General office of the national health and family planning commission of normative and orderly conduct peripheral cell-free fetal DNA in pregnant women prenatal screening and diagnosis of notice

The national health and family planning commission of the People's Republic of China

The 2016-11-09

The women and children who do hair [2016] no. 45

Provinces, autonomous regions and municipalities directly under the central government health and family planning commission, the xinjiang production and construction corps health bureau:

Two child policy to promote the implementation of a comprehensive, meet the pregnant women for prenatal screening and diagnosis of molecular genetic technology service demand, specification in order to carry out with fetal 21 three body syndrome, 18 and 13 three body three body syndrome syndrome as the target of disease pregnant women peripheral cell-free fetal DNA in prenatal screening and diagnosis work, prevent birth defects, improve the birth population quality, now we will notify the following related matters.

A reasonable planning and layout, perfect service network

The family planning administrative department of public health at various levels shall, in accordance with requirements of the measures for the administration of the prenatal diagnosis technology, pregnant women peripheral cell-free fetal DNA in prenatal screening and diagnosis in prenatal diagnosis technology unified administration within their respective jurisdictions. Provincial family planning administrative department of public health according to local actual and reasonable planning, establish a prenatal diagnosis mechanism as the core, prenatal screening mechanism as the blood collection point, to the ability of medical institute and other medical institutions for technical support of pregnant women prenatal screening and diagnosis network peripheral blood cell-free fetal DNA, optimize service process, establish a mechanism for referral, meet the demand of the masses. Can be independent or prenatal diagnosis mechanism and corresponding detection ability of medical institute and other medical institutions to carry out the pregnant women peripheral cell-free fetal DNA in prenatal screening and diagnosis service. Prenatal screening agency shall undertake in institutions under the guidance of prenatal diagnosis in pursuance of the service, and establish a cooperation mechanism, to carry out the follow-up detection and prenatal diagnosis service.

Second, standardization of technical services, improve service quality

By prenatal diagnosis at the early stage of the summary in high-throughput gene sequencing of prenatal screening and diagnosis of clinical application of pilot work experience, on the basis of organization developed the pregnant women peripheral cell-free fetal DNA in prenatal screening and diagnosis of technical specifications "(hereinafter referred to as the" technical specification ", see appendix 1, from the national health and family planning commission website to download), guiding the national specification in order to carry out related work. To "technical specifications" in strict accordance with the requirements of medical institutions, perfect rules and regulations, do a good job in screening, diagnosis and follow-up of effective connection, specification provides a pregnant woman peripheral cell-free fetal DNA in prenatal screening and diagnosis service. Medical staff should be in accordance with the principle of medical ethics, comprehensive and accurate told pregnant women related service content, respect for women's right to know and option, protect the privacy of pregnant women pregnant women's rights. Around to actively carry out standardized training of professional and technical personnel, strengthen the relevant work quality evaluation. Regularly submit related work as required information (see attachment 2), and do a good job in information analysis and use, continuously improve the quality of prenatal screening and diagnosis service.

Third, strengthen the supervision and management, to ensure orderly

The family planning administrative department of public health at all levels should be pregnant women peripheral cell-free fetal DNA in prenatal screening and diagnosis as an important content of special technical supervision and management of maternal and infant health care, family planning integrated into the health supervision and law enforcement. Strengthen the daily supervision, strengthen check check, set up a blacklist, establish a mechanism for the exit. In pregnant women who were not medical institutions and medical personnel to carry out the peripheral blood or cell-free fetal DNA tests, carried out in accordance with the illegal medical practice is investigated; In pregnant women don't have the qualifications to carry out the peripheral blood or blood cell-free fetal DNA detection, in accordance with the "regulations on the administration of medical institutions" article 47, "prenatal diagnosis technology measures for the administration of article 30 the provisions of punishment. At the same time, to set the suggestion box, 12320 hotline, and cooperate with the news media, encourages the masses and social media to report or expose illegal organizations and illegal behavior, to safeguard the rights and interests of the masses of pregnant women.

In this paper, from the date of printing. After the national health and family planning commission for women's and children's department of high-throughput gene sequencing of prenatal diagnosis in prenatal screening and diagnosis of the pilot clinical application notice (countries who women and women who dinner-table [2015] no. 4) and the national health and family planning commission medical hospital authority implementation of high flux of the pilot clinical application of gene sequencing technology notice (the health medical care dinner-table [2014] no. 407) involved in prenatal screening and diagnosis of the relevant regulations of the professional pilot institutions shall be repealed simultaneously.

Attachment: 1. Pregnant women peripheral cell-free fetal DNA in prenatal screening and diagnosis of technical specifications

2. Pregnant women peripheral cell-free fetal DNA in prenatal screening and diagnosis data reports

　　附件：1.孕妇外周血胎儿游离DNA产前筛查与诊断技术规范
　　　　　2.孕妇外周血胎儿游离DNA产前筛查与诊断数据信息报表  

General office of national health and family planning commission

On October 27, 2016