关键词: 新生儿筛查, 质量指标, 室间质量评价

Abstract: Objective To establish and apply an analysis platform for quality indicators of newborn genetic metabolic disease screening,and to analyze current status of 16 neonatal screening quality indicators in China. Methods According to ISO/IEC 17043:2012 mode 3,a network platform for survey on neonatal screening quality indicators was designed and developed.Electronic questionnaires were distributed to 224 newborn screening laboratories,who were asked to report their 2015 annual statistical data online.The aforementioned platform and SPSS 13.0 were utilized for statistical analysis wherein means,medians,the 5th and 95th percentiles (P₅ and P₉₅) of each quality indicators were calculated. Results A total of 151 screening laboratories submitted their results.The mediums of 5 quality indicators were above 95%,including awareness rates of neonatal screening health education,screening rates,timely turnaround rates of newborn screening samples,timely reporting rates of test results,and practice rates of internal quality control; Whereas the mediums of 4 quality indicators were below 1%,including the percentages of unacceptable dried blood spot samples,the percentages of samples that lacked important information,failure rates of CVs for internal quality control,and loss rates of follow-up cases.Individual quality indicators varied between laboratories,while the rates of quality indicators showed significant distinctions among different diseases.A majority of laboratories rendered a 3~5- day pre-examination turnaround time (TAT),and reporting TAT of test results were mostly within 3 days. Conclusions Newborn screening laboratories were obliged to analyze while monitoring the quality indicators,by participating external quality assessment programs and enhancing the construction of information system,so more reliable and effective quality management can be achieved.

Key words: neonatal screening, quality indicators, external quality assessment