参加全国新生儿遗传代谢病筛查室间质量评价4年回顾

Review of national external quality assessment for neonatal screening laboratory for 4 years

目的 对本筛查中心2017至2020年间参加国家卫生健康委临床检验中心开展的新生儿遗传代谢病筛查实验室室间质量评价结果进行回顾性分析,以发现实验室存在的问题,并制定相应的改进措施。方法 将室间质评标本的检测结果上报至国家卫生健康委临床检验中心,由该中心对数据进行统计反馈,本筛查中心对反馈结果进行分析总结。结果 4年共接收国家卫生健康委临床检验中心分发的Phe、TSH12批次60份质评标本,17-OHP和G6PD各12批次60份质评标本。定量结果全部通过,符合率均为100%。定性结果 Phe全部通过,符合率为100%,TSH、G6PD、17-OHP分别有1份标本定性判断未通过,符合率均为98.33%(59/60)。所有项目评分结果均大于80%。室间质评合格。结论 开展国家卫生健康委临床检验中心组织的质量评价活动,可以发现实验过程中存在的问题,帮助提高实验室的检测技术水平,保证筛查质量。

Objective To review the results of national external quality assessment(EQA) from the National Center for Clinical Laboratories in neonatal screening laboratory from 2017 to 2020, and identify the problems in the laboratory, then formulate corresponding improvement measures. Methods The test results of the external quality assessment specimens were reported to the National Center for Clinical Laboratories, which provided statistical feedback on the data, and the screening center analyzed and summarized the feedback results. Results In 4 years, there were 60 specimens of 12 batches of Phe and TSH in total. There were 60 specimens of 12 batches of 17-OHP and G6PD, respectively. The quantitative results were all passed, and the coincidence rate was 100%. All the Phe qualitative estimation in specimens were passed, and the coincidence rate was 100%. For TSH, G6PD and 17-OHP, the coincidence rate was 98.33%(59/60). The scoring results of all items were more than 80%. The external quality assessment was qualified. Conclusion The external quality assessment organized by the National Center for Clinical Laboratories can find out the problems in the experimental process, help to improve the quality of measurement and ensure the quality of screening.