Ministry of Health Order  

(No. 48)

　　The Measures for the Administration of Hospital Infections were deliberated and adopted at the Ministry of Health’s Executive Meeting on June 15, 2006, and are hereby promulgated, entering into force as of September 1, 2006.

Minister Gao Qiang
July 6, 2006

Measures for the Management of Hospital-Acquired Infections

Chapter I General Provisions

　　Article 1: In order to strengthen the management of hospital-acquired infections, effectively prevent and control such infections, improve the quality of medical care, and ensure patient safety, these Measures are hereby 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 relevant laws and administrative regulations.
　　Article 2: Hospital infection management refers to the preventive, diagnostic, and control measures undertaken by health administrative departments at all levels, medical institutions, and healthcare personnel to address hospital-acquired infections, iatrogenic infections, and associated risk factors arising in the course of diagnosis and treatment.
　　Article 3: Medical institutions at all levels and of all types shall implement hospital infection control in strict accordance with the provisions of these Measures.
　　Occupational health protection for medical personnel shall be implemented in accordance with the relevant provisions of the Law on Prevention and Control of Occupational Diseases, as well as its accompanying regulations and standards.
　　Article 4: The Ministry of Health is responsible for the supervision and administration of hospital infection control nationwide.
　　The health administrative departments of local people’s governments at or above the county level are responsible for the supervision and administration of hospital infection control within their respective administrative areas.

Chapter 2: Organizational Management

　　Article 5: Medical institutions at all levels and of all types shall establish a responsibility system for hospital infection management, formulate and implement relevant rules and regulations and operational standards for hospital infection control, strictly adhere to applicable technical procedures and work standards, and effectively prevent and control hospital-acquired infections, thereby preventing the transmission of pathogenic agents of infectious diseases, drug-resistant bacteria, opportunistic pathogens, and other pathogenic microorganisms.
　　Article 6 Hospitals with a total of 100 or more inpatient beds shall establish a Hospital Infection Control Committee and an independent hospital infection management department.
　　Hospitals with a total of fewer than 100 inpatient beds shall designate a department responsible for hospital infection management.
　　Other medical institutions shall have dedicated or part-time personnel responsible for hospital infection management.
　　Article 7 The Hospital Infection Control Committee shall be composed of the heads of the hospital infection control department, the medical affairs department, the nursing department, the clinical departments, the central sterile supply department, the operating room, the clinical laboratory, the pharmacy management department, the equipment management department, the logistics management department, and other relevant departments. The chairperson shall be the hospital president or the vice president in charge of medical affairs.
　　The responsibilities of the Hospital Infection Control Committee are:
　　(1) Diligently implement the laws, regulations, technical specifications, and standards pertaining to hospital infection management; formulate this hospital’s rules and procedures for the prevention and control of hospital-acquired infections, as well as diagnostic criteria for hospital-acquired infections, and oversee their implementation.
　　(2) In accordance with hospital infection prevention and hygiene requirements, review the hospital’s architectural design, the basic standards for the development of key departments, essential facilities, and work processes, and provide recommendations.
　　(3) To research and formulate the hospital’s infection control management plan, and to conduct assessment and evaluation of its implementation;
　　(4) Conduct research to identify the hospital’s priority departments, critical links, key processes, risk factors, and corresponding intervention measures, and clearly define the responsibilities of relevant departments and personnel in the prevention and control of healthcare-associated infections.
　　(5) To research and develop control plans for situations such as outbreaks of hospital-acquired infections, the emergence of infectious diseases of unknown etiology, or cases of infection caused by unusual pathogens within this hospital;
　　(6) Establish a meeting system to regularly review, coordinate, and resolve issues related to hospital infection management.
　　(7) In accordance with the characteristics of pathogens and the current antibiotic resistance patterns at this hospital, collaborate with the Pharmacy and Therapeutics Committee to formulate guidelines for the rational use of antimicrobial agents.
　　(8) Other important matters related to hospital infection management.
　　Article 8: The hospital infection management department, the departments in charge, and the full-time or part-time personnel responsible for hospital infection management shall be specifically tasked with the administrative and operational aspects of hospital infection prevention and control. Their principal responsibilities are as follows:
　　(1) Inspect and provide guidance on the implementation of relevant regulations and procedures for the prevention and control of hospital-acquired infections;
　　(2) Monitor, analyze, and provide feedback on hospital-acquired infections and their associated risk factors; propose control measures to address identified issues and guide their implementation.
　　(3) Conduct investigations and statistical analyses of hospital-acquired infection incidence, and report the findings to the Hospital Infection Control Committee or the head of the medical institution;
　　(4) Provide guidance on hospital cleaning, disinfection and sterilization, isolation, aseptic techniques, medical waste management, and other related tasks;
　　(5) Provide guidance on hospital infection control for infectious diseases;
　　(6) Provide guidance to medical personnel on occupational health and safety protection measures for the prevention of hospital-acquired infections;
　　(7) Report and conduct investigations and analyses of hospital-acquired infection outbreaks, propose control measures, and coordinate and organize relevant departments to implement appropriate responses.
　　(8) Conduct training for medical personnel on the prevention and control of hospital-acquired infections;
　　(9) Participate in the management of clinical antimicrobial use;
　　(10) Review the relevant documentation for disinfectants, disinfection equipment, and single-use medical devices and instruments;
　　(11) Organize and conduct research on the prevention and control of hospital-acquired infections;
　　(12) Perform other tasks assigned by the Hospital Infection Control Committee or the head of the medical institution.
　　Article 9: The Ministry of Health shall establish an Expert Group on Hospital Infection Prevention and Control, whose members shall be experts in hospital infection management, disease control, infectious diseases, clinical laboratory science, epidemiology, disinfection, clinical pharmacy, nursing, and other related fields. Its principal responsibilities are as follows:
　　(1) To research and draft technical standards and guidelines pertaining to the prevention and control of hospital-acquired infections, as well as the diagnosis of such infections;
　　(2) Provide professional guidance on hospital infection prevention and control nationwide;
　　(3) Conduct surveys and analyses of the incidence and risk factors of hospital-acquired infections nationwide;
　　(4) Conduct investigations and provide technical guidance on major hospital-acquired infection incidents nationwide;
　　(5) To carry out other tasks assigned by the Ministry of Health.
　　Article 10. The health administrative department of the provincial people’s government shall establish an expert group on hospital infection prevention and control, which shall be responsible for providing technical guidance on hospital infection prevention and control within its jurisdiction.

Chapter 3: Prevention and Control

　　Article 11: Medical institutions shall, in accordance with the relevant regulations and technical standards on hospital infection management, strengthen efforts to prevent and control hospital-acquired infections.
　　Article 12: Medical institutions shall, in accordance with the Measures for the Administration of Disinfection, strictly implement the technical specifications for the disinfection of medical devices and instruments, and meet the following requirements:
　　(1) Medical devices, instruments, and articles that come into contact with human tissues or sterile organs must achieve a sterilization level.
　　(2) Medical devices, instruments, and articles that come into contact with skin or mucous membranes must meet the standards for disinfection.
　　(3) All medical devices used for invasive procedures such as injection, puncture, and blood collection must be sterilized after each use.
　　Disinfectants, medical devices, and single-use medical instruments and apparatus used in medical institutions shall comply with relevant national regulations. Single-use medical devices and apparatus may not be reused.
　　Article 13: Medical institutions shall establish specific measures to ensure that healthcare personnel’s hand hygiene, clinical environment conditions, aseptic techniques, and occupational health protection comply with applicable requirements, and to control risk factors for hospital-acquired infections.
　　Article 14: Medical institutions shall strictly adhere to isolation technical standards and implement appropriate isolation measures in accordance with the routes of pathogen transmission.
　　Article 15: Medical institutions shall formulate specific measures for occupational health protection of medical personnel, provide necessary protective equipment, and ensure the occupational health of medical staff.
　　Article 16: Medical institutions shall, in strict accordance with the “Clinical Application Guidelines for Antimicrobial Agents,” strengthen the clinical use of antimicrobial agents and the monitoring and management of antimicrobial-resistant bacteria.
　　Article 17: Medical institutions shall, in accordance with the criteria for diagnosing hospital-acquired infections, promptly diagnose such cases, establish an effective surveillance system for hospital-acquired infections, analyze the risk factors associated with these infections, and implement preventive and control measures targeting those risk factors.
　　Medical institutions shall promptly identify cases of hospital-acquired infections and outbreaks, analyze the sources and transmission routes of infection, implement effective measures for management and control, and provide active treatment to patients.
　　Article 18: When a medical institution, upon investigation, confirms the occurrence of any of the following circumstances, it shall, within 12 hours, report to the health administrative department of the county-level local people’s government where it is located, and simultaneously report to the local disease prevention and control agency. Upon confirmation by the county-level health administrative department, the case shall be reported, in accordance with the hierarchical procedure, to the provincial-level health administrative department within 24 hours. Following review by the provincial-level health administrative department, the case shall be reported to the Ministry of Health within 24 hours.
　　(1) Outbreaks of hospital-acquired infections involving five or more cases;
　　(2) Patient death directly attributable to a hospital-acquired infection outbreak;
　　(3) An outbreak of hospital-acquired infection results in bodily harm to three or more persons.
　　Article 19: When a medical institution encounters any of the following circumstances, it shall submit a report in accordance with the requirements set forth in the “Provisional Regulations on the Management of Reporting Information Related to National Public Health Emergencies”:
　　(1) Hospital-acquired infection outbreaks involving 10 or more cases;
　　(2) Hospital-acquired infections caused by special or newly emerging pathogens;
　　(3) Hospital-acquired infections that may have a significant public impact or result in serious consequences.
　　Article 20: When a healthcare-associated infection in a medical institution is classified as a legally notifiable infectious disease, it shall be reported and managed in accordance with the provisions of the Law of the People’s Republic of China on the Prevention and Control of Infectious Diseases and the National Emergency Plan for Public Health Emergencies.
　　Article 21: When a healthcare facility experiences an outbreak of hospital-acquired infections, the local disease prevention and control agency shall promptly conduct an epidemiological investigation to identify the source of infection, the routes of transmission, and the contributing factors, and shall implement control measures to prevent the spread of the source of infection and the expansion of the scope of the outbreak.
　　Article 22: Upon receiving a report, the health administrative department shall, as appropriate, provide guidance to medical institutions in conducting investigations and implementing control measures for hospital-acquired infections, and may organize the provision of relevant technical support.

Chapter 4: Personnel Training

　　Article 23: Health administrative departments at all levels and medical institutions shall attach great importance to the development of hospital infection management as a discipline, establish systems for training specialized personnel, and fully leverage the role of hospital infection control professionals in the prevention and control of hospital-acquired infections.
　　Article 24: The health administrative departments of the people’s governments at the provincial level shall establish a standardized training and assessment system for hospital infection control professionals, strengthen continuing education, and enhance the professional competence and technical skills of such personnel.
　　Article 25: Medical institutions shall develop training plans for their staff and provide all personnel with training on relevant laws and regulations pertaining to hospital-acquired infections, the work norms and standards for hospital infection management, and specialized technical knowledge.
　　Article 26: Personnel specializing in hospital infection control shall possess the professional knowledge required for hospital infection prevention and control and be capable of undertaking both management and technical responsibilities in this field.
　　Article 27: Medical personnel shall acquire the knowledge related to the prevention and control of hospital-acquired infections pertinent to their duties, and shall implement the hospital infection management regulations, work standards, and requirements. Support staff shall master the basic principles of hygiene and the knowledge of disinfection and isolation relevant to the prevention and control of hospital-acquired infections, and apply this knowledge appropriately in their work.

Chapter Five: Supervision and Administration

　　Article 28: The health administrative departments of the people’s governments at or above the county level shall, in accordance with relevant laws and regulations and the provisions of these Measures, conduct supervision and inspection of medical institutions within their respective jurisdictions.
　　Article 29 The principal contents of the supervision and inspection of medical institutions are:
　　(1) The hospital’s infection control regulations and their implementation;
　　(2) Various tasks and control measures targeting risk factors for hospital-acquired infections;
　　(3) The status of disinfection and sterilization, isolation, medical waste management, and occupational health protection for healthcare personnel;
　　(4) The status of surveillance for hospital-acquired infections and outbreaks of hospital-acquired infections;
　　(5) On-site inspection.
　　Article 30: When conducting inspections, if the health administrative department identifies potential risks of hospital-acquired infections at a medical institution, it shall order the institution to make rectifications within a specified time limit, temporarily close the relevant departments, or suspend the relevant clinical specialties.
　　Article 31 Medical institutions shall cooperate with the health administrative departments in their inspections, investigations, and evidence collection, and may not refuse or obstruct such activities, nor may they submit false materials.

Chapter VI Penalties

　　Article 32: If the health administrative departments of people’s governments at or above the county level fail to perform their duties of supervision and management, as well as their responsibilities for reporting, investigating, and handling outbreaks of hospital-acquired infections, in accordance with the provisions of these Measures, and such failure results in serious consequences, the principal person in charge of the competent health administrative department, the directly responsible person, and other relevant persons shall be subject to administrative disciplinary measures, including demotion or removal from office.
　　Article 33: If a medical institution violates these Measures and engages in any of the following acts, it shall be ordered by the health administrative department of the local people’s government at or above the county level to make corrections; if it fails to correct within the prescribed time limit, it shall receive a warning and be publicly criticized. In cases of serious circumstances, the principal person in charge and the directly responsible persons shall be subject to administrative disciplinary measures, including demotion or removal from office.
　　(1) Failure to establish or implement hospital infection control regulations and operational standards;
　　(2) No hospital infection management department, designated responsible department, or dedicated (or part-time) personnel have been established to oversee hospital infection prevention and control.
　　(3) Violation of the technical specifications for the disinfection of medical devices and instruments;
　　(4) Violation of aseptic technique and isolation protocols;
　　(5) Failure to review the relevant documentation for disinfectant products and single-use medical devices and instruments;
　　(6) Occupational health protection has not been provided for healthcare workers exposed to occupational hazards.
　　Article 34: If a medical institution violates the provisions of these Measures by failing to implement preventive and control measures, or by failing to promptly take control measures upon the occurrence of hospital-acquired infections, thereby causing an outbreak of hospital-acquired infections, the spread of infectious diseases, or other serious consequences, the responsible persons in charge and those directly responsible shall be subject to administrative sanctions, including demotion, removal from office, or dismissal. In cases of serious circumstances, in accordance with Article 69 of the Law on the Prevention and Control of Infectious Diseases, the practice certificates of the relevant persons may be revoked in accordance with law; if the conduct constitutes a crime, criminal liability shall be pursued in accordance with law.
　　Article 35: If a medical institution fails to report an outbreak of hospital-acquired infections in accordance with the provisions of these Measures, it shall be publicly criticized by the health administrative department of the local people’s government at or above the county level; if serious consequences result, the responsible principal and other directly responsible personnel shall be subject to disciplinary measures including demotion, removal from office, or dismissal.

Chapter VII Supplementary Provisions

　　Article 36. In these Measures, the following terms shall have the meanings set forth below:
　　(1) Hospital-acquired infection: refers to an infection acquired by a hospitalized patient within the hospital, including infections that occur during hospitalization as well as those that develop after discharge but were acquired in the hospital; however, it does not include infections that had already begun prior to admission or that were in the incubation period at the time of admission. Infections acquired by hospital staff within the hospital also constitute hospital-acquired infections.
　　(2) Iatrogenic infection: refers to an infection caused by the transmission of pathogens during medical care.
　　(3) Outbreak of hospital-acquired infection: refers to the occurrence, within a healthcare facility or its departments, of three or more cases of infection with the same pathogen and source within a short period of time.
　　(4) Disinfection: refers to the use of chemical, physical, or biological methods to kill or remove pathogenic microorganisms from the environment.
　　(5) Sterilization: The elimination or destruction of all microorganisms on a transmission medium, including both pathogenic and non-pathogenic microorganisms, as well as bacterial spores and fungal spores.
　　Article 37: The management of hospital-acquired infections in medical institutions of the Chinese People’s Liberation Army shall be under the unified administration of the health authorities of the Chinese People’s Liberation Army.
　　Article 38: The management of prevention and control of healthcare-associated infections in blood collection and supply institutions and disease prevention and control institutions shall be conducted in accordance with these Measures.
　　Article 39 This Measures shall come into force on September 1, 2006, and the “Hospital Infection Management Specifications (Trial)” promulgated on November 30, 2000, shall be repealed simultaneously.

Source: National Health Commission of the People’s Republic of China