Training activity information
Details
Review viral screening results prior to storage or treatment to ensure compliance with HFEA regulations
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
- Implication of cross contamination
- Viral testing methods and laboratory accreditation for tests
- Local guidance for storage/treatment
- HFEA regulations and Code of Practice
- Professional body guidance
- National and international regulation
- Patient pathway for positive results
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 reviewing viral screening results, for example, what specific markers or tests are you looking for and what constitutes a compliant result according to HFEA regulations?
- Consider how the learning outcomes apply, specifically how ensuring compliance with HFEA regulations impacts the patient’s eligibility for storage or treatment.
- Discuss with your Training Officer to gain clarity of what is expected of you in relation to the specific standards and potential complexities in reviewing screening results.
What is your prior experience of this activity?
- Think about what you already know about interpreting laboratory test results, specifically for infectious diseases. Are you familiar with the common viral screening panels used in fertility?
- Consider possible challenges you might face during the activity, such as indeterminate results, results from external laboratories with different formats, or needing to understand the implications of a positive result, and how you might handle them.
- 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 viral results are borderline or if the timing of the screening relative to the treatment cycle is unclear.
- Acknowledge how you feel about embarking on this training activity, particularly given the regulatory importance and potential impact on the patient.
What do you anticipate you will learn from the experience?
- Consider the specific skills you want to develop, such as accurately interpreting screening reports, cross-referencing results against HFEA requirements, and understanding the required documentation and timelines.
- Identify the specific insights you hope to gain from engaging with the activity, such as a deeper understanding of the regulatory framework governing storage and treatment and the critical role of screening in ensuring safety.
What additional considerations do you need to make?
- Consult actions identified following previous experience with reviewing medical reports or applying regulations.
- Identify important information you need to consider before embarking on the activity, such as the latest HFEA guidelines on viral screening, the clinic’s specific SOPs for handling results, and what constitutes a ‘valid’ screening result (e.g., timing relative to treatment).
In action
Is anything unexpected occurring?
- Are you noticing anything surprising or different from what you anticipate whilst reviewing the viral screening results?
- Are you encountering situations such as:
- Finding results that were borderline, indeterminate, or clearly positive, contrary to expectation?
- Discrepancies in patient details or sample labelling that surprised you?
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 immediately recognising that the result might impact HFEA compliance or the treatment/storage plan?
- Consider the steps you are taking in the moment, such as stopping the review or taking a specific action to investigate the finding further.
- How are you feeling in that moment? For instance, are you finding it difficult to proceed with the treatment or storage? Is it affecting your confidence in ensuring HFEA compliance?
What is the conclusion or outcome?
- Identify how you are working within your scope of practice. For example, did your immediate response ensure that potential non-compliance with HFEA regulations was addressed? Or are you needing support because the result requires senior consultation regarding HFEA guidelines or patient pathway modification?
- What are you learning as a result of the unexpected development? For example, are you gaining insight into the criticality of identifying problematic results or key compliance issues during the review process?
On action
What happened?
- Begin by summarising the key steps you took when reviewing the viral screening results, including the process you followed to check them. Which specific results were you reviewing?
- Consider specific events, actions, or interactions which felt important, such as checking the key regulatory requirements you were following according to the HFEA statutory and regulatory framework.
- Include any ‘reflect-in-action’ moments where you had to adapt to the situation as it unfolded, for instance, immediately halting the compliance check to consult the departmental SOP when faced with a borderline viral marker result.
- How did you feel during this experience, e.g., did you feel confident in ensuring regulatory compliance or stressed by the responsibility of verifying safety parameters?
How has this experience contributed to your developing practice?
- Identify what learning you can take from this experience regarding reviewing screening results for regulatory compliance. What strengths did you demonstrate, e.g., meticulous cross-referencing of lab reports with HFEA guidelines?
- What skills and/or knowledge gaps were evident, e.g., unfamiliarity with specific regulatory definitions of ‘acceptable result’ for all viral markers?
- Compare this experience against previous engagement with similar activities – were any previously identified actions for development achieved? Has your practice improved in adhering to the statutory and regulatory framework?
- Identify any challenges you experienced, such as interpreting external laboratory results or ambiguity regarding a specific regulatory clause. Identify how you reacted to this, e.g., needing to seek advice or clarification on scope of practice regarding the implications of a positive screening result on the patient pathway.
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 your working knowledge of specific HFEA viral screening standards.
- What will you do differently next time you approach reviewing viral screening results for compliance, for instance, by proactively checking the date validity and format compliance of all incoming lab reports before reviewing the quantitative findings.
- Do you need to practise any aspect of the activity further, such as reviewing regulatory interpretation of complex infectious disease markers or key learning outcomes related to practicing in accordance with the statutory framework?
Beyond action
Have you revisited the experiences?
- How have your subsequent experiences of reviewing viral screening results since completing this specific training activity led you to revisit your initial approach or decisions during that activity? For example, how an instance where a subsequent patient presented with indeterminate results requiring specialist HFEA compliance interpretation forced you to re-evaluate the depth of your regulatory knowledge during your first attempt at this training activity.
- Considering what you understand about HFEA statutory and regulatory requirements for viral screening, managing unexpected results, and ensuring patient pathway appropriateness 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 screening review protocol based on further learning and experiences? For example, how you proactively integrated a documented cross-reference against the latest HFEA Code of Practice viral screening requirements based on further learning.
- Has discussing regulatory challenges or the implications of positive screening on patient management 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 time when missed compliance detail invalidated a storage decision refined your understanding of the critical nature of meticulous adherence to the statutory framework.
How have these experiences impacted upon current practice?
- How has the learning from this initial training activity, in combination with subsequent viral screening review experiences, contributed to your overall confidence and ability in ensuring HFEA compliant screening and contributing to the patient pathway, particularly in preparing for assessments like DOPS or OCEs? For example, how your accumulated knowledge of HFEA regulatory screening requirements enables confident documentation review during a DOPS assessment related to compliance checks.
- How has reflecting back on this specific training activity, combined with everything you’ve learned since, shaped your current approach to reviewing screening results? 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 HFEA Person Responsible (PR) immediately when borderline results or inconsistencies require urgent regulatory input, recognising this is critical for upholding the statutory framework.
- Looking holistically at your training journey, how has this initial viral screening review experience, revisited with your current perspective, contributed to your development in meeting the learning outcomes related to practicing in accordance with the statutory and regulatory framework? For example, how this foundational experience has supported your development in adhering to the statutory and regulatory framework governing patient eligibility for storage and treatment.
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 1 |
Outcome
Determine a patient’s pathway, including assisted reproduction options and stimulation regimens based on clinical presentation. |
| # 2 |
Outcome
Practice in accordance with the statutory and regulatory framework. |