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

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.