No.48
The Measures for the Administration of Hospital Infection have been discussed and passed at the ministerial meeting of the Ministry of Health on June 1 2006, and are hereby promulgated and shall come into force on September 1 2006.
Minister Gao Qiang
Press release issued on 6 July 2006
Measures for the administration of nosocomial infection
Chapter I General Provisions
Article 1 In order to strengthen the management of hospital infection, effectively prevent and control hospital infection, improve medical quality and ensure medical safety, these measures are formulated in accordance with the provisions of the Law on the Prevention and Control of Infectious Diseases, the Regulations on the Administration of Medical Institutions, the Regulations on Emergency Response to Public Health Emergencies and other laws and administrative regulations.
Article 2 Hospital infection management refers to the prevention, diagnosis and control activities carried out by health administrative departments, medical institutions and medical personnel at all levels in view of hospital infection, iatrogenic infection and related risk factors existing in diagnosis and treatment activities.
Article 3 All kinds of medical institutions at all levels shall implement hospital infection management in strict accordance with the provisions of these Measures.
The occupational health protection of medical personnel shall be implemented in accordance with the relevant provisions of the Law on the Prevention and Control of Occupational Diseases and its supporting regulations and standards.
Article 4 The Ministry of Health shall be responsible for the supervision and management of hospital infection management throughout the country.
The health administrative departments of local people's governments at or above the county level shall be responsible for the supervision and management of hospital infection management within their respective administrative areas.
Chapter II Organization and Management
Article 5 Medical institutions of all levels and types shall establish a responsibility system for hospital infection management, formulate and implement rules and regulations and work norms for hospital infection management, strictly implement relevant technical operation norms and work standards, effectively prevent and control hospital infection, and prevent the spread of infectious disease pathogens, drug-resistant bacteria, conditional pathogenic bacteria and other pathogenic microorganisms.
Sixth hospital beds 100 above the hospital shall set up a hospital infection management committee and an independent hospital infection management department.
Hospitals with the total number of inpatient beds less than 100 should designate departments to be responsible for hospital infection management.
Other medical institutions should have full-time (part-time) staff engaged in hospital infection management.
Article 7 The Hospital Infection Management Committee is composed of the principals of the hospital infection management department, medical department, nursing department, clinical department, disinfection supply room, operating room, clinical laboratory, pharmaceutical affairs management department, equipment management department, logistics management department and other relevant departments, with the director of the hospital or the vice president in charge of medical work as the chairman.
Hospital infection management committee is responsible for:
(a) conscientiously implement the laws, regulations, technical specifications and standards related to the management of hospital infection, formulate rules and regulations for the prevention and control of hospital infection and diagnostic standards for hospital infection, and supervise the implementation;
(two) according to the requirements of preventing hospital infection and health, the basic standards, basic facilities and workflow of architectural design and key department construction in our hospital are reviewed and opinions are put forward;
(three) to study and determine the hospital infection management work plan, and to assess and evaluate the implementation of the plan;
(four) to study and determine the key departments, key links, key processes, risk factors and intervention measures of nosocomial infection in our hospital, and to clarify the responsibilities of relevant departments and personnel in preventing and controlling nosocomial infection;
(five) to study and formulate the control plan for the outbreak of nosocomial infection and the occurrence of unexplained infectious diseases or special pathogen infection cases in our hospital;
(6) Establish a meeting system to regularly study, coordinate and solve problems related to hospital infection management;
(seven) according to the characteristics of pathogenic bacteria in our hospital and the current situation of drug resistance, cooperate with the Pharmaceutical Affairs Management Committee to put forward guiding opinions on the rational use of antibacterial drugs;
(eight) other important matters related to hospital infection management.
Article 8 Hospital infection management departments, competent departments and full-time (part-time) staff are specifically responsible for the management and business work of hospital infection prevention and control. The main responsibilities are:
(a) to inspect and guide the implementation of hospital infection prevention and control management rules and regulations;
(2) To monitor, analyze and give feedback on hospital infection and its related risk factors, put forward control measures for the problems and guide their implementation;
(3) To investigate and analyze the occurrence of nosocomial infection and report to the hospital infection management committee or the person in charge of the medical institution;
(four) to provide guidance for hospital cleaning, disinfection and isolation, aseptic operation technology, medical waste management and other work;
(five) to provide guidance for the hospital infection control of infectious diseases;
(six) to provide occupational health and safety protection guidance for medical personnel to prevent hospital infection;
(seven) report and investigate the epidemic situation of hospital infection, put forward control measures and coordinate and organize relevant departments to deal with it;
(eight) training for medical personnel to prevent and control hospital infection;
(nine) to participate in the management of clinical application of antibacterial drugs;
(ten) audit disinfection of medical devices and disposable medical devices related certificates;
(eleven) to organize scientific research on the prevention and control of hospital infection;
(twelve) to complete other tasks assigned by the hospital infection management committee or the person in charge of the medical institution.
Article 9 The Ministry of Health shall set up an expert group on the prevention and control of hospital infection, which is composed of experts in hospital infection management, disease control, epidemiology, clinical examination, epidemiology, disinfection, clinical pharmacy and nursing. The main responsibilities are:
(a) to study and draft technical standards and norms for the prevention and control of nosocomial infection and the diagnosis of nosocomial infection;
(two) to provide professional guidance for the prevention and control of hospital infection in the country;
(3) To investigate and analyze the occurrence and risk factors of hospital infection in China;
(four) to investigate the major hospital infection incidents in China and provide professional guidance;
(five) to complete other tasks assigned by the Ministry of health.
Article 10 The health administrative department of the provincial people's government shall set up an expert group for the prevention and control of hospital infection, which shall be responsible for guiding the technical work of preventing and controlling hospital infection in this area.
Chapter III Prevention and Control
Eleventh medical institutions should strengthen the prevention and control of hospital infection in accordance with the relevant rules and regulations and technical specifications of hospital infection management.
Twelfth medical institutions shall, in accordance with the "disinfection management measures", strictly implement the technical specifications for disinfection of medical devices, and meet the following requirements:
(1) Medical instruments, utensils and articles entering human tissues and sterile organs must reach the sterilization level;
(2) Medical instruments, appliances and articles in contact with skin and mucous membrane must reach the disinfection level;
(three) all kinds of medical devices used for injection, puncture, blood collection and other invasive operations must be disinfected once.
Disinfected medical devices, disposable medical devices and appliances used by medical institutions shall comply with the relevant provisions of the state. Disposable medical devices shall not be reused.
Thirteenth medical institutions should formulate specific measures to ensure that medical staff's hand hygiene, diagnosis and treatment environmental conditions, aseptic operation technology and occupational health protection work meet the prescribed requirements, and control the risk factors of hospital infection.
Fourteenth medical institutions should strictly implement the isolation technical specifications and take corresponding isolation measures according to the transmission route of pathogens.
Fifteenth medical institutions should formulate specific measures for the occupational health protection of medical staff, provide necessary protective equipment, and ensure the occupational health of medical staff.
Sixteenth medical institutions should strengthen the clinical use of antibacterial drugs and the monitoring and management of drug-resistant bacteria in strict accordance with the Guiding Principles for Clinical Application of Antibacterials.
Article 17 Medical institutions shall timely diagnose hospital infection cases according to the diagnostic criteria of hospital infection, establish an effective hospital infection monitoring system, analyze the risk factors of hospital infection, and implement preventive and control measures according to the risk factors leading to hospital infection.
Medical institutions should promptly discover hospital infection cases and epidemics, analyze the sources and ways of infection, take effective treatment and control measures, and actively treat patients.
Article 18 A medical institution shall report to the health administrative department of the local people's government at the county level within 12 hours and report to the local disease prevention and control institution if it is confirmed by investigation that there are any of the following circumstances. After confirmation, the health administrative department of the local people's government at the county level shall report to the health administrative department of the provincial people's government step by step within 24 hours. The health administrative department of the provincial people's government shall report to the Ministry of Health within 24 hours after the audit:
(a) more than 5 cases of hospital infection outbreak;
(two) the patient died directly due to the outbreak of hospital infection;
(three) the outbreak of hospital infection caused personal injury.
Nineteenth medical institutions in the following circumstances, should be reported in accordance with the "national public health emergencies related information reporting management standards (Trial)" requirements:
(1) Outbreaks of nosocomial infection above 10;
(two) the occurrence of special pathogens or new pathogens of hospital infection;
(3) Hospital infection that may cause significant public impact or serious consequences.
Twentieth is a legal infectious disease in medical institutions hospital infection, should be in accordance with the "People's Republic of China (PRC) infectious disease prevention law" and "national public health emergencies emergency plan" provisions of the report and treatment.
Article 21 When an outbreak of hospital infection occurs in a medical institution, the local disease prevention and control institution shall conduct epidemiological investigation in time, find out the source of infection, transmission route and infection factors, and take control measures to prevent the spread of the source of infection and the expansion of the scope of infection.
Article 22 After receiving the report, the administrative department of health shall, according to the situation, guide medical institutions to investigate and control hospital infection, and may organize and provide corresponding technical support.
Chapter IV Personnel Training
Twenty-third health administrative departments and medical institutions at all levels should pay attention to the discipline construction of hospital infection management, establish a professional training system, and give full play to the role of professional and technical personnel in preventing and controlling hospital infection.
Article 24 The health administrative department of the provincial people's government shall establish a standardized training and assessment system for hospital infection professionals, strengthen continuing education, and improve the professional and technical level of hospital infection professionals.
Article 25 A medical institution shall formulate a training plan for its staff, and train all the staff in the relevant laws and regulations on hospital infection, relevant work norms and standards for hospital infection management, and professional and technical knowledge.
Twenty-sixth hospital infection professionals should have professional knowledge of hospital infection prevention and control, and be able to undertake hospital infection management and professional and technical work.
Twenty-seventh medical personnel should master the knowledge of hospital infection prevention and control related to their own work, and implement the rules and regulations, work norms and requirements of hospital infection management. The staff should master the basic knowledge of hygiene, disinfection and isolation to prevent and control hospital infection, and use it correctly in their work.
Chapter V Supervision and Administration
Twenty-eighth health administrative departments of local people's governments at or above the county level shall, in accordance with the relevant laws and regulations and the provisions of these measures, supervise and inspect the medical institutions within their jurisdiction.
Article 29 The main contents of supervision and inspection of medical institutions are:
(a) the rules and regulations of hospital infection management and their implementation;
(two) the risk factors of hospital infection and control measures;
(3) Disinfection and isolation, medical waste management and occupational health protection for medical personnel;
(4) Monitoring of nosocomial infection cases and outbreaks;
(5) On-site inspection.
Thirtieth health administrative departments in the inspection found that there are hidden dangers of hospital infection in medical institutions, it should be ordered to rectify or temporarily close the relevant departments or suspend the relevant medical subjects.
Thirty-first medical institutions shall cooperate with the inspection, investigation and evidence collection of the administrative department of health, and shall not refuse or obstruct or provide false materials.
Chapter VI Punishment
Article 32 Where the health administrative department of the local people's government at or above the county level fails to perform the duties of supervision, management, reporting, investigation and handling of hospital infection outbreaks in accordance with the provisions of these Measures, resulting in serious consequences, the principal responsible person, the directly responsible person and the relevant responsible person of the health administrative department shall be given administrative sanctions of demotion or dismissal.
Thirty-third medical institutions in violation of these measures, one of the following acts, the health administrative department of the local people's governments at or above the county level shall be ordered to make corrections, overdue reform, given a warning and informed criticism; If the circumstances are serious, the principal responsible person and the person directly responsible shall be given administrative sanctions of demotion or dismissal:
(a) did not establish or implement the rules and regulations and work norms of hospital infection management;
(two) the hospital infection management department, the competent department and the designated full-time (part-time) staff are not established to be responsible for the prevention and control of hospital infection;
(3) Violating the technical specifications for disinfection of medical devices;
(4) Violating the technical specifications for aseptic operation and isolation;
(five) the relevant certificates of disinfection medical devices and disposable medical devices have not been audited;
(6) Failing to provide occupational health protection for the occupational exposure of medical personnel.
Article 34 If a medical institution, in violation of the provisions of these Measures, fails to take preventive and control measures or fails to take control measures in time when hospital infection occurs, resulting in the outbreak of hospital infection, the spread of infectious diseases or other serious consequences, the responsible person in charge and the person directly responsible shall be given administrative sanctions of demotion, dismissal and expulsion; If the circumstances are serious, the practicing certificate of the responsible person may be revoked in accordance with the provisions of Article 69 of the Law on the Prevention and Control of Infectious Diseases; If a crime is constituted, criminal responsibility shall be investigated according to law.
Thirty-fifth medical institutions hospital infection epidemic situation is not reported in accordance with the provisions of these measures, by the health administrative department of the local people's government at or above the county level informed criticism; If serious consequences are caused, the responsible person in charge and other directly responsible personnel shall be demoted, dismissed and dismissed.
Chapter VII Supplementary Provisions
Article 36 The meanings of the following terms in these Measures:
(1) Nosocomial infection: refers to the infection acquired by inpatients in the hospital, including the infection during hospitalization and the infection after discharge, but excluding the infection that started before admission or was in the incubation period when admission. The infection acquired by hospital staff in the hospital is also a hospital infection.
(2) Iatrogenic infection: refers to the infection caused by the spread of pathogens in medical services.
(3) Outbreak of nosocomial infection: refers to the phenomenon that more than 3 cases of homologous infection occur among patients in medical institutions or their departments within a short period of time.
(4) Disinfection refers to killing or eliminating pathogenic microorganisms in the environment by chemical, physical and biological methods.
(5) Sterilization: killing or eliminating all microorganisms in the culture medium, including pathogenic microorganisms and non-pathogenic microorganisms, as well as bacterial spores and fungal spores.
Article 37 Hospital infection management in medical institutions of China People's Liberation Army is under the centralized management of the Ministry of Health of China People's Liberation Army.
Thirty-eighth blood collection and supply institutions and disease prevention and control institutions of iatrogenic infection prevention and control management with reference to these measures.
Article 39 These Measures shall come into force as of September 6, 2006, and the Norms for Hospital Infection Management (Trial) promulgated on October 30, 2000/KLOC-0 shall be abolished at the same time.