2017 MnVFC Site Visit Questionnaire
Date of visit: _____________
Date forms sent to MDH: ______________
Site Information
Site name:
MnVFC PIN:
Address:
Separate Stock
City:
ZIP:
Medical Director:
Email:
Immunization Manager:
Phone:
Replacement
County:
Email:
Vaccine Coordinator:
Phone:
Email:
Vaccine Coordinator back-up:
Email:
Point of contact:
Phone:
Email:
Personnel at site visit:
IPI Advisor Information (staff that performed visit)
IPI Advisor:
Phone:
County:
Email:
Post Visit Steps
Education on Immunization Best Practices for Sites
Gave folder containing continuing education and clinical
information resources.
Required forms sent to MDH within 10 days of visit
(Email to [email protected] or fax to
651-201-5501):
MnVFC Site Visit Questionnaire
Storage & Handling Per Unit Answer Sheet
(one for each storage unit) Number sent: ________
Provider Follow-up Plan with signature
Required forms sent to site:
Thank you letter with survey link
To be completed by MnVFC clinical coordinator/planner at MDH
Date reviewed:
Site type:
Signature:
Private
Public Health
Hospital
School-based
Correctional Facility
Pharmacy
FQHC/RHC
Mass Vaccination Program
IM M UNI Z A T IO N P RA CT I CE S IM PR OV EM E N T (I P I)
Tribal/IHS
Site Visit Reviewer Guide Legend
Section Number: Content Area
Question number:
This area will always contain the text of the question
Note to reviewer:
The note to reviewer contains information that is necessary for properly asking and assessing responses to
the question above. This may include definitions of terms, requirement details and other helpful tips.
Answers:
This field will contain all the possible answer choices for this question. For most questions, answer choices
will be followed by the markings below:
▪ Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a
CDC requirement.
▪ Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC
recommendation.
Review CDC Requirement/Recommendation:
This field will be populated with the CDC requirement/recommendation associated with the given question
Actions if Non-Compliant:
Root Cause Analysis: As part of the site visit, reviewers are required to assess and understand the reasons why a provider office is
non-compliant with VFC program requirements – this is a root cause analysis. Reviewers must choose the
one root cause that they believe most contributes to the non-compliance. Upon establishing the root cause,
the reviewer must provide a clear explanation of his/her findings.
Immediate Action:
These are actions that CDC requires reviewers to take on site during the visit.
Future Follow-up:
These are future follow-up actions (with designated due dates) that are required of the reviewer and/or
provider to remedy non-compliance. Reviewers must complete all follow-up in accordance with CDC
established deadlines.
Notes:
Information you want the VFC program to be aware of or that explains your answer in detail.
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 2 of 31
1. Provider Details: Changes to Key Staff
Question 1.2:
A
(Choose all that
apply)
Ask the provider about changes to key staff to answer the questions below.
At the time of the visit, is the Medical Director
the same individual that signed the Provider
Agreement, and are the Immunization
Manager and Vaccine Coordinator the same as
those last reported to the program?
Yes
No, the Medical Director has changed
No, the Immunization Manager has changed
No, the Vaccine Coordinator has changed
B
(Choose one)
Were all changes communicated to the
Immunization Program according to your
program’s policy?
Yes, or no staff changes
No [X]
C
(Choose one)
Based on review of the training
documentation, have the current Immunization
Manager, Vaccine Coordinator, and back-up
completed all required training?
Yes
No [X]
Review CDC Requirement:
All changes in key staff must be communicated to the Immunization Program in the manner and timeframe defined by the
Immunization Program. Key staff include: the Medical Director or equivalent who signed the Provider Agreement; the
Immunization Manager, Vaccine Coordinator, and the back-up. VFC providers are required to ensure that all key staff are fully
trained on VFC program requirements at all times. All training must be documented.
Actions if Non-Compliant:
Root Cause:
Human Causes [Related to specific person]
Select one root cause
Personal beliefs/opinions
and explain in the
Does not understand rationale
space provided.
of requirement
Lack of concern for compliance
Organizational Causes [Related to organization as a whole]
Competing job assignments/workload
Lack of (or insufficient) staff to perform required duties
Budget limitations (for purchase of required equipment)
Lack of (or insufficient) training of staff
Lack of (or insufficient) processes/protocols
Explain:
Immediate Action:
Question C: Provide training on all key requirements during the site visit.
Future Follow-up:
Question C: Staff that have not taken the MnVFC online training must complete it and send the
certificate to the IPI advisor within 30 days.
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 3 of 31
2. Eligibility: VFC Eligibility Categories
Question 2.1:
Was the individual responsible for determining patient VFC eligibility able to explain all the factors
(including age) that make a child eligible to receive VFC vaccines?
A
Patient is less than 19 years of age
Yes
No [X]
B
Patient is Medicaid-eligible
Yes
No [X]
C
Patient is uninsured
Yes
No [X]
D
Patient is underinsured
Yes
No [X]
E
Patient is American Indian
Yes
No [X]
F
Patient is Alaska Native
Yes
No [X]
Review CDC Requirement:
VFC providers must possess a working knowledge of all VFC eligibility criteria and use those criteria to screen children prior to
administering VFC vaccines. In order to receive VFC vaccine, a patient must be under the age of 19 and must be at least one of the
following: (1) Medicaid-eligible; (2) Uninsured (i.e., child has no health insurance); (3) Underinsured (i.e., child has health insurance,
but coverage does not cover any or certain vaccines – underinsured children may only receive VFC vaccines in FQHC/RHC or
deputized VFC provider offices and only for vaccines not covered by insurance); and (4) American Indian or Alaska Native (AI/AN).
Actions if Non-Compliant:
Root Cause:
Human Causes [Related to specific person]
Select one root cause
Personal beliefs/opinions
and explain in the
Does not understand rationale
space provided.
of requirement
Lack of concern for compliance
Organizational Causes [Related to organization as a whole]
Competing job assignments/workload
Lack of (or insufficient) staff to perform required duties
Budget limitations (for purchase of required equipment)
Lack of (or insufficient) training of staff
Lack of (or insufficient) processes/protocols
Explain:
Immediate Action:
Provide educational materials/resources on VFC eligibility requirements. Depending on the findings of
the root cause analysis, add follow-up as needed to make sure the issue is addressed.
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 4 of 31
2. Eligibility: Billing Practices
Question 2.2:
Is the individual/department responsible for billing able to clearly explain how they bill for both the cost
of vaccine and the vaccine administration fee for each of the eligibility categories below?
A
Medicaid-eligible
Cost of Vaccine: Do not bill – provided by VFC
Admin Fee: Bill Medicaid
Yes
No [X]
B
Uninsured
Cost of Vaccine: Do not bill – provided by VFC
Admin Fee: If billing, can bill patient
Yes
No [X]
C
Underinsured
Cost of Vaccine: Do not bill – provided by VFC through FQHCs,
RHCs or deputized providers only; all other providers cannot
provide VFC vaccine to underinsured patients
Admin Fee: If billing, can bill patient
Yes
No [X]
D
American
Cost of Vaccine: Do not bill - provided by VFC unless patient is fully
Indian/Alaska Native insured and parent chooses to use insurance
(AI/AN)
Admin Fee: If patient is Medicaid-eligible, bill Medicaid; if billing,
and patient is uninsured/underinsured, can bill patient; if parent
chooses to use private insurance for cost of vaccine, bill
patient/insurance
Yes
No [X]
Do individuals responsible for billing have access to the results of eligibility screening to
ensure proper billing?
Yes
No [X]
E
Review CDC Requirement:
VFC providers must adhere to proper billing practices for vaccine administration fees and clearly understand that VFC vaccine is
provided at no cost to both the VFC provider and eligible children. At no time should billing occur for the cost of VFC vaccine. When
administering VFC vaccine, providers should never bill two different “payers” (i.e., patient, Medicaid, insurance) for the same
vaccine administration fee amount. For Medicaid-eligible children, Medicaid should be billed for the vaccine administration fee. For
all other VFC-eligible populations, the patient may be billed within the state/territory cap established by the Centers for Medicare
and Medicaid (CMS). However, patients cannot be turned away or reported to collections for inability to pay the administration fee.
Actions if Non-Compliant:
Root Cause:
Human Causes [Related to specific person]
Select one root cause
Personal beliefs/opinions
and explain in the
Does not understand rationale
space provided.
of requirement
Lack of concern for compliance
Organizational Causes [Related to organization as a whole]
Competing job assignments/workload
Lack of (or insufficient) staff to perform required duties
Budget limitations (for purchase of required equipment)
Lack of (or insufficient) training of staff
Lack of (or insufficient) processes/protocols
Explain:
Immediate Action:
If you have concerns about improper billing, conduct a record review to better understand billing
practices and add follow-up as appropriate based on your root cause findings. Call MDH at 651-201-5522
if you need assistance.
Future Follow-up:
Provider to submit in no later than one month: New or revised billing protocols addressing how your
office will bill for each VFC-eligible category.
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 5 of 31
2. Eligibility: Vaccine Administration Fee
Question 2.3:
Answers:
Document the actual vaccine administration fee charged to non-Medicaid, VFC-eligible patients (confirm
with billing department).
Fee: $
[X] Follow-up is required if the provider charges more than the fee cap established
by the Centers for Medicare and Medicaid (CMS) for your state/territory ($21.22).
Review CDC Requirement:
The VFC provider’s vaccine administration fee for non-Medicaid, VFC-eligible children must not exceed the state/territory vaccine
administration fee cap established by the Centers for Medicare and Medicaid (CMS). For current fee caps, refer to Medicaid
Program; Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under the
Vaccines for Children Program, Final Rule (http://www.gpo.gov/fdsys/pkg/FR-2012-11-06/pdf/2012-26507.pdf).
Actions if Non-Compliant:
Root Cause:
Human Causes [Related to specific person]
Select one root cause
Personal beliefs/opinions
and explain in the
Does not understand rationale
space provided.
of requirement
Lack of concern for compliance
Organizational Causes [Related to organization as a whole]
Competing job assignments/workload
Lack of (or insufficient) staff to perform required duties
Budget limitations (for purchase of required equipment)
Lack of (or insufficient) training of staff
Lack of (or insufficient) processes/protocols
Explain:
Future Follow-up:
Six months: Perform follow-up site visit to assess whether the provider is charging a vaccine
administration fee that does not exceed the state CMS fee cap.
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 6 of 31
3. Documentation: Eligibility Screening & Documentation
Question 3.1:
Note to Reviewer:
To answer the questions below, the provider must clearly demonstrate the patient intake process.
Review a minimum of 10 records that contain an immunization visit within the last 6 – 12 months.
Criteria for Record Selection:
1) Record selection must be completely random, and the provider must not know prior to the visit which
records will be reviewed.
2) Patient must have been 0-19 years of age at the last visit (Note: Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age).
3) Must review a mix of public and private-pay patients (if applicable).
A
Does the provider have a process that ensures that patients are screened for
VFC eligibility at each visit and that screening results are documented at each visit?
B
Does the provider’s process ensure that staff administering vaccine know which
vaccine stock to select from prior to drawing the vaccine?
C
Number of records reviewed:
If fewer than 10 records are reviewed, select the reason why:
Provider does not have 10 patient records with immunizations in last 12 months.
D
Do all records contain date of the immunization visit and patient’s date of birth?
Yes
No [X]
E
Do all records contain the patient’s specific eligibility status associated with the
date of the immunization?
Yes
No [X]
F
Do any of the provider’s records contain any evidence that the patient received
vaccine for which they were not eligible?
Yes [X]
No
Yes
No [X]
(If no, skip question F)
Yes
No [X]
Review CDC Requirement:
VFC providers must screen for and document VFC eligibility at each immunization visit. Documentation must include the date of the
visit and the child’s specific eligibility category. VFC providers must use screening results to ensure that only VFC-eligible children
receive VFC vaccine and that administration fees are billed for as appropriate. Eligibility status must be readily available to staff
administering vaccine prior to selecting which vaccine stock to use.
Actions if Non-Compliant:
Root Cause:
Human Causes [Related to specific person]
Select one root cause
Personal beliefs/opinions
and explain in the
Does not understand rationale
space provided.
of requirement
Lack of concern for compliance
Organizational Causes [Related to organization as a whole]
Competing job assignments/workload
Lack of (or insufficient) staff to perform required duties
Budget limitations (for purchase of required equipment)
Lack of (or insufficient) training of staff
Lack of (or insufficient) processes/protocols
Explain:
Immediate Action:
Provide guidance on establishing a screening process and add follow-up based on root cause findings.
Question A, D, E: Give the provider the CDC VFC Eligibility Screening Form.
Question A: Provider must begin screening patients age 0 through 18 years immediately.
Future Follow-up:
Provider to submit in no later than one month: New or revised protocols for conducting and
documenting eligibility screening for each patient at each visit or documentation explaining how the
identified non-compliance will be addressed.
Question A or F - Six months: Conduct a follow-up site visit to observe the screening and intake process.
Review a random selection of patient records that contain an immunization visit since the date of the
compliance visit to determine whether eligibility is being assessed and documented properly.
[Note: Number must be proportional to the provider’s overall patient population and not fewer than 20.]
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 7 of 31
3. Documentation: Vaccine Dose Documentation
Question 3.2:
Note to Reviewer:
Review a minimum of 10 patient immunization records from the last six months (or 12 months if
necessary) to assess compliance with documentation requirements set forth by Statute 42 US Code
300aa-25 (See note to reviewer below).
Criteria for Record Selection:
1) Record selection must be completely random: the Provider must not know prior to the visit which records
will be reviewed.
2) Patient must have been 0-19 years of age at the last visit (Note: Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age).
Records are Compliant if they Contain ALL the Below Elements:
•
•
•
•
Address of clinic where vaccine was administered
Name of vaccine administered
Date vaccine was administered
Date VIS was given
•
•
•
•
Publication date of VIS
Name of vaccine manufacturer
Lot number
Name and title of person who administered the
vaccine
A
Number of records reviewed
B
Number of records that contain ALL required documentation elements:
[X] Follow-up is
required if one or
If fewer than 10 records are reviewed, select the reason why:
more records do not
Provider does not have 10 patient records with immunizations in last 12 months. meet requirements
Review CDC Requirement:
In accordance with Federal law, all VFC providers must maintain immunization records that include ALL of the following elements:
(1) name of vaccine administered; (2) date vaccine was administered; (3) date VIS was given; (4) publication date of VIS; (5) name of
vaccine manufacturer; (6) lot number; (7) name and title of person who administered the vaccine; (8) address of clinic where
vaccine was administered.
Actions if Non-Compliant:
Root Cause:
Human Causes [Related to specific person]
Select one root cause
Personal beliefs/opinions
and explain in the
Does not understand rationale
space provided.
of requirement
Lack of concern for compliance
Organizational Causes [Related to organization as a whole]
Competing job assignments/workload
Lack of (or insufficient) staff to perform required duties
Budget limitations (for purchase of required equipment)
Lack of (or insufficient) training of staff
Lack of (or insufficient) processes/protocols
Explain:
Immediate Action:
Discuss with the provider how to improve their processes to ensure that all required fields are
documented for each dose of vaccine administered and add follow-up as appropriate based on your root
cause findings.
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 8 of 31
3. Documentation: Record Retention
Question 3.3:
Answers:
(Choose one)
Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFC
eligibility documentation for three years?
Yes
No [X]
Review CDC Requirement:
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if required
by state law) and upon request make these records available for review. VFC records include, but are not limited to, VFC screening
and eligibility documentation, billing records, medical records that verify receipt of vaccine, vaccine ordering records, and vaccine
purchase and accountability records.
Actions if Non-Compliant:
Root Cause:
Human Causes [Related to specific person]
Select one root cause
Personal beliefs/opinions
and explain in the
Does not understand rationale
space provided.
of requirement
Lack of concern for compliance
Organizational Causes [Related to organization as a whole]
Competing job assignments/workload
Lack of (or insufficient) staff to perform required duties
Budget limitations (for purchase of required equipment)
Lack of (or insufficient) training of staff
Lack of (or insufficient) processes/protocols
Explain:
Future Follow-up:
Provider to submit in no later than one month: Plan for maintaining historical patient eligibility
documentation for a minimum of three years.
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 9 of 31
3. Documentation: Borrowing Documentation
Question 3.4:
Note to Reviewer:
Discuss borrowing practices with the provider to answer the questions below.
• To be considered “fully documented,” documentation for each borrowed dose must include the
following information:
▪ Vaccine type borrowed
▪ Stock used (VFC or private)
▪ Patient name and date of birth
▪ Date the dose was administered
▪ Reason appropriate vaccine stock was not used
▪ Date dose was returned to appropriate stock
A
Did the provider state that they had borrowed any vaccines (whether
documented or not) since the last VFC Compliance Site Visit?
B
Are there any doses for which there is no documentation (i.e., provider has
indicated that doses were borrowed but cannot verify how many or why)?
All doses are
documented
Some doses are not
documented [X]
No doses are
documented [X] (if no
doses documented, skip
to question 3.6)
C
Were all borrowed doses fully documented? (See Note to Reviewer above)
Yes
No [X]
D
Were all borrowed VFC doses either replaced or an order submitted to replace
the doses?
Yes
No [X]
Yes
No
(If no, skip to question 3.6)
Review CDC Requirement:
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients. It is the
responsibility of the VFC provider to appropriately schedule and place vaccine orders. VFC providers must also rotate stock to
ensure timely use of short-dated vaccines. Borrowing of vaccine between private and public inventories must be a rare, unplanned
occurrence and cannot serve as a replacement system for a VFC provider’s privately purchased vaccine inventory. All instances of
borrowing must be properly documented, reported and replaced.
Actions if Non-Compliant:
Root Cause:
Human Causes [Related to specific person]
Select one root cause
Personal beliefs/opinions
and explain in the
Does not understand rationale
space provided.
of requirement
Lack of concern for compliance
Organizational Causes [Related to organization as a whole]
Competing job assignments/workload
Lack of (or insufficient) staff to perform required duties
Budget limitations (for purchase of required equipment)
Lack of (or insufficient) training of staff
Lack of (or insufficient) processes/protocols
Explain:
Immediate Action:
Question B, C: Follow Immunization Program policy on borrowing and provide instruction for proper
reporting, documentation, and replacement. Leave a borrowing form with the provider with instruction
on use if applies.
Future Follow-up:
Question B, C: Provider to submit in Six months: Borrowing reports for the six months since the site visit.
Question D: Provider to submit in no later than one month: Documentation of purchase of private stock
used to replace borrowed VFC doses.
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 10 of 31
3. Documentation: Borrowing Reasons
Question 3.5:
Based on your discussion with the provider and a review of borrowing reports, document the doses
borrowed for each reason and answer the questions below.
Note to Reviewer:
• Short-dated vaccines are doses that are likely to expire before they can be used.
• Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients.
A
(Enter the number of
vaccine doses
borrowed for each
reason in the spaces
provided)
B
C
Reasons for Borrowing a VFC Dose:
_____ Private vaccine shipment delay (order placed on time, but delay in shipping/receipt)
_____ Private vaccine not useable on arrival (vials broken, temperature monitor out of range)
_____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
_____ Short-dated private dose was exchanged with VFC stock
_____ Accidental use of VFC dose for a private patient (human error)
_____ Replacement of private dose with VFC when insurance plan did not cover vaccine
_____ Other/Documented dose did not include reason for borrowing [X]
(Explanation Required):
Reasons for Borrowing a Private Dose:
_____ VFC vaccine shipment delay (order placed on time, but delay in shipping/receipt)
_____ VFC vaccine not useable on arrival (vials broken, temperature monitor out of range)
_____ Ran out of VFC stock between orders (provider orders not placed on time) [X]
_____ Short-dated VFC vaccine dose was exchanged with private dose
_____ Accidental use of a private dose for a VFC-eligible patient (human error)
_____ Other/Documented dose did not include reason for borrowing [X]
(Explanation Required):
Enter date range for instances of borrowing reviewed in the borrowing report.
Note: If “Date of earliest instance” is not available, use the date of the last VFC
Compliance Visit. If “Date of last instance” is not available, use the date of the
current VFC Compliance Visit.
Does borrowing appear to be a routine practice?
Note: To determine whether borrowing is a routine practice, assess frequency of
and repeating reasons for borrowing.
Examples: Frequent accidental use of incorrect stock, exchanging short-dated
vaccines or issues with ordering and shipment
Date of earliest instance:
Date of last instance:
Yes [X]
No
Review CDC Requirement:
VFC providers are expected to maintain an adequate inventory of vaccine for patients served. It is the responsibility of the provider
to appropriately schedule and place vaccine orders and ensure vaccine stock is properly rotated to ensure timely use of short-dated
vaccines. Borrowing of vaccine between private and public inventories must be a rare, unplanned occurrence and cannot serve as a
replacement system for a provider’s privately purchased vaccine inventory. All instances of borrowing must be properly
documented, reported, and replaced.
Actions if Non-Compliant:
Root Cause:
Human Causes [Related to specific person]
Select one root cause
Personal beliefs/opinions
and explain in the
Does not understand rationale
space provided.
of requirement
Lack of concern for compliance
Organizational Causes [Related to organization as a whole]
Competing job assignments/workload
Lack of (or insufficient) staff to perform required duties
Budget limitations (for purchase of required equipment)
Lack of (or insufficient) training of staff
Lack of (or insufficient) processes/protocols
Explain:
Immediate Action:
Assess all the information collected above and have a conversation with the provider to identify what is
causing borrowing and what are possible solutions to prevent borrowing in the future. Add future followup specific to the circumstances identified.
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 11 of 31
Question 3.5 continued
Future Follow-up:
Provider to submit in no later than one month: New or revised protocols for managing vaccine ordering
and inventory and other internal processes to prevent routine borrowing.
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 12 of 31
3. Documentation: Vaccine Management Plan
Question 3.6:
Physically review the provider’s Vaccine Management Plan to answer the question below.
A
Does the provider have a Vaccine Management Plan?
Yes
No [X]
(If no, skip to
question 3.7)
B
Does the plan list the current Immunization Manager, Vaccine Coordinator, and
back-up?
Yes
No [X]
C
Does the plan address proper vaccine storage and handling practices?
Yes
No [X]
D
Does the plan specify vaccine receiving procedures?
Yes
No [X]
E
Does the plan contain procedures for what to do with vaccine in the event of an
emergency?
Yes
No [X]
F
Does the plan contain procedures for vaccine ordering?
Yes
No [X]
G
Does the plan address inventory control (example: stock rotation)?
Yes
No [X]
H
Does the plan address how to handle vaccine wastage?
Yes
No [X]
I
Does the plan address staff training and documentation on vaccine management,
storage & handling?
Yes
No [X]
J
Does the plan contain a review date that falls within the last 12 months?
Yes
No [X]
K
Has the plan been signed by the individual responsible for its content?
Yes
No [X]
Review CDC Requirement:
VFC providers must develop, maintain and implement a Vaccine Management Plan for routine and emergency vaccine
management. The plan must contain: the current Vaccine Coordinator and back-up; proper storage and handling practices;
shipping and receiving procedures; emergency procedures; procedures for vaccine ordering; inventory control (e.g., stock rotation);
how to handle vaccine wastage; and staff training/documentation on vaccine management, storage and handling. The plan must be
reviewed/updated annually or more frequently if changes occur. A “review date” and signature are required on all plans in order to
validate that they are current.
Actions if Non-Compliant:
Root Cause:
Human Causes [Related to specific person]
Select one root cause
Personal beliefs/opinions
and explain in the
Does not understand rationale
space provided.
of requirement
Lack of concern for compliance
Organizational Causes [Related to organization as a whole]
Competing job assignments/workload
Lack of (or insufficient) staff to perform required duties
Budget limitations (for purchase of required equipment)
Lack of (or insufficient) training of staff
Lack of (or insufficient) processes/protocols
Explain:
Immediate Action:
Provide a copy of the Immunization Program Vaccine Management Plan and/or Vaccine Emergency Plan
template(s).
Future Follow-up:
Provider to submit in no later than one month: Updated and complete Vaccine Management Plan
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 13 of 31
3. Documentation: VIS & VAERS
Question 3.7:
Review the provider’s Vaccine Information Statements (VISs) and discuss provider’s VAERS process to
answer the questions below.
A
Does the provider have readily available, up-to-date VISs for all ACIP-recommended
vaccines relevant to the populations it serves?
Yes
No [X]
B
Does the provider make a VIS available for patients/parents before each
vaccination?
Yes
No [X]
C
Does the provider know how and when to report clinically significant adverse
events using VAERS?
Yes
No [X]
Review CDC Requirement:
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and
maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA), which includes reporting clinically
significant adverse events to the Vaccine Adverse Event Reporting System (VAERS). For a list of current VISs, visit CDC’s Vaccine
Information Statements (http://www.cdc.gov/vaccines/hcp/vis/) website.
Actions if Non-Compliant:
Root Cause:
Human Causes [Related to specific person]
Select one root cause
Personal beliefs/opinions
and explain in the
Does not understand rationale
space provided.
of requirement
Lack of concern for compliance
Organizational Causes [Related to organization as a whole]
Competing job assignments/workload
Lack of (or insufficient) staff to perform required duties
Budget limitations (for purchase of required equipment)
Lack of (or insufficient) training of staff
Lack of (or insufficient) processes/protocols
Explain:
Immediate Action:
Question A, B: Provide missing VIS by showing provider the online repository on CDC’s Vaccine
Information Statements (http://www.cdc.gov/vaccines/hcp/vis/) website or leaving a hard copy.
Question C: Educate provider on how to report adverse events using the VAERS form or online process.
Supply hard copy of the form or refer provider to the VAERS: Report an Adverse Event
(https://vaers.hhs.gov/esub/index) page.
Notes:
3. Documentation: Anaphylaxis protocol
Question 3.8:
Answers:
(Choose one)
Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit?
Yes
No [X]
Review CDC Requirement:
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered.
Immediate Action:
Educate the provider about the requirement for an anaphylaxis protocol.
Future Follow-up:
Provider to submit in no later than one month: Complete anaphylaxis protocol.
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 14 of 31
NOTE: The sections that follow require reviewers to validate responses by looking at vaccine storage units, temperature
monitoring equipment, and the vaccine inventory inside a unit.
• For section 4, use a separate Storage & Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet).
• When an unmet requirement is identified, return to this questionnaire to complete the “Actions if Non-compliant” section for
that question.
• After you complete one answer sheet for each unit, return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units. The questions in sections 5 and 6 (Storage & Handling Site-Wide and Inventory) are not
unit-specific but do require that the response be based on a thorough assessment of all the providers’ units.
4. Storage & Handling Per Unit
Description
On the Storage & Handling Per Unit Answer Sheet, place a name that will allow you or someone else from
your program to easily identify this unit in the event of follow-up. We recommend using Brand + Location
(example: Samsung - Room 123).
▪ Save each Storage & Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example: Samsung.Room123.doc).
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 15 of 31
4. Storage & Handling Per Unit: Storage Unit Build & Use
Question 4.1:
Note to Reviewer:
Below, select the build and use of the vaccine storage unit you are assessing.
Dorm-style units: Do not add dorm-style units here. Dorm-style units will be addressed in section 5.
Units storing only private stock: You must review these storage units even if they contain only private stock
at the time of the visit because that vaccine could be administered to VFC patients.
A
What type of unit is this?
A. Stand-alone
B. Combination
B
Select use if stand-alone:
A. Freezer
B. Refrigerator
Select use if combination:
A. Use both sections to store vaccine
B. Use freezer section only to store vaccine
C. Use refrigerator section only to store vaccine
4. Storage & Handling Per Unit: CDC-Recommended Storage Units
Question 4.2:
Below, document the grade of the vaccine storage unit you are assessing.
Note to Reviewer:
Pharmaceutical: Also called “purpose-built,” these units are designed by the manufacturer specifically to
store vaccines or other biological materials.
Commercial: Although usually intended to store food and beverages, commercial units are often larger and
more powerful than the household units found in most homes. Though these units are intended to meet the
higher demands of larger facilities, these units are not specifically built for the storage of biological
materials.
Household (non-commercial/domestic): These units are usually smaller than commercial units and are
intended for use in small offices and in homes – typically for food storage. However, just like commercial
units, they are not designed specifically for the storage of biological materials. Such units are usually
available in common home supply stores.
Answers:
(Choose one)
Select grade: A. Pharmaceutical
[O] CDC does not recommend the use of both sections, or the
B. Commercial/Household freezer section only, of combination commercial/household units.
Review CDC Recommendation:
CDC recommends the following vaccine storage unit types (in order of preference): pharmaceutical grade stand-alone or
combination units (preferred); household/commercial stand-alone units; household/commercial combination units using the
refrigerator section only.
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 16 of 31
4. Storage & Handling Per Unit: Temperature Monitoring Device in the Unit
Question 4.3:
Determine whether there is a temperature monitoring device in this section of the storage unit and
answer the questions.
A
Is there a temperature monitoring device in this section of the Yes
storage unit?
No [X] (If no, skip to question 4.7)
B
Who is responsible for supplying the temperature monitoring
device in this section of the storage unit?
Provider
Review CDC Requirement:
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperatures
accurately. All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificate
of calibration testing. All certificates must contain: model/device name or number, serial number, date of calibration testing (report
or issue date), and Instrument Passed testing/Instrument in Tolerance. (Recommended uncertainty = +/-0.5º C (+/-1º F)).
Actions if Non-Compliant:
Root Cause:
Human Causes [Related to specific person]
Select one root cause
Personal beliefs/opinions
and explain in the
Does not understand rationale
space provided.
of requirement
Lack of concern for compliance
Organizational Causes [Related to organization as a whole]
Competing job assignments/workload
Lack of (or insufficient) staff to perform required duties
Budget limitations (for purchase of required equipment)
Lack of (or insufficient) training of staff
Lack of (or insufficient) processes/protocols
Explain:
Immediate Action:
Call MDH at 651-201-5522 to discuss situation with MnVFC staff.
Future Follow-up:
Provider to submit in no later than one month: (1) Receipt of purchase of a new temperature monitoring
device, (2) a copy of the certificate of calibration testing, and (3) one week of complete temperature
documentation using the new temperature monitoring device.
Reviewer within one week: If the provider lost storage space due to the absence of a temperature
monitoring device, discuss with the Immunization Program whether there is a need to adjust vaccine
order quantities for this provider until the provider is able to validate that they have sufficient space for
vaccine storage.
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 17 of 31
4. Storage & Handling Per Unit: CDC-Recommended Temperature Monitoring Device
Question 4.4:
Assess the temperature monitoring device in this section of the storage unit to answer the questions
below.
A
Is the temperature monitoring device a continuous monitoring and recording
device (e.g., data logger)?
Yes
No [O] (Skip D)
B
Does the temperature monitoring device have a probe in buffered material?
Yes
No [O]
C
Does the temperature monitoring device have a digital display that can be
easily read from the outside of this unit?
Yes
No [O]
D
Is data downloaded and reviewed routinely?
Yes
No [O]
Review CDC Recommendation:
As of Jan. 1, 2018, all VFC providers must use continuous temperature monitoring devices (e.g., data loggers) to monitor vaccines
that will be administered to VFC-eligible children. Routine review and accessibility of temperature data is critical for determining
whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion. To
meet VFC Program requirements the device must also be equipped with:
• A temperature probe
• An active temperature display that can be easily read from the outside of the unit
• The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices:
• Alarm for out-of-range temperatures
• Current, minimum, and maximum temperatures display
• Low battery indicator
• Accuracy of +/- 1°F (0.5°C)
• Memory storage of at least 4,000 readings
• User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes
• Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 18 of 31
4. Storage & Handling Per Unit: Certificate of Calibration Testing
Question 4.5:
Review the certificate of calibration testing for the temperature monitoring device in this section of the
storage unit and answer the questions below.
Note to Reviewer:
• How to determine certificate of calibration testing expiration date:
1) Identify the certificate issue/calibration date.
2) Apply the Immunization Program-required frequency for calibration testing. Example: If the
issue/calibration date is 12/31/2013 and Immunization Program policy requires testing every two
years, the expiration date is 12/31/2015.
• Certificates must include all of the below:
• Model/Device Name or Number
• Serial Number
• Date of Calibration Testing (Report or Issue Date)
• Instrument Passed testing (Instrument in Tolerance)
A
Is there a certificate of calibration testing for the temperature monitoring Yes
device in this section of the storage unit?
No [X]
B
What is the date of calibration for the temperature monitoring device in
this section of the storage unit?
C
What is the certificate’s date of expiration based on Immunization
Program policy? (See note to reviewer to determine expiration date.)
[X] Follow-up is required if
certificate is expired
D
Does the certificate contain all the necessary items listed in the Note to
Reviewer?
Yes
No [X]
E
Who is responsible for supplying the current and valid certificate of
calibration for this temperature monitoring device?
Provider
Review CDC Requirement:
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperatures
accurately. All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificate
of calibration testing. All certificates must contain: model/device name or number, serial number, date of calibration testing (report
or issue date), and Instrument Passed testing/Instrument in Tolerance. (Recommended uncertainty = +/-0.5º C (+/-1º F)).
Actions if Non-Compliant:
Root Cause:
Human Causes [Related to specific person]
Select one root cause
Personal beliefs/opinions
and explain in the
Does not understand rationale
space provided.
of requirement
Lack of concern for compliance
Organizational Causes [Related to organization as a whole]
Competing job assignments/workload
Lack of (or insufficient) staff to perform required duties
Budget limitations (for purchase of required equipment)
Lack of (or insufficient) training of staff
Lack of (or insufficient) processes/protocols
Explain:
Immediate Action:
Discuss with the provider how to establish a clear process and specific timelines for ensuring that a
temperature monitoring device either undergoes calibration testing or is replaced with a new
temperature monitoring device before the certificate of calibration testing expires.
Future Follow-up:
Provider to submit in no later than one month: A copy of the current and valid certificate of calibration
testing for the temperature monitoring device in this section of the storage unit.
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 19 of 31
4. Storage & Handling Per Unit: Probe Placement
Question 4.6:
Note to Reviewer:
Answers:
(Choose one)
Is the probe properly placed in this section of the storage unit?
“Properly” means that the probe in a commercial or household unit is placed in a central area of the unit
directly with the vaccines. Probes should not be placed in the doors, near or against the walls, close to
vents, or on the floor of the unit. The only allowable exemption related to this requirement is for providers
who have pharmaceutical storage units (built for vaccine storage) that have either: (1) a built-in
temperature monitoring device, OR (2) a dedicated port for the probe that dictates the placement of the
probe.
Yes
No [X]
Review CDC Requirement:
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measure
vaccine temperature. The probe should not be placed in the door, near or against the walls, close to vents, or on the floor of the
unit. For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in the
center of the section of the storage unit, consult your Immunization Program for guidance on placement.
Actions if Non-Compliant:
Root Cause:
Human Causes [Related to specific person]
Select one root cause
Personal beliefs/opinions
and explain in the
Does not understand rationale
space provided.
of requirement
Lack of concern for compliance
Organizational Causes [Related to organization as a whole]
Competing job assignments/workload
Lack of (or insufficient) staff to perform required duties
Budget limitations (for purchase of required equipment)
Lack of (or insufficient) training of staff
Lack of (or insufficient) processes/protocols
Explain:
Immediate Action:
Assist the provider with proper placement of the probe.
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 20 of 31
4. Storage & Handling Per Unit: Temperature Documentation
Question 4.7:
Review the temperature documentation over the past three months for this section of the storage unit to
determine whether the provider has a process in place for properly documenting temperatures twice a
day. Answer the questions below.
A
Are there two temperature readings recorded for this section of the storage Yes
unit per day?
No [X]
B
Is there a time, date, and name (or initials) recorded for each reading?
Yes
No [X]
C
What is the current temperature and min/max temperatures (if available) in
this section of the storage unit?
*Use the reviewer’s thermometer if the provider’s temperature monitoring
device does not have a current, valid certificate of calibration testing, or the
probe is not properly placed in this section of the storage unit.
Current Temperature
Minimum Temperature
Maximum Temperature
Fahrenheit
Celsius
D
Based on your review of the provider’s recent temperature documentation, Yes
including the current temperature, is this section of the storage unit
No [X]
maintaining appropriate temperatures?
Not enough information [X]
Review CDC Requirement:
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times. Acceptable temperature
ranges vary by vaccine type and the range is 36° F and 46° F (2° C and 8° C) and for frozen vaccines the range is -58° F and +5° F (50° C and -15° C). Exposure to temperatures outside of those included in the package inserts could affect vaccine viability and,
ultimately, could leave children unprotected against vaccine-preventable diseases. In order to maintain awareness of storage unit
temperatures and ensure that vaccines are being stored at appropriate temperatures at all times, VFC providers are required to
monitor and document temperatures for all vaccine storage units at least twice a day. Temperature documentation must contain:
(1) at least two temperature readings per day, (2) the time and date of each reading and (3) the name (or initials) of the person
who assessed and recorded the readings. CDC also recommends that VFC providers record the minimum and maximum
temperatures of each unit once each workday (preferably in the morning).
Actions if Non-Compliant:
Root Cause:
Human Causes [Related to specific person]
Select one root cause
Personal beliefs/opinions
and explain in the
Does not understand rationale
space provided.
of requirement
Lack of concern for compliance
Organizational Causes [Related to organization as a whole]
Competing job assignments/workload
Lack of (or insufficient) staff to perform required duties
Budget limitations (for purchase of required equipment)
Lack of (or insufficient) training of staff
Lack of (or insufficient) processes/protocols
Explain:
Immediate Action:
Question A-B: Offer guidance on proper documentation and provide paper log template if needed.
Question D: The vaccine must be moved to a section of a storage unit that: (1) maintains appropriate
temperatures; (2) has space available; AND (3) contains a temperature monitoring device with a current,
valid certificate of calibration testing. Follow Immunization Program protocol for investigating
temperature excursions and contact manufacturer to obtain documentation supporting the usability of
the vaccine. Suspend use of the section of the storage unit for vaccine storage until the provider can
demonstrate that it maintains appropriate temperatures.
Future Follow-up:
Provider to submit in no later than one month: Complete temperature documentation for this section of
the storage unit for three weeks since the Compliance Visit. Do not resume use of the unit for storing
public vaccine until receiving clearance to do so by the Immunization Program.
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 21 of 31
4. Storage & Handling Per Unit: Temperature Excursions
Question 4.8:
In the event that a temperature excursion(s) occurred in this unit within the last three months, request
and review documentation of actions taken to determine whether the provider has a process for properly
addressing excursions. Answer the questions below.
A
Were vaccines in this unit exposed to out-of-range temperatures in the last Yes
three months (including today)?
No (If no, skip to question 4.9)
B
Did the provider quarantine and label vaccines as “Do not use”?
C
Did the provider place vaccine in a unit where it can be stored under proper Yes
conditions, if applicable?
No [X]
D
Did the provider contact the Immunization Program to report the
excursion?
Yes
No [X]
E
Was the manufacturer contacted for documentation supporting the
usability of the vaccine?
Yes
No [X]
Yes
No [X]
Review CDC Requirement:
The provider must document all excursions and actions taken including the following: (1) Quarantine and label vaccines as “DO NOT
USE”; (2) Place vaccines in a unit where they can be stored under proper conditions; (3) Contact the Immunization Program to
report an excursion; and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine.
Actions if Non-Compliant:
Root Cause:
Human Causes [Related to specific person]
Select one root cause
Personal beliefs/opinions
and explain in the
Does not understand rationale
space provided.
of requirement
Lack of concern for compliance
Organizational Causes [Related to organization as a whole]
Competing job assignments/workload
Lack of (or insufficient) staff to perform required duties
Budget limitations (for purchase of required equipment)
Lack of (or insufficient) training of staff
Lack of (or insufficient) processes/protocols
Explain:
Immediate Action:
Label vaccines as “DO NOT USE.” Follow Immunization Program protocol for investigating temperature
excursions and contact manufacturer to obtain documentation supporting the usability of the vaccine.
Add custom follow-up as necessary based on the results of root cause analysis and actions taken on site.
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 22 of 31
4. Storage & Handling Per Unit: Vaccine Placement
Question 4.9:
Look inside the unit to answer the questions below.
A
Are vaccines placed in the middle of the unit with space between vaccines
and the side/back of the unit to allow cold air to circulate?
Yes
No [O]
B
Are vaccines stored in their original packages?
Yes
No [O]
C
Are there water bottles (for refrigerators) or frozen water bottles (for
freezers) in the unit?
Yes
No [O]
N/A: Confirmed it’s not
recommended by
manufacturer
D
Are vaccines stored in the doors, vegetable bins, under or near cooling
vents, or on the floor of the unit?
Yes [O]
No
E
Is food being stored in the unit?
Yes [O]
No
Review CDC Recommendation:
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging. They should be placed in the
middle of the unit, with space between the vaccines and the side/back of the unit to allow cold air to circulate. Vaccines SHOULD
NOT be stored in the doors, vegetable bins, or floor of the unit or under or near cooling vents and there should not be any food in
the unit. Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit in
order to: (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placement
of vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors, vegetable bins, floor, or
near/under cooling vents).
Immediate Action:
Assist provider with properly arranging vaccines in the unit.
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 23 of 31
4. Storage & Handling Per Unit: Disconnection from Power Source
Question 4.10:
Note to Reviewer:
Answers:
(Choose all that
apply)
Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are not
accidentally physically disconnected from the power supply. Which of the following describes the
measure(s) taken on this unit?
• Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuit
breakers. In such cases, verify that the practice has a comprehensive policy and standard operating
procedures in place to prevent the vaccine storage unit from being physically disconnected from the
power supply.
• While back-up generators may ensure power to the overall facility, this question ONLY addresses the
vaccine storage unit being accidentally disconnected from the power source either through the plug or
the circuit breaker.
A. “Do not disconnect” labels on the plug.
B. “Warning” label on the circuit breaker box.
C. Hard-wired (i.e. built-in) and has a “Do not disconnect” label on the
circuit breaker box.
[X] The response is
D. Hospital or large health care system with a comprehensive written policy non-compliant if only A, only
and standard operating procedures detailing measures taken to prevent
B, or E is selected.
vaccine storage units from being accidentally disconnected from the power
supply.
E. No acceptable measures for preventing accidental disconnection from
power supply. [X]
Review CDC Requirement:
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warning
labels on both the plug and the circuit breaker associated with all vaccine storage units. Large hospitals and healthcare systems can
meet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to prevent
vaccine storage units from being physically disconnected from the power supply.
Actions if Non-Compliant:
Root Cause:
Human Causes [Related to specific person]
Select one root cause
Personal beliefs/opinions
and explain in the
Does not understand rationale
space provided.
of requirement
Lack of concern for compliance
Organizational Causes [Related to organization as a whole]
Competing job assignments/workload
Lack of (or insufficient) staff to perform required duties
Budget limitations (for purchase of required equipment)
Lack of (or insufficient) training of staff
Lack of (or insufficient) processes/protocols
Explain:
Immediate Action:
Provide stickers or signs to place on electrical outlets and/or circuit breakers, as applicable.
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 24 of 31
5. Storage & Handling Site-Wide: Discussion of Cost & Quantity of Vaccine
Question 5.1:
Note to Reviewer:
Answer:
Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for
annually. Address the points listed in the note to reviewer below.
• Vaccine Shipped (Required): Share the cost of VFC vaccines shipped to the provider in the last calendar
year to make sure the provider understands the contribution made by the VFC Program to their practice.
For new providers who do not have “calendar year” data, share either the actual cost of their current
inventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately
$7,000) to help estimate their annual cost.
• Storage & Handling (Required): Make sure the provider understands the cost of vaccines for which they
are responsible when they make decisions about purchasing recommended vaccine storage and
temperature monitoring equipment.
I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar
year.
5. Storage & Handling Site-Wide: Dorm-Style Units
Question 5.2:
Note to Reviewer:
Determine whether the provider has any dorm-style units on site and answer the questions below.
A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a single
exterior door. Dorm-style units also have an evaporator plate (cooling coil), which is usually located inside
an icemaker compartment (freezer) within the refrigerator.
A
Does the provider have any dorm-style units that are used at any time to
store vaccines?
Yes [X]
No (Skip to question 5.3)
B
Does the provider have sufficient space in existing compliant vaccine
storage units to store all vaccines without use of the dorm-style unit at
any time?
Yes
No [X]
Review CDC Requirement:
Dorm- and bar-style units are prohibited for vaccine storage. Vaccines stored in dorm-style units are considered non-viable and
must be returned to the centralized distributor. CDC recommends the following vaccine storage unit types (in order of preference):
pharmaceutical grade stand-alone or combination units (preferred); household/commercial stand-alone units;
household/commercial combination units using the refrigerator section only.
Actions if Non-Compliant:
Root Cause:
Human Causes [Related to specific person]
Select one root cause
Personal beliefs/opinions
and explain in the
Does not understand rationale
space provided.
of requirement
Lack of concern for compliance
Organizational Causes [Related to organization as a whole]
Competing job assignments/workload
Lack of (or insufficient) staff to perform required duties
Budget limitations (for purchase of required equipment)
Lack of (or insufficient) training of staff
Lack of (or insufficient) processes/protocols
Explain:
Immediate Action:
Question A: Quarantine and label vaccine “DO NOT USE.” Follow Immunization Program protocol for
returning vaccines to the centralized distributor.
Future Follow-up:
Question B: Provider to submit in no later than one month: Documentation certifying that you have
acquired additional vaccine storage that complies with all program requirements. Submit one week of
complete temperature documentation for the unit(s) that will be used to replace the dorm-style unit.
Question B: Reviewer within one week: Notify the Immunization Program to adjust vaccine order
quantities for this provider until the provider is able to validate that they have sufficient space for vaccine
storage.
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 25 of 31
5. Storage & Handling Site-Wide: Storage Unit Space Availability
Question 5.3:
Answers:
(Choose one)
Does the provider have sufficient room across storage units to store current stock as well as any
additional stock acquired during peak season without overcrowding?
Yes
No [X]
Review CDC Requirement:
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding.
Actions if Non-Compliant:
Root Cause:
Human Causes [Related to specific person]
Select one root cause
Personal beliefs/opinions
and explain in the
Does not understand rationale
space provided.
of requirement
Lack of concern for compliance
Organizational Causes [Related to organization as a whole]
Competing job assignments/workload
Lack of (or insufficient) staff to perform required duties
Budget limitations (for purchase of required equipment)
Lack of (or insufficient) training of staff
Lack of (or insufficient) processes/protocols
Explain:
Immediate Action:
If a specific unit does not have sufficient storage space, a portion of the vaccine must be moved to a unit
that: (1) maintains appropriate temperature; (2) has space available; and (3) contains a temperature
monitoring device with a current, valid certificate of calibration testing. If necessary, vaccines can be
stored off-site in accordance with the provider’s Emergency Vaccine Management Plan.
Discuss possibility of ordering a new storage unit to accommodate stock throughout the year.
Future Follow-up:
Provider to submit in no later than one month: Documentation certifying that your office has sufficient
storage space (without overcrowding) to support your patient population. Examples of possible
documentation include changes in ordering amounts or frequency or proof of purchase of new unit.
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 26 of 31
5. Storage & Handling Site-Wide: Expired Vaccines
Question 5.4:
Answers:
(Choose one)
Look in each unit: Are there expired vaccines in any of the vaccine storage units at this site?
Yes [X]
No
Review CDC Requirement:
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorterdated vaccines. If vaccines expire, they can no longer be stored in the same storage unit with viable vaccines. They must be placed
in a container or bag clearly labeled “Do not use” and separated from viable vaccines to prevent inadvertent use. Expired vaccine
must be returned to the centralized distributor within six months of expiration.
Actions if Non-Compliant:
Root Cause:
Human Causes [Related to specific person]
Select one root cause
Personal beliefs/opinions
and explain in the
Does not understand rationale
space provided.
of requirement
Lack of concern for compliance
Organizational Causes [Related to organization as a whole]
Competing job assignments/workload
Lack of (or insufficient) staff to perform required duties
Budget limitations (for purchase of required equipment)
Lack of (or insufficient) training of staff
Lack of (or insufficient) processes/protocols
Explain:
Immediate Action:
Bag, label, and remove expired vaccine from the unit and follow Immunization Program protocol for
returning vaccines to the centralized distributor. Contact MDH at 651-201-5522 for guidance.
Educate the provider on how to properly rotate stock to prevent vaccines from expiring.
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 27 of 31
5. Storage & Handling Site-Wide: Back-up Thermometer
Question 5.5:
Note to Reviewer:
Answers:
(Choose one)
Does the provider have a readily available back-up thermometer with a current and valid certificate of
calibration testing?
“Readily available” means that the thermometer is available to perform twice-a-day monitoring for a unit as
required. CDC recommends that the back-up thermometer be maintained on site.
Yes
No [X]
Review CDC Requirement:
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing. To
prevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time, the date of
calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue
date) of the primary thermometer.
As of Jan. 1, 2018, all devices in use including back-up devices must be a continuous monitoring and recording device that meets
VFC program requirements.
Actions if Non-Compliant:
Root Cause:
Human Causes [Related to specific person]
Select one root cause
Personal beliefs/opinions
and explain in the
Does not understand rationale
space provided.
of requirement
Lack of concern for compliance
Organizational Causes [Related to organization as a whole]
Competing job assignments/workload
Lack of (or insufficient) staff to perform required duties
Budget limitations (for purchase of required equipment)
Lack of (or insufficient) training of staff
Lack of (or insufficient) processes/protocols
Explain:
Future Follow-up:
Provider to submit in no later than one month: Either: (1) proof of purchase of a back-up thermometer
and a copy of the current and valid certificate of calibration testing (preferable) OR (2) a clear plan for
how to obtain a back-up thermometer when needed in order to meet the twice-a-day monitoring
requirement.
Notes:
5. Storage & Handling Site-Wide: Preparation of Vaccine
Question 5.6:
Note to Reviewer:
Answers:
(Choose all that
apply)
When does this provider prepare vaccine for administration to the patient?
For mass vaccination clinics, if one type of vaccine is offered, providers may pre-draw up to 10 doses. If
using pre-filled syringes, pre-drawing also means activating the syringe by removing the needle guard or
attaching a needle.
Prepare dose immediately before administration
Pre-draw doses for upcoming patients (in a regular clinic/practice) [O]
Pre-draw up to 10 doses (in a mass-vaccination clinic)
Pre-draw more than 10 doses (in a mass-vaccination clinic) [O]
Other:
[O]
Review CDC Recommendation:
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccine
wastage. Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required range,
which can affect vaccine viability and, ultimately, can leave children unprotected against vaccine-preventable diseases.
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 28 of 31
6. Inventory: Inventory Comparison
Question 6.1:
Visually inspect storage units to determine if existing supply of vaccines proportionately mirrors
populations served. Choose the most accurate statement below.
Note to Reviewer:
• CDC recommends that providers maintain a four-week supply of inventory.
• For this question, do not take into account vaccine types that the provider does not order. Here simply
make sure that, overall, the vaccines in the provider’s storage units are available in sufficient amounts to
serve their patient population.
Answers:
(Choose one)
The current vaccine inventory proportionately reflects the populations identified.
Only public stock is insufficient [X]
Only private stock is insufficient [X]
Both public and private stock are insufficient [X]
Site uses the replacement method but does not appear to have enough vaccine for their population [X]
Other:
[X]
Review CDC Requirement:
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missed
vaccination opportunities. Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligible
patients and vice versa.
Actions if Non-Compliant:
Root Cause:
Human Causes [Related to specific person]
Select one root cause
Personal beliefs/opinions
and explain in the
Does not understand rationale
space provided.
of requirement
Lack of concern for compliance
Organizational Causes [Related to organization as a whole]
Competing job assignments/workload
Lack of (or insufficient) staff to perform required duties
Budget limitations (for purchase of required equipment)
Lack of (or insufficient) training of staff
Lack of (or insufficient) processes/protocols
Explain:
Immediate Action:
Discuss with the provider alternatives for resolving the stock shortage and maintaining proper inventory.
Determine whether the provider should adjust ordering.
Future Follow-up:
Provider to submit in no later than two weeks: Documentation verifying that there is sufficient public and
private inventory (as applicable).
Reviewer must, no later than one week, notify the Immunization Program to monitor provider orders to
ensure that they have sufficient public stock.
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 29 of 31
6. Inventory: ACIP-Recommended Vaccines
Question 6.2:
Review provider’s current inventory to answer the questions below.
A
Does the provider offer all routine ACIP-recommended
vaccines for their patient population?
Yes (Skip to question C)
No [X]
Offers all except varicella because direct ship of
vaccine is unavailable from manufacturer
B
Which routine vaccines are NOT being offered?
DTaP
Hepatitis A
Hepatitis B
HIB
HPV
Influenza
Meningococcal
C
According to Immunization Program Policy, does the
provider make accessible all non-routine ACIPrecommended vaccines for those VFC patients who
meet the criteria for receiving them?
D
Which non-routine vaccines are NOT being offered?
MMR
Pneumococcal
Polio
Rotavirus
Tdap/Td
Varicella
Yes (Skip to question 6.3)
No [X]
Pneumococcal polysaccharide vaccine (PPSV23)
Meningococcal Group B (MenB)
Other:
Review CDC Requirement:
VFC providers agree to comply with immunization schedules, dosages, and contraindications that are established by the Advisory
Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS:
• In the VFC provider's medical judgment, and in accordance with accepted medical practice, the VFC provider deems such
compliance to be medically inappropriate for the child;
• The particular requirements contradict state law, including laws pertaining to religious and other exemptions.
The VFC program entitles children to the following vaccines: DTaP, Hepatitis A, Hepatitis B, HIB, HPV, Influenza, Meningococcal,
MMR, Pneumococcal, Polio, Rotavirus, Tdap/Td and Varicella. VFC providers are also required to ensure that VFC-eligible children
have access to non-routine vaccines as needed.
Actions if Non-Compliant:
Root Cause:
Human Causes [Related to specific person]
Select one root cause
Personal beliefs/opinions
and explain in the
Does not understand rationale
space provided.
of requirement
Lack of concern for compliance
Organizational Causes [Related to organization as a whole]
Competing job assignments/workload
Lack of (or insufficient) staff to perform required duties
Budget limitations (for purchase of required equipment)
Lack of (or insufficient) training of staff
Lack of (or insufficient) processes/protocols
Explain:
Immediate Action:
Provide educational materials and resources on vaccines not currently being offered.
Question C: Discuss with the provider making non-routine vaccines available for VFC children by either
maintaining stock on site or having a protocol in place for ensuring access based on program policies.
Based on this discussion, add custom follow-up either to review provider orders to ensure vaccine has
been ordered OR for provider to submit protocols.
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 30 of 31
6. Inventory: Separation of Stock
Question 6.3:
Observe how the provider differentiates stock in each storage unit to answer the questions below.
A
Is it clear which vaccines belong to public stock and
which belong to private stock?
Yes
No [X]
Not applicable, replacement site
B
Is it clear which vaccines belong to VFC stock and
which belong to UUAV stock?
Yes
No [X]
Not applicable, replacement site
Not applicable, not UUAV-enrolled site
Review CDC Requirement:
In order to ensure that VFC vaccines are only administered to VFC-eligible children, VFC providers that serve both VFC and non-VFCeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from private
stock as well as VFC from other public stock.
Actions if Non-Compliant:
Root Cause:
Human Causes [Related to specific person]
Select one root cause
Personal beliefs/opinions
and explain in the
Does not understand rationale
space provided.
of requirement
Lack of concern for compliance
Organizational Causes [Related to organization as a whole]
Competing job assignments/workload
Lack of (or insufficient) staff to perform required duties
Budget limitations (for purchase of required equipment)
Lack of (or insufficient) training of staff
Lack of (or insufficient) processes/protocols
Explain:
Future Follow-up:
Six months: Conduct a follow-up site visit to assess whether the provider can differentiate public stock
from private stock and/or VFC stock from other public stock (if applicable).
Notes:
2017 MnVFC Site Visit Questionnaire
(February 2017) Page 31 of 31