Summary:
Summary Statement of Deficiencies D3007 FACILITIES CFR(s): 493.1101(b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. This STANDARD is not met as evidenced by: Based on observation of multiple Flammable reagents for processing and staining histopathology slides during Mohs procedures, the lack of a Flammables cabinet, and interview with a laboratory person, the laboratory failed to have an appropriate storage cabinet for Flammable materials. Findings include: a. The laboratory stored multiple containers of flammable reagents in the cabinet under the sink: Flammable reagent Quantity -------------------------------------------------------- Xylene substitute 2 containers, 1 Gallon each 100% Reagent Alcohol 1 x 1 Gallon Methanol 1 x 1 Gallon Isopropyl Alcohol 1 x 1 Gallon b. A laboratory person affirmed (12/19/18) the aforementioned flammable chemicals were routinely stored under the sink; and thus, the laboratory's failure to have the appropriate Flammables cabinet for storage. c. The volume of improperly stored Flammable chemicals totaled 5 Gallons. . 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: Based on the deficiency cited (D3007), the Laboratory Director is herein cited for deficient practice in ensuring a safe environment in which employees are protected 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 -- from flammable chemical hazards. Findings include: a. The Laboratory Director required flammable chemicals to be stored onsite, but failed to ensure an appropriate storage cabinet for Flammable materials was obtained. b. See D3007. -- 2 of 2 --