Thông tư 20/2021/TT-BYT

CIRCULAR

REGULATIONS ON HEALTH-CARE WASTE MANAGEMENT WITHIN THE PREMISES OF HEALTHCARE FACILITIES

Pursuant to Law on Environmental Protection No. 72/2020/QH14 dated November 17, 2020;

Pursuant to Decree No. 75/2017/ND-CP dated June 20, 2017 of the Government on function, duty, entitlement and organizational structure of the Ministry of Health;

At the request of the Director of the Health Environment Management Agency;

The Minister of the Ministry of Health promulgates the Circular on health-care waste management within the premises of healthcare facilities.

Chapter 1

GENERAL PROVISIONS

Article 1. Scope

1. This Circular provides for the detailed classification, collection, storage, management of health-care waste within the premises of healthcare facilities.

2. This Circular does not provide for regulations on radioactive waste management from health-care activities.  Management of radioactive waste from health-care activities shall comply with regulations of the Ministry of Science and Technology on radioactive waste management and used radioactive sources.

Article 2. Regulated entities

This Circular applies to healthcare facilities including medical examination and treatment facilities licensed as per the law on medical examination and treatment, preventive healthcare facilities, health sector training facilities, medical and pharmaceutical research and testing laboratories that generate health-care waste; domestic and foreign agencies, organizations, individuals related to health-care waste management on the territory of Vietnam.

Article 3. Interpretation of terms

For the purpose of this Circular, the following terms shall be construed as follows:

1. Health-care waste refers to waste that is generated from activities of healthcare facilities, including: hazardous health-care waste, ordinary solid waste, non-hazardous emissions and liquid waste and healthcare wastewater.

2. Infectious waste refers to waste that contains or is contaminated with the human blood or pathogenic microorganisms.

3. Health-care waste collection refers to the collecting process of health-care waste from where it is generated to temporary storage areas or to health-care waste disposal sites within the premises of healthcare facilities.

Chapter 2

CLASSIFICATION, SEGREGATION, COLLECTION, STORAGE, REDUCTION, RECYCLING, DISPATCH OF HEALTH-CARE WASTE

Article 4. Health-care waste classification

1. Hazardous health-care waste includes infectious waste and non-infectious hazardous waste.

2. Infectious waste includes:

a) Infectious sharps waste: needles, syringes with needles, intravenous line (IV) cannulas, puncture needles, acupuncture needles; scalpel blades, surgical nails, saws; used and disposed syringes, glass sharps, sharp objects, that is contaminated with or contains the human blood or pathogenic microorganisms;

b) Infectious non-sharps waste: cottons, bandages, gauzes, gloves, and other non-sharp wastes that is not contaminated with or contains blood or pathogenic microorganisms; discarded inactivated vaccine or attenuated vaccine bottles; infectious liquid waste (includes drainage fluid after surgery or medical procedures and fluid waste that contains human blood or pathogenic microorganisms);

c) Highly infectious waste: specimens, tools that contain specimens, wastes that contain discarded specimens from BSL-2 laboratories equivalent (biosafety level 2) or above; waste from isolation rooms, isolation wards, sampling areas for patients who have dangerous infectious diseases of group A and group B;

d) Surgery waste: tissues, discarded human parts, and experimental animal carcasses;

3. Non-infectious hazardous waste includes:

a) Discarded chemicals with ingredients and properties exceeding the hazardous waste threshold or with hazard warnings on their labels;

b) Discarded pharmaceutical products falling under the cytotoxicity category or with hazard warnings on their labels;

c) Medicine or chemical bottles and jars, other tools that contain medicine or chemical in the cytotoxicity category; or bottles that have hazard warnings on their labels;

d) Discarded used broken medical equipment which contains mercury, Cadmium (Cd); discarded batteries; discarded lead-coated materials used in radiation shielding;

dd) X-Ray film developer solutions, wastewater from testing and analysis equipment, and discarded fluids with hazardous elements exceeding the hazardous waste threshold;  

e) Other health-care wastes that have ingredients and properties exceeding the hazardous waste threshold or have hazard warnings on their labels;

4. Ordinary solid waste includes:

a) Solid domestic waste from daily activities of medical staff, patients, families of patients, students, guests, and outdoor wastes within healthcare facilities (excluding domestic waste generated from isolation wards for patients who have dangerous infectious diseases);

b) Discarded chemicals without ingredients and properties exceeding the hazardous waste threshold;

c) Medicine or chemical bottles and jars, other tools that contain medicine or chemicals that do not fall under the cytotoxicity category; or bottles and jars that do not have hazard warnings on their labels;

d) Discarded bottles of vaccines other than inactivated vaccines or attenuated vaccines;

dd) Non-infectious non-sharps that are wastes without ingredients and properties exceeding the hazardous waste threshold;

e) Treated infectious wastes that meet the national technical regulation on environment;

g) Discarded sludge without ingredients and properties exceeding the hazardous waste threshold from the wastewater treatment system; ashes or slag without ingredients or properties exceeding the hazardous waste threshold from solid health-care waste incinerators;

h) Other ordinary solid wastes;

i) The list of recyclable ordinary solid wastes allowed to be collected is prescribed in Appendix 1 promulgated with this Circular.

5. Emission includes emissions from laboratories for pathogens of dangerous and airborne infectious diseases; emissions from BSL-3 laboratories or above.

6. Non-hazardous liquid waste includes discarded liquid medicines and chemicals that do not fall under cytotoxicity category, do not have hazard warnings from manufacturers, do not contain ingredients or properties exceeding hazardous waste threshold, and do not contain pathogenic microorganisms.

7. Health-care wastewater includes wastewater from professional activities in healthcare facilities. Health-care wastewater management shall apply to domestic wastewater if they use the same wastewater collecting system.

Article 5. Packaging, tools, equipment that contain health-care wastes

1. Packaging (bag), tools (crate, container, can), and equipment that are used to contain health-care waste shall be safe for waste storage purpose, waterproof, leak-proof and appropriately fit for their content. Packaging, tools, and equipment that contain wastes shall specify the name of the waste it contains and have symbols prescribed in Appendix 2 promulgated with this Circular.

2. Colors of the packaging, tools, and equipment that contain health-care waste are prescribed in Clause 3, Clause 4, Clause 5, and Clause 6 Article 6 of this Circular.

3. Tools and equipment that contain waste shall have a lid that is convenient to open and close during its use, and is recyclable after being cleaned and disinfected.

4. Tools that contain sharps shall have hard walls and bottom that are puncture-proof. The mouth of waste containers and tools shall be well-designed to avoid spilling.

5. Tools and equipment that contain infectious wastes shall have a tight lid that can prevent animal invasion.

6. Tools and equipment shall be made from materials that are non-reactive with the chemicals which they contain and corrosion-resistant with chemicals that are corrosive.

7. Tools that contain liquid hazardous wastes shall have a lid to prevent evaporation and spill.

8. Packaging and equipment that contain burnt health-care wastes shall not be made from PVC plastic.

Article 6. Health-care waste segregation

1. Rules of health-care waste segregation:

a) Health-care wastes shall be segregated at the point and time of generation;

b) Each type of health-care waste shall be separately segregated into the packaging, tools, and equipment as prescribed in Article 5 of this Circular. In case the hazardous health-care wastes do not react with each other and are treated with the same method, segregate them into one containing packaging, tool, equipment (excluding infectious sharps waste);

c) In case the infectious wastes are mixed with other wastes, collect, store, and treat them as infectious wastes and keep handling them as after-treatment wastes.

2. Placing of segregation tools and packaging:

a) At faculties, departments, divisions: the storage tools, packaging, and equipment shall be placed appropriately and safely;

b) At the place where the storage tools, packaging, and equipment are placed, there shall be an instruction for segregation and collection of waste.

3. Infectious wastes segregation:

a) Infectious sharps waste: put in the yellow puncture-proof trash can or container;

b) Infectious non-sharps waste: put in the yellow lined trash can;

c) Highly infectious waste: put in the yellow lined trash can;

d) Surgery waste: double-bagged or put in the yellow lined trash can;

dd) Liquid infectious waste: put in a sealed bag or in a storage tool with a sealed lid.

4. Non-infectious hazardous waste segregation:

a) Non-infectious hazardous wastes shall be segregated by hazardous waste code to be stored in appropriate packaging, tools, and equipment.  Hazardous wastes that share the same properties; do not react with each other and treated with the same method; may be segregated in the same packaging, tool, equipment;

b) Non-infectious hazardous solid wastes: put in black bags, trash cans, or lined trash cans;

c) Non-infectious hazardous liquid waste: put in storage tools with a sealed lid.

5. Other ordinary solid waste segregation:

a) Non-recyclable ordinary wastes: put in blue bags, trash cans, or lined trash cans. Sharps shall be put in puncture-proof trash cans;      

b) Recyclable ordinary waste: put in blue bags, trash cans, or lined trash cans.

6. Non-hazardous liquid waste: put in labeled storage tools with a sealed lid.

Article 7. Health-care waste collection

1. Infectious waste collection:

a) A healthcare facility shall regulate the flow and time of infectious waste collection in a manner that they do not affect its patient care area and other areas.

b) Waste collection tools shall ensure no waste is leaked in the process; 

c) Infectious waste shall be separately collected from where it is generated to the temporary waste storage area in a health-care facility. Waste bags, trash cans shall be sealed before they are collected;

d) Highly infectious wastes shall be pre-treated near the place where it is generated to exterminate pathogens with disinfection equipment. For healthcare facilities that do not have disinfection equipment, highly infectious wastes shall be double-bagged, put in sealed trash cans labeled with " CHẤT THẢI CÓ NGUY CƠ LÂY NHIỄM CAO” (highly infectious waste) before being collected. These wastes shall be separately stored at the waste storage area to receive treatment or dispatch to handling units in accordance with regulations;

dd) Infectious liquid wastes shall be collected by the health-care wastewater collection system of a healthcare facility. These wastes shall be managed in accordance with regulations on wastewater management;

e) Infectious wastes shall be collected at least one time per day. For health-care facilities that generate less than 5 kg of infectious wastes per day, infectious wastes shall be collected at least one time per day and infectious sharps shall be collected at least one time per month.

2. Non-infectious hazardous waste collection:

a) Non-infectious hazardous waste shall be separately collected and stored at the waste storage area of a healthcare facility;

b) Discarded broken used medical equipment which contains mercury shall be separately collected and stored in containers made from plastic or other appropriate materials. These containers must ensure that there is no mercury vapor leakage or dispersion.

3. Ordinary solid waste collection: recyclable ordinary solid wastes and non-recyclable ordinary solid wastes shall be separately collected.

4. Non-hazardous liquid waste collection: non-hazardous liquid wastes shall be collected by the wastewater collection system of a healthcare facility. These wastes shall be managed in accordance with the regulations on wastewater management.

5. Emissions shall be treated to remove pathogenic microorganisms before being released into the surrounding environment.

6. Wastewater collection:

a) The wastewater collection system must be a closed system and ensure the collection of all of the wastewater generated in a healthcare facility;

b) Health-care wastewater shall be collected and managed in accordance with current law's regulations on wastewater management.

Article 8. Health-care waste storage

1. The waste storage area within the premises of a healthcare facility shall meet the following requirements:

a) Hospitals and healthcare facilities that treat health-care waste according to the cluster model shall ensure their waste storage area meet the technical requirements prescribed in Section A Appendix 3 promulgated with this Circular;

b) Healthcare facilities that are not entities prescribed in Point a of this Clause shall store their health-care waste according to technical requirements prescribed in Section B Appendix 3 promulgated with this Circular.

2. Each type of waste shall be stored separately at the temporary waste storage area within the premises of a healthcare facility unless these wastes share the same properties, do not react with each other, and are treated with the same method.

3. Infectious waste storage time:

a) The time of storage shall not exceed 2 days under normal conditions for infectious wastes generated at a healthcare facility. In case the infectious wastes are stored in cold storage equipment at temperatures below 8°C, the storage time shall not exceed 7 days;

b) Infectious wastes transferred from other healthcare facilities for treatment in a cluster model or centralized treatment shall be treated within the day. If the infectious wastes are not treated within the day, store at temperatures below 20°C. The storage time shall not exceed 2 days.

c) The time of storage shall not exceed 3 days under normal conditions for healthcare facilities that generate less than 5 kg of infectious wastes per day. The infectious wastes shall be stored in sealed packaging or in storage tools with a sealed lid.

4. Non-infectious hazardous waste storage time: the storage time shall not exceed 1 year from the date the waste is generated. In case the storage time exceeds 1 year due to unavailability of a waste transport and treatment plan or an appropriate hazardous waste treatment facility, the healthcare facility shall report that in a separate writing or in combination with the annual report on health-care waste management to competent agencies prescribed in Article 13 of this Circular; or to other competent agencies in accordance with the law.

5. Infectious sharps shall be safely stored in concrete tanks within the premises of the healthcare facility after they are sterilized for healthcare facilities that are in remote, mountainous areas or on islands without any appropriate treatment method. The waste storage area must have warning signs.

Article 9. Health-care waste minimization

Healthcare facilities shall conduct the following health-care waste minimization methods:

1. Buy, install, and use necessary supply and equipment, devices, medicines, chemicals, and materials suitable for use.

2. Upgrade equipment; update professional procedures and other methods in order to minimize health-care wastes.

3. Adopt measures, roadmap to limit the use of disposable plastic products, non-biodegradable plastic bags in order to reduce the generation of plastic waste.

4. Segregate plastic wastes for recycling or treatment in accordance with the law.

Article 10. Recyclable ordinary solid waste management

1. Healthcare facilities shall promulgate their recyclable ordinary solid waste list based on the list prescribed in Appendix 1 promulgated with this Circular. Healthcare facilities shall collect the mentioned waste according to their waste generation situation.

2. Treated infectious waste that meet the national technical regulation on environment shall be managed as recyclable ordinary solid wastes. When dispatching waste, healthcare facilities shall ensure that the packaging is sealed and labeled with a recycling symbol prescribed in Appendix 2 promulgated with this Circular; fill in the record of handover of disinfected waste that meet the national technical regulation on environment for recycling prescribed in Appendix 4 promulgated with this Circular.

3. Plastic wastes shall be segregated and collected for recycling and treatment in accordance with the law.

Article 11. Management and operation of health-care waste treatment equipment, system, and works

1. Healthcare facilities that treat health-care waste themselves or according to the cluster model shall regularly operate the health-care waste treatment equipment, system, and works according to the instruction of the manufacturer. Healthcare facilities shall ensure that the treated waste meets the national technical regulation on environment and comply with regulations of the law on environmental supervision.

2. Health-care waste treatment equipment, system, and works shall be regularly maintained according to the instruction of the manufacturer. Healthcare facilities shall provide information prescribed in Appendix 5 promulgated with this Circular.

Article 12. Health-care waste dispatch

1. Healthcare facilities that are not able to treat health-care waste themselves shall conduct health-care waste dispatch according to the following regulations:

a) Hazardous health-care waste shall be dispatched to licensed units in accordance with the law. Healthcare facilities shall provide information according to the form prescribed in Appendix 6 promulgated with this Circular and use hazardous waste records in accordance with regulations;

b) Ordinary solid waste shall be dispatched to appropriate functional units for transportation and treatment in accordance with the current law.

3. Units that receive the health-care waste shall ensure there is no leakage and transfer them in accordance with regulations. Health-care waste shall be treated in a manner that meets the national technical regulation on environment.

4. Healthcare facilities shall treat hazardous health-care waste according to the cluster model approved by the People’s Committee of the province or the centrally affiliated city. Healthcare facilities shall provide information according to the form prescribed in Appendix 6 promulgated with this Circular.

Chapter 3

HEALTH-CARE WASTE REPORT AND MANAGEMENT DOCUMENT

Article 13. Report

1. Frequency of report: The result of health-care waste management shall be reported annually, the reporting period begins from December 15 of the previous year to December 14 of the reporting year.

2. Form of report: The result of health-care waste management shall be sent via a written document or email, or reporting software.

3. Content and order of report:

a) Healthcare facilities shall report their result of health-care waste management according to the form prescribed in Section A Appendix 7 promulgated with this Circular. The report shall be sent to the Department of Health of the province or the centrally affiliated city (hereinafter referred to as Department of Health) in the area; or to the Ministry of Health (Health Environment Management Agency) for healthcare facilities affiliated with the Ministry of Health before December 16 of the reporting period;

b) The Department of Health shall send the report of the result of health-care waste management in the area to the Ministry of Health (Health Environment Management Agency) according to the form prescribed in Section B Appendix 7 promulgated with this Circular before December 20 of the reporting period.

Article 14. Health-care waste management document

Healthcare facilities shall keep and preserve the following documents:

1. Environmental license and other documents related to the environment in accordance with regulations (for healthcare facilities that are required to obtain environmental licenses).

2. Health-care waste delivery book; hazardous health-care waste records (if any).

3. Operation diary of health-care waste treatment equipment, system, works (for healthcare facilities that treat waste themselves)

4. Related minutes of inspection (if any).

5. Annual report of the result of health-care waste management; report of the result of environmental monitoring (if any).

6. Other related documents.

Chapter 4

IMPLEMENTATION

Article 15. Implementation responsibilities

1. Responsibilities of the Health Environment Management Agency

a) Direct, guide, and inspect the implementation of regulations of this Circular;

b) Promulgate technical guidelines for health-care waste management in the premises of a healthcare facility;

c) Provide training and propagate regulations on health-care waste management for the Department of Health and healthcare facilities under its management.

2. Responsibilities of the Department of Health

a) Direct, guide, and inspect the implementation of regulations of this Circular in the area under its management;

b) Provide training and propagate regulations on health-care waste management of this Circular for healthcare facilities under its management;

c) Direct healthcare facilities under its management to develop health-care waste management plan;

d) Cooperate with the Department of Finance in the allocation of budget to invest and upgrade the health-care waste treatment equipment, system, and works for healthcare facilities under its management;

dd) Report the result of health-care waste management in accordance with regulations prescribed in Article 13 of this Circular.

3. Responsibilities of healthcare facilities

a) Conduct health-care waste management in accordance with this Circular and other related legal documents;

b) Assign the head of the healthcare facility to undertake the health-care waste management; arrange health-care waste management officers; assign tasks to the Department of Infection Control or faculties, departments, divisions in charge of health-care waste management; arrange personnel or cooperate with external units in the operation of health-care waste treatment equipment, system, works according to requirements of the task (for healthcare facilities that treat waste themselves);

c) Develop health-care waste management plan separately or combine it with the annual operation plan of the healthcare facility; allocate budget to conduct health-care waste management;

d) Classify types of waste generated from activities of the healthcare facility to apply appropriate management methods in accordance with regulations of this Circular;

dd) Comply with demands of plans, methods, and equipment to prevent and respond to environmental incidents caused by the waste in accordance with the law (including treatment plans in case the hazardous health-care waste increases abnormally due to epidemic diseases or force majeure events);

e) Provide training and propagate regulations on health-care waste management for public employees, workers, and related entities;

g) Report the result of health-care waste management in accordance with regulations prescribed in Article 13 of this Circular.

Article 16. Implementation

1. Entry into force

a) This Circular comes into force as of January 10, 2022;

b) Joint Circular No. 58/2015/TTLT-BYT-BTNMT dated December 31, 2015 of the Ministry of Health and the Ministry of Natural Resources and Environment regulated on health-care waste management expires when this Circular comes into force.

2. Implementation

a) The Director of the Health Environment Management Agency, Chief of the Ministry Office of the Ministry of Health, Chief Inspector of Ministry of the Ministry of Health, Directors of departments of the Ministry of Health, and other related agencies, organizations, individuals shall implement this Circular;

b) Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health (Health Environment Management Agency) for consideration./.

APPENDIX NO. 1

LIST OF RECYCLABLE ORDINARY SOLID WASTES ALLOWED TO BE COLLECTED
(Promulgated with Circular No. 20/2021/TT-BYT dated November 26, 2021 of the Minister of the Ministry of Health)