In the second multi-million-dollar penalty levied against the American Red Cross in the past two years, the Food and Drug Administration has fined the agency nearly $9.6 million for “sloppy and unsafe blood management practices.”
Inspections at 16 Red Cross blood centers in 2010 revealed what the FDA said is ongoing problems that appeared to endanger donors and could allow potentially contaminated blood into the nation’s supply.
And while no evidence of actual harm to blood recipients was found, FDA spokeswoman Patricia El-Hinnawy said government officials “cannot definitively say there was never any danger to the blood supply since the violations can create conditions that could lead to potential safety consequences.”
A 32-page letter sent to J. Chris Hrouda, executive vice president of Biomedical Services for the Red Cross, details a blood collection system rife with poorly trained staff and inadequate record-keeping, as well as a system where donated blood was mishandled and misplaced.
“[The Red Cross] has known of these continuing problems and has failed to take adequate steps to correct them,” wrote Evelyn Bonnin, director of FDA’s Baltimore District.
For its part, the Red Cross, which supplies 40 percent of the nation’s blood, said in a statement that the problems were primarily found during an inspection of a site in Philadelphia more than a year ago and those issues have since been addressed.
Stephanie Millian, director of biomedical communications for the agency, added, “We are disappointed that the FDA believed it necessary to impose a fine for an inspection conducted so long ago. We are not aware of any adverse donor reactions or patient issues due to the problems in the FDA report.”