2016年至2019年先天性甲状腺功能减低症筛查质量分析

Quality analysis of screening for congenital hypothyroidism from 2016 to 2019

目的分析上报国家卫健委临床检验中心新生儿遗传代谢病筛查(新筛)中心的先天性甲状腺功能减低症(CH)16项质量指标的反馈结果,总结新筛流程中各项工作环节的质量问题。方法昆明医科大学第一附属医院新筛中心按照各项质量指标的数据填报要求,通过Clinet-EQA网络系统中的新筛质量指标分析平台,于2016年至2019年定期向国家卫健委临床检验中心上报CH质量指标的相应数据,并对反馈结果进行总结分析。结果在2016年至2019年中,每年填报上一年度新筛16项质量指标。不分病种的新筛健康教育知晓率、筛查率、检验前血片周转时间及时率(除外2015年,为89.51%)、检验报告发出时间及时率和室内质控开展率5项指标均≥90%,而不合格血片百分率(除外2016年,为1.07%)、重要信息遗漏血片百分率、室内质控变异系数不合格率和失访率4项指标均≤1%。分病种的质量指标结果与全国平均水平横向比对存在差异:CH的初筛阳性率(除外2015年)、筛查阳性率、初筛阳性召回率(除外2018年)、阳性预测值(除外2018年)、筛查病种患病率、筛查假阴性率(除外2018年)均低于全国平均水平(χ^2=0.064~308.536,均P<0.05),召回阳性率均高于全国平均水平(χ^2=45.299~159.793,均P<0.05);4年的质量指标结果纵向比较,CH的初筛阳性率、筛查阳性率、召回阳性率呈逐年降低趋势(χ^2值分别为58.483、121.359、79.264,均P<0.05),阳性预测值呈逐年增高趋势(χ^2=25.741,P<0.05),假阳性率不断降低;CH的初筛阳性召回率也呈逐年增高趋势(χ^2=84.536,P<0.05),筛查病种患病率变化较小。结论参加新筛质量指标室间质量评价并对反馈结果进行总结分析,利于及时发现问题并加以解决,评估和提高整个新筛工作流程中各环节的工作质量,以保证提供标准化、同质化的新筛服务。

Objective To analyze the feedback results of 16 quality indicators of congenital hypothyroidism(CH)reported to the neonatal genetic metabolic disease screening in the inspection center of the National Health Commission,and summarize the quality problems in the neonatal screening process.Methods According to the data filling requirements of various quality indexes,the neonatal screening center of First Affiliated Hospital of Kunming Medical University reported the corresponding data of CH quality indicators to the clinical laboratory center regularly every year through the neonatal screening quality index analysis platform in the network system of Clinet-EQA platform,and analyzed the feedback results.Results From 2016 to 2019,16 quality indexes of the neonatal screening in the previous year were filled out every year.All kinds of neonatal screening health education awareness rate,screening rate,timely rate of blood film turnaround time before examination(except 2015,89.51%),the inspection report timely rate and indoor quality control implementation rate were equal or more than 90%.And the percentage of unqualified blood tablets(except 2016,1.07%),the percentage of important information missing,interior quality variation coefficient(CV)fraction defective and lost to follow-up rate were 1%or less.There were differences between the quality index results of disease classification and the national average level:the primary screening positive rate(except 2015),screening positive rate,primary screening positive recall rate(except 2018),positive forecast value(except 2018),prevalence rate,screening false negative rates(except 2018)of CH were lower than the national average levels(χ^2=0.064~308.536,all P<0.05),while recall positive rate was higher than the national averages(χ^2=45.299~159.793,all P<0.05).The longitudinal comparison results of 4 years’quality index results showed that the primary screening positive rate,screening positive rate,recall positive rate decreased year by year(χ^2=58.483,121.359 and 79.264,respectively,all P<0.05),while positive predictive value increased year by year(χ^2=25.741,P<0.05).The false positive rate kept decreasing,while the initial screening positive recall rate of CH showed an increasing trend year by year(χ^2=84.536,P<0.05),there was little change in the prevalence rate of screened diseases groups.Conclusion To participate in the inter-room quality evaluation of neonatal screening quality indicators,analyze and summarize the feedback results,which is conducive to timely finding problems in time and solving them,evaluating and improving the work quality of each link in the whole neonatal screening process,so as to ensure to provide standardized and homogeneous neonatal screening services.