By Philip Rucker
Washington Post Staff Writer
Tuesday, June 10, 2008
Federal regulators said yesterday that they have fined the American Red Cross $1.7 million for continued failures to adequately manage the nation's blood supply.
The Red Cross, a charity based in the District that administers nearly half the U.S. blood supply, washed six units of red blood cells using the wrong saline solution, according to a review by the Food and Drug Administration.
The blood cells, which measure about six pints, were transfused to three patients in 2006 and last year at chapters in the Northeast and Southeast. Red Cross executives said that the violations did not endanger patients and that no adverse effects have been reported.
"There's really minimal, if any, risks to the patients," said Eva Quindley, senior vice president for quality and regulatory affairs. "Obviously, we take any error such as this very seriously. We don't tolerate errors."
FDA spokeswoman Peper Long said, "People shouldn't panic about the safety of the blood supply."
"These are very serious problems, and the American Red Cross is working to address them. But the nation's blood supply is perhaps as safe as it's ever been," she said.
The fine is the latest levied against the Red Cross under an agreement with federal regulators to eliminate chronic problems with blood safety. Since 1993, the charity has been under a court-supervised consent decree about its blood collection procedures. A 2003 agreement made the charity subject to federal fines for violations.
In February, the Red Cross was fined $4.6 million after an FDA review found 113 instances in which the charity retrieved "unsuitable blood components," according to federal documents. That could mean using an ineligible donor, failing to conduct proper testing or shipping the blood at an improper temperature.
The Red Cross is congressionally chartered to provide relief during major disasters. It has been fined more than $21 million for safety lapses over the past five years but said it has implemented new measures.
"The organization certainly has made progress, but we are still seeing errors. And the problems are certainly serious, and they need to be addressed," Long said.
In the latest incident, the six units of red blood cells were washed in a "hypertonic saline" instead of a "sterile normal saline," the federal documents show.
Chris Hrouda, the Red Cross's executive vice president for biomedical services, said it was "done out of protocol" but posed no danger.
"These were perfectly acceptable units of blood," he said. "They were fully tested and distributable units."
The Red Cross collects millions of units of blood in a manual process, Quindley said.
"If you consider that there are multiple opportunities during the process to make errors, we make very few," Quindley said. "But, nonetheless, none are acceptable to us."
She declined to say whether any employees have been disciplined.
"We have to fully investigate this issue, and we will do what is necessary," Quindley said.