External quality control in laboratory medicine. Progresses and future

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.