FDA EIR - Presbyterian/St. Luke's Medical Center Donor Services - April 22, 2019

An FDA inspection of HCA-HealthOne, LLC., an unlicensed hospital blood bank operating as HealthOne Presbyterian/St. Luke's Medical Center in Denver, CO, occurred from April 15 to April 22, 2019. The inspection, conducted under Compliance Program 7342.001 for blood bank operations, identified a significant, repeat violation detailed in an FDA-483. The main issue was the consistent failure of records to adequately identify the person performing specific tasks, include dates for entries, and provide a comprehensive history of the work, as mandated by 21 CFR 606.160(a)(1).

Specifically, technician initials were frequently missing from Component Preparation logs when storing blood products like Packed Cells and Frozen Plasma, and from Quality Control/Preventative Maintenance Irradiator records for daily checks. This critical record-keeping deficiency was a carryover from a January 2017 inspection, where it was one of seven observations, with the other six having since been corrected.

In response, company management, including President/CEO Maureen Tarrant, committed to reviewing and updating the Standard Operating Procedures for Component Preparation and Blood Irradiator operations to enhance clarity and ensure compliance. HCA-HealthOne, LLC. also pledged to submit a detailed written response outlining their corrective actions within 15 business days, acknowledging their responsibilities under the FD & C Act.