Circular No. 16/2018/TT-BYT stipulates on infection control in medical examination and treatment facilities.

CIRCULAR

REGULATIONS ON INFECTION CONTROL IN MEDICAL TREATMENT ESTABLISHMENTS

Pursuant to the Law on Medical Examination and Treatment No. 40/2009/QH12 issued on November 23, 2009;

Pursuant to the Government's Decree No. 75/2017/NĐ-CP dated June 20, 2017 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Department of Medical Examination and Treatment,

The Minister of Health issues this Circular on infection control in medical treatment establishments.

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates preventive measures, infection control measures, the infection control system, and responsibilities for implementing infection control in state-owned and private medical treatment establishments (hereinafter referred to as medical treatment establishments).

Article 2. Interpretation of Terms

1. Healthcare-associated infections (hereinafter referred to as hospital-acquired infections) are infections that occur during the care and treatment of patients at medical treatment establishments.

2. Hospital-acquired infection surveillance is the systematic and continuous process of collecting, analyzing, interpreting hospital-acquired infection data, and promptly reporting results to relevant parties.

3. Infection control is the establishment, implementation, and monitoring of regulations, guidelines, and professional procedures for infection control aimed at reducing the risk of pathogen transmission to patients, healthcare workers, and the community during the provision of medical examination and treatment services.

4. Standard precautions are basic preventive measures applied to all patients regardless of diagnosis, infection status, and time of examination, treatment, or care, based on the principle that blood, secretions, and excretions from patients are potentially infectious.

Chapter II
INFECTION CONTROL MEASURES IN MEDICAL TREATMENT ESTABLISHMENTS

Article 3. Development and dissemination of guidelines, regulations, procedures, and plans for infection control

1. Develop, approve, and disseminate guidelines, regulations, and procedures (collectively referred to as regulations) for infection control in accordance with this Circular.

2. Develop, approve, and disseminate infection control plans based on national action plans, quality objectives for infection control, and the resources and practical conditions of medical treatment establishments at each stage.

Article 4. Surveillance of hospital-acquired infections and infectious diseases with epidemic potential

1. Monitor, detect, report, and manage data on hospital-acquired infections, antibiotic-resistant bacteria, cases of suspected or confirmed infectious diseases with epidemic potential.

2. Implement timely intervention measures to reduce hospital-acquired infections and infectious diseases with epidemic potential, and use antibiotics appropriately based on surveillance results.

Article 5. Surveillance of compliance with infection control practices

1. Inspect and monitor compliance with infection control regulations, especially during surgery, procedures, and other invasive techniques, for all practitioners, other staff members (collectively referred to as healthcare workers), students, trainees (collectively referred to as trainees), patients, patient relatives, and visitors at medical treatment establishments.

2. Guide and remind healthcare workers, trainees, patients, patient relatives, and visitors to comply with infection control regulations.

Article 6. Hand Hygiene

1. Implement regulations on hand hygiene, provide necessary equipment and chemicals for hand hygiene to medical staff, students, patients, patient relatives, and visitors at examination, treatment, and care locations and places with high contact rates.

2. Inspect and supervise to ensure compliance with hand hygiene regulations by medical staff, students, patients, patient relatives, and visitors.

Article 7. Standard Precautions, Transmission-Based Precautions, and Personal Protective Equipment Use

1. Implement regulations on standard precautions, transmission-based precautions, and personal protective equipment use for medical staff, students, patients, patient relatives, and visitors.

2. Implement appropriate isolation measures for individuals suspected or confirmed to have infectious diseases and those infected with multidrug-resistant bacteria.

3. Guide and remind medical staff, students, patients, patient relatives, and visitors to comply with standard precautions, transmission-based precautions, and personal protective equipment use during examinations, treatments, and patient care.

4. Inspect compliance with standard precautions, transmission-based precautions, and personal protective equipment use by medical staff, students, patients, patient relatives, and visitors.

Article 8. Management and Handling of Medical Equipment and Instruments

1. Implement centralized management and handling of medical instruments, ensuring safe and quality reprocessing of reusable devices and instruments.

2. Store sterilized medical equipment and instruments safely before use on patients.

3. Monitor and supervise adherence to regulations on the management and handling of medical equipment and instruments in departments and wards.

Article 9. Management and Handling of Medical Textiles

1. Provide daily and as-needed medical textiles to patients and medical staff.

2. Centrally process medical textiles in laundry areas. Contaminated textiles, textiles with blood, and biological fluids must be processed separately to ensure safety.

3. Store processed textiles in cabinets and racks to ensure cleanliness and sterility, transported separately using specialized means.

4. Control quality and regularly monitor and supervise textile processing procedures.

5. Personnel managing and handling medical textiles must possess specialized knowledge about textile processing.

6. Arrange centralized washing, drying, or airing facilities for patient relatives.

Article 10. Healthcare Waste Management

1. Implement healthcare waste management according to legal provisions.

2. Inspect and supervise adherence to waste management practices, ensuring that waste is classified, stored, transported, and treated safely in accordance with legal provisions.

Article 11. Hospital Environmental Sanitation

1. Organize and inspect environmental sanitation in accordance with regulations, ensuring water, surface, and air quality meet Ministry of Health standards and national technical regulations for each area.

2. Provide sufficient toilets for patients, patient relatives, and medical staff.

3. Regularly carry out rodent and insect control.

4. Personnel engaged in environmental sanitation at healthcare facilities must have knowledge of environmental sanitation.

Article 12. Food Safety

1. Organize food safety inspections concerning microorganisms. Monitor and report cases of infection related to food used at medical examination and treatment facilities.

2. Collaborate with food safety management agencies in the locality to implement activities to disseminate information and promote food safety awareness among food processing and supply establishments, healthcare staff, patients, and patient relatives.

Article 13. Prevention and Management of Microorganism-related Exposure

1. Establish a system for managing, monitoring, handling, and reporting occupational accidents and risks related to microorganisms for healthcare staff.

2. Administer vaccines to prevent infectious diseases (hepatitis B, influenza, tuberculosis, and other infectious diseases) for healthcare staff at risk of exposure.

3. Develop a list and ensure the availability of medicines, vaccines, and medical supplies for prophylactic treatment of healthcare staff exposed to infectious diseases.

Article 14. Disease Prevention and Control

1. Develop plans to respond to epidemics; coordinate with preventive healthcare facilities and other healthcare facilities in disease prevention and control and emergency situations within the assigned area by the management agency.

2. Prepare physical infrastructure, equipment, medicines, chemicals, materials, and personnel for disease prevention and control.

3. Conduct training sessions for healthcare staff on disease prevention and control.

4. Implement information reporting and declaration systems for diseases and infectious diseases as prescribed.

Article 15. Management of Chemicals and Materials Used in Infection Control

1. Establish standards, check quality, and manage the use of chemicals and materials used in infection control.

2. Supervise and manage the use of chemicals and materials used in infection control to ensure safety, economy, and effectiveness.

Chapter III

INFECTION CONTROL SYSTEM IN MEDICAL EXAMINATION AND TREATMENT FACILITIES

Article 16. Infection Control System

1. The infection control system:

Depending on the number of beds, medical examination and treatment facilities must establish an infection control system including:

a) An infection control council;

b) A department or unit for infection control;

c) An infection control network.

2. Medical examination and treatment facilities with 150 planned beds or more must organize the infection control system as stipulated in Clause 1 of this Article.

3. Medical examination and treatment facilities with fewer than 150 minimum planned beds must have an infection control unit under the general planning department, an infection control network, and a full-time person responsible for infection control who has graduated from a health-related field, holds a certificate, certification, or degree in infection control.

4. Medical examination and treatment facilities without minimum inpatient beds must assign one person to be responsible for infection control.

Article 17. Organization and Duties of the Infection Control Council

1. Organization:

a) The infection control council is established by the head of the medical examination and treatment facility (hereinafter referred to as Director);

b) The chairman of the infection control council is the Director;

c) The secretary of the infection control council is the head of the infection control department or the person assigned the responsibility for infection control;

d) Members of the infection control council are representatives of clinical departments, paraclinical departments, and functional departments, among which there must be participation of leaders of functional departments, microbiology/laboratory testing departments, pharmacy departments, and some high-risk clinical departments.

2. Tasks:

a) Advise the Director on infection control in the medical examination and treatment facility and advise on the repair, design, and construction of new medical facilities that comply with infection control requirements;

b) Participate in monitoring, training, and scientific research on infection control;

c) Review, evaluate, and guide the implementation of infection control in the facility.

Article 18. Organization and Tasks of the Infection Control Department or Unit

1. Organization:

Depending on the scale of hospital beds, healthcare facilities shall organize an infection control department or unit.

a) The infection control department, depending on the scale of the hospital, shall have surveillance, sterilization, linen management, and environmental hygiene sections, as decided by the Director, with at least a surveillance section.

b) The head of the infection control department and the head nurse of the infection control department must have a university degree or higher and graduate from a health-related field, hold a certificate or certification or diploma in infection control, and work full-time in the infection control department.

c) The infection control unit shall have a unit head responsible for infection control, with an assignment letter from the healthcare facility's Director.

2. Tasks:

a) Serve as the point of advice to the Director on preventive and control measures against infections in accordance with Chapter II of this Circular;

b) Organize or coordinate with relevant departments to implement, inspect, and supervise the implementation of preventive and control measures against infections within the healthcare facility in accordance with Chapter II of this Circular;

c) Develop job descriptions for healthcare staff in the department;

d) Establish standards and technical criteria, and propose procurement of equipment, means, materials, and chemicals related to infection control activities, and monitor their usage;

e) Guide, direct, inspect, and supervise the implementation of infection control activities by network members;

f) Organize training and instruction on infection control for healthcare staff and students;

g) Organize communication on infection control for healthcare staff, students, patients, patient relatives, and visitors;

h) Conduct scientific research, international cooperation, and line guidance on infection control;

i) Perform other tasks assigned by the Director.

Article 19. Organization and Tasks of the Infection Control Network

1. Organization:

The infection control network shall be established and tasked by the Director, comprising representatives from clinical and paraclinical departments. Each department shall appoint at least one doctor and one nurse or midwife or medical technician to participate in the infection control network.

2. Tasks:

a) Participate in organizing the implementation of infection control in the department according to the Director's assignment and technical guidance from the head of the infection control department or the person in charge of infection control;

b) Guide, inspect, and supervise healthcare staff, students, patients, patient relatives, and visitors in the department to comply with infection control regulations;

c) Regularly and urgently report to the department leader and the head of the infection control department or the person in charge of infection control about the situation of hospital-acquired infections and compliance with infection control practices by healthcare staff, students, patients, patient relatives, and visitors in the department.

Article 20. Tasks and Authorities of the Head of the Infection Control Department or Unit

1. Duties:

a) Advise the Director on infection control;

b) Organize the implementation and be responsible for the tasks of the infection control department;

c) Summarize and report the results of infection control throughout the healthcare facility;

d) Perform other tasks assigned by the Director.

2. Authorities:

a) Exercise the general authority of the department head;

b) Inspect and require departments, rooms, healthcare staff, students, patients, patient relatives, and visitors in the healthcare facility to comply with infection control regulations;

c) Propose to the Director rewards or disciplinary actions for individuals or groups with achievements or violations of infection control regulations.

3. The person in charge of infection control in healthcare facilities with fewer than 150 planned hospital beds that do not establish an infection control department shall have the duties and authorities of the head of the infection control department except for Point a, Clause 2 of this Article.

4. The person in charge of infection control in healthcare facilities without inpatient beds, depending on the scope of expertise of the facility, shall have the duty to implement, inspect, and supervise the implementation of appropriate preventive and control measures against infections.

Article 21. Duties and Authorities of the Head Nurse of the Infection Control Department

1. Duties:

a) Perform the general duties of a head nurse of a department;

b) Assist the department head in planning the management and utilization of equipment, means, materials, and chemicals for infection control;

c) Participate in developing guidelines on infection control regulations and monitor their implementation;

d) Carry out other tasks assigned by the head of the infection control department.

2. Authorities:

Have the same authorities as other head nurses and have the right to inspect and supervise infection control activities in departments and rooms within healthcare facilities.

Article 22. Organization, Duties, and Authorities of the Surveillance Unit

1. Organization:

a) The surveillance unit is a specialized unit of the infection control department with the specific duty of inspecting and supervising infection control;

b) The surveillance unit includes full-time infection control surveillance staff with at least a college degree in a health-related field and a certificate or certification or diploma in infection control surveillance training;

c) Healthcare facilities with 150 beds or more must ensure one full-time surveillance staff member for every 150 beds. Healthcare facilities with fewer than 150 beds must have at least one full-time surveillance staff member;

d) For healthcare facilities without inpatient beds, the surveillance task shall be carried out by the person responsible for infection control.

2. Tasks:

a) Conduct hospital infection surveillance, inspect, and supervise compliance with infection control practices as stipulated in Articles 4 and 5 of this Circular;

b) Participate in other surveillance activities such as environmental monitoring, microbiological monitoring, and inspecting and supervising the implementation of regulations related to infection control for patients, patient relatives, and visitors;

c) Carry out other tasks assigned by the head of the infection control department.

3. Authorities:

Have the authority to inspect and supervise all activities related to infection control involving all medical staff, trainees, patients, patient relatives, and visitors within healthcare facilities.

Chapter IV
IMPLEMENTING PROVISIONS

Article 23. Effectiveness of Implementation

1. This Circular takes effect from October 1, 2018.

2. Circular No. 18/2009/TT-BYT dated October 14, 2009, issued by the Minister of Health guiding the organization and implementation of infection control work in healthcare facilities ceases to be effective from the date this Circular takes effect.

Article 24. Transitional Provisions

1. Leaders of the infection control department and persons responsible for infection control in healthcare facilities with fewer than 150 beds must complete a minimum three-month training program on infection control before January 1, 2021.

2. Persons responsible for infection control in healthcare facilities without inpatient beds must complete a minimum five-day training program on infection control before January 1, 2021.

3. Staff members of the surveillance and sterilization units must complete a minimum three-month training program on infection control before January 1, 2022.

4. Staff members of the Infection Control Committee and the Infection Control Network must complete a minimum five-day training program on infection control before January 1, 2022.

5. Health Bureau officers responsible for infection control must complete a minimum one-month training program on infection control before January 1, 2021.

Article 25. Responsibility for Implementation

1. The Department of Medical Examination and Treatment is responsible for organizing the implementation, inspection, and supervision of the enforcement of this Circular nationwide.

2. The Department of Science, Technology, and Training:

a) Take the lead in reviewing continuous education and advanced training programs on infection control within its jurisdiction;

b) Direct healthcare facilities to implement continuous training on infection control for medical staff;

c) Direct schools with health-related majors to incorporate infection control content into their curricula for students and trainees; enhance the capacity of infection control instructors; propose investment in practical and pre-clinical facilities to standardize and modernize infection control training quality.

3. Provincial Health Services:

a) Be responsible for organizing the implementation, inspection, and evaluation of the enforcement of this Circular within its jurisdiction;

b) Assign units and personnel to be the focal point for infection control at the Health Bureau. Personnel responsible for infection control must have at least a bachelor's degree in a health-related field, a certificate, certification, or diploma in infection control training;

c) Report periodically or ad hoc on the implementation of this Circular according to the requirements of the competent state management agency.

4. Health Departments of Ministries and Sectors are responsible for organizing the implementation, inspection, and supervision of the enforcement of this Circular at subordinate healthcare facilities.

5. Responsibilities of the Heads of Healthcare Facilities:

a) Bear overall responsibility for infection control work at healthcare facilities;

b) Organize the implementation, inspection, and supervision of this Circular at healthcare facilities;

c) Invest in infrastructure, purchase equipment, means, chemicals, materials, and arrange human resources to meet infection control requirements. When constructing, repairing, or renovating facilities or purchasing equipment, there must be participation and consultation from the Infection Control Committee, the infection control department, or the person responsible for infection control;

d) Allocate sufficient funds for infection control activities included in the service fee structure;

đ) Ensure that medical staff participating in the infection control system have certificates, certifications, or diplomas in infection control training;

e) Develop programs, materials, and conduct training and communication on infection control for medical staff and relevant parties in accordance with regulations and the actual conditions of healthcare facilities;

g) Conduct scientific research and international cooperation on infection control;

h) In cases where medical examination and treatment facilities enter into service provision contracts with external units for laundry services, disinfection, sterilization of equipment and tools, environmental sanitation, waste management, such facilities must select units with legal entity status and regularly monitor and inspect compliance with regulations and technical procedures to ensure service quality. Medical examination and treatment facilities are responsible for the quality of services provided by external units;

i) Implement appropriate intervention measures based on the results of monitoring and supervising the implementation of preventive and infection control measures to improve infection control quality in accordance with the resources and practical conditions of the medical examination and treatment facility;

k) Develop internal rules for medical examination and treatment facilities for patients, patient relatives, and visitors to comply with regulations regarding visiting hours; isolation measures; hand hygiene; personal hygiene; use of personal protective equipment; hospital hygiene; and classification of healthcare waste;

l) Report on the implementation results of infection control and hospital-acquired infection rates in accordance with regulations;

6. Healthcare staff, teachers, and interns at medical examination and treatment facilities are responsible for complying with infection control regulations, especially when performing surgeries, procedures, and other invasive techniques on patients;

7. Patients, patient relatives, and visitors are responsible for:

a) Adhering to regulations regarding visiting hours, isolation measures, personal hygiene, hospital hygiene, waste classification, and other infection control regulations of medical examination and treatment facilities;

b) Individuals suspected or confirmed to have infectious diseases belonging to Group A and certain diseases in Group B as specified by the Minister of Health must comply with treatment, isolation, movement, or discharge regulations;

8. Educational institutions offering health-related majors are responsible for:

a) Incorporating training content on infection control into their curricula for students and pupils;

b) Organizing infection control training for students and pupils and specialized training for healthcare workers involved in infection control according to needs. Ensuring that students and pupils receive infection control training before practicing at medical examination and treatment facilities;

During implementation, if there are difficulties or obstacles, agencies, organizations, and individuals are advised to report them to the Department of Medical Examination and Treatment (Ministry of Health) for consideration and resolution./.