Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Florida Dermatology Specialists PLLC on September 25, 2025. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiency cited is as follows: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation, interview, review of the laboratory procedure manual and safety data sheets, the laboratory failed to ensure protection from chemical hazards from the first day of testing on 03/21/2025 through 09/16/2025. Findings: A. 1. During a tour of the laboratory on 09/25/2025 at 9:15 AM, the container of flammable waste was observed sitting next to the flammable cabinet. 2. Review of the procedure titled, Infectious Waste and Tissue Disposal read, "Any flammable liquids, such as alcohol and eosin are stored in flammable cabinet located in the Mohs lab." 3. Review of the Safety Data Sheets for Ethyl Alcohol 95%, the Ethyl Alcohol 100% and Eosin Y Alcoholic stain noted, "Store locked up." Review of the Safety Data Sheets for all three reagents are classified as Category 2 fire hazard. 4. During interview on 09/25 /2025 at 9:20 AM, the Office Manager acknowledged the waste container had Ethyl Alcohol 95%, the Ethyl Alcohol 100% and Eosin stored in it, and was not stored in the flammable cabinet. B. 1. During a tour of the laboratory on 09/25/2025 at 9:15 AM, there was no fume hood over the staining work station and there were no respirators seen. 2. Review of the Safety Data Sheets for the following chemicals used for the laboratory's Hematoxylin and Eosin stained slides are Ethyl Alcohol 95%, Ethyl Alcohol 100%, Eosin Y Alcoholic stain, and Hematoxylin Vintage stain included the respiratory hazard symbol. 3. Review of the Safety Data Sheets for Ethyl 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 -- Alcohol 95% and Ethyl Alcohol 100% noted, " May cause damage to organs (respiratory system, central nervous system, liver, blood) through prolonged or repeated exposure. The Safety Data Sheets for Eosin Y Alcoholic stain noted, "Harmful if inhaled" and "Avoid breathing vapor." The Safety Data Sheets for Hematoxylin Vintage stain noted "Systems/Injuries After Inhalation: May cause respiratory irritation." 4. Review of Safety Data Sheets for Ethyl Alcohol 95%, Ethyl Alcohol 100%, and Eosin Y Alcoholic stain noted, "Special PPE Requirements: If ventilation hood not available wear respirator." 5. During an interview on 09/25/2025 at 9:22 AM, the Office Manager acknowledged there was no fume hood. -- 2 of 2 --