Laboratory quality control: what can be done when laboratory equipments are out of CONTROL STANDARD DEVIATION RANGE?

if the laboratory equipment deviates from the control standard range it should be recalibrated.

There are number of steps that are needed to be taken when controls are out of 2 SD (mostly)

1. check expiry of controls

2. check visually for any turbidy (contamination)

3. check calibration of your system

4. check lot and batch number

5. Operator's handling

6. call engineers to check the machine ( for optics, pressures, etc.)

7. Get it run in another laboratory to check your system 

Caliberate the machine,then run the QC again  and if QC with in the normal range proced the test

1. first ask is it an expired QC vial? get different one, run for valid QC.... if it beyond 2 SD, then go to #2 action to correct it.
2. The Lab should stop running patients samples on them, as there are systematic errors.
3. Review trouble shouting hostory for every lab instruments to determine key points to start with such as when, what, how...who? is in charge etc to determine exactly what happened.
4. every instrument should be taken care as per manufacturer instructions.... Re-calibration, preventive maintenance and or re-run QCs.

Take fresh QC and run. If qc still out side standard deviation, Calibrate the instrument with calibrators. If clibration is not succussful, change reagents and calibrate. If calibration succussful, rerun qc and see. If qc within standared deviation, we can run patient samples.

TECHNICIEN ANALYE MEDICALE

IT SIMPLY MEANS THE MEASURE SYSTEM SYSTEM IS NOT IN CONTROL, PREVENTIVE MAINTENANCE IS NOT IN PLACE, THE HISTORY OF EQUIPMENT IS NOT MAINTAINED FOR ANALYSIS OF THE TEST RESULTS.

SO ALL THE TEST PERFORMED NEED TO BE QUARANTINED, AND THE RESULT SHOULD BE RECALLED. LABORATORY EQUIPMENT NEEDS TO BE CALIBRATED AT EARLIEST AND THE QUARANTINED TEST TO BE RETESTED.

FURTHER ISO 17025 CALLS FOR THE RECORD OF CALIBRATIONS.

Equipments can be re calibrated by their standard calibration technique.

The equipments should not be use for the analysis of the Patient samples, it must be investigated and corrective actions should be done.

RECALIBRATE THE EQUIPMENTS WITH SPECIFIED CALIBRATORS

Recalibrate with certified control standard and if recalibration does not work, deviation might have been caused by a hardware malfunction or might need some firmware corrections.