Training activity information
Details
Undertake validation of the following:
- H&E stain
- Special stain
- Immunohistochemical stain
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
- Local SOPs
- RCPath tissue pathways
- Standards for accreditation
- Quality management system
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
What does success look like?
- Identify what is expected of you in relation to validating staining methods.
- Review the learning outcomes related to practicing safely in accordance with quality management and evaluating equipment and methods.
- Success means conducting validation experiments correctly, collecting and analysing data, and determining if the staining method meets predefined quality criteria.
- Discuss with your training officer to gain clarity of what is expected, focusing on the specific validation protocol, acceptance criteria, and documentation requirements.
What is your prior experience of this activity?
- Think about your previous exposure to validation processes, quality management principles, or data analysis. Have you participated in or observed validation activities before?
- Consider possible challenges you might face, such as understanding complex validation protocols, collecting sufficient and reliable data, or interpreting statistical analysis. Think about how you might handle these challenges.
- Recognise the scope of your own practice in conducting validation; know when and from whom you will need to seek advice or help, particularly regarding experimental design, data analysis, or interpretation of results.
- Acknowledge how you feel about embarking on this activity, especially if validation is a new concept or seems technically challenging.
What do you anticipate you will learn from the experience?
- Consider the specific skills you want to develop, such as designing validation experiments, performing validation runs, analysing and interpreting validation data, and documenting the validation process.
- Identify the specific insights you hope to gain into the principles of quality management, method validation, and their importance for ensuring accurate and reliable diagnostic results.
What additional considerations do you need to make?
- Consult actions identified following previous experiences related to quality control or method evaluation.
- Identify important information you need to consider before embarking on the activity, such as reviewing the specific validation protocol being used, understanding the rationale behind the acceptance criteria, and identifying who can provide guidance on the process.
In action
Is anything unexpected occurring?
- Are you noticing anything surprising or different from what you anticipate whilst performing the validation runs or assessing the data?
- Are you encountering situations such as:
- Unexpected results or inconsistencies are present across multiple validation runs, requiring immediate investigation e.g., the staining intensity varies significantly across control slides
- The validation process for this specific stain (H&E, Special, or IHC) feels challenging, leading you to question the validation criteria
How are you reacting to the unexpected development?
- How is this impacting your actions? For example, are you responding to the situation appropriately? Are you adapting or changing your approach to the experimental design?
- Consider the steps you are taking in the moment, such as:
- Immediately prioritising the criteria that appear to be failing for assessment
- Making real-time decisions about repeating a run or adjusting parameters e.g., changing incubation time or reagent concentration
- Documenting your observations and decisions meticulously in the validation log
- How are you feeling in that moment? For instance, are you finding it difficult to maintain objectivity when results are inconsistent? Is it affecting your confidence in making a clear decision about the method’s fitness for purpose?
What is the conclusion or outcome?
- Identify how you are working within your scope of practice. For example, are you successfully collecting and analysing the data according to the validation protocol? Or are you needing support because the inconsistency requires specialist interpretation to determine if the stain is acceptable?
- Identify what you learnt as a result of the unexpected development. For example, are you mastering the technique for interpreting validation data? Or gaining insight into the criticality of acceptance criteria for quality management?
On action
What happened?
- Begin by summarising the process of undertaking the validation for the specific stain(s) you were evaluating (H&E, Special, and/or IHC).
- Describe the data collected, the results obtained, and the conclusion reached regarding the validation.
- Consider specific observations or findings that felt important during the validation.
- Include any ‘reflect-in-action’ moments where you made immediate decisions about repeating runs, adjusting parameters, or investigating unexpected results during the process.
How has this experience contributed to your developing practice?
- Identify what learning you can take from the experience. What did you learn about the specific validation criteria and process for the stain(s) you evaluated?
- How did this experience enhance your ability to analyse validation data, identify issues, and determine suitability for clinical use?
- What strengths did you demonstrate e.g., meticulous execution or objective analysis? What skills or knowledge gaps were evident, particularly regarding validation principles or data analysis?
- Identify any challenges you faced e.g., inconsistent results, interpretation difficulty and how you reacted. Did you need to seek advice or clarification regarding the protocol, results, or conclusion? What was the outcome?
What will you take from the experience moving forward?
- Identify the actions / ‘next steps’ you will now take to support the assimilation of what you have learnt, including from any feedback you have received on your ability to undertake all the validation techniques specified.
- What specific aspects of the validation process will you approach differently or pay closer attention to next time?
- Do you need to practise any aspect of the activity further, such as reviewing general validation principles, statistical methods, or specific stain validation requirements?
Beyond action
Have you revisited the experiences?
- How have your subsequent experiences undertaking further validations, reviewing validation processes, or dealing with quality issues related to stains, since completing this specific training activity led you to revisit your initial approach to validation during that activity?
- Considering your current understanding of quality management and accreditation standards and evaluating equipment and methods to ensure an effective service, were the actions or considerations you identified after your initial reflection on this training activity sufficient? How have you since implemented or adapted improvements in your understanding or application of validation processes based on further learning and experiences? For example, how participating in UKAS accreditation activities demonstrated the necessity of rigorous documentation, leading you to implement improvements in logging minor validation deviations.
- Has discussing validation challenges, findings, or the importance of validation with colleagues, peers, or supervisors changed how you now view your initial experience in this training activity?
How have these experiences impacted upon current practice?
- How has the learning from this initial training activity, in combination with subsequent experiences related to quality control and validation, contributed to your overall confidence and skill in practicing safely in accordance with quality management and accreditation standards and evaluating equipment and methods?
- How has reflecting back on this specific training activity, combined with everything you’ve learned since about quality assurance and validation, shaped your current approach to understanding and contributing to validation processes? How does this evolved understanding help you identify when something is beyond your scope of practice or requires escalation in relation to validation? For example, your evolved understanding means you proactively look for instances where existing methods need reviewing, recognizing that complex statistical analysis for validation is beyond your scope of practice and requires input from a senior quality officer.
- Looking holistically at your training journey, how has this initial experience, revisited with your current perspective, contributed to your development in meeting the learning outcomes related to practicing safely and evaluating methods?
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 4 |
Outcome
Practice safely in accordance with quality management and accreditation standards. |
| # 5 |
Outcome
Evaluate equipment and methods to ensure the continued delivery and development of an effective histopathology service. |