Training activity information
Details
Perform a validation or verification of a diagnostic assay or method and draft a report for laboratory approval
Type
Entrustable training activity (ETA)
Evidence requirements
Evidence the activity has been undertaken by the trainee repeatedly, consistently, and effectively over time, in a range of situations. This may include occasions where the trainee has not successfully achieved the outcome of the activity themselves. For example, because it was not appropriate to undertake the task in the circumstances or the trainees recognised their own limitations and sought help or advice to ensure the activity reached an appropriate conclusion.
Reflection at multiple timepoints on the trainee learning journey for this activity.
Considerations
- Quality assurance
- Health and safety
- Local, national, international and manufacturer guidelines
- Selection of appropriate methodology
- Requirements for ethical approval and use of patient data/samples
- Adaptation to local equipment and workflows
- Workflow analysis and process mapping
- Statistical methods for performance characterisation, including specificity, sensitivity, and predictive values
- Documentation
- Approval processes
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 6 |
Outcome
Evaluate assay performance according to quality assurance frameworks |