Article 2 The term "medical quality" as mentioned in these Measures refers to the degree of medical care given to patients in the process of clinical diagnosis and treatment in accordance with the requirements of professional ethics and diagnosis and treatment norms under the existing medical technology level, conditions and capabilities.
Article 3 The term "medical quality management" as mentioned in these Measures refers to the process of using modern scientific management methods to manage and control the elements, processes and results of medical services in accordance with the formation law of medical quality and the requirements of relevant laws and regulations, so as to realize systematic and continuous improvement of medical quality.
Article 4 Medical quality management is the core of medical institution management. All kinds of medical institutions at all levels should comprehensively strengthen medical quality management.
Fifth medical institutions to carry out medical service activities should comply with the requirements of relevant laws, regulations and rules, and constantly improve the quality of medical care to ensure medical safety.
Article 6 The National Health and Family Planning Commission (hereinafter referred to as the National Health and Family Planning Commission) is responsible for the supervision and management of medical quality in medical institutions throughout the country.
The local health and family planning administrative departments at or above the county level shall be responsible for the supervision and management of the medical quality of medical institutions within their respective administrative areas.
Article 7 These Measures shall apply to the medical quality management of various medical institutions at all levels. Article 8 The National Health and Family Planning Commission is responsible for organizing or entrusting professional institutions to formulate relevant systems, norms, standards and guidelines for medical quality management, and guiding local health and family planning administrative departments and medical institutions at all levels to carry out medical quality management and control.
Local health and family planning administrative departments at all levels are responsible for supervising and guiding medical institutions to implement relevant rules and regulations on medical quality management. Provincial health and family planning administrative departments can formulate relevant systems, norms and specific implementation plans for medical quality management in light of local conditions.
Article 9 The State establishes a medical quality management and control system. Relying on various professional medical quality control centers (hereinafter referred to as quality control centers) and quality control management departments of various medical institutions at all levels, the relevant work requirements of medical quality management are implemented.
Article 10 The National Health and Family Planning Commission shall set up a national professional quality control center, entrust the quality control center to formulate national unified quality control indicators and standards, and collect, analyze and regularly publish quality control information.
All provinces and qualified municipal health and family planning administrative departments should set up quality control centers of corresponding levels and professions to carry out medical quality management and control.
Measures for the administration of medical quality control centers shall be formulated separately by the National Health and Family Planning Commission.
Eleventh medical institutions medical quality management to implement the hospital, department two-level responsibility system. The main person in charge of a medical institution is the first person in charge of medical quality management in this institution. The main person in charge of clinical departments, pharmacy and medical technology departments (hereinafter referred to as business departments) is the first person in charge of medical quality management in this department.
Twelfth medical institutions should establish a medical quality management and control system covering the whole process of clinical diagnosis and treatment services.
Thirteenth medical institutions should set up a special medical quality management department to be responsible for the medical quality management of their own institutions.
Clinics and village clinics can designate full-time (part-time) staff to be responsible for medical quality management.
Hospitals, maternal and child health centers and specialized disease prevention and control institutions (hereinafter referred to as hospitals above the second level) shall set up medical quality management committees. The director of the Medical Quality Management Committee is the main person in charge of medical institutions, and the members are the heads of relevant functional departments such as medical management, quality control, nursing, hospital infection management, medical engineering, information and logistics, and the heads of relevant clinical, pharmaceutical and medical technology departments. Designate or set up a special department to be responsible for daily management.
Other medical institutions shall set up medical quality management working groups or designate full-time (part-time) staff to be responsible for specific management work.
Fourteenth medical institutions medical quality management committee's main responsibilities are:
(a) to implement the laws, regulations and rules of the state on medical quality management, formulate the medical quality management system of this institution and organize its implementation;
(two) to organize the medical quality monitoring, early warning, analysis, feedback and evaluation of this institution, and regularly publish the quality management information of this institution;
(three) to formulate plans for the continuous improvement of medical quality in this institution and organize their implementation;
(four) to formulate the relevant work system for the introduction of new clinical technology and the management of clinical application of medical technology in this institution, and organize the implementation and evaluation of clinical application of medical technology.
(five) training, publicity and education of medical personnel in the laws, regulations, rules and technical specifications related to medical quality management;
(six) in accordance with the relevant requirements of the administrative department of health and family planning, submit the relevant information of the medical quality management of this institution;
(seven) other medical quality management related work.
Fifteenth hospital business departments should set up a working group on medical quality management, headed by the main person in charge of the department. Designate a person to be responsible for the daily specific work. The main responsibilities of the medical quality management working group are:
(a) to implement the laws, regulations and rules on medical quality management and the medical quality management system of undergraduate course room;
(two) to carry out the management and control of medical quality in departments;
(three) to formulate plans and specific measures for the continuous improvement of medical quality in undergraduate course room;
(four) regularly analyze and evaluate the medical quality of the department, put forward rectification measures for the weak links of medical quality and organize their implementation;
(five) training and publicity and education of laws, regulations, rules and technical specifications related to medical quality management for medical personnel in this department;
(six) in accordance with the relevant requirements, submit the relevant information of undergraduate course room medical quality management.
Article 16 Medical personnel shall abide by professional ethics, strengthen the study of laws, regulations and rules related to medical quality management and the medical quality management system of their own institutions, standardize clinical diagnosis and treatment behaviors, implement medical quality management requirements, and ensure medical quality and medical safety.
Seventeenth health and family planning administrative departments at all levels and medical institutions should establish and improve the training and assessment system for medical quality management personnel, improve and give full play to the position and role of industry organizations and professionals in medical quality management. Article 18 Medical institutions should strengthen the construction of professional ethics of medical staff, carry forward the humanitarian spirit of saving lives, adhere to the principle of "patient-centered", respect the personality and rights of patients, and perform the sacred duties of preventing and treating diseases, saving lives and protecting people's health.
Nineteenth medical institutions shall obtain the "Practice License for Medical Institutions" according to law, and practice in accordance with the approved and registered diagnosis and treatment subjects. Health technical personnel shall obtain professional qualifications according to law before carrying out medical activities.
Twentieth medical institutions shall, in accordance with the requirements of the Drug Administration Law of People's Republic of China (PRC), the Regulations on the Supervision and Administration of Medical Devices and the Regulations on the Administration of Narcotic Drugs and Psychotropic Drugs, use qualified medical devices, equipment, drugs, consumables and reagents to carry out diagnosis and treatment activities.
Twenty-first medical institutions should carry out medical technology in accordance with their functions and tasks, and implement classified management of medical technology and graded management of surgery in accordance with the relevant state regulations on medical technology and operation management.
Twenty-second medical institutions and their medical staff should carry out diagnosis and treatment in accordance with the relevant requirements of clinical diagnosis and treatment guidelines and clinical technical operation specifications, strictly abide by the core system of medical quality and safety, and achieve reasonable inspection, rational drug use and reasonable treatment.
Twenty-third medical institutions should strengthen the quality management of pharmaceutical departments and pharmaceutical affairs. Carry out the clinical pharmacist system, strengthen the capacity building of clinical pharmaceutical service, and use drugs for clinical diagnosis, prevention and treatment of diseases should follow the principle of safe, effective and economical rational drug use, and respect patients' right to know about drug use.
Article 24 Medical institutions should strengthen the quality management of medical technology departments, establish a quality management system that runs through the whole process of inspection and inspection, strengthen indoor quality control, cooperate with quality control centers to do a good job in external quality evaluation, and promote mutual recognition of clinical test results.
Article 25 Medical institutions should improve the management system of outpatient and emergency services, standardize the quality management of outpatient and emergency services, strengthen the allocation of professionals and technical forces in outpatient and emergency services, ensure the medical quality and safety of outpatient and emergency services, and regard the quality of outpatient and emergency services as an important content of assessment departments and medical personnel.
Article 26 Medical institutions should attach great importance to the management of hospital infection, strictly implement the regulations of disinfection and isolation, hand hygiene, rational use of antibacterial drugs and hospital infection monitoring, establish a mechanism of hospital infection risk monitoring, early warning and multi-department coordinated intervention, and carry out training and education on the knowledge of hospital infection prevention and control. Strict implementation of hospital infection outbreak reporting system.
Twenty-seventh medical institutions should strengthen the quality management of medical records, establish and organize the implementation of medical record quality management system, and ensure the objectivity, truthfulness, accuracy, timeliness, completeness and standardization of medical record writing.
Twenty-eighth medical institutions should strengthen the construction of specialty service capacity, formulate the development plan of specialty construction and organize its implementation, attach importance to personnel training, clinical technology innovation research and achievement transformation, and improve the ability and level of specialty clinical service.
Twenty-ninth medical institutions should conscientiously implement the relevant requirements of the health and family planning administrative department and the quality control center on the management and control of medical quality, actively cooperate with the quality control center to carry out the work, and promote the continuous improvement of medical quality.
Thirtieth medical institutions should strengthen the quality management and control of single diseases, establish their own single disease management index system, formulate reference standards for single disease medical quality, and promote the fine management of medical quality.
Article 31 A medical institution shall regularly train and examine medical and health technicians in medical and health management laws, administrative regulations, departmental rules, hospital management system, medical quality management and control methods, professional technical specifications and other related contents.
Thirty-second medical institutions should strengthen the hospital information construction with electronic medical records as the core, so that the information work can meet the needs of medical quality management and control, and make full use of information means to carry out medical quality management and control.
Article 33 Medical institutions shall carry out medical quality monitoring, improve the relevant index system of medical quality management of their own institutions and departments according to the quality control indicators and standards issued by the administrative department of health and family planning or the quality control center, and collect relevant medical quality information in a timely manner.
Article 34 Medical institutions shall timely analyze, evaluate and feedback the collected medical quality information, give early warning of medical quality problems and medical safety risks, take effective intervention measures in time for existing problems, and promote the continuous improvement of the system.
Thirty-fifth medical institutions should regularly or irregularly conduct on-site inspections and spot checks on the medical quality management of various departments.
Thirty-sixth medical institutions should establish an internal publicity system for medical quality, publicize the completion of key indicators of medical quality in various departments, and criticize and educate the departments with problems. If the circumstances are serious, it shall be handled in accordance with relevant regulations.
Thirty-seventh medical institutions and their medical staff should follow the principle of informed consent of patients and not violate protective treatment measures; Fully respect patients' right to choose and privacy, and keep patients' privacy confidential. Article 38 The State establishes a reporting system for medical quality and safety incidents. Medical institutions shall establish relevant systems for information collection, recording and reporting of medical quality and safety incidents of their own institutions and organize their implementation.
Thirty-ninth medical institutions and their medical staff should improve the awareness of medical safety, improve the relevant work systems and processes of medical safety management, and implement the patient safety objectives.
Fortieth medical institutions should establish a medical safety and risk management system, and strengthen the safety and risk management of key departments and key links of medical quality.
Article 41 Medical institutions should raise awareness of risk prevention, establish and improve relevant systems, make full use of medical liability insurance and other forms of risk sharing, and protect the legitimate rights and interests of both doctors and patients.
Forty-second medical institutions should formulate plans to prevent and deal with medical accidents, prevent the occurrence of medical accidents and reduce the damage of medical accidents. Improve complaint management, medical quality and safety incident reports, resolve disputes in a timely manner, and properly handle medical malpractice disputes. Forty-third health and family planning administrative departments at or above the county level shall strengthen the supervision and inspection of medical quality management of medical institutions within their respective administrative areas. The medical institution under inspection shall cooperate with it and shall not refuse, obstruct or conceal it.
Forty-fourth local health and family planning administrative departments at or above the county level shall establish an evaluation system for medical quality management of medical institutions, make full use of information technology to carry out evaluation work, and regularly publish evaluation results in the industry.
Forty-fifth local health and family planning administrative departments at or above the county level shall establish an interview system for medical quality management of medical institutions. Interview the heads of various medical institutions at all levels with serious medical quality and safety incidents, serious medical quality and safety risks or failure to rectify as required. If the situation is serious, it shall be notified and reported to the superior health and family planning administrative department for the record.
Article 46 The National Health and Family Planning Commission shall establish a national medical quality management and control information system to collect, analyze and feed back the main index information of national medical quality management.
Provincial health and family planning administrative departments shall establish medical quality management and control information systems within their respective administrative areas, collect, analyze and feedback information related to medical quality management of medical institutions within their respective administrative areas, and evaluate the medical quality of medical institutions.
Forty-seventh health and family planning administrative departments should incorporate the medical quality management of medical institutions into the key indicators of the assessment of medical institutions and their main responsible persons, and combine them with hospital assessment, appraisal and personal performance assessment. If the examination is unqualified, the medical institution and its principal responsible person shall be dealt with as appropriate.
Forty-eighth medical institutions should take the medical quality management of departments as an important index for the comprehensive target assessment, appointment, promotion and assessment of department heads. Those who fail the examination will be dealt with as appropriate.
Medical institutions should regard the medical quality management of departments and medical personnel as an important basis for regular assessment, promotion and performance evaluation of departments and medical personnel. Article 49 If a medical institution carries out medical treatment activities beyond the registered scope, uses non-health technicians to carry out medical treatment activities, or uses unqualified or unapproved medical technology, instruments, equipment, medicines, consumables and reagents to carry out medical treatment activities, the local health and family planning administrative department at or above the county level shall handle them in accordance with relevant national laws and regulations.
Fiftieth medical institutions in any of the following circumstances, the health and family planning administrative departments at or above the county level shall order them to make corrections within a time limit; Overdue reform, informed criticism, and give a warning; Causing serious consequences, the responsible person in charge and other directly responsible personnel shall be punished according to law:
(a) the medical quality management department has not been established or the full-time (part-time) staff has not been designated to be responsible for the medical quality management;
(two) the medical quality management department or full-time (part-time) staff did not play a role;
(three) the relevant rules and regulations of medical quality management have not been established;
(four) the medical quality management system is not implemented or not implemented in place, which leads to confusion in medical quality management and serious consequences;
(five) failing to train and assess medical personnel according to regulations;
(six) the occurrence of major medical quality and safety accidents;
(seven) failing to truthfully submit medical quality and safety related information in accordance with the provisions;
(eight) other acts in violation of the provisions of these measures.
Article 51 Medical personnel who commit any of the following acts in their practice shall be dealt with by local health and family planning administrative departments at or above the county level in accordance with the provisions of Article 37 of the Medical Practitioners Law and Article 31 of the Nurses Regulations and other relevant laws and regulations; If the case constitutes a crime, criminal responsibility shall be investigated according to law:
(a) in violation of health laws, regulations, rules, diagnosis and treatment norms or technical operation norms, resulting in serious consequences;
(two) due to irresponsible delay in the rescue and diagnosis and treatment of critically ill patients, resulting in serious consequences;
(3) disclosing the patient's privacy;
(four) do not abide by the principle of informed consent to carry out medical activities;
(five) the use of unapproved medical technology, drugs, equipment, instruments and consumables;
(six) other acts in violation of the provisions of these measures.
Other health technical personnel who violate the provisions of these measures shall be dealt with according to the provisions of relevant laws and regulations.
Fifty-second local health and family planning administrative departments at or above the county level fail to perform their supervisory duties in accordance with the provisions of these measures, resulting in serious consequences, and the directly responsible person in charge and other directly responsible personnel shall be given administrative sanctions according to law. Article 53 The core system of medical quality and safety as mentioned in these Measures refers to the relevant systems that medical institutions and their medical staff should strictly abide by in their diagnosis and treatment activities, mainly including: the first consultation system, the three-level rounds system, the consultation system, the graded nursing system, the duty and handover system, the difficult case discussion system, the emergency rescue system for critically ill patients, the preoperative discussion system, the death case discussion system, the investigation system, the operation safety verification system, the operation grading management system, the new technology and the new project access.
Article 54 The state administrative department of traditional Chinese medicine shall be responsible for the supervision and management of medical quality of medical institutions of traditional Chinese medicine within the scope of its duties.
Article 55 These Measures shall be interpreted by the National Health and Family Planning Commission.
Article 56 These Measures shall come into force as of +2065438.