Ghc-Scw Capitol Clinic

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of procedures and laboratory proficiency testing (PT) records and interview with the technical consultant, the laboratory did not verify the accuracy of the post vasectomy semen analysis motility testing twice annually in two of the last two years. Findings include: 1. Review of the "Semen Analysis - Post Vasectomy" procedure, effective date 6/8/2023, showed testing personnel evaluate patient post vasectomy semen samples for the presence of spermatozoa and for motility. 2. Review of PT records from 2024 and 2025 showed no evidence the laboratory evaluated PT samples for spermatozoa motility. 3. Interview with the technical consultant on August 26, 2025, at 11:40 AM, confirmed the laboratory did evaluate post vasectomy semen samples for motility and that the laboratory did not verify the accuracy twice annually of the spermatozoa motility evaluation included in the post vasectomy semen analysis. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, 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 -- and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies 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 surveyor review of competence evaluation records and interview with the technical consultant, the consultant did not evaluate competence in 2022 with the Vitros chemistry analyzer for three of five staff members reviewed. Findings include: 1. Review of annual competence records for the Vitros chemistry analyzer for five testing personnel showed three of the five did not have documented competence assessments in 2022. Records for staff members A, B, and C showed no evidence of evaluation for the Vitros chemistry analyzer in 2022. 2. Interview with the technical consultant on August 2, 2023, at 11:45 AM confirmed staff A, B, and C did not have documented competence evaluations in 2022 for the Vitros chemistry analyzer. 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 --