Chapter I General Principles
Article I In order to strengthen and standardize the management of the issuance of radiation diagnosis and treatment licenses, according to the "People's Republic of China *** and the State Prevention and Control of Occupational Diseases Law", "Regulations on the Safety and Protection of Radioisotopes and Radioactive Devices" and "Radiation Diagnosis and Treatment Management Regulations", combined with the actual situation of the province, has formulated the present measures.
Article II of this approach applies to the province to carry out radiological diagnosis and treatment of medical and health institutions.
Article III engaged in radiotherapy work of medical and health institutions, must obtain a health administrative department issued by the radiotherapy license (hereinafter referred to as the license), can engage in radiotherapy work within the scope of the license.
Article IV radiotherapy work refers to the use of radioisotopes, radiation devices for clinical medical diagnosis, treatment and health check activities. Divided into radiation therapy, nuclear medicine, interventional radiology and X-ray imaging diagnostic four categories.
Chapter II Radiology License
Article V medical and health institutions should have and carry out radiological diagnostic and treatment activities compatible with the conditions of practice.
Article 6 The medical and health institutions to set up radiotherapy program, should be carried out in accordance with the type of diagnostic and therapeutic activities, in accordance with the provisions of these measures, respectively, to the corresponding administrative department of health to submit an application.
Article VII of the provincial health administrative department is responsible for carrying out radiation therapy, nuclear medicine activities in the medical and health institutions to apply for acceptance, review, approval and license issuance. Provincial health administrative departments entrusted to the municipal health administrative departments (hereinafter referred to as municipal health administrative departments) to carry out nuclear medicine activities in medical and health institutions radiotherapy license acceptance, data review and on-site audit.
Article VIII of the municipal health administrative departments are responsible for the jurisdiction of the interventional radiology activities to carry out the acceptance of applications for medical and health institutions, review, approval and licensing work.
Article IX county-level health administrative departments are responsible for the jurisdiction of the X-ray imaging diagnostic activities to carry out the acceptance of the application, review, approval and license issuance of health care institutions.
Article 10 at the same time to carry out different types of radiological diagnostic activities of medical and health institutions, should be the highest category of approval by the health administrative department to apply for radiological diagnostic license.
Article 11 to carry out radiological diagnosis and treatment activities of medical and health institutions should be set up to the corresponding administrative department of health to apply for radiological diagnosis and treatment projects, and submit the following information:
(a) Radiological Diagnosis and Treatment Permit Application Form (Annex 1);
(b) "Medical Practice License" or "set up a medical institution approval letter" (copy);
(C) radiotherapy staff list (Annex 2) and radiotherapy professional and technical staff of the qualification certificate or relevant professional training (refresher) certificate (copy);
(D) radiotherapy equipment, radiation protection and quality control equipment list (Annex 3);
(E) health administrative department recognized institutions issued by the radiation protection test report;
( (F) construction project completion of health acceptance documents;
(VII) radiation protection regulations and emergency response plan for radiation accidents;
(VIII) health administrative department required by law to provide other relevant information.
Article XII of the application information is complete, meet the requirements of the administrative department of health shall be accepted in a timely manner, and within five working days to the applicant unit issued a notice of acceptance of the application for authorization; does not meet the requirements, it should be a one-time notification to the applicant unit needs to make corrections to all the contents of the application for authorization or issued notice of application for authorization to be inadmissible to inform the applicant unit is not admissible for the reasons.
Article XIII of the health administrative department shall be formally accepted within 20 working days from the date of decision on whether to grant administrative licenses. After review, meet the requirements, make a written decision to grant administrative licenses. After review does not meet the requirements, to make a written decision not to administrative licensing, while stating the reasons, and inform the corresponding right to relief.
Article XIV of the municipal health administrative departments under Article 7, paragraph 2 of the acceptance of nuclear medicine activities to carry out the application of health care institutions, should be formally accepted from the date of the application within 12 working days of the completion of the written review and on-site review of the application materials, review agreed to seal, the application materials will be reported to the provincial health administrative departments.
Article XV of the medical and health institutions to obtain a license, should be required to the issuance of "medical practice license" of the administrative department of health for the corresponding diagnostic and therapeutic subjects registration procedures. Not obtain a license or registration of diagnostic and therapeutic subjects, shall not carry out radiological diagnostic and therapeutic work.
Article 16 of the license and "medical institutions license" at the same time the verification. Medical and health institutions should be specified 30 days before the deadline for verification, to the original license issued by the health administrative department to apply, and submit the following relevant information:
(a) the license is a copy of the original and copy;
(b) the verification cycle, the health administrative department recognized institutions issued by the radiological protection test report;
(c) radiation diagnosis and treatment of staff professional and protective knowledge training, health check-ups and personal dose test report. Training, health checkups and personal dosage testing materials;
(d) the verification cycle of the unit's radiological work carried out in the report;
(e) health administrative departments required by law to provide other information.
The review meets the relevant provisions of the administrative department of health shall be allowed to calibration.
Article XVII of the medical and health institutions to change the radiotherapy project, should be to the original radiotherapy license approval authority to apply for permission to change, and submit the following materials:
(a) medical and health institutions to change the radiotherapy license application;
(b) the original license (original, copy);
(c) change the project corresponding to the professional and technical staff of a copy of the qualification certificate;
The corresponding professional and technical staff of a copy of the qualification certificate;
The health administrative department shall require other information. A copy of the qualification certificates;
(d) change the radiotherapy subject equipment, radiation protection and quality control equipment list;
(e) new radiotherapy construction project completion of the health acceptance documents;
(f) health administrative departments required by law to provide other information.
At the same time to the health administrative department to apply for registration of change in diagnosis and treatment subjects. The health administrative department shall accept the application for change within 20 working days from the date of review decision, without approval shall not be changed.
Article 18 The health administrative departments at or above the county level must be in strict accordance with the laws, rules and regulations stipulated in the authority, scope, conditions and procedures, follow the principle of openness, fairness, impartiality, convenience, and do a good job in the issuance of licenses and management. Health administrative departments at all levels should establish a license information management system, the regular announcement of the acquisition, revocation or cancellation of the license of the radiotherapy unit directory.
Article 19 The health administrative departments at or above the county level shall, in accordance with the law of the jurisdiction engaged in radiological diagnosis and treatment activities of health care institutions to carry out supervision and inspection.
Article 20 of the lost license, the original licensee should be lost within 60 days after the original approval of the health administrative organs to apply for replacement. License calibration period unchanged.
Chapter III Radiological Diagnostic Construction Project Health Review
Article 21 The new construction, alteration, expansion of radiological diagnostic construction projects (hereinafter referred to as construction projects) of radiation protection facilities must be designed with the main project at the same time, while construction, acceptance of the same time put into operation.
Article 22 Before the construction of construction projects, health care institutions should be in accordance with the provisions of these measures, to the appropriate health administrative department to apply for health review, submit the following information:
(a) health review of the construction project application;
(b) the health administrative department recognized the agency issued a pre-assessment of occupational hazards of radiological protection of the construction project report;
( (C) the construction project environment plan (including the name of the surrounding buildings within 50 meters, height, rivers, roads, etc.), radiotherapy workplace architectural design drawings (including floor plan layout, plan, section of the machine room, and ventilation diagrams, etc.);
(D) involves the planning and management of large-scale medical equipment configuration, should also provide the corresponding administrative department of health to provide the configuration of large-scale medical equipment license approved by or Related approvals.
The health administrative department shall receive the above materials within 30 working days from the date of organization review, after reviewing the corresponding national health standards and requirements, issued by the construction project design and health review of construction project design qualification documents, construction projects can be constructed.
Article 23 of the health care institutions in the construction project before acceptance, should be carried out to evaluate the effectiveness of occupational hazards control; meet the requirements of the corresponding administrative department of health to apply for health acceptance, and submit the following information:
(a) the completion of the construction project health acceptance of the application;
(b) health review of the construction project to certify that the document;
(C) the health administrative department recognized by the agency issued by the evaluation report on the effectiveness of occupational disease control;
(D) the list of radiological diagnosis and treatment of staff;
(E) the list of radiological protection and quality control equipment;
(F) radiological emergency response plan and other appropriate rules and regulations;
(VII) the radiological protection management organization or radiological protection management personnel list;
(VII) the radiological protection management organization;
(VII) the radiological protection management organization or radiological protection management personnel list;
(VII) the radiological protection management organization or radiological protection management personnel list;
(I) the radiological protection management organization or radiological Protection management personnel list;
(viii) health administrative departments required by law to provide other relevant information.
By the health administrative department of the organization's on-site acceptance, after passing the construction project issued by the completion of the health acceptance certificate.