FDA Faults Red Cross’ Handling of Blood Supply

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 preliminary inspection report, the latest since the Red Cross was first ordered by a federal court nearly a decade ago to correct systemic problems -- including inadequate testing and tracking of donations.

Officials said they were still trying to determine whether the latest violations, affecting a small portion of the Red Cross’ inventory, resulted in patients becoming sick from transfusions of contaminated blood. 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 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 provides nearly half of the nation’s blood, said the supply is safer than it has ever been. But the nonprofit organization acknowledged some shortcomings.

“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 Friday.

Among steps being taken: the introduction of new technology to reduce human error, the expansion of the quality assurance staff by 50% -- an addition of 175 new positions -- and improved training procedures.

Despite long-standing problems at the Red Cross, the organization dominates the industry and the federal government is in no position to curtail its operations. In Los Angeles, for example, the Red Cross supplies nearly all of the blood used in hospitals.

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, “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 in a 45-page report, were the result of an eight-month inspection at Red Cross biomedical headquarters in the Washington, D.C. area.

Regulators said the organization was unable to account for small amounts of blood infected with HIV and human cytomegalovirus. Cytomegalovirus, though a common infection, is potentially fatal for infants of 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.

The report said that the Red Cross had not fixed a host of deficiencies identified two years ago when the federal agency last conducted a review. These included a failure to properly quarantine potentially contaminated blood, to follow instructions on an HIV test kit and to keep track of blood supplies and donor medical histories.

The reviews are part of a 1993 federal court order requiring improvements. The FDA has grown increasingly dissatisfied, however, with the Red Cross’ progress. A year ago, the agency asked a federal judge to find the Red Cross in contempt of court for “persistent and serious violations” of blood safety rules.

At that time, FDA officials said monetary penalties -- as much as $10,000 a day for every new violation and as much as $50,000 for every unit of unsuitable blood circulated -- were the only way to prod the Red Cross into action.

But Red Cross officials argued they already had invested more than $280 million in improving safety and that such fines were out of proportion to what had been required of other blood suppliers. The two sides are involved in court-ordered mediation.

The court battle with the FDA came during a rough year for the Red Cross, which provides disaster relief as well as blood. It encountered scathing criticism from the public and lawmakers over its handling of monetary donations solicited in the wake of the Sept. 11 terrorist attacks, when some funds were used for unrelated efforts.

Also controversial was the group’s continued solicitation of blood in the days after the attacks, although it was not needed. Thousands of units had to be thrown out.

Some industry experts defended the Red Cross on Friday, saying the violations cited by the FDA were far from unique to the giant blood supplier.

Dr. Michael Busch, vice president for research at Blood Systems, a smaller blood supplier, said the FDA was picking on the Red Cross. “They’re, in my opinion, a quality, well-intentioned organization, and they’re doing the best they can,” said Busch, also a professor of laboratory medicine at UC San Francisco.

Keith Berman, a consultant who works for the Red Cross on plasma derivatives, said payments for blood products are far too low. “It’s a huge fundamental problem and the fallout from that is that the Red Cross is chronically unable to retain quality staff,” Berman said.

Among the FDA report’s specific findings:

Employees reported that they were encouraged to falsify records and pressured to turn away fewer donors, some of whom presented possible safety risks.

The Red Cross did not adequately investigate post-transfusion infections, particularly hepatitis, in blood recipients to see if their cases were linked to donations.

Despite being warned after the last inspection to account for lost blood products, the group could not account for the fate of 1,062 blood products since April 2000.

One of those was an HIV-positive donation of blood platelets collected in Kentucky, which was discovered missing in February 2001. Another was a plasma donation that tested positive for hepatitis C.

The Red Cross had to recall 1,850 “unsuitable” blood products since January 2001.

Dr. Ronald Gilcher, president and chief executive of the Oklahoma Blood Institute, said federal officials were right to demand action.

“When you find this kind of a problem, you’ve got to fix it,” he said.