Medical institutions should have the following qualifications to carry out clinical gene testing projects: medical examination/clinical cytomolecular genetics, which is a diagnosis and treatment subject approved by the competent health department, and obtain the qualification for admission (filing) of Class II medical technology (clinical gene amplification testing technology). The scope of clinical genetic testing items carried out by medical institutions should be strictly in accordance with the Catalogue of Clinical Testing Items of Medical Institutions (version 20 13). Without the approval of clinical application, the items under clinical molecular biology and cytogenetics testing should not be carried out beyond the scope.
When a medical institution entrusts a third-party medical testing institution (including a medical laboratory or other medical institution) to carry out clinical genetic testing projects, it shall sign an entrustment agreement with the entrusted institution with the medical institution as the main body, and may not entrust with individuals as the main body. The trustee must be qualified as a medical institution and conform to the provisions of Article 1. It is forbidden for medical institutions to entrust scientific research institutions, network platforms and other units that have not obtained the Practice License of Medical Institutions to carry out clinical genetic testing projects.
Extended data:
The relevant requirements of clinical genetic testing items stipulate:
1, the fees charged by medical institutions for clinical genetic testing should be strictly implemented in accordance with the relevant provisions of the price department. It is strictly forbidden for medical staff to bill commission and other irregularities. Genetic testing projects for scientific research purposes shall not charge any fees.
2. It is forbidden for medical institutions that have not obtained the qualification of prenatal screening or prenatal diagnosis medical institutions approved by the administrative department of health to carry out or send blood to entrust other institutions to carry out clinical genetic testing projects related to prenatal screening and prenatal diagnosis.
3. Involving entrusting a third-party medical testing institution to carry out clinical genetic testing projects, it shall report the name of the entrusted third-party unit and the specific entrusted testing projects to the Medical Administration Department of the Health Planning Commission and the Municipal Health Supervision Office within 15 days after the signing of the entrustment agreement.
Notice of Xiamen Municipal Health and Wellness Committee-Xiamen Municipal Health and Family Planning Committee on Standardizing Medical Institutions to Carry out Clinical Genetic Testing Projects