Red Cross Fined for Blood Safety Violations
FDA on Friday fined the American Red Cross $4.2 million for failing to properly screen and store its blood supply, the Baltimore Sun reports. The Red Cross in 2003 began operating under a consent agreement with FDA, under which the organization could be fined for every failure to comply with quality control regulations (Rockoff, Baltimore Sun, 9/9).
Since the 2003 agreement, the organization has been fined $5.7 million, not including the most recent violation (Harris, New York Times, 9/9). Friday's fine, the largest ever given out by the FDA for blood-related failures, was issued after a recall of 12,000 pints of blood that were collected improperly (Baltimore Sun, 9/9).
According to the Times, the recalls, which took place from 2003 to 2005, could have been prevented if Red Cross followed its own procedures (New York Times, 9/9).
FDA officials said the Red Cross committed a number of violations, ranging from failing to ask donors if they had traveled in a malaria zone to the failure to test for hepatitis B, among others.
FDA official Jay Epstein said testing of the recalled blood did not reveal contamination, and there is no indication that the recalled blood had been given to anyone (Baltimore Sun, 9/9). Epstein said, "We take all breaches of the safeguards very seriously because of their importance to ensuring the safety of the blood supply."
In addition to the fine, FDA ordered the Red Cross to evaluate its procedures to prevent such lapses from happening again.
In a statement, the Red Cross said it "is committed to full compliance" with the 2003 agreement and "remains dedicated to its mission and to the millions of Americans who rely on us to provide lifesaving blood and blood components each year" (Stein, Washington Post, 9/9).
The organization will rely on money collected from blood products and operating funds, not donations, to pay the fine, according to Ryland Dodge, an FDA spokesperson (AP/Richmond Times-Dispatch, 9/9).
Stephanie Millian, a Red Cross spokesperson, said the Red Cross recalled the blood voluntarily from April 2004 to April 2005. Millian said, "It doesn't mean the Red Cross' blood supply isn't safe. The blood supply is safer today than it ever was" (Baltimore Sun, 9/9).
The Red Cross said it would officially respond to the FDA fine within 20 days (New York Times, 9/9).