FDA cites SETA for obtaining tissue from wrong donor; Florida-based tissue bank says corrective actions taken.

The Southeast Tissue Alliance (SETA) in Gainesville, FL, has been cited by the US Food and Drug Administration (FDA) for obtaining tissue from the wrong donor twice over a period of 10 months in 2002 and 2003.

In a warning letter sent to SETA on June 18, 2004, the FDA listed a series of "significant deviations from the regulations for human tissue intended for transplantation" and ordered the tissue bank to "take prompt actions to correct the violations."

SETA Director of Professional Relations Michael Scott said the tissue bank took full responsibility for the mistakes and said steps have been taken to see that they don't happen again.

"These things happened quite awhile back, we put corrective actions in place and have no recurrence in 15 months," Scott told Transplant News.

"In both cases the mistakes were made by experienced people who were well trained with good procedures in place," Scott observed. "But for some reason, possibly complacency, they failed to follow the procedures."

Scott said that in the most recent case, which occurred on March 14, 2003, the donor verification procedure was in place which required the coordinators to call the tissue bank to properly identify the donor and they didn't.

In both cases the employees were terminated, Scott said.

The most serious "deviations" outlined in the FDA letter concerned improper identification of tissue donors.

For example, the FDA said that on June 13, 2002, 2 SETA employees failed to make a determination that a human tissue donor was "suitable," misidentified the donor's identity, and later released the tissue for transplantation.

"Two of your recovery specialists in Melbourne (Palm Bay), Florida, failed to properly identify [the] donor and obtained tissue from another cadaver," the FDA said. "This resulted in the recovery and distribution of unsuitable human tissues from a cadaver for whom donor suitability had not been determined."

The FDA cited a second incident in which 2 SETA "recovery specialists" failed to properly identify a donor which led to tissue being recovered whose "suitability had not been determined" but was never distributed.

"These were gut-wrenching incidents, but we are doing everything we can to assure they never happen again," Scott told the Associated Press on July 14t.

The warning letter outlined a series of lesser "deviations" discovered during an annual inspection last March and directed SETA to take action to see that they are corrected.

"Failure to correct these deviations may result in further regulatory action being taken by FDA without further notice," the letter said. "Such action includes an FDA Order for Retention, Recall and/or Destruction of Human Tissue."

Scott said SETA is preparing a final response which will be delivered to the agency by August 6th.

"The warning letter didn't include 2 updates on corrective actions we had already made and sent them which made it seem a little worse than it really was," Scott told Transplant News. "Our major concern is getting safe tissue to patients and we have made corrections to our processes. We are working with FDA on our response and are fully in sync with their expectations."

A copy of the FDA warning letter can be found at www.fda.gov/foi/warning_letters/g4832d.htm.