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: During an onsite recertification survey on 10/08/2019, based on laboratory procedure manual review, laboratory refrigerator temperature record review, and staff interview, it was determined that the laboratory failed to maintain acceptable refrigerator temperatures between for 24 of 30 days reviewed in January 2019. Findings include: 1. The laboratory procedure manual had a required refrigerator temperature range between 2 and 8 degrees Celsius. 2. Review of the laboratory's temperature records revealed that refrigerator temperatures were recorded below 2 degrees Celsius for a total of 24 of 30 days reviewed in January 2019. There was no