Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Radiance Dermatology LLC on 4 /27/2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are 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 (SDS), the laboratory failed to ensure protection from chemical hazards used for Histopathology testing of Hematoxylin and Eosin (H&E) stain from 8 /07/2025 to 4/27/2026. Findings: 1. During a tour of the laboratory on 4/27/2026 at 10: 22 AM, 95% Reagent Alcohol and Xylene Substitute was observed for use in staining of H & E slides. The containers of 95% Reagent Alcohol and Xylene Substitute each were labeled with symbol for health hazard. No fume hood was observed to provide protection from respiratory chemical hazards. 2. The SDS sheets for 95% Reagent Alcohol and Xylene Substitute both documented under Individual protection measures for respiratory protection "If exposure limits are exceeded or irritation is experienced, NIOSH/MSHSA approved respiratory protection should be worn. " 3. The MOHS Procedure Manual was approved by the Laboratory Director 4/20/2026. The manual included an OSHA list of Personal Protective/Safety Equipment list included "8. Fume Hood". 4. The Office Manager on 4/27/2026 at 10:35 AM confirmed there was no fume hood or any method to monitor respiratory chemical exposure to ensure protection from chemical hazards. 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 --