- The Washington Times - Friday, December 14, 2001

The Food and Drug Administration yesterday asked a federal judge to hold the Red Cross in contempt for ignoring a court-supervised agreement to improve the testing and tracking of the nation's blood supply.
The FDA accused the Red Cross of "persistent and serious violations of blood safety rules" despite an "agreement to make substantial improvements."
The agency asked U.S. District Judge John Garrett Penn to authorize the agency to fine the Red Cross as much as $15 million a year for failure to abide by a 1993 consent decree requiring the organization to make top-to-bottom revisions of its blood program.
Although federal officials were critical of what they characterized as Red Cross laxity, they hastened to add that the blood supply should not be considered unsafe.
Bernard A. Schwetz, the FDA's acting principal deputy commissioner, said in a statement that patients should not hesitate to receive blood. "The risk of not receiving a needed transfusion far outweighs the risk of receiving blood," he said.
Dr. Schwetz, a veterinarian, said his agency was acting "to ensure that the American Red Cross takes much more seriously its role as guardian of the nation's blood supply."
The Red Cross "has been willing to tolerate an unacceptably low level of quality assurance and a lack of concern for the public it is supposed to serve," Dr. Schwetz said. He added that the "prospective penalties" the FDA was seeking "are necessary to ensure that the [Red Cross] is held financially accountable for each unit of blood it fails to manage properly."
A Red Cross spokesman who was asked for a reply to the charges said the organization was preparing a response, but there was no immediate comment.
The FDA was moved to act following a series of inspections of Red Cross blood operations. Most recently, the agency reported, it found that blood "potentially contaminated" with cytomegalovirus had been mislabeled and released for use. Cytomegalovirus inhabits the salivary glands and causes an infection that can produce mental retardation, among other things.
The inspections also revealed what the FDA called inadequate control of blood and donor registration records and failure "to maintain accurate and current lists of deferred donors." As an agency spokesman explained, there also are "glitches in the computer system" that allow the Red Cross to mistakenly release for use blood that is required to be held for testing or for other reasons.
The action by the FDA is just the latest of many clashes between the agency and the Red Cross. In 1998, for instance, the FDA accused the Red Cross of misplacing thousands of records. It also said the organization was improperly storing blood plasma near plasma contaminated with hepatitis or other infectious elements.
Subsequently the agency has argued repeatedly that the Red Cross relies on an inferior computer system that permits mistakes.
In reaction to the criticism, the Red Cross reportedly has spent millions revamping its computer network and its blood-handling program.
But as evidenced by yesterday's action, the FDA still is not satisfied.

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