Acquisition of Class II medical technology (clinical gene amplification testing technology) access (for the record) qualifications.
Medical institutions to carry out clinical genetic testing program should have the following qualifications: with the health authorities approved by the diagnostic and treatment subjects: Medical Laboratory / Clinical Cytomolecular Genetics, and to obtain access (for the record) to the second class of medical technology (clinical gene amplification testing technology) qualification. Medical institutions to carry out clinical genetic testing program scope should be strictly in accordance with the "Medical Institutions Clinical Testing Program Catalog (2013 Edition)" Clinical molecular biology and cytogenetic testing under the project to carry out, shall not exceed the scope of the project is not approved for clinical applications.
Medical institutions commissioned third-party medical testing organizations (including medical testing laboratories or other medical institutions) to carry out clinical genetic testing programs, medical institutions should be the main body of the commissioning agreement with the commissioned organization, not the main body of the commissioning of individuals. The commissioned institution must have the qualification of medical institutions and comply with the provisions of Article 1, prohibiting medical institutions to commission research institutions, online platforms and other units that have not obtained the "license to practice in medical institutions" to carry out clinical genetic testing programs.
Expanded Information:
p>The relevant requirements of the clinical genetic testing program stipulates:
1, medical institutions to carry out clinical genetic testing program fees should be strictly in accordance with the relevant provisions of the price department. Strictly prohibit medical staff billing commission and other violations. Genetic testing programs for scientific research purposes shall not be charged any fees.
2. Medical institutions that have not obtained the qualification of prenatal screening or prenatal diagnosis medical institutions approved by the competent administrative department of health are prohibited from carrying out or sending blood to entrust other institutions to carry out clinical genetic testing programs involving prenatal screening and prenatal diagnosis.
3, involving the commissioning of third-party medical testing organizations to carry out clinical genetic testing program, should be commissioned within 15 days of the signing of the agreement will be entrusted to the third-party unit name and specific commissioned testing program reported to the Health Planning Commission, Medical Affairs and Medical Management Division and the Municipal Health Supervision.
Xiamen Health Commission - Xiamen Municipal Health and Family Planning Commission on the standardization of medical institutions to carry out clinical genetic testing program notice