WASHINGTON — Federal safety violations by the American Red Cross that have forced the charity to recall increasing numbers — thousands of pints — of blood products are prompting a Senate investigation.
The Red Cross issued 641 recalls in 2000, an 18-fold increase from 12 years earlier. While none of the recalls were the most serious type, most were classified as posing a small risk to patients — and government documents say some possibly hazardous blood was given to patients before word reached doctors not to use it.
Senate Majority Leader Tom Daschle and Sen. Edward Kennedy called the allegations serious, and Kennedy agreed to consumer advocates' requests to investigate.
The disclosures "raise serious questions about the ability of the American Red Cross to ensure the safety of its blood supply," said Kennedy, D-Mass. "Congress needs to deal with these questions, too, and take whatever steps are necessary to guarantee the safety of the blood supply."
It is the latest black eye for the Red Cross, which provides 45 percent of the nation's blood and is fighting government regulators in federal court over this very issue.
The Food and Drug Administration has accused the Red Cross of repeated and serious violations of blood safety regulations, including shipping contaminated blood, despite a 1993 court order requiring improvements. Last month, the FDA asked a federal judge to hold the charity in contempt of court and allow the government to levy millions of dollars in fines for continuing violations.
That court fight promises to last months. The consumer group Public Citizen told Daschle and Kennedy on Thursday that congressional intervention would speed solutions.
"Force the Red Cross to improve its public health-threatening record," the group wrote.
The Red Cross argues it has spent millions improving its blood business and that the blood supply is safer than ever.
"It is unfortunate Public Citizen is creating unnecessary fear and alarm about the safety of the blood supply," said Red Cross interim general counsel Larry Moore. "The chief priority of the Red Cross is to ensure that patients who depend upon blood receive the safest possible products."
FDA court documents say Red Cross recalls of blood jumped from 36 in 1988 to 641 in 2000. Those latest recalls totaled 12,701 units of blood products, including red blood cells and platelets.
One example involves cytomegalovirus, which doesn't harm most healthy adults but can kill or seriously injure the ill or newborns. In October 2000, the Red Cross recalled four units of blood labeled CMV-free when in fact they hadn't been tested — and three already had been given to patients, say the FDA documents.
The Red Cross argues that no one has been found to have been harmed by its mistakes.
That is "a notoriously dangerous assumption to make," FDA blood chief Dr. Jay Epstein said in court documents. It is very hard to detect transfusion-caused illnesses because some infections lie dormant for a long time and doctors aren't required to report suspicious infections to the government, he said.