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 review of daily temperature records and interview with the Office Manager, the laboratory failed to respond to temperature outliers for the microbiology incubator. Findings include: 1. Upon request for written documentatin of the refrigerator and incubator temperature logs, it was revealed that the incubator used to keep microbiology cultures at 36 degrees Celcius (body temperature) waiting to be transported to the main lab for this facility, had been out of range for 189 days. 2. The laboratory's established temperature range for the incubator is 34 degrees - 37 degrees Celcius. 3. The written recorded temperature for the incubator from 08/24/2021 thru 04/18/2023 (189 days) was in the range of 23 degrees to 27 degrees Celcius. 4. Interview with the Compliance Manager and Medical Assistant 1 (MA1) during survey 04/18/2023 at approximately 12:00 pm confirmed that instrument had been out of temperature range since 08/24/2021 (189 days). D5781