Red Cross Failing Blood Test http://www.cbsnews.com/
Oct. 22, 2002
During heart surgery four years ago, John (who doesn't want to be fully
identified) needed a blood transfusion, reports CBS News Correspondent
With it he got something he didn't bargain for: Hepatitis C, a contagious
disease that can cause serious liver damage and even death.
The blood John received came from the Red Cross.
"They located three of the four donors of the blood that was infused into
my body," he says, "and one of those donors tested positive for Hepatitis C."
The risk of contaminated blood is one reason why the Food and Drug
Administration is going to the mat with the Red Cross, which provides half
of the nation's blood supply and has been violating blood safety laws for
17 years. Now, a federal judge is set to decide whether to slap the Red
Cross with huge fines.
According to court documents, the Red Cross has repeatedly taken blood from donors with hepatitis and other diseases. In one of the worst cases, the
Salt Lake City Red Cross took blood from hundreds of admittedly high-risk
donors who had answered "yes" to questions like: "Do you have AIDS?" or
"Have you ever tested positive for AIDS?"
In theory, those mistakes should be caught in the Red Cross' "six layers of
The FDA agrees that blood tests are more accurate than ever, but has still
found problems at every level: infected blood mixed with safe blood,
mislabeling and release of contaminated blood, HIV-positive blood lost and
assumed "distributed and used."
"Each of these steps is important, and if one of them fails it increases
the chance that blood is going to be collected which is infected and
possibly distributed," says "Public Citizen" health advocate Dr. Sid Wolfe.
Some of the Red Cross' own workers are disgusted by what they see on the
job. Onetime bloodmobile manager Joe Szaller was fired after he
persistently complained about unsafe practices.
"I reached the point where I could not sleep at night," says Szaller. "The
blood was going out and I knew that it was not going to be in the condition
that the FDA expected it to be."
The Red Cross insists the "blood supply is as safe as it has ever been,"
that it's "working cooperatively with the FDA" and that only a tiny
fraction of blood recipients will ever get a disease.
Yet it's impossible to pinpoint the numbers because it turns out nobody's
The Red Cross tracks infections but doesn't report them to anyone because
it's not required to do so.
Though the FDA and Red Cross investigated and confirmed John's case,
there's no record of it at the Centers for Disease Control, which reports
no such cases in eight years.
"People would rather that I just go away with this situation and be quiet
probably," says John. "And I don't think that I can."
And, he wonders, how many others are out there like him.
The Red Cross refused to provide an interview for this report. Instead, the
Agency issued what it called a "Position Statement" stating: "The American
Red Cross agrees with the FDA's view that our nation's blood supply is as
safe as it has ever been. We are working cooperatively with the FDA to
address its concerns and are devoting all our energies to that end."
The Red Cross also states: "The Red Cross shares a common goal with the
Food and Drug Administration - to save and enhance lives through providing
the safest possible products to patients - and we continue to work toward
resolution with the agency. We are committed to working with the agency to
resolve issues and to be the most effective steward possible when it comes
to providing the safest possible blood supply. Because the Red Cross is
ensuring that the nation's blood supply is as safe as possible, any
potential problem is a serious matter to us. There are at least six layers
of overlapping safety that help protect the blood supply, which include
self-deferrals, pre-check, completion of the blood Alternative Treatments record, health
history screening, confidential unit exclusion, testing and post Alternative Treatments
information. DUe in no small part to the $287 million the Red Cross has
invested in its biomedical operations since 1993, the number of FDA
observations have decreased by more than 80 percent since the Consent
Decree's inception. The Red Cross continues to invest in its biomedical
operations to meet the highest quality and regulatory standards. Our
ongoing efforts emphasize quality assurance, information technology and
processing/supply chain of infrastructure."
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