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 (PDF).

Vaccine Storage Units

All NYS VFC providers must use stand-alone refrigerator and freezer units to store vaccine. 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). Always refer to the vaccine product insert for specific storage and handling information, as some vaccines have a more limited storage range. For example, the Mpox vaccine must be stored between -15° and -25° 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: Digital Data Loggers (DDLs)

The Centers for Disease Control and Prevention (CDC) requires all VFC providers to have certified, calibrated continuous temperature monitoring devices, called Digital Data Loggers (DDLs) in each storage unit containing publicly-funded vaccine. In addition, providers must have at least one certified, calibrated back-up DDL available in the event that current equipment fails or the primary DDL requires calibration testing. DDLs must meet the requirements listed under "Required Device Functionality" listed in the New York State Temperature Monitoring Guidance document, including an active temperature display and continuous monitoring and recording capabilities where the data can be routinely downloaded.

For more information on thermometer and calibration requirements, please see the New York State Temperature Monitoring Guidance document (PDF) and the California VFC Program's Checklist for Thermometer Certificate of Traceability and Calibration (PDF).

Providers may use any brand of DDL that meets the requirement described in the New York State Temperature Monitoring Guidance document. New York State currently has a contract to supply each VFC provider with one refrigerator and one freezer DDL once every two years. The current DDL supplied by New York State is called a Fridge-Tag®2L. Providers may choose to receive these data loggers or use their own purchased devices.

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

Click here to access a PDF version of the Fridge-Tag®2L Data Logger Training slides .

Additional resource videos:

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-Tag®2L DDLs programmable for either a refrigerator or a freezer, visit MicroDAQ.com.

Backup Data Loggers (DDLs):

Backup DDLs will be used when calibration of primary devices is due, in case of an emergency, or if one of the primary device(s) malfunction. The backup DDls must meet all of the requirements outlined in the New York State Temperature Monitoring Guidance document (PDF). Providers enrolled in the Vaccines for Children Program are responsible for purchasing at least one back up data logger per site.

What does this mean?

  • Regardless of storage conditions, there must be continuous temperature monitoring at all times, including during situations when your Emergency Plan is initiated.
  • Providers must have a sufficient supply of both backup refrigerator and backup freezer data loggers (or programmable DDLs that can be set to read either refrigerator or freezer temperatures) for use during the emergency situations.
  • The primary storage units and backup storage (emergency location) storage units must have DDLs in them to monitor the temps:
    • of the primary storage unit(s) when the vaccine was removed and returned (must be able to document that the temperature was stable when vaccines were returned post emergency)
    • of the emergency backup storage unit(s) to determine that the unit is in the correct temperature range when vaccines are transported there, and to record temps daily while vaccine is stored at the backup location.
  • In addition, providers must have DDLs to separately transport refrigerated and frozen vaccines, which are transported at different temperatures with different transport materials/conditions. Refer to the NYS VFC Program Guidance for Vaccine Transport.
  • The emergency plan and specific steps, including use of DDLs as listed above must be detailed in a written Vaccine Management Plan.
  • Backup DDLs must be "readily available" during an emergency. If sharing a backup DDL with another nearby site, you must have documentation of the location of the backup DDL and a copy of the calibration certificate on site and included in your Vaccine Management Plan. Please consider if the provider you are sharing with might also lose power at the same time. Also consider the commute to pick up the shared DDL during a potential ice storm, for example.

Temperature Monitoring Procedure

  • Digital Data Logger (DDL) data must be downloaded and reviewed at least once every two weeks, and any time an out-of-range temperature (excursion) is noted. The downloads must be saved for a minimum of 3 years.
  • Temperatures need to be recorded manually daily when the clinic opens for the day.
  • 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.
  • 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. As indicated in the Vaccine Storage Units section, always refer to the vaccine product insert for specific storage and handling requirements.

Responding to Temperature Excursions

VFC providers experiencing any instance of an out of range temperature should complete and submit a Temperature Excursion Report to the VFC Program at vaccinetempexcursion@health.ny.gov the same day it is noted.

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 – must notify NYS Vaccine Program in advance
  • Transport to another site or provider to avoid wastage – must notify NYS Vaccine Program in advance
  • Transport to an off-site clinic - Local Health Departments only, all other provider types must receive prior approval from NYS Vaccine Program

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.