Article 1 For the implementation of the Ministry of Health, "Radiotherapy Management Regulations", standardize the management of the city's radiotherapy license issuance, according to the relevant state laws, rules and regulations, combined with the actual situation in the city, the development of this approach.
Article 2 These measures apply to the use of radioisotopes, radiation devices for clinical medical diagnosis, treatment and health check activities of medical institutions.
Article 3 The municipal health administrative department is responsible for the city to carry out radiation therapy, nuclear medicine, interventional radiology work of medical institutions of radiotherapy license issuance.
District (county) health administrative department is responsible for the jurisdiction to carry out X-ray diagnostic imaging work of medical institutions radiotherapy license issuance.
Application for permission for the project involves both municipal health administrative departments and district (county) health administrative departments involved in the licensing management, medical institutions should be unified to the municipal health administrative departments to apply for a radiotherapy license.
Article IV of the medical institutions to carry out radiotherapy work, should be made to the appropriate health administrative department of radiotherapy license application, and submit the following materials:
(a) radiotherapy license application form, radiation protection and quality control equipment list, radiotherapy personnel list and its health check results, radiation protection expertise and knowledge of relevant laws and regulations of the training qualifications Proof of material;
(b) "Medical Practice License" or "set up medical institutions approved" (copy);
(c) radiotherapy professionals and technicians relevant qualifications (copy);
(d) radiotherapy construction projects completed acceptance of documents;
(e) radiotherapy equipment included in the management directory of large-scale medical equipment, should provide "large-scale medical equipment";
(f) radiotherapy equipment included in the management directory of large-scale medical equipment, should provide "large-scale medical equipment", should provide "large-scale medical equipment", should provide "large-scale medical equipment", should provide "large-scale medical equipment". Management directory, should provide "large medical equipment configuration license" or "large medical equipment configuration approval notice" (copy);
(F) by the health administrative department certified technical service agency issued by the radiological diagnostic equipment testing reports;
(G) radiation protection management agencies or organizations, radiation protection management personnel list;
(H) Radiation protection management system;
(ix) list of radiological diagnostic equipment.
Article V
Article IV (3) refers to the radiotherapy professional and technical personnel qualifications:
(a) carry out radiation therapy (except for separate nuclide dressing therapy), should provide (at least one of each of the following types of certificates): radiation oncology physician intermediate or higher professional and technical position qualifications; pathology, medical imaging professional and technical personnel certificate;
(i) the radiotherapy work (except for separate nuclide dressing therapy), should provide (each of the following types of certificates at least one): radiation oncology physician intermediate or higher professional and technical position qualifications; pathology, medical imaging professional and technical personnel certificate. Pathology, medical imaging professionals and technicians related certificates; medical physics personnel undergraduate degree or above certificate of qualification for professional and technical positions above the intermediate level; radiation therapy technicians and maintenance personnel of the "large-scale medical equipment on board personnel technical qualification certificate.
Individual nuclide dressing therapy, should provide the scope of practice for ? Medical imaging and radiation therapy professionals? Personnel of the "physician's license".
(B) to carry out nuclear medicine (except for radioimmunity alone) work, should provide (at least one of each of the following types of certificates): nuclear medicine physician intermediate or higher professional and technical position qualification certificates; pathology, medical imaging professionals and technicians related certificates; nuclear medicine technician or technician's undergraduate certificate or intermediate or higher professional and technical position qualification certificates. Qualification certificate.
Separate radioimmunization work, should provide the relevant certificates of medical examiners.
(C) to carry out interventional radiology work, should provide (each of the following types of certificates to provide at least 1): radiography physician undergraduate certificate or intermediate or higher professional and technical position qualification certificates; radiography technician certificates; the relevant department of professional and technical personnel certificates.
(D) to carry out diagnostic X-ray imaging work, should provide at least one radiographer's "physician's license". No professional radiographers engaged in dental X-ray imaging diagnostic medical institutions, the relevant practitioners should be dental practitioners, and obtain from the city health administrative department designated institutions issued by the radiographic professional training certificate.
Article 6
Article 4 (9) refers to the radiotherapy equipment:
(a) to carry out radiation therapy (in addition to a separate nuclide dressing therapy), should be equipped with at least one tele-radiation therapy device, with simulation and positioning equipment and the corresponding treatment planning system and other equipment;
(b) to carry out nuclear medicine work, should be With nuclear medicine equipment and other related equipment;
(C) to carry out interventional radiology work, should be equipped with medical diagnostic X-ray machine with image intensifier, digital subtraction device and other equipment;
(D) to carry out the work of diagnostic X-ray imaging, should be equipped with medical diagnostic X-ray machine or CT machine and other equipment.
Article VII
Article 4 (8) referred to in the management system of radiation protection means:
(a) radiological diagnosis and treatment work safety operation system;
(b) radiation workers health management system;
(c) radiological diagnosis and treatment place radiation protection safety management system;
(d) radiation source safety management system
(E) radioisotope receipt registration system;
(F) radiological diagnosis and treatment equipment maintenance, repair system;
(VII) radiological incident emergency plan.
Article VIII of the administrative department of health to meet the conditions of acceptance of the application shall be accepted immediately; does not meet the requirements, it should be within five days to inform the applicant in writing of the need to make corrections to the material or the reasons for inadmissibility.
Article IX of the administrative department of health acceptance of the application, in accordance with laws, regulations, rules, normative documents and health standards and other provisions of the applicant to provide materials for written review and on-site audit. On-site review of the contents of:
(a) Radiological diagnosis and treatment license application form. Content and the actual situation is consistent, in particular, the diagnosis and treatment projects and whether the site is consistent;
(b) the applicant to provide a list of radiological diagnostic equipment and diagnostic and treatment equipment at the site is consistent;
(c) radiological diagnosis and treatment of the workplace protective facilities and radiological protection instrumentation;
(d) radiological diagnostic and treatment of the qualifications of personnel and the submitted materials are consistent;
(d) radiological diagnostic and treatment personnel qualifications and submitted materials are consistent;
(a) the applicant's written review and on-site review of materials provided. (E) radiotherapy personnel physical examination, training, the establishment of health records and other information in accordance with laws and regulations on the health supervision of radiation workers;
(F) with the development and implementation of quality assurance program to engage in radiotherapy projects;
(G) whether the radiation impact on patients and examinees ( Especially for women of childbearing age, children and other special populations) effective ways to inform in advance;
(h) the radiation level of radiotherapy premises and equipment, the performance of the safety chain device on-site sampling results in line with the relevant national standards.
Article 10
Article IX (3) of the workplace protection facilities and radiation protection instrumentation and equipment should be equipped with the following requirements:
(a) radiation diagnostic equipment and places in accordance with the "Radiological Diagnosis and Treatment Management Regulations" requirements to set up a warning sign;
(b) radiation therapy places in accordance with the appropriate standards set up multiple safety interlocking System, dose monitoring system, image monitoring, intercom device and fixed dose monitoring alarm device, equipped with radiotherapy dosimeter, dose scanning device and personal dose alarm. To carry out nuclide dressing therapy, the workplace should be equipped with radioactive surface contamination monitor;
(C) nuclear medicine workplace with a special radioisotope dispensing, injection, storage space, configuration of radioactive waste shielding equipment and storage space, equipped with an activity meter, radioactive surface contamination monitor;
(D) interventional radiology and other diagnostic X-ray image work Places equipped with staff protective equipment and examinee personal protective equipment (each room is equipped with at least 1 set of examinee personal protective equipment).
Article XI of the administrative department of health verification, shall be accepted from the date of 20 days to make a decision on administrative licensing of health. In line with the provisions of the decision to grant administrative licenses to the applicant to issue "radiotherapy license". Does not meet the requirements, issued by the decision not to administrative licensing.
Article XII of the medical institutions to obtain "radiotherapy license", should be issued to the "medical license" of the health administrative practice registration department for the registration of the corresponding subjects. Practice registration department shall, according to the license, the medical imaging approved to the second level of diagnostic and therapeutic subjects.
Article XIII of the "Radiotherapy License" and "medical institutions license" at the same time verification, verification of the applicant shall be issued to the original health administrative department to submit the following materials:
(a) "Radiotherapy License" original, copy of the original;
(b) validation of the cycle of radiotherapy workplace test reports, radiotherapy equipment protection performance test report
(C) radiation therapy staff health monitoring materials;
(D) radiation therapy work and radiation protection management work carried out in the report;
(E) health administrative departments require the provision of other materials.
The original license issued by the health administrative department shall make a review decision within 30 days from the date of receipt of the application. To meet the requirements of the calibration, affixed with a qualified logo. Does not meet the requirements of the deadline for improvement. Improvement of qualified, labeled calibration mark.
Article XIV of the medical institutions to change the name of the unit, legal representative or person in charge, address (excluding relocation), radiological diagnosis and treatment of the project, shall be licensed to the original administrative department of health to apply, and submit the following materials:
(a) "Radiological Diagnosis and Treatment License" is the original, a copy of the original;
(b) Permit to change the application form;
(c) Medical institutions to change the name of the unit, legal representative or person in charge, address, should provide evidence related to the change;
(d) change the radiotherapy project, should provide a change in the project professional and technical personnel related certificates (copy), change the radiotherapy project equipment list, radiotherapy construction project completion and acceptance of the documents, radiotherapy equipment protection performance and Quality control test reports;
(E) health administrative departments to provide other materials.
The original license issued by the health administrative department shall be received within 20 days from the date of application for change to make a decision on the review.
Article XV of the medical institutions due to relocation and change of radiotherapy places or new radiotherapy projects, should be in accordance with the provisions of Article 3 of these measures, re-apply for radiotherapy license. The new radiotherapy project involves the municipal health administrative department licensing management scope, should be to the municipal health administrative department to re-apply for a license.
Article 16 of the following circumstances, the original license issued by the administrative department of health cancellation and timely collection of "radiotherapy license", according to the corresponding diagnosis and treatment subjects change (cancellation) procedures and registration archives, to be announced:
(a) the medical institutions to apply for the cancellation of the;
(b) late application for the verification or unauthorized changes in radiological diagnosis and treatment subjects;
(a) the medical institution to apply for the cancellation of the;
(b) overdue application for verification or unauthorized change of radiological diagnosis and treatment subjects;
(a) the medical institution to apply for the cancellation of the
(C) calibration or change does not meet the relevant requirements, and overdue improvement or improvement still does not meet the requirements;
(D) business or stop diagnosis and treatment of more than one consecutive year;
(E) by the administrative department of health to revoke the "license to practice in health care institutions.
Article XVII of the lost "radiotherapy license" shall be promptly published in the city's municipal newspapers and magazines in the loss of the notice, with the loss of the notice to the original issuance of health administrative departments to apply for reissue.
Article 18 "Radiological Diagnosis and Treatment License" in accordance with the "Radiological Diagnosis and Treatment Regulations" in the license format for the number of copies, the format is: Shanghai area referred to as the Wei Fangzhi word (year) No. From 0001 to start numbering.
Article 19 The administrative department of health shall promptly publicize the administrative licensing matters on the website, the basis, conditions, number, procedures, deadlines, and the need to submit all the materials of the directory and the application form model text.
Article 20 The application form for radiotherapy license, radiotherapy license change application form are four copies. By the district (county) health administrative departments to audit the issuance of "radiotherapy license", the relevant district (county) health administrative departments should be reported to the municipal health administrative departments to file an application form; by the municipal health administrative departments to audit the issuance of "radiotherapy license", the municipal health administrative departments should be sent to the appropriate district (county) health administrative departments to file an application form.
Article 21 of the medical institutions in violation of the provisions of this approach to engage in radiological diagnosis and treatment, by the health administrative department shall be investigated and dealt with according to law.
Article 22 The city engaged in radiological diagnosis and treatment of health institutions with reference to medical institutions for management.
Article 23 The specific application of these measures by the municipal health administrative department is responsible for interpretation.
Article 24 These measures shall come into force on the date of promulgation.
Article 24 These Measures shall come into force on the date of promulgation.