FDA 483 - Presbyterian/St. Luke's Medical Center Donor Services - January 26, 2017

HealthOne Presbyterian/St. Luke's Medical Center's hospital blood bank was cited for multiple deficiencies during an FDA inspection. The observations primarily concern inadequate record-keeping practices, including failure to document technician identities, maintain concurrent records, and conduct thorough investigations into discrepancies. Additionally, the facility failed to adhere to standard operating procedures for blood component processing and ensure proper donor consent for apheresis procedures.