Summary:
Summary Statement of Deficiencies D6084 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions provide a safe environment in which employees are protected from physical, chemical, and biological hazards. This STANDARD is not met as evidenced by: Citation 1 Based on observations of the laboratory and staff interviews, the laboratory director failed to ensure that the laboratory environment was safe for personnel when an eyewash station was not available in 2024. The findings include: 1. Observation of the laboratory on 08/20/2024 at 9:35 a.m. revealed the following: The laboratory did not have an eyewash station present. Reagents for processing and staining patient samples included 70% Isopropyl Alcohol, Eosin Multichrome stain, potassium hydroxide (KOH) reagent, and Hematoxylin stain. 2. An interview with the laboratory director on 08/20/2024 at 11:00 a.m. confirmed that the laboratory did not have an eyewash station. Citation Two: Based on observation of the laboratory and staff interviews, the laboratory director failed to ensure that the laboratory environment was safe when flammable reagents used to stain patient tissue samples removed during Mohs micrographic surgical procedures were not stored in a fireproof cabinet in 2024. The findings include: 1. Observation of the laboratory on 08/20/2024 at 9:35 a.m. revealed Eosin Multichrome stain used for patient tissue samples removed during Mohs micrographic surgeries stored in a cabinet that was not fireproof. The storage instructions on the bottle (lot 198462) stated, "Store in a fireproof, dry, cool, and well- ventilated place". 2. An interview on 08/20/2024 at 11:00 a.m. with the laboratory director confirmed the Eosin Multichrome stain was not stored in a fireproof cabinet, and the laboratory did not have a fireproof cabinet for reagent storage. 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 --