Red Cross agrees to meet blood safety standards, could stiff face fines if it fails

WASHINGTON -- The Red Cross is promising to upgrade its blood collection program to meet government safety standards and could face substantial fines if it fails to do so.

The agreement announced Friday by the Food and Drug Administration comes after 17 years of government complaints about procedures at the nation's largest blood collector.

Two years ago, the FDA went to court seeking a contempt citation against the Red Cross for not following a 1993 agreement to meet blood safety standards. The settlement will be submitted to that judge for approval.

The Red Cross said it welcomed the agreement as marking "a new era of cooperation" with the FDA.

Under the settlement, fines for various violations could total up to 1 percent of the Red Cross's $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.

"The new financial penalties in the consent decree create an important new incentive for (the American Red Cross) to improve the processes and controls necessary for making safer blood products," said FDA Commissioner Dr. Mark B. McClellan.

McClellan stressed that, while the Red Cross revises its procedures, people who need blood transfusions should not hesitate to get them.

There are overlapping safety procedures in effect and any particular breach of the safeguards does not necessarily result in unsafe blood products, he said.

The Red Cross hired a new president last summer, retired admiral Marsha Johnson Evans. She declined to discuss the blood problems at the time, but promised to act to improve the trust many Americans have in her organization.

McClellan said he is "hopeful that the acceptance of this agreement by ARC's new leadership reflects a new willingness to implement a management culture that expects and achieves good blood safety practices."

The Red Cross issued a statement saying it recognizes the need to strengthen its procedures and is launching an aggressive quality program.

The organization said that if it is forced to pay fines it will not use donations from the public to do so.

The Red Cross provides about 45 percent of the nation's blood supply.