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: Base on review of maintenance records and discussion with the staff the laboratory failed to perform scheduled preventive maintenance of the Microscope and Cryostats. Findings include: 1. No documentation of yearly preventive maintenance of the microscope for the year 2017 and 2018 at the time of survey. 2. No documentation of yearly preventive maintenance of the Cryostats QS-12 and the Leica CM 1850 for 2017 and 2018 at the time of survey. 3. The Quality Compliance Officer concur with this findings 10/24/2018 @ 15:30 PM. 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 --