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
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
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
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
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.