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Quality Control01:05

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Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
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Quality Assurance01:19

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Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
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Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
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External quality control in laboratory medicine. Progresses and future.

Carmen Ricós1, Pilar Fernández-Calle1,2, Carmen Perich1

  • 1Sociedad Española de Medicina del Laboratorio (SEQCML), Barcelona, Spain.

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Summary

External quality assessment (EQA) programs have evolved significantly, improving laboratory performance and ensuring accurate patient testing. Understanding different EQA models, like those using commutable controls, is key for reliable diagnostic results.

Keywords:
external controlperformance specificationsquality assurance

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Area of Science:

  • Clinical Laboratory Science
  • Quality Management in Healthcare
  • Analytical Chemistry

Background:

  • External quality assessment (EQA) programs have been crucial since the mid-20th century for identifying and addressing discrepancies in laboratory results.
  • Early EQA initiatives highlighted significant variations among laboratories, prompting the development of standardized approaches.

Purpose of the Study:

  • To review the historical development and evolution of various external quality control programs over the past four decades.
  • To analyze the strengths and weaknesses of different EQA program models.
  • To discuss the practical implications of EQA participation for laboratories.

Main Methods:

  • A critical analysis of different EQA program models based on historical data and practical experience.
  • Review of literature concerning the evolution of EQA strategies and harmonization efforts.
  • Examination of the impact of control sample types (commutable vs. non-commutable) on laboratory performance assessment.

Main Results:

  • EQA programs have advanced from simply identifying discrepancies to focusing on the clinical utility of laboratory tests.
  • Key developments include establishing common performance specifications, using EQA as an educational tool, and employing commutable control materials.
  • Harmonization efforts and collaborative forums for EQA organizers have emerged since 2000.

Conclusions:

  • Participation in EQA with commutable-reference method assigned values provides accurate insights into result inaccuracy and clinical impact.
  • EQA using non-commutable controls assesses a laboratory's performance relative to peers using the same analytical method.
  • Continued evolution and harmonization of EQA programs are essential for ensuring reliable and clinically relevant laboratory diagnostics.