Summary:
Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must 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. The laboratory must 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 observation and staff interview, the laboratory failed to document maintenance and function checks for the microscope and fume hood used for reading and making Histopathology slides in 2021 and 2022. Findings include: 1) Observation on 9/29/2022 at 9:15 a.m. of the Leica microscope and AirFiltronix Fume Hood located in the laboratory revealed no indication of annual preventative maintenance. Annual preventative maintenance service records were requested but were not be provided during the survey. 2) Interview with the Histotech on 9/29/2022 confirmed the microscope was used for reading the Histopathology slides and the staining of these slides is performed under the fume hood. The Histotech revealed on 9/29/2022 at 10:00 a.m. that the laboratory could not locate the documentation for any service records of this equipment from 2021 or 2022. 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 --