Summary:
Summary Statement of Deficiencies D0000 An initial certification survey conducted at CLEVELAND CLINIC FLORIDA CORAL SPRINGS HEALTH CENTER on 10/25/2022 found the clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 and staff interview, the laboratory failed to dispose the 100% Reagent Alcohol, Hematoxylin Stain Solution, Eosin Y Stain Solution and Xylene Substitute according to manufacturer's instruction since August 2022. Findings include: Observation of reagents in the flammable cabinet on 10/25/2022 at 11:40 AM revealed the labels on the 100% Reagent Alcohol, Hematoxylin Stain Solution, Eosin Y Stain Solution and Xylene Substitute noted "Dispose of contents/container to an approved waste disposal plant." During an interview on 10/25/2022 at 12:30 PM, the MOHS Technician confirmed that the observed reagents were not disposed as per manufacturer instructions. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step 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 -- performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)