Radiopharmacy —
Training activity: 1

Details

Run a preparation session for a range of radiopharmaceuticals, from order to release, including kit preparation and quality control testing and prioritisation of work

Type

Entrustable training activity (ETA)

Evidence requirements

Evidence the activity has been undertaken by the trainee repeatedly, consistently, and effectively over time, in a range of situations. This may include occasions where the trainee has not successfully achieved the outcome of the activity themselves. For example, because it was not appropriate to undertake the task in the circumstances or the trainees recognised their own limitations and sought help or advice to ensure the activity reached an appropriate conclusion. ​

Reflection at multiple timepoints on the trainee learning journey for this activity.

Considerations

• National legislation and guidance
• Nuclear medicine protocols
• Unit SOPs
• Local rules
• Safe and accurate working
• Cleanroom comportment and behaviours
• Checks required to sign off the unit, equipment and staff prior to work commencing
• Prioritisation and urgency of work
• Incident reporting
• Order, receipt and storage of radioactive products
• Decay calculations
• Gowning
• Periodic operator validation and process validation
• Cleaning and disinfection
• Transfer
• Product documentation
• Pre and in-process checks
• Release process
• Limits of practice
• Quality assurance and quality control
• Radiation monitoring
• Troubleshooting
• Product formulation
• Dispatch and transport regulations
• Clinical impact of non-compliance and deviation

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 does success look like for running a radiopharmaceutical preparation session?
  • What are the precise requirements for managing the entire process from order to release, including kit preparation, QC testing, and prioritisation, as per your local Standard Operating Procedures (SOPs)?
  • Discuss with your Training Officer to gain clarity of what is expected of you. What specific aspects of efficiency, accuracy, safety protocols, and handling unexpected issues during a session should you focus on to ensure a successful outcome?
  • Consider the regulatory aspects of radiopharmaceutical preparation and supervision. Recognise the scope of your own practice for this activity. Understand what you are permitted to do independently and when you will need to seek advice or help and from whom.
• What is your prior experience of running radiopharmaceutical preparation sessions?
  • Have you observed these sessions before? Have you participated in parts of the process, such as kit preparation or quality control testing, previously?
  • What difficulties might arise with prioritisation of work, unexpected delays, or issues with quality control results? How would you plan to mitigate these?
  • When would you need to seek advice or help regarding complex orders, out-of-specification QC results, or significant deviations in workflow? From whom would you seek this advice?
  • How do you feel about leading a full preparation session, including managing its various stages and prioritising tasks?
• Consider the specific skills you want to develop – drawing upon previous experiences of the activity.
  • Are you aiming to improve your time management, decision-making under pressure, or your ability to troubleshoot QC issues effectively during a session?
  • What new understanding do you seek regarding the interdependencies of different steps in the preparation process or the critical points for ensuring product quality and patient safety?
• What additional considerations do you need to make before running this session?
  • Have you identified any areas for improvement from previous observations or partial involvements in preparation sessions that you need to consciously apply now?
  • Do you need to review specific product monographs, QC protocols, or prioritisation guidelines before starting?
  • Are there any staff availability or equipment considerations that might impact the session?

In action

• Are you noticing anything surprising or different from what you anticipate during the process of running a preparation session?
  • Are you encountering situations such as:
    • An unexpected issue arising with a kit
    • A Quality Control (QC) test result being unexpected
    • An issue with equipment
    • Problems with staff availability
    • A change in prioritisation
• How does this experience compare with previous observations or participations in similar preparation sessions?
  • Is the deviation more significant or different from what you’ve seen before?
  • How is any unexpected development being resolved as you progress during the session?
  • How are you working within your scope of practice? Do you know when to proceed independently and when to escalate or seek expert advice regarding the unexpected issue?
  • What are you learning in this moment as a result of any unexpected development? For example, what new insights are you gaining about managing unforeseen circumstances in radiopharmaceutical preparation, quality control, or work prioritisation?
• How is this impacting your actions? For instance, are you pausing the process, consulting a SOP, or seeking immediate advice?
  • Are you responding to the situation appropriately, and are you adapting or changing your approach to continue the session safely and effectively?
  • How are you feeling in this moment? For example, are you finding it difficult to adapt to the unexpected issue, or is it affecting your confidence in managing the session?

On action

• Summarise the key points of the preparation session.
  • Include specific events, actions, or interactions that felt important, such as the initial order processing, specific challenges encountered during kit preparation or quality control testing, and any adjustments made to prioritisation.
  • Incorporate any ‘reflect-in-action’ moments you experienced, for example, if an unexpected QC result required an immediate decision or if a change in patient needs led to reprioritisation of batches.
• What strengths did you demonstrate during the session (e.g., ability to multitask, problem-solve an unexpected QC issue)?
  • What skills and/or knowledge gaps were evident, particularly concerning safe practice with sterile radiopharmaceuticals or planning and managing the session effectively?
  • Were any previously identified actions for development achieved? Has your practice improved in areas like aseptic technique, efficiency of kit preparation, or accuracy of QC testing?
  • Identify any challenges you experienced and how you reacted to these. Did these challenges affect your ability to deal with the situation independently? Were you able to overcome them, for instance, by consulting a SOP or seeking advice for a complex problem during the preparation or release process?
  • Identify anything significant about the activity. Did you need to seek advice or clarification regarding a specific radiopharmaceutical, a QC deviation, or an unusual prioritisation request? Or did you need to escalate a situation to ensure that you were working within your scope of practice, especially concerning patient safety or product quality?
  • Do you feel more confident, or are there areas where you realise you need further development?
  • Discuss the session with your training officer and reflect on any feedback they give, and on any times when they intervened during the session.
• Identify the actions / ‘next steps’ you will now take to support the assimilation of what you have learnt, including from any feedback you have received.
  • What will you do differently next time you run a preparation session, particularly regarding managing unexpected issues, ensuring safe practice, or optimising workflow and prioritisation?
  • Has anything changed in terms of what you would do if you were faced with a similar situation again, perhaps a specific type of QC failure or a sudden change in demand?
  • Do you need to practise any aspect of the activity further to gain more confidence or proficiency, such as troubleshooting specific QC tests or making real-time prioritisation decisions?

Beyond action

• Have you revisited the experiences of running radiopharmaceutical preparation sessions?
  • Have you reviewed your actions from your previous reflections for this activity? Specifically, have you looked back at areas such as ensuring aseptic technique, interpreting quality control (QC) results, handling unexpected deviations, or effectively prioritising work during a session?
  • What actions did you identify you would need to take to improve your practice in these areas?
  • Have you completed these actions? Are you now ready to demonstrate this new learning into practice, particularly regarding your proficiency in safe practice, efficient kit preparation, accurate QC testing, and real-time problem-solving during a preparation session?
  • Consider if your view of managing a full preparation session, dealing with unexpected challenges (e.g., out-of-specification results, generator problems), or ensuring final product release has changed because of analysing this with others.
• How have these combined experiences impacted upon your current practice in running radiopharmaceutical preparation sessions?
  • Consider how the learning from all your radiopharmaceutical preparation session experiences will support you in preparing for the observed ‘in-person’ assessments for this module.
  • Consider how your practice has developed and evolved over time in terms of running preparation sessions, including your ability to independently manage the workflow, respond to unexpected issues, and ensure compliance with quality management systems.
  • Do you now more readily recognise when something is beyond your scope of practice, requiring consultation or escalation, especially concerning patient safety, complex QC deviations, or regulatory compliance?

Relevant learning outcomes

#	Outcome
# 1	Outcome Demonstrate safe practice with sterile radiopharmaceuticals and blood products.
# 2	Outcome Plan and manage preparation sessions for a range of diagnostic and therapeutic radiopharmaceuticals.