Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 27, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 equipment maintenance document review and staff interview, the laboratory failed to monitor and document temperature for each day of laboratory testing as required. Findings include: 1. Floyd County maintenance document review revealed the laboratory failed to monitor and document the laboratory refrigerator temperature for January through December of 2018. 2. An interview with the nurse manager in the conference room on 3/27/2019 at approximately 4::00 p.m. confirmed the laboratory refrigerator temperature was not monitored and documented for the aforementioned dates. D5785