2016 MnVFC Provider Follow-up Plan
Site:
MnVFC PIN:
Date of Visit:
Thank you for participating in this MnVFC site visit. Please review the summary of your visit below. MnVFC requirements
assessed during the visit that were “unmet” and require some follow-up have a checked box next to them. If you have
any questions, please contact your site visit reviewer.
Unmet
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Ques
Q1.2
VFC Requirements – Section 1: Provider Details
All changes in key staff must be communicated to the immunization program by emailing
health.mnvfc@state.mn.us.
Notes:
All key staff must undergo annual training on VFC program requirements. Training must be
documented.
☐ Required Action:
▪ Staff that have not taken the MnVFC online training on the MnVFC website
(www.health.state.mn.us/vfc), must complete it and send the certificate to the IPI advisor.
▪ Due date: 1 month
Notes:
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Q1.2
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VFC Requirements – Section 2: Eligibility
Q2.1
Sites must possess a working knowledge of all VFC eligibility criteria and use those criteria to screen
children prior to administering VFC vaccines.
Notes:
Q2.2
Sites must adhere to proper billing practices for vaccine administration fees and clearly understand
VFC vaccine is provided at no cost both to the provider and eligible children. At no time should
billing occur for the cost of VFC vaccine.
☐ Required Action:
▪ Submit in new or revised billing protocols addressing how your office will bill for each VFCeligible category
▪ Due date: 1 month
Notes:
Q2.3
The provider’s vaccine administration fee for non-Medicaid, VFC-eligible children must not exceed
the vaccine administration fee cap established by the Centers for Medicare and Medicaid (CMS). In
Minnesota, this is $21.22. VFC-eligible children must not be denied vaccine based on the patient’s
inability to pay the vaccine administration fee.
☐ Required Action:
▪ Your site will receive a follow-up site visit to assess if this requirement is being met.
▪ Due date: 6 months
Notes:
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IM M UNI ZA T IO N P RA CT I C E S IM PR OV EM E NT PR O GR AM ( IP I)
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MNVFC PROVIDER FOLLOW-UP PLAN
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VFC Requirements – Section 3: Documentation
Q3.4
VFC providers must screen for and document VFC eligibility at each immunization visit. 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.
☐ Required Action:
▪ Submit new or revised protocols for conducting and documenting eligibility screening for each
patient at each visit.
▪ Due date: 1 month
Notes:
Q3.5
Q3.6
Q3.7B
Q3.7C
In accordance with Federal law, all VFC providers must maintain immunization records that include
all of the following elements: (1) name of vaccine administered; (2) date vaccine was administered;
(3) date VIS was given; (4) publication date of VIS; (5) name of vaccine manufacturer; (6) lot
number; (7) name and title of person who administer the vaccine; (8) address of clinic where
vaccine was administered.
Notes:
VFC providers are required to maintain all records related to the VFC program for a minimum of
three years 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, records
that verify receipt of vaccine, vaccine ordering records, and vaccine purchase and accountability
records.
☐ Required Action:
▪ Submit a plan for maintaining historical patient eligibility documentation for a minimum of
three years.
▪ Due date: 1 month
Notes:
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFCeligible 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.
All instances of borrowing must be properly documented.
☐ Required Action:
▪ Submit borrowing reports for the six months since the site visit.
▪ Due date: 6 months
Notes:
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFCeligible 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.
All instances of borrowing must be replaced.
☐ Required Action:
▪ Submit documentation of purchase of private stock used to replace borrowed doses.
▪ Due date: 1 month
Notes:
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MNVFC PROVIDER FOLLOW-UP PLAN
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Q3.8
Q3.9
VFC Requirements – Section 3: Documentation
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFCeligible 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.
☐ Required Action:
▪ Submit new or revised protocols for managing vaccine ordering and inventory and other
internal processes to prevent routine borrowing.
▪ Due date: 1 month
Notes:
VFC providers must develop, maintain and implement a Vaccine Management Plan for routine and
emergency vaccine management. 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.
☐ Required Action:
▪ Submit an updated and complete Vaccine Management Plan.
▪ Due date: 1 month
Notes:
Q3.10
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.
Notes:
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Q3.11
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered.
☐ Required Action:
▪ Submit a complete anaphylaxis protocol.
▪ Due date: 1 month
Notes:
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VFC Requirements – Section 4: Storage & Handling per Unit
Q4.3
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 = +/-0.5°C (+/-1°F).
☐ Required Action:
▪ Submit the following: (1) receipt of purchase of a new temperature monitoring device, (2) a
copy of the certificate of calibration testing, and (3) one week of complete temperature
documentation using the new temperature monitoring device.
▪ Due date: 1 month
Notes:
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VFC Requirements – Section 4: Storage & Handling per Unit
Q4.5
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 = +/-0.5°C (+/-1°F).
☐ Required Action:
▪ Submit a copy of the current and valid certificate of calibration testing for the temperature
monitoring device in this section of the storage unit.
▪ Due date: 1 month
Notes:
Q4.6
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.
Notes:
Q4.7
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.
☐ Required Action:
▪ Submit complete temperature documentation of your temperatures over the next three weeks
for this section of the storage unit.
▪ Due date: 1 month
Notes:
Q4.8
The site must document all excursions and actions taken including the following: (1) quarantine and
label exposed vaccines, (2) place vaccine in a unit where it can be stored under proper conditions,
(3) contact immunization program to report excursion, (4) contact the vaccine manufacturer to
obtain documentation of vaccine potency.
Notes:
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Q4.10
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Q5.2
Providers must take steps to protect the power source for all vaccine storage equipment by means
of warning labels, back-up generators, and/or developing appropriate policies/protocols.
Notes:
VFC Requirements – Section 5: Storage & Handling Site Wide
Dorm- and bar-style units are prohibited for vaccine storage.
☐ Required Action:
▪ Submit documentation certifying that you have acquired additional vaccine storage that
complies with all program requirements. Submit one week of complete temperature
documentation for the unit(s) that will be used to replace the dorm-style unit.
▪ Due date: 1 month
Notes:
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VFC Requirements – Section 5: Storage & Handling Site Wide
Q5.3
The site must have sufficient storage space to accommodate vaccine stock at the busiest time of
year without crowding.
☐ Required Action:
▪ Submit documentation certifying that your office has sufficient storage space to support your
patient population. Examples of possible documentation include changes in ordering amounts
or frequency of proof of purchase of new unit.
▪ Due date: 1 month
Notes:
Q5.4
Vaccines should be rotated every week and when a new shipment comes in so that longer-dated
vaccines are stored behind shorter-dated 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.
Notes:
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Q5.5
VFC providers must have a readily available back-up thermometer with a current and valid
certificate of calibration testing.
☐ Required Action:
▪ Submit either: (1) proof of purchase of a back-up thermometer and a copy of the current and
valid certificate of calibration testing (preferable) or (2) a clear plan for how to obtain a backup thermometer when needed in order to meet the twice-a-day monitoring requirement.
▪ Due date: 1 month
Notes:
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VFC Requirements – Section 6: Inventory
Q6.1
VFC providers must order and stock routine vaccines in accordance with their patient population in
order to prevent missed vaccination opportunities.
☐ Required Action:
▪ Submit documentation verifying that there is sufficient public and private inventory.
▪ Due date: 2 weeks
Notes:
Q6.2
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 or the particular requirements contradict
state law, including laws pertaining to religious and other exemptions.
Notes:
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Q6.3
Sites that serve both VFC and non-VFC-eligible children must maintain separate vaccine inventories
that allow them to clearly differentiate public stock from private stock and allow them to
differentiate VFC vaccines from other public stock.
☐ Required Action:
▪ Your site will receive a follow-up site visit to assess if this requirement is being met.
▪ Due date: 6 months
Notes:
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MNVFC PROVIDER FOLLOW-UP PLAN
VFC Program Recommendations
The following items provide additional information on current CDC recommendations.
▪ To assure viability of vaccines, providers should prepare vaccine immediately prior to administration.
▪ CDC storage unit recommendations are as follows: (1) pharmaceutical grade stand-alone or combination units
(preferred); (2) household/commercial stand-alone units; (3) household/commercial combination units using the
refrigerator section only.
▪ CDC recommends the use of a digital data logger thermometer with a detachable probe in a buffered material
with continuous monitoring and recording capabilities. The temperature should be easily readable from the
outside of the unit.
▪ Temperature probes should be buffered so that temperature monitoring devices measure the temperature of
vaccine vials – not the temperature of the air in a storage unit.
▪ When selecting a data logger, CDC recommends the following features:
▪ Alarm for out-of-range temperatures
▪ Current, minimum and maximum temperatures
▪ Low battery indicator
▪ Accuracy of +/- 1° F (0.5° C)
▪ Memory stores at least 4,000 readings
▪ Vaccines should be in their original packaging from the manufacturer and/or CDC centralized distributor and
placed in the middle of the unit, with space both between the vaccines and the side/back of the unit. Vaccines
should not be stored in the doors, vegetable bins, or floor of the unit or under or near cooling vents and there
should not be any food in the unit.
▪ Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage
unit in order to (1)stabilize or extend temperatures during a power outage and (2) serve as physical blocks
preventing the placement of vaccines in areas of the unit that are at higher risk for temperature excursions.
To be completed by the site visit reviewer
I,
(Site visit reviewer), acknowledge that a VFC site visit was performed on
(visit date). A follow-up plan,
which includes any issues identified (if applicable) was provided at the end of the visit.
Site visit reviewer:
Phone:
Email:
Reviewer Signature:
Date:
To be completed by the provider
I,
(Responsible Individual designated by MD), acknowledge that my practice took part in the VFC site visit noted
above. I will communicate the plan and any follow-up items to the Medical Director. I understand the issues identified
during the visit (if applicable) and agree to complete any required follow-up actions within the designated timeframe.
Provider Signature:
Date:
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