Article 1 These provisions are formulated in accordance with the provisions of the Law of the People's Republic of China on the Prevention and Control of Occupational Diseases, the Regulations on the Safety and Protection of Radioisotopes and Radiation Devices and the Regulations on the Administration of Medical Institutions and other laws and administrative regulations, in order to strengthen the management of radiological diagnostic and therapeutic work, to ensure the quality of medical treatment and medical safety, and to safeguard the health rights and interests of the staff of the radiological diagnostic and therapeutic work, the patients and the public.
Second Article This provision applies to the medical institutions to carry out radiological diagnosis and treatment work.
The radiotherapy work referred to in these provisions refers to the use of radioisotopes, radiation devices for clinical medical diagnosis, treatment and health examination activities.
Article 3 The Ministry of Health is responsible for the supervision and management of the national radiation therapy work.
The health administrative departments of the local people's governments at or above the county level are responsible for the supervision and management of radiological diagnosis and treatment in their administrative regions.
Article 4 radiotherapy work in accordance with the diagnosis and treatment risk and technical difficulty is divided into four categories of management:
(a) radiation therapy;
(b) nuclear medicine;
(c) interventional radiology;
(d) X-ray imaging diagnosis.
Medical institutions to carry out radiological diagnosis and treatment work, should have the radiological diagnosis and treatment work carried out by its appropriate conditions, by the location of the local health administrative department at or above the county level of radiological diagnosis and treatment technology and medical radiation agency licensing (hereinafter referred to as radiological diagnosis and treatment licensing).
Article V medical institutions shall take effective measures to ensure radiation protection, safety and quality of radiation therapy in accordance with relevant regulations, standards and norms. Article VI of the medical institutions to carry out radiological diagnosis and treatment work, should have the following basic conditions:
(a) with the approved registration of medical imaging diagnosis and treatment subjects;
(b) in line with the relevant national standards and regulations of radiological diagnosis and treatment of premises and supporting facilities;
(c) with quality control and safety and protection of full-time (part-time) management personnel and management system, and equipped with the necessary protective equipment and monitoring instruments. Necessary protective equipment and monitoring instruments;
(D) the generation of radioactive waste gas, waste liquid, solid waste, has to ensure that radioactive waste gas, waste, solid waste discharge standards or feasible treatment programs;
(E) has a radiological incident emergency response plan.
Article VII of the medical institutions to carry out different categories of radiological diagnosis and treatment work, shall have the following personnel:
(1) to carry out radiation therapy work, shall have:
1. Radiation oncologists with intermediate or higher qualifications of professional and technical positions;
2. Pathologists, medical imaging professionals and technicians;
3. Medical physicists with bachelor's degree or above or intermediate or above professional and technical job qualifications;
4. Radiation therapy technicians and maintenance personnel.
(2) to carry out nuclear medicine, should have:
1. Intermediate or higher professional and technical qualifications of nuclear medicine physician;
2. Pathology, medical imaging professionals and technicians;
3. Undergraduate degree or above, or intermediate or above, professional and technical qualifications of technicians or nuclear medicine technicians.
(C) to carry out interventional radiology work, should have:
1. Undergraduate degree or above, or intermediate or above professional and technical qualifications of radiographers;
2. Radiographic technologists;
3. Relevant medical and surgical professionals and technicians.
(d) to carry out diagnostic X-ray imaging work, should have a professional radiographer.
Article VIII of the medical institutions to carry out different types of radiotherapy work, should have the following equipment:
(1) to carry out radiation therapy work, at least one tele-radiotherapy device, and simulation of positioning equipment and the corresponding treatment planning system and other equipment;
(2) to carry out nuclear medicine work, with nuclear medicine equipment and other related equipment;
(C) to carry out interventional radiology work, with a medical diagnostic X-ray machine with image intensifier, digital subtraction device and other equipment;
(D) to carry out diagnostic X-ray imaging work, there are medical diagnostic X-ray machine or CT machine and other equipment.
Article IX 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 should be set up in accordance with the appropriate standards for multiple safety interlock systems, dose monitoring systems, image monitoring, intercom devices and fixed dose monitoring alarm devices; equipped with radiotherapy dosimeters, dose scanning devices and personal Dose alarms;
(B) to carry out nuclear medicine work, with specialized radioisotope dispensing, injection, storage sites, radioactive waste shielding equipment and storage sites; equipped with activity meter, radioactive surface contamination monitors;
(C) interventional radiology and other X-ray imaging diagnostic workplaces should be equipped with staff protective equipment and personal protective equipment for the examinee. (d) The X-ray imaging workplace should be equipped with staff protective equipment and personal protective equipment for the examinee.
Article X. Medical institutions shall set up conspicuous warning signs for the following equipment and places:
(1) equipment and containers containing radioisotopes and radioactive waste, with signs of ionizing radiation;
(2) radioisotopes and radioactive waste storage places, with signs of warning of ionizing radiation and the necessary text description;
(3) Radiological diagnosis and treatment of the entrance to the workplace, there is a warning sign of ionizing radiation;
(4) radiological diagnosis and treatment of the workplace should be divided into control area, supervision area in accordance with the requirements of the relevant standards, in the control area of the import and export and other appropriate locations, there is a warning sign of ionizing radiation and work indicators. Article XI of the medical institutions to set up radiological diagnosis and treatment projects, should be carried out in accordance with its radiological diagnosis and treatment of the categories of work, respectively, to the appropriate administrative department of health to put forward the health of the construction project review, completion and acceptance of the project and set up radiological diagnosis and treatment project application:
(a) to carry out radiation therapy, nuclear medicine work, to the provincial administrative department of health to apply for the process;
(b) to carry out interventional radiology (ii) to carry out interventional radiology work, to the municipal health administrative department for application;
(iii) to carry out diagnostic X-ray imaging work, to the county-level health administrative department for application.
At the same time to carry out different categories of radiological diagnosis and treatment work, to the higher categories of approval authority of the health administrative department to apply for processing.
Article XII of the new construction, expansion, alteration of radiotherapy construction projects, medical institutions should be in the construction project before the construction of the corresponding health administrative departments to submit a pre-evaluation of occupational hazards of radiological protection report, apply for construction project health review. Stereotactic radiotherapy, proton therapy, heavy ion therapy, with cyclotron positron emission tomography diagnostic radiation therapy construction projects, should also be submitted to the Ministry of Health designated radiological health technology organizations issued by the pre-evaluation report of the technical review.
The health administrative department shall receive the pre-evaluation report within 30 days from the date of the audit decision. After the review meets the relevant national health standards and requirements before construction.
Article XIII of the medical institutions in the radiation diagnosis and treatment of construction projects before the completion of acceptance, shall carry out the evaluation of the effectiveness of the control of occupational disease hazards; and submit the following information to the appropriate administrative department of health, apply for health acceptance:
(a) construction project completion of the application for health acceptance;
(b) health review of the construction project information;
(c) occupational disease Hazard control effect of radiation protection evaluation report;
(D) radiation diagnosis and treatment of construction project acceptance report.
Stereotactic radiation therapy, proton therapy, heavy ion therapy, with cyclotron positron emission tomography diagnostic radiotherapy construction projects, should be submitted to the Ministry of Health designated by the Radiation Health Technical Organization of occupational hazards of the evaluation report issued by the evaluation report on the effectiveness of the technical review of the opinions and equipment performance test report.
Article XIV of the medical institutions to carry out radiotherapy work, shall submit the following information to the appropriate administrative department of health to apply for a radiotherapy license:
(a) radiotherapy license application form;
(b) "Medical Practice License" or "set up a medical institution approval" (copy);
(c) radiotherapy Professional and technical personnel qualification certificates (copy);
(d) radiotherapy equipment list;
(e) radiotherapy construction project completion and acceptance of documents.
Article 15 of the administrative department of health to meet the conditions for acceptance of the application shall be accepted immediately; does not meet the requirements, it shall be within five days to inform the applicant of the need to make corrections to the information or the reasons for inadmissibility.
The administrative department of health shall, within 20 days from the date of acceptance, make a decision on the examination and approval of the qualified, and issue the "radiotherapy license"; not approved, shall state the reasons in writing.
The format of the "radiation treatment license" by the Ministry of Health (see annex).
Article XVI of the medical institutions to obtain "radiotherapy license" to the issuance of "medical institutions license" of the health administrative practice registration department for the registration of the appropriate subjects. Practice registration department shall, according to the license, the medical imaging section approved to the second level of diagnostic and therapeutic subjects.
Without obtaining the "Radiology Diagnosis and Treatment License" or registration of diagnosis and treatment subjects, shall not carry out radiological diagnosis and treatment work.
Article XVII of the "Radiotherapy License" and "medical institutions license" at the same time verification, application for verification should be submitted to the current cycle of the performance of radiotherapy equipment and radiation workplace test reports, radiotherapy staff health monitoring information and work carried out report.
Medical institutions to change the radiotherapy project, should be approved to the radiotherapy license authority to apply for permission to change, and submit the name of the project to change the license, radiation protection evaluation report and other information; at the same time to the health administrative practice registration department to apply for a change in the subject of diagnosis and treatment, and to submit a change in the registration of the project and the reasons for the change and other information.
The health administrative department shall receive the application for change within 20 days from the date of review decision. Without approval shall not be changed.
Article 18 of the following circumstances, the original approval of the department cancellation of radiological diagnosis and treatment license, and registration and archiving, to be announced:
(A) the medical institutions apply for cancellation;
(B) overdue application for verification or unauthorized changes in radiological diagnosis and treatment of the subject;
(C) the verification or change does not meet the relevant requirements, and overdue for improvements Or after improvement still does not meet the requirements;
(D) business or stop treatment subjects for more than one year;
(E) by the administrative department of health to revoke the "license to practice in medical institutions. Article 19 of the medical institutions shall be equipped with full-time (part-time) management personnel, responsible for radiological diagnosis and treatment of quality assurance and safety protection. Its main responsibilities are:
(1) organization to develop and implement radiotherapy and radiation protection management system;
(2) regular organization of radiotherapy workplaces, equipment and personnel for radiation protection testing, monitoring and inspection;
(3) organization of the organization's radiological diagnosis and treatment of staff to receive professional and technical knowledge, knowledge of radiation protection and the relevant provisions of the training and Health checks;
(D) the development of emergency response plan for radiological incidents and organize drills;
(E) record the occurrence of radiological incidents in the institution and report to the health administrative department in a timely manner.
Article 20 of the medical institutions of radiological diagnostic and treatment equipment and testing instrumentation, shall meet the following requirements:
(a) new installation, maintenance or replacement of important parts of the equipment, it should be certified by the health administrative department above the provincial level of qualification of the testing organization to test it, qualified before it can be activated;
(b) regular stability testing, calibration and maintenance. By the provincial health administrative department certified testing organizations at least 1 state testing annually;
(C) in accordance with relevant state regulations for radiation protection and quality control testing or calibration of instrumentation;
(D) radiological diagnostic and treatment equipment and its related equipment, technical indicators and safety, protection performance, should be in line with the relevant standards and requirements.
Unqualified or the relevant state departments to eliminate the radiation diagnostic equipment shall not be purchased, used, transferred and rented.
Article 21 of the medical institutions shall regularly on the radiotherapy workplace, radioisotope storage places and protective facilities for radiation protection testing to ensure that the radiation level in line with relevant regulations or standards.
Radioisotopes shall not be stored with flammable, explosive, corrosive substances in the same storage; storage places shall take effective measures to prevent leakage, and install the necessary alarm devices.
Radioisotope storage places should have a person in charge, have a perfect system of deposit, collection, return registration and inspection, so as to achieve a strict handover, timely inspection, a clear account, the account matches the goods, and the record information is complete.
Article 22 Radiological diagnosis and treatment of staff should be in accordance with the relevant provisions of the personal dosimeter.
Article 23 of the medical institutions shall, in accordance with the relevant provisions and standards, the radiotherapy staff for pre-service, in-service period and leave the post of health checks, regular professional and protective knowledge training, and the establishment of personal dose, occupational health management and education and training files.
Article 24 of the medical institutions should be developed with the unit engaged in radiological diagnosis and treatment of projects appropriate quality assurance program, comply with the quality assurance monitoring norms.
Article 25 of the radiological diagnosis and treatment staff of patients and examinees for medical irradiation, shall comply with the justification of medical irradiation and radiation protection optimization principle, with a clear medical purpose, strict control of irradiated dose; adjacent to the irradiation of sensitive organs and tissues of the field of shielding and protection, and to inform the patients and examinees in advance of the impact of radiation on health.
Article 26 of the medical institutions in the implementation of diagnostic radiological examination should be carried out before the pros and cons of different inspection methods, under the premise of ensuring the diagnostic effect, give priority to the use of diagnostic techniques that have less impact on human health.
The implementation of the examination shall comply with the following provisions:
(1) the strict implementation of the registration, preservation, extraction and lending system of examination data, shall not be due to data management, referral of the examinee to the examination of the reasons for the examinee to receive unnecessary repeated irradiation;
(2) shall not be included in the nuclide imaging examination and X-ray chest examination of infants, children and adolescents in the physical examination of the routine examination items;
(2) the examination shall not be included in the physical examination of infants, young people, children and teenagers (c) Before conducting nuclide imaging or X-ray examination of the abdomen or pelvis of women of childbearing age, they should be asked whether they are pregnant or not; non-special needs, women of childbearing age between 8 and 15 weeks after conception should not be subjected to radiographic examination of the lower abdomen;
(d) Chest X-ray radiography should be used as far as possible instead of fluorescent fluoroscopic examination of the chest;
(e) Implementation of radiopharmaceutical administration and X-ray irradiation operations;
(f) The implementation of radioactive (E) the implementation of radiopharmaceuticals and X-ray irradiation operations, should be prohibited from entering the operation site of non-examinees; due to the patient's condition requires other personnel to accompany the examination, should be accompanied by protective measures for the examinee.
Article 27 of the medical institutions to use radiological imaging technology for health screening, should be fully justified, develop a comprehensive screening program, to 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.
Radiographic health census within the province, autonomous region and municipality directly under the Central Government, should be reported to the provincial health administrative department for approval.
Trans-provincial, autonomous regions and municipalities or within the country to conduct radiographic health screening, shall be reported to the Ministry of Health for approval.
Article 28 of the radiotherapy medical institutions, in the implementation of radiation therapy to patients before, should be imaging, pathology and other relevant examinations, strictly grasp the indications for radiation therapy. If radiation therapy is necessary, a scientific treatment plan shall be formulated and implemented in accordance with the following requirements:
(1) For extracorporeal long-distance radiation therapy, the radiotherapy staff shall first check the source display on the operation console before entering the treatment room, and confirm that the radiation beams or sources are in the closed position before entering;
(2) For brachytherapy, the radiotherapy staff shall use a special tool to hold the source in the closed position. (b) For brachytherapy, the diagnostic and treatment staff should use special tools to take the radioactive source, and should not operate it with bare hands; the patient who receives the dressing treatment should be taken care of in a safe manner, so as to prevent the radioactive source from being taken away by the patient or being lost;
(c) In the implementation of the permanent seed insertion treatment, the diagnostic and treatment staff should always count the radioactive seeds used, so as to prevent them from being lost in the process of the operation; after the radioactive seeds are implanted, a medical imaging examination should be carried out to confirm the implantation of the radioactive seed. After implantation of radioactive seeds, a medical imaging examination must be conducted to confirm the implantation site and the number of radioactive seeds;
(d) During the treatment process, there should be at least two radiotherapy staff members at the treatment site, who should pay close attention to the display of the treatment device and the patient's condition, and solve any problems arising from the treatment in a timely manner; it is strictly prohibited for other unrelated personnel to enter the treatment site;
(e) Radiotherapy staff members should strictly follow the Radiotherapy practice standards, procedures for the implementation of irradiation; shall not modify the treatment plan;
(f) radiation therapy staff should verify the implementation of the treatment plan, found deviation from the plan, should take timely remedial measures and report to the head of the department or the institution responsible for medical quality control.
Article 29 of the nuclear medicine diagnosis and treatment of medical institutions, shall comply with the corresponding operating norms and procedures to prevent radioisotope contamination of the human body, equipment, workplaces and the environment; in accordance with the provisions of the relevant standards for the acceptance of internal radiopharmaceuticals in the body of the patient diagnosis and treatment of the control, to avoid other patients and the public to be exposed to irradiation exceeding the permissible level.
Article 30 of the nuclear medicine diagnosis and treatment of radioactive solid wastes, waste liquids and radioactive discharges from patients shall be collected separately, and other wastes, waste liquids are stored separately, in accordance with relevant state regulations.
Article 31 of the medical institutions shall develop emergency plans for the prevention and disposal of radiological incidents; radiological incidents should be immediately after the occurrence of effective emergency rescue and control measures to prevent the expansion and spread of the incident.
Article 32 of the following radiation incidents occurring in medical institutions shall promptly investigate and deal with one of the circumstances, factual records, and in accordance with the relevant provisions of the timely report to the administrative department of health and the relevant departments:
(a) diagnosis of radiopharmaceuticals, the actual amount of deviation from the prescribed dose of more than 50%;
(b) radiation therapy, the actual dose of radiation exposure from the prescribed dose of more than 25%;
(b) radiation therapy, the actual dose of radiation exposure from the prescription dose of 25% or more;
(3) personnel mis-illumination or misuse of radiopharmaceuticals;
(4) radioisotopes lost, stolen and contaminated;
(5) equipment failures or other radiological events caused by human error. Article 33 The medical institutions shall strengthen the management of radiation therapy work of the institution, regularly check the implementation of radiation therapy management laws, regulations, rules and other systems to ensure that the quality of medical care and medical safety of radiation therapy.
Article 34 of the local people's governments at or above the county level, the health administrative department shall regularly carry out radiological diagnosis and treatment activities within the administrative region of the medical institutions for supervision and inspection. Inspection includes:
(a) the implementation of laws, regulations, rules, standards and norms;
(b) the implementation of radiation therapy regulations and staff responsibility system and other systems;
(c) health monitoring system and the implementation of protective measures;
(d) radiation incident investigation and handling and reporting.
Article 35 The law enforcement officers of the administrative department of health shall show their credentials when carrying out supervision and inspection in accordance with the law; the unit being inspected shall cooperate, truthfully reflect the situation, provide the necessary information, and shall not refuse, obstruct or conceal.
Article 36 of the health administrative department of law enforcement officers or health administrative departments authorized to implement the inspection, testing institutions and their staff in accordance with the law, shall keep the technical and business secrets of the inspected unit.
Article 37 The administrative department of health shall strengthen supervision and law enforcement team building, improve the operational quality of law enforcement personnel and law enforcement level, establish and improve the supervision and management of law enforcement personnel system. Article 38 The medical institutions in one of the following circumstances, by the health administrative department at or above the county level to give a warning, ordered to make corrections within a certain period of time, and may, depending on the circumstances of the fine of less than 3,000 yuan; the circumstances are serious, the revocation of its "license to practice in medical institutions".
(A) did not obtain a radiotherapy license to engage in radiotherapy;
(B) did not register the diagnostic and treatment subjects or not in accordance with the provisions of the calibration;
(C) without authorization to change the radiological diagnostic and treatment projects or beyond the scope of the approval to engage in radiological diagnostic and treatment work.
Article 39 of the medical institutions do not have the appropriate qualifications of personnel engaged in radiological diagnosis and treatment work, by the health administrative department at or above the county level shall order a period of time to make corrections, and may be fined less than 5000 yuan; the circumstances are serious, the revocation of its "medical institutions license".
Article 40 of the medical institutions in violation of the construction project health review, completion and acceptance of the relevant provisions, in accordance with the "Chinese People's Republic of China *** and the State Law on Prevention and Control of Occupational Diseases" shall be punished.
Article 41 If a medical institution violates these provisions and engages in any of the following acts, it shall be given a warning by the health administrative department at or above the county level and ordered to make corrections within a specified period of time; and it may also be subject to a fine of not more than RMB 10,000 yuan:
(1) Acquiring or using radiological diagnostic and therapeutic equipment that is unqualified or eliminated by regulations of the state departments concerned;
(2) Failing to use safety protection devices and personal (C) not in accordance with the provisions of the radiotherapy equipment, workplace and protective facilities for testing and inspection;
(D) not in accordance with the provisions of the radiotherapy staff personal dose monitoring, health checks, the establishment of personal dose and health records;
(E) the occurrence of a radiation incident and caused serious damage to the health of the personnel;
(F) the occurrence of a radiation incident did not immediately take emergency rescue and control measures or not in accordance with the provisions of the timely report;
(VII) violation of the provisions of other circumstances.
Article 42 of the health administrative departments and their staff in violation of the provisions of the medical institutions do not meet the conditions of the issuance of "radiotherapy license", or failure to perform their statutory duties, resulting in radiological accidents, the directly responsible persons in charge and other directly responsible persons, shall be given administrative sanctions; the circumstances are serious, constituting a crime, shall be investigated for criminal responsibility. Article 43 The meaning of the following terms in these provisions:
Radiation therapy: refers to the use of ionizing radiation's biological effect of the treatment of tumors and other diseases technology.
Nuclear medicine: refers to the use of radioisotopes to diagnose or treat diseases or medical research techniques.
Interventional radiology: refers to the technology of diagnosing and treating diseases by percutaneous needle puncture or introduction of catheter for suction and injection, drainage, or molding, perfusion, and embolization of tubular lumen and blood vessels under the monitoring and guidance of medical imaging system.
X-ray diagnostic imaging: refers to the use of X-rays, such as the nature of the penetration of organs and tissues within the body to obtain image information to diagnose disease technology.
Article 44 has been carried out radiological diagnosis and treatment of medical institutions should be September 1, 2006 in accordance with the provisions of this approach, to the health administrative department to apply for radiological diagnosis and treatment technology and medical radiation agency license, and re-approved medical imaging subjects.
Article 45 The Ministry of Health shall be responsible for the interpretation of these provisions.
Article 46 These Regulations shall come into force on March 1, 2006, and the Measures for the Administration of Health Protection for Radiation Work issued on October 23, 2001 shall be repealed at the same time.
Attachments: 1. Original and copy of radiotherapy license (omitted)
2. Application form for radiotherapy license (omitted)