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 a review of the laboratory's policy for thermometer certification, the direct observation of two thermometers, a lack of calibration records, and staff interview, the laboratory failed in 2016 and 2017 to follow their written policy to annually perform and document the calibration of two thermometers used in the laboratory. Findings include: a. The laboratory's policy states, "Once a year, all of the thrermometers are checked at operating temperatures against one of the NIST-traceable thermometers" and, "Annual Thermometer Calibration Reports for NIST-traceable thermometers are stored in the Thermometers Calibration Certificates Notebook." b. No calibration date was indicated on thermometers #H1 and #H2. c. No operator's manual or package insert was found for the thermometers. d. No documentation existed to show the thermometers had been calibrated each year. e. Staff stated they were unaware of any calibration performed on the thermometers and confirmed no calibration documentation for the thermometers could be found in the laboratory. D5781