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What This Guide Helps With
Addresses failed or incomplete calibration caused by material condition, preparation, aspiration, environmental conditions, analyzer readiness, or unresolved quality issues.
Step-by-Step Troubleshooting
1. Protect Patient Results
Do not report patient results from affected parameters when required calibration is incomplete or unacceptable. Follow the laboratory's approved alternate-testing process.
Confirm which calibration activity failed and whether the failure is consistent or intermittent.
Expected outcome: Result integrity is protected and the specific calibration failure is identified.
2. Review the Exact Calibration Failure
Record the exact analyzer message, parameter, point in the calibration process, and whether the run stopped or completed unsuccessfully.
Do not immediately repeat calibration without first checking likely external causes.
Expected outcome: A reproducible calibration condition is documented.
3. Verify Calibration Material
Confirm the correct calibration material is being used and that its laboratory-controlled identification, storage, handling, and preparation are appropriate.
Inspect for contamination, leakage, improper mixing, or insufficient volume.
Expected outcome: Calibration material is suitable for use. If material condition is questionable, replace it with appropriate material before proceeding.
4. Verify Sample Presentation
Check that the calibration material container is correctly loaded, properly positioned, and compatible with the validated laboratory workflow.
Inspect labels and container condition for anything that could interfere with aspiration or identification.
Expected outcome: Calibration material is presented correctly. If correcting loading resolves calibration, complete verification and stop.
5. Check Analyzer Readiness
Confirm no reagent, waste, wash, fluidics, temperature, initialization, or other visible analyzer condition is preventing reliable calibration.
Resolve external readiness issues before repeating calibration.
Expected outcome: The analyzer is fully ready for calibration. If correcting an external readiness condition permits successful calibration, troubleshooting can stop after quality verification.
6. Inspect for Aspiration or Fluidic Problems
Look for visible signs of bubbles, leakage, empty fluid containers, waste restrictions, loose accessible connections, or repeated aspiration-related messages.
Do not proceed into internal fluidic disassembly.
Expected outcome: No obvious external fluidics condition is affecting calibration. If an external fluid issue is corrected and calibration then succeeds, verify quality and stop.
7. Compare With Fresh or Known-Good Material
When permitted by laboratory procedure, repeat using another suitable calibration material preparation or validated material source.
This helps distinguish material-related failure from analyzer-related failure.
Expected outcome: Calibration succeeds with suitable material. If the failure follows the original material, remove that material from use and stop.
8. Review Environmental Conditions
Check for recent relocation, unusual room temperature conditions, power disturbances, analyzer shutdown, reagent replacement, or maintenance that coincided with the calibration problem.
Correct only clearly identifiable external environmental issues.
Expected outcome: No environmental condition remains that would reasonably interfere with stable analyzer operation.
9. Perform Calibration and Quality Verification
Repeat calibration according to the laboratory-approved workflow after external causes are corrected. Complete required quality-control verification afterward.
Expected outcome: Calibration completes successfully and subsequent quality checks are acceptable. The issue is resolved and troubleshooting can stop.
If the Problem Persists
Calibration material, presentation, analyzer readiness, accessible fluidics, and obvious environmental causes have been ruled out. The remaining cause may involve internal fluidics, optical or measurement systems, sensor performance, configuration, calibration data handling, or another service-level condition.
The analyzer should be:
- Removed from service for affected testing
- Labeled Out of Service
- Sent for repair or bench/service evaluation
- Evaluated using appropriate Abbott documentation and approved test equipment
- Repaired, calibrated, or configured only by qualified personnel
Do not force calibration acceptance or bypass required laboratory quality criteria. Following service, complete required calibration and quality-control verification before return to patient testing.
Knowing when to stop external troubleshooting is proper troubleshooting.
Clinical Use Tip
Never use repeated recalibration to make an unexplained quality problem disappear; identify and correct the underlying cause first.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Laboratory staff reported that calibration on the Abbott Alinity hq repeatedly failed to complete."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found the calibration material container was improperly positioned and not presenting reliably for aspiration."
Resolution
What action was taken.
Example:
"Clinical Engineering corrected the container placement, confirmed calibration completed successfully, and documented that laboratory quality-control verification was required before patient testing resumed."
Helpful Details to Include (If Known)
- Calibration activity or parameter affected
- Exact failure message
- Calibration material identification
- Material preparation and condition
- Sample-container condition
- Reagent and fluid status
- Aspiration behavior
- Recent reagent replacement or maintenance
- Environmental or power events
- Calibration result after correction
- Subsequent QC result
Final Thought
Calibration failure should be approached as a measurement-integrity problem. Verify material, presentation, fluidics, readiness, and environment before assuming an internal analytical fault, then document and escalate appropriately.
That is successful troubleshooting.