The Vaccines for Children (VFC) Program in the U.S. is a federally funded program that provides vaccines for 16 preventable diseases at no cost to children who might not otherwise be vaccinated because of inability to pay. The program is administered under the direction of the Centers for Disease Control and Prevention (CDC), which buys the vaccines at a discount and distributes them to grantees — i.e., state health departments and certain local and territorial public health agencies — that distribute them at no charge to private physicians’ offices and public health clinics registered as VFC providers.¹

The network consists of 61 grantees and approximately 44,000 eligible enrolled providers throughout the U.S., Puerto Rico and U.S. territories. In 2010, nearly 82 million VFC vaccine doses were administered to an estimated 40 million children at a cost to taxpayers of $3.6 billion.² The program has, by and large, been a success. According to CDC, the U.S. has achieved 90% or greater reduction in most vaccine-preventable diseases among babies, young children and adolescents through public and private vaccination efforts.

The 44,000 VFC-eligible providers, under the guidance and recommendation of CDC, must meet certain requirements for vaccine management — commonsense stuff like storing them within required temperature ranges, properly rotating stock, and monitoring for expiration dates, to ensure that vaccine potency and efficacy remain high and children are afforded the maximum protection against preventable diseases. These requirements are also intended to decrease VFC program fraud, waste, and abuse.

But early in 2012, suspecting vulnerabilities in vaccine management at the provider level within the program, the Office of the Inspector General (OIG) at the Department of Health and Human Services issued a study. Using CDC data, 45 VFC providers were selected from the five grantees with the highest volume of vaccines ordered in 2010. The study was conducted in accordance with the Quality Standards for Inspection and Evaluation issued by the Council of the Inspectors General on Integrity and Efficiency. Site visits were arranged and conducted at these 45 providers’ medical practice locations, their vaccine coordinators were interviewed, their vaccine management practices were observed, and their storage facilities monitored for temperature for two consecutive weeks. They also interviewed the five grantees’ VFC program staff regarding their program oversight.

What the OIG found as a result of this study ranged from troubling to disastrous, exceeding the worst suspicions that management of the vaccine program was out of control and fraught with waste. It sent a shockwave through CDC, its grantees and state health departments nationwide. In a nutshell here is what the OIG found:

• 76% percent of the 45 providers whose vaccine storage units (refrigerators and freezers) were independently measured over a two-week period were found to have exposed their vaccine stocks to inappropriate temperatures for at least five cumulative hours during that period, potentially decreasing vaccine potency and efficacy and increasing the risk children are not provided with maximum protection. The most egregious offenders involved freezer storage facilities and improper or inadequate temperature monitoring.
• 35.5% of the 45 providers reviewed had expired vaccine in their inventories; 29% stored expired vaccines together with non-expired vaccines, significantly increasing the risk of mistakenly administering expired vaccine.
• 84.4% of the 45 providers reviewed did not have proper documentation. Selected providers generally did not meet vaccine management minimum requirements or maintain required documentation such as distinguishing between publicly and privately purchased vaccines, storing them separately or segregating them within freezers and refrigerators, and ensuring that vaccines are properly administered to the corresponding populations.
• None of the five selected grantees interviewed met all 10 categories of VFC program oversight requirements, indicating grantee sites were not effective in ensuring that providers met vaccine management requirements over time.
• 88% of the 45 provider sites did not meet all the requirements in at least half of the 10 vaccine management categories.

The effected vaccines on the days the OIG made their visits to the 45 providers cumulatively put at risk 18,346 doses, worth an estimated $737,640. The 45 providers represent about one-tenth of one percent of the entire VFC Program. The resulting potential harm to children receiving the effected vaccines is incalculable.

While these results apply only to the five grantees and 45 providers, and the OIG is careful to mention that the numbers should not be extrapolated out to the total population of 61 VFC grantees or approximately 44,000 providers, it doesn’t take a giant leap of faith to assume the problem is systemic across the VFC program, or that the problem exists in equal measure across the pediatric healthcare spectrum as public and private providers are often one in the same. Think about that.

OIG Recommendations and CDC Response
The OIG’s Report — https://oig.hhs.gov/oei/reports/oei-04-10-00430.pdf — recommends that CDC continue to work with grantees and providers to ensure that:

1. VFCs vaccines are stored according to requirements
2. Expired vaccines are identified and separated from non-expired vaccines
3. Grantees better manage providers vaccine inventories
4. Grantees meet oversight requirements

With regard to the first recommendation, CDC stated that it will work with its partners, including state health officials, immunization program managers, and professional organizations, to improve compliance with vaccine storage equipment and temperature-monitoring requirements to ensure proper vaccine storage.³

With regard to the second and third recommendations, CDC said that it is implementing significant changes to the VFC vaccine ordering and provider inventory reporting systems. Improvements to these systems and associated processes will result in better vaccine management, reducing the risk of expired vaccines. CDC will also review its guidance and training materials to ensure that program requirements related to managing expired vaccines are communicated to and understood by VFC providers and grantees.⁴

With regard to the fourth recommendation, CDC stated that it will work with VFC grantees and provider organizations to ensure that program requirements are necessary for effective program oversight. In addition, CDC will task working groups with reviewing VFC provider site visit procedures and documentation to ensure that site visits are effective in enforcing program requirements.⁵
At the time of this writing, 23 states are actively evaluating and correcting these vulnerabilities and shortcomings, either internally or through an RFP process involving private and industry consultants, in order to meet the OIG’s list of recommendations. Leading the charge are the states of Massachusetts, Virginia and New Mexico, with others close behind. Both state and federal funding is being provided for the assessments and implementation.

It will be a long, hard culture change but such improvements in vaccine management will likely lead to minimizing risk among public and private vaccine providers. Here’s hoping that at least some improvements are in place before your child’s next scheduled vaccination. 

References

1. Centers for Disease Control and Prevention website, About VFC http://www.cdc.gov/vaccines/programs/vfc/about/index.html
2. Levinson, Daniel, R., Vaccines for Children Program: Vulnerabilities in Vaccine Management, Office of the Inspector General Report, Department of Health and Human Services, June, 2012
3. ibid;
4. ibid;
5. ibid;

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Kevin O’Donnell is senior partner at Exelsius Cold Chain Management Consultancy – U.S. He is the former chair for the International Air Transport Association (IATA) Time & Temperature Task Force, a member of the USP Expert Committee on Packaging, Storage and Distribution, a temporary advisor and certified mentor to the World Health Organization (WHO), co-author of PDA Technical Report No. 39, and a member of the International Safe Transit Association (ISTA) Thermal Council. He blogs at www.clutchcargo.us. He can be reached at [email protected].