Decree No. 92/2010/ND-CP of August 30, 2010, detailing the implementation of the Law on infectious disease prevention and control, regarding biosafety in laboratories

DECREE

DETAILING THE IMPLEMENTATION OF THE LAW ON INFECTIOUS DISEASE PREVENTION AND CONTROL, REGARDING BIOSAFETY IN LABORATORIES

GOVERNMENT

Pursuant to the Law on organization of Government dated December 25, 2001;

Pursuant to Article 24 of the Law on Infectious Disease Prevention and Control dated November 21, 2007;

At the proposal of Minister of Health,

DECREES:

Chapter 1.

GENERAL PROVISIONS

Article 1. Scope of adjustment

This Decree prescribes classification ofmicroorganisms causing infectious diseases and laboratories according to the bio-safety levels; conditions for ensuring bio-safety in laboratories; competences, dossiers of, and procedures for grant, re-grant and revocation of certificate of satisfying the bio-safety standard; bio-safety inspection; prevention, handling and remedy of bio-safety incidents.

Article 2. Subjects of application

This Decree applies to laboratories conducting the test of microorganisms with risk causing infectious diseases to human (hereinafter abbreviated to laboratories).

Chapter 2.

CLASSIFICATION OF MICROORGANISMS AND LABORATORIES ACCORDING TO THE BIO-SAFETY LEVELS

Article 3. Classification of microorganisms according to risky groups

1. Microorganisms with risk causing infectious diseases to human are divided into 04 groups:

a) Group 1 means group not yet or had less risk of infection to individual and community including types of microorganisms not yet detected capability of causing diseases to human;

b) Group 2 means group having risk of infection to individuals at average level but risk to community at low level including microorganisms with capability of causing diseases but not causing many serious diseases to human, able to infect to human and have effective measures for prevention and control of infection, treatment in cases of getting diseases.

c) Group 3 means group having high risk of infection to individuals but risk to community at average level including microorganisms with capability of causing serious diseases to human, able to infect to human and have effective measures for prevention and control of infection, treatment in cases of getting diseases;

d) Group 4 means group having high risk of infection to individuals and community at high level including microorganisms with capability of causing serious diseases to human, able to infect to human and not yet had effective measures for prevention and control of infection, treatment in cases of getting diseases.

2. The Minister of Heath shall specify list of microorganisms causing infectious diseases of each group classified in Clause 1 of this Article.

Article 4. Classification of laboratories according to the bio-safety levels

1. Laboratories for microorganisms causing infectious diseases are classified into 04 bio-safety levels as follows:

a) Level-I bio-safety laboratories which perform tests for microorganisms of group 1 specified in point a Clause 1 Article 3 of this Decree and products from microorganisms of other groups but have been processed and not able to cause diseases;

b) Level-II bio-safety laboratories which perform tests for microorganisms of group 2 specified in point b Clause 1 Article 3 of this Decree;

c) Level-III bio-safety laboratories which perform tests for microorganisms of group 3 specified in point c Clause 1 Article 3 of this Decree;

d) Level-IV bio-safety laboratories which perform tests for microorganisms of group 4 specified in point d Clause 1 Article 3 of this Decree.

2. Laboratories with higher bio-safety level may perform tests of laboratories with lower bio-safety level.

3. All laboratories conducting tests of microorganisms causing infectious diseases must apply classification of bio-safety level defined in Clause 1 of this Article.

4. The Minister of Health specified the testing techniques for microorganisms causing diseases that need be performed in laboratories required the appropriate bio-safety level.

Chapter 3.

CONDITIONS FOR BIO-SAFETY ASSURANCE IN LABORATORIES

Article 5. Conditions of level-I bio-safety laboratory

1. Conditions of material facilities:

a) Its minimum area is 12m²(excluding area for doing administrative jobs related to tests);

b) There are solid doors and windows enclosed with locks, wall and laboratory table are flat, waterproof, and resistant to heat and corrosive chemicals;

c) There are wash basin, tap for washing eyes in emergency case, first-aid box;

d) There are electricity and clean water; pipeline for direct water provision to laboratory must haveanti-refluxvalveto protect the public water system;

e) There are equipment for prevention and fighting against fire and explosion.

2. Conditions of equipment:

a) The testing equipment must be appropriate with techniques and the tested microorganism types;

b) There are instruments containing waste satisfying the standards prescribed for each waste type;

c) There are equipment to disinfect instruments and swabs;

d) The equipment for individual protection appropriate with the testing techniques performed in the level-I bio-safety laboratories.

3. Human conditions

The responsible person, and staff of laboratory must have diplomas or certificate of training in conformity with type of testing and have the written certification of training bio-safety from level I or higher issued by the medical establishments appointed by the Ministry of Health, except objects that had the written certification of training bio-safety abroad from level I or higher issued by foreign competent agencies.

Article 6. Conditions of level-II bio-safety laboratory

1. Conditions of material facilities:

a) Its minimum area is 20m²(excluding area for doing administrative jobs related to tests);

b) Conditions specified in Points b, c, d and e Clause 1 Article 5 of this Decree;

c) There is a sewage treatment system satisfying national technical regulations of environment before discharging into place containing common sewage;

d) It must be separate with other laboratories of the testing establishments;

e) There is biological hazard notice board as prescribed in Annex issued together with this Decree on door of laboratory.

2. Conditions of equipment:

a) Conditions of equipment specified in Points a, b Clause 2 Article 5 of this Decree;

b) There are a level-II bio-safety cupboard and autoclave for sterilization;

c) The equipment for individual protection appropriate with the testing techniques performed in the level-II bio-safety laboratories.

3. Human conditions

The responsible person, and staff of laboratory must have diplomas or certificate of training in conformity with type of testing and have the written certification of training bio-safety from level II or higher issued by the medical establishments appointed by the Ministry of Health, except objects that had the written certification of training bio-safety abroad from level II or higher issued by foreign competent agencies.   

Article 7. Conditions of level-III bio-safety laboratory

1. Conditions of material facilities:

a) There are two rooms including a room for tests and a padded room before entering the testing room. Of which, room for tests must have minimum area of 20m²;

b) Conditions specified in Points b and c Clause 1 Article 6 of this Decree; it must have the system of treating liquid waste by chemicals satisfying the national technical regulations of environment before discharging into the common drainage system;

c) It must be separate with other laboratories of the testing establishments, if it in the same building, it must be arranged at the end of passageway where there are less persons go by;

d) Before entering the testing room, all persons must go by the padded room. The padded room must have pressure lower than outside;

dd) The testing room must be tight for sterilization; air pressure in the testing room must be lower than air pressure in the padded room;

e) System of gates must ensure the following conditions:

- All windows and doors must be made of materials anti fire, breaking;

- There is biological hazard notice board as prescribed in Annex issued together with this Decree on door of the testing room;

- It must have system of automatic open and closure for door of the padded room and the testing room. This system must ensure the principle which in the same time, it may open only door of the padded room or door of the testing room.

g) System of air ventilation must ensure the following conditions:

- It must be designed under one-dimensional principle; air going out the bio-safety laboratory at level III must go through a filter satisfying national technical regulations before discharging into environment;

- There is a system control direction of airflow provided for laboratory;

- There is an alarming system when temperature and pressure of laboratory fail to satisfy standard;

h) There are showers in emergency case in area of laboratory and exits in case of emergency.

2. Conditions of equipment:

a) Conditions of equipment specified in Points a, b Clause 2 Article 5 of this Decree;

b) There are a level-II bio-safety cupboard and autoclave for sterilization being laid in laboratory;

c) Equipment for individual protection suitable to the level-III bio-safety laboratory.

3. Human conditions

The responsible person, and staff of laboratory must have diplomas or certificate of training in conformity with type of testing and have the written certification of training bio-safety from level III or higher issued by the medical establishments appointed by the Ministry of Health, except objects that had the written certification of training bio-safety abroad from level III or higher issued by foreign competent agencies.  

Article 8. Conditions of level-IV bio-safety laboratory

1. Conditions of material facilities:

a) Conditions specified in Points a, b, c, d, dd, e and h Clause 1 Article 7 of this Decree;

c) It must have bathroom and dressing room between the padded room and the testing room;

c) Apart from ensuring provision in point g Clause 1 Article 7 of this Decree, the ventilation system of laboratory must ensure the following conditions:

- There is a separateaperiodicventilation system for the level-III bio-safety cupboard.

- There is an independent system providing air for the protective clothes which able to supply more 100% of air volume in case of happening bio-safety incidents.

2. Conditions of equipment:

a) Conditions of equipment specified in Points a, b Clause 2 Article 5 of this Decree;

b) There are a level-II bio-safety cupboard and a two-door steaming cabinet;

c) Equipment for individual protection suitable to the level-IV bio-safety laboratory.

3. Human conditions

The responsible person, and staff of laboratory must have diplomas or certificate of training in conformity with type of testing and have the written certification of training bio-safety from level IV issued by the medical establishments appointed by the Ministry of Health, except objects that had the written certification of training bio-safety abroad from level IV issued by foreign competent agencies.  

Article 9. Provisions on practice in the bio-safety laboratories

1. Laboratories of level I, level II, level III, level IV must observe provisions on management and administration; use and practice; healthy and medical supervision, maintenance, repair, standards provided for laboratory; supervision of implementation in bio-safety laboratories.

2. The Minister of Health shall promulgate the national technical regulations on practicing and bio-safety in laboratories.

Chapter 4.

COMPETENCE, DOSSIER OF, AND PROCEDURES FOR GRANT, RE-GRANT AND REVOCATION OF CERTIFICATE OF SATISFYING BIO-SAFETY STANDARD

Article 10. Competence of grant, re-grant and revocation of certificate of satisfying bio-safety standard

1. Directors of the Health Departments of provinces and central-affiliated cities shall appraise, grant, re-grant and revoke certificate of satisfying bio-safety standard for laboratories of level I, level II in localities under their management, except the testing establishments under management competence of the Ministry of Public Security and the Ministry of National Defense.

2. The Minister of Health shall appraise, grant, re-grant and revoke certificate of satisfying bio-safety standard for laboratories of level III, level IV, except the testing establishments under management competence of the Ministry of Public Security and the Ministry of National Defense.

3. To assign the Minister of Public Security and the Minister of National Defense, base on provisions of this Decree and the national technical regulations on bio-safety in laboratories, to organize the appraisal, grant, re-grant and revocation of certificate of satisfying bio-safety standard for laboratories under their management competence.

Article 11. Dossier requesting for grant, re-grant of certificate of satisfying bio-safety standard

1. Dossier requesting for grant of certificate of satisfying bio-safety standard:

a) Written request for grant of certificate of satisfying bio-safety standard;

b) Declaration of human affairs, equipment, ground diagram of laboratory;

c) Legal copies of diplomas, certificates, confirmations of staff of laboratory;

d) Legal copies of documentary evidences for establishment and operation of facility having laboratory as prescribed by law.

2. Dossier requesting for re-grant of certificate of satisfying the bio-safety standard for case where certificate of satisfying the bio-safety standard is expired, damaged, lost or name of the facility having laboratory is changed:

a) Written request for re-grant of certificate of satisfying bio-safety standard, in which clearly state the reason thereof;

b) Certificate of satisfying bio-safety standard (if any);

Article 12. Procedures for grant, re-grant of certificate of satisfying bio-safety standard

1. Dossier requesting for grant, re-grant of certificate of satisfying bio-safety standard for laboratory of level I or level II is sent to the provincial Health Department where the testing facility located its head office. Dossier requesting for grant, re-grant of certificate of satisfying bio-safety standard for laboratory of level III or level IV is sent to the Ministry of Health.

2. Within 30 working days, after receiving full dossier, the receiving-dossier agency as prescribed in Clause 1 of this Article must organize appraisal, and grant the certificate of satisfying bio-safety standard; in case of refusal, it must have written reply and clearly stating the reason thereof.

3. The valid duration of Certificate of satisfying bio-safety standard:

a) The Certificate of satisfying bio-safety standard of the level-I laboratory is valid in 05 years from the day of issue;

b) The Certificate of satisfying bio-safety standard of the level-II laboratory is valid in 03 years from the day of issue;

c) The Certificate of satisfying bio-safety standard of the level-III or level-IV laboratory is valid in 01 year from the day of issue;

4. The agencies competent to grant, re-grant of certificates of satisfying bio-safety standard as prescribed in Article 10 shall organize collection of fees for grant of certificate in accordance with regulation.

5. The Minister of Health shall specify procedures for grant, re-grant of certificate of satisfying bio-safety standard.

Article 13. Revocation of Certificate of satisfying bio-safety standard

1. Cases subject to revocation of Certificate of satisfying bio-safety standard:

a) Failing to satisfy provisions on conditions for bio-safety assurance;

b) The certificate of satisfying bio-safety standard has been granted improperly with competence;

c) Certificate of satisfying bio-safety standard contains illegal content;

d) Pass 12 months from the day of issuing the Certificate of satisfying bio-safety standard, the laboratory still fails to operate;

dd) The facility having laboratory is bankrupted, or dissolved, or merged;

e) Laboratory is changed position;

g) Laboratory is in operation while the Certificate of satisfying bio-safety standard was expired;

2. Agencies competent to grant of Certificate of satisfying bio-safety standard or competent person of health inspectorate agencies shall decide on revocation of Certificate of satisfying bio-safety standard falling in one of cases specified in Clause 1 of this Article.

Chapter 5.

BIO-SAFETY INSPECTION

Article 14. Content of bio-safety inspection

1. Inspect compliance of technical process during the course of testing.

2. Inspect conditions of bio-safety assurance as prescribed in Chapter III of this Decree.

Article 15. Responsibilities of facilities having laboratories

Facilities having laboratories are responsible for elaboration and organization of implementation of Regulation on bio-safety self-examination.  Regulation on bio-safety self-examination includes content of examination specified as Article 14 of this Decree and suitable to laboratories, orders of examination and time of examination.

Article 16. Responsibilities of the medical state management agencies

1. Periodically or irregularly, the Ministry of Health shall examine, inspect laboratories issued Certificate of satisfying the bio-safety standard nationwide; the provincial Departments of Health shall examine, inspect laboratories issued Certificate of satisfying the bio-safety standard in localities under their management.

2. In the course of examination or inspection, if these agencies realize a bio-safety laboratory fail to ensure conditions as prescribed in this Decree, these agencies must conduct handling or propose to the competent state management agencies for handling in accordance with Article 13 of this Decree.

Chapter 6.

PREVENTION, HANDLING AND REMEDY OF BIO-SAFETY INCIDENTS

Article 17. Bio-safety incidents

1. Bio-safety incident means situation of error in technical manipulation or feature of safety equipment in laboratory or leakage, dispersal of microorganisms in laboratory or from laboratory to outside.

2. Bio-safety incidents include two levels:

a) Bio-safety incidents at less-serious level mean incidents happening in scope of facility having laboratory but having less risk of infection to staff of laboratory and facility having laboratory have full capability to control them;

b) Bio-safety incidents at serious level mean incidents happening in scope of facility having laboratory but having high risk of infection to staff of laboratory and community or incidents which facility having laboratory fail to have sufficient capability to control;

Article 18. Prevention of bio-safety incidents

1. Facilities having bio-safety laboratories are responsible for:

a) Assessing risks happening bio-safety incidents in laboratories;

b) Elaborating plans on prevention and handling of bio-safety incidents including the following principal contents: to define, make zoning of risky points of happening bio-safety incidents in laboratories; measures, equipment, and human affairs for handling and remedying incidents; plans to coordinate with relevant agencies in responding to the bio-safety incidents;

c) Training staff of facility having laboratory in measures to prevent and remedy the bio-safety incidents;

2. Annually, the level-III and level-IV bio-safety laboratories must organize rehearsal of prevention and remedy of bio-safety incidents as prescribed by the Minister of Health.

Article 19. Handling and remedy of consequences due to bio-safety incidents

1. When bio-safety incidents happen, facilities having laboratories are responsible for:

a) Expeditiously mobilizing human resource and equipment for handling incidents according to the plan on prevention and handling of bio-safety incidents specified in point b Clause 1 Article 18 of this Decree;

b) For bio-safety incidents at less-serious level, facilities having laboratories must make minutes on handling and remedy of incidents and archived these minutes at units;

b) For bio-safety incidents at serious level, facilities having laboratories must report on incidents and measures applied for handling and remedy of bio-safety incidents to the provincial Health Departments;

2. The provincial Health Departments shall direct specialized agencies where the facilities having laboratories locate their head offices in handling, remedying their bio-safety incidents.

3. In case of falling beyond their capabilities, the provincial Health Departments must report to the provincial People’s Committees for mobilizing resources in localities or suggesting the Ministry of Health for support in handling and remedying the bio-safety incidents.

4. For laboratories managed by the Ministry of National Defense, the Ministry of Public Security, in case of arising incidents, reports to the responsible management agencies must be performed immediately for handling and remedy of bio-safety incidents.

5. If an incident happening in a bio-safety laboratory of level II, level III or level IV is spread widely, influence seriously to population communities or national security, the handling and remedy of incident shall comply with provisions in section 2 Chapter IV of the Law on infectious disease prevention and control.

6. After consequences due to the bio-safety incidents have been handled and remedied, the facility having laboratory must conduct review, analyze reason of incident and revise the plan on prevention and handling of bio-safety incidents.

Chapter 7.

PROVISIONS OF IMPLEMENTATION

Article 20. Effect

This Decree takes effect on November 01, 2010.

Article 21. Transitional provisions

1. Laboratories which are built or repaired after the effective day of this Decree must satisfy conditions prescribed on bio-safety in conformity with each level as prescribed in this Decree.

2. Laboratories which have operated before the effective day of this Decree must rebuild to satisfy conditions prescribed on bio-safety in conformity with each level as prescribed in this Decree till the end of December 31, 2010.

Article 22. Responsibilities of implementation

1. The Minister of Health shall guide and inspect implementation of this Decree.

2. The Minister of National Defense, the Minister of Public Security shall guide and inspect implementation of this Decree for laboratories under their management.

3. Ministers, Heads of ministerial-level agencies, Heads of Governmental agencies, chairpersons of the provincial People’s Committees shall implement this Decree.

ANNEX

FORM OF BIOLOGICAL HAZARD NOTICE BOARD
(Issued together with the Government s Decree No. 92/2010/ND-CP dated August 30, 2010)

1. Color of notice board:

- Background color of notice board is yellow;

- Color of letters and symbol is black.

2. Size: Paper size of A4.