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What This Guide Helps With
Use this guide when assay calibration fails, aborts, produces unacceptable results, or repeatedly does not reach a completed valid status.
Step-by-Step Troubleshooting
1. Protect Patient Testing and Identify the Affected Assay
Do not report patient results for an assay that requires valid calibration when calibration has failed or remains incomplete.
Determine:
- Which assay is affected
- Whether one or multiple assays fail
- Whether failure occurs at the same point
- Whether the analyzer aborts calibration or completes it unsuccessfully
- Any displayed message associated with the failure
Expected outcome: The affected assay and exact calibration failure are identified. If calibration subsequently completes successfully and QC passes, troubleshooting can stop.
2. Verify Calibrator Selection and Condition
Confirm the correct calibrator is being used for the intended assay.
Inspect for:
- Wrong material
- Incorrect preparation
- Visible contamination
- Damaged container
- Inadequate volume
- Improper storage or handling history identified by laboratory staff
- Material outside laboratory-defined usability criteria
Clinical Engineering should not independently redefine reagent or calibrator acceptance criteria.
Expected outcome: Correct, acceptable calibrator material is available. If replacing an unsuitable calibrator results in successful calibration, the issue is resolved.
3. Verify Sample Container and Loading
Confirm calibrator containers are appropriate, correctly positioned, and loaded in the expected sequence or locations required by the laboratory workflow.
Check for:
- Mispositioned containers
- Tube obstruction
- Poor seating
- Label interference
- Inadequate accessible volume
- Caps or closures affecting aspiration
Expected outcome: Calibrator containers are properly prepared and positioned for reliable aspiration. Correcting loading resolves the issue if calibration then completes successfully.
4. Verify Reagent Status
Confirm the assay reagent is:
- Correctly identified
- Properly loaded
- Available to the analyzer
- Not showing an unresolved reagent condition
If the reagent itself is not being recognized or shows questionable status, correct that issue before repeating calibration.
Expected outcome: The assay reagent has a valid, stable onboard status. If reagent correction permits successful calibration, troubleshooting can stop after QC verification.
5. Check for Aspiration or Fluidic Problems
Review whether the analyzer is also reporting:
- Aspiration errors
- Probe-related conditions
- Insufficient volume messages
- Bubble or clot-related events
- Wash or fluidic faults
A calibration failure may be secondary to a broader sample- or reagent-handling issue.
Expected outcome: No active sample, probe, or fluidic condition is interfering with calibration. If such a condition is corrected and calibration succeeds, the issue is resolved.
6. Compare With Other Assays
Determine whether:
- Only one assay fails calibration
- Several unrelated assays fail
- Quality-control testing is also abnormal
- The analyzer has broader readiness or fluidic problems
A single-assay failure more strongly points toward assay-specific material or setup, while multiple failures suggest a broader analyzer or process issue.
Expected outcome: The failure is categorized as assay-specific or analyzer-wide, guiding appropriate escalation.
7. Repeat Calibration Only After Correcting an Identified Cause
Do not repeatedly rerun calibration without changing or correcting anything.
Once an identifiable external issue has been addressed, repeat the calibration using the approved laboratory process.
Expected outcome: Calibration completes with a valid status. If it does, proceed to required QC and stop troubleshooting when QC also meets laboratory acceptance criteria.
8. Verify Quality Control Before Patient Testing
After successful calibration, run the required quality-control material according to laboratory procedure.
Clinical Engineering should verify analyzer function but should not independently establish clinical QC acceptance criteria.
Expected outcome: Required QC is accepted by the laboratory and the assay is released for patient testing. Troubleshooting can stop.
9. Escalate Repeatable Calibration Failure
If correct calibrators, reagents, loading, aspiration conditions, and analyzer readiness have been verified but calibration repeatedly fails, remove the affected assay from service.
Do not enter restricted calibration parameters or alter assay-specific service settings unless authorized.
Expected outcome: The unresolved calibration failure is documented and escalated for qualified application or technical service support.
If the Problem Persists
If calibrator material, reagent status, sample loading, aspiration conditions, and basic analyzer readiness have been verified, common external causes have been ruled out.
Remaining causes may include assay-specific configuration, analyzer measurement performance, internal fluidics, optical or detection performance, software, or another service-level condition.
The affected analyzer or assay should be:
- Removed from service for patient testing
- Labeled Out of Service when appropriate
- Sent for repair or qualified service evaluation
- Evaluated using Siemens Healthineers documentation and approved test equipment
- Repaired, calibrated, or configured only by qualified personnel
Successful calibration alone is not sufficient if required post-calibration QC has not been accepted.
Knowing when to stop external troubleshooting is proper troubleshooting.
Clinical Use Tip
Treat a failed calibration as a patient-result reliability issue; do not resume the affected assay until calibration and required QC are both acceptable.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Laboratory staff reported repeated calibration failure on one Atellica IM 1600 assay."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found the calibrator tube was improperly positioned, causing unreliable aspiration while the reagent and analyzer were otherwise normal."
Resolution
What action was taken.
Example:
"The calibrator was correctly loaded, calibration completed successfully, and required quality-control results were accepted before the assay returned to service."
Helpful Details to Include (If Known)
- Assay affected
- Exact calibration failure or message
- Calibrator identity and condition
- Reagent status
- Tube positioning and available volume
- Aspiration or probe errors
- Other assays affected
- Repeat calibration result
- QC result after successful calibration
- Final assay and analyzer status
Final Thought
Calibration troubleshooting should verify assay materials, loading, reagent status, and reliable aspiration before assuming instrument failure. A valid calibration must be followed by acceptable quality control and clear documentation before patient testing resumes.
That is successful troubleshooting.