Laboratuvar Tıbbında Kalite Göstergeleri: IFCC WG-LEPS Modeli, Kalite Spesifikasyonları ve Son Konsensus
Özet
Bu bölüm, laboratuvar tıbbında kalite göstergelerinin gelişimini, güncel kalite spesifikasyonlarını ve IFCC Laboratuvar Hataları ve Hasta Güvenliği Çalışma Grubu (WG-LEPS) tarafından geliştirilen Model of Quality Indicators (MQI) çerçevesini kapsamlı olarak ele almaktadır. Laboratuvar sonuçlarının klinik karar verme sürecindeki kritik rolü nedeniyle kalite yönetiminin yalnızca analitik fazı değil, pre-analitik ve post-analitik süreçleri de kapsaması gerektiği vurgulanmaktadır. Güncel MQI modeli, toplam test sürecini değerlendiren 26 kalite göstergesi ve 53 ölçümden oluşmakta; kalite spesifikasyonları ise gerçek laboratuvar performans verilerine dayalı persentil yaklaşımı ile optimal, istenen ve minimum performans düzeyleri olarak tanımlanmaktadır. Ayrıca kalite göstergelerinin Altı Sigma metodolojisi ile entegrasyonu sayesinde süreç performansının nesnel olarak değerlendirilmesi sağlanmaktadır. Bölümde, 2016 Padova Konsensus Konferansı ile getirilen temel değişiklikler, erken persentil yaklaşımı ile güncel konsensus modeli arasındaki farklılıklar ve Türkiye'deki laboratuvar uygulamalarına ilişkin güncel çalışmalar özetlenmektedir. Son olarak, glikoz hasta başı testlerinde (POCT) kalite göstergelerinin uygulanması, MQI modeli ile entegrasyonu ve gelecekte uluslararası harmonizasyon, ISO 15189 uyumu, sürekli kalite iyileştirmesi ve hasta güvenliğini destekleyecek stratejiler değerlendirilmektedir.
This chapter comprehensively reviews the development of quality indicators in laboratory medicine, current quality specifications, and the Model of Quality Indicators (MQI) developed by the IFCC Working Group on Laboratory Errors and Patient Safety (WG-LEPS). Because laboratory results play a critical role in clinical decision-making, quality management should encompass not only the analytical phase but also the pre-analytical and post-analytical phases of the total testing process. The current MQI framework consists of 26 quality indicators and 53 measurements designed to evaluate the entire testing process, while quality specifications are established using a percentile-based approach derived from real laboratory performance data and categorized into optimal, desirable, and minimum performance levels. Furthermore, integration of quality indicators with the Six Sigma methodology enables objective assessment of process performance and supports continuous quality improvement. The chapter also summarizes the major revisions introduced by the 2016 Padova Consensus Conference, highlights the differences between the early percentile approach and the current consensus model, and reviews recent studies on the implementation of MQI in Turkish laboratories. Finally, the application of quality indicators to glucose point-of-care testing (POCT), their integration into the MQI framework, and future strategies supporting international harmonization, compliance with ISO 15189, continuous quality improvement, and patient safety are discussed.
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