Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) Proficiency Testing (PT) Chemistry records, the laboratory director and testing person failed to sign the attestation forms attesting that the PT samples were tested in the same manner as patient specimens for all events of the 2020, 2021, 2022, and 2023. Confirmed finding on an interview with office manager on 2/7/2023 about 10:30 A.M. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of API PT reports, the laboratory failed to evaluate and document