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What This Guide Helps With
Addresses unacceptable staining quality or QC results related to reagents, slides, racks, protocols, contamination, positioning, or equipment performance.
Step-by-Step Troubleshooting
1. Protect Patient Results and Stop Questionable Processing
Do not release or rely on staining performed during an unresolved QC failure. Follow laboratory procedures for affected slides and move testing to another verified process if necessary.
Expected outcome: Patient results are protected while the QC condition is investigated.
2. Confirm the QC Failure
Identify the specific QC material, staining protocol, batch, rack, station, and observed deficiency. Determine whether the failure is isolated or repeatable.
Expected outcome: The problem is clearly defined and linked to a specific workflow rather than treated as a generic stainer fault.
3. Review Reagent Identity and Placement
Verify that the correct reagents are installed in the correct stations and correspond to the intended staining protocol.
Expected outcome: Physical reagent placement matches the approved staining setup. If a placement error is corrected and QC passes, troubleshooting can stop after final verification.
4. Inspect Reagent Condition
Look for obvious contamination, unexpected appearance, depleted volume, incorrect replacement, or other visible condition that could affect staining performance. Follow laboratory policies regarding reagent suitability.
Expected outcome: Reagents used for QC are suitable and correctly prepared for the workflow.
5. Inspect Slides, Racks, and Carriers
Check for damaged racks, improper slide placement, contamination, or mechanical conditions that could prevent consistent reagent exposure or transfer.
Expected outcome: Slides and carriers are positioned correctly and are free of obvious external problems.
6. Review the Selected Staining Program
Verify that the intended user-accessible staining protocol or program was selected and that no unintended workflow change occurred.
Expected outcome: The configured workflow matches the laboratory-approved procedure.
7. Determine Whether the Problem Follows a Reagent, Rack, or Station
Where laboratory procedures permit, compare a known-good reagent lot, rack, or equivalent workflow condition.
Expected outcome: The comparison helps isolate whether the QC issue is associated with external materials or remains with the stainer.
8. Inspect Accessible Areas for Carryover or Contamination
Check accessible reagent and rack areas for spills, residue, or cross-contamination. Clean only according to approved procedures.
Expected outcome: Accessible staining areas are clean and suitable for operation.
9. Repeat QC According to Laboratory Procedure
After correcting any confirmed external cause, repeat the applicable QC process using appropriate control material.
Expected outcome: QC returns to the laboratory's acceptable range. The issue is resolved and troubleshooting can stop.
10. Escalate Persistent QC Failure
If QC remains unacceptable after reagents, racks, slides, workflow selection, and contamination have been ruled out, remove the stainer from clinical service.
Expected outcome: The equipment is routed for qualified evaluation rather than used for patient specimens with uncertain staining performance.
If the Problem Persists
Common external reagent, slide, rack, workflow, contamination, and setup causes have been ruled out. Remaining possibilities include internal movement, timing, temperature-control where applicable, sensing, software configuration, or another service-level performance issue.
Remove the device from service, label it Out of Service, and send it for repair or bench evaluation. Use appropriate manufacturer documentation and approved test equipment. Repairs or configuration changes should be performed only by qualified personnel.
Successful QC and required functional checks must be documented before return to service. Knowing when to stop external troubleshooting is proper troubleshooting.
Clinical Use Tip
Do not return a slide stainer to patient use based only on mechanical operation; acceptable staining QC must also be demonstrated when required.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Laboratory staff reported unacceptable staining QC results from the HistoCore SPECTRA ST."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering and laboratory staff found that a required reagent had been placed in the wrong staining station."
Resolution
What action was taken.
Example:
"The reagent was returned to the correct station, QC was repeated successfully, normal staining performance was confirmed, and the unit was returned to service."
Helpful Details to Include (If Known)
- QC material and staining protocol
- Nature of the staining defect
- Reagents and lots involved
- Physical reagent locations
- Rack and slide condition
- Program selected
- Known-good comparisons
- Cleaning performed
- QC result after correction
- Final device status
Final Thought
Protect patient results, investigate reagents and workflow before assuming equipment failure, require successful QC after correction, and escalate when acceptable staining performance cannot be demonstrated.
That is successful troubleshooting.