Module 1.

1 of Biosafety Definition of Biosafety

Fundamental Concepts
Biosafety
Topics: ➔ Containment principles, technologies,
01 History of Biosafety and practices implemented to prevent
02 Definition of Biosafety unintentional exposure to pathogens
03 Containment and toxins, or their unintentional release.
04 Elements of Containment ➔ Practices and controls that reduce the
05 Biosafety Level risk of unintentional exposure or release
of biological materials.
Historical Background of Biosafety ➔ Established to promote the use of safe
microbiological practice, safety
1908 equipment and facility safeguard that will
● “Microbiological Safety” reduce LAIs and protect the public
● Winslow described a new method of health and environment.
examination to count bacteria present
in the air
1941
● Meyer and Eddie described laboratory
acquired infections.
1947
● Research laboratory especially tailored
for microbiological safety (NIH)

The principle and profession of biosafety

have developed concurrently through the
American Biological Safety Association
Containment/Biocontainment
(ABSA).
The combination of physical design
● First meeting (1995)
parameters, safety equipment, and
- The members of the military
operational practices that protect personnel,
- The focus addressed “the
the immediate work environment and the
role of safety in the biological
community from exposure to biological
warfare effort”
agents.
● Succeeding meetings
- Attendees included the US
Elements of Containment
Centers for Disease Control
and Prevention (CDC) and
the National Institutes of
Health (NIH), universities,
laboratories, hospitals, and
representatives from the
industries.
International issues on biosafety and
studies on the individual or group of agents
became the focus in the 1980s.
 Good Microbiological Practice and
Procedure (GMPP)
➔ A basic laboratory code of practice
applicable to all types of laboratory
activities with biological agents,
including general behaviours and
aseptic techniques that should
always be observed in the
laboratory. (examples: not eating
inside the laboratory, observing
1. Laboratory Practice and Techniques proper dress code while working in
2. Safety Equipment (Primary Barrier) the lab, decontamination of lab
3. Facility Design (Secondary Barrier) surfaces and so on.)
➔ This code serves to protect
Biosafety Breach laboratory personnel and the
Biosafety breach can result from poor community from infection, prevent
biosafety practices. It can lead to accidental contamination of the environment,
exposure of laboratory workers to the and provide for the work materials in
infectious agents which will initiate use.
unwanted transmissions within the
community, endangering public health. 2. Safety Equipment (Primary Barrier)
- Protects laboratory workers from
1. Laboratory Practice and Techniques exposure to infectious material/agent.
- The most important element of Examples:
containment ● Biosafety Cabinet (BSC)
- Strict adherence to standard ➔ Protects the laboratory personnel
microbiological practices and from exposure in two ways:
techniques (trained and proficient a. It limits exposure of the
personnel) laboratory by containing the
- Protects laboratory personnel inside infectious agent within the
from microbiological agents. work space.
Standard Practices: b. Limits its escape back to the
● Access Control laboratory by the air flow
● Biohazard sign ● Personal Protective Equipment
● Laboratory hygiene (PPE)
● Safe practices ➔ Any equipment of a person to
● Sharps safety protect that individual from
● Proper transport of biological exposure to one or more
materials hazards.
● Medical surveillance ● Enclosed containers (Safety
● Trained personnel centrifuge cap)
● Decontamination ➔ These are equipment with safety
● Waste management features
● Pest control Note: Vaccination may provide an increased
level of personal protection.
3. Facility Design (Secondary Barriers) ● Undergraduate and secondary
- Functions to protect the primary training and
barrier ● Teaching laboratories
● Basic Laboratory ● Bacillus subtilis, Naegleria
● Containment Laboratory gruberi, infectious canine hepatitis
● Maximum containment Laboratory virus, Saccharomyces cerevisiae,
- Will depend on the biological material [Link] K-12, and other
being handled by the laboratory (th non-infectious bacteria.
more dangerous biological material
the more complex the laboratory Biosafety Level 2
design) - Specifications are applicable to
laboratories in which work is performed
Biosafety Levels using a broad-spectrum of biological
agents and toxins that are associated
with causing disease in humans of
varying severity.
● These agents and toxins can
generally be handled safely on an
open bench, provided the
potential for producing splashes
and aerosols are low.
● Primary routes of exposure to
personnel is exposure via the
percutaneous or mucosal routes
and ingestion of potentially
infectious materials.
● Procedures with aerosol or high
splash potential are conducted
within primary containment
equipment such as BSC or Safety
centrifuge caps.
● Hepatitis A virus, Streptococcus
Biosafety Level 1 pyogenes, Borrelia burgdorferi
- BSL-1 represents a basic level of (Lyme disease), Salmonella
containment that relies on standard, species
microbiological best practices and
procedures with no special primary or Biosafety Level 3
secondary barriers, other than a door, a - Specifications are applicable to
sink for handwashing, and non-porous laboratories in which work is
work surfaces that are cleanable and performed using indigenous or
easy to decontaminate. exotic biological agents with a
- Specifications are generally appropriate potential for respiratory
for laboratories that work with defined transmissions and those that may
and characterized strains of viable cause serious and potentially lethal
biological agents not known to infection.
consistently cause disease in healthy
adult humans.
 ● Mycobacterium tuberculosis, St. - Primary routes of exposure
Louis encephalitis virus, and ● Exposure via the percutaneous and
Coxiella burnetii mucous membrane routes and
● Yersinia pestis (plague), SARS, inhalation of potentially infectious
rabies virus, West Nile virus, aerosols.
hantaviruses - Primary Barrier
- Primary routes of exposure to ➢ Class III BSC or in a Class II
personnel BSC with a full-body, air-supplied
● Exposure via the percutaneous positive-pressure personnel suit.
or mucosal routes and - Secondary Barriers
● Inhalation of potentially infectious ➢ Containment laboratory
aerosols requirements
- All procedures involving the ➢ Erected in a separate building or
manipulation of infectious materials completely isolated zone with
are conducted within a BSC or other complex, specialized ventilation
primary containment device. requirements and waste
- No work with open vessels is management systems, for both
conducted on the bench solid and liquid waste.
- A combination of PPE and other
primary containment strategies are WHO LBM 4th
implemented in case a procedure - Moved to a risk-based and evidence
cannot be performed in BSC. based approach without being
- Secondary barriers for BSL-3 prescriptive about risk groups and
laboratories include: biosafety levels so that any facilities
● Basic containment laboratory safety practices, safety equipment, are
requirements (BSL-1 and BSL-2) locally available and relevant.
● Enhanced ventilation strategies - But the actual risk is influenced by
to ensure inward directional many factors:
airflow ● The infectious agent
● Controlled access zones to limit ● The procedure
access, and ● The staff and their
● Anterooms airlocks, exit experience
showers, and/or exhaust HEPA Core Requirements
filtration. - A set of minimum requirements to
describe a combination of risk
Biosafety Level 4 control measures that are both the
- Specifications are applicable primarily foundation for, and an integral part
for laboratories working with a of, laboratory biosafety.
dangerous and exotic biological agents - These measures reflect international
that pose a high individual risk of standards and best practices in
life-threatening disease that may be biosafety that are necessary to work
transmitted via the aerosol route and safely with biological agents even
for which there is no available vaccine where the associated risks are
or therapy minimal.
● Marburg virus and Congo-Crimean - Good microbiological practice
hemorrhagic fever virus and procedure
● Ebola virus and smallpox virus
 - Personnel Competence and
Training
- Facility Design
- Specimen receipt and storage
- Decontamination and waste
management
- Personal Protective Equipment
- Laboratory Equipment
- Emergency/Incident Response
- Occupational Health

Heightened Control Measures

- A set of risk control measures
- The activities to be performed are
associated with a risk that cannot be
brought below an acceptable risk
with the core requirements only.
Maximum Containment Measures
- A set of highly detailed and stringent
risk control measures based on risk
assessment.
- Extremely high levels of protection
must be provided.
- Work with biological agents that may
have catastrophic consequences if
an exposure or release were to
occur.
 Module 1.2 of Biosafety
Laboratory Acquired Infections (LAIs)

Topics:
01 Definition
02 Risk Factors
03 Routes of Exposure

Definition

Laboratory-associated infection/
Laboratory Acquired Infection
- Any infection acquired or reasonably
assumed as a result of exposure to a
biological agent in the course of
laboratory-related activities.
Risk factors associated with LAI Common Agents of LAI
Laboratory Incidents ● Bacteria (Brucella species,
● Lack of training and supervision Francisella tularensis,
● Faculty, poorly maintained Mycobacterium tuberculosis)
equipment ● Parasites (Trypanosoma cruzi,
● Improper risk assessment and Toxoplasma gondii, Plasmodium
controls spp.)
● Performance Pressures ● Genetically Modified Organisms
● Volume of work and time constraints (Recombinant Vaccinia Virus in
● Improper or not following SOPs vaccine and therapeutic studies)
● Virus (SARS-CoV, buffalopox,
hantavirus, Cytomegalovirus,
Herpes virus, Zika virus)
Reality of LAI Documentation
➔ Much information is obtained from
anecdotal cases. However, such reports
do not always signify possible failure of
biosafety procedures or unintended
accidents
➔ While accidental parenteral inoculation
of infectious materials appears to be one
of the leading cases of LAIs, most LAIs
appear to occur even with the best
safety precautions in place.
➔ Adherence to the guidelines by
regulatory agencies decreases the risk
of occupational exposures to infectious
agents.

Routes of exposure
01. Inhalation (most common)
02. Ingestion
03. Percutaneous inoculation
04. Direct contact
 Module 1.3 of Biosafety
International and Local Policies,
Guidelines, and Standards

Topics:
01 International Guidelines and
Standards
02 Local Guidelines and Standards

International Guidelines and Standards

The Global Challenge
- Identification of needs and gaps, and
recommendations to optimize biosafety,
biosecurity, and control are essential
key points to foster the development
and sustain the culture of biosafety and
biosecurity in the Philippines and
beyond our borders.

WHO Laboratory Biosafety Manual 4th UN Security Council Resolution 1540

Edition (2004)
- Moved to a risk-based and - All states shall refrain from providing
evidence-based approach without any form of support to non-state actors
being prescriptive about risk groups that attempt to develop, acquire,
and biosafety levels so that any manufacture, possess, transport,
facilities’ safety practices, safety transfer, or use nuclear, chemical, or
equipment are locally available and biological weapons and their means
relevant. of delivery, in particular, for terrorist
- But the actual risk is influenced by purpose
many factors:
● The infectious agent National Policies, Guidelines, and
● The procedure Standards
● The staff and their experience Executive Order 514
- Establishing the national biosecurity
Laboratory Biosecurity Guidance framework prescribing guidelines for
- Aims to expand biosecurity practices its implementation, strengthening the
- Has 7 major parts national committee on biosafety of the
Philippines, and other purposes.
Biosafety in Microbiological and Executive Order 430 of 1990
Biomedical Laboratories 6th Edition National Committee on Biosafety on the
- Protocol driven risk-assessment Philippines (NCBP)
- Competent National Authorities and
ISO Biorisk Management for associated Department and Agencies
Laboratories and other related ● Department of Science and
organizations Technology - Secretariat of
- Process to identify, assess, and NCBP
evaluate the risk of biological materials. ● Department of Agriculture
 ● Department of Environment and and requiring the registration of the
Natural Resources same with the Department of Health,
● Department of Health Providing Penalty for the Violation
● Department of Foreign Affairs thereof, and of other purposes”
● Department of Trade Industry
● National Commission on DOH AO No. 2021-0037
Indigenous Peoples - New rules and regulations governing
● Department of Interior and Local the regulation of clinical laboratories in
Government the Philippines.
Philippine Biosafety Guidelines 1991 1. Physical Plants
Covers: - Policy guidelines on laboratory
- Genetic engineering, and activities biosafety and biosecurity which
requiring the importation, introduction, includes risk assessment that
field release and breeding of will serve as the basis of
non-indigenous or exotic organisms biosafety level required for the
even though these are not genetically specific CL…
modified. B. Registered Medical Technologist
Includes: (RMT)
- The organizational structure for - Laboratory in Biosafety and
biosafety; procedures for evaluation of Biosecurity Officer in charge of
proposals with biosafety concerns; risk assessment
procedures and guidelines on the VII. Environmental Management
introduction, movement and field - Policy on laboratory biosafety
release of regulated materials and and biosecurity
physico-chemical and biological - Biosafety and Biosecurity Officer must
containment and procedures. be a licensed Medical Technology with
DOH Laboratory Biosafety and training from RITM or RITM-DOH
Biosecurity Standards recognized training institution(s).
SECTION 1 Biorisk Management - Local risk assessment and protocols on
System laboratory biosafety and biosecurity
SECTION 2 Roles, Responsibilities, documents.
and Authorities DOH AO No. 2020-0014
SECTION 3 Biosafety LIO for COVID-19 Testing Laboratory
SECTION 4 Biosecurity - To ensure public health and reliability of
Local Health Authority the results in the laboratory
- The Department of Health (DOH) DOH AO No. 2021-0037 Amendments
through the Health Facility Services - No. 2020-0014-A / May 20, 2020
Regulatory Bureau (NFSRB) released - No. 2020-0014-B / Sept. 08, 2020
guidelines and rules regulating DOH AO No. 2023-004
COVID-19 testing laboratories and Licensure of COVID-19 Testing Laboratories
clinical laboratories in the Philippines. Performing NAAT (RT-PCR)
- These essential components of biorisk RITM Biorisk Management Office (BRMO)
management are required to obtain a Interim Biosafety Guidelines
license to operate. - Specifying the minimum biosafety
Republic Act No. 4688 guidelines for handling, testing,
“An Act regulating the operation and storage, and transport of specimens.
maintenance of clinical laboratories
 Module 2.1 of Risk Assessment Plan
Biorisk Management - Planning, including identification of
hazard and risk and establishing goals.
Topics: Do
01 Biorisk Management - Implementing, including training and
02 Responsibilities operational issues.
03 AMP Model Check
04 Strategies for Biorisk Control - Checking, including monitoring and
corrective action
Biorisk Management System Act
- Revieqing, including process innovation
Laboratory Biorisk Management and acting to make needed changes to
- Coordinated activities to direct and the management system.
control an organization with regard
to biorisk (ISO 35001 2019) Key factors in establishing and
- A system or process to control implementing a biorisk management
safety and security risks associated system include:
with the handling or storage and - Commitment by top management
disposal of biological agents and - Focus on continual improvement
toxins in laboratories and facilities
(CWA) Responsibilities
- System or process to control safety
and security risks associated Top Management
biological agents and toxins in ● Has the ultimate responsibility for the
laboratories and facilities (ISO organization’s biorisk management
35001 2019) ● Must demonstrate commitment to
- Assist an organization to fulfill the biorisk management
legal requirements and other ● Overall responsibilities of biorisk lies on
requirements (ISO 35001 2019) the top management
- Establishes biorisk management
principles Senior Management
- Defines the essential components of a ● Operational responsibility/system
biorisk management framework. oversight
- Describes a comprehensive biorisk ● Provision of resources
management process. ● Communication with top management
- Provides guidance on implementation ● Ensure review, audit, and reporting
and use of the standards.
BRM Committee
● Independent review/approval (protocol
incidents, biorisk communication and
risk assessment/ risk management)
● Develop policy and guidelines
● Report to the senior management
and/or top management

*Used to achieve continual improvement

Biosafety Officer (BSO)/ Biorisk ● Facility Management
Management Advisor - Engineer
● Conduct risk assessment ● Security Management
● Provide guidance/ advice on biorisk - With in-depth knowledge of lab
issues security
● Provide training/ orientation ● Animal Care
● Delegated authority to stop work - With in-depth knowledge of
● Functions of the biorisk animal handling and zoonotic
management advisor should and animal diseases.
include:
➢ Verifying that all biorisk have been The AMP Model
addressed Biorisk Management: The AMP Model
➢ Advising or participating in the
reporting, investigation, and A - Assessment
follow-up of accidents, incidents; M - Mitigation
➢ Ensuring that relevant and P - Performance
up-to-date information and advice
on biorisk management is made The AMP Model
available to scientific and other - Aims to reduce risks of the laboratories
workers as necessary by applying appropriate control
➢ Advising on biorisk management measures and validating its
issues within the organization effectiveness and suitability.
➢ Contributing to the development Biorisk Assessment
and/or delivery of biorisk - Process of identifying the hazards and
management training activities evaluating the risks associated with
and, biological agents and toxins, taking into
➢ Advising and assisting account the adequacy of any existing
organization management in controls, and deciding whether or not
ensuring that required the risks are acceptable
authorizations for work are in - The backbone of the practice of
place. biosafety and biosecurity
● This function should normally be - Forms the basis of biorisk management
regarded as an advisory position and Biorisk Mitigation
not directly responsible for managing - Actions and control measures that are
biorisk. put into place to reduce or eliminate the
● This role shall be independent of those risks associated with biological agents
responsible for implementing the and toxins
programme of work. Biorisk Performance
- Improving biorisk management by
Scientific Management recording, measuring, and evaluating
● Follow/ Implement Mitigation measures organizational actions and outcomes to
● Report Incidents reduce biorisk
- Directed towards continuous
Others improvement
● Occupational Health
- Medical Doctor or Occupational
Health Nurse
 Protection
Protect Personnel or the environment
● PPE
● Engineering controls (e.g., directional
airflow)
● Vaccinate personnel

Compliance
Administrative controls and effective
biosafety program management in place
● Good Microbiological Practices and
Procedures
● Good communication of hazards, risk
and risk control measures
● Appropriate training
● Clear SOP
● Established safety culture

Strategies of Biorisk Control

Elimination
Eliminate the hazards
● Use of inactivated biological agent
● Use harmless surrogate

Reduction and substitution

Reduce the risk
● Substitute with an attenuated or less
infectious biological agent,
● REduce the volume/ titre being used
● Change the procedure for one that is
less hazardous (e.g., PCR rather than
culture)

Isolation
Isolate the hazard
● Elimination and reduction might not be
possible, particularly in clinical setting
● Isolate biological agent(s) using
primary containment device
 Module 2.2 of Risk Assessment - Isolates or culture
Biohazards and Biorisk
Biological Agent
Hazard - Any microorganism including those
Adapted from OHSAS 18001-2007 which have been genetically modified,
- An object, situation or act that has the toxins or biological substances which
potential to cause adverse effects when may be able to provoke any infection,
an organism, system or population is allergy or toxicity in humans, animals or
exposed to it. plants.
● Physical situation
e.g., fire or explosion Biohazardous Agent
● Activity - Influenza Virus
e.g., pipetting - SARS Coronavirus 2 (SARS-CoV-2)
● External Condition - Ebola Virus
e.g., weather, individual who could - It can be transmitted via different routes
steal and/or misuse materials or (direct or indirect contact) and can be
information found in different settings
● Material Risk Group Classification (unknown risk
e.g., biological agent or toxin, factor)
chemical, radiological material and - Pathogenicity
asphyxiating gases such as - Transmission
nitrogen - Host Range
- Population
Hazard has the potential for causing ● Immunity
harm ● Density
CEN Workshop Agreement 16393 ● Movement of host
- Regardless of what the cause might be - Vector
- Standard of environmental hygiene
Biohazards - Local availability of effective preventive
Adapted from ISO/IEC Guide 51-1999 measures
- An object or situation that has the ● Sanitary Precaution
potential to cause adverse effects when ● Control of animal
an organism, system or population is reservoirs/animal vectors
exposed to it. ● Movement of people and animals
- Note: Potential source of harm ● Importation of potentially infected
caused by biological agents or animals or animal products
toxins ● Prophylaxis by vaccination or
antiserum
Biological Material
- Tissue samples from animal and
humans
● Blood and
● Other body fluid
● Proteins, genetic materials, toxins
and other organic compounds
including toxins or biologic
products
Four Risk Groups Classifications “Risk Group is not sufficient for a Risk
Assessment”
Risk Group 1
● Individual: Low Risk
● Community: Low - A combination of the likelihood of an
● A microorganism that is unlikely to incident and the severity of the harm if
cause human disease or animal that incident were to occur.
disease Likelihood
● e.g., Non pathogenic [Link], S. - The probability of incident
cerevisiae occurring
Consequence
Risk Group 2 - The severity of harm
● Individual: Moderate
● Community: Low
● A pathogen that can cause human or
animal disease but is unlikely to be a
serious hazard to laboratory workers,
the community, livestock or the
environment
● e.g., Influenza (H1N1, H3), Measles,
Enterovirus, Dengue Virus Biorisk
- A combination of the probability of
Risk Group 3 (lethal) occurrence of harm and the severity of
● Individual: High that harm where the source of harm is
● Community: Low a biological agent or toxin.
● A pathogen that usually causes serious - Note: The source of harm may be an
human or animal disease but does not unintentional exposure, accidental
ordinarily spread from one infected release or loss, theft, misuse,
individual to another. Effective diversion, unauthorized access, or
treatment and preventive measures are intentional unauthorized release.
available
● e.g., Avian Influenza (H5, H7), Novel
Influenza, MERS-CoV, SARS-CoV

Risk Group 4 (lack treatments)

● Individual: High
● Community: High
● A pathogen that usually causes serious
human or animal disease and that can
be readily transmitted from one
individual to another, directly or
indirectly. Effective treatment and
preventive measures are not usually
available
● e.g., Hanta, Ebola Virus
 Module 2.3 of Risk Assessment
Risk Identification, Characterization, and
Evaluation

Topics:
01 Risk Assessment
02 Risk Characteristics
03 Risk Evaluation
04 Risk Control Measures
05 Risk Communication

Risk Assessment
- A systematic process of gathering
information and evaluating the
likelihood and consequences of Likelihood of an exposure and/or release
exposure to or release of workplace Likelihood of an exposure or release
hazard(s) and determining the occurring during the proposed laboratory
appropriate risk control measures to work
reduce the risk to an acceptable risk. Rare: Almost impossible to occur
Unlikely: Not very possible to occur
Biorisk Assessment Possible: Might occur
Adapted from OHSAS 18001-2007 Likely: Very possible to occur
- Process of evaluating the biorisk(s) Almost Certain: Highly possible to
arising from a biohazard(s), taking occur
into account the adequacy of any
existing controls, and deciding whether Consequences of an exposure and/or
or not the biorisk(s) is acceptable. release
Severity of the consequences of an
Why conduct a biological risk assessment? exposure/release
- To define preventive measures that Negligible: Trivial incident or near miss
are adapted to the nature and level of Minor: Incident with self-limiting
risk consequences
- For the sound allocation of Moderate: Incident that requires
resources to preventive measures medical treatment and/or has
- Basic legal requirement in countries insignificant environmental
that have biosafety regulations consequences
Major: Incident with potential lost time
Basic Steps in Risk Assessment due to infection but non-permanent
● Hazard/ Risk Identification (Hazard, consequence and/or limited
Situation, Risk) environmental impact
● Risk Characterization Severe: Potential fatality or serious
● Risk Evaluation illness with permanent disability and/or
serious environmental impact.
Risk Characterization
- An Isoquant is used in the risk
characterization
Risk Matrix

Risk Evaluation
● The goal of a risk evaluation is to
determine whether the assessed risk is
acceptable, or whether further targeted
control measures should be
implemented to prevent or reduce the
risks within a tolerance level.

Risk Assessment Tool

Things to Consider:
1. Environment
2. Nature of the situation

Factors associated with high likelihood

of incident occurring
● Laboratory activities associated with:
- Aerosolization ● Initial Risk
- Sharps - Risk associated with laboratory
● Low competency of personnel activities or procedures that are
● High environmentally stable biological conducted in the absence of risk
agents generally and non-compliant control measures
facility ● Residual Risk
● Low infectious dose - Risk that remains after careful
● High communicability selected control measures are
● High morbidity/mortality applied
● Limited in availability of effective
prophylaxis or therapeutic intervention/
treatment
● Large susceptible population
● Lack of endemicity

Factors associated with high likelihood

and consequence
● High concentration or volume of the
biological agent ● Risk Tolerance
● Airborne route of transmission - The level of risk that is considered
acceptable and allows work to
proceed bearing in mind the
 expected benefit of the planned
activities.
● Acceptable Risk
- The risk that is considered
acceptable and allows work to
proceed bearing in mind the
expected benefit of the planned
activities

Risk Control Measures

● Use of a combination of tools, which
include communication, assessment,
training, physical and operational
controls to reduce the risk of an
incident/event to an acceptable level

Risk Communication
● An interactive and systematic process
to exchange information and opinion on
risk(s) that inclusively engages all
relevant personnel of various
categories as well as community
leaders and officials where appropriate
 Module 2.4 of Risk Assessment ● Emerging infectious disease
WHO Risk Assessment Framework ● Re-emerging infection with agents that
developed multiple antibiotic resistance
Topics: increased risk resulted from:
00 WHO Risk Assessment Framework - No effective treatment
01 Gather Information - Absence of data/ information
02 Evaluate Risk needed for risk assessment
03 Develop Risk Control Measures
04 Select/Implement Risk Control Measures Laboratory Procedures Hazard
05 Review Risk and Control Measures ● Aerosols
Pipetting, vortexing, blending,
WHO Risk Assessment Framework pouring
● Parenteral Hazard
Needlestick, cut from sharp object
and surfaces
Bite/scratch from experimental
animals/insects
● Direct skin (intact/ non-intact
mucous membrane)
Spills, splashes
Touch on contaminated surfaces
● Ingestion
Mouth pipetting
Gathering Information
Factors to consider
● Pathogenic characteristics of the
● Potential for generation of aerosols
biological agents
- Pipetting, centrifugation,
● Type of laboratory work and/or
homogenizing, pouring, sonicating,
procedures
blending, vortexing
● Type(s) of equipment
● Potential for parenteral inoculation
● Type of laboratory facility
- Needlesticks, cuts from sharp
● Human factors exist
object and surfaces
● Other factors (legal, cultural, social,
- Bite/scratches from insects or
economic)
animal
● Contamination of skin, non-intact
Pathogenic Characteristics of the
skin, or mucous membrane
Biological Agents
- Splashes, splatter
● Infectious Dose
- Touching of contaminated surfaces
● Route of Exposure
● Potential for ingestion
● Quantity, concentration
- Mouth pipetting, splashes of
● Virulence, pathogenicity
material to mouth
● Communicability
- Contaminated articles or fingers in
● Morbidity/Mortality
mouth
● Environmental stability
- Consumption of food and drinks in
● Availability of vaccine or treatment
laboratory
● Susceptible population
● Gene products effects
● Origin of agents/endemicity
● Quantity - Public Health/ Surveillance
- Volume, concentration, titer, Laboratory
infectious dose ● Biosafety Level
● Work proposed - BSL 1
- In vitro/ In vivo - BSL 2
- Aerosol Challenge - BSL 3
- Environmental disease - BSL 4
- Recombinant activities
- Scale up and large scale activities Human Factors Exist
Factors influencing performance and
compliance
● Mental Health
● Stress, fatigue
● Skill
● Training, behavior, attitude

Other factors
● Legal
● Cultural
● Social
● Economic

Risk Assessment Short Template

Type(s) of Equipment
● Ventilated Enclosures
- Biosafety Cabinets (BSC Class
1,2,3)
- Laminar flow hood (horizontal,
vertical)
- Chemical fume hood
● Equipments that generate infectious
aerosols
- Centrifuge
- Vortex mixers
- Sonicators
- Pipette

Types of Laboratory Facility

● Purpose
- Clinical Laboratory
Routine Diagnostic
Special Laboratory
- Academic/ Teaching Laboratory
- Research Laboratory
Evaluate the Risk ● Identify resources are available and
● Potential exposure and/or release sufficient
incident ● Are proposed control strategies
● Likelihood of an exposure and/or effective, sustainable and achievable in
release the local context
- Factors that influences the
likelihood
● Consequences of an exposure and/or
release
- Factors that influences the
consequences
● Overall initial risk
● Acceptable risk

A good risk control strategy

● Provide direction of the risk control
measures
● Achievable locally available resources
● Minimize resistance to the work being
performed
● Align with the goals, objective and
mission of organization

Select and Implement Risk Control

Measures
● National/ Local Regulations
- AO 2021-0037
New Rules and Regulation
Governing the Regulation of
Clinical Laboratories in the
Philippines
● National/ International Regulations
● Control measures
- Locally available and sustainable
- Adequately efficient, or should
multiple risk control measures be
used in combination
- Has it reduced the residual risk to
acceptable level
● Has approval to conduct the work
Note: There will never be zero risk! :) been granted?
● Have the risk control strategies been
Develop Risk Control Measures communicated to relevant personnel?
● Identify risk control ● Have necessary items been included in
measures/strategies applicable the budget and purchased?
Review Risk and Control Measures
● Have there been any changes in
activities, biological agents, personnel,
equipment or facilities?
● Is there any new knowledge available
of biological agents and/or the
processes being used?
● Are there any lessons learnt from
incident reports and investigations
that may indicate improvements to be
made?
● Has a periodic review cycle been
established?
 Module 3.0 of Biosafety 101 ● Personal Protective Equipment –
Core Requirements Importance and types of PPE (e.g.
mask, gloves, etc.)
Topics: ● Laboratory Equipment – safe use,
01 Good Microbiological Practices records maintenance
02 Personnel Competence and Training o BSC
03 Facility Design o Autoclave
04 Specimen Receipt and Storage ● Emergency/ Incident Response –
05 Waste Management and records, accidental exposures,
Decontamination biological spill response kits and
06 Personnel Protective Equipment procedures, first aid
07 Laboratory Equipment ● Occupational Health – Protocols for
08 Emergency/ Incident Response yearly medical exams, prophylaxis,
09 Occupational Health OHSA, BOSH, Philippine
Regulations.
Core Requirements
⮚ A set of minimum requirements to
describe a combination of risk control
measures that are both the foundation
for, and an integral part of, laboratory
biosafety.
⮚ These measures reflect international
standards and best practices in biosafety
that are necessary to work safely with
biological agents, even where the
associated risks are minimal.

The core requirements are the ff.:

● Good microbiological practices
and procedures – adherence to
biosafety guidelines in performance
of technical procedures, and use of
proper PPEs.
● Personnel competence and
training – Biosafety 101 Training,
Technical Proficiency (EQAP),
Training Protocol for New Hires.
● Facility Design – Areas in the
laboratory: Pre-analytic, Analytic,
and Post-analytic, and facility design
features.
● Specimen receipt, storage and
transport – Completion of
Requisition Protocols, triple
packaging systems and transport
regulations.
● Decontamination and waste
management – waste classification,
common disinfectants, and waste
management steps.
 Module 3.1 of Core Requirements supplies and are never left
Good Microbiological Practices and unattended.
Procedures (GMPPs)
Technical Procedures
Topics: ⮚ A special subset of GMPP which relates
01 Definition directly to controlling risks through safe
02 Best Practices conduct of laboratory techniques.
03 Technical Procedures ⮚ Avoiding inhalation of biological
agents
Good Microbiological Practices and ● Do not forcibly expel substances
Procedures (GMPPs) from pipette tips into liquids,
⮚ A set of standard operating procedures over-vigorous mixing, and carelessly
and practices (SOPPs) applicable to all flipping open tubes.
types of activities with biological agents. ● Where pipette tips are used for
⮚ Includes both general behaviors, best mixing, this must be done slowly and
working practice and technical with care
procedures. ⮚ Avoiding injection of biological agents
⮚ Most essential risk control measure ● Alternative sharps container should
also have the basic features of a
Best Practices: good sharps’ disposal:
● Never store food or drink, or o Made of a heavy-duty plastic;
personal items such as coats and o Able to close with a
bags in the laboratory tight-fitting, puncture-resistant
● Perform handwashing lid;
● Ensure adequacy of supplies: lab o Upright and stable during use;
equipment, consumables, reagents, o Leak-resistant
PPE, disinfectants o Properly labelled to warn of
● Ensure safe storage of supplies to hazardous waste inside the
reduce accidents and incidents container.
● Ensure proper labelling of all o Sharps container should not
biological agents, chemical and be filled to the brim
radioactive material ⮚ Preventing dispersal of biological
● Protect written documents from agents
contamination using barriers (such ● Use of leak-proof containers to
as plastic coverings) discard specimens
● Ensure that the work is performed ● Regularly empty waste containers
with care and without hurrying ● Proper waste labelling
● Keep the work area tidy, clean, and ● Protocols for opening culture tubes,
free of non-essential objects and bottles in place.
materials ● Use recommended disinfectants and
● Prohibit use of earphones, which decontaminating agents
can distract personnel and prevent ● Inactivation protocols in place
equipment or facility alarms from
being heard Key Messages
● Remove jewelry that could tear - Good Microbiological Practices and
gloves, easily become contaminated Procedures are important and should be
or become fomites strictly adhered to.
● Refrain from using portable devices - Strict adherence to documented
● Ensure open flames or heat sources laboratory best practices and procedures
are never placed near flammable is an essential element of a robust
biosafety program
 Module 3.2 of Core Requirements ▪ Ensure that the competence of a
Personnel Competence and Training worker transferred into another
position is re-evaluated;
Topics: ▪ Where applicable, take actions to
01 Staff Training Requirements acquire the necessary competence,
02 Roles of Organization and evaluate the effectiveness of the
03 Local Regulations actions taken;
▪ Retain appropriate documented
Personnel Competence Training information as evidence of
⮚ Competent and trained personnel is competence.
essential in the prevention and control of Training
laboratory acquired- infections The organization shall ensure that
requirements and procedures for biorisk
Staff Training Requirements management training of workers are
⮚ General familiarization and awareness identified, established and maintained.
training (mandatory to all personnel) The procedures shall include, but not
⮚ Job-specific training limited to:
⮚ Safety and security training (mandatory ▪ Identification of biorisk training
to all personnel) needs;
▪ Provision of programmes based on
Training/Competencies biorisk training needs;
o Biosafety training ▪ Provision of required biorisk training
o Participation in EQAP Testing: in line with biorisk management
evaluates performance of lab plans;
o Technical / Job-specific Training: e.g. ▪ Determination of effectiveness of
training for blood banking etc. biorisk training;
o Staff Coaching / Mentoring: ▪ Provision of refresher biorisk training
mandatory: awareness of hazards, on a consistent basis;
security measures, emergency ▪ Assessment to ensure that workers
response (until personnel is are competent to perform assigned
competent) tasks; and
▪ Maintenance of biorisk training
Roles of Organization: to ensure staff records.
competence (ISO 35001)
Competence Local Regulations: AO 2021-0037
The organization shall: Personnel
▪ Determine the necessary Every CL shall have an adequate
competence of person(s) who work number of trained personnel, depending on
under its control and affect its biorisk the workload, to provide safe, effective
management performance; services to clients.
▪ Ensure that these persons are A. Head of the Laboratory (HOL)
competent on the basis of 1. The head of the laboratory shall
appropriate education, training, or be a competent and experienced
experience; professional, with a specialized
▪ Ensure that all workers are under skill set related to and
close supervision until they proportionate to the laboratory
demonstrate the ability to perform category, to ensure that the
activities in a safe and secure laboratory runs efficiently. The
manner; head of the laboratory is
essentially responsible for the
operation of the entire laboratory,
 its personnel, functions, and
data, all of which shall meet the
quality assurance criteria and
regulatory requirements.
B. Personnel
9. The duties and responsibilities
shall be clearly stated
10. There is an adequate number of
qualified personnel with
documented training and
experience to conduct/perform
the laboratory procedures

Key Messages
- Training and evaluation of competency
are key to achieving high levels of
biosafety
- Laboratory professionals must receive
information, resources, and training, and
must be given sufficient time to build
good habits that make them risk
conscious and attentive to safety
practices
 Module 3.3 of Core Requirements ● Facilities for storing food and drink,
Facility Design personal items and outwear should be
provided outside the lab
Topics: ● Facilities for eating and drinking must
01 Laboratory areas be provided outside the laboratory
02 Facility Design Features ● First-aid facilities must be readily
03 Philippine Regulations accessible and suitably
equipped/stocked
Laboratory Areas ● Appropriate methods for
⮚ Pre-analytic – usually composed of decontamination of waste must be
departments involved in specimen available in proximity to the laboratory
receiving and preparation (reception ● Waste management must be
and extraction areas) considered in the design
⮚ Analytic – where testing and ● There must be a reliable and adequate
experimental procedures are being electricity supply and lighting to permit
performed safe exit
⮚ Post-analytic – houses the ● Emergency situations must be
decontamination, storing, and archives considered in the design. Fire security
and flood risk must be considered.
Facility Design Features
● Ample space must be provided for the Philippine Regulations
safe conduct of laboratory work and for AO 2021-0037: Philippine Regulations
cleaning and maintenance.
● Provision of designated hand-washing ANNEX A: LICENSING STANDARDS FOR
basins operated by hands-free CLINICAL LABORATORY
mechanism I. PHYSICAL PLANT
● Laboratory must be a restricted-access A. Conform to all applicable local and
area (addresses biosafety and national regulations for
biosecurity concerns) constructions, renovation,
● Doors must be appropriately labelled maintenance and repair of CL.
with the international biohazard warning B. Conform to the required space for
symbols the conduct of its activities.
● Laboratory walls, floors and furniture C. There must be well-ventilated,
must be smooth, easy to clean, lighted, clean, safe and functional
impermeable to liquids areas based on the services
● Laboratory bench tops must be provided.
impervious to water and resistant to D. A program of proper maintenance
disinfectants, acids, alkalis, organic and monitoring of physical plans
solvents and moderate heat. and facilities.
● Laboratory furniture must be fit for E. Policy guidelines on laboratory
purpose biosafety and biosecurity
● Laboratory lighting (illumination) must F. There shall be an area for
be adequate for all activities confirmatory testing for Rapid HIV
● Laboratory ventilation where provided Diagnostic Algorithm and G6PD
should ensure airflows do not
compromise safe working ANNEX D1: PLANNING AND DESIGN
● Laboratory storage space must be GUIDELINES FOR GENERAL CLINICAL
adequate to hold supplied for LABORATORIES
immediate use I. GENERAL CONSIDERATIONS
1. Location
2. Privacy
3. Conformance with Building Laws
4. Ventilation
5. Spaces Required
6. Functional and Planning
Considerations
 Module 3.4 of Core Requirements a. Primary receptacle – tube or a vial
Specimen Receipt, Storage, Packaging with leak-proof seal and labelled with
and Transport permanent marker
b. Secondary packaging –
Topics: water-resistant polyethylene box that
01 Specimen Receipt protects the primary receptacle
02 Specimen Storage c. Outer Container – a box that protects
03 Specimen Packaging the secondary packaging
04 Specimen Transport

Specimen Receipt
Specimen received by the laboratory
must be accompanied by sufficient
information:
⮚ Proper identification
⮚ Date and time of collection
⮚ Referring facility
⮚ Tests and/or procedures requested
In case of suspected breach, perform
the following:
⮚ Do not touch the package
⮚ Inform the consignor/sender of the
package about the incident
⮚ Document in the event log of this Specimen Transport
breach and do not process until Transport can occur:
further notice ⮚ Within facility
*Specimens must be thoroughly checked ⮚ Within national borders (e.g. NEQAS)
upon receipt: intact and correctly packed ⮚ Internationally

Specimen Storage Shipping Regulations

It is essential to maintain the quality of the IATA DANGEROUS GOODS
specimen. REGULATIONS
⮚ International Air Transport
Guidelines on Specimen Storage Association
A written policy must be developed and ⮚ Restrictive and universal
must include the following: ⮚ Majority of air transport services
a. Description of samples that must be are members
stored ⮚ Compatible with UN/ICAO
b. Retention time regulations
c. Location ⮚ 290-member airlines as of Junes
d. Conditions for storage 2022
e. System for storage organization
Specimen Transport Guidelines
Specimen Packaging 1. Classification of specimen – UN
It plays a vital role in specimen transport. Number (based on hazard
classification and composition)
⮚ Triple Packaging System *biological hazards falls under
Triple packaging provides three layers of class 6
containment to protect the substances 2. Packaging – triple packaging system
being shipped. is recommended to almost all
specimen transport.
 3. Marking – provide information about
the contents of the package, nature
of the package, and hazards. Must
be clearly visible and not
overlapping other markings.

2. Category B (UN 3373) – infectious

substances that do not meet the
criteria for category A. Substances
that do not contain substances that
may cause disease to humans or
animals

4. Labelling – to identify hazardous

contents inside the package. It is
universal in nature

3. Exemptions

Training Course on Infectious Substance

Shipping (ISS)
5. Documentation – must contain: It is a 3-day course that covers all personnel
details of consignor/sender, details involved in handling, transport, and
of consignee/receiver, and specimen packaging of infectious substances.
information

Classification
Infectious substances are divided into the
following:
1. Category A (UN 2814 (affects both
human and animal), UN 2900
(substances affecting animals only)
– capable of causing permanent
disability, fatal diseases in humans
and/or animals
 - The ff. are the Categories of
Module 3.5 of Core Requirements Decontamination:
Biological Waste Management and ● Chemical
Decontamination ❖ Gas/Vapour
- Formaldehyde
Topics: - Hydrogen peroxide
01 Introduction - Chlorine dioxide
02 Methods of Decontamination ❖ Liquid
03 Waste Management - Phenols
- Peroxide
Biowaste Management and - Hypochlorites
Decontamination - Chlorine dioxide
- Any surface or material known to or - Peracetic acid
potentially be contaminated by - Formaldehyde
biological agents during laboratory - Glutaraldehyde
operations must be correctly managed - Quaternary
to control biological risks. ammonium
- Identification and segregation of compounds
contaminated materials be adopted - Alcohols
before decontamination and/or disposal ● Physical
❖ Heat
** Please observe the maximum capacity - Autoclave
of the biowaste containers, usually ¾ full - Incineration
per container volume. - Hot air oven
** Spill kits which are specialized kits - Boiling
designed to handle and clean up biological
spills, such as blood, bodily fluids or
Cleaning and Hand Hygiene
potentially infectious materials must be part
of the basic decontamination protocol. Cleaning removes:
- Dirt and organic matter from an item
Methods of Decontamination that would inactivate chemical
Cleaning and Hand Hygiene disinfectants
Chemical Disinfection - A high proportion of biological agents,
Gaseous Disinfection making subsequent chemical
Heart Disinfection disinfection more effective.
Sterilization Two types of laboratory Hand Hygiene:
Biological and chemical indicators** a. Alcohol-based hand rub:
- 60-96% concentration
Decontamination - Should only be used with visibly
- Reduction of viable biological agents or clean hands
other hazardous materials on a surface b. Handwashing:
or object(s) to a predefined level by - 20 seconds with soap and running
chemical and/or physical means. water
- The ff. are the levels of contamination:
★ Sterilization - Elimination or Chemical Disinfection
destruction of all viable biological - Preferred for decontamination of
agents and spores laboratory surfaces
★ Disinfection - Elimination of Chemical Disinfectants
viable biological agents ➔ Chlorine compounds
★ Cleaning - Reduction of viable ● 1:10 dilution (1 part sodium
biological agents hypochlorite and 9 parts of water)
● 15-20 minutes contact time
 ● Sodium hypochlorite (household ➔ Moist Heat
bleach = most common), Calcium ● Autoclaving
hypochlorite, Sodium - Saturated steam under
dichloroisocyanurate, Chloramine, pressure
Chlorine dioxide - Most effective and reliable
➔ Phenols means of decontaminating or
● Greater stability than sodium sterilizing laboratory materials
hypochlorite, used at a and wastes.
concentration of at least 5% in ● Boiling
water
● Phenol Sterilization
➔ Peroxides - Used when a complete elimination of
● Widely used microbiocidal agents any biological agent, including spores
● Hydrogen peroxide, Peracetic acid and prions, is necessary (e.g. for
➔ Aldehydes medical items and infectious waste)
● Commonly used for fumigation - Achieved using several
● Formaldehyde, Glutaraldehyde decontamination methods:
➔ Quaternary ammonium compounds ➢ Autoclaving
● Effective against bacteria in ➢ Chemical disinfectants and
non-spore forms and enveloped gaseous disinfection combined with
(lipid-containing) viruses. a strict SOP, and irradiation.
➔ Alcohols
● Commonly used at 70% Waste Management and
concentration (Anywhere between Decontamination of Waste Products
60% and 90% can be effective Consideration for waste management
depending on the alcohol used) Decontamination of liquid waste
● Ethanol, Propanol/Isopropanol Decontamination of solid waste
Methods of inactivation
Gaseous Disinfection
Gaseous Disinfectant Examples of waste generated in
- Also known as fumigants laboratories:
- Widely used to:
➢ Decontaminate the laboratory
space (e.g. widespread
contamination, difficult to access
areas)
➢ Disinfect equipment out of a
contaminated area and/or prior
repair or maintenance
- Hydrogen peroxide, Chlorine dioxide,
Formaldehyde (all are most common)
Waste Management Considerations
Heat Disinfection - Facilities and decontamination methods
Heat available
➔ Dry Heat - Type and volume of waste (objects,
● Incineration materials, liquids)
- Disposal of animal carcasses, - Method of decontamination
and other anatomical wastes - Segregation categories
without prior disinfection (uncontaminated, contaminated,
● Hot air oven sharps, glass)
- non-corrosive but longer - Packaging, labelling and transport
- Presence of radioactive material - Third party certified biowaste
separate protocol for disposal management service providers is an
- Presence of chemicals, and option for laboratory wastes.
- Recycling and reuse requirements - The storage area of contaminated and
disinfected wastes must be free from
Methods of Waste Decontamination pests, rodents and fly infestations.
Liquid Wastes
- Sewer System
- Chemical Disinfectants (rarely
preferred)
- Autoclaving
Solid Wastes
- Autoclaving (preferred)
- Incineration (preferred)
- Alkaline Digestion
- Rendering

1-B-i. / 2-C-ii / 3-A-iii

Methods of Inactivation on viable

biological agents
➢ Nucleic Acid Extraction
➢ Thermal Inactivation
➢ Formaldehyde
➢ Ionizing Radiation

Key Messages
- Disinfection, sterilization and waste
management are key to safe handling
of biological agents.
- Specific decontamination requirements
will depend on the type of laboratory
activity or procedure and the nature of
the biological agents being handled.
- Laboratories should determine
appropriate waste management
strategies based on the outcomes of
the risk assessment, and that are
applicable to local needs and
conditions.
 Module 3.6 of Core Requirements Types of PPE
Personal Protective Equipment PPE: Core Requirements
- Laboratory gown/coat
Topics: - Face shield
01 Introduction - Gloves
02 Types of PPE - Closed Footwear
- Goggles
Introduction to PPE - Footwear with shoe cover
Review of Risk Reduction Strategies
Laboratory Gown
Purpose: Protect the body/skin and scrub
suit against contamination from biological
materials.
- Made of different materials
- Fluid resistant
- Cuffed sleeves
- Solid front / tied at the back
- Disposable (gown) / reusable (coat)

Footwear
Purpose: Reduces likelihood of injury from
falling objects, minimizes slips and trips and
exposure to infectious materials, hazardous
liquid
- Enclosed footwear with NO heels or
LOW heels
- Easy to clean or disinfect
Personal Protective Equipment - Reusable or disposable
- Equipment and/or clothing worn by
personnel to provide a barrier against Examination Gloves
biological agents, thereby minimizing Purpose: Protect hands from contamination
the likelihood of exposure. - Disposable, non-sterile, powder-free
- Different types depending on the nature
Important Considerations for PPE of work or handling process
Selection - Nitrile (preferable), latex,
➔ Characteristics of the biological agent polychloroprene or PVC
being handled
➔ Volumes and concentrations of the Goggles/Face Shield (Eye Protection)
biological agent Purpose: Protect the eyes, nose, or mouth
➔ Presence of additional hazards (e.g., from splashes of infectious materials or
extreme temperatures, chemical or toxins, impacting objects or artificial
radiological hazards) ultraviolet radiation
➔ Type of work being carried out - Eye protection devices can be re-used
➔ Other risk control measures being but must be cleaned each time after
used, such as a biological safety use.
cabinet (BSC) - If splashed, devices must be
➔ Other PPE being worn decontaminated with an appropriate
➔ Individual needs of the laboratory disinfectant
personnel, and
➔ Availability of national regulations and
organizational requirements
PPE: Heightened Control Measures Respirator Fit Testing
PPE Core Requirements + Respiratory - The only accepted way to determine if
Protection the respirator fits properly.
- Surgical Mask - Used to assess whether the respirator
- Fit-Tested NIOSH-approved assigned to a person forms an
Respirators adequate seal around their face.
- Coveralls - Periodic testing is needed to ensure the
- Apron fit continues to be acceptable
- Fit testing is required for tight-fitting
Apron facepiece respirators.
Purpose: Additional hazard-specific splash
protection may be required for certain Head Protectors/Covers
procedures: Purpose: Protect the hair and scalp from
- Removal of specimens from liquid contamination (for certain activities)
nitrogen - Hair that is long enough to be tied back
- Handling liquid chemicals and large should be tied back before entering the
liquid volumes laboratory.
- Autopsies - Need for and selection of head
protection should be based on a risk
Coverall assessment
Purpose: Coveralls cover the whole body
and are generally worn on top of scrubs or Key Messages
personal clothes - Any PPE used in the laboratory must
- May be disposable or reused if properly be correctly fitted.
decontaminated - Personnel must be given adequate
- Decontamination procedures for re-use training in order to ensure it is used
must be validated and approved properly and effectively.
- Care must be taken while removing - Incorrect use of PPE will not give the
coveralls protection they are designed to provide.

Surgical Mask
- Disposable, fluid resistant ear loop
- Good breathability
- Internal and external faces should be
clearly identified
- 98% droplet filtration
- 3-ply pleated
- Must be disposed properly
- It is not an example of a respirator but it
is intended to protect patients and the
environment from infectious agents
from the person wearing the mask.

Fit-Tested NIOSH Approved Respirators

- Good particle filtration (minimum 94%
or 95%) that provides a level of filtration
of 94-95% or greater
- Good breathability with design that
does not collapse against the mouth
(e.g. duckbill, cup-shaped)
 Module 3.7 of Core Requirements
Laboratory Equipment

Topics:
01 Safe use of laboratory equipment
02 Essential Laboratory Equipment:
Autoclave
03 Essential Laboratory Equipment:
Biosafety Cabinet

Safe Use of Laboratory Equipment

Here are some general guidelines for the
safe use of laboratory equipment: Active: with vacuum, Passive: w/o vacuum
a. Read and follow instructions (most
important) Types of Autoclave
b. Training and familiarization a. Gravity displacement autoclave
c. PPE - Commonly-used, but not for
d. Equipment inspection and porous materials
maintenance b. Vacuum-assisted autoclave
e. Emergency procedures - Can be used for porous materials
f. Hazard identification - Conditioning: alternating pressure,
g. Workplace organization maintained at 26 psi
h. Communication - S: 270 degrees F
i. Waste management - Drying
j. Documentation
Safe Use of the Autoclave
Essential Laboratory Equipment: - Operation and maintenance must be
Autoclave assigned to trained and competent
Essential Laboratory Equipment individuals.
- For laboratory equipment to effectively - Operating instructions for the autoclave
reduce risk: must be available.
➢ Sufficient space is provided for its - A loading plan must be available.
use - A preventive maintenance program
➢ Appropriate budget must be must be developed and must be
available for the equipment’s conducted by qualified personnel.
operation and maintenance - A reliable steam source must be used.
➢ Personnel involved in the - Waste or materials placed in autoclave
operation and maintenance should must be in containers that readily allow
be trained and demonstrate removal of air and permit heat
proficiency penetration.
- The chamber of the autoclave must be
Autoclave loosely packed.
- Saturated steam under pressure is the - Hazardous chemical wastes, mercury,
most effective and reliable means of or radioactive waste must not be
decontaminating/sterilizing laboratory treated in an autoclave.
materials and wastes by destroying the - Appropriate PPE must be worn by the
biological agents. operator during use.
- Temperature: 121 degrees Celsius,
Pressure: 15 psi
- Time required depends on the nature of
the material to be sterilized.
Monitoring of Autoclave Performance Class II
Biological Indicators - Like Class I BSC, entrance of air
- Vials or ampoules with heat-resistant through the front opening
spore, i.e. Geobacillus - Provide personnel and environmental
sterothermophilus protection and offer product protection
- Positive (Failed) and Negative
(Passed) results can be interpreted by
change in the color of the medium or
through a rapid read-out machine.
- Note: Always follow the
manufacturer's instructions!
Chemical Indicators
Show proper parameters of:
➢ Time
➢ Temperature
➢ Pressure
- Indicated by change in color or change
from white to black band

Essential Laboratory Equipment: Class III

Biosafety Cabinet - Closed, sealed, negative-pressure
enclosure
Biological Safety Cabinet (BSC) - Access to the working area uses
- Reduces exposure to aerosols and can integrated gloves or gauntlets
also act to isolate higher-risk - Offer the highest degree operator
aerosol-generating work or equipment protection
from other areas of the laboratory.

Classes of BSCs
Inward flow of air; HEPA filter
a. Class I
b. Class II
c. Class III

Class I
- Open-fronted enclosures
- Provide personnel and environmental
protection, but do not offer product
protection.
 Module 3.8 of Biosafety ➢ Minimize loss of life, limb and
Emergency/Incident Response property (in decreasing order)

Topics: Alerting
01 Introduction - An institution’s incident response plan,
02 Incident Response System as developed by management, should
03 Spill Response address procedures for alerting
appropriate personnel in the event of
Introduction to Emergency/Incident an emergency/incident.
Response - The process of identifying an
Introduction emergency/incident in real-time or
- An emergency/incident is a sudden or after it occurred and using all
unexpected event that requires information to generate response.
immediate attention to prevent harm or - Can either be through sound and/or
damage. visual communication
- Emergency/incident response refers - Primarily directed at:
to the set of procedures set in place to ➢ Emergency responders
address and mitigate incidents or ➢ Possible victims
accidents involving biological materials,
pathogens or toxins. Assessment
- Types of emergencies in the lab: - Evaluation of the type and severity of
● Chemical incidents an emergency/ incident, to determine
● Fire electrical breakdown the most appropriate response
● Pest infestation - Predetermined during planning
● Flooding - Must be immediate: an emergency is
● Personal health issues of happening
personnel - Must be initially performed by someone
on the scene
Incident Response System
Assessment Factors:
➔ Type of emergency/incident
➔ Nature of materials involved
➔ Geographical/spatial coverage
➔ Number of affected personnel
➔ Medical background of affected
personnel
➔ Risk of contamination
Planning and Preparation ➔ Need for external assistance
- “Pre-”
- Have a contingency plan with specific Alerting and Assessment
SOPs - Both provide information as to the
➢ Based on applicable laws, expert existence and nature of the emergency
advice and adapted to local /incident
settings.
➢ Involves stakeholders with their Mobilization
roles, actions to be taken and details - Process of activating personnel and
about resources must be identified. deploying equipment to respond
➢ Output = a standard document directly to an incident or emergency to
➢ Must be reviewed and clarified expedite its resolution.
- Some incidents are self-resolving and
may not require a specific response.
- May require inter-agency cooperation - Sharps disposal container
depending on scale, capability or law. - Plastic container bin
2. PPE
External Responders - 2 goggles, 2 face shields
- Large-scaled or difficult emergencies - 4 pairs of gloves
may require assistance from external - 2 surgical face mask and 2
agencies (fire, earthquake, flood, major n95
spills). - 2 pairs of vinyl rubber shoe
- Depending on the laws of the covers
jurisdiction where the institution is - 2 disposable gowns and 2
located, some emergencies/ incidents coveralls
that the institution cannot respond to. 3. Absorbent materials
- Engagement with the police, fire - towel
brigades and emergency medical - paper towels
services are vital for an effective 4. Clean up tools and materials
incident response. - forceps and tongs
- small disposable broom with
Incident Management dustpan and wiper
- autoclavable biohazard
waste bags
- disinfectant (sodium
hypochlorite)
- a bottle with water
- 70% alcohol
- spill kit checklist
- biological spill response SOP
- ‘Do not enter’ signage
Drills
➢ Earthquake Drill Note: Initiate clean-up as soon as possible;
➢ Fire Drill Evacuate the laboratory if necessary; Wait
➢ Major Spill Drill 30 minutes before re-entry; Work in buddy
system.
Spill Response
Biological Spill Response
- A process of mitigating a biological spill
which may release hazardous materials
to the environment.
- “Post-”

Biological Spill Response Workflow How to clean up spill outside BSC

1. Notify a. Don PPE and prepare the spill kit
2. Protect b. Cover the spill with wet-absorbing
3. Confine materials starting at the edges and
4. Clean-up towards the center
5. Dispose c. Carefully pour the disinfectant over
6. Report the absorbent-material starting at the
edges and towards the center
(whole area must be saturated with
Biological Spill Kit (Outside BSC) a disinfectant)
1. Container
- Bucket
 d. Allow sufficient contact time to the - biological spill response SOP
disinfectant (15-20 minutes for - ‘Do not enter’ signage
non-viscous spill; 30 minutes for
viscous spill) Note: Initiate clean-up as soon as possible;
e. Wipe up spill using paper towels and Evacuate the laboratory if necessary; Wait
use tongs and forceps to pick up 30 minutes before re-entry; Work in buddy
contaminated materials system.
f. Discard absorbent-material into a
biohazard waste bag
g. Alternatively, place the reusable
items in a container with 10%
sodium hypochlorite solution
h. Clean the spill area again with fresh
absorbent-material and should be
followed by a disinfectant for another
15 minutes. wipe any remaining How to clean up spill inside BSC
splatter a. Don appropriate PPE and prepare
i. Doff PPE and place inside the the clean up materials
biohazard bag b. Remove the specimen tube and
j. Use double bag place it inside the biohazard
k. Remove DO NOT ENTER sign disposable waste bag inside the
BSC
Biological Spill Response (inside BSC) c. Cover the spill with wet-absorbing
Spill Kit materials starting at the edges and
1. Container towards the center
- Bucket d. Carefully pour the disinfectant over
- Sharps disposal container the absorbent-material starting at the
- Plastic container bin edges and towards the center
2. PPE (whole area must be saturated with
- 2 goggles, 2 face shields a disinfectant)
- 4 pairs of gloves e. Allow sufficient contact time to the
- 2 surgical face mask and 2 disinfectant (15-20 minutes for
n95 non-viscous spill; 30 minutes for
- 2 pairs of vinyl rubber shoe viscous spill)
covers f. Wipe up spill using paper towels and
- 2 disposable gowns and two use tongs and forceps to pick up
coveralls contaminated materials
3. Absorbent materials g. Discard absorbent-material into a
- towel biohazard waste bag inside the BSC
- paper towels h. Clean the spill area again with fresh
4. Clean up tools and materials absorbent-material and should be
- forceps and tongs followed by a disinfectant for another
- small disposable broom with 15 minutes. wipe any remaining
dustpan and wiper splatter
- autoclavable biohazard i. Rinse the surface with
waste bags absorbent-material containing 10%
- disinfectant (sodium sodium hypochlorite
hypochlorite) j. Doff PPE and place inside the
- a bottle with water biohazard bag
- 70% alcohol k. Use double bag
- spill kit checklist l. Remove DO NOT ENTER sign
 Module 3.9 of Biosafety Implication to Laboratory Safety
Occupational Safety and Health - While laboratory-related occupational
health and safety problems can occur,
Topics: their frequency can be minimized
01 Definition of Terms through the implementation of proper
02 Relevance of OSH in the Laboratory safety measures, adherence to
03 International and Local Regulations protocols, and strong safety culture
within the laboratory.
Definition of Terms - Regular training, inspections, and
compliance with regulations are
Occupational Safety and Health essential to prevent incidents and
- Discipline dealing with the prevention of protect the well-being of laboratory
work-related injuries and diseases as workers.
well as the protection and promotion of
the health of the personnel. Most Common Occupational Hazards in
- Aims to improve working conditions the Health Sector (WHO)
and environment. ➔ Occupational infections
➔ Unsafe patient handling
Occupational Safety ➔ Exposure to hazardous chemicals
- Refers to the discipline that deals with ➔ Exposure to radiation
the physical safety of workers ➔ Psycho-social risks and mental health
(protecting employees) ➔ Violence and harassment
- Focuses on reducing risks at workplace ➔ Risks in ambient work environment
➔ Occupational injuries
Occupational Health ➔ Environmental health hazards
- Refers to the discipline that maintains
the physical and mental well-being of Consequences of Occupational Hazard
workers (promoting wellness) Exposures
- Includes nutrition, stress management - Biosafety proponents maintain that
and ergonomics in a workplace regardless of what caused the
- Four Categories: SARS-CoV-2 outbreak in China in
1. Health and Safety 2019, the fact that a lab accident could
2. Mental Health - aims to eliminate spark a pandemic is reason alone for
psychological harm better oversight.
3. Worksite Health Promotion - aims
to increase health resources Cascading errors because of not
4. Environment and Community - no reporting work hazard exposures
harm from the environment and ➔ It can create and spread infection to
the community in the workplace communities
➔ It can spread infection to the natural
Relevance of OSH in the Laboratory environment and potential vectors of
the agent (Example of the
Chikungunya Virus at a laboratory in
the US can initiate a natural cycle of
the virus among the mosquito
population in Missouri.)
➔ It can lead to increased health risks
➔ Compromised research and test
results
➔ Weakened safety culture
 ➔ Legal and reputational implications

International and Local Regulations

International Standards
OHSAS (Occupational Health and
Safety Management System) 18001
- One of the International Standard for
Occupational Health and Safety
Management Systems
ISO 45001
- International standard for
occupational health and safety,
- Issued to protect employees and
visitors from work-related accidents
and diseases.

Local Legal Legislations

RA 11058
- An act strengthening compliance
with occupational safety and health
standards and providing penalties
for violations thereof
DOLE Occupational Safety and
Health Standards
- Formulated in 1978, an improved
tool for promoting and maintaining a
safe and conducive working
environment.

DOLE OSH Standards

➢ Rule 1040 - Health and Safety
Committee
➢ Rule 1050 - Notification and
Keeping of Records of Accidents
and/or Occupational Illnesses
➢ Rule 1070 - Occupational Health
and Environmental Control
➢ Rule 1080 - Personal Protective
Equipment and Devices
➢ Rule 1090 - Hazardous Materials
➢ Rule 1960 - Occupational Health
Service
 Module 4.1 - Specific testing protocols (i.e.
Heightened Control Measures inactivation)
- Safe operation of equipment
Topics: - Infectious substance shipping
01 Operational working practices and - Emergency response
procedures - Risk ethics and tolerance evaluation
02 Personnel Competence and Training
03 Facility Design Facility Design
04 Decontamination and Waste
Management Site Selection
05 Personal Protective Equipment The laboratory facility can be
06 Laboratory Equipment - Build in a separate building
07 Emergency Response - In an area located behind or away from
common walkways, between other
Hazard rooms or buildings of the facility.
Adapted from OHSAS 18001-2007 - At the end of a corridor with no onward
- An object, situation or act that has the access,
potential to cause adverse effects when - By constructing wall(s) and/or doors to
an organism, system or population is separate the laboratory from
exposed to it. unrestricted areas of traffic.
- Where specific procedures are being
● Physical situation
conducted within the laboratory,
e.g., fire or explosion
physical separation may also be
● Activity achieved by building additional rooms
e.g., pipetting or by incorporating a primary
● External Condition containment device (BSC) into the
e.g., weather, individual who could laboratory design.
steal and/or misuse materials or
information Facility Design
● Material ➢ Separate area from offices and food
e.g., biological agent or toxin, traffic
chemical, radiological material and ➢ Separate area for personal belongings
asphyxiating gases such as ➢ Anterooms are used to separate two
nitrogen departments in a laboratory. This is a
sealed space with air filtration to
remove harmful particles or pathogens
Operational Working Practices and from the air. Both doors should not be
Procedures opened at the same time
- Strict access control that requires - Doors with interlocks
additional prerequisites for entry - such - Door with airlock
as specific immunizations, clearances, ➢ Added door interlock control through
training. sensor-enabled doors
- Use of primary containment such as ➢ Emergency by-pass switch for
BSC and/or respiratory protection. emergency egress
- Develop additional internal transfer and ➢ Coved floors (prevent build-up of dirt
transport mechanisms. inside the laboratory), slip-resistant
➢ Negative pressure rooms with pressure
Personnel Competence and Training gauge for monitoring
Specifications and Protocols ➢ Passbox with interlock, and UV light
Training should include competency in: disinfection
- Biorisk management
➢ Hands-free faucet and hand-washing Should only be used to fumigate
sink (near entry and exit of the spaces if the vapor can be
laboratory) completely contained, properly
➢ CCTV inactivated and exhausted safely
➢ Two-way communication device/s after fumigation.
➢ Alarm system ➔ After formaldehyde fumigation,
the walls and ceiling of the
Decontamination and Waste room may have to be wiped
Management down with ammonia to
- Waste should be decontaminated neutralize any residue.
onsite to prevent unwanted release of
hazards outside the environment. Personal Protective Equipment
- Autoclaving is the most effective way
of decontaminating or sterilizing Personal Protective Equipment
laboratory and waste materials. - Alternative protective clothing such as
- All wastes should be autoclaved prior gowns, scrubs and coveralls, can be
to disposal except for procedures that used.
typically states that autoclaving is not - Reusable items should undergo an
recommended (e.g., PCR products) appropriate decontamination procedure
- Wastes should be pre-treated with (such as autoclaving) before
agent-appropriate disinfectant, laundering.
following appropriate contact time,
before loading in the autoclave. Respiratory Protection
- BSL III laboratories are recommended Consideration in using respiratory
to use double-door autoclave. protection:
- Level of protection must be appropriate
Laboratory Space Decontamination for the risks identified.
- Fumigation should be done, - The wearer must be able to work freely
● In case of widespread and without additional risks while
contamination in areas that are wearing the respiratory protective
difficult to access. equipment.
● Before an equipment is taken out - It must fit and be suitable for the person
for maintenance, or from a wearing it.
contaminated area. - It must be worn correctly and according
- Fumigation should be conducted at, to the manufacturer’s instructions.
● Ambient temperature of 20 - When reusable respiratory protective
degrees Celsius equipment is used, it must be
● Relative humidity of more than appropriately decontaminated after
70% use, and properly stored and
- Chemical disinfectants: maintained.
● Hydrogen peroxide - It must complement any other PPE
➔ Optimal concentration: 2.4 being worn. This is especially important
mg/L with a contact time of in the use of eye protection.
at least one hour. - Types of Respiratory Protection:
➔ Appropriate for a. Air-purifying
decontamination of glove Removes contaminants from the
boxes, walk-in incubators and air: tight-fitting (with upper and
small rooms. lower straps e.g., N95, N100
● Formaldehyde - stabilized P100) and loose-fitting (does not
solution of about 37% have straps and the wearer puts it
 in the head that also covers the Biological Safety Cabinet (BSC)
neck e.g., PAPR). - Most common equipment used for
b. Atmosphere-supplying maintaining high-aerosol risk
Provides clean, breathable air - Provides effective primary
from uncontaminated sources containment for work with infectious
(e.g., self-contained breathing material or toxins when they are
apparatus (SCBA)). properly maintained and used in
conjunction with good laboratory
Respiratory Protection Program techniques.
- Procedures for selecting respirators for
use in the workplace. Basic Principles of Biological Safety
- Medical evaluations of employees Cabinets
required to use respirators. - Personnel protection is provided
- Fit testing procedures for tight-fitting through a continuous stream of inward
respirators. air, known as inflow, which helps
- Procedures for proper use of prevent aerosols from escaping
respirators in routine and reasonably through the front opening.
foreseeable emergency situations. - Product or biological material protection
- Procedures and schedules for cleaning, is provided by the downflow of HEPA
disinfecting, storing, inspecting, filtered air to work area
repairing, discarding, and otherwise - Environment protection is provided by
maintaining respirators. the HEPA-filtered exhaust air, which is
- Procedures to ensure adequate air exhausted into the surrounding
quality, quantity, and flow of breathing containment zone or directly to the
air for atmosphere-supplying outside atmosphere
respirators.
- Training of employees in the respiratory Classes of Biological Safety Cabinets
hazards to which they are potentially ● Class I - Personnel and Environment
exposed during routine and emergency Protection
situations. ● Class II and Class III - Personal,
- Training of employees in the proper use Product, and Environment Protection
of respirators, including putting on and
removing them, any limitations on their Types of Class II Biological Safety
use, and their maintenance. Cabinets
- Procedures for regularly evaluating the ● A1
effectiveness of the program. - No longer widely used
- Ducting: Non-ducted
Respirator Fit Testing - Exhausted Air: 30%
- The only accepted way to determine if - Re-circulated Air: 70%
the respirator fits properly. - Usage: BSL 1-3, small amount of
- Used to assess whether the respirator volatile and non-volatile toxic
assigned to a person forms an chemicals and radionuclides
adequate seal around their face. ● A2
- Periodic testing is needed to ensure the - Ducting: Non-ducted
fit continues to be acceptable. - Exhausted Air and Recirculated
Air: Similar to II, A1, but exhaust
Laboratory Equipment air can be ducted to the outside
- Examples: BSC, Autoclave through a canopy unit (specialized
(Double-door), Centrifuge with safety duct-fitting designed to link primary
buckets containment devices to an
exhaust)
 - Usage: BSL 1-3, small amount of BSC Clearances
volatile and non-volatile toxic - BSC not connected to an exhaust
chemicals and radionuclides when system should have at least 12 inches
exhausted outside (300 mm) clearance from the filter
● B1 face and any overhead obstructions
- Suitable for use for hazardous when the cabinet is in its final operating
materials position, to allow for testing of the
- Ducting: Ducted Exhaust HEPA/ULPA filter
- Exhausted Air: 70%
- Re-circulated Air: 30%
- Usage: BSL 1-3, small amount of
volatile and non-volatile toxic
chemicals and radionuclides
● B2
- Ducting: Ducted
- Exhausted Air: 100%
- Re-circulated Air: No
recirculation
- Usage: BSL 1-3, small amount of
volatile and non-volatile toxic
chemicals and radionuclides
-
● C1 - Note: Do not place fluorescent
lamps directly above BSC as it will
disrupt the air sensor.
BSL Location - Minimum of 6 inches (150 mm) from
adjacent walls or columns
- 6 inches (150 mm) space between
both sides of the BSC and 6 inches
(150 mm) behind the BSC
- Minimum of 6 inches (150 mm)
between BSCs

- Away from traffic patterns, doors, fans, - 40 inches (1020 mm) of open space in
ventilation registers, fume hoods and front of the BSC
any other air-handling device that could - 60 inches (1520 mm) from opposing
disrupt its airflow patterns walls, bench tops and areas of
- Located at the wall farthest from and occasional traffic
facing the entry door (If not possible: - 100 inches (2540 mm) between two
place on the side wall perpendicular to BSCs facing each other
the hinge side of the door)
 - More frequent recertification should be
considered for particularly hazardous or
critical applications or workloads (e.g.,
every 6 months depending on high
workload, local risk assessment, and
institutional policy)

Field Certification in accordance with

NSF/ANSI 49
- Downflow velocity profile test
(measures downflow velocity)
Roof Exhaust Systems - Inflow velocity test (measures the
- Roof exhaust systems serving inflow velocity)
biosafety cabinets should have a stack - Airflow smoke patterns test (provides
that extends straight upwards at least visualization of the airflow inside the
10 ft (3 m) above the roof surface to BSC)
produce higher velocity flow to avoid - HEPA filter leak test/ integrity
re-entrainment by the building - Site installation assessment tests:
➢ Alarm functions as required by this
standard;
➢ Blower interlock
➢ Exhaust system performance
(proper exhaust duct negative
pressure and canopy performance).

Emergency Response

Emergency/Incident Response
- An emergency or incident response
plan, that includes sourcing of
post-exposure prophylaxis and
therapeutics that may be necessary.
- Emergency response procedures
should include in spill management, the
use of emergency equipment such as
the emergency shower, and emergency
bypass buttons.
- Spill kits are specialized kits to ensure
safe and effective cleanup, including
PPE, absorbent materials to soak the
biological spill, disinfectants or
sanitizers. Special training on this must
Maintenance and Testing be part of preparedness response.
Recommended recertification of BSCs - All staff should be aware and trained in
- At the time of installation and at least the facility’s alarm system
annually thereafter - A 24-hour CCTV recording that is
- Whenever HEPA filters are changed regularly monitored by an authorized
- Maintenance repairs are made to personnel.
internal parts - Should be reviewed periodically
- Cabinet is relocated
 Module 4.2 Two Models for Maximum Containment
Maximum Containment Measures Laboratory
a. Suit Laboratory
Topics: - Operators work in a
01 Operational working practices and positive-pressure encapsulating
procedures suits in open-fronted BSCs, also in
02 Personnel Competence and Training a negative-pressure laboratory.
03 Facility Design - Anterooms where positive
04 Decontamination and Waste pressure suits are stored, donned,
Management doffed, and maintained
05 Personal Protective Equipment - Pressure gauges to monitor
06 Laboratory Equipment negative pressure in the rooms
07 Emergency Response and positive pressure within the
suit
Operational Working Practices and - Shower room before exiting the
Procedures laboratory

Use of Communication and Record b. Cabinet Line Facility

Technology Designs - All work is carried out in a closed
● Two-way radio communication system of Class III BSCs, within a
● Visual monitoring and record of negative-pressure laboratory
activities inside the laboratory
● Specimen receptacles enter the facility
through a dunk tank filled with
disinfectant
● Required shower with disinfectant
before exiting the laboratory
● All procedures are done inside the
facility, no paper worlds are brought
outside the laboratory
● Keyboards are specially designed with
large prints to facilitate easy - Samples are transported into the
visualization through the PPE Class III cabinet from a specialized
transport tray from the suit
Personnel Competence and Training laboratory
- Supplies are placed inside the
Personnel Competence and Training Class III BSC through a dunk tank
- Personnel must have an appropriate filled with disinfectant
level of laboratory experience, and a
specialized, in-depth, pre-service Decontamination and Waste
training programme Management
- Regular drills and emergency or ● All wastes are decontaminated through
scenario-based training a double-door autoclave.
- Stringent requirements for competency, ● All effluents from the suit area,
training, and operational updates decontamination chamber, suit shower
and cabinet line (BSCs or isolators)
Facility Design must be decontaminated before final
- Place an impermeable physical barrier discharge using either heat (preferred
between the lab personnel and the method for effluents since it can be
biological agent validated more consistently and reliably
 than chemical treatment) or chemical
treatment.
● Effluents may also require subsequent
correction to a neutral pH and suitable
temperature before discharge.
● All wastes are decontaminated through
a double-door autoclave connected to
the Class III BSC.
● Gas disinfection for BSC Class III
decontamination
- With fumigation for materials that
Personal Protective Equipment autoclave cannot contaminate.

Personal Protective Equipment Laboratory Equipment

● Positive pressure suits (must be
designed to withstand contact with Laboratory Equipment
materials used inside the laboratory) - Laboratory Equipment must be able to
supplied with HEPA-filtered air withstand fumigation or be able to be
● Inspect for any tears and verify wrapped or moved to a gas-tight,
air-tightness of the suit fumigation-free zone within the
● Wear hair cover, and appropriate inner laboratory during routine laboratory
gloves fumigation.
● Attach air supply for breathing - The use of sharps must be avoided
- Parameters in choosing suits for whenever possible. If their use is
maximum containment laboratory unavailable, specific and detailed SOPs
➢ Internal pressure tests must be developed and implemented,
➢ Integrated tests for chemical and extensive training in the use of
protection suits sharps in the containment system is
➢ Tear resistance and puncture test required.

Class III Biological Safety Cabinet Emergency Response

- It was designed for work with highly
infectious microbiological agents and Emergency/Incident Response
the conduct of hazardous operations - National and local health authorities
and provides maximum protection for should actively cooperate in preparing
the environment and the worker. this programme.
A. Glove ports with O-ring for attaching - Other emergency services, for example,
arm-length gloves to cabinet (gloves fire, police, and designated receiving
are replaced annually) hospitals, should also be involved.
B. Window (non-opening) - Emergency responders should be
C. Exhaust HEPA filter properly trained in responding to BSL 4
D. Supply HEPA filter pathogens.
E. Double-ended autoclave or
pass-through box Occupational Health
F. Pass-through dunk tank (not in - Working policies should ensure that the
picture) number of hours worked in the
laboratory on a single occasion is kept
to a minimum to prevent physical and/or
mental fatigue.
- Injuries, in particular, percutaneous
injury, such as from a needlestick or
 bites from infected animals, sustained in
the laboratory carry an elevated risk due
to the consequences of any subsequent
infection because of the nature of the
biological agents being handled.
- Depending on the incident, personnel
should monitor and record body
temperature and any symptoms, for an
agreed period of time. If disease-specific
symptoms are noted, arrangements
should be made for medical advice and
support and for transfer to a suitable
health care facility for isolation and
appropriate medical care.
 Module 5.1 of Biosecurity
Introduction to Biosecurity

Topics:
01 Definition of Biosecurity
02 Bioterrorism of Events
03 Local and International Legislations
04 The Biosecurity Assessment Team
05 Biosecurity of Events in the Philippines

Definition of Biosecurity
- Protection, control and accountability for
valuable biological materials within Category: Biological Material
laboratories, in order to prevent their ● RG1
unauthorized access, loss, theft, misuse, Components/Individual:
diversion or intentional release. - Bacillus subtilis
- Note: Hazard is for BIOSAFETY - Bacillus licheniformis
ISSUES while Threat is for - Adeno-associated virus
BIOSECURITY ISSUES ● RG2
Components/Individual:
- Actinobacillus pleuropneumoniae
- Hepatitis D Virus
- Sporothrix schenckii

- Balance of biosecurity and biosafety ● RG3

refers to the need of safe handling and Components/Individual:
containment while also implementing - Mycobacterium tuberculosis
protocols - Penicillium marneffei
- Rabies Virus
● RG4
- Herpes B Virus
- Hendra Virus
- Lassa Fever Virus
● Toxin
- Cholera
- Diphtheria
● SSBA
What is a Biosecurity Event?
- Shiga-like toxin (verotoxin)
- A deliberate act involving or related to
- Bacillus anthracis
pathogens or toxins, information, or
- Lassa Virus
equipment that could cause disease or
harm to people, animals, or both, as well
Bioterrorism Events
as to the organization.
- Refers to the deliberate release or
dissemination of biological agents such
 as bacteria and/or virus with the
intention to harm or cause fear to a The Biosecurity Assessment Team
population (used as weapons towards - The purpose of the BAT is to evaluate
the society) and to assess the level of biosecurity
- Oregon, USA 1984: One of the salad measures within an organization, facility,
bars contaminated by Salmonella by the or system. Identifying potential
members if the Bhagwan Shree vulnerabilities, weaknesses, and gaps
Rajneesh commune on the biosecurity procedures.
- Japan, 1990: Religious cult Aum - It is usually composed of the following
Shinrikyo tried to conduct bioterrorism personnel:
with botulinum toxin and Bacillus ● Biological Safety Officer (BSO)
anthracis (BBC News, 2018) ● Senior Managers
- USA, 2001: Anthrax Letters containing ● Security specialists
spores of Bacillus anthracis ● Scientists
● Laboratory personnel
● Human Resource personnel
● IT personnel
● Individuals who may contribute
valuable knowledge

Biosecurity Events in the Philippines

Local and International Legislation

- It aims to protect biosecurity
- National Committee on Biosafety of the
Philippines (NCBP) - signed by
President Corazon Aquino 1950
- EO 514 National Biosafety Framework
(NBF)
- 1991 Philippine Biosafety Guidelines
- Department of Health, Administrative
Order 2021-0037

International Legislations
- IAP Statement of Biosecurity -
addresses the 5 fundamental issues in
biosciences
- 1972 Biological and Toxin Weapons
Convention
- United Nation Security Council
Resolution 1540 (UNSCR 1540)
- The Danish Biosecurity Law 2008
- United States Government Policy for
Oversight for Life Sciences Dual use
Research of Concern
- United States Government Policy for
Institutional Oversight of Life Sciences
Dual Use Research of Concern
- Cartagena Protocol on Biosafety
 Module 5.2 of Biosecurity ● Management
Components of Biosecurity ➢ Biorisk management system
➢ Biorisk policy and procedures
Topics: ➢ Biorisk/biosecurity budget and
01 Pillars of Good Biosecurity Management resources
02 Components of Biosecurity ➢ Reporting to management
03 Biosecurity needs and challenges in the ● Physical Security
Philippines ➢ Access control
➢ Monitoring (e.g., cameras,
Pillars of Good Biosecurity Management resources)
● Awareness ➢ Building management security
➢ General biosecurity awareness ➢ Security culture in organisation
among management and
employees Components of Biosecurity
➢ Biosecurity risk and responsibility ● Inventory Control
awareness ● Information Control
➢ Biosecurity response awareness ● Personnel Control
➢ Awareness concerning biosecurity ● Physical Security Control
procedures ● Transport Control
● Personnel Reliability ● Emergency and Incident Response
➢ Personnel screening ● Dual Use Research of Concern
➢ Authorisation of personnel ● Emerging Biotechnology
➢ Confidentiality measures
➢ Integrity program (reporting 1. Physical Security
suspicious behaviour) ➢ Detection
● Transport Security ➢ Delay Response
➢ Transport rules, regulation and laws ➢ Access Control
➢ Transport procedures, chain of - Graded Protection
custody, compliance ● Concentric rings of increasing
➢ Transport risk analyses security spanning from outside
➢ Screening of transportation to inside the facility
companies ● Different areas of a facility will
● Information Security have different levels of security
➢ Guidelines for confidential based on risk.
information 2. Personnel Management
➢ Assess dual use aspects of
research and knowledge
➢ Information and knowledge security
● Accountability for Materials
➢ Secure storage of biological
hazards
➢ Inventories, verification of stocks 3. Material Control
➢ Internal transport ➢ Inventory
➢ Access to materials ➢ Checklist
● Response ➢ Markings
➢ Emergency and crisis response ➢ Access
➢ Procedures and responsibility - To prevent theft in inventory.
during incidents 4. Transport Security
➢ Communication and information - Relies on chain of custody principles
during incidents and user agreements
➢ Incident training and evaluation - e.g., Triple Packaging System
 - Packaging, shipping and transport of ➢ Promote life sciences research
specimens must comply with the while protecting public health and
local and international requirements national security
for transportation of infectious ➢ Minimizing the potential threats
substances. posed by biological pathogens and
● For local and transport, patient the potential misuse of information,
sample must be shipped products, or technologies derived
following the basic triple from such research
packaging system 8. Dual Use Research of Concern
● For air shipments, sample from ➢ Pathogen or toxin, knowledge, or
confirmed and/or suspected equipment
patient must be shipped as ➢ Used for illegitimate scientific
Category B: UN Number and applications (e.g., commercial,
Proper Shipping Name: e.g., medical, or research purposes),
UN 3373, “Biological ➢ Intentionally misused as a biological
Substance, Category B” weapon to cause harm (e.g.,
● For air shipments of COVID-19 bioterrorism).
viral culture or isolates must be
shipped as Category A: Un Biosecurity needs and challenges in the
Number and Proper Shipping Philippines
Name: e.g., UN 2814,
“Infectious substance, 5 Fundamental Biosecurity Issues and
affecting humans” Challenges (According to IAP)
5. Information Security ● Awareness
➢ Data Breach ● Safety and Security
➢ Data Privacy ● Education and Information
➢ Information/ Data Inventory ● Accountability
➢ Retention Period ● Oversight
6. Emergency/Incident Response Plan
➢ Natural disasters Biosecurity Needs in the Philippines
➢ Man-made disasters (e.g., - Reforms in biosecurity policies
accidental release of SARS virus - Effective trainings and workshops
2003, use of anthrax spores in - Awareness-level trainings to
bioterrorism) policymakers
➢ Contingency Plan - Expanding the concepts of biosafety
➢ Incident Response Plan and biosecurity in National Biosafety
➢ Drills, training, updating Framework 514
7. Emerging Biotechnology - Incorporate the four pillars of disaster
➢ Scientific, ethical, and social risk reduction and management in the
implications of certain context of biohazards
biotechnologies development ➔ Prevention and mitigation
➢ Integration of those technologies ➔ Preparedness
into scientific and clinical practice. ➔ Response
➢ Clustered Regularly Interspaced ➔ Rehabilitation and recovery
Short-Palindromic Repeats - Multidisciplinary approach and linkage
(CRISPR) among agencies and other concerned
- Emerging biotechnology entities
(allows sciences make precise
changes in an agents DNA)
 Module 5.3 of Biosecurity ➢ Review and Continual
Biosecurity Risk Assessment Improvement

Topics: Biosecurity Event Hierarchy

01 Risk Assessment Framework - It is recommended that elements of
02 Biosecurity Risk Assessment Guidelines biosecurity risk assessment follow a
03 Conducting Biosecurity Risk Assessment hierarchical structure (Class, Category,
Group, Event) to greatly reduce the
Risk Assessment Framework workload and the complexity of the
assessment

Risk Assessment Framework

- Provides the overview of the key
considerations that apply during each
step of the cycle.
- When conducting a risk assessment, it
must be remembered that the risk is
not based on the pathogenicity of the
biological agent alone, but on the
likelihood and consequence of an
incident occurring - in other words, the
risk of exposure to and/or release of
the biological agent during laboratory
Note: The latter of the above table shall
operations.
be used for this module
Biosecurity Risk Assessment Guidelines
Conducting Biosecurity Risk
Assessment
Biosecurity Risk Assessment and
Biosecurity Plan
Conducting a Biosecurity Risk
- Biosecurity plan manages biosecurity
Assessment Guideline (step-by-step)
risks and addresses the risks identified
1. Preparation
in a biosecurity risk assessment.
● Gathering documentation
- This includes the ff.:
● Threat environment (internal,
➢ Preparation
external) (written overview)
➢ Develop and asset inventory
● Assessment team
➢ Assess biosecurity event likelihood
● Risk Assessment Schedule
➢ Assess biosecurity event
2. Asset Inventory
consequences
● Asset Identification
➢ Analyze risk
- Tangible (pathogens, toxins,
➢ Determine risk tolerance
equipments, and hardware)
➢ Mitigation
 - Intangible (specific information, Likelihood Assessment
knowledge, biosecurity plan,
logical processes, and even
the reputation of the
organization
- People (individuals who play a
key role in meeting the
organization's mandate such
as personnel, students,
contractors, senior managers,
and scientists)
- SSBA (Security Sensitive
Biological Agents)
● Dual use potential
● Asset Priority

4. Consequence
● Determine physical and
psychological impact to Public
Health, Animal Health, and the
3. Likelihood Organization
● Identification of Deliberate ● Effectiveness and Vulnerability of
Biosecurity Events Mitigation Measures using the
● Determine Adversary Motive (like following criteria:
an employee telling others that ●
he/she will free the research
animals). Adversary means they
are capable
● Means and Capability

1 - Negligible (Very Low)

2 - Limited, no death (Low)
3 - Several cases, minimal death (Medium)
4 - Widespread, some death (High)
Biosecurity Event Frequency 5 - Widespread, significant death (Very High)
Assessment
1 - Very Effective (Very Low)
2 - Effective (Low)
3 - Somewhat Effective (Medium)
4 - Ineffective (High)
5 - Very ineffective or no mitigation measures (Very
High)
 c. Risk Reduction Measures -
to implement measures to
reduce the identified risks.
d. Biosafety Levels - this
involves assignment of
biosafety levels to facilities or
activities based on the level
of risk associated.
e. Training and Education -
mitigation efforts should
5. Risk Analysis include comprehensive
● Willingness of an organization to training and education.
accept or reject a given level of f. Emergency Response
residual risk Planning - to develop and
● Risk tolerance is based on the implement emergency
premise that risk tolerance is response plans
unachievable unless all potential g. Ongoing Monitoring and
threats are removed. It involves Review - to regularly monitor
defining the organization's and review in order to ensure
threshold or acceptable risk. Senior effectiveness and identify
management is responsible for any necessary adjustments
determining the acceptable level of and improvements
the residual risk for the organization h. Compliance and Regulations
as well as ensuring that sufficient - all mitigation efforts should
resources are available to mitigate align with relevant
risks deemed above the risk regulations, guidelines, and
tolerance threshold. standards related to biorisk
management.
7. Review and Continual Improvement
(Review)
● Biosecurity Risk Assessment
Report
● The narrative report must include
the following items in
chronological order:
1. Executive Summary
2. Purpose
3. Scope
4. Background
5. Threat Environment
6. Mitigation (cost-benefit analysis) 6. Asset Inventory
● Considerations: 7. Risk Assessment Results
a. Hazard Identification - to 8. Risk Tolerance
identify and understand the 9. Recommendations
hazards associated with 10. Appendix:
biological agent a. Asset Inventory
b. Risk Evaluation - to assess b. Biosecurity Event Table
the likelihood and severity of c. Likelihood Table
potential risk d. Consequence Table
e. Risk Register
f. Schedule
g. Team members