AIDS-Risk Transfusions Unreported, Study Finds

The American Red Cross failed to notify federal regulators of about 230 cases over the last 10 years in the Washington, D.C., area in which patients may have received AIDS-contaminated blood transfusions, according to a report released Tuesday by the Food and Drug Administration.

FDA officials said that all but about six of the cases occurred before 1985 when a test was instituted to screen for AIDS infection.

The report, which stemmed from an inspection at the American Red Cross national headquarters in Washington this spring, outlined numerous problems within the organization, including deficiencies in its computer systems and in its procedures for dealing with error and accident reports.

“There are no procedures for reviewing and tracking transfusion-associated AIDS cases by National (headquarters) to assure all regions are submitting the initial reports and follow-up investigations are complete,” the report said.

Officials at the national headquarters failed to review at least 380 reports of errors submitted by regional blood centers, the report said. Examples of problems that should have been reported included incidents of bacterial contamination in which recipients subsequently died.

The National Red Cross issued a statement Tuesday, saying it feared that publicity about the report would “needlessly alarm the American public about the safety of the blood supply.”

Further, the Red Cross said, it did not fail to comply with FDA requirements to report transfusion-associated AIDS “for the simple reason that there are no such requirements.” The “actual reporting mechanism calls for the personal physicians of AIDS patients to report confirmed cases of AIDS” to the federal Centers for Disease Control, “which does follow-up to prevent the spread of the disease.”

Jeff Nesbitt, a spokesman for the FDA, said: “If it’s a potential AIDS transfusion case, they must report it to the FDA. Also, all local Red Cross centers must report such cases to the national headquarters.”

Investigators for the House Energy and Commerce oversight and investigations subcommittee, which is investigating the safety of the nation’s blood supply, said that they also are looking into the organization’s activities since the blood screening began. Also, they said, they are examining potential problems related to other diseases transmitted through blood, including hepatitis.

The subcommittee has scheduled a hearing for Friday.

The Red Cross emphasized that the congressional inquiry “has been under way for some time and was not begun as a result of the FDA inspection of Red Cross national headquarters.”

Further, the Red Cross said, “each year millions of Americans will need a blood transfusion. These individuals and their families have a vital interest in the safety of the blood they will receive. So do we. Misleading reports do a serious disservice to both patients and donors.”