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 observation of refrigerator and incubator thermometers, lack of documentation for accuracy verification and interview with the Histotechnologist, the laboratory failed to have the thermometers verified for accuracy since 2016. The findings include: 1. Observed thermometers in place in laboratory refrigerator and incubator. 2. No documentation for verification of accuracy for thermometers since 2016. 3. Interview at approximately 1:30 p.m. June 11, 2019 with the Histotechnologist confirmed the refrigerator and incubator thermometers had not been verified for accuracy since 2016. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --