Methods for the Management of Surgical Classification in Medical Institutions (for Trial Implementation) Article 1 These measures are formulated in accordance with the Law of the People's Republic of China on Practicing Physicians, the Regulations on the Administration of Medical Institutions and other laws and regulations in order to strengthen the management of surgical classification in medical institutions, improve the quality of medical care, safeguard medical safety, and safeguard the legitimate rights and interests of patients.
Second Article The operation referred to in these measures refers to the medical institutions and their medical staff to use surgical instruments in the human body local operation, in order to remove diseased tissue, repair damage, transplantation of tissues or organs, implantation of medical devices, relief of pain, improve the function of the organism or form of diagnostic or therapeutic measures for the purpose.
Article 3 of the medical institutions to implement surgical grading management system. Surgery grading management catalog is separately formulated by the Ministry of Health.
Article IV These measures apply to all levels and types of medical institutions surgical management.
Article 5 The Ministry of Health is responsible for the supervision and management of the work of the national medical institutions surgical classification and management.
Local health administrative departments at or above the county level are responsible for the supervision and management of surgical grading and management of medical institutions in their administrative regions. Article VI medical institutions should establish and improve the work of surgical grading management system, the establishment of surgical access system, the strict implementation of surgical site marking and surgical safety verification system, the medical department is responsible for the day-to-day management.
Article VII According to the different degrees of risk and difficulty, surgery is divided into four levels:
The first level of surgery refers to the lower risk, the process is simple, low technical difficulty;
The second level of surgery refers to a certain level of risk, the process of complexity of the general, with a certain degree of technical difficulty;
The third level of surgery refers to the risk of a higher, more complex process, more difficult surgery;
Grade IV surgery is defined as surgery with high risk, complexity of process, and difficulty.
Article 8 Medical institutions shall carry out surgeries appropriate to their levels and treatment subjects.
Article IX medical institutions in accordance with the provisions of the "Measures for the Administration of Clinical Application of Medical Technology", to obtain the second and third class of clinical application of medical technology qualification before carrying out the corresponding surgery.
Article X. Tertiary hospitals focus on the third and fourth level of surgery. Secondary hospitals focus on two, three-level surgery. First-class hospitals, township health centers can carry out first- and second-degree surgery, focusing on first-degree surgery.
Article XI of the second-level hospitals to carry out level IV surgery should meet the following conditions:
(A) meet the standards of the second-class hospitals;
(B) the intensive care medicine and the proposed level IV surgery with the appropriate diagnostic and therapeutic subjects;
(C) with the fourth level of surgery, personnel, equipment, facilities, and other necessary conditions;
(D) approved by the Provincial health administrative department approval.
Article XII: First-level hospitals, township health centers and central township health centers shall meet the following conditions for carrying out second-level surgeries:
(1) conforming to the standards of a first-class hospital;
(2) having an anesthesiology department and diagnostic and therapeutic subjects compatible with the proposed second-level surgeries;
(3) possessing the necessary conditions for carrying out second-level surgeries in terms of staffing, equipment, facilities, etc. (d) approved by the health administrative department that issued its "license to practice in medical institutions" and filed with the municipal health administrative department in the district.
Article XIII community health centers, community health service stations, health care clinics, outpatient clinics (except for stomatology), clinics (except for stomatology), health clinics (rooms), infirmaries and other medical institutions, in addition to the implementation of emergency surgical hemostasis to save the patient's life, the disposal of small wounds, or other provincial administrative departments of health have clearly defined the project, in principle, shall not be carried out in accordance with the provisions of this method Provisions of the operation.
Article XIV of elective surgery patients, the need for general anesthesia (including basic anesthesia) or the need for blood transfusion, the level of the operation is correspondingly raised one level. When the preanesthesia assessment (ASA) is grade III or above and general anesthesia support is required, the surgery shall be performed in a tertiary hospital or a grade IIA hospital approved by the provincial health administrative department to carry out some of the grade IV surgeries.
Article 15 In case of emergency surgery to save lives of patients with acute and critical illnesses, the medical institution may carry out the surgery at a higher level and do the following:
(1) safeguard the legitimate rights and interests of the patients, and fulfill the procedures related to informed consent;
(2) ask the higher-level hospitals to carry out an emergency consultation;
(3) within 24 hours after the end of the surgery, report to the medical institution which issued its "Medical Institution Practice License" for the operation to be performed. its License to Practice in Medical Institutions to the health administrative department for the record.
Article XVI of the medical institutions should be based on the level of surgery, professional characteristics, physicians actually employed in professional and technical positions and surgical skills, the organization's expert group on the clinical application of the ability of the physician technical audit, audit and grant the appropriate surgical authority.
Article XVII of the medical institutions shall regularly assess the technical ability of physicians, timely adjustment of the physician's surgical privileges, and into the management of the physician's technical file.
Article 18 In addition to emergency surgery for patients with acute and critical illnesses require emergency surgery, outside physicians, consulting physicians shall not be carried out beyond the implementation of the highest level of surgery can be carried out by the medical institution. Further training in accordance with the Ministry of Health and the provincial health administrative department of the relevant provisions of the management of surgical privileges. Article 19 The local health administrative departments at or above the county level shall strengthen the administrative region of the medical institutions within the supervision and inspection of the management of surgical classification.
Article 20 The local health administrative departments at or above the county level shall establish a medical institution surgical safety assessment system, for the existence of safety risks of medical institutions and surgical procedures, shall immediately order them to stop.
Article 21 of the medical institutions in one of the following circumstances, the health administrative department shall not be allowed to carry out the corresponding level of surgery; has been allowed to carry out, shall immediately order it to stop:
(a) beyond the registered diagnostic and therapeutic subjects;
(b) did not obtain the corresponding level of qualification for clinical application of medical technology;
(c) in the application for The corresponding level of clinical application of surgery in the process of fraud;
(D) due to changes in personnel, equipment, facilities and other conditions no longer have to carry out the corresponding surgical conditions;
(E) health administrative departments at or above the provincial level of other circumstances.
Article 22 of the medical institutions in one of the following circumstances, the health administrative department shall immediately order its correction; causing serious consequences, shall be held responsible for the main person in charge of the medical institution and the person directly responsible for the responsibility:
(a) to carry out the administrative department of health abolished or prohibited to carry out the surgical procedures;
(b) unauthorized to carry out the administrative department of health explicitly require Immediate cessation of the surgical program;
(3) unauthorized to carry out should be approved by the administrative department of health to carry out the surgical program;
(4) Provincial or above, the administrative department of health of other circumstances. Article 23 These Measures shall come into force on October 1, 2012 .