Training activity information
Details
Participate in a formal review of performance characteristics or perform a verification/validation of a procedure, for one assay involved in the investigation of the following:
- Immunodeficiency
- Immune response to pathogens
- Immune dysregulation
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
- Standard operating procedures (SOPs)
- Ongoing monitoring, review of trueness and uncertainty of measurement
- Verified to UKAS 15189 standard for use in a lab
- Verification vs validation of an assay under ISO15189 standard
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 is the difference between performance characteristics review of an assay and the initial verification or validation of that assay? What key performance characteristics need to be considered for an assay? What are the general steps involved in a verification or validation process?
- What do you anticipate learning about the performance characteristics of the chosen assay?? What challenges might you face in collecting and analysing data for performance characteristics or during verification/validation, and how will you address them?
- How will you prepare for this activity? Will you review guidance on assay verification and validation, discuss the chosen assay and its performance requirements with experienced staff, and familiarise yourself with the relevant documentation? What are your thoughts on the importance of assay verification and validation in the clinical laboratory?
In action
- During the review of performance characteristics or conducting of the verification/validation, are the results meeting the expected performance criteria? If not, what immediate actions are you considering?
- Which performance characteristics have the highest importance based upon the clinical purpose of the assay?
- Are there any unexpected findings or challenges arising during the process that are influencing your assessment of the assay’s performance?
On action
- Describe the assay for which you reviewed performance characteristics or conducted a verification/validation. What were the key performance characteristics examined? Did the assay meet the expected performance criteria? Were any limitations or areas for concern identified?
- How did this activity enhance your understanding of the principles and processes of assay verification and validation? What did you learn about the importance of demonstrating that an assay performs as intended in the clinical laboratory setting?
- How will you apply your understanding of performance characteristics and verification/validation to your future work with laboratory assays? What aspects of assay validation and quality control would you like to explore further? What resources or guidances are important to consider in assay verification and validation?
Beyond action
- Have you participated in other verification or validation activities since this DTA? How did this initial experience contribute to your understanding of the principles and processes involved?
- How has this DTA enhanced your understanding of the importance of ensuring the reliability and accuracy of laboratory testing?
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 4 |
Outcome
Practice in accordance with quality and accreditation standards, assess the performance of laboratory tests or procedures and take corrective action where required. |
| # 6 |
Outcome
Apply verification and validation procedures for diagnostic assays investigating immunodeficiency. |