Training activity information
Details
Validate and verify a test using a new reagent
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
- Introduction of new tests including normal ranges, cost, controls and volume
- Local SOPs
- End to end testing, including reproducibility, linearity, accuracy, and measurement of uncertainty
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 prior knowledge of validation and verification processes is required?
- What do you expect to learn about the specific steps involved in validating or verifying a new reagent and the criteria for acceptance? What is your current understanding of the difference between validation and verification?
- How will you prepare for this activity (e.g., reviewing validation protocols, understanding performance characteristics)?
- What challenges might you encounter during the validation/verification process (e.g., unexpected results, stability issues), and how might you address them?
- What are your initial thoughts and feelings about validating a new reagent?
In action
- What stages of the validation/verification process are you currently undertaking? Are you adhering to the established protocol?
- As you run controls and patient samples with the new reagent, are the results aligning with expectations? If not, what immediate adjustments or investigations are you considering?
- Are you encountering any issues with reagent handling or analyser compatibility? How are you addressing these in the moment?
- Are you comparing the new reagent’s performance with the old reagent as you proceed?
- What immediate conclusions are you drawing?
On action
- What were the specific performance characteristics (e.g., accuracy, precision, sensitivity, specificity) that were assessed during the validation or verification process?
- What samples or controls were used to evaluate the new reagent?
- What were the results obtained for each of the performance characteristics tested?
- How did these compare to the expected values or acceptance criteria?
- Were there any challenges or unexpected findings during the validation or verification process?
- What is the difference between test validation and test verification?
- When is each required?
- Why is it essential to validate or verify a test when introducing a new reagent?
- What are the potential risks if this is not done?
- What are the key performance characteristics that need to be considered when evaluating a new reagent?
- What acceptance criteria are typically used to determine if a new reagent is performing adequately?
- How will this experience inform your approach to validating or verifying new tests or reagents in the future?
- What documentation is required for test validation and verification?
- How will you ensure that a validated or verified test continues to perform as expected in routine use (e.g., through quality control)?
Beyond action
- Have you been involved in other validation or verification processes since this training activity, perhaps for different tests or reagents? How did those experiences compare?
- Have you looked back at your reflect-on-action notes from this training activity? What aspects of the validation/verification process do you now understand more deeply?
- Can you identify instances in your current practice where understanding the principles of test validation and verification is important?
- Have you discussed test validation or reagent verification with colleagues? Did these discussions offer new perspectives on the process?
- Has this training activity enhanced your understanding of the regulatory requirements and quality standards related to laboratory testing? Do you now have a greater appreciation for the importance of validation and verification in ensuring the reliability and accuracy of patient results?
- Has this experience influenced how you interpret information provided by reagent manufacturers? Have the skills learned in planning, performing, and analysing data for validation/verification been useful in other areas of your work?
- How will your experience with test validation and reagent verification equip you for future roles that may involve implementing new tests or procedures?
- Will your understanding of these processes enable you to contribute more effectively to quality improvement initiatives within the laboratory?
- How might this experience support your development as a senior scientist or specialist with responsibility for maintaining test quality?
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 1 |
Outcome
Identify appropriate clinical and laboratory investigations for the investigation of haemostasis. |
| # 7 |
Outcome
Perform quality assurance and control tasks across the range of investigations. |