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Path 19.01 and 19.07 > 19.07.03 EQA > Flashcards

19.07.03 EQA Flashcards

1
Q

What is EQA

A

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

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2
Q

Main objective of EQA

A

To establish inter-laboratory compatibility (WHO 1981). Benefits patient care. To educate and improve laboratory performance.

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3
Q

What is involved in EQA

A

Testing specimens of known but undisclosed content. Accuracy of technical, analytical and interpretive performance assessed compared to recognised standards. Done periodically.

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4
Q

What should an EQA cover

A
  • Entire examination process (from sample reception, preparation and analysis to interpretation and reporting).
  • Entire range of tests
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5
Q

If a disease is not covered by EQA what should a lab do

A

Develop a mechanism for determining the acceptability of procedures. Could use reference materials or inter-laboratory exchange.

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6
Q

What should a lab do with EQA results

A

Discuss at a meeting (both negative and positive results. Make actions, both preventative or corrective. These should be implemented and documented.

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7
Q

How do users view a lab that participates in EQA

A

Competent to produce results that are reliable and accurate

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8
Q

What does EQA measure

A

lab performance. Technical, analytical and interpretive. Measured against standards

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9
Q

How does EQA have a surveillance role

A

Monitors labs are adhering to professional guidelines and international standards.

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10
Q

What other benefits does EQA have

A

Educational (aiming to improve service). Can identify flaws in quality management system

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11
Q

What is accreditation

A

Formal third party recognition of competence to perform specific tasks.

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12
Q

What does UKAS stand for

A

United Kingdom accreditation service

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13
Q

What is UKAS

A

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)

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14
Q

What does UKAS accreditation mean

A

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.

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15
Q

How does UKAS operate

A

Independent of the Government. Appointed the national accreditation body by the Accreditation Regulations 2009.

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16
Q

The memorandum of understanding is between UKAS and who

A

Government via the Secretary of State for Business, Innovation and Skills (BIS)

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17
Q

How is accreditation maintained globally

A

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.

18
Q

Purpose of ILAC and IAF

A
  • 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.
19
Q

Objective of Multilateral recognition arrangements (MRA)

A

So that it covers all accreditation bodies in all countries. Once certified, accepted everywhere

20
Q

UKAS ISO 15189. Assessment stages

A

Pre-assessment (initial visit), assessment, post-assessment, surveillance, re-assessment

21
Q

How often are labs assessed

A

Main examination every 4 years. Annual surveillance in between.

22
Q

How are new lab tests accredited

A

Extension to scope assessment

23
Q

What is GenQA

A

Genomics Quality Assessment. Member of UKNEQAS consortium. Self funded not-for-profit organisation

24
Q

What kind of schemes do GenQA run

A

Somatic, germline, acquired disease, technical.

25
Q

Purpose of GenQA

A

Ensures lab test results are accurate, reliable and comparable to other labs. Requirement for UKAS accreditation

26
Q

What are the two types of GenQA assessment

A
  • Retrospective: lab audit data and or distribution of reference material
  • Prospective assessment: wet samples or web-based case scenarios.
27
Q

Genqa specimens should be processed identically to routine samples in terms of:

A
  • Staff involved
  • Testing strategy (controls, assays etc)
  • Reporting of results (issuing, data checking, authorising)
28
Q

Who marks GenQAs

A
  • Member of steering committee who set the question or by invited expert guest of committee
  • Second check by second expert
29
Q

Who determine marking criteria

A

Scheme steering committee and UK National Quality Assurance Advisory Panel (NQAAP)- Genetics. Specialist Advisory Group (SAG).

30
Q

Who monitors performance

A

Scheme organiser. They should take action if there is persistently poor performance.

31
Q

Why are performance criteria used

A

To measure a lab’s performance against national/international standards. Help to identify labs failing to meet them

32
Q

What is scored in an EQA submission

A
  • 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.
33
Q

Who ratifies performance criteria for poor performance

A

GenQA Specialist Advisory Group. Endorsed by UK National Quality Assessment Advisory Panel (NQAAP) for genetics

34
Q

What happens if a lab gets a poor performance

A
  • 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.
35
Q

Reasons for poor performance

A
  • 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
36
Q

What is persistent poor performance

A

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

37
Q

What is EMQN

A

European molecular genetics quality network. EMQN is a UKAS accredited provider of EQA services. Largest provider.

38
Q

What do EMQN EQA schemes focus on

A

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.

39
Q

Aim of EMQN

A

To harmonise professional practice by developing consensus-based guidelines

40
Q

How do EMQN EQAs work

A
  • 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

Path 19.01 and 19.07 (45 decks)

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