Questions About Safety of Red Cross’ Blood Program Linger
The American Red Cross, the nation's largest supplier of donated blood, is "struggling" to show the FDA that it has adequately addressed concerns raised over a decade ago about the safety of its blood program, the Washington Post reports. The organization could face multimillion-dollar fines from the government if it does not demonstrate greater improvement in its blood safety record. Collecting, processing and selling blood constitutes the not-for-profit Red Cross's "biggest activity," as its $1.5 billion-a-year program is operated by 36 regional centers, nine testing laboratories and 16,000 employees. The FDA first began investigating the organization in the mid-1980s, when the lack of a test for HIV and the decentralization of its blood program -- 28 different computer systems were used -- meant that a donor who tested HIV-positive at one of the then more than 50 regional centers "could appear at another, which would not have a record of the test." After the FDA cited a St. Louis center in 1988 for safety violations involving HIV-positive blood, the Red Cross agreed to "evaluate its computer systems, establish rules for tracking dangerous donors and develop training programs." But the Post reports that by the early 1990s, it "was clear" that this agreement had failed, as the FDA continued to find "numerous safety violations" in the Red Cross' blood system. In 1993, the FDA entered into "a court-supervised consent degree" with the Red Cross in which the organization "promis[ed] to make major improvements in its testing, handling and tracking of blood supplies" or face being held in contempt of court. Since then, the FDA says it has spent more than 30,000 hours investigating Red Cross centers.
Are Fines Needed?
Red Cross officials say that the "blood supply is safer than ever and the risk of contracting a disease through a transfusion is minimal." They point out that FDA violations have declined from an average of 15 per site in 1994 to four per site in 2000, and say that no safety violations have occurred at its new testing facilities. In court filings, Red Cross lawyers said that government fines would "only add to the financial burden the consent decree has imposed on the Red Cross" and would "needlessly divert resources from its efforts to improve Blood Services and substantially compromise the goal of a safe and available blood supply." However, FDA attorneys say that while the Red Cross has made "some advances," its claims of improvements to its blood system are "inaccurate and incomplete," adding that investigators have found 10 "significant deviations" from safety regulations since the consent decree was established. For instance, at an April 2000 inspection of the organization's national blood headquarters in Arlington, Va., investigators discovered the "release of blood products that tested positive for a virus that can cause retardation and liver damage in infants." Last year, the FDA took steps to amend the consent decree to allow for penalties of up to $15,000 a day for each violation found at a blood center (Gaul/Flaherty, Washington Post, 12/9).