Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on Sept. 10, 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: D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) 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 testing personnel (TP) training/competency documents and an interview with the lab director (LD), the technical consultant failed to perform semiannual competency on all testing personnel. Findings: 1. Review of the TP training/competency documents reveals TP#1 (CMS 209 page 1 of 6) had initial competency evaluated 2/5/24 and annual competecny evaluated on 2/28/25 but no semiannual competency evaluation performed. 2. Review of the TP training /competency documents reveals TP#2 (CMS 209) had initial competency evaluated 1 /29/25 but no semiannual competency evaluation performed to date. 3. Interview with the LD in the conference room on 9/10/25 at 11:10 am confirmed the lack of semi annual competency on the aforementioned TP. 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 --