Thông tư 18/2009/TT-BYT hướng dẫn tổ chức thực hiện công tác kiểm soát nhiễm khuẩn trong các cơ sở khám bệnh, chữa bệnh do Bộ Y tế ban hành

CIRCULAR

GUIDELINE ON THE IMPLEMENTATION OF INFECTION CONTROL IN HEALTH CARE FACILITIES

- Pursuant to the Law on people’s health protection dated 11 June 1989;

- Pursuant to the Communicable Diseases Prevention and Control Law dated 21 November 2007;

- Pursuant to Decree No. 188/2007/ND-CP dated 27 December 2007 issued by the Government stipulating the roles, responsibilities, authority and organizational structure of the Ministry of Health;

- Pursuant to Decision No. 153/2006/QD-TTg dated 30 June 2006 issued by the Prime Minister on approval of the master plan on development of Vietnam Health System for the period from 2010 to 2020.

The Ministry of Health issues these guidelines on infection control in all public and private health facilities as follows:

Chapter I

PROFESSIONAL TECHNIQUES IN INFECTION CONTROL

Article 1. Hand hygiene

1. Health care workers, staff, teachers, students and student trainees in all health facilities should wash hands with proper techniques and standards in adherence with current guidelines issued from the Ministry of Health.

2. Patients, family members and all visitors should wash hands and comply with regulations and guidelines of health care facilities.

Article 2. Execution of regulations on sterilisation

1. When conducting surgical procedures including minor surgery and other invasive techniques, sterile conditions must be maintained. All equipment/devices should be guaranteed as sterile and all sterile techniques conducetd should conform to the current technical procedures of the Ministry of Health.

2. All used medical devices that are able to be reused should be disinfected and sterilised in centrally sterilisation departments and must be sterility must be maintained until patient use.

3. Gloves must always be changed between patients and must be changed between providing care at a contaminated or unclean body area to other body areas of the same patient. Sterile gloves must be worn when conducting sterile procedures.

4. All health care workers must observe regulations on sterilisation, standard precautions, and regulations on isolation when entering and working in designated sterile areas.

Article 3. Cleaning, disinfection and sterilisation of devices and equipments for medical care and treatment

1. Medical devices, equipment and materials used in surgical procedures, minor surgery and other invasive techniques should be disinfected and sterilized.The sterilisation quality should be inspected and guaranteed before use in accordance with guidelines of the Ministry of Health.

2. Medical equipment used for providing care and treatment should be handled in compliance with proper disinfection and sterilisation procedures between patients if reused.

3. Used medical devices/equipment should be initially decontaminated at hospital wards before being transferred to central disinfection and sterilization department.

4. At the central disinfection and sterilisation departments all devices should be cleaned, disinfected, packed, sterilised and stored in compliance with procedures and guidelines issued by the Ministry of Health.

5. Central disinfection and sterilisation departments should have necessary adequate cleaning, disinfecting and sterilizing equipment and use separate designated trolleys/carts and containers for receiving unclean devices and for transporting sterilised devices to departments and wards in health care facilities.

6. Hospital departments and wards should have separate rooms, and necessary equipment, detergents and disinfecting chemicals to ensure the initial treatment of used devices. All hospital departments and wards should have adequate cabinets for safely storing sterilised devices.

7. Medical equipment must be re-sterilised before use if packages/ packets are not-intact; boxes have exceeded expiry dates; or remaining devices in opened sterilised packets and boxes and not used.

Article 4. Implementation of Standard precautions and preventive isolation

1. Health care facilities should provide training and actively promote adherence to standard precautions and additional isolation precautions to all health workers, patients, patients’ family members and visitors

2. Health workers should apply appropriate standard precautions apply to all patients receiving care in health organizations, regardless of their diagnosis or presumed infection status and apply additional precautions based on disease transmission routes.

3. Health facilities should establish a system of management, surveillance, detection, response and reporting of workplace occupational accidents/incidents; Health facilities should coordinate with the relevant preventive health system to ensure the timely reporting and response to epidemics.

4. Patients suspected or confirmed with a communicable disease should be immediately handled with proper additional precautions in compliance with regulations of the Communicable Disease Prevention and Control Law.

5. All medical doctors, health care workers and staff working in all health facilities should be vaccinated against communicable diseases including Hepatitis B, seasonal influenza, and other fatal communicable diseases.

6. Patients suffering infections caused by multi-drug resistant bacteria should be handled with appropriate additional precautions as determined by the transmission routes of the organism/s.

Article 5. Surveillance and Detection of Health Care Acquired Infections and Communicable Diseases in Health Care Facilities

1. Health facilities shall be responsible for the organization, surveillance, detection and notification of all patients with notifiable infectious and communicable diseases in compliance with regulations of the Communicable Disease Prevention and Control Law.

2. Health facilities shall be responsible conducting surveillance, case detection, reporting and maintaining records of cases of all health care acquired infections.

Article 6. Environmental Cleaning and Health Care Waste Management

1. Health care facilities shall:

a) Be equipped with adequate appropriate and specialised environmental cleaning equipment such as buckets, cleaning towels, floor mops, detergents and cleaning chemicals and trolleys/carts for mobilising cleaning equipment.

b) Establish environmental cleaning schedules and procedures appropriate to each specific area in compliance with regulations and guidelines of the Ministry of Health.

c) Conduct micro-biological surveillance at least in every six months to assess the air quality within areas high risk clinical departments and assess water supply sources to ensure compliance with national technical standards.

d) Execute medical waste management in compliance with Ministry of Health regulations.

e) Develop and execute facility regulations for cleaning and disinfection of patient wards and related care equipment immediately after patients with a communicable diseases of epidemic potential are transferred to another department, referred to another hospital, leave the hospital or die.

f) Ensure appropriate cleaning is conducted in all hospital departments/ wards, outside environment, and conduct appropriate periodic insect and rodent erradication in compliance with Ministry of Health regulations to ensure a safe, green, clean environment.

2. All nurse assistants and cleaning staff in all health facilities should be provided with training on health facility hygiene and cleaning in accordance with training programs regulated by the Ministry of Health.

Article 7. Hygiene Practices for Patients and their family members

1. Patients their family members and all visitors should wear hospital uniforms in compliance with the medical dress code including using one uniform for each individual.

2. Prior to surgery, patients should be prepared and draped in compliance with technical guidelines and procedures issued by the Ministry of Health.

Article 8. Food Safety and Hygiene

1. Infection control units are responsible for conducting surveillance and implementing the legal documents concerning food safety and hygiene for all food and beverage processing sections within health facilities.

2. Units directly processing and distributing food and drink in health facilities should have Food Safety and Hygiene Certificates, and staff directly working in those units should be provided with periodic health checks and are responsible for implementing legal regulations on food safety and hygiene.

Article 9. Laundry Management

1. Health facilities should properly follow the medical dress code for patients, their family members/ visitors and health workers. Linen change schedules should be on a daily basis and if also as necessary.

2. Linen in health facilities should be washed daily. Used linen, especially linen soiled with blood and body secretions from patients with communicable diseases should be gathered, transferred and treated on a separate basis. Standard Precautions must be followed.

3. Clean linen should be adequately stored in clean cabinets. Linen to be used for aseptic procedures should meet quality and sterilisation requirements.

4. Health facilities should be equipped with separate collection trolleys and containers for transporting contaminated linen clean linen to the relevant departments/wards.

Article 10. Hygiene practices for holding, burying/cremating and transporting corpses for coronial investigation

Holding, burying/cremating and transportation of corpse should be implemented in compliance with regulations in Circular No 02/2009/TT-BYT dated 26/05/2009 on guidelines for hygiene practices for burial and cremation issued by the Ministry of Health.

Chapter II

CONDITIONS FOR INFECTION CONTROL

Article 11. Physical facilities and equipments Health facilities shall:

1. Have architectural designs and physical facilities/equipments to meet requirements on infection control. Designing for newly-built or renovated health facilities should be based on counsel by infection control units and staff.

2. Have central disinfection and sterilization sections (units) with required standards: design on a one-way basis, separation between 3 areas (infected, clean, and sterile areas); provision of appropriate device treatment machines, based on respective medical treatment categories and levels, including disinfecting washers, wet autoclaves, low-temperature sterilizers, dryers, and device packing machines; availability of cleaning devices, chemicals, sterilization quality tests; rooms, cabinets and pallets for storing sterile devices.

3. Have own laundry houses in one-way design with adequate equipment and devices including washing machines and dryers, equipment for ironing linen, cart/trolleys for transporting clean and unclean linen, tanks or containers of disinfectant liquid for soaking contaminated linen, cabinets for storing linen; and detergents and disinfecting chemicals. Health facilities can enter outsource contracts with companies specializing in washing and disinfecting hospital linen, ensuring adequate washing and supplying of linen to meet professional and patient requirements.

4. Have appropriate infrastructure to ensure safe treatment of medical liquid waste, solid waste and gas waste in compliance with regulations on medical waste management.

5. Departments should have adequate bathrooms, toilets, clean water supply, hand washing devices and supplies for use by patients, patients’ family members and health workers.

6. Each department should have at least one room for storing unclean objects and handling medical devices.

7. Surgery rooms and special care rooms should be equipped with appropriate air ventilating and filtering systems to ensure the required sterile condition.

8. Clinical departments should have at least one isolation room equipped with isolating equipment and devices in accordance with guidelines of the Ministry of Health for isolation of patients with potential of spreading etiologic agents of fatal communicable diseases.

9. Clinical departments should have at least one minor surgery room with adequate equipments/devices and be designed to meet infection control requirements: with washing basins, water taps, clean water supply, soap or hand wash detergents, hand towels, or handrub brushes, specialised beds/tables for minor surgery, cabinets for storing sterile devices, and waste containers.

10. Laboratories should ensure biological safety conditions relevant to each degree and are allowed to conduct tests in their professional scopes in compliance with the Communicable Disease Prevention and Control Law.

11. Departments for communicable diseases should have adequate conditions for prevention of disease transmission and be in safe environmental distance from other departments, wards and populated areas in compliance with the Communicable Disease Prevention and Control Law.

12. Food processing and distributing facilities in hospitals should be designed and constructed in compliance with legal regulations on food safety and hygiene.

Article 12. Equipment and devices

Health facilities should have adequate equipments and conditions to ensure infection control requirements as follows:

1. Ensuring adequate and appropriate environmental sanitary conditions and equipement:

a) Hand washing equipments and supplies: hand washing basins, hand disinfecting materials, disposable clean hand towels and hand washing chemicals.

b) Adequate specialized sanitary equipment to ensure efficient sanitization in health facilities.

c) In the event health facilities enter outsource contracts with industrial cleaning service companies, provisions should be clearly stipulated in the contracts on requirements for equipments and devices, chemicals, sanitary standards, sanitization procedures, organization of training, and on how to coordinate in periodic sanitary quality inspections and appraisals.

d) Adequate equipment for gathering, transporting and storing waste, and containers and bags for storing waste in adequate quantity and quality with proper colour code in compliance with regulations.

2. Infection control units should be equipped with office equipments for surveillance and training including computers, printers, and other equipments for environmental quality inspection and appraisals and infection control.

3. Food processing and distributing facilities in hospitals should be equipped adequate equipment and devices to be used in food processing in compliance with legal regulations on food safety and hygiene.

Article 13. Specialised infection control human resource

Health facilities should ensure human resource for the operation of infection control units (teams): personnel for sections including disinfecting, sterilising and laundry sections. Infection surveillance sections should have at least 1 staff with specialised infection control expertise per 150 patient beds.

Article 14. Training for enhancing infection control expertise and skills of health workers

1. Medical doctors and staff of infection control units (teams) should be provided with specialised training, and regularly updated expertise and practical skills on infection control.

2. Medical doctors and health workers of health facilities should be given training on professional technical procedures on infection control and proper use of personal protection equipments.

Chapter III

ORGANIZATIONAL SYSTEM, RESPONSIBILITIES AND AUTHORITY

Article 15: Organizational system of infection control in health facilities

1. Hospitals should establish organizational systems of infection control comprising:

a) Infection control councils (committees)

b) Infection control units (teams)

c) Infection control network.

2. Other health facilities should establish organizational systems of infection control in accordance with items 1, a and c of this Article and have staff responsible for infection control.

Article 16. Organization and responsibilities of Infection control councils (committees)

1. Organization:

a) The establishment of infection control councils is decided by Directors or Heads of health facilities. An infection control council is comprised of a chairman, a vice-chairman, a standing executive member and other executive members.

b) The Chairman of the infection control council is a leader or head of the health facility. The vice-chairman and the standing executive member is either head of the infection control unit or one of the leaders of a department/ward who is experienced in infection control.

c) Executive members of the infection control council are representatives for clinical and sub-clinical departments, the general planning department, the nursing department, the administration department, the finance and accounting department, the personnel department, the medical equipment department and other relevant sections.

2. Responsibilities:

a) Reviewing, making proposals and giving counsel to Directors or Heads of the facilities for development of and amendments and supplements to professional technical regulations on infection control appropriate to regulations of the Ministry of Health.

b) Giving advice to Directors or Heads of the facilities on the development plan for infection control and prevention of healthcare associated infections, diseases and epidemics; giving advice on repair, design, new construction of medical facilities in health facilities appropriate with infection control principles.

c) Conducting training, scientific research, direction over lower levels, and promotion on infection control within the management scope of the facilities.

Article 17. Organization and responsibilities of infection control units or teams

1. Organization:

a) Health facilities with from 150 patient beds or more or hospital grade II or higher should establish infection control units; health facilities with less than 150 patient beds should establish infection control teams; general clinics and health stations should have specialized staff responsible for infection control.

b) Depending on the size of the hospital, the infection control unit should be comprised of the following sections: administration and surveillance section, disinfection and sterilization section, laundry section and other sections are decided by Director of the hospital.

c) Leaders of an infection control unit (team) include the Unit Head (Team leader), Unit Deputy-Heads, and Head nurses. The Head of the infection control unit (Team leader) must own a university or higher degree majoring in medicine, nursing or pharmacy and have been trained on specialized infection control.

2. Responsibilities:

a) Developing annual and periodic infection control plans to be submitted to infection control councils (committees) for appraisals prior to approval by Directors (Heads) and implementation.

b) Acting as a focal point in developing infection control regulations and procedures based on common regulations and guidelines of the Ministry of Health to be submitted to Directors (Heads) for approval before implementation.

c) Acting as a focal point in coordinating with relevant departments/wards for conducting infection control surveillance, including:

- Detecting, conducting surveillance and making reports on communicable diseases and epidemics in compliance with the Communicable Disease Prevention and Control Law.

- Detecting and receiving reports on healthcare associated infection cases from clinical departments and bacteria culture results from microbiology departments (laboratories) and proposing timely intervention measures.

- Monitoring and making reports on drug resistant bacteria.

d) Conducting inspections and encouraging permanent and contractual workers and staff, teachers, students, pupils, patients, patients’ family members and visitors to properly follow infection control regulations in health examination and treatment.

đ) Conducting promotion, training, scientific research and participating in direction over lower levels on specialized infection control techniques, guidance on prevention of fatal communicable disease transmission and conducting scientific research and being maintaining international cooperation on infection control.

e) Managing and supervising disinfection, sterilization, laundry work, supply of sterile devices, disinfecting and sterilizing chemicals, linen and consumable materials for infection control throughout the facility.

g) Monitoring, appraising, and reporting of exposures and workplace occupational incidents related to microbiological etiologic agents happening to health workers.

h) Cooperating with microbiology departments, pharmacy departments and clinical departments in monitoring drug resistant microorganisms and appropriate antibiotic use.

i) Coordinating with departments, wards and members of infection control network in detecting and solving problems related to infection control.

Article 18. Organization and responsibilities of infection control network members

1. Organization: The infection control network is comprised of members representing clinical and sub-clinical departments; each department appoints at least a doctor or a nursing staff or midwife as members of the infection control network operating under the professional leadership of infection control units (teams). These members shall be given regular training on updated expertise on infection control.

2. Responsibilities:

a) Participating and coordinating in implementation of infection control in the facility.

b) Participating in inspection and supervision, and encouraging medical doctors and staff in the facility to follow professional regulations and procedures related to infection control.

Article 19. Responsibilities and authority of Head of infection control units (teams).

1. Responsibilities: being accountable to the Director (Head) of the health facility for the overall infection control within the facility:

a) Organizing proper implementation of all responsibilities of infection control units.

b) Making infection control plans to be submitted to the Director for approval and organizing implementation...

c) Directing in surveillance and detection, and making proposals for timely intervention measures aimed at controlling healthcare associated infection cases and diseases of epidemic potential.

d) Participating in development of infection control regulations and procedures and directing the inspections and encouragement for execution.

đ) Making proposals on procurement plans and technical standards and specifications for equipment, consumable materials, and chemicals for infection control in the whole facility.

e) Participating in promotion, guidance, and training on expertise and skills of infection control to health workers, teachers, pupils, medical students, patients, patients’ family members and visitors.

g) Organizing scientific research and training, and giving direction over lower levels on infection control.

h) Coordinating with related departments and wards in assessing the implementation efficacy of specialized infection control techniques

i) Making reviews and reports on performance and outcomes of infection control in the whole facility.

2. Authority:

a) Executing the overall authority of the unit head.

b) Inspecting and requiring departments, wards and individuals to properly follow infection control regulations.

c) Making proposals to the Director (Head of the facility) for rewards or disciplinary actions on individuals and teams getting achievements or violating professional techniques on infection control.

d) Acting as the standing executive member of the infection control council, executive member of the quality management council (if any), and executive member of the medication and treatment council.

Article 20: Responsibility and authority of head nurses of infection control units.

1. Responsibilities:

a) Executing overall responsibilities of head nurses.

b) Assisting heads of infection control units in executing responsibilities of infection control units.

c) Assisting unit heads in making plans for management of equipment and devices, use of consumable materials, and chemicals for professional activities in the unit.

d) Participating in development of infection control regulations and procedures and inspection and supervision on execution.

e) Executing other responsibilities delegated by Heads of infection control units.

2. Authority:

Having authority similar to that of other head nurses and being authorized to conduct inspections and supervision on infection control in departments or wards within health facilities.

Article 21: Responsibilities and authority of medical doctors and specialized staff of infection control units (teams):

1. Responsibilities:

a) Strictly observing infection control regulations.

b) Participating in development of infection control regulations and procedures and inspection and supervision on execution.

c) Conducting surveillance, detection, monitoring, and reviewing of healthcare associated infections in departments.

d) Managing equipments and devices, materials and chemicals for professional work if delegated.

đ) Executing other responsibilities delegated by Heads of infection control units.

2. Authority:

Conducting inspections and supervising the execution of the circular on guidelines for implementation of infection control over individuals and departments in accordance with delegation by heads of infection control units.

Chapter IV 

RESPONSIBILITIES FOR IMPLEMENTATION

Article 22. Responsibilities of Directors (Heads) of health facilities.

1. Directing and organizing the execution of the circular on guidelines for implementation of infection control in health facilities; Developing and issuing specific regulations on professional techniques on infection control appropriate to situation of particular facilities in accordance with guidelines in this Circular.

2. Allocating annual budgets sufficient for expenses on infection control.

3. Ensuring adequate human resource, equipments and devices, chemicals, materials for professional practice, infection control, waste management and sanitation to ensure green, clean and nice health facilities.

4. Directing in training, scientific research, inspections and surveillance on the implementation of infection control.

5. Ensuring safety and prevention of communicable disease transmission for health workers and patients, especially in epidemic situations.

6. Launching emulation campaigns and implementing rewarding and disciplinary actions on infection control.

Article 23: Responsibilities of infection control councils

1. Giving counsel to Directors (Heads) of health facilities on infection control.

2. Taking into consideration proposals by infection control units (teams) and members of infection control councils for providing counsel to Directors (Heads) of health facilities on plans and amendments to regulations, procedures and matters related to infection control.

3. Giving comments and making proposals related to infection control if required by Directors (Heads) of health facilities.

Article 24. Responsibilities of functional departments

Nursing departments, general planning departments, and related departments coordinate with infection control units (teams) in developing infection control regulations and procedures and conducting inspections and surveillance related to infection control.

Article 25. Responsibilities of heads of departments in health facilities

1. Organizing the execution of infection control regulations and procedures.

2. Arranging for giving guidance to patients, patients’ family members, visitors on execution of infection control regulations for patients, patients’ family members, and visitors.

3. Coordinating with infection control units (teams) in training, surveillance and assessment on infection control activities in departments.

4. Detecting and reporting in a timely manner acquired infection cases in departments to infection control units (teams) and Directors (heads) of health facilities. Coordinating with infection control units (teams) in conducting surveillance and confirming cases of epidemics, nosocomial infections, and drug resistant bacteria in departments.

Article 26. Responsibilities of head nurses

1. Inspecting and reminding medical doctors, health workers, patients, patients’ family members, learners, students, learning health workers of observing infection control regulations and procedures in health care and treatment.

2. Giving guidance and inspecting the implementation of hand wash procedures by medical doctors, health workers, patients, patient’s family members and visitors.

3. Managing, giving guidance on, and supervising the use of personal protection equipments to ensure proper use for the right purpose and the right persons to achieve the highest efficacy of infection control.

4. Delegating nursing staff or midwives to participate in the infection control network.

Article 27. Responsibilities of microbiology departments (laboratories)

1. Coordinating with infection control units (teams) in investigation and surveillance on acquired infections and environmental sanitation.

2. Reporting in a timely manner to infection control units (teams) and clinical departments on microorganism culture results and drug resistance of disease-causing bacteria in compliance with regulations.

Article 28. Responsibilities of pharmacy departments

1. Providing information on disinfecting chemicals, antibiotics, and the safe and appropriate use of antibiotics in health facilities to infection control units (teams).

2. Coordinating with infection control units (teams) in making proposals for procurement, supply and use of chemicals and consumable materials to meet the need of infection control.

Article 29. Responsibilities of medical doctors, health workers, teachers, pupils, and student trainees in health facilities

1. Participating in training courses on knowledge of infection control.

2. Properly following infection control regulations and procedures.

Article 30. Responsibilities of patients, patients’ family members and visitors

1. Strictly complying with regulations on visiting hours and isolation measures in accordance with regulations and guidelines of health facilities.

2. Executing regulations on individual hygiene and hospital sanitation, and waste classification/segregation, and other regulations of health facilities.

3. For patients contracting and people suspected of contracting epidemic-causing communicable diseases group A and some other diseases group B decided by the Ministry of Health, observing procedures on treatment, isolation, moving and leaving hospitals in accordance with regulations of health facilities.

Chapter V

ENFORCEMENT AND IMPLEMENTATION

Article 31. Effective dates

1. This Circular shall come into effect from 1 December 2009.

2. Infection control regulations, regulations on activities of infection control units, and regulations on roles and responsibilities of heads of infection control units in the Regulation on Hospitals promulgated with Decision No 1895/1997/BYT-QD dated 19 September 1997 issued by the Minister of Health shall become null and void.

Article 32. Responsibilities of implementation

Chief administrator of the Ministry of Health, Head of Department of Medical Examination and Treatment Management, Chief Inspector of the Ministry of Health, Heads of all Departments under the Ministry of Health, Directors of hospitals, Institutes involved in patient care and treatment under the Ministry of Health, Directors of centrally-run provincial and municipal Departments of Health, and heads of heath sections of different sectors shall be responsible for implementation, inspection and assessment of the execution of this Circular./.

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