Summary:
Summary Statement of Deficiencies D0000 An initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on February 07, 2025. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following standard level deficiencies were cited: D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the Laboratory Personnel competencies for 2023, 2024, January 2025, and staff interview, the Technical Consultant(TC) failed to perform semi-annual competency assessments on two out of seven testing personnel(TP) listed on the Centers for Medicare and Medicaid Services (CMS) Laboratory Testing Personnel Report (CMS 209 form) Findings: 1. Review of the laboratory personnel competencies for 2023, 2024 and January 2025, confirmed the TC failed to perform semi-annual competency assessments on two out of seven TP Listed on the CMS 209 form. 2. Staff interview with the Chief Operation Officer, on 02/07/2025, at approximately 12 pm, in the exam room, confirmed the above finding. 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 --