Article 1 In order to strengthen the management of clinical blood use in medical institutions, to promote the use of blood in a scientific and reasonable manner, to protect the blood resources, and to ensure the safety of clinical blood use and quality of medical care, according to the "People's Republic of China Blood Donation Act", these measures are formulated.
Article 2 The Ministry of Health is responsible for the supervision and management of clinical blood use in medical institutions across the country. Local people's governments at or above the county level health administrative departments are responsible for the supervision and management of clinical blood use in medical institutions in their administrative regions.
Article 3 medical institutions should strengthen the management of clinical blood use, as an important element of medical quality management, improve the organization, establish and improve the job responsibility system, develop and implement the relevant rules and regulations and technical procedures.
Article IV These measures apply to all levels and types of medical institutions of clinical blood management.
Chapter II organization and responsibilitiesArticle Ministry of Health set up a clinical blood expert committee, its main responsibilities are:
(a) to assist in the development of the national clinical blood related systems, technical specifications and standards; (b) to assist in guiding the national management and quality assessment of clinical blood, and to promote the improvement of rational clinical blood level (C) to assist in the investigation and analysis of major clinical blood safety incidents, put forward treatment opinions; (D) to undertake the Ministry of Health assigned to other tasks related to the management of clinical blood. The Ministry of Health to establish a coordinating mechanism to do a good job in the management of clinical blood, improve the level of reasonable clinical use of blood to ensure the quality of blood transfusion therapy.Article 6 provinces, autonomous regions, municipalities directly under the Central People's Government, the health administrative department set up provincial clinical blood quality control center, responsible for the jurisdiction of the medical institutions of clinical blood management guidance, evaluation and training.
Article 7 medical institutions should strengthen the organization and management, clear job responsibilities, improve the management system.
The legal representative of the medical institution is the first person responsible for clinical blood management.Article VIII secondary 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, 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 special (part-time) staff responsible for the daily management.Article 9 Clinical blood management committee or clinical blood management working group shall perform the following duties:
(a) conscientiously implement the clinical blood management of relevant laws, regulations, rules, technical specifications and standards, the development of the organization's rules and regulations of clinical blood management and supervise the implementation of the organization; (b) assess the determination of the clinical use of blood (C) regular monitoring, analysis and assessment of clinical blood use, clinical blood quality assessment work to improve the level of rational clinical use of blood; (D) analysis of clinical blood use of adverse events, and put forward measures to deal with and improve; (E) guidance and promote the development of autologous blood transfusion and other blood protection and transfusion of new technologies; (F) bear the responsibility for Other tasks related to clinical blood use assigned by medical institutions.Article 10 medical institutions should be set up in accordance with the relevant provisions of the clinical blood transfusion or blood bank, and according to their own functions, tasks, scale, and blood transfusion work with appropriate professional and technical personnel, facilities and equipment.
Medical institutions that do not have the conditions to set up blood transfusion or blood bank, should be arranged for full-time (part-time) staff responsible for clinical blood work.Article 11 blood transfusion and blood bank's main responsibilities are:
(a) the establishment of clinical blood quality management system, to promote the rational use of blood in the clinic; (b) is responsible for the development of clinical blood reserve plan, according to the blood supply of early warning information and the hospital's blood inventory to coordinate the clinical use of blood; (c) is responsible for the booking, warehousing, storage, distribution of blood. (C) Booking, warehousing, storage and distribution of blood; (D) Immunohematological testing related to blood transfusion; (E) Participating in the promotion of autologous transfusion and other blood protection and transfusion of new technologies; (F) Participating in the consultation of special transfusion treatment cases and providing consultation on rational use of blood in the clinic; (G) Participating in the investigation of adverse events in clinical use of blood; (H) Participating in the development of blood therapy according to the needs of clinical therapy; (I) Participating in the development of clinical blood treatment programs in accordance with the needs of clinical treatment. (H) according to the clinical treatment needs, to participate in the development of blood treatment-related technology; (IX) to undertake other tasks related to the clinical use of blood assigned by the medical institutions. Chapter III clinical blood managementArticle 12 medical institutions should strengthen clinical blood management, establish and improve the management system and work standards, and ensure the implementation.
Article 13 medical institutions shall use the blood station designated by the administrative department of health to provide blood.
Medical institutions research blood by the local provincial health administrative department is responsible for the 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 14 medical institutions shall scientifically formulate clinical blood plan, establish a clinically rational use of blood evaluation system, to improve the level of clinically rational use of blood.
Article 15 medical institutions shall manage the blood booking, receiving, warehousing, storage, discharge, and inventory warning to ensure that the blood storage, delivery in accordance with the relevant state standards and requirements.
Article 16 medical institutions to receive the blood sent by the blood station, the blood bag label should be checked. In line with the relevant national standards and requirements of the blood into storage, registration; and according to the different varieties, blood type and date of blood collection (or expiration date), respectively, in order to be stored in special storage facilities.
The main contents of the blood bag labeling check is: (a) the name of the blood station; (b) blood donation number or bar code, blood type; (c) blood varieties; (d) the date and time of blood collection or preparation date and time; (e) the expiration date and time; (f) storage conditions. It is prohibited to store blood with substandard bag labels.Article 17 medical institutions shall check the blood distribution and transfusion, and designate medical personnel responsible for the receipt and distribution of blood.
Article 18 medical institutions shall ensure the effective operation of blood storage facilities, whole blood, red blood cells should be controlled at a storage temperature of 2-6 ° C, platelet storage temperature should be controlled at a temperature of 20-24 ° C. Blood storage custodian should be done to store the temperature of the blood 24-hour monitoring records. The environment of blood storage should meet the hygiene standards and requirements.
Article 19 medical personnel shall conscientiously implement the technical specifications for clinical blood transfusion, strictly grasp the clinical indications for blood transfusion, according to the patient's condition and laboratory test indicators, blood transfusion indications for a comprehensive assessment, and the development of transfusion treatment program.
Article 20 medical institutions shall establish a clinical blood application management system.
The same patient a day to apply for blood less than 800 milliliters, with intermediate or higher qualifications of professional and technical positions by the physician to apply for approval of the superior physician issued before the preparation of blood. The same patient a day to apply for the preparation of 800 ml to 1600 ml of blood, by the intermediate or higher professional and technical qualifications of the physician to submit an application, by the supervisor of the physician audit, department director approval and issuance, before the preparation of blood. If the amount of blood for the same patient reaches or exceeds 1600 ml in a single day, the blood can be prepared only after the application is made by the physician with the qualification of intermediate or above professional and technical position, and the approval and issuance by the head of the department is reported to the medical department for approval. The provisions of the second, third and fourth paragraphs above do not apply to emergency blood.Article 21 before the blood transfusion treatment, the physician shall explain to the patient or his close relatives the purpose of blood transfusion, the way and the risk, and sign the informed consent for clinical blood transfusion treatment.
Emergency blood transfusion is needed to rescue patients with life-threatening conditions, and cannot obtain the views of the patient or his next of kin, approved by the head of the medical institution or authorized by the person in charge of blood transfusion can be carried out immediately after the treatment.
Article 22 medical institutions should actively promote the use of blood-saving new medical technology.
Tertiary hospitals, hospitals with the conditions of the second level and maternal and child health centers should carry out autologous blood transfusion technology, establish and improve the management system and technical specifications, improve the level of rational use of blood to ensure the quality and safety of medical care. Medical institutions should mobilize eligible patients to receive autologous blood transfusion technology, improve the effectiveness and safety of blood transfusion therapy.Article 23 medical institutions shall actively promote the component blood transfusion, to ensure medical quality and safety.
Article 24 medical institutions shall strengthen the publicity and education of the knowledge of gratuitous blood donation, and standardize the work of mutual blood donation.
Blood stations are responsible for the collection and testing of blood for mutual blood donation, as well as the allocation of blood for use.Article 25 medical institutions shall, in accordance with relevant state laws and regulations and norms to establish clinical blood adverse events monitoring and reporting system. Clinical blood transfusion adverse reactions found, should actively treat patients, timely report to the relevant departments, and make observations and records.
Article 26 Provinces, autonomous regions, municipalities directly under the Central People's Government, the health administrative department shall formulate clinical blood safeguard measures and contingency plans to ensure that natural disasters, emergencies and other large numbers of casualties and special cases, scarce blood type and other emergency blood supply and safety.
For emergency blood or to avoid the waste of blood, under the premise of ensuring blood safety, approved by the provincial, autonomous regions and municipalities directly under the Central People's Government of the administrative department of health, blood can be transferred between medical institutions. Specific programs developed by the provincial health administrative departments.Article 27 Provinces, autonomous regions, municipalities directly under the Central People's Government, the health administrative department shall strengthen the remote areas of medical institutions to ensure the clinical use of blood, scientific planning and construction of the central blood bank and blood storage points.
Medical institutions should 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 location of the 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 the cross-matching and hepatitis B virus surface antigen, hepatitis C virus surface antigen and blood transfusion of blood, and other medical measures can not replace the blood transfusion treatment. Surface antigen of hepatitis B virus, hepatitis C virus antibody, HIV antibody and syphilis spirochete antibody detection capacity; (d) comply with the blood collection and supply of relevant operating procedures and technical standards. Medical institutions should be in the temporary collection of blood within 10 days after the situation reported to the health administrative department of the people's government at or above the county level.Article 28 medical institutions shall establish a 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 efficacy of the evaluation of the situation recorded in the medical record; clinical blood transfusion treatment informed consent, blood transfusion record sheet with the medical record.
Article 29 medical institutions shall establish a training system to strengthen the training of medical personnel in clinical use of blood and knowledge of blood donation, clinical use of blood-related knowledge training into the content of continuing education. Newly employed medical personnel shall receive pre-service training and assessment of clinical blood-related knowledge.
Article 30 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 AdministrationArticle 31 the local people's governments at or above the county level, the health administrative department shall strengthen the supervision and inspection of the clinical use of blood in medical institutions within the administrative region.
Article 32 local people's governments at or above the county level, the health administrative department shall establish a medical institution clinical blood evaluation system, regular evaluation of the work of medical institutions clinical blood.
Article 33 local people's governments at or above the county level, the 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 for the ranking, will be ranked to the administrative region of the medical institutions announced, and reported to the higher administrative department of health.
Article 34 local people's governments at or above the county level, the health administrative department shall incorporate the clinical use of blood into the medical institutions assessment index system; the clinical use of blood as a medical institution assessment, evaluation of important indicators.
Chapter V Legal LiabilityArticle 35 medical institutions have one of the following circumstances, the people's governments at or above the county level by the health administrative department ordered to make corrections within a specified period of time; overdue, to notify the criticized and warned; the circumstances are serious or serious consequences, may be sentenced to 30,000 yuan fine, and the responsible supervisors and other directly responsible personnel shall be punished according to law. Other directly responsible personnel shall be punished according to law:
(a) failure to set up a clinical blood management committee or working group; (b) failure to draw up a clinical blood use plan or within one year, the implementation of the plan is not evaluated and assessed; (c) failure to establish a system for the distribution of blood and transfusion verification; (d) failure to establish the management of clinical blood use system; (e) failure to establish a system of clinical blood use management; (f) failure to establish a system of medical staff clinical blood use; (h) failure to establish a system of clinical blood use management; (i) failure to establish a system of clinical blood use; (j) failure to set up a system of clinical blood use; (F) did not establish the department and physician clinical blood evaluation and publicity system; (G) the economic income as the blood transfusion department or blood bank work assessment indicators; (H) violation of this approach to other behavior.Article 36 medical institutions using blood without the blood station designated by the administrative department of health supply, by the local people's government at or above the county level of the administrative department of health to give a warning and impose a fine of less than 30,000 yuan; the circumstances are serious or cause serious consequences, the supervisory personnel responsible and other directly responsible personnel shall be given punishment according to law.
Article 37 medical institutions in violation of these measures on emergency blood collection, by the people's governments at or above the county level of the health administrative department shall order rectification within a specified period of time, be given a warning; the circumstances are serious or cause serious consequences, impose a fine of 30,000 yuan, and the competent person in charge of the person in charge of the person in charge of the person in charge of the person in charge of the person in charge of the person in charge of the person in charge of the person in charge of the person in charge of the person in charge of the person in charge of the person in charge of the person in charge of the person in charge of the person in charge of the person in charge of the person.
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 government at or above the county level of the administrative department of health shall order rectification; to the patient's health caused by the damage 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 directly responsible personnel shall be given punishment according to law. Responsible persons in charge and other directly responsible persons shall be given sanctions in accordance with the law.
Article 39 the local health administrative departments above the county level did not fulfill the supervision duties in accordance with the provisions of this Measures, resulting in serious consequences, on the directly responsible persons in charge and other directly responsible personnel shall be given a major demerit, demotion, dismissal, expulsion and other administrative sanctions.
Article 40 medical institutions and their medical staff violate the provisions of clinical blood management, constituting a crime, shall be investigated for criminal responsibility.
Chapter VI Supplementary ProvisionsArticle 41 These measures shall come into force on August 1, 2012 . The Ministry of Health on January 5, 1999 announced "the management of clinical blood use in medical institutions (for trial implementation)" shall be repealed simultaneously.