Аннотация
В обзоре проведён анализ международных моделей внешней оценки качества (ВОК) клинических лабораторных исследований. Рассмотрены нормативно-обязательные, профессионально-ориентированные и гибридные государственно-профессиональные системы. Оценивались правовой статус ВОК, обязательность участия, охват лабораторий, санкционные механизмы, аккредитация провайдеров, внедрение метрологической прослеживаемости и использование биологических эталонов (WHO IS, NIBSC, CDC GeT-RM, материалы JCTLM). Представлены унифицированные качественные характеристики и ориентировочные аналитические метрики, отражающие межлабораторную вариабельность, успешность прохождения EQA и межметодные смещения.
Анализ показывает, что наиболее устойчивые модели ВОК объединяют высокий охват, строгое регулирование или зрелые профессиональные механизмы, развитую метрологическую инфраструктуру и системное использование эталонов. Российская система характеризуется добровольным участием и ограниченным охватом, но демонстрирует положительную динамику благодаря развитию метрологической базы и созданию национальной сети биостандартизации. Международный опыт позволяет определить ключевые направления совершенствования российской модели ВОК для повышения сопоставимости и клинической надёжности лабораторных результатов.
Annotation
The analysis of international models of external quality assessment (EQA) in clinical laboratory testing is presented in this review. Mandatory regulatory systems, professionally-driven models, and hybrid state-professional frameworks are examined. The assessment covered the legal status of EQA, requirements for laboratory participation, coverage of laboratory networks, sanctioning mechanisms, accreditation of EQA providers, implementation of metrological traceability, and the use of biological reference materials (WHO IS, NIBSC, CDC GeT-RM, JCTLM-listed materials). Unified qualitative characteristics and indicative analytical metrics reflecting interlaboratory variability, EQA pass rates, and intermethod biases are provided.
The analysis shows that the most robust EQA models combine high participation coverage, strict regulatory or mature professional oversight mechanisms, well-developed metrological infrastructure, and systematic use of reference materials. The Russian system is characterized by voluntary participation and limited coverage but demonstrates positive dynamics due to the development of metrological infrastructure and the establishment of the national network for biological standardization. International experience makes it possible to identify priority directions for strengthening the Russian EQA model to improve the comparability and clinical reliability of laboratory results.
Key words: external quality assessment; proficiency testing; metrological traceability; biological reference materials; standardization; clinical laboratory diagnostics
Список литературы
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