Summary:
Summary Statement of Deficiencies D0000 An initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on October 9, 2024. 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: D6054 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 annually, after the first year. This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) competency documents and interview with the lab compliance officer (LCO) , the Technical Consultant failed to perform annual competency on all testing personnel. Findings: 1. Review of the TP competency documents revealed TP # 2 (CMS 209) did not have an annual competency performed in July 2024. 2. Interview with the LCO on 10/9/24 at 10:22 a.m in the front conference room, confirmed the finding above. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) competency documents and an interview with the lab compliance officer (LCO), the lab director failed to ensure the annual competency was performed on all testing personnel. Findings: 1. A review of the TP competency documents revealed TP # 1 (CMS 209) did not have an annual competency performed in August 2024. 2. A review of the TP competency documents revealed TP # 2 (CMS 209) did not have an annual competency performed in July 2024. 3. Interview with the LCO on 10/9/24 at 10:15 a.m in the front conference room, confirmed the aforementioned findings. -- 2 of 2 --