Radiant Dermatology & Aesthetics Pllc

Summary Statement of Deficiencies D0000 As a result of a complaint investigation a survey of the laboratory was conducted on 09/24/2025. Surveyor 's review of laboratory ' s records, observations and staff interviews did not provide evidence to substantiate the complaint allegations. The laboratory was found in compliance with applicable CLIA conditions (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) (e)(15) Specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of laboratory's policies/procedures, personnel records and staff interview, the Laboratory Director failed to ensure delegation of specific duties for each component of laboratory processes was documented in writing for each of the six of six personnel employed by the facility in 2024 and 2025. Findings included: 1. Review of laboratory's policies/procedures revealed the laboratory had a Delegation of Duties policy (last reviewed January 2025) that specified each person's duties by title, specifically Laboratory Director, Clinical Consultant, Technical Supervisor, General Supervisor and Testing Personnel. The policy did not differentiate specific duties between the employed personnel involved in laboratory processes (Mohs surgeons or histotechs). The policy also did not address which personnel were delegated the different components of histopathology/Mohs surgery laboratory 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 -- processes (testing components of grossing [sample measuring/ orienting/ describing/ dissecting/ inking/ marking], microscopic examination/interpretation and reporting, versus non-testing components of sample accessioning, freezing and cutting, slide preparation, staining and cover slipping). 2. Review of laboratory's personnel records revealed the laboratory did not have documentation of Laboratory Director's written delegation of specific duties for each of the six individuals (as indicated on submitted Form CMS 209) involved in facility's laboratory processes (three Mohs surgeons and three histotechs). 3. In an interview on 09/24/2025 at 0930 hours in the office, the facility's Practice Manager (as indicated on submitted Entrance/Exit Conference document) confirmed the findings. Key: CMS - Centers for Medicare and Medicaid Services -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 08/19/2024. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor's observations, review of laboratory's annual test volumes and staff interview, the laboratory failed to ensure 3 of 4 marking dyes used for Mohs procedures were not used after exceeding their expiration date. Findings included: 1. Surveyor's observations on 08/19/2024 at 0910 hours in the laboratory revealed the following marking dyes used for laboratory procedures exceeded their expiration date: Avantik Yellow Tissue Marking Dye Lot: 148630 Expired: 2024-04-30 Avantik Green Tissue Marking Dye Lot: 154057 Expired: 2024-07-31 Avantik Red Tissue Marking Dye Lot: 151000 Expired: 2024-06-30 2. Review of laboratory's submitted annual test volumes revealed the laboratory performed 674 Mohs procedures annually. 3. In an interview on 08/19/2024 at 0910 hours in the laboratory, the laboratory's Histotechnologist on duty, after review of the expired products, confirmed the 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 1 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) 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 in compliance with applicable CLIA Conditions, and certification is recommended. Note: The CMS- 2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the