FDA 483 - SSM-SLUH, Inc. - April 19, 2022

During an FDA inspection from April 6-19, 2022, of SSM-SLUH, Inc., a Hospital Blood Bank located at 1201 S Grand Blvd, Saint Louis, MO, several observations were made. Pamela V. Hunt, Laboratory Manager, was the individual to whom the report was issued.

Observation 1 noted a lack of maintained written records and validation data for automated processes. Specifically, the Quality Control Unit did not follow their "Process/Procedure Validation (v. 4)" for equipment like the (b) (4) X-Ray Blood Irradiator, (b) (4) Version (b) (4), and (b) (4) Version (b) (4).

Observation 2 detailed instances where standard operating procedures were not followed. A Transfusion Medicine Service employee was observed on April 13, 2022, performing ABO/RH compatibility testing for three different patients using one test tube rack, with tubes not properly labeled with patient initials or specific test identifiers as required by the "ABO RH TESTING (v.3)" procedure. Additionally, the Quality Control Unit failed to implement written validation plans for equipment such as (b) (4) Thawers, a (b) (4) Platelet Rotator, and a (b) (4) Refrigerator, violating their "Process/Procedure Validation (v.4)" procedure.

Observation 3 indicated that