FDA 483 - Summa Health System - March 21, 2023

An FDA inspection of Summa Health System, a hospital blood bank, identified significant deviations from written standard operating procedures for blood and blood component processing and distribution. The firm failed to ensure physicians signed emergency release forms for uncrossmatched blood and did not consistently follow protocols for monitoring vital signs during transfusions or stopping transfusions when reactions were suspected. These issues indicate a lack of adherence to established procedures, which could impact patient safety.