FDA 483 - Edward W Sparrow Hospital Association - March 18, 2019

An FDA inspection of Edward W. Sparrow Hospital's Transfusion Service in Lansing, MI, from March 12-18, 2019, identified a significant failure in patient notification. The hospital failed to inform the physician of record or legal representatives of transfusion recipients about the increased risk of HCV infection from blood components, even after a donor's subsequent reactive HCV NAT test. This lapse in communication potentially jeopardized patient health and follow-up care.