Summary:
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 a review of the Centers for Medicare & Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), laboratory policy, Provider Performed Microscopy (PPM) test logs, and staff interview, the laboratory failed to perform twice-yearly verification of accuracy for KOH fungal testing and scabies testing for seven of eight testing personnel (TP) in 2023, eight of eight TP in 2024, and ten of ten TP in 2025. The findings include: 1. A review of the Form CMS-209 revealed ten TP listed, eight employed in 2023 and 2024, and ten employed in 2025. 2. A review of the Provider Performed Microscopy (PPM) Lab Manual revealed the following requirements: - "To evaluate and demonstrate proficiency, at least twice per year, split- sample testing is performed on at least two specimens for each test performed." - "Proficiency testing/split-sample testing duties will be rotated among all personnel who examine patient samples for PPM." 3. A review of the PPM Split-Sample Testing Log/Quality Assurance revealed the following reviews performed: 2023 - 30 patient tests performed TP1- 04/26/2023 TP3- 09/20/2023 TP5- 08/04/2023 TP6- 02/21/2023 & 10/09/2023 TP7- 06/28/2023 2024 - 30 patient tests performed The laboratory performed no documented reviews. 2025 - 25 patient tests performed The laboratory performed no documented reviews. 4. The Mohs technicians 1 and 2 confirmed the survey findings in an interview on 08/06/2025 at 11:15 a.m. 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 --