Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Dermatology and Skin Care Associates laboratory on 12/29/2025 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 Clinical Team Leader (CTL) on 12/29 /2025, 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 and records for the twice annual peer slide review of histopathology Mohs slide examinations for calendar years 2024 and 2025. Per the laboratory's procedure "Every 100th case is selected from the Mohs laboratory log and a 2nd Dermatopathologist will consult/review on the slides." The review revealed that the laboratory performed the peer slide review only once for calendar year 2024 on 12/20/2024 and only once for calendar year 2025 on 12/10 /2025. Three Mohs cases were reviewed for each calendar year. The CTL confirmed in an interview on 12/29/2025 at 10:19 A.M. that the twice annual peer slide review was performed only once annually for calendar year 2024 and only once annually for calendar year 2025. The laboratory performs approximately 250-300 Mohs cases annually. . D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient 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 -- identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . Based on record review and interview with the Clinical Team Leader (CTL) on 12/29 /2025, the laboratory failed to indicate on the patient final test report the correct address of the laboratory where the test was performed as evidenced by the following: The surveyor reviewed six (6) patient final test reports for Mohs cases between April 2024 and November 2025 in the Electronic Medical Record (EMR) Epic. The review revealed that the laboratory failed to indicate the correct address of the laboratory where the Mohs case was performed for six (6) out of six (6) patient final test reports. The address of the laboratory on the patient's final test reports in the Epic EMR was 332 Washington Street, Suite 355, Wellesley, MA 02481. The laboratory's physical address on the CLIA certificate is 10 Laurel Avenue, Suite 300, Wellesley, MA 02481. The CTL confirmed in an interview on 12/29/2025 at 1:04 P.M. that the patient final test reports for Mohs cases did not indicate the correct address of the laboratory where the test was performed. The laboratory performs approximately 250- 300 Mohs cases annually. -- 2 of 2 --