Equipment, Culture Systems and Quality Management in the IVF Laboratory —
Training activity: 1

Details

Perform inward receipt of consumables, including:

• Quality control checks
• Toxicity testing
• Traceability checks

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

• Regulatory requirements and quality issues relating to consumables used in the laboratory
• Steps required in the event of a product re-call
• Stock rotation
• CE marking
• Role in maintaining patient safety

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 performing the inward receipt of consumables, including quality control checks, toxicity testing, and traceability checks.
• Consider how the learning outcomes apply, specifically in relation to practicing according to quality management and regulatory standards and demonstrating safe and effective practice, minimising risk.
• Discuss with your Training Officer to gain clarity of what is expected of you in relation to the specific expectations for quality control, toxicity testing, and traceability checks during this process.

What is your prior experience of this activity?

• Think about what you already know about reviewing quality control certificates, performing toxicity testing or ensuring traceability of consumables in a laboratory setting.
• Consider possible challenges you might face during the activity, such as supply chain issues or quality verification of incoming goods.
• 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 the receipt or quality check process might be beyond your scope of practice.
• Acknowledge how you feel about performing these specific checks and managing the associated documentation.

What do you anticipate you will learn from the experience?

• Consider the specific skills you want to develop, such as toxicity testing interpretation or traceability documentation.
• Identify the specific insights you hope to gain into the importance of these checks for maintaining the quality management system and ensuring patient safety.

What additional considerations do you need to make?

• Consult actions identified following previous experiences of similar receiving or quality check tasks.
• Identify important information you need to consider before embarking on the activity, such as specific product specifications, supplier certificates, or regulatory requirements for traceability.

In action

Is anything unexpected occurring?

• Are you noticing anything surprising or different from what you anticipate whilst verifying documentation, performing visual checks, or checking quality control (QC) tests?
• Are you encountering situations such as:
  • Discrepancies, damage, or unexpected findings with the consumables or documentation (e.g., missing supplier certificate or damaged packaging)?
  • An in-house toxicity test yields an unexpected result, deviating from the required standards?

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 adjusting your immediate actions or thought process when a QC check yields an unexpected result?
• Consider the steps you are taking in the moment, such as pausing the process, documenting the discrepancy immediately, or consulting the relevant Standard Operating Procedure (SOP) regarding the unexpected finding.
• How are you feeling in that moment? For instance, are you finding it difficult to address missing or incorrect documentation appropriately? Is it affecting your confidence in the accuracy of the checks you are performing?

What is the conclusion or outcome?

• Identify how you are working within your scope of practice. For example, were you able to implement an alternative plan or complete documentation verification despite initial challenges? Or are you needing support because the quality control issue requires definitive senior input or the receipt process might be beyond your scope of practice?
• What are you learning as a result of the unexpected development? For example, are you gaining insight into handling specific documentation or quality assurance issues in the moment?

On action

What happened?

• Begin by summarising the key steps you took when receiving consumables, including QC and ensuring traceability.
• Consider specific events, actions, or interactions which felt important, such as verifying documentation against the supplier certificate and ensuring traceability of each batch.
• Include any ‘reflect-in-action’ moments where you had to adapt to the situation as it unfolded, for instance, pausing the receipt process to document a discrepancy immediately. How did you feel during this experience, e.g., focused on the accuracy of the checks?

How has this experience contributed to your developing practice?

• Identify what learning you can take from this experience regarding performing quality control, toxicity, or traceability checks. What strengths did you demonstrate, e.g., meticulous adherence to the traceability process?
• What skills and/or knowledge gaps were evident, e.g., unfamiliarity with the interpretation of toxicity testing protocols?
• Compare this experience against previous engagement with similar activities – were any previously identified actions for development achieved? Has your practice improved in managing associated documentation?
• Identify any challenges you experienced, such as quality verification of incoming goods, and how you reacted to this. This might include needing to seek advice or clarification on scope of practice regarding quality verification of incoming goods, and how you reacted to this.

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 performing inward receipt of consumables.
• What will you do differently next time you approach receiving consumables?
• Do you need to practise any aspect of the activity further, such as performing toxicity tests or key learning outcomes related to practising according to quality management and regulatory standards.

Beyond action

Have you revisited the experiences?

• How have your subsequent experiences of performing inward receipt and using consumables in the laboratory 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 urgent need for traceability on a recalled product forced you to re-evaluate the diligence of documentation during your initial receipt and traceability checks during your first attempt at this training activity.
• Considering what you understand about QC, toxicity testing, and regulatory standards for consumables 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 routine practice related to documentation and quality checking based on further learning and experiences? For example, how you proactively integrated observable behaviours and practices related to ensuring quality and traceability into your routine practice based on further learning.
• Has discussing quality management or regulatory standards for consumables or the critical importance of accurate documentation 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 incorrect usage of a consumable led to a failure refined your understanding of the critical nature of pre-use quality checks and adherence to protocols.

How have these experiences impacted upon current practice?

• How has the learning from this initial training activity, in combination with subsequent consumable receipt, contributed to your overall confidence and ability in managing laboratory inventory and quality assurance, particularly in preparing for assessments like DOPS or OCEs? For example, how your accumulated knowledge gained from this training activity about QC, toxicity testing, and traceability now enables you to confidently present and justify the necessary documentation and procedural steps related to checking consumables and maintaining traceability during observed ‘in-person’ assessments.
• How has reflecting back on this specific training activity, combined with everything you’ve learned since, shaped your current approach to handling and managing laboratory consumables? 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 your Training Officer immediately if the receipt or quality check process is compromised, recognising that issues such as discrepancies, damage, or unexpected QC results require careful management to ensure patient safety and adherence to regulatory standards.
• Looking holistically at your training journey, how has this initial inward receipt experience, revisited with your current perspective, contributed to your development in meeting the learning outcomes related to practicing in accordance with quality management and regulatory standards and demonstrating safe and effective practice, minimising risk? For example, how this foundational experience has supported your development in attention to detail, adherence to protocols, and understanding of quality systems, skills that are transferable and critical for maintaining laboratory standards.

Relevant learning outcomes

#	Outcome
# 2	Outcome Practice in accordance with quality management and regulatory standards.
# 4	Outcome Demonstrate safe and effective practice, minimising risk to all staff and patients.