Professional Documents
Culture Documents
Background:
The general public expects laboratory personnel to act responsibly and not to
expose the community to bio-risks. They should follow safe working practices
(Biosafety) associated with practices that will keep their work and materials safe
and secure (Biosecurity), and to follow an ethical code of conduct (bioethics).
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Advisor (Health) Planning Commission
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Member (Social Sector) Planning Commission
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Acting Chief (Health) Planning Commission
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Intern (Health) Planning Commission
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refusal to acknowledge ethical considerations, lack of codes of conduct, etc. may
be at the origin of laboratory-acquired infections.
The data collected from various sources shows that Pakistan has a collection of
all kinds of communicable and non communicable diseases. Viral diseases
include all types of hepatitis viruses, Encephalitis virus, Polio virus, Congo
Crimean Haemorrhagic Fever and Dengue fever viruses while bacterial infections
include a range of pathogens from neonatal tetanus to tuberculosis, salmonellae
and other pathogens causing acute respiratory infections and diarrhoea.
Protozoan and parasitic diseases also contribute a lot to the disease burden. As
all kinds of diseases are prevalent in Pakistan with some having pandemic
setting and others as epidemic or sporadic, therefore the laboratories both in the
public and private sector regularly receive infectious materials as routine
specimens and handle them as routine without taking into consideration the bio
safety and bio security issues. Disposal of these specimens is also variable with
very few labs following the protocols while most just discard it in the sewage.[1]
While the objectives are different, biosafety and biosecurity measures are usually
complementary. Biosafety looks at appropriate laboratory procedures and
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practices necessary to prevent exposures and occupationally acquired infections,
while biosecurity addresses procedures and practices to ensure that biological
materials and relevant sensitive information remain secure.
As all laboratories, may it be public or private, small or large, rural or urban deal
with known or unknown pathogens therefore there is a fear that these pathogens
may become a health hazard for the lab workers and for the community if they
are not properly handled, stored or discarded. Similarly there is a danger that
those working in the labs might get exposed to these known or unknown
pathogens without being aware of them or by not taking proper precautions or
using personnel protection equipment (PPE).[2]
In Pakistan only a few labs are following the biosafety or biosecurity guidelines
while majority are not even aware about the basic concept of safety and security.
As a starter the purpose of this planning exercise is to formulate a strategic
framework for the development of Public sector hospital Laboratories in Pakistan
so as to improve/upgrade these laboratories to BSL-2 or more. As a starter one
laboratory in each province shall be upgraded to BSL-2 and shall be projected as
a model laboratory for others to follow and improve their laboratory set up. All this
shall be done with consultation of the provincial heads preferably Director
General or Secretary Health.
Pathogens and toxins have been used, even in the recent past, to threaten and
harm people, to disrupt society, economies and the political status quo. This has
happened in spite of applicable international agreements banning the use of
biological agents for malicious use.
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GOALS:
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Implementation Mechanism
Current situation:
The world today is faced with increased risks of exposure to emerging and re-
emerging pathogens. These originate not only from natural hosts, but from
diagnostic and research laboratories handling and manipulating these
biohazardous organisms. Applied Biosafety and Biosecurity at national and
international levels required to ensure the safety of individuals involved with
research, and to protect the environment and public health against accidental
and intentional release of pathogens and toxins. In recent years, several
countries have developed and implemented laboratory bio-security legislation to
regulate possession, use and access to biological materials to permit their
appropriate use.
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laboratory that handles infectious substances are at risk of exposure to the
substances they handle. Laboratory-acquired infections are not uncommon.
Situation in Pakistan:
In the past century, medical research has led to improved health and increased
life expectancy largely because of major stress being given by the public/private
sector in preventing and treating infectious diseases. This success has come
about through improved hygiene, and increased public awareness. New threats
to health continually emerge, however, as bacteria and viruses evolve and are
transported to new environments, or develop resistant to drugs and vaccines.
Some familiar examples of these so-called emerging or re-emerging infections
include Viral Hepatitis, Multi drug resistance, Tuberculosis, HIV/AIDS,
Hemorrhagic/Dengue fever, and annual outbreaks of gastroenteritis, influenza,
typhoid and cholera.
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requirement for work with biohazards material. The risk assessment process
should identify features of microorganisms as well as host environmental factors
that influence the potential for workers to have a biohazards exposure. This
responsibility cannot be shifted to inexperienced or untrained personnel.
The principal investigator or laboratory director should consult with a biosafety
officer to ensure that the laboratory is in compliance with established guidelines
and regulations. When performing a risk assessment, it is advisable to take a
conservative approach if there is incomplete information available.
Infective micro organisms have been classified into different risk groups for
laboratory work.
Risk Group 1: (No or low community risk). These micro organisms are unlikely
to cause human or animal disease.
Risk group 2: (Moderate individual risk, low community risk) Pathogen can
cause disease but is unlike to have serious hazard to laboratory workers,
community, live stock or environment. Laboratory exposure may cause serious
infection but effective treatment and preventive measures are available and risk
of spread is limited
Risk group 3: (High individual risk, low community risk) Pathogen causes
serious disease but does not ordinarily spread from one infected person to other.
Effective treatment and preventive measures are available
Risk group 4: (High individual and community risk) pathogen causes serious
disease that can be readily transmitted from one case to other. Effective
treatment and preventive measures are not available.
Laboratory facilities are designated as basic – Bio safety Level 1 (BSL-1), Bio
safety Level 2 (BSL-2), Bio safety Level 3 (BSL-3) and maximum containment -
Bio safety Level 4 (BSL-4). The Bio safety levels are based on the design of
laboratory, construction, containment facilities, equipment, practices and
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operational procedures required for working with agents of various risk groups
(table 1).[4]
Countries make their own classification of micro organisms, by risk group, taking
into consideration:
1. Pathogenicity of the organism
2. Mode of transmission and host range of organism. These are influenced
by immunity levels of the population, density and movement of host
population, presence of appropriate vectors and standards of
environmental hygiene.
3. Local availability of preventive measures like prophylaxis, food and water
hygiene, control of vectors
4. Local availability of effective treatment like passive immunization, post
exposure vaccination, use of antimicrobials, antivirals and chemotherapy.
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The bio safety level for a laboratory and its workers must be based on risk
assessment and on predefined parameters.
The facility requirements at 4 BSLs are shown in table 2. The assignment of BSL
takes into consideration the organisms studied, facilities available, equipment
practices and procedures required to conduct work in the laboratory.
BIOSAFETY LEVEL
1 2 3 4
Isolation of laboratory No No Yes Yes
Room sealable for decontamination No No Yes Yes
Ventilation:
- inward airflow No Desirable Yes Yes
- controlled ventilating system No Desirable Yes Yes
- HEPA-filtered air exhaust No Desirable Yes/No b Yes
Double-door entry No No Yes Yes
Airlock No No No Yes
Airlock with shower No No No Yes
Anteroom No No Yes -
Anteroom with shower No No Yes/No c No
Effluent treatment No No Yes/No c No
Autoclave:
- on site No Desirable Yes Yes
- in laboratory room No No Desirable Yes
- double ended No No Desirable Yes
Biological safety cabinets No Desirable Yes Yes
Personnel safety monitoring capability d No No Desirable Yes
a
Environmental and functional isolation from general traffic.
b
Dependent on location of exhaust.
c
Dependent on agent(s) used in the laboratory.
d
For example, window, closed-circuit television, two-way communication.
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various loops of development cycle of this system for generating ownership and
mobilizing resources and developing required human resource.
PERSONAL PROTECTION
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¾ Health education specially in respect of enhancing the awareness of the
worker to the danger.
¾ Strict check on entry of unauthorized personnel in the laboratory.
¾ Initial medical examination of all lab personnel/Immunization status.
¾ Periodic medical examination if necessary.
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3. Identification of at-risk personnel and populations
4. Identification of responsible personnel and their duties, e.g. biosafety officer,
safety personnel, local health authority, clinicians, microbiologists, veterinarians,
epidemiologists, and fire and police services
5. Lists of treatment and isolation facilities that can receive exposed or infected
persons
6. Transport of exposed or infected persons
7. Lists of sources of immune serum, vaccines, drugs, special equipment and
supplies
8. Provision of emergency equipment, e.g. protective clothing, disinfectants,
chemical and biological spill kits, decontamination equipment and supplies.
The affected individual should remove protective clothing, wash the hands and
any affected area(s), apply an appropriate skin disinfectant, and seek medical
attention as necessary. The cause of the wound and the organisms involved
should be reported, and appropriate and complete medical records kept.
All persons should immediately vacate the affected area and any exposed
persons should be referred for medical advice. The laboratory supervisor and the
biosafety officer should be informed at once. No one should enter the room for an
appropriate amount of time (e.g. 1 h), to allow aerosols to be carried away and
heavier particles to settle. If the laboratory does not have a central air exhaust
system, entrance should be delayed (e.g. for 24 h).
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Signs should be posted indicating that entry is forbidden. After the appropriate
time, decontamination should proceed, supervised by the biosafety officer.
Appropriate protective clothing and respiratory protection should be worn.
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Unbroken, capped tubes may be placed in disinfectant in a separate container
and recovered.
The centrifuge bowl should be swabbed with the same disinfectant, at the
appropriate dilution, and then swabbed again, washed with water and dried. All
materials used in the clean-up should be treated as infectious waste.
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6. Hospitals/ambulance services/medical staff (names of individual clinics,
departments, and/or medical staff, if possible)
7. Police
8. Water, gas and electricity services.
REFERENCES
1. PC-1 of Establishment of Biosafety/ Biosecurity system for public sector
Hospital/ Health institution dealing with infectious materials in Pakistan-2005
2. Strategic Frame work for Biosafety and Biosecurity in Public sector Hospitals I
Pakistan, PMRC-Ministry of Health.
3. National Biosafety guidelines, Ministry of Enviornment-2005
4. Biological safety Manual, Third Edition-2005.
5. Laboratory Biosafety manual, World Health Organization-2004
6. Biosafety in Microbiological and Biomedical Laboratories 4th Edition:
http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm
7. http://cns.miis.edu/research/cbw/biosec/pdfs/biosec.pdf
8. http://www.fas.org/programs/ssp/bio/resource/biosafetylevels.html
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