Violations uncovered at Army blood center - Walter Reed Army Medical Center - Investigators' Reports

FDA Consumer, Sept, 1996 by Dori Stehlin

The U.S. Army voluntarily discontinued much of its blood collection at Walter Reed Army Medical Center, Washington, D.C., in March while it worked on correcting numerous blood collection violations.

Investigators with FDA's Baltimore district office uncovered the violations while inspecting the Walter Reed blood center Sept. 28 through Oct. 17, 1995. Problems found included:

* lack of proper equipment and supplies for blood drives

* failure to maintain an up-to-date donor disqualification deferral list

* improperly refrigerated whole blood

* failure to investigate reactions to transfusions

* lack of privacy for donors filling out blood donation questionnaires

* failure to maintain equipment monthly as required.

The Army responded to FDA's findings in a letter last Dec. 18, but, because of discrepancies between the Army's response and FDA's findings, investigators returned to Walter Reed on Jan. 30, 1996. They found many of the same problems, as well as new ones, including:

* using out-of-date blood for transfusions

* improperly maintaining the blood product irradiator, a device that exposes blood to radiation to reduce the risk of rejection when transfusing infants or a member of the donor's family

* failing to verify repeat testing on samples testing positive for hepatitis B.

Last April 16, Army representatives met with FDA and told the agency that as of March 18 it had discontinued all blood collections except for autologous donations and plateletpheresis. In autologous donations, individuals donate blood for their own use. Plateletpheresis is a process in which platelets are removed from the donor's blood, and then the rest of the blood is returned to the donor. The Army said it was continuing these two types of collections because demand for them couldn't be met from other sources.

The Army informed FDA that it was addressing the problems by:

* having a blood quality assurance expert review all facets of the operation

* retraining all blood bank staff

* reviewing records for the last six months to determine whether any blood was inappropriately released

* installing a new computer system.

The Army also said it would inspect North American Biological Inc., Miami, a company under contract to Walter Reed to test blood for infectious diseases, to ensure that it was following regulations.

"We believe that if the Army's aggressive plans are vigorously pursued, there will be no concern for the safety of Walter Reed's blood products," said Ken Shelin, FDA's Baltimore district director.