Blood refers to whole blood and component blood for clinical use. Article 3 The management of blood stations in provinces, autonomous regions and municipalities directly under the Central Government as a region, the implementation of unified planning and set up blood stations, unified management of blood collection and supply and unified management of clinical use of blood principle. Article 4 The health administrative departments of the people's governments at or above the county level shall be responsible for the supervision and management of the blood stations under their jurisdiction. Chapter II set up for approval Article 5 Provinces, autonomous regions, municipalities directly under the Central People's Government health administrative departments according to the population of the administrative region, medical resources, the need for clinical blood and the actual situation of the local regional health development planning, the development of the administrative region to set up the blood station planning. Article 6 Setting of blood stations:
(1) Blood stations are divided into blood centers, central blood stations, grass-roots blood stations or central blood banks, etc., and are responsible for the collection and supply of blood in designated service areas.
Municipalities directly under the Central Government, provincial capitals, the capital city of autonomous regions to set up blood centers; cities with districts to set up central blood stations; counties and county-level cities can set up basic blood stations or central blood bank.
(2) blood center or central blood station for the collection and supply of blood needs, approved by the provincial, autonomous regions, municipalities directly under the Central People's Government of the health administrative department, within the jurisdiction of the blood station can be set up sub-stations or blood collection points (rooms), under the blood center or central blood station. Article 7 The establishment of the blood center must be approved by the health administrative department of the State Council, and the establishment of the central blood station, basic blood station or central blood bank must be approved by the health administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government. Article VIII set up a blood station, by the person in charge of the preparatory application; set up a central blood bank, by the legal representative of the medical institution to apply. Article 9 The setting up of a blood bank shall submit a feasibility study report on the setting up of the following:
(1) the name of the applying organization, the basic situation and the applicant's name, age, curriculum vitae, identity card number;
(2) the name of the proposed blood bank, the scale, the task, the function, the organizational structure, the source of funds, etc.;
(3) the medical and health care resources in the service area of the proposed blood bank, the situation of medical blood demand, and the situation of medical blood use demand. (c) the state of medical and health resources in the service area of the proposed blood station, the demand for medical blood, and the forecast and analysis of the operation of the organization;
(d) the location of the proposed blood station and the architectural design plan;
(e) the information on the business projects to be carried out by the proposed blood station, the conditions of the technical equipment, and the deployment of the technical staff;
(f) the other materials prescribed by the approving authority to be submitted.
Applications for the establishment of a central blood bank shall also be submitted to the License to Practice in Medical Institutions. Article 10 The health administrative department of the people's government shall, upon receipt of the application for setting up, conduct a preliminary examination within twenty working days and gradually report the examination opinions and documents submitted by the applicant. The health administrative department of the people's government responsible for approval shall conduct an examination within thirty working days after accepting the application for setting up, and issue the corresponding approval letter for setting up if the examination is qualified. By the provincial, autonomous regions, municipalities directly under the Central People's Government health administrative department approved the establishment of the State Council health administrative department for the record. Audit failed, the results of the audit in writing to the applicant and the local people's government health administrative department. Chapter III License Article XI of the blood station practice and central blood bank to carry out blood collection and supply business must be accepted by the practice and registration, and respectively, to receive the "blood station license" or "central blood bank blood collection and supply license" before proceeding.
The "blood station license", "central blood bank blood supply license" by the State Council administrative department of health unified supervision. Article 12 The acceptance of the practice of blood centers shall be entrusted by the health administrative department of the State Council to the China Blood Transfusion Association.
Central blood stations, basic blood stations or central blood bank practice acceptance by the provincial people's government health administrative department entrusted to the provincial blood transfusion association.
The acceptance of qualified issued a certificate of qualification, the acceptance of unqualified written notice to the applicant. Without acceptance of qualified blood stations shall not be implemented.
The Basic Standards for Blood Stations shall be formulated by the health administrative department of the State Council. Article XIII of the blood station registration authority for the approval of its establishment of the people's government health administrative department. Article 14 An application for registration shall be made to the health administrative department of the people's government of the place where it is located, and the following documents shall be submitted:
(1) the corresponding approval letter for the establishment of the blood station or the License for Practicing in Medical Institutions;
(2) the name, address, and the name of the legal representative of the blood station or the medical institution;
(3) the certificate of acceptance of the blood station for practice;
(4) the source of funds and proof of capital verification appropriate to the business it carries out;
(5) proof of property rights or proof of use of the premises used for practice;
(6) a report on the plan for blood collection and supply, including the type of blood collection and supply program, the scope of collection and supply of blood (service radius, mode of service), and the amount of supply (the blood plan of the health care institution, the program, the amount of supply);
< p>(vii) the rules and regulations of the blood station;(viii) the approval of the scope of collection and supply of blood (service radius, mode of service), the supply volume (medical institutions of the blood plan, project, supply volume), etc.;
(ix) the approval authority stipulates the submission of other materials. Article 15 The health administrative department of the people's government within twenty working days of receipt of the application for registration to sign the opinion, and reported to the level by level, by the people's government responsible for approving the establishment of the health administrative department of the people's government within fifteen working days after accepting the application for registration for examination. If the audit is qualified, it shall be registered and issued with the License to Practice Blood Stations or the License to Collect and Supply Blood from the Central Blood Bank; if the audit is not qualified, the applicant shall be notified in writing of the results of the audit and the reasons for not approving the application.
The blood center, central blood station, grass-roots blood station license number: province, autonomous region, municipality directly under the Central Government referred to as the word year of health blood station No. × × ×; central blood bank blood collection and supply license number: province, autonomous region, municipality directly under the Central Government referred to as the word year of health blood bank No. × × ×.