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 American Association of Bioanalysts (AAB) proficiency testing (PT) records and interview with the technical supervisor, testing personnel did not attest to the routine integration of PT samples into the patient workload using the laboratory's routine methods for five of five PT events in 2023. Findings include: 1. Review of AAB PT records from 2023 showed testing personnel did not sign the attestation form for the following events: Embryology, Andrology & Fetal S1 2023 Embryology, Andrology & Fetal S2 2023 Chemistry M1 2023 Chemistry M2 2023 Chemistry M3 2023 2. Interview with the technical supervisor on April 8, 2024, at 10: 00 AM confirmed testing personnel did not attest to the routine integration of PT samples into the patient workload using the laboratory's routine methods in 2023. 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 --