Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Marianne Carroll DO PA on July 9, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiency cited is 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 interview, observation, review of the laboratory procedure manual and safety data sheets, the laboratory failed to ensure protection from chemical hazards from the first day of testing on 07/23/2024 through 07/09/2026. Findings: 1. During a tour of the laboratory on 07/09/2026 at 1:15 PM, the container of flammable waste was observed sitting next to the flammable cabinet. 2. Review of the Safety Data Sheets (SDS) for the reagents used in the Hematoxylin and Eosin (H&E) stain revealed, the Stat Lab XS-3 Xylene Substitute, Stat Lab 100% Reagent Alcohol, and Stat Lab Eosin Y Alcoholic 0.25% all had the symbol for flammable. 3. Review of the SDS for XS-3 Xylene Substitute and 100% Reagent Alcohol noted, "Store locked up." 4. Review of the SDS for XS-3 Xylene Substitute and Eosin Y Alcoholic 0.25% noted, "Keep in a fireproof place." 5. During interview on 07/09/2026 at 1:20 PM, the Risk Manager acknowledged the flammable waste container with the waste from the H&E stain was not stored in the flammable cabinet. 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 --