Abstract:

Objective To investigate the optimization and monitoring strategies for pre-analysis process in medical laboratory accreditation,and to improve management efficiency and ensure determination quality. Methods According to CNAS-CL02：2012 Guidelines for Quality and Competence of Medical Laboratories（ISO 15189：2012）,laboratory internal audit mechanism was used to find and analyze the problems in pre-analysis process and take effective measures. The optimization effect was assessed. Results After the optimization of technology and management,the key quality indices of pre-analysis process were improved,and the satisfaction from doctors and patients was improved. Conclusions ISO 15189 combined with pre-analysis process optimization and monitoring can improve management efficiency,in order to ensure determination quality and improve doctors' and patients' satisfaction.

Key words: Laboratory accreditation, Pre-analysis process, Process optimization