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Red Cross agrees to upgrade blood safety

Hospital Safety Connection, April 16, 2003

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After a string of governmental complaints about its safety record, the Red Cross agreed April 11 to meet new federal safety standards, the Associated Press reports.

The Food and Drug Administration (FDA) reached a settlement with the Red Cross to improve blood collection procedures. Under the deal, fines for various violations could total up to 1% of the Red Cross' $1.9 billion in annual revenues-or $19 million-in the first year, increasing to a maximum of 4% by the fourth year.

Two years ago, the FDA went to court seeking a contempt citation against the Red Cross for not following a 1993 agreement to meet blood safety standards. The settlement will be submitted to the judge in that case for approval.

There are overlapping safety procedures in effect and any breach of the safeguards doesn't necessarily result in unsafe blood products, the FDA said. The Red Cross provides about 45% of the U.S. blood supply. Independent blood centers collect another 45% and hospitals collect the remainder.

In its most recent Red Cross inspection last December, the FDA cited numerous problems, including a lack of management control and quality assurance oversight that could lead to a patient receiving potentially unsafe blood. The FDA found records altered to allow the Red Cross to accept blood from an unsuitable donor, failure to keep good inventory records in the case of a blood product recall, and mislabeled blood products.

For more information on the agreement, visit http://www.fda.gov/bbs/topics/NEWS/2003/NEW00891.html

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