Clinical Use Of Medical Institutions Management

Original Language Title: 医疗机构临床用血管理办法

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now

Read the untranslated law here: http://www.chinalaw.gov.cn/article/fgkd/xfg/gwybmgz/201207/20120700370461.shtml

Clinical use of medical institutions management

    (June 7, 2012 the Ministry of Health announced as of August 1, 2012, 85th) Chapter I General provisions

    First for the purpose of strengthening medical institutions management for clinical use and promote scientific and rational clinical use of blood, blood resources protection, guarantee safety and health care quality for clinical use, according to the People's Republic of China Law on blood donation, these measures are formulated. Second Ministry of health is responsible for the national supervision and administration of medical institutions of blood for clinical use.

    Health administrative departments under local people's Governments at or above the county level shall be responsible for the supervision and administration of medical institutions in the administrative area of blood for clinical use.

    Third medical institutions should strengthen the management of clinical blood use, use it as an important part of medical quality management, improve the organizational building, establish and improve the system, to develop and implement regulations and technical rules.

    Fourth article of the measures shall be applicable at all levels of the blood for clinical use and administration of medical institutions.

    Chapter II Organization and function

    Fifth Ministry of health set up a Committee of experts for clinical use, its main functions are:

    (A) assist the development of national systems for clinical use, technical specifications and standards;

    (B) to assist in guiding the national management and quality assessment for clinical use, promoting the advancement of clinical rational use of blood levels;

    (C) assist in the investigation and analysis of major security incidents for clinical use, and put forward opinions;

    (D) take on tasks assigned by the Ministry of health of other tasks related to management of blood for clinical use.

    The Ministry of Health established coordination mechanisms, good management of blood for clinical use, improving the level of clinical rational use of blood, ensure the quality of blood transfusion therapy.

    Article sixth of all provinces, autonomous regions and municipalities directly under the Administrative Department of health under the provincial quality control center for clinical use, responsible for medical institutions management for clinical use within guidance, evaluation and training and so on.

    Article seventh medical institutions should strengthen the Organization and management, clear responsibilities, perfect the management system.

    Legal representatives of medical institutions management responsibility for human clinical use. Eighth grade hospitals and Hospital Management Committee for clinical use should be established, in charge of the institutions management for clinical use. President Director or Associate Dean in charge of medical, and members from the medical sector, blood transfusions, anaesthesia, blood transfusion in the treatment of the main clinical departments, nursing departments, operating rooms and other section chiefs.

    Medical and clinical rational use of blood, blood transfusion departments are jointly responsible for day-to-day management.

    Other medical institution shall establish a management working group for clinical use, and specify (and) staff responsible for the day-to-day management.

    Nineth blood for clinical use management committees or clinical use of blood management working group shall perform the following duties:

    (A) related to conscientiously implement the clinical use of blood management laws, regulations, rules, technical norms and standards, the formulation of the clinical use of blood regulations and supervise the implementation of the management;

    (B) assessing the key departments of the clinical use of blood, key points and processes;

    (C) regular monitoring, analysis and evaluation of clinical blood situation, carry out quality assessment for clinical use, improving the level of clinical rational use of blood;

    (D) analysis of adverse events for clinical use, handling and improvements;

    (E) supervise and facilitate autologous blood transfusion, blood conservation and new technologies for blood transfusion;

    (F) medical institutions other tasks as assigned by the clinical use of blood.

    Tenth medical institutions shall, in accordance with the relevant provisions and needs blood transfusions or blood for clinical use, and according to their function, mandate, size, equipped with blood transfusion work suitable for professional and technical personnel, facilities, and equipment.

    Do not have conditions to set a blood transfusion or blood bank medical institutions shall arrange (and) staff is responsible for the clinical use of blood.

    11th blood transfusion branch and the blood bank's main responsibilities are:

    (A) the establishment of quality management system for clinical use, promoting the rational use of blood;

    (B) is responsible for formulating plans for clinical use, according to blood for blood warning information and inventory coordination of blood for clinical use of blood in hospitals;

    (C) responsible for blood reserve, warehousing, storage and issuing of work;

    (D) be responsible for transfusion-associated immunity blood testing;

    (E) participation in the promotion of autologous blood transfusion, blood conservation and new technologies for blood transfusion;

    (Vi) participation in special cases of transfusion therapy consultation, provide advice to the rational use of blood;

    (VII) participation in investigation of adverse events for clinical use;

    (H) according to clinical need, participation in treatment of blood-related technology;

    (I) medical institutions other tasks as assigned by the clinical use of blood.

    Chapter III administration of blood for clinical use

    12th medical institutions should strengthen the management of clinical blood use, establish and improve the management system and work specifications, and ensure implementation.

    13th medical institutions should use blood provided by the Administrative Department of public health designated blood stations.

    Medical institutions of scientific research in blood approved by the provincial health Administrative Department is responsible for.

    Medical institutions shall cooperate with the blood center blood inventory dynamic early warning mechanisms established to guarantee demand for clinical use and normal medical order.

    14th medical organizations should be scientific development of clinical blood use plans, establishing evaluation system of clinical rational use of blood, improve the level of clinical rational use of blood.

    15th medical institutions should be on the blood reserve, receive, receipt, storage, issue, and manage inventory alert, blood storage, transport in accordance with the relevant national standards and requirements. 16th medical institutions receive blood from blood banks, blood bag labels should be checked.

    Comply with the relevant national standards and requirements for blood storage, registration and according to different varieties, blood type and blood sampling date (or expiration), ordered separately stored in special storage facilities.

    Blood bag labels check the main elements are:

    (A) the name of the blood;

    (B) the number or bar code, blood group of blood donation;

    (C) blood;

    (D) date and time of sampling or preparation date and time;

    (E) the duration and time;

    (F) storage conditions.

    Blood bag labeling of qualified blood storage is prohibited.

    17th medical organizations should be checked in the distribution and transfusion of blood, and whether the medical staff is responsible for the collection of blood lead, distribution work. 18th medical blood run facilities should ensure that effective, whole blood, red blood cell storage temperature should be controlled at 2-6 platelet storage temperature should be controlled at 20-24. Blood holder, shall do a 24-hour monitoring of blood storage temperature records.

    Blood storage environment should meet the health standards and requirements.

    Article 19th medical personnel should earnestly implement the specification of clinical blood transfusion, master of clinical blood transfusion indications, according to the patient's condition and laboratory, testified on blood transfusion in conducting integrated assessments, development of blood transfusion therapy.

    20th medical institutions shall establish application management system for clinical use.

    The same day applied for preparation of blood in patients with less than 800 ml, by a mid-level professional and technical posts at or above qualifications apply to the physician, superior physician approved after the issuance, to be blood.

    Applications for patients with same day blood volume in 800 cc to 1600 CC, by a mid-level professional and technical posts at or above qualifications apply to the physician, examined by the superior doctors and Directors approved issue, to be blood.

    Patients with the same applications meet or exceed 1600 ml of blood a day, by a mid-level professional and technical posts at or above qualifications apply to the physician, after Directors approved issue, reported to the Health Department approval to be blood.

    Above the second and the third and fourth paragraphs shall not apply to emergency blood.

    Article 21st before the transfusion therapy, physicians should ask patients or their close relatives describe blood transfusion purposes, and risks, and clinical therapy, informed consent.

    Due to rescue dying patients need emergency blood transfusion, and views of the patient or his close relatives may not be acquired, upon approval by the head of the head of the medical institution or authorized, you can immediately implement blood transfusion therapy.

    22nd medical institutions shall actively promote the saving blood of new medical technologies.

    Level-III hospitals, conditions of the level-II hospital and hospital for autologous blood transfusion should be conducted, establish and improve the management system and technical specifications, to improve rational use of blood levels, to ensure quality and safety.

    Medical institutions should be mobilized to meet the conditions of the patients received autologous blood transfusion technology, improving therapeutic effects and safety of blood transfusion.

    Article 23rd medical institutions shall actively carry out blood component, to ensure quality and safety.

    24th medical institutions should strengthen the publicity and education work of free blood donation knowledge, standardized mutual blood donation.

    Blood Union donation of blood collection, testing and use of blood on blood provision and so on. 25th medical institutions shall, in accordance with the relevant State laws and regulations and norms established monitoring adverse events reporting system for clinical use.

    Clinical findings after adverse transfusion reactions, should be actively treating patients, timely reports to the relevant authorities, and to observe and record.

    Article 26th of all provinces, autonomous regions, municipalities directly under the Administrative Department of health under the development of clinical blood use safeguards and contingency plans, ensuring natural disasters, emergencies, such as a large number of wounded and the special cases, rare blood types and emergency blood supplies, and security. For emergency or avoid waste of blood with blood, on the premise of ensuring blood safety, approved by the health administrative departments of provinces, autonomous regions, municipalities, medical institutions can adjust blood.

    Specific programme formulated by the provincial health Administrative Department.

    27th of provinces, autonomous regions and municipalities health Administrative Department should strengthen the remote area medical institutions guaranteed work for clinical use, the Scientific Centre for planning and construction of blood banks and blood. Medical emergency blood work plan should be developed.

    In order to guarantee emergency blood, medical institutions can be a temporary blood, but you must meet the following conditions:

    (A) endanger the life of patients need blood transfusions;

    (B) timely delivery of blood where blood cannot, and does not regulate blood from other medical institutions in a timely manner, and other medical measures are not a substitute blood transfusion therapy;
(C) requirements for cross-matching blood and hepatitis b virus surface antigen and antibodies to hepatitis c virus and HIV antibodies and Treponema pallidum antibody detection capabilities;

    (D) comply with the blood collection and supply of relevant operating procedures and technical standards.

    Medical institutions shall in the blood in the 10th after interim report Department of the people's Governments above the county level health. 28th medical institutions shall establish a medical instrument management system for clinical use, ensure the clinical blood information objectivity, integrity and traceability.

    Indications for transfusion in patients with physicians should be assessed, blood transfusion and blood transfusion after evaluation of the particulars of medical clinical therapy, informed consent, blood transfusion records with medical records to save. 29th medical institutions shall set up training systems, strengthening of medical personnel training in clinical use of blood and blood donation knowledge and training into the continuing education for clinical use.

    LAN on the new medical personnel should be subject to pre clinical blood use training and assessment. 30th medical institutions shall set up departments and physicians evaluation and notification system for clinical use.

    Inclusion of blood for clinical use and assessment index system of medical staff in the Department.

    Prohibits the use of blood volume and income as the indexes of blood transfusion or blood banks work in the Department.

    Supervision and administration of the fourth chapter

    31st health administrative departments under local people's Governments at or above the county level shall strengthen the administrative supervision of the blood for clinical use in medical institutions.

    Article 32nd health administrative departments under local people's Governments at or above the county level shall establish evaluation system for clinical use in medical institutions, medical institutions on a regular basis to evaluate the clinical use of blood work. Article 33rd health administrative departments under local people's Governments at or above the county level should establish clinical rational use of blood rankings, released system.

    Medical institutions within the administrative area of blood for clinical use and irrational use of ranks, ranking released to the medical institutions within their respective administrative areas, and report to the superior administrative departments of public health.

    Article 34th health administrative departments under local people's Governments at or above the county level medical institutions should be incorporated into the evaluation index system of medical institutions for clinical use; the blood for clinical use as evaluation and evaluation index of medical institutions.

    The fifth chapter legal liability

    35th medical institution has any of the following circumstances, rectification by the people's Governments above the county level health administrative departments; fails to change, reprimanded and warned serious or serious consequences, to a fine of up to 30,000 yuan, the persons in charge and other direct liable persons shall be given administrative sanctions:

    (A) has not set up a Management Committee for clinical use or working groups;

    (B) do not develop clinical blood use plans within one year or no assessment and appraisal of the implementation of the plan;

    (C) failure to establish issuing and checking system for blood transfusion of blood;

    (D) failure to establish application management system for clinical use;

    (E) failure to establish medical personnel of the clinical use of blood and blood donation knowledge training system;

    (Vi) failure to establish departments and physicians evaluation for clinical use, and keeping the public informed of;

    (VII) income as an indicator of the assessment of blood transfusion or blood banks work in the Department;

    (VIII) other acts in violation of these regulations.

    36th medical institutions designated by the Administrative Department of public health of blood supply of blood, by the health Administrative Department under local people's Governments at or above the county level shall give a warning and fines of between 30,000 yuan in serious or grave consequences, the persons in charge and other direct liable persons shall be given administrative sanctions.

    37th medical institutions violate the provisions of these measures regarding emergency blood with blood, rectification by the people's Governments above the county level health administrative departments and give a warning in serious or serious consequences, fines of between 30,000 yuan, the persons in charge and other direct liable persons shall be given administrative sanctions.

    Article 38th medical institutions and medical personnel who violate these rules, do not meet the standards set by the State of blood for patients, by the health Administrative Department under local people's Governments at or above the county level shall order rectification pose risk to patient health, and should be handled according to relevant laws and regulations of the State and the persons in charge and other direct liable persons shall be given administrative sanctions.

    39th local health administrative departments at and above the county level shall not perform supervisory duties in accordance with these measures, resulting in serious consequences, directly responsible in charge and other direct liable persons shall be given demerit, demotion, dismissal, fired on them.

    40th medical institutions and medical personnel who violate regulations for clinical use, constitute a crime, criminal responsibility shall be investigated according to law.

    The sixth chapter supplementary articles 41st these measures shall come into force on August 1, 2012. Announced on January 5, 1999, by the Ministry of health institutions management approach for clinical use (trial) be repealed simultaneously.