Food and Drug Administration Raps Red Cross for Blood-Safety Lapses
October 24, 2002
The Food and Drug Administration has singled out the Salt Lake City branch of the Red Cross for particular criticism of the national organization's handling of blood supplies. Salt Lake City Red Cross officials insisted on Wednesday that their blood supplies are safe.
In 1993, the FDA negotiated a court-approved consent decree with Red Cross that was supposed to ensure the safety of the nation's blood supply. FDA spokesperson Lenore Gelb said Wednesday the agency has not been satisfied with Red Cross efforts over two decades to screen blood donors.
The FDA found sloppy procedures at SLCRC during weeks-long inspections in 2000 and 2001. In May 2000, Red Cross headquarters told the FDA it had taken steps to comply with federal regulations, but a blood quality assurance officer in Salt Lake City admitted to having taken none of the corrective actions.
In May 2001, FDA inspector Mary T. Carden found SLCRC was accepting blood from hundreds of people whose donations should have been rejected based on their answers to health questions -- even people who said they were HIV-positive.
The Red Cross insisted it called the donors in question and changed their high-risk "yes" answers to "no" based on their conversations. The FDA says that follow-up effort was "deeply troubling" and unlawful -- that since the Red Cross could not have known that the people on the phone were in fact the blood donors and that their answers were truthful, the blood should have been discarded. Last December, the FDA asked a federal court to cite SLCRC with contempt and impose a schedule of fines for future violations. Instead, the court appointed a mediator, but Gelb said the case has not been resolved.
Julia Wulf, medical director for SLCRC, insisted blood transfusions are safe, and that the risk of getting AIDS or hepatitis from donated blood is one in 2 million, according to American Red Cross estimates. Wulf and other American Red Cross officials said they could not address FDA allegations under litigation. Of every 10 bags of blood used in Utah hospitals, eight come from the American Red Cross.
10.23.02; Paul Foy
This article was provided by U.S. Centers for Disease Control and Prevention. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update. Visit the CDC's website to find out more about their activities, publications and services.