Lewis H Kaminester Md Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Lewis H Kaminester MD PA on October 29, 2025. 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 observation, review of the laboratory procedure manual, review of the Safety Data Sheets (SDS) and interview, the laboratory failed to ensure protection from chemical hazards from 06/08/2023 through 10/29/2025. Findings 1. During a tour of the laboratory on 10/29/2025 at 9:20 AM, there was no fume hood observed in the laboratory. The laboratory used the following chemicals for their Hematoxylin and Eosin stained slides: Reagent Alcohol 100%, Hematoxylin Stain Solution Gill III, Eosin Y Stain Solution, and Xylene Substitute 2. Review of the procedure titled, Guidelines for Handling Chemicals noted, "Use Chemical fume hoods or other engineering controls to minimize exposure to airborne contaminants." 3. Review of the SDS for Reagent Alcohol 100%, Eosin Y Stain Solution, and Xylene Substitute included the respiratory hazard symbol. 4. Review of the SDS for Reagent Alcohol 100%, Hematoxylin Stain Solution Gill III, Eosin Y Stain Solution, and Xylene Substitute noted, "If exposure limits are exceeded or irritation is experienced, NIOSH /MSHA (National Institute for Occupational Safety and Health, Mine Safety and Health Administration) approved respiratory protection should be worn." The SDS for Reagent Alcohol 100% and Eosin Y Stain Solution noted, "If swallowed or inhaled, causes irritation." The SDS for Hematoxylin Stain Solution Gill III noted, "Causes skin, eye and respiratory tract irritation." The SDS for Xylene Substitute noted 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 -- "Harmful if inhaled" and "May cause respiratory irritation." 5. During an interview on 10/29/2025 at 9:30 AM, the Histology Consultant acknowledged there was no fume hood and they did not monitor the exposure to the chemicals. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 5/6/21 at Lewis H Kaminester Md Pa, a clinical laboratory in North Palm Beach, Florida. Lewis H Kaminester Md Pa is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. The following is a description of the noncompliance. . 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 office manager, the laboratory failed to document room temperature in the cabinet where patient Dermatophyte Test Medium (DTM) specimens were incubated for two out of two years (2019 - 2021). The findings included: Review of the "Dermatophyte Test Medium - DTM" procedure revealed "Incubation at room temperature, 20 to 30 degrees C (68 to 86 degrees F) is satisfactory for growth of most dermatophytes". Review of laboratory logs revealed that the laboratory had not documented room temperature for two out two years (2019 - 2021). Interview on 5/6/21 at 8:55 a.m., the Office Manager stated she was never told to keep record of room temperature for the DTM testing. 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 --