Vaccines for Children Program: Vulnerabilities in Vaccine Management

WHY WE DID THIS STUDY

CDC's Vaccines for Children (VFC) program provides free vaccines to eligible children through a network of 61 grantees and 44,000 enrolled providers. In 2010, approximately 82 million VFC vaccine doses were administered to an estimated 40 million children at a cost of $3.6 billion. VFC providers must meet certain requirements for vaccine management, such as storing vaccines within required temperature ranges and monitoring expiration dates, to ensure that these vaccines provide children with maximum protection against preventable diseases. These requirements are also intended to decrease VFC program fraud, waste, and abuse.

HOW WE DID THIS STUDY

Using CDC data, we selected a sample of 45 VFC providers from the 5 grantees with the highest volume of vaccines ordered in 2010. We conducted site visits at these providers' medical practice locations, interviewed their vaccine coordinators, and observed their vaccine management practices. We also independently measured these providers' vaccine storage unit temperatures for a 2-week period. Finally, we interviewed the five grantees' VFC program staff regarding their program oversight.

WHAT WE FOUND

Although the majority of storage temperatures we independently measured during a 2 week period were within the required ranges, VFC vaccines stored by 76 percent of the 45 selected providers were exposed to inappropriate temperatures for at least 5 cumulative hours during that period. Exposure to inappropriate temperatures can reduce vaccine potency and efficacy, increasing the risk that children are not provided with maximum protection against preventable diseases. Thirteen providers stored expired vaccines together with nonexpired vaccines, increasing the risk of mistakenly administering the expired vaccine. Finally, the selected providers generally did not meet vaccine management requirements or maintain required documentation. Similarly, none of the five selected grantees met all VFC program oversight requirements, and grantee site visits were not effective in ensuring that providers met vaccine management requirements over time.

WHAT WE RECOMMEND

We recommend that CDC continue to work with grantees and providers to ensure that (1) VFC vaccines are stored according to requirements, (2) expired vaccines are identified and separated from nonexpired vaccines, (3) grantees better manage providers' vaccine inventories, and (4) grantees meet oversight requirements. CDC concurred with all four of our recommendations and noted that vaccination is one of the most successful public health tools in preventing and controlling disease.