Provisions on the Administration of Radiological Diagnosis and Treatment (2016 Amendment Version)

Provisions on the Administration of Radiological Diagnosis and Treatment (2016 Amendment Version) Provisions on the Administration of Radiological Diagnosis and Treatment (Issued by the Order No. 46 of the Ministry of Health on January 24, 2006 and amended in accordance with the Decision of the National Health and Family Planning Commission on Amending Eight Departmental Rules Including the Interim Measures for the Administration of Foreign Doctors' Temporary Practice of Medicine in China by the order No. 8 of the National Health and Family Planning Commission of the People's Republic of China on January 19, 2016) Chapter I General Provisions Article 1 For purposes of strengthening the administration of radiological diagnosis and treatment, ensuring medical quality and safety, and safeguarding the health rights and interests of radiological diagnosis and treatment staff, patients and the general public, pursuant to the Law of the People's Republic of China on the Prevention and Control of Occupational Diseases , the Regulation on the Safety and Protection of Radioisotopes and Radiation Devices , the Regulations on Administration of Social Health Services , and other laws and administrative regulations, these Provisions are enacted. Article 2 These Provisions apply to medical institutions engaged in radiological diagnosis and treatment. For the purpose of these Provisions, the term "radiological diagnosis and treatment" means activities in which radioisotopes and radiation devices are used for clinical medical diagnosis, medical care and health checkups. Article 3 The Ministry of Health shall be responsible for the supervision and administration of nationwide radiological diagnosis and treatment. Health administration departments of local people's governments at and above the county level shall be responsible for the supervision and administration of radiological diagnosis and treatment within their respective administrative regions. Article 4 Radiological diagnosis and treatment shall fall into four categories based on the risks to diagnosis and treatment and technical complexity: (1) radiotherapy; (2) nuclear medicine; (3) interventional radiology; and (4) diagnostic X-ray imaging. If a medical institution provides radiological diagnosis and treatment services, it shall have conditions corresponding to the radiological diagnosis and treatment services it provides and hold a radiological diagnosis and treatment permit technology and medical radiation institution (hereinafter referred to as "radiological diagnosis and treatment permit") as granted by the local health administrative department at or above the county level. Article 5 A medical institution shall adopt effective measures to ensure that radiation prevention, safety and the quality of radiological diagnosis and treatment conform to the requirement of the relevant provisions, standards and specifications. Chapter II Conditions of Practice Article 6 Where a medical institution provides radiological diagnosis and treatment services, it shall satisfy the following basic conditions: (1) having medical imaging diagnosis and treatment items as confirmed and registered; (2) having radiological diagnosis and treatment venues and supporting facilities conforming to the relevant state standards and provisions; (3) having full (part)-time management personnel and management systems of quality control and safety protection, equipped with necessary protective equipment and monitoring instruments; (4) if generating radioactive waste gas, liquid waste or solid waste, having the treatment capacity or having a feasible treatment plan to ensure that the radioactive waste gas, liquid waste or solid waste are discharged up to the standard; and (5) having emergency response and disposition plans for radiation incidents. Article 7 Where a medical institution provides radiological diagnosis and treatment services of different categories, it shall respectively have the following personnel: (1) in the case of providing radiotherapy, it shall have: i. radiation oncologists with qualifications for the professional and technical posts at or above the medium level; ii. professional technical personnel of pathology and medical imaging; iii. medical physicists with academic degrees at or above undergraduate education or qualifications for the professional and technical posts at or above the medium level; and iv. radiotherapists and maintenance personnel. (2) in the case of nuclear medicine, it shall have: i. nuclear medicine physicians with qualifications for the professional and technical posts at or above the medium level; ii. professional technical personnel of pathology and medical imaging; and iii. technicians or nuclear medicine technicians with academic degrees at or above undergraduate education or qualifications for the professional and technical posts at or above the medium level; and (3) in the case of interventional radiology, it shall have: i. radiographers with academic degrees at or above undergraduate education or qualifications for the professional and technical posts at or above the medium level; ii. radiography technicians; and iii. relevant internal medicine and surgery professional technicians. (4) In the case of providing diagnostic X-ray imaging, it shall have specialized radiographers. Article 8 Where a medical institution provides radiological diagnosis and treatment services of different categories, it shall respectively have the following equipment: (1) in the case of providing radiotherapy, having at least one linear accelerator, radiotherapy simulators, corresponding treatment planning system and other devices; (2) if providing nuclear medicine services, having nuclear medicine equipment and other relevant equipment; (3) if providing interventional radiology services, having medical diagnostic X-ray systems with image intensifiers, digital subtraction angiography equipment and other devices; and (4) in the case of diagnostic X-ray imaging, having medical diagnostic X-ray systems or CT scanners or other devices. Article 9 A medical institution shall be equipped with and use safety and protection devices, radiation detectors and personal protective equipment according to the following requirement: (1) at radiotherapy venues, there shall, according to corresponding standards, be equipped with multiple safety interlock systems, dose monitoring systems, surveillance cameras, intercoms, fixed-position dose monitoring and alarming devices; as well as radiotherapy dosimeters, dose scanning devices and personal alarm dosimeters. (2) in the case of nuclear medicine, there shall be established special venues for sub-packaging, injecting and storing radioisotopes, radioisotope shielding devices and storage devices; and equipped with radioactivity meters and radioactive contamination monitors; and (3) at venues of interventional radiology and other diagnostic X-ray imaging work, there shall be equipped with protective equipment for staff and personal protective equipment for patients. Article 10 A medical institution shall establish striking warning signs for or at the following equipment and venues: (1) establishing ionizing radiation signs for equipment and containers containing radioisotopes and radioactive waste; (2) establishing ionizing radiation warning signs and necessary text description at venues storing radioisotopes and radioactive waste; (3) establishing ionizing radiation warning signs at the entrance to venues of radiological diagnosis and treatment; and (4) a venue of radiological diagnosis and treatment shall, according to the relevant standards, be divided into control area and supervision area, and there shall be established ionizing radiation warning signs and work indicator lights at the entrance and exit of the control area and other appropriate places. Chapter III Establishment and Approval of Radiological Diagnosis and Treatment Article 11 A medical institution shall establish radiological diagnosis and treatment items according to the categories of radiological diagnosis and treatment services it provides, and file applications with corresponding health administrative departments for the health review of construction projects, check for acceptance on completed construction and establishment of radiological diagnosis and treatment items: (1) in the case of radiotherapy or nuclear medicine, applying to the provincial-level health administrative department; (2) in the case of interventional radiology, applying to the health administrative department at the level of the city divided into districts; and (3) in the case of diagnostic X-ray imaging, applying to county-level health administrative department. In the case of providing different radiological diagnosis and treatment services, applying to the health administrative department with a higher approval power. Article 12 A medical institution shall, before constructing, expanding or reconstructing a radiological diagnosis and treatment construction project, submit a pre-assessment report on occupational disease hazard and radiation protection to the corresponding health administrative departments, and apply for health review of the construction project. In respect of radiological diagnosis and treatment construction projects for stereotactic body radiation therapy, proton therapy, carbon ion radiotherapy, cyclotron-based positron emission tomography, etc., it shall, in addition, submit technical review opinions on the pre-assessment report as issued by a radiation health technical institution designate by the Ministry of Health. A health administrative department shall, within 30 days from the date of the receipt of th......