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 years.
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 said Monday.
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.
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 Monday.
The Red Cross declined comment on the hepatitis cases Monday. But the charity, which provides 45 percent of the nation's blood supply, reiterated a statement it recently released saying it is working hard to improve overall safety.
"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 say.
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.