Chapter I General Provisions

Article 1 In order to strengthen the grading management of surgery in medical institutions, improve medical quality, ensure medical safety, and safeguard the legitimate rights and interests of patients, these measures are formulated in accordance with laws, regulations, rules and normative documents such as the Law of People's Republic of China (PRC) on Medical Practitioners, the Regulations on the Administration of Medical Institutions, the Regulations on the Handling of Medical Accidents, and the Measures for the Administration of Clinical Application of Medical Technology.

Article 2 The term "operation" as mentioned in these Measures refers to the diagnostic or therapeutic measures implemented by medical institutions and their medical personnel on the local part of the human body in order to remove diseased tissues, repair injuries, transplant tissues or organs, relieve pain, and improve body function or morphology.

Article 3 Medical institutions shall implement a grading management system for operations. The catalogue of surgical grading management shall be formulated separately by the Ministry of Health.

Article 4 These Measures shall apply to the operation and management of various medical institutions at all levels.

Article 5 The Ministry of Health shall be responsible for the supervision and management of classified management of medical institutions throughout the country.

The local health administrative departments at or above the county level shall be responsible for the supervision and management of the grading management of surgery in medical institutions within their respective administrative areas.

Chapter II Operation Classification and Authorization Management

Article 6 A medical institution shall establish and improve a hierarchical management system for its own operation, and the Medical Department shall be responsible for daily supervision and management.

Seventh according to the risk and difficulty, the operation is divided into four levels:

First-class operation refers to ordinary operation with low risk, simple process and low technical difficulty;

Secondary operation refers to the operation with certain risks, complicated general process and certain technical difficulties;

The third-level operation refers to the operation with high risk, complex process and great difficulty;

Grade Ⅳ operation refers to a major operation with high risk, complicated process and great difficulty.

Eighth medical institutions should carry out operations consistent with the level of institutions and registered diagnosis and treatment subjects.

Article 9 Third-level hospitals can carry out operations at all levels, with emphasis on third-and fourth-level operations.

Article 10 Secondary hospitals are mainly engaged in secondary and tertiary operations. As a regional medical center, a second-class first-class hospital, if it has the necessary conditions (including venues, personnel, equipment, etc. ) to carry out Class A surgery, and some Class IV operations can be carried out with the approval of the provincial health administrative department. A general hospital with a registered diagnosis and treatment subject in the Department of Critical Care Medicine shall apply to the provincial health administrative department for approval to carry out a four-level surgical project suitable for its diagnosis and treatment subject.

Eleventh first-class hospitals (including health centers) can carry out first-class surgery. First-class and first-class general hospitals with anesthesiology department and good emergency rescue equipment should apply to the health administrative department that issued the "Practice License of Medical Institution" to carry out the second-class operation project that is suitable for their diagnosis and treatment subjects, and can only be carried out after being approved by the municipal health administrative department for the record.

Twelfth community health service centers, health service stations, primary and secondary health care centers, outpatient departments, clinics, health centers (rooms), infirmary, etc. A, in order to save the lives of patients and the implementation of emergency surgery to stop bleeding or minor wound treatment and other projects clearly defined by the provincial health administrative department, shall not carry out more than one level of surgery.

Thirteenth patients undergoing elective surgery, such as general anesthesia (including basic anesthesia) or blood transfusion surgery, their surgical level will be upgraded to one level. If the pre-anesthesia assessment (ASA) is above level 3 (including level 3) and general anesthesia support is needed, the operation should be carried out in a level 3 hospital or a level 2 A hospital approved by the health administrative department, and some level 4 surgical projects should be carried out.

Fourteenth medical institutions should establish and improve the operation access system and approval process to ensure the continuous improvement of medical quality.

Fifteenth medical institutions shall, according to the type of operation, professional characteristics, professional and technical positions and surgical skills actually employed by doctors, and after the technical evaluation of clinical application ability by the expert group, grant doctors the corresponding surgical authority.

Sixteenth medical institutions should regularly evaluate the technical ability of doctors, adjust the operating authority of doctors in time, and bring it into the management of doctors' technical files.

Seventeenth medical institutions to carry out operations involving the third and second types of medical technology projects, should be declared in accordance with the requirements of the corresponding medical technology audit standards.

Eighteenth medical institutions that need unregistered doctors to perform or participate in the operation shall be implemented in accordance with the relevant regulations of the Ministry of Health and the local area.

Twenty-first secondary general hospitals registered with the diagnosis and treatment subjects of the Department of Critical Care Medicine, when it is really necessary to carry out emergency surgery on critically ill patients to save lives, can carry out four-level surgery and do the following work:

(a) consciously safeguard the legitimate rights and interests of patients, and conscientiously perform the relevant procedures of informed consent;

(two) please go to a hospital for emergency consultation;

(three) within 24 hours after the operation, to the practice registration authority of the hospital for the record.

Chapter III Supervision and Administration

Twenty-second medical institutions in any of the following circumstances, the administrative department of health shall not register medical technology; If registration has been granted, the registration of medical technology shall be revoked in time:

(a) beyond the scope of registered medical subjects;

(two) failed to pass the clinical application ability technical audit of the surgical project expert group;

(three) practicing fraud in the process of technical audit of clinical application ability of surgical projects;

(four) although passed the examination, but due to changes in personnel, equipment, site, no longer have the qualification to carry out an operation.

Twenty-third medical institutions in any of the following circumstances, the administrative department of health shall immediately order them to correct; Causing serious consequences, the main person in charge of the medical institution and the person directly responsible shall be investigated for responsibility according to law:

(a) to carry out surgical projects abolished or prohibited by the administrative department of health;

(two) without the permission of the administrative department of health, to carry out the second and third kinds of medical technology surgery projects;

(three) to carry out the operation project that the health administrative department explicitly requires to stop immediately without authorization;

(four) to carry out other surgical projects that should be declared and allowed to be carried out without authorization;

(five) in violation of other relevant provisions of the administrative department of health.