Chapter I Information of Regulations on the Management of Radiological Diagnosis and Treatment

Article 1 In order to strengthen the management of radiation diagnosis and treatment, ensure medical quality and safety, and safeguard the health rights and interests of radiation diagnosis and treatment personnel, patients and the public, these Provisions are formulated in accordance with the Law of People's Republic of China (PRC) on the Prevention and Control of Occupational Diseases, the Regulations on the Safety Protection of Radioisotopes and Radiation Devices, and the Regulations on the Administration of Medical Institutions.

Article 2 These Provisions shall apply to medical institutions that carry out radiation diagnosis and treatment.

The term "radiation diagnosis and treatment" as mentioned in these Provisions refers to the activities of clinical medical diagnosis, treatment and health examination by using radioisotopes and ray devices.

Article 3 The Ministry of Health shall be responsible for the supervision and administration of radiation diagnosis and treatment throughout the country.

The health administrative department of the local people's government at or above the county level shall be responsible for the supervision and management of radiation diagnosis and treatment within its administrative area.

Article 4 Radiological diagnosis and treatment work is divided into four categories according to the risk and technical difficulty of diagnosis and treatment:

(1) radiotherapy;

(2) nuclear medicine;

(3) Interventional radiology;

(4) X-ray image diagnosis.

Medical institutions that carry out radiation diagnosis and treatment work shall have the conditions suitable for their radiation diagnosis and treatment work, and obtain the Permit for Radiological Diagnosis and Treatment Technology and Medical Radiological Institution issued by the local health administrative department at or above the county level (hereinafter referred to as the Radiological Diagnosis and Treatment Permit).

Article 5 Medical institutions shall take effective measures to ensure that radiation protection, safety and quality of radiation diagnosis and treatment meet the requirements of relevant laws, regulations, standards and norms. Sixth medical institutions to carry out radiation diagnosis and treatment work, should meet the following basic conditions:

(a) with the approval and registration of medical imaging diagnosis and treatment subjects;

(2) Having radiation diagnosis and treatment institutions and supporting facilities that meet the relevant national standards and regulations;

(3) Having full-time (part-time) quality management personnel and safety protection management system, equipped with necessary protective equipment and monitoring instruments;

(4) If radioactive waste gas, waste liquid and solid waste are generated, it has the treatment capacity or feasible treatment scheme to ensure that the radioactive waste gas, waste liquid and solid waste meet the emission standards;

(5) Having an emergency plan for radiation accidents.

Seventh medical institutions to carry out different types of radiation diagnosis and treatment work, should have the following personnel:

(a) to carry out radiotherapy work, should have:

1. Radiation oncologist with intermediate or above professional and technical post qualifications;

2. Pathology and medical imaging professionals;

3. Medical physics personnel with bachelor degree or above or intermediate professional and technical post qualifications;

4. Radiotherapy technicians and maintenance personnel.

(two) to carry out nuclear medicine work, should have:

1. Nuclear medicine physician with professional and technical post qualifications above intermediate level;

2. Pathology and medical imaging professionals;

3. Technicians or nuclear medical technicians with bachelor degree or above or intermediate professional and technical post qualifications.

(three) to carry out interventional radiology work, it shall have:

1. Radiographer with bachelor degree or above or intermediate professional and technical post qualification;

2. Radiographic imaging technician;

3. Relevant medical and surgical professionals.

(4) To carry out X-ray image diagnosis, a professional radiologist shall be available.

Eighth medical institutions to carry out different types of radiation diagnosis and treatment work, should have the following equipment:

(a) to carry out radiotherapy, at least 1 long-distance radiotherapy device, and equipped with analog positioning equipment and corresponding treatment planning system;

(two) to carry out nuclear medicine work, with nuclear medical instruments and other related equipment;

(3) Having a medical diagnostic X-ray machine with an image intensifier and a digital subtraction device capable of carrying out interventional radiology;

(four) to carry out X-ray image diagnosis, with medical diagnostic X-ray machine or CT machine and other equipment.

Article 9 Medical institutions shall equip and use safety protection devices, radiation detection instruments and personal protective equipment according to the following requirements:

(1) Radiotherapy sites should be equipped with multiple safety interlocking systems, dose monitoring systems, image monitoring, intercom devices and fixed dose monitoring and alarm devices according to corresponding standards; Equipped with radiotherapy dosimeter, dose scanning device and personal dose alarm;

(2) To carry out nuclear medicine, special places for subpackaging, injection and storage of radioactive isotopes, radioactive waste shielding equipment and storage places shall be set up; Equipped with radioactive activity meter and radioactive surface pollution monitor;

(3) Interventional radiation and other X-ray image diagnosis workplaces should be equipped with personal protective equipment for staff and subjects.

Tenth medical institutions should set up eye-catching warning signs for the following equipment and places:

(1) Equipment and containers containing radioisotopes and radioactive wastes are marked with ionizing radiation signs;

(2) The radioactive isotope and radioactive waste storage places are equipped with warning signs of ionizing radiation and necessary written explanations;

(three) set up warning signs of ionizing radiation at the entrance of the radiation diagnosis and treatment workplace;

(4) The workplace for radiation diagnosis and treatment shall be divided into a control area and a supervision area according to the requirements of relevant standards, and warning signs and work indicators of ionizing radiation shall be set at appropriate positions such as the entrances and exits of the control area. Eleventh medical institutions to set up radiation diagnosis and treatment projects, should be carried out in accordance with the categories of radiation diagnosis and treatment work, respectively, to the corresponding health administrative departments to put forward the construction project health review, completion acceptance and the establishment of radiation diagnosis and treatment projects:

(a) to carry out radiotherapy and nuclear medicine and apply to the provincial health administrative department;

(two) to carry out interventional radiology work and apply to the municipal health administrative department with districts;

(three) to carry out X-ray image diagnosis and apply to the health administrative department at the county level.

At the same time, carry out different types of radiation diagnosis and treatment work, and apply to the health administrative department with high-level approval authority.

Twelfth new construction, expansion, renovation of radiation diagnosis and treatment construction projects, medical institutions should be submitted to the corresponding health administrative departments before the start of the construction project, and apply for health examination of the construction project. Stereotactic radiotherapy, proton therapy, heavy ion therapy, cyclotron positron emission tomography and other radiation diagnosis and treatment construction projects shall also be submitted to the technical review opinions of the pre-evaluation report issued by the radiation health technical institutions designated by the Ministry of Health.

The administrative department of health shall make an audit decision within 30 days from the date of receiving the pre-evaluation report. The construction can only be started after the examination meets the relevant national hygiene standards and requirements.

Thirteenth medical institutions should evaluate the effect of occupational hazard control before the completion and acceptance of radiation diagnosis and treatment construction projects; And submit the following materials to the corresponding health administrative department to apply for health inspection and acceptance:

(a) the application for health inspection and acceptance of the completion of the construction project;

(two) health examination data of construction projects;

(3) Radiation protection evaluation report on the control effect of occupational hazards;

(four) the acceptance report of the radiation diagnosis and treatment construction project.

Stereotactic radiotherapy, proton therapy, heavy ion therapy, positron emission tomography with cyclotron and other radiotherapy construction projects. The evaluation report on the control effect of occupational disease hazards, technical review opinions and equipment performance test report issued by the radiation health technical institution designated by the Ministry of Health shall be submitted.

Fourteenth medical institutions shall submit the following materials before carrying out radiation diagnosis and treatment, and apply to the corresponding health administrative department for a radiation diagnosis and treatment license:

(a) the application form for the radiation diagnosis and treatment license;

(2) Practice License of Medical Institution or Approval Letter for Establishment of Medical Institution (copy);

(3) Qualification certificate (photocopy) of professional and technical personnel in radiation diagnosis and treatment;

(4) List of radiation diagnosis and treatment equipment;

(five) the certificate of completion and acceptance of the radiation diagnosis and treatment construction project.

Article 15 The administrative department of health shall immediately accept the application that meets the acceptance conditions; If it does not meet the requirements, it shall inform the applicant of the contents that need to be corrected or the reasons for not accepting it within 5 days.

The administrative department of health shall, within 20 days from the date of acceptance, make a review decision, approve the qualified ones, and issue a license for radiation treatment; If it is not approved, it shall explain the reasons in writing.

The format of the Permit for Radiological Diagnosis and Treatment shall be uniformly stipulated by the Ministry of Health (see Annex).

Sixteenth medical institutions to obtain the "radiation diagnosis and treatment license", to issue the "medical institutions practicing license" of the health administrative practice registration department for the corresponding diagnosis and treatment subjects registration. The practice registration department shall, according to the license, approve the medical imaging department to carry out secondary diagnosis and treatment subjects.

Radiological diagnosis and treatment shall not be carried out without obtaining the Permit for Radiological Diagnosis and Treatment or without registering the subjects of diagnosis and treatment.

Seventeenth "radiation diagnosis and treatment license" and "medical institution practice license" should be reviewed at the same time. When applying for verification, the performance test report of radiation diagnosis and treatment equipment and radiation workplace, health monitoring data of radiation diagnosis and treatment personnel and work development report shall be submitted within this period.

If a medical institution changes the radiation diagnosis and treatment project, it shall apply to the radiation diagnosis and treatment license examination and approval authority for license change, and submit the name of the license change project, radiation protection evaluation report and other materials; At the same time, apply to the health administrative practice registration department to change the diagnosis and treatment subjects, and submit the information such as the change registration items and the reasons for the change.

The administrative department of health shall make a review decision within 20 days from the date of receiving the application for change. Without approval, it shall not be changed.

Eighteenth in any of the following circumstances, the original approval department shall cancel the license for radiation diagnosis and treatment, register and make an announcement:

(a) medical institutions to apply for cancellation;

(2) Failing to apply for calibration within the time limit or changing the subject of radiation diagnosis and treatment without authorization;

(three) after verification or change does not meet the relevant requirements, and failed to improve or improve still does not meet the requirements;

(four) the closure or closure of medical subjects 1 year or more;

(5) The Practice License of Medical Institution has been revoked by the administrative department of health. Nineteenth medical institutions should be equipped with full-time (part-time) management personnel, responsible for the quality assurance and safety protection of radiation diagnosis and treatment. Its main responsibilities are:

(a) to organize the formulation and implementation of radiation diagnosis and treatment and radiation protection management system;

(two) regularly organize the radiation protection detection, monitoring and inspection of the workplace, equipment and personnel for radiation diagnosis and treatment;

(three) to organize the radiation diagnosis and treatment staff of this institution to receive training and health examination in professional technology, radiation protection knowledge and relevant laws and regulations;

(four) to formulate emergency plans for radiation accidents and organize drills;

(five) record the radiation incidents in this institution and report to the administrative department of health in a timely manner.

Article 20 Radiological diagnosis and treatment equipment and testing instruments of medical institutions shall meet the following requirements:

(1) Equipment newly installed, repaired or replaced with important parts shall be tested by a testing institution with the qualification certification of the health administrative department at or above the provincial level, and can only be put into use after passing the test;

(two) to carry out stability testing, calibration and maintenance on a regular basis, and the testing institutions recognized by the health administrative departments at or above the provincial level shall carry out at least 1 national testing every year;

(three) in accordance with the relevant provisions of the state, inspection or calibration of testing instruments used for radiation protection and quality control;

(four) the technical indicators, safety and protective performance of radiation diagnosis and treatment equipment and related equipment shall meet the relevant standards and requirements.

It is not allowed to purchase, use, transfer or lease the radiation diagnosis and treatment equipment that is unqualified or eliminated by the relevant state departments.

Twenty-first medical institutions should regularly carry out radiation protection tests on radiation diagnosis and treatment workplaces, radioactive isotope storage sites and protective facilities to ensure that the radiation level meets relevant regulations or standards.

Radioisotopes shall not be stored in the same warehouse with inflammable, explosive and corrosive articles; Storage places should take effective measures to prevent leakage and install necessary alarm devices.

Radioisotope storage sites should be responsible for the special person, with a perfect registration and inspection system for deposit, receipt and withdrawal, so as to ensure strict handover, timely inspection, clear accounts, consistent accounts and complete records.

Twenty-second radiation medical personnel should wear personal dosimeter in accordance with the relevant provisions.

Article 23 Medical institutions shall, in accordance with relevant regulations and standards, conduct pre-post, in-post and post-post health examinations for radiation diagnosis and treatment personnel, conduct regular professional and protective knowledge training, and establish personal dose, occupational health management and education and training files respectively.

Twenty-fourth medical institutions should formulate quality assurance programs suitable for the radiation diagnosis and treatment projects they are engaged in, and abide by the quality assurance monitoring norms.

Twenty-fifth radiation medical personnel should abide by the principle of optimizing medical irradiation and radiation protection for patients and subjects, have a clear medical purpose and strictly control the dose; Shielding and protecting sensitive organs and tissues near the irradiation field, and informing patients and subjects of the health effects of radiation in advance.

Twenty-sixth medical institutions should analyze the advantages and disadvantages of different examination methods before carrying out radiological diagnostic examination, and give priority to the diagnostic techniques that have little impact on human health on the premise of ensuring the diagnostic effect.

The implementation of inspection shall comply with the following provisions:

(a) strictly implement the system of registration, preservation, extraction and borrowing of inspection data, and do not expose the subjects to unnecessary repeated irradiation due to data management, referral and other reasons. ;

(two) radionuclide imaging examination and X-ray chest examination shall not be included in the routine examination of infants;

(3) Women of childbearing age should be asked whether they are pregnant before radionuclide imaging or X-ray examination of abdomen or pelvis; If there is no special need, women of childbearing age who are 8- 15 weeks after conception are not allowed to undergo lower abdominal radiation examination;

(4) Chest X-ray photography should replace chest fluoroscopy as much as possible;

(5) When radioactive drugs and X-ray irradiation operations are carried out, non-examinees are prohibited from entering the workplace; When the patient's condition needs to be accompanied by other people, protective measures should be taken against the people accompanying the examination.

Twenty-seventh medical institutions should fully demonstrate the use of radiological imaging technology in health census, formulate a thorough census plan, and take strict quality control measures.

The use of portable X-ray machines for group fluoroscopy shall be reported to the county-level health administrative department for approval.

The health survey of radiological images within the scope of provinces, autonomous regions and municipalities directly under the Central Government shall be reported to the provincial health administrative department for approval.

Radiological health surveys across provinces, autonomous regions, municipalities directly under the Central Government or nationwide shall be reported to the Ministry of Health for approval.

Twenty-eighth medical institutions to carry out radiotherapy should carry out imaging, pathology and other related examinations before radiotherapy for patients, and strictly grasp the indications of radiotherapy. If radiotherapy is really necessary, a scientific treatment plan shall be formulated and implemented in accordance with the following requirements:

(a) for in vitro long-distance radiotherapy, before entering the treatment room, radiation diagnosis and treatment personnel should first check the source display of the operation console and confirm that the radiation beam or radioactive source is in the closed position before entering;

(2) During brachytherapy, radiation diagnosis and treatment personnel shall use special tools to take radioactive sources, and shall not operate with bare hands; Carry out safety monitoring on patients receiving application treatment to prevent radioactive sources from being taken away or lost by patients;

(three) in the implementation of permanent particle implantation treatment, radiation diagnosis and treatment staff should always count the radioactive particles used to prevent them from being lost in the operation process; After radioactive particles are implanted, medical imaging examination must be carried out to confirm the implantation site and the number of radioactive particles;

(four) in the process of treatment, there should be at least two radiation diagnosis and treatment personnel at the treatment site, and pay close attention to the display of the treatment device and the patient's situation, and solve the problems in the treatment in time; Prohibit other irrelevant personnel from entering the treatment place;

(five) radiotherapy staff should be treated in strict accordance with the norms and procedures of radiotherapy; The treatment plan shall not be modified without authorization;

(six) radiation diagnosis and treatment staff should verify the implementation of the treatment plan, found that the deviation from the plan, it should take remedial measures in time, and report to the person in charge of the department or the department in charge of medical quality control.

Twenty-ninth medical institutions that carry out nuclear medical diagnosis and treatment shall abide by the corresponding operating norms and procedures to prevent radioactive isotopes from polluting the human body, equipment, workplace and environment; In accordance with the provisions of relevant standards, patients receiving internal radiopharmaceuticals should be controlled to prevent other patients and the public from being exposed to radiation exceeding the allowable level.

Article 30 Radioactive solid waste, waste liquid and radioactive discharge from patients produced by nuclear medicine diagnosis and treatment shall be collected separately, stored separately from other wastes and waste liquid, and disposed of in accordance with relevant state regulations.

Thirty-first medical institutions should formulate emergency plans for preventing and handling radiation incidents; After the radiation incident, effective emergency rescue and control measures should be taken immediately to prevent the incident from expanding and spreading.

Thirty-second medical institutions shall promptly investigate and deal with the following radiation incidents, truthfully record them, and report to the health administrative department and relevant departments in a timely manner in accordance with relevant regulations:

(a) the actual dose of radioactive diagnostic drugs differs from the prescribed dose by more than 50%;

(two) the actual radiation dose of radiotherapy deviates from the prescribed dose by more than 25%;

(3) Misirradiation or misuse of radioactive drugs by personnel;

(4) Loss, theft and pollution of radioactive isotopes;

(five) other radiation events caused by equipment failure or human error. Thirty-third medical institutions should strengthen the management of their own radiation diagnosis and treatment work, regularly check the implementation of laws, regulations and rules on radiation diagnosis and treatment management, and ensure the medical quality and safety of radiation 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 the medical institutions that carry out radiation diagnosis and treatment activities within their respective administrative areas. The inspection contents include:

(a) the implementation of laws, regulations, rules, standards and norms. ;

(two) the implementation of the rules and regulations of radiation diagnosis and treatment and the post responsibility system of the staff;

(three) the implementation of health monitoring system and protective measures;

(4) Investigation, handling and reporting of radiation accidents.

Thirty-fifth law enforcement officers of the administrative department of health shall produce their certificates when conducting supervision and inspection according to law; The units under inspection shall cooperate, truthfully report the situation and provide necessary information, and shall not refuse, obstruct or conceal.

Article 36 Law enforcement officers and their staff of the health administrative department or the institutions authorized by the health administrative department to conduct inspection and testing shall keep the technical secrets and business secrets of the inspected units.

Thirty-seventh health administrative departments should strengthen supervision and law enforcement team building, improve the professional quality and law enforcement level of law enforcement personnel, and establish and improve the supervision and management system for law enforcement personnel. Thirty-eighth medical institutions in 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 3000 yuan according to the circumstances; If the circumstances are serious, its Practice License of Medical Institution shall be revoked.

(a) engaged in radiation diagnosis and treatment work without obtaining the "radiation diagnosis and treatment license";

(two) did not apply for the registration of medical subjects or did not check in accordance with the provisions;

(3) changing the project of radiation diagnosis and treatment without approval or engaging in radiation diagnosis and treatment beyond the approved scope.

Thirty-ninth medical institutions use personnel who do not have the corresponding qualifications to engage in radiation diagnosis and treatment, and the health administrative department at or above the county level shall order them to make corrections within a time limit and may impose a fine of not more than 5,000 yuan; If the circumstances are serious, its Practice License of Medical Institution shall be revoked.

Fortieth medical institutions that violate the relevant provisions of the health examination and completion acceptance of construction projects shall be punished in accordance with the provisions of the Law of People's Republic of China (PRC) on the Prevention and Control of Occupational Diseases.

Forty-first medical institutions in violation of these provisions, one of the following acts, given a warning by the health administrative department at or above the county level, ordered to make corrections within a time limit; And may be fined 65,438 yuan+0,000 yuan:

(a) the purchase and use of unqualified or obsolete radiation diagnosis and treatment equipment by the relevant departments of the state;

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

(3) Failing to test and inspect the radiation diagnosis and treatment equipment, workplaces and protective facilities in accordance with regulations;

(four) failing to carry out personal dose monitoring and health examination for radiation diagnosis and treatment personnel and establish personal dose and health records in accordance with the regulations;

(five) radiation accidents and serious damage to the health of personnel;

(6) Failing to take emergency rescue and control measures immediately or failing to report in time in accordance with regulations when a radiation accident occurs;

(seven) other circumstances in violation of these provisions.

Article 42 If the administrative department of health and its staff violate these regulations, issue licenses for radiation diagnosis and treatment to unqualified medical institutions, or fail to perform their statutory duties, resulting in radiation accidents, the directly responsible person in charge and other directly responsible personnel shall be given administrative sanctions according to law; If the circumstances are serious enough to constitute a crime, criminal responsibility shall be investigated according to law. Article 43 The meanings of the following terms in these Provisions:

Radiotherapy: refers to the technology that uses the biological effects of ionizing radiation to treat diseases such as tumors.

Nuclear medicine: refers to the technology of using radioisotopes to diagnose or treat diseases or conduct medical research.

Interventional radiology: refers to the technique of aspiration, injection and drainage by percutaneous puncture or catheter introduction under the monitoring and guidance of medical imaging system, or molding, perfusion and embolization of lumens and blood vessels to diagnose and treat diseases.

X-ray image diagnosis: refers to the technology of obtaining the image information of organs and tissues in human body by using the characteristics of X-ray penetration and so on, and making disease diagnosis.

Article 44 Medical institutions that have carried out radiation diagnosis and treatment projects shall, in accordance with the provisions of these Measures before September/KLOC-0, 2006, apply to the administrative department of health for the License for Radiological Diagnosis and Treatment Technology and Medical Radiological Institutions, and re-approve the medical imaging diagnosis and treatment subjects.

Article 45 The Ministry of Health shall be responsible for the interpretation of these Provisions.

Article 46 These Provisions shall come into force as of March 6, 2006. The Management Measures for Health Protection of Radiological Work, issued on 23 October 2006/KLOC-0, was abolished at the same time.

Attachment: 1 Original and photocopy of radiation diagnosis and treatment license (omitted)

2. Application form for radiation diagnosis and treatment license (omitted)