计划生育系统实验室质量管理体系的建立与实践

ESTABLISHMENT AND PRACTICE OF QUALITY MANAGEMENT SYSTEM FOR CLINIC LABORATORIES OF FAMILY PLANNING INSTITUTION

目的研究与建立适合计划生育系统实验室的质量评价管理体系。方法基于国家免费孕前优生健康检查项目,调研河北省计划生育与人口系统的临床实验室,建立相关操作规范与培训制度,并通过自主开发的室间质量评价系统进行统计分析。结果逐项发布了计划生育系统实验室的指导性规范文件,建立系统化的培训制度,成功开发与运行相关室间质量评价系统与交叠型评价方式。结论实验室建设、人员培训、制定行业规范与室间质量评价活动相结合能够快速、全面地建立质量管理体系,促进计划生育系统实验室质量提高,更好地完成国家免费孕前优生健康检查项目。

Objective To study and establish the quality evaluation and management system for the clinical laboratories of family planning institutions. Methods Based on the health examination program of pre-pregnancy of the nation,laboratories of the family planning institution were investigated. Relational standards of operation and training system were established. All the test data were analyzed by the external quality assessment system which was developed autonomously. Results Guidance documents were issued,training system was established systematically,EQA system and overlapping evaluation methods related to the clinical laboratories of family planning were developed. Conclusion Together with the laboratories developing,personnel training and composing of guidance documents,quality management system of the family planning laboratories were improved rapidly and completely by the EQA. And the examinations of the health examination program of pre-pregnancy of the nation will be completed better.