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Notice on the issuance of measures for the graded management of surgical procedures in medical institutions

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Health commissions of all provinces, autonomous regions, municipalities directly under the Central Government and the Xinjiang Production and Construction Corps:

In order to strengthen the hierarchical management of surgery in medical institutions, standardize the surgical behavior of medical institutions, improve medical quality, ensure medical safety, and safeguard the legitimate rights and interests of patients, our committee organized the revision of the Measures for the Graded Management of Surgery in Medical Institutions
.
It is now issued to you, please follow it
.

General Office of the National Health Commission

December 6, 2022

(Information disclosure form: active disclosure)

Measures for the hierarchical management of surgery in medical institutions

Chapter I General Provisions

Article 1: These Measures are formulated in accordance with the "Medical Practitioners Law of the People's Republic of China", "Regulations on the Administration of Medical Institutions", "Measures for the Management of Medical Quality", "Measures
for the Administration of Clinical Application of Medical Technology" and other laws, regulations and rules in order to strengthen the hierarchical management of surgical operations in medical institutions, improve the quality of surgery, ensure medical safety, and safeguard the lawful rights and interests of patients.

Article 2: These Measures apply to the hierarchical management of surgery in all levels and types of
medical institutions.

Article 3: "Surgery" as used in these Measures refers to medical techniques in which medical establishments and their medical personnel carry out medical operations such as removing diseased tissue, repairing damage, reconstructing form or function, transplanting cell tissues or organs, and implanting medical devices on the human body for the purpose of diagnosing or treating diseases, and the operation shall be verified by clinical research and proven to be safe and effective
.

"Graded management of surgery" as used in these Measures refers to the process
in which medical institutions grade the operations carried out by the institution according to the degree of surgical risk, difficulty, resource consumption and ethical risk for the purpose of ensuring the quality and safety of surgery, and adopt corresponding management strategies for different levels of surgery.

Article 4: Medical establishments and their medical personnel carrying out the clinical application of surgical techniques shall follow the principles of
science, safety, standardization, effectiveness, economy, and ethics.

Article 5 The National Health Commission shall be responsible for the supervision and administration
of the hierarchical management of surgery in medical institutions nationwide.

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

Chapter II: Organization and Management

Article 6: Medical establishments bear the main responsibility
for the hierarchical management of their own operations.
Medical establishments shall formulate a hierarchical management catalog of surgery based on their functional positioning, medical service capacity level, and diagnosis and treatment subjects, and carry out hierarchical management
.

Article 7 The hierarchical management of surgery in medical institutions shall implement a two-level responsibility system
at the hospital and department levels.
The main person in charge of the medical institution is the first responsible person for the hierarchical management of surgery in the institution; The main person in charge of the clinical department related to surgery is the first person responsible for the hierarchical management of
surgery in the department.

Article 8: The medical technology clinical application management organization of medical institutions is responsible for the hierarchical management of the operation of the institution, and the specific work is the responsibility of the medical affairs management department
.

Article 9 The main duties of medical technology clinical application management organizations of medical institutions in the hierarchical management of surgery are:

(1) Formulate systems and norms for the hierarchical management of surgery in the institution, clarify the rules of procedure and workflow for the hierarchical management of surgical operations in departments, periodically review the implementation, and put forward improvement measures and requirements;

(2) Examine and approve the institution's hierarchical management catalogue of surgery, periodically assess the quality and safety of surgery, and dynamically adjust it;

(3) Grant or cancel the corresponding surgical level and specific surgical authority according to the professional ability and training of the operator, and make dynamic adjustments according to the regular assessment;

(4) Organize and carry out training
on laws, regulations, rules, and relevant systems and norms for hierarchical management of surgery.

Article 10 Each operating department of a medical institution shall establish a working group for the hierarchical management of surgery in the department, the leader of which shall be the main person in charge of the department, and designate a special person to be responsible for daily specific work
.
The main responsibilities of the Surgical Grading Management Working Group are:

(1) Implement laws, regulations, rules, normative documents related to the graded management of surgery, and the institution's graded management system for surgery;

(2) Formulate the implementation plan for the annual surgical grading management of the department, and organize and carry out the department's surgical grading management work;

(3) Regularly analyze and evaluate the hierarchical management of surgery in the department, propose corrective measures for the weak links of hierarchical management of surgery, and organize their implementation;

(4) Regularly evaluate the clinical application ability of surgical techniques of surgeons in the department, formulate surgical technology training plans, and improve the clinical application ability and quality of surgical technology of the department;

(5) Submit relevant information on the hierarchical management of surgery in the department in accordance with relevant
requirements.

Chapter III: Graded Management of Surgery

Article 11 Surgery is divided into four levels according to the degree of risk, difficulty, resource consumption or ethical risk of surgery:

Level 1 surgery refers to surgery with low risk, simple procedure and low technical difficulty;

Secondary surgery refers to surgery with certain risks, average complexity and technical difficulty;

Tertiary surgery refers to surgery with higher risk, more complex process, greater difficulty, and more resource consumption;

Fourth-level surgery refers to surgery
that is high-risk, complex, difficult, resource-intensive, or involves significant ethical risks.

Article 12 Surgical risks include anesthesia risks, risks of major complications of surgery, and perioperative mortality risks
.

The difficulty of surgery includes the complexity of the operation, the status of the patient, the duration of the operation, the qualification requirements of the operator, the staffing required for the operation, the complexity of the surgical instruments and equipment required, etc
.

Resource consumption refers to the type, quantity, and scarcity of
medical resources used during surgery.

Ethical risk refers to the possibility
that people's social and ethical relationships may have negative ethical effects under the influence of surgery.

Article 13: Medical establishments shall establish a hierarchical surgery information reporting system, and submit the information of the institution's third- and fourth-level surgical management catalog information to the health administrative department that issued its "Medical Establishment Practice License", and promptly update the information if there are adjustments
.
The departments receiving the information shall promptly submit the directory information to the provincial-level health administrative department
step by step.

Article 14: Medical establishments shall establish a system for publicizing the grading of operations, include the hierarchical management catalogue of surgery in the scope of disclosure of that institution's hospital affairs, actively disclose the third- and fourth-level surgical management catalogue to the public, and promptly update it
.

Article 15: Medical establishments shall establish a system for dynamic adjustment of surgical grading, dynamically adjusting the institution's surgical grading management catalog
based on the effects of the surgery carried out by the institution and surgical complications.

Article 16: Medical establishments shall establish a surgical authorization system, and grant the surgeon corresponding surgical authority
after comprehensive assessment based on the surgical level, professional characteristics, the professional and technical position of the surgeon, and the clinical application ability and training of the surgical technique.
Third- and fourth-level surgery shall grant the surgeon surgical authority
one by one.
In principle, surgical authorization shall not be linked
to the title and position of the operator.

For medical personnel who are not registered with the main practice institution, the management of surgical authorization shall be consistent
with that of the medical staff of the institution.

Article 17: Medical establishments shall establish systems for assessing the clinical application capacity of surgical techniques and for dynamic adjustment of surgical authorization
.

The surgeon's application for surgical authority shall be evaluated by the surgical hierarchical management working group of the department where he or she belongs, and those who pass the assessment shall report to the medical management department, and after review by the medical management department, report to the medical technology clinical application management committee for review and approval, and the medical institution shall confirm
it in the form of an official document.

Medical institutions shall periodically organize and evaluate the clinical application ability of surgical techniques, including surgical technical ability, surgical quality and safety, perioperative management ability, doctor-patient communication ability, etc.
, focusing on the assessment of newly
obtained four-level surgical authority.
According to the evaluation results, the surgical authority is dynamically adjusted and included in the management of personal professional and technical files, and the evaluation cycle of the four-level surgery shall not exceed one year
in principle.

Article 18: Medical establishments shall establish a demonstration system for the clinical application of
surgical techniques.
For surgical techniques that have been proven to be safe and effective, but are the first time to be carried out by the institution, the demonstration of surgical technical capabilities and safety assurance capabilities shall be organized, and the clinical application
of the surgical technology can only be carried out through the demonstration.

Article 19: Medical establishments shall create conditions for medical personnel to participate in standardized training in surgical skills, and increase medical personnel's ability to
apply surgical techniques in clinical practice.

Medical institutions should focus on the standardized training of surgical techniques carried out for the first time in their own institutions
.

Article 20: Where medical establishments carrying out restricted medical technologies at the provincial level or above involve surgery, they shall manage
it in accordance with level 4 surgery.

Article 21: Medical establishments shall establish a management system for carrying out surgery beyond the scope of surgical authority during the state of emergency, and when an acute or critical patient really needs emergency surgery to save his life, if there is no operator with corresponding surgical authority on site, other surgeons may carry out surgery beyond their authority, and the specific management system shall be formulated
by the medical establishment itself.

Article 22: Medical establishments shall establish a multidisciplinary discussion system before the operation of four-level surgery, and the operating department shall organize a multidisciplinary discussion of the indications, methods, expected effects, risks, and disposal plans of the operation before the implementation of each fourth-level operation, determine the surgical plan and perioperative management plan, and record it in accordance with provisions to ensure the quality of surgery and patient safety
.

Article 23: Medical establishments shall establish a follow-up system for surgery, determining the length and frequency of follow-up visits according to the characteristics of the disease and relevant diagnosis and treatment norms, and in principle, follow-up visits shall not be less than once a
year for patients after fourth-level surgery.

Article 24: Medical establishments shall improve the case reporting system for adverse surgical events, and for situations such as unplanned secondary surgery or serious adverse medical quality (safety) events occurring in fourth-level surgery, they shall organize general practice discussions within 3 days after the occurrence, and report the results of the discussion to the medical quality management committee of the institution, and at the same time report
to the health administrative department in accordance with the relevant provisions on adverse event management.

Article 25: Medical establishments shall strengthen discussion and management
of perioperative death cases.
If a patient with grade IV surgery dies perioperatively, the medical management department shall organize and complete a multidisciplinary discussion
within 7 days after death.
Medical establishments shall conduct a summary analysis of all perioperative death cases annually and put forward suggestions
for continuous improvement.

Chapter IV: Supervision and Management

Article 26: Medical establishments shall establish a surgical quality and safety assessment system, and the medical establishment's medical technology clinical application management organization shall periodically evaluate the surgical indications, preoperative discussions, surgical safety verification, perioperative complication rates, unplanned secondary surgery rates, perioperative all-cause mortality, and so forth, and disclose them
in the hospital.
First- and second-level surgeries shall be evaluated annually, tertiary surgeries shall be evaluated every six months, and fourth-level surgeries shall be evaluated
quarterly.

Medical institutions should focus on the quality and safety
of surgical techniques performed for the first time in their own institutions.

Article 27: Medical establishments shall establish a hierarchical surgical management supervision system, and the medical affairs management department of that institution shall conduct regular supervision of the implementation of the hierarchical surgical management system for each operating department, and use the results of the supervision as a key indicator
for the assessment of the relevant departments of the medical institution and their main responsible persons.

Article 28: Where serious adverse medical quality (safety) events occur, medical establishments shall suspend the operation and re-evaluate
the surgical technique and the operator's ability to apply the surgical technique clinically.
If the assessment result is satisfactory, it can be continued; If the evaluation results find that the clinical application ability of the surgical technique of the surgeon is insufficient, the surgical authorization shall be canceled; If the assessment results find that the surgical technique has major quality and safety defects, the clinical application of the surgical technique shall be stopped, and the relevant situation shall be immediately reported
to the health administrative department that issued the "Medical Institution Practice License".

Where the main operator engaged in the surgical technique or the key equipment, facilities and other auxiliary conditions change, which cannot meet the requirements of the relevant technical clinical application management specifications or affect the clinical application effect, the medical institution shall stop the clinical application
of the surgical technique.

Article 29: Medical establishments at level 2 or above shall make full use of information technology to strengthen hierarchical management of surgery, fully grasp the implementation and implementation of the department's hierarchical management system for surgery, strengthen inspections of surgical orders, surgical notices, anesthesia records, and other links, focusing on verifying the relevant circumstances
of surgical authority, restricted technologies, emergency surgery, and key technical projects supervised by that institution.

Article 30: Local administrative departments of health at the county level or above shall strengthen monitoring and periodic assessment of the hierarchical management of surgery in medical establishments within their jurisdiction, promptly feedback the monitoring situation and assessment results to medical establishments, periodically analyze, rank, and publicize the average surgical case combination index (CMI) of medical establishments at all levels, and guide medical establishments to scientifically level and standardize management
.
Timely correct the disorder of surgical grading management, and report regularly
.

Article 31: Local administrative departments of health at the county level or above shall guide the strengthening of hierarchical management of surgical operations in medical establishments within their administrative regions, establish incentive and constraint mechanisms, and popularize advanced experience and practices
.
Combine
the hierarchical management of surgical operations of medical institutions with medical institution verification, hospital review, evaluation and individual performance evaluation.

Chapter V Supplementary Provisions

Article 32: Carrying out operations for which laws and regulations specifically provide for human organ transplantation, human assisted reproduction, and so forth, are to be carried out
in accordance with relevant laws and regulations.

Article 33: "Operator" as used in these Measures refers to the person who has completed the
operation.

Article 34: The perioperative period referred to in these Measures refers to the patient's 24 hours before surgery to the basic end
of treatment related to this operation.

Article 35: "Serious medical quality (safety) adverse events as used in these Measures refers to medical quality and safety events
that occur during diagnosis and treatment, causing patients to need treatment to save lives, causing permanent injury or death to patients.

Article 36: The State organization to formulate a catalog of surgeries used in the performance appraisal of public hospitals is not to be used as the basis
for each medical institution to carry out hierarchical management of surgery.

Article 37 These Measures shall take effect
on the date of issuance.
The Notice of the General Office of the Ministry of Health on Printing and Distributing the Measures for the Graded Management of Surgery in Medical Institutions (for Trial Implementation) (Weiban Medical Zhengfa [2012] No.
94) is abolished
at the same time.

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