Training activity information
Details
Assist in the preparation and take part in ISO surveillance visit for solid cancers
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.
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 your understanding of the ISO 15189 standard and its relevance to a diagnostic genomic service for solid cancers?
- Are you familiar with the key quality management system documentation (e.g., SOPs, quality manuals, records) that might be reviewed during a surveillance visit?
- What are some common areas of focus for ISO surveillance visits in a molecular diagnostics laboratory?
- What is your role likely to be during the preparation and the visit itself?
- Consider potential challenges you might face in explaining laboratory processes or demonstrating compliance with ISO requirements.
- Review relevant quality management system documentation and understand the processes related to solid cancer genomic testing.
- Consider potential questions that the assessors might ask and how you can prepare informative responses.
- Reflect on the importance of maintaining quality standards for patient safety and service delivery.
In action
- Pay attention to your actions. How are you contributing to the preparation process (e.g., reviewing documentation, preparing evidence)? What are you doing during the surveillance visit itself (e.g., answering questions, demonstrating procedures)? Why are you highlighting specific aspects of the service’s quality management system? What decisions are you making about how to present information to the auditors? What aspects of ISO preparation and participation feel intuitive, and what requires more conscious effort (e.g., understanding the rationale behind specific standards)?
- How effective are the preparation activities in demonstrating compliance with ISO standards? What challenges are you observing or experiencing during the surveillance visit (e.g., unexpected questions, areas of non-compliance being identified)? What can you learn about quality management systems and ISO standards as you participate in this process? How does this activity connect to the overall quality and safety of the diagnostic service?
- Are there alternative ways you could be presenting information or responding to auditor questions to ensure clarity and accuracy? Do you need to seek clarification on specific ISO requirements or audit findings at this moment? Are you ensuring that your contributions align with the laboratory’s quality policies and procedures?
On action
- What did you notice during the preparation for and participation in the ISO surveillance visit for solid cancers? Summarise the key areas of focus for the audit and the process of the visit.
- What did you learn about the requirements of ISO 15189 standards and their application within a diagnostic laboratory setting? How does the ISO surveillance process contribute to maintaining quality and patient safety? Were there any specific findings or areas of discussion that stood out? What did you learn from these? Did any questions you asked or contributions you made during the preparation or the visit itself
- What areas for further learning or involvement in quality management processes have you identified? How can you apply the learning from this activity to your future practice? What actions will you take to enhance your understanding of quality assurance, and what opportunities to be involved in audits or quality improvement initiatives would be beneficial?
Beyond action
- Have you revisited your reflections on the ISO surveillance visit? How has your understanding of quality management systems and regulatory requirements in a diagnostic laboratory evolved since this experience?
- Revisit your reflections from this DTA, what key learning or actions related to ISO standards and laboratory quality management are now more significant?
- Reflect on any subsequent involvement you have had with quality management activities in the lab. How did your experience with the ISO visit inform your approach?
- How has this experience impacted your current practice in adhering to laboratory protocols and quality procedures? Are you more aware of the importance of documentation and compliance?
- How has your understanding of ISO 15189 and quality management systems developed since this activity?
- How might your experience with the ISO surveillance visit contribute to your future practice, ensuring that you work within a quality-focused and compliant environment?
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 4 |
Outcome
Interpret QC data including bioinformatic and NGS quality metrics in relation to assay performance, EQA and ISO:15189 standards. |