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Asset Type
Viscoelastic Hemostasis Analyzer
Manufacturer
Model
What This Guide Helps With
Addresses failed or out-of-range quality control caused by QC material, cartridge, handling, environment, setup, or analyzer conditions.
Step-by-Step Troubleshooting
1. Protect Patient Testing
Do not release patient results from an analyzer that has not met required quality-control expectations.
Move clinical testing to another verified analyzer or approved alternate workflow until the QC issue is resolved.
Expected outcome: Patient testing is protected from an analyzer with unresolved QC performance.
2. Confirm the Exact QC Failure
Record:
- Which QC level or material failed.
- Whether the run was invalid, incomplete, or numerically out of range.
- Whether one or multiple parameters were affected.
- Whether the issue occurred once or repeatedly.
Expected outcome: The QC failure is clearly characterized before corrective action begins.
3. Inspect QC Material
Verify the QC material is appropriate for the assay and has been handled according to its labeling and laboratory procedure.
Check for:
- Expiration.
- Improper storage.
- Incorrect preparation.
- Contamination.
- Inadequate mixing where applicable.
- Evidence the material has exceeded its approved use conditions.
Expected outcome: QC material is suitable for use. Replace questionable material before assessing the analyzer.
4. Verify Cartridge Type and Condition
Confirm the correct cartridge is being used and inspect it for package damage, contamination, improper storage, or physical defects.
Expected outcome: The cartridge is appropriate and intact. Replace a suspect cartridge and repeat QC.
5. Review QC Preparation and Transfer
Confirm the QC material was introduced into the cartridge through the approved workflow without:
- Insufficient volume.
- Bubbles.
- Leakage.
- Delay inconsistent with the laboratory procedure.
- Incomplete transfer.
Expected outcome: QC preparation and loading are performed consistently. If corrected technique produces an acceptable result, troubleshooting can stop.
6. Repeat QC With Fresh Materials
Use fresh appropriate QC material and a known-good cartridge when available.
Avoid repeating indefinitely with the same questionable materials.
Expected outcome: QC passes when fresh verified materials are used. If so, document the material or cartridge issue.
7. Check Analyzer Environment
Verify the analyzer is:
- Stable and level.
- Free from excessive vibration.
- Not exposed to direct heat, cold, drafts, spills, or condensation.
- Operating in its intended laboratory environment.
Expected outcome: Environmental contributors are ruled out or corrected.
8. Verify Analyzer Readiness and Configuration
Confirm normal startup and verify that the intended assay and QC workflow are selected.
Do not alter protected configuration or assay parameters without authorization.
Expected outcome: The analyzer is in a normal operating state with the expected workflow selected.
9. Repeat QC and Evaluate Reproducibility
Repeat the appropriate QC process after external causes are corrected.
Expected outcome: QC meets the laboratory's approved acceptance criteria. Once required QC passes and no other abnormal behavior exists, troubleshooting can stop.
10. Escalate Repeated QC Failure
If fresh QC material and known-good cartridges repeatedly fail on one analyzer, remove it from service.
Expected outcome: The analyzer is withheld from patient testing and sent for qualified evaluation.
If the Problem Persists
QC material, cartridge condition, preparation, handling, environment, workflow selection, and basic analyzer readiness have been ruled out. Persistent QC failure may involve calibration status, internal sensing or measurement functions, software, cartridge interaction, or another service-level condition.
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, calibrated, or configured only by qualified personnel.
Required QC and return-to-service testing must pass before patient testing resumes.
Knowing when to stop external troubleshooting is proper troubleshooting.
Clinical Use Tip
Failed QC is a patient-safety condition, not merely a maintenance inconvenience; do not release the analyzer until required QC has been successfully repeated.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Laboratory staff reported that the TEG 6s repeatedly failed the scheduled quality-control run."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found the QC material in use had been improperly stored and fresh QC material produced acceptable results."
Resolution
What action was taken.
Example:
"Removed the compromised QC material, repeated control testing with properly handled material and an appropriate cartridge, verified acceptable QC performance, and returned the analyzer to service."
Helpful Details to Include (If Known)
- QC material identification.
- QC level.
- Exact failure description.
- Storage condition.
- Expiration status.
- Cartridge type and lot.
- Fresh QC result.
- Known-good cartridge result.
- Environmental observations.
- Whether other TEG 6s analyzers passed the same QC.
- Final QC status.
- QC material identification.
- QC level.
- Exact failure description.
- Storage condition.
- Expiration status.
- Cartridge type and lot.
- Fresh QC result.
- Known-good cartridge result.
- Environmental observations.
- Whether other TEG 6s analyzers passed the same QC.
- Final QC status.
Final Thought
Treat failed QC as a clinical reliability issue, verify control materials and cartridges before blaming the analyzer, require successful repeat QC before release, and escalate persistent failures with clear documentation.
That is successful troubleshooting.