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Transcript for audio podcast:
Vaccines for Children Program: Vulnerabilities in Vaccine Management

From the Office of Inspector General of Department of Health and Human Services

http://www.oig.hhs.gov

Dwayne Grant, Atlanta Regional Inspector General, sits down with Holly Williams, Program Analyst for the Office of Evaluations and Inspections (OEI) in Atlanta, to discuss the recent OEI report titled "Vaccines for Children Program: Vulnerabilities in Vaccine Management."

[Dwayne Grant] I'm Dwayne Grant, Regional Inspector General for the Office of Evaluation and Inspections speaking with Program Analyst Holly Williams about a report called "Vaccines for Children Program: Vulnerabilities in Vaccine Management." Holly, tell us about the Vaccines for Children Program and the focus of this report?

[Holly Williams] Sure. The Vaccines for Children program, called the "VFC program," provides free vaccines to children who would not otherwise be vaccinated due to an inability to pay. The Centers for Disease Control and Prevention (CDC) provides grant money to state and local health departments, called "grantees," to administer the program through a network of over 44,000 enrolled providers. In 2011, approximately 40 million children received vaccinations through the VFC program.

Our report examined how 45 providers in 5 grantee locations stored and managed VFC vaccines. Improper vaccine storage and management practices, such as exposure to temperatures that are too warm or too cold, can result in reduced vaccine effectiveness. This can increase the risk that children are not provided maximum protection against preventable diseases. We also determined whether the five selected grantees' met VFC program requirements.

[Dwayne Grant] What types of vaccine storage and management practices did the team evaluate?

[Holly Williams] We evaluated 10 categories of vaccine storage and management practices established in CDC guidance, focusing on vaccine storage temperatures and expiration dates, which are also regulated by the Food and Drug Administration or FDA. To do this, we evaluated providers' storage equipment, like refrigerators, freezers, and thermometers.

We also focused on required documentation and on how the five grantees oversaw VFC providers to ensure vaccines are properly stored and managed.

[Dwayne Grant] Tell us, how did you do this study and what did you find?

[Holly Williams] We conducted site visits of 45 VFC providers to interview VFC program coordinators and evaluate how vaccines were stored.

We also independently recorded temperatures of freezers and refrigerators where providers stored VFC vaccines. We measured temperatures for two weeks using a temperature recording device called a "TempTale." Devices like these are used in Government and the pharmaceutical industry to ensure that vaccines are stored within the temperature ranges required by the FDA.

We found numerous instances where VFC vaccines were not appropriately stored and managed.

[Dwayne Grant] So, what does this mean in terms of vaccine vulnerabilities and effectiveness?

[Holly Williams] Determining the vaccines' effectiveness was not part of our study. However, we do know that vaccines exposed to temperatures that are too warm, too cold, or past the expiration date, may not provide maximum protection against disease.

[Dwayne Grant] What else did you find?

[Holly Williams] We found that the 45 providers generally did not meet vaccine management requirements or maintain required documentation. None of the five selected grantees met all VFC program oversight requirements and grantee site visits didn't ensure that providers met vaccine management requirements over time.

[Dwayne Grant] Because CDC distributes vaccines, funding, and guidance to help grantees and providers in meeting vaccine storage and management requirements, what is the Office of Inspector General recommending to CDC?

[Holly Williams] We recommended CDC continue to work with grantees and providers to ensure that (1) VFC vaccines are stored according to requirements, (2) expired VFC vaccines are identified and separated from non-expired vaccines, (3) grantees better manage providers' vaccine inventories, and (4) grantees meet oversight requirements.

[Dwayne Grant] What's been the CDC's response to this report?

[Holly Williams] CDC agreed with all of our recommendations and plans to work with the relevant parties to ensure vaccines are stored appropriately. CDC also noted that vaccination is one of the most successful public health tools in preventing and controlling disease. Finally, CDC believes that their efforts to strengthen VFC program storage and handling practices will help improve vaccination services nationally and benefit children vaccinated with both publicly and privately purchased vaccines.

[Dwayne Grant] Holly Williams, a program analyst for the Office of Evaluation and Inspections, thank you for sharing this important work on VFC vaccine storage and management.

[Holly Williams] Thank you.

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