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Legal Basis

Measures for the Management of Complaints of Medical Institutions

Chapter 1_General Provisions

Article 1__ is to strengthen medical care Institutional complaint management, standardizing complaint handling procedures, improving medical services, ensuring medical safety and the legitimate rights and interests of both doctors and patients, and maintaining normal medical order are formulated in accordance with the provisions of the "Regulations on the Prevention and Handling of Medical Disputes", the "Regulations on the Management of Medical Institutions" and other laws and regulations this method.

Article 2__ The term "complaint management" as mentioned in these Measures refers to patients reporting problems to medical institutions and putting forward opinions, suggestions or complaints regarding problems existing in medical service behavior, medical management, medical quality and safety, etc. Request that medical institutions conduct investigation, processing and result feedback activities.

Article 3__ These Measures apply to the complaint management of all types of medical institutions at all levels.

Article 4__ The National Health Commission is responsible for the supervision and guidance of the complaint management of medical institutions nationwide.

Local health authorities at or above the county level are responsible for the supervision and guidance of complaint management of medical institutions within their respective administrative regions.

Article 5__ The reception and handling of complaints by medical institutions shall implement the concept of "patient-centered" and follow the principles of legality, fairness, timeliness and convenience.

Article 6__Medical institutions shall do a good job in information disclosure in accordance with regulations and actively accept social supervision.

Article 7__ Medical institutions should improve their management level, strengthen medical risk management, optimize service processes, improve the treatment environment, improve the quality of medical services, prevent safety hazards, and reduce medical disputes and complaints.

Article 8__ Medical institutions shall formulate emergency response plans for major medical disputes, organize and carry out relevant publicity, training and drills to ensure that conflicts and disputes are resolved in a timely and effective manner in accordance with the law.

Article 9__ Medical institutions should incorporate complaint management into the patient safety management system, regularly summarize and analyze complaint information, sort out weak links in medical management and medical quality and safety, implement rectification measures, and continuously improve medical quality. Safety.

Article 10__Medical institutions shall do a good job in linking medical institution complaint management with people's mediation, administrative mediation, litigation, etc. of medical disputes. _

Chapter 2_Organization and Personnel

Article 11__The principal person in charge of a medical institution is the first person responsible for complaint management of the medical institution.

Medical institutions at level II or above should set up a doctor-patient relations office or a designated department (hereinafter collectively referred to as the complaint management department) to be responsible for unified complaint management. Other medical institutions should be equipped with full-time (part-time) personnel, and if conditions permit, they may also set up a complaint management department.

Article 12__ Medical institutions above the second level shall designate a person in charge of the medical institution to be in charge of complaints and guide and manage the relevant work of the complaint management department of the medical institution.

The complaint management department performs the following responsibilities:

(1) Organize, coordinate, and guide the complaint handling work of this medical institution;

(2) Accept complaints in a unified manner , investigate and verify complaints, put forward handling opinions, and respond to patients in a timely manner;

(3) Establish and improve complaints reception and handling procedures;

(4) Participate in the medical quality of medical institutions Safety management;

(5) Carry out training on doctor-patient communication and complaint handling, and carry out medical risk prevention education;

(6) Regularly summarize and analyze complaint information, and propose strengthening and improvement work opinions or suggestions and strengthen supervision and implementation. _

For medical institutions with only full-time (part-time) complaints staff, the full-time (part-time) complaints staff shall at least assume the second responsibility of the preceding paragraph.

Article 13__ Complaint management personnel of medical institutions shall meet the following conditions:

(1) Have good professional ethics and work responsibility;

(2) Have certain knowledge of medicine, management, law, psychology, ethics, social work and other disciplines, and be familiar with laws and regulations related to medical treatment and complaint management, as well as the rules and regulations of medical institutions;

(3) Strong social adaptability, good social interpersonal skills, good communication skills and adaptability.

Article 14__ Medical institutions at level 2 or above shall establish a three-level complaint management mechanism among medical institutions, complaint management departments, and departments. Each department and department of the medical institution shall designate at least one person in charge to cooperate. Good complaint management.

All departments and departments of medical institutions should regularly assess the risks involved in complaints, identify potential risks in complaints, propose targeted preventive measures for high-incidence risks, strengthen communication with patients, and resolve conflicts and disputes in a timely manner Check and resolve work.

Medical institutions should encourage staff to proactively collect patients’ opinions and suggestions on medical services, medical quality and safety, etc., and report them to the complaint management department or relevant functional departments through prescribed channels.

Article 15__ Medical institutions at level 2 or above should improve the linkage mechanism between the complaint management department and the clinical, nursing, medical technology and logistics, security and other departments to improve medical quality, ensure medical safety, and maintain normalcy Medical Order.

Article 16__Medical institutions should gradually establish and improve relevant mechanisms to encourage and attract social workers, volunteers and other people familiar with medical and legal professional knowledge or third-party organizations to participate in the reception and handling of complaints by medical institutions. Processing work.

Chapter 3__ Doctor-patient communication

Article 17__Medical institutions should improve the professional ethics of medical staff, enhance service awareness and legal awareness, pay attention to humanistic care, and strengthen Communicate between doctors and patients and strive to build a harmonious doctor-patient relationship.

Article 18__Medical staff should abide by professional ethics, be patient-centered, do their jobs enthusiastically, patiently and meticulously, and embody respect, understanding and care for patients throughout medical services. process.

__Article 19__Medical institutions shall establish and improve the doctor-patient communication mechanism, improve the content of doctor-patient communication, strengthen the training of medical personnel in doctor-patient communication skills, and improve the doctor-patient communication ability.

Medical staff should patiently explain and explain the consultations, opinions and suggestions put forward by patients during the diagnosis and treatment process, and handle them in accordance with regulations; questions raised by patients about their treatment behavior should be verified in a timely manner and handled independently. Check, communicate with the patient, and explain the situation truthfully.

Article 20__Medical personnel shall respect patients’ rights to privacy, right to know, and right to choose according to law, and shall highlight key points and adopt appropriate methods based on the patient’s condition, prognosis, and actual needs. communicate.

Important content related to diagnosis and treatment in doctor-patient communication should be recorded in the medical record in a timely, complete and accurate manner, and signed by the patient for confirmation.

Article 21__Medical institutions can formulate medical risk notification and preoperative conversation systems based on actual conditions, standardize specific procedures, fully inform patients in a way and language that is easy for patients to understand, and obtain other information. Written consent.

Chapter 4_Complaint Reception and Handling

Article 22__Medical institutions should establish smooth and convenient complaint channels, and publish complaint handling procedures, Location, reception hours and contact details.

Medical institutions are encouraged to strengthen public opinion monitoring and promptly grasp patients’ demands through other channels.

Article 23__Medical institutions should set up a special complaint reception place, and the reception place should provide relevant laws, regulations, complaint procedures and other information to facilitate patients' inquiries.

Medical institutions should take measures to protect the legitimate rights and interests and personal safety of complaint management staff.

Article 24__ Medical institutions shall implement the "first complaint responsibility system" for complaints. If a patient complains to the relevant department or department, the staff of the department or department that receives the complaint shall warmly receive the complaint, and the staff who can coordinate on the spot shall If it is handled, it should be coordinated and resolved on the spot as much as possible; for cases that cannot be coordinated and handled on the spot, the receiving department or department should take the initiative to guide the patient to the complaint management department (including full-time (part-time) complaint management personnel, the same below), and shall not shirk or prevaricate.

Article 25__ Complaint reception staff should listen carefully to the opinions of patients, patiently and meticulously explain their work to avoid intensification of conflicts; they should verify relevant information, truthfully record the situation reported by the patient, and keep written records in a timely manner Complaint materials.

Article 26__ Patients should express their opinions and demands in a civilized manner in accordance with the law, provide true and accurate complaint-related information to the complaint management department of the medical institution, cooperate with the investigation and inquiry of the complaint management department of the medical institution, and shall not Disrupting the normal medical order shall not involve any illegal or criminal behavior.

In principle, the number of people making complaints at a time should not exceed 5. If there are more than 5 people, representatives should be selected to collectively reflect the demands.

Article 27__ Complaint reception staff should promptly take control and preventive measures if they discover that a patient has committed suicide, self-mutilation, or other extreme behavior at the reception venue, or insulted, assaulted, or threatened the complaint reception staff. , and at the same time report to the public security organs and report to the local health authorities; any complaints discovered during the reception that may intensify conflicts and cause public security cases or criminal cases should be reported to the local public security organs in a timely manner and handled in accordance with the law.

Article 28__ After receiving a complaint or a complaint assigned by the health authority, the complaint management department of a medical institution shall promptly understand and verify the situation with the department, department and relevant personnel concerned, and after investigation Provide handling opinions based on clear facts and responsibilities, and provide feedback to patients.

Departments, departments and relevant personnel involved in complaints should actively cooperate with the complaint management department to investigate, verify and handle complaints.

Article 29__ For repeated complaints about the same or similar issues, the complaint management department of the medical institution shall summarize and report to the person in charge of the medical institution, and the medical institution may consolidate and investigate the relevant complaints as appropriate. , The links that cause complaints or the medical personnel who have caused complaints multiple times should be handled accordingly in a timely manner based on the investigation results.

Article 30__ The complaint management department of medical institutions shall handle complaints in a timely manner. If they can verify and handle them on the spot, they shall find out the situation in a timely manner; if there are indeed errors, they shall be corrected immediately and informed to the patient on the spot (or issue) handling opinions.

If medical quality and safety are involved and may endanger the patient's health, active measures should be taken immediately to avoid or reduce the damage to the patient's health and prevent the damage from expanding.

If the situation is complex and requires investigation and verification, the relevant handling situation or handling opinions should generally be fed back to the patient within 5 working days from the date of receipt of the complaint.

If multiple departments are involved and it is necessary to organize and coordinate the relevant departments to carry out joint research, the patient shall be given feedback on the handling situation or handling opinions within 10 working days from the date of receipt of the complaint.

Article 31__If the complaint has been handled and the patient has a dispute with the medical institution's handling of the complaint and can provide new information and evidence, it will be handled again according to the complaint process.

Article 32__ If the content of the complaint involves a medical dispute, the medical institution shall inform the patient to actively negotiate in accordance with the relevant laws and regulations on the handling of medical disputes; if it cannot be resolved through negotiation, the patient shall be guided to mediate, Solve the problem through litigation and other means, and do a good job of explanation and guidance.

Article 33__ If a complaint involves violations of laws and disciplines by medical institution staff, the complaint management department shall promptly transfer it to the relevant functional departments for handling in accordance with laws and regulations.

Article 34__ Complaints that fall under any of the following circumstances will not be handled by the complaint management department, but the patient shall be informed of the situation and relevant handling regulations:

(1) ) The patient has filed a lawsuit with the people's court or applied for mediation to a third party on the complaint matter;

(2) The patient has reported the complaint matter to the health authority or the petition department and handled it;

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(3) There is no clear target of the complaint and no specific facts;

(4) The content of the complaint already involves public security cases or criminal cases;

(5) Others Complaints that do not fall within the purview of the Complaints Management Department.

Article 35__ If a major medical dispute occurs, the medical institution shall report to the local health authority at or above the county level in accordance with regulations. After receiving the report, the health authorities should promptly understand the situation and guide both doctors and patients to resolve disputes through legal channels.

Article 36__Medical institutions shall protect the privacy of patients and medical staff related to complaints, properly respond to public opinion, and are strictly prohibited from publishing information that violates or exaggerates facts or exaggerates the complaint handling process.

Article 37__Medical institutions shall establish and improve complaint files, file them, and keep them for future reference.

The complaint files of medical institutions should include the following contents:

(1) Basic patient information;

(2) Complaint matters and relevant supporting materials;

(3) Investigation, handling and feedback;

(4) Other materials related to the complaint.

Article 38__ Medical institution staff have the right to put forward opinions and suggestions on the management and services of medical institutions. Medical institutions and relevant departments such as complaint management should pay attention to them and handle them in a timely manner. ,feedback.

Clinical front-line staff should report any problems found in medicines, medical devices, water, electricity, gas and other medical quality and safety assurance to the complaint management department or relevant functional departments. Complaint management and other relevant departments It should be handled and fed back in a timely manner.

Chapter 5_Supervision and Management

Article 39__ Local health authorities at or above the county level shall strengthen supervision and inspection of the complaint management of medical institutions within their own administrative regions, Strengthen daily management and evaluation.

Article 40__ Local health authorities at or above the county level shall collect, analyze and provide feedback on complaints and medical disputes related to medical institutions in their respective administrative regions, guide medical institutions to improve their work, and improve the quality of medical services.

Article 41__ The health authorities shall commend medical institutions and relevant personnel that have performed well in the management of complaints from medical institutions and effectively prevented major mass incidents or other serious consequences.

__For medical institutions within the administrative region that fail to carry out complaint management work in accordance with regulations, the health and health authorities should notify the criticism and conduct an interview with the main person in charge of the medical institution.

__Article 42__Medical institutions shall standardize complaint management and regularly compile statistics on complaints. The statistical results shall be combined with year-end assessments, regular assessments of physicians, medical ethics assessments, and excellence assessment. .

Chapter 6_Legal Responsibilities

__Article 43__Medical institutions have not established a complaint reception system, have not set up a unified complaint management department, or have full-time (part-time) staff Personnel, or who fail to report major medical disputes to the health authorities as required, shall be handled by the local health authorities at or above the county level in accordance with the provisions of Article 47 of the Regulations on the Prevention and Handling of Medical Disputes.

Article 44__ If a medical institution violates the provisions of these Measures and has any of the following circumstances, the local health department at or above the county level shall order it to make corrections within a time limit; if it fails to make corrections within the time limit, it will be given a warning and A fine of not more than 10,000 yuan shall be imposed; if serious consequences are caused, a fine of not less than 10,000 yuan but not more than 30,000 yuan shall be imposed, and the main person in charge of the medical institution, the directly responsible person in charge and other directly responsible personnel shall be punished in accordance with the law:

(1) Failure to formulate an emergency response plan for major medical disputes;

(2) Complaint management is chaotic;

(3) Failure to establish and improve a doctor-patient communication mechanism in accordance with regulations

(4) Failure to handle complaints and feedback to patients in a timely manner as required;

(5) Respond to complaints discovered during the reception that may intensify conflicts and cause public security cases or criminal cases Complaints and failure to report to local public security organs in a timely manner;

(6) Publish information that violates or exaggerates the facts or exaggerates the incident handling process.

Article 45__ If a medical staff leaks the privacy of a patient related to a complaint, causing serious consequences, the local health authorities at or above the county level shall handle the matter in accordance with the "Practicing Physician Law", "Nursing Regulations" and other laws and regulations. Handling relevant regulations.

Article 46__ If local health authorities at or above the county level fail to perform their duties as required in the management of complaints about medical institutions, resulting in serious consequences, the directly responsible person in charge and other persons in charge shall be punished in accordance with the law. Those directly responsible will be punished; if a crime is constituted, criminal responsibility will be investigated in accordance with the law.