Training activity information
Details
Perform and interpret assays for the analysis for three of the following:
- Methotrexate
- Phenytoin
- Theophylline
- Gentamicin
- Vancomycin
- Digoxin
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
- Local and national training guidelines, standards and pathways
- Method selection, including pre-analytical issues, assay advantages and limitations, quality parameters, and interferences
- Equipment calibration and maintenance
- Quality control; EQA and IQC
- National and international guidelines
- Role of the duty biochemist
- Turnaround times and impact on patient care
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?
- Identify what is expected of you in relation to successfully performing the assay according to SOPs and accurately interpreting the results in a clinical context.
- Consider how the learning outcomes apply, specifically in relation to performing analytical assays and applying pharmacokinetic principles for Therapeutic Drug Monitoring (TDM).
- Discuss with your training officer to gain clarity of what is expected of you in relation to the expected level of technical proficiency, understanding of the clinical scenario, and depth of interpretation required for the three chosen drugs, including appropriate sampling times and sample types.
What is your prior experience of this activity?
- Think about what you already know about the pharmacokinetics, therapeutic ranges, and toxicity of the three drugs you will focus on.
- Consider possible challenges you might face during the activity, such as challenges in performing the assays (e.g., technical steps, using specific analytical platforms) or interpreting the results (e.g., complex patient history, timing of sample).
- Recognise the scope of your own practice for this activity i.e. know when you will need to seek advice or help, and from whom. You will need to seek advice from your Training Officer when required, for example if unexpected analytical issues arise or if the interpretation requires confirmation regarding complex patient history or sample timing.
- Acknowledge how you feel about performing and interpreting the assays for the three specific medications.
What do you anticipate you will learn from the experience?
- Consider the specific skills you want to develop, such as performing analytical assays for therapeutic drugs and interpreting their results in the context of TDM.
- Identify the specific insights you hope to gain into the application of pharmacokinetic principles to clinical practice, particularly for achieving optimal drug levels.
What additional considerations do you need to make?
- Consult actions identified following previous experiences of performing quantitative assays or interpreting results requiring clinical correlation.
- Identify important information you need to consider before embarking on the activity, such as reviewing the SOPs for the chosen assays, understanding the clinical indications for TDM for these drugs, and confirming appropriate sample collection.
In action
Is anything unexpected occurring?
- Are you noticing anything surprising or different from what you anticipate whilst performing the assay or interpreting the results for your chosen three therapeutic drugs?
- Are you encountering situations such as:
- An analyser error or unexpected QC result during the performance of the methotrexate assay?
- A gentamicin trough level that is unexpectedly high, conflicting with the documented sample timing or patient monitoring protocol?
How are you reacting to the unexpected development?
- How is this impacting your actions? For example, are you responding to the situation appropriately? Are you adapting or changing your approach to troubleshooting the method or applying pharmacokinetic principles?
- Consider the steps you are taking in the moment, such as:
- Immediately questioning the sample integrity or timing for a discordant digoxin level
- Troubleshooting the assay according to SOP when an unexpected analyser error occurs during phenytoin analysis
- How are you feeling in that moment? For instance, are you finding it difficult to adapt your interpretation due to poor sample timing? Is it affecting your confidence in performing the assay independently? Did you feel confident you could handle the situation?
What is the conclusion or outcome?
- Identify how you are working within your scope of practice. For example, are you successfully troubleshooting a minor QC failure and re-running the control to validate the vancomycin assay? Or are you needing support because the complex pharmacokinetics of a specific drug (e.g., theophylline) in a patient with multi-organ failure requires senior interpretation?
- What are you learning as a result of the unexpected development? For example, are you gaining insight into the technical aspects of TDM assays and the consequences of pre-analytical errors?
On action
What happened?
- Begin by summarising the key steps you took when performing and interpreting assays for the three selected therapeutic drugs.
- Consider specific events, actions, or interactions which felt important, such as how you managed technical proficiency during the assay (e.g., for methotrexate) or how you applied knowledge of sample timing (e.g., trough levels for gentamicin/vancomycin) during interpretation.
- Include any ‘reflect-in-action’ moments where you had to adapt to the situation as it unfolded, for instance, immediately troubleshooting the analyser when faced with unexpected QC results during the phenytoin assay or questioning the sample validity due to an unusually high digoxin level.
- How did you feel during this experience, e.g., did you feel confident in troubleshooting technical challenges or stressed by interpreting results outside the therapeutic range?
How has this experience contributed to your developing practice?
- Identify what learning you can take from this experience regarding performing analytical assays and applying pharmacokinetic principles.
- What strengths did you demonstrate, e.g., technical proficiency in performing the assay or understanding of pharmacokinetics?
- What skills and/or knowledge gaps were evident, e.g., difficulty with troubleshooting analyser errors, uncertainty about appropriate sampling times for theophylline, or the influence of drug interactions?
- Compare this experience against previous engagement with similar activities – were any previously identified actions for development achieved? Has your practice improved in performing and interpreting assays for these therapeutic drugs?
- Identify any challenges you experienced, such as analyser error, unexpected QC results, or a patient result outside the therapeutic range, and how you reacted to these.
What will you take from the experience moving forward?
- Identify the actions or ‘next steps’ you will now take to support the assimilation of what you have learnt, including from any feedback you have received, with regards to improving technical troubleshooting and interpretation of TDM results.
- What will you do differently next time you approach performing and interpreting these therapeutic drug assays, for instance, by proactively reviewing the specific methodology for one of the drugs or the complex pharmacokinetics of another (e.g., vancomycin)?
- Do you need to practise any aspect of the activity further, such as practising interpreting TDM results in different clinical scenarios or key learning outcomes related to applying pharmacokinetic principles?
Beyond action
Have you revisited the experiences?
- How have your subsequent experiences of performing TDM assays and interpreting pharmacokinetic principles since completing this specific training activity led you to revisit your initial approach or decisions during that activity? For example, how subsequent technical difficulties with analysing low concentration trough levels (e.g., Vancomycin) forced you to re-evaluate the rigor of your analytical calibration and instrument maintenance checks during your first attempt at this training activity.
- Considering what you understand about pharmacokinetic principles, therapeutic ranges, and sample timing criticality now, were the actions or considerations you identified after your initial reflection on this training activity sufficient? How have you since implemented or adapted improvements in your pre-analytical confirmation process and interpretive methodology based on further learning and experiences? For example, how you proactively reviewed and integrated specific criteria for assessing steady-state kinetics when interpreting Methotrexate results, demonstrating adapted improvements based on further learning.
- Has discussing complex TDM cases involving drug interactions or the impact of pre-analytical timing errors with colleagues, peers, or supervisors changed how you now view your initial experience in this training activity? For example, how professional storytelling with a senior colleague about a patient overdose due to incorrect timing of a Digoxin sample refined your understanding of the critical nature of pre-analytical verification in Therapeutic Drug Monitoring.
How have these experiences impacted upon current practice?
- How has the learning from this initial training activity, in combination with subsequent TDM and analytical method experiences, contributed to your overall confidence and competence in performing TDM assays and interpreting results based on pharmacokinetic principles, particularly in preparing for assessments like DOPS? For example, how your accumulated ability in ensuring accurate sampling times and method performance now enables you to confidently execute analytical steps and address pre-analytical issues for a Vancomycin or Gentamicin assay during a DOPS assessment.
- How has reflecting back on this specific training activity, combined with everything you’ve learned since, shaped your current approach to TDM performance and critical result interpretation? How does this evolved understanding help you identify when something is beyond your scope of practice or requires escalation? For example, how your evolved approach means you now routinely seek advice from the Pharmacy team or Senior Clinical Scientist immediately when interpreting a result where complex drug interactions or specific pharmacogenetic factors are suspected to be influencing the Methotrexate level, recognising this requires specialised pharmacological or senior input.
- Looking holistically at your training journey, how has this initial TDM assay performance and interpretation experience, revisited with your current perspective, contributed to your development in meeting the learning outcomes related to performing analytical assays and applying pharmacokinetic principles? For example, how this foundational experience has supported your development in evaluating new TDM assays or contributing to ward rounds where therapeutic drug monitoring is discussed.
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 1 |
Outcome
Analyse drugs, vitamins and trace elements in various biological matrices via quantitative and qualitative assays using automated and manual methodologies. |
| # 2 |
Outcome
Apply the appropriate investigative strategy to clinical situations which may involve drugs or poisons, advising clinical teams on the appropriate course of action. |
| # 5 |
Outcome
Demonstrate the application of pharmacokinetics and pharmacogenomics in therapeutic drug monitoring. |
| # 6 |
Outcome
Illustrate how toxicology results are used in clinical practice and the legal consequences of drug testing in various settings. |