The health ministry about "the medical treatment organization blood for clinical use management measures (draft) the notice of the public to solicit their opinions

Health ministry of China www.moh.gov.cn the 2012-01-10 13:48:11

        In order to strengthen the management of medical institution blood for clinical use, ensure the quality and clinical blood use medical security, the effective use of blood resources to promote science reasonable blood use, according to the law of the People's Republic of the act, our organization draft the measures for the administration of medical institutions blood for clinical use (draft). Now to solicit comments from the public. The public by the following ways and the way feedback:

        1. On the Chinese legal system information nets (web site: http://www.chinalaw.gov.cn), into the home page on the left of the "department regulations draft opinion solicitation system" comments.

        2. The health ministry website login (web site: http://www.moh.gov.cn), into the "comments" click "" the medical treatment organization blood for clinical use management measures (draft) for public opinion".

        3. Email: weisheng@chinalaw.gov.cn

        4. The communication address: the xizhimen, xicheng district, Beijing south road no. 1, the state department of health policy and regulations FaGuiChu; Zip code: 100044.

        The deadline for feedback February 13, 2012

January 9,

Measures for the administration of medical institutions blood for clinical use (drafts)

The first chapter is always

        Article 1 in order to strengthen the management of medical institution blood for clinical use, ensure the quality and clinical blood use medical security, the effective use of blood resources to promote science reasonable blood use, according to the law of the People's Republic of the act, these measures.

        Article 2 the term "clinical blood use management, it is to show medical institutions in order to ensure medical safety and treatment for patients with purpose, for clinical use whole process management, promote the clinical science, reasonable, safe and effective blood use.

        Article 3 these measures shall be applicable in clinical blood use at various levels and of various kinds of medical institution.

        Article 4 the medical institutions shall strengthen the management of clinical blood use, as the medical quality management and continuously improve the important content, perfect the organization construction, establish and perfect the post responsibility system, make and carry out the relevant rules and regulations.

        Article 5 health medical institution shall be responsible for the supervision and administration of blood for clinical use. The local people's government at or above the county level public health administrative departments shall be responsible for the administrative area medical institutions of the supervision and administration of the blood for clinical use.

        Article 6 the medical institution for the legal representative of the first person in clinical use. A medical institution shall not establish clinical blood use reasonable responsibility system.

The second chapter organization and responsibility

        Article 7 the state of health expert committee established clinical use. The main responsibility is as follows:

        (1) to assist develop blood for clinical use of the relevant laws, regulations and rules, technical specifications and standards.

        (2) guidance national blood for clinical use work, help organize business training.

        (3) to the national blood for clinical use situation analysis and evaluation.

        (4) participate in clinical blood use a major security investigation and handling of the incident.

        (5) undertake assigned by the administrative department of public health of the task.

        Article 8 the people's government at the provincial level public health administrative department at the provincial level expert committee was established clinical use. The main responsibility is as follows:

        (1) to implement the blood for clinical use of the relevant laws, regulations and rules, technical specifications and standards.

        (2) guidance in the administrative areas blood for clinical use work, help organize business training.

        (3) is responsible for clinical use within their respective administrative areas situation analysis and evaluation Price.

        (4) participate in the administrative areas in blood for clinical use a major security investigation and handling of the incident.

        (5) undertake assigned by the administrative department of public health of the task.

        Article 9 the medical institutions shall establish a management committee of blood for clinical use, the chairman of the committee is composed of the vice President of the medical treatment charge or as, members shall include medical management, clinical, and blood transfusion, anesthesia, nursing, inspection, hospital infection, pharmaceutical and other professional experts. Clinical blood use management committee shall perform the following functions:

        (1) based on clinical use of management laws, regulations, rules, technical specifications and standards, etc, make the institutions of blood for clinical use management system and operation procedures, implementation and supervision.

        (2) monitoring, to analyze and evaluate the quality of blood and blood for clinical use institution.

        (3) investigation and analysis of the clinical blood use security incident, put forward the intervention and improvement measure.

        (4) guide to blood transfusions and new technology protection.

        (5) to determine the clinical blood use key departments, and the key link and process, relevant departments, and clear responsibility personnel, and supervise implementation.

        Article 10 medical institutions according to their function, task, scale, equipped with and blood transfusion work adaptation of the professional technical personnel, facilities, equipment.

        Article 11 level 3 general hospital, shall set up a blood transfusion, blood transfusions families main responsibilities are as follows:

        (1) the establishment of a blood transfusion, quality management system, and ensure that effective operation.

        (2) develop blood for clinical use reserves plan, according to blood stations pumping blood early warning information coordination clinical blood use; Development and promotion of autologous blood transfusion.

        (3) is responsible for the blood reservation, inventory, storage, delivery work.

        (4) responsible for blood transfusion related immune hematology detection, ensure the quality of detection.

        (5) participate in difficult cases of blood transfusion consultation to cooperate with the investigation of the clinical use of adverse events, for rational clinical blood use provide consultation.

        (6) according to the clinical treatment need for therapeutic compounds from blood, replacement and related technology.

        Article 12 the two-level comprehensive hospital shall set up a blood bank, the blood bank main responsibilities are as follows:

        (1) the establishment of a blood transfusion management system and technical operation procedures.

        (2) develop blood for clinical use reserves plan.

        (3) is responsible for the blood reservation, inventory, storage, delivery work.

        (4) responsible for blood transfusion compatibility test, quality assurance testing.

        Article 13 the other medical institutions can, according to the medical service needs, set up a blood transfusion or blood Banks, or arrange the specialist is responsible blood for clinical use, work responsibilities are the same as above.

        Article 14 a medical institution shall set up blood and blood bank stocks early warning mechanism, ensure the blood for clinical use demand and normal medical order.

        Chapter 3 clinical blood use management

        Article 15 a medical institution shall draw up blood for clinical use plan, to the implementation of the plan to examine and evaluation.

        Article 16 medical institutions must use by provincial people government designated by the administrative department of public health of blood supply of blood.

        Article 17 a medical institution shall establish blood inventory management system, including blood reservation, receive check, inventory, storage, outbound and inventory warning content, and ensure that the blood storage, transportation to meet the relevant national standards and requirements.

        Article 18 the medical institution for clinical useand may do not conform to the standards prescribed by the state's blood for clinical.

        Article 19 a medical institution shall apply for establishment blood for clinical use classification management system.

        One application for HP to meet or exceed 10 units, the patients in the administrative offices group discussion, department chief signed, the blood transfusion division (blood bank) audit, submitted to the medical department for approval. Emergency rescue except with blood.

        The same patients total blood use 24 hours more than 10 units and more than the blood for, by a blood transfusion division (blood bank) medical department for the record, and the blood for clinical use management committee evaluation of blood.

        Article 20 the medical institutions shall establish a blood transfusion issue and check the management system.

        Article 21 physicians should be controlled strictly clinical transfusion indications, according to patients with illness and laboratory testing indexes, the blood transfusion testify, a comprehensive evaluation for blood transfusion treatment.

        Article 22 in a blood transfusion before treatment, doctors should to patients or their agent that blood transfusion purpose, way and the risk, and signed the clinical transfusion treatment informed consent form ".

        Dying patients because of the rescue, and other special case needs to emergency blood transfusion, and can't get patients or their close relatives of the opinion, the medical institution authorized person in charge of, or the person in charge of the approved, can implement a blood transfusion treatment.

        Article 23 a medical institution shall actively carry out blood conseration techniques, establish autologous blood transfusion, perioperative blood transfusion protection technology management system, to meet the conditions of the patients actively carry out relevant technology, and will effect evaluation index into department.

        Article 24 a medical institution shall establish a blood transfusion adverse events monitoring report system. Clinical departments find blood transfusion adverse reactions, shall actively cure patients, promptly to blood transfusion division (blood bank) report, and ready to observe and record.

        Article 25 a medical institution shall for clinical use information of the whole process monitoring, ensure that the blood of the information can be traceable.

        Article 26 a medical institution shall set up an emergency blood transfusion management system, including the coordination blood transfusion, emergency numerous transfusions, not the same type a blood transfusion, etc.

        Article 27 the medical institution for emergency blood use need temporary collection of blood, must meet the following conditions:

        (1) medical establishment is located in remote areas and can't get blood stations to provide in time the blood.

        (2) endanger the patient life, no other alternative treatment, need a blood transfusion.

        (3) have cross matching hepatitis b virus blood and test surface antigen and antibody of third hepatitis virus, HIV antibodies and syphilis helicoid antibody ability.

        A medical institution shall collect blood in temporary within 10 days after the case report to the local people's government at or above the county level public health administrative department.

        Article 28 a medical institution shall establish clinical blood use medical documents management system. Doctors should patients will be a blood transfusion indications of evaluation, blood transfusion process and effect assessment after blood transfusion situation credited to medical records; The clinical transfusion treatment informed consent form ", "blood transfusion record form with the medical record preservation. Other blood for clinical use related medical documents for at least 10 years.

        Blood for clinical use of medical documents type and format of provinces, autonomous regions, municipalities directly under the central government health administrative department of the state council.

        Article 29 a medical institution shall establish full blood for clinical use and blood donation knowledge training system, will a blood transfusion knowledge training into education project to continue. Admission to new medical staff shall conduct pre-job training and assessment knowledge of blood transfusion. Will a blood transfusion, medical personnel into resident (specialist) training plan.

        Article 30 a medical institution shall establish department and physician blood for clinical use and evaluation system of public. Will be blood for clinical use department and medical personnel individual work evaluation indicator system.

        Article 31 for emergency use blood or to avoid waste, ensure the safety in blood, under the premise of via setting above the level of public health administrative department agree, medical institutions can adjust blood between each other. Specific measures by provincial responsible for health administration.

The fourth chapter supervision and management

        Article 32 the health ministry to the national medical institutions responsible for the quality and safety of blood for clinical use guide, evaluation and supervision inspection.

        The health administrative departments at the county level or above shall strengthen the clinical use of medical institutions management work of supervision and administration, regular blood for clinical use of medical institutions conduct supervision and examination work.

        Article 33 the public health administrative department and its authorized agencies or organizations for medical institutions work blood for clinical use and inspection, a medical institution shall cooperate with, and may not refuse or obstruct, shall not provide false materials.

        Article 34 the medical institution violates relevant blood management laws, regulations and administrative rules, it shall be dealt with according to law.

Chapter 5 is attached

        Article 35 the way to the definition of the following terms:

        Blood for clinical use is to point to whole blood, the blood stations offer blood composition and special blood composition, and medical institutions and autologous blood transfusion technology activities for the clinical treatment of collected blood and blood components.

        Coordination is to point to by blood transfusions for both sides ABO blood group phase and cross matching blood consistency or not in agreement of blood transfusion principle.

        Not the same type blood transfusion is to point to in an emergency situation, type O blood donor to the type O blood transfusion use by the principle, or ABO blood group the same, Rh blood donors accept negative by Rh blood transfusion positive principles.

        Blood conservation is to point to in the treatment of different stages take different technology or joint use a variety of technologies for the protection of the blood quality and quantity, reduce blood loss, less to lose with blood, or even lose the purpose of foreign blood.

        Article 36 the measures by the ministry of public health is responsible for the explanation.

        Article 37 the measures in the date of promulgation. Jan. 5, 1999 promulgated "medical institutions blood for clinical use management measures (trial) shall be repealed at the same time.