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What This Guide Helps With
Troubleshoot unacceptable QC results caused by control material, handling, consumables, calibration state, contamination, environment, or analyzer performance.
Step-by-Step Troubleshooting
1. Protect Patient Testing and Confirm the QC Failure
Do not release patient results when required quality-control acceptance criteria are not met. Follow laboratory policy for affected patient results and redirect testing if necessary.
Document which QC material, level, and measured parameter are affected, without assuming the analyzer is defective.
Expected outcome: The exact QC failure is identified and patient testing is appropriately suspended or redirected.
2. Verify the QC Material
Confirm the control material is the correct product and level, is within its approved use period, and has been stored and handled according to applicable laboratory and manufacturer instructions.
Inspect for obvious contamination, leakage, damage, or improper preparation.
Expected outcome: The QC material is appropriate and usable. If a compromised control is identified, replace it before troubleshooting the analyzer further.
3. Repeat With Properly Prepared Control Material
Use fresh or known-good control material when appropriate and follow correct preparation, mixing, handling, and presentation practices.
Avoid repeatedly testing the same questionable aliquot.
Expected outcome: Known-good QC returns to the acceptable range. If so, the original control material or handling was the likely cause and troubleshooting can stop after confirming stability.
4. Verify Analyzer Calibration and Readiness
Confirm the analyzer shows an acceptable calibration state and no unresolved reagent, fluidics, temperature, or consumable condition.
Expected outcome: The analyzer is fully ready and calibrated. If resolving a readiness issue restores acceptable QC, perform final verification.
5. Check Reagents and Consumables
Inspect reagent and related consumable status, expiration, recognition, and seating. Consider whether the QC problem began after a recent consumable change.
Expected outcome: Required consumables are correct, in date, recognized, and properly installed. If replacing a suspect consumable restores QC, troubleshooting can stop after repeat verification.
6. Look for a Pattern in the QC Failure
Determine whether one parameter, one QC level, or multiple measurements are affected.
A broad shift may indicate a common analytical or consumable issue, while an isolated result may point toward control material, handling, or a parameter-specific analyzer condition.
Expected outcome: The failure pattern is defined and documented without assuming a specific internal component has failed.
7. Inspect Accessible Sampling Areas
Check the accessible sample inlet and surrounding surfaces for residue, dried blood, contamination, or another condition that could affect aspiration or sample integrity.
Perform only approved external cleaning.
Expected outcome: Accessible sampling areas are clean. If cleaning restores acceptable QC, repeat QC to confirm the correction.
8. Perform Final QC Verification
Repeat the required QC according to laboratory procedure after correcting an identified cause. Do not return the analyzer to patient use based on a single unexplained acceptable result if repeated failures have occurred.
Expected outcome: Required QC results are consistently acceptable and the analyzer is ready for patient testing.
If the Problem Persists
Control material, handling, consumables, calibration status, accessible contamination, and obvious environmental causes have been ruled out. Persistent QC failure may involve the analyzer's measurement system, internal fluidics, sensors, calibration control, temperature regulation, or another service-level issue.
The analyzer should be:
- Removed from service.
- Labeled Out of Service.
- Sent for repair or bench evaluation.
- Evaluated using appropriate Radiometer documentation and approved test equipment.
- Repaired or configured only by qualified personnel.
Do not adjust analytical values or service calibration parameters merely to bring QC into range. Complete required calibration and QC verification after repair.
Knowing when to stop external troubleshooting and escalate is proper troubleshooting.
Clinical Use Tip
When QC is unacceptable, treat the analyzer's patient results as potentially unreliable until acceptable analytical performance is re-established according to laboratory policy.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Laboratory staff reported that quality-control results on the Radiometer ABL90 FLEX PLUS were outside the laboratory's acceptable range."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering and laboratory staff isolated the problem to compromised QC material after known-good control material produced acceptable results."
Resolution
What action was taken.
Example:
"The affected control material was removed from use, fresh QC was run successfully, analyzer performance was verified, and the analyzer remained in service."
Helpful Details to Include (If Known)
- QC material and level
- Parameter or parameters affected
- Pattern of high, low, or inconsistent results
- Control storage and handling condition
- Fresh or known-good control comparison
- Calibration status
- Reagent and consumable status
- Recent consumable replacement
- Accessible contamination found
- QC results after correction
- Final device status
Final Thought
QC failure should trigger verification of the control material, handling, calibration, consumables, and sampling condition before assuming internal failure. Require repeatable acceptable performance and document the evidence supporting return to service.
That is successful troubleshooting.