Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Main objective of EQA

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

How do users view a lab that participates in EQA

A

Competent to produce results that are reliable and accurate

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

What does EQA measure

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

How does EQA have a surveillance role

A

Monitors labs are adhering to professional guidelines and international standards.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

What other benefits does EQA have

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

What is accreditation

A

Formal third party recognition of competence to perform specific tasks.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

What does UKAS stand for

A

United Kingdom accreditation service

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

How does UKAS operate

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

The memorandum of understanding is between UKAS and who

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions