Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Skin and Cancer Associates LLP on October 30, 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 and review of the laboratory procedure manual, and Safety Data Sheets (SDS), the laboratory failed to ensure protection from chemical hazards from 06/09/2023 through 10/30/2025. Findings 1. During a tour of the laboratory on 10/30/2025 at 9:40 AM, there was no fume hood observed in the laboratory. The laboratory used the following chemicals for their Hematoxylin and Eosin stained slides: Reagent Alcohol 100%, Hematoxylin Stain Solution Gill III, Eosin Y Stain Solution, and Xylene Substitute. 2. Review of the procedure titled, Guidelines for Handling Chemicals noted, "Use Chemical fume hoods or other engineering controls to minimize exposure to airborne contaminants." 3. Review of the SDS for Reagent Alcohol 100%, Eosin Y Stain Solution, and Xylene Substitute included the respiratory hazard symbol. 4. Review of the SDS for Reagent Alcohol 100%, Hematoxylin Stain Solution Gill III, Eosin Y Stain Solution, and Xylene Substitute noted, "If exposure limits are exceeded or irritation is experienced, NIOSH /MSHA (National Institute for Occupational Safety Health/Mine Safety and Health Administration) approved respiratory protection should be worn." The SDS for Reagent Alcohol 100% and Eosin Y Stain Solution noted, "If swallowed or inhaled, causes irritation." The SDS for Hematoxylin Stain Solution Gill III noted "Causes skin, eye and respiratory tract irritation." The SDS for Xylene Substitute noted, 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 -- "Harmful if inhaled" and "May cause respiratory irritation." 5. During an interview on 10/30/2025 at 9:45 AM, the Histology Consultant acknowledged there was no fume hood and they did not monitor the exposure to the chemicals. -- 2 of 2 --