Summary:
Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory director (LD) and Testing person (TP), the laboratory failed to calibrate the Rees continuous temperature monitoring system. The findings include: 1.There were no available records for the calibration of the Rees continuous temperature monitoring system. 2.Calibration materials for temperature monitoring are available in the form of certified National Institute for Standards and Technology (NIST) thermometers. 3.During the exit interview on October 24, 2019 at approximately 12:15pm ,The LD and TP confirmed that the laboratory had not calibrated the temperature monitoring system. D5781