Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on July 17, 2025. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 the American Proficiency Institute (API) proficiency testing (PT) attestation sheets, competency evaluations, CMS 209 personnel report, and a staff interview the laboratory failed to rotate PT samples with all testing personnel (TP). Findings: 1. Review of the 2023, 2024, and 2025 competency evaluations and the CMS 209 personnel report revealed 5 testing personnel performing complete blood counts (CBC) on the Sysmex 350N analyzer. 2. Review of the API attestation forms of 2023 event 3; 2024 events 1, 2, & 3; and 2025 event 1 revealed only 3 TP (TP #1, TP #2, TP #3) were running the PT samples for evaluation. 3. Interview with TP #1 (CMS 209) on 7/17/25 in the review office at 12:35 PM confirmed the aforementioned findings. D5785