FDA Cites Red Cross for Violations at Blood Bank : Safety: A Miami facility distributed blood even though some donors’ medical records were incomplete. Officials say there was no health risk.

The American Red Cross’ regional blood bank for South Florida distributed 18 pints of blood in a two-month period last year even though the medical records of the donors 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.” He reviewed the report at the request of the Associated Press.

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 by the office of Sen. Bob Graham (D-Fla.).

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,” Felix Perez said.

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

In response to the report, 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.” Details of the plan were not disclosed.

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.

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 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 blood-borne 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 center’s 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. Investigators found irradiated blood marked with its original expiration dates, which were too far in the future.