It was reported last month that federal health officials fined the American Red Cross nearly $9.6 million for blood management practices described as “sloppy and unsafe.” This is the second multi-million-dollar penalty levied against the Red Cross in the last two years. This most recent fine by the Food and Drug Administration came after inspections at 16 Red Cross blood centers between April and October 2010, which were said to reveal ongoing problems. According to the FDA, those problems appeared to endanger donors and to allow potentially contaminated blood into the nation’s blood supply. But, an FDA spokeswoman said the agency found no evidence of actual harm to blood recipients. Red Cross officials say they remain confident about sources of blood in the U.S. The Red Cross supplies 40% of the nation’s blood.
The FDA said in a letter to the Red Cross that the blood collection system was plagued with “poorly trained staff and inadequate record-keeping,” and that donated blood was “mishandled or misplaced and, in some cases, potentially infected blood was transfused into patients.” The letter stated further that the Red Cross “has known of these continuing problems and has failed to take adequate steps to correct them.”
A Red Cross spokeswoman said in a statement that the problems primarily centered on an inspection at a Philadelphia site conducted 15 months ago and that the agency has since addressed many of the issues. The spokesperson said the Red Cross was “not aware of any adverse donor reactions or patient issues due to the problems in the FDA report.” The latest fine, however, follows a $16 million fine in June 2010 for similar failures.
For almost two decades, trouble at the Red Cross has been reported. About 17 million units of blood are donated each year and about 15 million units are transfused, according to a 2009 survey conducted by AABB, an international association of blood products groups. The Red Cross has been operating under terms of a consent decree first issued in 1993 and then amended in 2003 to allow the FDA to impose stiff fines for ongoing failures to meet regulations and laws governing quality and safety of the nation’s blood supply.
While I believe the public generally trusts the Red Cross, and considers what it does to be very important, a number of problems have been reported. The problems detected in previous years included: overworked staff, sloppy clinical practices and inadequate record-keeping. Despite repeated heavy fines and even the informal threat of criminal penalties from some FDA officials, the Red Cross appears to still have problems. The latest sanctions at least demonstrate the existence of problems. Due to the subject matter and the potential for harm, this is a matter that needs to be resolved.
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