Red Cross to Overhaul Blood Safety Oversights : Health: Officials say the changes will improve quality control and record-keeping. Federal watchdogs had criticized the agency’s procedures.
WASHINGTON — The American Red Cross, whose blood-handling procedures are under scrutiny by Congress and the Food and Drug Administration, announced a series of changes Friday to ensure “the American people can count on a blood supply that is safe and meets our needs.”
“I think the restructuring will mean a significant change for the better for the entire Red Cross organization,” said George F. Moody, chairman of the American Red Cross, which handles half of the nation’s blood supply.
Moody, speaking at a press conference, said the changes “will lead to greater standardization, better quality control, an even higher accountability to the American people and, ultimately, an even safer blood supply.”
Stephen H. Richards, executive vice president, acknowledged that the Red Cross had made mistakes in the past in its record-keeping and in its reporting and monitoring of mistakes and accidents involving blood supplies.
But he insisted that none of these shortcomings had resulted in blood contaminated with AIDS or hepatitis B “being transfused into a patient.”
The Red Cross said it will increase oversight of its 54 regional blood centers, where many of the problems occurred, by requiring them to report to officers paid and appointed by the national headquarters rather than to local Red Cross chapters.
These officers will then report directly to the newly appointed senior vice president of blood services in Washington, Dr. Jeffrey McCullough, formerly director of Red Cross blood services in St. Paul, Minn.
Also, the organization said it will substantially increase its staffing and financial resources to improve its monitoring procedures and computer systems.
In July, the FDA released a report outlining numerous problems within the organization, including deficiencies in its computer systems and in its procedures for dealing with error and accident reports.
The FDA criticized the Red Cross for failing to notify federal regulators of 230 cases during the last 10 years in the Washington, D.C., area in which patients may have received AIDS-contaminated blood transfusions.
FDA officials have said that all but a “handful” of the cases occurred before 1985, when a test was instituted to screen blood for AIDS infection. The Red Cross is now the target of a class-action suit on behalf of those 230 individuals.
Rep. John D. Dingell (D-Mich.), chairman of the House Energy and Commerce Committee, has charged that the Red Cross has “released infected blood, mixed up records, violated AIDS testing procedures and failed to deter infected or undesirable donors.”
Jeff Nesbit, a spokesman for the FDA, said the agency “is encouraged by the restructuring,” adding: “The Red Cross’ plan to centralize the operations of its blood centers should help make sure they operate in a consistently safe and proper manner.”
Nesbit said the changes were “a significant move toward correcting the deficiencies.”
Dingell called the action “overdue, but welcome,” and said his committee “will continue to scrutinize all the components of the blood industry to make sure everything is being done to ensure that the blood supply is the safest and best that it can possibly be.”
Moody, who is a director and chairman of the executive committees of Security Pacific Corp. and Security Pacific National Bank, said the outside investigations had been surpassed “only by our own internal concern and searing self-examination.”
He said he believed that there had not yet been any erosion of public trust in the Red Cross. Nevertheless, he said, “these are serious issues” that made it necessary that “we act responsibly and earn the respect and confidence of the American public.”
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