HIGH PRIORITY QUESTION KEY

All questions indicated with the ! icon are considered high priority questions. 
Inappropriate or incorrect responses given to any of these questions require that 
a corrective action plan be developed with the provider by the staff person conducting
the VFC site visit. The newly added “pre-visit” review question was added to 
incorporate a review of the provider profile related to the provider’s vaccine ordering
patterns to identify issues that may need further follow-up.  If a reviewer is unable
to identify a valid reason for the ordering discrepancy then the situation should be 
documented as a potential case of fraud and abuse and followed-up based on the grantee’s 
fraud and abuse policy. The table below is to be used as a key. It outlines the correct
response to each of the high risk questions.



(Table of High priority Question Key)
#: Pre-vist Review
Question: Are vaccine orders consistent with most current provider profile?
Response Options:1.Yes
2.No
Acceptable:Yes
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33 :
No. Conduct further review/research to determine if the provider’s patient 
population significantly changed in size but the provider profile was not updated.  
If this is the case, an updated provider profile must be submitted to the immunization 
program as soon as possible.  The VFC staff should follow-up to make sure the revised 
provider profile is submitted.

If no reason can be identified for vaccine orders that are greater than expected 
based on the current provider profile, the situation should be documented as a potential
case of fraud and abuse  and, following the grantee’s written policy, be referred 
for further investigation or education.


#1.
Question: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)?
Response Options:Open-ended
Acceptable:Within state cap (varies by state)
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33:
In excess of state cap. 
Universal states may set their administration fee for the non-Medicaid VFC 
eligible children higher than the listed maximum regional charge but only if the
proper protocol was followed and documented.  The protocol that must be followed 
is outlined in the Federal Register,  Vol 59, No.190, October 3, 1994

#4
Question:When does this clinic/practice provide patients
with copies of the Vaccine Information Statements (VIS) to keep?
Response Options:
1. Every time the patient receives a vaccination
2. When the child receives the first dose of vaccine within a particular series 
(e.g. 1st dose of DTaP)
3. Do not provide
4. Other (specify)
Acceptable:
Option 1
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33:
Option 2-4

#6
Question:When does the clinic/practice screen patients for VFC eligibility?
Response Options:
1. First immunization visit to the office
2. Every immunization visit
3. Do not screen for VFC eligibility
4. Not Applicable clinic /practice serves 100% VFC eligible children and has 
the appropriate Comprehensive Certificate with up to date signature on file.
5. Other (specify)
Acceptable:
Option 2,4
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33:
Option 1, 3, 5

#7
Question: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?
Response Options:
1. Yes
2. No
Acceptable:Option 1
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33:
Option 2

#8
Question: When does the clinic/practice prepare vaccine for administration to patients?
Response Options:1.Immediately before administration
2.Other: specify
Acceptable:Option 1
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33:
Option 2

#9
Question:Does the clinic/practice have a written plan for vaccine management? 
(ask to see a copy)
Response Options:
1. Yes
2. No
Acceptable:
Option 1-Yes
All 8 components must be present and content must  accurately reflect requirements 
in Module 6 of  VFC Operations Guide(August 2007 release)
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33:
No to all 8 components or any combination of Yes and No answer to the components 
Any component with a “No” response selected must have a corrective action plan 
developed with the provider by the staff person conducting the VFC site visit 
for that specific component

#10
Question:Please identify the publication date for each VIS 
currently being used in this clinic/practice and then check the appropriate status 
for each VIS
Response Options:
1. Current
2. Outdated
3. None Used
4. Does not administer
Acceptable:Options 1 or 4
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33:
Options 2 or 3 to any VIS for a VFC vaccine 
provided within the practice.
Please note: The VIS dates listed in Question 10 were current at the time the word 
version of the questionnaire was provided to the grantees.  VIS are updated on an 
as-needed basis so each grantee must have a process to check for new VIS form dates
between the annual release of the VFC site visit questionnaire 


#11
Question: What type of storage units does this clinic/practice use to store  varicella-containing 
vaccine? 
Response Options:
1.Stand-alone freezer
2.Stand–alone refrigerator
3.Dormitory style refrigerator/freezer
4.Combined refrigerator/freezer with separate external refrigerator and freezer doors (e.g. household-style appliance)
5.Combined refrigerator/freezer with a single door
6.Does not administer vaccines requiring  freezer storage
Acceptable: Option 1,4, 6
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33 :
Option,2, 3, 5


#11
Question:What type of refrigeration unit is used to store all other vaccines
 (except varicella containing)?  (check all that apply)

 Response Options:
1. Stand alone freezer
2. Stand-alone refrigerator
3. Dormitory style refrigerator/freezer
4. Combined refrigerator/freezer with separate external refrigerator and freezer doors
 (e.g. household-style appliance)
5. Combined refrigerator/freezer with single door (e.g. household-style appliance)
Acceptable:Options:  2, 4
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33:
Options: 1, 3, 5

#12
Question: Are working thermometers placed in a central area of each refrigerator and freezer?
See note in right column.
Response Options:
1.Yes
2.Have thermometer but not placed properly
3.No thermometer
Acceptable:Option 1
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33:
Options 2, 3
Use of multiple thermometers: Although multiple thermometers are not required
within a storage unit, it is recognized that some providers may wish to thoroughly 
monitor temperatures throughout their storage unit.  When a site is using multiple
thermometers, it is important that they select only one certified and 
centrally-located thermometer as their official recorder of temperatures.  


#13b.
Question: For each type of thermometer used by the practice, indicate if the thermometer
is certified (check all that apply)? Refer to 13(A) for type of  thermometer
Response Options:
1. Yes
2. No
Acceptable:Option 1- Yes
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33:
Option 2- If “No” is selected for any of the storage units, a 
corrective action plan must be developed even if only one unit does not have a 
certified thermometer.  If any units have both certified and uncertified thermometers
located in the unit, the staff must be instructed to use only the certified thermometer 
to record the temperature on the log sheets. 


#14
Question:For each refrigerator and freezer indicate how 
often temperatures are recorded (check all that apply)
Response Options:
1.Once a day
2.Less than once a day
3.Twice a day
4.More than twice a day
Acceptable: Options 3, 4
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33:
Options 1, 2 specify in corrective action section (#32)
If Option 4 is selected if the practice monitors the temperatures more than twice a day.
It is important to acknowledge to the office that the VFC program appreciates their 
diligence, but it is not necessary to monitor the temperatures more than twice a day 
(a.m. & p.m.) and discuss with the practice staff how that time could be used to 
improve another aspect of vaccine management & document corrective action section.

#15
Question:
Record highest and lowest temperatures logged in the last 3 months. If no log is 
available document current temperatures for both highest and lowest. If log is 
available for all 3 months select, “Yes” for section 3. If no log is available, 
select “No” for section 3. If log is available for any part of last  3 months, 
select “Partial” for section 3.
Response Options:
Record lowest & highest temperatures from log.  If no log available use current 
temperatures for both lowest & highest temperatures.
Log available?  Yes, No, Partial
Acceptable:
Record lowest & highest temperatures from available temperatures. If no log 
available use current temperatures for both lowest & highest temperatures.
Correct answer to “Log available for last 3 months?”-“YES”
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33:
Log Available? Answer of No or Partial
Storage Units temperatures must be recorded twice a day (am & pm) on a log. If log is 
not available or only available for part of the last 3 months –corrective action plan
must be developed


#16
Question:During past 3 months, how many times were the temperatures outside the
recommended range?
Response Options:
Number of occurrences
Unknown: no log is available
Acceptable: 0
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33:
Anything greater than 0 or documentation that no temperature log is available in question
#15. Review responses to question # 17 and #18 to determine if all necessary actions 
were taken when the temperature was identified as outside the recommended range 
and actions were documented.


#17 (Only if out–of-range temp has been documented)
Question:
When temperatures were outside the range, 
what action(s) did the clinic/practice take?
Response Options:
1. Adjust thermostat in refrigerator /freezer
2. Measure temperature with different thermometer to check accuracy of original reading
3. Moved vaccine to a different refrigerator/freezer
4. Called the vaccine manufacturer to determine potency of the vaccine
5. Called the local/state immunization program for assistance
6. Did not do anything
7. Not applicable, no temperatures outside range 
Acceptable:
Options 1-5
Depending on situation, the most acceptable answer may be a combination 
of options or selecting all options 1-5  or
Option 7-Not applicable, No temperatures outside range
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33:
Option 6, or selecting only 1 or 2 of the acceptable options when the 
situation required further action to safeguard or determine the viability 
of the vaccine. 
Reviewers must use their judgment to decide if all necessary steps were taken for 
identified situation. 

#18 (Only if out–of-range temp has been documented)
Question: Does the clinic/practice have 
written documentation of action taken when the temperatures were outside the 
recommended range?
Response Options:
1. Yes
2. No
3. Not applicable, no temperatures outside range
Acceptable:
Option 1- Yes
Option 3-Not Applicable no temperatures outside range
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33:
Option 2- No
All actions must be documented on the back of temperature log or on a 
separate page attached to log with the date that the temperature was out of range. 


#20
Question: 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)        
Response Options:
1.Yes
2.No
Acceptable: Option 1-Yes to all units
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33:
Option 2-No- to any unit
If any unit is out of temperature range, the reviewer must assist /instruct the staff on 
the actions to determine if the vaccine is still viable and how to document actions correctly.


#21
Question: Is food stored with vaccines in the refrigerator or Freezer
Response Options:
1.  Yes
2.   No
Acceptable: Option 2- No to all units
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33:
Option 1- Yes to any unit
Reviewer should instruct on why food should not be stored with vaccine and develop 
timeframe to correct

#22
Question:Are vaccines stored in the doors of the refrigerator and freezer?
Response Options: 1. Yes
2. No
Acceptable: 
Option 2-No to all units
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33:
Option 1-Yes to any unit
Reviewer should instruct/demonstrate how to properly arrange stored vaccine.

#23
Question: 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?
Response Options:
1. Yes
2.No
Acceptable: Option 1- Yes to all units
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33:
Option 2-No to any unit
Reviewer should instruct/demonstrate how to  properly arrange stored vaccine.


#24
Question: Is there a “DO NOT DISCONNECT” sign on the refrigerator/freezer electrical outlets?
Response Options:
1. Yes
2.No
Acceptable:
Option 1- Yes 
to all units
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33:
Option 2- No to any unit
Reviewer should provide warning sign and offer to assist in placing sign in proper location.


#25
Question: Is there a “DO NOT DISCONNECT” sign on the circuit breaker?
Response Options:
1. Yes
2. No
3. Don’t know
Acceptable: Option 1-Yes to all units
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33:
Option 2, 3- No or Don’t know to any unit
Reviewer should provide warning sign and offer to assist in placing sign in proper location

#26
Question: Are short-dated vaccines stored in front and used first, rotating stock effectively?
Response Options:
1. Yes
2. No
Acceptable: Option 1-Yes to all units
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33:
Option 2- No to any unit 


#27
Question:
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
Response Options:
1. Yes 
2. No
3. Not applicable clinic/practice is located in a universal state, has no private stock
4. Not applicable clinic/practice serves 100% VFC eligible children, has no private stock
5. Other
Acceptable:
Options 1, 3*,4,5
Option 1 is acceptable if method allows provider to identify public from private stock.  
Option 3-universal purchase  grantees would select this method and document that provider 
does not have private stock.
Option 4 can only be selected if provider has Comprehensive Certificate on file and 
the certificate is current.
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33:
Option 2- No  

#28
Question: Upon checking the clinic/practice’s 
vaccine supply, did reviewer find any unreported wasted or expired vaccine?
Response Options:
1. Yes
2. No
Acceptable: Option 2- No
Unacceptable - Requires corrective Action to be documented in #32 and follow-up in #33:
Option 1- Yes




2009 VFC Site Visit Questionnaire High Priority Answer Key
September  4,  2008		  Page 1 through 7	




This document can be found on the CDC website at: 
http://www.cdc.gov/vaccines/programs/vfc/downloads/2009-vfc-site-visit-answ-key-508.txt