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 Bi-Annual Quality Control (QC) Peer Review (PR) Proficiency Testing (PT) records, the Policy and Procedure Manual and an interview with the MOHS Technician, the laboratory failed to document one of the two accuracy verification reviews due in 2023, as per laboratory policy. The findings include: 1. A review of the 2023 Bi-Annual QC PR PT records revealed no documentation of MOHS surgery accuracy verification the last six months of 2023. 2. A review of the PT Procedure revealed twice per year the laboratory will submit 10 slides per surgeon per location to Skin Pathology Group for accuracy verification of the MOHS surgeons' diagnoses. 3. The MOHS Tech and the Laboratory Director confirmed the above findings during the exit conference on 08-21-2025 at 12:00 PM. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 -- This STANDARD is not met as evidenced by: Based on reviews of the Daily Room Temperature (RT) and Humidity logs, the Policy and Procedure (P&P) manual, patient testing logs and an interview with the MOHS Technician, the laboratory failed to document the