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More on the blood-safety story:

http://www.boston.com/business/healthcare/articles/2006/09/09

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FDA fines Red Cross $4.2m for blood safety problems

By Diedtra Henderson
September 9, 2006

WASHINGTON -- Federal regulators fined the American Red Cross a record $4.2 million for failing to properly screen potential blood donors and other safety problems.

The fine, disclosed by the Food and Drug Administration yesterday, follows $5.7 million in previous fines since 2003, spotlighting a troubling pattern of quality control failures.

The Red Cross, a humanitarian organization that depends heavily on volunteers, handles 45 percent of the nation's blood supply. Like community-based blood centers and hospitals that supply blood, the Red Cross follows FDA rules for identifying and barring donations from people with such infectious diseases as AIDS, the human form of mad cow and -- in recent years -- West Nile virus.

The agency said the nation's blood supply remains safe and advised patients who need a transfusion to follow the advice of their physicians.

The Red Cross ended up pulling 12,000 units of questionable blood and blood products from its shelves and voluntarily recalled it from hospitals and treatment centers across the nation. The recalls ``were preventable," according to the FDA.

The FDA added that none of the recalled units had evidence of contamination with a transmissible infectious agent. But the agency also acknowledged that in such voluntary blood recalls it does not routinely track patients who received blood from batches that were later recalled.

The Red Cross is governed by a 2003 consent decree that permits the FDA to levy significant fines if it fails to comply with federal regulations. The organization, in a statement, said it takes the fine “seriously” and “is committed to full compliance.”

“It is not acceptable that the quality system has failed in this way,” said Margaret Glavin, FDA's associate commissioner for regulatory affairs.

The agency ordered the Red Cross to review how the quality-control breaches occurred and to take actions to ensure they don't happen again. The Red Cross said it would respond to the FDA concerns, which it received on Thursday, within 20 days.

Blood centers ask donors a series of questions to screen out people with actual or potential blood-borne infections that could be passed to people who receive blood donations after accidents, surgeries, and childbirth.

According to the FDA, the Red Cross erred by accepting blood from donors who had not completely filled out questionnaires. By failing to check the donor's travel history, for instance, the Red Cross opened the ``remote" possibility of donation by people who would normally be deferred, said Dr. Jay Epstein, director of the FDA's Office of Blood Research and Review.

That included donors who had lived in England when mad cow infection rates spiked in animals and spilled into humans, and donors who had traveled to regions where malaria risks were high.

In addition, the Red Cross also distributed blood products despite incomplete or problem results from laboratory tests for such infections as hepatitis B that the centers run to certify blood donations are safe before use.

The fine was driven by the number of units of blood the Red Cross voluntarily recalled, but also serves ``as an incentive to address the issues," said Susan Bro, an FDA spokeswoman.
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