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 document review, direct observation, and interview with the histotechnician, room temperature and humidity of the laboratory was not monitored and documented since the last survey conducted on 10/16/2019. The laboratory performs approximately 332 MOHS procedures annually using the Leica CM1860 Cryostat. Findings include: 1. Document review of the Leica CM1860 Cryostat Instruction Manual revealed the cryostat requires an operating environment of 18C to 35C and relative humidity of up to 60%. 2. Direct observation of the laboratory on 03/21/2024 at 2:05 PM failed to locate a thermometer, hygrometer, and a laboratory conditions log. 3. In an interview on 03/21/2024 at 2:10 PM, the histotechnician confirmed room temperature and humidity were not monitored and documented for the Leica CM1860 Cryostat. 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 --