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 record review and interview with laboratory staff, the laboratory did not ensure preventive maintenance and cleaning of the microscope used for histology testing was performed according to the written procedure. Findings: 1. The laboratory did not have documentation showing that annual maintenance was performed on the microscope as stated in the labs written procedure; and 2. Laboratory staff stated during interview on the day of survey that the microscope was cleaned periodically, but the lab did not have a written procedure for the frequency, instructions and documentation of the cleaning. 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 --