|
MINISTRY OF
HEALTH
OF VIETNAM
-------
|
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
|
|
No. 40/2018/TT-BYT
|
Hanoi, December
7, 2018
|
CIRCULAR
PRESCRIBING
MANAGEMENT OF INFECTIOUS DISEASE SPECIMENS
Pursuant to the Law on Prevention and Control of
Infectious Diseases;
Pursuant to the Government's Decree No.
75/2017/ND-CP dated June 20, 2017, defining the functions, tasks, powers and
organizational structure of the Ministry of Health;
Upon the request of the Director of the General
Department of Preventive Medicine;
The Minister of Health hereby promulgates the
Circular prescribing management of infectious disease specimens.
Chapter I
GENERAL PROVISIONS
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
1. This Circular provides for management of
infectious disease specimens for the purposes of prophylaxis, research,
diagnosis and medical treatment of human diseases, including collection,
storage, packing, retention, use, exchange, elimination infectious disease
specimens and transport thereof out of test facilities.
2. This Circular shall not apply to specimens that
do not contain infectious substances or contain infectious substances in a
neutralized or inactive form without being likely to inflict diseases on
humans, or blood or blood product samples used in blood transfusion activities.
3. This Circular shall apply to entities or persons
having competence in and carrying out collection, storage, packing, custody,
usage, exchange, elimination of infectious disease specimens and transport
thereof out of test facilities.
Article 2. Definition
For the purposes of this Circular, terms used
herein shall be construed as follows:
1. Pathology specimen includes samples of blood,
serum, plasma, urine, faeces, bodily fluid and other samples collected from
persons infected with infectious substances or microorganisms, or samples
containing microbes having the potential to cause diseases in humans.
2. Infectious substance means a substance
containing or likely to contain microbes (including viruses, bacteria,
parasites or fungi) and prions causing communicable diseases in humans which
are classified into type A and type B.
3. Class-A infectious substance means a substance
that, once being exposed to infection during transport, may threat human lives,
cause death or permanent disability for humans as defined in the Appendix I
hereto.
4. Class-B infectious substance means an infectious
substance falling outside of the list of class-A infectious substances defined
in clause 3 of this Article.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
6. UN 3373 is the abbreviation for United Nations
3373 which is accepted as the United Nations’ symbol used in transport of
class-B infectious substances.
7. Class 6.2 means a particular classification of
substances likely to inflict infection according to the United Nations’
guidance.
8. Cultured specimen means a specimen collected as
a result of the process of deliberate multiplication of pathogenic agents.
Chapter II
REGULATIONS ON COLLECTION, STORAGE, PACKING,
TRANSPORT, CUSTODY, USE, RESEARCH, EXCHANGE AND ELIMINATION OF PATHOLOGY
SPECIMENS
Article 3. Collection of pathology specimens
1. Collection of pathology specimens must conform
to technical processes and avoid infecting specimen collectors, patients and
other related persons, communities and environment.
2. Upon collection of pathology specimens,
collectors must completely fill out the attached information checks under the
provisions of the Appendix II hereto and then send them together with pathology
specimens.
Article 4. Custody and packing of pathology
specimens
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
2. Packing of pathology specimens containing or
suspected of containing class-A or class-B infectious substances shall be
subject to provisions laid down in the Appendix IV hereto.
Article 5. Labeling of pathology specimens
1. Label of each test tube or instrument containing
pathology specimens must include the following information:
a) Full name or code of the patient;
b) Type of pathology specimen (for instance, whole
blood, serum, plasma, urine, faeces, cerebrospinal fluid or others);
c) Duration of collection of specimen (including
time and date).
In case the encryption method is employed, all
information specified in this clause must be given in full.
2. The outer label must include the following
information:
a) Name, telephone number and address of the
sender;
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
c) Name, telephone number and address of the
receiving test facility (receiving entity);
d) Appropriate code conforming to the UN’s
regulations on international and inland transport;
dd) Required storage temperature;
e) In case of using dry ice or liquid nitrogen,
name of the refrigerant and UN-designated code and net weight are needed;
g) Classification label of specimen for transport
which is corresponding to the category of infectious substance as prescribed in
the Appendix V hereto.
Article 6. Transport of pathology specimens
1. Entities collecting pathology specimens shall be
required to inform test facilities or other receivers of these pathology
specimens; sending date; means of transport and expected date of arrival.
2. Pathology specimens must be stored and preserved
under the provisions of the Appendix III hereto during transport thereof to
test facilities.
3. In case of transporting pathology specimens by
air, packing size, weight and volume of pathology specimen shall be subject to
the following regulations:
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
b) As for pathology specimens containing class-B
infectious substances, each package of liquid pathology specimen shall not be
greater than 01 l and all packages of liquid pathology specimens shall not be
greater than 04 l. Each package of solid pathology specimen shall not be
greater than 04 kg.
4. Transport of pathology specimens by sea, road
and rail: Each package shall have the minimum side dimension of 100 mm x 100 mm
and shall have no maximum size.
5. Carriers of pathology specimens shall be
required to use available equipment and appliances in order to prevent
infectious substances from spreading to people and environment.
Article 7. Handling of emergencies or incidents
in case of spillage or leak of pathology specimens during transport
1. Responses to emergencies or incidents arising
from spills or leaks shall adhere to the procedures for response to spills or
leaks specified in the Appendix VI hereto.
2. The carrier of pathology specimens shall be
obliged to contact the nearest receiving or sending entity or health department
in order to receive instructions for appropriate actions.
3. In case of being directly exposed to infectious
substances, the affected area shall have to be cleaned with detergent and water
or a disinfectant. Then, the person exposed to infectious substances shall need
to be promptly referred to the nearest healthcare establishment to seek medical
consultation and treatment.
4. After already taking actions specified in clause
2 and 3 of this Article, the person taking these actions must report to the
specimen sending entity. In case of class-A infectious substances, it shall be
advised that an immediate report is sent to the Department of Health having
authority over the area where such incident occurs.
Article 8. Handling, use and custody of
pathology specimens
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
2. The receiving entity shall proceed to test the
received pathology specimen according to technical and professional procedures
appropriate for specific pathology specimens and their stated purposes.
3. Pathology specimens which are stored and
retained must ensure that they do not cause infection for people and
environment.
4. Handling, use, custody and retention of
pathology specimens must ensure biosafety as provided in the Circular No.
37/2017/TT-BYT dated September 25, 2017 of the Minister of Health prescribing
implementation of biosafety practices in test laboratories.
Article 9. Elimination of pathology specimens
The elimination of pathology specimens shall be
subject to regulations on disposal of medical hazardous wastes in the Circular
No. 37/2017/TT-BYT dated September 25, 2017 of the Minister of Health on
implementation of biosafety practices in test laboratories and the Joint
Circular No. 58/2015/TTLT-BYT-BTNMT dated December 31, 2015 of the Ministry of
Health and the Ministry of Natural Resources and Environment on management of
medical wastes.
Chapter III
IMPLEMENTARY PROVISIONS
Article 10. Entry into force
1. This Circular shall enter into force on January
25, 2019.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Article 11. Implementary responsibilities
1. The General Department of Preventive Medicine
shall preside over implementation and inspection of implementation of this
Circular.
2. The Department of Medical Examination and
Treatment, the Department of Science, Technology and Training in collaboration
with the General Department of Preventive Medicine shall provide guidance on
and inspect the research, use and custody of pathology specimens by
organizations and individuals.
3. The Inspectorate of the Ministry of Health shall
cooperate with authorized Departments and Administrations affiliated to the
Ministry of Health in the nationwide-scale inspection and audit of
transportation, preservation, storage, retention, use, research, exchange and
elimination of pathology specimens related to pathogenic agents causing
infectious diseases.
4. Departments of Health in provinces and
centrally-affiliated cities shall carry out the local-scale inspection and
audit of collection, transport, storage, retention, custody, use, research,
exchange and elimination of pathology specimens relating to pathogenic agents
causing infectious diseases.
5. Institutes of Hygiene and Epidemiology, and
Pasteur Institute directly controlled by the Ministry of Health, Preventive
Medicine Centers/ Disease Control Centers of provinces and centrally-affiliated
cities, hospitals, entities or persons concerned, shall be responsible for implementing
this Circular.
In the course of implementation of this Circular,
if there is any query or difficulty that may arise, entities, organizations and
individuals should promptly inform the Ministry of Health (General Department
of Preventive Medicine) for its review and grant of the decision to apply
possible actions./.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.