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THE
GOVERNMENT
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SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom – Happiness
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No.
92/2010/ND-CP
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Hanoi, August 30, 2010
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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.
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Article 1. Scope of
adjustment
This Decree
prescribes classification of microorganisms 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;
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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.
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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;
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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
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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.
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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:
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- 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;
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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 separate
aperiodic ventilation system for the level-III bio-safety
cupboard.
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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.
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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;
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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;
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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;
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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
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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;
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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;
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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
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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.
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ON
BEHALF OF THE GOVERNMENT
THE PRIME MINISTER
Nguyen Tan Dung
ANNEX
FORM OF BIOLOGICAL HAZARD NOTICE BOARD
(Issued together with the Government's Decree No. 92/2010/ND-CP dated August
30, 2010)
BIOLOGICAL
HAZARD
Bio-safety Level:
………………………………………………
The responsible
investigator: ……………………………..…………
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Telephone number at
agency:...... Telephone number at private house:……….
Only the
responsible investigator named above has right to allow the entry
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.