Advanced Dermatology And Cosmetic Surgery

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Advanced Dermatology and Cosmetic Surgery on 4/3/2026. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D3001 FACILITIES CFR(s): 493.1101(a)(1) (a) The laboratory must be constructed, arranged, and maintained to ensure the following: (a)(1) The space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to ensure that the ventilation system was maintained to properly remove chemical vapors for the testing performed, when the facility lacked a chemical fume hood required by the manufacturers of the histopathology reagents (100% Dehydrant and Eosin-Y with Phloxine). Findings include: 1. During an observation of the laboratory on 4/3/2026, it was noted that the facility lacked a chemical fume hood. An Epredia Linistat Linear Stainer was observed situated on a workbench with multiple open reagent containers used for staining patient specimens. There was no local exhaust ventilation or fume hood present above or around this equipment. 2. The following chemical reagents, used for histopathology testing, were stored in the facility's flammable cabinet on 4/3 /2026: 100% Dehydrant (Manufacturer: Cardinal Health) Eosin-Y w/ Phloxine (Manufacturer: Epredia) 3. A review of the Safety Data Sheets (SDS) for both the 100% Dehydrant and the Eosin-Y w/ Phloxine on 4/3/2026 revealed manufacturer instructions regarding ventilation requirements: The SDS for 100% Dehydrant stated under Section 7 (Handling) and Section 8 (Engineering Measures): "Use only under a chemical fume hood." The SDS for Eosin-Y w/ Phloxine stated under Section 7 (Handling) and Section 8 (Engineering Measures): "Use only under a chemical fume 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 -- hood." 4. In an interview on 4/3/2026 at 9:30 AM, the Mohs Technician confirmed the laboratory did not have a chemical fume hood. The Mohs Technician further stated they were aware the safety data sheets for the dehydrant and Eosin stains required the use of a chemical fume hood to protect personnel from chemical vapors during the testing process. -- 2 of 2 --

Summary Statement of Deficiencies D0000 At the time of the announced onsite initial survey, Advanced Dermatology and Cosmetic Surgery, was found to NOT be in compliance with the CLIA laboratory requirements of 42 CFR 493. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document annual competency assessment for Testing Person A in 2021. Findings include: The review of competency records for Testing Person A, who performs KOH (Potassium Hydroxide) and Scabies testing ,showed no annual assessment was performed in 2021. The interview with the Office Manager on 10/28/22 at 11:23am confirmed the competency assessment was not completed in 2021. 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 a review of the quality assurance records and staff interview, the laboratory failed to verify the accuracy of the KOH (Potassium hydroxide) and Scabies testing twice annually for 2021. The findings include: 1. Review of the laboratory's quality 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 -- assurance records for 2021 indicated the laboratory had not verified accuracy of test results for KOH and Scabies testing on a twice annual basis. The interview with the Office Manager at 11:23am on 10/28.22 confirmed the accuracy of the KOH and Scabies testing had not been verified at least twice a year. -- 2 of 2 --