Summary:
Summary Statement of Deficiencies D0000 An initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on May 26, 2026. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 the American Proficiency Institute (API) profiency test (PT) records and interview with the laboratory technical consultant (TC) , the laboratory testing personnel and lab director failed to attest that PT samples were tested in the same manner as patient specimens. Findings: 1. Review of the API PT records revealed the lack of required signatures on the attestation statements on 2025 event 3- Hematology and 2025 event 3- Chemistry. 2. Interview with the TC (CMS 209) on 6 /26/26 at 2:30 PM in the review office space confirmed the aforementioned finding. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require