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 a review of the Room Temperature and Humidity Charts and an interview with the MOHS Technician, the laboratory failed to ensure humidity in the room where the cryostat equipment was operated was within the manufacturer's specifications. The surveyor noted the humidity was above the acceptable ranges for 21 days of the 3 months reviewed in 2023. The findings include: 1. A review of the Room Temperature and Humidity Charts revealed Humidity was above the manufacturer's acceptable limits (10-60%) for a total of 21 days as follows: A) June 2023: 4 days B) July 2023: 7 days C) August 2023: 10 days 2. The MOHS Technician confirmed the above findings during the exit conference on 06-04-2025 at 4:30 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 --