For 15 years, the American Red Cross has been under a federal court order to improve the way it collects and processes blood. Yet, despite $21 million in fines since 2003 and repeated promises to follow procedures intended to ensure the safety of the nation's blood supply, it continues to fall short.
The situation has proved so frustrating that in January the commissioner of the Food and Drug Administration attended a Red Cross board meeting – a first for a commissioner – and warned members that they could face criminal charges for their continued failure to bring about compliance, according to three Red Cross officials who attended the meeting.
“If fear is a motivator, we're happy to help out in that way,” said Eric Blumberg, deputy general counsel at the FDA, though he declined to confirm what the commissioner, Andrew von Eschenbach, said at the meeting.
Some critics, including former Red Cross executives, have even suggested breaking off the blood services operations from the rest of the organization, as the Canadian Red Cross did a decade ago.
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No reliable records
The problems, described in more than a dozen publicly available FDA reports — some of which cite hundreds of lapses — include shortcomings in screening donors for possible exposure to diseases; failures to spend enough time swabbing arms before inserting needles; failures to test for syphilis; and failures to discard deficient blood.
In some cases, the lapses have put the recipients of blood at risk for diseases such as hepatitis, malaria and syphilis. But according to the FDA, the Red Cross has repeatedly failed to investigate the results of its mistakes, meaning there is no reliable record of whether recipients were harmed by the blood it collected.
The Red Cross agrees that it has had quality-control problems and says that it is working to fix them. Its officials and the FDA point out that none of the identified problems involve the most serious category of infractions. For instance, the Red Cross does a good job of testing for HIV and hepatitis B, officials on all sides agree. And in general, Red Cross blood is regarded as some of the safest in the world.
Still, the FDA says, the problems that remain in screening donors and following protocols for blood collection add unnecessary risk to blood transfusions, almost 5 million of which were done in 2007, according to the National Heart, Lung and Blood Institute.
“This is a critical piece of the public health infrastructure,” said Mary Malarkey, director of the FDA's Office of Compliance and Biologics Quality. “I know it's difficult to get so many people trained and properly supervised, but it has to be done.”
This week, the FDA sent the Red Cross the results of yet another recent investigation that makes her point: From December 2006 to April 2008, the Red Cross distributed more than 200 blood products that it had already identified as problematic, according to the investigation report.
Blood is big business
While many Americans see the Red Cross as the ubiquitous organization that responds to disasters, its disaster relief operation, which spends $400 million to $500 million annually, is small compared with its blood business, which generated $2.1 billion in revenue in the fiscal year that ended in June 2007.
In fact, the Red Cross controls 43 percent of the U.S. blood supply, making it the largest single steward of blood, more than twice the size of the second-largest known blood collection operation.
After years of quiet complaints about the Red Cross's blood business, the FDA reluctantly decided to go public with its concerns in 1993, obtaining a consent decree that required the Red Cross to strengthen quality control and training and improve its ability to identify, investigate and record problems.
“It was one of the hardest things I did as commissioner,” said Dr. David Kessler, the FDA commissioner from 1990 to 1997. He said he had agonized that the move would cause undue alarm.
Fifteen years later, that consent decree, toughened in 2003 to allow the FDA to impose fines for failing to properly identify, handle and report quality control problems, has produced only modest improvements, food and drug officials said.
“Leaving aside who's at fault here, it's not working,” said Kessler, now a professor of pediatric medicine at the University of California, San Francisco.
Kessler said Congress should intervene at this point.
Dr. Bernadine Healy, the former chief executive of the Red Cross who made repairing the organization's blood operations a paramount goal, said the best solution might be to spin off the Red Cross's blood services.
“Two-thirds of the revenue base of the Red Cross is blood, yet the Red Cross is run by people who think of it as primarily a disaster relief organization, relegating blood to stepchild status,” Healy said. “When is the last time you saw a Red Cross fundraising appeal for money to make the blood supply safer or support its blood research?”
The Red Cross has toyed with selling off its blood operations, or otherwise decoupling them from its disaster work, but has never done so, in part because of a belief that the billions in revenue from blood has subsidized its disaster operations. But its financial systems are so antiquated that no one really knows.