Administrative Measures for Blood Stations

Administrative Measures for Blood Stations

Order of the Ministry of Health [2005] No. 44

November 17, 2005

The "Administrative Measures for Blood Stations", which were deliberated and adopted at the executive meeting of the Ministry of Health, are hereby promulgated, and shall come into force on March 1, 2006.

Minister Gao Qiang

Attached: Administrative Measures for Blood Stations

Chapter I General Provisions

Article 1 The present Measures are formulated in accordance with the "Law of the People's Republic of China on Blood Donation" for the purpose of guaranteeing the blood safety, regulating blood stations' practicing activities, and promoting the construction and development of blood stations.

Article 2 The term "blood station" as mentioned in the present Measures shall refer to a non-profit public welfare health institution that collects and supplies blood for clinical use.

Article 3 Blood Stations are divided into ordinary blood stations and special blood stations.
The ordinary blood stations include blood centers, central blood stations and central blood banks.
The special blood stations include umbilical cord blood stem cell banks and other types of blood banks established upon approval of the Ministry of Health when required in medical development.

Article 4 Blood centers, central blood stations and central blood banks shall be established by the local people's governments.
The construction and development of blood stations shall be included into the local national economic and social development plan.

Article 5 The Ministry of Health shall, on the basis of the allocation of medical treatment resources nationwide, and the demands for blood for clinical use, formulate the guiding principles of the planning on establishment of blood collection and supply institutions throughout China, and shall take charge of guiding the construction planning on blood stations throughout China.
The administrative department of health of the people's government of each province, autonomous region, or municipality directly under the Central Government shall, in accordance with the preceding paragraph, and in light of the actual circumstances such as the population, medical treatment resources, and the demands for blood for clinical use within the jurisdiction, as well as the local regional health development planning, formulate the planning on establishment of blood stations within the jurisdiction, submit it to the people's government at the same level for approval, and to the Ministry of Health for archival filing.

Article 6 The Ministry of Health shall be in charge of the supervision and administration of blood stations throughout China.
The administrative department of health of a local people's government at the county level or above shall take charge of supervising and administering blood stations within its own jurisdiction.

Article 7 The blood application researches and technical innovations, as well as the international scientific and technological exchanges and cooperation on clinical blood transfusion are encouraged and supported.

Chapter II Administration of Ordinary Blood Stations

Section 1 Establishment, Duties and Practice Registration

Article 8 A blood center shall be established in a municipality directly under the Central Government, or in the capital city of a province or autonomous region. Its main duties are as follows:
1. Following the requirements of the administrative department of health of the people's government at the provincial level to, within the prescribed scope, recruit blood donors, collect and prepare blood, supply blood for clinical use, and provide work guidance on blood for medical treatment use;
2. Undertaking the quality control and appraisal of the blood stations in the province, autonomous region, or municipality directly under the Central Government where it is located;
3. Undertaking the business training and technical guidance of the blood stations in the province, autonomous region, or municipality directly under the Central Government where it is located;
4. Undertaking the tasks of centralized test of blood in the province, autonomous region, or municipality directly under the Central Government where it is located;
5. Carrying out the scientific research work relevant to blood; and
6. Undertaking tasks assigned by the administrative department of health.
A blood center shall have good technical capabilities for comprehensive quality appraisal.

Article 9 A central blood station shall be established in a districted city, with its main duties as follows:
1. Following the requirements of the administrative department of health of the people's government at the provincial level to, within the prescribed scope, recruit blood donors, collect and prepare blood, supply blood for clinical use, and provide work guidance on blood for medical treatment use;
2. Undertaking quality control of the blood storage within the scope of blood supply area;
3. Making quality control of the central blood banks within its jurisdiction; and
4. Undertaking tasks assigned by the administrative department of health.
Where a municipality directly under the Central Government, or a capital city of a province or autonomous region has established a blood center, it needs to establish no more central blood station; while if it has not established a blood center, it may strengthen the capacity construction on the basis of the established central blood station, and perform the duties of a blood center.

Article 10 A central blood bank shall be established in a comprehensive hospital at the county level where the services of the central blood station cannot cover. Its main duties shall be: following the requirements of the administrative department of health of the people's government at the provincial level to, within the prescribed scope, recruit blood donors, collect and prepare blood, supply blood for clinical use, and provide work guidance on blood for medical treatment use, and so on.

Article 11 The administrative department of health of a people's government of the province, autonomous region, or municipality directly under the Central Government shall, on the basis of the planning on establishment of blood collection and supply institutions, approve the establishment of blood stations, and shall report each approved blood station to the Ministry of Health for archival filing.
The administrative department of health of the people's government of a province, autonomous region, or municipality directly under the Central Government shall take charge of clarifying the supervisory responsibilities of the administrative department of health at each level and the duties of blood stations within its jurisdiction, and take charge of delimiting the blood collection and supply service areas of blood stations in light of the actual blood supply distance and capacity, etc. The blood collection and supply service areas may not have to be restricted by the jurisdiction.
No blood center or central blood station may be repeatedly established within the same jurisdiction.
A blood station and a blood plasma collection station shall not be established within the same jurisdiction at the county level.

Article 12 The administrative department of health of the people's government of a province, autonomous region, or municipality directly under the Central Government shall make uniform planning on establishing laboratories of centralized test, and implement the planning step by step.

Article 13 A blood station shall, when carrying out blood collection and supply activities, apply to the administrative department of health of the local people's government of the province, autonomous region, or municipality directly under the Central Government for practice registration, and obtain the "Practicing License of the Blood Station". If it fails to obtain the "Practicing License of the Blood Station", it may not carry out the blood collection and supply activities.
The valid term of a "Practicing License of the Blood Station" shall be three years.

Article 14 A blood station must, when applying for practice registration, fill out the "Application Letter of the Blood Station for Practice Registration" .
The administrative department of health of a people's government at the provincial level shall, after acceptance of an application letter of the blood station for practice registration, organize the relevant experts or entrust a technical department to, in accordance with the "Quality Management Norms of the Blood Station" and the "Quality Management Norms of the Laboratory of the Blood Station", make technical examination of the entity applicant, and submit the technical examination report.
The administrative department of health of a people's government at the provincial level shall, within 20 days as of receipt of the technical examination report of the experts or technical department, check the matter in question.
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