Shandong Province, large medical equipment configuration and application of management methods

Article 1 In order to strengthen the configuration and application of large medical equipment management, play a comprehensive benefit of health resources, and promote the healthy development of health undertakings, according to the relevant provisions of the state, combined with the actual situation in this province, the formulation of these measures. Article 2 The large medical equipment referred to in these measures refers to the application of medical work with a high level of technology, large, sophisticated, expensive instruments and equipment, including the following types:

(a) X-ray computed tomography device (CT);

(b) magnetic **** vibration imaging device (MRI);

(c) Positron emission tomography device (PET);

(D) ultra high-speed CT (UFCT);

(E) color Doppler ultrasound diagnostic instrument;

(F) Acu-Knife (X-Knife), Gamma-Knife (γ-Knife);

(VII) more than 1 million yuan Laser therapy equipment;

(h) medical linear gas pedal (LA);

(ix) digital subtraction angiography device (DSA);

(j) other large medical equipment should be included in the management. Article III of this approach applies to all levels and types of medical machinery within the administrative region of the province's large medical equipment configuration and application management. Article IV of the provincial health administrative department in charge of the province's large medical equipment configuration and application management.

Settlement of municipalities, counties (cities, districts) health administrative departments to assist the provincial health administrative departments to do a good job in the region of large-scale medical equipment configuration and application management. Article V configuration of large medical equipment should be rationally distributed, total control, in line with the provincial health resource allocation standards, and regional health development planning and medical service needs. Article VI of the medical institutions to apply for the configuration of large medical equipment, should have the appropriate configuration conditions.

Large medical equipment configuration conditions in accordance with national uniform provisions; the state has not made uniform provisions, by the provincial health administrative departments. Article VII configuration of large medical equipment license management system. Medical institutions need to configure large medical equipment, should apply to the provincial health administrative department, after approval and obtain a large medical equipment configuration license before purchase. Article VIII of the medical institutions to apply for the configuration of large-scale medical equipment, the provincial health administrative department shall provide the following materials:

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

(b) feasibility study;

(c) to configure the equipment to be configured, such as model information;

(d) other materials should be provided. Article IX of the provincial health administrative department shall, upon receipt of the application, within 30 days from the date of receipt of the application for approval or disapproval of the decision, notify the medical institution in writing; approval, at the same time, in accordance with the relevant provisions of the State issued a <>.

Profit medical institutions large medical equipment configuration, the provincial health administrative department only review its configuration and application conditions, eligible for approval should be configured.

According to regulations should be reported to the national health administrative department for approval, in accordance with relevant regulations and procedures. Article X promotes the use of public bidding and tendering for the purchase of large medical equipment.

Prohibit the acquisition of old large medical equipment has been eliminated. Article XI of large-scale medical equipment into use, must be applied before the technical review, and obtain "large-scale medical equipment application quality certification" before being put into use. Review every two years thereafter. Article XII of large-scale medical equipment application quality review by the provincial health administrative departments to organize the implementation of the specific review by the provincial health administrative departments in accordance with the relevant provisions of the state. Article XIII of the provincial health administrative department shall receive an application within 30 days from the date of completion of the application of quality assessment work, the assessment of qualified issuance of "large-scale medical equipment application quality certificate", the assessment of unqualified notify the medical institutions. Article XIV of large-scale medical equipment must be used by operators through the relevant technical examination, and obtain "large-scale medical equipment on duty personnel technical qualification certificate.

Large-scale medical equipment using the operator's induction technical assessment and qualification by the provincial health administrative departments in accordance with the relevant provisions of the national organization and implementation. Article XV configuration of large medical equipment, medical institutions, should be applied to the equipment in the process of major accidents in a timely manner to report to the provincial health administrative departments.

Large medical equipment routine management in accordance with the national and provincial health institutions, instrumentation management. Article XVI of the use of large medical equipment for examination and treatment of the charges, by the provincial health administrative department in conjunction with the price management department. Article XVII configuration of large medical equipment, medical institutions should be configured to large medical equipment configuration license, application quality certification, fees and charges hanging in a conspicuous position, shall not be altered or forged.

Medical institutions need to update or scrap large medical equipment, should be reported to the provincial health administrative departments, and for licensing or cancellation procedures. Article XVIII of the medical institutions in the configuration and application of large-scale medical equipment, one of the following circumstances, by the health administrative department above the county level or the relevant competent department shall be warned, and given directly responsible for the administrative sanctions in charge:

(a) without obtaining the configuration of large-scale medical equipment license to purchase without authorization;

(b) the acquisition of large-scale medical equipment has been phased out of the old equipment;

(C) without obtaining large medical equipment application quality certification, unauthorized use of large medical equipment for inspection and treatment;

(D) the use of large medical equipment without obtaining a certificate of competency of the induction technology to operate the personnel.