Circular No. 25/2012/TT-BYT Issuing National Technical Regulations on Laboratory Practices and Biosafety in Laboratories

CIRCULAR

Issued Article 24Technical standard for laboratory practices and biosafety

at laboratories

____________________ 

THE MINISTER OF HEALTH

Based on the Law on Prevention and Control of Infectious Diseases dated November 21, 2007;

Pursuant to the Law on Technical Standards and Regulations dated June 29, 2006;June 2024;Pursuant to Article 6 of the Law on Standards and Technical Regulations dated June 6, 2006 and Decree No. 127/2007/NĐ-CP dated August 1, 2007 of the Government detailing certain provisions of the Law on Standards and Technical Regulations;

Pursuant to DecreeNo. Pursuant to Decree No. 63/2012/NĐ-CP dated August 31, 2012 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;of the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Home AffairsFor traditional medicine doctors, traditional medicine practitioners, licensed traditional medicine practitioners, and those with hereditary prescriptions or hereditary treatment methods, the scope of professional activities shall be implemented according to another Circular issued by the Minister of Health.

Considering the proposals of the Director of the Preventive Medicine Department and the Head of the Legal Department;

The Minister of the Ministry of Science and Technology issues this Circular on the issuance of National Technical Regulations on Radioactive Waste Containing Naturally Occurring Radioactive Materials.concerning the classification and determination of state management authority in the field of crop productionThe Minister of Health promulgates the National Technical Regulation on Laboratory Practices and Biosafety at Laboratories.

Article 1. National Technical Regulation on Laboratory Practices and Biosafety at Laboratories

This Circular promulgates the National Technical Regulation - QCVN 15-1:2012/BYT on Laboratory Practices and Biosafety at Laboratories.

Article 2. Effective Date

This Circular takes effect from June 1, 2013.

Article 3. Responsibility for Implementation

The Director of the Preventive Medicine Department, Heads of units under the Ministry of Health, subordinate units of the Ministry of Health, Directors of Health Departments of provinces and centrally-run cities, and organizations and individuals concerned are responsible for implementing this Circular.

 

NATIONAL TECHNICAL REGULATION

ON LABORATORY PRACTICES AND BIOSAFETY

National technical regulation on practice and biosafety in laboratoriesfhoạt động trong实验室中的活动

Part 1

GENERAL PROVISIONS

I. SCOPE OF REGULATION AND APPLICABLE OBJECTS

- The national technical regulation on laboratory practices and biosafety at laboratories sets forth requirements for infrastructure, equipment, personnel, and practices to ensure biosafety at laboratories;

- The national technical regulation on laboratory practices and biosafety at laboratories applies to laboratories conducting microbiological testing that pose a risk of infectious disease transmission to humans.

II. DEFINITIONS

In this regulation, the following terms are understood as follows:

- Decontamination: refers to processes for removing, destroying microorganisms; eliminating or neutralizing hazardous chemicals and radioactive substances. Decontamination processes include cleaning, disinfection, and sterilization, which are carried out based on safety requirements and actual conditions of each laboratory.

- Cleaning: Involves removing dust and chemicals from the laboratory using water, detergents, and other cleaning chemicals.

- Disinfection: Is the process of eliminating nearly all pathogenic microorganisms except bacterial spores.

- Sterilization: Is the destruction of all forms of life of microorganisms, including spores.

- Laboratory Personnel: Includes all individuals working in the laboratory such as laboratory supervisors, testers, or decontamination staff.

Part 2

b) Welding materials must produce welds with a tensile strength no less than that of the base material used to manufacture the cylinders.

I. BIOLOGICAL SAFETY LEVEL I LABORATORY

1. Infrastructure of the laboratory

A Biological Safety Level I laboratory must comply with all regulations set forth in Clause 1, Article 5 of Decree No. 92/2010/NĐ-CP dated August 30, 2010 of the Government and the following requirements:

a) Technical requirements for doors and windows:

- Doors: Must have frames, locks, and safety mechanisms; door panels made of wood, composite materials, or metal combined with clear glass.

- Windows: Must have frames and safety locks; window panels made of wood, composite materials, or metal combined with clear or frosted glass for natural lighting.

b) Technical requirements for floors, walls, and ceilings of the laboratory:

- Floors:

+ Must be level, without thresholds, smooth, non-slippery, resistant to chemicals, waterproof, and easy to clean;

+ In washing, sterilization preparation, sample preparation, and medium preparation areas, there must be drainage facilities for cleaning;

+ The junction between the floor and walls must be easy to clean and prevent water accumulation.

- Walls: Must be flat, easy to clean, waterproof, and resistant to commonly used chemicals in laboratories.

- Ceilings: Must be flat, smooth, waterproof, and able to accommodate installation of equipment (lighting, fire protection, air conditioning, or other devices).

c) Laboratory work surfaces: Must be waterproof, resistant to disinfectants, acids, bases, organic solvents, and heat.

d) Storage spaces for personal clothing and items for laboratory personnel outside the laboratory and hanging space for laboratory coats inside near the entrance;

e) The laboratory must provide adequate lighting for activities: Lighting in the testing area must have a minimum illuminance of 400 lux, in washing, sterilization, sample preparation, medium preparation, shower, and changing areas 250 lux, administrative and auxiliary areas 140 lux;

f) Emergency eye wash stations and first aid boxes must be placed in easily accessible locations;

g) Electrical system must meet national safety standards:

- Must have backup power supply;

- Wiring and electrical control and supply equipment must be safe and meet technical specifications (power capacity, quality);

- Must have overload protection systems;

- The entire system must be grounded;

- Power outlets must be at least 40 cm above the laboratory floor and not near water taps;

h) Areas with ultraviolet light, laser, radioactive, and toxic substances must have corresponding warning signs;

i) Fire prevention and firefighting equipment must be installed according to regulations.

2. Equipment of the laboratory

A Biological Safety Level I laboratory must comply with all requirements set forth in Clause 2, Article 5 of Decree No. 92/2010/NĐ-CP dated August 30, 2010 of the Government and the following requirements:

a) Equipment must have labels with sufficient information such as name, serial number, date of commissioning, inspection status, calibration status; equipment history and user manual;

b) During operation, equipment must meet technical parameters specified by the manufacturer.

3. Personnel of the laboratory

A Biological Safety Level I laboratory must comply with all requirements set forth in Clause 3, Article 5 of Decree No. 92/2010/NĐ-CP dated August 30, 2010 of the Government and the following requirements:

a) Number of personnel: At least two personnel;

b) Before and during work in the laboratory, personnel must undergo health examinations and monitoring according to Circular No. 19/2011/TT-BYT dated June 6, 2011 of the Minister of Health on guidelines for occupational health management and occupational diseases;

c) Must be trained and instructed on occupational safety, fire prevention, and firefighting;

d) Must be retrained annually on testing and biosafety according to Circular No. 07/2008/TT-BYT dated May 28, 2008 of the Minister of Health on guidelines for continuous training for healthcare workers.

4. Provisions on practices

4.1. Entry and exit regulations for the laboratory: Only authorized persons may enter the laboratory.

4.2. Provisions on safety practices in laboratories

a) Having and complying with testing procedures, equipment usage guidelines, and waste handling procedures;

b) Not sucking pipettes by mouth;

c) Not using syringes or pumps for purposes other than injection, infusion, or aspiration from experimental animals; used syringes must be placed in specialized sharp containers or automatic destruction machines, not bent, broken, recapped, or removed from the pump;

d) Washing skin areas that come into contact with chemicals, washing hands before leaving the laboratory;

đ) Wearing protective clothing and closed-toe shoes when working in the laboratory, not wearing protective clothing in public areas;

e) Not mixing protective clothing with regular clothing;

g) Not bringing personal items or food into the laboratory;

h) Not using laboratory equipment to store or prepare food;

i) Not eating, smoking, shaving, or applying cosmetics in the laboratory.

4.3. Decontamination and Waste Management

a) Decontaminating work surfaces immediately after completing tests, at the end of the workday, or in case of spills or leaks of infectious samples;

b) Classifying, transporting, and managing waste according to regulations.

5. Prevention, Handling, and Mitigation of Biological Safety Incidents

Meeting all requirements set forth in Article 18 and Article 19 of Decree No. 92/2010/NĐ-CP dated August 30, 2010 of the Government, and the following provisions:

a) Having incident response procedures;

b) Keeping incident records and response measures for at least three years.

II. BIOLOGICAL SAFETY LEVEL C LABORATORY CẤP II

1. Infrastructure of the laboratory

A Level II biological safety laboratory must comply with all physical facility requirements of a Level I biological safety laboratory, and the provisions of Clause 1, Article 6 of Decree No. 92/2010/NĐ-CP dated August 30, 2010 of the Government, and wastewater treatment systems meeting QCVN 28:2010/BTNMT standards of the Ministry of Natural Resources and Environment for medical wastewater before discharge into the common drainage system.

2. Equipment of the laboratory

A Level II biological safety laboratory must comply with all equipment requirements of a Level I biological safety laboratory, and the provisions of Clause 2, Article 6 of Decree No. 92/2010/NĐ-CP dated August 30, 2010 of the Government, and the following provisions:

a) Wet autoclaves must be located within the laboratory area;

b) Laboratory equipment such as biosafety cabinets and wet autoclaves must be tested using appropriate methods before use. Subsequent retesting and certification must be conducted by authorized agencies at least once a year or as recommended by the manufacturer.

3. Laboratory Personnel

A Level II biological safety laboratory must comply with all personnel requirements of a Level I biological safety laboratory, and the provisions of Clause 3, Article 6 of Decree No. 92/2010/NĐ-CP dated August 30, 2010 of the Government, and the following provisions:

a) Number of personnel: At least two personnel;

b) The entity operating the laboratory must designate a person responsible for biological safety;

c) Laboratory staff must be vaccinated or provided with prophylactic medication related to pathogens when conducting tests;

d) Pregnant laboratory staff, those with infectious diseases, or those with compromised immune systems must inform the laboratory supervisor to be assigned tasks that reduce the risk of pathogen exposure.

4. Provisions on practices

A Level II biological safety laboratory must comply with all operational requirements of a Level I biological safety laboratory, and the following provisions:

a) Using biosafety cabinets for testing operations that may generate aerosols capable of causing disease;

b) Wearing gloves during all direct or potential contact with infectious materials. After use, gloves must be removed properly and hands washed;

c) The biological safety officer and laboratory staff must conduct risk assessments to apply appropriate biological safety measures;

d) Having procedures for storing and preserving infectious agents in the laboratory.

5. Prevention, Handling, and Mitigation of Biological Safety Incidents

A Level II biological safety laboratory must comply with all prevention, handling, and mitigation requirements of a Level I biological safety laboratory, and have procedures for handling incidents involving pathogens used in the laboratory.

III. LEVEL III BIOLOGICAL SAFETY LABORATORY

1. Infrastructure of the laboratory

A Level III biological safety laboratory must comply with all physical facility requirements of a Level II biological safety laboratory, and the provisions of Clause 1, Article 7 of Decree No. 92/2010/NĐ-CP dated August 30, 2010 of the Government, and the following provisions:

a) The laboratory has a full glass window or observation equipment allowing viewing from outside;

b) The laboratory has two-way communication and alarm systems;

c) The laboratory pressure must always be lower than the outside when the laboratory is operating normally; when the door is closed, the buffer room pressure must be at least 12.5 Pa lower than the outside, and the laboratory pressure must be at least 12.5 Pa lower than the buffer room;

d) The air exchange rate of the laboratory must be at least six times per hour;

đ) The design and operation procedures of the laboratory must be documented;

e) The air supply system can only operate when the exhaust system is functioning and will automatically stop if the exhaust system stops.

2. Laboratory Equipment

A Level III biological safety laboratory must comply with all equipment requirements of a Level II biological safety laboratory, and the provisions of Clause 2, Article 7 of Decree No. 92/2010/NĐ-CP dated August 30, 2010 of the Government, and the following provisions:

a) Protective clothing, head coverings, safety glasses, masks, respiratory protection equipment (masks, N95 respirators), and other necessary equipment; reusable protective equipment must be made of sterilizable material;

b) Laboratory protective clothing must be long-sleeved, not buttoned or tied in front.

3. Laboratory Personnel

A biosafety level 3 laboratory must comply with all personnel requirements for a biosafety level 2 laboratory and the provisions set forth in Clause 3, Article 7 of Decree No. 92/2010/NĐ-CP dated August 30, 2010, of the Government, as well as the following provisions:

a) Number of staff: at least two laboratory technicians and one technical operator for the laboratory;

b) Pregnant women, those suffering from infectious diseases, or those with weakened immune systems shall not work in a biosafety level 3 laboratory;

c) Staff suspected of being infected with pathogens from the laboratory must immediately contact healthcare facilities for monitoring and timely treatment;

d) Laboratory technicians must be proficient in practical procedures and microbiological techniques.

4. Operational Provisions

4.1. Operational Procedures in the Laboratory

A biosafety level 3 laboratory must comply with all operational procedures for a biosafety level 2 laboratory and the following additional provisions:

a) The biosafety officer and laboratory staff must conduct risk assessments to implement appropriate biosafety measures;

b) There must be and compliance with procedures for using the laboratory and transporting equipment and specimens in and out of the laboratory;

c) Laboratory staff must use appropriate personal protective equipment;

d) Upon entering and exiting the laboratory, staff must check and record safety parameters such as room pressure and other laboratory forms;

e) When centrifuging infectious materials, sealed plastic test tubes must be used; after centrifugation, open the test tube inside a biosafety cabinet;

f) Pathogen strains must be stored in leak-proof containers. Storage cabinets and rooms for pathogens must be locked, and there must be a person responsible for pathogen storage.

4.2. Decontamination

a) Materials and equipment must be sterilized before removal from the laboratory;

b) Infectious substances must be sterilized within the laboratory;

c) All equipment must be sterilized before maintenance or removal from the laboratory;

d) Infectious waste must be transported out of the laboratory for collection and disposal in sealed, non-breakable, and non-leaking containers according to regulations;

e) The entire laboratory must be sterilized at least once a year or when necessary.

5. Prevention, Handling, and Mitigation of Biological Safety Incidents

A biosafety level 3 laboratory must comply with all preventive, handling, and remediation procedures for biosafety incidents in a biosafety level 2 laboratory and establish emergency response procedures related to laboratory pressure, temperature, and humidity.

IV. BIOSAFETY ROOM CẤP IV

1. Laboratory Facilities

A biosafety level 4 laboratory must comply with all facility requirements for a biosafety level 3 laboratory and the provisions set forth in Clause 1, Article 8 of Decree No. 92/2010/NĐ-CP dated August 30, 2010, of the Government, as well as the following provisions:

a) Must be isolated, secure, and protected;

b) Must have transport boxes for moving infectious materials in and out of the laboratory;

c) Air intake and exhaust from the laboratory must be filtered through high-efficiency particulate air filters.

2. Laboratory Equipmentpoliciest

A biosafety level 4 laboratory must comply with all equipment requirements for a biosafety level 3 laboratory and the provisions set forth in Clause 2, Article 8 of Decree No. 92/2010/NĐ-CP dated August 30, 2010, of the Government.

3. Personnel of the laboratory

A biosafety level 4 laboratory must comply with all personnel requirements for a biosafety level 3 laboratory and the provisions set forth in Clause 3, Article 8 of Decree No. 92/2010/NĐ-CP dated August 30, 2010, of the Government, and establish a system for reporting incidents, monitoring staff absences, and monitoring infections related to the laboratory.

4. Operational Provisions

A biosafety level 4 laboratory must comply with all operational provisions for a biosafety level 3 laboratory and the following additional provisions:

a) Transport materials and equipment in and out of the laboratory through transport boxes or double-door autoclaves;

b) Have sterilization procedures for equipment and items that cannot be sterilized in autoclaves;

c) Maintain complete records of biosafety level 4 laboratory usage (entry and exit logs) with full information on date and time;

d) Upon entering the laboratory, staff must change into dedicated protective clothing and upon leaving, must shower and change back into regular clothing;

e) Materials removed from the laboratory must be decontaminated appropriately or approved by the biosafety officer or laboratory supervisor;

f) When working in the laboratory, staff must have technical support available outside the laboratory in case of emergencies.

5. Prevention, Handling, and Mitigation of Biological Safety Incidents

A biosafety level 4 laboratory must comply with all preventive, handling, and remediation procedures for biosafety incidents in a biosafety level 3 laboratory and must have emergency response procedures for a biosafety level 4 laboratory.

Part 3

IMPLEMENTATION

1. The Minister of Health assigns the Preventive Medicine Department to coordinate with relevant Departments, Bureaus, and units to guide organizations with laboratories to strictly follow national technical standards on operational procedures and biosafety in laboratories;

2. Organizations and individuals performing testing functions must strictly adhere to these standards and bear responsibility for their unit's activities;

3. Based on management requirements and actual conditions, the Preventive Medicine Department has the responsibility to recommend the Minister of Health to amend and supplement these standards;

4. In cases where the national standards cited in these standards are amended, supplemented, or replaced, the new documents shall apply.