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 humidity records for review, review of the manufacturer's specifications for the Leica CM1850 UV Cryostat and interview with the facility personnel, the laboratory failed to monitor and document the ambient humidity of the room where the cryostat is utilized. Findings include: 1. The laboratory begain patient testing on 9/3/2024. The laboratory utilizes the Leica CM1850 UV Cryostat in conjunction with Mohs testing under the subspecialty of Histopathology with an annual test volume of 814. 2. The manufacturer's specifications for the Leica CM1850 UV Cryostat reviewed during the survey listed an operating relative humidity range of 0%-60%. 3. The laboratory failed to provide documentation demonstrating the ambient humidity of the room where the cryostat is utilized was monitored and recorded on each day of patient testing. 4. The facility personnel interviewed on 7/11 /25 at 8:30 AM confirmed the laboratory failed to monitor and document the ambient humidity on each day of patient testing as indicated above. 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 --