Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. 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 direct observation, review of manufacturer's instruction manual, laboratory records, and confirmed in staff interview, the laboratory failed to monitor temperature and humidity requirements for the microscope, located in the laboratory director's office for seven of seven months in 2023 and four of four months in 2024. Findings included: 1. During a tour of the laboratory director's office on 04/17/2024 at 10:56 am, the surveyor observed the Olympus BX43 Microscope (Serial #2J53658) on the desk. The microscope was used to perform slide reviews for histopathology diagnostic testing. 2. Review of Olympus CX43 Microscope instruction manual page 20 revealed: "BX53/BX43/BX46 SPECIFICATIONS Operating Environment ... Ambient temperature: 5 to 40C (41 to 104F) Maximum relative humidity: 80% for temperatures up to 31C (88F)" 3. Review of the laboratory records for 2023 and 2024 revealed no documentation of temperature or humidity monitoring for the Olympus CX43 Microscope. The laboratory was asked to provide documentation, and none was Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- provided. 4. During an interview on 04/17/2024 at 10:54 am, the Laboratory Director was asked if temperature and humidity were monitored and documented, and he stated "No". This confirmed the above findings. Word Key: C - Celsius F- Fahrenheit -- 2 of 2 --