Haematological Malignancies 2 —
Training activity: 15

Details

Perform and document a validation or verification for haematological malignancies

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 performing and documenting a validation or verification related to molecular assays for haematological malignancies.
• Consider how the learning outcomes apply, specifically in relation to applying ISO:15189 standards, including validation/verification.
• Discuss with your training officer to gain clarity of what is expected of you in relation to expectations for experimental design, defining appropriate acceptance criteria (e.g., limit of detection, accuracy), and comprehensive documentation.

What is your prior experience of this activity?

• Think about your knowledge of quality management systems (ISO:15189) and experience with laboratory procedures that require validation or verification.
• Consider possible challenges you might face during the activity, such as designing a statistically robust plan, executing the experiment with sufficient control samples, or documenting findings according to accreditation standards.
• 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 validation data fails to meet pre-defined acceptance criteria or if systematic technical issues arise during the experimental phase.
• Acknowledge how you feel about undertaking this critical quality management exercise.

What do you anticipate you will learn from the experience?

• Consider the specific skills you want to develop, such as designing, executing, analysing, and documenting validation or verification studies according to ISO standards.
• Identify the specific insights you hope to gain into the critical analytical and technical parameters that need to be assessed to ensure a molecular test is fit for clinical purpose.

What additional considerations do you need to make?

• Consult actions identified following previous experiences of quality control or EQA activities.
• Identify important information you need to consider before embarking on the activity, such as the specific assay or method being assessed, the pre-defined acceptance criteria (e.g., sensitivity/specificity), and the required documentation template.

In action

Is anything unexpected occurring?

• Are you noticing anything surprising or different from what you anticipate whilst performing the validation or verification procedure?
• Are you encountering situations such as:
• Unexpectedly low sensitivity observed at the limit of detection?
• A technical issue arising that challenges the ability to adhere to ISO:15189 standards?
• Meticulous documentation proving difficult to maintain while addressing practical issues?

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 or immediately pausing the procedure to re-verify reagent expiry dates?
• Consider the steps you are taking in the moment, such as immediately documenting the unexpected outcome with specific details or seeking assistance from a senior colleague to troubleshoot.
• How are you feeling in that moment? For instance, are you finding it difficult to analyse performance metrics accurately? Is it affecting your confidence in adhering to required quality standards?

What is the conclusion or outcome?

• Identify how you are working within your scope of practice. For example, are you successfully troubleshooting minor issues and documenting findings systematically? Or are you needing support because the validation data fails to meet acceptance criteria and requires senior technical review regarding compliance with ISO:15189 standards?
• What are you learning as a result of the unexpected development? For example, are you gaining insight into the performance characteristics and limitations of the assay or mastering a more effective technique for troubleshooting unexpected technical outcomes?

On action

What happened?

• Begin by summarising the key steps you took when performing or assisting with the validation or verification activity for the haematological malignancy assay.
• Consider specific events, actions, or interactions which felt important, such as the type of data or evidence collected and documented, the key steps involved in performance, or the outcomes or findings of the process.
• Include any ‘reflect-in-action’ moments where you had to adapt to the situation as it unfolded, for instance, immediately consulting a senior technical specialist and modifying the experimental plan when unexpected results (e.g., poor limit of detection) were encountered mid-process.
• How did you feel during this experience, e.g., did you feel focused on quality standards and meticulous documentation or stressed by the technical challenge of achieving performance criteria?

How has this experience contributed to your developing practice?

• Identify what learning you can take from this experience regarding validation and verification. What strengths did you demonstrate, e.g., meticulous documentation of the process and evidence?
• What skills and/or knowledge gaps were evident, e.g., unfamiliarity with the specific statistical analysis required for setting the limit of detection?
• Compare this experience against previous engagement with similar activities – were any previously identified actions for development achieved? Has your practice improved in your understanding of validation and verification processes and how these activities relate to ISO:15189 accreditation and compliance?
• Identify any challenges you experienced, such as needing to seek advice or clarification on scope of practice regarding whether the observed performance metrics justified the clinical use of the assay when results were borderline, 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 your documentation of quality management tasks.
• What will you do differently next time you approach validation, for instance, by proactively reviewing specific clauses of ISO:15189 relevant to assay performance metrics before planning the experiment?
• Do you need to practise any aspect of the activity further, such as performing and documenting quality metrics analysis or key knowledge outcomes related to laboratory quality processes?

Beyond action

Have you revisited the experiences?

• How have your subsequent experiences of performing validation or verification procedures 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 assay validation failed due to issues around the limit of detection forced you to re-evaluate the rigour of your initial statistical planning and acceptance criteria definition you applied during your first attempt at this training activity?
• Considering what you understand about validation methodology, documentation, and quality standards (ISO:15189) 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 technical execution and quality assurance (QA) documentation based on further learning and experiences? For example, how you proactively reviewed and integrated specific criteria for calculating limit of detection and reporting analytical sensitivity to improve documentation compliance?
• Has discussing complex validation failures or the impact of poor verification on accreditation compliance 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 quality manager about a near-miss where insufficient documentation compromised assay confidence refined your understanding of the critical nature of meticulous adherence to validation protocols?

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 performing and documenting validation/verification activities, particularly in preparing for assessments? For example, how has your accumulated ability in applying ISO:15189 standards now enable you to confidently present and defend a verification report during a relevant assessment?
• How has reflecting back on this specific training activity, combined with everything you’ve learned since, shaped your current approach to assay quality management? 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 validation data fails to meet pre-defined acceptance criteria or requires deviation from SOPs?
• Looking holistically at your training journey, how has this initial validation experience, revisited with your current perspective, contributed to your development in interpreting QC data, including ISO:15189 requirements, and ensuring the technical accuracy of diagnostic testing?

Relevant learning outcomes

#	Outcome
# 4	Outcome Analyse, interpret and prepare interpretive reports for common haematological malignancies, including results for somatic variants, clonality, and somatic hypermutation.
# 5	Outcome Interpret the associated IQC and EQA of the laboratory tests for investigation of haematological malignancies.
# 6	Outcome Practice with the relevant specialties for the diagnosis, monitoring and management of haematological malignancies.
# 8	Outcome Apply the standards of ISO:15189 accreditation and compliance including root cause analysis (RCA) and verfication/validation requirements for cancer genomics.