Newsletter

OIG Report Reveals Vaccine Storage Failures

CHPSO continues to monitor the problem of incorrect storage temperatures for vaccines (for the latest of several articles on this issue, see the March 2012 CHPSO Patient Safety News). Many vaccines include an adjuvant that will separate from the immunogen when frozen, reducing or eliminating its efficacy. This article focuses on a recent Office of Inspector General (OIG) report, Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-10-00430).

The results of an OIG audit of the Centers for Disease Control’s (CDC’s) Vaccines for Children program reveal vaccine storage issues nationwide. It is important to note that only two of the 45 locations reviewed for compliance were hospitals; the majority were private practice clinics. While the overall statistics below are not representative of hospital performance, they do point out risk areas worthy of review.

CDC’s Vaccines for Children (VFC) program provides free vaccines to eligible children. In 2010, program providers administered approximately 82 million vaccines to an estimated 40 million children.

The OIG found that vaccine storage issues were widespread. Investigators measured prolonged (> 5 hours) inappropriate storage temperature at 76 percent of the locations. Roughly half of the locations’ temperature monitoring systems were significantly inaccurate, with recorded readings at least 5 degrees Fahrenheit off from the independent, calibrated measurement.
Providers of the Vaccines for Children program must perform required activities in 10 management categories: vaccine storage equipment, vaccine storage practices, temperature monitoring, vaccine storage and handling plans, vaccine personnel, vaccine waste, vaccine security and equipment maintenance, vaccine ordering and inventory management, receiving vaccine shipments and vaccine preparation.

None of the providers satisfied all of these requirements. The most common deficiencies were in storage equipment, storage practices, and temperature monitoring, with 96 percent of all providers failing to meet the requirements for storage equipment, 93 percent for storage practices, and 89 percent for temperature monitoring.

Deficiencies were also common in the other categories, excluding vaccine preparation, for which only one provider was deficient.

OIG recommendations contained in the report include the following:

  • Ensure that freezers and refrigerators can maintain vaccines at the required temperature ranges and have accurate temperature‐monitoring devices that are regularly calibrated and centrally placed within freezers and refrigerators.
  • Immediately remove expired vaccines from freezers and refrigerators used to store nonexpired vaccines to prevent inadvertent administration of expired vaccines.
  • Improve inventory systems and management to reduce excessive inventories and resulting waste of expired vaccines.

Hospitals participating in the Vaccines for Children program have additional management requirements (see Appendix B of the report). The complete OIG report, Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-10-00430) is available to download at oig.hhs.gov/oei/reports/oei-04-10-00430.asp.

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