FDA 483 - The Johns Hopkins Hospital HATS Service - February 13, 2025

During an inspection conducted from February 10-13, 2025, the FDA issued a Form 483 to Johns Hopkins Hospital, specifically concerning its Hospital Blood Bank/Transfusion Service. The inspection identified two primary observations related to critical documentation and procedural controls for emergency blood transfusions. The first observation detailed that records for emergency transfusions consistently lacked the required signature of the physician requesting the procedure. This deficiency was noted across multiple instances for both identified and unidentified emergency room patients, with some forms signed by non-physician staff instead of the physician. The second observation highlighted inadequacies in the hospital’s written standard operating procedures (SOPs) for the emergency release of blood and blood components. Specifically, two SOPs, "Haemobank-Emergency Release" and "Emergency Release/Uncrossmatched Blood Products," failed to include instructions mandating the requesting physician’s signature on emergency release records. Furthermore, these SOPs also lacked requirements for maintaining complete documentation justifying the emergency release of uncrossmatched blood/blood components for patients in the emergency room. These observations, issued under Section 704(b) of the Federal Food, Drug, and Cosmetic Act, indicate a need for Johns Hopkins Hospital to implement corrective actions. These actions should focus on revising documentation practices to ensure physician signatures are consistently obtained for emergency blood releases and updating SOPs to explicitly include these critical documentation requirements and the necessary justification for emergency transfusions.