Children's vaccination program found lacking

June 21, 2012

Auditors found that there is room for improvement in numerous areas of the Centers for Disease Control and Prevention’s Vaccines for Children program. What areas failed to make the grade?

There is room for improvement in the storage and oversight of vaccines used in the Centers for Disease Control and Prevention’s Vaccines for Children (VFC) program, a $3.6 billion Medicaid program in which 61 grantees and 44,000 providers vaccinate eligible children free of charge.

Inspectors selected for review 45 providers from the 5 grantees who ordered the most vaccines in 2010.

According to a report issued by the US Department of Health and Human Services Office of the Inspector General, more than three-quarters of the 45 providers selected stored at least some vaccines at inappropriate temperatures for at least 5 cumulative hours during the 2-week sampling period. All 45 providers recorded temperatures that differed at least once during the 2-week period from those determined by the inspectors, indicating that either the providers’ thermometers were faulty or that their staff members were not recording temperatures correctly.

Additionally, 16 providers were stocking expired vaccine that was, on average, 186 days past the expiration date. Some doses were as much as 673 days past the expiration date. Thirteen providers stored expired and unexpired vaccines together.

None of the 45 providers met all the required management activities in all 10 vaccine-management categories; 40 of 45 providers did not meet all the requirements in half the categories; and 38 of 45 providers did not have the required documentation.

Shortcomings also existed with grantees that administer the program at state and local levels. None of the 5 grantees sampled met all the oversight requirements, and grantee site visits did not improve providers’ abilities to meet vaccine-management requirements over time.

In response, the American Academy of Pediatrics (AAP) issued a statement saying that even though inspectors found variations in vaccine storage temperatures, no vaccines were deemed unsafe, and no children required revaccination. The AAP said that additional resources and funding are necessary for physicians’ offices to be able to continue to deliver the approximately 82 million immunizations required for the approximately 40 million eligible children in the VFC program.

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