FDA 483 - Inova Health Care Services - August 07, 2019

Inova Health Care Services, operating a blood bank at 45745 Nokes Blvd, Sterling, VA, underwent an FDA inspection from July 29 to August 7, 2019. The inspection identified several compliance issues primarily related to the firm's standard operating procedures (SOPs) and quality control processes.

Key violations included the failure to maintain and adhere to SOPs for donor screening and phlebotomy. Specifically, the SOPs did not ensure proper documentation of donor contact information and failed to enforce correct procedures for inverting blood collection tubes, as per manufacturer instructions. Additionally, there were lapses in monitoring blood flow and agitating blood with anticoagulant during collection.

Further observations highlighted deficiencies in the labeling process, where employees did not perform mandatory visual inspections for hemolysis and clots in red blood cell units. The quality review and approval of equipment validation records were also not conducted in accordance with established SOPs, with new equipment being used prior to completing necessary validation reviews.

Another critical issue was the inadequate presentation of educational materials to donors. It was observed that donors were not given sufficient time to review important information, and there were instances of incorrect documentation of donor responses on the history questionnaire.

The FDA requires Inova Health Care Services to address these issues by revising and strictly implementing SOPs, ensuring proper training of staff, and enhancing quality control measures. Immediate corrective actions and a detailed response plan must be submitted to the FDA to demonstrate compliance and prevent future violations.