Health Supervision and Development [2006] No. 479
Provinces, autonomous regions and municipalities directly under the Central Health Department and Bureau, Xinjiang Production and Construction Corps Health Bureau, Health Supervision Center of the Ministry of Health, the Chinese Center for Disease Control and Prevention:
For the purpose of implementing the "Radiological Diagnosis and Treatment Regulations", guiding and standardizing the work of radiological diagnosis and treatment licensing in various places, according to the "Measures for Administration of the Administrative Licensing of Health" and the relevant According to the "Administrative Measures for Health Administrative Licensing" and relevant laws, rules and regulations, the Ministry has formulated the "Administrative Procedures for Issuance of Radiological Diagnosis and Treatment Licenses", which is hereby issued to you with the following requirements:
I. Provincial health administrative departments are requested to take into account the actual situation of their respective regions, and to make reference to this procedure to formulate the specific procedures for the issuance of licenses for their respective regions and put forward the requirements for their careful organization and implementation. To carry out extensive publicity and implementation of activities and technical training to ensure the smooth implementation of radiological diagnosis and treatment license issuance.
Second, radiological diagnosis and treatment license issuance should be strictly based on the corresponding laws, regulations, standards, norms and procedures, for the issuance of licenses found in the work of illegal, disciplinary actions, to be corrected and investigated according to law.
Third, to give full play to the role of social supervision, in accordance with standard procedures to inform the community in a timely manner to the jurisdiction of the radiation treatment license.
Four, the Ministry will organize in due course on the part of the provinces and municipalities in the radiation diagnosis and treatment of the work of issuing licenses for random checks, the results of the random checks will be announced to the community through the Ministry of Health in the form of circulars.
The annex to this notice can be downloaded from the website of the Ministry of Health. Please contact the Health Supervision Bureau of the Ministry of Health for any specific problems in implementation. Article 1 In order to implement the "Regulations on the Administration of Radiological Diagnosis and Treatment" and to standardize the issuance of radiological diagnosis and treatment licenses, this procedure is formulated in accordance with the "Measures for the Administration of Administrative Licenses for Health" and relevant laws, rules and regulations.
Second, the local people's governments at or above the county level of the health administrative department in accordance with this procedure, is responsible for handling the "radiotherapy license" related matters, in accordance with the law to perform the supervision and management of radiotherapy work.
Article 3 Provincial health administrative departments can be based on the provisions of this procedure, combined with the actual situation in the region, the administrative region to develop specific procedures for the implementation of radiotherapy license work.
Article IV of the administrative department of health to issue "radiological diagnosis and treatment license", shall follow the principles of openness, fairness, impartiality and accessibility, and publish the name of the accepting organization, location, acceptance and approval of the conditions, acceptance of the time and approval of the period and other matters.
Article V of the medical institutions to carry out radiotherapy work, should be in accordance with this procedure to the local health administrative department to apply for a "radiotherapy license" and for the corresponding diagnosis and treatment subject registration, before engaging in the scope of permission to engage in radiotherapy work. Article VI of the medical institutions to apply for radiotherapy license shall be submitted to the local health administrative department application materials.
Application materials include:
(a) radiotherapy license application form (Attachment 1);
(b) "medical license" (copy) or "set up a medical institution approval" (copy);
(c) radiotherapy staff qualification certificate of professional and technical positions (copy);
(d) Radiological diagnosis and treatment equipment list.
Of which (a) and (d) need to be submitted electronically at the same time.
Other materials to be provided:
(A) belonging to the configuration of licensing management of radiological diagnostic equipment, large medical equipment still need to submit the configuration of licensing documents (copy);
(B) "Radiation Health License" or "Radiation Safety License" (copy);
(C) the current year's radiological diagnostic equipment, protection and performance test report (copy);
(d) If it is a new construction, alteration or expansion project after the implementation of the "Regulations on the Administration of Radiological Diagnosis and Treatment", it is necessary to submit the certificate of acceptance of the completion of the radiological diagnosis and treatment construction project (copy).
Article VII of the medical institutions in accordance with the type of radiological diagnosis and treatment work carried out to the local health administrative department to apply for a permit:
(a) the use of X-ray CT machine, CR, DR, general X-ray machine or dental, mammography, etc. to carry out diagnostic work of X-ray imaging medical institutions, to the county-level administrative department of health to submit an application.
(2) to carry out (a) the radiological diagnostic work, while carrying out interventional radiotherapy work of medical institutions, to the municipal level of the local health administrative department to apply.
(C) to carry out (a), (b) listed in the radiological diagnosis and treatment work, and at the same time the use of γ-knife, X-knife, medical gas pedal, proton therapy device, neutron therapy device, heavy ion therapy device, cobalt-60 machine, aftermath treatment machine, deep X-ray machine, dressing therapy source, PET, SPECT, γ camera, γ bone densitometer, seed insertion of therapeutic sources or radiopharmaceuticals, etc. to carry out Radiotherapy or nuclear medicine work of medical institutions, to the provincial health administrative department to apply.
Article VIII of the application materials should be true and complete, the original should be stamped with the official seal of the applicant organization.
To meet the requirements for acceptance, the local health administrative department shall accept and issue a notice of acceptance of the application to the applicant organization within five working days.
Does not meet the admissibility requirements, the local health administrative department shall, within five working days to the applicant organization to issue a notice of inadmissibility. Notification of inadmissibility shall state the reasons for inadmissibility. Article IX of the local health administrative department shall apply for a radiation diagnosis and treatment of medical institutions to review the information, if necessary, on-site audits can be carried out.
Article X on-site audit should have more than two staff. The composition of the audit staff should meet the audit of the required legal knowledge and professional and technical skills. Auditors shall strictly abide by the relevant provisions, shall not be audited units or projects with economic interests, shall not be audited units to collect fees or seek other improper interests.
Article XI on-site auditor shall verify the contents of the application materials listed on the medical institutions, fill out the "Radiological Diagnosis and Treatment License Site Audit Form" (Attachment 2), issued on-site audit, give "recommended approval", "recommended rectification" or "recommended disapproval". or "recommended disapproval" of the conclusion.
Article 12 The local health administrative department shall make a review decision within 20 working days from the date of acceptance.
Article XIII of the conclusion of the review is "recommended for approval" by the local health administrative department to carry out the approval process, and the issuance of "radiotherapy license.
Article XIV of the applicant organization with the "radiotherapy license" to the issuance of "medical institutions license" of the administrative department of health to apply for registration of the corresponding radiotherapy subjects. Procedures for registration in accordance with the "Regulations for the Implementation of Medical Institutions Regulations" shall be implemented.
Article XV of the audit concluded that "recommended rectification", the local health administrative department shall issue a "rectification notice" to the applicant organization.
The applicant organization shall, within three months from the date of receipt of the "Notice of Rectification", carry out rectification in accordance with the requirements and submit a rectification report to the local health administrative department. The rectification period is not counted in the license period. If it fails to complete the rectification in accordance with the requirements after the deadline, it shall explain the reasons in writing to the health administrative department.
Article XVI of the local health administrative department within 20 working days from the date of receipt of the rectification report to complete the review, and put forward the review opinion.
Article XVII of the audit or review of the conclusion of the "proposed disapproval" of the local health administrative department to review and make a decision not to permit, to the applicant organization to issue a "decision not to administrative licensing", the decision should state the reasons for not permitting. Article XVIII of the medical institutions, "radiological diagnosis and treatment license" verification and "medical institutions license" verification, and by the issuance of "medical institutions license" of the health administrative department responsible for the specific verification matters. Medical institutions should submit the following materials:
(a) "radiotherapy license" original and copy;
(b) radiotherapy equipment, personnel list and changes;
(c) radiation staff personal dose monitoring, health checks and education and training;
(d) radiological protection and quality control management and testing, and testing reports
(v) the occurrence and handling of radiation incidents.
Calibration department from the date of receipt of the application within 30 working days to review the declaration materials, if necessary, can ask the relevant professional and technical personnel or professional and technical management department to put forward the evaluation opinion, meet the requirements, to be calibrated; does not meet the requirements of the corrective action proposed by the opinion that the medical institutions require rectification within a certain period of time.
Article 19 of the medical institutions to change the radiotherapy premises, diagnostic equipment or diagnostic and treatment projects, should be in accordance with the requirements of Article VI to Article VIII of this procedure to change the project approval authority of the health administrative department to apply for the change procedures, submit the application materials and change the content of the application materials indicated.
Article 20 The local health administrative department in accordance with the provisions of Articles 9 to 17 of this procedure for radiotherapy license change procedures.
Article 21 of the medical institutions in one of the following circumstances, the original permit by the local health administrative department cancellation of radiological diagnosis and treatment license, and shall be announced:
(a) medical institutions apply for cancellation;
(b) overdue application for verification or unauthorized changes in the radiological diagnosis and treatment subjects;
(c) verification or change does not meet the relevant requirements for handling (C) the calibration or change does not meet the relevant requirements, and overdue improvement or improvement still does not meet the requirements;
(D) suspend business or stop radiotherapy subjects for more than one year;
(E) was revoked by the law, "Medical Practice License", large-scale medical equipment, configuration permits. Article 22 of the medical institutions to obtain a "radiation diagnosis and treatment license" shall be hung in a conspicuous position, subject to supervision; is strictly prohibited forgery, alteration, transfer, lending or selling.
Article 23 of the medical institutions lost "radiotherapy license", should be promptly published in the main newspaper where the licensing authority of the loss of the announcement, and within one month after the announcement of 30 days to the original licensing department to apply for a replacement.
Article 24 The local health administrative departments at or above the county level shall establish and improve the supervision and management system for the issuance of "radiotherapy license".
Article 25 The inspection found or reported and verified that one of the following circumstances, the administrative department of health or its higher administrative department of health shall revoke the "radiation diagnosis and treatment license" to make a decision on radiation diagnosis and treatment license:
(a) medical institutions by deception, bribery, and other improper means to obtain the "radiation diagnosis and treatment license";
(b) the administrative department of health abuse of power and abuse of authority. (B) the administrative department of health staff abuse of power, dereliction of duty, to the applicant institution does not meet the conditions of the issuance of "radiotherapy license";
(C) the administrative department of health staff beyond the legal authority to issue "radiotherapy license";
(D) other circumstances that can be revoked by law.
Article 26 of the local health administrative departments at or above the county level shall establish a radiotherapy licensing information management system, mutual notification of the "radiotherapy license" issued, cancellation and other licensing management, regular bulletin of the jurisdiction to obtain and cancel the "radiotherapy license" directory of medical institutions.
Article 27 These procedures shall be implemented from the date of publication.
Attached: 1. Radiological diagnosis and treatment license application form
2. Radiological diagnosis and treatment license on-site audit form