Vaccines For Children (VFC) Provider Refrigerator and Freezer Requirements

Published by Nick Barrowclough on

child vaccination

What are the refrigerator and freezer requirements to be part of the VFC program? All VFC providers must comply with the requirements relating to the storage and handling of vaccines. You must have the correct equipment in place to conform to the policies implemented by the state.

vaccines for children VFC program

The temperature at which vaccines are stored is critically important to the efficacy of the immunization program. Too cold and vaccines are destroyed, too much or too long exposure to elevated temperatures and the potency degrades. Ideally, vaccines are kept at a stable temperature between 36°F and 46°F (2°C – 8°C). Failure to comply with this can result in millions of dollars worth of vaccines being lost. A recent study by the office of the inspector general found that out of 45 providers 76% exposed vaccines to temperatures outside the recommended range for at least 5 hours or more.

In New York State VFC providers as one Jan 1st, 2020 must have a stand-alone refrigerator and freezer unit in which to store vaccines. The freezer must be capable of maintaining a temperature at or below 5°F (-15°C). The refrigerator must stay between 36°F and 46°F (2°C – 8°C). More details on proper storage guidelines for vaccines from the CDC can be found here.

The below graphic illustrates the best practices and guidelines for the setup and use of a vaccine storage refrigerator

VFC refrigerator and freezer requirements. vaccine refrigerator storage guidelines
Checklist for vaccine storage unit recommendations
  • Refrigerator maintain a temperature between 35°F – 46°F (2°C -8°C)
  • Frost-free with defrost cycle
  • If manual defrost ensure periodic defrosting is performed as ice build-up diminishes the capacity of the freezer to maintain temperature.
  • Enough capacity to store the year’s inventory
  • Space for storing water bottles in the refrigerator and ice packs in the freezer to stabilize the temperatures and minimize temperature excursions
  • dedicated vaccine refrigerated, it should not store food and beverages
  • Have calibrated NIST certified and traceable sensors inside the storage unit
  • dedicated vaccine refrigerated, it should not store food and beverages
  • No gaps in the seal when door is closed

Temperature Monitoring and Data Loggers 

Despite vaccines coming with vaccine vial monitoring labels, as per guidance from the Center for Disease Control and Prevention (CDC) all VFC providers must have a suitable temperature monitoring device installed on each vaccine refrigerator. The sensor must continuously show the active temperature and provide downloadable data logs. A pre calibrated backup sensor must be kept on-site.

Refrigerator Unit Sizing 

The number of doses that your office utilizes per year will determine the type and size of refrigerated unit you will need to have available. 

No. Doses / year Required Equipment 
Very High Volume 10,000 doses/year Pharmacy-grade or biologic-grade refrigerator-only units and stand-alone freezer units 
High Volume 
2,000-10,000 doses/year  
Refrigerator-only (16.7 cubic feet minimum) and stand-alone freezer units 
Medium
Volume 500 – 2,000 doses/year 
&
Low Volume 
Less than 500 doses/year 
Refrigerator-only (16.7 cubic feet minimum) and stand-alone freezer units OR Pharmacy-grade OR biologic-grade under the counter units. 

Backup Power Systems

Each year the VFC program looses thousands of dollars of vaccines due to power outages. Wastage caused by temperature excursions can be avoided by having a battery backup power system or generator that can support the vaccine refrigerator. A high volume provider doing 10,000 doses per year typically restocks every quarter. This means they can hold up to $54,000 USD of inventory at any one time at an average of $16 per dose.


2 Comments

brad · August 20, 2020 at 1:46 am

great article.

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