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 surveyor review of 2023 and 2024 proficiency testing attestation statements and interview with testing personnel #1 (CMS-209 form), the laboratory failed to ensure the analyst(s) performing the testing and laboratory director, signed the attestation statements on all proficiency testing events reviewed 2023 - event 1, 2023 - event 2, 2023 - event 3, and 20204 - event 1. 1. Review of proficiency testing attestation statements from 2023 - event 1, 2023 - event 2, 2023 - event 3, and 2024 - event 1 revealed no signatures from the analyst(s) performing the testing and no signature from the lab director. 2. Interview with testing personnel #1 (CMS-209), on 5/9/2024 at 10:03 AM, confirmed no signatures from the analyst(s) performing the testing and no signature from the lab director on proficiency testing attestation statements from 2023 - event 1, 2023 - event 2, 2023 - event 3, and 2024 - event 1. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --