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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update

CALIFORNIA: Refrigeration Problems at South San Francisco Kaiser Tied to Two Deaths


San Jose Mercury News (12.09.11) - Tuesday, December 13,

State health regulators fined a Kaiser hospital in South San Francisco $50,000 for improperly storing vaccines and medications later tied to patient illnesses and at least two deaths. The products were supposed to be stored at temperatures above freezing, but a hospital refrigerator dipped as low as 14.4 degrees Fahrenheit, according to a California Department of Public Health (CDPH) report released on Dec. 8.

The temperature drop rendered vaccines against hepatitis B, pneumonia, and other diseases ineffective and also compromised TB tests. Altogether, 3,921 people received "unknown or ineffective vaccination," the report said. Failure to maintain the refrigerator at the proper level went against manufacturer recommendations, state law and the pharmacy's policies, it said.

The head of the hospital pharmacy intended refrigerator maintenance checks to be conducted every three months, but hospital staff had last conducted one in 2006. The refrigerator problem was discovered during an August 2009 visit by state regulators. It was 110 days before most patients affected received an explanation or any communication from Kaiser about the problem, the report noted.

The defective refrigerator has been replaced; all other hospital refrigerators have been checked; and hospital staff members have received additional policy training, a Kaiser South San Francisco executive said. Hospital policy required a refrigerator temperature of between 36 and 46 degrees Fahrenheit.

Two patients with pre-existing medical conditions died, apparently from pneumonia, after receiving frozen pneumonia vaccine in 2009. A handful of other vaccinated patients got pneumonia but survived, according to the report.

The hospital was one of 14 in the state cited for safety violations and fined a total of $850,000 by CDPH.


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