FDA Inspection in Transfusion Service

 Duke Hospital Transfusion Service

The Duke Hospital Transfusion Service is pleased to report the results of our unannounced biennial FDA inspection. Consumer Safety Officer Marla A. Cassidy completed the inspection 1/13/17. Her report will specify that there is "No Action Indicated" for the Duke Hospital Transfusion Service.

FDA inspection results in 3 possible outcomes: No Action Indicated, Voluntary Action, or Official Action.  Voluntary and Official Actions result in being issued a form called a 483, which is public record.

The inspector was highly complimentary to our Service in the following specific areas:

  • Timely reporting (7-8 days for Duke / requirement is within 45 days) and successful corrective actions to Biologic Product Deviations (BPDs) 
  • The number of BPDs were low for a facility/operation of our complexity and size
  • Transfusion Reaction reporting - notable for thorough evaluation, content, follow up, and completeness
  • Staff adherence to policies and procedures  (by direct observation)
  • Technical staffs’ ability to describe what they are performing while being observed, their professionalism, knowledge, and helpfulness

- Nick Bandarenko MD,  Medical Director