Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the DermPhysicians of New England laboratory on 2/15/2024 pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 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 Histology Technician on 2/15/2024, the laboratory failed to follow procedures and policies for twice annual verification of testing it performs that is not included in subpart I of this part as evidenced by the following: The surveyor reviewed the laboratory's procedure for twice annual accuracy verification of histopathology (Mohs) slide cases on 2/15/2024. The review revealed that the laboratory's procedure for peer slide review of Mohs cases stated that five (5) cases are randomly selected and would be twice annually reviewed by another Mohs surgeon to verify the accuracy of the diagnoses. A review of calendar years 2022 and 2023 quality assessment records revealed that all ten (10) Mohs slide case reviews for 2022 were performed on 1/26/2023 and all ten (10) Mohs slide case reviews for 2023 were performed on 10/05/2023. The Histology Technician interviewed on 2/15/2024 at 12:55PM confirmed that twice annual accuracy verification for histopathology (Mohs) slide cases was not performed at least twice annually for calendar years 2022 and 2023. The laboratory performs 325 Mohs slide exams 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 --