Summary:
Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on surveyor review of American Association of Bioanalysts (AAB) proficiency testing (PT) records and laboratory records and interview with the quality manager, staff A, and the center manager, staff B, the laboratory did not examine or test the proficiency testing samples in the same manner as it's patient specimens for total protein performed for three of three events in 2022 and two of two events in 2023. Findings include: 1. Review of AAB PT records from 2021 showed the laboratory received a score of eighty percent on total protein for event 3 in 2021. 2. Review of the "Deviation (Event) Detailed Report" showed under heading "CAPA Assessment" the laboratory stated, "Our