FDA EIR - Quest Diagnostics Nichols Institute - September 23, 2019

An FDA inspection of Quest Diagnostics Nichols Institute in Chantilly, VA, was conducted from September 9 to September 23, 2019. The inspection covered their operations as a CLIA-certified and FDA-registered donor testing laboratory for living human cells, tissues, and cellular and tissue-based products (HCT/P) and blood donors. This comprehensive review, part of the Office of Biological Products Operations Division's work plan, assessed the Quality Assurance System and Product Testing System, adhering to established FDA compliance programs for blood banks and HCT/P inspections.

The inspection identified several significant issues, leading to the issuance of a Form FDA-483, "Inspectional Observations," to the Medical Director. A primary concern was that communicable disease testing, specifically for HIV-1/HCV/HBV NAT, was not performed according to manufacturer instructions. The company's practice of reporting non-discriminated test results with insufficient sample as "TEST ORDER CANCELED" deviated from the manufacturer's requirement to report them as "non-discriminated."

Furthermore, the quality program was found inadequate in maintaining and following appropriate procedures related to current good tissue practice requirements. This included an SOP for HIV-1/HCV/HBV NAT testing that did not align with manufacturer guidelines, and another SOP for HIV antibody screening that failed to exclude specimens subjected to more than four freeze-thaw cycles, a limitation specified by the manufacturer. Management also failed to adequately document manual temperatures during refrigeration unit excursions.

In response, Quest Diagnostics Nichols Institute's management acknowledged the observations and committed to submitting a written response to the FDA within 15 business days. They also agreed to expand a deviation report to cover all impacted specimens since the relevant SOP's inception in 2010 and improve documentation practices for temperature monitoring.