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 and staff interview, the laboratory failed to provide evidence of monitoring and documenting humidity requirements. Findings include: 1. Record review on 5/24/2021 of the laboratory room temperature logs for the years 2020 and 2021 revealed the following: a. Acceptable humidity readings were less than 60 percent(%). b. Statement indicating "The humidity will be documented at the beginning of each work day. Any