Presbyterian/St. Luke's Medical Center Donor Services – FDA EIR, Jan 26, 2017

An FDA inspection of HealthONE Presbyterian/St. Luke's Medical Center, an unlicensed hospital blood bank in Denver, CO, was conducted from January 9 to January 26, 2017. This Level I Good Manufacturing Practice (GMP) inspection, performed under C.P. 7342.001 for blood establishments, uncovered both recurrent and new violations of regulatory requirements. Uncorrected issues from a 2012 inspection included failures to thoroughly investigate discrepancies, maintain complete records with personnel identification and detailed work history, and ensure a second person reviewed laboratory records for accuracy. New deviations noted instances where apheresis platelet collection and processing occurred in a donor room with out-of-specification temperatures, lacking documented corrective actions. Records for significant processing steps, such as platelet unit transport, were not concurrently maintained with complete time, temperature, and personnel details. Additionally, the facility failed to follow standard operating procedures regarding the immediate refrigeration of packed red blood cells after processing and did not consistently record Batch ID numbers on blood irradiator quality control forms, or adequately document reasons for discarded blood products. Following the inspection, an FDA-483 was issued to Dr. Sharon S. Kelly, the Blood Bank Medical Director. The facility was advised of potential regulatory sanctions, including warning letters, and committed to submitting a formal written response within 15 business days to address the observations.