VFC Program Vaccine Storage and Handling Requirements

VFC providers must comply with the requirements and activities listed in the Vaccine Storage and Handling Plan. Storage and handling errors result in the loss of millions of dollars' worth of vaccine each year in the United States. Appropriate vaccine storage and handling depends on choosing the right equipment, conforming to policies implemented across the state, and keeping vigilant about vaccine temperatures. Vaccines should be properly stored and administered to ensure maximum efficacy and safety. Specific recommendations for proper handling and storage should be posted on, or near, each refrigerator and freezer used for vaccine storage. For guidance refer to the CDC Vaccine Storage and Handling Toolkit.

Vaccine Storage Units

NYS VFC providers purchasing new refrigerators or freezers to store publicly-funded vaccine are required to purchase stand-alone storage units (units that are only a refrigerator or only a freezer). Providers who were enrolled with VFC prior to January 1, 2015 and using household combination units may continue to do so as long as those units continue to maintain acceptable temperature ranges. The freezer must be able to maintain temperatures at or below 5° Fahrenheit (-15° Celsius) and the refrigerator must be able to maintain temperatures consistently between 36° and 46° Fahrenheit (2° to 8° Celsius).

Please see Storage Unit Purchasing Guidance for more information.

Regular maintenance of vaccine storage units is recommended to ensure proper operation and to maintain temperatures suitable for vaccine storage. Refer to the Vaccine Storage Unit Maintenance Guidance document for more information.

If your practice uses a freezer that requires manual defrost, refer to the Manual Defrost Guidance document for instructions on how to safely defrost your freezer.

Vaccine Placement

In all storage unit types, vaccines should be placed in the middle shelf of the unit and away from any cold air vents. Vaccine should not be placed in doors of storage units.

Temperature Monitoring

Temperature Monitoring Devices

VFC providers are required to have certified, calibrated temperature monitoring devices in each storage unit containing publicly-funded vaccine and one certified, calibrated back-up temperature monitoring device available (in the event that current equipment fails or requires calibrating testing). For more information on thermometer and calibration requirements, please see the NYS VFC Temperature Monitoring Device Guide (PDF) and the California VFC Program's Checklist for Thermometer Certificate of Traceability and Calibration.

Data Loggers

On January 1, 2018, the Centers for Disease Control and Prevention (CDC) will require that all New York State Vaccines for Children (VFC) use a continuous temperature monitoring device with an active temperature display and continuous monitoring and recording capabilities where the data can be routinely downloaded. Additional information can be found by reviewing the updated Temperature Monitoring Requirements document. Questions should be directed to dataloggers@health.ny.gov.

For more information on the NYS supplied Fridge-Tag®2L data loggers, please review the following documents:

Please refer to the recorded training webinar for step by step instructions on using the FridgeTag2L Data Loggers or here click to access a PDF version of the Fridge-Tag2L Data Logger Training slides.

Additional and Backup Data Loggers

Additional storage units:

  • VFC Providers are responsible for purchasing data loggers as needed for each additional storage unit beyond the first two, which were supplied by the NYS VFC Program.
  • To purchase additional Fridge-Tag2L Data loggers programmed for either a refrigerator or a freezer, visit https://www.microdaq.com/berlinger-fridge-tag2-vaccination-system.php. The approximate price is $149 each.

Backup Data Loggers:

  • You are responsible for purchasing at least one back up data logger per site. The backup data logger will be used when calibration of primary devices is due or if one of the primary device(s) malfunction. The backup data logger must meet all of the requirements outlined in the Temperature Monitoring Requirements document.
  • To purchase a programmable version of the Fridge-Tag®2L (can be set for either a refrigerator or a freezer), contact the product manufacturer, Berlinger USA at 1-508-366-0084 or info.us@berlinger.com. The approximate price is $159 for the programmable version.

Temperature Monitoring Procedure

  • The NYSDOH VFC Program now requires using a digital data logger for continuous temperature monitoring and recording in all vaccine storage units.
  • Temperatures need to be recorded manually twice daily when the clinic opens and when it closes for the day. This requirement applies even if the clinic is only open for a few hours or only for a half day. For example
    • If the office is only open from 8 am – 12 pm, the temperature should be checked at the time of opening (8 am) and before closing (around 12 pm).
    • If the office is only open from 4-7 pm, the temperature should be checked at the time of opening (4 pm) and before closing (around 7 pm).
  • Minimum and maximum (min/max) storage unit temperatures must be checked each day, preferably when the office first opens, and be recorded in the NYSIIS temperature log (or on a paper temperature log) at least once per day. Ideally, paper temperature logs should be entered in NYSIIS weekly, but can entered in NYSIIS up to 14 days after the date the temperature was observed.
  • Acceptable unit temperature ranges are 36° to 46°F (2° to 8°C) for refrigerators, and 5°F (-15°C) or colder for freezers. Providers should strive for 40°F and 0°F for refrigerators and freezers, respectively.
  • For more information on temperature monitoring requirements and recommended data logger functionality, please see the NYS VFC Temperature Monitoring Device Guidance (PDF)

Responding to Temperature Excursions

Any instance of an out-of-range temperature should be reported to the NYS VFC Program within one business day by calling 1-800-KID-SHOT (1-800-543-7468). When contacting the program please have ready: the amount of time that temperatures were out of range, the minimum and maximum temperatures if known, the type of storage unit and the amount of vaccines affected. Depending on the out- of-range temperatures, providers may need to contact the vaccine manufacturers to assess vaccine viability, and complete a NYS VFC Vaccine Manufacturer Follow-up Information Sheet.

Vaccine Transport

Routine transport of vaccine is not recommended. Each transport increases the risk of exposing vaccine to inappropriate storage conditions, which compromises the viability of vaccines. However, in certain situations transporting vaccine may be necessary.

Possible situations for transport include:

  • Transport to another facility in an emergency
  • Transport due to physical office relocation
  • Transport to another site or provider to avoid wastage
  • Transport to an off-site clinic

All Vaccines for Children (VFC) providers must have an individualized emergency vaccine storage plan which includes protocols on the safe transport of vaccines. Vaccine coordinators and/or backup coordinators are responsible for execution of the plan when indicated.

Refer to the NYS VFC Program Guidance for Vaccine Transport for more information on transporting vaccine.