Adventist Health Walla Walla General Hospital shows complete recovery.

Adventist Health Walla Walla General Hospital, Walla Walla, WA, Seattle District

Registered hospital blood bank and autologous donor center Adventist Health Wall Walla General Hospital passed an April 2003 FDA inspection with flying colors.

A previous audit in December 2002 discovered substantial deficiencies, which included more than 20 occasions where the facility failed to perform quality control of blood reagents when patient samples were tested. In addition, an expired reagent was used for patient testing, and the hospital was not documenting significant steps in thawing frozen products and the production of pooled cryptoprecipitate.

The current inspection, conducted by Rocco Black of FDA's Seattle District, verified that deficiencies from the previous inspection were corrected.

The establishment operates as a hospital transfusion service and as a collection center for autologous and therapeutic blood units. The audit covered blood collection reports, ABO/Rh and compatibility test records, proficiency testing, SOPs, storage, quality control of equipment and reagents, transfusion reactions and emergency release of units and distribution.

Autologous units are used within the hospital and are not tested for viral markers, the EIR stated. Therapeutic units are discarded as biohazardous waste. Black reviewed expiration dates of autologous blood units collected since the last inspection and noted that he did not find any units that were "assigned a wrong expiration date."

He also verified the establishment was in compliance "with the new final rules, including the required labeling of autologous units with 'Donor Untested.'"

Rocco also noted in the EIR that there were no transfusion reactions in the last year and the facility did not release uncross-matched blood products in an emergency. Black also reviewed the Wisconsin State Laboratory of Hygiene proficiency survey, in which the facility participates, and found no significant deficiencies.

In a discussion with management, Black discussed some minor deficiencies he discovered during the inspection.

For example, according to the facility's SOPs, blood bank reagents must be tested daily with appropriate controls; whereas, during a review of reagent QC records, Black found one instance where the quality control of the blood bank reagents "was not documented as being performed on the same day that patient samples were tested."

"Although the firm has substantially reduced the frequency of this deficiency since the previous inspection, I stated that they should try to ensure that reagent QC is performed every day that patient samples are tested," Black wrote in the EIR.

The facility said it would "try to ensure that reagent QC is performed every day that patient samples are tested."

Adventist did not return calls requesting comment.

Adventist Health Walla Walla General Hospital, Walla Walla, WA, 4/9-10/03, Doc. 109591M, $17.00 plus retrieval.