What is the basic steps of an Audit
1) Set Standards
2) Measure current practice
3) Compare results of current practice Vs standards set
4) reflect, plan and implement change
5) re-audit
why audit?
1 - demonstrate quality of service to users
2 - identify areas for change
3 - improve quality
4 -assist with implementation of policies + guidelines
5 - monitor consistency of performance
6 - measure actual performance Vs benchmark
what are the 4 types of audit?
1) Clinical
systematic review of care against explicit criteria
2) Verticle
exams all parts of a process on a single item (i.e. a sample - from booking in, to extraction, to testing, reporting etc)
3) horizontal
looks at a single process - multiple items
4) examination
witness a procedure being performed - is it done in accordance to SOP
What are the 5 key aspects of a Quality Management System
1) People, training and experience
2) Equipment and facilities
3) Reviewing and checking
4) Processes
5) Documents and records
What may be considered under the QMS People, training and experience category?
- job descriptions
- staff profiles
- records of staff training (competency docs)
- CPD
- staff reviews (PDRs)
What may be considered under the QMS Equipment and facilities category?
- equipment lists
- maintenance records
- calibration
What may be considered under the QMS Reviewing and checking category?
- descriptions of set standards
- records of update
What may be considered under the QMS Processes category?
- SOP
- COSSH
- risk assessment
- BPG
What may be considered under the QMS Documents and records category?
- lists of secure controlled documents
- meeting minutes
- distribution lists
- contacts
What approaches can be taken to met ‘Quality improvement’ in a diagnostic lab
- Internal audits (non-compliance found and corrective actions put in place)
- Set quality objectives
- User Surveys
- Use of error log / adverse incident recording system
- complaint policy
What approaches can be taken to met ‘Quality maintenance’ in a diagnostic lab
- Assigned quality manager / team
- regular assessment of Key Performance Indicators (KPIs)
- staff training
- assessment through external quality schemes
- appropriate laboratory management structure
what is the key ISO standard for diagnostic lab
ISO15189
What are the 8 sections CPA / UKAS assess based upon ISO15189
1 - Organisation and QMS 2 - Personnel 3 - Premise and environment 4 - Equipment (inc. IT) 5 - Pre-examination process 6 - Examination process 7 - post-examination process 8 - Evaluation & quality assurance
What can be assessed by an EQA
1 - technical performance (DNA quantification)
2 - Analytical (detection of abnormality)
3 - Interpretative (variant classification)
What is UKAS
- UKAS is the UK accreditation Service
- Sole national accreditation body recognised by the government
- genetic labs are expected to comply with ISO15189
Can you provide an example of an EQA scheme
GenQA
what are the 5 steps UKAS follows
1 - Pre-assessment 2 - Assessment (on site visit) 3 - Post-assessment 4 - Surveillence Report 5 - Re-assessment
Name the most common framework used to evaluate the performance of a genetic test (was previously used by UKGTN)
ACCE:
A - Analytical Validity
C - Clinical Validity
C - Clinical Utility
E - ethical, legal and social implications
What is Analytical Validity
- need to consider how accurate and reliable the test measures genotype of interest
- sensitivity
- specificity
- repeatability
What is Clinical Validity
- how consistently / accurately the test detects/predicts the immediate/final outcome of interest:
- positive predictive value - the probability of having / developing a disorder with a positive test result
- negative predictive value - the probability of NOT having / NOT developing a disorder following a negative test result.
i.e. if 50 mutations are currently known to cause disease - if test all 50 and get negative result = highly unlikely to develop disorder. BUT if only offer test for 1 / 50 mutations and get a negative result, its a bit of a futile test
what is Clinical Utility
- how likely will a test significantly improve a patients life (i.e. why test?). Reasons could be:
> Diagnosis (would a diagnosis change management / prevent another more invasive test?)
> Prognosis and Management - would result benefit prognosis/managment
> Pre-symptomatic testing - do results open upon accurate future predictive testing
> Genetic Risk assessment - will as result reduce the need for clinical investigation in other family members
What can the ACCE framework help with
Implementing a new diagnosis test
What is the main difference between a Verification and a Validation
Is a suitable performance specification available?
If yes = Verifiation
If No = validation
Provide an example of a Verification
- Introduction of a new test which has been CE marked.
- Introduction of CF-EU2 kit from commercial company.
- Kit has specified protocol to adhere to and performance (mutations detected, sensitivity and specificity) is all documented.
- verification is required to confirm that kit complies with its own set standards (i.e. the mutations it should detect, are detected)
