FDA 483 - HSHS St. John's Hospital - September 01, 2022

HSHS St. John's Hospital in Springfield, IL, was cited on a Form FDA 483 for failing to adhere to its established procedure for Hepatitis C Virus (HCV) lookback. The hospital did not adequately notify the ordering physician or recipient following a recall notification for a unit of cryoprecipitate confirmed positive for HCV. This lapse in protocol resulted in insufficient attempts and documentation for patient notification regarding potentially infectious blood products.