Thông tư 16/2018/TT-BYT về kiểm soát nhiễm khuẩn trong các cơ sở khám bệnh, chữa bệnh

THE MINISTRY OF HEALTH 

CircularNo. 16/2018/TT-BYT dated July 20, 2018 of the Ministry of Healthprescribing infection control in healthcare facilities

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

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

Upon the request of the Director of the Medical Service Administration,

The Minister of Health hereby promulgates the Circular prescribing infection control in healthcare facilities.

Chapter I

GENERAL PROVISIONS

Article 1.Scope of regulation

This Circular provides for measures to prevent and control infection, infection control systems and responsibilities for controlling infection in state- or privately-owned healthcare facilities (hereinafter referred to as healthcare facilities).

Article 2. Definitions

1. Infection related to medical care(hereinafter referred to as hospital-acquired infection) means an infection that occurs when patients are cared for and treated in healthcare facilities.

2. Hospital-acquired infection monitoring and surveillancemeans the process of collecting, analyzing and interpreting hospital-acquired infection data in a systematic and continuous manner, and informing results to related persons in a timely manner.

3. Infection controlmeans the construction, implementation and oversight of implementation of specialized regulations, instructions and procedures regarding infection control with the aim of minimizing the risks of spreading of harmful microbes to humans, medical staff and communities that may arise during provision of medical services.

4. Standard preventionmeans basic preventive measures applied to every patient without reliance on the diagnosis and state of infection and the time of medical examination, treatment and care according to the principles of considering all blood, bodily produced or secreted substances of patients to incur potential risks of infection.

Chapter II

MEASURES TO CONTROL INFECTION IN HEALTHCARE FACILITIES

Article 3. Formulation and dissemination of instructions, regulations, procedures and plans for control of infection

1. Develop, approve and disseminate instructions, regulations and procedures (collectively referred to as regulations) for control of infection under the provisions of this Circular.

2. Draw up, approve and disseminate plans for control of infection based on the plan of action and objectives of quality of control of infection which must be in line with actual resources and conditions of healthcare facilities over periods of time.

Article 4. Oversight and surveillance of hospital-acquired infection and other infectious diseases that may lead to epidemic outbreaks

1. Conduct the oversight, surveillance, detection, reporting and management of data on hospital-acquired infections, antibiotic resistant bacteria and confirmed or suspected cases of infectious diseases that may lead to epidemic outbreaks.

2. Implement timely intervention measures in order to reduce hospital-acquired infections and other infectious diseases that may lead to epidemic outbreaks, and enable the proper use of antibiotics on the basis of oversight and surveillance results.

Article 5. Oversight and surveillance of compliance with infection control practices

1. Check, oversee and monitor compliance of all practitioners and other staff members (collectively referred to as medical staff), pupils, students and learners (collectively referred to as trainees), patients, patients family relatives and guests at healthcare facilities with infection control regulations, especially after medical surgery, procedures and other invasive techniques are performed.

2. Instruct and warn medical staff, trainees, patients and patients’ family relatives and guests to observe infection control regulations.

Article 6. Hand wash

1. Organize implementation of regulations on hand wash and make hand washing accessories and chemicals available for use for medical staff, trainees, patients, patients’ family relatives and guests at outpatient, patient treatment and care locations and areas where people often come into contact with each other.

2. Carry out checking, oversight and surveillance in order to ensure compliance with hand wash regulations of medical staff, trainees, patients, patients’ family relatives and guests.

Article 7. Standard prevention or prevention based on transmission routes and use of personal protective equipment

1. Organize implementation of regulations on standard prevention or prevention specific to transmission routes and use of personal protective equipment for medical staff, trainees, patients, patients family relatives and guests.

2. Apply proper preventive isolation measures to patients known or suspected to contract infectious diseases and patients infected with multi-resistant organisms.

3. Instruct and warn medical staff, trainees, patients, patients’ family relatives and guests to obey regulations on the standard prevention and prevention specific to transmission routes and use personal protective equipment during the medical examination, treatment and care process.

4. Check compliance of medical staff, trainees, patients, patients family relatives and guest with regulations on the standard prevention or prevention specific to transmission routes and use of personal protective equipment.

Article 8. Management and handling of medical equipment and accessories

1. Carry out the centralized management and handling of medical equipment, control the disposal of medical equipment and accessories with the aim of ensuring conformance to safety and quality requirements.

2. Store and preserve medical equipment and accessories after handling thereof in order to ensure they are sterile before use.

3. Check, oversee and monitor compliance with regulations on management and handling of medical equipment and accessories at wards and departments.

Article 9. Management and handling of medical textiles

1. Provide medical textiles for patients and medical staff on a daily basis and where needed.

2. Carry out the centralized handling of medical textiles at laundry areas. Textiles, fabrics with microbial contamination, or soiled with blood and biological fluids must be treated separately to ensure safety.

3. Store and preserve medical textiles inside cabinets and racks to ensure they are clean, sterile and are carried by dedicated means of transport.

4. Control quality and regularly check, oversee and monitor medical textile handling procedures.

5. Staff in charge of managing and handling medical textiles must have professional knowledge about handling of medical textiles.

6. Arrange concentrated laundry and drying locations for patients’ family relatives.

Article 10. Management of medical wastes

1. Carry out the management of medical wastes as per laws.

2. Check, oversee and monitor compliance with waste management practices, ensure these wastes are sorted, stored, transported and disposed of in a safe manner as prescribed by laws.

Article 11. Hospital environmental hygiene

1. Carry out and check environmental hygiene in accordance with regulations in force, assure quality of water, surface and aerial environment of each region in accordance with regulations adopted by the Ministry of Health and other national technical regulations.

2. Make sure there are enough toilets for patients, patients’ family relatives and medical staff.

3. Get rid of rats and pests regularly.

4. Persons in charge of performing environmental hygiene tasks at healthcare facilities must have knowledge about environmental hygiene.

Article 12. Food safety

1. Organize the inspection of food safety in terms of microorganisms. Oversee, monitor and report cases of foodborne infection relating to food used by healthcare facilities.

2. Cooperate with regulatory bodies having authority over food safety issues within localities in carrying out food safety communications and propaganda campaigns to raise awareness amongst food processing and catering facilities, medical staff, patients and patients’ family relatives.

Article 13. Prevention and handling of microbial exposures

1. Set up systems for management, oversight, surveillance, handling and reporting of occupational accidents and risks of medical staff’s exposure to microbes.

2. Implement immunization programs to prevent infectious diseases (e.g. Hepatitis B, influenza, tuberculosis and other infectious diseases) for medical staff facing risks of exposure.

3. Enumerate and ensure availability of drugs, vaccines and biologicals for the purpose of providing medical staff with prophylactic medications in case of exposures to infectious diseases.

Article 14. Epidemic prevention and control

1. Work out plans for response to epidemics; collaborate with preventive healthcare and other healthcare establishments in preventing and controlling epidemics and emergencies that may occur within localities under the authority delegated by regulatory bodies.

2. Prepare facilities, equipment, medicines, chemicals, supplies and personnel involved in epidemic prevention and control activities.

3. Provide medical staff with epidemic prevention and control training sessions.

4. Implement the regime for reporting, disseminating and declaring diseases and outbreaks of infectious diseases in accordance with regulations in force.

Article 15. Management of chemicals and supplies used for control of infection

1. Set norms, inspect quality and manage the use of chemicals and supplies used for control of infection.

2. Check and manage the use of chemicals and supplies used for control of infection in order to ensure safety, cost-efficiency and effectiveness.

Chapter III

INFECTION CONTROL SYSTEMS IN HEALTHCARE FACILITIES

Article 16. Infection control systems

1. Infection control systems:

Depending on the number of medical beds, a healthcare facility shall be required to establish its infection control system, including:

a) Infection control board.

b) Infection control department or division.

c) Infection control network.

2. Healthcare facilities with at least 150 medical beds according to their plans must organize infection control systems defined in clause 1 of this Article.

3. Healthcare facilities with less than 150 medical beds according to their plans must, as a minimum requirement, organize infection control divisions subordinate to general planning departments, infection control networks and personnel in charge of infection control who work full time, have graduated in healthcare majors, obtained diplomas, certificates or other equivalents in infection control.

4. Healthcare facilities without inpatient beds shall meet the minimum requirement under which each of them is bound to assign an employee to undertake infection control tasks.

Article 17. Structure and roles of infection control board

1. Structure:

a) The infection control board is established under the decision issued by a healthcare facility (hereinafter referred to as Director).

b) The Board’s Chair is the Director.

c) The Board’s Secretary is the head of the infection control department or the person charged with infection control tasks.

d) The Board’s members are representatives of leaderships of clinical, subclinical departments and functional divisions. As a minimum requirement, leaderships of functional divisions, microbiology/laboratory departments, pharmacy departments and other clinical departments facing high risks of hospital-acquired infection must join the Board as members.

2. Roles:

a) Provide the Director with counseling for control of hospital-acquired infection and repair, design and construction of internal medical service works suitable for infection control tasks.

b) Get involved in infection control oversight, surveillance, training and scientific researches.

c) Review, evaluate and plan infection control activities at each healthcare facility.

Article 18. Structure and roles of infection control departments or divisions

1. Structure:

Depending on the number of medical beds, healthcare facilities may organize their infection control departments or divisions.

a) Each infection control department shall, depending on the scale of the hospital to which it is subordinate, have different divisions tasked with oversight, disinfection, sterilization, management of medical textiles and environmental hygiene according to the Director s decision, including the supervisory division as a minimum requirement.

b) The head and nurses of an infection control department must hold at least undergraduate degrees, graduate in healthcare majors, obtain certificates, diplomas or equivalents in infection control, and must work full time at the infection control department.

c) Each infection control division is composed of the division’s head who is in charge of infection control tasks and receives the letter of appointment from the Director.

2. Roles:

a) Play a pivotal role in providing the Director with counseling for measures to prevent and control infection in healthcare establishments as per Chapter II hereof.

b) Organize or cooperate with other relevant wards and departments in organizing implementation, inspection and overseeing implementation of measures to prevent and control hospital-acquired infections under the provisions of Chapter II hereof.

c) Give job descriptions of the department’s medical staff.

d) Set up technical norms and standards, propose procurement of equipment, means, supplies and chemicals related to infection control tasks, and inspection and oversee the use thereof.

dd) Provide guidance on, direct, check and supervise infection control activities carried out by members of infection control networks.

e) Provide medical staff and trainees with infection control training and drilling sessions.

g) Organize communication campaigns for infection control for medical staff, trainees, patients, patients’ family relatives and guests.

h) Carry out scientific researches, international cooperation and directions at the level of the healthcare network in terms of infection control.

i) Perform other duties assigned by the Director.

Article 19. Structure and roles of infection control network

1. Structure:

The infection control network shall be established and assigned tasks under the Director’s decision, and shall be composed of representatives of clinical and subclinical departments. Each department must assign at least a doctor and a nurse or a midwife or medical engineer working under the multi-employment regime to participate in the infection control network.

2. Roles:

a) Organize infection control activities at specific departments as assigned by the Director and following technical instructions of the head of the infection control department or the person in charge of infection control tasks.

b) Provide instructions, carry out inspection, oversight or surveillance in order to ensure medical staff, trainees, patients and patients’ family relatives and guests at each department must observe infection control regulations.

c) Send regular and ad-hoc evaluation reports to leaderships of departments and the head of the infection control department or the person in charge of infection control tasks on the current state of hospital acquired infection, and compliance with infection control practices of medical staff, trainees, patients, patients’ family relatives and guests in a department.

Article 20. Rights and duties of the head of a department or the head of an infection control division

1. Duties:

a) Provide the Director with counseling for infection control.

b) Carry out and bear responsibilities for tasks of the infection control department.

c) Prepare review and evaluation reports on infection control activities in the entire healthcare facility.

d) Perform other duties assigned by the Director.

2. Rights:

a) Exercise general rights of the department s head.

b) Inspect and require wards, departments, medical staff, trainees, patients and patients’ family relatives and guests in the healthcare facility to observe infection control regulations.

c) Recommend persons and collectives that excel in complying with or violate infection control regulations to the Director for rewards or disciplinary actions.

3. The person in charge of infection control in a healthcare facility that has less than 150 medical beds according to its plan and does not establish the infection control department shall have rights and duties the same as the head of the infection control department, except the rights specified in point a, clause 2 of this Article.

4. The person in charge of infection control in the healthcare facility without inpatient beds shall, depending on its scope of specialization, have duties to implement, check and oversee the implementation of proper infection control measures.

Article 21. Rights and duties of the head nurse of the infection control department

1. Duties:

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

b) Assist the department’s head in working out the plan for management and use of equipment, means, supplies and chemicals used for performing infection control tasks.

c) Get involved in establishing instructions for regulations on infection control and carry out the inspection, oversight and surveillance of implementation of these instructions.

d) Perform other duties as assigned by the head of the infection control department.

2. Rights:

Assume the same rights as head nurses of other departments and have the right to inspect and monitor infection control activities in wards or departments of a healthcare facility.

Article 22. Structure, rights and duties of the surveillance division

1. Structure:

a) The surveillance division is a specialized division of the infection control department, and undertakes the full-time duties to inspect, oversee and monitor infection control.

b) The surveillance division shall be composed of staff members in charge of full-time infection control tasks who hold associate degrees and graduated in healthcare majors, obtain diplomas or certificates or equivalents in oversight and surveillance of infection control.

c) The healthcare facility with at least 150 medical beds must assign 1 full-time staff member in charge of infection control tasks for every 150 medical beds. The healthcare facility with less than 150 medical beds must have at least 1 full-time staff member in charge of infection control tasks.

d) With respect to healthcare facilities without inpatient beds, oversight and surveillance duties shall be performed by the persons in charge of infection control tasks.

2. Duties:

a) Carry out oversight and surveillance of hospital-acquired infections, inspect and oversee compliance with infection control practices referred to in Article 4 and Article 5 hereof.

b) Get involved in other oversight and surveillance activities such as environmental, microbiological oversight and surveillance activities, inspect and oversee the implementation of regulations related to infection control by patients, patients family relatives and guests.

c) Perform other duties as assigned by the head of the infection control department.

3. Rights:

Have the right to inspect, oversee and monitor activities relating to infection control performed by all of medical staff, trainees, patients, patients family relatives and guests in a healthcare facility.

Chapter IV

IMPLEMENTATION PROVISIONS

Article 23.Effect

1. This Circular takes effect on October 01, 2018.

2. The Circular No. 18/2009/TT-BYT dated October 14, 2009 of the Minister of Health providing guidance on implementation of  on the implementation of infection control in health care facilities shall be repealed from the effective date of this Circular.

Article 24. Transitional provisions

1. The leadership of the infection control department, the person in charge of infection control tasks in healthcare facilities with less than 150 medical beds as defined in their plans must complete the infection control training program lasting for 3 months before January 1, 2021 as a minimum requirement.

2. The person in charge of infection control tasks in healthcare facilities without any medical beds must complete the infection control training program lasting for 5 days before January 1, 2021 as a minimum requirement.

3. Staff members of the surveillance division and the disinfection and sterilization division must complete the infection control training program lasting for 3 months before January 1, 2022 as a minimum requirement.

4. Members of the infection control board and the infection control network must complete the infection control training program lasting for 5 days before January 1, 2022 as a minimum requirement.

5. The officer in charge of infection control tasks in the Department of Health must complete the infection control training program lasting for a month before January 1, 2021 as a minimum requirement.

Article 25. Implementation responsibilities

1. The Medical Service Administration shall be responsible for organizing, inspecting and monitoring the implementation of this Circular nationwide.

2. Administration of Science Technology and Training:

a) Preside over evaluating programs and materials for continuing and intensive education of infection control under its management.

b) Direct healthcare facilities to enable medical staff to participate in programs for continuing education of infection control.

c) Direct educational institutions with healthcare disciplines to integrate infection control contents in their curriculum for learners and students; improve competences of infection control lecturers; impossible failure revoke; propose investments in construction of practice and preclinical establishments that are standardized and modernized to elevate the quality of infection control training.

3. Departments of Health of provinces and centrally-affiliated cities:

a) Assume responsibilities for organizing, inspecting and assessing the implementation of this Circular within localities under their jurisdiction.

b) Assign divisions and officers playing pivotal roles in performing infection control tasks of Departments of Health. The officer in charge of infection control tasks must hold at least undergraduate degrees and graduate in healthcare majors, obtain diplomas or certificates or equivalents in infection control.

c) Make assessment reports on implementation of this Circular on a regular or ad-hoc basis upon the request of competent authorities.

4. Health entities of ministries and sectoral administrations shall be responsible for organizing, inspecting, overseeing and monitoring the implementation of this Circular at healthcare facilities under their jurisdiction.

5. Responsibilities of the head of the healthcare facility:

a) Bear full responsibilities for infection control activities carried out by healthcare facilities.

b) Organize, inspect, oversee and monitor the implementation of this Circular by healthcare facilities.

c) Invest in development of infrastructure, purchase equipment, means, chemicals, supplies and arrange personnel to ensure conformance to infection control requirements. Construction, repair or refurbishment of infrastructure, purchase of equipment and means must be counseled by the infection control board, the infection control department or the person in charge of infection control tasks.

d) Spend an adequate amount of finances for infection control activities which have been included in the schedule of medical service prices.

dd) Ensure that medical staff participating in the infection control system must hold diplomas, certificates or equivalents in infection control.

e) Draw up training syllabus and curriculum and implement training and communication programs for infection control for medical staff and relevant persons in compliance with regulations and actual conditions of healthcare facilities.

g) Carry out scientific researches and international cooperation on infection control activities.

h) If a healthcare facility enters into service agreements with outsourced providers of such services as medical textile laundry, disinfection, sterilization of medical equipment and devices, environmental hygiene and waste disposal, it shall be required to select an entity having full legal personality and regularly oversee, monitor and inspect compliance with technical regulations, procedures and ensure conformity with service case, the healthcare facility shall be responsible for quality of services provided by outsourced providers.

i) Implement proper intervention measures based on the results of inspection, oversight and surveillance of the implementation of infection prevention and control measures in order to improve quality of infection quality standards. In this control activities in line with actual resources and conditions of healthcare facilities.

k) Set out internal rules of healthcare facilities applied to patients, patients’ family relatives and guests, including guest reception hours, isolation methods, hand wash, personal hygiene, use of personal protective equipment, hospital hygiene and medical waste sorting.

l) Report the results and percentage of infection control in accordance with regulations in force.

6. Medical staff, teachers and trainees at healthcare facilities shall be responsible for complying with infection control regulations, especially when surgeries, other medical procedures and other invasive techniques are performed on patients.

7. Patients, patients’ family relatives and guests shall assume the following responsibilities:

a) Observe internal rules regarding guest reception hours, isolation methods, personal hygiene, hospital hygiene, waste sorting and other infection control rules that take effect at healthcare facilities.

b) Known or suspected patients with infectious diseases classified into group A and certain pathological conditions in the group B as decided by the Minister of Health must abide by therapeutic, isolation, movement or discharge regimens in accordance with regulations in force.

8. Educational institutions providing training in healthcare majors shall assume the following responsibilities:

a) Consolidate infection control contents into training programs intended for pupils and students.

b) Hold infection control training sessions for pupils and students and in-depth training sessions for medical staff who are tasked with performing infection control tasks on demand. Ensure that pupils and students must be trained in infection control before being allowed to become interns at healthcare facilities.

In the course of implementation of this Circular, if there is any difficulty that arises, entities, organizations and individuals should inform the Medical Service Administration (Ministry of Health) for its assessment and possible solutions./.

For the Minister

The Deputy Minister

Nguyen Viet Tien