QUALITY CONTROL 14Art: 714376-01P Rev. Date: 27-Jan-17 14-1Overview This section describes the steps to be taken to verify the performance of the analyzerand cartridges. The rationale for the i-STAT cartridge and analyzer quality regimenis described in the Theory section of this manual.Customization The quality control behavior of the analyzer can be customized via the Central DataStation or analyzer Customization Change function to:• turn the external Electronic Simulator reminder on or off.• prompt the operator to use the external Electronic Simulator atscheduled intervals.• turn the internal Electronic Simulator on or off, and select the simulatortest cycle intervals.• disable further cartridge testing when the internal Electronic Simulatortest fails.See the Customization section for default values.Data Retention Quality control data is transmitted to the Central Data Station. If a Central DataStation is not being used, the charts at the end if this section can be used to recordliquid and electronic control results.QUALITY CONTROL FOR i-STAT CARTRIDGES AND THE ANALYZER’S CARTRIDGE TEST CYCLEVerify Performance ofAnalyzers DailyVerify the performance of each analyzer on site using the Electronic Simulator(external or internal) once a day on the days the analyzers are in use. Note thatregulatory or accreditation requirements may dictate more frequent intervals.Verify Newly ReceivedCartridges and ControlMaterials1. Verify that the transit temperatures were satisfactory using the four-windowtemperature indicator strip included in the shipping container.Note: Controls and calibration verification materials shipped with gel packswill also include a four-window indicator to monitor temperature during transit.2. From each lot in each shipment of cartridges, analyze multiple levels of i-STATcontrols (and TriControls if testing for hematocrit) using any verified analyzer.** This information is not a manufacturer's system instruction. It is a suggestionto comply with regulatory requirements that may pertain to your laboratory.Check RefrigeratorStorage DailyVerify that the cartridges stored in the refrigerator are within the expiration dateprinted on the boxes.Verify that the storage refrigerator did not exceed the temperature limits of2 to 8 °C (35 to 46 °F). If storage conditions are in doubt, use controls to verifythat the cartridges are performing properly. This is especially important if freezingconditions are suspected at the back of the refrigerator.
