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What This Guide Helps With
Unexpected hemolysis indications related to specimen quality, collection technique, sample handling, cartridge condition, analyzer status, or detection-system problems.
Step-by-Step Troubleshooting
1. Protect Patient Result Integrity
Do not dismiss or override an unexpected hemolysis indication solely because the specimen appears visually acceptable. Follow facility policy for result acceptance, recollection, or alternate testing.
If clinically urgent, route testing through another verified method.
Expected outcome: Potentially affected results are not released without appropriate evaluation.
2. Confirm the Exact Hemolysis Indication
Record the displayed hemolysis flag, detection error, or associated analyzer message and identify whether it occurred with one sample or repeatedly across different samples.
Determine whether the issue is an expected sample-quality flag or an analyzer error condition.
Expected outcome: The reported condition is accurately characterized before technical troubleshooting begins.
3. Review the Affected Specimen
Inspect the specimen and collection device for visible sample-quality issues, bubbles, clotting, contamination, or handling problems.
Consider whether the specimen may have been affected during collection, transport, mixing, or storage, but do not attribute the problem to collection technique without evidence.
Expected outcome: Obvious specimen-related causes are identified or ruled out.
If recollection produces an acceptable result without an unexpected hemolysis indication and analyzer checks remain normal, troubleshooting can stop.
4. Compare Multiple Specimens
Determine whether the hemolysis indication follows a single patient's specimen or appears on unrelated specimens.
A pattern across multiple properly collected samples increases concern for analyzer, cartridge, or detection-system involvement.
Expected outcome: The issue is separated into a likely specimen-specific problem or a repeatable analyzer-side pattern.
If the problem is isolated to one compromised specimen and verification is normal, no further analyzer troubleshooting is required.
5. Verify GEM PAK Status
Confirm the GEM PAK is recognized and no cartridge loading, quality, fluidic, or other analyzer condition is active.
Inspect externally for damage or leakage.
Expected outcome: The cartridge is properly recognized and does not show an obvious external condition associated with the unexpected flag.
If a cartridge-related external issue is corrected and hemolysis detection returns to expected operation, complete final verification.
6. Check Sample Inlet Cleanliness
Inspect the accessible sample inlet for contamination or dried material and clean only using approved methods.
Contamination at the sample interface may interfere with reliable sample handling.
Expected outcome: The accessible inlet is clean and free from obvious contamination.
If approved cleaning resolves the repeated condition, verify analyzer performance before returning to use.
7. Verify Analyzer Quality Status
Confirm the analyzer's required calibration and quality processes are acceptable and that no unresolved quality-control conditions are present.
Do not use patient testing to validate a questionable hemolysis-detection system.
Expected outcome: The analyzer has acceptable quality status and no other analytical warning indicates unreliable operation.
If all analyzer checks are normal and the unexpected flag does not recur with appropriate verification, troubleshooting can stop.
8. Escalate Repeated Unexpected Flags
If unexpected hemolysis indications recur across appropriate specimens despite normal external conditions, remove the analyzer from service.
Do not attempt internal optical, sensor, calibration, or fluidic adjustments without approved service documentation.
Expected outcome: A possible detection-system, cartridge, software, or internal analytical issue is escalated appropriately.
If the Problem Persists
Specimen handling, sample device, inlet condition, cartridge recognition, and general analyzer quality status have been evaluated. Persistent unexpected hemolysis indications may involve the detection system, cartridge, internal optics or sensors, fluidics, software, or another service-level condition.
The analyzer should be:
- Removed from service
- Labeled Out of Service
- Sent for repair or bench evaluation
- Evaluated using appropriate Werfen documentation and approved test equipment
- Repaired or configured only by qualified personnel
Complete required QC and functional verification before restoring clinical use.
Knowing when a sample-quality flag may reflect a technical problem and stopping patient testing is proper troubleshooting.
Clinical Use Tip
Treat unexpected hemolysis indications as a patient-result integrity concern first, not simply as an analyzer nuisance message.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Clinical staff reported repeated unexpected hemolysis flags on multiple specimens analyzed on the GEM Premier 7000."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found dried contamination around the accessible sample inlet while analyzer quality status was otherwise acceptable."
Resolution
What action was taken.
Example:
"Cleaned the inlet using the approved method, completed required analyzer verification without recurrence of the unexpected flag, and returned the analyzer to service."
Helpful Details to Include (If Known)
- Exact hemolysis message or flag
- Number of affected specimens
- Whether multiple patients were involved
- Specimen appearance
- Collection device used
- Sample inlet condition
- GEM PAK status
- Analyzer QC status
- Results following recollection or verification
- Final analyzer status
Final Thought
Unexpected hemolysis indications require attention to both specimen quality and analyzer performance. Verify collection-related factors and external analyzer conditions first, avoid overriding uncertain results, and escalate recurring detection problems with clear documentation.
That is successful troubleshooting.