The Florida Vaccines for Children (VFC) Program

Vaccine Storage

The Bureau of Immunization (BOI) field staff travel across the state of Florida performing on-site immunization reviews at VFC provider sites. These reviews reveal that an alarmingly high number of VFC providers are improperly storing their vaccines. This results in wasted vaccine and, in some cases, suspension of providers from the VFC Program. When VFC providers do not maintain the recommended refrigerator/freezer temperatures, vaccines may lose their potency and result in children being inadequately immunized and required to get additional vaccinations.

• Recommendations for Handling and Storage of Selected Biologicals
• Emergency Vaccine Storage and Handling Advisory

Requirements Necessary to Ensure Proper Vaccine Storage:

Vaccine Storage Equipment

Providers must have appropriate vaccine storage equipment that can maintain proper temperature conditions. The provider must have temperature-monitored, alarm-equipped, stand-alone refrigerators and freezers. The refrigerator units should maintain temperatures between 35° to 46°F (2° and 8°C). It should have a separate freezer compartment with a separate exterior door.

The freezer compartment should maintain an average temperature of 5°F (-15°C) or colder. A combination refrigerator/freezer unit sold for home use is acceptable for vaccine storage.

NOTE: The Florida VFC Program does not approve dormitory-style refrigerators for VFC vaccine storage. Dormitory-style refrigerator/freezer combinations are no longer acceptable for storing VFC vaccine. A dormitory-style refrigerator is defined as a small combination refrigerator/freezer unit that is outfitted with one external door, an evaporator plate (cooling coil), which is usually located inside an icemaker compartment (freezer) within the refrigerator, and is void of a temperature alarm device. Its temperature control sensor reacts to the temperature of the evaporator, rather than the general air in the storage compartment. When the compressor is on, the evaporator cools to lower the temperature in the refrigerator, in most cases to below 0°C.

Refrigerators or freezers used for vaccine storage must comply with the following requirements:

• Be able to maintain required vaccine storage temperatures year-round.
• Be large enough to hold the year's largest inventory.
• Have a working thermometer certified in accordance with the National Institute of Standards and Technology (NIST) or the American Society for Testing and Materials (ASTM) standards placed in a central area inside each storage compartment.
• Be dedicated to the storage of vaccines. Food and beverages must not be stored in a vaccine storage unit because this practice results in frequent opening of the door and destabilization of the temperature.

Temperature Monitoring

Temperature monitoring should be the responsibility of the primary and back-up vaccine coordinators. If other staff must monitor temperatures, train them on how to respond to and document actions taken when temperatures are outside the appropriate range.

• Post a Fahrenheit or Celsius Temperature Log for Vaccines form on the storage unit door or in a readily accessible place.
• Record refrigerator and freezer temperatures in the Temperature Log for Vaccines form twice a day (beginning and end)
  • Ensure that refrigerator temperatures are between 35° to 46°F (2° and 8°C).
• Keep the freezer temperature 5°F or lower (-15°C or colder).
• Monitoring and recording temperature twice a day is required, even if a continuous graphing/recording thermometer or a digital data logger is used.
• Correct improper vaccine storage conditions immediately, including inappropriate exposure to light and storage temperatures outside the recommended ranges.
• Maintain and store the completed Temperature Log for Vaccines form for 3 years. The BOI field staff will review this form when they conduct on-site visits.
• Monitor vaccine storage temperatures by using a minimum/maximum thermometer or continuous recording thermometer in the refrigerator and freezer. Follow the manufacturer’s recommended schedule for recalibration of the certified thermometers.

Because of the critical importance of administering safe and effective vaccines, we cannot guarantee continued participation in the VFC Program for providers who do not adhere to these requirements. If it is determined the vaccine is stored improperly and is not usable during an onsite review, providers will be instructed to return it to McKesson Specialty, the centralized national vaccine distributor, immediately. Vaccine shipments will be suspended until the provider meets the proper requirements. Be sure to:

1. Familiarize the appropriate staff with vaccine storage and handling requirements.
2. Post the temperature log on the storage unit door or a readily accessible place.
3. Record refrigerator and freezer temperatures twice daily, as indicated on the log.
4. Adjust the thermostat if temperature is recorded outside the recommended range and contact the vaccine manufacturer for further instructions.

If you have any questions, please contact the VFC Program at 1 (800) 483-2543.