Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Estero Dermatology & Skin Surgery Center, LLC on 12/03/2025. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. A Standard deficiency was cited and 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, and record review, the laboratory failed to ensure protection from chemical hazards from 7/21/2025 through 12/03/2025. Findings 1. During a tour of the laboratory on 12/3/2025 at 11:45 a.m., no fume hood was observed in the laboratory. 100% Reagent Alcohol for Histology testing was in use and stored in the safety cabinet. Hazard labeling on the 100% Alcohol stated "Do not breathe dust/fumes/gas/mist/vapors/spray". 2. The contracted Laboratory Consultant confirmed on 12/03/2025 at 1:00 p.m. the laboratory did not have a process in place to ensure air quality safety from chemical hazards and did not have a fume hood in place. 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 --