Legacy Dermatology, Pllc

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiency was cited. 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 review of laboratory twice annual accuracy assessment documentation, and confirmed in interview, the laboratory failed to perform twice annual accuracy assessments in dermatopathology for two of two occurrences in 2024. Findings included: 1. Review of laboratory twice annual accuracy documentation in 2024, revealed the laboratory failed to perform twice annual accuracy assessments in dermatopathology for two of two occurrences needed in 2024. The laboratory was asked to provide the two of two assessments performed in 2024, and none were provided. 2. In an interview on 08/21/2025 at 10:40 AM in the facility office, the facility manager confirmed the laboratory failed to perform twice annual accuracy assessments for two of two occurrences in 2024. 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 An announced recertification survey conducted 04/25/2023 found the facility in substantial compliance with CLIA regulations (42 CFR Part 493). Standard level deficiencies were cited. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of laboratory policy, patient test records, and confirmed in interview, the laboratory failed to ensure patient histopathology (Mohs) slides were labeled with at least 2 unique patient identifiers for 44 of 44 slides from 2022 (March, April, and June) and 2023 (January and February). The findings include: 1. Review of the laboratory policy titled "DAILY LAB MAINTENANCE" revealed: "Slides: Slides are placed in numerical order on the slide folders. Slides are labeled with accession number, stage number, and level/deeper/recut." The laboratory policy did not include labeling instructions to reliably identify patients using at least 2 unique patient identifiers to distinguish between specimens. 2. A random review of patient slides from 2022 (March, April, and June) and 2023 (January and February) revealed 44 slides labeled with a patient last name and first initial, Mohs accession number, stage number with level, and date of service. The laboratory failed to ensure patient histopathology (Mohs) slides were labeled with at least 2 unique patient identifiers. 3. During an interview on 04/25/2023 at 12:30 p.m., the Chief Operations Officer confirmed the above findings. 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 -- 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 review of patient test reports and confirmed in interview, the laboratory failed to include the address of the testing facility on 15 of 15 Mohs maps (random review) in 2022 (March, April, and June) and 2023 (January and February). The findings include: 1. A random review of patient test reports from 2022 (March, April. and June) and 2023 (January and February) revealed the following 15 Mohs maps missing the address of the testing facility: 03/30/2022 Mohs Accession #'s: LD22-047, LD22-048, LD22-049 04/13/2022 Mohs Accession #'s: LD22-060, LD22-062, LD22- 063 06/09/2022 Mohs Accession #'s: LD22-130, LD22-131, LD22-132 01/26/2023 Mohs Accession #'s: LD23-016, LD23-017, LD23-018 02/09/2023 Mohs Accession #'s: LD23-021, LD23-022, LD23-024, 2. During an interview on 04/25/2023 at 12:30 p.m., the Chief Operations Officer confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An entrance conference was held with the laboratory representatives. The survey process was discussed, and survey forms were provided. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The laboratory representatives were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in COMPLIANCE with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the