Thomas S Breza Md

Summary Statement of Deficiencies D0000 A recertification survey was conducted on April 17, 2024. Thomas S Breza MD clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical 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 record review and interview, the laboratory failed to follow the manufacturers instructions for disposal of the reagents used during the staining process which included Eosin Working Solution, Xylene, Reagent 190 Proof and Reagent 200 Proof for 2 out of 2 years (2022-2024) reviewed. Findings: 1. During the laboratory tour, on 4/17/2024 at 9:37 AM, reagents were observed stored inside a fire proof cabinet and no container for waste was found. 2. During interview on 04/17 /2024 at 9:45 AM the Laboratory staff revealed that the chemical waste is poured down the sink drain. 3. Review of the Safety Data Sheets for the Eosin Working Solution (04/15/2015) revealed in section 13: "Disposal considerations, Ecology - waste materials: Avoid release to the environment." 4. Review of the Safety Data Sheets for the Xylene RS4050 (Revision date: 02.11.13) revealed in section 13: "Disposal considerations, Description of waste residues an information on their sage handling and methods of disposal, including the disposal of any contaminated packaging: Burn in a chemical incinerator equipped with an after burner and scrubbed but exert extra care in igniting as this material is highly flammable. Offer surplus and non-recyclable solutions to a licensed disposal company. Contact a licensed professional waste disposal service to dispose of this material." 5. Review of the Safety Data Sheets for Reagent 190 Proof and Reagent 200 Proof (Issue date: 22- 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 -- January-2019) revealed in section 13. "Disposal considerations: Disposal instructions Collect and reclaim or dispose in sealed containers at licensed waste disposal sites." -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory director, the laboratory failed to document the room humidity from 2016 to 2018. Findings include: Review of the cryostat manual Leica CM1510 indicated a requirement for room humidity not above 60 %. Quality control records of histopathology room revealed that no documentation of the humidity room done from 2016 to 2018. During an interview on 08/10/18 at 11:30 a.m., the laboratory director confirmed that there was no record of room humidity for the period of 2016-2018. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with laboratory director, the laboratory had an 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 -- open partially used expired reagent in the flammable cabinet. Findings include: During tour of the laboratory at approximately 11:00 AM on 08/10/2018 the surveyor found a bottle of Eosin Y, alcoholic lot #39166 expired 11/2016. During an interview on 8/10/2018 at 11:30 AM, with the laboratory director, he confirmed the existence of the expired reagent in the cabinet. -- 2 of 2 --