Training activity information
Details
Review an EQA report, recommend corrective actions and draft a plan to action recommendations
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 does success look like?
- Identify what is expected of you in relation to reviewing an EQA report and proposing corrective actions.
- Consider how the learning outcomes apply, specifically in relation to interpreting QC data including EQA and ISO:15189.
- Discuss with your training officer to gain clarity of what is expected of you in relation to expectations for identifying root causes of non-conformance.
What is your prior experience of this activity?
- Think about what you already know about EQA schemes, interpreting EQA results, and quality management systems like ISO:15189.
- Consider possible challenges you might face during the activity, such as interpreting specific EQA findings or identifying root causes for non-conformance and think about 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 EQA non-conformance suggests a systematic failure across multiple assays that requires complex investigation.
- Acknowledge how you feel about reviewing EQA reports and proposing actions.
What do you anticipate you will learn from the experience?
- Consider the specific skills you want to develop, such as critically evaluating EQA performance and formulating effective corrective action plans.
- Identify the specific insights you hope to gain into the process of maintaining quality standards in a diagnostic genomic service through EQA.
What additional considerations do you need to make?
- Consult actions identified following previous experiences of quality control or EQA issues.
- Identify important information you need to consider before embarking on the activity, such as the specific EQA scheme guidelines, internal standard operating procedures for handling non-conformances, and the impact of findings on assay performance.
In action
Is anything unexpected occurring?
- Are you noticing anything surprising or different from what you anticipate whilst reviewing the EQA report and formulating recommendations?
- Are you encountering situations such as:
- A discrepancy in the EQA results that you did not anticipate based on internal quality control data?
- Difficulty identifying a root cause in real-time for a failed EQA sample?
- Uncertainty about the most appropriate corrective action to recommend, as multiple steps could be taken?
How are you reacting to the unexpected development?
- How is this impacting your actions? For example, are you responding to the situation appropriately? Did you need to quickly consult relevant SOPs or quality documentation to verify the expected performance range?
- Consider the steps you are taking in the moment, such as immediately initiating a review of the raw data from the EQA run to locate the technical error or pausing the recommendation draft to consult departmental non-conformance protocols.
- How are you feeling in that moment? For instance, did handling this issue in the moment impact your confidence in your ability to review EQA critically? Are you finding it difficult to adapt your procedural checklist?
What is the conclusion or outcome?
- Identify how you are working within your scope of practice. For example, are you successfully proposing an interim corrective action for the failed EQA sample? Or are you needing support because the unexpected discrepancy suggests a systematic failure across multiple assays that requires senior quality management intervention?
- What are you learning as a result of the unexpected development? For example, are you gaining insight about the EQA review process by adapting in that moment, such as the direct link between instrument maintenance logs and EQA failures?
On action
What happened?
- Begin by summarising the key steps you took when reviewing the EQA report, focusing on areas of non-conformance or unexpected findings, and subsequently identifying potential corrective actions.
- Consider specific events, actions, or interactions which felt important, such as how you used ISO:15189 standards to evaluate the non-conformance, or how you formulated the root cause analysis for a specific assay failure.
- Include any ‘reflect-in-action’ moments where you had to adapt to the situation as it unfolded, for instance, immediately consulting the assay’s technical validation report when the EQA result was unexpectedly low, to verify the expected performance range.
- How did you feel during this experience, e.g., did you feel focused on quality management principles or stressed by the technical challenge of diagnosing the cause of the EQA failure?
How has this experience contributed to your developing practice?
- Identify what learning you can take from this experience regarding quality management. What strengths did you demonstrate, e.g., systematic approach to documenting findings and clear articulation of corrective actions?
- What skills and/or knowledge gaps were evident, e.g., difficulty determining the root cause when multiple factors contributed to the EQA failure?
- Compare this experience against previous engagement with similar activities – were any previously identified actions for development achieved? Has your practice improved in critically interpreting EQA performance data against expected standards?
- Identify any challenges you experienced, such as needing to seek advice or clarification on scope of practice regarding whether the proposed corrective action required modification of a validated SOP, 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 improving the interpretation of EQA results and the quality management system.
- What will you do differently next time you approach EQA review, for instance, by proactively reviewing instrument calibration logs alongside the EQA results to narrow down the potential root cause more efficiently?
- Do you need to practise any aspect of the activity further, such as formulating clear, measurable corrective actions or reviewing key principles of quality management systems (e.g., ISO:15189)?
Beyond action
Have you revisited the experiences?
- How have your subsequent experiences of reviewing EQA reports since completing this specific training activity led you to revisit your initial approach or decisions during that activity? For example, how a subsequent EQA non-conformance suggested a common, recurring theme across different assays forced you to re-evaluate the depth of your initial root cause analysis you applied during your first attempt at this training activity?
- Considering what you understand about interpreting QC data, EQA, and ISO:15189 standards 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 formulation of corrective actions based on further learning and experiences? For example, how you proactively integrated a standardised template for impact assessment to evaluate the severity of EQA failures before proposing action?
- Has discussing specific assay performance issues revealed by EQA or the impact of EQA findings on laboratory accreditation 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 major EQA failure that nearly compromised accreditation refined your understanding of the critical nature of proactive quality assurance and continuous improvement?
How have these experiences impacted upon current practice?
- How has the learning from this initial training activity, in combination with subsequent experiences, contributed to your overall confidence and competence in quality management and EQA review, particularly in preparing for assessments like Observed Communication Events (OCEs) where you discuss quality issues? For example, how your accumulated ability in interpreting QC data now enables you to confidently discuss EQA results and propose corrective actions in a quality meeting?
- How has reflecting back on this specific training activity, combined with everything you’ve learned since, shaped your current approach to EQA review? 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 immediately when a systematic failure across multiple assays requires complex investigation that exceeds routine single assay troubleshooting?
- Looking holistically at your training journey, how has this initial experience, revisited with your current perspective, contributed to your development in interpreting QC data including EQA and ISO:15189?
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 2 |
Outcome
Analyse, interpret and prepare interpretive reports of clinically relevant findings for patients with central nervous system (CNS), sarcoma tumours, and somatic and germline variants in ovarian and breast cancer. |
| # 4 |
Outcome
Interpret QC data including bioinformatic and NGS quality metrics in relation to assay performance, EQA and ISO:15189 standards. |