Red Cross blood donation practices unsafe, FDA says

The Washington Post

WASHINGTON — The government on Thursday asked a federal judge to hold the American Red Cross in contempt of court and to impose heavy fines for the organization’s continuing safety violations in collecting, testing and distributing more than 6 million blood donations a year.

The Red Cross continues to run its blood services operation with "cavalier disregard" for federal regulations, and "pervasive and long-standing violations" show the nonprofit has failed to abide by a 1993 consent decree ordering improvements, the Food and Drug Administration charged in a court filing.

The FDA contends the Red Cross’ own officials, while balking at fines, have acknowledged in letters and meetings that lax procedures have led to some "chilling near misses."

Inspections conducted as recently as this spring found problems at Red Cross blood centers that create "an imminent and serious potential for harm to blood donors and recipients," the FDA alleged. Among the recent problems were the release of blood tainted with a virus that could cause liver, brain and eye damage in infants, failure to follow-up with potential high-risk donors, and commingling clean products with products that tested positive for infectious diseases in the same storage area.

"It has been a matter of great frustration to FDA to witness ARC’s (American Red Cross’s) historic and continuing failure to correct its inadequacies despite more than a decade of enforcement efforts by the FDA," Jay Epstein, director of FDA’s Office of Blood Research and Review, said in a court filing.

The Red Cross supplies 45 percent of the nation’s blood as part of a $1.5 billion-a-year business that operates 36 centers nationwide. Red Cross spending on its blood operations dwarfs its spending on disaster relief.

In a written statement, the Red Cross said Thursday that it had spent $280 million and made great progress correcting its shortcomings since the FDA took it to court in 1993. "The Red Cross will vigorously contest the FDA’s motion and is confident that it will prevail," the organization said.

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