基于风险分析的规范实施产前诊断技术服务监管策略探讨  

Discussion on regulatory strategy of standardized implementation of prenatal diagnostic technical services based on risk analysis

作　　者：周爱文 王鑫 孙梦露 程锦隆 ZHOU Aiwen;WANG Xin;SUN Menglu;CHENG Jinlong(Hebei Provincial Health Commission Comprehensive Supervision Service Center,Hebei Province,Shijiazhuang050071,China;Health Supervision Bureau,Hebei Province,Shijiazhuang050081,China)

机构地区：[1]河北省卫生健康委员会综合监督服务中心,河北石家庄050071 [2]石家庄市卫生监督局,河北石家庄050081

出　　处：《中国医药导报》2024年第3期192-196,F0003,共6页China Medical Herald

基　　金：河北省医学科学研究课题计划项目(20200811)。

摘　　要：运用危害分析和关键控制点(HACCP)方法原理,借鉴相似案例研究成功经验,综合国家法律、法规、标准、技术规范对产前诊断技术服务的相关要求,结合技术特点及服务流程,对产前诊断技术服务各环节进行风险评估。根据评估结果,提出制订了包括机构资质及组织管理、临床技术服务、实验室技术服务、医学影像诊断技术服务4个环节共18个关键控制点的监管策略,达到对产前诊断机构“规范实施产前诊断技术服务”进行全面、动态监管,防控发生不良医疗结局和医疗纠纷,提高诊断质量,提升监管效力的目的。By applying the principle of hazard analysis and critical control point(HACCP) method,drawing on the successful experience of similar case studies,integrating the relevant requirements of national laws,regulations,standards and technical specifications for prenatal diagnostic technical services,and combining technical characteristics and service processes,the risk assessment of each link of prenatal diagnostic technical services is carried out.A total of 18 key control points have been formulated,including institutional qualification,and organizational management,clinical technical services,laboratory technical services,and medical imaging diagnostic technical services,to achieve comprehensive and dynamic supervision of prenatal diagnostic institutions “standardized implementation of prenatal diagnostic technical services”,prevent and control adverse medical outcomes and medical disputes,and improve diagnostic quality.The purpose of enhancing the effectiveness of regulation.

关 键 词：风险 产前诊断技术 监管 危害分析和关键控制点 

分 类 号：R197.1[医药卫生—卫生事业管理]