探索基于ISO 15189和生物安全的风险管理框架，提升生化检验的风险管理能力。

依据CLSI QMS03要求，构建风险管理实践框架，包括标准化的在线理论教学、基于ISO 15189和WS/T 442的不符合管理实践、基于ISO 22367风险管理过程的数智化实践。2025年42位学员对该框架的培训效果进行验证，评估掌握程度（5分制）和理论考核效果（100分制），评估生化检验的风险管理及风险系数（RPN）。

学员对风险管理实践的掌握程度（4.50±0.27）分，理论考核成绩从（61±15）分大幅提升至培训后（91±11）分（P＜0.001）。构建实验室通用的风险源库（122项），识别出适用于生化检验领域的30个潜在风险点，其中低风险27个，中风险2个，高风险1个。针对中高风险点：全过程质控监控（RPN是48）、传染性样本处理（RPN是24）及危急值报告延迟（RPN是24），采取相应的风险控制措施后，3项中高风险降低至可接受水平，并纳入风险监测列表。

构建了融合理论学习、情境化实践和工具评估的风险管理框架，可提升风险管理的能力和实践水平。

To explore a risk management framework based on ISO 15189 and biosafety to enhance risk management capabilities in biochemical testing.

According to CLSI QMS03 requirements, a risk management practice framework was constructed, including standardized online theoretical training, nonconformity management practices based on ISO 15189 and WS/T 442, and digital intelligence-based practices following the ISO 22367 risk management process. In 2025, 42 trainees were enrolled to validate the training effectiveness of this framework by assessing their mastery level (5-point scale) and theoretical assessment results (100-point scale), while evaluating risk management practices and risk priority numbers (RPN) in biochemical testing.

Trainees achieved a mastery level of 4.50±0.27 for risk management practices, and theoretical assessment scores significantly increased from 61±15 to 91±11 after training (P＜0.001). Established A general laboratory risk source database containing 122 items was established and 30 potential risk points specific to biochemical testing were identified, including 27 low-risk, 2 medium-risk, and 1 high-risk point. For the three medium- and high- risk points, quality control monitoring throughout the process (RPN 48), handling of infectious specimens (RPN 24), and delayed critical value reporting (RPN 24), corresponding risk control measures were implemented, reducing the risks to acceptable levels, and these were incorporated into the risk monitoring list.

An effective risk management framework has been established, integrating theoretical learning, contextualized practice, and risk assessment tools, thereby enhancing risk management capabilities and practical proficiency.