PROPRIETARY INFORMATIONCONFIDENTIAL MATERIALAssays/Reagents Not for Customer Distribution78 AEROSET ® System Troubleshooting Guide94816-107—November 2004d. After calibration, if any control is not within itscontrol limits, check control, calibrator, and reagenthandling, then rerun the control. If the control iswithin its control limits after retesting, test patientsamples.8. Use the temporary limits until permanent control limitsare established. Record and plot all routine control resultson Levey-Jennings charts. These control results are used todetermine the permanent control limits.Permanent Control Limits1. Start on the first testing day after temporary control limitswere established; assay one aliquot each of two or morecontrols in a single run.2. Use the following rules to determine if the run can beaccepted.a. If controls are within the temporary control limits,test patient samples.b. If the control is still not within its control limits,reject the run and recalibrate. Run controls again.After recalibration, if the controls are within theircontrol limits, accept the run.c. If the control is still not within its control limits,reject the run then recalibrate. Run controls again.After recalibration, if the controls are within theircontrol limits, accept the run.d. If after recalibration the control is not within itscontrol limits, check the control, calibrator, andreagent handling, then rerun the control. If thecontrol is within its control limits after retesting, testpatient samples.3. Evaluate control results for 30 calendar days (a minimumof 20 values for control level) to determine the permanentcontrol limits. Recalibrate whenever a control fails orevery 14 calendar days. Record control results. Do notdiscard any result unless it was generated by operator erroror instrument malfunction, or results can be rejected as astatistical outlier.
