Training activity information
Details
Assist in the preparation and take part in ISO surveillance visit for haematological malignancies
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 do you know about the key requirements of ISO:15189 relevant to haematological malignancies?
- What are the typical focus areas of an ISO surveillance visit in a cancer genomics laboratory? What documentation and processes might be reviewed?
- What is your role in assisting with the preparation and during the visit itself?
- What are some common findings or non-conformities identified during such visits?
- How can you contribute to maintaining and improving quality management systems? What is the role of surveillance visits in ensuring ongoing compliance?
- Discuss with the quality manager or relevant colleagues the scope and focus of the upcoming surveillance visit.
- Review relevant quality management system documents, such as SOPs and audit reports.
- Consider potential questions the auditors might ask and how you would respond based on your understanding of the laboratory’s processes.
- Think about how you can actively participate in the visit and demonstrate your understanding of quality standards.
In action
- Pay attention to your actions during the preparation (e.g., gathering documents, reviewing procedures, addressing potential audit questions). Why are you prioritising these tasks? During the visit, how are you responding to auditor questions or demonstrating adherence to procedures?
- What decisions are you making in the moment regarding what information to provide to the auditors or how to demonstrate compliance?
- How effectively are the preparation activities addressing the anticipated scope of the audit? During the visit, how well are you demonstrating your understanding of and adherence to relevant ISO standards?
- What challenges are you facing in gathering the necessary information or articulating your understanding of the quality system?
- What are you learning about the practical application of ISO:15189 standards in the laboratory as you participate in this activity?
- Are there alternative ways to present evidence of compliance or explain a particular process to the auditors?
- What support or clarification might you need from colleagues or the quality manager during the preparation or the visit itself?
On action
- What were the key areas of focus during the ISO surveillance visit? What documentation or processes were reviewed? What were the strengths and areas for improvement identified during the visit (if any)?
- How has your understanding of ISO:15189 accreditation and compliance in a laboratory setting improved? What did you learn about the preparation process for an ISO surveillance visit? How did participating in the visit enhance your awareness of quality management systems and their importance in haematological malignancies testing? What did you learn about the specific standards and requirements relevant to your work area?
- What specific ISO standards or quality management processes do you need to understand in more detail? How will you apply your learning to ensure your work practices align with ISO requirements? What actions will you take to further your understanding of quality assurance and accreditation in the laboratory? What resources or training would be beneficial for your continued development in this area?
Beyond action
- Have there been subsequent ISO audits or surveillance visits in your department? Were the findings similar or different?
- Have you had opportunities to review the outcomes of other quality audits or participate in quality improvement initiatives? How does this relate to your experience of the ISO visit?
- How has your awareness of ISO:15189 standards influenced your daily work practices and attention to quality control?
- Has this experience made you more proactive in identifying and addressing potential quality issues in the laboratory?
- How has this activity contributed to your understanding of the importance of documentation and adherence to protocols?
- How will you continue to contribute to maintaining and improving quality standards in your future role?
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 4 |
Outcome
Analyse, interpret and prepare interpretive reports for common haematological malignancies, including results for somatic variants, clonality, and somatic hypermutation. |
| # 5 |
Outcome
Interpret the associated IQC and EQA of the laboratory tests for investigation of haematological malignancies. |
| # 6 |
Outcome
Practice with the relevant specialties for the diagnosis, monitoring and management of haematological malignancies. |
| # 8 |
Outcome
Apply the standards of ISO:15189 accreditation and compliance including root cause analysis (RCA) and verfication/validation requirements for cancer genomics. |