Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on Aug. 26, 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: D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual (SOP), personnel files, and staff interview, the laboratory director (LD) failed to specify, in writing the duties and responsibilities of each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of laboratory testing. Findings include: 1. SOP review revealed the LD failed to specify in writing the duties and responsibilities of the Clinical Consultant (CC) or the testing personnel (TP). 2. Personnel file reviews revealed the LD failed to specify in writing the duties and responsibilities of the CC or the TP. 3. An interview with the Technical Consultant (TC) (CMS 209), in the practice manager's office, on 08/26/25 at 1 p.m., confirmed the LD failed to specify the duties and responsibilities of the CC and 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 --