Training activity information
Details
Carry out validation or re-validation for a piece of equipment used in the preparation/testing of samples for immunohistochemistry and/or molecular testing, report results and make recommendations for remedial actions where required
Type
Developmental training activity (DTA)
Evidence requirements
Evidence the activity has been undertaken by the trainee​.
Reflection on the activity at one or more time points after the event including learning from the activity and/or areas of the trainees practice for development.
An action plan to implement learning and/or to address skills or knowledge gaps identified.
Considerations
- Local SOPs
- Quality management system
- Communication with the colleagues
- Role of the quality manager
- Escalation of issues
- Sensitivity, specificity and accuracy with regard to UKAS requirements
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 specific aspect of validation or re-validation will this activity focus on (e.g., sensitivity testing, specificity testing, new equipment installation)?
- What is the specific equipment you will be working with? Do you have a good understanding of its function and operation?
- Are you familiar with the standard operating procedures (SOPs) for validation/re-validation and for using this equipment?
- What are the acceptance criteria or performance standards that need to be met during the validation/re-validation process?
- What regulatory guidelines (if any) are relevant to the validation of this type of equipment in immunohistochemistry and molecular pathology?
- What specific insights do you hope to gain into the process of equipment validation/re-validation?
- How do you expect this activity to enhance your understanding of quality control in the lab?
- What practical skills in data collection, analysis, and reporting do you hope to develop?
- Discuss the validation/re-validation process with your training officer or a senior colleague to clarify expectations and procedures.
- Review relevant SOPs, equipment manuals, and any previous validation reports for this or similar equipment.
- Consider potential challenges you might face during the process (e.g., unexpected results, equipment malfunctions) and think about how you might handle them.
In action
- Are you following the validation protocol precisely? Are there any deviations, and if so, why?
- What observations are you making about the equipment’s performance during the process?
- What potential issues are you anticipating based on the data you are collecting?
- Are you adapting your approach based on the initial results you are seeing?
- While analysing the results and formulating recommendations:
- How are you interpreting the data in real-time? What immediate conclusions are you drawing?
- What remedial actions are you considering, and what is your reasoning for these choices?
On action
- What were the key steps involved in the validation/re-validation process?
- What were the main findings from the data you collected?
- What recommendations for remedial actions did you make?
- What did you learn about the specific piece of equipment and its performance?
- How did the actual results compare to what you expected?
- Were there any surprises?
- What challenges did you encounter during the validation/re-validation, and how did you address them?
- How effective do you think your recommendations for remedial actions will be?
- What aspects of the validation/re-validation process will you approach differently in the future?
- What further knowledge or skills do you need to develop in equipment validation?
- What resources or guidelines will you refer to in future validation tasks?
Beyond action
- How have your subsequent experiences with other equipment validation or re-validation processes, either in this module or others, influenced your perspective on the effectiveness of the validation/re-validation you performed in this DTA?
- Considering your current understanding of laboratory quality management and UKAS accreditation, how do you now evaluate the significance of the remedial actions you recommended at the time?
- In retrospect, how did this DTA contribute to your broader understanding of maintaining equipment functionality and ensuring the reliability of diagnostic testing within the histopathology service?
- Have you encountered situations where the learning from this validation/re-validation activity helped you troubleshoot issues with other laboratory equipment? If so, how?
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 1 |
Outcome
Evaluate equipment and methods used in immunohistochemistry and molecular pathology to ensure the continued delivery of an effective histopathology service. |