Primary VFC Contact/Back-Up VFC Contact

The Primary VFC Contact is responsible for ensuring all vaccines are stored and handled properly. Each VFC provider must have at least one Back-Up VFC Contact to serve in the absence of the primary contact. Both the Primary VFC Contact and the Back-Up VFC Contact should be fully trained in routine and emergency policies and procedures. Primary VFC Contact and Back-Up VFC Contact responsibilities include:

1. Ordering vaccines
2. Overseeing receipt and proper storage of vaccine deliveries
3. Completing vaccine reconciliation
4. Organizing vaccines within the storage units
5. Setting up DDLs
6. Reading and recording storage unit temperatures (including actual, minimum and maximum)
7. Downloading and reviewing DDL information at least monthly
8. Rotating stock to ensure the earliest expiration dates are used first
9. Removing expired vaccines from storage units
10. Responding to temperature excursions
11. Maintaining all documentation
12. Ensuring staff is properly trained
13. Monitoring operation of storage equipment and systems
14. Overseeing proper vaccine transport (if needed)
15. Overseeing emergency preparations

Vaccine Storage

Placement and organization within the storage unit is vital to maintaining vaccine stability. The following vaccine management practices are required for VFC providers:

1. Store vaccine in the original packaging (including UV protective bags used by CDC’s centralized distributor for single dose vaccines).
   1. Original Packing:
      1. Acts as a moisture barrier for the vaccine
      2. Prevents breaking
      3. Has the correct lot number
      4. Eliminates errors
   2. Exceptions:
      1. Vaccines transferred without a box
      2. Single dose shipments
      3. Damaged boxes
      4. Storage in a Pyxis © like refrigerator
2. Store vaccines in the central or middle part of the unit, with space between both the vaccine and the sides/back of the unit.
3. Do not store vaccines in the doors, vegetable or crisper bins, or on the floor of the unit, or under or near cooling vents.
4. Do not store food or drink in vaccine storage units.
5. Place water bottles or coolant packs throughout the refrigerator and freezer storage units to:
   1. Stabilize or extend temperatures during a power outage,
   2. Dampen the effects of frequent opening/closing of door, and
   3. Serve as physical barriers preventing the placement of vaccines in areas of the unit that are at high risk for temperature excursions. The only exception is if a unit manufacturer indicates water bottles or coolant packs could negatively impact unit functionality.
6. Rotate stock regularly or when a new shipment arrives so that newer vaccines are stored behind the soonest-to-expire.
7. Immediately remove any expired vaccine from the storage unit. Bag and label all expired vaccine as “Do Not Use” until the vaccines are able to be returned.
8. Open only one vial or box of a particular vaccine at a time to control vaccine use and allow for easier inventory control. For multi-dose vials, indicate on the label the date and time the vial was reconstituted or first used. Make a tick mark on the label when administered in order to keep inventory control of the multi-dose vial. Do not discard multi-dose vials of IPOL (Inactivated Poliovirus Vaccine) before the expiration date on the vial until the vaccine has expired. Open vials of IPOL cannot be returned or transferred.
9. Store vaccine products with similar packaging in different locations in the storage unit to avoid confusion and vaccination errors.
10. Limit access to the vaccine supply to authorized personnel only.
11. Install locks on refrigerators and, if possible, the electrical plugs. Label the plugs “Do Not Disconnect.”
12. Vaccines must be prepared immediately prior to administration.
13. Write the expiration date on the outside of the box so it is easily visible yet not obscuring vital vaccine information on the box.
14. Check to make sure that refrigerator and freezer doors are shut regularly.
15. Organize your vaccine by age group.
16. VFC, 317 and private stock must be easily distinguished. You may use separate shelves, separate units, or bin storage.
17. Use open baskets for vaccine organization and air circulation.
18. Arrange vaccines/diluent in rows, allowing for air circulation.
19. Arrange vaccines/diluents centrally at least two to three (2 – 3) inches from walls, ceiling, floor and door

Question: Can we store other biologics or medicine in the vaccine refrigerator or freezer?

Answer: Storing biologics or medicine is not a recommended practice. This can lead to administration mistakes. However, if done, the biologics or medicine must be on the lowest shelf in the unit.

Vaccine Temporary Storage/Transport

The VFC Program and CDC do NOT recommend routine transport of VFC vaccines. If transport does occur, vaccines should only be transported using appropriate packing materials that provide maximum protection. The CDC and the VFC Program recommend a portable refrigerator/freezer for vaccine transport (this type of unit is powered and is specifically designed for use during vaccine transport). Transfers of VFC stock can only occur:

• With approval from the VFC Program to another VFC provider.
• When a process is in place to ensure VFC vaccine viability, as outlined in CDC’s Vaccine Storage and Handing Toolkit [BROKEN LINK]. This must include use of a current certified, calibrated DDL for temperature monitoring during transport, as well as other appropriate equipment below.
• Ensuring total time for transport or transport plus off-site clinic cannot exceed eight (8) hours.

If any temperature excursion occurs during transport or off-site clinics, follow the excursion protocol as noted in Section 5.7 of this manual.

Transport Situations and Packing Methods

Transport packing methods differ between 1) Emergency transport and 2) Planned transport such as for off-site clinic, satellite clinics, or re-location of stock. A portable refrigerator/freezer is always the preferred method. Do not utilize food/beverage coolers or soft-sided coolers for transporting vaccine.

• Emergency transport requires either portable vaccine storage units (portable vaccine refrigerator/freezer), qualified containers and pack-outs, or the conditioned water bottle transport system. For step-by-step guidance on packing a cooler for emergencies using the conditioned water bottle method, see CDC’s Packing for Emergency Transport.
• Planned transport requires either portable refrigerators/freezers or qualified container and pack-outs. The conditioned water bottle method cannot be used for planned transport. Follow instructions specific to the portable refrigerator/freezer or qualified container/pack-out.

Materials for Transport

Maintain sufficient materials for transport of your largest inventory. Keep these available at all times. Materials include:

• Portable vaccine storage units (refrigerator/freezer units)*
• Qualified vaccine-specific coolers or pack-out containers*
• Hard-sided insulated containers or Styrofoam coolers
• Coolant materials (phase change materials (PCMs) for vaccine-specific coolers above*
• Gel or ice packs
• Frozen water bottles that are conditioned to maintain vaccine storage ranges (for emergency transport only)
• A DDL (current, certified calibrated and place the probe as close to the vaccine as possible)
• Insulating materials (packing peanuts, bubble wrap)
• Stabilization materials (corrugated cardboard cut to fit the container)

* Recommendations only. These items are recommended, but not required.

Do not use dry ice, the vaccine cooling packs from shipments, or soft-sided food/beverage coolers for transport or temporary storage.
 

Vaccine Expiration Dates/Expired VFC vaccine

Please see the picture below for guidance on expiration dates for vaccines. Remove any expired VFC vaccine(s) or diluent and place in a bag or box labeled “Do Not Use – Expired”. VFC providers should complete the return process for expired VFC stock prior to the monthly reconciliation. Once a VFC vaccine expires, it will no longer appear in the ‘On Hand’ Inventory menu in ShowMeVax. The individual completing the reconciliation will need to go into the inventory menu, change the status from on-hand to depleted/expired and complete a return for the expired inventory item. The Vaccine Support Team will approve the return and the Primary VFC Contact will receive a return label from pkginfo@ups.com. The expired vaccine will be listed in red on the reconciliation and the individual completing the reconciliation will report how many doses were given prior to the expiration and report zero on hand. The expired vaccine(s) will need to be packed in a box, labeled with the emailed return label and picked up by UPS (calling for a pick-up will result in a charged fee).

VFC providers must make at least three attempts to transfer public vaccines (VFC, CHIP, or 317) to other approved VFC providers at least ninety (90) days in advance of the expiration. Failure to make three attempts to transfer the public vaccines could result in having to replace the vaccine dose-for dose with private stock. Transfer attempt information (VFC Provider, name, date) should be documented in ShowMeVax under the ‘Clinic Comment’ section of the return and kept on file at the clinic for at least three years. VFC Consultants may review the transfer attempts at VFC site visits.

If you need assistance with VFC vaccine returns, you may contact the Vaccine Support Team at 866- 256-3166 or by email at VFC-SMVsupport@health.mo.gov.