Article I In order to further standardize the management of radiation therapy construction project health review, according to the "People's Republic of China *** and the State Law on Prevention and Control of Occupational Diseases", "radioisotopes and radiation device safety and protection regulations" and "Radiological Diagnosis and Treatment Regulations" and other laws, rules and regulations, the development of the provisions of this regulation.
Second This provision applies to the radiotherapy construction projects of occupational hazards of radiation protection evaluation audit, radiation protection facilities, such as the completion of the acceptance of health review activities.
Article 3 above the county level, the local health administrative department is responsible for the jurisdiction of the construction of radiation therapy project health review.
Provincial health administrative departments are responsible for radiation therapy, nuclear medicine construction project health review.
Prefecture and municipal health administrative departments are responsible for interventional radiology construction project health review.
County-level health administrative departments are responsible for X-ray imaging diagnostic construction project health review.
The same medical institution has a different category of radiological diagnosis and treatment of construction projects by the health of the administrative department of health with a high category of approval authority.
Provincial health administrative departments can adjust the approval authority according to the actual situation in the region.
Article IV of the radiological diagnosis and treatment of construction projects in accordance with the degree of radioactive hazards and diagnosis and treatment of risk is divided into two categories of serious hazards and general hazards.
Serious categories of radiation therapy construction projects, including stereotactic radiation therapy device (γ knife, X-knife, etc.), medical gas pedal, proton therapy device, heavy ion therapy device, cobalt-60 therapy machine, neutron therapy device and aftermath of the treatment machine and other radiation therapy facilities, positron emission computed tomography (PET) and single-photon emission computed tomography (SPECT) and use of radiopharmaceuticals and computed tomography (PET). SPECT) and the use of radioactive drugs for treatment of nuclear medicine facilities. Other radiotherapy construction projects for the general category of hazards.
Article 5 The construction unit shall be in the feasibility stage and completion and acceptance of the radiological health technical service organizations with the appropriate qualifications were commissioned to prepare radiological diagnosis and treatment of occupational hazards of construction projects, radiological protection pre-evaluation report and occupational hazards of radiation protection assessment of the effectiveness of the control of radiological protection report.
Stereotactic radiation therapy devices, proton therapy devices, heavy ion therapy devices, neutron therapy devices, positron emission tomography (PET) and other construction projects of radiation protection evaluation should be made by the qualification of Class A evaluation of radiation hygiene and technical services institutions.
Article VI Radiological diagnosis and treatment of occupational hazards in construction projects radiation protection evaluation report is divided into evaluation report and evaluation report form. Serious radiological hazards of construction projects, should be prepared to evaluate the report. The general category of radioactive hazards of construction projects, should be prepared to evaluate the report form. At the same time with different categories of radioactive hazards of construction projects, should be in accordance with the more serious categories of hazards to prepare an evaluation report.
Article VII The construction unit shall apply to the health administrative department before the construction of radiotherapy construction projects to pre-assessment of occupational hazards of radiation protection of construction projects and submit the following information:
(a) radiotherapy construction projects pre-assessment of occupational hazards of radiation protection of the audit application form;?
(B) radiotherapy construction project occupational hazards of radiation protection pre-evaluation report;
(C) entrusted to declare, shall provide proof of entrusted declaration;
(D) the provincial health administrative department of other information.
Article 8: Before applying for review and approval by the administrative department of health, the pre-evaluation report on radiation protection against occupational disease hazards of radiation diagnosis and treatment construction projects in the category of serious hazards shall be evaluated by more than five experts organized by the radiation hygiene technology service organization undertaking the evaluation, of which the experts drawn from the expert database of the evaluation of radiation hygiene technology shall be not less than 3/5 of the total number of experts.
Stereotactic radiation therapy Stereotactic radiation therapy devices, proton therapy devices, heavy ion therapy devices, neutron therapy devices and positron emission tomography (PET) and other project pre-evaluation report of the review, the experts drawn from the national radiation health technology assessment expert database should be not less than 2/5 of the total number of experts.
Hazard of general radiotherapy construction project occupational hazards of radiation protection pre-evaluation report whether the need to expert Review by the provincial health administrative department to determine.
The composition of the evaluation experts, expert evaluation opinions, evaluation opinions and the handling of expert group review shall be attached as an annex to the pre-evaluation report.
Article IX of the health administrative department shall complete the review of the pre-evaluation within 20 days from the date of acceptance. Review agreed to be approved; review does not agree, shall notify the construction unit in writing and explain the reasons.
Article X After the completion of the radiotherapy construction project, the construction unit shall apply to the health administrative department of the pre-assessment of occupational hazards of radiation protection of the construction project for completion and acceptance, and submit the following information:
(a) radiotherapy construction project of occupational disease radiation protection facilities completion acceptance of the application form;
(b) the effect of occupational hazards of radiation protection of radiotherapy construction project control Radiological protection evaluation report;
(C) radiotherapy construction project of occupational hazards pre-evaluation of review and approval of certificates (copy);
(D) entrusted to declare, shall provide proof of entrusted declaration;
(E) the provincial health administrative department of the other information required.
Article XI of the health administrative department accepts the application for completion and acceptance of the general category of hazards of construction projects, shall be in accordance with the time limit for health administrative licensing of the completion of the acceptance of radiation protection facilities for occupational diseases; serious categories of hazards of construction projects, shall be in accordance with the time limit for health administrative licensing of the organization of experts on the control of the effectiveness of the evaluation report for review, and completion of the acceptance of radiation protection facilities for occupational diseases.
Hazards of general radiotherapy construction projects in the category of occupational disease hazards of radiation protection control effect evaluation report whether the need for expert review by the provincial health administrative departments to determine.
Article XII of the completion and acceptance of the radiation diagnosis and treatment construction projects, the health administrative department shall, within 20 days after the completion and acceptance of the acceptance of the document; the need for rectification, the construction unit shall submit a rectification report, the health administrative department of the organization to review and confirm compliance with the requirements of the acceptance of the document; the completion of the acceptance of the unqualified, the administrative department of health shall notify the construction unit and in writing. Explain the reasons.
Article XIII of the pre-evaluation review and acceptance of the completion of the application materials shall meet the following requirements:
(1) the application content is complete, true and accurate, and shall not be altered;
(2) the use of A4-size paper printing;
(3) the application materials in duplicate and stamped with the official seal of the applicant unit;
(4) entrusted to the declaration of proof should be (d) The certificate of entrusted declaration shall contain the entrusted matters, the name of the entrusted unit, the name of the entrusted person and the date of entrustment, and the official seal of the entrusted unit shall be affixed.