AEGiS-AP: Problems Cited At Florida Blood Bank: The Food and Drug Administration finds that 18 pints of blood were distributed in 1993 despite incomplete records of donors.

Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.

Problems Cited At Florida Blood Bank: The Food and Drug Administration finds that 18 pints of blood were distributed in 1993 despite incomplete records of donors.

The Associated Press - June 18, 1994
Marcy Gordon, The Associated Press

WASHINGTON The American Red Cross' regional blood bank for South Florida distributed 18 pints of blood during a two-month period last year although the donors' medical records were incomplete, federal investigators say.

Investigators with the Food and Drug Administration found that some of the blood distributed between May 2 and July 6, 1993, was used in transfusions before the Red Cross issued a recall. Missing information included donors' vital signs.

The Red Cross said there had been no health risk.

However, Dr. Mark Simpson, director of transfusion services at George Washington University Medical Center, said, "When you're not keeping records properly . . . there would be some increased risk of a defective product getting through."

FDA investigators discovered numerous violations of safety rules at the Miami center, which receives donations of about 100,000 pints of blood a year.

The March 25 report cited the "failure of laboratory personnel to follow criteria specified by local operating procedure" and of the blood bank to "have an adequate monitoring system in place ... for documenting the final disposition of blood components."

A copy of the three-page report was provided to the AP by the office of Sen. Bob Graham, D.Fla. Stories on the report also appeared Friday in The Wall Street Journal and the Miami Herald.

A Red Cross official in Washington said the problems at the Miami center did not endanger the blood supplies. "If public health had been at risk, we would have moved to shut it down," said Felix Perez, a Red Cross spokesman.

The Miami blood bank's top official, Steven Nathan, said some of the lapses have been corrected and that the remainder will be by July 1, when a Red Cross review of its blood bank procedures nationwide is partly completed.

"None of the citations (listed by investigators ) affected the safety, purity or potency of the blood supply. Many of them were procedural issues that were being discussed on a national level" by the Red Cross, Nathan said.

In response to the reported the Red Cross submitted to the FDA on April 14 a plan of corrective action for the Miami blood bank, FDA spokeswoman Monica Revelle said. she said the plan "appeared satisfactory."

Neither Revelle nor Perez would disclose details of the plan.

The FDA licenses blood banks and monitors their compliance with the safety rules, which are designed to ensure that the blood collected from donors for transfusions is free of blood-borne diseases such as AIDS and hepatitis.

BACKGROUND: Blood Handling Errors Were Made, Report Says Among the FDA report's findings:

* There were no records showing the final disposition of 2,850 units of blood components, including 197 units that had tested positive for viruses and/or had been rejected by laboratory technicians for other reasons.

Blood components include plasma, the liquid part of blood, and platelets, small disks that help blood to clot. A pint of whole blood often is separated into two or three components that are given to different transfusion patients, thereby multiplying the risk of contracting bloodborne diseases.

* The center neglected to have on file the necessary FDA approval to distribute autologous blood in interstate commerce. That is blood transfused from people who wish to store it for their own possible use in an emergency. Autologous blood supplies sometimes are shipped across state lines when the individual who stored them needs specialized treatment in a hospital in another state.

* The Centers procedures for irradiating blood and components, used for certain types of transfusions, do not include instructions to change the expiration date of irradiated blood to 28 days. The investigators found irradiated blood marked with original expiration dates, which were too far in the future.

Copyright (c) 1994 - The Associated Press. Reproduced with Permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, The Associated Press, 50 Rockefeller Center, New York, NY 10022.
940618
AP940618

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, National Library of Medicine, Pacific Life Foundation, and donations from users like you.

Always watch for outdated information. This article first appeared in 1994. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 1994. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .