Measures of Shandong Province for the Administration of Configuration and Use of Large Medical Equipment

Article 1 In order to strengthen the configuration and application management of large-scale medical equipment, give full play to the comprehensive benefits of health resources and promote the healthy development of health undertakings, these Measures are formulated in accordance with the relevant provisions of the state and combined with the actual situation of this province. Article 2 The term "large-scale medical equipment" as mentioned in these Measures refers to high-tech, large-scale, precise and expensive instruments and equipment used in medical work, including the following types:

(1) x-ray computed tomography (CT);

(2) magnetic resonance imaging equipment;

(3) positron emission tomography (PET);

(4) Ultra-high speed CT (UFCT);

(5) Color Doppler ultrasonic diagnostic instrument;

(6) axe knife (X knife) and gamma knife (γ knife);

(seven) laser treatment equipment with a price of 6,543,800 yuan or more;

(8) medical linear accelerator;

(9) Digital subtraction angiography;

(ten) other large medical equipment that should be included in the management. Article 3 These Measures shall apply to the configuration and application management of large medical equipment of various types of medical machinery at all levels within the administrative region of this province. Fourth provincial health administrative departments in charge of the province's large-scale medical equipment configuration and application management.

The health administrative departments of cities and counties (cities, districts) divided into districts shall assist the provincial health administrative departments to do a good job in the configuration and application management of large medical equipment in the region. Article 5 The allocation of large-scale medical equipment shall be reasonably arranged and the total amount shall be controlled, which shall conform to the provincial health resource allocation standards and meet the regional health development planning and medical service demand. Sixth medical institutions to apply for the allocation of large medical equipment, should have the corresponding allocation conditions.

The configuration conditions of large medical equipment shall be implemented according to the unified national regulations; Where the state has not made uniform provisions, it shall be formulated by the provincial health administrative department. Seventh large medical equipment configuration to implement the licensing management system. If a medical institution needs to be equipped with large medical equipment, it shall apply to the provincial health administrative department, and can only purchase it after approval and obtaining the License for Configuration of Large Medical Equipment. Eighth medical institutions to apply for the allocation of large medical equipment, shall provide the following materials to the provincial health administrative department:

(a) the application form for the configuration of large medical equipment;

(2) Feasibility study report;

(3) Information such as the model of the equipment to be configured;

(4) Other materials to be provided. Ninth provincial health administrative departments shall, after receiving the application, make a decision of approval or disapproval within 30 days from the date of receiving the application, and notify the medical institution in writing; Upon approval, the License for Configuration of Large Medical Equipment shall be issued in accordance with the relevant provisions of the state.

For-profit medical institutions are equipped with large-scale medical equipment, and the provincial health administrative department only examines its configuration and application conditions. If it meets the conditions, it shall approve its configuration.

In accordance with the provisions, it shall be reported to the state health administrative department for examination and approval, and it shall be handled in accordance with the relevant provisions. Tenth advocate the procurement of large medical equipment through public bidding.

It is forbidden to purchase large-scale old medical equipment explicitly eliminated by the state. Eleventh large medical equipment before put into use, must carry out the application technology review, and obtain the "large medical equipment application quality certificate" before put into use. It is reviewed every two years. Twelfth large medical equipment application quality evaluation by the provincial health administrative department to organize the implementation, the specific evaluation methods formulated by the provincial health administrative department in accordance with the relevant provisions of the state. Thirteenth provincial health administrative departments shall, within 30 days from the date of receiving the application, complete the application quality assessment, issue the application quality certificate of large medical equipment after the assessment is qualified, and notify the medical institutions if the assessment is unqualified. Fourteenth large medical equipment operators must pass the relevant technical examination, and obtain the "large medical equipment post technical certificate".

The technical examination and qualification certification of users of large medical equipment shall be organized and implemented by the provincial health administrative department according to the relevant provisions of the state. Fifteenth medical institutions equipped with large medical equipment shall promptly report major accidents in the process of equipment application to the provincial health administrative department.

The routine management of large medical equipment shall be implemented in accordance with the measures for the management of instruments and equipment of national and provincial medical and health institutions. Sixteenth use of large medical equipment for examination and treatment fees, formulated by the provincial health administrative department in conjunction with the price management department. Article 17 Medical institutions equipped with large-scale medical equipment shall hang the License for Configuration of Large-scale Medical Equipment, the Application Quality Certificate and the charging standards in obvious positions, and shall not alter or forge them.

If a medical institution needs to update or scrap large medical equipment, it shall report to the provincial health administrative department and go through the licensing or cancellation procedures. Eighteenth medical institutions in the configuration and application of large medical equipment, one of the following circumstances, by the health administrative department at or above the county level or the relevant competent departments to give a warning, and give administrative sanctions to the directly responsible person in charge:

(1) Purchasing without obtaining the configuration license of large-scale medical equipment;

(two) the purchase of large medical equipment explicitly eliminated by the state;

(three) without obtaining the application quality certificate of large medical equipment, unauthorized use of large medical equipment for inspection and treatment;

(four) the use of personnel who have not obtained the technical qualification certificate to operate large medical equipment.