City Dermatology Llc

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on policy review, lack of documentation, and interview with the Mohs Tech (MT), the laboratory director (LD) failed to perform and document the required yearly procedure review as specified in the laboratory's policies for 2 of 2 years from 02/05 /2026 to 09/29/2026. Findings include: 1. On the day of the survey, 09/29/2026 at 9: 00 am, review of the laboratory's policy manual table of content page revealed, "The above policies and procedures have been reviewed and are effective as of open date. It will be updated as procedures change. Reviewed yearly." 2.The LD failed to provide documentation for the yearly policy review performed for 2 of 2 years from 02/05 /2025 to 09/29/2026. 3. The laboratory performed 1,031 histopathology microscopic slide examinations in 2025 (CMS 116, estimated annual volume, dated 09/29/2026). 4. The MT confirmed the finding above on 09/29/2026 at 09:15 am. 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 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 the laboratory's peer review records, and interview with the office manager (OM), the laboratory failed to ensure that the verification of accuracy for MOHS micrographic surgery slide examinations were performed at least twice annually in 2022. Findings Include: 1. On the day of the survey, 02/21/2022 at 01:00 pm, the laboratory could not provide documentation that the verification of accuracy for MOHS micrographic surgery slide examinations stained using hematoxylin and eosin (H&E) were performed at least twice annually in 2022. 2. The laboratory performed 1054 MOHS micrographic surgery slide examinations in 2022 (annual volume listed on form CMS-116). 3. The OM confirmed the findings above on 02/21 /2023 around 01:30 pm. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: 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 -- Based on review of the laboratory's quality control (QC) records and interview with the office manager (OM), the laboratory failed to document Hematoxylin and Eosin (H&E) QC monitoring activities for intended reactivity each day of patient testing for MOHS micrographic surgery slide examinations performed from 03/03/2021 to 09/27 /2022. Findings Include: 1. On the day of the survey, 02/21/2023 at 12:21 pm, review of the staining QC records revealed the laboratory did not document QC monitoring activities for intended reactivity each day of patient testing for MOHS micrographic surgery slide examinations stained using H&E for the following 17 of 542 days from 03/03/2021 to 09/27/2022: - 03/03/2021 - 04/21/2021 - 05/26/2021 - 06/01/2021 - 08 /31/2021 - 09/14/2021 - 09/15/2021 - 09/27/2021 - 01/27/2022 - 03/28/2022 - 05/10 /2022 - 06/16/2022 - 06/20/2022 - 07/28/2022 - 07/30/2022 - 08/02/2022 - 09/27/2022 2. The OM confirmed the finding above on 02/21/2023 around 01:30 pm. -- 2 of 2 --

Summary Statement of Deficiencies D6024 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(7) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(7) Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance specifications are identified, This STANDARD is not met as evidenced by: Based on review of laboratory policy and procedure, Cryostat temperature 2020 record and interview with Mohs Tech, the laboratory failed to ensure that