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Microbiology Identification System
Manufacturer
Model
What This Guide Helps With
Use this guide when a required calibration or verification process fails, stops unexpectedly, or cannot be completed successfully.
Step-by-Step Troubleshooting
1. Protect Test Validity
Do not use an analyzer for patient testing when a required calibration or associated verification has failed and the system's performance cannot be assured.
Laboratory staff should redirect testing through an alternate validated process.
Expected outcome: Patient results are not produced from an analyzer with unresolved calibration status.
2. Confirm What Procedure Failed
Determine exactly which calibration or verification process was attempted and whether the failure:
- Occurred before the process started
- Occurred during the process
- Happened consistently at the same stage
- Appeared after maintenance, power interruption, or material change
Record the exact failure message.
Expected outcome: The affected procedure and failure point are clearly documented.
3. Verify Analyzer Readiness
Confirm that the analyzer:
- Completed initialization normally
- Is not showing unrelated alarms or faults
- Has stable AC power
- Has required communication and workstation connections
- Is in the correct operational mode
Calibration should not be used to mask an unrelated system fault.
Expected outcome: The analyzer is otherwise stable and ready for the procedure.
4. Verify Calibration Materials
Have qualified laboratory personnel confirm that the correct approved materials are being used and that they are acceptable for the procedure.
Check externally for:
- Damage
- Contamination
- Incorrect material
- Improper handling
- Identification problems
- Obvious storage concerns
Clinical Engineering should not determine laboratory acceptability beyond the scope of technical support.
Expected outcome: Appropriate material is available and acceptable for use.
5. Check Loading and Positioning
Verify that required materials, cards, racks, or carriers are correctly positioned and fully seated.
Inspect the loading area for contamination, obstruction, or damaged accessories.
Expected outcome: Calibration materials are positioned normally and detected by the system.
6. Verify External Environmental Conditions
Check for facility conditions that may affect system stability, including:
- Recent power disturbance
- Excessive room temperature
- Blocked ventilation
- Moisture
- Recent relocation
- Significant vibration
Do not invent or apply environmental limits not provided by the manufacturer.
Expected outcome: No obvious environmental problem is present.
7. Repeat the Procedure Only When Appropriate
If the failure appears attributable to a correctable external cause and laboratory personnel confirm the material is suitable, repeat the approved procedure once.
Do not repeatedly consume calibration materials or force repeated attempts when the same failure recurs.
Expected outcome: Calibration completes successfully after the external cause is corrected.
If calibration completes and subsequent required checks are acceptable, troubleshooting can stop.
8. Compare With Known-Good Materials When Authorized
If the laboratory has another verified set of appropriate materials, use that comparison to determine whether the failure follows the material or remains with the analyzer.
Expected outcome: The comparison separates material-related issues from analyzer-related issues.
9. Perform Final Functional Verification
After successful calibration, confirm that:
- The analyzer reports the expected completion status
- No new alarms are present
- Associated QC or laboratory verification is completed as required
- Laboratory staff accepts the system for testing
Expected outcome: Calibration and required post-calibration checks are complete and acceptable.
If the Problem Persists
If analyzer readiness, materials, loading, environment, external connections, and an appropriate repeat attempt have been verified, common external causes have been ruled out.
The remaining problem may involve a sensor, optical or mechanical condition, internal control issue, software problem, stored calibration data, or another service-level fault.
The device should be:
- Removed from service
- Labeled Out of Service
- Sent for repair or bench evaluation
- Evaluated using appropriate manufacturer documentation and approved test equipment
- Repaired or configured only by qualified personnel
Do not make unauthorized internal adjustments to force calibration to pass. Knowing when to stop external troubleshooting is proper troubleshooting.
Complete required calibration, QC, and laboratory acceptance before return to service.
Clinical Use Tip
A failed calibration is a test-validity issue; do not return the analyzer to patient testing merely because it otherwise appears operational.
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 bioMerieux VITEK 2 Compact repeatedly failed before completion."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found that the calibration material carrier was not fully seated because of debris in the loading area."
Resolution
What action was taken.
Example:
"Cleaned the accessible loading area using approved methods, verified proper carrier seating, and laboratory staff completed calibration and required verification successfully."
Helpful Details to Include (If Known)
- Calibration procedure attempted
- Exact failure message
- Stage at which failure occurred
- Analyzer ready status
- Material identification and condition
- Loading position
- Known-good material comparison
- Recent power or environmental event
- Whether failure repeated
- Post-calibration verification result
- Final device status
Final Thought
Treat calibration failure as a reason to stop patient testing, verify external conditions and materials first, and escalate when successful calibration cannot be restored without service-level intervention.
That is successful troubleshooting.