The Food and Drug Administration released a preliminary inspection report yesterday critical of operating procedures at the national headquarters of the American Red Cross in Washington.
The report alleges that the country's largest blood supplier has been lax in reviewing and following up reports of HIV infection from transfusions performed with blood provided by its regional affiliates.
For example, the Washington regional center, the report said, informed Red Cross headquarters of four of the 228 cases of HIV infection by transfusion that have occurred in the area over the last 10 years. That occurred despite a pledge by the organization to exercise tighter supervision over its regional centers.
FDA officials said the deficiencies in Red Cross procedures were not in any way responsible for those 228 HIV infections. According to the agency, almost all of the local infections from donated blood occurred before 1985, when antibody tests for the AIDS virus were introduced.
"In the course of our own inspection there was no evidence found that any blood that tested positive after 1985 was improperly released," FDA spokesman Jeff Nesbit said.
"This problem appears to have nothing to do with public safety," said Walter Lawrinson, medical director of the blood bank at Washington Hospital Center, which is unaffiliated with the American Red Cross. "The national headquarters is a paper mill. They don't deal with people."
The FDA report was made public yesterday after the Philadelphia Inquirer obtained a copy of the inspection document and published a story based on its finding. The Inquirer stated, based on a reference in the FDA inspection, that the Red Cross had failed to disclose reports of transfusion-related HIV infection in the Washington region to federal regulators.
However, FDA officials said yesterday that the Red Cross was not required to report to federal health officials cases of HIV infection from blood transfusions, but rather that that responsibility lay with individual doctors.
Preliminary FDA inspection reports usually are not released to the public because they contain only the observations of individual agency inspectors and not official conclusions. The agency also typically permits the organization under scrutiny to respond to allegations contained in the report before any regulatory action is taken.
In a statement released yesterday, a spokesman for the American Red Cross called the Inquirer article misleading and said that it would "needlessly alarm the American public about the safety of the blood supply."
"The primary allegation made in the article is false," the Red Cross stated. "The Red Cross has not failed to comply with FDA requirements to report transfusion-related AIDS cases for the simple reason that there are no such requirements."
The organization also said that despite the problems cited in the report "no patient has ever been known to have acquired hepatitis B or AIDS as a result of a procedural or technical or computer error on the part of the Red Cross."
The statement by the blood bank, however, did not respond to other allegations in the FDA report. Among them:
That 308 reports of errors and accidents in collecting, processing and distributing blood submitted by various regional Red Cross organizations to the blood banks' parent organization have not been reviewed or followed up by headquarters.
several management and safety problems that had plagued the Red Cross in the past and had led to the Red Cross agreeing two years ago to tighten supervision of its regional affiliates have not been corrected.
That the Red Cross has been slow to carry out programs designed to identify blood donors who are HIV positive and identify people who might have been given their blood.
That "numerous error reports reviewed did not provide sufficient information to determine the cause of the error or an adequate description of the corrective actions taken."