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Kaiser fined over vaccine monitoring
December 09, 2011, 02:42 AM By Michelle Durand Daily Journal Staff

The Kaiser Foundation Hospital in South San Francisco was fined $50,000 for improperly storing vaccines below freezing temperatures, potentially weakening the inoculations and tuberculosis skin test solutions for up to 3,921 patients.

In 2009, a survey to reduce medication errors by the California Department of Public Health found that vaccines were refrigerated at temperatures as low as minus eight degrees Celsius for a 32-month span. As a result, the vaccination status for nearly 4,000 patients was deemed either ineffective or unknown.

Three of the patients who received a compromised vaccine developed pneumonia and one 80-year-old died from the condition, according to the CDPH.

None of the three patients were ever notified their vaccines were potentially faulty which the CDPH cited as its reason for the penalty.

The CDPH did not specify all of which medications were specifically affected but noted that “do not freeze” warnings are issues for a number of drugs including those for diabetes, rabies, hemophilia, blood transfusions, rattlesnake bites and arthritis.

Between October and December 2009, Kaiser Permanente identified patients who received vaccines or TB skins tests between November 2006 and 2009, said Frank Beirne, senior vice president and area manager for the hospital.

The patients were given re-vaccinations or retests at no charge if they chose and Beirne said Kaiser expressed its “sincere apologies to our patients for any concern or inconvenience this may have caused.”

Following the discovery, the hospital replaced the vaccine stock and installed a manual temperature monitoring system, according to its response to the CDPH.

All medication refrigerators were reviewed and all pharmacy staff were retrained on proper storage methods.

No other problems were uncovered.

The administrative penalty is a first for the hospital and is one of 14 California facilities assessed fines for noncompliance issues that put patients at risk of serious injury or death, according to CDPH.

The fines, which ranged from $25,000 to $100,000, totaled $850,000 between all the penalized hospitals. The other facilities were in Fresno, Los Angeles, Orange, San Diego, San Francisco, Santa Barbara, Santa Clara, Solano and Ventura counties.

Half of the fines involved incidents in which patients had objects left inside them after operations and had to undergo additional surgery. Others involved wrongly administered medications, like Kaiser Foundation Hospital South San Francisco.

 

Michelle Durand can be reached by email: michelle@smdailyjournal.com or by phone: (650) 344-5200 ext. 102.




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