Tianjin large medical equipment configuration and application of the interim provisions of management

Article 1 In order to strengthen the city's large medical equipment management, to promote the development of health care, according to the relevant provisions of the state, combined with the actual situation in the city, the formulation of these provisions. Article 2 These provisions shall apply to all medical and health institutions within the administrative jurisdiction of the city. Including the People's Liberation Army, the Armed Police Force in Tianjin medical and health units open to the community (hereinafter collectively referred to as medical institutions). Article large medical equipment configuration management, should adhere to the medical service capacity, medical consumption demand, medical equipment level with the national financial resources, social burden and regional development planning and focus on equipping key hospitals and leading disciplines of the principle of unified planning, total control, planning and configuration. Article IV of the provisions of the large medical equipment refers to:

(a) Gamma Knife (Υ knife)

(b) Aix knife (X-knife)

(d) X-ray computed tomography (CT)

(e) Positron emission tomography device (PEI)

(F) ultra high-speed CT (UFCT)

(G) ophthalmic excimer laser therapy device

(H) medical linear accelerator

(IX) the Ministry of Health designated other large medical equipment. Article V Municipal Planning Commission unified coordination? Configuration and application of large-scale medical equipment management; Municipal Health Bureau in charge of large-scale medical equipment configuration and application of management, supervision; Municipal Economic Commission, the Municipal Finance Bureau in accordance with their respective responsibilities to participate in the configuration of large-scale medical equipment and application of management. Article VI of the Municipal Health Bureau in charge of large medical equipment configuration and application of management, supervision of the main responsibilities are:

(a) the preparation of the city's large-scale medical equipment, regional configuration planning, annual equipment plan, and organize the implementation of the approval and management;

(b) in accordance with the provisions of the Ministry of Health, combined with the city's hospital levels, professional and technical levels, supporting facilities and basic conditions of the technical staff, the development of Tianjin's large-scale medical equipment. To develop large medical equipment configuration standards in Tianjin;

(3) organization of large medical equipment application technology assessment;

(4) the issuance of certificates;

(5) supervision and inspection of the implementation of this provision;

(6) in accordance with the relevant provisions of the penalties imposed.

The Municipal Health Bureau set up a large medical equipment application technology review committee, responsible for the application of large medical equipment safety, health protection, technical quality management review. Article VII of medical institutions configure large medical equipment, must be reviewed and approved by the Municipal Health Bureau and obtain a certificate of approval; the application of large medical equipment must obtain large medical equipment to apply quality certification (hereinafter referred to as the "quality certificate"); large medical equipment operators must obtain large medical equipment on duty personnel technical qualification certificate (hereinafter referred to as the technical qualification certificate). Article VIII need to configure large medical equipment for medical institutions, must have the basic conditions and standards for large medical equipment equipment prescribed by the Municipal Health Bureau, and has been included in the configuration of the planning and annual plan, before applying for configuration. Article IX meets the requirements of the preceding article of the medical institutions, apply for the configuration of large medical equipment, must be subject to the consent of the competent departments before the Municipal Health Bureau to submit a written application, fill out the application form for the configuration of large medical equipment (hereinafter referred to as the configuration of the application form), and submit the following materials:

(a) Feasibility study report (demonstration report);

(b) the economic benefits of the demonstration report

(iii) detailed information on the equipment;

(iv) other materials to be provided.

The Municipal Health Bureau in accordance with the relevant provisions of the state, the annual allocation of large medical equipment plan, the city of large medical equipment application technology review committee's comments and medical institutions to submit the configuration of the application form for review. Qualified by the review, in accordance with relevant state regulations issued by the corresponding certificate of approval. Medical institutions in the certificate of approval, before the purchase of large medical equipment.

Without the approval of the Municipal Health Bureau, medical institutions shall not be configured for any reason large-scale medical equipment, the relevant departments shall not deal with matters related to them or provide conditions. Article X configuration of large medical equipment, medical institutions, equipment installation and commissioning, should be submitted to the Municipal Health Bureau to apply for technical review. Municipal Health Bureau in the application of technology review application, the organization of the review committee on the application of the equipment safety, health protection, technical quality and other aspects of the review. Qualified review, issued by the quality certificate.

Quality certificate is valid for two years. Three months before expiration, the use of units should be submitted to the Municipal Health Bureau to review the application, the review qualified to continue to use; review failed to revoke the certificate of quality; has obtained a certificate of quality of large-scale medical equipment, stop running for more than half a year and then start again, should be re-applied to the Municipal Health Bureau to apply for the review of the quality of the technical procedures. Technical performance indicators of equipment operation from time to time monitoring. Article XI of large medical equipment operators to implement technical assessment, qualification system. Municipal Health Bureau in accordance with the qualification assessment standards and methods developed by the Ministry of Health, large-scale medical equipment operators to conduct an assessment of those who have passed the assessment, issued by the technical qualification certificate, and on duty with a license. Article XII of the medical institutions in the activation of large medical equipment, must be configured with the certificate of approval, quality certification, technical qualification and the unit to develop the appropriate system and operating procedures, job responsibility system and other documents to the Municipal Health Bureau for the announcement procedures. Municipal Health Bureau approved within 30 days after the media to be announced in the newspaper. The equipment from the date of the announcement into use.