Red Cross Violations Of Blood Safety Rules. The Red Cross, accused by the government of “persistent and serious violations” of blood safety rules, promised in a court settlement Friday to meet all safety requirements and pay fines that could reach into the millions if it fails to do so.
The Food and Drug Administration said the consent agreement settles concerns stemming from inspections going back 17 years.
The Red Cross, the nation’s leading collector of blood donations, said it welcomed the agreement as marking “a new era of cooperation” with FDA.
Contempt Citation Against The Red Cross
Two years ago, the FDA went to court seeking a contempt citation against the Red Cross for not following a 1993 deal to meet blood standards.
Under the new settlement, fines for various violations could total up to 1 percent of the “Red Cross” $1.9 billion in annual revenues — or $19 million in the first year, increasing to a maximum of 4 percent by the fourth year, the FDA said.
In its most recent inspection of the Red Cross last December, FDA said it found “numerous and troubling problems in producing blood products including a lack of management control and quality assurance oversight that could lead to a patient receiving potentially unsafe blood.”
Among problems cited by FDA Commissioner Mark McClellan were alteration of records so blood could be accepted from an unsuitable donor, failure to keep good inventory records so blood could be recalled if necessary and mislabeled blood products.