Chương III Nghị định 103/2016/NĐ-CP: Điều kiện bảo đảm an toàn sinh học tại cơ sở xét nghiệm

Chapter III

REQUIREMENTS FOR ENSURING BIOSAFETY IN LABORATORIES

Article 5. Requirements for level I biosafety-testing facilities

The area of laboratories working with microorganisms with risk of causing infectious diseases to human and pathology specimens likely to carry microorganisms with risk of causing infectious diseases to human (hereinafter referred to as testing area) must fulfill the following requirements:

1. Required facilities:

a) Floors, walls and lab tables that are flat, waterproof, resistant to heat and corrosive chemicals and easy to cleanse;

b) Washbasins, emergency eye wash stations and first aid kits;

c) Electricity supply; the electricity system that is earthed and standby electricity sources;

dd) Fresh water carried directly to the testing area equipped with a backflow prevention device to protect the public water supply system;

dd) Fire safety equipment;

e) Sufficient lighting for testing activities.

2. Required equipment:

a) Testing equipment suitable for the testing technique and the pathology specimens/microorganisms undergoing the tests;

b) Wrapping, tools and devices for packaging biomedical wastes according to regulations;

c) Equipment for pasteurizing tools and specimens;

d) Personal protective equipment in accordance with the testing techniques conducted at level I biosafety-testing facilities.

3. Requirements for employees:

a) Number of employees: at least 02 test technicians. Any employee of a testing facility who directly performs the microorganism tests (hereinafter referred to as the test technician) must have qualifications suitable for the tests  performed by such facility.

b) Any facility with a laboratory must assign a person in charge of the biosafety;

c) Test technician and the person in charge of the biosafety must receive training in biosafety of level I or higher;

d) Other employees working in the testing area must be provided with training in biosafety suitable for their tasks.

4. Required regulations and procedures:

a) Regulations on entrance to and exit from testing areas;

b) Regulations on reporting;

c) Document storing procedures;

d) Testing process in accordance with the technique and the pathology specimen or the microorganism undergoing the test;

dd) Guidelines on use of equipment serving the testing activities;

e) Decontamination and waste treatment process;

g) Regulations on health and healthcare supervision.

Article 6. Requirements for level II biosafety-testing facilities

The testing area must fulfill the following requirements:

1. Required facilities:

a) The facilities specified in clause 1 Article 5 of this Decree;

b) Wastewater collection and treatment system and equipment. Regarding testing facilities which have been operated before the effective date of this Decree, the wastewater testing result proving the wastewater satisfying National technical regulation on water environment must be presented before discharging such wastewater to the septic tank;

c) The laboratory must be separate from other rooms of the testing facilities;

d) There shall be a biohazard sign on the door of the testing area using the Model No. 01 in the Annex enclosed with this Decree.

2. Required equipment:

a) The equipment specified in point a and point b clause 2 Article 5 of this Decree;

b) Biosafety cabinets;

c) Infectious healthcare waste autoclave or sterilizer;

d) Personal protective equipment in accordance with the testing techniques conducted at level II biosafety-testing facilities.

3. Requirements for employees:

a) Conditions specified in point a, point b and point d clause 3 Article 5 of this Decree;

b) The test technician and the person in charge of the biosafety must receive training in biosafety of level II or higher;

4. Required regulations and procedures:

a) Regulations and procedures specified in clause 4 Article 5 of this Decree;

b) Plans for training for employees working in testing areas;

c) Regulations on retention and storage of pathology specimens and specimens of agents of infectious diseases at testing facilities;

d) Plans for the assessment of risk of biosafety incidents at testing facilities and formulation of plans on prevention and treatment of biosafety incidents.

Article 7. Requirements for level III biosafety-testing facilities

The testing area must fulfill the following requirements:

1. Required facilities:

a) Laboratories for conducting tests and anterooms;

b) The facilities specified in point a, point b and point d clause 1 Article 6 of this Decree;

c) The laboratory must be separate from other rooms and areas of the testing facilities;

dd) The laboratory must be airtight to ensure being sterilized;

dd) Windows and doors which are made of fireproof and strength materials;

e) Door system which ensures that in normal conditions, only either the door of the anteroom or of the testing area is opened at a time;

g) Glass windows or devices for observing the inside of the laboratory from the outside;

h) Ventiation system which is designed in one-way princple; air from the testing area must go through an air filter with high filtration performance before discharging to the outside area;

i)  System for alerting when the pressure of the testing area is unconformable; the pressure of the testing area must be always lower than that of the outside area when the testing area is in working order;

k) The air changes rate of the testing areas must be at least 6 times per hour;

l) The air supply system must operates only when the air discharge system has operated and must automatically stop when the air discharge system stop;

m) Bathing devices for emergencies in the testing area;

n) Two-way communication system and alert system.

2. Required equipment:

a) Conditions regarding equipment specified in point a and point b clause 2 Article 5 of this Decree;

b) Biosafety cabinet of level II or higher;

c) Infectious healthcare waste autoclave or sterilizer placed in the testing area;

d) Personal protective equipment in accordance with the testing techniques conducted at level III biosafety-testing areas.

3. Requirements for employees:

a) Number of employees: at least 02 test technicians and 01 technician in charge of operating the laboratory. Test technicians must have qualifications suitable for the tests, the technician in charge of operating the laboratory must have qualifications suitable for the task of operating the testing area;

b) Conditions specified in point b clause 3 Article 5 of this Decree;

c) Test technicians and the technicians in charge of operating the testing area and the person in charge of the biosafety must receive training in biosafety of level III or higher.

4. Required regulations and procedures:

a) Regulations and procedures specified in clause 4 Article 6 of this Decree;

b) Procedures for pasteurizing materials, tools, equipment and infectious substances before they are taken to the outside of the laboratory;

c) Procedures for sterilizing the testing area;

d) Procedures for handling emergencies in the testing area;

dd) Plans for prevention, elimination and treatment of biosafety incidents.

Article 8. Requirements for level IV biosafety-testing facilities

1. Required facilities:

a) The facitities specified in points a, b, d, dd, e, g and h clause 1 Article 7 of this Decree;

b) Changing rooms between the anteroom and the testing area;

c) Separate aperiodic ventilation system for the level III biosafety cabinet;

d) Independent system providing air for the protective clothes which are able to supply 100% more air volume in case of biosafety incidents;

dd) The laboratories must be separate and secured;

e) Specialized boxes for transporting infectious materials out and into the testing area;

g) Air supplied to and discharged from the testing area must be filtered with an air filter with high filtration performance.

2. Required equipment:

a) The equipment specified in point a and point b clause 2 Article 5 of this Decree;

b) Biosafety cabinet of level III or higher;

c) Two-door infectious healthcare waste autoclave;

d) Personal protective equipment in accordance with the testing techniques conducted at level IV biosafety-testing facilities.

3. Requirements for employees:

a) Conditions regarding employees specified in point a and point b clause 3 Article 7 of this Decree;

b) Test technicians and the technicians in charge of operating the testing area and the person in charge of the biosafety must receive training in biosafety of level IV.

4. Required regulations and procedures:

a) The regulations and procedures specified in clause 4 Article 7 of this Decree;

b) Procedures for transporting materials and tools into and out of the testing area using a transporting box or a two-door infectious healthcare waste autoclave;

c) Procedures for securing the testing area;

Article 9. Regulations on practices in biosafety-testing facilities

1. Level I, level II, level III and level IV biosafety-testing facilities must comply with the requirements for facilities, equipment, employees and practices; restoration, maintenance and calibration of testing equipment and supervision of practces in the laboratory.

2. The Minister of Health shall promulgates guilines on practices of ensuring biosafety in laboratories.

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