Discussion on regulatory strategy of standardized implementation of prenatal diagnostic technical services based on risk analysis
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.
RiskPrenatal testing technologySupervisionHazard analysis and critical control point
万方数据
维普
