2017 IPI Advisor Manual
A Guide to MnVFC Site Visits
MINNESOTA VACCINES FOR CHILDREN PROGRAM
Table of Contents
Introduction ............................................................................................................3
Welcome to the Immunization Practice Improvement (IPI) Program!
Helpful Definitions
Contact Information
Chapter 1: The Immunization Practices Improvement Program................................5
Vaccines for Children Program
Requirements to Participate in the MnVFC Program
Chapter 2: IPI Advisors.............................................................................................7
Your Role as an IPI Advisor
New IPI Advisor Training Requirements
Your MnVFC Clinical Coordinator/Planner
Types of Visits Reimbursement for MnVFC Visits
Reasons MDH Would Do All or Part of a Visit
Chapter 3: Site Visits..............................................................................................11
Scheduling the Visit
Site Visit Checklist
Information for the Visit
Preparing for the Visit
Conducting the Visit
Future follow-up
Chapter 4: The 2017 MnVFC Site Visit Paperwork ..................................................17
Required Paperwork for Site Visits
MnVFC Site Visit Questionnaire
The Site Visit Reviewer Legend
Section 1: Provider Details
Section 2. Eligibility
Section 3: Documentation
Section 4: Storage & Handling Per Unit
Section 5: Storage & Handling Site-Wide
Section 6: Inventory
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
MnVFC Provider Follow-up Plan
After the Site Visit
Chapter 5: IPI Advisor Resource List.......................................................................52
Introduction
Welcome to the Immunization Practice Improvement (IPI) Program!
IPI is a component of the immunization program at the Minnesota Department of Health. IPI merges
key aspects of the overall immunization program at the provider level: vaccine management, vaccine
accountability, and clinical immunization practices.
As an IPI advisor you will be conducting visits to sites that provide vaccines to children through the
Minnesota Vaccines for Children (MnVFC) program.
This manual, along with the appropriate MnVFC Policies and Procedures Manual for the type of site you
are visiting, will provide you with the information that you need to complete these visits.
The most up to date version of this manual is available on the IPI Program Resources (www.health.
state.mn.us/divs/idepc/immunize/ipi/resources.html) website. Changes and additions will be included
as they occur.
By performing site visits, you help ensure that children in Minnesota receive safe, viable immunizations
and are protected from vaccine-preventable diseases. Thank you!
Helpful Definitions
Sites: In this manual, all organizations that administer vaccine to MnVFC-eligible children and/or store
vaccine for MnVFC-eligible children will be referred to as sites.
Separate stock: Method of vaccine management where sites keep privately-purchased vaccine in a
separate stock from MnVFC vaccine obtained through MDH. Patients eligible for MnVFC must receive
vaccine from the MnVFC stock.
Replacement method: Method of vaccine management where sites use privately-purchased vaccine
to vaccinate MnVFC-eligible children and then the MnVFC program replaces the private vaccine that
was administered. Only sites with grandfathered status and who have a signed replacement method
agreement are allowed to use the replacement method.
Parent site: A parent site is a location where vaccine is ordered and delivered to be redistributed
to satellite sites. It is based on how the system is set up for ordering vaccine in the MnVFC ordering
software. This may or may not be how the site is structured as an organization. The parent site orders
all the vaccines for the other sites except for varicella-containing vaccines. Varicella-containing vaccine
must be delivered directly to the site where it will be used. The parent site is responsible for the MnVFC
Annual Report for itself and all of its satellite sites.
Satellite site: A satellite site is a site that receives redistributed vaccine from a parent site. All satellite
sites need to have an enrollment visit and a PIN number to receive MnVFC vaccine from the parent
site. Sites that are considered a satellite of another site usually have a letter at the end of the PIN to
indicate that they are a satellite. All vaccines, except varicella-containing vaccines, are ordered by the
parent site for the satellite site. Varicella-containing vaccines are ordered using the satellite PIN and are
delivered directly to the satellite site. Sites must sign a separate provider agreement for each satellite
site that stores MnVFC vaccine.
IPI Advisor Manual | February 2017
Page 3 Introduction cont. Federally Qualified Health Center (FQHC): A site that is located in an area of need of services. Sites
apply to receive this federal designation. They offer a sliding scale for patients that are uninsured.
Rural Health Center (RHC): A site that is located in an underserved rural area. They apply to receive this
federal designation.
Local Public Health (LPH): Clinics are deputized in Minnesota to allow vaccination of underinsured
children at their site.
Contact Information
Immunization Practices Improvement (IPI)
Email: [email protected]
Website: www.health.state.mn.us/divs/idepc/immunize/ipi/index.html
Minnesota Vaccine for Children (MnVFC) Program
Phone: 651-201-5522
Website: www.health.state.mn.us/vfc
Minnesota Department of Health
625 N. Robert St. (street address)
P.O. Box 64975 (mailing address)
St. Paul, MN 55164-0975
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Chapter 1
The Immunization Practices Improvement Program
The goal of the Immunization Practices Improvement (IPI) Program is to help ensure that all eligible
children receive viable vaccine at low or no cost.
The Minnesota Department of Health (MDH) contracts with local public health departments to provide
IPI services in their community. IPI advisors from these departments complete site visits at MnVFCenrolled sites in their county. Local public health (LPH) staff often already have a relationship with
primary care providers in their community, and if not, visits may help facilitate building relationships
and sharing information. Visits ensure enrolled sites meet the following objectives:
• Adhere to MnVFC eligibility and programmatic requirements and recommendations.
• Manage vaccines to ensure proper storage and handling and minimize waste.
• Administer and document vaccines according to current immunization guidelines.
Vaccines for Children Program
The Vaccines for Children (VFC) Program is a federal entitlement program which provides vaccines to
children whose parents or guardians may not be able to afford them. This helps ensure that all children
have a better chance of getting their recommended vaccinations on schedule. Vaccines available
through the VFC Program are those recommended by the Advisory Committee on Immunization
Practices (ACIP) (www.cdc.gov/vaccines/acip/index.html). These vaccines protect babies, young
children, and adolescents from 16 diseases.
Funding for the VFC program is approved by the Office of Management and Budget (OMB) and
allocated through the Centers for Medicare & Medicaid Services (CMS) to the Centers for Disease
Control and Prevention (CDC). CDC buys vaccines at a discount and distributes it to grantees (i.e., state
health departments) who then distribute the vaccine at no charge to enrolled sites.
History of the Vaccines for Children Program
From 1989 - 1991, a measles epidemic in the United States resulted in tens of thousands of cases of
measles and hundreds of deaths. Upon investigation, CDC found that more than half of the children
who had measles had not been immunized, even though many of them had seen a health care
provider.
In partial response to that epidemic, Congress passed the Omnibus Budget Reconciliation Act (OBRA)
on Aug. 10, 1993, creating the Vaccines for Children (VFC) Program. VFC became operational Oct. 1,
1994. Known as section 1928 of the Social Security Act, the VFC Program is an entitlement program (a
right granted by law) for eligible children, age 18 and younger.
Minnesota Vaccines for Children Program
The Minnesota Vaccines for Children (MnVFC) program is Minnesota’s version of the federal VFC
program. By collaborating with over 820 sites throughout Minnesota, MnVFC provides vaccines at no
cost to children who may not otherwise be vaccinated because of the inability to pay. Approximately
one-third of Minnesota children are eligible for the MnVFC program. These are children who are 18
years of age or younger and fall into one of the following categories:
IPI Advisor Manual | February 2017
Page 5 The IPI Program
Chapter 1
• Uninsured,
• Enrolled in a Minnesota Health Care Program: Medical Assistance (MA) or MinnesotaCare
• American Indian or Alaskan Native, or
• Underinsured children that are seen at a local health department, Federally Qualified Health Center
(FQHC), or Rural Health Center (RHC), Indian Health Services (IHS), and tribal health clinics.
The majority of pediatric and family practice clinics are enrolled in MnVFC so children can stay with
their health care home and still receive low-cost immunizations.
When Congress enacted the VFC program, they wanted to ensure that:
• Sites manage their VFC vaccine appropriately so that there is little to no wastage of this valuable asset.
• All eligible children receive the vaccine.
• Immunization coverage rates increase by removing barriers to vaccination, especially among high-risk children, and by reducing disparities in access to health care.
• Vaccine is not used for the purpose of gaining profit for the provider or site.
To assure these goals are achieved, all states are required to conduct site visits for each enrolled site at
least every other year. As an IPI advisor, you will be conducting the required MnVFC site visits in your
county.
Minnesota receives approximately $48 million of federally funded vaccine through the MnVFC program
each year. It is extremely important that these vaccines are managed properly and given only to the
individuals that are eligible to receive them.
Requirements to Participate in the MnVFC Program
Initially, providers must go through an enrollment process with MDH to receive vaccine from the
MnVFC program. This requires filling out the enrollment paperwork, meeting the requirements in the
appropriate MnVFC Policies and Procedures Manual, and having an enrollment site visit by MDH staff.
Following enrollment, all sites receive their first MnVFC site visit within one year (preferably in 3-6
months) and then a MnVFC site visit at least every other year. If you know of a provider who is not
enrolled in the program, a new clinic opens, or if a site opens a satellite site in your county, have them
call the MnVFC program at 651-201-5522 to begin the enrollment process.
Sites must meet many requirements to receive vaccine from the MnVFC program. These requirements
are identified in the MnVFC Policies and Procedures Manual. There are two versions of the manual;
one for sites that keep separate stocks of public and private vaccine and another for sites that use the
replacement method of vaccine management. A copy of the appropriate manual is mailed to each
site every fall. The immunization manager, vaccine coordinator, and their back-ups must complete
the annual online training based on the method of vaccine management their site uses. All of the
materials can be found on the MnVFC website (www.health.state.mn.us/vfc). Sites must complete the
appropriate reports, agreements, and online training each year in order to continue to receive vaccine
from the MnVFC program.
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Chapter 2
IPI Advisors
Your Role as an IPI Advisor
As part of an MDH grant agreement with community health boards, MDH contracts with local public
health agencies to conduct MnVFC site visits in their county.
As an IPI advisor, you will be responsible for:
• Attending the annual training provided by MDH.
• Reviewing your county site visit lists and providing any known updates to your MnVFC clinical coordinator/planner.
• Conducting site visits, completing, and submitting paper work within 10 days of the visit.
• Following up with sites for unmet requirements identified at MnVFC site visits.
• Notifying MDH when new sites open that will be storing and administering immunizations (in order
to recruit new providers).
• Keeping up-to-date with new recommendations and requirements for immunizations as well as the
MnVFC program.
▫ Read and be familiar with MnVFC and IPI web pages.
▫ Sign up to receive email alerts for these resources by clicking on the red envelope at the top of
these pages:
◦ MnVFC Announcements (www.health.state.mn.us/divs/idepc/immunize/mnvfc/bfax.html)
◦ Got Your Shots? News newsletter (www.health.state.mn.us/divs/idepc/newsletters/gys/index.
html)
◦ Immunization Practices Improvement Program (www.health.state.mn.us/divs/idepc/
immunize/ipi/index.html)
▫ Be designated as the IPI contact in Workspace (https://oep.health.state.mn.us/workspace) for
your organization. Contact your organization’s Workspace administrator to assign you this role.
Annual training
Every spring MDH provides training for IPI advisors. This training may be in-person or by webinar. All IPI
advisors are required to attend training each year to review site visit paperwork, hear updates on the
MnVFC program, and ask questions about the process.
Clinic lists
Early in the year, MDH will send you a clinic list. Your list will include all sites in your county that are
enrolled in the MnVFC program. The priority column indicates whether the IPI advisor, MDH staff, or
the field epidemiologist should complete the visit. Those sites not due for a visit that year will have the
next year listed. Every active MnVFC site is required to receive a site visit at least every other year. You
can do visits every year if you would like, but this is not required. Please review the list and notify your
MnVFC clinical coordinator/planner about any changes.
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Chapter 2
Included with the list is a one-page information sheet for each site. This contains the site’s demographic
information, vaccine coordinator and immunization manager listed in our records, whether they are a
separate stock or replacement site, and the doses and cost of vaccine they received last year. Confirm
this information with the site and discuss their vaccine quantity and value as part of the questionnaire
during your visit.
All site visits must be completed by Sept. 30, 2017. If you think you will be unable to complete all your
visits by then, you will need to contact your MnVFC clinical coordinator/planner to determine how the
visit will be completed.
New IPI Advisor Training Requirements
New IPI advisors need to contact MDH before performing any MnVFC site visits on their own. A MnVFC
clinical coordinator/planner will help you prepare to perform site visits. They will:
• Guide your training
▫ See the Training Checklist for IPI Advisors on the IPI Program Resources (www.health.state.
mn.us/divs/idepc/immunize/ipi/resources.html) page.
• Have you shadow them or another experienced IPI advisor on one or two site visits.
• Shadow you on a visit or two.
• Complete the training document.
Your MnVFC Clinical Coordinator/Planner
Your MnVFC clinical coordinator/planner is a MDH staff member that will help support you. See who
your clinical coordinator/planner is on IPI Contact Information (www.health.state.mn.us/divs/idepc/
immunize/ipi/contact.html).
The role of the MnVFC clinical coordinator/planner
• Provide assistance to IPI advisors.
• Perform enrollment visits for new sites that will be administering MnVFC vaccine.
• Review MnVFC site visit paperwork for accuracy.
• Conduct MnVFC site visits where necessary.
• Provide additional education or follow-up with sites.
• Provide assistance and guidance regarding MnVFC requirements and recommendations to sites.
• Provide training to IPI advisors and staff at MnVFC-enrolled sites.
• Field storage and handling incident calls.
Types of Visits
MnVFC Site Visit – also known as the Compliance Visit
CDC requires all state immunization programs to conduct site visits to all VFC providers. MnVFC site
visits are required every other year, but sites can be visited on a yearly basis if needed. The site visit
objectives are to:
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IPI Advisor Manual | February 2017
IPI Advisors
Chapter 2
• Complete the MnVFC site visit paperwork found on IPI Advisor Site Visit Materials (www.health.
state.mn.us/divs/idepc/immunize/ipi/svmaterials.html).
• Provide education about MnVFC program requirements and recommendations to site staff.
• Ensure MnVFC program requirements are properly implemented and are being met.
• Provide feedback and, as necessary, execute corrective action.
• Follow-up on identified issues.
• Notify your MnVFC clinical coordinator/planner of issues that are not resolved by the due date.
Follow-Up Visit
In-person follow-up visits will not be necessary for most MnVFC site visits—only those where significant
issues are identified in the original visit. If you are not able to complete part of the initial site visit
because you found a storage and handling incident or you found multiple issues that need to be
addressed, a follow-up visit may be necessary. Please contact the MnVFC clinical coordinator/planner
for approval and guidance for conducting a follow-up site visit.
Educational Visit
Some sites may need more information and education than you can provide during a normal site visit.
This may be on topics related to immunizations, immunization practices or administration, or storage
and handling issues. These visits go beyond the sharing of pamphlets, resources, or information that
is presented at a site visit. Education visits should be conducted with a group and should focus on a
topic that is identified during a site visit or requested by site staff. Regularly scheduled meetings are not
considered educational visits. Educational visits need to be approved prior to the visit by the MnVFC
clinical coordinator/planner in order for you to receive reimbursement from the MnVFC program.
Unscheduled (Unannounced) Storage & Handling Visit
Unscheduled (unannounced) visits are not pre-scheduled with the site. These visits require different
paperwork and focus primarily on the storage and handling portion of a MnVFC site visit. The MnVFC
program is required to visit 5 percent to 10 percent of enrolled sites as unannounced visits each year.
Please discuss any unscheduled visits you would like to do with the MnVFC clinical coordinator/planner.
You should plan to complete all of your regularly scheduled visits before doing any unscheduled visits.
Enrollment Visit
All sites (including satellite clinics) that receive, stock, or supply MnVFC vaccine must have an
enrollment visit that is conducted by MDH staff. As an IPI advisor, you may be asked to attend the
enrollment visit. This is an opportunity for you to start your relationship with the site and help with
follow-up that may be necessary for the site to receive MnVFC vaccine. Newly enrolled sites are
scheduled for their first regular site visit within the first year (preferably within 3 to 6 months), and
then every other year.
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Page 9 IPI Advisors
Chapter 2
Reimbursement for MnVFC Visits
Local public health agencies are paid for the site visits they conduct. MDH will reimburse participating
agencies only after we receive all of the required paperwork. Paperwork submitted with incorrect or
missing information may delay the reimbursement.
IPI program reimbursement is processed on a quarterly basis and is processed in the month following
each quarter, through an electronic transfer of money. Your agency/county IPI advisor contact will
receive an email notification of the reimbursement.
Reimbursement rates are updated annually and available on the Contracts and Reimbursements (www.
health.state.mn.us/divs/idepc/immunize/ipi/contreim.html) page.
2017 MnVFC Site Visit Reimbursement Rates
MnVFC Site Visit ......................................$400
Follow-up Visit.........................................$150
Education Visit.........................................$100
Unscheduled Visit....................................$300
Reasons MDH Would Do All or Part of a Visit
MDH may complete site visits or accompany you on a site visit if:
• The site is new to the MnVFC program (enrollment visit).
• The site has known issues or concerns regarding the MnVFC program, especially if you are having
difficulty resolving these issues.
• The site is refusing a site visit from local public health or you’re having a difficult time scheduling
a visit.
• The site is part of tribal health or Indian Health Services.
• MDH district epidemiologists will perform site visits at local health departments.
• A new IPI advisor needs training from MDH staff.
• Note: MDH district epidemiologists will perform site visits at local health departments.
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Chapter 3
Site Visits
Scheduling the Visit
• Check the information sheet or contact the site to confirm who the contact person is in charge of
the MnVFC program. In general this is the immunization manager or vaccine coordinator. If the
contact is no longer there, ask for the person in charge of the site’s vaccines or the clinic manager.
They can usually direct you to the appropriate person. You may want to follow a suggested phone
script when contacting the site:
Sample Phone Script for Scheduling a Visit
“Hello. My name is _______. I am calling from ________ Health Department. May I speak to
(contact name)? [If not available, determine appropriate person to talk to or a better time to call
back.] I am calling to schedule a MnVFC site visit. This visit will involve a review of immunization
practices at your site. We will look at vaccine administration, storage and handling, screening for
eligibility, and documentation of vaccinations. It usually takes about two hours for a visit depending
on the number of vaccine storage units you have. Is there a day or time of day that works best for
you?
I have a pre-visit worksheet to send to you to help you prepare for the visit. It contains information
about what I will need at the visit, such as temperature logs and immunization documentation
information. Completing this worksheet prior to me arriving will help the visit be more efficient. Is
there any other information that I can send to help you prepare for the visit?
If you have any questions, call me at ________. Thank you for your time and assistance. I look
forward to working with you.”
• Arrange a date and time for the visit.
• Let them know an approximate visit length. Visits are usually around two hours long depending on
the size of the site, the number of vaccine storage units they have, or if they have new staff.
• Request that key staff be present at the visit. This could include the immunization manager, vaccine
coordinator, immunization staff, clinic manager, nurse manager, billing staff, and/or medical director.
• Inform your site contact that you will be sending them an email confirmation along with the MnVFC
Pre-Visit Worksheet.
Site Visit Checklist
Use the Site Visit Checklist on IPI Advisor Site
Visit Materials (www.health.state.mn.us/divs/
idepc/immunize/ipi/svmaterials.html) to make
sure all necessary steps are covered.
MINNESOTA VA C CI N ES FO R CHI LD REN PROGRAM
Site Visit Checklist
Date of visit:
Time:
Site Name:
PIN:
Address:
Contact:
Complete
Phone:
Before the visit
Comments
Review the clinic list. Identify and prioritize which sites you will visit.
Email or call to schedule a date and time for the visit.
▪ Ask for the immunization manager or vaccine coordinator.
Email appointment confirmation, attach Pre-visit Worksheet, and
provide instructions for returning it prior to the visit (sample email on
website).
▪ Include length of the visit and which staff should be present.
Add site visit to Outlook calendar and reserve a car (if needed).
Review temp logs and Pre-visit Worksheet.
Send a reminder email 2-3 days ahead of the visit.
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Page 11 Site Visits
Information for the Visit
Send an appointment reminder email and the MnVFC
Pre-Visit Worksheet to the MnVFC contact. A sample
letter and the MnVFC Pre-Visit Worksheet can be found
on the IPI Advisor Site Visit Materials (www.health.state.
mn.us/divs/idepc/immunize/ipi/svmaterials.html) page.
You can request that the MnVFC Pre-Visit Worksheet and
temperature logs be sent to you prior to the visit for your
review.
Contact the site by phone or email one or two working
days before the scheduled visit to confirm your
appointment. This is also a good time to ask for directions
and parking information if you are not familiar with the
site.
Chapter 3
2017 MnVFC Pre-Visit Worksheet
Site name:
MnVFC PIN:
Address:
Medical director:
Email:
Immunization manager:
Phone:
Vaccine coordinator:
Phone:
Vaccine coordinator back-up:
Email:
Email:
Email:
IPI Site Visit Preparation Checklist
The staff listed have completed the MnVFC online training and printed a certification of completion
Immunization Manager
Vaccine coordinator
Vaccine coordinator back-up
Have a copy of the most recent provider agreement
Check if the above listed staff have changed since the provider agreement was completed
Check all of the vaccines administered at your site, and list the corresponding publication date for each VIS you give to patients.
DTaP _____________
Hepatitis A _____________
Hepatitis B _____________
Hib _____________
HPV _____________
Influenza _____________
MCV4 _____________
MMR _____________
MMR-V _____________
PCV13 _____________
Polio _____________
Rotavirus _____________
Tdap _____________
Varicella _____________
Non-Routine Vaccines:
Men B__________
PPSV23 _____________
Td _____________
Vaccine administration fee charged for MnVFC eligible children is: $
Have a Vaccine Management and Emergency Plan that has been reviewed and dated within the last year
Have the borrowing reports, if applicable, for the last 12 months available at the visit
Have an anaphylaxis protocol that is clearly posted and reviewed annually
Preparing for the Visit
Review the site visit paperwork to familiarize yourself with the questions. For most of the questions
there is a “Note to the reviewer.” These notes give helpful tips about the information you are looking
for when asking this question. It contains the rationale for the question and which resources to provide
to the site to support the rationale. Some sections also require immediate on-site actions—things you
must do while you are at the site and some require future follow up.
• Print copies the of site visit paperwork.
• Site visit forms are available on the IPI Advisor Site Visit Materials (www.health.state.mn.us/divs/
idepc/immunize/ipi/svmaterials.html) page:
▫ 2017 MnVFC Site Visit Questionnaire
▫ 2017 MnVFC Site Visit Storage & Handling per Unit Answer Sheet (print one for each standalone and/or combination storage unit at the site)
▫ 2017 MnVFC Provider Follow-up Plan (print two copies)
• Review any previous site visit paperwork that is available. You should check in with MDH staff after
your visits if the site continues to have the same issues as past visits.
• Also be sure to bring:
▫ Your thermometers.
◦ If the site’s certificate of calibration is expired or the probe is not properly placed, place your
thermometer in the storage unit when you arrive and read the temperature just prior to
reviewing the site visit findings.
▫ The MnVFC folder with additional immunization resources you wish to add (see chapter 5) and
the Vaccine Storage & Handling magnet (to order, email [email protected]).
▫ A copy of the appropriate MnVFC Policies and Procedures Manual found on the MnVFC website
(www.health.state.mn.us/vfc).
▫ Appropriate temperature logs (Celsius or Fahrenheit).
▫ Site information sheet that contains the quantity and value of the vaccine distributed to the
site/system.
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Site Visits
Chapter 3
Conducting the Visit
Education is a large part of the MnVFC site visit. Often approaching this visit as an exchange of
information with the site is more successful than a “regulatory” visit. Putting the staff at ease,
answering their questions, and making a plan to address issues that arise during the visit, is more
helpful than a “pass/fail” attitude. Education will usually consist of providing the rationale for the
requirement, referring to the requirement in the MnVFC Policies and Procedures Manual, and providing
resources to help address the situation. Some questions will require additional follow-up to assure the
site has corrected the issue(s) and is meeting the MnVFC requirement(s). This will be addressed further
in the follow-up section.
Completing the Paperwork
There are three documents that you must complete for the MnVFC site visit:
• 2017 MnVFC Site Visit Questionnaire
• 2017 MnVFC Site Visit Storage & Handling per Unit Answer Sheet (one for each storage unit)
• 2017 MnVFC Provider Follow-up Plan (two copies, or you may ask them to make you a copy of the
completed form for their records)
Answer the questions on the MnVFC Site Visit Questionnaire based on how things are when you arrive
at the site. If they correct the issue during the visit, you will still mark it as an unmet requirement and
document how it was addressed during the visit.
The “Answer” 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 with no marking mean the site meets the CDC requirement.
• 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.
If you marked the box with the [X], which is non-compliant with the CDC requirement, conduct a
root cause analysis to determine the reason for non-compliance. Root cause analysis is an important
component to a successful site visit. It is used to identify the cause of the problem and help to resolve
the issue. There are several possible root causes that can be identified. Choose only one root cause:
• Human cause:
▫ Personal beliefs/opinions
▫ Does not understand rationale of requirement
▫ Lack of concern for compliance
• Organizational cause:
▫ Competing job assignments/workload
▫ Lack of (insufficient) staff to perform required duties
▫ Budget limitations (for required equipment)
▫ Lack of (insufficient) training of staff
▫ Lack of (insufficient) processes/protocols
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Page 13 Site Visits
Chapter 3
Once identified, the root cause should be documented in the questionnaire, including a brief
explanation of why you chose that cause. This allows for follow-up with the site and a way to help
find improvements to meet the unmet requirement. Complete any immediate on-site action. These
often require providing education and resources for the site. Mark the box for each action taken. If you
provide additional resources or information, you can use the notes section to indicate the additional
items.
“Future follow-up” are actions the site needs to take to meet the requirements of the program. We’ll go
over more specific information about the site visit questionnaire in Chapter 4.
Performing the Site Visit
As you become familiar with the MnVFC program and develop a relationship with your sites, you will
develop a visit pattern that works for you. Here is one possible sequence for conducting MnVFC site
visits:
• When you arrive at the site, if you have a business card, it is helpful to provide it to the front desk staff person. • When you meet with the immunization manager and/or vaccine coordinator, introduce yourself and
explain the expectations for the visit.
• Ask to see the temperature monitoring device(s). It must have a current certificate of calibration
and the probe must be properly placed in the unit. If it does not meet the requirements, place
your thermometer in the unit at the beginning of the visit so that it has sufficient time to reach an
accurate temperature by the time you complete your assessment of the storage units.
• 2017 MnVFC Site Visit Questionnaire
▫ Ask all of the questions. You may have to modify the order of the questions based on what is
best for the site.
▫ When you get to the storage and handling section (section 4), use the answer sheet(s) to
document the answers to the questions for each storage unit that stores vaccine (MnVFC or
private). Do not write answers in the questionnaire unless there is an unmet requirement. Be
sure to ask if there is vaccine stored anywhere else, at any time, at this location. This includes a
co-located pharmacy. If so, these additional units will need to be assessed as well.
◦ If the site has a combination refrigerator/freezer household unit and is using both sections,
discuss with them the recommendation (and probable future requirement) to have a
separate freezer. Refer to MDH if they have further questions or need more information.
◦ Be prepared to address any storage and handling mishaps that you may find. A copy of the
Clinician’s Vaccine Mishap Checklist is with your visit materials and the Emergency Response
Worksheet is in the MnVFC Policy and Procedure Manual. If you are unsure how to handle
the problem, call the MnVFC program at 651-201-5522 during or after the visit.
Page 14
IPI Advisor Manual | February 2017
Site Visits
Chapter 3
Ending the Visit
• Fill out the two copies of the 2017 MnVFC Provider Follow-up Plan (or ask them to make a copy once it is completed for their records).
▫ Indicate if they have not met the requirement by checking the box in the “Unmet” column.
▫ If they are not meeting requirements, check the required actions.
▫ Review the plan with them, reinforcing the positive things they are doing as well as reviewing
the required follow-up action(s).
▫ Give the site a copy of the Provider Follow-up Plan.
▫ Keep the signed copy of the Provider Follow-up Plan to submit with your paperwork. Do not
leave a copy of the Site Visit Questionnaire at the site.
• Let them know you will be sending a thank you email that will summarize the site visit. Included in
the email will be a survey link you would appreciate them completing regarding the visit.
After the Visit
• Send the site a thank you email.
▫ There is a template thank you letter on the IPI Advisor Site Visit Materials (www.health.state.
mn.us/divs/idepc/immunize/ipi/svmaterials.html) page. Be sure you include the issues that you
identified and the timeline for their completion, as well as the good things you found at the visit.
▫ In the template letter, be sure to include the survey link. The survey is very brief – a few
questions and space to write comments.
• Either transfer your MnVFC Site Visit Questionnaire and MnVFC Site Visit Storage & Handling per
Unit Answer Sheet information to the fillable version or submit the handwritten form to MDH.
Documentation of the Visit
Paperwork must be submitted to MDH within 10 days of the visit in order to meet the federal VFC
program’s reporting requirements. Do not wait to complete your follow-up before submitting the site
visit paperwork.
Send the following documents to MDH:
• 2017 MnVFC Site Visit Questionnaire (includes the cover sheet)
• 2017 MnVFC Site Visit Storage & Handling per Unit Answer Sheet (one for each unit)
• 2017 MnVFC Provider Follow-up Plan (original signed plan)
Submit site visit materials to:
• Email: [email protected] (preferred)
• Mail: IPI Program Specialist
Immunization Practices Improvement Program Minnesota Department of Health
P.O. Box 64975
St. Paul, MN 55164-0975
IPI Advisor Manual | February 2017
Page 15 Site Visits
Chapter 3
Future follow-up
Follow-up is an important component of the site visit. It helps us ensure that the unmet requirements
have been corrected. The questionnaire has different time periods for follow-up, depending on the
question. Do not wait to complete your follow-up before submitting the site visit paperwork.
When you complete the Follow-Up Form, make sure to keep a copy for yourself. MDH also keeps track
of follow-up required and will remind you if follow-up has not been completed by the deadline. Most
follow-up can be done with a phone call or email. In-person follow-up is rarely required and should be
discussed with MDH before scheduling a follow-up visit.
All requirements that need follow-up are identified with a [X] on the site visit paperwork and are listed
on the MnVFC Provider Follow-up Plan.
• Follow-up with the site to see how they have resolved the unmet requirements.
• Document your follow-up on the Follow-Up Form, available on the IPI Advisor Site Visit Materials (www.health.state.mn.us/divs/idepc/immunize/ipi/svmaterials.html) page. ▫ If follow-up was done via letter or email, a copy can be attached to the Follow-Up Form.
• Send your Follow-Up Form to MDH ([email protected]), with supporting documents
and emails.
• If a site is not responding to your requests regarding follow-up, contact your MnVFC clinical coordinator/planner. They can help with additional follow-up as needed.
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IPI Advisor Manual | February 2017
Chapter 4
The 2017 MnVFC Site Visit Paperwork
This chapter will go through the required MnVFC site visit paperwork with notes about information or
resources to help the site address questions or issues that may arise during the visit.
The MnVFC site visit paperwork is available on the IPI Advisor Site Visit Materials (www.health.state.
mn.us/divs/idepc/immunize/ipi/svmaterials.html) page.
Please download the paperwork shortly before your visit, as there may be updates and changes and
this will be the most up-to-date version of the questionnaire. We will send out a Workspace message
with major changes.
Required Paperwork for Site Visits
• 2017 MnVFC Site Visit Questionnaire
• 2017 MnVFC Storage & Handling Per Unit Answer Sheet – one for each unit assessed during site
visit
• 2017 MnVFC Provider Follow-up Plan – with provider signature
Make sure to include the site’s PIN on all your paperwork. Please complete and submit your site visit
paperwork as soon as possible after your visit. It may be helpful to schedule some time into your
calendar to complete your paperwork in the days following your visit. Once you have completed the
post-visit follow-up, send in the Follow-Up Form with documentation of the follow-up actions. Please
do not wait until you have completed your follow-up before sending in your initial paperwork.
MnVFC Site Visit Questionnaire
The questionnaire includes these six sections:
1.
2.
3.
4.
5.
6.
Provider details
Eligibility
Documentation
Storage & handling per unit
Storage & handling site-wide
Inventory
IPI Advisor Manual | February 2017
Page 17 The 2017 MnVFC Site Visit Paperwork
Chapter 4
The Site Visit Reviewer Legend
The legend explains the formatting of the 2017 questionnaire. This includes information that will be
helpful in completing the site visit.
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.
• Note to reviewer: These are notes to help you understand what the question is asking for and to
clarify things you might want to know when asking or rephrasing the question.
• Answers: This section helps you to know when the answer does not meet the CDC requirement [X]
or recommendation [O]. Whenever an answer with a [X] is checked, the “Actions if Non-compliant
section must be completed. The recommendations are usually good teaching points about best
practices and/or future requirements of the VFC program.
• Review the CDC Requirement/Recommendation: This section provides a specific outline of the
requirement or recommendation to give you information to use in talking with the site staff.
• Actions if Non-Compliant: This section describes what to do if the site is not meeting a
requirement.
▫ Root cause analysis: This section asks you to probe beyond the surface to find what is driving
the non-compliance. It is intended to help uncover reasons for recurring non-compliance issues,
identify additional training needs, and inform reviewer follow-up actions. Select only one root
cause and explain the particular circumstances in the space “Explanation of root cause” line
provided. If there appear to be multiple issues, choose the one that most contributes to the
non-compliance and describe all factors in the explanation.
▫ Immediate actions: A list of actions to take during the site visit to address the issue.
▫ Future follow-up: A list of actions to take after the site visit by the set deadline.
• Notes: This section can be used for notes to yourself or to MDH.
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IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork
Chapter 4
Section 1: Provider Details
Questionnaire Coversheet
The first page of the questionnaire collects the demographic information for the site. You can use this
page to help prepare for the visit. Most of the demographic information about the site should be on
the site-specific document you received with your clinic list. You will validate that this information is
current at the time of the site visit. It also helps to know if this is a separate stock site or a replacement
site before the visit, so you can bring a copy of the appropriate MnVFC Policies and Procedure Manual.
2017 MnVFC Site Visit Questionnaire
Date of visit: _____________
Date forms sent to MDH: ______________
Site Information
Site name:
MnVFC PIN:
Address:
☐ Separate Stock ☐ Replacement
City:
ZIP:
Medical Director:
Email:
Immunization Manager:
Phone:
County:
Email:
Vaccine Coordinator:
Phone:
Email:
Vaccine Coordinator back-up:
Email:
Point of contact:
Phone:
Email:
Personnel at site visit:
On this page:
• The date of the visit and the date when you send these forms to MDH.
▫ This information helps us track the timeliness of our review and data entry process.
• The vaccine management method used by the site (replacement or separate stock).
• The name and email of the medical director (ideally this is the person who signed the MnVFC Program Provider Agreement).
• Contact information for the immunization manager, vaccine coordinator, vaccine coordinator backup, and point-of-contact for this visit.
▫ The immunization manager, vaccine coordinator, vaccine coordinator back-up roles are
described in the MnVFC Policies and Procedure Manual.
▫ The vaccine coordinator back-up may be the immunization manager or another staff person
depending on the size of the site and available personnel.
▫ The Point of Contact is the person you set up the appointment with, signs the Provider Followup Plan, and receives the follow-up email. This may be one of the people listed above.
The Post Visit Steps section is a reminder to you about what needs to done after the visit. The
Education on Immunization Best Practices for Sites section reminds you to provide the resource folder
to the site.
IPI Advisor Manual | February 2017
Page 19
The 2017 MnVFC Site Visit Paperwork
Chapter 4
Question 1.2
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
☐ Yes
documentation, have the current Immunization ☐ No [X]
Manager, Vaccine Coordinator, and back-up
completed all required training?
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.
Goal of this question: Determine if there are new staff in key positions at the site and to make sure staff
are properly educated about the MnVFC program.
A. This information can help you determine the level of knowledge and experience the staff have
with the MnVFC program. Follow-up throughout the visit can be tailored for various levels of staff
experience. Likewise, you may identify additional training needs for new staff.
B. When sites notify us of changes in key personnel we update their information in MIIC and on the
clinic lists. We also send the new staff information for completing the online training and direct
them to read the appropriate MnVFC Policies and Procedures Manual. If the answer to this part
is no, update the demographic area of the questionnaire and inform the staff that in the future
they must notify the MnVFC program (via email or phone) if the immunization manager or vaccine
coordinator changes.
▫ Resource: Section 12 of the MnVFC Policies and Procedures Manual
C. Annual training must be verified by looking at the certificates for the online training. If the answer
to this part is no, refer the staff to complete the appropriate MnVFC online training found on the
MnVFC website (www.health.state.mn.us/vfc) for their program (separate stock/replacement) for
the current year and send you a copy of the certificate within 30 days.
Resource
• Sections 12 and 14 of the MnVFC Policies and Procedures Manual
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IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork
Chapter 4
Section 2. Eligibility
Question 2.1
Goal of this Question: Assess whether
staff correctly understand which patients
are eligible for the MnVFC program.
Screening ensures that eligible children
receive the vaccines that they are
entitled to receive under the MnVFC
program and helps to prevent fraud or
abuse of the program.
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).
Children 18 years and younger in these
categories can receive MnVFC vaccine at any enrolled site:
• Uninsured
• Enrolled in a Minnesota Health Care Program (MHCP): Medical Assistance (MA) or MinnesotaCare
• American Indian or Alaskan Native
The following categories are considered underinsured and are only MnVFC-eligible at local public
health (LPH), Federally Qualified Health Centers (FQHC), Rural Health Centers (RHC), Indian Health
Services (IHS), and tribal health clinics:
• Has health insurance that does not cover one or more vaccines, as can be the case with newly
licensed vaccines that aren’t yet covered (MnVFC-eligible for non-covered vaccines only).
• Has health insurance that caps vaccine coverage at a certain amount. Once that amount is reached,
the child is MnVFC-eligible.
Children with insurance that does not cover vaccines until a deductible has been met are considered to
be fully insured and are not MnVFC-eligible.
Helpful information
• Sites are not required to verify the patient’s response to the screening questions. For example,
if a patient states they lost their insurance, the site does not need to call the patient’s insurance
company to confirm.
If the site cannot correctly describe the eligibility categories, provide educational materials/resources
on MnVFC eligibility requirements.
Resources
• Patient Eligibility Screening Record on MnVFC Forms (www.health.state.mn.us/divs/idepc/
immunize/mnvfc/forms.html)
• Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017
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The 2017 MnVFC Site Visit Paperwork
Chapter 4
Question 2.2
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)
☐ Yes
Admin Fee: If patient is Medicaid-eligible, bill Medicaid; if billing,
and patient is uninsured/underinsured, can bill patient; if parent
☐ No [X]
chooses to use private insurance for cost of vaccine, bill
patient/insurance
E
Do individuals responsible for billing have access to the results of eligibility screening to
ensure proper billing?
☐ Yes
☐ No [X]
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.
Goal of this question: Determine if the staff correctly understand how to bill patients that are eligible
for the MnVFC program. Billing appropriately ensures that children can receive low cost immunizations
and the site is in compliance with the VFC program.
• If there is any indication that sites could be billing insurance companies or parents for VFC vaccines,
this should be investigated further.
• Most sites in Minnesota will bill Medicaid with the SL modifier – which indicates this is a Medicaid
claim.
• The main point is to ensure the site is not billing uninsured children for VFC vaccine, and are not charging them more than $21.22 per vaccine for the administration fee.
• Non-compliance is usually unintentional and may be resolved with some training. In rare cases, it could be a glimpse into a larger problem where a site is intentionally billing for financial gain.
• If you think the site is billing inappropriately, it is the responsibility of the IPI advisor to report concerns to MDH staff for further assistance.
Resources
• Immunization Billing Guidance for MnVFC (www.health.state.mn.us/divs/idepc/immunize/mnvfc/
billingtips.html) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www.
health.state.mn.us/divs/idepc/immunize/mnvfc/replacement/billingtipsrep.html)
• Section 2 of the MnVFC Policies and Procedures Manual
Page 22
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The 2017 MnVFC Site Visit Paperwork
Chapter 4
Question 2.3
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).
Goal of this question: Ensure that sites are not charging more than the federal allowable vaccine
administration fee of $21.22.
• The Centers for Medicaid and Medicare (CMS) establishes a maximum fee that sites can charge to
non-Medicaid-eligible VFC patients in each state/territory for vaccine administration. Health Plans
usually negotiate this fee with the site, but Medicaid will not pay more.
• If a parent cannot pay the vaccine administration fee, the patient cannot be turned away or reported to collections: VFC-eligible children must be vaccinated regardless of their ability to pay.
• If the person with whom you are conducting the site visit does not know the exact fee charged to non-Medicaid, VFC-eligible patients, ask to speak to someone who can verify the exact amount.
• If they are charging more than $21.22 for the administration fee – please contact MDH staff for help
with addressing this situation.
Resources
• Immunization Billing Guidance for MnVFC (www.health.state.mn.us/divs/idepc/immunize/mnvfc/
billingtips.html) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www.
health.state.mn.us/divs/idepc/immunize/mnvfc/replacement/billingtipsrep.html)
• Section 2 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017
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The 2017 MnVFC Site Visit Paperwork
Chapter 4
Section 3: Documentation
Question 3.1
3. Documentation: Eligibility Screening & Documentation
Question 3.1:
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.
Note to Reviewer:
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
☐ Yes
VFC eligibility at each visit and that screening results are documented at each visit? ☐ No [X]
(If no, skip question F)
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]
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.
Goal of this question: Ensure the site is screening for eligibility and documenting the eligibility category
in the medical record.
Review a minimum of 10 records from within the last 6-12 months where the patient received an
immunization. You must review a mix of public and private pay patients (if applicable).
Random selection is important. If the staff have pre-selected records for review, do not use and identify
additional, randomly selected records to review.
Helpful information
• Discuss upgrading the electronic health record to make documentation of VFC eligibility screening
a required field. Documenting eligibility screening in the immunization field promotes better MIIC
data.
• Q 3.1 B. Sites using the replacement method of vaccine management only have one stock, so you
will answer “Yes” to this question.
Resources
• Patient Eligibility Screening Record on MnVFC Forms (www.health.state.mn.us/divs/idepc/
immunize/mnvfc/forms.html)
• Section 1 of the MnVFC Policies and Procedures Manual
Page 24
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The 2017 MnVFC Site Visit Paperwork
Chapter 4
Question 3.2
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
Goal of this question: Assess whether the site is documenting all required information in each patient’s
medical record for every vaccine dose administered in accordance with the National Childhood Vaccine
Injury Act.
Resources
• Section 6 of the MnVFC Policies and Procedures Manual
• National Vaccine Injury Compensation Program (www.hrsa.gov/vaccinecompensation)
Question 3.3
3. Documentation: Record Retention
Question 3.3:
Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFC
eligibility documentation for three years?
Answers:
(Choose one)
☐ 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.
Goal of this question: Make sure the site understands they are required to keep all MnVFC screening
documentation for at least three years, either electronically or on paper. This information should be
available to you at the time of the visit and future visits.
Resource
• Section 7 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017
Page 25
The 2017 MnVFC Site Visit Paperwork
Chapter 4
Question 3.4
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?
☐ Yes ☐ No
(If no, skip to question 3.6)
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 ☐ Yes ☐ No [X]
the doses?
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.
Goal of this question: Assess vaccine accountability by verifying that children are receiving vaccine from
the appropriate stock.
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child
receives a dose of private vaccine. This should be a rare, unplanned occurrence. The site must
document any borrowing of vaccine between stocks, ideally on the VFC Borrowing Report Form. If
they are not currently using the form, review it with them and encourage them to post it close to their
vaccines. It does not need to be sent to MDH, but should be kept for 3 years and filed with their MnVFC
documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit.
Helpful information
• Understand and report on staff’s verbal (i.e., anecdotal) accounts of borrowing obtained during the
visit. Often sites do not know that what they do is considered borrowing or they think borrowing is
acceptable and documentation isn’t needed so long as those vaccines are eventually replaced.
• Since sites using the replacement method only have one stock of vaccine, they very rarely borrow.
• This question asks for future follow-up in 6 months. Make a note on your calendar and ask them to
send you a copy of their borrowing reports for the previous 6 months with documentation of doses
borrowed and replaced. We will remind you if we don’t hear from you at the 6 month time frame.
Complete the Follow-up Form and attach the borrowing form.
Resources
• Vaccine Borrowing Report on MnVFC Forms (www.health.state.mn.us/divs/idepc/immunize/mnvfc/
forms.html)
• Section 10 of the MnVFC Policies and Procedures Manual
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Chapter 4
Question 3.5
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.
Date of earliest instance:
Date of last instance:
Does borrowing appear to be a routine practice?
Note: To determine whether borrowing is a routine practice, assess frequency of ☐ Yes [X]
and repeating reasons for borrowing.
☐ No
Examples: Frequent accidental use of incorrect stock, exchanging short-dated
vaccines or issues with ordering and shipment
Goal of this question: Determine the reasons why the site is borrowing vaccine.
If sites are using the Vaccine Borrowing Report, review the reasons for borrowing to help document
borrowed VFC and/or private doses. If they have not been documenting borrowing on this report
(or any other form), estimate their borrowing practices. If you do not know the date range for their
borrowing, use the last site visit date to the current visit date. The use of “other” as the reported
reason for borrowing should be rare, if ever, and would require explanation and follow up.
Helpful information
• Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing.
• Pay attention to borrowing cases documented as “accidental.” Repetitive accidental borrowing may
indicate an issue with ordering processes or insufficient staff training.
• Borrowing is not a place to document wasted or lost doses.
• The time period of the borrowing may give you clues about the root cause. Were the borrowed
doses concentrated in a short period or spread out across several months or a year? Are all vaccine
types being borrowed, or just one?
• If borrowing seems to be an issue, discuss vaccine management ordering procedures.
Resources
• Vaccine Borrowing Report on MnVFC Forms (www.health.state.mn.us/divs/idepc/immunize/mnvfc/
forms.html)
• Section 10 in the MnVFC Policies and Procedures Manual
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Chapter 4
Question 3.6
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.
Goal of this question: Evaluate the site’s plan for vaccine management. It is especially important that
they have a plan for emergency management of their vaccine in the case of equipment failure or power
outage. Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete
the emergency plan or be able to show you a plan of their own.
If the provider is not able to physically show you the plan at the time of the visit or if the recorded
review date is not within the last 12 months, you must mark that this requirement is unmet. The
Vaccine Management Plan is important in times of emergency and it should be easy to access by any
staff member at any time. Encourage them to post the plan and put a copy with the packing supplies.
Helpful information
• Encourage the site to fill in the “Immunization Manager” and “Vaccine Coordinator” fields in the MnVFC Policies and Procedures Manual for their own reference.
• The emergency plan in the manual can be reviewed from last year and included in this year’s manual (with an updated signature and date) if there have not been any changes.
• If information in the plan is outdated, site staff will not be well equipped to safely manage vaccines
in the event of a power-outage or other emergency situation.
• If their institutional policy is only reviewed and updated every 3-4 years (as many are), the staff may
need to sign the MnVFC Polices and Procedure Manual to meet this requirement.
Resource: Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC
Policies and Procedures Manual
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Chapter 4
Question 3.7
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 ☐ Yes
vaccines relevant to the populations it serves?
☐ 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.
Gal of this question: Ensure the site has the most current VISs and is giving them to each patient/parent
before administering the vaccine in compliance with the federal law. Parents must be educated about
the vaccine their child will receive and be aware of possible contraindications and side-effects in order
to make well-informed decisions about their child’s health.
Helpful information
• Ask to see the site’s VISs to determine if they have an active protocol for giving VISs to parents. Review
to make sure they are current. Ask if they know where and how to report vaccine adverse events.
Resources
• Section 3 in the MnVFC Policies and Procedures Manual
• CDC Vaccine Information Statements (www.cdc.gov/vaccines/hcp/vis/index.html). Site may sign up
for email updates for the current list of VIS publication dates for the most up-to-date version.
• IAC: It’s Federal Law! You must give your patients current Vaccine Information Statements (www.
immunize.org/catg.d/p2027.pdf)
• VAERS (https://vaers.hhs.gov/index)
Question 3.8
3. Documentation: Anaphylaxis protocol
Question 3.8:
Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit?
Answers:
(Choose one)
☐ Yes
☐ No [X]
Review CDC Requirement:
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered.
Goal of this question: Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine.
Resources
• Section 11 in the MnVFC Policies and Procedures Manual
• IAC protocols: Child and Teens (www.immunize.org/catg.d/p3082a.pdf) and Adults (www.immunize.
org/catg.d/p3082.pdf)
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Chapter 4
Section 4: Storage & Handling Per Unit
The goal of this section is to assess vaccine storage
practices in each unit at the site.
The 2017 MnVFC Storage & Handling Per Unit Answer
Sheet is a worksheet to document the answers to the
questions in this section for each unit (combination
or stand-alone). Fill in the answers to the questions in
Section 4 on the answer sheet, not in the questionnaire.
The answer sheet has an abbreviated form of each
question. If you need further information on that
question, refer back to the full questionnaire. Also,
if you find an area where the site is not meeting the
requirements, you will need to go back to that question
on the 2017 MnVFC Site Visit Questionnaire to complete
“Actions if Non- compliant” section, including the
root cause analysis and follow-up sections. If there is
a problem in more than one unit make a note on the
questionnaire which unit you are referring to in the
Notes section.
2017 MnVFC Site Visit Storage & Handling Per Unit Answer Sheet
MnVFC PIN: ___________________
Question number and
content area
Unit description – Brand:
Location:
4.1A Type of unit
Stand-alone
4.1B Use if stand-alone
Refrigerator
4.1B Use if combination
Both sections
Refrigerator only
4.2
Pharmaceutical
Commercial/household
Select grade
Combination
Freezer
Freezer only
[O] CDC does not
recommend using both
sections of household units
Temperature Monitoring Device Questions: Questions 4.3-4.7 must be answered separately for the freezer and
refrigerator if the unit is a combo. Be sure to document responses in the appropriate column.
Storage unit section
Refrigerator
Freezer
4.3A Temperature monitoring device
Yes
No [X] (if no, skip to 4.7)
Yes
No [X] (if no, skip to 4.7)
4.4A Continuous monitoring and
recording device
Yes
No [O] (if no, skip D)
Yes
No [O] (if no, skip D)
4.4B Have a probe in buffered
material
Yes
No [O]
Yes
No [O]
4.4C Digital display that can be read
from outside the unit
Yes
No [O]
Yes
No [O]
4.4D Data downloaded and reviewed
routinely (e.g., weekly)
Yes
No [O]
Yes
No [O]
4.5A Certificate of Calibration Testing
Yes
No [X]
Yes
No [X]
4.5B Date of calibration
4.5C Date certificate expires
[X] Follow-up is required if expired
[X] Follow-up is required if expired
4.5D Certificate contains all necessary
items
Yes
No [X]
Yes
No [X]
4.6
Yes
No [X]
Yes
No [X]
4.7A Two temperature readings per
day
Yes
No [X]
Yes
No [X]
4.7B Time, date and name (or initials)
for each reading
Yes
No [X]
Yes
No [X]
Probe properly placed
4.7C Current temperature and
min/max temperatures (if
Current: ________°
Minimum: ________°
Maximum:
_°
Current: ________°
Minimum: ________°
Maximum:
_°
Important: You must fully assess any unit that may be used to store VFC vaccines even if there are
no VFC vaccines there on the day of the visit. If there are no vaccines and the site is not documenting
twice a day temperatures, discuss the need to ensure the unit is maintaining stable temperatures by
monitoring for one week before placing vaccines in the unit.
Sections 5 and 6 contain questions about storage and handling site wide and inventory. It is helpful
to keep those questions in mind as you assess the individual storage units. Think about dorm-style
units, expired vaccine, vaccine supply, room for vaccine, stocking all the recommended vaccines, and
separation of stock if appropriate.
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
Page 30
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).
IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork
Chapter 4
Question 4.1
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
Goal of this question: Identify the unit you are evaluating. The description asks you to create a unique
name for this unit so that you will be able to identify the same unit in future site visits. Put this
description on the top of the answer sheet (i.e., make and location).
Helpful information
• A stand-alone unit is either a refrigerator or a freezer. It does not have both sections in the unit.
• If there is a combination unit, note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines. CDC does not recommend the use of either section or the freezer section only of combination household units. • If your site utilizes the separate stock method of vaccine management, you must review storage
units even if they contain only private stock at the time of the visit because there is a chance that
those vaccines could be administered (borrowed) to VFC-eligible patients.
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Chapter 4
Question 4.2
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.
Goal of this question: Assess the grade and type of each storage unit.
• Pharmaceutical grade units may be stand-alone or combination units that are often metal, may
have glass in the door for viewing inside, often have an external digital temperature display, and are
manufactured by medical companies.
• Commercial or household units often look like your kitchen appliance, have vegetable/meat drawers in the unit, and are manufactured by household appliance companies. • Occasionally you might find a medical grade unit, which is usually a commercial/household unit
with a lock and 3-prong plug. These are still considered household units because of their ability to
maintain proper temperatures and air flow.
▫ Studies show that household stand-alone units are better able to maintain consistent
temperatures than their combination counterparts. Combination household units used to store
vaccine in both sections of the unit is no longer recommended and may be prohibited in the
future.
▫ Combination household storage units that are having difficulty maintaining a cold enough
freezer temperature and a warm enough refrigerator temperature should be replaced or a
separate stand-alone freezer should be purchased.
For frozen vaccines, the most cost effective solution is for the site to purchase a small stand-alone
freezer. The site may need time to budget for a stand-alone storage unit.
Resources
• Replacing Combination Household Units Tip Sheet on IPI Program Resources (www.health.state.
mn.us/divs/idepc/immunize/ipi/resources.html)
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Chapter 4
Question 4.3
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)).
Goal of this question: Assess whether there is a temperature monitoring device in the unit. If the unit is
not being monitored at all, call MDH at 651-201-5522 for guidance.
Helpful information
• This question does not ask whether the temperature monitoring device is working or the characteristics of the device. These issues will be addressed later in the questionnaire.
• For part B, the provider is always responsible for supplying the temperature monitoring device.
Even if their thermometer or data logger was originally from MDH, it is their responsibility to ensure
it is functional and calibrated.
Resources
• Section 8 in the MnVFC Policies and Procedures Manual
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The 2017 MnVFC Site Visit Paperwork
Chapter 4
Question 4.4
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)
Goal of this question: Assess the temperature monitoring device in the storage unit. Note that these
are all recommendations, not requirements at this time.
This is a great teaching opportunity for sites who do not currently have a continuous temperature
monitoring device. Beginning Jan. 1, 2018, all units that store MnVFC vaccine will be required to have a
continuous temperature monitoring device (i.e., a data logger or a continuous temperature monitoring
system). Unlike a min/max thermometer, a continuous temperature monitoring device provides
detailed information on all temperatures recorded at pre-set intervals. For excursions, it can provide
information on when a temperature went out-of-range, for how long, and what the temperatures were.
This is essential information that vaccine manufacturers need to know to assess the viability of the
vaccine following an excursion.
Helpful information
• Sites are required to monitor and record temperatures twice daily; however, temperature excursions can easily occur in the 12 hours or longer between readings. Continuous temperature monitoring can help manufacturers determine vaccine viability.
• Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures!
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The 2017 MnVFC Site Visit Paperwork
Chapter 4
• It is recommended that sites download and review data weekly. Discuss with sites that reviewing
temperature monitoring device data also includes responding appropriately if they identify out-ofrange temps.
• There is sometimes confusion about the difference between a data logger and a continuous
temperature monitoring system. Here are some differences:
Data Loggers
Have an external display similar to thermometers
Have a detachable probe
Need to be plugged into the computer or cradle
to download information on a regular schedule
Create a file of data that needs to be saved on the
computer
Doesn’t allow documentation of twice a day
temperature checks in the file
Continuous Monitoring Systems
May or may not have an external display
Probe is usually attached to transmitter
Wirelessly sends data to computer system
Data is stored within the system, not a separate
file
May allow documentation of twice a day
temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device:
Required Features
• The continuous temperature monitoring device must have:
▫ Continuous monitoring and recording capabilities to track and record temperatures over time.
▫ The capacity to routinely download temperature data to a computer (recommended at least
weekly) or wirelessly transmit data.
▫ Detachable probe in a bottle filled with a thermal buffer (e.g., bio-safe glycol) if the data logger
needs to be detached in order to download data.
▫ Active temperature display.
Recommended Features
• MnVFC recommends continuous temperature monitoring devices with:
▫ Alarm for out-of-range temperatures.
▫ Accuracy within +/-1°F (+/- 0.5°C).
▫ Low battery indicator.
▫ Display of current, minimum, and maximum temperatures.
▫ Memory storage of at least 4,000 readings.
▫ User programmable logging intervals (e.g., the user can set how often the device records the
temperature).
Note that these are all currently recommendations, not requirements yet.
Resources
• Section 8 in the MnVFC Policies and Procedures Manual
• MnVFC Guide to Temperature Monitoring Devices on MnVFC website (www.health.state.mn.us/vfc)
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Chapter 4
Question 4.5
Goal of this question: Ensure the
temperature monitoring device is properly
calibrated. The certificate of calibration
testing means that the device has been
tested and it is accurately measuring
temperatures within established testing
limits. The certificate of calibration ensures
that the device meets all the required
components.
Helpful information
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.)
D
Does the certificate contain all the necessary items listed in the Note to
Reviewer?
[X] Follow-up is required if
certificate is expired
Yes
No [X]
• The provider is always responsible for
Who is responsible for supplying the current and valid certificate of
E
Provider
calibration for this temperature monitoring device?
having a current certificate of calibration Review CDC Requirement:
(or copy) on-site.
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
testing. All certificates must contain: model/device name or number, serial number, date of calibration testing (report
• To be considered “valid,” a certificate of ofor calibration
issue date), and Instrument Passed testing/Instrument in Tolerance. (Recommended uncertainty = +/-0.5º C (+/-1º F)).
calibration must contain these required
elements:
▫ Model/device name or number
▫ Serial number
▫ Date of calibration testing (report or issue date). Note: If there is no expiration date, the
certificate expires 2 years from the date of calibration.
▫ Whether the instrument passed or failed testing (or instrument in tolerance/not in tolerance)
• Recommended element:
▫ Documented uncertainty of +/- 1°F [0.5°C]
If these elements are present, the certificate is considered valid. If the certificate contains information
about the recommended element or the entity that issued the certificate that is helpful, but not
required.
To determine if a certificate of calibration testing was issued by an appropriate entity, check to see if
the certificate indicates one or more of these items (this is the wording used to help sites evaluate if
their calibration is accurate, but is not required on the certificate itself to be considered valid):
• Conforms to ISO 17025.
• Performed by an ILAC/MRA Signatory body accredited laboratory. You can review this list of the ILAC MRA and Signatories (http://ilac.org/ilac-mra-and-signatories/).
• Traceable to the standards maintained by NIST
• Meets specifications and testing requirements for the American Society for Testing and Materials
(ASTM) Standard E2877 tolerance Class F (≤ 0.5 °C) or better.
• Includes reference to another acceptable accuracy validation method, such as comparison to other
traceable reference standards or tests at thermometric fixed points.
Note: CDC recommends that certifications be issued for the entire monitoring unit (detachable probe,
data logger, etc.) and not individual certificates for each component.
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Chapter 4
For 4.5 E, the provider is always responsible for supplying the current and valid certificate of calibration
for a temperature monitoring device.
• Tip: If the temperature monitoring device has a sticker on the back with the calibration date, the
site can usually call the company who calibrated the device and get a copy of the certificate if they
don’t have one.
Resources
• Section 8 in the MnVFC Policies and Procedures Manual
• MnVFC Guide to Temperature Monitoring Devices on MnVFC website (www.health.state.mn.us/vfc)
Question 4.6
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.
Goal of this question: Make sure the temperature monitoring device is in the best location to accurately
measure the temperature of the vaccines stored in the unit.
Helpful information
• The probe of the temperature monitoring device should be placed directly with the vaccines in
the middle of the unit. The ONLY allowable exception is for pharmaceutical storage units that have
either a built-in thermometer or a dedicated port for the probe that indicates placement of the
probe.
• Temperatures can vary within the unit, especially household units.
• Call MDH at 651-201-5522 if you have questions.
Resources
• Section 8 in the MnVFC Policies and Procedures Manual
• Vaccine Storage Guide (www.health.state.mn.us/divs/idepc/immunize/hcp/vaxhandling.html)
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Chapter 4
Question 4.7
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).
Goal of this question: Ensure the temperature is being monitored twice daily, is within the required
range, and documented correctly. Use your thermometer to check the temperature if the site’s
temperature monitoring device’s probe is not properly placed or there is not a current certificate of
calibration. Place your thermometer in the unit at the beginning of the visit to allow sufficient time
to reach an accurate temperature. The purpose of using your thermometer is to ensure the vaccine is
being stored at the proper temperature, not to “validate” their reading.
Question 4.7 D is an assessment question based on information you have learned during your visit. You
might answer “not enough information” if the unit is new and they don’t have at least three months
of data, or if the unit is only used as overflow and they are inconsistent with temperature monitoring.
Mark “No” if you have reason to believe the storage unit is not maintaining temperatures properly.
Helpful information
• All sites must document temperatures twice a day, every day the site is open, even if they have a data logger or continuous monitoring system.
• Sites can document the information electronically with some continuous monitoring systems as
long as it can show what the current temp is, the date, time, and initials of the person checking –
this needs to be someone at the site – not checking remotely or centrally for a large site or system.
The site must be able to produce these records during their site visit. Reviewing these files can be a
challenge due to large volumes and lots of paper.
Resources
• Section 9 in the MnVFC Policies and Procedures Manual
• Vaccine Storage Temperature Logs on Managing Vaccine (www.health.state.mn.us/divs/idepc/
immunize/hcp/provguide/mangvax.html)
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Chapter 4
Question 4.8
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.
Goal of this question: Address any out-of-range temperatures (temperature excursions) identified in
reviewing the last three months of temperature logs or during the site visit. If there were any out-ofrange temperatures, did the site respond appropriately to the situation? This is a great opportunity to
discuss what to do in the event of an excursion. The Clinicians Storage and Handling Mishap Checklist is
in the IPI Site Visit information folder and is a good review of the process.
Helpful information
• Sites need to know that an excursion does not automatically mean that exposed vaccines are nonviable or unusable. Exposed vaccines must be quarantined (marked “Do Not Use”) and stored under
proper conditions until they have received information from vaccine manufacturers regarding the
viability of the vaccine.
• Sites must inform MDH when an excursion occurs.
Resources
• Section 9 in the MnVFC Policies and Procedures Manual
• Clinicians Storage and Handling Mishap Checklist (www.health.state.mn.us/divs/idepc/immunize/
ipi/vaxchklst.pdf)
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Chapter 4
Question 4.9
Goal of this question: Ensure proper
placement of vaccines in the storage
unit.
Note: These are all recommendations
(best practices), not requirements.
Helpful information
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]
D
Are vaccines store in the doors, vegetable bins, under or near cooling vents, ☐ Yes [O]
or on the floor of the unit?
☐ No
E
Is food being stored in the unit?
☐ Yes [O]
☐ No
• Store vaccine in the middle of the
Review CDC Recommendation:
compartment, two to three inches
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
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
away from the coils, walls, floor and NOT
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
vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors, vegetable bins, floor, or
cold air vent. The temperature near ofnear/under
cooling vents).
the floor and walls of the unit differs
from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines.
• Vaccines should be kept in their original packaging to:
▫ Protect them from light.
▫ Help prevent medication errors by making labels easier to read.
▫ Provide a moisture barrier that serves as insulation in case of an out-of-range temperature,
power outage, door left open, or mechanical failure.
▫ Simplify managing vaccine inventory.
• Store water bottles in the doors, on the floor and near the cold air vent in the refrigerator and
frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure
and when the door is opened frequently. Too many water bottles in the door can prevent the door
from closing tightly. Mark water bottles “Do Not Drink.”
• Do not store vaccine in the door or drawers of the refrigerator or freezer. Vegetable bins and crisper
drawers should be removed from refrigerators or used to store other medical supplies or water
bottles.
• If vaccine is stored in a household combination refrigerator/freezer:
▫ The top shelf should not be used for storing vaccine because the cold air vent blowing from the
freezer will freeze vaccine located there. If you must use the top shelf of this type of unit, place
water bottles underneath the cold air vent to prevent vaccine from being stored there.
▫ It is recommended that only the refrigerator be used for vaccine storage and a separate standalone freezer be used to store frozen vaccine.
• Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability. There is also a risk of contaminating vaccines.
Resources
• Section 9 in the MnVFC Policies and Procedures Manual
• Vaccine Storage Guide (www.health.state.mn.us/divs/idepc/immunize/hcp/vaxhandling.html)
• Vaccine Storage Tip Sheet on IPI Program Resources (www.health.state.mn.us/divs/idepc/
immunize/ipi/resources.html)
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Chapter 4
Question 4.10
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.
Goal of this question: Decrease the chance that a vaccine storage unit will be accidently unplugged or
power will be turned off while vaccine is in the unit. This question addresses only what measures the
site has taken to ensure the storage unit is not physically disconnected from its power source.
If the site uses labels on the plugs and circuit breakers, perform a visual inspection to assess whether
the way the stickers are positioned make it clear and obvious to anyone that these units are not to be
disconnected.
Resources
• Section 8 in the MnVFC Policies and Procedures Manual
• Do Not Unplug and Warning stickers are included in the folder or available to order on the For Professionals Order Form (www.health.state.mn.us/divs/idepc/immunize/ordermat.html)
Note: Once you have completed the 2017 MnVFC Site Visit Storage & Handling Per Unit Answer Sheet
for each unit, return to the questionnaire to complete sections 5 and 6.
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Chapter 4
Section 5: Storage & Handling Site-Wide
Question 5.1
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.
Goal of this question: Inform sites of the quantity and value of vaccines that they receive as part of the
MnVFC program. Providers often don’t realize the value of the vaccine in their unit. This information is
included on your clinic list and on the one page, site-specific information.
Helpful information
• This discussion must occur and the box on the questionnaire must be checked.
• If there isn’t actual vaccine value information available, tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7,000.
• MDH may not have specific information for individual sites if they receive vaccine from a central
warehouse or pharmacy. For those sites, MDH will give you numbers for the whole system so you
can discuss system wide data as appropriate. If individual site information is also included, it is
usually just varicella-containing vaccines that must be shipped directly to the site.
Question 5.2
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.
Goal of this question: Ensure no vaccine is stored in dorm-style units, even for short periods of time.
Encourage them to label any units “No Vaccine Storage Allowed.” Vaccine stored in these units is
considered non-viable. If a site is using a dorm-style unit, call the MnVFC program (651-201-5522).
Resource: Section 8 in the MnVFC Policies and Procedures Manual
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Chapter 4
Question 5.3
5. Storage & Handling Site-Wide: Storage Unit Space Availability
Question 5.3:
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?
Answers:
(Choose one)
☐ 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.
Goal of this question: Ensure that sites have sufficient space in their units to maintain vaccines at
the busiest time of year. Overcrowding of vaccine limits air circulation and affects the unit’s ability to
maintain stable temperatures.
Helpful information
• Look for signs of overcrowding, such as vaccines that are pushed up against the wall, bins that are
overflowing, or storage units that are full during non-peak seasons.
Discuss immediate actions if the unit is overcrowded: Move some of their vaccines, order less vaccine
more frequently (once per month preferably), and/or purchase another storage unit for overflow.
Resource
• Section 8 MnVFC Policy and Procedure Manual
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Chapter 4
Question 5.4
5. Storage & Handling Site-Wide: Expired Vaccines
Question 5.4:
Look in each unit: Are there expired vaccines in any of the vaccine storage units at this site?
Answers:
(Choose one)
☐ 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.
Goal of this question: Ensure there is no expired vaccine in any storage unit.
Helpful information
• Sites can prevent their stock from expiring by rotating vaccines every week and/or when a new
shipment arrives. Longer-dated vaccines are stored towards the back of the unit and shorter-dated
vaccines are up front.
• Pay attention to vaccines that expire within the next three months.
▫ Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use
the vaccine, preferably a site close by. It is the transferring site’s responsibility to arrange the
transfer of the vaccine. Be sure to complete the MDH Vaccine Transfer Record form and send it
to MDH.
▫ If they are having difficulty finding a location to accept vaccine, contact MDH.
• This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process
for returning vaccine. The VFC program does get some credit for taxes and fees on vaccine that is
returned to the distribution center.
Resources
• Section 10 in the MnVFC Policies and Procedures Manual
• MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (www.health.
state.mn.us/divs/idepc/immunize/mnvfc/forms.html)
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Chapter 4
Question 5.5
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.
Goal of this question: Ensure sites have one calibrated back-up thermometer onsite that is readily
available in the event that the temperature monitoring device in unit fails, transportation of vaccine is
needed, or there are other unexpected circumstances.
Helpful information
• 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.
Resources
• Section 10 in the MnVFC Policies and Procedures Manual
• MnVFC Guide to Temperature Monitoring Devices on MnVFC website (www.health.state.mn.us/vfc)
Question 5.6
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.
Goal of this question: Discuss proper timing and preparation of vaccine(s) for administration. These are
recommendations, not requirements.
Helpful information
• Educate staff on the importance of preparing vaccine immediately before administration. Predrawing of vaccines may lead to concerns related to vaccine viability, potency, sterility, and wastage.
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Chapter 4
Section 6: Inventory
Question 6.1
6. Inventory: Inventory Comparison
Question 6.1:
Note to Reviewer:
Answers:
(Choose one)
Visually inspect storage units to determine if existing supply of vaccines proportionately mirrors
populations served. Choose the most accurate statement below.
• 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.
☐ 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.
Goal of this question: Assess whether the site is ordering appropriate quantities of vaccine for the
population they serve at their site.
Helpful information
• If the site sees 30 percent private-pay patients and 70 percent VFC, the stock in their storage units
should reflect that proportion. If you don’t know, you can ask the site about their population.
• This is meant to be a general assessment, so in a big site if they have only a small amount of vaccine, that may indicate an issue with vaccine management.
• CDC recommends smaller, more frequent orders (i.e. monthly) rather than large orders to minimize
the amount of vaccine loss if an incident occurs during shipment or in the storage unit. Sites should
not order more frequently than once a month.
• Sites using the replacement method will only have one stock, but it should appear to be large enough for their population.
• Only assess the vaccine types that the site currently stocks in their unit. We know there are sites
that do not offer all ACIP-recommended vaccines for various reasons. That issue will be addressed
in question 6.2.
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Chapter 4
Question 6.2
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.
Goal of this question: Assess if the site is offering all the ACIP-recommended vaccines for the
population they serve and these vaccines are in stock on the day of the visit. It is important that every
MnVFC-eligible child that comes to a provider’s office for an immunization is vaccinated.
Helpful information
• The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health
experts that develops recommendations on how to use vaccines to control diseases in the United
States.
• Specialty providers are not required to offer all routine vaccines, but should provide the vaccines appropriate for their population.
• If the site does not offer all routine ACIP-recommended vaccines appropriate for their population,
check the “No” box in Part A, then check the appropriate box(es) in Part B for any vaccines not
offered. Please contact MDH as this situation offers us the opportunity to provide education to the
site.
• For non-routine vaccines, they must either be in stock or the site must have an alternative protocol
in the routine management plan that ensures these children have access when applicable.
Resources
• IAC Diseases and Vaccines (www.immunize.org/vaccines)
• CDC Advisory Committee on Immunization Practices (ACIP) (www.cdc.gov/vaccines/acip/index.html)
IPI Advisor Manual | February 2017
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The 2017 MnVFC Site Visit Paperwork
Chapter 4
Question 6.3
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-VFC­
eligible 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.
Goal of this question: Assess whether the site can distinguish between MnVFC vaccine and private
vaccine. If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program, they
should also be able to distinguish between MnVFC stock and UUAV stock. Some sites use labels, bins,
boxes, etc. to differentiate their stock. If it is not clear how the site differentiates their stock, discuss
vaccine management with the staff. For follow-up, call MDH to discuss doing a follow-up site visit.
Sites using the replacement method will not have separate stocks—this is an approved alternative
method for keeping track of vaccine.
Resource
• Section 10 of the MnVFC Policy and Procedure Manual
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IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork
Chapter 4
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
2017 MnVFC Site Visit Storage & Handling Per Unit Answer Sheet
MnVFC PIN: ___________________
Question number and
content area
Unit description – Brand:
Location:
4.1A Type of unit
Stand-alone
4.1B Use if stand-alone
Refrigerator
4.1B Use if combination
Both sections
Refrigerator only
4.2
Pharmaceutical
Commercial/household
Select grade
Combination
Freezer
Freezer only
[O] CDC does not
recommend using both
sections of household units
Temperature Monitoring Device Questions: Questions 4.3-4.7 must be answered separately for the freezer and
refrigerator if the unit is a combo. Be sure to document responses in the appropriate column.
Storage unit section
Refrigerator
Freezer
4.3A Temperature monitoring device
Yes
No [X] (if no, skip to 4.7)
Yes
No [X] (if no, skip to 4.7)
4.4A Continuous monitoring and
recording device
Yes
No [O] (if no, skip D)
Yes
No [O] (if no, skip D)
4.4B Have a probe in buffered
material
Yes
No [O]
Yes
No [O]
4.4C Digital display that can be read
from outside the unit
Yes
No [O]
Yes
No [O]
All the questions on the Site Visit Storage & Handling Per Unit Answer Sheet have been discussed
previously in section 4 of this manual. Use this sheet to record information about all the units at the
site visit. You will need one sheet for each unit. If it is a combination unit (either pharmaceutical or
household), you can record both sections on one sheet. If they have stand-alone units, use one sheet
for each unit. Do not enter the answers to the questions in section 4 of the questionnaire.
If you need more information about any of the questions, refer back to the main questionnaire—the
complete question, additional guidance including notes to the reviewer, and the CDC requirements are
there. Also, if the site is not meeting the requirement you will go back to the questionnaire to complete
the “Actions if Non-compliant” section including the root cause analysis and follow-up sections.
When you have completed the assessment of all the storage units, remember to go back to the
questionnaire to complete sections 5 and 6.
IPI Advisor Manual | February 2017
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The 2017 MnVFC Site Visit Paperwork
Chapter 4
MnVFC Provider Follow-up Plan
The goal of the Provider Follow-up Plan
is to communicate with the site all
of the VFC requirements, any unmet
requirements found during your site
visit, and the timeline for completing
the required action. The left hand
column is a box to check for “Unmet”
requirements.
2017 MnVFC Provider Follow-up Plan
Site: _______________________________________________ MnVFC PIN: ____________ Date of Visit: ___________
Thank you for participating in this MnVFC compliance site visit. Please review this visit summary including follow-up
actions and timelines for completion. Unmet MnVFC requirements and recommendations have a checked box next to
them. The goal of this plan is to support you with successfully implementing the program and improving access to
vaccines for VFC-eligible children.
Unmet
Question
VFC Requirements – Section 1: Changes to Key Staff
Q1.2
Key Staff
Changes
Change in the Medical Director, Immunization Manager, Vaccine Coordinator, or back-up
must be communicated to the immunization program by emailing [email protected].
Notes:
Key staff must complete the annual training on VFC program requirements and print the
Q1.2
Annual Training certificate of completion. Documentation
Required Action:
▪ Staff that have not completed the MnVFC online training must complete it and send a
copy of the certificate to the reviewer. Training can be found on the MnVFC website
(www.health.state.mn.us/vfc).
▪ Due date: 1 month
Notes:
Helpful information
• The form can be used to review what
the site is doing well and what they
need to work on.
Unmet
Question
VFC Requirements – Section 2: Eligibility
• For requirements that have specific
Q2.1
Provider staff must possess a working knowledge of all VFC eligibility criteria and use those
VFC Eligibility criteria to screen children prior to administering VFC vaccines.
documentation that needs to be
Categories
Notes:
sent to you, use the notes section.
• This form provides documentation needed for follow-up actions when you send your thank you email.
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program
recommendations. These are to remind the site about best practices they may want to improve
upon even though they are not yet requirements of the program. For example, you could discuss the
recommendation about storage units if they currently have a combination household unit and are using
both sections.
The last section is for your signature and the person you met with. In most sites, it will be the
immunization manager or vaccine coordinator who signs the form, unless the medical director
attended the site visit. You keep the original copy and the site will need to keep a copy for themselves.
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date). The follow-up plan, which
includes a list of all current VFC program requirements and recommendations assessed during the visit and any
required follow-up actions was provided at the end of the visit.
Site visit reviewer:
Phone:
Email:
Reviewer Signature:
Date:
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above. I understand the findings of the visit and any
required actions that must be taken by our office in order to meet VFC program requirements.
Page 50
Medical Director (or designee) Name:
Title:
Medical Director (or designee) Signature:
Date:
IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork
Chapter 4
After the Site Visit
Send a thank you email highlighting the unmet requirements, documents you need from the site to
resolve the issue(s), and the date you need them. Make sure to include the link to the Site Visit Survey
(https://survey.vovici.com/se.ashx?s=56206EE334CE0B14).
Please refer to Chapter 3 for more information about future follow-up required after the visit including
forms and documentation.
Resource
• Sample Thank You letter on IPI Advisor Site Visit Materials (www.health.state.mn.us/divs/idepc/
immunize/ipi/svmaterials.html)
IPI Advisor Manual | February 2017
Page 51
Chapter 5
IPI Advisor Resource List
MnVFC Program: 651-201-5522
MnVFC
www.health.state.mn.us/vfc
• Separate Stock and Replacement Method Policies and Procedures Manuals
• Online trainings
• MnVFC Announcements: sign up to receive them via email
• Ordering MDH vaccine
• MnVFC forms:
◦ Screening forms
◦ Reporting forms
◦ Others: MDH Nonviable Vaccine Form, MDH Vaccine Transfer Record, and Vaccine Borrowing Report
• MnVFC promotional materials
• Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites
Immunization Practices Improvement Program (IPI)
www.health.state.mn.us/divs/idepc/immunize/ipi
• IPI Advisor Site Visit Materials (www.health.state.mn.us/divs/idepc/immunize/ipi/svmaterials.html)
• IPI Program Resources (www.health.state.mn.us/divs/idepc/immunize/ipi/resources.html)
◦ IPI Resource Folder Contents (www.health.state.mn.us/divs/idepc/immunize/ipi/ipifolder.pdf)
Minnesota Immunization Information Connection (MIIC)
www.health.state.mn.us/miic
• MIIC regions and regional coordinators
Clinical Practice
MDH Immunization Program
www.health.state.mn.us/immunize
Got Your Shots? News
www.health.state.mn.us/divs/idepc/newsletters/gys
MDH Immunization Information for Health Care Providers
www.health.state.mn.us/divs/idepc/immunize/hcp
• Got Your Shots? A Providers Guide to Immunization in Minnesota
• Vaccine protocols
• Forms for tracking patient immunizations
• Immunization schedules for Health Care Providers
Immunization Action Coalition (IAC)
www.immunize.org
• Ask the Experts
• VISs (Vaccine Information Statements and translations)
• Administration screening questions
• Medical management of vaccine reactions
• Order form for California’s Immunization Technique DVD: Best Practices with Infants, Children, and Adults
Page 52
IPI Advisor Manual| February 2017
IPI Advisor Resource List
Chapter 5
CDC “Pink Book”
www.cdc.gov/vaccines/pubs/pinkbook/index.html
CDC Advisory Committee on Immunization Practices (ACIP)
www.cdc.gov/vaccines/acip
CDC Vaccines and Immunizations
www.cdc.gov/vaccines
VAERS reporting
http://vaers.hhs.gov/index
Storage and Handling
Got Your Shots Providers Guide – Managing Vaccine
www.health.state.mn.us/divs/idepc/immunize/hcp/provguide/mangvax.html
MnVFC Guide to Temperature Monitoring Devices
www.health.state.mn.us/vfc
MDH Clinician’s Vaccine Mishap Checklist
www.health.state.mn.us/divs/idepc/immunize/ipi/vaxchklst.pdf
MDH Vaccine Storage Guide
www.health.state.mn.us/divs/idepc/immunize/hcp/vaxhandling.html
CDC Vaccine Storage and Handling Toolkit
www.cdc.gov/vaccines/recs/storage/toolkit
You Call the Shots
www.cdc.gov/vaccines/ed/youcalltheshots.html
Vaccine manufacturer phone numbers
www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/F/contact-info-manufact.pdf
IAC Checklist for Safe Vaccine Handling and Storage
www.immunize.org/catg.d/p3035.pdf
IAC Don’t Be Guilty of These Errors in Vaccine Storage and Handling
www.immunize.org/catg.d/p3036.pdf
Additional Resources
Print materials from MDH – order forms
www.health.state.mn.us/divs/idepc/immunize/ordermat.html
Vaccine Education Center – Children’s Hospital of Philadelphia
www.chop.edu/service/vaccine-education-center/home.html
California Department of Public Health – Interactive training on vaccine administration and storage
and handling, handout on transporting vaccine and how to package
www.eziz.org
IPI Advisor Manual | February 2017
Page 53 Chapter 5
IPI Advisor Resource List
CDC vaccine price list
www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/index.html
Vaccine Information Statements (VIS)
www.cdc.gov/vaccines/hcp/vis/index.html
CEU Opportunities
CDC Immunization Education and Training
www.cdc.gov/vaccines/ed/index.html
Immunization: You Call the Shots
www.cdc.gov/vaccines/ed/youcalltheshots.html
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IPI Advisor Manual| February 2017