Circular No. 37/2017/TT-BYT on the practice of ensuring biosafety in laboratories.

CIRCULAR

Regulations on the practice of ensuring biosafety in laboratories

THE MINISTER OF HEALTH

Pursuant to Decree No. 103/2016/NĐ-CP dated July 1, 2016 of the Government on ensuring biosafety in laboratories,

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

At the proposal of the Director of the Preventive Medicine Department,

The Minister of Health issues this Circular regulating the practice of ensuring biosafety in laboratories.

Article 1. Scope of Regulation and Applicability

This Circular regulates the practice of ensuring biosafety in laboratories working with microorganisms that pose a risk of transmitting infectious diseases to humans and samples containing such microorganisms (hereinafter referred to as laboratories).

Article 2. Interpretation of Terms

The following terms shall be understood as follows:

1. Decontamination is the process of cleaning, disinfection, or sterilization to eliminate, destroy microorganisms; remove or neutralize hazardous chemicals and radioactive materials.

2. Cleaning is the process of removing dust and organic matter in the laboratory by sweeping, vacuuming, dry dusting, washing, rinsing, and using detergents and other cleaning chemicals.

3. Disinfection is the process of using physical or chemical methods to eliminate most microorganisms but not spores.

4. Sterilization is the process of eliminating all types of microorganisms including spores.

Article 3. Regulations on the practice of ensuring biosafety in Biosafety Level I laboratories

1. Regulations on entering and exiting the laboratory:

Persons authorized to enter and exit the laboratory, others must obtain permission from the competent authority and be guided and supervised when entering and exiting the laboratory.

2. Regulations on personal protection and health monitoring:

a) Wearing long-sleeved protective clothing when working in the laboratory;

b) Protective clothing used in the laboratory must be kept separately;

c) Not wearing protective clothing used in the laboratory outside the laboratory area;

d) Using appropriate gloves during work involving contact with microorganisms that pose a risk of transmitting infectious diseases to humans or samples containing such microorganisms; gloves must be worn over the protective clothing;

đ) Changing gloves when they become contaminated, torn, or when necessary; removing gloves after completing testing and before leaving the laboratory; not reusing gloves; not using gloves currently or previously used in the laboratory when opening or closing doors;

e) Wearing closed-toe shoes; not wearing high-heeled shoes in the laboratory;

g) The laboratory must conduct medical surveillance of laboratory staff in accordance with the Labor Law No. 10/2012/QH13 and Decree No. 45/2013/NĐ-CP dated May 10, 2013 of the Government detailing certain provisions of the Labor Code on working hours, rest periods, and occupational safety and hygiene.

3. Regulations on work areas and equipment usage:

a) Lighting in the testing area in accordance with Circular No. 22/2016/TT-BYT dated June 30, 2016 of the Minister of Health on national technical standards for lighting - permissible illumination levels at workplaces;

b) Providing clean water for the testing area in accordance with Circular No. 05/2009/TT-BYT dated June 17, 2009 of the Minister of Health on national technical standards for drinking water quality;

c) Laboratory equipment must have complete information and be labeled, managed, used, inspected, and calibrated in accordance with Decree No. 36/2016/NĐ-CP dated May 15, 2016 of the Government on medical equipment management;

d) When installing and operating, equipment must meet the requirements and technical specifications of the manufacturer;

đ) Not using laboratory equipment for other purposes.

4. Regulations on performing procedures in the laboratory:

a) Washing hands according to standard procedures or quick sanitizing before and after testing, after removing gloves, and before leaving the laboratory;

b) Having and adhering to testing procedures to ensure that operations are performed in a manner that minimizes the generation of droplets or aerosols;

c) Packaging specimens for transport out of the testing facility in accordance with Circular No. 43/2011/TT-BYT dated December 5, 2011 of the Minister of Health on the management of infectious disease specimen samples;

d) Not using syringes or needles to replace pipettes or for any purpose other than injection, infusion, or aspiration from experimental animals;

đ) Not eating, smoking, shaving, or applying makeup in the laboratory; not bringing personal items, food into the laboratory; not removing or inserting contact lenses, using mobile phones while conducting tests.

5. Regulations on decontamination, waste management, prevention, handling, and remediation of biosafety incidents:

a) Having and adhering to decontamination and medical waste management procedures;

b) Classifying, collecting, storing, transporting, and disposing of waste in accordance with Joint Circular No. 58/2015/TTLT-BYTBTNMT dated December 31, 2015 of the Ministry of Health and the Ministry of Natural Resources and Environment on medical waste management;

c) Disinfecting surfaces in the work area after completing testing or when there is a spill of infectious agent-containing specimens;

d) All equipment and tools must be cleaned thoroughly and disinfected before maintenance, repair, or transportation out of the laboratory;

đ) Having and adhering to procedures for biological risk assessment, incident handling, which includes reporting all incidents occurring in the laboratory;

e) Retaining incident records and handling measures for at least three years.

Article 4. Provisions on the practice of ensuring biosafety in Biosafety Level 2 laboratories

1. Regulations on entering and exiting the laboratory:

Biosafety Level 2 laboratories must comply with all provisions set forth in Clause 1, Article 3 of this Circular and implement security measures.

2. Regulations on personal protection and health monitoring:

Biosafety Level 2 laboratories must comply with all provisions set forth in Clause 2, Article 3 of this Circular and the following regulations:

a) Use eye and face protection equipment (masks, goggles, face shields) when performing operations that may generate splashes, aerosols during testing without using biosafety cabinets, operations that may splash chemicals, or involve exposure to ultraviolet radiation.

b) Laboratory personnel conducting tests must be vaccinated or provided with prophylactic medication related to pathogens handled in the laboratory, except where there is no vaccine or prophylactic medication available for such pathogens.

c) Pregnant laboratory personnel, those suffering from infectious diseases or having weakened immune systems, those who have sustained accidents affecting their ability to move hands or feet, or those with open wounds must report to the laboratory supervisor to be assigned appropriate tasks.

3. Regulations on work areas and equipment usage:

Biosafety Level 2 laboratories must comply with all provisions set forth in Clause 3, Article 3 of this Circular and the following regulations:

a) Laboratory doors must remain closed during testing.

b) Use medical waste sterilization equipment and conduct periodic inspections according to Circular No. 07/2014/TT-BLDTBXH dated March 6, 2014, issued by the Minister of Labor, Invalids, and Social Affairs regarding 27 technical safety inspection procedures for machines and equipment with strict requirements for labor safety.

4. Regulations on performing procedures in the laboratory:

Biosafety Level 2 laboratories must comply with all provisions set forth in Clause 4, Article 3 of this Circular and the following regulation:

Testing techniques that may generate splashes and aerosols must be performed in biosafety cabinets unless the test is conducted using specialized testing equipment or additional protective measures are employed as stipulated in Circular No. 41/2016/TT-BYT dated November 14, 2016, issued by the Ministry of Health regarding the list of infectious disease-causing microorganisms categorized by risk groups and biosafety levels suitable for testing techniques.

Article 5. Provisions on the practice of ensuring biosafety in Biosafety Level 3 laboratories

Biosafety Level 3 laboratories must comply with all provisions set forth in Clause 1, Article 4 of this Circular and record entries and exits from the laboratory, including the following information: name of person and time of entry and exit from the laboratory.

Biosafety Level 3 laboratories must comply with all personal protective equipment and health monitoring regulations set forth in Clause 2, Article 4 of this Circular and the following regulations:

1. Regulations on entering and exiting the laboratory:

a) Use personal protective clothing that covers the front, head coverings, and shoe covers or use full-body protective suits.

2. Regulations on personal protection and health monitoring:

b) Use double gloves when conducting tests.

c) Reusable personal protective equipment must be sterilized before reuse, and protective clothing must be sterilized before washing.

Biosafety Level 3 laboratories must comply with all provisions set forth in Clause 3, Article 4 of this Circular and meet the following requirements:

a) Have and follow procedures for monitoring and recording pressure when entering and exiting the laboratory area.

3. Regulations on work areas and equipment usage:

b) All facilities and equipment of the laboratory must be inspected and maintained at least once a year.

Biosafety Level 3 laboratories must comply with all provisions set forth in Clause 4, Article 4 of this Circular and the following requirements:

Testing techniques must be performed in biosafety cabinets unless the test is conducted using specialized testing equipment or additional protective measures are employed as stipulated in Circular No. 41/2016/TT-BYT dated November 14, 2016, issued by the Minister of Health regarding the list of infectious disease-causing microorganisms categorized by risk groups and biosafety levels suitable for testing techniques.

4. Regulations on performing procedures in the laboratory:

Biosafety Level 3 laboratories must comply with all provisions set forth in Clause 5, Article 4 of this Circular and the following regulations:

5. Regulations on decontamination, waste management, prevention, handling, and remediation of biosafety incidents:

a) Infectious materials must be sterilized within the laboratory.

b) The entire laboratory must be sterilized at least once a year or as needed.

c) Have and implement emergency response procedures for incidents and emergencies in the laboratory.

d) Conduct emergency response drills at least once a year.

d) Phải tiến hành diễn tập xử lý các sự cố ít nhất một lần mỗi năm.

Article 6. Provisions on the practice of ensuring biosafety in Biosafety Level 4 laboratories

1. Regulations on entering and exiting the laboratory:

Biosafety Level 4 laboratories must fully comply with the provisions set forth in Clause 1, Article 5 of this Circular.

2. Regulations on personal protection and health monitoring:

Biosafety Level 4 laboratories must fully comply with the provisions set forth in Clause 2, Article 5 of this Circular and the following regulations:

a) When entering the laboratory, laboratory staff must change all outer clothing for specialized protective attire in the changing room; before leaving the laboratory, staff must shower and remove their specialized protective attire in the changing room.

b) No personal items may be brought into the laboratory except glasses or contact lenses, which must be decontaminated before being taken out of the laboratory.

3. Regulations on work areas and equipment usage:

Biosafety Level 4 laboratories must fully comply with the provisions set forth in Clause 3, Article 5 of this Circular.

4. Regulations on performing procedures in the laboratory:

Biosafety Level 4 laboratories must fully comply with the provisions set forth in Clause 4, Article 5 of this Circular and the following regulations:

a) When staff work inside the laboratory, there must be staff outside to monitor and provide support in emergency situations;

b) All testing procedures involving pathogens must be conducted within Biosafety Cabinet Class III;

c) There must be and follow standard communication procedures between staff working inside the laboratory and staff monitoring outside.

5. Regulations on decontamination, waste management, prevention, handling, and remediation of biosafety incidents:

Biosafety Level 4 laboratories must fully comply with the provisions set forth in Clause 5, Article 5 of this Circular and the following regulations:

a) Materials and equipment transported into and out of the laboratory must be carried in transport boxes that have been decontaminated chemically or sterilized using a two-door medical waste autoclave;

b) Infectious materials removed from the laboratory must be double-packaged in non-breakable material, decontaminated appropriately, and approved by the person responsible for biosafety;

c) There must be and follow sterilization procedures applicable to equipment and tools that cannot be sterilized using a two-door medical waste autoclave.

Article 7. Reference Provisions

In case the referenced documents in this Circular are replaced or amended, they shall be applied according to the replaced or amended documents.

Article 8. Effective Date

1. This Circular takes effect from December 15, 2017.

2. Circular No. 25/2012/TT-BYT dated November 29, 2012 issued by the Minister of Health regarding national technical standards for practices and biosafety in laboratories shall cease to be effective from the date this Circular comes into force.

Article 9. Responsibility for implementation

1. The Preventive Medicine Department is the lead unit, coordinating with relevant Departments, Bureaus, and units to implement the following tasks:

a) Directing, inspecting, auditing, and evaluating biosafety assurance activities in laboratories nationwide;

b) Developing guidance materials for standard procedures in laboratories.

2. Provincial and municipal health departments are responsible for directing, inspecting, auditing, and evaluating biosafety assurance activities in laboratories under their jurisdiction.

3. Testing facilities are responsible for:

a) Establishing and approving professional procedures related to biosafety in their laboratories;

b) Conducting training and retraining for laboratory staff in accordance with current laws;

c) Adhering to the provisions of this Circular and bearing full responsibility under the law for their activities.

During implementation, if difficulties arise, units and localities should report to the Ministry of Health for research and resolution./.