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What This Guide Helps With
Use when QC results are unexpectedly high, low, shifted, imprecise, or outside laboratory-defined acceptance criteria.
Step-by-Step Troubleshooting
1. Stop Affected Patient Result Release
Follow laboratory policy for results generated since the last acceptable QC. Do not continue reporting affected analytes until QC performance is restored.
Expected outcome: Potentially unreliable patient results are contained and testing continuity is managed safely.
2. Confirm the QC Pattern
Determine which analytes and QC levels are affected and whether the problem is isolated, consistently biased, random, or affecting several assays.
Expected outcome: The scope and pattern of the QC failure are clearly defined.
3. Verify QC Material
Check that the correct QC material and level were used. Confirm lot, expiration, storage, preparation, mixing, and handling are consistent with laboratory procedures. Inspect for contamination, evaporation, or inadequate volume.
Expected outcome: QC material is confirmed suitable or a material-related cause is identified.
4. Review Reagent Status
Verify reagent identity, lot, expiration, placement, and displayed status for affected assays. Look for a recent reagent change that corresponds with the QC shift.
Expected outcome: Reagent-related external causes are either identified or ruled out.
5. Check Calibration Status
Confirm affected assays have valid calibration status according to the normal laboratory workflow. Note any recent calibration failures, reagent changes, or calibration events.
Expected outcome: Calibration status supports accurate testing or identifies a likely contributing condition.
6. Check Sample Presentation and Aspiration Conditions
Inspect QC cups or tubes for adequate volume, bubbles, foam, debris, improper placement, or contamination. Confirm no recurring aspiration or pipetting message is present.
Expected outcome: QC material is being presented consistently for aspiration.
7. Repeat QC With Fresh Approved Material
When laboratory procedure allows, run fresh QC material using a new aliquot or known-good control. Avoid repeatedly rerunning the same questionable sample solely to obtain an acceptable result.
Expected outcome: Acceptable fresh QC indicates the original material or preparation was the likely cause. If QC remains unacceptable, continue troubleshooting.
8. Look for Broader Analyzer Conditions
Determine whether several unrelated assays are affected, which may indicate a common issue such as fluidics, wash performance, aspiration, environmental condition, or measurement instability rather than a single reagent problem.
Expected outcome: The problem is categorized as assay-specific or analyzer-wide.
9. Verify Stable QC Before Return to Patient Testing
Follow laboratory requirements for confirming acceptable QC performance before releasing patient results.
Expected outcome: QC meets laboratory acceptance criteria consistently. Troubleshooting can stop and affected testing may resume.
If the Problem Persists
QC material, reagent, calibration, sample presentation, and obvious external conditions have been ruled out. The remaining problem may involve aspiration, wash performance, temperature regulation, measurement optics, fluidics, contamination, or other internal service-level conditions.
Remove affected testing from service and label the analyzer Out of Service when reliable results cannot be assured. Arrange qualified evaluation using Beckman Coulter documentation and approved test equipment. Internal repair, calibration adjustment, or configuration changes should be performed only by qualified personnel.
Return the analyzer to service only after corrective action and acceptable QC verification.
Knowing when to stop external troubleshooting and escalate is proper troubleshooting.
Clinical Use Tip
An out-of-range QC result is a patient-safety issue even when the analyzer appears otherwise normal; do not resume reporting until performance is verified.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Laboratory staff reported repeated high QC results for one chemistry assay on the DxC 700 AU."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found the affected QC material had been improperly prepared and contained visible foam."
Resolution
What action was taken.
Example:
"Fresh QC material was prepared correctly, repeat QC met laboratory acceptance criteria, and the assay was returned to service."
Helpful Details to Include (If Known)
- Assays and QC levels affected
- Direction and pattern of QC shift
- QC lot and expiration
- QC preparation and storage
- Reagent lot and status
- Calibration status
- Recent reagent or calibration change
- Aspiration-related messages
- Fresh QC results
- Final testing status
Final Thought
Treat abnormal QC as a result-integrity problem first. Verify materials, reagents, calibration, and sample presentation before assuming internal failure, and return testing to service only after acceptable QC performance is demonstrated and documented.
That is successful troubleshooting.