Summary:
Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 the laboratory's standard operating procedure (SOP) for Cryostat use, maintenance and cryostat temperature control and interview with the Laboratory Director (LD), the laboratory failed to follow their written SOP that designates the operating temperature of the cryostat maintained for Mohs dermatopathology surgery specimens from humans. Findings include: 1. Upon review of the SOP for the Cryostat maintained in the Mohs laboratory space, the SOP, titled "Maintenance Record for Cryostat", stated that the temperature for the Cryostat will be maintained at -20 to -30 degrees Celcius. 2. Also noted under Equipment Quality Control for Cryostats, in the "Maintenance Record for Cryostat", #3 states: "