To the Editor: Newborn screening (NBS) plays a valuable and important role in the early identification of treatable and preventable inborn errors of metabolism (IEMs) to avoid severe outcomes and improve quality of life. The Lancet Commission reported that China has made remarkable achievements in women's reproductive, maternal, newborn, child, and adolescent health (RMNCAH) and succeeded in reducing the mortality of newborns over the past 70 years. As the third floor of a whole RMNCAH building, the NBS system has played a key role in early treatment to reduce neonatal morbidity and mortality and improve quality of life. To ensure the quality, dignity, equity, and universal coverage of the NBS, China has been devoted to establish a rationally distributed NBS system over the past 40 years [Supplementary Figure 1, https://links.lww.com/CM9/B175]. In China, the NBS network is consisted of hierarchical administrations and service agencies, and NBS health care services are provided under the joint administration of national-, provincial-, prefecture-, and county-level governments. To standardize the NBS healthcare service and increase the demand for high-quality NBS health care, China has formulated and launched numerous policies, legislations, regulations, diagnosis and treatment guidelines, and technical standards. Based on such a solid foundation supported by national consensus on women's and children's rights, health policies, financial support, scientific research, clinical guidelines and standards, and information technologies, the quality management of the NBS network (QMIP-NBS) in China has been carefully planned and implemented.
Without effective and efficient quality management measures, the progress of NBS services in China might be slowed or even stopped. Quality management is a key concept in the field of NBS system management. In current healthcare services, quality assurance, quality control, quality evaluation, and quality improvement are frequently used quality management concepts; this is also the case for NBS services. These quality aspects are crucial elements in establishing and strengthening the confidence of healthcare providers and policy makers and in maintaining the sustainability of the NBS system. However, a literature search of ((“newborn screening”[Title] OR “neonatal screening”[Title])) AND (quality[Title]) in PubMed yielded 56 hits, which appears to indicate quality has not received enough attention in the context of NBS services.
Quality management of a complex system can be hard, and precise quality management of a complex network can be very difficult. A single NBS system is a multidimensional and systematic healthcare process involving multiple services of publicity, education, screening (specimen collection and delivery, laboratory testing and reporting), follow-up (including abnormal results notification, recall of suspected patients, tracking and confirmatory testing), diagnosis (clinical and biochemical evaluation), and management (treatment monitoring and long-term follow-up), crossing numerous institutions and diverse personnel, including midwives, nurses, laboratorians, pediatricians, and maternal and child healthcare workers.[3,4] Supplementary Figure 1, https://links.lww.com/CM9/B175 shows the key process and stakeholders of the NBS service in China. In an individual complex system, errors can occur in any processes or personnel at any time when there is not effective control and monitoring, leading to harm for patients and hospitals. The prevention of everyday medical errors is extremely difficult in the complex NBS network, which consists of many individual NBS systems in all regions of China. In addition, issues such as high no-show rates, poor patient follow-up, delays in treatment, and untimely and inefficient testing reporting have been frequently reported; behind these recurrent issues is the poor-quality management of NBS services.
The quality management of integrated NBS networks has been carefully organized and carried out in China. We have promoted a systematic quality indicator (QI) system for the entire NBS system (QIS-NBS) and an implementation procedure for QMIP-NBS; which constitute the quality management system for the NBS network (QMS-NBS) in China.
Among the numerous quality improvement and evaluation tools, the most widely applied, rigorous, and recognized methodology is the QI. QIs are employed to evaluate and monitor key links of the entire NBS system. The whole process that newborns experience in NBS services in China, NBS/IEMs-related literature, laws, regulations, technical standards, NBS management measures, and clinical pathways applied in China have been systematically reviewed to formulate the initial draft indicators and implementation procedure. To measure the QIs, corresponding questionnaires and investigation methods were designed. To quantify the QIs, scores were assigned to each question according to the significance of the QI. To make the QIs and procedure practicable and efficient, multiple rounds of expert consultations and field research in representative institutions in the eastern, central, and western regions of China were carried out. Supplementary Figure 2, https://links.lww.com/CM9/B176 illustrates the process that the QIS-NBS and QMIP-NBS formulated.
Finally, a three-tier QIS-NBS and a powerful QMIP-NBS were developed, constituting the QMS-NBS in China. Supplementary Figure 3, https://links.lww.com/CM9/B177 shows the framework of the QIS-NBS. It was designed in two parts for NBS agencies and blood collection agencies. For the NBS agencies, the QIS-NBS includes three first-tier indicators, 15 second-tier indicators, and 68 third-tier indicators covering the aspects of institutional setting, personnel, laboratory construction, information system construction, pretesting publicity and education, pretesting quality, laboratory testing quality, post-testing quality management, specimen preservation, case management, follow-up, treatment effect, and medical records management. For blood collection agencies, the QIS-NBS has three first-tier QIs, seven second-tier QIs, and 16 third-tier QIs, and the assessment contents mainly involve personnel and institution building, education and publicity, specimen collection, informed notification, specimen quality, and materials preservation. The definition, characteristics, and reference value of each QI are presented in Supplementary Tables 1, https://links.lww.com/CM9/B179 and 2, https://links.lww.com/CM9/B180. The QMIP-NBS is a working procedure and includes various tools to guide and standardize administrative agencies and service agencies for control and evaluation work.
Supplementary Tables 3, https://links.lww.com/CM9/B181 and 4, https://links.lww.com/CM9/B182 show the working tools in the QMIP-NBS, which include questionnaires, scoring criteria, and investigation methods. In the questionnaire, a series of questions are set for each QI, and each question corresponds to a certain score. A total of 81 questions were designed for NBS centers, and 16 questions were designed for blood collection agencies. Both qualitative and quantitative questions are included. The investigation methods for questionnaire completion are flexible, including on-site inspection of the agency environment and operation, interviewing related personnel, and consultations. Scoring criteria are designed for each QI. The total score for the QIS-NBS was 1000 points, of which 700 points were for the QIS of NBS centers and 300 points were for the QIS of blood collection agencies. The assessment is divided into four grades: 900 to 1000 points are considered excellent performance; 700 to 899 points are good; 600 to 699 points are passing; and ≤600 points are failing.
The working procedure in Supplementary Figure 1, https://links.lww.com/CM9/B175 illustrates who, what, where, how, and when (4 W + H) for performing the external quality control and evaluation for the NBS system (QCE-NBS). Supplementary Figure 4, https://links.lww.com/CM9/B178 shows the organization and implementation of QCE-NBS at the national, provincial, prefecture-level, and county-level and the internal QCE inside the NBS service agencies (i.e., NBS centers and their assigned blood collection agencies). The National Health Commission (Department of Women and Children's Health, MCH division) leads the supervision of nationwide health bureaus (MCH division) and NBS service agencies, and under the leadership of the National Health Commission (MCH division), the National Office for Maternal and Child Health Surveillance of China and National Center for Clinical Laboratories jointly undertake professional guidance and training. Provincial, prefecture-level, and county-level health bureaus (MCH division); and NBS service agencies are responsible for the QCE-NBS in their jurisdiction and accept the QCE-NBS from superior agencies.
The quality management of the massive NBS network in China systems covers the key aspects of personnel, method and equipment resources, materials, laws, and the local and comprehensive environments that affect patient care and safety, truly enhancing and ensuring patient care and safety in NBS healthcare. It overcomes challenges related to the large population and the unbalanced territorial development, realizes the equity and homogenization of NBS service quality, provides opportunities and support to standardize quality management irrespective of regions and time, and enables multidimensional control and evaluation within an individual system or complex network; it can be a reference for NBS quality management in the developing world.
The quality management experience/practice of the entire NBS system has been little reported worldwide. Burgard et al reported that the practices of NBS, quality control, and quality assurance were varied across countries, but clear quality measures have not been reported comprehensively. Therrell et al described the Performance Evaluation and Assessment Scheme (PEAS) in the USA, which is considered a well-developed quality management program providing an advanced experience of NBS quality management in the developed world. The PEAS provides a checklist containing a series of questions considering the general, preanalytical, analytical, and post-analytical characteristics of an NBS program. References for each question are provided, and users in different agencies can flexibly use and adjust the PEAS checklist according to their situation. The potential answers for each question are Yes, No, and In progress. Padilla et al described successful experiences of NBS system quality improvement in the Philippines through the Philippine Performance Evaluation and Assessment Scheme which was designed based on using the comprehensive elements in the model PEAS system in the U.S.
The QIS-NBS we developed is based on Chinese practices in technical standards, clinical guidelines, and requirements for NBS services. The QMIP-NBS we developed is based on the hierarchical administrative structure of the NBS service agencies in China and is a combination of on-site investigation and interactive web investigation through developed information systems. We employed QIs, questions for each QI, scoring criteria, assigned scores for each question, and developed investigation methods to allow the abstract quality performance to be visualizable and measurable. When the different aspects of the entire NBS system are integrated, the performance of the local, individual or overall system or the national, provincial, prefecture-level, or county-level NBS network can be revealed, and the problems in such a complex system and network can be precisely tracked.
QMS-NBS in this study can be a reference for the quality management of NBS systems/networks in the developing world. First, an annual QCE-NBS has low cost. The total costs for running a round of the QCE-NBS include travel, accommodation, labor wages for experts, and fees for questionnaire printing. Second, the QMS-NBS in China was developed by field visits to representative NBS service agencies in the eastern, central and western areas of China, where the economic and educational development levels are different. Therefore, both high-income and low-income countries can be encouraged to critically apply content in the QMS-NBSs. Third, the scoring criteria in the QMS-NBS are designed according to the requirements (e.g., timeline goals, workload) specified for NBS services, and these requirements can be a reference for benchmarking when other low–middle-income countries want to improve their NBS strategies. Fourth, the QMS-NBS offers a supportive environment for carrying out improvements, the integrated information network provides convenience for routine data submission and web-based investigations, and governments at all administrative levels provide power and finances for the planning and implementation of the QCE-NBS. Fifth, the QMS-NBS enhances the homogeneity and equity of NBSs in all areas of China irrespective of economic and educational development levels and regional distributions. Finally, the establishment and sustainability of a quality management system require a supportive environment, so when referencing the QMS-NBS in China, the following necessary environmental support should be considered: (1) the consensus on women and children's health rights in the society, (2) the management model of NBS service, (3) planning and leadership, (4) policy development, (5) medical and technical support, (6) education support, and (7) financial support.
We sincerely thank the experts who provided consulting services and the institutions for field research.
The project was supported by a grant from the National Key Research and Development Program of China (No. 2018YFC1002204).
Conflicts of interest
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