Lab management Flashcards
How is audit defined?
Systematic, independent, documented process for obtaining audit evidence & evaluating it to objectively determine the extent to which audit criteria/requirements are fulfilled
What is the purpose of auditing?
Ongoing evaluation & improvement of the QMS
Ensure service meets needs/requirements of users
What are the steps in the audit cycle?
- Set standards
- Measure current practice
- Compare results to set standards
- Reflect & implement change
- Re-audit
What are the 3 types of audit?
- Vertical - >1 step in a process
- Horizontal - 1 step in a process
- Examination - a person undertaking a task to ensure compliance with SOP
What is the purpose of lab accreditation?
Accrediting body sets out standards for quality management systems and assessment of technical competence
Through accreditation, lab demonstrates that it complies with these standards - gives confidence to service users
How is the QMS defined?
Framework of processes and procedures used to ensure that the lab can fulfill all tasks required to achieve its objectives
Subject to continual improvement to ensure highest standard of quality & efficiency
What are the key documents of the QMS?
- Quality policy - outlines commitments to meeting needs and requirements of users
- Quality manual - lists key policies and procedures for managing the organisation and quality processes. Acts as an index for documents that describe policies and procedures that demonstrate fulfilment of ISO criteria
What are the 2 key areas of the QMS & what do they involve?
- Management requirements - lab organisation, document control, EQA, identification & resolution of NCs, continual improvment/audit
- Technical requirements - training & competence, lab equipment, pre-exam, exam (validation.verification. UoM) and post-exam
What are the criteria for evaluating a genetic test?
ACCE
- Analytical validity - how accurately and reliably the test measures the genotype of interest
- Clinical validity - how consistently and accurately the test detects or predicts the outcomes of interest
- Clinical utility - how likely the test is to significantly improve patient outcomes (for diagnosis, prognosis predictive etc.)
- Ethical, legal and social implications that may arise in the context of using the test
What is the role of NICE?
To produce evidence-based guidelines on the most effective way to treat conditions
What factors should be taken into consideration when implementing a new test?
- Clinical need based on nature of disease (inheritance, incidence, penetrance, carrier freq, severity)
- Clinical demand - who will request test?
- Clinical utility - impact on diagnosis, treatment, what are the acceptance criteria?
- Legal/ethical - incidental findings, data sharing/storage for WGS
- Change management
- Plan technical testing strategy - technology, validation, sample type, UoM, obtain controls
- Impact on current working practices - training and time required to implement service, lab workload, TAT, EQA scheme, BPG
- Budget
- Staffing requirements & training - technical, scientific, bioinformatics/IT, admin
- Equipment and laboratory considerations
- Documentation, worksheets, reporting templates
- Extension to scope of ISO accreditation
- Feedback from users
- Ongoing audit, review of figures
- Contingency planning
What is the purpose of a screening test?
Detect early disease or risk factors for disease in large numbers of apparently healthy individuals
To save lives or improve quality of life
What is the purpose of a diagnostic test?
Establish the presence or absence of disease as a basis for treatment decisions in symptomatic or screen positive individuals (confirmatory test)
What is the difference in testing methodologies for screens vs tests?
Screens - simple, cheaper, acceptable to patients & staff
Test - May be invasive, expensive but justifiable to provide diagnosis
What is validation?
Confirmation, through the provision of objective evidence, that the requirements for a specific intended use have been fulfilled
Required when there is no suitable performance specification available - used to define the performance characteristics
What is verification?
Applicable when suitable performance specification is available - compare performance characteristics with specification
Applicable for CE marked kits
What is the purpose of EQA?
To monitor test reliability and accuracy
Define sensitivity
True positive rate
True positives / (True positives + False negatives)
Define specificity
True negative rate
True negatives / (True negatives + False positives)
Define reproducability
The closeness of results obtained when using the same samples under different test conditions (e.g. different operators)
Define repeatability
The closeness of results obtained when using the same samples under the same test conditions (e.g. same operators, equipment)
Define robustness
How well a test maintains precision when variables such as test conditions are changed
What is contingency planning?
Process where stakeholders:
- Identify potential events/scenarios that might impact provision of lab services
- Establish arrangements in advance to enable effective response to such events
Ensure business continuity
What type of events might occur in a genetics lab that require implementation of contingency plans?
Services going down due to issues with equipment, suppliers/consumables
Staff shortage
IT issues
New guidelines requiring additional testing
What are the 3 key steps in contingency planning?
- Assess the risks
- Create a contingency plan
- Maintain the contingency plan
