National health and family planning commission concerning the human organ transplant physician training and the relevant documents such as the measures for the administration of the notification

The national health and family planning commission of the People's Republic of China

The 2016-10-08

The medical hair [2016] no. 49

 

Provinces, autonomous regions and municipalities directly under the central government health and family planning commission, the xinjiang production and construction corps health bureau:

According to the reform of administrative examination and approval of the state council work, human organ transplant physicians practicing qualification of administrative examination and approval matters devolved to the family planning administrative department of public health at the provincial level. To do a good job after approval down about, in order to strengthen the management of human organ transplant physicians, on the basis of the professional medical act, the human organ transplant ordinance, by commission formulated the "measures for the management of human organ transplant physicians training and recognition (try out)" and "human organ transplant physicians training base basic requirements" (which can be downloaded from the national health and family planning commission web site). Hereby printed and distributed to you, please comply with them.

Provincial family planning administrative departments for public health shall in accordance with the requirements of this circular formulate concrete implementation plan, carry out relevant work earnestly, and in accordance with the law and strengthen the things according to regulation regulation afterwards.

Attachment: 1. The human organ transplant physicians training and recognition management approach (trial)

2. The human organ transplant physicians training base basic requirements (trial)

The national health and family planning commission

On September 25, 2016

Attachment 1

Training and recognition measures for the management of human organ transplant physicians

(trial)

The first chapter the general

Article 1 with a view to strengthening the human organ transplant physician team construction, regulate human organ transplant physician training and management, continuous improvement and improve the level of human organ transplant technology and medical quality, to ensure medical safety, on the basis of the professional medical act, the human organ transplant ordinance and the state council about cancellation and adjustment of a batch of the decision of the administrative examination and approval items, etc "(guo fa [2014] 27), etc., are formulated.

Article 2 the term "human organ transplant physicians, refers to the human organ transplant physicians training base (hereinafter referred to as the training base) to complete the training, the training base or the third party entrusted by the family planning administrative department of public health at the provincial level, after assessment is eligible for the family planning administrative department of public health at the provincial level determination, obtain corresponding human organ transplant physicians and qualification, to be independent to carry out the corresponding human organ transplant medical practitioners.

Article 3 the state health and family planning commission is responsible for coordinating the human organ transplant physician training and recognition, to guide and supervise the provincial health administrative departments of family planning work. Entrust the conditional industry organizations and units to carry out the following work:

(a) according to actual needs to formulate training plan;

(2) organizes human organ transplant physicians training syllabus and the teaching material;

(3) to guide training base construction and management;

(4) assessment standards and requirements.

Article 4 the provincial family planning administrative department of health is responsible for the jurisdiction of human organ transplant physicians practicing qualification, supervision and guidance of the training and examination work of training base within their respective jurisdictions.

The second chapter training human organ transplant physicians

Article 5 the physician physician qualification to apply for human organs for transplants, ought to attend training.

Article 6 of the training base is responsible for the qualification to apply for human organs for transplants for training of doctors. Training content including human organ donation and transplantation related laws and regulations and specification requirements, ethical and moral education, human organ transplant technology theory and clinical practice skills, etc.

Article 7 the family planning administrative department of public health at the provincial level shall be based on the basic requirements for human organ transplant physicians training base designated training base, submitted to the national health and family planning commission for record and open to the society.

Article 8 the training base of dynamic management, cycle for 4 years. Family planning administrative department of public health at the provincial level shall be 6 months before the end of the cycle to evaluate the overall training base work, determine the work continue to bear the training base of the unit.

Article 9 of the training base in human organ transplantation technology training for physicians (hereinafter referred to as trainers) by various training base conditions according to this method is preferred to recommend, the provincial family planning administrative department of public health organization expert assessment.

Article 10 training base should establish and perfect rules and regulations and procedures, clear responsibilities and management requirements, strengthen the management of training teachers. Strictly in accordance with the unified state of training syllabus and the teaching material training plan and plan, establish training physician) (hereinafter referred to as the cords from physicians training files, completes the participation from physicians of theoretical knowledge and clinical practice skills training, to ensure the training quality and effect.

Article 11 training supervisor shall earnestly perform their duties, in strict accordance with the training programs and plans to launch training, ensure that the time needed for training and training effects.

Article 12 the training mentor period is 4 years. Training base, training mentor number should not be less than 5 people, each training tutor each instruction and training doctors shall not exceed 2 people.

Article 13 the training base should be in 2 months prior to the start of the training work, release to the industry training plan, training places, registration way and other relevant information.

Article 14 the application to attend training of physician, shall be at the same time satisfy the following conditions:

(a) hold the physician's practice certificate, for clinical practice category, the scope of practice for pediatric (direction of pediatric surgery), surgical or practice location for tertiary hospitals;

(2) for nearly three years, there was no more than secondary fully responsible or primary responsibility of medical accidents, no violation of medical and health related laws, regulations, rules and ethical principles and human organ transplant technology, management norms of behavior;

(3) the doctor professional technical position qualifications, 5 years working experience in human organ transplant clinical or 8 years working experience in related surgery or clinical pediatric surgery.

Article 15 the cords from the physician registration is not subject to regional restriction. Ginseng from physicians to training base, they shall apply for registration, submit the application materials, training base shall verify the application materials, according to the training plan according to the public the principle of fairness, merit, two-way choice decide whether to accept the cords from the physician.

Article 16 the training base should be in recruiting work shall, within 15 working days from the date of the end to the local provincial family planning administrative department of public health shall submit acceptable information from physicians, provincial family planning administrative departments for public health shall promptly to the national health and family planning commission for the record.

Article 17 the human organ transplant physicians training period for one year. Within the prescribed period of time did not complete the training according to the requirement from physicians, training time can be postpone, total training time shall not exceed two years.

Article 18 the cords from the physician shall, in accordance with the human organ transplant physician training curriculum and teaching requirements, complete the following tasks:

(a) complete the human organ transplant related foundation course, the relevant laws and regulations, ethics, including the human organs for transplants anatomy, immune, physiology, pathology, pharmacology, human organ transplant surgery technology, and human organ transplant complications and postoperative complications of the diagnosis and treatment, etc.;

(2) in the liver, kidneys, heart, lung, pancreas and small intestine transplantation training physician should be completed in training under the guidance of a mentor to participate in the corresponding number of transplant were not less than 10 cases, 15 cases, 5 cases, 5 cases, 1 case, 1 case, participate in the management of the number of cases of not less than 15 cases, 20 cases, 8 cases, 8 cases, 2 cases, 2 cases;

(3) the cords from the physician should be completed in training under the guidance of tutor at least 5 cases citizens after the death of the donation of body organs.

Article 19 the completion of training shall be subject to examination and culture physicians. Assessment of the training base or the family planning administrative department of public health at the provincial level shall entrust the third party to organize the implementation. Specific be determined by the provincial family planning administrative department of public health.

Article 20 the cords from physician including the process of examination and graduation examination.

(a) process assessment is a prerequisite for graduation examination, is the training base of dynamic comprehensive evaluation of the participation physician training process, the content including ethics, attendance, daily clinical practice ability, training target completion and enter the business of learning situation, etc.

(2) graduation examination including theory and clinical practice ability of examination. Theory to shut of examination. Clinical practice ability appraisal shall be conducted by three or more trainers on-site audit score, at least 1 for another training base for training teachers. The participation of physicians tutors should withdraw.

The third chapter of human organ transplant physician qualification

Article 21. At the same time meet the following conditions, by the provincial family planning administrative department of public health that human body organ transplant physician qualification:

(a) hold the physician's practice certificate, for clinical practice category, the scope of practice for pediatric (direction of pediatric surgery), surgical or practice location for tertiary hospitals;

(2) for nearly three years, there was no more than secondary fully responsible or primary responsibility of medical accidents, no violation of medical and health related laws, regulations, rules and ethical principles and human organ transplant technology, management norms of behavior;

(3) the doctor professional technical position qualifications, 5 years working experience in human organ transplant clinical or 8 years working experience in related surgery or clinical pediatric surgery;

(4) the training base for training and test qualified.

Article 22 the family planning administrative department of public health at the provincial level shall be the human organ transplant physicians practicing qualification to apply for review. And shall accept the application materials are complete and handling within 20 workdays as of the date of decision. Can't make a decision, with the approval of the provincial, head of the family planning administrative department of public health, could be extended by 10 days, and the reason to inform the applicant of the extension.

Article 23 the approved obtain related human organ transplantation of physician qualification, by provincial family planning administrative department of public health in the physician's practice certificate.

Article 24 the measures announced before work in the human organ transplantation, and at the same time meet the following conditions of medical practitioners, can be directly to the local provincial family planning administrative department of public health to apply for that. The term see article 22 of these measures. In conformity with the conditions, the provincial family planning administrative departments for public health shall be identified, and indicate in the "physicians practicing certificate".

(a) professional site for a corresponding hospital diagnosis and treatment subject of human organs for transplants, with associate chief physician and professional technical position qualifications above;

(2) the nearly 8 years continuous work in the human organ transplant related clinical;

(3) the past five years is so as to implement transplant surgery doctors reach regulation number and organs for transplant survival rate in accordance with the relevant state technical management specification.

1. Apply for liver transplant physicians practicing qualification, nearly 5 years accumulated so as to implement a liver transplant surgery doctors shall be not less than 30 cases;

2. The application of kidney transplant physicians practicing qualification, nearly 5 years accumulated so as to implement the kidney transplant surgery doctors shall be not less than 50 cases;

3. The application of heart and lung transplant physicians practicing qualification, nearly 5 years accumulated so as to implement heart and lung transplant surgery doctors shall be not less than 5 cases;

4. The application of small intestine, pancreas transplant physicians practicing qualification, nearly 5 years accumulated so as to implement small intestine, pancreas transplant surgery doctors shall be not less than 2 cases.

Article 25 any of the following circumstances, shall not be recognized human organ transplant physician qualification:

(a) does not have full capacity for civil ACTS;

(2) the revocation of the physicians practicing certificate for the administrative punishment, not from the date of receipt of the application for registration;

(3) the suspended physician practice administrative punishment, in the suspension of physician practice period from the date of application;

(4) does not meet the requirements for the training, and through improper means to obtain training qualifications;

The provisions of article 24 of the (5) in addition to the circumstances, without training base training or test not qualified.

Article 26 for the human body organ transplantation disagrees with the decision of the physician qualification is not recognized, can bring administrative reconsideration in accordance with the law or the administrative litigation.

Chapter iv supervision and administration

Article 27 the training base in any of the following circumstances, designated by the provincial family planning administrative department of public health to cancel, the training base training shall no longer be working:

(a) does not conform to the human organ transplant physicians training base of the basic requirements, through improper means to obtain qualification training base;

(2) the violation of the human organ transplant ordinance and other laws, regulations and the relevant provisions of the state;

(3) not in accordance with the requirements for the measures to carry out the training work effectively.

Article 28 the training period is one of the following circumstances, cancel the training teacher qualifications:

(a) above the secondary medical accident responsible fully (or primary responsibility);

(2) failed to training supervisor responsibilities;

(3) of the criminal punishment;

(4) the suspend physicians practice or revocation of administrative penalties "physicians practicing certificate";

(5) other illegal situation.

Article 29 of the human organ transplant physicians to obtain qualification after one of the following circumstances, on the basis of "administrative licensing law" article sixty-nine, article seventy, by the local provincial family planning administrative department of public health revocation or cancellation:

(a) the third year in a row not to carry out the human organ transplant clinical work;

(2) the doctor's practice certificate is revoked, revoked or cancelled;

(3) regular physician examination unqualified;

(4) the death or incapacity of the physician;

(5) laws and regulations, and other conditions of the administrative license shall be revoked.

Article 30 the human organ transplant physician qualification has been cancelled, applies for the recognition, should go back to attend the training and examination.

The fifth chapter bylaws

Article 31 of the army doctors (including military and civilian personnel, and the local hire medical practitioners in the army hospital) for human organ transplant physicians practicing qualification, with reference to the above regulations specific measures shall be formulated by the logistics security bureau of the central military commission.

Health and family planning commission and logistics security bureau of the central military commission of the state, regularly report publishes each other hospital training base on recruitment, training, human organ transplant physicians decided that information, etc.

Article 32 the family planning administrative department of public health at the provincial level may, in accordance with these measures, formulate specific measures for its implementation.

Article 33 these measures come into force from the date of release.

The attachment 2

Human organ transplant physicians training base basic requirements (trial)

One, the basic conditions

(a) tertiary hospital, have to carry out the corresponding diagnosis and treatment subject of human organs and transplant program registration.

(2) in recent five years, there was no violation of laws, regulations and provisions relating to the human organ transplant.

Second, have adapted to human organ transplantation technology training work, equipment and facilities such as site condition

(a) transplantation ward. Liver and kidney transplantation should be set up relatively independent units, common area and isolation setting meets the requirements; Each ward approved more than 30 beds. Heart transplantation and need to set up 5 special beds, lung transplantation of pancreas transplantation and small intestine transplantation need to set up 2 special beds. Transplantation ward equipment configuration complete, yuan each sheet set meets the requirements. Transplant units shall establish and earnestly implement the rules and regulations, personnel responsibility, medical nursing technical operation procedures and related technical specifications, etc.

(2) intensive medicine (ICU or TICU). Set up in accordance with the original of the ministry of health "for the construction and management of severe medicine guidelines (try out)" requirements, building layout, function flow is reasonable; Bed set care beds for transplantation of 15% 20%, basic facilities equipped with meets the requirements.

(3) the surgery department. Set up in accordance with the original of the ministry of health the surgical department (room) regulations (try out) "and" hospital clean operating department construction technology specification (GB50333-2013) "requirements, such as building layout, function flow is reasonable; Purification procedure between the usable floor area of not less than 80 m2; Anesthesia recovery room set up in conformity with the requirement.

(4) the clinical laboratory. To carry out the biochemical, blood, immunity, drug concentration, pathogens, associated with pathologic examination and transplantation.

(5) blood purification room. Blood dialysis machine more than 30 Taiwan, continuous renal replacement therapy apparatus (CRRT) more than 5 units; A complete routine dialysis, bedside dialysis, plasma exchange, pure ultrafiltration and other technical ability.

(6) of brain death determination conditions. Adapt to independently carry out death decision, equipment and facilities such as site condition. Among them, the ability of brain death determination technology should reach the brain death standard and technical specification (adult and children's quality version) "the relevant requirements.

(7) the human body organ procurement organization. Set up independently or with other medical institutions established by the human body organ procurement organizations (OPO), developing for human organs, save maintenance adapted to transport the whole process of teaching, such as personnel, equipment and facilities. Include:

1. Venue: business work area layout conform to the requirements of the working process and technical specification; Organ donor maintenance unit not less than four, with intensive care instruments and equipment; Fixed the OPO office; Organ donor's family reception room and resting places; Organ procurement training teaching field.

2. The equipment and facilities: breathing machine, such as ecg monitor is a necessary equipment for intensive care; Portable electroencephalography (eeg), somatosensory evoked potential, neural electrophysiological examination equipment; Portable bed colour to exceed, extracorporeal membrane oxygenation (ECMO), artificial liver or organ perfusion in vitro preservation repair facilities; Organ procurement instrument, organ preservation box, the perfusion fluid, preservation solution, fiber bronchoscope, drug, consumables, etc; Special vehicles, including the human organ transplant coordinator commuter car, organ donor transport vehicle (equipped with breathing machine, ECMO, etc.), organ procurement operation special automobile, organ transport vehicle; Information technology equipment, including information submitted and transfer function of the computer and other equipment; Organ procurement training teaching facilities, such as simulation, etc.

(eight) on animals possess the experimental condition of organ transplantation.

Three, have to carry out the human organ transplant technology adapt to the training of professional and technical personnel

(a) human organ transplant trainers. At least five training supervisor, at least 2 called chief physician. Training supervisor shall also meet the following conditions:

1. Continuous engaged in clinical work for more than 10 years, human organ transplant has above of doctor of vice director of professional technical position qualifications.

2. Nearly three years of accumulated charge kidney transplant is more than 100 cases, or liver transplant more than 30 cases, or heart transplant surgery more than 10 cases, or lung transplant is more than 5 cases, or pancreas and small intestine transplant is greater than 2 cases; There was no more than secondary medical accidents associated with human organ transplant technology (primarily responsible or full responsibility); For nearly three years is not in violation of the relevant laws and regulations of organ transplantation; No use of medical and health services to seek improper interests violations.

(2) of brain death determination and technical personnel. Obtains the national center for health and family planning commission brain damage quality evaluation training certificate of brain death clinical evaluation physicians not less than 4 people; Electroencephalogram (eeg), evoked potential appraisal and assessment of transcranial doppler ultrasound doctor or health technical personnel each not less than 1.

(3) the OPO. Full-time work in the human organs for medical personnel not less than 5 people; Receive specialized training and inspection qualified, qualified professional human organ donation coordinator of not less than 4 people; In the intensive care, rescue technology, senior professional and technical qualifications of doctors shall not be less than 3 people; Intensive care professional job training certificate of practice nurses not less than 3 people; Professional engaged in the human body organ procurement, distribution, and sharing data report to professional not less than 1 person.

(4) other people. Breathing endoscopy, anesthesia, nursing, medical imaging, inspection, pathology and other professional and technical personnel have a higher service ability and level.

Four, have strong ability of human organ donation and get work

(a) applies for kidney and liver transplant physicians training base, where the OPO for nearly three years to complete the organ donation after the death of citizens (DCD) case number ranked within the top 20; Organ procurement rate (number of donor organs quantity/donate) higher than the national average (2.66).

(2) application of heart and lung transplant physicians training base, where the OPO for nearly three years the total DCD case quantity not less than 10 cases; Organ procurement rate (number of donor organs quantity/donate) higher than the national average (2.66).

(3) the application of pancreas and small intestine transplantation physician training base, where the OPO for nearly three years the total DCD case quantity not less than 10 cases; Organ procurement rate (number of donor organs quantity/donate) higher than the national average (2.66).

Five, have strong ability of human organ transplant technology clinical application

(a) apply for kidney transplant physicians training base, nearly three years accumulative total kidneys transplanted not less than 300 cases, among them, the implementation of DCD source kidney transplant is not less than 150 cases. Kidney transplantation survival rate of no less than 90% 1 year, 3 year survival rate of no less than 75%, the 5 - year survival rate of no less than 65%.

(2) applies for liver transplant physicians training base, nearly three years accumulative total performed liver transplant not less than 150 cases, among them, the implementation of DCD source of not less than 75 cases of liver transplantation surgery. Liver transplantation for end-stage hepatic disease 1 year survival rate of no less than 85%, 3 year survival rate of no less than 75%, 5 years survival rate of no less than 65%; Liver tumor transplanted liver 1 year survival rate of no less than 75%, 3 year survival rate of no less than 55%.

(3) to apply for a heart transplant physicians training base, heart transplant surgery for nearly three years is not less than 45 cases, among them, the implementation of DCD source heart transplants of not less than 25 cases. Heart transplantation survival rate of no less than 85% 1 year, 3 year survival rate of no less than 75%, the 5 - year survival rate of no less than 70%.

(4) application of lung transplant physicians training base, nearly three years in lung transplant not less than 30 cases, among them, the implementation of DCD source lung transplant is greater than 15 cases. Lung transplantation survival rate of no less than 65% 1 year, 3 year survival rate of no less than 55%, the 5 - year survival rate of no less than 45%.

(5) apply for pancreas transplant physicians training base, nearly three years is not less than 5 cases performed pancreas transplant.

(6) for small bowel transplant physicians training base, nearly three years accumulative total small bowel transplantation surgery not less than 3 cases.

Six, have good transplant data submitted to the quality

The data submitted to the relevant professional human organs for transplants quality among the top 20.

Seven, have strong ability of scientific research

(a) for nearly three years in domestic core journals or science citation index (SCI) journals published academic papers on human organ transplantation technology not less than 15.

(2) of human organ transplantation related national fund project, held a national human organ transplant technology professional conferences or undertake national continuing medical education programs.