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 review of laboratory temperature records, lack of documentation and interview with the Lead Mohs Tech (LMT), the laboratory failed to monitor and document humidity to ensure proper test system operating conditions were met for 1 of 1 Nikon Eclipse E400 microscope and 1 of 1 Avantik QS12 Cryostat used to perform histopathology slide examinations from 07/13/2023 to 06/24/2025. Findings include: 1. On the day of survey, 06/24/2025 at 1:15 pm, the laboratory failed to provide documentation for monitoring humidity to ensure operating conditions were met for 1 of 1 Nikon Eclipse E400 microscope (acceptable range: less than 85%) and 1 of 1 Avantik QS12 Cryostat (acceptable range: less than 60%) used to perform histopathology slide examinations from 07/13/2023 to 06/24/2025. 2. The laboratory performed 2205 histopathology slide examinations in 2024 (CMS-116, estimated annual volume). 3. The LMT confirmed the above findings on 06/24/25 at 2:20 pm. 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 --