Advanced Dermatology And Cosmetic Surgery

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted at Advanced Dermatology & Cosmetic Surgery on 9/8/25. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 observation and staff interview, the laboratory failed to ensure the potassium hydroxide (KOH) was not expired prior to patient testing. Findings include: Observations made during a tour of the laboratory on 9/8/25 at 10:00 AM, showed one bottle of "Potassium Hydroxide" with lot number 1342 expired 12/8/2023 During an interview on 9/8/25 at 10:05 AM with the Office Manager, it was confirmed the bottle of KOH was expired. 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 CLIA initial survey was conducted at Advanced Dermatology & Cosmetic Surgery on 5/18/2022. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. . 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 staff interview, the laboratory failed to send Mohs histopathology patient slides for peer review more than once annually in 2021. Findings include: The record review of documented peer review for 2021 showed that patient slides for Deland office were reviewed on 7/13/21. Documentation showing peer review for the surgeon's Ormond Beach (10D1029479) location was included dated 12/2021. The laboratory did not have a second peer review documented for the Deland office. During an interview with the Mohs technician on 5/18/22 at 10:30am, it was stated that they were told by their supervisor that they could combine peer review documentation since the surgeon performs the testing at multiple offices. She confirmed individual office peer review for 2021 had not been performed. . D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to identify that the room temperature and humidity range established to run the Avantik QS12 cryostat and Microm HM520 cryostat was outside the required operating temperature range for five of five months reviewed. (January - May 2022). The findings include: The instruction manual for the Avantik QS12 cryostat states under Technical Specifications the "Temperature (Operating limits) are 5C to +35C (+41F to +95F) at a max. Relative humidity of 60%. Temperature (Recommended Operation) +15C to +30C (+59F to +86F) NOTE: Performance may deteriorate when operated outside of this range." The instruction manual for the Microm HM520 cryostat states "Operating Conditions: +5C up to +35C (at a max. rel. humidity of 60%)". The review of the document titled "Advanced Dermatology Laboratory Temp/Humidity Log" showed the acceptable room temperature range is "36-105 degrees" with no indication of Fahrenheit or Celsius. The acceptable range for lab humidity on the form is documented as "0%-87%". During the interview with the Office Manager on 5/18/22 at 10:30am, it was confirmed the laboratory was not monitoring room temperature and humidity based on manufacturers instructions. . D5781