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What This Guide Helps With
Calibration fails, aborts, or produces unacceptable results because of material, preparation, handling, analyzer condition, reagent, or workflow-related causes.
Step-by-Step Troubleshooting
1. Protect Patient Testing and Confirm the Calibration Failure
Do not report patient results that depend on an unresolved calibration condition. Determine what calibration was attempted, when it failed, and whether failure occurred during material aspiration, analysis, calculation, or acceptance.
Expected outcome: The failure stage is identified and affected patient testing remains appropriately restricted.
2. Review the Exact Analyzer Message
Record the displayed calibration message or status exactly. Determine whether the analyzer indicates a problem with material identification, aspiration, replicate consistency, reagent condition, or another observable category without assuming a failed component.
Expected outcome: The troubleshooting path is based on the actual reported condition.
3. Inspect Calibration Material
Verify that the correct approved calibration material is being used and that the vial or tube is intact, properly identified, and free of obvious leakage, contamination, clotting, or inadequate volume.
Expected outcome: Calibration material is physically suitable for use. An unsuitable material is replaced before another attempt.
4. Verify Preparation and Handling
Confirm that calibration material was prepared, mixed, handled, and used according to the applicable laboratory and manufacturer instructions. Avoid repeated calibration attempts with questionable material.
Expected outcome: Calibration material handling is confirmed appropriate.
5. Check Sample Presentation
Inspect the calibration sample tube, cap condition if relevant, barcode or identification, placement, and loading method. Ensure the material is being presented through the intended workflow.
Expected outcome: The analyzer can reliably identify and aspirate the calibration material.
6. Verify Reagent and Consumable Status
Confirm required reagents and consumables are recognized, available, and properly installed. Check accessible reagent and waste connections for obvious problems.
Expected outcome: No external reagent, waste, or consumable condition is preventing calibration.
7. Review Recent Analyzer Performance
Determine whether routine QC, background checks, or other analyzer performance indicators were abnormal before calibration was attempted. A broader analyzer problem should not be treated as a calibration-only issue.
Expected outcome: It is clear whether the problem is isolated to calibration or associated with a wider performance issue.
8. Repeat Calibration Only When Justified
After correcting a clear external cause, perform another calibration attempt using properly prepared material. Do not repeatedly recalibrate simply to force acceptance of an unresolved problem.
Expected outcome: Calibration completes and meets the analyzer's approved acceptance criteria. If it does, proceed to QC verification.
9. Verify Calibration With Quality Control
Run appropriate QC after successful calibration and confirm analyzer performance is acceptable before patient testing resumes.
Expected outcome: QC verifies acceptable analyzer performance. Troubleshooting can stop.
10. Escalate Repeated Calibration Failure
If properly prepared calibration material repeatedly fails after reagents, sample presentation, and external analyzer conditions are verified, stop external troubleshooting.
Expected outcome: The analyzer remains unavailable for affected patient testing and qualified service or laboratory escalation begins.
If the Problem Persists
Common calibration-material, preparation, identification, reagent, aspiration, and workflow causes have been ruled out. The remaining problem may involve analyzer measurement performance, fluidics, optical or sensing systems, internal calibration data, software, or another service-level condition.
Remove the analyzer from service for affected testing, label it Out of Service when appropriate, and arrange service or bench evaluation using Sysmex documentation and approved test equipment. Internal adjustments, calibration data changes, or component repair should be completed only by qualified personnel.
Return the analyzer to service only after successful calibration where required, acceptable QC, and any other required performance verification. Knowing when to stop external troubleshooting is proper troubleshooting.
Clinical Use Tip
A calibration that merely completes is not enough; verify acceptable QC before releasing the analyzer for patient testing.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Laboratory staff reported that calibration repeatedly failed before the analyzer would accept the calibration run."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found the calibration material contained visible bubbles and had not been adequately prepared before loading."
Resolution
What action was taken.
Example:
"Laboratory staff prepared a fresh calibration sample according to the approved procedure, calibration completed successfully, and subsequent QC was acceptable."
Helpful Details to Include (If Known)
- Calibration being performed
- Exact displayed failure message
- Calibration material identity and condition
- Material preparation and handling
- Sample tube and barcode condition
- Reagent status
- Recent QC status
- Whether failure repeated with fresh material
- Calibration result after correction
- Post-calibration QC result
- Final analyzer status
Final Thought
Calibration problems require disciplined verification of material, handling, reagents, and analyzer condition before internal failure is suspected. Keep patient testing restricted until calibration and QC demonstrate acceptable performance.
That is successful troubleshooting.