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What This Guide Helps With
Troubleshooting calibration or QC failures caused by strips, controls, handling, analyzer setup, environment, or maintenance conditions.
Step-by-Step Troubleshooting
Ensure Patient Safety First
Confirm the CLINITEK Novus is not being used to report active patient results while calibration or QC is failing.
If patient testing is needed, have the lab use another validated analyzer or follow approved downtime procedures.
Expected outcome: Patient results are not reported from an analyzer with unresolved calibration or QC concerns.
Verify the Reported Failure
Ask laboratory staff what specifically failed.
Confirm whether the issue involves:
- Calibration failure
- QC failure
- Abnormal QC recovery
- QC lockout
- Failed calibration check
- Lot-related QC issue
- Repeated failures after maintenance or reagent change
Expected outcome: The failure type and timing are clearly identified before troubleshooting continues.
Check Whether the Failure Affects One Level or All Levels
Review which QC level failed and which analyte or chemistry pad was abnormal.
If only one QC level or one analyte failed, suspect control material, strip handling, lot setup, or sample application first.
If all QC levels or many analytes failed, suspect strip lot setup, calibration, environmental conditions, instrument readiness, or analyzer contamination.
Expected outcome: The failure pattern helps separate operator/material issues from analyzer-related issues.
Confirm Correct Reagent Strips Are Being Used
Verify the reagent strips are approved for use with the CLINITEK Novus configuration.
Check the strip bottle, lot number, expiration date, and open-vial dating.
Confirm the strip container cap has been kept closed and the strips have not been exposed to moisture, heat, cleaning chemicals, or prolonged room air.
Expected outcome: Expired, damaged, or incompatible strips are ruled out.
If replacing the strip bottle resolves the issue, document the failed lot or bottle condition and stop.
Verify QC Material Condition
Confirm the QC material is the correct type for the analyzer and reagent strip method.
Check the QC lot number, expiration date, open-vial stability, storage requirements, and whether the control was mixed or prepared according to lab procedure.
Look for signs of contamination, improper storage, evaporation, or use of the wrong control level.
Expected outcome: QC material problems are ruled out before suspecting the analyzer.
If new QC material passes, remove the suspect control from use and stop.
Confirm Lot Setup and QC Ranges
Verify the reagent strip lot and QC lot are correctly entered or selected in the analyzer or associated data management system.
Confirm the expected QC ranges match the current reagent and control lots.
Expected outcome: The analyzer is comparing QC results against the correct lot-specific ranges.
If correcting the lot setup resolves the failure, document the setup error and stop.
Check Operator Technique
Observe the QC process if possible.
Confirm the strip is handled correctly, dipped or applied properly, excess fluid is removed according to lab procedure, and the strip is loaded without delay or misalignment.
Expected outcome: Timing, saturation, carryover, and placement errors are ruled out.
If retraining or correct technique resolves the issue, return the analyzer to service after acceptable QC per lab policy.
Inspect the Strip Loading and Transport Area
Stop testing and inspect the accessible strip loading area for dried urine, QC fluid, reagent residue, dust, paper fibers, broken strip pieces, or other obstruction.
Clean only external and user-accessible areas using facility-approved cleaning procedures.
Expected outcome: The strip path is clean and free of contamination that could affect positioning or reading.
Check Analyzer Readiness and Startup Condition
Restart the analyzer if safe and permitted by lab workflow.
Confirm it completes startup, self-check, initialization, and any required readiness checks without errors.
Expected outcome: The analyzer is starting normally and not reporting a separate mechanical, optics, waste, or system fault.
If startup errors occur, troubleshoot those first or remove the device from service.
Verify Calibration Workflow Requirements
Confirm whether calibration is due, overdue, failed, or required after a lot change, maintenance action, software prompt, or analyzer reset.
Follow the facility’s approved calibration workflow and do not bypass required calibration or QC lockouts.
Expected outcome: Calibration is performed only when required and under proper conditions.
Check Environmental Conditions
Confirm the analyzer is on a stable, level surface away from direct sunlight, vibration, excessive humidity, splashes, drafts, heat sources, or chemical fumes.
Urine chemistry strips and optical readers can be sensitive to moisture, lighting, contamination, and unstable placement.
Expected outcome: Environmental conditions are suitable for reliable strip reading and QC recovery.
Review Recent Changes
Ask whether any of the following occurred before the failure:
- New reagent strip lot
- New QC lot
- Analyzer moved
- Recent cleaning or spill
- Software/settings change
- Power interruption
- LIS or middleware configuration change
- New operator or workflow change
Expected outcome: A recent change may point to the most likely cause.
Repeat QC Only After Corrective Action
Do not repeatedly run QC without changing something meaningful first.
After correcting a suspected external cause, have the lab repeat QC according to policy.
Expected outcome: QC either passes after corrective action or continues to fail despite external checks.
Check for Related Error Messages
Review the analyzer display, event log, or user-reported messages for optics, strip positioning, transport, waste, barcode, temperature, or calibration-related errors.
Expected outcome: Any related fault is identified and documented for repair evaluation.
Determine Final Device Status
If calibration and QC pass after correcting an external issue, return the analyzer to service according to lab policy.
If calibration or QC continues to fail after strips, controls, lot setup, technique, environment, and accessible cleaning have been checked, remove the device from service.
Expected outcome: The analyzer is either safely returned to service or escalated appropriately.
If the Problem Persists
If calibration or QC failure continues after common external causes have been ruled out, the issue may involve internal optics, strip sensing, transport alignment, calibration hardware, software, or analyzer performance.
The CLINITEK Novus should be:
- Removed from service
- Labeled Out of Service
- Sent for repair, vendor service, or bench evaluation
Knowing when to stop is proper troubleshooting. Do not keep running patient samples on a urine analyzer that cannot pass required calibration or QC checks.
Clinical Use Tip
Do not troubleshoot calibration or QC failure while the analyzer is being used for active patient testing. Move patient testing to another validated analyzer or approved backup process first. QC and calibration failures directly affect result reliability, so the safest action is to stop patient reporting until the issue is resolved.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Laboratory staff reported the CLINITEK Novus failed urine chemistry QC and would not release patient testing."
Cause
What was observed during troubleshooting.
Example:
"Troubleshooting found expired QC material was being used with the current reagent strip lot."
Resolution
What action was taken.
Example:
"Replaced QC material with an in-date bottle, verified correct lot setup, QC passed per lab policy, and the analyzer was returned to service."
Helpful Details to Include (If Known)
- QC level or analyte that failed
- Alarm behavior, calibration message, or failure code
- Reagent strip lot and expiration date
- QC material lot and expiration date
- Accessories, strip bottle, or QC material swapped
- Power behavior, startup, or self-check behavior
- Environmental factors or concerns noted
- Indicator lights, display messages, or related error messages present
- Open-vial dates checked
- Lot setup verified
- Operator technique observed
- Strip loading area inspected
- Cleaning performed
- Whether QC passed after corrective action
- Final device status
Final Thought
Calibration and QC failures should be handled with patient safety first and a logical external-first approach. Strips, controls, lot setup, handling, environment, and accessible contamination should be checked before assuming internal analyzer failure. If the CLINITEK Novus still cannot pass required checks, removing it from service and documenting the troubleshooting clearly is the correct Clinical Engineering response.
That is successful troubleshooting.