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THE
GOVERNMENT
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 103/2016/ND-CP
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Ha
Noi, July 01, 2016
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DECREE
ON BIOSAFETY IN LABORATORIES
Pursuant to the Law on Government
organization dated June 19, 2015;
Pursuant to the Law on prevention
and control of infectious diseases dated November 21, 2007;
Pursuant to the Law on investment
dated November 26, 2014;
At the request of the Minister of Health;
The Government hereby promulgates
the Decree on biosafety in laboratories.
Chapter
I
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Article 1. Scope
of regulation
This Decree provides for the
conditions for ensuring biosafety at facilities with laboratories studying
microorganisms with risk of causing infectious diseases to human and pathology
specimens likely to carry microorganisms with risk of causing infectious
diseases to organizations and/or individuals (hereinafter referred to as
testing facilities), including: classification of microorganisms causing
infectious diseases and testing facilities according to biosafety levels;
conditions for ensuring biosafety in laboratories; competence, documents,
procedures for issuance, reissuance and revocation of the Certificate of satisfaction
of biosafety standards and declaration of laboratories satisfying biosafety
standards; biosafety testing; prevention, handling and remedy for bisafety
incidents.
Article 2.
Conditions for operation of facilities providing infectious microorganism
testing services
Any facility providing infectious
microorganism testing services must:
1. Be legally established according
to laws; and
2. Have laboratories satisfying the
requirements specified in this Decree. If the infectious microorganism testing
services provider is a healthcare facility, then apart from fulfillment of
requirements specified in this Decree, such facility must comply with
regulations in the Law on Medical examination and treatment.
Chapter II
CLASSIFICATION
OF MICROORGANISMS AND TESTING FACILITIES ACCORDING TO BIOSAFETY LEVELS
Article 3.
Classification of microorganisms according to risky category
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a) Group 1 means group of
microorganisms which have not yet or have less risk of infection to individuals
and community including types of microorganisms not yet detected capability of
causing diseases to human;
b) Group 2 means group of
microorganisms having risk of infection to individuals at an average level but
their risk to the community is at a low level, including microorganisms with
capability of causing diseases but not causing many serious diseases to human,
able to infect human and effective measures for prevention and treatment for
the infection are available;
c) Group 3 means group of
microorganisms having high risk of infection to individuals but their risk to
the community is at an average level, including microorganisms with capability
of causing serious diseases to human, able to infect human and effective
measures for prevention and treatment for the infection are available;
d) Group 4 means group of
microorganisms having high risk of infection to individuals and the community,
including microorganisms with capability of causing serious diseases to human,
able to infect human and not any effective measure for prevention and treatment
for the infection is available;
2. The Minister of Health shall
specify the list of microorganisms causing infectious diseases sorted by risky
categories.
Article 4.
Classification of testing facilities according to biosafety level
1. Testing facilities are divided
into 04 biosafety levels as follows:
a) Level I biosafety-testing
facilities are those which are eligible to conduct tests of group 1
microorganisms specified in point a clause 1 Article 3 of this Decree and
derivatives of microoganisms of other groups which have been treated and are no
longer able to cause a disease;
b) Level II biosafety-testing
facilities are those which are eligible to conduct tests of group 1 and group 2
microorganisms specified in point a and point b clause 1 Article 3 of this
Decree and derivatives of microoganisms of group 3 and group 4 which have been
treated in accordance with conditions of the level II biosafety-testing
facilities;
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d) Level IV biosafety-testing
facilities are those which are eligible to conduct tests of 4 groups of
microorganisms specified in Article 3 of this Decree.
2. The Minister of Health shall
specify biosafety levels in accordance with the testing techniques.
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;
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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:
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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;
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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:
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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;
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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;
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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;
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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;
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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;
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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.
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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.
Chapter IV
POWER TO ISSUE,
REISSUE, DECLARE AND REVOKE CERTIFICATES OF SATISFACTION OF BIOSAFETY STANDARDS
Article 10.
Power to issue, reissue, declare and revoke certificates of satisfaction of
biosafety standards
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2. Depending on provisions of this
Decree, the Minister of National Defense shall organize the inspection,
issuance, reissuance and revocation of Certificates of biosafety for testing
facilities under its management.
3. Testing facilities obtaining
Certificates of biosafety shall themselves declare their satisfaction of level
I and level II biosafety standards. On the basis of the written declaration of
the facility, the Department of Health shall post on its website the list of
testing facilities satisfying level I and level II biosafety standards.
Article 11.
Application for issuance/reissuance of Certificate of biosafety
1. An application for issuance of the
Certificate of biosafety shall comprise:
a) An application form for the
Certificate of biosafety using the Form No. 02 in the Annex enclosed with this
Decree;
b) A list of employees using the Form
No. 03 in the Annex enclosed with this Decree and personal dossiers of each of
them comprising a certified true copy of the recruitment decision or the labor
contract and qualifications;
c) A list of equipment using the Form
No. 04 in the Annex enclosed with this Decree;
d) A site plan of the testing
facility, showing the testing area, window and door system; electricity system;
water supply and drainage system; position of fire safety equipment;
dd) A certified true copy of
documents proving the lawful establishment and operation of the testing
facility;
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Regarding testing facilities which
have been in operation 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;
g) Reports on maintenance of testing devices for
testing facilities operating before the effective date of this Decree;
h) A design enclosed with a description of the
specifications of technical materials for each types of equipment in the
ventilation system;
i) Plans for prevention, elimination
and treatment of biosafety incidents.
2. An application for reissuance of the Certificate of biosafety in case of expiry shall comprise:
a) An application form for
reissuance of the Certificate of biosafety using the Form No. 05
in the Annex enclosed with this Decree;
b) A duplicate of the issued Certificate of biosafety;
c) A report on changes in employees (if any) enclosed with documents specified in point b
clause 1 of this Article;
d) A report on changes to equipment: name of the
equipment, quantity, conditions of the additional or
replaced equipment according to regulation in point c clause 1 of this Article;
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e) A report on biosafety
incidents which occurred (if any). The report must specify the time when each incident occured, the seriousness of each incident and the remedial measures
taken.
3. Regarding the application
for reissuance of the Certificate of biosafety which is damaged or lost shall
comprise the application form for reissuance of the Certificate of biosafety
using the Form No. 05 enclosed with this Decree.
4. An application
for reissuance of the Certificate of biosafety due
to the change in name of the testing facility shall comprise:
a) An application form for reissuance
of the Certificate of biosafety using the Form No. 05 in the Annex enclosed
with this Decree;
b) The issued
Certificate of biosafety;
c) Documents proving the change in name of the
testing facility, including a certified true copy of the establishment decision (applicable to public
healthcare facilities) or a certified true
copy of the Certificate of Business registration
(applicable to private healthcare facilities) or the Certificate of investment, applicable to foreign invested healthcare
facilities.
Article 12.
Procedures for issuance/reissuance of the Certificate of biosafety
1. The Minister
of Health shall establish an inspectorate, issuance
or reissuance of the Certificate of biosafety, which
consists of representatives of relevant units, professionals and shall assign
an organization as the standing unit of the inspectorate
(hereinafter referred to as the standing unit).
2. Procedures for issuance of the
Certificate of biosafety
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b) When the satisfactory application has been
received, the standing unit shall send the applicant for the Certificate of
biosafety a receipt note using the Form No. 06 enclosed with this Decree;
c) Within 10 days from the day on which the
application is received, the standing unit shall verify
the application. Contents of the verification: inspection of the satisfactoriness of facilities, equipment, human resources organization, practices
of the testing facility applying for the Certificate of biosafety;
d) If the application is not satisfactory, within
05 working days from the day on which the application receives inspection, the
standing unit shall send a written notification to the applicant to request
completion of the application. The notification must specify the contents to be
supplemented or modified;
dd) If the application is satisfactory, the
standing unit shall conduct a site inspection at the
testing facility within 10 days from the day on which the application receives
inspection;
e) If the testing facility fully complies with the
requirements in the inspection record, the standing unit
shall request the Minister of Health to issue the
Certificate of biosafety within 07 working days from the
date of inspection;
e) If the testing facility fails
to comply fully with the requirements in the
inspection record, the standing unit shall send a written notification
to the applicant within 07 working days from the date of
inspection;
3. Procedures for reissuance of the Certificate of biosafety:
a) The testing facility shall send an application
to the standing unit within 60 days before the expiry date of the Certificate of biosafety. Past such time limit, if the facility
fails to submit the application for reissuance of the Certificate of biosafety,
it shall carry out the procedures for issuance of the new Certificate of
biosafety;
b) When the satisfactory application has been
received, the standing unit shall send the applicant for the Certificate of
biosafety a receipt note using the Form No. 06 enclosed with this Decree;
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d) If the application is not satisfactory, within
05 working days from the day on which the application receives inspection, the
standing unit shall send a written notification to the applicant to request
completion of the application. The notification must specify the
contents to be supplemented or modified;
dd) In case of necessity, an site inspection
at the laboratory shall be conducted within 10 days from the day on which the
application is inspected. If the application is
satisfactory and the inspection at the testing facility is not conducted, the
Certificate of biosafety shall be reissued within 10 days from the date of
inspection of the application.
4. Each testing facility shall
be issued only 01 Certificate of biosafety using the Form No. 07 in the Annex
enclosed with this Decree.
5. After issuing the
Certificate of biosafety, the Ministry of Health shall
send a written notification to the People’s Committee of
province and the Department of Health where the testing
facility obtained the Certificate of biosafety is located, within 15 days from
the day on which the Certificate of biosafety is issued/reissued.
6. The Certificate of
biosafety of the laboratory shall be effective for 01 year from the date of
issue.
7. The agencies competent to
issue/reissue the Certificate of biosafety specified in Article 10 shall
collect the charges for inspection of the Certificate of biosafety-testing
laboratory according to regulations on charges and fees.
Article 13.
Procedures for declaration of testing facilities satisfying biosafety standards
1. The representatives at law
of the testing facility shall send the declaration of satisfaction of biosafety
standards using the Form No. 08 in the Annex enclosed with this Decree to the Department of Health for management.
2. Testing facilities may conduct testing within
their profession after declaring their satisfaction of biosafety standards.
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4. During the inspection of biosafety conditions,
any facility in the list specified in clause 2 of this Article fails to comply
with requirements specified in Article 5 and Article 6 of this Decree shall has
its name withdrawn from such list.
Article 14.
Revocation of the Certificate of biosafety
1. Cases where the Certificate of
biosafety is revoked:
a) the testing facility is not put
into operation within 06 months from the day on which the Certificate of
biosafety is issued
b) The testing facility is bankrupt, dissolved or merged;
c) The testing area is relocated.
2. The authority that issued the Certificate of biosafety shall decide its revocation
in any of the cases specified in clause 1 of this Article or at the request of
an inspection agency.
Chapter V
BIOSAFETY INSPECTION
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1. Inspection of conditions of biosafety as
prescribed in Chapter III of this Decree.
2. Inspection of the compliance with regulations in
practices of biosafety in laboratories.
Article 16. Responsibilities
of testing facilities
Testing facilities shall formulate and conduct and implement regulations on biosafety self-inspection,
including: specific inspection contents specified in Article 15 of this Decree
in accordance with the characteristics of the testing facilities, procedures
and time of inspection.
Article 17. Responsibilities
of healthcare management authorities
1. The Ministry of Health shall conduct regular or irregular inspections of testing
facilities which have obtained the Certificate of biosafety of level III or
level IV and the testing facilities which have declared themselves the
satisfaction of biosafety standards of level I or level II nationwide.
2. At least every 03 year, Departments of Health hall conduct an inspection of testing
facilities which have obtained the Certificate of biosafety and have declared themselves the satisfaction of biosafety standards in
areas under their management.
3. During the inspection process, if any
biosafety-testing laboratory is discovered unconformable with regulations in
this Decree, healthcare management authorities shall handle themselves or
request a competent authority to handle according to laws.
Chapter VI
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Article 18. Levels of
biosafety incident
1. A biosafety incident is a situation when there
is a technical incident of a safety equipment in the laboratory that causes
leakage and/or dispersion of microorganisms between
objects in the laboratory or from the laboratory to the outside.
2. Levels of biosafety incident
include:
a) Bio-safety incidents at less-serious level mean
incidents happening in scope of facility having laboratory but having less risk
of infection to the test technician and testing facility 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 the test technician and the community or
incidents which the testing facility does not have full capability to control
them.
Article 19.
Prevention of biosafety incident
1. Any biosafety-testing
facility shall:
a) Assess the risks of biosafety incident in the
laboratory;
b) Elaborate plans on prevention and handling of
bio-safety incidents including the following principal contents: 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;
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2. Annually, the level III and level IV biosafety
laboratories must organize rehearsal of prevention and remedy of biosafety
incidents.
Article 20. Handling and
remedy of consequences due to biosafety incidents
1. When a biosafety
incident occurs, the testing facility shall:
a) Expeditiously mobilize human resource and
equipment for handling incidents according to the plan on prevention and
handling of biosafety incidents specified in point b Clause 1 Article 19 of
this Decree;
b) For biosafety incidents at less-serious level,
facilities having laboratories must make minutes on handling and remedy of
incidents and archived these minutes at units;
c) For bio-safety incidents at serious level,
facilities having laboratories must report on incidents and measures applied
for handling and remedy of biosafety incidents to the Departments
of Health.
2. Departments
of Health shall direct specialized agencies where the facilities having
laboratories locate their head offices in handling, remedying their biosafety
incidents.
3. In case of falling beyond their
capabilities, Departments of Health shall report to People’s Committees of provinces for
mobilizing resources in localities or suggesting the Ministry of Health for
support in handling and remedying the biosafety incidents.
4. If an incident happening in a biosafety
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 prevention and control of infectious diseases.
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Chapter VII
IMPLEMENTARY
CLAUSE
Article 21. Effect
This Decree comes into effect from July 01, 2016.
The Decree No. 92/2010/ND-CP dated August 30, 2010 by the Government detailing
the implementation of the Law on prevention and control of
infectious diseases regarding biosafety in laboratories shall be
annulled by the effect of this Decree.
Article 22. Transitional
clause
1. Testing facilities which are established or renovated after the effective date of this Decree must comply
with regulations on biosafety specified in this Decree.
2. Testing facilities operating before the
effective date of this Decree but having not obtained the Certificate of
biosafety shall be renovated to fulfill the biosafety
requirements specified in this Decree by December 31, 2018.
3. Testing facilities operating
before the effective date of this Decree and having
obtained the Certificate of biosafety must maintain the conditions
according to the regulations within the effect of the Certificate and must
fulfill the biosafety requirements specified in this Decree.
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1. The Minister of Health
shall provide guidelines on the implementation of clause 2 Article 3, clause 2
Article 4, clause 2 Article 9 and shall inspect the implementation of this
Decree.
2. Ministers, Heads of ministerial-level agencies,
Heads of Governmental agencies, Presidents
of People’s Committees of provinces shall be responsible
for implementing this Decree./.
ON BEHALF OF
THE GOVERNMENT
THE PRIME MINISTER
Nguyen Xuan Phuc