FDA Fines Red Cross Over Unsafe Blood Management Practices

The U.S. Food and Drug Administration (FDA) just fined The American Red Cross over unsafe blood management practices. This is not the first time the agency has levied a large fine on the Red Cross.

This recent fine, of nearly $9.6 million, involves what the FDA described as sloppy and unsafe blood management practices and comes after inspections at 16 Red Cross blood centers, said MSNBC. The inspections took place April – October 2010 and revealed continuing problems that endanger donors and enable possibly contaminated blood to enter the nation’s supply.

FDA spokeswoman, Patricia El-Hinnawy, told MSNBC that, to date, there has been no evidence of harm to blood recipients and Red Cross officials are confident about blood sources in the United States. She did concede that issues at the Red Cross are troubling. “FDA cannot definitely say there was never any danger to the blood supply since the violations can create conditions that could lead to potential safety consequences,” she said, wrote MSNBC. The Red Cross supplies 40 percent of the country’s blood.

Violations were detailed in a 32-page letter sent January 13th to the executive vice president of Biomedical Services for the Red Cross, J. Chris Hrouda, said MSNBC. The letter discusses staff who are not appropriately trained and insufficient record-keeping, in which donated blood was handled inappropriately, misplaced, and, in some situations, in which potentially infected blood was transfused into recipients, said MSNBC. “ARC 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.

A Red Cross spokeswoman said problems mostly concerned an inspection at a Philadelphia site 15 months ago, and have since been addressed, said MSNBC. “We are disappointed that the FDA believed it necessary to impose a fine for an inspection conducted so long ago,” wrote Stephanie Millian, director of biomedical communications. “We are not aware of any adverse donor reactions or patient issues due to the problems in the FDA report,” she added, according to MSNBC.

The FDA letter also discussed failure to process and review records of donor reactions and injuries and a backlog of about 15,000 records in Charlotte, North Carolina. The letter said that Red Cross sites that have not maintained an accurate list of deferred donors, should be barred from giving blood over, wrote MSNBC. Other issues involve a failure to conduct “lookback” investigations that track donated blood from infected donors and notify potentially contaminated recipients and failure to investigate complaints and other problem notifications, said MSNBC.

Last year, we wrote that the FDA issued a massive $16 million fine to the American Red Cross for its prior failures to comply with Federal laws and regulations related to the collection and manufacture of blood products. The failures were described as slipshod practices concerning the collection and manufacture of blood products in just one of a string of multi-million dollar penalties for failure to meet blood safety standards.

The prior November we wrote that the FDA discovered what it described as “widespread and persistent problems with the storage and distribution” of blood supplied by the Red Cross. Based on agency investigation, which took place the prior year, significant violations were found, including over 200 violations discovered at 12 Red Cross facilities nationwide. The FDA noted that from 2003 through 2008 the Red Cross had to recall 7,363 “unsuitable” blood components. The FDA previously assessed fines totaling $16.18 million: $9.79 million for violations related to mismanagement of certain blood products and $6.39 million for Good Manufacturing Practice violations.

Despite repeated, high fines and informal threats concerning criminal penalties, the Red Cross has not improved its records, said MSNBC, citing the latest sanctions.