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 reviews of the Cryostat Temperature (CT) logs, Policies and Procedure Manual (P&P) and an interview with MOHS Technician, the staff failed to monitor and document the CT for 12 of the 92 days from October - December 2024 prior to patient testing. The findings include: 1. A review of the CT logs revealed the staff failed to record the CT for 12 days in 2024 when patient testing was performed. The days were as follows. A) October 3, 17, 30, 31 B) November 6. 7, 13, 21 C) December 5, 11, 19, 26 2. A review of the P&P Manual titled, "Cryostat: Protocol for Calibrating, Cleaning and Maintenance Activities" revealed, 1. Temperature is recorded daily and documented. 2. Temperature range is minus 20 degrees Celsius to minus 30 degrees Celsius. 3. During the exit conference on 08-14-2025 at 12:30 PM, the MOHS Technician confirmed the above findings. 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 --