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 with the Technical Consultant (TC), the laboratory failed to perform and document thermometer calibrations and/or replace an expired thermometer for 1 (S/N 200260571) of 2 thermometers in use. Findings include: 1. During a tour of the laboratory on 5/10/2022 at 9:42 am the surveyor observed a thermometer in the Criterion refrigerator/freezer had an expiration date of 4 /25/2022. 2. When queried on 5/10/2022 at 9:42 am, the TC was not able to provide the surveyor documentation to show the thermometer had been calibrated. 3. An interview on 5/10/2022 at 9:42 am, the TC confirmed the laboratory failed to perform and document thermometer calibrations and/or replace the expired 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 --