Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Nature Coast Pathology Services Inc. on 05/05/22. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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: Based on observation, record review, and interview with the Laboratory Supervisor, the laboratory failed to dispose of 100% Reagent Alcohol, Eosin Y Stain Solution, and 10% Formalin Fixative according to manufacturer's instructions for 2 out of 2 (2020-2022) years reviewed. Findings Included: Observation of reagents in the flammable cabinet on 05/05/2022 at 10:45 a.m. revealed the labels on the 100% Reagent Alcohol, Eosin Y Stain Solution, and 10% Formalin Fixative noted "Dispose of contents/container to an approved waste disposal plant." Review of the laboratory's procedure, which was not per manufacturer's instructions, revealed "Formalin which is poured off during grossing...is transferred into a one gallon container and 300 ml of Aldex is added. Once this container is full...it must sit and neutralize for 24 hours before disposal. The neutralized solution is now safe to dispose of into the sewer system." On 05/05/22 at 10:45 a.m., the Laboratory Supervisor stated that 100% Reagent alcohol and Eosin Y Stain Solution was disposed of down the drain of the sink, and the 10% Formalin was neutralized with Aldex and then poured down the toilet. The Laboratory Supervisor confirmed that this was not in accordance with the manufacturer's labels for disposal. Photographic evidence was obtained. 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 --