FDA 483 - Lenox Hill Hospital - April 01, 2024

An FDA inspection of Lenox Hill Hospital's Blood Bank in New York, NY, revealed significant deficiencies in record-keeping practices. The hospital failed to maintain concurrent records for the distribution of blood and blood components, particularly concerning emergency releases from a satellite facility and discrepancies in electronic system entries. Additionally, the inspection found a lack of records verifying the proper functioning of new scanners used in the blood bank's electronic system.