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 surveyor's review of the laboratory's temperature records and an interview with the laboratory supervisor, the laboratory failed to follow the laboratory's temperature policy for laboratory testing. FINDINGS: 1. The laboratory's temperature policy requires the refrigerator temperature to be between 4 to 10 degree Celsius. 2. The laboratory supervisor confirmed on September 11, 2018 at approximately 2:30 PM, the surveyor's findings that the laboratory failed to take and document