Training activity information
Details
Review a recent UKAS visit in your department. Consider the preparation required, the findings and how the findings were cleared.
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 are the intended outcomes of the training activity?
- How will reviewing the recent UKAS visit help you outline the principles of quality management and demonstrate their contribution to the delivery of high-quality rare disease genomics services?
- What essential knowledge regarding the ISO 15189 standards and the specific role of UKAS accreditation in a clinical laboratory must you acquire before you begin your review?
- How have you considered the ways in which the findings of an external assessment directly impact patient safety and the overall reliability of genomic investigations?
What do you anticipate you will learn from the experience?
- What specific insights do you hope to gain regarding the logistical and technical preparation required for a departmental assessment, such as the role of internal audits and evidence folders?
- How do you expect this activity to improve your understanding of the CAPA (Corrective and Preventative Action) process and the evidence required to effectively clear non-conformances?
- In what ways do you anticipate this experience will help you distinguish between human error and systemic failure within a laboratory’s Quality Management System (QMS)?
What actions will you take in preparation for the experience?
- How have you planned to gain clarity on the scope of the visit and the department’s strategy for addressing the findings?
- Which specific resources, such as the formal UKAS report, internal non-conformance logs, or the laboratory’s Quality Manual, will you review to ensure your understanding is evidence-based?
- What possible challenges do you foresee when trying to interpret technical findings or complex systemic changes, and how do you plan to handle these difficulties?
- How do you feel about embarking on this activity, given that it involves evaluating the department’s compliance with national standards and may highlight areas where service improvements were required?
In action
What are you doing?
- How are you currently approaching the analysis of the UKAS assessment report and the department’s response?
- Why have you chosen this particular sequence of steps to investigate the preparatory actions, the specific findings, and the clearance process?
- What real-time decisions are you making about which non-conformances or observations require the most detailed scrutiny to understand their systemic impact?
- Which aspects of the Quality Management System (QMS) feel intuitive to you as you work through the report, and which require more conscious effort or research into ISO 15189 standards?
How are you progressing with the activity?
- How effective is your current method of review in helping you outline how quality management principles were applied during the visit?
- What challenges are you facing in this moment, such as interpreting technical terminology in the findings or understanding the complexities of the systemic changes required for clearance?
- What are you learning from the evidence as it unfolds regarding the logistical reality of maintaining a high-quality rare disease genomics service?
- In what ways do these findings connect to your existing knowledge of laboratory accreditation and its role in ensuring patient safety?
How are you adapting to the situation?
- If the rationale behind a specific finding or the method used to clear it remains unclear, what alternative investigative strategies are you considering?
- What immediate support or guidance do you need to resolve any ambiguities in the assessment documentation?
- How are you ensuring that your analysis of the visit and your conclusions regarding the findings remain strictly within your professional scope of practice?
- How are you adapting your thinking to reconcile the theoretical principles of quality management with the real-world feedback provided by the UKAS assessors?
On action
What did you notice?
- How would you summarise the key aspects of the experience, specifically regarding the departmental preparation, the primary themes of the findings, and the clearance process?
- What were the most significant clinical or technical details you noticed in the UKAS report that influenced the department’s response?
- Which specific actions taken by the department to clear the findings did you notice were most effective in addressing the root cause of the issues?
What did you learn from the activity?
- What specific knowledge regarding the principles of quality management and the ISO 15189 standards did you develop or improve through this review?
- What did you learn from any unexpected challenges or successes encountered during the visit or the subsequent clearance period, such as the complexity of providing evidence for systemic improvements?
- In what ways did your reflection-in-action influence your final understanding of the accreditation process?
- How does this experience of evaluating compliance with national quality standards relate to the requirements for your post-programme practice as a Clinical Scientist?
What will you take from the experience moving forward?
- What areas for continued development in quality management or audit processes have you identified as a result of this activity?
- How will you apply the learning from this review to your routine practice to ensure the delivery of a safe and high-quality rare disease genomics service?
- What specific ‘next steps’ will you take to support the assimilation of what you have learned, such as reviewing internal audit protocols or seeking feedback from the Quality Lead?
- What support or resources (e.g., access to specialist quality databases, expert mentorship, or further training on root cause analysis) do you need to further develop in these areas?
Beyond action
Have you revisited the experiences?
- Have you revisited your analysis of the UKAS report and the subsequent clearance process? Consider re-evaluating the findings in light of your subsequent experience with internal audits or routine quality control—has your understanding of the ‘root cause’ of those non-conformances deepened?
- How do the quality management strategies you reviewed during the UKAS visit compare with the observable professional behaviours of the Quality Lead or senior scientists you work with? Which of these practices have you now assimilated into your own routine work?
- Have you discussed the visit with colleagues? In what ways has this mutual exchange of perspectives changed your view on the value of external accreditation or the challenges of maintaining ISO 15189 standards?
- As part of a module review, what overarching themes have you identified by revisiting this reflection alongside other quality-related activities? What patterns are emerging regarding your ability to justify laboratory processes against national standards?
How has this experience impacted your current practice?
- Recognising that this review is not an isolated incident, how has it supported the development of wider skills? For example, are you now more adept at writing technical reports, presenting quality metrics, or explaining the principles of quality management to others?
- How have you applied the knowledge of the CAPA (Corrective and Preventative Action) process gained from this review to your daily work? Are you now more attentive to potential ‘risk points’ or bottlenecks in your routine assays?
- How has this experience influenced your wider practice in the laboratory, such as how you approach the review of Standard Operating Procedures (SOPs) or the documentation of non-conformances?
- Consider how this learning will support you in preparing for observed ‘in-person’ assessments. How does your understanding of the UKAS visit inform your readiness for a Case-based Discussion (CBD) regarding the delivery of a safe and high-quality rare disease genomic service?
How might this experience contribute to your future practice?
- What transferable skills in risk assessment, technical troubleshooting, and strategic planning have you solidified through this activity that will be vital to your future role as a Clinical Scientist?
- What clear actions for continued development have you identified to ensure you stay current with evolving accreditation standards? For example, do you plan to attend workshops on the latest ISO 15189 updates or participate in regional quality management forums?
- How has this experience underscored the importance of a patient-centred approach in a high-pressure clinical service? Reflect on how maintaining a robust Quality Management System directly ensures the reliability of results for patients and their families.
- In what ways will your mastery of these quality principles help you contribute to future service improvements or innovations as genomic testing becomes more integrated into patient pathways?
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 6 |
Outcome
Outline how the principles of quality management contribute to the delivery of high-quality rare disease genomics services. |