FDA 483 - Saint Alphonsus Regional Medical Center - May 04, 2023

An FDA inspection of Saint Alphonsus Regional Medical Center in Boise, ID, a hospital blood bank, identified two significant observations. The facility failed to report the issuance of two expired units of Red Blood Cells. Additionally, their standard operating procedures for compatibility testing lacked adequate provisions for expediting transfusions in emergencies, as evidenced by numerous unsigned emergency release slips.