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 TOSOH operator's manual, review of the laboratory's 2020, 2021, 2022, and 2023 humidity logs and interview with TP (testing personnel) #1 on 5 /17/23, the laboratory failed to establish a humidity range that adhered to the operational humidity range required by the manufacturer. The TOSOH operator's manual requires operation of the instrument within an environment of 40-80% humidity. A review of the laboratory's 2020, 2021, 2022, and 2023 humidity logs revealed the laboratory's acceptable range was listed as 20-80%. During an interview at approximately 12:05 p.m., TP #1 confirmed that the laboratory utilized a humidity range of 20-80%. D5781