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What This Guide Helps With
Troubleshoots unacceptable QC results caused by control materials, handling, identification, loading, environment, calibration status, or analyzer readiness.
Step-by-Step Troubleshooting
1. Stop Affected Patient Testing
Do not release or rely on patient results from a system when required quality-control acceptance criteria are not met. Coordinate with laboratory staff to move testing to a verified alternate system or approved workflow.
Clinical Engineering should support equipment troubleshooting while laboratory personnel retain responsibility for QC acceptance and result disposition.
Expected outcome: Patient testing is protected from use of an analyzer with unacceptable QC status.
2. Confirm the QC Failure Pattern
Determine whether one control, one level, one run, one position, or all QC testing is affected. Record the laboratory's reported out-of-range condition and any analyzer messages.
Do not reinterpret clinical laboratory QC limits unless that is within authorized responsibility.
Expected outcome: The scope and repeatability of the QC problem are clearly defined.
3. Verify Analyzer Readiness and Calibration Status
Confirm the system is fully initialized and not reporting unrelated faults. Ask laboratory staff to verify required calibration and maintenance status for the affected testing process.
Expected outcome: The analyzer is otherwise ready and required calibration status is acceptable. If calibration is not acceptable, address that condition before continuing.
4. Verify QC Material Condition
Have laboratory personnel verify the correct QC material, lot, preparation, storage, expiration, and handling according to their approved laboratory procedure.
Clinical Engineering should not modify or extend control-material use criteria.
Expected outcome: QC material is suitable for use. If the problem follows an unsuitable control material, replace it through laboratory workflow and verify acceptable QC.
5. Check Container Identification and Placement
Inspect the external condition of QC containers, labels, and barcodes. Verify they are loaded in the proper position and orientation and are fully seated.
Expected outcome: QC material is correctly identified and positioned. If correcting placement resolves the failure, proceed to repeated QC verification.
6. Compare With Fresh or Known-Good QC Material
When laboratory staff approve, repeat the test using an appropriate fresh or known-good control to determine whether the abnormal result follows the original material.
Expected outcome: The issue is isolated to the QC material or remains with the system. If fresh QC passes, document the material-related cause and stop after laboratory acceptance.
7. Inspect Accessible Analyzer Areas
Inspect accessible loading areas, optical surfaces, holders, and positions for contamination, obstruction, residue, or physical damage that could affect detection or processing.
Clean only areas intended for routine external cleaning.
Expected outcome: Accessible areas are clean and unobstructed. If cleaning restores acceptable QC, complete the required repeat verification.
8. Check Environmental Conditions
Verify the system is not experiencing abnormal temperature, blocked ventilation, direct sunlight, excessive vibration, or other obvious environmental influence.
Expected outcome: No external environmental problem is present. If correcting one restores acceptable QC, document the condition and verify stability.
9. Repeat QC Under Laboratory Control
After any identified external cause is corrected, laboratory personnel should repeat QC according to their approved procedure.
Do not return the analyzer to patient testing based only on a technical functional check when required QC remains unacceptable.
Expected outcome: Required QC returns to the laboratory's acceptable range and remains acceptable. If not, stop and escalate.
If the Problem Persists
Common external causes involving QC materials, handling, identification, placement, analyzer readiness, calibration status, accessible contamination, and environment have been ruled out. The remaining problem may involve an internal optical, temperature-control, detection, calibration, software, or other service-level condition.
The analyzer should be:
- Removed from service for affected testing.
- Labeled Out of Service.
- Sent for repair or bench evaluation.
- Evaluated using current BD documentation and approved test equipment.
- Repaired or configured only by qualified personnel.
After service, complete required manufacturer checks and laboratory QC before patient testing resumes.
Recognizing unacceptable QC as a stop condition is part of proper Clinical Engineering troubleshooting.
Clinical Use Tip
A technically operational analyzer is not ready for patient testing until required laboratory QC is acceptable.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Laboratory reported repeated out-of-range QC results on the BD BACTEC FX."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering and laboratory staff isolated the problem to improperly stored QC material while the analyzer passed external operational checks."
Resolution
What action was taken.
Example:
"Laboratory replaced the QC material, repeat QC was acceptable, and normal analyzer operation was verified before return to use."
Helpful Details to Include (If Known)
- QC level or material affected
- Whether one or multiple QC levels failed
- Lot and expiration status
- Storage or handling observations
- Calibration status
- Loading position used
- Accessible contamination found
- Known-good QC comparison
- Environmental conditions
- Repeat QC result
- Final analyzer status
Final Thought
Out-of-range QC requires patient-testing protection first. Verify the control material, setup, calibration status, and analyzer environment before assuming an internal failure, and require acceptable laboratory QC before return to service.
That is successful troubleshooting.