Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted on 03/20/2025 for the DermWellesley LLC laboratory pursuant to the Clinical Laboratory Improvement Act (CLIA) of 1988 and CLIA regulations at 42 CFR CFR 493. 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 record review and interview with the Medical Assistant on 03-20-2025 the laboratory failed to follow the procedure and policy for twice annual verification of testing that is performed that is not included in subpart I of this part as evidenced by the following: The surveyor reviewed the laboratory's Biannual Proficiency Testing for Mohs Micrographic Surgery policy procedure for review of Mohs Surgeon's histopathology skin tissue slide cases. The review revealed that bi-annually, the Mohs histology technician will select three random cases of the Mohs Surgeon for review by the onsite Dermatopathologist. A review of Proficiency Testing records from 07-25- 2023 through 03-20-2025 revealed cases had dated reviews on 07-25-2023, 12-12- 2023, 06-11-2024 and 01-25-2025. There were two dated case reviews for 2023 and thus far, one dated case review for 2025. There was only one dated case review performed for 2024. The record review and interview with Medical Assistant at 10: 39am on 03-20-2025 confirmed that the laboratory failed to perform twice annual accuracy verification procedure for Mohs histopathology tissue slide cases and had performed only one PT review for 2024. Laboratory performs 400 Mohs cases (610) histopathology skin slide examination annually. 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 --