Medical X-ray diagnostic radiation health protection and imaging quality assurance regulations

Chapter I General Provisions Article 1 In order to improve the quality of medical X-ray diagnostic, to protect the examinee, radiation workers and the public's health and safety, according to the "Regulations on Radiation Protection of Radioisotopes and Radiation Devices", the formulation of these provisions. Article 2 These provisions apply to the Chinese people **** and the State, all the use of medical X-ray diagnostic equipment units and individuals. Article 3 The state of medical X-ray diagnostic radiation health protection and image quality assurance supervision and management. Article IV medical X-ray diagnostic work units must accept the supervision and guidance of the health administrative departments of the people's governments at or above the county level. Effective measures must be taken to improve the quality of images; reduce the rate of re-shooting, misdiagnosis and diagnostic errors; attention to the shielding of the examinee to protect, reduce and control the dose of exposure to the examinee, and do a good job of radiation hygiene and prevention and quality assurance of imaging. Chapter II license application and management of Article 5 Where engaged in medical X-ray diagnostic work units must be prior to the local people's government above the county health administrative department for the application procedures, after examination and qualification, to receive the "ray device work permit" before engaging in the work within the scope of the permit. Article 6 The new construction, expansion and alteration of the X-ray machine room, in the site selection, building design, protective facilities, etc., must meet the requirements of the relevant state regulations and standards. Must be in accordance with the prescribed procedures to accept the people's governments above the county health administrative department for preventive review and completion acceptance. Article VII where the application for medical X-ray diagnostic work units, individuals, must have the following basic conditions:

(a), with the X-ray diagnostic projects carried out in a place compatible with the facilities and protection performance is qualified to meet the operating indicators to carry out diagnostic project requirements of the equipment.

(2), with the people's health administrative departments to confirm the appropriate professional skills, familiar with the knowledge of protection, qualified health conditions, and obtain the "radiation staff card" staff.

(3), with radiation protection organization or full-time (part-time) radiation protection personnel, and the establishment of staff and examinee protection and quality assurance management system. Article VIII of medical X-ray diagnostic equipment installation is completed, must be designated by the provincial, autonomous regions and municipalities directly under the Central People's Government health administrative departments for acceptance testing. Proof of its main operational indicators and protective performance in line with relevant national standards, to receive the "radiation device work license" before being put into clinical use. Article IX issued "radiation device license" of the people's government health administrative department in accordance with the relevant provisions of the licensed units and individuals for regular verification, verification of the record in the license attached to the book. Article X engaged in medical X-ray diagnostic work units or individuals, the need to change the scope of the license or terminate the radiological work before, should be promptly to the original approval department for change or cancellation procedures. Chapter III Protection of the examinee Article XI clinicians and radiologists, under the premise of obtaining the same diagnostic results, to avoid the use of radioactive diagnostic techniques, the rational use of X-ray examination, to reduce unnecessary exposure. Article XII units engaged in X-ray diagnostic work, must establish and improve the registration, preservation, extraction and loan system of X-ray examination data. Not due to data management and patient referrals and other reasons for the examinee to receive unnecessary irradiation. Article 13 The physical examination of infants, young children, children and adolescents shall not include X-ray chest examination in the routine examination program; for pre-employment or regular physical examination of practitioners, the interval of X-ray chest examination shall generally be not less than two years; the interval of X-ray chest examination of dust catching workers shall be implemented according to the relevant regulations. Article 14 Clinicians and radiologists shall try their best to use X-ray photography instead of fluoroscopy for diagnosis. Without the permission of the health administrative department of the provincial people's government, portable X-ray machines shall not be used for group fluoroscopy. Article 15 The X-ray examination of the abdomen of fertile women and infants and young children shall strictly control the indications. Pregnant women, especially after conception 8 - 10 weeks, non-special needs, X-ray examination of the lower abdomen shall not be carried out. Article 16 The radiology medical technician must pay attention to take appropriate measures to reduce the dose of the examinee; the examinee adjacent to the irradiation field of sensitive organs and tissues for shielding protection. Article XVII waiting for and accompanying the examination (except the patient must be supported to carry out the examination), shall not be in the absence of shielding protection in the X-ray machine party stay. Chapter IV X-ray diagnostic quality assurance Article XVIII of the medical units and X-ray diagnostic section (room), must be in accordance with the requirements of the hospital grading management standards, the establishment of departmental quality assurance organization and the development of X-ray diagnostic quality assurance program (hereinafter referred to as "Quality Assurance Program"), the implementation of the quality assurance program as a hospital review and radiology department (room) clinical department (room). (The implementation of the quality assurance program as an important basis for hospital accreditation and radiology clinical department (room) performance appraisal. Article 19 The X-ray diagnostic department (room) of each medical unit shall establish the evaluation standard of each X-ray examination system and a strict film evaluation system; waste films and re-take films should be recorded and analyzed for reasons; and put forward improvement measures. Article 20 The content and format of the X-ray diagnostic report written by the medical unit to develop certain specifications, and validation and issuance system. The diagnostic report of the radiology department of hospitals above the municipal (prefecture) level must be issued by the attending physician or above, or by a senior resident authorized by the director. Article 21 X-ray diagnostic department (room) should have a variety of records of quality assurance work, quality control testing film and other information. Save at least five years, and regularly analyzed and evaluated.