危害分析和关键控制点法在产前诊断技术服务医疗风险管理中的研究与应用

Research and application of hazard analysis critical control point method in medical risk management of prenatal diagnostic technology services

本文运用危害分析和关键控制点(HACCP)法对产前诊断技术服务医疗风险进行管控,以提高医疗机构风险防控效能,保障母婴安全。通过对产前诊断技术服务流程进行危害分析,建立4个维度(资质管理和组织建设、临床技术、实验室检测技术、医学影像诊断技术)18个关键控制点(CCP),针对CCP制订计划、实施管控措施、评价管控效果。HACCP实施后,产前诊断技术服务的风险行为减少,不良医疗结局(漏诊、误诊、投诉举报、医疗纠纷、行政处罚)发生率降低,同时,构建科学有效的风险管控体系,提高了机构及工作人员的风险预警意识和诊断技术水平。

This article uses hazard analysis and critical control point(HACCP)method to control medical risks in prenatal diagnostic technology services,aims to improve the effectiveness of risk prevention and control in medical institutions,and ensure the safety of mother and baby.By conducting hazard analysis on the service process of prenatal diagnosis technology,18 critical control points(CCP)were established in four dimensions(qualification management and organizational construction,clinical technology,laboratory testing technology,and medical imaging diagnosis technology),plans were formulated,control measures were implemented,and control effects were evaluated for CCP.After the implementation of HACCP,the risk behavior of prenatal diagnostic technology services has significantly decreased,and the incidence of adverse medical outcomes(missed diagnosis,misdiagnosis,complaints and reports,medical disputes,administrative penalties)has significantly decreased.At the same time,a scientific and effective risk control system has been established,which has improved the risk warning awareness and diagnostic technology level of staff.