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:
Unmet
Question
VFC Requirements – Section 2: Eligibility
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.
Categories Notes:
Providers must adhere to proper billing practices for vaccine administration fees and clearly
Q2.2
Billing Practices understand VFC vaccine is provided at no cost both to the VFC provider and eligible children.
At no time should billing occur for the cost of VFC vaccine. MnVFC-eligible patients must not
be turned away or sent to collections for the inability to pay the administration fee.
Required Action:
▪ Submit 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
Vaccine
Administration Medicaid (CMS). In Minnesota, this is $21.22.
Fee
Required Action:
▪ Assure you are not charging more than $21.22 for the MnVFC administration fee.
▪ Your site will receive a follow-up site visit to assess that you are charging a vaccine
administration fee that does not exceed $21.22.
▪ Due date: 6 months
Notes:
IM M UNI Z A T IO N P RA CT I CE S IM PR OV EM E N T PR O GR AM ( IP I)
(February 2017) Page 1 of 8
MNVFC PROVIDER FOLLOW-UP PLAN
Unmet
Question
VFC Requirements – Section 3: Documentation
Eligibility
VFC providers must screen for and document VFC eligibility at each immunization visit.
Screening & Documentation must include the date of the visit and the child’s specific eligibility category.
Documentation 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:
Q3.1
▪ Submit new or revised protocols for conducting and documenting eligibility screening for
each patient at each visit or documentation explaining how the identified noncompliance will be addressed.
▪ Due date: 1 month
Q3.1 A, F
Required Action:
▪ Your site will receive a follow-up site visit to observe the screening and intake process to
determine whether eligibility is being assess and documented properly.
▪ Due date: 6 months
Notes:
Q3.2
In accordance with Federal law, all VFC providers must maintain immunization records that
Vaccine Dose include all of the following elements: (1) name of vaccine administered; (2) date vaccine was
Documentation administered; (3) date VIS was given; (4) publication date of VIS; (5) name of vaccine
manufacturer; (6) lot number; (7) name and title of person who administered the vaccine; (8)
address of clinic where vaccine was administered.
Notes:
Q3.3
Record
Retention
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:
Borrowing VFC providers are expected to maintain an adequate inventory of vaccine for VFC and nonDocumentation 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. All instances of borrowing must be properly documented, reported,
and replaced.
Q3.4 B, C
Required Action:
▪ Submit borrowing reports for the six months since the site visit.
▪ Due date: 6 months
Q3.4 D
Required Action:
▪ Submit documentation of purchase of private stock used to replace borrowed VFC doses.
▪ Due date: 1 month
Notes:
(February 2017) Page 2 of 8
MNVFC PROVIDER FOLLOW-UP PLAN
Unmet
Unmet
Question
VFC Requirements – Section 3: Documentation
Q3.5
Borrowing
Reasons
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and nonVFC-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. 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:
Q3.6
Vaccine
Management
Plan
VFC providers must develop, maintain, and implement a vaccine management plan for
routine and emergency vaccine management. The plan should consist of clearly written,
detailed, and up-to-date storage and handling procedures. A “review date,” to validate it is
current, and signature are required annually or more frequently if changes occur.
Required Action:
▪ Submit an updated and complete Vaccine Management Plan.
▪ Due date: 1 month
Notes:
Q3.7
VIS & VAERS
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 (www.cdc.gov/vaccines/hcp/vis/) website.
Notes:
Q3.8
Anaphylaxis
Protocol
An anaphylaxis protocol must be clearly posted near the emergency kit.
Required Action:
▪ Submit a complete anaphylaxis protocol.
▪ Due date: 1 month
Notes:
Question
VFC Requirements – Section 4: Storage & Handling per Unit
Q4.3
Temperature
Monitoring
Device
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 three things: receipt of purchase of a new temperature monitoring
device, copy of the certificate of calibration testing, and one week of complete
temperature documentation using the new temperature monitoring device.
▪ Due date: 1 month
Notes:
(February 2017) Page 3 of 8
MNVFC PROVIDER FOLLOW-UP PLAN
Unmet
Question
VFC Requirements – Section 4: Storage & Handling per Unit
Q4.5
Certificate of
Calibration
Testing
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.
▪ Due date: 1 month
Notes:
Q4.6
Probe
Placement
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. The only
allowable exemption related to this requirement is for providers who have pharmaceutical
storage units that have either: a built-in temperature monitoring device, OR a dedicated port
for the probe that dictates the placement of the probe.
Notes:
Vaccines must be stored under appropriate temperatures as described in the package inserts
Q4.7
Temperature at all times. Acceptable temperature ranges vary by vaccine type. For refrigerated vaccines,
Documentation the range is 36°F and 46°F (2°C and 8°C). 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 at least two temperature
readings per day, the time and date of each reading, and 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).
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 provider must document all excursions and actions taken including: quarantine and label
Temperature vaccines “do not use,” place vaccine in a unit where it can be stored under proper conditions,
contact the immunization program to report an excursion, and contact the vaccine
Excursions
manufacturer to obtain documentation supporting the usability of the vaccine.
Notes:
Q4.10
Disconnection
from Power
Source
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:
(February 2017) Page 4 of 8
MNVFC PROVIDER FOLLOW-UP PLAN
Unmet
Question
VFC Requirements – Section 5: Storage & Handling Site Wide
Q5.2
Dorm-Style
Units
Dorm- and bar-style units are prohibited for vaccine storage. Vaccines stored in dorm-style
units are considered non-viable.
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:
Q5.3
Storage Unit
Space
Availability
VFC providers 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 or proof of purchase of new unit.
▪ Due date: 1 month
Notes:
Q5.4
Expired
Vaccines
Vaccines should be rotated weekly 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. Return expired vaccine to the centralized distributor within six months of expiration.
Notes:
Q5.5
VFC providers must have a readily available back-up thermometer with a current and valid
certificate of calibration testing.
Back-Up
Thermometer Note: As of Jan. 1, 2018, all devices in use including back-up devices must be a continuous
monitoring and recording device.
Required Action:
▪ Submit either: proof of purchase of a back-up thermometer and a copy of the current
and valid certificate of calibration testing (preferable) or a clear plan for how to obtain a
back-up thermometer when needed in order to meet the twice-a-day monitoring
requirement.
▪ Due date: 1 month
Notes:
(February 2017) Page 5 of 8
MNVFC PROVIDER FOLLOW-UP PLAN
Unmet
Question
Q6.1
Inventory
Comparison
Q6.2
ACIPRecommended
Vaccines
VFC Requirements – Section 6: Inventory
In order to prevent missed vaccination opportunities, VFC providers must order and stock
routine vaccines appropriate for their patient population. Having sufficient amounts of all
stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligible patients and vice
versa.
Required Action:
▪ Submit documentation verifying that there is sufficient public and private inventory.
▪ Due date: 2 weeks
Notes:
VFC providers agree to comply with immunization schedules, dosages, and contraindications
that are established by the Advisory Committee on Immunization Practices (ACIP) for their
patient population 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. 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.
Notes:
Q6.3
In order to ensure that VFC vaccines are only administered to VFC-eligible children, VFC
Separation of providers that serve both VFC and non-VFC-eligible children must maintain separate vaccine
inventories in such a way that they can clearly differentiate public stock from private stock.
Stock
Required Action:
▪ Your site will receive a follow-up site visit to assess if this requirement is met.
▪ Due date: 6 months
Notes:
(February 2017) Page 6 of 8
MNVFC PROVIDER FOLLOW-UP PLAN
VFC Program Recommendations
CDC recommendations:
▪
Q 4.2 Storage Units: CDC recommends the following vaccine storage unit types (in order of preference):
pharmaceutical grade stand-alone or combination units, household/commercial stand-alone units,
household/commercial combination units using the refrigerator section only.
▪
Q 4.4 Temperature Monitoring Device: As of Jan. 1, 2018, all VFC providers must use continuous temperature
monitoring devices (i.e., 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 stores 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)
▪
Q 4.9 Vaccine Placement: 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 stabilize or extend temperatures
during a power outage and serve as physical blocks preventing the placement of vaccines in areas of the unit that
are at higher risk for temperature excursions.
▪
Q 5.6 Preparation of Vaccine: CDC recommends preparing vaccines immediately prior to administration in
order to assure viability of vaccine and prevent vaccine wastage. Vaccines 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.
(February 2017) Page 7 of 8
MNVFC PROVIDER FOLLOW-UP PLAN
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.
Medical Director (or designee) Name:
Title:
Medical Director (or designee) Signature:
Date:
(February 2017) Page 8 of 8