Summary:
Summary Statement of Deficiencies D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) (a)(2) Function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturers established limits before patient testing is conducted. (b) 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 do the following: This STANDARD is not met as evidenced by: Based on review of the microscope maintenance policy, laboratory maintenance logs for 2024 and 2025, instruction manuals, and interviews with the Technical Consultant (TC) and Testing Personnel (TP) on 10/14/2025, the laboratory failed to perform and document microscope maintenance as required each day of use from July 17, 2024 to October 14, 2025. Findings: Review of the laboratory "Microscope Maintenance" policy revealed, "It is the policy of the Duplin County Health Department Laboratory to perform and document maintenance on the microscope each day of use... Guidelines...Daily...Drop a small amount of lens cleaner onto a piece of lens paper... clean...Initial the maintenance/task log." Review of maintenance logs for 2024 and 2025, "Laboratory Maintenance/Tasks Log," revealed the absence of performance and documentation each day of use for microscope maintenance. Review of "Galen Professional Microscope Instruction Manual," Section 8, "...Clean immersion objectives immediately after use..." Review of "Instructions BX43 System Microscope," Section 2, "...clean the lenses and other glass components...wipe gently using a piece of cleaning paper...after using the microscope, set the main swith to "O" (OFF)...and keep it covered..." During interview with the TC at approximately 1:40 p. m., the TC confirmed the maintenance log did not include the daily maintenance 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 -- required for the microscopes. During interview with the TP at approximately 1:52 p. m., the TP said the primary microscope is used daily, cleaned after each patient and cleaned at the end of the day, and the other microscope is stored as a backup. -- 2 of 2 --