Summary:
Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a tour of the laboratory and an interview with the Laboratory Director (LD) and Technical Supervisor 1 (TS1), the laboratory failed to accurately monitor and document the conditions (2) temperature and (3) humidity with NIST calibrated thermometers/hydrometers essential for proper storage of reagents, specimens, and test systems. Findings: 1. The room temperature and humidity of the laboratory were being monitored and documented from a thermometer/hydrometer Therm Pro TP50. No documentation of a NIST certified calibration could be located. 2. The temperature of the freezer was being monitored and documented from a Temp Chex Enviro Safe thermometer lot 240054. No documentation of NIST calibration or verification could be located. 3. The temperature of the refrigerator was being monitored and documented from a Temp Chex Enviro Safe thermometer lot 240052. No documentation of NIST calibration or verification could be located. 4. An interview with LD and TS1, on 11/20/19 at approximately 11:00 AM, confirmed the findings. 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 --