Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at DERMATOLOGY360 LLC on August 10, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiency cited 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 protection from chemical hazard used for Histopathology testing of Hematoxylin and Eosin (H&E) stain on from 03/25/2026, to present. Findings included: 1-During the tour of the laboratory on 08/10/2026 at 11:30 AM, no fume hood was observed in the laboratory. A 1-pint bottle of Stat lab Glacial Acetic Acid (HAC) with lot number 002699 was used. 2-Review of safety data sheets (SDS) for glacial HAC, revealed that stated in Section "Handling and Storage" for handling "Avoid breathing vapor or mist. Use only with adequate ventilation. Wear appropriate respirator when ventilation is inadequate. Review of the Exposure controls/personal protection revealed that the OSHA Permissible Limits (PELS) was 10.00 ppm (parts per million)." 3-Review of policy "Histology Reagent Management Policy" signed by the laboratory director on 03/25/2026, revealed that in section "Personal Protective Equipment (PPE)" stated regarding the handling of the glacial HAC: "The following PPE is required when handling concentrated HAC: Laboratory coat, Nitrile gloves, chemical splash googles, closed-toe shoes. Preparation should be performed inside a functioning chemical fume hood whenever practical." 4- Review of the preparation log for the 2% HAC revealed that the laboratory did preparation of this solution from glacial HAC in 03/25/2026 and 06/24/2026. During an interview on 08/10/2026 at 11: 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 -- 35 AM, the risk consultant confirmed that the laboratory failed to ensure the protection from chemical hazard. -- 2 of 2 --