previous serious allergic reaction to eggs Previous serious reaction to influenza vaccine components Moderate or serious acute illness currently History of Guillain-Barre Syndrome
Previous serious allergic reactions to eggs Previous serious reaction to influenza vaccine components. Moderate or serious acute illness currently History of Guillain-Barre Syndrome.
MANUFACTURER: Medimmune Sanofi
(Title)
Bid Line 2: Form Number FLU-01: Influenza Service Form FECHA DE SERVICIO / Nombre del Paciente
Fecha de Nacimiento
/
Apellido del Paciente
Mayor de 65? Si
Edad
Número de Medicare
No
Dirección del Paciente
Raza Afro Americano
Código Postal
Blanco
Número de Teléfono
Hispano Asiático/Islas Pacífico Nombre del Jefe de Familia o Tutor
Nativo Americano
Apellido del Jefe de Familia o Tutor
Otra He recibido una copia y la he leído o se me ha explicado el contenido de la hoja de información acerca de la(s) vacuna (s) que se me aplicarán hoy. He tenido la posibilidad de hacer preguntas y ellas fueron respondidas satisfactoriamente. Creo que entiendo los beneficios y los riesgos de la(s) vacuna(s) que se me aplicarán o se le aplicarán a la persona mencionada en esta forma por quien estoy autorizada a realizar esta petición. Mi firma indica que entiendo perfectamente la información que he recibido.
X ___________________________________________________________
Fecha___________________________________
Firma del recipient, padre o tutor Se me ha informado sobre las Prácticas de Información Confidencial de salud de la Ciudad de Chicago.
Patient refused to sign acknowledgement box.
X _____________________________________________________
_______________________________________________
(Firma del Paciente)
(Fecha)
(Staff Signature)
(Date)
History of receiving nasal spray, MMR or varicella vaccine in the past 4 weeks Long-term health care problems with: -heart disease -kidney disease or liver disease -lung disease -metabolic disease -asthma -anemia, and other blood disorders Weakened immune system Age 50 years or older Age younger than 2 years Age younger than 5 years with one or more episodes of wheezing within the past year Long-term aspirin treatment Pregnancy Previous serious allergic reaction to eggs Previous serious reaction to influenza vaccine components Moderate or serious acute illness currently History of Guillain-Barre Syndrome
Previous serious allergic reactions to eggs Previous serious reaction to influenza vaccine components Moderate or serious acute illness currently History of Guillain-Barre Syndrome
VACCINE MANUFACTURER: Medimmune Sanofi
(Title)
DOSE:
0.25 mL
0.5 mL
DOSE Number:
#1
#2
ROUTE: IM
Intranasal
Vaccinator Signature________________________________________Title____________________________
Line 3: Form Number FLU-02: Flu Clinic Tally Chicago Department of Public Health INFLUENZA & PNEUMOCOCCAL VACCINE ORDER FORM Clinic Date:
Support Staff:
P/U
Nurses: CDPH Contract Nurses
Site Name: Hours: Address:
606
Contact Person ________________________________
Contact Phone: __________________________
Clinic Type: Church CPD DFSS Other: _______________________________________
Notes:
Vaccine Type
Unit Size
Doses Ordered
Doses Given
Lot Number
EXP Date
Doses Returned
10-dose vial
*INFLUENZA INFLUENZA – Fluzone HD (>65 years of age)
Prefilled syringes, 10 dose per box 5-dose vial
PNEUMOCOCCAL Authorized by:
Date: ________
Received by:
Date: _________
Filled by:
Date: ________
Returned by:
Date: _________
* Includes partial vials – Use First
Number of vials:_________
Supplies required:
YES
Est. Number of Doses: _________
NO
Return Doses Administered Report and Consent Forms to Rosemarie Lake within 2 days after clinic:
Doses Administered Report TOTAL NUMBER OF IMMUNIZATIONS BY AGE GROUP Less than () 65 years
Medicare Patients
INFLUENZA PNEUMOCOCCAL Vaccine
Total Number of Immunizations by Age, Group & Race 65 yrs 65 yrs 65 yrs 65 yrs 65 yrs 65 yrs CA AP AP NA NA Other Other
INFLUENZA
PNEUMOCOCCAL
AA= African American September 2010
HP= Hispanic
CA= Caucasian
AP= Asian/Pacific Islander
white copy – Vaccine Management Unit
NA= Native American
yellow copy – Screener (return to WSCDC when complete)
Bid Line 4: Vaccine Information Statements VACCINE INFORMATION STATEMENT
DTaP Vaccine
What You Need to Know
1
Why get vaccinated?
Diphtheria, tetanus, and pertussis are serious diseases caused by bacteria. Diphtheria and pertussis are spread from person to person. Tetanus enters the body through cuts or wounds. DIPHTHERIA causes a thick covering in the back of the throat. • It can lead to breathing problems, paralysis, heart failure, and even death. TETANUS (Lockjaw) causes painful tightening of the muscles, usually all over the body. • It can lead to “locking” of the jaw so the victim cannot open his mouth or swallow. Tetanus leads to death in up to 2 out of 10 cases. PERTUSSIS (Whooping Cough) causes coughing spells so bad that it is hard for infants to eat, drink, or breathe. These spells can last for weeks. • It can lead to pneumonia, seizures (jerking and staring spells), brain damage, and death. Diphtheria, tetanus, and pertussis vaccine (DTaP) can help prevent these diseases. Most children who are vaccinated with DTaP will be protected throughout childhood. Many more children would get these diseases if we stopped vaccinating. DTaP is a safer version of an older vaccine called DTP. DTP is no longer used in the United States.
should get DTaP vaccine 2 Who and when? Children should get 5 doses of DTaP vaccine, one dose at each of the following ages: • 2 months • 4 months • 6 months • 15–18 months • 4–6 years DTaP may be given at the same time as other vaccines.
(Diphtheria, Tetanus and Pertussis)
Many Vaccine Information Statements are available in Spanish and other languages. See www.immunize.org/vis Hojas de información sobre vacunas están disponibles en español y en muchos otros idiomas. Visite www.immunize.org/vis
children should not get 3 Some DTaP vaccine or should wait • Children with minor illnesses, such as a cold, may be vaccinated. But children who are moderately or severely ill should usually wait until they recover before getting DTaP vaccine. • Any child who had a life-threatening allergic reaction after a dose of DTaP should not get another dose. • Any child who suffered a brain or nervous system disease within 7 days after a dose of DTaP should not get another dose. • Talk with your doctor if your child: - had a seizure or collapsed after a dose of DTaP, - cried non-stop for 3 hours or more after a dose of DTaP, - had a fever over 105°F after a dose of DTaP. Ask your doctor for more information. Some of these children should not get another dose of pertussis vaccine, but may get a vaccine without pertussis, called DT.
4
Older children and adults
DTaP is not licensed for adolescents, adults, or children 7 years of age and older. But older people still need protection. A vaccine called Tdap is similar to DTaP. A single dose of Tdap is recommended for people 11 through 64 years of age. Another vaccine, called Td, protects against tetanus and diphtheria, but not pertussis. It is recommended every 10 years. There are separate Vaccine Information Statements for these vaccines.
are the risks from DTaP 5 What vaccine?
if there is a serious 6 What reaction?
Getting diphtheria, tetanus, or pertussis disease is much riskier than getting DTaP vaccine.
What should I look for? • Look for anything that concerns you, such as signs of a severe allergic reaction, very high fever, or behavior changes.
However, a vaccine, like any medicine, is capable of causing serious problems, such as severe allergic reactions. The risk of DTaP vaccine causing serious harm, or death, is extremely small.
Signs of a severe allergic reaction can include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness. These would start a few minutes to a few hours after the vaccination.
Mild problems (common) • Fever (up to about 1 child in 4) • Redness or swelling where the shot was given (up to about 1 child in 4) • Soreness or tenderness where the shot was given (up to about 1 child in 4) These problems occur more often after the 4th and 5th doses of the DTaP series than after earlier doses. Sometimes the 4th or 5th dose of DTaP vaccine is followed by swelling of the entire arm or leg in which the shot was given, lasting 1–7 days (up to about 1 child in 30). Other mild problems include: • Fussiness (up to about 1 child in 3) • Tiredness or poor appetite (up to about 1 child in 10) • Vomiting (up to about 1 child in 50) These problems generally occur 1–3 days after the shot. Moderate problems (uncommon) • Seizure (jerking or staring) (about 1 child out of 14,000) • Non-stop crying, for 3 hours or more (up to about 1 child out of 1,000) • High fever, over 105°F (about 1 child out of 16,000) Severe problems (very rare) • Serious allergic reaction (less than 1 out of a million doses) • Several other severe problems have been reported after DTaP vaccine. These include: - Long-term seizures, coma, or lowered consciousness - Permanent brain damage. These are so rare it is hard to tell if they are caused by the vaccine. Controlling fever is especially important for children who have had seizures, for any reason. It is also important if another family member has had seizures. You can reduce fever and pain by giving your child an aspirin-free pain reliever when the shot is given, and for the next 24 hours, following the package instructions.
What should I do? • If you think it is a severe allergic reaction or other emergency that can’t wait, call 9-1-1 or get the person to the nearest hospital. Otherwise, call your doctor. • Afterward, the reaction should be reported to the Vaccine Adverse Event Reporting System (VAERS). Your doctor might file this report, or you can do it yourself through the VAERS web site at www.vaers.hhs.gov, or by calling 1-800-822-7967. VAERS is only for reporting reactions. They do not give medical advice.
National Vaccine Injury 7 The Compensation Program The National Vaccine Injury Compensation Program (VICP) is a federal program that was created to compensate people who may have been injured by certain vaccines. Persons who believe they may have been injured by a vaccine can learn about the program and about filing a claim by calling 1-800-338-2382 or visiting the VICP website at www.hrsa.gov/vaccinecompensation.
8
How can I learn more?
• Ask your doctor. • Call your local or state health department. • Contact the Centers for Disease Control and Prevention (CDC): - Call 1-800-232-4636 (1-800-CDC-INFO) or - Visit CDC’s website at www.cdc.gov/vaccines
Vaccine Information Statement
DTaP Vaccine 5/17/2007 42 U.S.C. § 300aa-26
Office Use Only
CHICAGO DEPARTMENT OF PUBLIC HEALTH
Bid Line 5: Form Number VFC-01: Field Sheet
VACCINES FOR CHILDREN PROGRAM
Routine VFC Contact Form
VFC Pin
Date
Start Time
Provider Site Name
Contact
End Time
Address
Zip Code
Phone
Purpose of Visit and Outcome
Recommended Corrective Actions
1. Current Temperatures (ALWAYS REQUIRED) Refrigerator 1 Freezer 1 Refrigerator 2 Freezer 2
Current Minimum Maximum ________F/C _______F/C ________F/C ________F/C ________F/C ________F/C ________F/C ________F/C ________F/C ________F/C ________F/C ________F/C
Review and initial all temp logs since last visit (required at all visits)
2. VFC Contact Visit Purpose per PEAR VFC In-service (training) Vaccine Pick up or Delivery Scheduled Storage and Handling Visit Enrollment Visit Follow up from a VFC In-service
Follow up from a Vaccine Pick up or Delivery Follow up from a scheduled Storage and Handling visit Follow up from an Enrollment Visit Other Specify:__________________________________________ _________________________________________________ __________________________________________________ A. CHIP Vaccine Check 1. Using MEDI (or equivalent) for ALL screening prior to immunization Y N 2. Maintaining appropriate amounts of PRIVATE STOCK vaccine supply Y N B. Evaluate Vaccine Returns (if present) • Identify if any Expired or Spoiled Vaccine in appliance Y N • Verify amounts and reasons for returns Y N • Review Vaccine Return policy with staff Y N
3. Review Current VFC Procedures A. B. C. D.
Using Current VIS for all vaccines in use Ordering through I-CARE Has DDLs with current certificate of calibration Downloading and reviewing DDL data routinely
2017 Field Sheet/M. Levin
PHA
Y Y Y Y
N N N N
# of months of temp logs reviewed R________ F_________ R________ F_________ R________ F_________
Follow-Up Date
CHICAGO DEPARTMENT OF PUBLIC HEALTH VACCINES FOR CHILDREN PROGRAM
QAR Follow up/Storage & Handling Follow up
VFC Pin
Date
Start Time
Provider Site Name
Contact
End Time
Address
Zip Code
Phone
Purpose of Visit and Outcome
1. Current Temperatures (ALWAYS REQUIRED) Refrigerator 1 Freezer 1 Refrigerator 2 Freezer 2
2.
Current ________F/C ________F/C ________F/C ________F/C
Minimum Maximum _______F/C ______F/C _______F/C ______F/C _______F/C ______F/C _______F/C ______F/C
Non-Compliance with QAR requirements
3. Second (or more) follow up for Non-compliance with QAR requirements
4. Non-compliance with Unannounced Storage & Handling requirements
5. Second (or more) follow up for Unannounced Storage and Handling requirements
2017 Field Sheet/M. Levin
PHA
Recommended Corrective Actions # of months of temp logs reviewed R________ F_________ R________ F_________ R________ F_________
Follow-Up Date
Bid Line 6: Form Number VFC-02: Site Visit Questionnaire
Date: Reviewer’s Name: Provider Site Name: Provider address: Contact person: Telephone & FAX Numbers: Email: VFC Number: County: Region: Vaccine manager: _____________________________________Back up:_______________________________________
Type of Practice: Public hospital based clinic Private hospital based clinic Substance abuse HIV/STD Clinic Pharmacy-Flu only
Private Practice Public Health Dept Clinic FQHC/RHC Private Preschool/daycare/etc WIC Indian Health Center Public clinic non-HD Mass Vaccinator-Flu only Pharmacy-Flu & other vaccines
Military Health Care Facility Public Preschool/daycare/etc Corrections Facility Mass Vaccinator-Flu & other vaccine
Provider does not supply all ACIP vaccines (pharmacy, hospital Hep B only, or specialty clinic-select provider type in addition as applies-list all vaccines not supplied in question #4)
How many providers are practicing at this site? The following question should be answered
to the site visit, so the findings can be discussed during the site visit.
Are vaccine orders consistent with most current provider profile? _____ 1. What is the vaccine administration fee charged to non-Medicaid VFC eligible patients (uninsured, American Indian/Alaska Native, under-insured if vaccinated at FQHC/RHC)? _________ 2. Under what circumstances is a child referred to another facility for immunization services? Not applicable children are never referred Child is underinsured Vaccine is unavailable Parent is unable to pay administration fee Parent is unable to pay office visit fee Other (specify) 3. Which of the following vaccines are routinely administered in this clinic/practice? DTaP Influenza Pneumococcal Polysaccharide (high risk patients) Hepatitis A Meningococcal Conjugate Polio Hepatitis B MMR Rotavirus HIB Pneumococcal Conjugate Td Human Papillomavirus Tdap Administers all ACIP Recommended Vaccines Varicella Other: 2013 VFC Site Visit Questionnaire
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4. When does this clinic/practice provide or offer patients copies of the Vaccine Information Statements (VIS) to keep? Every time the patient receives a vaccination When the child receives the first dose of vaccine within a particular series (e.g. 1st dose of DTaP) Do not provide Other (specify): 5. In order to complete the annual provider profile, how does this clinic/practice determine the number of VFC-eligible patients in this clinic/practice? Use doses administered data Use benchmarking data Use Medicaid & billing data Use Immunization Information System (Registry) Does not capture data for annual provider profile Other-acceptable (please describe): Other-non-compliant (please describe): 6a. When does the clinic/practice screen patients for VFC eligibility? First immunization visit to the office Every immunization visit Do not screen for VFC eligibility Not applicable, clinic/practice serves 100% VFC eligible children and has appropriate Comprehensive Certification form with up to date signature on file Other (specify): 6b. When does the clinic/practice document VFC screening results? First immunization visit to the office Every immunization visit Do not screen for VFC eligibility Not applicable, clinic/practice serves 100% VFC eligible children and has appropriate Comprehensive Certification form with up to date signature on file Other (specify): 7. Does this clinic/practice always notify the Immunization Program when publicly purchased vaccine has been involved in a cold chain failure, has expired or been wasted? Yes No 8. When does this clinic/practice prepare vaccine for administration to patient? Immediately before administration Other (specify process):
9a. Does the clinic/practice “borrow vaccine” between public stock and private stock? Yes No Not Applicable: All vaccine provided by the state program
2013 VFC Site Visit Questionnaire
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9b. Review the borrowing reports for the . Are the reports completed correctly and do the reports document timely replacement of vaccine to the appropriate stock? To answer “Yes,” all components must be documented correctly. Yes No Not Applicable, Borrowing not allowed by State VFC Program 9c. Does the frequency of borrowing vaccine indicate an inventory/stock problem? Yes No If yes, the inventory problem is related to: Lack of private stock Lack of public stock Other (specify): If no, the insufficient inventory is related to: Private stock order delay Private non-viable on delivery VFC stock order delay VFC stock non-viable on delivery A specific national vaccine shortage (list vaccines): Other (specify): 10. Does the clinic/practice have a content):
for vaccine management including the following (review for accurate
Designation of primary vaccine coordinator and at least one back-up staff Proper vaccine storage and handling Vaccine shipping receiving Procedures for vaccine transport in the event of a power failure, mechanical difficulty or emergency situation (emergency plan) Has the emergency plan been reviewed or updated annually or since change in responsible staff? Vaccine ordering Inventory control (e.g. stock rotation) Vaccine wastage Staff training on vaccine management including storage and handling 11. Please identify the publication date for each of the VIS currently being used in this clinic/practice and then check the appropriate status for each VIS.
DTaP (5/17/07) Polio (11/08/11) MMR (4/20/2012) MMRV (5/21/10) Hepatitis B (2/02/2012) Varicella (03/13/08) 2013 VFC Site Visit Questionnaire
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Hepatitis A (10/25/11) Hib (12/16/98) Pneumococcal Conjugate (4/16/10) Inactivated Influenza (7/02/12) Live Intranasal Influenza (7/02/12) Adult Pneumococcal Polysaccharide (PPV23) (10/6/09) Meningococcal (10/14/11) Td/Tdap (1/24/2012) Rotavirus (12/6/10) Human Papillomavirus (2/22/2012) Multiple Vaccine (11/16/2012) Other ______________________ * VIS 12. What type of storage units does this clinic/practice use to store varicella-containing vaccines and all other vaccines? (check and enter number of units)
Stand alone freezer (full size or under counter) Stand alone refrigerator Number of units_______ Number of units_______ Dormitory style refrigerator/freezer Dormitory style refrigerator/freezer Number of units_______ Number of units_______ Combined refrigerator/freezer with separate external Combined refrigerator/freezer with separate external refrigerator and freezer doors (e.g. household style refrigerator and freezer doors (e.g. household style appliance). Number of units_______ appliance). Number of units_______ Pharmaceutical/medical grade Pharmaceutical/medical grade Number of units_______ Number of units_______ Does not administer vaccines requiring freezer storage Please note: Combination refrigerator/freezers that are outfitted with one exterior door and an evaporator plate (cooling coil), which is usually located inside an icemaker compartment (freezer) within the refrigerator is NOT acceptable for any vaccine storage (temporary or permanent.) 13. Are calibrated thermometers placed in a central area of each refrigerator and freezer? #1.
2013 VFC Site Visit Questionnaire
#2.
#3.
#4.
#5.
#1.
#2.
#3.
#4.
#5.
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14. (A) What type of thermometer is used by the clinic/practice (check all that apply)? #1.
Probe in glycol?
#1.
Probe in glycol?
2013 VFC Site Visit Questionnaire
#2 .
Probe in glycol?
#3.
#2.
Probe in glycol?
#3.
Probe in glycol?
Probe in glycol?
#4.
Probe in glycol?
#5.
Probe in glycol?
#4.
Probe in glycol?
#5.
Probe in glycol?
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14. (B) For each type of thermometer used by the clinic/practice, indicate if the thermometer has a current certificate of calibration (check all that apply) and document the date of expiration. #1.
Date
2013 VFC Site Visit Questionnaire
#2.
Date
#3.
Date
#4.
Date
#5.
Date
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Note: Each vaccine storage unit requires one primary thermometer with a current certificate of calibration. For each type of thermometer used by the clinic/practice, indicate if the thermometer has a current certificate of calibration (check all that apply) and document the date of expiration. #1.
Date
#2.
Date
#3.
Date
#4.
Date
#5.
Date
Note: Each vaccine storage unit requires one primary thermometer with a current certificate of calibration.
2013 VFC Site Visit Questionnaire
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15. For each refrigerator and freezer indicate how often temperatures are recorded (check all that apply).
#1.
#2.
#3.
#4.
#5.
#1.
#2.
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#5.
16. Record the highest and lowest temperatures logged in the last 3 months. If partial log is available for the past three months, record the highest and lowest temperatures from available logs. If no log is available, use current temperature for both lowest and highest temperatures and select no log is available for last 3 months. If practice does not have a thermometer, leave the lowest and highest temperature recording spaces blank. If log is available for less than 3 months, use lowest and highest temperatures from timeframe available on log and select partial log is available for last 3 months. Please indicate if recordings are Celsius (oC) or Fahrenheit (oF (2-8°C / 35-46°F) (-15°C / 5°F or lower) #1. #2. #3. #4. #5. #1. #2. #3. #4. #5. °
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17. During past 3 months or for the amount of time log is available, if less than 3 months, how many times were the temperatures outside the recommended range? If no log is available, select the “unknown: no log available” answer.
#1.
(2-8°C / 35-46°F) #2. #3. #4.
#5.
(-15°C / 5°F or lower) #1. #2. #3. #4. #5.
18. When the temperatures were outside the recommended range, what action did the clinic/practice take? Adjusted thermostat in refrigerator/freezer Measured temperature with different thermometer to check accuracy of original reading Moved vaccine to a different refrigerator/freezer maintained at proper temperature Called the vaccine manufacturer to determine the potency of the vaccine Called the local/state immunization program for assistance Did not do anything Not applicable, no temperatures outside range Unable to answer, no log available 2013 VFC Site Visit Questionnaire
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19. Does the clinic/practice have written documentation of the action taken when the temperatures were outside the recommended range? Yes No Not applicable, no temperatures outside range Unable to answer, no log available 20. Record the current temperatures (2-8°C / 35-46°F) #2. #3. #4.
#1.
#5.
#1.
(-15°C / 5°F or lower) #2. #3. #4.
#5.
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21. Are current temperatures within the guidelines according to the reviewer’s thermometer? (Refrigerator: 2-8°C / 35-46°F, Freezer: -15°C / 5°F or lower) #1.
#2.
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22. Is food stored with vaccines in the refrigerator or freezer? #1.
#2.
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23. Are vaccines stored in the doors of the refrigerator or freezer? #1.
#2.
#3.
2013 VFC Site Visit Questionnaire
#4.
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24. Is vaccine stored in the middle of the storage unit and stacked with air space between the stacks and side/back of the unit to allow cold air to circulate around the vaccine? #1.
#2.
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25. Is there a “DO NOT DISCONNECT” sign on the refrigerator/freezer electrical outlet? #1.
#2.
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26. Is there a “DO NOT DISCONNECT” sign on the circuit breaker? Yes No Don’t Know 27. Are short-dated vaccines stored in front and used first, rotating stock effectively? #1.
#2.
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28. Can the clinic/practice physically differentiate privately purchased vaccine from publicly purchased vaccine? To answer yes, clinic/practice must be able to demonstrate how this is done. Yes, clinic/practice can physically differentiate public vaccine from private vaccine No, clinic/practice cannot physically differentiate public vaccine from private vaccine Not applicable, clinic/practice is located in a universal state, has no private stock Not applicable, clinic/practice serves 100% VFC eligible children, has no private stock (Comprehensive Certificate on File) Not applicable, clinic/practice serves 100% VFC eligible children, has no private stock (No Comprehensive Certificate on File) 29. Upon checking the clinic/practice’s vaccine supply, did the reviewer find any unreported expired vaccine in the storage unit(s)? Yes No
30. What is the VFC eligibility screening coverage in this clinic/practice? VFC screening coverage of 100% of charts reviewed VFC screening coverage of at least 95% of charts reviewed VFC screening coverage of at least 90% of charts reviewed VFC screening coverage below 90% of charts reviewed
2013 VFC Site Visit Questionnaire
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31. What methodology was used to determine VFC eligibility screening coverage during this site visit? CDC-supplied Lot Quality Assurance (LQA) 30 chart protocol CoCASA Grantee-developed methodology Other: 32. Do all immunization records contain the following documentation required by statute 42 US Code 300aa-25 and 300aa26? Name of vaccine given Date vaccine was given Date VIS was given Name of vaccine manufacturer Lot number Name and title of person who gave the vaccine Address of clinic where vaccine was given Publication date of VIS
33. Are corrective actions recommended for this VFC enrolled site? Yes No 34. Please indicate your Follow-up plan with the site to ensure recommendations were implemented (select all that apply). Provided technical assistance at time of site visit, no further follow-up is needed Formal Corrective Action Plan (should be signed by provider and each follow up activity documented in CoCASA) Removal of VFC vaccine Hold VFC vaccine ordering Program termination or referral to external agency for investigation of fraud and abuse
VFC Program Staff Signature (optional): ____________________________________________ Provider Signature (optional): ____________________________________________________ Date: ______________________________
2013 VFC Site Visit Questionnaire
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VFC Training Elements Eligibility categories Eligibility screening and documentation Provider vaccine manager and back up-reporting changes Enrollment requirements and form Provider profile and instructions for completion CHIP populations Borrowing Complying with ACIP Immunization Schedule Record maintenance No allowable charge for vaccine Administration fees Deputization for underinsured (if applies) Vaccine ordering through IIS/VTrckS VFC Compliance Site Visits requirement Educational visits/Other educational options Streamlined oversight (If applies) Signature requirements Corrective action plans and follow up Elements of routine vaccine management plans Elements of emergency vaccine management plans Testing management plans Cold chain Appropriate procedures for receiving of vaccine No dorm style refrigerators allowed Appropriate vaccine storage units Appropriate vaccine and thermometer placement Appropriate temperature monitoring and documentation Appropriate response to temperature excursions Appropriate procedures for preventing, reporting and returning expired/wasted/spoiled vaccine
Completed
Does not apply
List of Attendees:
2013 VFC Site Visit Questionnaire
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SECTION II. Standards for Pediatric & Adolescent Immunization Practices (Optional) Vaccine Administrative Policy 1. How does the clinic/practice offer immunization services to patients? (Check all that apply) During well-child visits Immunization-only appointments Walk-in immunizations Dedicated days/times for immunizations Off-site immunizations Other (specify) 2.
Is an office visit fee charged in addition to any vaccine administration fees? Yes No If yes, what is the amount of the office visit fee?
3. Is a physical exam required before immunizations are given? Yes No Assessment of Vaccination Delivery 4. Does the clinic/practice routinely immunize when the child has: A cold Low grade fever (e.g. 100.4°F [38°C] or lower) Recently been exposed to infectious illness Mild diarrhea Convalescing from an acute illness Effective Communication about Vaccine Benefits and Risks 5. Does the clinic/practice staff know how to obtain foreign-language Vaccine Information Statements (VIS) for patients/families whose first language is not English? Yes No Proper Storage and Administration of Vaccines and Documentation of Vaccinations 6. Does the clinic/practice have a current copy of the following documents?
7. Are up-to-date, written vaccination protocols accessible at all locations where vaccines are administered? (If Yes, ask to see a copy) Yes No 8. Who gives immunization injections? (Check all that apply) MD NP PA RN LVN LPN
MA
9. How do persons who administer vaccines and staff who manage or support vaccine administration receive ongoing education regarding immunization? (Check all that apply.) No ongoing training In-house training by health dept./professional organization at least once a year In-house training by staff at least once a year Off-site conferences or workshops at least once a 2013 VFC Site Visit Questionnaire
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Distribution of written materials Other (specify)
year Web-based training
10. Does the practice document ongoing education regarding immunization for persons who administer vaccines and staff who manage or support vaccine administration? Yes No 11. Does the clinic/practice simultaneously administer all vaccines for which the child is eligible? Yes No 12. What size needles are generally used for intramuscular injections? 5/8” (inch) 1” (inch) 7/8” (inch) Depends on age Other (Specify):__________________ 13. Does the clinic/practice pre-fill syringes? Yes No 14. Does the clinic/practice have VAERS forms and know how to report to VAERS? Yes No 15. Does the clinic/practice require staff that have contact with patients to be immunized or show proof of immunity against the following vaccine-preventable diseases? (Check all that apply) None required Measles/Mumps/Rubella Hepatitis B Hepatitis A Varicella Influenza Td Other (specify) VFC Program Staff Signature (optional): ____________________________________________ Provider Signature (optional): ____________________________________________________ Date: ______________________________
2013 VFC Site Visit Questionnaire
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Bid Line 7: Form Number VFC-03: Patient Eligibility Chart Review
Bid Line 8: Form Number VFC-04: VFC Patient Eligibility
Vaccines for Children (VFC) Program Patient Eligibility Screening Record
A record of all children 18 years of age or younger who receive immunizations must be kept in the health care provider’s office for 3 years or longer depending on state law. The record may be completed by the parent, guardian, individual of record, or by the health care provider. VFC eligibility screening and documentation of eligibility status must take place with each immunization visit to ensure the child’s eligibility status has not changed. While verification of responses is not required, it is necessary to retain this or a similar record for each child receiving vaccine. Providers using a similar form (paper-based or electronic) must capture all reporting elements included in this form. 1. Child’s Name :___________________________________________________________________________________ Last Name
First Name
MI
2. Child’s Date of Birth: __ __/__ __/__ __ __ __ 3. Parent/Guardian/Individual of Record:__________________________________________________________________ Last Name
First Name
MI
4. Primary Provider’s Name:___________________________________________________________________________ Last Name
First Name
MI
5. To determine if a child (0 through 18 years of age) is eligible to receive federal vaccine through the VFC and state programs, at each immunization encounter/visit enter the date and mark the appropriate eligibility category. If Column A-D is marked, the child is eligible for the VFC program. If column E or F is marked the child is not eligible for federal VFC vaccine.
A Date
Medicaid Enrolled
Eligible for VFC Vaccine B C No Health Insurance
American Indian or Alaskan Native
D *Underinsured served by FQHC
Not eligible for VFC Vaccine E F Has health insurance that covers vaccines
**Enrolled in CHIP
*Underinsured includes children with health insurance that does not include vaccines or only covers specific vaccine types. Children are only eligible for vaccines that are not covered by insurance. In addition, to receive VFC vaccine, underinsured children must be vaccinated through a Federally Qualified Health Center (FQHC) or Rural Health Clinic (RHC) or under an approved deputized provider. The deputized provider must have a written agreement with an FQHC/RHC and the state/local/territorial immunization program in order to vaccinate underinsured children. **CHIP- Children enrolled in the state Children’s Health Insurance Program (CHIP). These children are considered insured and are not eligible for vaccines through the VFC program. Vaccine must be privately purchased for administration to children enrolled in CHIP.
Bid Line 9: Form Number VFC-05 Temperature Log
Temperature Log for Vaccines (Celsius)
Month/Year: _________________ Days 1–15
Instructions: Place an “X” in the box that corresponds with the temperature. The RED REGIONS represent unacceptable temperature ranges. If the temperature recorded is in the red region: 1. Store the vaccine under proper conditions as quickly as possible, 2. Call Chicago VFC for further assistance: (312) 746-6358.
Name of Practice: ____________________________________________
Freezer temp
Refrigerator temperature
Day of Month Exact Time C Temp
1 am
2 pm
am
3 pm
am
4 pm
am
5 pm
am
6 pm
am
7 pm
am
8 pm
>11 10 9 8 7 6 5 4 3 2 1 0 -12 -13 -14 -15 -16 -17 -18 -19 11 10 9 8 7 6 5 4 3 2 1 0 -12 -13 -14 -15 -16 -17 -18 -19