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Wednesday, September 27, 2006

Blood bank fined for 2 incidents

Appalachian Blood Services sells blood to 37 hospitals in Southwest Virginia and southern West Virginia.

The Food and Drug Administration has fined the blood collectors serving Southwest Virginia $161,000 over two seemingly minor incidents that were taken seriously because mishandled blood is a potential health threat.

Beckie Johnson, chief executive officer of the Roanoke-based American Red Cross Appalachian Blood Services Region, said no one was injured or placed at serious risk in either case of noncompliance. She vouches for the safety of the blood collected and processed in Roanoke and shipped for medical use, often with lifesaving benefits. That amounted to 72,500 units of blood and 9,000 units of platelets last year, which was made available to be transfused into cancer, burn and surgery patients, to give but a few examples.

Johnson heads a not-for-profit enterprise that operates a blood collection center and blood bank on Church Avenue in Roanoke and collects blood regionally.

It is distinct from the Roanoke Valley chapter of the American Red Cross, which is engaged in disaster relief, safety training and assistance to families of those in the military. The chapter accepts cash donations to support its activities, but the blood program doesn't.

Appalachian Blood Services, on the other hand, maintains a $17 million budget through frequent blood drives publicized in the newspaper, on television and on signs posted at intersections. It sells the blood to 37 hospitals in Southwest Virginia and southern West Virginia.

Although the Red Cross is frequently mentioned in the news, Johnson hadn't given the news media any information about the fines, explaining that local blood banks are prohibited by Red Cross headquarters from divulging such information without specific permission. But a review of Food and Drug agency records shows two fines on Appalachian's record.

In 2004, it shipped 52 bags of platelets that later testing revealed contained or possibly contained slightly fewer platelets than expected, Johnson said. Red Cross headquarters notified the FDA of the lapse and paid a $156,000 fine. It was part of a $3.4 million fine against the Red Cross organization in 2005.

Johnson said most of the units were probably used before a recall notice went out. Those patients didn't receive bad platelets, just too few.

Platelets, which are important for normal blood clotting, can prevent or stop bleeding and help treat patients with cancer, leukemia and other diseases, according to a Red Cross Web site.

Johnson can't explain why the platelet batches came up short, but said the problem hasn't recurred. Johnson said she believes the medical risk to patients was low. She said doctors monitor patients receiving platelets and would have been in a position to give more if the first transfusion proved insufficient.

It's even possible that some of the 52 bags contained sufficient platelet quantities, Johnson said, but all the platelets collected at a Lynchburg donor center over a three-month period were declared suspect as a precaution.

A more recent case, in 2005, concerned a bag of blood that a patient donated in advance of a medical procedure for his use during the procedure. A test indicated the patient had possibly been exposed to hepatitis. While that's normally grounds for discarding a unit of blood, the blood bank shipped this blood anyway for the specific use by the person who donated it. This is done routinely, Johnson said, with the knowledge that doctors ordinarily prefer to give a patient his or her own blood rather than banked blood -- even if it harbors a potentially dangerous organism (because it's clear the patient already has that organism in his or her body).

In this case, the Red Cross sent the blood to an out-of-region hospital that had been flagged internally as one that declines to handle self-donated blood that has tested positive for certain antibodies, antigens or bacteria, including hepatitis.

For failing to recognize the hospital's special status beforehand, the Red Cross organization was fined $5,000.

This was part of a $4.2 million fine levied by the FDA on Sept. 7. The FDA cited lapses at 29 of the 36 Red Cross blood operations across the nation.

Problems at other locations included failure to screen out people who should not donate blood and lapses in collection and processing.

Stephen King, spokesman for the FDA, said the rules are strict because human blood is a potential health risk. In the case of the blood with the hepatitis marker, it could have been mistakenly given to someone else, he said.

In spite of the fines, Johnson described her Red Cross branch as having a positive overall record with the FDA, noting that facility inspectors have repeatedly found it to be in compliance with regulations. "Even the FDA has complimented us on that," Johnson said.

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