Article 1: These Measures are formulated in accordance with the Law of the People's Republic of China on Blood Donation in order to strengthen the management of clinical blood use in medical institutions, promote scientific and rational use of blood in the clinic, protect blood resources, and safeguard the safety of clinical blood use and the quality of medical care.
Second___The Ministry of Health is responsible for the supervision and management of clinical blood use in medical institutions nationwide. The health administrative departments of local people's governments at or above the county level are responsible for the supervision and management of clinical blood use in medical institutions in their administrative regions.
Article 3 ___ medical institutions shall strengthen the clinical blood management, as an important element of medical quality management, improve the organization, establish and improve the post responsibility system, develop and implement relevant regulations and technical procedures.
Article 4___These measures are applicable to all levels and types of medical institutions of clinical blood management.
Chapter II: Organization and Responsibilities
Article 5: The Ministry of Health has set up an Expert Committee on Clinical Blood Use, whose main responsibilities are:
(1) to assist in the formulation of national clinical blood use-related systems, technical specifications and standards;
(2) to assist in guiding the national clinical blood use management and quality assessment, and to promote the improvement of rational use of blood in clinical practice;
(3) to assist in the clinical blood use management and quality assessment, and to promote the improvement of rational use of blood in clinical practice. p>(3) assisting in the investigation and analysis of major safety incidents related to clinical blood use, and putting forward opinions on their handling;
(4) undertaking other tasks related to the management of clinical blood use assigned by the Ministry of Health.
The Ministry of Health establishes a coordinating mechanism for the management of clinical blood use, improves the level of rational clinical use of blood, and ensures the quality of blood transfusion treatment.
Article 6 ___ Provinces, autonomous regions and municipalities directly under the Central People's Government of the health administrative department to set up provincial clinical blood quality control centers, is responsible for the jurisdiction of the medical institutions of clinical blood management guidance, evaluation and training work.
Article 7___Medical institutions shall strengthen the organization and management, clear job responsibilities, and improve the management system.
The legal representative of a medical institution is the first person responsible for clinical blood management.
Article VIII above the second level of hospitals and maternal and child health centers should be set up clinical blood management committee, responsible for the organization's clinical management of reasonable use of blood. Chairman of the president or vice president in charge of medical as members of the medical department, blood transfusion, anesthesiology, blood transfusion therapy to carry out the main clinical departments, nursing departments, operating rooms and other departments responsible for the composition. Medical and blood transfusion department **** the same responsible for clinical rational use of blood daily management.
Other medical institutions should set up clinical blood management working group, and designate a full-time (part-time) staff responsible for the daily management.
Article IX ___ clinical blood management committee or clinical blood management working group shall perform the following duties:
(1) conscientiously implement the clinical blood management of relevant laws, regulations, rules, technical norms and standards, formulate the rules and regulations of the institution's clinical blood management and supervise the implementation of the rules and regulations;
(2) assessment to determine the clinical blood of the focus of the department, the key links and processes;
(3) regularly monitoring, analyzing and assessing clinical blood use, carrying out quality evaluation of clinical blood use, and improving the level of rational clinical blood use;
(4) analyzing the adverse events of clinical blood use, and proposing measures for treatment and improvement;
(5) guiding and promoting the development of autologous transfusion and other blood protection and new blood transfusion technologies;
(6) Undertake other tasks related to clinical blood use assigned by medical institutions.
Article 10___Medical institutions shall set up blood transfusion departments or blood banks in accordance with the relevant regulations and clinical blood demand, and shall be equipped with professional and technical personnel, facilities and equipments appropriate to the work of blood transfusion in accordance with their own functions, tasks and scales.
If a medical institution does not have the conditions to set up a blood transfusion department or blood bank, it shall arrange for full-time (part-time) personnel responsible for clinical blood work.
Article 11___The main duties of the Blood Transfusion Department and the Blood Bank are:
(1) to establish a quality management system for clinical blood use, and to promote the rational use of blood in the clinic;
(2) to be responsible for formulating a reserve plan for clinical blood use, and to coordinate the use of blood for clinical use in accordance with the early warning information on the supply of blood by the blood stations and the hospital's blood inventory;
(3) to be responsible for the booking, storage, and issuance of blood;
(3) to be responsible for blood booking, storage, (d) To be responsible for transfusion-related immunohematological testing;
(e) To participate in the promotion of autologous transfusion and other blood protection and new technology of blood transfusion;
(f) To participate in the consultation of special transfusion therapy cases and to provide consultation on rational use of blood in the clinic;
(g) To participate in the investigation of adverse events of clinical blood use;
(h) To participate in the investigation of adverse events of clinical blood use in accordance with the needs of clinical treatment;
() (viii) Participate in the development of blood treatment-related technologies according to the needs of clinical treatment;
(ix) Undertake other tasks related to clinical blood use assigned by the medical institutions.
Chapter III Management of Clinical Blood Use
Article 12___ The medical institutions shall strengthen the management of clinical blood use, establish and improve the management system and work norms, and ensure the implementation.
Article XIII ___ medical institutions shall use the health administrative department designated blood stations to provide blood.
Medical institutions research blood by the local provincial health administrative department is responsible for approval.
Medical institutions shall cooperate with the blood station to establish a blood inventory dynamic early warning mechanism to protect clinical blood demand and normal medical order.
Article XIV of the medical institutions shall scientifically formulate clinical blood plan, the establishment of clinical rational use of blood evaluation system, to improve the level of clinical rational use of blood.
Article 15 The medical institutions shall manage the blood booking, receiving, warehousing, storage, discharge and inventory warning, etc., to ensure that the blood storage, delivery in accordance with the relevant national standards and requirements.
Article 16 After receiving blood sent by blood stations, medical institutions shall check the labels of blood bags. The blood that meets the relevant state standards and requirements shall be put into storage and registered; and according to the different varieties, blood types and dates of blood collection (or expiration date), they shall be stored in special storage facilities in an orderly manner.
The main contents of the blood bag label checking are:
(a) the name of the blood station;
(b) the blood donation number or bar code, blood type;
(c) the blood varieties;
(d) the date and time of the blood collection or the preparation date and time;
(e) validity date and time;
(f) storage conditions.
It is prohibited to store blood with substandard bag labels.
Article 17 The medical institutions shall check the blood at the time of blood distribution and transfusion, and designate the medical personnel responsible for the receipt and distribution of blood.
Article 18 The blood storage facilities of the medical institutions shall ensure effective operation, and the storage temperature of whole blood and red blood cells shall be controlled at 2-6℃, and the storage temperature of platelets shall be controlled at 20-24℃. The custodian of blood storage shall make a record of 24-hour monitoring of blood storage temperature. The environment of blood storage shall comply with the health standards and requirements.
Article 19 The medical personnel shall conscientiously implement the clinical blood transfusion specifications, strictly grasp the clinical indications for blood transfusion, according to the patient's condition and laboratory test indexes, blood transfusion indications for comprehensive assessment, and formulate the transfusion treatment plan.
Article 20 Medical institutions shall establish a clinical blood application management system.
The same patient to apply for blood less than 800 milliliters a day, by the intermediate or higher professional and technical qualifications of the physician to apply, the superior physician approved and issued before the preparation of blood.
If the same patient applies for blood preparation of 800 ml to 1600 ml in one day, the physician with the qualification of intermediate or above professional and technical positions shall make the application, and the blood preparation shall be made only after the examination by the superior physician and the approval and issuance by the head of the department.
If the amount of blood for the same patient reaches or exceeds 1,600 ml in one day, it shall be applied by the physician with the qualification of intermediate or above professional and technical position, and then approved and issued by the head of the department, and then reported to the medical department for approval before the blood is prepared.
The provisions of the second, third and fourth paragraphs above do not apply to emergency blood.
Article 21 Before blood transfusion treatment, the physician shall explain to the patient or his/her close relatives the purpose, mode and risk of blood transfusion, and sign the informed consent for clinical blood transfusion treatment.
The need for emergency blood transfusion for the rescue of patients with life-threatening conditions, and can not obtain the views of the patient or his or her next of kin, approved by the head of the medical institution or the authorized person in charge of the implementation of blood transfusion therapy can be immediately.
Article 22___Medical institutions shall actively implement new medical technologies that conserve blood.
Tertiary hospitals, second-tier hospitals where available, and maternity and childcare centers shall carry out autologous blood transfusion techniques, establish and improve management systems and technical specifications, improve the level of rational use of blood, and ensure medical quality and safety.
Medical institutions should mobilize eligible patients to accept autologous blood transfusion technology, and improve the effectiveness and safety of blood transfusion therapy.
Article 23 Medical institutions shall actively promote component blood transfusion to ensure medical quality and safety.
Article 24 Medical institutions shall incorporate gratuitous blood donation into the content of health education, proactively and widely publicize it to patients, their families and the society, encourage healthy citizens of age to voluntarily participate in gratuitous blood donation, and enhance the public's knowledge of and participation in gratuitous blood donation.
Article 25 Medical institutions shall establish a monitoring and reporting system for adverse events in clinical blood use in accordance with relevant national laws and regulations and norms. Clinical discovery of adverse reactions to blood transfusion, should actively treat patients, timely report to the relevant departments, and make observations and records.
Article 26 The health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall formulate clinical blood safeguard measures and contingency plans to ensure the supply and safety of blood for natural disasters, emergencies and other large numbers of casualties and special cases, and emergency blood supply for scarce blood types.
Due to emergency blood or to avoid the waste of blood, under the premise of ensuring blood safety, approved by the health administrative department of the people's government of the provinces, autonomous regions and municipalities directly under the central government, blood can be transferred between medical institutions. Specific programs developed by the provincial health administrative departments.
Article 27 of the provincial, autonomous regions, municipalities directly under the Central People's Government, the health administrative department shall strengthen the remote areas of medical institutions to ensure clinical blood, scientific planning and construction of central blood bank and blood storage.
Medical institutions shall develop emergency blood work plan. In order to ensure emergency blood, medical institutions can temporarily collect blood, but must also meet the following conditions:
(a) endangering the lives of patients, in urgent need of blood transfusion;
(b) the local blood station can not provide blood in a timely manner, and can not be timely transfer of blood from other health care institutions, and other medical measures can not be replaced by transfusion of blood treatment;
(c) have the ability to carry out cross-matching and Hepatitis B virus blood transfusions, the blood transfusion of patients in remote areas, and the blood transfusion of patients in remote areas. (C) have the ability to carry out cross-matching and testing of surface antigen of hepatitis B virus, antibody to hepatitis C virus, antibody to HIV and antibody to syphilis spirochete;
(D) comply with the operating procedures and technical standards related to blood collection and supply.
Medical institutions shall report the situation to the health administrative department of the people's government at or above the county level within 10 days after the temporary collection of blood.
Article 28 The medical institutions shall establish clinical blood medical document management system to ensure that the clinical blood information is objective, true, complete and traceable. Physicians shall assess the patient's indications for blood transfusion, blood transfusion process and post-transfusion evaluation of the efficacy of medical records; informed consent for clinical blood transfusion therapy, blood transfusion record sheet with the medical records.
Article 29 Medical institutions shall establish a training system to strengthen the training of medical personnel in clinical blood use and knowledge of blood donation, clinical blood use related knowledge training into continuing education. Newly employed medical personnel shall receive pre-service clinical blood-related knowledge training and assessment.
Article 30 of the medical institutions shall establish departments and physicians clinical blood evaluation and publicity system. Clinical use of blood into the department and medical personnel work assessment index system.
Prohibit the use of blood and economic income as the blood transfusion department or blood bank work assessment indicators.
Chapter IV Supervision and Management
Article 31 The health administrative departments of the local people's governments at or above the county level shall strengthen the supervision and inspection of the clinical use of blood in medical institutions within the administrative region.
Article 32 The health administrative departments of the local people's governments at or above the county level shall establish a system for evaluating the clinical use of blood in medical institutions, and regularly evaluate the clinical use of blood in medical institutions.
Article 33 of the local people's governments at or above the county level health administrative department shall establish a clinically reasonable use of blood ranking, announcement system. Clinical blood use and unreasonable use of medical institutions within the administrative region, such as ranking, the ranking will be announced to the medical institutions within the administrative region, and reported to the higher level of health administration.
Article 34 of the local people's governments at or above the county level, the health administrative department shall incorporate the clinical blood use of medical institutions into the assessment index system of medical institutions; clinical blood use as an important indicator of the assessment and evaluation of medical institutions.
Chapter V Legal Liability
Article 35 If a medical institution has one of the following circumstances, the health administrative department of the people's government at or above the county level shall order it to make corrections within a certain period of time; if it fails to make corrections after the expiration of the period of time, it shall be notified of the criticisms, and shall be warned; if the circumstances are serious or if serious consequences result, it may be fined not more than RMB 30,000 yuan, and the competent persons in charge of the responsible persons and other persons directly in charge of the responsible persons shall be given punishment according to the law.
(1) Failure to establish a clinical blood use management committee or working group;
(2) Failure to draw up a clinical blood use plan or failure to evaluate and assess the implementation of the plan within one year;
(3) Failure to establish a system of blood issuance and transfusion verification;
(4) Failure to establish a system of management of application for clinical blood use;
( (E) failure to establish a system for training medical personnel in clinical use of blood and knowledge of non-remunerated blood donation;
(F) failure to establish a system for evaluating the clinical use of blood by departments and physicians and making public announcements;
(G) taking economic income as an assessment indicator for the work of blood transfusion departments or blood banks;
(H) other violations of the Measures.
Article 36 If a medical institution uses blood supplied by a blood station that has not been designated by the administrative department of health, the administrative department of health of the local people's government at or above the county level shall give a warning and impose a fine of not more than RMB 30,000 yuan; if the situation is serious or serious consequences are caused, the supervisory personnel in charge of the situation and other personnel directly responsible shall be given sanctions according to law.
Article 38 Medical institutions and their medical personnel in violation of the provisions of this Law, the blood does not meet the national standards for patients, by the local people's governments at or above the county level of the administrative department of health ordered to make corrections; to the patient's health caused by damage to the state shall be dealt with in accordance with the relevant state laws and regulations, and on the supervisory personnel in charge of the responsibility and other personnel directly responsible for the punishment given in accordance with the law.
Article 39 The local health administrative departments at or above the county level fail to fulfill their supervisory duties in accordance with the provisions of these Measures, resulting in serious consequences, the directly responsible officers in charge and other directly responsible personnel shall be given administrative sanctions such as demerit, demotion, dismissal, expulsion and so on according to law.
Article 40___ Medical institutions and their medical personnel violate the provisions of clinical blood management, constituting a crime, shall be investigated for criminal responsibility.
Chapter VI ___ Rules
Article 41 These Measures shall come into force on August 1, 2012 . The "Measures for the Administration of Clinical Blood Use in Medical Institutions (for Trial Implementation)" promulgated by the Ministry of Health on January 5, 1999 shall be repealed at the same time.