Steps of Troubleshooting when Internal quality Controls Are Out in clinical laboratory,IQC trouble shooting

Controls have to be reconstituted as per instructions, given in the pack insert.

Step 1 : Ensure that The first time when you run a control, it is at Room Temperature. 

Step 2 : If control is beyond one 2 SD , then rerun the same control after making sure it’s at room temperature. 

Step 3 : If still out, then take a freshly reconstituted Control at room temperature and run that.

Step 4 : If Still Out, then Do a Delta Check by running previous day’s sample and compare the Bias ( has to be less than 10 % ) 

Bias is ( Run 2 – Run 1 ) ÷ ( Run 1 ) and multiplied by 100.

Step 5 : If still out, then Calibrate and rerun the control 

Step 6 : If Still out, then Call the Application specialist. 

Check Expiry of Reagents on board and instrument factors where necessary. Directly Going for Calibration when controls are out,  is an incorrect process.
Make sure Lab mean is set, on 30, 60 & 90 points.


1) Check control material
 Change in manufacturer Lot
 Improper reconstitution of control
 Expired control used
 Inadequate storage

2) Check last calibration
 Calibration as per frequency
 Calibration signals & Variation

3) Check calibration material
 Change in manufacturer Lot
 Improper reconstitution
 Expired calibrator used
 Inadequate storage

4) Check Reagents
 Change in manufacturer Lot
 Improper reconstitution
 Expired Reagent
 Inadequate storage
 Bubbles in reagent

5) Check Instruments
 Untrained operator
 Inadequate Daily Maintenance
 Instrument Preventive maintenance
 Instrument calibration

6) Check Trends
 Compare data with peer group
 Bottle mean/SD & Lab mean/SD Variation

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