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 laboratory maintenance procedures, review of maintenance records and interview with the general supervisor (GS), the laboratory failed to perform and document annual maintenance of the microscope as required by the laboratory's established maintenance procedure. Findings include: 1. Upon request, the laboratory was unable to provide documentation of annual microscope maintenance for calendar year 2025 or 2026 to date. a. Review of the laboratory's Lab Maintenance procedure revealed that the microscope is to be checked annually by the appropriate vendor. 2. Interview with the GS on 09/10/2026 at 10:30 am confirmed that the required annual microscope maintenance had not been performed or documented. 3. The laboratory performs 500 microscopic tests annually. 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 --