Center for Clinical Molecular Medicine & Newborn Screening, Children's Hospital of Chongqing Medical University; National Clinical Research Center for Child Health and Disorders; Ministry of Education Key Laboratory of Child Development and Disorders; China International Science and Technology Cooperation Base of Child Development and Critical Disorders; Chongqing, China.
Chongqing Key Laboratory of Pediatrics, Chongqing, China.
J Int Med Res. 2021 Apr;49(4):3000605211002999. doi: 10.1177/03000605211002999.
Newborn screening (NBS) programs benefit tens of millions of infants worldwide each year. However, the extremely large screening populations and number of laboratories involved pose great challenges to maintaining high screening quality. To achieve continuous quality improvement, we established a comprehensive quality management system (CQMS) in southwest China.
External quality assessment (EQA) and internal quality control were carried out for basic quality management. We used 16 quality indicators (QIs) to monitor the entire screening process, with external supervision from the China National Accreditation Service for Conformity Assessment. All retrospective data for quality assessment were collected consecutively from laboratory management and patient follow-up systems.
From 2015 to 2019, satisfactory EQA performance was achieved, with an average score greater than 97 for each screening item. QI monitoring showed that NBS quality improved continuously. The rate of health education provision increased from 90.9% to 100% and the recall rate after a positive primary screening increased from 85.4% to 99.2%. The unsatisfactory specimen rate and rate of newborns lost to follow-up decreased to 0.38% and 0.08%, respectively.
Implementing a CQMS and monitoring the whole screening process using QIs may yield continuous quality improvement of NBS.
新生儿筛查（NBS）项目每年使全球数千万婴儿受益。然而，庞大的筛查人群和众多实验室参与，给保持高质量筛查带来了巨大挑战。为了实现持续质量改进，我们在中国西南部建立了全面质量管理体系（CQMS）。
采用外部质量评估（EQA）和内部质量控制进行基本质量管理。我们使用 16 个质量指标（QIs）来监测整个筛查过程，外部监督由中国合格评定国家认可委员会提供。所有用于质量评估的回顾性数据均连续从实验室管理和患者随访系统中收集。
2015 年至 2019 年，EQA 表现令人满意，每个筛查项目的平均得分均大于 97。QI 监测显示，NBS 质量持续提高。健康教育覆盖率从 90.9%提高到 100%，初筛阳性后的召回率从 85.4%提高到 99.2%。不满意标本率和失访新生儿率分别降至 0.38%和 0.08%。
实施 CQMS 并使用 QIs 监测整个筛查过程可实现 NBS 的持续质量改进。
