CDC issues new requirements for providers enrolled in the VFC program.
The Centers for Disease Control and Prevention (CDC) issued new requirements for all providers in the Vaccines for Children (VFC) program, effective January 1, 2018.
New regulations require all VFC providers to use continuous temperature monitoring devices for vaccines that will be used for children in the VFC program, including routine onsite storage and transportation of vaccines, as well as at mass vaccination clinics.
In addition, VFC providers must assess and record minimum and maximum temperatures daily, as well as meet CDC data logger requirements for both primary and back-up thermometers. These requirements include a temperature probe, a temperature display easily visible from the outside of the unit, and the capacity for routine downloading of continuous temperature monitoring and recording.
Why is the storage of vaccines important?
The temperature at which a vaccine is stored largely influences the usability of a vaccine, making access to and regular review of temperature data crucial. Exposing vaccines to temperatures outside of recommended ranges compromises both their potency and efficacy, sometimes rendering entire batches of a vaccine unusable when improperly stored.
Vaccines travel along a cold chain as they progress through each step from manufacturer to administration. The cold chain refers to all temperature-controlled equipment along the supply chain, including transport and handling of the vaccine. Maintaining the cold chain assures the quality of vaccines through storage, and is the shared responsibility of manufacturers, distributors, public health staff, and health care providers.
What other recommendations currently exist for vaccine storage?
To maintain the safety of vaccines, the CDC recommends stand-alone refrigerators and freezers, both with enough space to hold the maximum inventory without crowding. The CDC also recommends a digital data logger (DDL) for each unit, with at least one back up on hand. In situations where vaccines must be transported, emergency transport containers are recommended for the storage of vaccines, each with their own DDL.
The CDC also offers specific recommendations on the quality of refrigerator and freezer units, temperature monitoring devices, frequency of temperature recording, placement and power supply of units, approved temperature ranges, and organization and storage of vaccines in the unit.
What is the VFC?
The VCF, or the Vaccines for Children program, is a federally funded initiative allowing children access to vaccines who might otherwise be unable to pay. The vaccines are purchased at a discount by the CDC and are distributed to medical facilities registered as VFC providers.
Under this program, there is no cost for the vaccine, although the patient may incur other fees for administration of the shot, office visits, and other non-vaccine services. For those who have been injured by routine administration of vaccines, the National Vaccine Injury Compensation Program exists.
National Vaccine Injury Compensation Program
Vaccines are an important part of public health, working to save lives by preventing disease. Most of the time, vaccines are administered without any serious problems. Like with any medication, however, there is a risk of side effects, ranging from mild to serious.
For this reason, the US government created the National Vaccine Injury Compensation Program (NVICP), a “no-fault” alternative to the traditional legal system. Petitions can be filed by any individual, at any age, after developing an injury believed to be a result of a covered vaccine, if jurisdictional requirements are met.
Conway Homer, P.C. is the most experienced vaccine injury law firm in the United States. We represent clients from all 50 states and have advocated for landmark cases that have shaped the Vaccine Program and made it friendlier and more generous to those individuals who suffer from vaccine injuries. To get in touch with our dedicated team, click here for a free consultation.