Inspectors flag gaps in Vaccines for Children program

Jun 6, 2012 (CIDRAP News) – A review of five of the biggest jurisdictions that supply and monitor providers in the Vaccines for Children (VFC) program found several problems, including improperly stored and expired vaccine, according to findings released yesterday.

The review was conducted by the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) in 2011, and HHS published the 49-page OIG findings and recommendations yesterday on its Web site.

Implemented in 1994 as a component of state Medicaid plans, VFC is a federally funded program that provides free vaccine to children who don't have health insurance or can't afford the cost. The federal government funds the program through the Centers for Disease Control and Prevention (CDC), which purchases discounted vaccine from manufacturers and distributes them to 61 grantees, mainly states and large cities. The grantees in turn send them to 44,000 enrolled providers, including public health departments, private clinics, and federally funded clinics.

Sixteen vaccines are included in the VFC program, ranging from diphtheria to varicella zoster. In 2010, the program provided 82 million vaccine doses to about 40 million children at a cost of $3.6 billion, according to the report.

To maximize protection against disease and prevent fraud and waste in the VFC program, providers must meet several management requirements, such as storing vaccine at the correct temperature and ensuring that expired doses are removed from vaccine inventories. Grantees must periodically monitor how providers are managing VFC vaccine.

OIG investigators visited, interviewed staff, and took serial storage-temperature readings at 45 providers from five grantees that received the highest volume of VFC vaccine in fiscal year 2010—California, Florida, Georgia, New York City, and Texas.

Several of the concerns raised in the report focused on vaccine storage. Overall, the OIG found that vaccine stored by 76% of providers was exposed to inappropriate temperatures for at least 5 cumulative hours during a 2-week monitoring period. In some instances, vaccines in refrigerators were exposed to freezing temperatures, and some providers were using dorm-type refrigerators, which the VFC program doesn't allow for permanent storage.

Thirteen of the 45 providers had expired vaccine on hand that was stored alongside unexpired vaccine, which poses a risk of mistakenly administering expired vaccine that may not provide optimal protection, the inspectors found.

Investigators found several other gaps related to inventory management, planning, documentation, and oversight. Grantees have been required to visit a percentage of their providers each year to ensure that they are meeting requirements, but the OIG found that the visits didn't ensure that providers were meeting them.

The OIG had four recommendations for the CDC covering its continuing work with grantees and providers:

  • Ensure that VFC vaccines are stored according to requirements, and that grantees ensure that providers have freezers and refrigerators that maintain proper temperatures and thermometers that are regularly calibrated and properly placed.
  • See that expired vaccines are identified and separated from unexpired stocks.
  • Improve inventory management and procedures to ensure that orders meet provider needs and reduce vaccine waste.
  • Make sure grantees meet oversight requirements.

The CDC, in response to the findings, concurred with all four of the OIG's recommendations, according to the report. The CDC said it would work with its partners to improve compliance with storage requirements and is implementing significant changes in the VFC ordering system.

The agency said it is reviewing its guidance and training materials and will work with grantees to review provider site-visit procedures and documentation.

See also:

Jun 5 HHS OIG report on VFC management vulnerabilities

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