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FDA Says Red Cross May Have Released Unsafe
Blood to Hospitals
By Laura Meckler
Associated Press Writer
Published:
Dec 20, 2002
WASHINGTON (AP) - The American Red Cross may have released tainted
blood to hospitals, the government said Friday, reporting more than 200
violations of federal blood safety rules in its battle to get the Red
Cross to improve the quality of its blood operation.
The Food and Drug Administration said it was investigating further to
determine whether patients received bad blood.
"The blood supply is not as safe as it should be," said FDA
Commissioner Mark McClellan. "I am troubled by apparent lapses in blood
safety."
The Red Cross, which provides 45 percent of the nation's blood
supply, said it is working hard to improve safety.
A year ago, the FDA went to court seeking contempt charges for 10
years of Red Cross safety violations. Friday's preliminary report on
safety at the Red Cross biomedical headquarters suggests the problems
have not been fixed, McClellan said, suggesting they point to "a culture
willing to accept noncompliance."
Specifically, the FDA alleges that some Red Cross employees were
instructed to skip required safety steps, and others altered records, to
allow release of blood that had failed safety testing.
In addition, the Red Cross failed to screen out some people who were
not supposed to give blood, the FDA said. It was unclear what happened
to the units these people donated, the agency said.
More than 1,000 units of blood were unaccounted for, it said.
The FDA emphasized that anyone who needs a blood transfusion should
get one, because the risk of forgoing a medical procedure is much higher
than the risk of getting bad blood. The agency also noted that people
who donate blood face no risk.
The Red Cross acknowledged problems and promised to fix them.
"The Red Cross understands more work needs to be done to further
strengthen our processes and procedures, and we are fully committed to
working collaboratively with the FDA to enhance our systems," Remesh
Thadani, who heads biomedical services, said a statement Friday.
More than 200 individual violations were identified, the FDA said.
Among them:
-Lack of management control and quality assurance oversight. Required
testing steps were not always documented, and some employees reported
being told to skip required steps.
-Data integrity: Employees were alleged to have changed records to
indicate that flagged blood was safe.
-Failure to correct deviations from previous inspections, including
failure to follow standard operating procedures.
-Release of unsuitable products. Donors in one Red Cross region who
are found unsuitable are supposed to be listed in a donor deferral
registry. They were not, and some went on to donate in other regions. In
some cases, the FDA does not know what happened to their donated blood.
It was the first inspection of the Red Cross headquarters since last
December, when the government asked a federal judge to hold the Red
Cross in contempt for repeated violations of blood safety regulations,
including shipment of contaminated blood.
In court, the FDA charged cited "persistent and serious violations"
dating back 16 years and continuing despite a 1993 federal court order
requiring improvements.
A year ago, the Red Cross vowed to fight the FDA. After getting a new
director this summer, however, the two sides entered negotiations toward
a settlement. The Red Cross said Friday it is making substantial
progress; the FDA would not characterize the status of the talks.
The Red Cross refused to respond to specific allegations. But in a
pre-emptive move, Red Cross officials had gathered reporters early this
week to explain improvements made in recent months.
They said they have hired 175 people to work on quality and vowed
better training for employees and improved computer systems that would
be less prone to human error.
The Red Cross also has moved to an electronic blood donor record. In
the past, some blood banks accepted blood from people who had not
answered questions about the risk of HIV infection or who had answered
"yes" to questions about high-risk behavior. Under the new system,
people who leave these questions blank or answer "yes" will not be
allowed to donate.
The Red Cross also displayed a chart demonstrating that the number of
FDA violations had fallen over the past several years to about 100 in
2001. With Friday's inspection, more than 200 have been identified for
2002.
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Associated Press Medical Writer Lauran Neergaard contributed to this
report.
AP-ES-12-20-02 1914EST
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