[The analytic quality in laboratory medicine: problems and perspectives (a lecture)]

Area of Science:

• Clinical laboratory analysis
• Medical diagnostics
• Quality management systems

Background:

• The article analyzes analytical error structures in clinical diagnostic laboratory analysis based on GOST R ISO 15189-2009.
• It highlights the critical importance of metrologic traceability for accurate laboratory testing.

Discussion:

• The study discusses the roles of standard reference materials, control materials, and statistical methods in ensuring analytical quality.
• International practices and methodologies for implementing ISO 15189 requirements, including validation and verification of analytical quality, are presented.
• Approaches from the Institute for Clinical and Laboratory Standards (USA) protocols (E3 23-A, ER 15-A2, N59-A) are demonstrated.

Key Insights:

• Metrologic traceability is fundamental to reliable clinical diagnostic analysis.
• Validation and verification processes are essential for meeting ISO 15189 standards in laboratory medicine.
• Optimization of quality requirements for laboratory diagnostic production is a critical area for improvement.

Outlook:

• The review of reference materials and methods provides a basis for future improvements.
• The establishment of a National Institute of Laboratory Standards is proposed to enhance overall quality and competence.