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.
Reflective practice guidance
The guidance below is provided to support reflection at different time points, providing you with questions to aid you to reflect for this training activity. They are provided for guidance and should not be considered as a mandatory checklist. Trainees should not be expected to provide answers to each of the guidance questions listed.
Before action
- Identify what is expected of you when performing a validation or verification and drafting the report.
- Explore any relevant considerations for validation/verification processes or report drafting in local procedures.
- Discuss with your training officer to gain clarity on the specific assay or method to be validated/verified, the scope of the validation/verification, the required data, and the expected format/content of the report.
- Think about what you already know about the principles of validation and verification, the types of parameters evaluated (e.g., sensitivity, specificity, precision), and the requirements for quality assurance frameworks. Have you ever drafted a technical report before?
- Consider possible challenges you might face, such as experimental design for validation, data collection, statistical analysis, interpreting acceptance criteria, or structuring the report. How might you plan to handle these?
- Do you know when you will need to seek advice or help, particularly regarding experimental design, data analysis, or seeking laboratory approval?
- Consider the specific skills you want to develop related to designing validation/verification experiments, performing the necessary tests, analysing the data, interpreting results against predefined criteria, and writing a clear, concise report for approval. Draw upon previous experiences, if any, that inform these learning goals.
- Identify specific insights you hope to gain about the practical application of quality assurance principles in the laboratory setting.
- Consult actions identified following any previous experience you have had with similar quality control or evaluation processes.
- Identify important information you need to consider before embarking on this activity, such as accessing the specific assay protocol, understanding the relevant validation/verification guidelines (local or national), identifying who needs to approve the report, and setting a realistic timeline.
In action
- As you plan or perform the experiments for the validation or verification, does anything surprising happen (e.g., unexpected variability in results, difficulty obtaining or preparing samples, equipment not performing as expected, unexpected data points)?
- When you are analysing the data or applying statistical methods, do you encounter anything different from what you anticipate (e.g., difficulty interpreting results against acceptance criteria, challenges with statistical software or methods)?
- While drafting the validation/verification report, do you face any surprising difficulties (e.g., structuring the report, presenting complex data, finding appropriate reference material)?
- During any informal review of your work (data or draft report), do you receive unexpected feedback or questions?
- In that moment, how do you respond when something unexpected happens during the experiment, data analysis, or report drafting? Do you pause to reconsider? Do you seek immediate advice? How do you feel about adapting your plan?
- Do you adjust your experimental approach, data analysis method, or report structure on the spot?
- Do you consider if this unexpected event highlights a need to seek advice or confirms you are working within your scope of practice (e.g., knowing when to escalate or seek clarification before proceeding)?
- Are you able to address the unexpected situation and continue with or complete the validation/verification experiments and report drafting?
- What do you learn in that moment about the practicalities of assay validation/verification, data interpretation, or technical report writing?
- Do you work within your scope of practice when reacting to the unexpected issue, particularly concerning the process for drafting the report for laboratory approval?
On action
- Summarise the key points of the experience of performing the validation or verification experiments, analysing the data, and drafting the report for laboratory approval.
- Consider specific steps, actions, or interactions during the activity that felt important (e.g., designing the experiment, collecting data, interpreting results against acceptance criteria, structuring the report).
- Include your own feelings during the experience (e.g., about the complexity of the process, confidence in data analysis, challenges in writing).
- Include any reflect-in-action moments, where you adapted your plan or approach as the activity unfolded (e.g., adjusting an experimental detail, changing how you presented data).
- Identify what learning you can take from this experience regarding the process of assay validation/verification, data analysis for this purpose, and drafting technical reports for laboratory approval.
- What strengths did you demonstrate during this activity (e.g., in experimental design, data handling, technical writing)?
- What skills and/or knowledge gaps were evident to you (e.g., understanding specific statistical methods, interpreting complex validation data, meeting regulatory requirements for reports)?
- Compare this experience against any previous engagement with validation, verification, or technical report writing. Were any previously identified actions for development achieved? Has your practice improved?
- Identify any challenges you experienced (e.g., obtaining required samples, unexpected results, difficulties with report structure or content) and how you reacted to these. Did this affect your ability to deal with the situation? Were you able to overcome the challenges?
- Identify anything significant about the activity. Did you need to seek advice or clarification (e.g., on acceptance criteria, data interpretation, report format)? Or did you need to escalate to ensure that you were working within your scope of practice, particularly concerning the approval process?
- How does performing this training activity contribute to your development towards being able to evaluate assay performance according to quality assurance frameworks?
- Identify the actions or ‘next steps’ you will now take to support the assimilation of what you have learnt, including from any feedback you received (e.g., on your report draft or experimental design).
- What will you do differently next time you perform a validation/verification or draft a report for approval?
- Has anything changed in terms of what you would do if you were faced with a similar unexpected situation again during a validation process?
- Do you need to practise any aspect of the activity further to improve your proficiency and confidence towards being entrusted with performing validations/verifications and drafting reports independently?
Beyond action
- Evaluate and re-evaluate your previous experiences of performing validation or verification studies and drafting reports. What were your initial understandings of the process, the challenges in experiment design or data analysis, or difficulties in structuring the report? How has your grasp of these elements deepened with subsequent experiences?
- Review your actions from your previous reflections for this activity. What specific steps did you plan to take to improve your approach to experimental design, data interpretation against criteria, or report writing following earlier attempts? Have you actively implemented these changes in later validation/verification work? Are you consistently applying improved methods now?
- Engage in professional storytelling with peers, training officers, or colleagues about the validation/verification process or report writing. Discuss the rationale behind specific acceptance criteria or challenges in presenting complex data. Consider if discussing these experiences has refined your understanding or approach.
- Consider how the learning from undertaking this training activity multiple times, including your reflections, has contributed to skills relevant to other areas of your training. For example, how has your experience in critically evaluating assay performance informed your understanding of quality assurance when interpreting results in other training activities in this module?
- How does your experience with this training activity contribute to preparing you for presenting validation or verification results to an internal meeting?
- Consider how your overall practice in understanding and applying quality assurance principles and conducting technical evaluations has developed and evolved over time. Do you feel more equipped to critically assess the performance of different assays encountered in the laboratory? Has your ability to identify when external expertise might be needed during a validation process improved?
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 6 |
Outcome
Evaluate assay performance according to quality assurance frameworks |