(November 17, 2005 Ministry of health, the 44th release as of March 1, 2006) Chapter I General provisions article I in order to ensure the safety of the blood, regulating blood bank practice, and promote the construction and development of blood banks, according to the law on blood donation procedures are formulated.
    Second blood stations in these measures refers to the not for profit-making purposes, collection, provide public health agencies for clinical use.
    Article is divided into General and special blood station in blood station in blood station.
    General blood includes blood centers, Central Blood Bank and the Central Blood Bank.
    Special blood stations, including umbilical cord blood stem cell Bank and the Ministry of health based on medical needs ratifying, set other types of blood banks.
    The fourth blood centers, Central Blood Bank and the Central Blood Bank set up by the local people's Governments.
    Construction of blood stations and development into local economic and social development plan.
    Fifth Ministry of health under the national allocation of medical resources, clinical blood demand, developing national blood collection and supply institutions planning guidelines, and is responsible for national planning guidance of construction of blood stations.
    Health administrative departments of provinces, autonomous regions and municipalities shall be according to the provisions of the preceding paragraph, this administrative area population, medical resources, clinical blood demand situation and local regional health development plan, blood stations set their respective administrative areas planning, reported to the people's Government at the same level, and reported to the Ministry of health records.
    The sixth Ministry of health responsible for supervision and administration of blood stations nationwide.
    Health administrative departments under local people's Governments at or above the county level shall be responsible for the supervision and administration of blood stations in the administrative area.
    Article seventh encourages and supports the blood applied research and technological innovation, as well as clinical blood transfusion-related international exchanges and cooperation in science and technology. First section of chapter II General blood management, duty practising registration article eighth blood centers should be set up in municipalities, the capital city, the capital city of the autonomous region.
    Its main duties is: (a) according to provincial government health administrative sector of requirements, in provides range within carried out free blood who of recruitment, and blood of collection and preparation, and clinical with blood supply and medical with blood of business guide, work; (ii) bear where province, and autonomous regions, and municipalities blood station of quality control and evaluation; (three) bear where province, and autonomous regions, and municipalities blood station of business training and technical guidance; (four) bear where province, and autonomous regions, and municipalities blood of concentrated of detection task;
    (E) blood-related scientific research; (vi) undertake the task assigned by the Administrative Department of public health.
    Blood centers should have a comprehensive quality evaluation of higher technical ability. Nineth blood center should be set up in the city divided into districts.
    Its main duties is: (a) according to provincial government health administrative sector of requirements, in provides range within carried out free blood who of recruitment, and blood of collection and preparation, and clinical with blood supply and medical with blood of business guide, work; (ii) bear for blood regional range within blood store of quality control; (three) on where administrative within of Center blood bank for quality control; (four) bear health administrative sector assigned by of task.
    Municipalities, provincial capital city, capital city of the autonomous region has set the blood center, no longer sets the blood center; the blood center has not been set, may have set up on the basis of the blood center to enhance capacity-building to fulfil duties of the blood center. Tenth Central Blood Bank should be set up in the central blood bank service covering the county hospital.
    Its main duty is, in accordance with the requirements of provincial health administrative departments, carried out within the stipulated blood donor recruitment, blood collection and preparation, supply and medical use of blood for clinical use operational guidance, and so on.
    11th of provinces, autonomous regions and municipalities directly under the blood collection and supply institutions set up by administrative departments of health under planning approved blood stations, and reported to the Ministry of health records.
    The provinces, autonomous regions, municipalities directly under the jurisdiction of administrative departments of health under a clear health administrative departments at all levels within regulatory responsibilities and blood functions according to the actual distance and blood supply, and so on, is responsible for the delineation of the blood collection and supply of blood services region, blood services regions can not be limited by administrative regions.
    Shall not be repeated within the same administrative area blood centers, Central Blood Bank.
    Blood stood Apheresis plasma stand may not be set in the same County.
    12th of provinces, autonomous regions and municipalities directly under the Administrative Department of health under unified planning, set up centralized testing laboratory, and gradually implemented. 13th blood station carrying out blood collection activities shall be made to provinces, autonomous regions and municipalities directly under the Administrative Department of health under the applying for a practising registration, obtained a license to practice in blood station.
    The blood stations practitioner without license, may not engage in blood collection and supply activities.
    The blood bank practice license will be valid for three years.
    14th blood station to apply for a practising registration must fill in the application for registration of the blood bank practice.
    Provincial health Administrative Department accepting blood bank practice registration application, shall organize relevant experts or entrust the technical departments, under the blood station quality management norms and the code for quality management in blood station laboratory, the technical examination of the applicant and submitted technical reviews. Provincial health Administrative Department shall receive expert technical review reports or technical departments to audit applications in the 20th.
    Audit qualified, practising registered, sent to the Ministry of health practice license of uniform styles of the blood and its copy.
    15th under any of the following circumstances shall not be practising registration: (a) the technical review of the blood station quality management practices are not qualified; (b) the technical review of the specification for quality management in blood station laboratory is not qualified; (c) failed to pass the quality of blood test results.
    Certified registration authority registration of auditing is not qualified, not practicing, the results and reasons in writing notify the applicant.
    16th the blood station three months before the expiration of the license to practice, blood stations shall have again practice registration and submit application for practising registration again, the blood and the blood of license to practice. Provincial health Administrative Department shall, according to blood center operations and supervision and inspection by the audit, examination, continue to practise.
    Has not been approved, order the rectification; failed to pass the examination by the rectification, cancellation of practice license of its blood.
    Again without practising registration or cancellation of practice license of the blood bank's blood, may not continue to practice.
    17th blood for blood collection and supply needs, establish branch offices within the service areas provided, shall be reported to the host Governments of provinces, autonomous regions and municipalities directly under the approval of the public health Administrative Department; set a fixed sampling points (room) or mobile blood collection vehicle should be reported to health administration departments of provinces, autonomous regions and municipalities. In order to ensure the area needed for clinical use, blood stations can set the blood point blood storage.
    Blood should have the necessary storage conditions, and approved by the provincial health Administrative Department. 18th under the plan and revocation of blood stations shall be abolished within 15th practising registration authority for the cancellation of practice registration.
    Fails to go through, by certified registration authority in accordance with procedures to be cancelled, and withdrawing the blood stations and copies of the license to practice and a full set of stamps.
    Practice practise 19th blood station in section II shall comply with the relevant laws and administrative rules and regulations and technical specifications.
    20th blood stations shall, in accordance with medical institutions demand for clinical use, development of blood collection, preparation, supply planning, safety of blood for clinical use and timely and effective.
    21st blood blood donation advocacy should be conducted.
    Blood donor recruitment and blood donors should be provided a safe, hygienic and convenient conditions and good service.
    22nd blood stations shall, in accordance with the relevant provisions of the donor health screening and blood collection.
    Blood blood donor identity checks and should be carried out before registration. Collecting the imposter's blood is strictly prohibited.
    Non-excessive, frequent blood.
    Blood stations shall not collect blood plasma products used for the production of raw materials.
    23rd donors should demand proof of real identity.
    No unit or individual may organize an impostor to donate blood.
    24th blood stations collecting blood shall follow the principle of free and informed consent, and the donors to carry out its mandated duty.
    Blood stations shall establish blood donor information confidential system, and confidentiality to donors.
    25th blood station should be built on blood-borne diseases dangerous behavior of blood donors after blood donation work programs, blood donation screening and elimination system.
    26th blood for blood collection and supply businesses should carry out comprehensive quality control, strict adherence to the China practice for blood transfusion, the blood station quality management standard and quality management in blood station laboratory specifications and other technical norms and standards.
    Blood stations shall establish a personnel post responsibility system and blood collection and supply management-related work, and periodic inspection, examination rules and regulations and the implementation and follow-up of all categories of personnel at all levels of personal responsibility.
    27th blood station staff should meet the job qualifications requirements and accept job training and the assessment blood safety and business, receive job training certificates before they can post.
    Blood Bank staff shall receive not less than 75 hours a year post continuing education.
    Job training and assessment organized by the people's Governments above provincial level health Administrative Department is responsible for the implementation.
    28th blood stations operational work record should be true, project complete, well-formed, clear writing, recording, and operator's signature.
    Records when changes are required, shall maintain records of the original contents clearly visible, indicating the content and reason for the change and the date and change the signature.
    Blood donation, testing and blood supply of original records shall be kept for at least ten years, otherwise stipulated by laws, administrative regulations and the Ministry of health, in accordance with the relevant provisions.
    29th blood stations shall ensure the collection of blood from the blood test laboratory qualified laboratories for testing.
    Screening unqualified and scrapping of the blood, blood stations shall be strictly in accordance with the relevant provisions.
    30th blood station laboratory should be developed for internal quality control and external quality assessment system to ensure health equipment, reagents, apparatus and equipment used in the process to achieve the desired effect.
    Blood Center of biosafety of the laboratory shall be equipped with the necessary equipment and facilities, and bio-security training for staff.
    31st the shelf life of blood testing whole blood specimens should be the same as the validity of whole blood serum (plasma) specimen storage should be in whole blood after the expiry of six months.
    Article 32nd blood stations shall strengthen the management of disinfection and isolation work to prevent and control the spread of infectious diseases.
    Blood stations shall be in accordance with the regulations on the management of medical waste medical waste regulations, records and signatures to avoid cross infection.
    33rd blood station and duty personnel found that a statutory epidemic situation of infectious diseases, in accordance with the law on prevention of infectious diseases and the provisions of the Ministry of Health reported to the relevant authorities. Article 34th blood packing, storage, transportation, shall comply with the requirements of the specification for quality management in blood station.
    Blood bags shall be marked: (a) the name and license number of the blood bank; (b) blood donor number or bar code, (iii) blood (iv) blood (v) date and time of sampling or preparation date and time; (f) the effective date and time; (g) the storage conditions.
    35th blood stations shall ensure the quality of issued blood consistent with national standards, the varieties, specifications, quantities, activity and blood-type error-free without inspection or failed to pass the test of blood shall not be provided to medical institutions.
    Article 36th blood stations shall establish quality complaints, adverse reaction monitoring and blood recovery systems.
    37th blood shall strengthen the blood points established by the quality supervision to ensure that storage conditions, guarantee the quality of stored blood; blood storage and Exchange in accordance with clinical need.
    38th blood stations using drugs, in vitro diagnostic reagents and disposable sanitary equipment shall comply with the relevant provisions of the State.
    Blood stations shall, in accordance with the relevant provisions of the 39th article, fill the blood collection and supply institutions statistics, timely and accurate reporting. 40th blood station emergency disaster contingency plans should be developed, and from blood, management systems and technology capabilities and equipment guarantee the implementation of the plan.
    Subject to emergency disaster Department of the people's Governments above the county level health fields.
    41st special blood type blood from other provinces, autonomous regions and municipalities directly under the provision, approved by the provincial health Administrative Department.
    Blood due to scientific research or special needs provision, approved by the provincial health Administrative Department.
    For humanitarian and life-saving purposes, you need to provide blood to the medical institutions outside China, and specific blood components shall be in strict accordance with the relevant rules of procedure.
    42nd blood donated without compensation must be used, and cannot be bought or sold.
    Blood plasma remaining components by provinces, autonomous regions and municipalities directly under the Administrative Department of health under the coordination of production units of blood products to solve.
    43rd blood banks must strictly implement the State blood-related scrap processing and there is blood-borne disease risk provisions governing confidentiality give up blood after blood donation among blood donors.
    44th blood plasma remaining components as well as scientific research or special need of blood for the provisioning of the income fee for all returned with blood in voluntary blood donors, blood stations shall not be appropriated for other purposes.
    45th chapter special blood Management Department of health under the national population distribution, health resources, clinical hematopoietic stem cell transplantation, the actual situation, unified China cord blood stem cell Bank and other special blood bank setting planning and principles.
    States did not ratify the setting for profit of umbilical cord blood hematopoietic stem cells and other special blood banks. 46th, application settings special blood stations such as umbilical cord blood stem cell Bank, shall, in accordance with the conditions laid down in the Ministry of health to the local people's Government at the provincial level health administrative departments.
    Provincial administrative departments of health under examination and then reported to the Ministry of health.
    Ministry of health on umbilical cord blood stem cells and other special blood stations approved in accordance with the application in the order.
    47th umbilical cord blood stem cells and other special blood bank practice should apply to the local people's Government at the provincial level health administrative departments practice registration. The provincial health administrative departments shall organize relevant experts and technical departments in accordance with this approach and the Ministry of health developed special blood stations such as umbilical cord blood stem cell bank standards, technical specifications, the technical examination of the applicant and the medical industry acceptance. Examination, blood bank practice license will be issued, specifying the business.
    The blood bank practice license will be valid for three years.
    Without the blood of license to practice, may not carry out hematopoietic stem cells from umbilical cord blood collection and supply business.
    48th special blood of umbilical cord blood hematopoietic stem cells in the blood after the expiration of the license to practice to continue to practise, shall practise in the blood stations permit three months before the expiry of the original practice of registration of provincial administrative departments of health under application for practising registration again. 49th article cord blood hematopoietic stem cell library, special blood station practice industry except should comply with this approach second chapter second section General blood station of practice industry requirements outside, also should comply with following provides: (a) according to Ministry of health provides of cord blood hematopoietic stem cell library, special blood station of basic standard, and technology specification, practice industry; (ii) cord blood, special blood components of collection must meet medical ethics of about requirements, and followed voluntary and informed agreed of principles. Cord blood hematopoietic stem cell library must and donated who signed by practice industry registration organ audit of informed agreed book; (three) cord blood hematopoietic stem cell library, special blood station only to has hematopoietic stem cell transplant experience and based, and equipment has hematopoietic stem cell transplant by needed of no bacteria Ward and other must facilities of medical institutions provides cord blood hematopoietic stem cell; (four) for humanitarian, and heal of purpose, must to outside medical institutions provides cord blood hematopoietic stem cell, special blood components of,
    Should be strictly in accordance with national regulations related to human genetic resources management procedures; (e) the special blood components such as cord blood must be used in the clinic.
    Fourth chapter supervision management 50th article County above government health administrative sector on mining for blood activities perform following duties: (a) developed clinical with blood store, and distribution management approach, and supervision implementation; (ii) on subordinate health administrative sector perform this approach provides of blood station management duties for supervision check; (three) on area within blood station practice industry activities for daily supervision check, organization carried out on mining for blood quality of not regularly sampling; (four) on area within clinical for blood activities for supervision check;
    (E) the law for violations of this approach in the investigation.
    51st levels of Administrative Department of health under the blood donor recruitment, blood collection, the supply of blood in their support and guidance.
    52nd provincial health administration of blood stations within their respective jurisdictions to implement the relevant provisions and voluntary blood donation, blood collection and supply service quality, business guidance, training, comprehensive quality assessment of technical capacity for evaluation and supervision and inspection, in accordance with the relevant provisions of the Ministry of Health reported the results, and announced to the public.
    53rd Blood Center on a regular basis the implementation of relevant provisions of the Ministry of health and the proportion of voluntary blood donation, blood collection and supply service quality, business guidance, training, comprehensive quality evaluation of technical ability and umbilical cord blood stem cells and other special quality management in blood station status evaluation and supervision and inspection, and publicize the results.
    54th in conducting supervision and inspection, the Administrative Department of public health has the right to obtain the information, blood stations shall not conceal, obstruct or refuse.
    Administrative Department of public health on blood banks obliged to confidentiality of information provided by the laws, administrative regulations, or except as otherwise provided in the regulations.
    55th article health administrative sector and staff in perform duties Shi, shall not has following behavior: (a) on not meet statutory conditions of, approved its set, and practice industry registration or change registration, or beyond terms approved blood station set, and practice industry registration or change registration; (ii) on meet statutory conditions and blood station set planning of, not approved its set, and practice industry registration or change registration; or not in statutory term within approved its set, and practice industry registration or change registration; (three) on blood station not perform supervision management duties;
    (D) other acts in violation of these measures.
    56th levels of Administrative Department of health under the supervision and administration of blood stations should be established to report and complaint mechanisms.
    Administrative Department of public health to informants and complainants have a duty of confidentiality.
    57th State of blood quality monitoring and verification system in blood station quality management system, quality management in blood station laboratory for technology review, specific measures shall be formulated separately by the Ministry of health.
    58th blood station, one of the following circumstances, the provincial health Administrative Department cancelled its license to practice in blood station: (a) the expiry of the current practising certificate have not been fulfilled in blood station again practice registration; (b) obtained a license to practice in blood station commenced within one year after blood work. Fifth chapter legal responsibility 59th article has following behavior one of of, belongs to illegal collection blood, by County above place Government health administrative sector according to blood method 18th article of about provides be punishment; constitute crime of, law held criminal: (a) without approved, unauthorized set blood station, carried out mining for blood activities of; (ii) has was cancellation of blood station, still carried out mining for blood activities of; (three) has made set approved but yet made blood station practice industry license that carried out mining for blood activities, or
    Blood bank practice license expiry date is still not registered again in blood collection and supply activities; (iv) rent, loan, lease, lend, altered, forged the practice license of blood collection and supply of blood.
    60th blood stations in volunteer blood donors of blood, by the health Administrative Department under local people's Governments at or above the county level in accordance with the relevant provisions of 18th of the blood donation law, penalties constitutes a crime, criminal responsibility shall be investigated according to law.
    61st article blood station has following behavior one of of, by County above place Government health administrative sector be warning, and ordered corrected; late not corrected, or caused by blood spread disease occurred, or other serious consequences of, on has responsibility of competent personnel and other directly is responsible for personnel, law give administrative sanctions; constitute crime of, law held criminal: (a) beyond practice industry registration of project, and content, and range carried out business activities of; (Ii) staff not made related post practice industry qualification or without practice industry registered and engaged in mining for blood work of; (three) blood detection laboratory not made corresponding qualification that for detection of; (four) unauthorized collection raw materials plasma, and sale blood of; (five) collection blood Qian, not according to national issued of blood who health check requirements on blood who for health check, and detection of; (six) collection impostor who, and health check not qualified who blood and excess, and frequently collection blood of; (seven) violation transfusion technology operation , And about quality specification and standard of; (eight) blood Qian not to blood who, and special blood components donation who perform provides of told obligations of; (nine) unauthorized altered, and damage or not by provides save work records of; (ten) using of drug, and body outside diagnosis reagents, and one-time health equipment not meet national about provides of; (11) repeat using one-time health equipment of; (12) on detection not qualified or scrap of blood, not by about provides processing of; (13) without approved unauthorized and provincial, and autonomous regions, and
    Municipality level blood (14) unauthorized foreign medical institutions or special blood components of blood (15) does not save the required blood sample (16) special blood stations such as umbilical cord blood stem cell bank in breach of the technical specifications.
    Blood stations caused by blood-borne disease or other serious consequences, health administrative departments administrative penalties at the same time, you can cancel its practice license of the blood bank.
    62nd blood for clinical use in the packaging, storage, transport, which does not comply with national health standards and requirements, by the health Administrative Department under local people's Governments at or above the county level shall be ordered to correct and given a warning.
    63rd blood station in violation of regulations, medical institutions do not meet the standards set by the State of the blood, the people's Governments above the county level health administrative departments shall be ordered to correct serious, caused by blood-borne disease spread or a serious risk of transmission of deadlines for reorganization, in charge and other personnel directly responsible shall be given administrative sanctions constitutes a crime, criminal responsibility shall be investigated according to law.
    64th article health administrative sector and staff violation this approach about provides, has following case one of of, according to blood method, and administrative license method of about provides, by superior administrative organ or monitored organ ordered corrected; plot serious of, on directly is responsible for of competent personnel and other directly responsibility personnel law give administrative sanctions; constitute crime of, law held criminal: (a) not by provides of program review and makes not meet conditions of application who get license of; (Ii) on not meet conditions of application who granted license or beyond statutory terms made granted license decided of; (three) in license approval process in the fraud of; (four) on meet conditions of set and the practice industry registration application not accepted of; (five) on meet conditions of application not in statutory term within made license decided of; (six) not law perform supervision duties, or supervision poor caused serious consequences of; (seven) other in implementation this approach process in the, exists abuse, negligence, engages in,
    Bribes and other acts.
    The sixth chapter supplementary articles the 65th the following terms shall have the meanings herein: blood, refers to the whole blood, blood components and specific blood components.
    Cord blood refers to has nothing to do with maternal and neonatal blood volume and blood circulation, by the tied percentage of newborn umbilical cord placenta blood collected by the remote.
    Umbilical cord blood stem cell Bank, refers to the human hematopoietic stem cell transplantation for purposes, collection, processing, storage and providing the capacity of hematopoietic stem cells, and research strength of the special blood banks.
    66th before the implementation of these measures has been the establishment of blood banks shall, within nine months after the implementation of these measures, adjusted in accordance with this regulation. The provincial health administrative departments shall, in accordance with standards for auditing existing blood center blood center, does not meet the standards of blood center, shall order the rectification. Rectification is not qualified, the administrative departments for public health shall cancel the blood center settings.
    To meet the blood center standards of practice, according to blood Center standard auditing settings registered with the practice. 67th these measures shall come into force on March 1, 2006.
                              Under the measures for the administration of blood stations, on September 21, 1998 (provisional) repealed simultaneously.