Summary:
Summary Statement of Deficiencies 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: Citation One: Based on laboratory observation, review of the laboratory's procedures, review of manufacturer's Safety Data Sheets, and staff interview, the laboratory failed to follow established safety procedures for storage of flammable reagents used to process tissue removed during Mohs surgery. The findings included: 1. Laboratory observation on April 20, 2026, at 8:40 a.m. revealed a Leica Cryostat CM1850, inks, stains, and reagents used to process tissue removed during Mohs surgery in preparation for slide interpretation. Containers of Eosin Y and 95% Reagent Alcohol were stored on top of the flammable cabinet. 2. A review of the laboratory's procedure titled "MOHS Micrographic Surgery" revealed that reagents are to be stored "according to manufacturer's instructions." 3. A review of the Safety Data Sheets (SDS) from the manufacturer revealed that Eosin Y and 95% Reagent Alcohol are classified as Category 2 Flammable Substances and are to be stored "in an approved flammable liquids storage area." 4. The Laboratory Director confirmed the findings during an interview on April 20, 2026, at 2:00 p.m. Citation Two: Based on laboratory observation, review of laboratory procedure manual, and staff interview, the laboratory failed to follow the procedure for ensuring an eyewash station was present in the laboratory area. The findings included: 1. Laboratory observation on April 20, 2026, at 8:40 a.m. revealed a Leica Cryostat CM1850, inks, stains, and reagents used to process tissue removed during Mohs surgery in preparation for slide interpretation. No eyewash was observed in the laboratory area. 2. A review of the laboratory's procedure policy titled "Eyewash station policy and Procedure" stated that an eyewash station "must be located on the same level as the hazard" and "less than 10 seconds 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 -- travel time from the hazard, with no obstruction." 3. The Laboratory Director confirmed the findings during an interview on April 20, 2026, at 2:00 p.m. -- 2 of 2 --