MARC KAUFMAN / Washington Post 3dec00
WASHINGTON--The American Red Cross is failing to ensure the safety of the nation's blood supply, putting transfusion recipients at risk of being infected with viruses and bacteria, the Food and Drug Administration has concluded.
Despite years of warnings and legal action to prod the nation's largest blood supplier--a key resource in times of emergency--to quickly improving its safety controls, recent FDA inspections continue to find serious problems, agency officials say.
"The FDA believes that existing violations are serious because they present a real potential for harm," Jay Epstein, director of the FDA's office of blood research and review, said Friday.
"The bottom line is that the U.S. blood supply is safe," he said. "However, it can and should be made safer, and in particular the system to assure safety must be improved."
FDA inspections have found problems including contaminated blood being stored with blood for distribution, an inadequate system for preventing the release of potentially harmful blood products, and the actual improper distribution of some blood with cytomegalovirus--which is harmless to most people but harmful to newborns and people with impaired immune systems.
The president of the American Red Cross, Bernadine Healy, said Friday that she agreed with the FDA's assessment, and that her agency recently had begun the process of borrowing $100 million to address some of the problems.
"Yes, there have been some near-misses that should never have occurred, and we weren't moving as fast as we should have," Healy said. "But nobody was harmed, and the public should know that the blood supply is safe."
Concerned that the Red Cross is not improving fast enough, the FDA is seeking the right to impose financial penalties to spur the organization to faster action.
That effort to levy multimillion-dollar penalties on the nonprofit blood supplier brought the dispute to U.S. District Court this week. The Red Cross asked for a federal mediator to resolve the issue of possible future penalties, and the FDA answered that the track record of the Red Cross made the agency's actions necessary. The Red Cross has been under a federal court decree since 1993, and has been out of compliance with FDA regulations since 1985.
In its filing, the FDA included summaries of highly critical inspections made in the summer of 1999 at the Red Cross Atlanta center, and others made at the Red Cross national biomedical headquarters in Arlington, Va., last spring, that showed widespread and serious problems.
At the Southern Regional Blood Service Center, inspectors found infractions such as "inadequate inventory management resulting in the inability to account for unsuitable blood products, including units that had positive test results for infectious diseases."
At the national headquarters, they found the "improper release of cytomegalovirus positive blood products" and "donors being associated with incorrect histories."
The violations could send the wrong blood to patients. For instance, half of all donated blood carries cytomegalovirus, and it is harmless to most recipients. But it can cause difficulties for infants and people with impaired immune systems.
"We consider these types of violations to be very serious," Epstein said. "They raise real points of public health concern."
Healy said she was "stunned" when she saw the "devastating" inspection reports, especially since improvements at the organization had been widely proclaimed by former FDA commissioner David Kessler and Health and Human Services Secretary Donna Shalala.
Elizabeth Dole had been president of the Red Cross from 1991 to early 1999, when she resigned to seek the Republican nomination for president, and the organization was believed to have resolved its problems under her direction.
"I brought in the investigators to meet with me and our board so we could all learn what the problems were," Healy said. "We've worked very hard with the FDA since then to improve. I understand the frustration at the FDA because we have not been moving as fast as we should have."
But Healy said her organization had no choice but to oppose imposing financial penalties.
"We have zero operating profit," she said. "We couldn't accept a situation where money for our programs might go to pay penalties rather than to improve those programs."
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