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The Organization for Quality Assessment of Laboratory Diagnostics (SKML) now uses sigma metrics in its external quality assessment (EQA) schemes to provide participants with a robust evaluation of analytical accuracy against performance specifications.

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Area of Science:

  • Clinical Chemistry
  • Laboratory Diagnostics
  • Quality Assessment

Background:

  • The Organization for Quality Assessment of Laboratory Diagnostics (SKML) has enhanced its general chemistry external quality assessment (EQA) scheme.
  • Innovations include using commutable samples with values assigned by Joint Committee for Traceability in Laboratory Medicine (JCTLM)-listed reference laboratories.
  • New feedback reports aim to help participants assess trueness and imprecision against performance specifications.

Purpose of the Study:

  • To introduce innovations in SKML feedback reports for evaluating laboratory performance.
  • To enable participants to judge whether their trueness and imprecision meet analytical performance specifications.
  • To enhance the accuracy assessment within EQA schemes.

Main Methods:

  • Sigma metrics were employed to calculate performance indicators known as 'sigma values'.
  • Tolerance intervals were established based on Total Error allowable (TEa) from biological variation data and state of the art (SA) criteria.
  • The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Milan consensus guided the tolerance interval calculations.

Main Results:

  • SKML feedback reports now incorporate sigma values alongside existing trueness and imprecision assessments.
  • Sigma values reflect the degree to which combined trueness and imprecision fall within defined tolerance limits.
  • Graphical representations and a two-point scoring system enhance the interpretation of results.

Conclusions:

  • The integration of sigma metrics into SKML's EQA schemes offers a powerful tool for assessing analytical accuracy.
  • Performance evaluation is now benchmarked against both TEa and SA tolerance intervals.
  • Participants gain an actionable method to verify their laboratory's performance and accuracy.