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 and interview, the laboratory failed to perform and document the calibration for the Fisher Scientific room temperature and humidity thermometer for two (April 12, 2016 to April 12, 2018) of two years. Findings include: 1. During a tour of the laboratory on April 12, 2018 at 9:20 a.m., the surveyor observed the Fisher Scientific thermometer in use with a calibration due date of January 11, 2015. 2. On April 12, 2018 at 9:20 a.m. when queried, testing personnel #3 as listed on the CMS- 209 was unable to provide the surveyor with documentation to show the Fisher Scientific thermometer had been calibrated. 3. During the interview on April 12, 2018 at 9:20 a.m., testing personnel #3 confirmed the thermometer had not been calibrated prior to the due date listed on the back of the thermometer. 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 --