Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on September 19, 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: D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) (e)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; This STANDARD is not met as evidenced by: A review of 2023 - 2025 Personnel Records confirmed that the Laboratory Director (LD) failed to assure that testing personnel had the appropriate education to perform the duties of Testing Personnel (TP). THE FINDINGS INCLUDE: 1. A review of 2023 - 2025 Personnel Records confirmed that proof of education was not available for TP5, TP7, TP9, TP10, and TP15 (see Form 209 Laboratory Personnel Report (CLIA) form). 2. An exit interview, with the Laboratory Director and the Technical Consultant, on September 19, 2025, at 12:30pm, confirmed that the LD failed to assure that testing personnel had the appropriate education to accurately perform the duties of 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 --