基于ISO 15189： 2012个体化药学实验室质量管控实践

Practice of Quality Management and Control in Individualized Pharmaceutical Laboratory Based on ISO 15189: 2012

关键词:  ISO 15189:2012  个体化药学实验室  过程管理  环节控制  质量指标

Key words:  ISO 15189:2012  individualized pharmaceutical laboratory  process management  link control  quality indicator

摘要:

目的 探讨适合个体化药学实验室质量控制的管理模式。方法 按照ISO 15189：2012对医学实验室质量控制的要求，以样本为中心优化管理流程、痕迹管理完善质量管控全程化、确定实验室质量指标、梳理核查要点、强化临床沟通等措施，对比分析管理前后各项指标变化。结果 各项管理手段实施后样本运送问题发生率和超时交付报告百分率明显下降，临床沟通满意率、危急值通报率、报告投送准确率显著升高。结论 规范化药学实验室质量管理，严把分析前、中、后三大质量控制环节，定期考察各环节质量指标，确保个体化药学服务结果准确可靠。

Abstract:

OBJECTIVE To discuss a management mode which is used in quality control in individualized pharmaceutical laboratory (IPL). METHODS A quality control system was built and improved in individualized pharmaceutical laboratory based on the requirement of ISO 15189:2012. Five strategies had also been summarized for the link control and process management. And the indicators were compared before and after the management. RESULTS After these managements, the sample delivery problem incidence rate and overdue reporting percentage decreased obviously, and clinical satisfaction rate, critical value notification rate and report delivery accuracy increased as well. CONCLUSION An accurate and reliable individualized pharmaceutical service result can be ensured by standardizing quality management of IPL, and strictly controlling the three links of pre-test, test and post-analytical process.