Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on May 2, 2025. Advanced Dermatology and Cosmetic Surgery clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 staff interview, the laboratory failed to use chemicals under a fume hood when required for an undetermined amount of time. The findings include: During the tour of the laboratory on 5/2/2025 around 1:00pm, the chemical stain line used for Mohs surgery (a procedure used to treat skin cancer) was observed. The stains used in the stain line consisted of a xylene substitute (Aliphatic Clearing Reagent), 100% alcohol (100% Dehyrdrant), Eosin, Hematoxylin, Acid Alcohol 1%, and Bluing Reagent. A review of the chemical's safety data sheets (SDS) was performed. 1. The SDS for the Aliphatic Clearing Reagent stated "Use only under a chemical fume hood. Use explosion-proof equipment. Keep away from open flames, hot surfaces and sources of ignition. Use only non-sparking tools. Take precautionary measures against static discharge. Do not get in eyes, on skin, or on clothing. Do not breathe vapors or spray mist." 2. The SDS for the 100% Alcohol stated "Keep away from open flames, hot surfaces and sources of ignition. Use only non-sparking tools. Use explosion-proof equipment. Take precautionary measures against static discharges. Use only under a chemical fume hood. Do not breathe vapors/dust. Do not get in eyes, on skin, or on clothing. Do no ingest." 3. The SDS for the Eosin stated "Use only under a chemical fume hood. Use explosion-proof equipment. Keep away from open flames, hot surfaces and sources of ignition. Take precautionary measures 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 -- against static discharges. Do not breathe vapors or spray mist. Do not get in eyes, on skin, or on clothing. During the interview with the Mohs technician on 5/2/25 at 1: 00pm, an inquiry of the location of the fume hood was made. The technician stated that "the office was told we did not need a fume hood." -- 2 of 2 --