Northeast Dermatology Associates Pllc

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Northeast Dermatology Associates - Beverly laboratory on 04/22/2025 pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 4 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 record review and staff interview with the Histotech (HT) the laboratory failed to verify at least twice annually the accuracy of testing in the specialty of Histopathology. Findings include: 1. Record review on 4/22/2025 of the laboratory's Procedure Manual, Section 8, The Proficiency Testing and Quality Assurance Contract states "At least biannually, at least 3 cases will be randomly selected...to be evaluated for any inconsistencies." 2. Record review on 4/22/2025 of the laboratory's Quality Control binder revealed in 2023, 2024, and 2025 to date three cases for each year were all reviewed on April 1, 2025. 3. Interview with the HT on 4/22/2025 at 10: 00 AM confirmed the above. The laboratory performs 1031 patient tests annually in the specialty of Histopathology 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 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Northeast Dermatology Associates, PLLC 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, the laboratory failed to follow policies and procedures for twice annual verification of testing it performs that is not included in subpart I of this part as evidenced by the following: a) A review of the laboratory's policies for histopathology skin slide case reviews for accuracy of diagnoses indicated that the laboratory performs semiannual case reviews of 3 randomly selected cases. b) A review of histopathology skin slide case reviews performed for calendar year 2019 and 2020 revealed that skin slide case reviews for accuracy verification were not performed semiannually during calendar years 2019 and 2020. Record review further revealed that the case reviews for the latter part of 2019 and all of 2020 were performed on 3/19/21. c) The histotehnologist interviewed on 9/28/21 at 11:15 AM confirmed that twice annual accuracy verification for histopathology cases had not been performed semiannually during calendar years 2019 and 2020. The laboratory performs approximately 1,200 histopathology skin 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 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Northeast Dermatology Associates PLLC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient 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, the laboratory failed to indicate on the test report the name of the laboratory where the test was performed as evidenced by the following: Surveyors reviewed six (6) Mohs test reports between 2/3/17 and 12/20/18. The review revealed the name of the laboratory on the test reports was NEDA - Beverly. The laboratory's name is Northeast Dermatology Associates, PLLC. The training manager confirmed on 2/8/19 at 3:15 PM that the test report did not indicate the name of the laboratory where the test was performed. 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 --