Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Aqua Dermatology of Florida PA on 08/04/2025 - 08/05/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: 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, review of reagent safety data sheets, and staff interview, the laboratory failed to ensure protection from chemical hazards for 2 of 2 years (08/2023 - 08/2025). Findings included: 1. Observations were performed during a tour of the laboratory with the Clinical Laboratory Specialist (CLS) on 08/04/2025 at 10:25 a.m. Xylene substitute reagent was observed stored in the flammable cabinet. The CLS stated the reagent present (Reagent #A), when completely used up, would be supplied by a different manufacturer (Reagent #B). No fume hood was observed above the staining station. 2. The manufacturer Safety Data Sheet (SDS) for Reagent #A currently used by the laboratory, with a revision date of 12/08/2024 was reviewed. The SDS stated "Harmful if inhaled" and "Use only outdoors or in a well-ventilated area." The manufacturer SDS for Reagent #B with a revision date of 10/05/2015 was reviewed. The SDS showed "...where exposure levels are not known wear approved respiratory protection," and "IF INHALED: Remove person to fresh air." 3. On 08/04 /2025 at 12:40 p.m., the CLS confirmed the lab did not monitor air quality/exposure to reagent and did not have a fume hood to mitigate exposure to the Xylene substitute reagent. 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 --