With Red Cross Under Fire For Safety Violations and Shortage Worsening, Some Centers Consider Paying Donors for Blood
Facing regulatory and financial problems, the American Red Cross, the top supplier of blood to American hospitals, is charging "dramatically higher" prices, leaving some hospitals "scrambling" to find alternative sources as the nation's blood shortage worsens, the Los Angeles Times reports. Chief among the organization's problems is what the FDA calls a "long-standing and ongoing" failure to comply with a 1993 consent decree. The court-ordered decree, which came after the Red Cross "unwittingly" distributed HIV-contaminated blood in the early- to mid-1980s, calls for periodic FDA inspections to ensure that "management and quality control" are being improved. However, an April 2000 inspection of the organization's headquarters found "widespread" violations, including failures to "properly quarantine potentially contaminated blood"; follow HIV test kit instructions; and inventory blood supplies and donor medical histories. A May inspection of a Red Cross facility in Salt Lake City, Utah, which resulted in 34 violations, was "particularly troubl[ing]," to regulators, who found among the "most serious" charges that the site failed to quarantine blood with missing test results, then released the blood for shipment. The FDA has requested the authority to fine the Red Cross $15,000 for each violation of the court order, saying it has sent the organization letters citing "significant" consent decree violations 10 times since 1993. American Red Cross President Dr. Bernadine Healy said she was "alarmed and surprised" by the "seriousness" of the April 2000 findings but "insisted" that overall violations have decreased. FDA-noted violations fell to 103 last year from 633 in 1994, and 15 of the organization's 27 blood centers had no violations, she said. "We have the best of the best within our system, and we have some problem children," she acknowledged, adding that the FDA holds the Red Cross to a "higher standard" than other blood collection agencies. She also noted that the Red Cross is not the only blood agency being held to a consent decree by the FDA, citing 1996 agreements made by United Blood Services, which services parts of the southwest, and by the New York Blood Center. However, according to the FDA's 2000 annual report, both of those agencies are meeting all parts of their agreements. The Red Cross has requested a review of the FDA's authority to issue the fines and asked for a "court-appointed" mediator to work out an agreement between the two groups.
The American Red Cross is $339 million in debt and was recently "forced" to use a $100 million reserve to pay for renovations to its blood centers and computer systems and to increase employee wages, making it necessary to increase blood costs, the Times reports. Part of the increased costs is due to a new blood filtering system meant to improve blood safety by removing leukocytes, white blood cells that can cause adverse immune reactions in recipients (Ornstein/Hernandez, Los Angeles Times, 7/30). The process adds about $35 to $40 to the cost of a pint of blood, and many hospitals have seen their blood costs double as a result. Also likely to reduce supply and drive up the cost of blood are strict new safety measures against mad-cow disease, under which the Red Cross will in September stop taking blood from anyone who has spent more than three months in Britain or six months in Europe. Critics say that the Red Cross, after coming under fire in the 1980s for "failing to safeguard the nation's blood supply against" AIDS, may now be "overreacting" to public health scares (Johannes, Wall Street Journal, 7/30). In addition to the new leukocyte filtering process, the Red Cross has also begun nucleic acid testing blood for viruses such HIV. The test can detect such viruses even before antibodies are present in the blood, but adds to costs (Los Angeles Times, 7/30).
Charging for Blood
As the blood shortage continues, some hospitals and blood banks are considering paying donors for their blood. Critics, including some ethicists and health officials, said that paying donors would "compromise the safety [of the blood supply]" by "encouraging" people to lie about their medical history and their behavioral risk factors. "The safest blood donor is the volunteer donor that donates for altruistic reasons," Red Cross Senior Vice President Jackie Fredrick said. "Clearly, the experience with the AIDS epidemic has created an environment in which ... blood bankers tend to bend over backward to do almost anything they can think of to improve the safety [of the blood supply]," Dr. Jeffrey McCullough, editor of Transfusion magazine and a professor of laboratory medicine at the University of Minnesota, said. However, those in favor of the pay-for-donation plan contend that blood screening processes today are "so advanced" that the safety of blood collected would not be compromised. They also argue that donors already get "incentives" such as paid time off work or food. In addition, they note that many collection centers already pay donors for platelets, blood components that cause clotting, as platelet donation is "more arduous and time-consuming" than regular plasma donation and as the platelet shortage is "even more severe" than the blood shortage (Hernandez, Los Angeles Times, 7/30).