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Red Cross agrees to meet FDA blood safety rules

Red Cross agrees to meet FDA blood safety rules

Ending years of contention with the Food and Drug Administration over violations of blood safety rules, the Red Cross on Friday agreed in a court settlement to meet all FDA blood rules or pay fines for failing to comply. The FDA has accused the Red Cross of "persistent and serious violations" of blood testing, handling, and tracking, including losing blood samples that had tested positive for HIV antibodies and having employees falsify records about testing donated blood for HIV and other pathogens. Two years ago the FDA went to court to seek a contempt citation against the Red Cross for failing to follow a 1993 agreement on blood safety standards. The agreement calls for fines of up to $10,000 per event or $10,000 per day for safety violations. Also included is an agreement on fines of up to $50,000 for the preventable release of blood that could cause a serious health problem or death, including blood infected with HIV, with a maximum fine of $500,000 for multiple release violations. Until Friday the Red Cross had opposed the idea of fines, noting that it has spent $300 million since 1991 to improve blood safety and that fines would delay ongoing safety improvements.

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