Summary:
Summary Statement of Deficiencies D0000 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 record review and interview with the Center Manager, the laboratory failed to test its proficiency testing samples in the same manner as it tests patient specimens for 5 (Q3 Chemistry 2022, Q1 Chemistry 2023, Q2 Chemistry 2023, Q3 Chemistry 2023, Q1 Chemistry 2024) of 6 proficiency testing events reviewed. Findings include: 1. A review of the laboratory's proficiency testing documentation revealed the laboratory's