19.07.03 EQA Flashcards
What is EQA
A system of objectively assessing the laboratory performance by an external agency. Results are compared to those of an approved reference lab. Now required for lab accreditation
Main objective of EQA
To establish inter-laboratory compatibility (WHO 1981). Benefits patient care. To educate and improve laboratory performance.
What is involved in EQA
Testing specimens of known but undisclosed content. Accuracy of technical, analytical and interpretive performance assessed compared to recognised standards. Done periodically.
What should an EQA cover
- Entire examination process (from sample reception, preparation and analysis to interpretation and reporting).
- Entire range of tests
If a disease is not covered by EQA what should a lab do
Develop a mechanism for determining the acceptability of procedures. Could use reference materials or inter-laboratory exchange.
What should a lab do with EQA results
Discuss at a meeting (both negative and positive results. Make actions, both preventative or corrective. These should be implemented and documented.
How do users view a lab that participates in EQA
Competent to produce results that are reliable and accurate
What does EQA measure
lab performance. Technical, analytical and interpretive. Measured against standards
How does EQA have a surveillance role
Monitors labs are adhering to professional guidelines and international standards.
What other benefits does EQA have
Educational (aiming to improve service). Can identify flaws in quality management system
What is accreditation
Formal third party recognition of competence to perform specific tasks.
What does UKAS stand for
United Kingdom accreditation service
What is UKAS
A national accreditation body, recognised by the government to assess (against internationally agreed standards- ISO) organisations that provide testing (also labs that calibrate, inspect or certification services)
What does UKAS accreditation mean
That the evaluator can demonstrate to customers that it has been successfully assessed against internationally recognised standards. They can demonstrate their competence, impartiality and performance capability.
How does UKAS operate
Independent of the Government. Appointed the national accreditation body by the Accreditation Regulations 2009.
The memorandum of understanding is between UKAS and who
Government via the Secretary of State for Business, Innovation and Skills (BIS)
How is accreditation maintained globally
UKAS member of European Co-operation on Accreditation (EA), International Laboratory Accreditation cooperation (ILAC), International accreditation Forum (IAF). Work together and coordinate efforts to enhance accreditation and conformity assessment worldwide.
Purpose of ILAC and IAF
- Ensure that its accreditation body members only accredit bodies that are competent to do the work they undertake and are to subject to conflicts of interest
- Establish mutual recognition arrangements (Multilateral recognition arrangements MRA) between accreditation bodies.
Objective of Multilateral recognition arrangements (MRA)
So that it covers all accreditation bodies in all countries. Once certified, accepted everywhere
UKAS ISO 15189. Assessment stages
Pre-assessment (initial visit), assessment, post-assessment, surveillance, re-assessment
How often are labs assessed
Main examination every 4 years. Annual surveillance in between.
How are new lab tests accredited
Extension to scope assessment
What is GenQA
Genomics Quality Assessment. Member of UKNEQAS consortium. Self funded not-for-profit organisation
What kind of schemes do GenQA run
Somatic, germline, acquired disease, technical.
Purpose of GenQA
Ensures lab test results are accurate, reliable and comparable to other labs. Requirement for UKAS accreditation
What are the two types of GenQA assessment
- Retrospective: lab audit data and or distribution of reference material
- Prospective assessment: wet samples or web-based case scenarios.
Genqa specimens should be processed identically to routine samples in terms of:
- Staff involved
- Testing strategy (controls, assays etc)
- Reporting of results (issuing, data checking, authorising)
Who marks GenQAs
- Member of steering committee who set the question or by invited expert guest of committee
- Second check by second expert
Who determine marking criteria
Scheme steering committee and UK National Quality Assurance Advisory Panel (NQAAP)- Genetics. Specialist Advisory Group (SAG).
Who monitors performance
Scheme organiser. They should take action if there is persistently poor performance.
Why are performance criteria used
To measure a lab’s performance against national/international standards. Help to identify labs failing to meet them
What is scored in an EQA submission
- Analysis: quality of data, HGVS nomenclature, written description
- Interpretation: interpretation of result, including clinical advice and follow up studies
- Clerical accuracy: report contents and clerical accuracy.
Who ratifies performance criteria for poor performance
GenQA Specialist Advisory Group. Endorsed by UK National Quality Assessment Advisory Panel (NQAAP) for genetics
What happens if a lab gets a poor performance
- Referred to relevant SAG or GenQA advisory board
- Asked to do a root cause analysis
- To provide a summary of corrective and preventative actions to scheme.
Reasons for poor performance
- Non submission of results
- Critical genotyping/analytical error (incorrect result for patient)
- Critical interpretation error which adversely affects patient management
- No interpretation of results
- Incorrect/inappropriate advice
What is persistent poor performance
Labs who perform poorly in two out of any three consecutive EQA rounds. Or incur a poor performance within one year following a previous persistent poor performance designation
What is EMQN
European molecular genetics quality network. EMQN is a UKAS accredited provider of EQA services. Largest provider.
What do EMQN EQA schemes focus on
The whole analytical process of molecular genetics labs. Genotyping, interpreting data in light of clinical information supplied with the referral and to produce a clear and accurate report.
Aim of EMQN
To harmonise professional practice by developing consensus-based guidelines
How do EMQN EQAs work
- 3 samples once a year with mock clinical referrals.
- 8 to 10 weeks to perform analysis and report findings.
- Assessed by 2 expert peer assessors
- Results with general comments, recommendations and improvements
