Performance Specifications for EQAS Graham Jones (Australia) - - PowerPoint PPT Presentation

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Performance Specifications for EQAS Graham Jones (Australia) - - PowerPoint PPT Presentation

Performance Specifications for EQAS Graham Jones (Australia) Membership Chair: Graham Jones (AU) Graham.Jones@svha.org.au Stphanie Albarde (FR) steph.albarede@gmail.com Gabriela Gutirrez (SP) gguti@clinic.ub.es Mauro


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Performance Specifications for EQAS

Graham Jones (Australia)

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Membership

  • Chair: Graham Jones (AU) Graham.Jones@svha.org.au
  • Stéphanie Albarède (FR) steph.albarede@gmail.com
  • Gabriela Gutiérrez (SP) gguti@clinic.ub.es
  • Mauro Panteghini (IT) EFLMpresident@efcclm.eu
  • Marc Thelen (NL) mthelen@amphia.nl
  • Anne Vegard Stavelin (NO) anne.stavelin@noklus.no
  • Annette Thomas (UK) annette.thomas2@wales.nhs.uk
  • Pat Twomey (UK) taptwomey@aol.com
  • Emma Ventura (SP) eventura@seqc.es
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External Quality Assessment

  • A “Pillar” of Traceability
  • Confirms manufacturer’s / laboratory claims
  • Assess

– Within-laboratory performance – Between-laboratory performance

  • Assess:

– Precision – Bias – Analytical Specificity

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EQA Assessment (single Result)

  • Assessment: Distance from target

– Target – Distance from Target

  • Performance Specification is used to assess

distance from Target

  • “Defining Analytical Performance”

(Milan 2014)

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Aims

  • Apply Milan Criteria to describe EQA

performance specifications

  • Develop common performance specifications

based on Milan Criteria

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EQA Performance Specifications

  • Currently wide variation in practice
  • Range between very “tight” and very “loose”
  • May be based on:

– Statistics (State of the Art, Milan 3) – Clinical effect (Outcome or BV, Milan 1 or 2) – Other (eg regulatory, combination)

  • Can these be harmonised?
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  • 1. Description of Performance

Specification

  • Minimum specification, which all reasonable

laboratories would be expected to pass;

  • Expected specification, which most laboratories

should pass but with the aim to improve those that do not meet the specification

  • Aspirational specification where some or many

laboratories will not meet until better methods are developed.

  • Across this continuum, the specifications would be

expected to move from looser to tighter.

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Performance Specifications

(looser) Regulatory (3)SAE ++ All labs/tests pass (tighter) Aspirational (2) Optimal BV Some tests fail

EQA Performance Specifications

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  • 2. Expected Response
  • Regulatory. Laboratories should not fail. An example is

the CLIA regulations in the USA.

  • Mandated Response. Failures require mandatory

investigation involving time and effort with compliance.

  • Laboratory determined response. Results outside limits

should be followed up, with the amount of effort depending on the nature and severity of the failure.

  • Industry response. If limits are too tight for current

methods, the response must come from industry rather than individual laboratories.

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  • 3. Clinical Implications
  • Assays meet a tight specification: indicates that

patients can be appropriately monitored with sequential results from different laboratories where all their assays meet this standard.

  • Assays meet a looser specification: monitoring

may be sub-optimal, but sharing of reference intervals is supported.

  • Assays do not meet a loose specification: Use of

common decision points not supported, separate reference intervals are required.

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Assessment of current EQAS performance specifications

  • Surveys / other tools to:

– Compare the types of EQAS performance specifications in use – Assess the information provided by EQAS providers to their customers – Identify best practice

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Recommending Specifications

  • Consider criteria for “Common Specifications”
  • Consider assessment process
  • This should focus on “Type 1” EQA programs

(Commutable material, reference measurement for target, repeated samples).

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Actions

  • Develop terminology to describe EQA

Performance Specifications

  • Use terminology to describe current limits
  • Support EQA using descriptions to

communicate specifications (and meaning of specification) to clients

  • Consider best specifications to meet goals

(May be different for different EQA programs)

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Action Plan

  • 1. Initial draft proposal circulated ~ 2 weeks ago
  • 2. Meeting of most members tomorrow night
  • 3. Aim for further meeting at EQALM (Bergen,

October 2015)

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Comments / Questions (from me)

  • 1. We need a good relationship with EQALM
  • 2. Should we engage other non-European EQA

providers (eg CAP, CEQAL)?

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Comments / Questions