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目的建立并应用新生儿遗传代谢病筛查新筛质量指标分析平台,分析全国16项新生儿筛查质量指标的现状。方法按照解释性能力验证计划的方式,通过设计开发的新筛质量指标分析平台和Clinet-EQA平台系统,统一向224家新筛实验室发放电子调查表。要求参与的实验室统计2015年全年的数据并在线回报结果。采用开发的软件结合SPSS13.0进行统计分析,统计各质量指标的均值、中位数、第5百分位数(P5)和第95百分位数(P95)。结果共151家实验室回报调查结果。新筛健康教育知晓率、筛查率、检验前血片周转时间及时率、检验报告发出时间及时率和室内质控开展率5项指标的中位数均在95%以上;而不合格血片百分比、重要信息遗漏血片百分比、室内质控变异系数(CV)不合格率和失访率4项指标中位数在1%以下。同一指标各实验室之间存在较大差异。不同疾病之间的质量指标结果也存在明显差异。大多实验室的检验前血片周转时间中位数为3~5 d,检验报告发出时间中位数多在3 d内。结论新筛实验室在监测质量指标的同时应进行分析总结,并且积极持续地参加质量指标室间质量评价,加强信息化建设,实现更真实和有效的质量管理。
OBJECTIVE To establish and apply the platform for analyzing new quality indicators of neonatal screening for genetic metabolic diseases and analyze the status quo of screening quality indicators for 16 newborn infants nationwide. Methods According to the method of explanatory proficiency testing plan, the electronic questionnaire was uniformly distributed to 224 new screening laboratories through the designed and developed new screen quality index analysis platform and Clinet-EQA platform system. Participating laboratories are required to count the full year 2015 data and report the results online. The developed software and SPSS13.0 were used for statistical analysis. The mean, median, 5th percentile (P5) and 95th percentile (P95) of each quality index were calculated. Results A total of 151 laboratories return survey results. The new screen health education awareness rate, screening rate, pre-test blood bank turnover time and timely rate, test report issued time and timely rate and indoor quality control rate of 5 indicators of the median were above 95%; and unqualified blood film Percentage, the percentage of missing information of important information, indoor CV coefficient of failure (CV) and the rate of loss of follow-up rate were below 1%. The same indicator there is a big difference between the laboratories. There are also significant differences in quality indicators between different diseases. In most laboratories, the median pretest blood chip turnover time was 3 to 5 days, and the median time for the test report was within 3 days. Conclusion The new screening laboratory should analyze and summarize while monitoring the quality index, and actively and continuously participate in the quality evaluation of inter-room quality, strengthen information construction and achieve more realistic and effective quality management.