Summary:
Summary Statement of Deficiencies D0000 An announced onsite validation survey was performed on 04/11/2025 and the laboratory was found to not be in compliance with the following CLIA conditions for specialties/subspecialties surveyed for 42 CFR: 493.1403 Laboratories performing moderate complexity testing; laboratory director. 493.1421 Laboratories performing moderate complexity testing; testing personnel. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the laboratory's submitted Centers for Medicare and Medicaid Form-209, review of the laboratory's personnel records, and confirmed in interview, the laboratory director failed to provide overall management and direction for four of seven testing persons in 2025. Refer to D6029. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) (e)(11) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on review of the laboratory's submitted Centers for Medicare and Medicaid 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 -- Form-209, review of the laboratory's personnel records, and confirmed in interview, the laboratory director failed to ensure laboratory personnel had appropriate documentation of education to qualify for moderate complexity testing for four of seven testing persons in 2025. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's submitted Centers for Medicare and Medicaid (CMS) Form-209, review of the laboratory's policy, review of the laboratory's personnel records, and confirmed in interview, the laboratory failed to have documentation of education to qualify four of seven testing personnel who performed moderate complexity testing in 2025. Findings include: 1. Review of the laboratory's submitted CMS Form-209 form determined there were seven testing persons performing moderate complexity testing. 2. Review of the laboratory's personnel records determined the laboratory failed to have documentation of education for four of seven testing persons who performed moderate complexity testing in 2025: a. Testing person-3 Associate in Arts b. Testing person-4 Associate of Applied Science Radiologic Technology c. Testing person-6 Associate in Applied Arts and Sciences d. Testing person-7 Bachelor of Arts in Health Care Management 4. Testing person-1 (as listed on the CMS Form-209) confirmed the findings during an interview conducted on 04/11/2025 at 1037 hours in the break room. -- 2 of 2 --