Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on January 28, 2026. 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: D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: A review of the 2024 - 2026 Personnel Records confirmed that the Laboratory Director failed to perform personnel competencies as required. THE FINDINGS INCLUDE: 1. A review of 2024 - 2026 Personnel Records confirmed that personnel competencies were performed by an unqualified Testing Personnel #1 (see CMS- Form 209: Laboratory Personnel Report). 2. An exit interview, with Laboratory Staff, on January 28, 2026, at 1:30 pm, confirmed that the Laboratory Director failed to perform personnel competencies as required. 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 --