FDA reports problems with blood safety methods
Posted on Sat, Dec. 21, 2002
Government regulators disclose violations in screening, storing blood
CHARLES ORNSTEIN AND MEGAN GARVEY
Los Angeles Times
Federal regulators on Friday disclosed widespread problems with the screening, storage and distribution of blood by the American Red Cross, calling into question the safety of the nation's blood supply.
The FDA cited more than 200 safety violations and deficiencies in its inspection report, the latest since the Red Cross was first ordered by a federal court to correct systemic problems -- including poor donor screening and release of potentially tainted blood -- nearly a decade ago.
The Red Cross is far and away the nation's largest supplier of blood, collecting nearly 7 million donations in the last fiscal year alone.
"I am troubled by the apparent lapses in blood safety practices," said Dr. Mark McClellan, commissioner of the U.S. Food and Drug Administration in a statement released Friday. "Our observations appear to show continuing evidence of a culture that is willing to accept noncompliance, as in many previous inspections."
The news comes at a time of year when blood banks often issue pleas to donors sidelined by illness or holiday obligations. FDA officials took pains to say there is no risk associated with donating blood.
They also encouraged people needing blood transfusions to get them. "The risk of not receiving a blood transfusion far outweighs the risk of receiving blood," said FDA spokesman Jason Brodsky.
The Red Cross, which supplies nearly half the nation's blood, said the supply is safer than it has ever been. But the nonprofit organization acknowledged some shortcomings in its own practices.
"The Red Cross understands more work needs to be done to further strengthen our processes and procedures, and we are fully committed to working collaboratively with the FDA to enhance our systems," said Ramesh Thadani, the organization's Executive Vice President and CEO of Biomedical Services, in a written statement.
The dilemma facing the government, experts say, is that despite long-standing problems with Red Cross procedures, the organization dominates the industry.
Dr. Arthur Caplan, former chairman of the federal Advisory Committee on Blood Safety and Availability, said the Red Cross has deflected punishment by flexing its powerful lobbying clout and threatening blood shortages, "using the threat of no blood as a way to fend off the need to ensure they have the safest possible blood."
"It's sort of this pattern of abuse, and they've gotten away with it," said Caplan, a bioethicist at the University of Pennsylvania.
The FDA's findings, contained within a 45-page report, were the result of an eight-month investigation at Red Cross biomedical headquarters in the Washington, D.C., area.
Investigators said the organization was unable to account for small amounts of blood infected with the human immunodeficiency virus, which causes AIDS, and human cytomegalovirus.
Cytomegalovirus, though a common infection, is potentially fatal for infants born to newly infected women and dangerous for those with compromised immune systems.
Inspectors also found evidence of employees falsifying records and shipping orders without completing testing, as well as instances of blood products that were labeled unsuitable for release and then released anyway.
The report noted that employees who saw problems feared coming forward because of possible retaliation.
A quality control officer at one of the Red Cross' national testing laboratories described a "culture to hide problems" and said, "There is a pervasive attitude that the staff can clean problems up so they can never be found," according to the FDA report