What Are the Different Types of Radiology Prerequisites?

Decree No. 46 of the Ministry of Health was issued on January 24, 2006. According to the Decision of the National Health and Family Planning Commission on Amending the 8 Regulations of the Ministry of Health and Family Planning on the Temporary Management of Foreign Doctors' Short-term Practice in China (National Health and Planning) Fertility Commission Order No. 8). Medical institutions conducting radiation diagnosis and treatment work shall have the conditions suitable for the radiation diagnosis and treatment work carried out by them, and shall be licensed by the radiation diagnosis and treatment technology and medical radiation institution of the local health administrative department at or above the county level (hereinafter referred to as radiation diagnosis and treatment license).

Radiological diagnosis and treatment regulations

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Chinese name: Radiological diagnosis and treatment regulations
By: June 2, 2005

Implement: March 1, 2006
Unit: Ministry of Health
Modify: January 19, 2016

Radiological diagnosis and treatment regulations

Order of the Ministry of Health of the People's Republic of China No. 46

Gao Qiang

January 24, 2006

On January 19, 2016, in accordance with the "Decision of the National Health and Family Planning Commission on Amending 8 Departmental Regulations, including the Interim Administrative Measures for Foreign Physicians' Short-term Medical Practice in China" (National Health and Family Planning Commission Order No. 8) ^[1]

Chapter I General Provisions

The first is to strengthen the management of radiological diagnosis and treatment, ensure the quality and safety of medical treatment, and protect the health rights and interests of radiological diagnosis and treatment staff, patients, and the public. The Regulations and the "Regulations on the Administration of Medical Institutions" and other laws and administrative regulations provide for these regulations.

Article 2 This regulation applies to medical institutions conducting radiological diagnosis and treatment.

The radiological diagnosis and treatment referred to in these regulations refer to the activities of using radioisotopes and radiation devices for clinical medical diagnosis, treatment and health examination.

Article 3 The Ministry of Health is responsible for the supervision and management of radiological diagnosis and treatment nationwide.

The health administrative department of the local people's government at or above the county level is responsible for the supervision and management of radiological diagnosis and treatment in its own administrative area.

Article 4 Radon diagnosis and treatment work is divided into four types of management according to the risks and technical ease of diagnosis and treatment:

(1) radiation therapy;

(2) nuclear medicine;

(3) interventional radiology;

(4) X-ray image diagnosis.

Medical institutions conducting radiation diagnosis and treatment work shall have the conditions suitable for the radiation diagnosis and treatment work carried out by them, and shall be licensed by the radiation diagnosis and treatment technology and medical radiation institution of the local health administrative department at or above the county level (hereinafter referred to as radiation diagnosis and treatment license).

Article 5: Medical institutions shall take effective measures to ensure that the quality of radiation protection, safety and radiation diagnosis and treatment meets the requirements of relevant regulations, standards and norms.

Chapter II Practice Conditions

Article 6: Medical institutions shall meet the following basic conditions for radiation diagnosis and treatment:

(1) Having approved medical imaging diagnosis and treatment subjects;

(2) It has radiation diagnosis and treatment places and supporting facilities that meet relevant national standards and regulations;

(3) Having full-time (part-time) management personnel and management systems for quality control and safety protection, and equipped with necessary protective supplies and monitoring instruments;

(4) Those who produce radioactive waste gas, waste liquid, or solid waste have a treatment capacity or a feasible treatment plan to ensure that radioactive waste gas, waste, or solid waste is discharged in compliance with standards;

(5) Having a plan for emergency response to radiation incidents.

Article 7: Medical institutions carrying out different types of radiation diagnosis and treatment shall have the following personnel:

(1) Those who carry out radiotherapy work shall have:

1. Qualified radiation oncologists with intermediate or higher professional and technical positions;

2. Professional technicians in pathology and medical imaging;

3. Medical physics personnel with a bachelor's degree or above or an intermediate or higher professional and technical position;

4. Radiotherapy technicians and maintenance staff.

(2) Those who carry out nuclear medicine work shall have:

1. Qualified nuclear medicine physicians with intermediate or higher professional and technical positions;

2. Professional technicians in pathology and medical imaging;

3. Qualified technicians or nuclear medicine technicians with a bachelor's degree or above and intermediate or higher professional and technical positions.

(3) Those who carry out interventional radiology should have:

1. A radiologist who has a bachelor's degree or above and a professional qualification in an intermediate or higher level;

2. Radiographer;

3. Relevant professional and technical personnel of internal medicine and surgery.

(4) To carry out X-ray imaging diagnosis, a professional radiographer shall be employed.

Article 8: Medical institutions carrying out different types of radiation diagnosis and treatment shall have the following equipment:

(1) Those who carry out radiotherapy work must have at least one long-range radiotherapy device and have equipment such as simulated positioning equipment and corresponding treatment planning systems;

(2) those who carry out nuclear medicine work have nuclear medicine equipment and other related equipment;

(3) those who carry out interventional radiology work, have medical diagnostic X-ray machines with image intensifiers, digital subtraction devices and other equipment;

(4) For diagnostic X-ray imaging work, there are medical diagnostic X-ray machines or CT machines.

Article 9: Medical institutions shall be equipped with and use safety protection devices, radiation detection instruments and personal protective equipment in accordance with the following requirements:

(1) Radiation therapy sites shall be equipped with multiple safety interlocking systems, dose monitoring systems, image monitoring, intercom devices, and fixed dose monitoring and alarm devices in accordance with corresponding standards; equipped with radiation dosimeters, dose scanning devices, and personal dose alarm devices;

(2) For nuclear medicine work, there are special radioisotope repackaging, injection, storage sites, radioactive waste shielding equipment and storage sites; equipped with activity meters and radioactive surface pollution monitors;

(3) Intervention radiology and other X-ray imaging diagnosis workplaces shall be equipped with protective equipment for workers and personal protective equipment for the subject.

Article 10: Medical institutions shall set up eye-catching warning signs for the following equipment and places:

(1) Equipment and containers filled with radioactive isotopes and radioactive waste, with an ionizing radiation mark;

(2) Radioactive isotopes and radioactive waste storage sites are provided with warning signs of ionizing radiation and necessary written instructions;

(3) Ionizing radiation warning signs are set at the entrance of the radiation diagnosis and treatment workplace;

(4) The radiological diagnosis and treatment workplace shall be divided into a control area and a supervision area in accordance with the requirements of relevant standards. Ionization radiation warning signs and work indicators shall be provided at the entrance and exit of the control area and other appropriate locations.

Chapter III Setup and Approval of Radiological Diagnosis and Treatment

Article 11: When a medical institution sets up a radiological diagnosis and treatment project, it shall, according to the type of radiological diagnosis and treatment work carried out by it, submit to the corresponding health administrative department an application for sanitary review of the construction project, completion acceptance and establishment of a radiological diagnosis and treatment project:

(1) Those who carry out radiotherapy and nuclear medicine work shall apply to the provincial health administrative department for processing;

(2) those who carry out interventional radiology work shall apply to the municipal health administrative department with districts;

(3) Those who carry out X-ray imaging diagnosis work shall apply to the county-level health administrative department.

If different types of radiation diagnosis and treatment work are carried out at the same time, they shall apply to the health administrative department with high category approval authority.

Article 12 (1) For new construction, expansion, and reconstruction of radiation diagnosis and treatment construction projects, medical institutions shall submit a pre-evaluation report on occupational disease hazard radiation protection to the corresponding health administrative department before construction project construction, and apply for a health review of the construction project. Stereotactic radiation therapy, proton therapy, heavy ion therapy, positron emission tomography diagnosis with cyclotron, and other radiological diagnosis and treatment construction projects shall also submit a technical review opinion of the pre-evaluation report issued by the radiological technical institution designated by the Ministry of Health.

The administrative department of health shall make an examination decision within 30 days from the date of receiving the pre-evaluation report. Construction can only be carried out after it has been verified that it meets relevant national health standards and requirements.

Article 13: Before the completion of the radiation diagnosis and treatment construction project , medical institutions shall perform an evaluation of the effects of occupational disease hazard control; and submit the following materials to the corresponding health administrative department for application for health acceptance:

(1) Application for sanitary acceptance of construction project completion;

(2) Sanitation review materials for construction projects;

(3) Evaluation report on radiation protection of occupational hazard control effect;

(4) Acceptance report of radiation diagnosis and treatment construction project.

Stereotactic radiotherapy, proton therapy, heavy ion therapy, positron emission tomography diagnosis with cyclotron, and other radiological diagnosis and treatment construction projects shall submit technical review opinions and evaluation reports on the evaluation of occupational hazard control effects issued by the radiological technical institution designated by the Ministry of Health Equipment performance test report. ^[2]

Article 14: Before carrying out radiological diagnosis and treatment , medical institutions shall submit the following materials and submit an application for radiological diagnosis and permission to the corresponding health administrative department:

(1) Application form for permission for radiation diagnosis and treatment;

(2) "Practice License for Medical Institutions" or "Approval for Establishment of Medical Institutions" (copy);

(3) Qualification certificates of professional and technical personnel of radiological diagnosis and treatment (copy);

(4) List of radiation diagnosis and treatment equipment;

(5) Certificates of acceptance of the completion of the radiological diagnosis and construction project.

Article 15: The health administrative department shall accept applications that meet the acceptance conditions immediately; if they do not meet the requirements, they shall inform the applicant of the materials that need to be corrected or the reasons for rejection within one day within 5 days.

The administrative department of health shall make a review decision within 20 days from the date of acceptance, approve the qualified ones, and issue a "radiation diagnosis and treatment permit"; if it is not approved, the reasons shall be stated in writing.

The format of the Radiological Diagnosis and Treatment Permit is uniformly stipulated by the Ministry of Health (see attachment).

Article 16 After the medical institution obtains the Radiological Diagnosis and Treatment Permit, it shall go through the corresponding medical treatment subject registration formalities with the health administrative practice registration department that issued the Medical Institution Practice Permit. The practice registration department shall approve the medical imaging department to the second-level diagnosis and treatment subject according to the permission.

Those who have not obtained the "radiation diagnosis and treatment permit" or registration of the diagnosis and treatment subjects shall not carry out radiation diagnosis and treatment.

Article 17 The "radiation diagnosis and treatment license" and "medical institution practice license" are checked at the same time. When applying for the verification, the test report on the performance of the radiation diagnosis and treatment equipment and the radiation workplace, and the health monitoring data of the radiation diagnosis and treatment staff should be submitted during the application. And work progress reports.

If a medical institution changes a radiological diagnosis and treatment project, it shall submit an application for a permit change to the radiological diagnosis and approval authority and submit information such as the name of the changed permit project and radiation protection evaluation report; at the same time, it shall submit an application for change of the medical treatment department to the health administrative practice registration department and submit the change registration Items and reasons for changes.

The health administrative department shall make a review decision within 20 days from the date of receiving the application for change. It cannot be changed without approval.

Article 18 In case of any of the following circumstances, the original approval department shall cancel the radiological diagnosis and treatment permit, register it for archiving, and announce it:

(1) a medical institution applies for cancellation;

(2) failing to apply for calibration or changing the radiological diagnosis and treatment subjects without authorization;

(3) failing to meet the relevant requirements during the verification or change process, and failing to improve after the deadline, or failing to meet the requirements after improvement;

(4) Subjects that have been out of business or whose diagnosis and treatment have been suspended for more than one year;

(5) The "Practice License for Medical Institutions" has been revoked by the health administrative department.

Chapter IV Safety Protection and Quality Assurance

Article 19: Medical institutions shall be equipped with full-time (part-time) management personnel who are responsible for the quality assurance and safety protection of radiation diagnosis and treatment. Its main responsibilities are:

(1) Organizing the formulation and implementation of radiation diagnosis and treatment and radiation protection management systems;

(2) Regularly organizing radiation protection testing, monitoring and inspection of radiation diagnosis and treatment workplaces, equipment and personnel;

(3) Organizing the radiation diagnosis and treatment staff of this institution to receive training and medical examinations on professional technology, radiation protection knowledge and related regulations;

(4) Formulating emergency plans for radiation incidents and organizing drills;

(5) Record the radiation incidents in this institution and report to the health administrative department in time.

Article 20 The radiological diagnosis and treatment equipment and detection instruments of medical institutions shall meet the following requirements:

(1) Equipment newly installed, repaired or replaced with important components shall be tested by a testing agency qualified by the health administration department at or above the provincial level, and may only be used after passing the test;

(2) Regularly carry out stability testing, calibration and maintenance, and the testing institutions certified by the health administrative department at the provincial level or above shall perform state inspection at least once a year;

(3) inspecting or calibrating detection instruments used for radiation protection and quality control in accordance with relevant national regulations;

(4) The technical indicators and safety and protection performance of radiation diagnosis and treatment equipment and related equipment shall meet relevant standards and requirements.

Radiological diagnosis and treatment equipment that fails or is obsolete as stipulated by relevant state departments may not be purchased, used, transferred, or leased.

Article 21 Medical institutions shall regularly conduct radiological protection tests on radiological diagnosis and treatment workplaces, radioisotope storage sites and protective facilities to ensure that the radiation level meets relevant regulations or standards.

Radioisotopes must not be stored in the same warehouse as flammable, explosive, and corrosive materials; storage sites should take effective measures to prevent leakage, and install necessary alarm devices.

The radioisotope storage site should have a special person responsible, and have a complete system of deposit, receipt, return and registration and inspection to ensure strict handover, timely inspection, clear accounts, consistent accounts, and complete records.

Article 22 The staff of thoracic radiation diagnosis and treatment shall wear personal dosimeters in accordance with relevant regulations.

Article 23 Medical institutions shall, in accordance with relevant regulations and standards, conduct medical examinations of radiological diagnosis and treatment staff before, during, and after leaving their posts, regularly conduct professional and protective knowledge training, and establish individual dose and occupational health management, respectively. And education and training archives.

Article 24: Medical institutions shall formulate quality assurance programs that are compatible with the radiological diagnosis and treatment projects undertaken by their units, and abide by the quality assurance monitoring specifications.

Article 25 When conducting medical exposure to patients and subjects, radiological diagnosis and treatment staff shall abide by the principles of legitimization of medical exposure and optimization of radiation protection, have a clear medical purpose, and strictly control the exposure dose; Shield sensitive organs and tissues, and inform patients and subjects about the health effects of radiation.

Article 26: Medical institutions shall analyze the advantages and disadvantages of different examination methods before implementing radiological diagnostic examinations, and on the premise of ensuring the diagnosis results, priority is given to the use of diagnostic technologies that have less impact on human health.

The inspection shall be carried out in accordance with the following provisions:

(1) Strictly implement the system of registration, storage, extraction and loan of inspection data, and do not subject the subject to unnecessary repeated exposure due to data management, referral of the subject, etc .;

(2) Radionuclide imaging examination and X-ray chest examination shall not be included in the routine inspection items for physical examination of infants and young children;

(3) Before performing radionuclide imaging or X-ray examination on the abdomen or pelvis of women of childbearing age, they should be asked whether they are pregnant; for special needs, women of childbearing age 8 to 15 weeks after conception should not undergo radiographic examination of the lower abdomen;

(4) As far as possible, chest X-ray photography should be used instead of chest fluoroscopy;

(5) When carrying out radiopharmaceutical administration and X-ray irradiation operations, non-inspected persons should be prohibited from entering the operation site; when other personnel are required to accompany the patient due to the patient's condition, protective measures should be taken for the accompany person.

Article 27: Where medical institutions use radiographic technology for health censuses, they shall fully demonstrate, formulate a thorough census plan, and adopt strict quality control measures.

Article 28: Medical institutions that carry out radiation therapy shall perform imaging, pathology, and other related examinations before performing radiation therapy on patients, and strictly control the indications for radiation therapy. For those who really need radiotherapy, a scientific treatment plan should be formulated and implemented in accordance with the following requirements:

(1) For extracorporeal long-distance radiotherapy, before entering the treatment room, radiation diagnosis and treatment staff should first check the source position display of the operation console to confirm that the radiation beam or radiation source is in the closed position before entering;

(2) For brachytherapy, radiation diagnosis and treatment staff should use special tools to pick up the radioactive source and not operate it with bare hands; take safe care for patients receiving the application treatment to prevent the radioactive source from being taken away or lost by the patient;

(3) During the implementation of permanent seed implantation treatment, the radiological diagnosis and treatment staff should always check the radioactive seeds used to prevent loss during the operation. After the radioactive seeds are implanted, medical imaging inspection must be performed to confirm the implantation site. And the number of radioactive seeds;

(4) During the treatment process, there should be at least two radiation diagnosis and treatment staff at the treatment site, and pay close attention to the display of the treatment device and the patient's condition to solve the problems in the treatment in time; other unrelated personnel are strictly prohibited from entering the treatment place;

(5) The radiation diagnosis and treatment staff shall implement the radiation in strict accordance with the radiation treatment operation specifications and procedures; they shall not modify the treatment plan without authorization;

(6) The radiation diagnosis and treatment staff shall verify the implementation of the treatment plan, and when they find deviations from the plan, they shall promptly take remedial measures and report to the person in charge of the undergraduate department or the department in charge of medical quality control of this institution.

Article 29 Medical institutions conducting nuclear medicine diagnosis and treatment shall abide by the corresponding operating rules and regulations to prevent radioisotopes from contaminating human bodies, equipment, workplaces and the environment; control patients receiving radiopharmaceutical treatment in vivo in accordance with the relevant standards , To prevent other patients and the public from exposure to more than the allowed level.

Article 30 Radioactive solid wastes, waste liquids and radioactive effluents from patients during tritium nuclear medicine diagnosis and treatment shall be collected separately, stored separately from other wastes and waste liquids, and disposed of in accordance with relevant state regulations.

Article 31: Medical institutions shall formulate emergency plans for the prevention and treatment of radiological events; effective emergency rescue and control measures shall be taken immediately after a radiological event to prevent the event from expanding and spreading.

Article 32: Any of the following radiation incidents in a medical institution shall be investigated and processed in a timely manner, truthfully recorded, and reported to the health administrative department and relevant departments in a timely manner in accordance with relevant regulations:

(1) The actual dosage of the diagnostic radiopharmaceutical deviates by more than 50% from the prescribed dosage;

(2) The actual radiation dose of radiation therapy deviates by more than 25% from the prescribed dose;

(3) Personnel mistaking photos or misusing radiopharmaceuticals;

(4) Radioactive isotopes have been lost, stolen or contaminated;

(5) Other radiation events caused by equipment failure or human error.

Chapter V Supervision and Management

Article 33: Medical institutions shall strengthen the management of the radiological diagnosis and treatment of their own institutions, and regularly check the implementation of the laws, regulations, rules and other systems of radiological diagnosis and management to ensure the medical quality and safety of radiological diagnosis and treatment.

Article 34 The health administrative department of the local people's government at or above the county level shall regularly supervise and inspect medical institutions that carry out radiation diagnosis and treatment activities within their own administrative areas. The inspections include:

(1) Implementation of laws, regulations, rules, standards and specifications;

(2) the implementation of the rules and regulations on radiological diagnosis and treatment and the system of staff position responsibility;

(3) implementation of health monitoring system and protective measures;

(4) Investigation, processing and reporting of radiation incidents.

Article 35: Law enforcement personnel of the health administrative department shall show their credentials when conducting supervision and inspection in accordance with the law; the units under inspection shall cooperate, truthfully report the situation, provide necessary information, and shall not refuse, obstruct, or conceal.

Article 36 (1 ) When law enforcement officials of the health administrative department or agencies authorized by the health administrative department to conduct inspections and inspections and their staff perform inspections in accordance with law, the technical and business secrets of the inspected units shall be kept confidential.

Article 37: The health administrative department shall strengthen the construction of supervision and enforcement teams, improve the professional quality and enforcement level of law enforcement personnel, and establish and improve the supervision and management system for law enforcement personnel.

Chapter VI Legal Liability

Article 38 If a medical institution has any of the following circumstances, the health administrative department at or above the county level shall give a warning, order it to make corrections within a time limit, and may impose a fine of less than 3,000 yuan according to the circumstances; if the circumstances are serious, its "medical institution practice license certificate".

(1) engaging in radiological diagnosis and treatment without obtaining a radiological diagnosis and treatment permit;

(2) failing to register for diagnosis and treatment subjects or failing to check in accordance with regulations;

(3) Changing radiological diagnosis and treatment items without approval or engaging in radiological diagnosis and treatment beyond the approved scope.

Article 39 If a medical institution uses a person without corresponding qualifications to perform radiological diagnosis and treatment, the health administrative department at or above the county level shall order correction within a time limit and may impose a fine of less than 5,000 yuan; if the circumstances are serious, its "medical institution practice license".

Article 40: Any medical institution that violates the relevant regulations on sanitation review and completion acceptance of construction projects shall be punished in accordance with the provisions of the Law of the People's Republic of China on Occupational Disease Prevention and Control.

Article 41: If a medical institution violates these regulations and commits one of the following acts, the health administrative department at or above the county level shall give a warning and order it to make corrections within a time limit; and may impose a fine of less than 10,000 yuan:

(1) purchasing or using radiological diagnosis and treatment equipment that fails or is eliminated by the relevant state departments;

(2) Failure to use safety protection devices and personal protective equipment in accordance with regulations;

(3) Failure to detect and inspect radiation diagnosis and treatment equipment, workplaces and protective facilities in accordance with regulations;

(4) Failure to conduct personal dose monitoring, health examination, and establishment of personal dose and health files for radiological diagnosis and treatment staff in accordance with regulations;

(5) where a radiation incident occurs and causes serious damage to the health of personnel;

(6) Failure to take emergency rescue and control measures immediately or fail to report in time in accordance with regulations;

(7) Other situations in violation of these regulations.

Article 42 If the administrative department of health and its staff violate these regulations and issue a "radiation diagnosis and treatment license" to a medical institution that does not meet the requirements, or fail to perform their legal duties and cause a radiation accident, the person in charge directly responsible and other Those who are directly responsible shall be given administrative sanctions in accordance with the law; if the circumstances are serious enough to constitute a crime, criminal responsibility shall be investigated in accordance with the law.

Chapter VII Supplementary Provisions

Article 43 : The meaning of the following terms in these regulations:

Radiation therapy: A technique that uses the biological effects of ionizing radiation to treat tumors and other diseases.

Nuclear medicine: A technology that uses radioisotopes to diagnose or treat a disease or to conduct medical research.

Interventional radiology: refers to the technique of diagnosing and treating diseases by percutaneous needle puncture or introduction of catheters for suction injection, drainage or shaping, perfusion, embolization, etc. under the guidance of medical imaging system monitoring.

X-ray image diagnosis: refers to the technology of obtaining image information of organs and tissues in the human body to diagnose diseases by using properties such as the penetration of X-rays.

Article 44: Medical institutions that have carried out radiological diagnosis and treatment projects shall apply to the health administrative department for permits for radiological diagnosis and treatment technology and medical radiation institutions according to the provisions of these Measures before September 1, 2006, and re-examine the medical imaging department diagnosis and treatment subjects.

Article 45: The Ministry of Health is responsible for the interpretation of these regulations.

Article 46: These regulations shall come into effect on March 1, 2006. The "Administrative Measures for the Hygiene Protection of Radiation Work" issued on October 23, 2001 was repealed at the same time.

What Are the Different Types of Radiology Prerequisites?

Radiological diagnosis and treatment regulations

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