Analysis Of Governance Approach And Effects Of Prenatal Diagnosis Services Regulation

[Background]:With the development of social economics, China’s maternal and children’s health have made great progress, the maternal and infant mortality rate falls continually, more focus are given to the problem of birth defects. Birth defects are leading to a large disease burden to the patient children, their families and the society. There are three levels protective measures, prenatal diagnosis (including prenatal screening) is the secondary measure, which is to screen the risk of given genetic disorders (prenatal screening) and diagnose if the fetus is congenital anomalies, to decrease the birth of infants with congenital anomalies and genetic disorders. However, prenatal diagnosis is high technology with high risk, so it needs to be regulated strictly. In2002, the Ministry of Health issued the "Administrative regulation of prenatal diagnosis technology"(including related annexes), aims to regulate prenatal diagnosis services delivery in a manner that ensures the quality, accessibility and effectiveness of prenatal diagnosis services, and pregnant women and infants can benefit from them. Before the regulation issued, prenatal screening and diagnosis services had been provided in Shanghai; after the regulation issued, Shanghai local health authority interpreted and implemented the regulation in time.[Objective]:The research takes Shanghai as an example, aims to describe the regulation interpretation and implementation progress, actors and their relationship, the situation of prenatal screening and prenatal diagnosis services, regulation approach, analysis the regulation effects and the influencing factors, and propose policy suggestions to improve prenatal screening and prenatal diagnosis services.[Methods]:Qualitative methods and quantitative methods were utilized in this study.28key informants were interviewed, and their interview contents were transcribed and analyzed by Nvivo8.0. Based on the Andersen behavior model of health service utilization,1020parturients were surveyed about their social demographic characteristics, their knowledge and utilization of prenatal screening and prenatal diagnosis services. Descriptive methods, Chi-square tests, Wilcoxon tests and Logistic regression methods were used to analyze. [Results]:1. Regulation interpretation and implementation progress:According to the national regulation and local situation, Shanghai interpreted the regulation, including health planning for prenatal diagnosis services delivery and developing the local service delivery criteria. The regulation implementation process included approval and certification, evaluation and supervision.2. Actors:The Shanghai Bureau of Health was leading the regulation interpretation and implementation work. The Municipal Women’s Health Institute and the Municipal Health Inspection Institute carried out the professional training, management and supervision work. The services provision institutions accepted management and supervision as well as provided services. Professionals took responsibility for personnel training, evaluation and institutional assessment of prenatal diagnosis technology and services delivery, certain professionals also took part in the development of new technology and the formulation of professional standards. Users have the right to select medical institutions and decide whether to receive prenatal screening and diagnosis services. Certain relative medical and pharmaceutical companies provide devices, kits, softwares, consumables and different service models mainly to health institutions to meet the needs of users.3. Knowledge and utilization of prenatal screening and diagnosis services:86.5%of respondents were heard of Down’s syndrome,79.6%of respondents were heard of prenatal screening for Down’s syndrome. The most common channels of knowledge were through "medical staff’,"friends, family and work staff " and " Internet".69.3%of respondents thought "every pregnant women need receive prenatal screening services".69.7%of respondents accepted doctors’ suggestions and63.1%of respondents received prenatal screening services,0.6%of respondents received prenatal diagnosis services straightly. After the health education,94.6%of respondents expressed they would like to receive prenatal screening services.91.9%of respondents whose prenatal screening results were high risk accepted doctors’ suggestions, and91.7%thought chorionic villus sampling (trophoblast cells analysis), amniocentesis (amniotic fluid cells analysis) and cordocentesis (Percutaneous Umbilical Blood Sampling) had risk, and69.4%received prenatal diagnosis services.96.0%of respondents who received prenatal diagnosis services signed informed consent.4. Regulation approach:The state-centered approach was the major regulatory approach, which included licensure and withdrawal of institution and personnel, tier administration, regional health planning, clinical guidelines setting, delivery system construction, personnel system construction, advisory committee construction and service quality control. The consumer-oriented approach played a role in the relationship between prenatal screening institutions and prenatal diagnosis centers, the relationship between service provision and companies, users’ free choice, etc. Self-regulated approach and market-oriented approach also affected services.5.Regulation effects:In terms of quality, the safety and effects of prenatal diagnosis services had been improved, but the quality of prenatal screening services provided by pure prenatal screening institutions needed to be promoted. In terms of equity, the registration pregnant women’s utilization of high-quality health resource were better than migrant pregnant women, the proportion of special needs services was small, which didn’t affect equity a lot. In terms of accessibility, the accessibility of prenatal screening services was fine, medical institutions, the attitude toward necessity, receiving advice from healthcare providers, and more than8prenatal examinations were main influencing factors. However, the prenatal diagnosis services couldn’t meet the needs.87.8%of respondents thought the price of prenatal screening services was reasonable. The economical accessibility of prenatal screening services was fine, different delivery institutions, knowledge of prenatal screening stages were main influencing factors,44.0%of respondents who received prenatal diagnosis services thought the price of prenatal diagnosis services was high. The economical accessibility of pregnant diagnosis needed to be improved, especially for the people who didn’t have the medical insurance and weren’t wealthy. Most of the respondents could get the prenatal screening and prenatal diagnosis institutions in one hour, so the geography accessibility was fine.[Recommendation]:The formulation of a health system regulation should focus on a health issues rather than a single technology; the formulation of a health system regulation should try to integrate more approaches. The regulatory process for prenatal diagnosis services should be developing as fast as its associated technology; the prenatal diagnosis center planning and certification work should be promoted to increase the accessibility of prenatal diagnosis services; promotion and education of prenatal screening and prenatal diagnosis services should be strengthened to help more people know about the services and make better choices.