WASHINGTON, Dec. 31 - The American Red Cross received reports
that 134 people, including one who died, got hepatitis B after
blood transfusions, but the organization did not investigate them
because of internal policies that violate government safety
rules, federal regulators say.
IN ONE CASE, an Ohio Red Cross chapter challenged the policies
and eventually uncovered two additional patients who got the
dangerous liver infection after transfusions that came from the
same blood donor. The evidence got that donor kicked off the
blood donor list, government records show.
They are the latest in a series of revelations about safety
violations that have plagued the Red Cross for more than 10
The Food and Drug Administration, which uncovered the hepatitis
infections in a recent inspection of Red Cross headquarters, is
pushing the organization to find out if bad blood really caused
the rest of the infections.
"We will insist that they follow up," FDA spokesman Brad Stone
But the hepatitis examples show that "the blood supply is much
less safe than the Red Cross, and even to some extent the FDA,
has led people to believe," said Dr. Sidney Wolfe of the consumer
advocacy group Public Citizen, which is urging a congressional
investigation of Red Cross problems.
HUNDREDS OF VIOLATIONS
While previous FDA inspections have uncovered procedural errors
that could have harmed patients, this one may have uncovered a
death, said Wolfe, who alerted lawmakers to the documents on
"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," that statement said.
The FDA cited the hepatitis discovery as one of more than 200
violations of federal safety rules it found during its latest
inspection of Red Cross headquarters.
The FDA also 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 FDA charged the Red Cross failed to screen out
some people who weren't supposed to give blood, and couldn't
account for what happened to the resulting donations.
In the case of the hepatitis reports, the FDA said the failure to
investigate the 134 cases resulted from Red Cross policies that
limit the number of possible blood-related infections the charity
investigates. It said those policies violated federal safety
standards that the charity agreed to follow as part of an ongoing
legal battle with the government.
Specifically, the policies called for investigating only if the
donor was known to have had an abnormal hepatitis test or didn't
qualify to give blood, and forbade investigation if the patient
received transfusions from more than 10 donors, FDA documents
In January 2001, a northern Ohio Red Cross chapter got special
permission to investigate one hepatitis infection linked to
multiple transfusions, and discovered that one of the donors
involved had been linked to an earlier, unproven hepatitis
infection, the FDA inspectors found. After that discovery, the
Red Cross barred the donor from giving again.
The FDA called such policies a violation of a 1993 court order
demanding that the Red Cross improve its safety procedures to
comply with federal standards.
Last year, the FDA went back to court seeking contempt charges
against the Red Cross for repeated safety violations since 1993.
The FDA and Red Cross have been in negotiations for several
months to settle those charges.