Summary:
Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 lack of documentation and interview with the Practice Manager (PM), the laboratory failed to monitor and document room humidity (RH) to ensure operating conditions were met for 1 of 1 Olympus BX45TF microscope and 2 of 2 Leica cryostats used to perform histopathology microscopic slide examinations from 06/26 /2024 to 05/14/2026. Findings include: 1. On the day of the survey, 05/14/2026 at 09: 45 am, the laboratory failed to provide documentation for the monitoring of RH to ensure operating conditions were met for the following instruments used to perform histopathology microscopic examinations from 06/26/24 to 05/14/2026: - 1 of 1 Olympus BX45TF microscope (manufacturer's operating environment specifications: 5-40 degrees Celsius, maximum 80 % relative humidity) - 1 of 1 Leica 1520 Cryostat (manufacturer's operating environment specifications: 18-35 degrees Celsius maximum 60 % relative humidity) - 1 of 1 Leica 1860 Cryostat (manufacturer's operating environment specifications: 18-35 degrees Celsius maximum 60 % relative humidity) 2. The laboratory performed 1,586 histopathology microscopic slide examinations in 2025 (CMS 116, estimated annual volume, dated 04/15/2026). 3. The PM confirmed the above findings on 05/14/2026 at 10:40 am. 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 -- D5781