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 a review of the refrigerator temperature logs and interview with the testing personnel at 1:15pm on 2/21/20, the laboratory failed to document daily temperature readings for the proper storage of reagents and specimens. Findings include: a) The laboratory failed to document the daily temperature reading for the "Clinic Refrigerator in the Laboratory," between October 22, 2019- November 15, 2019. b) Testing personnel confirmed during interview that the refrigerator is used to store quality control material and reagents for the FT4 (Free Thyroxine) and TSH (Thyroid Stimulating Hormone) tests that are performed on the Beckman Coulter Access 2 analyzer, as well as to store patient specimens. c) Based on the Beckman Coulter Access 2 Load Lists, there were 129 FT4 tests and 180 TSH tests performed during October 22, 2019- November 15, 2019. D5785