Rare Disease 1 —
Training activity: 9

Details

Draft a plan to introduce a change that needs to be made in your department to include:

• Requirements for validation and verification
• Management of risks
• Stakeholder engagement
• Accreditation requirements (ISO 15189)

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?

• Review the learning outcome related to this activity to focus your attention: how will drafting this change plan demonstrate your ability to employ specialist knowledge of quality management within the genomics laboratory?
• What do you need to know before embarking on the activity? Consider what you need to research regarding the specific requirements for validation and verification of the new process, and which specific ISO 15189 standards apply to the change you are planning.
• How will you identify the risks associated with this change and what tools (e.g., FMEA or risk registers) do you need to understand beforehand?

What do you anticipate you will learn from the experience?

• Consider the specific insights you hope to gain. For example, what will you learn about the complexities of stakeholder engagement when navigating different professional perspectives within the department?
• How do you expect this activity to improve your understanding of how accreditation requirements directly influence operational decisions in a genomics service?
• Think about what you already know about the task. How does your existing knowledge of laboratory quality systems provide a foundation for managing this specific change?

What actions will you take in preparation for the experience?

• How will you ensure your plan aligns with the department’s existing quality management system?
• Consider possible challenges you might face—such as identifying hard-to-reach stakeholders or managing the technical limitations of a validation study—and think about how you might handle them.
• Identify how you feel about embarking on this training activity: given that poorly managed changes can impact patient safety and accreditation status, how are you preparing for the professional responsibility of this task?

In action

What are you doing?

• How are you approaching the drafting of this change plan? Why have you chosen to focus on these specific requirements for validation and verification or risk management?
• What decisions are you making as you progress through the plan? For example, how are you determining which stakeholders need to be engaged at each stage?
• Which aspects of your practice—such as identifying potential laboratory risks—feel intuitive, and which—such as mapping the change to specific ISO 15189 accreditation requirements—require more conscious effort?

How are you progressing with the activity?

• How effective are your current actions in creating a plan that is robust enough to implement the change safely and effectively?
• What challenges are you facing while drafting this plan—perhaps conflicting stakeholder interests or complex validation requirements—and what are you learning as the plan unfolds?
• How does this activity connect to your existing knowledge and skills regarding quality management and laboratory workflows?

How are you adapting to the situation?

• Are there alternative approaches you could be considering for managing the risks or engaging with stakeholders that might be more effective?
• What support or guidance might you need to ensure the plan meets all regulatory standards?
• As you propose these changes and draft the requirements, are you ensuring that you are working strictly within your professional scope of practice?
• How are you adapting your approach to ensure the plan remains aligned with the specialist knowledge required for a Genomics laboratory quality system?

On action

What did you notice?

• Summarise the key points of the experience, specifically the nature of the departmental change you planned and the process you followed to address the core requirements.
• What were the essential technical or quality details—such as a specific ISO 15189 standard, a significant identified risk, or a particular validation requirement—that most heavily influenced the structure of your plan?

What did you learn from the activity?

• What specific skills or knowledge did you develop or improve regarding the employment of specialist knowledge of quality management while navigating this change?
• How has this activity enhanced your ability to integrate risk management and stakeholder engagement into operational planning?
• Were there any unexpected challenges or successes—such as identifying a previously overlooked risk or finding a creative solution for stakeholder buy-in—and what did you learn from these?
• In what ways did your reflection-in-action influence the final robustness of the document?
• How does the experience of managing departmental change and accreditation requirements relate to the professional responsibilities of your post-programme practice as a Clinical Scientist?

What will you take from the experience moving forward?

• What specific areas for continued development in change control, validation, or quality management have you identified as a result of this activity?
• How can you apply the learning from this experience to your routine practice to ensure that future changes in the department are managed safely and effectively?
• Identify the specific actions you will now take—such as presenting the plan to the management team or overseeing the first stage of the validation—to support the assimilation of what you have learned.
• What support or resources (e.g., mentorship from the Quality Lead, specific project management tools, or further training on ISO 15189) might you need to further develop in the areas identified?

Beyond action

Have you revisited the experiences?

• Evaluate and re-evaluate the experience of planning this change: how has your perspective on employing specialist knowledge of quality management evolved as you have seen the plan progress toward implementation?
• Compare this experience with your Observed Training Activities (OTAs). What observable behaviours or practices—such as managing stakeholders or interpreting ISO 15189 standards—have you assimilated into your routine practice?
• As part of a review of the module, what recurring themes or necessary actions have you identified by revisiting reflections from this and other training activities related to quality systems?
• Through discussions with peers or senior colleagues, how has your understanding of navigating departmental change transformed as a result of that mutual exchange?

How have these experiences impacted upon your current practice?

• How has this experience supported your development in wider professional areas, such as communication skills, presentation skills, or writing technical reports, rather than being seen as an isolated incident?
• How have you applied the knowledge of validation, verification, and risk management since the original planning experience to improve the quality and safety of your wider laboratory work?
• How is the learning from this activity supporting your preparation for in-person assessments for this module, such as Case-based Discussions (CBDs) regarding service improvement or Direct Observations of Practical Skills (DOPS) related to quality control?

How might these experiences contribute towards your future practice?

• What transferable skills—such as strategic planning, risk-based thinking, or organisational leadership—are you continuing to develop as you move toward becoming a Clinical Scientist?
• What clear actions have you identified for the continued development of your skills in managing quality and change to ensure you consistently deliver a high standard of patient-centred care in your future post-programme practice?

Relevant learning outcomes

#	Outcome
# 5	Outcome Employ specialist knowledge of quality management within a Genomics laboratory.