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For blood safety gaffes, Red Cross fined millions

Published September 9, 2006

WASHINGTON - Millions of people rely on the American Red Cross for the "gift of life," but how it collects and handles that blood has repeatedly violated federal regulations.

In turn, the government has hit the Red Cross with millions of dollars in fines for violating those blood-safety laws. On Friday, the Food and Drug Administration announced the latest: a record $4.2-million penalty.

For years, the FDA has worked to get the Red Cross in line with federal laws and rules meant to ensure the safety of the nation's blood supply. A 2003 court settlement was to have put its concerns to rest. Instead, the FDA has fined the Red Cross multiple times since then, assessing a total of $5.7-million - excluding the latest penalty.

"FDA does not consider the current situation acceptable," said Margaret Glavin, the agency's associate commissioner for regulatory affairs. "It is not acceptable that the quality system has failed in this way, and we will continue to work to make sure that the quality system is improved in its design and in its implementation, so these types of problems do not continue to occur."

The latest violations included failing to turn away donors who had traveled to areas rife with malaria and allowing blood and other blood products to enter distribution without proper testing, Glavin said. While the potential risk the violations represented was worrisome, officials stressed that they had no evidence the violations had caused serious health problems.

Meanwhile, the American Red Cross said its senior management "is committed to full compliance with the amended consent decree and all applicable federal regulations." It planned to respond to the FDA within 20 days.

The Red Cross provides nearly half the nation's blood supply, selling blood products to health facilities. Although the Red Cross depends in large part on donations - of both blood and cash - it will not use donated money to pay the fine, spokesman Ryland Dodge said. Instead, it will dip into revenues to do so, he said.

The fine is so large in part because it's linked to size of various recalls investigated by the FDA.

The recalls took place from 2003 to 2005 and involved about 12,000 units of blood and blood products. The recalls were preventable, the FDA said.

The 2003 agreement settled charges that the Red Cross had committed "persistent and serious violations" of federal blood safety rules dating back 17 years.

That settlement spelled out changes the Red Cross would have to make to comply with FDA rules, including improved training and record-keeping. The FDA is requiring the Red Cross to review its quality-control system, Glavin said.

"We will certainly continue to work with them to ensure there is full compliance," she said.

The amended consent decree also gave the FDA the authority to immediately fine the Red Cross for violations.

[Last modified September 9, 2006, 01:33:04]

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