Wednesday, June 11, 2008
Yesterday's Washington Post reported that federal regulators have announced that they have fined the American Red Cross $1.7 million for continued failures to adequately manage the nation's blood supply.
According to a review by the Food and Drug Administration, the Red Cross, a charity based in the District of Columbia that administers nearly half the U.S. blood supply, washed six units of red blood cells using the wrong saline solution.
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.
Echoing that sentiment, FDA spokeswoman Peper Long said, "People shouldn't panic about the safety of the blood supply."
However, in light of the seriousness of violation, the FDA levied the $1.7 million fine.
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.
The Red Cross is congressionally chartered to provide relief during major disasters. Over the past five years, the organization has been fined more than $21 million for various safety lapses. However, according to Peper Long, "The organization certainly has made progress, but we are still seeing errors. And the problems are certainly serious, and they need to be addressed."
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."