Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Brookline Dermatology Associates PC laboratory 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 Regional Director of Laboratory Operations on 2/08/2023, the laboratory failed to verify at least twice annually procedures it performs that are not included in subpart I of this part as evidenced by the following: The surveyor reviewed the laboratory's procedure for twice annual peer slide review of Mohs cases on 2/08/2023. The review revealed that laboratory's procedure for peer slide review of Mohs cases stated that three (3) Mohs cases would be twice annually reviewed by a second certified pathologist to verify the accuracy of the diagnoses. A review of calendar years 2021 and 2022 quality assessment records revealed that the peer slide review was only documented once for the calendar years 2021 and 2022. The documented peer slide reviews were performed on 7/21/2021 and 7/11/2022. The Regional Director of Laboratory Operations confirmed in an interview on 2/08/2023 at 11:00 A.M. that the twice annual peer slide review for the Mohs cases was only performed once in the calendar years 2021 and 2022. The laboratory performs 256 Mohs procedures 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 --