Evaluation of the Comprehensive Quality Management System by Quality Indicators of Newborn Screening in China from 2015 to 2020: An Observational Study

Background: The quality indicators (QIs) were issued to monitor the comprehensive quality management system (CQMS) of newborn screening (NBS) in China in 2014. However, few studies on the evaluation of CQMS are available in China. This study aims to evaluate the CQMS by QIs of NBS at the national level in China between 2015 and 2020.Methods: Data were sourced from the National Center for Clinical Laboratories (NCCL) from 2015 and 2020, and 16 QIs monitoring the entire screening process were used to assess the CQMS of NBS. We firstly estimated the rates of 16 QIs by laboratory types (NBSCs vs. non-NBSCs), and regions (Eastern vs. Central vs. Western). Then, we used the Radar chart and the Topsis method to evaluate the performance of the CQMS (PCQMS) of NBS. We further used euclidean distance and ranking-order consistency to optimize the QIs, by assessing the similarity of CQMS before and after deleting some QIs. Results: From 2015 to 2020, a total of 351 NBS laboratories participated in the CQMS program, including 231 (65.8%) NBSCs and 120 (34.2%) non-NBSCs. For regional distribution, there were 142 (42.6%), 109 (32.7%), and 82 (24.6%) NBS laboratories in Eastern, Central, and Western China, respectively. For a single QI, the overall rate of QI1(Newborn health education provision), QI4 (DBS samples with acceptable transport time), QI5 (Test reports with an acceptable time from the specimen), QI6 (Test items running IQC), QI15 (Newborns that received NBS) were all above 90%, and that of QI2 (Unsatisfactory DBS samples), QI3 (Cards missing essential information), QI7 (Unsatisfactory testing results in IQC), QI16 (Newborns lost to follow-up) were controlled under 3%. In terms of QIs related to screening diseases, the positive rate in primary screening of phenylketonuria (PKU) and congenital hypothyroidism (CH) was 0.3±1.7% and 1.4±2.6%, respectively. For evaluating the PCQMS, the data of Radar and Topsis was highly correlated (R=0.99). From 2015 to 2020, the PCQMS in NBSCs has gradually improved and NBS quality is significantly better than that in the non-NBSCs (P<0.001). In addition, the PCQMS of different regions in China also showed significant differences. The Eastern region had the highest quality, followed by the Western and Central regions (P<0.05). For the further optimization of QIs, there was no significant reduction in the NBS quality after deleting QI1, QI2, QI3, QI7, and QI16. Together with the clinical significance and our data, QI3 may be removed in the next. Conclusions: This study first comprehensively evaluated the NBS quality based on the national dataset in China. A continuous quality increase was noted for NBSCs from 2015 to 2020. Efforts to strengthen the quality control of NBS, especially in non-NBSCs, are needed with the increasing number of NBS laboratories.Funding Information: The reported work was supported in part by research grants from the National Natural Science Foundation of China (81870126 and 82070167 to LZ), the Chongqing Science and Technology Bureau Major Project (cstc2019jscx-msxm0189 to LZ), and the Shanghai Sailing Program (22YF1437200 to J-X W).Declaration of Interests: The authors declare that they have no competing interests.