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What This Guide Helps With
Troubleshoot unacceptable quality-control results by checking materials, handling, module patterns, environment, workflow, configuration, and system readiness before service escalation.
Step-by-Step Troubleshooting
1. Stop Affected Patient Testing
If required quality control is unacceptable, follow laboratory policy for withholding patient testing or results on the affected system, assay, or module.
Move urgent testing to another validated system when necessary.
Expected outcome: No patient result is released from an affected testing pathway until laboratory acceptance criteria are met.
2. Confirm the Exact QC Failure
Review the exact QC result, message, assay, module, cartridge, and timing with laboratory personnel. Determine whether the issue affects one control, one lot, one assay, one module, or multiple areas.
Clinical Engineering should not independently reinterpret clinical QC acceptance criteria.
Expected outcome: The scope and pattern of the failure are clearly established.
3. Verify QC Material and Handling
Have laboratory staff confirm that the correct QC material was used and that preparation, storage, handling, expiration evaluation, and required equilibration were performed according to their validated procedure.
Expected outcome: The QC material and preparation process are appropriate.
4. Inspect Cartridges and Consumables
Inspect applicable cartridges and consumables externally for damage, contamination, identification problems, or improper seating.
Expected outcome: Consumables are intact, correctly identified, and properly loaded.
5. Check for a Lot or Material Pattern
Determine whether QC failures began with a new lot or occur only with one control or cartridge lot. A laboratory-approved comparison with other acceptable material may help separate reagent-related causes from equipment causes.
Expected outcome: Material-related and analyzer-related possibilities are separated without altering the validated workflow.
6. Determine Whether the Failure Follows a Module
Review whether the unacceptable QC repeatedly occurs in the same analyzer module or location while other modules perform acceptably.
Expected outcome: A module-specific pattern is identified or ruled out.
7. Verify Environmental and Power Stability
Check for recent power interruptions, relocation, unusual room conditions, blocked ventilation, excessive heat, or other environmental changes.
Expected outcome: The system is operating under stable external conditions.
8. Verify Configuration and Workflow
Confirm with laboratory personnel that the correct assay workflow and validated configuration are active. Check whether recent software, assay-definition, network, or configuration changes coincide with the QC issue.
Do not change restricted parameters to force QC acceptance.
Expected outcome: The intended validated configuration is confirmed.
9. Repeat QC Only According to Laboratory Procedure
If laboratory policy permits, allow laboratory staff to repeat QC using approved material after any identified external condition has been corrected.
Clinical Engineering should observe equipment behavior rather than repeatedly consuming QC materials without a troubleshooting hypothesis.
Expected outcome: QC meets laboratory criteria after correction. If so, complete verification and stop troubleshooting.
10. Verify Stable Operation
If acceptable QC is restored, verify the system remains free of related hardware, module, automation, or communication errors.
Expected outcome: The affected testing pathway is stable and laboratory QC requirements are met.
11. Escalate Persistent QC Failure
If materials, handling, cartridges, configuration, environment, and module patterns have been assessed but QC remains unacceptable, stop external troubleshooting.
Expected outcome: The affected module or system remains unavailable for patient testing pending service evaluation.
If the Problem Persists
Common external QC material, handling, consumable, environmental, and configuration causes have been ruled out. Remaining causes may involve an analyzer module, thermal or optical performance, software, assay-related configuration, or another internal service-level condition.
The affected GeneXpert Infinity system or module should be:
- Removed from service for the affected testing workflow
- Labeled Out of Service
- Sent for repair or qualified service evaluation
- Evaluated using current manufacturer documentation and approved test equipment
- Repaired or configured only by qualified personnel
Laboratory QC and any required verification must be acceptable before return to patient testing.
Knowing when to stop external troubleshooting is proper troubleshooting.
Clinical Use Tip
Do not treat repeated QC failure as merely a nuisance alarm; it directly affects confidence in patient test results.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Laboratory staff reported repeated unacceptable quality-control results on one GeneXpert Infinity module."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering confirmed acceptable QC materials and workflow and found that failures consistently followed the same module."
Resolution
What action was taken.
Example:
"Clinical Engineering removed the affected module from clinical use, documented the repeated module-specific failure, and escalated it for qualified service evaluation."
Helpful Details to Include (If Known)
- Exact QC failure or message
- Assay involved
- QC and cartridge lot information
- Affected module
- Whether other modules passed
- Material handling confirmation
- Recent environmental or power changes
- Configuration changes
- Repeat QC result
- Final laboratory disposition
- Final equipment status
Final Thought
Unacceptable QC must be approached as a patient-result reliability issue. Rule out materials and workflow first, look for repeatable equipment patterns, and escalate rather than forcing a questionable analyzer back into service.
That is successful troubleshooting.