临床生化检验分析前阶段关键质量控制指标的建立与应用评价

Establishment and Application Evaluation of Key Quality Control Indicators in the Pre-Analytical Stage of Clinical Biochemical Laboratory Tests

摘要: 临床生化检验是现代医学诊断、治疗监测和预后评估的重要依据。检验全过程可分为分析前、分析中和分析后三个阶段。大量研究表明，超过60%~70%的检验误差发生于分析前阶段，该阶段已成为影响检验质量的最主要环节。因此，建立一套科学、系统、可量化的分析前阶段关键质量控制指标(Key Quality Indicators, KQIs)，并对其应用效果进行持续监测与评价，对于全面提升临床检验质量、保障患者安全具有至关重要的意义。本文旨在系统综述临床生化检验分析前阶段KQIs的建立原则、国内外常见指标内容、实施应用策略以及其评价体系，并展望未来发展趋势，为实验室质量管理提供理论参考和实践指导。

Abstract: Clinical biochemical testing serves as a crucial basis for modern medical diagnosis, treatment monitoring, and prognosis assessment. The entire testing process can be divided into three stages: pre-analytical, analytical, and post-analytical. Numerous studies have shown that over 60% to 70% of testing errors occur in the pre-analytical stage, which has become the most significant factor affecting the quality of testing. Therefore, establishing a scientific, systematic, and quantifiable set of key quality indicators (KQIs) for the pre-analytical stage and continuously monitoring and evaluating their application effects are of vital importance for comprehensively enhancing the quality of clinical testing and ensuring patient safety. This article aims to systematically review the establishment principles of KQIs in the pre-analytical stage of clinical biochemical testing, the common indicators both domestically and internationally, the implementation and application strategies, as well as their evaluation systems, and to look forward to future development trends, providing theoretical references and practical guidance for laboratory quality management.