Article I
These Measures are formulated in accordance with the Blood Donation Law in order to ensure the safety of blood, regulate the practice behavior of blood stations and promote the construction and development of blood stations.
Article 2
The blood stations referred to in these Measures are public health institutions that collect and provide clinical blood without profit-making.
Article 3
Blood stations are divided into general blood stations and special blood stations.
General blood stations include blood centers, central blood stations and central blood bank.
Special blood stations include umbilical cord blood hematopoietic stem cell banks and other types of blood banks approved and set up by the Ministry of Health according to the needs of 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 into the local national economy and social development plan.
Article 5
The Ministry of Health, in accordance with the allocation of national medical resources, clinical blood demand, the development of national blood collection and supply institutions set up planning guidelines, and is responsible for the national blood station construction planning guidance.
Provinces, autonomous regions, municipalities directly under the Central People's Government health administrative departments shall, in accordance with the preceding paragraph, combined with the population of the administrative region, medical resources, clinical blood demand and the actual situation and local regional health development plan, the administrative region to develop blood station setup planning, reported to the people's government at the same level for approval, and reported to the Ministry of Health for the record.
Article 6
The Ministry of Health shall be in charge of the supervision and management of blood stations throughout the country.
The administrative departments of health of the local people's governments at or above the county level shall be responsible for the supervision and management of the blood stations in their administrative regions.
Article 7
Encouragement and support for the development of applied blood research and technological innovation, as well as international exchanges and cooperation in science and technology related to clinical blood transfusion. Section I Setting, Duties and Practice Registration
Article 8 Blood centers shall be set up in municipalities directly under the central government, provincial capitals and autonomous region capitals. Its main duties are:
(1) in accordance with the requirements of the health administrative department of the provincial people's government, within the scope of the recruitment of non-remunerated blood donors, the collection and preparation of blood, clinical blood supply, as well as medical use of blood business guidance;
(2) undertake the provinces, autonomous regions and municipalities directly under the Central Blood Stations of the quality control and evaluation;
(3) undertake the provinces, autonomous regions and municipalities directly under the Central Blood Stations of the quality control and evaluation;
(3) undertake to be in the
(3) to undertake the provinces, autonomous regions, municipalities directly under the Central Blood Stations business training and technical guidance;
(4) to undertake the provinces, autonomous regions, municipalities directly under the Central Blood centralized testing tasks;
(5) to carry out scientific research on blood;
(6) to undertake the task of the administrative department of health.
The blood center should have a high level of technical capacity for comprehensive quality evaluation.
Article IX central blood station shall be set up in the city of the district. Its main duties are:
(1) in accordance with the requirements of the health administrative department of the provincial people's government, to carry out the recruitment of non-remunerated blood donors, the collection and preparation of blood, the supply of blood for clinical use as well as the operational guidance of medical use of blood within the prescribed scope;
(2) to undertake the quality control of the storage of blood within the scope of the region of blood supply;
(3) to carry out quality control of the central blood bank within the administrative area where it is located;
(3) to conduct quality control on the (c) to carry out quality control of the central blood bank in its administrative region;
(d) to undertake the tasks assigned by the administrative department of health.
Municipalities directly under the Central Government, provincial capitals, the capital city of an autonomous region has set up a blood center, no longer set up a central blood station; not yet set up a blood center, can be set up on the basis of the central blood station to strengthen the capacity building, to perform the duties of the blood center.
Article 10 of the central blood bank shall be set up in the central blood station services do not cover the county-level general hospital. Its main responsibilities are, in accordance with the requirements of the health administrative department of the provincial people's government, within the scope of the provisions of the recruitment of non-remunerated blood donors, the collection and preparation of blood, clinical blood supply, as well as medical use of blood business guidance and other work.
Article 11 The health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall approve the setting up of blood stations on the basis of the planning of the establishment of blood collecting and supplying organizations, and report them to the Ministry of Health for the record.
Provinces, autonomous regions, municipalities directly under the Central People's Government, the health administrative department is responsible for defining the jurisdiction of all levels of health administrative supervision and responsibility of the blood station; according to the actual distance and capacity of the blood supply is responsible for the delineation of the blood station blood collection and supply service area, blood collection and supply service area can be unrestricted by the administrative area.
There shall be no duplication of blood centers and central blood stations within the same administrative area.
Blood stations and single plasma stations shall not be set up in the same county-level administrative areas.
Article XII of the provincial, autonomous regions and municipalities directly under the Central People's Government health administrative departments shall be unified planning, set up centralized testing laboratories, and gradually implemented.
Article XIII of the blood station to carry out blood collection and supply activities, shall apply to the provincial, autonomous regions and municipalities directly under the Central People's Government of the administrative department of health for practice registration, to obtain the "blood station license". Without obtaining the "blood station license", shall not carry out blood collection and supply activities.
The license is valid for three years. Article XIV of the blood station to apply for registration of the industry must fill out the "application for registration of blood station practice".
Provincial people's government health administrative department in accepting the application for registration of blood station practice, shall organize relevant experts or commissioned by the technical department, according to the "blood station quality management standards" and "blood station laboratory quality management standards", the applicant for technical review, and submit a technical review report.
The provincial people's government health administrative department shall receive experts or technical departments of the technical review report within twenty days after the application for review. Qualified audit, to be registered to practice, issued by the Ministry of Health unified style of "blood station license" and its copy.
Article XV of the following circumstances, shall not be practicing registration:
(1) "blood station quality management standards" technical review failed;
(2) "blood station laboratory quality management standards" technical review failed;
(3) blood quality test results failed.
The practice registration authority of the review failed, not to practice registration, the results and reasons in writing to inform the applicant.
Article XVI of the "blood station license" three months before the expiration of the validity of the license, the blood station shall apply for re-registration of practice, and submit the "application for re-registration of practice of the blood station" and "blood station license".
Provincial people's government health administrative departments shall be based on the blood station business and supervision and inspection of the audit, audit qualified, to continue to practice. Failure to pass the audit, ordered to rectify; after rectification is still unqualified audit, cancel its "blood station license".
No re-registration procedures or cancellation of the "blood station practice license" of the blood station, shall not continue to practice.
Article XVII of the blood station for the collection and supply of blood needs, set up branches in the specified service area, shall be reported to the people's governments of the provinces, autonomous regions and municipalities directly under the Central People's Government of the approval of the administrative department of health; set up a fixed point of blood collection (room) or mobile blood collection vehicle shall be reported to the people's governments of the provinces, autonomous regions and municipalities directly under the Central People's Government of the record of the administrative department of health.
In order to ensure the need for clinical blood within the jurisdiction, the blood station can set up blood storage points to store blood. Blood storage points should have the necessary storage conditions, and approved by the provincial health administrative department. Article 18 According to the planning to be abolished blood stations, should be abolished within fifteen days after the practice registration authority to apply for cancellation of practice registration. Failure to do so, by the practice registration authority in accordance with the procedures to be canceled, and withdraw the "blood station license" and its copy and a full set of seals.
Section II Practice
Article 19 The practice of blood stations shall comply with relevant laws, administrative regulations, rules and technical specifications.
Article 20 The blood station shall, according to the clinical blood demand of medical institutions, formulate plans for blood collection, preparation and supply, and ensure that the clinical blood is safe, timely and effective.
Article 21 The blood station shall carry out publicity on blood donation.
The blood station carries out the recruitment of blood donors, shall provide safe, hygienic, convenient conditions and good services for blood donors.
Article 22 of the blood station shall, in accordance with the relevant provisions of the State for blood donors to carry out health checks and blood collection.
Blood stations shall check the identity of blood donors and register them before collecting blood.
It is strictly forbidden to collect blood from impostors. Excessive and frequent collection of blood is strictly prohibited.
The blood stations shall not collect raw plasma for the production of blood products.
Article 23 A blood donor shall present true proof of identity upon request.
No unit or individual shall organize blood donation by impostors.
Article 24 The collection of blood by blood stations shall be based on the principles of voluntary and informed consent, and blood donors shall be given the required notification obligations.
The blood stations shall establish a system of confidentiality of the information of blood donors and keep the confidentiality of blood donors.
Article 25 The blood stations shall establish the reporting procedures, blood donation shielding and elimination system for the blood donors who are susceptible to the risk of infection of blood-borne diseases after blood donation.
Article 26 The blood stations shall carry out the business of collecting and supplying blood by implementing comprehensive quality management and strictly abiding by the technical specifications and standards such as the "China's Blood Transfusion Technical Operating Procedures", the "Code of Practice for the Quality Management of Blood Stations", and the "Code of Practice for the Quality Management of Laboratories of Blood Stations".
The blood station shall establish the personnel post responsibility system and blood collection and supply management related work system, and regularly check and assess the implementation and realization of the rules and regulations and all levels and types of personnel post responsibility system.
Article 27 The staff of the blood station shall comply with the provisions of the post practice qualification, and accept the blood safety and business post training and assessment, and receive the post training certificate before going on duty.
The blood station staff shall each receive no less than 75 hours of continuing education per year.
Job training and assessment by the people's governments at or above the provincial level health administrative departments responsible for the organization and implementation. Article 28 The work records of the blood station business positions should be true, complete, standardized format, clear handwriting, timely records, with the operator's signature.
When the content of the record needs to be changed, the original content of the record shall be kept clear and legible, indicating the content of the change, the reason and the date, and signing at the change.
The original records of blood donation, testing and blood supply shall be kept for at least ten years, and where otherwise provided by laws, administrative regulations and the Ministry of Health, the records shall be executed in accordance with the relevant provisions.
Article 29 The blood stations shall ensure that the collected blood shall be tested by the laboratories with the qualification of blood testing laboratories.
The blood stations shall deal with the unqualified or scrapped blood in strict accordance with the relevant provisions.
Article 30 The blood stations shall formulate the indoor quality control and inter-room quality assessment system of the laboratories to ensure that the reagents, hygienic equipments, instruments and equipments can achieve the expected results in the process of using.
The laboratories of blood stations shall be equipped with necessary biosafety equipment and facilities, and staff training in biosafety knowledge.
Article 31 The preservation period of blood specimens shall be two years after the use of whole blood or component blood.
Article 32 The blood stations shall strengthen the management of disinfection and isolation work to prevent and control the spread of infectious diseases.
The medical wastes generated by the blood stations shall be handled in accordance with the provisions of the Regulations on the Administration of Medical Wastes, and records and signatures shall be made properly to avoid cross-infection.
Article 33 The blood stations and their personnel performing their duties shall report to the relevant departments in accordance with the Law on Prevention and Control of Infectious Diseases and the provisions of the Ministry of Health when they find out the outbreak of statutory infectious diseases.
Article 34 The packaging, storage and transportation of blood shall conform to the requirements of the Code for Quality Management of Blood Stations. The blood package shall be marked with:
(1) the name of the blood station and its license number;
(2) the blood donation number or bar code;
(3) the blood type;
(4) the variety of the blood;
(5) the date and time of blood collection or the date and time of preparation;
(6) the effective date and time;
(vii) Storage conditions.
Article 35 The blood stations shall ensure that the quality of the issued blood conforms to the relevant state standards, and that there is no error in its variety, specification, quantity, activity, and blood type; the untested or unqualified blood shall not be provided to the medical institutions.
Article 36 The blood stations shall establish a system of quality complaint, adverse reaction monitoring and blood retrieval.
Article 37 The blood stations shall strengthen the quality supervision of the blood storage points established by them, ensure the storage conditions, and guarantee the quality of blood storage; and carry out the storage and transfer of blood in accordance with the clinical needs.
Article 38 The medicines, in vitro diagnostic reagents and disposable sanitary equipments used by the blood stations shall comply with the relevant state regulations.
Article 39 The blood stations shall, in accordance with the relevant provisions, carefully fill out the statistical reports of blood collection and supply organizations, and report them timely and accurately.
Article 40 blood stations shall formulate emergency disaster contingency plan, and from the blood source, management system, technical capacity and equipment conditions to ensure the implementation of the plan. In the emergency disaster to obey the people's governments at or above the county level of the health administrative department of the deployment.
Article 41 If the blood of special blood type needs to be deployed from other provinces, autonomous regions or municipalities directly under the central government, it shall be approved by the health administrative department of the people's government at the provincial level.
The deployment of blood for scientific research or special needs shall be approved by the health administrative department of the people's government at the provincial level.
For the purpose of humanitarianism and saving lives and helping the injured, if it is necessary to provide blood and special blood components to medical institutions outside of China, the procedures shall be carried out in strict accordance with the relevant provisions.
Article 42 Blood donated without compensation must be used for clinical purposes and may not be bought or sold.
The remaining component plasma in blood stations shall be resolved by the health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government in coordination with the blood product production units.
Article 43 The blood station must strictly implement the provisions of the state on the disposal of scrapped blood and blood donors susceptible to the risk of infection of blood-borne diseases and confidentiality of blood disposal after blood donation.
Article 44 The income derived from the remaining component plasma of the blood stations and from the deployment of blood for scientific research or special needs shall be used entirely for the return of the expenses for the use of blood by the unpaid donors, and shall not be appropriated by the blood stations for any other purposes. Article 45
The Ministry of Health shall, in accordance with the actual situation of the national population distribution, health resources, and clinical hematopoietic stem cell transplantation needs, uniformly formulate the planning and principles for the setting up of special blood stations, such as umbilical cord blood hematopoietic stem cell banks, in China.
The State does not approve the establishment of special blood stations such as umbilical cord blood hematopoietic stem cell banks for profit-making purposes.
Article 46
Anyone who applies for the establishment of special blood stations such as cord blood hematopoietic stem cell banks, etc., shall apply to the administrative department of health of the people's government at the provincial level where it is located in accordance with the conditions prescribed by the Ministry of Health. The health administrative department of the provincial people's government shall organize the preliminary examination and submit it to the Ministry of Health.
The Ministry of Health on the cord blood hematopoietic stem cell bank and other special blood stations set up for approval in accordance with the order of application.
Article 47
Cord blood hematopoietic stem cell bank and other special blood station practice, shall apply to the local provincial people's government administrative department of health for practice registration.
The provincial health administrative department shall organize relevant experts and technical departments, in accordance with these Measures and the Ministry of Health to formulate the cord blood hematopoietic stem cell bank and other special blood stations of the basic standards, technical specifications, the applicant for technical review and practice acceptance. If the applicant passes the examination, it shall be issued the License to Practice Blood Stations, and the business to be carried out shall be indicated. The License to Practice Blood Stations is valid for three years.
Without obtaining the License to Practice in Blood Stations, the business of collecting and supplying umbilical cord blood and hematopoietic stem cells shall not be carried out.
Article 48
Cord blood hematopoietic stem cell banks and other special blood stations in the "blood station practice license" expires after the continuation of the practice, should be in the "blood station practice license" three months before the expiration of the validity of the provincial people's government of the original registration of the health administrative department for the registration of the practice of the formalities again.
Article 49
In addition to complying with the requirements for the practice of general blood stations in Section 2 of Chapter 2 of these Measures, the practice of special blood stations, such as cord blood hematopoietic stem cell banks, shall also comply with the following provisions:
(1) practicing in accordance with the basic standards, technical specifications and other regulations for cord blood hematopoietic stem cell banks, such as the Ministry of Health;
(2) collection of special blood components, such as cord blood, must comply with the medical standards and technical specifications;
(2) the collection of special blood components, such as cord blood, must comply with the medical requirements for the collection of special blood components, such as cord blood. The collection of special blood components must comply with the relevant requirements of medical ethics and follow the principles of voluntary and informed consent. Cord blood hematopoietic stem cell banks must sign with the donors an informed consent form that has been examined and approved by the practicing registration authority;
(3) special blood banks such as cord blood hematopoietic stem cell banks can only provide cord blood hematopoietic stem cells to medical institutions that have the experience in and basis for hematopoietic stem cell transplantation and are equipped with sterile wards and other necessary facilities required for hematopoietic stem cell transplantation;
(4) for the purpose of humanitarian and life-saving purposes, where it is necessary to provide special blood components such as cord blood hematopoietic stem cells to medical institutions outside China, the formalities shall be handled in strict accordance with the national regulations on the management of human genetic resources;
(e) cord blood and other special blood components must be used for clinical purposes. Article 50 The health administrative departments of the people's governments at or above the county level shall perform the following duties with respect to blood collection and supply activities:
(1) to formulate management measures for the storage and distribution of clinical blood and supervise the implementation thereof;
(2) to supervise and inspect the performance of the duties of management of the blood stations stipulated in the present Measures by the administrative departments of the people's governments at the lower levels of health;
(3) to carry out day-to-day supervision and inspection of the practice of the blood stations within the jurisdiction, and to organize and carry out the supervision of the blood stations under the jurisdiction. (c) To carry out daily supervision and inspection of the practice of blood stations under its jurisdiction, and to organize and carry out occasional sampling inspections of the quality of blood collection and supply;
(d) To carry out supervision and inspection of clinical blood supply activities under its jurisdiction;
(e) To investigate and deal with violations of these Measures in accordance with the law.
Article 51 The health administrative departments of the people's governments at all levels shall support and guide the recruitment, blood collection and blood supply activities of non-remunerated blood donors.
Article 52 The health administrative departments of the people's governments at the provincial level shall evaluate and supervise and inspect the implementation of the relevant provisions of the blood stations under their jurisdiction and the proportion of unpaid blood donations, the quality of services for the collection and supply of blood, the operational guidance, personnel training, and the technical capability of comprehensive quality evaluation, and report the results in accordance with the relevant provisions of the Ministry of Health, and at the same time publicize them to the society.
Article 53 The Ministry of Health regularly evaluates and supervises and inspects the implementation of the relevant regulations by the blood centers and the ratio of non-remunerated blood donation, the quality of blood collection and supply services, business guidance, personnel training, comprehensive quality evaluation and technical capacity, as well as the quality management of special blood stations such as cord blood hematopoietic stem cell banks, and publishes the results to the society.
Article 54 The administrative department of health shall have the right to request relevant information when conducting supervision and inspection, and the blood stations shall not conceal, hinder or refuse.
The administrative department of health shall be obliged to keep the information provided by the blood station confidential, except as otherwise provided by laws, administrative regulations or departmental rules.
Article 55 In the performance of their duties, the administrative department of health and its staff shall not do any of the following:
(1) Approve the setting up, registration of practice, or change of registration of a blood station if it does not meet the statutory conditions, or approve the setting up, registration of practice, or change of registration of a blood station beyond the scope of its authority;
(2) Refuse to approve the setting up, registration of practice, or change of registration of a blood station if it meets the statutory conditions and the planning of the setting up of the station.
Article 56 The health administrative departments of the people's governments at all levels shall establish the supervision and management of blood stations reporting and complaint mechanism.
Health administrative departments of the whistleblower and the complainant has the obligation of confidentiality.
Article 57 The state to implement blood quality monitoring, verification system, the quality management of blood stations, blood station laboratory quality management of the implementation of technical review system, the specific measures to be formulated by the Ministry of Health.
Article 58 If a blood station has any of the following circumstances, the health administrative department of the provincial people's government shall cancel its "license to practice blood station":
(1) the expiration of the validity period of the "license to practice blood station" without re-registration of the practice;
(2) obtaining the "license" within one year after the blood station does not carry out the work of blood collection and supply. Article 59 Any one of the following acts shall be regarded as illegal collection of blood, and shall be punished by the health administrative department of the local people's government at or above the county level in accordance with the relevant provisions of Article 18 of the Blood Donation Law; if the act constitutes a crime, it shall be investigated for criminal responsibility in accordance with law:
(1) Setting up a blood station without authorization to carry out the activities of collecting and supplying blood;
(2) carrying out the activities of collecting and supplying blood in the blood station that has been canceled;
(2) carrying out the activities of collecting and supplying blood in the blood station that has been canceled;
(C) has obtained approval for the establishment but has not yet obtained the "blood station license" to carry out blood collection and supply activities, or "blood station license" validity period has expired without re-registration to carry out blood collection and supply activities;
(D) renting, borrowing, leasing, lending, altering, falsifying, and forging the "blood station license" to carry out blood collection and supply activities.
Article 60 If a blood station sells blood donated without compensation, it shall be punished by the health administrative department of the local people's government at or above the county level in accordance with the relevant provisions of Article 18 of the Blood Donation Law; and if a crime is constituted, it shall be investigated for criminal responsibility according to law.
Article 61 If a blood station engages in any of the following acts, the health administrative department of the local people's government at or above the county level shall give a warning and order rectification; if it fails to do so, or if it results in the occurrence of a blood-borne disease or any other serious consequences, the competent person in charge and other persons directly in charge shall be given administrative sanctions in accordance with the law; and if it constitutes a crime, it shall be held criminally liable in accordance with the law:
(a) exceeding the project, content, scope of practice registration to carry out business activities;
(b) staff did not obtain the relevant post qualifications or without practice registration to engage in the collection and supply of blood;
(c) the blood testing laboratory without obtaining the appropriate qualifications to carry out the test;
(d) the unauthorized collection of raw plasma, trade in blood;
(e) the collection and sale of blood; and
(5) Collecting blood without conducting health examination and testing of blood donors in accordance with the health examination requirements for blood donors promulgated by the State before collection;
(6) Collecting blood from imposters and those who are unqualified in the health examination, as well as collecting blood in excessive or frequent quantities;
(7) Violating the technical operation procedures of blood transfusion and the relevant quality standards and criteria;
(8) Collecting blood without providing information to the donors, specialists, or specialists before collection;
(9) Collecting blood without providing information to the donors, specialists, or specialists before collection; and (h) Failure to fulfill the stipulated notification obligations to blood donors and donors of special blood components before blood collection;
(ix) Unauthorized alteration, destruction, or failure to keep the work records in accordance with the regulations;
(x) Use of medicines, in vitro diagnostic reagents, and disposable sanitary equipment that do not comply with the relevant state regulations;
(xi) Reuse of disposable sanitary equipment;
(xii) Failure to dispose of unqualified or scrapped blood in accordance with relevant regulations;
(xiii) Unauthorized deployment of blood with foreign provinces, autonomous regions and municipalities directly under the Central Government;
(xiv) Unauthorized provision of blood or special blood components to overseas medical institutions;
(xv) Failure to preserve blood specimens in accordance with the regulations;
(xvi) Failure to use cord blood hematopoietic reagents in accordance with the relevant provisions of the State;
(xviii) Reuse of disposable sanitary equipment; and (xvi) violation of relevant technical specifications by special blood stations such as cord blood hematopoietic stem cell banks.
Blood stations causing the occurrence of blood-borne diseases or other serious consequences, the administrative department of health in the administrative punishment at the same time, may cancel its "blood station license".
Article 62 of the clinical blood packaging, storage, transportation, does not meet the state health standards and requirements, by the local people's government at or above the county level of the administrative department of health ordered to make corrections, and given a warning.
Article 63 If a blood station violates the regulations and provides medical institutions with blood that does not conform to the standards prescribed by the state, the health administrative department of the people's government at or above the county level shall order correction; if the situation is serious enough to cause the spread of diseases transmitted through the blood route or if there is a serious danger of the spread of such diseases, the situation shall be rectified for a limited period of time, and the directly responsible supervisory personnel and other responsible personnel shall be given administrative sanctions according to the law; and if the situation constitutes a crime, it shall be investigated for criminal responsibility according to the law. Criminal responsibility shall be investigated according to law.
Article 64 The administrative department of health and its staff in violation of the relevant provisions of these Measures, one of the following circumstances, according to the "Blood Donation Law", "Administrative Licensing Law" of the relevant provisions of the higher administrative organ or supervisory organ shall order rectification; the circumstances are serious, the directly responsible persons in charge of other directly responsible persons shall be given administrative sanctions in accordance with the law; constitutes a crime, shall be investigated for criminal responsibility.
(1) failure to review in accordance with the prescribed procedures so that the applicant does not meet the conditions to obtain permission;
(2) granting permission to an applicant who does not meet the conditions or exceeding the statutory authority to make a decision to grant permission;
(3) fraud in the process of licensing and examination and approval;
(4) failure to accept applications for setting up and registration of practice of the eligible;
(5) failure to accept applications for setting up and registration of practice; and Acceptance;
(5) Failure to make a licensing decision on an eligible application within the statutory period;
(6) Failure to perform supervision duties in accordance with the law, or ineffective supervision resulting in serious consequences;
(7) Any other acts of abuse of power, negligence, favoritism, solicitation and acceptance of bribes, etc., in the course of implementing these Measures. Article 65
The meaning of the following terms in these Measures:
Blood means whole blood, blood components and special blood components.
Cord blood, means placental blood collected from the distal end of the umbilical cord of a newborn after it has been tied off, which is not related to the blood volume and blood circulation of the pregnant woman and the newborn.
Cord blood hematopoietic stem cell bank means a special blood bank that has the ability to collect, process, preserve and provide hematopoietic stem cells for the purpose of human hematopoietic stem cell transplantation and has considerable research capabilities.
Article 66
Blood stations that have been established before the implementation of these Measures shall be adjusted in accordance with the provisions of these Measures within nine months after the implementation of these Measures.
The health administrative department of the provincial people's government shall, in accordance with the standards of the blood center for the existing blood center audit, does not meet the standards of the blood center, shall order rectification within a certain period of time. Rectification is still unqualified, the health administrative department shall cancel the blood center set up. In line with the central blood center practice standards, in accordance with the central blood center standard audit set up and practice registration.
Article 67
These Measures shall come into force on March 1, 2006, and the Measures for the Administration of Blood Stations (Provisional) promulgated on September 21, 1998 shall be repealed at the same time.
Notice of the Ministry of Health on the Revision of Article 31 of the Measures for the Administration of Blood Stations
Medical Administration of Health [2009] No. 28
Provinces, autonomous regions and municipalities directly under the Central Government Health Departments and Bureaus, and the Bureau of Health of Xinjiang Production and Construction Corps:
After the study, it was decided to revise Article 31 of the Measures for the Administration of Blood Stations to include the words "The preservation period of whole blood specimens for blood testing shall be the same as the validity period of whole blood; the preservation period of serum (plasma) specimens shall be half a year after the expiration of the validity period of whole blood." Revised to read, "The preservation period of blood specimens shall be two years after the use of whole blood or component blood."
This notice shall come into force on the date of its publication.
March 27, 2009