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
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
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.