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Analytical performance specifications for external quality assessment - definitions and descriptions.

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External Quality Assurance (EQA) performance specifications (APS) vary widely between schemes. This paper recommends standardized terminology for EQA APS to ensure consistent quality assessment globally.

Keywords:
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Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Quality Management

Background:

  • External Quality Assurance (EQA) is crucial for medical laboratory analytical quality.
  • Analytical Performance Specifications (APS) assess result deviations but vary significantly across EQA schemes.
  • Harmonizing EQA APS is essential for consistent quality messaging to laboratories worldwide.

Purpose of the Study:

  • To address the wide differences in EQA APS used for the same measurands across various schemes.
  • To propose recommendations and clear terminology for EQA APS from the EFLM Task and Finish Group.
  • To facilitate understanding of EQA APS for participants and stakeholders.

Main Methods:

  • Reviewing the current landscape of EQA APS and contributing factors to variation.
  • Applying consensus models from a 2014 Milan conference for setting EQA APS.
  • Developing a standardized terminology covering six key elements of APS.

Main Results:

  • Identified significant variations in EQA APS criteria, data application, goals, and participant response elicitation.
  • Proposed six essential elements for understanding EQA APS: material matrix/commutability, target value assignment, data set, analytical property, rationale, and Milan model type.
  • Established clear terminology to ensure EQA participants understand APS compliance.

Conclusions:

  • Standardized terminology for EQA APS is necessary for harmonized quality assessment.
  • The proposed terminology will enhance clarity and consistency in EQA performance evaluation.
  • Adoption of these recommendations will improve the reliability of quality messages delivered to laboratories.