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

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from April 6 to April 19, 2022, SSM-SLUH, Inc., a hospital blood bank in Saint Louis, MO, received a Form FDA 483 outlining significant observations related to regulatory compliance. The inspection identified several critical issues pertaining to quality control, procedure adherence, and record-keeping for blood and blood components.

Key violations included a failure to maintain written validation plans for automated and electronic equipment, such as X-ray blood irradiators, thawers, and platelet rotators, as required by the firm's own procedures. Additionally, staff did not consistently follow standard operating procedures for ABO/RH compatibility testing, specifically regarding the proper labeling of patient specimens and test tubes, which is essential for preventing errors.

The FDA also observed deficiencies in equipment maintenance, standardization, and calibration, with missing dosimetry reports and maintenance records for a blood irradiator. Furthermore, the facility failed to maintain complete records for emergency transfusions, with instances of missing physician and witness signatures and inadequate documentation justifying emergency actions.

These observations indicate a need for SSM-SLUH, Inc. to implement comprehensive corrective and preventive actions to ensure compliance with federal regulations governing blood banks and to uphold the safety and quality of blood products.