The American Red Cross and the Food and Drug Administration yesterday agreed to a consent decree over how the Red Cross runs its blood-collection operations.
FDA officials have long criticized the Red Cross for violations of blood safety laws and regulations.
Although the Red Cross had embarked on a long-term effort to improve its operations, the federal agency brought the nonprofit organization into federal court to formalize their pact.
The two organizations agreed to a number of measures intended to ensure the safety of the nation's blood supply, including a more comprehensive quality assurance program and increased training for all Red Cross blood program workers. The Red Cross also agreed to improve its data systems and records management as well as strengthen policies for investigating and reporting errors, accidents and adverse reactions.
In a statement, Fred Kyle, Red Cross senior vice president of biomedical services, said, "Our blood services operations are safer than ever," although "In the age of AIDS, nothing about blood can be 'business as usual.' " In a statement, Elizabeth Dole, president of the American Red Cross, said "we will not only fulfill the requirements of the FDA, we will surpass them."
Rep. John D. Dingell (D-Mich), chairman of the House Energy and Commerce Committee and a vocal critic of the Red Cross, released a statement saying "While it's unfortunate that it has taken so long to settle these matters, the steps announced today should further ensure the safety of the blood supply."
Many of the actions announced today were already part of a two-year-old, $148 million effort to upgrade the blood program. That program was announced in 1990 after FDA inspections found that the Red Cross had inadvertently released blood contaminated with hepatitis, failed to follow adequate safety precautions to guard against the use of AIDS-tainted blood and repeatedly failed to report accidents and errors to the agency.
For its part, the FDA has agreed to answer Red Cross inquiries about compliance and other issues within 90 days through a newly created panel. In the past, Red Cross officials have complained that they were willing to comply with FDA rules but could not get clear or prompt guidelines from the agency.
The consent decree, filed in U.S. District Court for the District of Columbia, replaces a 1988 voluntary agreement between the FDA and the American Red Cross that had previously governed oversight of the blood program. That agreement was not judicially enforceable.
"We need a new way of working with them and finding out what they want from us and what we can give them," Karen Shoos Lipton, general counsel for the Red Cross. "While I'm not happy about a consent decree I'd have to say there are a lot of things about it that are certainly beneficial for us."
Despite the efforts of the Red Cross under the improvement program, the FDA said it continued to find violations of blood safety laws and regulations at Red Cross facilities, and responded with "the appropriate regulatory notices" of its findings to Red Cross officials. Some cases went beyond mere warnings. According to court records, the FDA initiated proceedings to revoke the licenses of three regional Red Cross facilities in Albany, N.Y., Portland, Ore., and Charleston, S.C.
FDA officials said that despite the problems at the various blood banks, the overall system is sound. "For any patient requiring a blood transfusion, the risk of not receiving that transfusion outweighs the risk of receiving blood," FDA Commissioner David A. Kessler said in a statement. The nation's blood system is made up of many overlapping layers of protection to ensure that tainted blood does not infect recipients of transfusions. "Though individual layers were breached," said an FDA spokesman, "the overall risk is minimal."