Methods for the Management of Medical Quality (Exposure Draft) Article 1 These Measures are formulated in accordance with the relevant laws and regulations in order to strengthen the management of medical quality, standardize the behavior of medical services, ensure medical safety, and safeguard the legitimate rights and interests of doctors and patients.
Article 2 The medical quality referred to 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 diagnostic and therapeutic norms under the existing level of medical technology and conditions and capabilities.
Article 3 The medical quality management referred to in these measures, refers to the formation of medical quality in accordance with the law and the relevant laws and regulations, the use of modern scientific management methods, the elements of medical services, processes and results of management and control, in order to achieve systematic improvement of the quality of medical care, the process of continuous improvement activities.
Article IV medical quality management is the core of the management of medical institutions. All levels and types of medical institutions should comprehensively strengthen medical quality management.
Article V medical institutions to carry out medical services should comply with relevant laws, regulations, rules and regulations, 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 the quality of medical care in medical institutions throughout the country.
Local health planning administrative departments at or above the county level are responsible for the supervision and management of the quality of medical care in medical institutions within their administrative regions.
Article 7 These measures shall apply to all levels and types of medical institutions, medical quality management. Article 8 The National Health and Family Planning Commission is responsible for organizing or commissioning professional institutions to develop medical quality management related systems, norms, standards and guidelines to guide local health and family planning administrative departments at all levels and medical institutions to carry out medical quality management and control.
Local health planning administrative departments at all levels are responsible for supervising and guiding medical institutions to implement rules and regulations related to medical quality management. Provincial health planning administrative departments can be based on the actual situation in the region, the development of medical quality management related systems, norms and specific implementation programs.
Article IX of the state to establish medical quality management and control system. Relying on all levels and specialties of medical quality control center (hereinafter referred to as quality control center) and all levels and types of medical institutions quality control management department to implement the relevant work requirements of medical quality management.
Article 10: The National Health and Family Planning Commission has set up national quality control centers for various specialties, commissioned the quality control centers to formulate nationally uniform quality control indicators and standards, and to collect, analyze, and regularly release quality control information.
Provinces and municipal health administrative departments with the conditions to set up the corresponding level, professional quality control center, to carry out medical quality management and control work.
Methods for the management of medical quality control centers are separately formulated by the National Health and Family Planning Commission.
Article XI of the medical quality management of medical institutions to implement hospitals and departments at the two levels of responsibility. The main person in charge of the medical institution is the first person responsible for the management of medical quality in the institution. Clinical departments as well as pharmacy, medical technology and other departments (hereinafter referred to as business units) is the main person in charge of the medical quality management of the first person responsible for the department.
Article XII of the medical institutions shall establish the organization's full participation, covering the whole process of clinical diagnosis and treatment services, medical quality management and control system.
Article XIII of the medical institutions should be set up to manage the quality of medical care special department, responsible for the institution's medical quality management.
Clinics, village health centers can be designated full-time (part-time) personnel responsible for medical quality management.
Hospitals above the second level (including the second level), maternal and child health centers and specialized disease control institutions (hereinafter referred to as hospitals above the second level) shall establish a medical quality management committee. Medical quality management committee director by the medical institution as the main person in charge, members of the medical management, quality control, nursing, hospital infection management, medical engineering, information, logistics and other relevant functional department heads, as well as relevant clinical, pharmacy, medical technology and other department heads. Designated or set up a specialized department specifically responsible for the day-to-day management.
Other medical institutions to set up medical quality management team or designate a full-time (part-time) staff, responsible for specific management.
Article XIV of the medical quality management committee of medical institutions, the main responsibilities are:
(1) the implementation of national laws, regulations, rules and regulations of medical quality management, the development of the institution's medical quality management system and organize the implementation of;
(2) the organization of the institution's medical quality monitoring, early warning, analysis, feedback and assessment and evaluation, and regularly publish the institution's quality management information;
(2) the organization of the institution's medical quality monitoring, early warning, analysis, feedback and assessment and evaluation, and regularly publish the institution Quality management information;
(3) the development of the institution's medical quality continuous improvement plan and organization and implementation;
(4) the development of the institution's clinical new technology introduction and clinical application of medical technology management system and organization and implementation of the organization to carry out the assessment of the clinical application of medical technology.
(E) medical staff for medical quality management related laws, regulations, rules and regulations, technical specifications of the training and publicity and education;
(F) in accordance with the relevant requirements of the administrative department of health planning and health care institutions to report the quality of medical management of the information;
(VII) other medical quality management related work.
Article XV of the second level above the hospital business departments should be set up in the medical quality management work group, the head of the department as the main person in charge. Designated specialists responsible for the day-to-day specific work. Medical quality management work team's main responsibilities are:
(a) implementation of medical quality management related laws, regulations, rules and regulations and the department's medical quality management system;
(b) to carry out the department's medical quality management and control work;
(c) the development of the department's plan for continuous improvement in the quality of medical care and the specific implementation of measures;
(d) Regularly analyze and evaluate the medical quality of the department, propose corrective measures for the weak links of medical quality and organize the implementation of such measures;
(e) Provide training and publicity and education for the medical staff of the department on laws, regulations, rules and technical specifications related to medical quality management;
(f) Report information related to the medical quality management of the department in accordance with the relevant requirements.
Article XVI of the medical staff shall abide by professional ethics, strengthen the quality of medical care management related laws, regulations, rules and regulations and the institution's medical quality management system, standardize the clinical diagnosis and treatment behavior, the implementation of medical quality management requirements to protect the quality of medical care and medical safety.
Article XVII of the administrative departments of health and medical institutions at all levels shall establish and improve the cultivation of medical quality management personnel and assessment system, to improve and give full play to the status and role of industry organizations and professionals in the management of medical quality. Article XVIII of medical institutions should strengthen the professional ethics of medical personnel, carry forward the humanitarian spirit of saving lives, adhere to the "patient-centered", respect for the personality and rights of patients, and perform the prevention and treatment of disease, saving lives and protecting people's health sacred duties.
Article 19 of the medical institutions shall obtain a "license for medical institutions" in accordance with the law, in accordance with the approved registration of the diagnosis and treatment subjects practice. Health professionals to carry out diagnostic and therapeutic activities should be qualified to practice in accordance with the law.
Article 20 of the medical institutions shall, in accordance with the "Chinese People's Republic of China *** and the State Drug Administration Law", "Medical Device Supervision and Administration Regulations" and "Regulations on the Administration of Narcotic Drugs and Psychotropic Substances," the requirements of the use of qualified medical equipment, medical instruments, medicines, consumables, reagents to carry out diagnostic and therapeutic activities.
Article 21 of the medical institutions to carry out medical technology should be appropriate to their functions and tasks, in accordance with the relevant provisions of the State on medical technology and surgical management, the implementation of classification and management of medical technology, the implementation of graded management of surgery.
Article 22 of the medical institutions and their medical staff shall follow the clinical diagnosis and treatment guidelines and clinical practice standards for diagnosis and treatment of the relevant requirements, and strictly abide by the core system of medical quality and safety, to achieve reasonable inspection, rational use of medication, rational treatment.
Article 23 of the medical institutions shall strengthen the pharmacy department and pharmaceutical quality management. The implementation of clinical pharmacist system, strengthen the capacity of clinical pharmacy services, clinical diagnosis, prevention and treatment of disease medication should follow the principle of safe, effective, economical and rational use of drugs, respect for the patient's right to information on the use of drugs.
Article 24 of the medical institutions shall strengthen the quality management of medical technology departments, the establishment of the whole process of inspection, test quality management system, strengthen indoor quality control, with the quality control center to do a good job in the inter-room quality evaluation, and promote mutual recognition of clinical inspection and test results.
Article 25 of the medical institutions shall improve the outpatient emergency management system, standardize the quality management of outpatient emergency, strengthen the outpatient emergency professionals and technical force to ensure the quality of outpatient emergency medical care and medical safety, and the quality of outpatient emergency work as an important part of the assessment of the department and medical personnel.
Article 26 Medical institutions shall attach great importance to the management of hospital infection, strict implementation of disinfection and isolation, hand hygiene, rational use of antimicrobial drugs and monitoring of hospital infection, the establishment of risk monitoring of hospital infections, early warning and multi-departmental collaborative intervention mechanism, to carry out training and education on the prevention and control of hospital infection. Strictly implement the hospital infection outbreak reporting system.
Article 27 of the medical institutions shall strengthen the quality management of medical records, the establishment of medical records quality management system and organization and implementation, to ensure that the medical records written objectively, truthfully, accurately, timely, complete and standardized.
Article 28 of the medical institutions shall strengthen the specialty service capacity building, develop specialty construction and development planning and implementation, pay attention to personnel training, clinical technology, innovative research and transformation of results, improve the clinical service capacity and level of specialties.
Article 29 The medical institutions shall conscientiously implement the administrative departments of health planning and quality control center on medical quality management and control of the relevant requirements, and actively cooperate with the work of the quality control center, and promote the continuous improvement of medical quality.
Article 30 The medical institutions shall strengthen the quality management and control of single disease, the establishment of the institution's single disease management index system, the development of single disease medical quality reference standards, and promote the fine management of medical quality.
Article 31 The medical institutions shall regularly carry out medical and health care technicians in health care management laws, administrative regulations, departmental regulations, hospital management system, medical quality management and control methods, professional and technical specifications and other relevant content of the training and assessment work.
Article 32 of the medical institutions shall strengthen the electronic medical records as the core of the hospital information technology construction, so that information technology to meet the needs of medical quality management and control, and make full use of information technology to carry out medical quality management and control.
Article 33 of the medical institutions shall carry out medical quality monitoring work, according to the quality control indicators and standards issued by the health planning and health administrative departments or quality control center to improve the quality of medical care in the institution and each department of medical quality management of the relevant indicator system, and timely collection of relevant information on the quality of medical care.
Article 34 The medical institutions shall analyze, evaluate and feedback the collected medical quality information in a timely manner, provide early warning of medical quality problems and medical safety risks, take timely and effective interventions on existing problems, and promote the continuous improvement of the system.
Article 35 The medical institutions shall regularly or irregularly on-site inspection and random inspection of the medical quality management of each department.
Article 36 The medical institution shall establish the institution's medical quality internal publicity system, the completion of the key indicators of medical quality of each department to be internally announced, the problematic departments to criticize and educate, the situation is serious, according to the relevant provisions of the treatment.
Article 37 of the medical institutions and their medical staff to carry out diagnostic and treatment activities, without violating the premise of protective therapeutic measures, should follow the principle of informed consent of the patient; full respect for the patient's right to choose and the right to privacy, and confidentiality of the patient's privacy. Article 38 The state establishes a medical quality and safety incident reporting system. Medical institutions shall establish the institution of medical quality and safety events information collection, recording and reporting system and organization and implementation.
Article 39 The medical institutions and their medical staff should improve medical safety awareness, improve medical safety management related work systems and processes, the implementation of patient safety goals.
Article 40 The medical institutions shall establish medical safety and risk management system, strengthen the medical quality of key departments and key aspects of safety and risk management.
Article 41 of the medical institutions should improve the awareness of risk prevention, establish and improve the relevant systems, make full use of medical liability insurance and other forms of risk sharing, to protect the legitimate rights and interests of doctors and patients.
Article 42 The medical institutions shall formulate the prevention and treatment of medical accidents plan to prevent the occurrence of medical accidents, to mitigate the damage of medical accidents. Improve the management of complaints, medical quality and safety incident reporting, timely resolution of disputes, proper disposal of medical malpractice disputes. Article 43 The administrative departments of health planning above the county level shall strengthen the supervision and inspection of medical quality management of medical institutions in the administrative region. The inspected medical institutions shall cooperate and shall not refuse, obstruct or conceal.
Article 44 The local health planning administrative departments at or above the county level shall establish a medical quality management assessment system for medical institutions, make full use of information technology to carry out the assessment work, and regularly release the assessment results in the industry.
Article 45 The local health planning administrative departments at or above the county level shall establish a medical quality management of medical institutions interview system. The occurrence of major, major medical quality and safety incidents, the existence of serious medical quality and safety hazards, or failure to comply with the requirements of the rectification of all levels and types of medical institutions in charge of the interview, the situation is serious shall be notified, and reported to the higher level of health planning administrative department for the record.
Article 46 The National Health and Family Planning Commission establishes a national medical quality management and control information system to collect, analyze and provide feedback on the main indicators of national medical quality management.
Provincial health planning administrative departments shall establish medical quality management and control information systems in their administrative regions, collect, analyze and feedback information related to medical quality management of medical institutions in their administrative regions, and evaluate the medical quality of medical institutions.
Article 47 The administrative department of health planning shall incorporate the medical quality management of medical institutions into the key indicators of the assessment of medical institutions and their principals, and with hospital accreditation, evaluation and individual performance assessment. Failure to pass the assessment, as appropriate, the medical institution and its principal officers to deal with.
Article 48 The medical institutions should be the department of medical quality management as the department head of the comprehensive target assessment and appointment, promotion, evaluation and appraisal of the important indicators. Failure to pass the assessment, as appropriate, be dealt with.
Medical institutions should be the department and medical staff medical quality management as a regular assessment of physicians, promotion, and department and medical personnel performance appraisal is an important basis. Article 49 The medical institutions to carry out diagnostic and treatment activities beyond the scope of registration, the use of non-health professionals engaged in diagnostic and treatment work, the use of unqualified or unapproved use of medical technology, instruments, equipment, medicines, consumables, reagents to carry out diagnostic and treatment activities, by the county level and above the local health administrative departments in accordance with the relevant laws and regulations of the state.
Article 50 Medical institutions in one of the following circumstances, by the county-level or above the administrative department of health planning and ordered to make corrections within a certain period of time; overdue, notification of criticism, and given a warning; causing serious consequences, the supervisory personnel responsible and other personnel directly responsible, shall be given sanctions in accordance with the law:
(a) failure to establish a medical quality management department or failure to designate a full-time staff responsible for the management of medical quality;
(i) failure to establish a medical quality management department or failure to designate a full-time staff responsible for medical quality management;
(ii) medical quality management department or full-time (part-time) personnel did not play a role;
(iii) failure to establish rules and regulations related to medical quality management;
(iv) medical quality management system is not implemented or implementation is not in place, leading to confusion in medical quality management, resulting in serious consequences;
(v) Failure to carry out training and assessment of medical personnel in accordance with the provisions;
(F) the occurrence of major medical quality and safety incidents hidden and not reported;
(G) failure to truthfully report medical quality and safety-related information in accordance with the provisions;
(H) other violations of the provisions of these Measures.
Article 51 The medical and health care personnel in the practice of one of the following acts, by the local health planning and health care administrative departments at or above the county level in accordance with the "Practicing Physicians Law" Article 37, "Nurses Regulations" Article 31 and other relevant laws and regulations; constitutes a crime, shall be investigated for criminal responsibility:
(a) violation of health laws, regulations, rules and regulations, diagnostic and treatment norms
(ii) delaying the rescue and treatment of patients in critical condition due to irresponsibility, resulting in serious consequences;
(iii) disclosing the privacy of patients;
(iv) carrying out medical activities without complying with the principle of informed consent;
(v) using unapproved medical technology, drugs, equipment, devices, supplies , consumables;
(F) other violations of the provisions of these measures.
Other health technicians who violate the provisions of these Measures shall be dealt with in accordance with the provisions of relevant laws and regulations.
Article 52 The local health planning administrative departments at or above the county level have failed to fulfill their supervisory duties in accordance with the provisions of these Measures, resulting in serious consequences, the directly responsible persons in charge and other directly responsible persons shall be given administrative sanctions in accordance with the law. Article 53 The core system of medical quality and safety referred to in these Measures refers to the relevant systems that should be strictly observed by medical institutions and their medical personnel in their diagnosis and treatment activities, including: the first diagnosis and responsibility system, the three-level check-up system, the consultation system, the hierarchical nursing care system, the duty and shift handover system, the system of discussing difficult cases, the system of rescuing patients with acute and critical illnesses, the system of pre-operative discussion, the system of discussing fatal cases, the checking system, the surgical safety verification system, the surgical grading system, the system of checking and checking.
Article 54 The State Administration of Traditional Chinese Medicine shall be responsible for the supervision and management of the quality of medical care in TCM medical institutions within its scope of responsibilities.
Article 55 These Measures shall be interpreted by the National Health and Family Planning Commission.
Article 56 These Measures shall come into force on January, 2014.