Woodruff Institutue Llc, The

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at The Woodruff Institute LLC on 10/21/2025. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. A Standard deficiency was cited as follows: . 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 interview, it was determined safety procedures failed to be observed to ensure protection from chemical hazards. Findings included: 1. A jug of Eosin Y, Alcoholic reagent was observed in the laboratory stored outside of the safety /fire cabinet on 10/21/2025 at 11:30 a.m. The danger labeling on the jug indicated the reagent was flammable and precautionary measures were to be taken. 2. The laboratory administrator confirmed on 10/21/2025 at 11:30 a.m. the jug of Eosin Y, Alcoholic reagent was not stored safely based on the hazard labeling of the product. 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 --

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 11/1/21 at The Woodruff Institute a clinical laboratory in Fort Myers, Florida. The Woodruff Institute is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. 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 direct observation, review of Material Safety Data Sheets (MSDS), and interview with the Office Manager, the laboratory failed to store flammable liquid in an approved flammable liquids storage area for two (Cancer Diagnostics Reagent Alcohol, 200 Proof and StatLab Eosin - Y, Alcoholic 0.25% ) out of five (Cancer Diagnostics Reagent Alcohol, 200 Proof, Zero Xylene, Acetone, StatLab Eosin - Y, Alcoholic 0.25% , and Citra - Clear ) flammable liquids. The findings included: During observations taken on 11/1/21 at approximately 10:45 a.m., it was revealed Cancer Diagnostics Reagent Alcohol, 200 Proof, Zero Xylene, and Acetone, and StatLab Eosin - Y, Alcoholic 0.25% Gill Hematoxylin , and Citra - Clear were stored under the laboratory's sink. Record review of the MSDS for the Cancer Diagnostics Reagent Alcohol, 200 proof revealed the MSDS states "Inside storage should be in a National Fire Protection Association (NFPA) approved flammable liquid storage or cabinet". Review of the MSDS sheets for the StatLab Eosin - Y, Alcoholic 0.25% revealed the statement "Keep in fireproof place". Interview on 11/1/21 at 10:50 a.m., 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 -- the Office Manager did not know that the laboratory needed to store Cancer Diagnostics Reagent Alcohol, 200 proof in a flammable cabinet and StatLab Eosin - Y, Alcoholic 0.25% in a fireproof place. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on histopathology twice annual verification of accuracy record review and interview with the Office Manager, the Laboratory Director failed to ensure that