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 record review, direct observation, and interview with the director, room temperature and humidity of the laboratory was not monitored. The laboratory performs approximately 17 histopathology tests annually. Findings include: 1. Record review did not include recorded room temperature and humidity on the maintenance log. There was no written policy for the monitoring room temperature of room humidity. 2. No thermometer or hygrometer was present in the laboratory during observation on 09/06/2022 at approximately 1:20 PM 3. The Thermo Scientific HM525 NX Cryostat requires an operating environment of 5C to 35C and relative humidity of up to 60%. 4. In an interview on 09/06/2022 at approximately 1:30 PM, the laboratory director confirmed room temperature and humidity was not monitored. 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 --