American Red Cross Fined Millions for “Shoddy” Blood Collection—Again

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January 19, 2012; Source: Care2 | The American Red Cross has been fined $9.6 million after the U.S. Food and Drug Administration (FDA) found hundreds of violations in its blood collection procedures. The fines have been levied against half of the blood collection centers nationwide. The violations—which include having donated blood infected with HIV, Hepatitis C and the West Nile Virus—were detailed in a 32-page Adverse Determination Letter (ADL) written by Evelyn Bonnin, the FDA Director of the Baltimore District and issued by the FDA. The letter details problems including poorly trained staff and inadequate record keeping where donated blood was mishandled or misplaced. In some cases, potentially infected blood was transfused into patients.

The Red Cross has responded that they are disappointed in the FDA for relying on the results of an inspection carried out 15 months ago. They say that they have cleaned up their procedures in the meantime and that their blood supply is “safer than ever.” But this argument may be difficult to sell since this is not the first time the Red Cross has been fined for such infractions. In fact, they have apparently been fined $47 million for similar violations since 2003. The FDA letter states, “many of the violations recounted in this letter are virtually identical to violations charged in previous ADLs. [The Red Cross] has known of these continuing problems and has failed to take adequate steps to correct them.” –Ruth McCambridge