Interpretation issued by the national health and family planning commission about human organ transplant physician training and the relevant documents such as the measures for the administration of the notice

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

The 2016-10-08

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 made the \"measures for the management of human organ transplant physicians training and recognition (try out)\" and \"human organ transplant physicians training base basic requirements (try out)\". Interpretation will now about the main points are as follows:

First, the drafting background

In may of 2007, China promulgated the \"human organ transplant ordinance (hereinafter referred to as the regulations), marked the our country human organ transplant technology management into the legal track, has since developed in China for more than 30 of the supporting documents of organ transplantation, further refined to carry out the regulations rules. According to the regulations and issued by the ministry of health of the liver, kidney, heart and lung transplant technology management specification of notice, in 2007, issued the general office of the ministry of health, about clinical application of human organ transplant technology planning and approval to carry out the human organ transplant medical institutions and physicians carry out the work of examination and approval notice, organization expert technology access audit strictly, human organ transplant qualification examination and physicians. In 2013, in accordance with the relevant standard of the administrative examination and approval work of the state council's request, \"human organ transplant physicians practicing qualification\" into by the administrative examination and approval of projects. In 2014, the \"human organ transplant physicians practicing qualification examination and approval authority down to the provincial health administrative departments of family planning. In order to further strengthen the management of human organ transplant physicians work, guide the local well \"human organ transplant physicians practicing qualification\" down after the examination and approval matters, all work by commission drew up the measures for the management of human organ transplant physicians training and recognition (try out) \"and\" human organ transplant physicians training base basic requirements (try out) \", \"human organ transplant physicians practicing qualification\" clearly down after examination and approval matters in the provincial administrative department of health to human organ transplant physicians practicing qualification and training of relevant procedures and requirements, stepping up efforts in supervising affairs of after the event.

Second, the drafting process

Since the \"human organ transplant physicians practicing qualification\" after devolution of administrative examination and approval items, by commission immediately set out to implement the related work of specific measures, together with the family planning administrative department of public health at the provincial level to do a good job of examination and approval matters devolved cohesion. To research the relevant provinces, and provincial family planning administrative department of public health and the organ transplant hospital related personnel to study \"human organ transplant physicians practicing qualification\" down after examination and approval matters related matters, and to strengthen the regulation of human organ transplant physicians. Part of the family planning administrative department of public health at the provincial level and the national well-known experts, relevant workshops were held to study the terms, according to a meeting of experts to the file modification, formed the draft. Across the country and the industry for two rounds of opinion, China's human organ donation and transplantation committee meeting is the first and second file of a careful research discussion, further revised and submitted to the commission, director of the meeting examined and approved.

Third, the main content

(a) clearly defined human organ transplant physicians. 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.

(2) clarify the national and provincial health and family planning commission. National 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. Conditional industry organization, unit according to the actual demand to develop training plan; Organizes the human organ transplant physicians training syllabus and teaching materials; Standards for training and examination requirements; Provide guidance for the training base construction and management work. 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, and formulate concrete measures for implementation.

(3) the specification of human organ transplant physician training. One is the training base of duties. Training base is responsible for the qualification to apply for human organs for transplants for training of doctors. Second, the clear training base management. Training base by provincial family planning administrative department of public health on the basis of the human organ transplant physicians training base basic requirements specified, the dynamic management. List submitted to the national health and family planning commission for the record and open to the society. Three is a tutor training, management. Training mentor recommended by training base merit, the provincial family planning administrative department of public health organization expert assessment, period is 4 years. Four is clear training application conditions. 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; Responsible fully for nearly three years, there was no more than secondary 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; Attending physician 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. Five is clear training time and training content. Human organ transplant physicians training cycle is 1 year, total training time shall not exceed two years. And doctors according to the human organ transplant physicians training outline and the requirement of teaching material, complete the study task. Six is clear the inspection requirements. Completion of training shall be subject to examination and culture physicians. Assessment by training base or the third party entrusted by the family planning administrative department of public health at the provincial level to organize the implementation.

(4) clear the human organ transplant physicians practicing qualification standards and processes. One is the \"new man\" standards and procedures. The training base, training and assessment of the qualified physician, you can apply to the local provincial family planning administrative department of public health professional human organ transplant physicians practicing qualification, provincial family planning administrative department of public health to make a decision within 20 days. Through the established by the provincial family planning administrative department of public health in the physician's practice certificate. The second is \"old man\" standards and procedures. These measures enacted before work in the human organ transplantation, and at the same time conform to the practice site with corresponding hospital diagnosis and treatment subject of human organs for transplants, with associate chief physician and professional technical position qualifications above; Nearly eight years continuous work in the human organ transplant related clinical; In recent five years accumulated so as to implement transplant surgery doctors reach regulation number and organs for transplant survival rate in accordance with relevant national technical standard management practitioners, can be directly to the local provincial family planning administrative department of public health to apply for that. Three doctors' qualification is not recognized human organs for transplants: do not have full capacity for civil conduct; The revocation of the physicians practicing certificate administrative punishment, not from the date of receipt of the application for registration; Administrative penalties by the suspension of physician practice, during the suspension of physician practice period from the date of receipt of the application for; Does not meet the requirements for the training, and through improper means to obtain training qualifications; Unless explicitly stated in article 23 of the circumstances, without training base training or test not qualified. Fourth, the administrative reconsideration. Physicians for human organ transplantation disagrees with the decision of the qualification is not recognized, can apply for administrative reconsideration to the provincial administrative department of health first, with the administrative reconsideration decision disaffected, can mention lawsuit of politics of start on a journey to a people's court in accordance with the law.

(5) specific regulatory requirements. A specified is to cancel the training bases for: do not conform to the \"human organ transplant physicians training base basic requirements\", through improper means to obtain qualification training base; Occurred in violation of the human organ transplant ordinance and other laws, regulations and the relevant provisions of the state; Failure to comply with requirements to carry out the training work effectively. 2 it is disqualified from training mentor: second class above medical accident responsible fully (or primary responsibility); Failure to meet training supervisor responsibilities; Criminal punishment; The suspend physicians practice or revoke the physicians practicing certificate of administrative punishment; Other illegal situation. Three is to cancel the situation of human organ transplant physician qualification: the third year in a row not to carry out the human organ transplant clinical work; The physician's practice certificate is revoked, withdrawn or cancelled. Physicians regular examination unqualified; Death or incapacity of the physician; Laws and regulations, and other circumstances of the administrative license shall be revoked. Four is to training requirements. Human organ transplant physician qualification has been cancelled, applies for the recognition, should go back to attend the training and examination.

(6) clear the army the rules of the human organ transplant physicians practicing qualification. 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.

(7) clear the human organ transplant physicians training base basic conditions. Human organ transplant physicians training base must meet the following conditions: one is the human organ transplant qualification and nearly 5 years, there was no violation of laws, regulations and provisions relating to the human organ transplant. 2 it is to have adapted to human organ transplantation technology training work, equipment and facilities such as site condition. 3 it is to have to carry out the human organ transplant technology adapt to the training of professional and technical personnel. Four is a strong human organ donation and gain the ability to work. Five is to have strong ability of human organ transplant technology clinical application. Six is to have good transplant data submitted to the quality. Seven is a strong scientific research ability.

Relevant link: 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