目的 评估优化质量控制体系对新生儿先天性甲状腺功能减退症（congenital hypothyroidism, CH）筛查结果的影响。 方法 回顾性收集2013—2023年新生儿CH筛查数据，并比较优化质量控制体系前（2013—2018年）和优化质量控制体系后（2019—2023年）质量指标变化情况，探讨促甲状腺激素（thyroid⁃stimulating hormone, TSH）初筛值与阳性预测值的关系。 结果 共完成新生儿CH筛查1 264 541例，筛查率为90.23%，初筛阳性召回率为94.87%，失访率为5.13%。确诊CH患儿419例，CH检出率为0.33‰，阳性预测值为3.60%，开始治疗的中位日龄为32 d。与优化质量控制体系前相比，优化质量控制体系后初筛阳性召回率、召回阳性率、CH检出率均增高，失访率降低，开始治疗的日龄缩短，差异均有统计学意义（P<0.05）。TSH初筛值≥20.0 mIU/L的新生儿的CH阳性预测值为57.82%，高于TSH初筛值<20.0 mIU/L的新生儿（P<0.001）。 结论 优化质量控制体系可提升新生儿CH筛查质量；优先召回TSH初筛值≥20.0 mIU/L的新生儿有助于改善预后。

Objective To evaluate the impact of an optimized quality control system on neonatal screening outcomes for congenital hypothyroidism (CH). Methods Screening data from 2013 to 2023 were retrospectively collected. Quality indicators were compared between the pre-optimization period (2013-2018) and the post-optimization period (2019-2023). The relationship between initial thyroid-stimulating hormone (TSH) screening values and positive predictive value (PPV) was examined. Results A total of 1 264 541 neonates were screened, with a screening rate of 90.23%. The recall rate for initially positive cases was 94.87%, and the loss-to-follow-up rate was 5.13%. CH was confirmed in 419 infants, yielding a detection rate of 0.33‰ and a PPV of 3.60%. The median age at treatment initiation was 32 days. Compared with the pre-optimization period, the post-optimization period showed higher recall rate for initial positives, higher positivity among recalled cases, and higher CH detection rate, alongside a lower loss-to-follow-up rate; the age at treatment initiation was also reduced (all P<0.05). Neonates with initial TSH values ≥20.0 mIU/L had a PPV of 57.82%, significantly higher than those with TSH <20.0 mIU/L (P<0.001). Conclusions Optimizing the quality control system improves the quality of neonatal CH screening. Prioritizing the recall of neonates with initial TSH values ≥20.0 mIU/L may contribute to better prognosis.