Red Cross Blood Donation Safety Violations Result in $9.59M Fine

Federal regulators have fined the American Red Cross nearly $10 million for lapses in the safety measures employed in its blood collection efforts. 

The FDA released a letter (PDF) sent to the Red Cross on January 13, announcing that the organization was being fined for failing to correct multiple violations of blood safety rules and for failing to properly train workers in how to properly screen potential blood donors for individuals who should be disqualified.

The blood donation safety fines came after an inspection of 16 American National Red Cross Blood Service facilities nationwide from April through October 2010.

The FDA fined the Red Cross a total of $9.59 million for newly discovered problems, but also mostly for violating earlier consent decrees entered into by the organization to make its blood supply safer. In the letter, the agency points out that the organization has been cited for many of the same violations in the past.

The violations included understaffing of facilities, inadequate quality assurance policies, failure to comply with reporting requirements, failing to maintain an adequate national donor deferral register, and for failing to take proper action to prevent a recurrence of previous failures to control suspect blood or blood products.

The FDA noted that failing to deal with problems with suspect blood was “particularly serious because the failure to control suspect products and to correct the causes of errors increases the likelihood that unsuitable blood products will be transfused.”

According to the FDA, the Red Cross found approximately 18 major risk problems in managing suspect blood products at its Philadelphia facility in 2010, but failed to conduct an adequate root cause analysis of the problems, develop an appropriate corrective action plan or conduct an effectiveness check on some of the problems.

The American Red Cross has refused to comment on the fines, stating that it does not discuss its relationship with the FDA.

The fines came after a heavy push for accountability by the consumer watchdog group, Public Citizen, which urged the FDA to levy fines for the 2010 inspection findings.

The fines were assessed under a 2003 consent decree between FDA and Red Cross, reached between the agency and the non-profit organization after similar problems were discovered in 1993. The consent decree allows the FDA to impose significant fines on Red Cross when the organization fails to comply with federal blood collection regulations. Before the most recent fines, the Red Cross has been fined about $46 million by FDA since the consent decree.