Summary:
Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's microscope maintenance policy and interview with the testing personnel (TP-1), the laboratory failed to perform and document annual maintenance of the microscope during 2024. Findings include: 1. The laboratory began grossing patient specimens under the subspecialty of Histopathology in March 2023 with an annual reported test volume of 9,100. 2. The laboratory's maintenance policy for the microscope states, "Microscope-Annual: The microscope will have preventative maintenance performed at least once per year as specified by the manufacturer." 3. The laboratory failed to provide evidence of annual maintenance for the microscope from 2024. 4. The TP-1 interviewed on 3/4/25 at 11:00 AM confirmed the laboratory failed to perform annual maintenance on the microscope in 2024. 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 --