Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at NAPLES DERMATOLOGY, P.A. on July 28, 2026. 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, record review and staff interview, the laboratory failed to ensure that chemical waste from Histology testing was handled in accordance to manufacturer at least since October 3, 2024, to July 28, 2026. Findings included: 1- During a tour of the laboratory on 07/28/2026 at around 12:30 PM, it was observed there was no waste container in the laboratory. 2- Review of reagent label for the EKI Ammonium Hydroxide 28% Lot 2223823 stated, "Dispose of content/container to an approved waste disposal plant." 3- Review of the procedure manual signed by the Laboratory Director on 01/06/2025 revealed that the Hematoxylin & Eosin stain protocol stated as part of Maintenance of the stain lines: "The solutions are properly disposed of and containers are cleaned with a 10% or greater bleach solution as needed." 4- During an interview with the Quality Assurance laboratory manager on 07 /28/2026 at approximately 12:30 PM, confirmed that all the stain waste was disposed down the drain after diluting with water. 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 --