江苏省国家免费孕前优生项目实验室现场质量督查结果分析

Analysis of on site quality inspection results of laboratories of the free pre pregnancy physical examination project in Jiang-su Province

目的:分析江苏省国家免费孕前优生项目实验室现场质量督查结果,为持续提升孕前优生项目实验室的质量管理水平与技术服务能力提供依据和建议.方法:在全省99个开展国家免费孕前优生项目的实验室中,共选取64个作为现场质量督查的对象,以现场检测、文件查阅、现场交流、问卷调查等方式对实验室人员的专业素养、设备性能、检测项目开展情况、质量管理文书文件、室内质控、室间质评等方面进行综合评估.结果:多数孕前优生实验室已建立比较完善的质量管理体系,能较好地满足国家免费孕前优生项目规范开展的需求.制定了仪器设备、检测项目标准操作规程的实验室占比分别为90.6%、76.6%,具有分析前、中、后管理文件和仪器设备使用管理记录的实验室占比分别为75.0%、62.5%,能规范开展室内质控、积极参加临检中心组织的室间质评活动的实验室占比分别为60.9%、81.3%.但在质量管理方面也存在一些问题,如未规范开展室内质控、缺乏仪器设备校准记录、质量管理培训的参加率偏低(分别占39.1%、36.5%、55.4%).结论:江苏省开展国家免费孕前优生项目的实验室临床检验质量总体较好,在后续的工作中应该进一步加强监管,督促相关实验室持续改进临床检验质量.

Objective: To analyze the results of on-site quality inspection of laboratories of the free pre-pregnancy physical examination project in Jiangsu Province, and to provide evidences and suggestions for continuously improving the quality management level and technical service capacity of project laboratories. Methods: A total 64 laboratories were selected as the objects of the on-site quality inspection from 99 service institutions that carried out the national free pre-pregnancy physical examination project in Jiangsu Province. Comprehensive evaluation on professional quality, equipment performance, testing project development, quality management documents, internal quality control, and external quality assessment were carried out by means of on-site inspection, document consulting, on-site communication, and questionnaire survey. Results: Most laboratories had established relatively perfect quality management system, which could meet the needs of standardized development of national free pre-pregnancy physical examination project. The proportions of the laboratories instrument with planning and the formulated SOP of test items were 90.6% and 76.6%, the proportions of laboratories with management documents about before, during, and after analysis and instrument used management records were 75.0% and 62.5%, and the proportions of laboratories with standardize internal quality control and actively participated in the external quality assessment organized by the inspection center were 60.9% and 81.3%. However, there were still some problems in the quality management, such as unstandardized internal quality controlling,lack of equipment calibration records,and the low participation rate of quality management training,the proportions of which were 39.1%,36.5%,and 55.4%,respectively.Conclusion:The clinical test quality of the laboratories in the national free pre-pregnancy physical examination in Jiangsu province is generally good,but there are still some problems.So,the supervision of laboratories should be further strengthened,and the quality of clinical test of the relevant units should be urged to continuously improve in the later work.