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 and room temperature records, humidity records, Quality Assurance (QA) procedure, and an interview with the Technical Consultant, the Laboratory failed to document refrigerator and room temperatures and humidity. This was noted for 65 days in 2022 and 17 days in 2023. The findings include: 1. A review of the refrigerator temperature records revealed the laboratory failed to document temperatures for the refrigerator for 34 days in 2022. 2. A review of room temperature and humidity records revealed the following days not documented: a) 31 days in 2022 b) 17 days in 2023 2. A further review of the Environmental Monitoring of Laboratory procedure revealed, "Check thermometers and hygrometer daily... Refrigerator... Room Temperature and Room Humidity." 3. During an interview on 12 /19/2023 at 1:10 PM, both Technical Consultants confirmed the above findings. D5781