Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: FRIDAY, April 19, 1991 TAG: 9104190047
SECTION: NATIONAL/INTERNATIONAL PAGE: A4 EDITION: METRO
SOURCE: Associated Press
DATELINE: WASHINGTON LENGTH: Medium
The latest known problem involved the Red Cross' Portland, Ore., blood-collection center, which according to an FDA inspection report, released blood that was improperly tested for AIDS and hepatitis B.
The FDA on Wednesday threatened to pull the license of the Portland center because of many violations of procedures found during the inspection.
At a hearing before the House Energy and Commerce investigations subcommittee, Dr. Jeffrey McCullough, a senior vice president for the American Red Cross, acknowledged that the Portland center has problems. But, he said, "these situations have not resulted in the transfusion of infected blood, to the best of our knowledge."
But Mary Carden, the FDA official who inspected the Portland center, testified that the written records indicate that blood improperly tested for hepatitis B was shipped out of the center to hospitals.
McCullough said he believes the two units of blood in question were retested, and came out negative for hepatitis B, but that a record-keeping error made it appear otherwise. He conceded that the evidence that the blood was retested was circumstantial.
Blood that was improperly tested for AIDS was found at the center before it could be shipped, Carden said, but added "it would have been shipped if we hadn't found the error."
The Red Cross collects and distributes about half of the nation's blood supply.
Carden acknowledged McCullough's efforts to improve procedures to ensure that blood from Red Cross centers is free of infectious viruses and bacteria. Last year, the Red Cross restructured its operations to centralize management of its network of local blood service regions.
"They have to demonstrate to us that these changes they are putting into place have worked," she testified.
"It's important to remember that changes will take some period of time," she added. "It's our concern that while those changes are being made, blood products are still being distributed."
She said the Red Cross was "attempting to make some very good, important changes, but they haven't been made yet to the point that they have filtered down to stopping unsuitable blood products from getting out the door."
Unsuitable blood is defined very broadly, McCullough noted. "It can range from extremely dangerous to units that really wouldn't pose any real danger but were not handled with proper operating procedure."
by CNB