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What This Guide Helps With
QC results are outside acceptable limits due to control material, handling, reagent, aspiration, analyzer condition, or broader performance problems.
Step-by-Step Troubleshooting
1. Protect Patient Testing and Confirm the QC Failure
Pause or restrict affected patient result reporting according to laboratory policy when QC is unacceptable. Determine which QC level, parameter, or channel is affected and whether the problem is isolated or widespread.
Expected outcome: The affected testing scope is understood and potentially unreliable patient results are not released.
2. Review the QC Pattern
Determine whether the failure affects one control level, several levels, one parameter, or multiple parameters. Compare current results with recent QC performance without adjusting limits simply to make results acceptable.
Expected outcome: The pattern helps distinguish a control-material problem from a broader analyzer problem.
3. Inspect the QC Material
Verify the correct QC material is being used. Check the container for adequate volume, damage, contamination, clotting, evaporation, or other visible abnormality.
Expected outcome: QC material appears suitable. Questionable material is replaced rather than repeatedly rerun.
4. Verify QC Preparation and Handling
Confirm control material was mixed, prepared, stored, and handled according to applicable instructions and laboratory procedures. Verify the correct control identification and lot information are being used.
Expected outcome: Control preparation and identification are correct.
5. Run Fresh or Known-Good QC Material
When appropriate, repeat testing using properly prepared fresh or known-good control material.
Expected outcome: QC returns to the acceptable range. If it does, the issue is isolated to the original control material or preparation.
6. Check Reagent Status
Verify required reagents are correctly installed, recognized, and available. Look for recently changed reagents, near-empty containers, disconnected accessible tubing, or other obvious reagent-related conditions.
Expected outcome: Required reagents are correctly recognized and externally intact.
7. Inspect for Aspiration or Sample Presentation Problems
Check the control tube, sample volume, bubbles, tube position, and accessible sample path. Determine whether the analyzer has shown recent aspiration or sample-volume problems.
Expected outcome: QC material can be aspirated reliably and no external sample-presentation issue is present.
8. Review Calibration and Recent Maintenance History
Confirm whether recent calibration, maintenance, reagent replacement, shutdown, or service coincided with the QC shift. Do not recalibrate automatically unless the applicable procedure supports doing so.
Expected outcome: Any relevant recent change is identified and addressed through the proper workflow.
9. Repeat QC and Verify Stability
After correcting an identified external cause, run appropriate QC again and confirm results are acceptable and stable.
Expected outcome: QC meets established laboratory acceptance criteria. Patient testing may resume according to policy and troubleshooting can stop.
10. Escalate Persistent QC Failure
If fresh, correctly handled QC remains unacceptable after external causes are ruled out, stop external troubleshooting.
Expected outcome: The analyzer is removed from affected patient testing and qualified service or laboratory technical escalation is initiated.
If the Problem Persists
Common control-material, handling, reagent, sample-presentation, and workflow causes have been ruled out. The remaining condition may involve calibration, internal fluidics, measurement systems, optical or sensing performance, software, or another service-level problem.
Remove the analyzer from service for affected testing, label it Out of Service as appropriate, and arrange service evaluation using Sysmex documentation and approved test equipment. Internal adjustments or repairs should be performed only by qualified personnel.
Before return to clinical use, complete appropriate analyzer checks, calibration if required, and acceptable QC verification. Knowing when to stop external troubleshooting is proper troubleshooting.
Clinical Use Tip
Do not treat repeated QC reruns as troubleshooting if the underlying cause remains unknown; investigate the trend before patient testing resumes.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Laboratory staff reported that one QC level was repeatedly outside the laboratory's acceptable range."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found the control vial had insufficient remaining volume and visible bubbles near the aspiration area."
Resolution
What action was taken.
Example:
"A properly prepared replacement control was tested, QC returned to the acceptable range, and analyzer operation was verified."
Helpful Details to Include (If Known)
- QC level and affected parameters
- Whether one or multiple levels failed
- Control lot and physical condition
- Preparation and mixing status
- Sample volume and bubbles
- Reagent status
- Recent calibration or maintenance
- Results with fresh QC material
- Repeatability after correction
- Final analyzer status
Final Thought
Out-of-range QC must be treated as a potential analyzer-performance issue until proven otherwise. Verify the control material and external conditions first, then escalate persistent failures rather than forcing repeated reruns.
That is successful troubleshooting.