By Rob Stein
Washington Post Staff Writer
Saturday, September 9, 2006

The federal government yesterday announced that it was fining the American Red Cross $4.2 million for continued failures to adequately protect the safety of the nation's blood supply.

The fine, the largest levied against the Red Cross under a 2003 agreement to improve chronic problems with blood safety, stems from the recall of about 10,000 units of blood between 2003 and 2005, triggered by repeated lapses, the Food and Drug Administration said.

The agency found no evidence that the violations resulted in any blood being contaminated or of any transfusion recipients becoming infected, but officials said they represented serious procedural failures that endangered public health.

"Absolutely it is not acceptable that the quality system has failed in this way," said Margaret Glavin, associate commissioner for regulatory affairs, during a telephone briefing. "FDA does not consider the current situation acceptable."

In a statement, the Red Cross, a private, nonprofit, District-based organization, said it "is committed to full compliance" with the 2003 agreement and "remains dedicated to its mission and to the millions of Americans who rely on us to provide lifesaving blood and blood components each year."

The lapses included failing to test blood properly and to ask donors required questions to determine their risk of carrying infectious agents that could be transmitted through their blood, such as those causing malaria and mad cow disease, officials said.

Because the system for protecting the blood supply has overlapping layers, the failures did not endanger any patients, but the continued lapses nevertheless pose a danger, officials said.

"We take all breaches of the safeguards very seriously because of their importance to ensuring the safety of the blood supply," said Jay Epstein of the FDA's Office of Blood Research and Review. "We're talking about breaches that may have increased the potential for contamination."

The FDA also ordered the Red Cross to review its procedures to prevent such lapses from occurring again.

The Red Cross has been under a court-supervised consent degree since 1993 to eliminate safety problems in its blood program, and the 2003 agreement made the organization subject to fines for violations.

Nevertheless, the FDA has continued to find repeated failures in the organization's procedures. Under the terms of the consent degree, the agency had previously imposed a total of $5.7 million in fines, including a $3.5 million penalty last year.

Although the Red Cross has been working closely with the FDA to try to address the agency's concerns, the "accumulation" of problems prompted the agency to impose the large fine and hold a news conference to publicize it.

"This fine is designed to serve as an incentive to address the issue," said FDA spokeswoman Susan Bro.