Clinical Laboratory Biosafety

Tapeshwar Yadav
(Lecturer)
BMLT, DNHE,
M.Sc. Medical Biochemistry
Introduction:
The application of knowledge, techniques and
equipment to prevent a personal laboratory and
environmental exposure to potentially infectious
agents or biohazard is known as biosafety.
Biosafety defines the containment conditions under
which infectious agents can be safely manipulated.
The objective of containment is to confine biohazard
and to reduce the potential exposure of the laboratory
worker, persons outside of the laboratory, and the
environment to potentially infectious agents.
Contd…
The backbone of the practice of biosafety is risk
assessment. While there are many tools available to
assist in the assessment of risk for a given procedure or
experiment, the most important component is
professional judgment.
Risk assessment should be performed by the individual
most familiar with the specific characteristics of the
organisms.
Biological safety cabinet:
This equipment is designed for controlling aerosols
and micro particles associated with managing
potentially toxic or infectious biological material in
laboratories.
Safety cabinets have been designed to protect the user,
the environment and the sample manipulated using
appropriate ventilation conditions.
They are also known as laminar air flow cabinets or
biosafety cabinets.
 
Classification of infective micro
organisms by risk group:
The following guidelines are recommended by the
centers for disease control and prevention and the
National Institutes of Health. Four biosafety levels
( BSLs) are described :
Risk group 1: No or low individual and community risk.
Risk group 2: Moderate individual risk, low community
risk.
Risk group 3: High individual risk, low community risk.
Risk group 4: High individual and community risk.
1.Biosafety level 1:
Biosafety level 1 (BSL-1) is suitable for work
involving agents of no known or minimal potential
hazard to laboratory personnel and the environment.
The laboratory may be integral to general traffic
patterns in the building.
Work may be conducted on open bench tops.
Special containment equipment is neither required nor
generally used.
Laboratory personnel shall have specific training in
procedures conducted in the laboratory.
Contd…
Standard practices for BSL-1
The laboratory shall have an established policy for the
safe handling of sharps.
Eating, drinking and applying cosmetics are not
permitted.
Laboratory personnel shall wash their hands after they
handle viable materials and animals and before leaving
the laboratory.
Work surfaces shall be decontaminated once a day and
after any spill of viable materials.
Contd…
Safety equipment for BSL-1
It is recommended that laboratory coats, or uniforms be
worn for prevention.
Gloves should be worn if skin is broken or afflicted by a
rash.
Laboratory facilities for BSL-1
The laboratory shall be designed so that it can be easily
cleaned.
Bench top shall be impervious to water and resistant to
acids, alkali and organic solvents and moderate heat.
Each laboratory shall contain a sink for hand washing.
Biosafety Level 1 laboratory.
2.Biosafety level 2:
Biosafety level 2 is similar to level 1 and is suitable for
work involving the agents of moderate potential
hazards to personnel and the environment. It differs in
that ;
Laboratory personnel are specifically trained to handle
pathogenic agents.
Access to the laboratory is limited when work is being
conducted.
Extreme precautions are taken with contaminated
sharps items.
Contd…
Special practices for BSL-2
 Laboratory personnel receive appropriate immunization.
 Receive appropriate training on the potential hazards
associated.
 A high degree of precaution must always be taken with any
contaminated Sharp items.
 Broken glassware must not be handled directly.
 Containers of contaminated needles, sharp equipment, and
the broken glass are decontaminated before disposal.
 Cultures, tissues and specimens of body fluids are placed in a
container that prevents leakage during collection, handling,
processing, storage, transport.
 Work surfaces should be decontaminated with an appropriate
disinfectant.
Contd…
Safety equipment for BSL-2
Properly maintained biological safety cabinets or other
appropriate personal protective equipment or physical
containment devices are used whenever necessary.
Face protection (goggle, mask, or other splatter
guards) is used.
Personal protective coat, gowns are worn in the
laboratory.
Contd…
Laboratory facilities for BSL2
The laboratory is designed so that it can be easily
cleaned.
An eyewash facility is readily available.
Biological safety cabinets shall be installed in such a
manner that fluctuations of the room supply and
exhaust air do not cause them to operate outside their
parameters for containment.
Biosafety Level 2 laboratory
3.Biosafety level 3:
The containment laboratory - Biosafety level 3 is
designed and provided for work with Risk group 3
micro organisms and with large volumes or high
concentration of Risk Group 2 micro organisms that
pose an increased risk of aerosol spread.  
Biosafety Level 3 containment requires the
strengthening of the operational and safety
programmes over and above those for basic
laboratories -Biosafety Levels 1 and 2.
Contd…
Special practices for BSL 3
 The international biohazard warning symbol and sign
displayed on laboratory access doors must identify the
Biosafety level and indicates any special conditions for
entry into the area ex: immunization
 Front-buttoned standard laboratory coats and half sleeves
that do not fully cover the forearms are unsuitable.
 Open manipulation of all potentially infectious materials
must be conducted within a biological safety cabinet.
 Respiratory protective equipment are necessary laboratory
procedures or working with animals infected with certain
pathogens.
Contd…
Laboratory design for BSL 3
The laboratory must be separated from the areas that
are open to unrestricted traffic flow within the building.
Surfaces of walls, floors and ceiling should be water
resistant and easy to clean.
The laboratory room must be sealable for
decontamination.
There must be a controlled ventilation system that
maintains a directional airflow into the laboratory room.
Contd…
Laboratory facilities for BSL3
 The objective of Health and medical surveillance
programme for basic laboratories - Biosafety Levels 1
and 2 also apply to containment laboratories -
Biosafety level 3, except where modified as follow :
Medical examination of all laboratory personnel who
work in containment laboratories.
After a satisfactory clinical assessment, the examiner
may be provided with a medical contact card stating
that he / she is employed in a facility with a
containment laboratory - Biosafety Level 3.
Biosafety Level 3 laboratory
4.Biosafety level 4:
The maximum containment laboratory - Biosafety
level 4 is designed to work with Risk Group 4 micro
organisms.
Before constructing such laboratories and putting them
into operation, intensive consultation should be done
with institutions are experienced in operating similar
laboratories.
Operation of maximum containment laboratories
‘Biosafety Level 4’ should be under the control of
national or other authorized health authorities.
Contd…
Special practices for BSL 4
 Along with BSL 3 practices following codes must be
exercised:
The two person rule should be applied, whereby no
individual ever works alone.
A complete change of clothing and shoes is required
prior to entering and upon exiting the laboratory.
Personnel must be trained in emergency extraction
procedures in the event of injury or illness.
Contd…
Laboratory design and facilities for BSL 4
 Passage through a minimum of two doors prior to entering the
rooms containing the class III biological safety cabinets is
required.
 A protective suit laboratory with self- contained breathing
apparatus differs significantly in design and facility
requirements from a Biosafety level 4 laboratory with class III
biological safety cabinets.
 The maximum containment laboratory - Biosafety Level 4 must
be located in a separate building or in a clearly delineated zone
within a secure building.
 All effluents from the suit area, decontamination chamber,
shower or class III biological safety cabinet must be
decontaminated before final discharge.
 Heat treatment is the preferred method.
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