Overview
Error investigation gathers facts after a molecular quality failure. Corrective action contains the hazard, corrects affected results, and addresses causes to reduce recurrence. Contamination events are a high-yield Module 6 capstone pattern.
Classification
| Phase | Focus |
|---|---|
| Hold | Stop related pending releases |
| Contain | Unidirectional discipline; zone protection |
| Trace | Lots, runs, instruments, operators, controls |
| Correct | Clean/decontaminate; amend/retract per SOP |
| Prevent | Retrain, redesign, monitor as required |
Morphologic Features
Not applicable, this entry covers molecular error response, not morphologic identification.
Laboratory Characteristics
- Unexpected positives + bad negative control raise contamination concern
- Never move post-amp materials into pre-amp areas during cleanup
- Resume testing only after SOP restart criteria
- CAPA naming varies, follow institutional procedure
Reference Intervals
Not applicable as a numeric interval. Restart and acceptability criteria after corrective action are defined by laboratory SOP.
Clinical and Laboratory Significance
Until containment and investigation are complete, related molecular results, especially unexpected detected calls, must not be treated as trustworthy clinical answers.
Differential Considerations
Differentiate true target detection from contamination, reagent lot failure, documentation/transcription error, and control-system failure using traceability and control review, do not guess under clinical pressure.
Comparison Tables
Capstone response checkpoints
| Event clue | Safe response | Unsafe shortcut |
|---|---|---|
| Post-amp into pre-amp traffic | Hold + contain + investigate | Keep testing in contaminated clean zone |
| Weak signal in negative control | Treat as validity/contamination alert | Authorize patient positives anyway |
| Partial lot documentation | Widen hold until trail clarified | Assume only one specimen affected |
Classification Frameworks
Not applicable . WHO disease classifications do not define molecular laboratory corrective-action worksheets.
Laboratory Notes
- Hold → contain → trace → correct → prevent
- Contamination response is Module 6 capstone behavior
- Use corrective-action exercises and Module 6 assessment for practice
References
Authoritative textbooks, guidelines, and reviews supporting this reference entry. Verify reference intervals, critical limits, and reflex criteria against institutional protocols and current guideline editions.
Textbooks
- McPherson RA, Pincus MR. Henry's Clinical Diagnosis and Management by Laboratory Methods. 24th ed. Elsevier; 2021. (Molecular diagnostics chapters, verify current edition.)
- Buckingham L. Molecular Diagnostics: Fundamentals, Methods, and Clinical Applications. 3rd ed. F.A. Davis; 2019. (Verify current edition.)
CLSI and Professional Guidelines
- Clinical and Laboratory Standards Institute (CLSI). Consult current CLSI molecular method documents available through your laboratory, document numbers and editions change; do not treat any single CLSI title as universal.
- Institutional molecular laboratory SOPs, assay manufacturer instructions for use (IFU), and locally adopted accreditation requirements. Always verify current local practice.
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