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What This Guide Helps With
Troubleshoots out-of-range QC caused by control material, reagent condition, calibration status, handling, loading, aspiration, or broader analyzer performance problems.
Step-by-Step Troubleshooting
1. Protect Patient Testing and Confirm the QC Failure
Do not release affected patient results while required QC is unacceptable.
Identify:
- Assay affected
- QC level affected
- Whether one or multiple levels fail
- Whether the failure is isolated or widespread
- Whether the result is consistently high, low, or variable
- Any accompanying analyzer message
Follow laboratory policy for evaluating patient results generated since the last acceptable QC.
Expected outcome: The scope of the QC problem is known and affected patient testing is contained.
2. Verify QC Material
Confirm the intended QC material and level were used.
Inspect for:
- Incorrect level
- Expired or unacceptable status
- Improper preparation
- Storage concerns
- Contamination
- Insufficient volume
- Visible bubbles or foam
Do not continue rerunning suspect QC material.
Expected outcome: Appropriate QC material is available and properly prepared.
3. Verify Reagent Condition and Status
Confirm the reagent associated with the failed QC:
- Is correctly identified
- Is correctly positioned
- Has no unresolved warning
- Is not visibly compromised
- Has acceptable status according to the analyzer and laboratory process
Expected outcome: Reagent status is acceptable.
4. Verify Calibration Status
Check whether the affected assay has an acceptable calibration status.
Consider whether anything recently changed, such as:
- Reagent replacement
- New reagent lot
- Calibration event
- Maintenance
- Analyzer restart
- QC lot change
Do not recalibrate automatically without first understanding the sequence of events and following laboratory policy.
Expected outcome: Calibration status and recent changes are understood.
5. Inspect QC Loading and Aspiration Conditions
Verify:
- Correct sample cup or container
- Proper positioning
- Adequate volume
- No visible bubbles
- No obstruction
- Normal sample aspiration
If the analyzer shows aspiration, probe, or fluidics errors, address those conditions first.
Expected outcome: QC material can be aspirated normally.
6. Compare the Pattern Across Assays and QC Levels
Determine whether:
- Only one QC level fails
- One assay fails across levels
- Several assays fail simultaneously
- Multiple unrelated assays become unstable
A broader pattern may indicate an analyzer-wide condition rather than a single reagent or control problem.
Expected outcome: The failure pattern points toward material-specific, assay-specific, or analyzer-wide troubleshooting.
7. Use Fresh Verified QC Material When Appropriate
Following laboratory policy, test fresh QC material prepared correctly.
Avoid repeated testing solely to obtain an acceptable result.
Expected outcome: Fresh verified QC produces acceptable results. If so, document the material-related cause and troubleshooting can stop after the laboratory completes required release steps.
8. Perform Final Verification
If QC returns to acceptable range, verify:
- No unresolved analyzer alarms
- Reagent and calibration status are acceptable
- Required QC levels pass
- Laboratory release requirements are met
Expected outcome: QC performance is stable and the affected assay can return to clinical use.
If the Problem Persists
If QC material, reagent condition, calibration status, loading, aspiration, and handling have been verified but QC remains unacceptable, common external causes have been ruled out.
The remaining cause may involve assay performance, fluid delivery, pipetting accuracy, temperature control, optical or mechanical measurement systems, configuration, or another service-level issue.
The affected assay or analyzer should be:
- Removed from patient testing
- Labeled Out of Service as appropriate
- Sent for repair or bench evaluation when required
- Evaluated using current Werfen documentation and approved test equipment
- Repaired, calibrated, or configured only by qualified personnel
Do not repeatedly rerun QC to achieve an acceptable value without identifying the cause.
Return the assay to service only after required QC is acceptable and any necessary laboratory review is complete.
Knowing when to stop external troubleshooting is proper troubleshooting.
Clinical Use Tip
Out-of-range QC is a patient-result integrity issue; contain affected testing before attempting to restore analyzer availability.
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 for an ACL TOP 750 LAS assay was repeatedly out of range."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering and laboratory staff found the QC material had visible bubbles and had been inadequately prepared before loading."
Resolution
What action was taken.
Example:
"Fresh QC material was prepared according to laboratory procedure, acceptable QC results were obtained, and the assay was released for patient testing."
Helpful Details to Include (If Known)
- Assay and QC level affected
- Direction and pattern of failure
- QC lot and status
- Reagent lot and status
- Calibration status
- Recent reagent or calibration changes
- Sample volume and visible bubbles
- Associated analyzer alarms
- Fresh-QC result
- Final patient-testing status
Final Thought
Treat QC failure as a test-quality problem first, verify controls, reagents, calibration, and aspiration logically, and escalate when acceptable performance cannot be demonstrated.
That is successful troubleshooting.