Prenatal diagnostic technology programs include genetic counseling, medical imaging, biochemical immunity, cytogenetic and molecular genetics. Article III of this management shall apply to all types of health care institutions to carry out prenatal diagnostic techniques. Article 4 The application of prenatal diagnostic techniques should be for medical purposes, in line with relevant state laws and ethical principles, by qualified medical personnel in the licensed health care institutions.
Healthcare institutions and medical personnel shall not perform any prenatal diagnostic techniques for non-medical purposes. Article 5 The National Health Commission shall be responsible for the supervision and management of the application of prenatal diagnostic techniques nationwide. Chapter II Management and Approval Article 6 The National Health Commission shall formulate plans for the application of prenatal diagnostic technology in accordance with medical needs, the state of technological development, the needs of organization and management and other actual circumstances. Article 7 The application of prenatal diagnostic technology is subject to hierarchical management.
The NCHK formulates the basic conditions and personnel conditions for healthcare institutions to carry out prenatal diagnostic technology; promulgates technical specifications for prenatal diagnostic technology; designates national healthcare institutions to carry out prenatal diagnostic technology; carries out quality management and information management on the application of prenatal diagnostic technology throughout the country; and plans the training of prenatal diagnostic specialists and technicians throughout the country.
The competent health authorities of the people's governments of provinces, autonomous regions and municipalities directly under the central government (hereinafter referred to as the provincial health authorities), according to the actual situation of the localities, plan, approve or set up, according to the local conditions, the healthcare institutions that carry out prenatal diagnostic techniques within the administrative regions; conduct systematic training and qualification recognition of the professionals engaged in the prenatal diagnostic techniques; and carry out quality management and information management of the application of the prenatal diagnostic techniques. information management.
The competent departments of health care of the people's governments at or above the county level are responsible for the daily supervision and management of the application of prenatal diagnostic techniques within the administrative regions. Article 8 Health professionals and technicians engaged in prenatal diagnosis shall meet all of the following conditions:
(1) those engaged in clinical work shall obtain the qualification of practicing physicians;
(2) those engaged in medical technology and auxiliary work shall obtain the corresponding health professional and technical titles;
(3) those in line with the "Basic Conditions for Health Professionals and Technicians Engaged in Prenatal Diagnosis"
(4) those who have been approved by the provincial health and health department shall be responsible for the daily supervision and management of the application of prenatal diagnosis technology within the administrative region. p>(D) qualified by the provincial health care authorities, to obtain engaged in prenatal diagnosis of "maternal and child health technology assessment certificate" or "physician's license certificate" with the addition of maternal and child health technology (prenatal diagnosis category) qualified assessment. Article 9 The application to carry out prenatal diagnostic technology of health care institutions shall meet all of the following conditions:
(1) with obstetrics and gynecology diagnostic and therapeutic subjects;
(2) with health professionals and technicians appropriate to the technology being carried out;
(3) with the technology and equipment appropriate to the technology being carried out;
(4) with a medical ethics committee (e) conforming to the Basic Conditions for Healthcare Institutions Carrying Out Prenatal Diagnostic Techniques and the relevant technical specifications. Article 10 A healthcare institution applying to carry out prenatal diagnostic techniques shall submit the following documents to the competent healthcare department at the provincial level where it is located:
(1) a copy of the license of the healthcare institution;
(2) documents of application for license to carry out prenatal diagnostic techniques of the mother and child healthcare technical services;
(3) a feasibility report;
(4) the staffing of the proposed Prenatal diagnostic technology staffing, equipment and technical conditions;
(v) regulations for carrying out prenatal diagnostic technology;
(vi) other materials required to be submitted by the competent health authorities at or above the provincial level.
The healthcare institutions applying to carry out prenatal diagnosis technology must clearly present the specific technical items of prenatal diagnosis to be carried out. Article 11 The application to carry out prenatal diagnostic technology health care institutions, by the people's governments of the provinces, autonomous regions and municipalities directly under the Central People's Government of the competent department of health examination and approval. After receiving the materials stipulated in Article 10 of these Measures, the competent health department of the people's government of the province, autonomous region or municipality directly under the central government shall organize relevant experts to carry out the demonstration, and shall conduct the examination and approval within 30 working days after receiving the report of the experts' demonstration. If the audit agrees, it shall issue a license to carry out prenatal diagnostic technology for the practice of maternal and child health care technical services, indicating that it carries out prenatal diagnostics as well as specific technical services; if the audit does not agree, it shall notify the applicant in writing. Article 12 The National Health Commission shall, in accordance with the needs of the development of prenatal diagnostic technology, designate national-level healthcare institutions to carry out prenatal diagnostic technology among the healthcare institutions qualified to carry out prenatal diagnostic technology services upon examination and approval. Article 13 The License to Practice Maternal and Infant Health Care Technology Services to carry out prenatal diagnostic technology shall be verified once every three years, and the verification shall be handled by the original approval authority. Those who pass the verification may continue to carry out prenatal diagnostic techniques; those who fail the verification shall have their licenses revoked. Article XIV of the people's governments of provinces, autonomous regions and municipalities directly under the Central People's Government health care institutions designated by the competent department of health care to assist the competent department of health care is responsible for the organization and management of prenatal diagnosis in the administrative region.