Summary:
Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation of the microscope, maintenance records and interview with the Office Manager (OM), the laboratory failed to perform and document annual maintenance on the microscope used in Histopathology, and Cytology testing from May 2022 to the date of the survey. The OM confirmed on 7/2//24 at 10:35 am there was no documented evidence that annual maintenance was performed. 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 --