National Naval Medical Center orders blood bank shut down FDA says 126 units of blood were not properly screened for HIV

December 29, 1997|By NEW YORK TIMES NEWS SERVICE

WASHINGTON -- Administrators at the National Naval Medical Center have ordered a halt to services at the hospital's blood bank after a report by the Food and Drug Administration questioning the reliability of some blood used for transfusion.

The FDA report uncovered clerical errors and cited 126 units of blood that were not properly screened for HIV, the virus that causes AIDS.

Cmdr. Ryland Dodge, a spokesman at the medical center in Bethesda, Md., did not dispute the findings of the FDA's three-month audit of the naval hospital.

Dodge said that some "discrepancies" occurred in the voluminous paper trail necessary to track the thousands of units of blood collected, stored and distributed every year by the 200-bed hospital. He described these problems as small clerical oversights that left unclear "the final disposition" -- including the location -- of more than 500 units of blood.

Asked whether any of the blood could have been tainted, Dodge said, "Absolutely not."

According to the FDA's report, 126 units of blood were transfused, distributed or left in storage without having been properly screened for the human immunodeficiency virus. Officials said no one has been infected from the blood, although the FDA asserts that 33 units cannot be accounted for.

On Nov. 26, the FDA filed its report summarizing the results of an annual audit of the medical center, which is renowned for having examined every American president since Franklin Delano Roosevelt, along with countless members of Congress and other dignitaries. The hospital voluntarily suspended its blood-donor services the same day.

Dodge said that the 126 units in question had been subjected to all normal HIV tests, except for one test that had only recently been introduced.

The FDA also said that because of documenting errors, the final status of an additional 400 units of blood remained unclear. Whether they had been shipped, transfused or destroyed after a maximum 35-day holding period was not verifiable. The hospital spokesman said that the undocumented units had not been shipped or transfused, and had therefore "in all likelihood" been destroyed.

Dodge attributed the clerical errors in the medical center's blood facility to a "cumbersome and difficult" tracking system in which five forms can be required to monitor the progress of one unit of blood. A computerized system is being introduced to make the process more efficient.

Dodge said the National Naval Medical Center was aware of the clerical problems before the FDA audit began and had informed the inspectors of the shortcomings. Since then, he said, the FDA and the hospital have worked closely to pinpoint problems and ensure that there will be no further discrepancies in the tracking system.

The problems with the hospital's blood bank were first reported by the Washington Post.

The blood bank is likely to resume operations in February.

Pub Date: 12/29/97

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