FDA Cites Concerns Over Red Cross’ Handling of Blood

The Food and Drug Administration asked a federal judge Thursday to hold the American Red Cross in contempt of court for “persistent and serious violations” of blood safety rules, escalating a years-long dispute between the FDA and the nation’s largest blood supplier.

The Red Cross “has exhibited a corporate culture that has been willing to tolerate an unacceptably low level of quality assurance and a lack of concern for the public it is supposed to serve,” Bernard A. Schwetz, the FDA’s acting principal deputy commissioner, said in a statement.

The Red Cross provides about 45% of the nation’s blood supply. It supplies nearly all of the blood used by hospitals in Los Angeles.

The court filing in Washington ends 16 months of out-of-court negotiations between the Red Cross and the federal regulators about how to guarantee the safety of the blood supply. In 1993, the FDA and Red Cross agreed on a court order requiring the charity to improve management and quality control. The FDA says the Red Cross has not met its obligations under that agreement.

FDA officials cited numerous violations of the court order, including inadequate procedures to ensure that bad blood stays out of circulation. Potentially, the errors could have endangered people who got blood transfusions, although the FDA says there is no proof of any harm.

Other serious problems include poor donor screening, the release of mislabeled blood, collecting blood from disqualified donors and flawed procedures aimed at keeping unsuitable blood in quarantine.

FDA officials said monetary penalties are the only way to prod the Red Cross into making improvements and asked U.S. District Judge John Garrett Penn for permission to fine the Red Cross as much as $10,000 a day for every new violation it discovers and as much as $50,000 for every unit of unsuitable blood circulated.

Even before the court filing, Penn had scheduled a hearing for today to review mediation efforts between the two sides.

Responding to the government move, Red Cross officials said the organization has invested more than $280 million to improve its blood operation and would contest the proposed fines. Red Cross officials said such penalties go beyond the authority granted the FDA by Congress and exceed what other blood banks face.

“The Red Cross remains committed to working cooperatively with the FDA to achieve the highest levels of blood safety,” the group said in a statement.

The FDA motion comes at a particularly bad time for the Red Cross. The organization is under fire in Congress for its initial attempt to use some donations to its special Liberty Fund for purposes other than compensating survivors and families of victims of the Sept. 11 terrorist attacks on the World Trade Center and the Pentagon.

Critics also have faulted the Red Cross for its unrelenting call for blood donors after Sept. 11, even though little blood was needed to help the victims in New York City and Arlington, Va. Because red blood cells expire 42 days after they are collected, the Red Cross was forced to discard at least 250,000 pints of red blood cells that were too old to use.

Red Cross and FDA officials emphasized Thursday that the public should not avoid needed blood transfusions because of fears about the blood supply.

“The risk of not receiving a needed transfusion far outweighs the risk of receiving blood,” Schwetz said.

In addition, donors face no risks by giving blood, said Julie Juliusson, a spokeswoman for the Red Cross in Southern California. “For the donor lying on the bed to donate blood, at no time has their safety ever been compromised,” she said.

Red Cross officials in Los Angeles said the FDA found nine violations in the last year at its regional headquarters and donor centers. None involved improper labeling or inappropriate releases of blood, Juliusson said.

She said she hopes donors will not be afraid to give blood because of the dispute, adding that the December holiday season is particularly tough for blood banks because regular donors go on vacation.

“We’re going to be in a real jam” if donors choose not to give, Juliusson said. “The holidays are just a real tough time for the whole community, not just the Red Cross. If people are put off about donating blood, this can affect patient care.”

The government’s move drew praise from Dr. Arthur Caplan, former chairman of a federal advisory panel on the blood supply.

“It’s overdue, but I support this action,” said Caplan, a bioethicist at the University of Pennsylvania. “The Red Cross has let this problem fester inexplicably. . . . They’re not discharging their duty to those who make the gift of blood.”

Dr. Jeffrey McCullough, a former top Red Cross official, also lamented the group’s current problems.

“The Red Cross has spent a lot of money and made a lot of effort in the last few years to improve its quality,” said McCullough, a professor of transfusion medicine at the University of Minnesota. “It’s unfortunate that it does not yet seem to be at a level that meets the FDA’s expectations.”

In its court filing, the FDA said it has spent nearly 33,000 hours inspecting Red Cross facilities to evaluate the group’s compliance with the law, regulations and the 1993 consent order. Since 1993, the FDA has sent the Red Cross letters 11 times detailing significant violations of the court decree.

The Red Cross entered into the 1993 court order after unwittingly distributing HIV-contaminated blood in the early to mid-1980s. But during an inspection of the group’s headquarters in April 2000, the FDA found widespread violations of the court order.

The violations included a failure to properly quarantine potentially contaminated blood, failure to follow instructions on an HIV test kit, and not keeping track of blood supplies and donor medical histories.

Regulators also have been troubled by a Red Cross blood center in Salt Lake City, which was inspected this year between March and May. For instance, the office failed to quarantine blood despite missing test results, then released the blood for shipment.

In another instance, an ineligible donor who had traveled to an area at high risk for malaria was allowed to donate. The blood was labeled for distribution before the error was caught.

The Red Cross says it has devoted resources to rigorous and effective blood testing, establishing a national quality assurance program, creating a standardized national computer system, centralizing oversight of management and record-keeping, and implementing a national training system.

In an interview with The Times last summer, Dr. Bernadine Healy, the Red Cross chief executive who resigned in October, acknowledged the problems but said the Red Cross was making progress to fix them.

“The organization from top down--and particularly at the top--has gotten religion on this issue,” she said at the time. But she said she has come to realize that “we have a very long way to go.”

“We have the best of the best within our system, and we have some problem children.”