Management / Development Flashcards
What is the definition of sensitivity and what is the equation?
The ability of a test to correctly identify patients with the specified condition
TP/(TP+FN) * 100
What is the definition of specificity and what is the equation?
The ability of a test to correctly identify patients without the specified condition
TN/(TN+FP) * 100
What is the definition of the positive predictive value/precision and what is the equation?
The probability that patients with a positive result truly have the specified condition
TP/(TP+FP) * 100
What is the definition of the negative predictive value and what is the equation?
The probability that patients with a negative result truly does not have the specified condition
TN/(TN+FN) * 100
What is the definition of accuracy and what is the equation?
The ability of a test to differentiate between the specific condition/disease and a healthy individual
(TP + TN) / (TP + TN + FP + FN) * 100
What is the definition of a tests limit of detection?
The limit of detection is the estimated lowest level that can be reliably distinguished from absence.
What is the definition of the repeatability of a test?
The level of agreement between replicates in the exact same conditions (operator, reagents etc)
What is the definition of the reproducibility of a test?
Ability of a test to produce the same result under different conditions (operator, reagents etc)
What is the definition of the robustness of a test?
Assessment of the ability of a test to produce the same results when used outside is verified range (e.g. differences in temp, humidity etc)
What are the 15 considerations to be taken into account when deciding on whether to introduce a new test into the laboratory?
- Is there a clinical need for the test? - # of samples, disease incidence etc.
- Is there a clinical demand for the test? - who will order the test, where would referrals come from?
- Does the test have clinical utility? - would results affect treatment or health outcome, low penetrance, environmental effect?
- Is the test ethical/legal?
- Technical testing strategy - what type of test? what sample type? mutation types? Accuracy, reliability, sensitivity/specificity etc. Screen or diagnostic?
- Impact on current working practices - potential workload, staffing, set-up time
- Will the new test replace an existing test? - improve TAT? improve DxYx, how much DNA/cells needed? controls needed? externally or internally validated test? confirmation of results?
- Budget considerations - staffing, consumables, equipment, competitive pricing, need a business case? NCG funded test?
- Implications for staffing and training requirements
- Equipment/lab set-up - which techniques are best, new or existing equipment?
- Population factors
- Background work - disease information etc
- Validation work - including SOP writing, audits, enrol in EQA scheme
- Implement service - training other staff, ongoing improvements, authorise SOP, worksheets and information management, report templates, advertise service, gene dossier?
- Request user feedback once test established - user surveys
What training should be offered to minimise risk to staff?
Manual handling
COSHH assessments
Prevention of infection
Clinical risk/risks to service provision
Give some examples of risks in the lab
Sample mix-up Hazardous chemical usage Manual handling Incorrect information on report Streamlining services to cut budget / staff shortages Introduction of a new a technology Needlestick injury
What should be considered the most effective way to reduce risk?
Staff training
How can risk be managed?
Identify what can go wrong
Understand what causes things to go wrong
Learning lessons from adverse effects
Ensuring action is taken to precent recurrence
Put measures in place to reduce risk.
Define Risk
The potential that an action or inaction will result in an adverse outcome.
List some components of clinical governance
Clinical audit Clinical effectiveness Education and training Risk management Openness R&D Clinical information and IT Patient and public involvement Staffing
What are the three key attributes of clinical governance?
- recognisably high standards of care
- Accountability and responsibility for those standards of care
- Constant improvement
Define clinical governance
Clinical governance is a system through which NHS organisations are responsible and accountable improving quality of their services and safeguarding high standards of care.
Outline the Continuous Improvement Cycle
Plan (determine user requirements and plan how these will be met)
Do (acquire resources to meet requirements, document procedures, provide traiinng, implement working procedure)
Check (audit to ensure activities are carried out correctly)
Act (correct and prevent when things go wrong)
What are CAPA?
Corrective and Preventative actions.
Corrective actions eliminate the cause of the non-conformity
Preventative actions stop a potential non-conformity
How does a QMS stop errors occurring?
Ensures all aspects of a process are considered
Documents procedures to ensure standards are met
Encourages review of techniques to ensure up-to-date methods are used
Controls SOP changes
Provides platform for continuous improvement
Give examples of QMS documentation
Quality Manual Policies Calibration certificates COSHH forms SOPs H&S records Meeting minutes Job descriptions and staff records Staff training records and CPD Appraisal records Maintenance records Batch records Incident forms Audit records Verification/Validation records Test results/reports
What are the 9 components of the QMS?
Quality manual QMS documentation Quality Assurance - getting it right first time Internal QC Quality Improvement Continual Improvement cycle Quality Assessment Audit Accreditation
What is a Quality Management System?
A defined set of procedures, structures, regulations and responsibilities that ensure the organisation is capable of delivering required standard of services
What should be contained within an audit record?
Name of staff member performing the audit Date performed Reference number The scope of the audit Any non-conformaties Any CAPAs Date and signature on completion
Describe the 4 classes of audit and give an example of each
Clinical audits - they form part of clinical governance, they are required to provide evidence of current practice against national guidelines and monitor patient outcomes. They can be prospective or retrospective. e.g. referral patterns or TATs
Vertical audits - allow audit of an entire workflow/process. Used in labs to follow one sample from receipt to report - record everything (temperature of fridges, lot numbers, staff training records etc.)
Horizontal audits - examine one part of the process in detail. Can be used to determine if all batch records are held in the right place.
Examination audits - Witness to see if a SOP is being correctly followed, or staff members are appropriately trained.
Name the 4 classes of Audit.
- Clinical audit
- Horizontal Audit
- Vertical Audit
- Examination audit
What are the purposes of audit?
To demonstrate quality of service Identify areas for change Continued improvement Assist in implementation of guidelines and services Monitor consistency of performance Measure performance against benchmark
What are the 5 stages of the audit cycle?
Set standards Measure current practice Compare practice vs standards Reflect, plan, implement change Re-audit
What is the definition of “Audit”
A systematic, documented and independent process to obtain evidence and objectively evaluate the extent to which a set of criteria are fulfilled.
How can stratified medicine be defined?
Various definitions:
The grouping of patients based on risk of disease or response to therapy by using diagnostic tests or techniques.
The tailoring of medical treatment to the individual characteristics of each patient [through assigning patients to certain subpopulations].
[Within genetics}: The use of genetic or other biomarker information to improve the safety, effectiveness and health outcomes of patients via more efficiently targeted risk stratification, prevention and tailored medication and treatment management approaches.
An emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.
What are the main benefits of personalised medicine within genomic testing?
Better/more accurate diagnosis (molecular sub typing of disease) e.g. in CNS tumours
Optimal treatment selection e.g. response to TKIs / immunotherapy
Improved/more accurate prognostication e.g. high/low risk profiles in acute leukaemias
Avoidance of drug toxicities (e.g. DPYD/TPMT testing)
More cost effective healthcare (improved response rates by not giving patients expensive drugs that are unlikely to work)
What are the four ‘P’s of precision medicine?
Precision medicine involves the ‘Four Ps’:
- Prediction and prevention of disease
- Precise diagnosis
- Personalised interventions
- Participatory role for patients
What is personalised medicine?
Selection of the best approach to manage a specific patient, based on available biological information about the patient as well as a patient’s personal preferences, environmental factors, social factors and other factors that may affect the treatment choice.
What is precision medicine?
A disease treatment or prevention that takes into account some individual variability. An example may be the decision to proceed with allogeneic stem cell transplant in the context of AML patients in complete morphological remission: clinicians have to consider not just the prognostic risk associated with the genetic profile of the AML clone, but also patient’s age, co-morbidities, MRD, personal preferences.
What are the main advantages to the integration of molecular pathology services?
- Higher volumes of testing mean lower costs per test
- Expertise is concentrated, resulting in higher-quality testing
- All molecular tests are available to all patients in each region in a single location, simplifying logistics
What are the main challenges to integration of molecular pathology services?
• Turnaround times deteriorate severely, both from transporting tissue/reports and in cases being queued for testing in large laboratories.
