Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of CAP Proficiency Testing (PT) reports, 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. FINDINGS: 1. Attestation forms for the first, second, and third events of 2022 as well as the first event of 2023 did not include documented signatures. 2. Confirmed the findings by interview with the lab director on June 2, 2023, at approximately 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 CAP PT reports, the laboratory failed to evaluate and document