Examination and approval of the establishment of central blood station

In order to ensure blood safety, standardize the practice of blood stations and promote the construction and development of blood stations, these measures are formulated in accordance with the Blood Donation Law.

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The term "blood station" as mentioned in these Measures refers to a public health institution that collects and provides blood for clinical use for non-profit purposes.

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Blood stations are divided into general blood stations and special blood stations.

General blood stations include blood centers, central blood stations and central blood banks.

Special blood banks include umbilical cord blood hematopoietic stem cell banks and other types of blood banks approved 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 local people's governments.

The construction and development of blood stations should be incorporated into the local national economic and social development plan.

Article 5

According to the allocation of medical resources and the demand for clinical blood use, the Ministry of Health formulates the guiding principles for the establishment of blood collection and supply institutions nationwide, and is responsible for guiding the construction planning of blood stations nationwide.

The health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall, in accordance with the provisions of the preceding paragraph, formulate plans for the establishment of blood stations in their respective administrative areas in combination with the actual situation of population, medical resources, blood demand for clinical use and local regional health development plans, and report them to the people's government at the same level for approval and the Ministry of Health for the record.

Article 6

The Ministry of Health is responsible for the supervision and management of blood stations throughout the country.

The health administrative department of the local people's government at or above the county level shall be responsible for the supervision and management of blood stations within their respective administrative areas.

Article 7

Encourage and support blood application research and technological innovation, as well as international scientific and technological exchanges and cooperation related to clinical blood transfusion. Section 1 Establishment, Responsibilities and Practice Registration

Article 8 Blood centers shall be located in municipalities directly under the central government, provincial capital cities and capital cities of autonomous regions. Its main responsibilities are:

(a) in accordance with the requirements of the health administrative department of the provincial people's government, to carry out the recruitment of unpaid blood donors, blood collection and preparation, clinical blood supply and medical blood business guidance within the prescribed scope;

(two) to undertake the quality control and evaluation of blood stations in provinces, autonomous regions and municipalities directly under the central government;

(three) to undertake business training and technical guidance of blood stations in provinces, autonomous regions and municipalities directly under the central government;

(four) to undertake the task of centralized blood testing in provinces, autonomous regions and municipalities directly under the central government;

(five) to carry out scientific research related to blood;

(six) to undertake the tasks assigned by the administrative department of health.

Blood center should have high comprehensive quality evaluation technical ability.

Article 9 A central blood station shall be established in a city divided into districts. Its main responsibilities are:

(a) in accordance with the requirements of the health administrative department of the provincial people's government, to carry out the recruitment of unpaid blood donors, blood collection and preparation, clinical blood supply and medical blood business guidance within the prescribed scope;

(two) to undertake the quality control of blood storage in the blood supply area;

(three) to control the quality of the central blood bank within their respective administrative areas;

(four) to undertake the tasks assigned by the administrative department of health.

If a blood center has been established in a municipality directly under the central government, a provincial capital city or an autonomous region, no central blood station will be established; If a blood center has not yet been established, capacity building can be strengthened on the basis of the established blood center to perform the duties of the blood center.

Article 10 A central blood station shall be located in a county-level general hospital outside the service scope of the central blood station. Its main duties are, in accordance with the requirements of the health administrative department of the provincial people's government, to carry out the recruitment of unpaid blood donors, the collection and preparation of blood, the supply of blood for clinical use and the guidance of blood for medical use within the prescribed scope.

Article 11 The administrative department of health of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall, according to the establishment plan of blood collection and supply institutions, approve the establishment of blood stations and report them to the Ministry of Health for the record.

The health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for clarifying the supervisory responsibilities of the health administrative departments at all levels within their respective jurisdictions and the responsibilities of blood stations; According to the actual blood supply distance and capacity, it is responsible for defining the blood collection and supply service area of the blood station, and the blood collection and supply service area may not be restricted by administrative regions.

Blood centers and central blood stations shall not be set up repeatedly in the same administrative area.

Blood stations and plasmapheresis stations shall not be located in the same county-level administrative area.

Article 12 The health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall uniformly plan and set up centralized testing laboratories, and gradually implement them.

Article 13 To carry out blood collection and supply activities, a blood station shall apply to the health administrative department of the local people's government of the province, autonomous region or municipality directly under the Central Government for practice registration and obtain a practice license for the blood station. Without obtaining the "blood station practice license", blood collection and supply activities shall not be carried out.

The validity period of the blood station practice license is three years. Article 14 When applying for industrial and commercial registration, a blood station must fill in the Application for Practice Registration of Blood Station.

After accepting the application for registration of blood station practice, the health administrative department of the provincial people's government shall organize relevant experts or entrust a technical department to conduct a technical review of the applicant according to the Standards for Quality Management of Blood Station and the Standards for Quality Management of Blood Station Laboratory, and submit a technical review report.

The health administrative department of the people's government at the provincial level shall, within 20 days after receiving the technical review report of experts or technical departments, review the application matters. Those who pass the examination shall be registered to practice, and a unified blood station practice license and its copy shall be issued to the Ministry of Health.

Fifteenth in any of the following circumstances, registration shall not be granted:

(a) the technical review of the "Standards for Quality Management of Blood Stations" is unqualified;

(two) the technical review of the "Quality Management Standards for Blood Station Laboratories" is unqualified;

(three) the blood quality test results are unqualified.

If the examination is unqualified and the practice registration is refused, the practice registration organ shall notify the applicant in writing of the results and reasons.

Article 16 Three months before the expiration of the practice license of a blood station, the blood station shall re-register its practice, and submit the Application for Re-registration of Blood Station and the Practice License of Blood Station.

The health administrative department of the provincial people's government shall conduct an audit according to the business development, supervision and inspection of the blood station, and continue to practice if it passes the audit. If it fails to pass the audit, it shall be ordered to make rectification within a time limit; If the inspection is still unqualified after rectification, the practice license of blood station shall be cancelled.

Blood stations that have not gone through the re-registration procedures or have been cancelled the Practice License for Blood Stations shall not continue to practice.

Article 17 Where a blood station establishes a branch in a prescribed blood collection and supply service area, it shall report to the health administrative department of the people's government of a province, autonomous region or municipality directly under the Central Government for approval; The establishment of fixed blood collection points (rooms) or mobile blood collection vehicles shall be reported to the health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government for the record.

In order to ensure the needs of clinical blood use within the jurisdiction, blood stations can set up blood storage points to store blood. Blood storage points should have the necessary storage conditions and be approved by the provincial health administrative department. Article 18 A blood station cancelled according to the plan shall apply to the practice registration authority for cancellation of practice registration within 15 days after cancellation. If it fails to be handled within the time limit, it shall be cancelled by the practice registration authority according to the procedure, and the "Practice License for Blood Station" and its copy and full set of seals shall be recovered.

Section 2 Practice

Article 19 The practice of blood stations shall abide by relevant laws, administrative regulations, rules and technical specifications.

Article 20 A blood station shall make plans for blood collection, preparation and supply according to the clinical blood demand of medical institutions to ensure the safety, timeliness and effectiveness of clinical blood use.

Twenty-first blood stations should carry out publicity on blood donation without compensation.

When recruiting blood donors, blood stations should provide safe, hygienic and convenient conditions and good services for blood donors.

Twenty-second blood stations shall conduct health examination and blood collection for blood donors in accordance with relevant state regulations.

Blood stations should check and register the identity of blood donors before taking blood.

It is forbidden to collect blood from impostors. Excessive and frequent blood collection is strictly prohibited.

Blood stations shall not collect raw plasma for the production of blood products.

Twenty-third blood donors should show their true identity certificates as required.

No unit or individual may organize an impostor to donate blood.

Twenty-fourth blood stations should follow the principle of voluntary and informed consent and fulfill the obligation to inform blood donors.

A blood station shall establish a blood donor information confidentiality system to keep blood donors confidential.

Twenty-fifth blood stations should establish a reporting procedure, blood donation screening and elimination system for blood donors who are prone to blood-borne diseases.

Twenty-sixth blood stations to carry out blood collection and supply business should implement total quality management, strictly abide by the "China blood transfusion technology operating rules", "blood station quality management norms" and "blood station laboratory quality management norms" and other technical norms and standards.

A blood station shall establish a post responsibility system for personnel and a work system related to the management of blood collection and supply, and regularly check and assess the implementation and implementation of various rules and regulations and post responsibility system for personnel at all levels.

Twenty-seventh blood station staff should meet the post qualification requirements, and accept the on-the-job training and assessment of blood safety and business, and receive the on-the-job training certificate before taking up their posts.

Blood station staff should receive no less than 75 hours of continuing education every year.

On-the-job training and assessment shall be organized and implemented by the health administrative department of the people's government at or above the provincial level. Article 28 The work records of each business post of a blood station shall be true in content, complete in items, standardized in format, legible in handwriting, recorded in time and signed by operators.

When the contents of the records need to be changed, the original records should be kept clear and readable, and the contents, reasons and dates of the changes should be indicated, and the changes should be signed.

The original records of blood donation, testing and blood supply shall be kept for at least ten years, unless otherwise stipulated by laws, administrative regulations and the Ministry of Health.

Article 29 A blood station shall ensure that the blood collected is tested by a laboratory with blood testing qualification.

Blood stations should deal with unqualified or discarded blood in strict accordance with relevant regulations.

Thirtieth blood stations should establish laboratory indoor quality control and interstitial evaluation system to ensure that reagents, sanitary equipment, instruments and equipment can achieve the expected results in the use process.

The blood station laboratory shall be equipped with necessary biosafety equipment and facilities, and the staff shall be trained in biosafety knowledge.

Article 31 Blood samples shall be kept for two years after the whole blood or blood components are used.

Thirty-second blood stations should strengthen disinfection and isolation management to prevent and control the spread of infectious diseases.

Medical wastes generated by blood stations should be treated in accordance with the Regulations on the Management of Medical Wastes, and recorded and signed to avoid cross-infection.

Article 33 When a blood station and its personnel performing their duties discover the epidemic situation of legal infectious diseases, they shall report to the relevant departments in accordance with the Law on the Prevention and Control of Infectious Diseases and the provisions of the Ministry of Health.

Article 34 The packaging, storage and transportation of blood shall meet the requirements of quality management standards of blood stations. Blood packaging bags should be marked with:

The name of the blood station and its license number;

(2) blood donation number or barcode;

(3) blood type;

(4) blood variety;

(5) Date and time of blood collection or date and time of preparation;

(6) Effective date and time;

(7) Storage conditions.

Thirty-fifth blood stations should ensure that the quality of blood distributed conforms to the relevant national standards, and its variety, specification, quantity, activity and blood type are correct; Blood that has not been tested or failed to pass the test shall not be provided to medical institutions.

Thirty-sixth blood stations should establish quality complaints, adverse reaction monitoring and blood recovery system.

Thirty-seventh blood stations should strengthen the quality supervision of their blood storage points, ensure the storage conditions and ensure the quality of blood storage; Store and exchange blood according to clinical needs.

Article 38 Drugs, in vitro diagnostic reagents and disposable sanitary equipment used in blood stations shall comply with the relevant provisions of the state.

Thirty-ninth blood stations shall, in accordance with the relevant provisions, carefully fill in the statistical statements of blood collection and supply institutions and report them promptly and accurately.

Article 40 A blood station shall formulate an emergency plan for sudden disasters and ensure the implementation of the plan from the aspects of blood source, management system, technical ability and equipment conditions. In case of emergency, obey the dispatch of the health administrative department of the people's government at or above the county level.

Article 41 Where it is necessary to transfer blood of special blood type from other provinces, autonomous regions and municipalities directly under the Central Government, it shall be approved by the health administrative department of the provincial people's government.

The deployment of blood due to scientific research or special needs shall be approved by the health administrative department of the provincial people's government.

Those who provide blood and special blood components to overseas medical institutions for humanitarian and life-saving needs shall go through the formalities in strict accordance with relevant regulations.

Forty-second blood donated without compensation must be used for clinical purposes and may not be bought or sold.

The residual plasma in blood stations shall be solved 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 production units of blood products.

Forty-third blood stations must strictly implement the provisions of the state on the disposal of abandoned blood and the confidential disposal of blood after donating blood to blood donors who are at risk of contracting blood-borne diseases.

Article 44 The surplus plasma of blood stations and the income from blood preparation due to scientific research or special needs shall all be used for blood reimbursement of unpaid blood donors, and blood stations shall not be used for other purposes. Article 45

According to the actual situation of population distribution, health resources and clinical hematopoietic stem cell transplantation demand in China, the Ministry of Health has formulated the planning and principles for the establishment of specialized blood banks such as umbilical cord blood hematopoietic stem cell bank in China.

The state does not approve the establishment of special blood stations such as umbilical cord blood hematopoietic stem cell bank for profit.

Article 46

To apply for the establishment of a special blood bank such as umbilical cord blood hematopoietic stem cell bank, an application shall be submitted to the health administrative department of the local provincial people's government in accordance with the conditions stipulated by the Ministry of Health. The health administrative department of the provincial people's government shall organize the preliminary examination and report it to the Ministry of Health.

The Ministry of Health shall, in accordance with the order of application, approve the establishment of special blood stations such as umbilical cord blood hematopoietic stem cell bank.

Article 47

Those who practice in special blood stations such as cord blood hematopoietic stem cell bank shall apply to the health administrative department of the local provincial people's government for registration.

The health administrative department at the provincial level shall organize relevant experts and technical departments to conduct technical examination and professional acceptance of the applicant in accordance with the basic standards and technical specifications of the special blood bank such as umbilical cord blood hematopoietic stem cell bank formulated by these measures and the Ministry of Health. Those who pass the examination shall be issued with a "Practice License for Blood Stations", and the business carried out shall be indicated. The validity period of the blood station practice license is three years.

Without obtaining the Practice License for Blood Station, the business of collecting and supplying umbilical cord blood hematopoietic stem cells shall not be carried out.

Article 48

Special blood stations, such as umbilical cord blood hematopoietic stem cell bank, which continue to practice after the expiration of the practice license of the blood station, shall apply to the health administrative department of the provincial people's government for re-practice registration three months before the expiration of the practice license of the blood station.

Article 49

The practice of special blood stations such as umbilical cord blood hematopoietic stem cell bank shall meet the following requirements in addition to the practice requirements of general blood stations in Section 2 of Chapter II of these Measures:

(1) Practicing in accordance with the basic standards and technical specifications of special blood stations such as umbilical cord blood hematopoietic stem cell bank stipulated by the Ministry of Health;

(two) the collection of special blood components such as umbilical cord blood must meet the relevant requirements of medical ethics and follow the principle of voluntary and informed consent. Umbilical cord blood hematopoietic stem cell bank must sign an informed consent form with the donor audited by the practice registration authority;

(3) Special blood stations such as cord blood hematopoietic stem cell bank can only provide cord blood hematopoietic stem cells to medical institutions with experience and foundation in hematopoietic stem cell transplantation and equipped with sterile wards and other necessary facilities required for hematopoietic stem cell transplantation;

(four) for humanitarian and life-saving purposes, it is necessary to provide special blood components such as umbilical cord blood hematopoietic stem cells to overseas medical institutions, and shall go through the formalities in strict accordance with the provisions of the state on the management of human genetic resources;

(5) Umbilical cord blood and blood with other special components must be used clinically. Article 50 The health administrative department of the people's government at or above the county level shall perform the following duties for blood collection and supply activities:

(a) to formulate management measures for the storage and distribution of blood for clinical use, and supervise the implementation;

(two) to supervise and inspect the health administrative departments at lower levels to perform the duties of blood station management as stipulated in these Measures;

(three) to conduct daily supervision and inspection of the practice of blood stations within their jurisdiction, and organize irregular sampling inspection of the quality of blood collection and supply;

(four) to supervise and inspect the clinical blood supply activities within the jurisdiction;

(five) to investigate and deal with violations of these measures according to 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 unpaid blood donors.

Article 52 The administrative department of health of the people's government at the provincial level shall evaluate, supervise and inspect the implementation of the relevant provisions of blood stations within its jurisdiction, the proportion of unpaid blood donation, the service quality of blood collection and supply, professional guidance, personnel training and technical ability of comprehensive quality evaluation, and announce the results to the public in accordance with the relevant provisions of the Ministry of Health.

Article 53 The Ministry of Health regularly evaluates, supervises and inspects the implementation of relevant regulations, the proportion of unpaid blood donation, the service quality of blood collection and supply, business guidance, personnel training, technical ability of comprehensive quality evaluation, and quality management of special blood stations such as umbilical cord blood hematopoietic stem cell bank, and announces the results to the public.

Article 54 When conducting supervision and inspection, the health administrative department has the right to request relevant information, and the blood station shall not conceal, obstruct or refuse it.

The administrative department of health has the obligation to keep confidential the information provided by blood stations, except as otherwise provided by laws, administrative regulations or departmental rules.

Fifty-fifth health administrative departments and their staff shall not have the following acts when performing their duties:

(1) approving the establishment, practice registration or change registration of persons who do not meet the statutory requirements, or approving the establishment, practice registration or change registration of blood stations beyond their functions and powers;

(two) to meet the statutory conditions and blood station planning, not to approve its establishment, practice registration or change of registration; Or not approving its establishment, practice registration or change registration within the statutory time limit;

(3) Failing to perform the duties of supervision and management of blood stations;

(four) other acts in violation of these measures.

Fifty-sixth health administrative departments of people's governments at all levels shall establish a reporting and complaint mechanism for the supervision and management of blood stations.

The administrative department of health has the obligation to keep confidential the informants and complainants.

Article 57 The state implements the system of blood quality monitoring and verification, the system of quality management of blood stations and the system of technical evaluation of laboratory quality management of blood stations. The specific measures shall be formulated separately by the Ministry of Health.

Fifty-eighth blood stations in any of the following circumstances, the health administrative department of the provincial people's government shall cancel its practice license for blood stations:

(1) Failing to apply for re-registration of blood station practice license upon expiration;

(2) Failing to collect and supply blood within one year after obtaining the practice license of blood station. Fifty-ninth one of the following acts is illegal blood collection, and the health administrative department of the local people's government at or above the county level shall be punished in accordance with the relevant provisions of Article 18 of the Blood Donation Law; If the case constitutes a crime, criminal responsibility shall be investigated according to law:

(a) without approval, the establishment of blood stations to carry out blood collection and supply activities;

(two) the eliminated blood stations are still carrying out blood collection and supply activities;

(3) Carrying out blood collection and supply activities after obtaining the approval of establishment but without obtaining the practice license of the blood station, or carrying out blood collection and supply activities without re-registration after the expiration of the practice license of the blood station;

(4) leasing, lending, leasing, lending, altering or forging the practice license of a blood station to carry out blood collection and supply activities.

Article 60 Where a blood station sells blood donated without compensation, the health administrative department of the local people's government at or above the county level shall punish it in accordance with the relevant provisions of Article 18 of the Blood Donation Law; If a crime is constituted, criminal responsibility shall be investigated according to law.

Article 61 If a blood station commits any of the following acts, the health administrative department of the local people's government at or above the county level shall give it a warning and order it to make corrections; If it fails to make corrections within the time limit, or causes blood-borne diseases or other serious consequences, the responsible person in charge and other directly responsible personnel shall be given administrative sanctions according to law; If the case constitutes a crime, criminal responsibility shall be investigated according to law:

(a) to carry out business activities beyond the items, contents and scope of practice registration;

(two) the personnel engaged in blood collection and supply work have not obtained the relevant post qualifications or practice registration;

(three) the blood testing laboratory has not obtained the corresponding qualification for testing;

(4) collecting raw plasma or buying or selling blood without authorization;

(five) before collecting blood, failing to carry out health examination and testing for blood donors in accordance with the requirements of health examination for blood donors promulgated by the state;

(six) to take blood from imposters and those who fail the health examination, and to take excessive and frequent blood samples;

(seven) in violation of the operating rules of blood transfusion technology and related quality norms and standards;

(8) failing to fulfill the obligation of informing blood donors and blood donors with special blood components before blood collection;

(nine) unauthorized alteration, damage or failure to save the work record;

(ten) the drugs, in vitro diagnostic reagents and disposable sanitary products used do not meet the relevant provisions of the state;

(eleven) repeated use of disposable sanitary equipment;

(twelve) failing to deal with unqualified or discarded blood according to relevant regulations;

(thirteen) unauthorized deployment of blood with other provinces, autonomous regions and municipalities directly under the central government;

(14) Providing blood or special blood components to overseas medical institutions without approval;

(fifteen) failing to keep blood samples in accordance with the provisions;

(sixteen) the umbilical cord blood hematopoietic stem cell bank and other special blood stations violate the relevant technical specifications.

If a blood station causes blood-borne diseases or other serious consequences, the administrative department of health may cancel its practice license of blood station at the same time of administrative punishment.

Article 62 If the packaging, storage and transportation of blood for clinical use do not meet the hygienic standards and requirements stipulated by the state, the health administrative department of the local people's government at or above the county level shall order it to make corrections and give it a warning.

Article 63 If a blood station, in violation of regulations, provides blood to a medical institution that does not meet the standards prescribed by the state, the health administrative department of the people's government at or above the county level shall order it to make corrections; If the circumstances are serious, resulting in the spread of blood-borne diseases or serious risk of spread, rectification shall be made within a time limit, and the directly responsible person in charge and other responsible personnel shall be given administrative sanctions according to law; If a crime is constituted, criminal responsibility shall be investigated according to law.

Sixty-fourth health administrative departments and their staff in violation of the relevant provisions of these measures, one of the following circumstances, by the superior administrative organs or supervisory organs in accordance with the relevant provisions of the blood donation law, administrative licensing law shall be ordered to make corrections; If the circumstances are serious, the directly responsible person in charge and other directly responsible personnel shall be given administrative sanctions according to law; If the case constitutes a crime, criminal responsibility shall be investigated according to law:

(1) Failing to conduct examination according to the prescribed procedures, so that unqualified applicants are allowed;

(2) granting permission to unqualified applicants or making a decision on granting permission beyond the statutory authority;

(three) practicing fraud in the process of licensing examination and approval;

(four) the application for establishment and practice registration that meets the requirements is not accepted;

(5) Failing to make a licensing decision on the qualified application within the statutory time limit;

(six) do not perform their supervisory duties according to law, or poor supervision has caused serious consequences;

(seven) in the implementation of these measures, there are abuses of power, dereliction of duty, bribery and other acts. Article 65

The meanings of the following terms in these Measures:

Blood refers to whole blood, blood components and special blood components.

Umbilical cord blood refers to placental blood collected from the distal umbilical cord of newborns, which has nothing to do with the blood volume and blood circulation of pregnant women and newborns.

Umbilical cord blood hematopoietic stem cell bank refers to a special blood bank with considerable research strength, which aims at human hematopoietic stem cell transplantation and has the ability to collect, process, preserve and provide hematopoietic stem cells.

Article 66

Blood stations 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 people's government at the provincial level shall review the existing blood stations according to the blood station standards, and shall order rectification within a time limit if it does not meet the blood station standards. If the rectification is still unqualified, the health administrative department shall cancel the establishment of the blood center. Those who meet the practice standards of the central blood station shall be examined and registered according to the standards of the central blood station.

Article 67

These Measures shall come into force as of March 6, 2006. The Measures for the Administration of Blood Stations (Provisional) promulgated on September 2 1998+0 shall be abolished at the same time.

Notice of the Ministry of Health on Amending Article 31 of the Measures for the Administration of Blood Stations

Weifa [2009] No.28

Health bureaus of all provinces, autonomous regions and municipalities directly under the Central Government, and Health Bureau of Xinjiang Production and Construction Corps:

After research, it is decided to amend Article 31 of the Measures for the Administration of Blood Stations: "The storage period of whole blood samples for blood testing shall be the same as the validity period of whole blood; The storage period of serum (plasma) samples should be half a year after the expiration of whole blood. " Revised as: "The storage period of blood samples is two years after the whole blood or blood components are used."