Laboratory

Biorisk Mitigation Strategies

PASMETH-PhBBA WORKSHOP

JOY POTENCIANO-CALAYO, RMT, MSC, CBO

*Member, Technical Working Group
National Standards on Laboratory Biosafety & Biosecurity, Department of Health
*President, Philippine Biosafety & Biosecurity Association (PhBBA)
*Chief Medical Technologist-Central Laboratory, San Lazaro Hospital
*Senior Lecturer, Graduate School, Trinity University of Asia
 Thinking out loud

This talk not only serves to teach our teachers

what to teach our students about biosafety,
biosecurity, biorisk management…
but also serves as an advocacy of the
organization and all the persons who come
together with the aim to instill biosafety and
biosecurity in both theory and practice towards
sustainability.
Outline
• Reference materials used for this lecture
• Why need biorisk management: Real-life scenarios
• Differentiating between lab biosafety and lab
biosecurity
• Lab Biorisk Management (BRM): definition and
components
• Management role in BRM; factors influencing
management decisions
Outline
• Review of Risk Assessment (RA) with examples
• Review of the AMP Model
• Self-test/exercise
• Risk Mitigation controls/measures
• Implementing mitigation controls: advantages,
disadvantages
• Points to consider in selecting the mitigation measure
• The “WOW” effect
• RA + Mitigation: knowing the impact
• Promoting a culture of safety: proposed solutions,
examples and challenges
• Take home messages
 REFERENCE MATERIALS:
BIOSAFETY/BIORISK MANAGEMENT
WHO Biosafety Guidelines (2004) but no international standards
- Difficult to develop a national standard or guidelines
- Is physical protection enough to ensure safety? (are the other
social elements relevant to the issue?)

Laboratory Biorisk Management Standard (CWA-15793:2008)

- “ The CWA 15793:2008 is the first internationally recognized
management standard to specifically address hazards associated
with microbiological laboratories at all containment levels.”

- “The standard “also provides a structured approach to managing

risk associated with people, facilities and working procedures in
laboratory environments.”
WHY BIORISK MANAGEMENT?
(BRM)

BIOSAFETY + BIOSECURITY= BIORISK

ATM… (in the year 2003)
Severe Acute Respiratory Syndrome (SARS)

Laboratory acquired SARS

outbreaks

Singapore – September
2003

2003 – infected over 8,000 Taiwan – December 2003

people and killed almost 800
Mainland China (Beijing
and Anhui) – March 2004
Who got infected, where and how?
Who Where How
Singapore Male graduate BSL3 lab, Inappropriate lab procedures
student Environmental and cross-contamination of
Health Institute West Nile virus with SARS CoV

Taiwan Male lab BSL4 lab, Inst. Of Was working on SARS CoV.
scientist Preventive Found a spillage of material
Medicine, disinfected with 70% ethanol
National and cleaned manually
Defense Medical
Center (+) SARS - Environmental
samples from handle of alcohol
spray bottle and switch panel of
cabinet
*The source of the outbreak was failed or incomplete inactivation of SARS-CoV (cold inactivation).
The risk associated with biological materials in the
laboratory has a safety and a security component
Laboratory biosafety: containment principles,
technologies, and practices implemented to prevent
unintentional exposure to pathogens and toxins, or
their unintentional release

PROTECTING PEOPLE FROM DANGEROUS

PATHOGENS

Laboratory biosecurity: institutional and personal

security measures designed to prevent the loss, theft,
misuse, diversion, or intentional release of pathogens
and toxins

PROTECTING PATHOGENS FROM DANGEROUS

PEOPLE
Laboratory biosafety manual, Third edition (World Health Organization, 2004)
Laboratory Biorisk Management

System or process to control safety and security

risks associated with the handling or storage and
disposal of biological agents and toxins in
laboratories and facilities
COMPONENTS OF A BIORISK MANAGEMENT PROGRAM
 Role of Managers in BRM

Conduct judicious evaluation of risks, selecting

which mitigation measures will be employed

Arrive at a decision
outcome (good or bad)
 Identify
BIO-threats
Biosecurity Threats

Determine Biosecurity
Determine risks
Risks “MANAGEMENT”
Proceed with
work,
is all about
YES
monitor
Acceptable controls
decisions !
?
Terminate
NO
project
• Support VS Not Support
“Prepare” Biosecurity
Prepare
Revise • Prioritize VS Not Prioritize
Project
Risk
RiskControl
ControlPlan
Plan • Implement VS Not implement

Implement Control
Measures

Review adequacy of Plan

Fig. 1 Laboratory Biosecurity
BIorisk Risk Management
 INFLUENCES TO
MANAGEMENT DECISION
• Perception of Risk
– ( Risk Tolerant VS Risk Averse)
influenced by:
– Financial
– Political
HUMAN FACTORS
– Cultural
– Communication
– Geography
REVIEW OF RISK ASSESSMENT
 Risk assessment questions
Pathogen
• Risk group? ROT/MOT?
• Agent stability and ID50?
• Concentration?
• Availability of effective prophylaxis or therapy? Antibiotic
resistance?
• PSDS/MSDS (Public Health Agency of Canada Association or
ABSA)
Procedures
• Type of laboratory procedures?
Personnel
• Skill level and vulnerability of at-risk personnel?
Personnel protective equipment
• Appropriate combination of personal protective clothing and
safety equipment?
Place
• Appropriate facility and equipment for work to be done?
RISK ASSESSMENT
• Involves team work
• identify all the risks : 5Ps
Pathogen
Procedures
Personnel
PE
Place
RISK ASSESSMENT

• identify the specific hazard or threat

• determine the consequences of an identified
risk
• identify all the existing controls and any
additional ones that need to be applied
Hazard, Threat, and Risk

A hazard is an object that can cause harm

A threat is a person who has intent and/or

ability to cause harm to other people,
animals, or the institution

A risk can be based on either a hazard and/or

a threat
Risk, Likelihood, and Consequences

Risk is the likelihood of an event/incident with

a hazard that has consequences
Time X
Incident
Likelihood Consequences

Likelihood is the probability an event occurring

Consequence is the severity of an event

Determining likelihood of an event
matrix no. 1

LEVEL DESCRIPTOR LIKELIHOOD – DESCRIPTION

1 Rare May occur only in exceptional

circumstances
2 Unlikely Could occur at some time
3 Possible Might occur at some time
4 Likely Will probably occur in most
circumstances
5 Almost Certain Expected to occur in most
circumstances
Assessing consequences (matrix no. 2)

LEVEL DESCRIPTOR CONSEQUENCE – DESCRIPTION

1 Insignificant No injuries, low financial loss

2 Minor First aid treatment, on site release
immediately contained
3 Moderate Medical treatment required, on site
release contained with outside assistance,
high financial loss
4 Major Extensive injuries, loss of production
capability, off site release with no
detrimental effects, major financial loss
5 Catastrophic Death, toxic release off site with
detrimental effect, huge financial loss
LIKELIHOOD CONSEQUENCES

Insignificant Minor Moderate Major Catastrophic

(1) (2) (3) (4) (5)

(5) Almost M M H H H
Certain

(4) Likely M M M H H

(3) Possible L M M H H

(2) Unlikely L L M M H

(1) Rare L L M M H

H High risk immediate action required

M Moderate risk; management responsibility must be specified
L Low risk; manage by routine procedures
Acknowledgement: This model was created by Tony DellaPorta for the WHO
EXAMPLE OF RA (only)
RISK ASSESSMENT
HAZARD RISK CONSEQUENCE
RISK ASSESSMENT

HAZARD RISK CONSEQUENCE

RISK ASSESSMENT
HAZARD RISK CONSEQUENCE
RISK ASSESSMENT
HAZARD RISK CONSEQUENCE

Aerosol spread from

open flame.

Bunsen burner in a BSC

 RISK ANALYSIS
HAZARD RISK CONSEQUENCE
No SOPs. Work outside
BSC. No mask. No face
shield. No vaccines.

LIKELIHOOD CONSEQUENCES
Insignificant Minor Moderate Major Catastrophic
(1) (2) (3) (4) (5)
(5) Almost M M H H H
Certain
(4) Likely M M M H H
(3) Possible L M M H H
(2) Unlikely L L M M H
(1) Rare L L M M
Lab Procedures That Can Produce Aerosols

• Pipetting • Sonic Disruption

• Opening Lyophilized Cultures
• Mixing
• Flaming bacteriologic loops
• Shaking
• Opening vessels at non-ambient
• Centrifugation pressures, fermenters, freezer vials
• Grinding • Changing animal bedding
• Blending • Homogenizers
• Vortexing
• Pouring
• Loading syringes WHICH PROCEDURES ARE
• Harvesting tissue, eggs YOU DOING IN YOUR LABS?
• Lasers, cell sorters
• Injecting /intranasal innoculation of
animals
The AMP Model of
Laboratory Biorisk Management

AssessmentBiorisk
, Mitigation, Performance
Management =
Assessment + Mitigation + Performance
 BIORISK MANAGEMENT = AMP

Assessment Mitigation Performance

Elimination or substitution
Risk identification
Engineering controls Control
Hazard/threat identification
Administrative controls Assurance
Likelihood evaluation
Practices and procedures Improvement
Consequences evaluation
Personal protective equipment
 EXERCISE: In your own quiet spot,
decide which items should go together
Biosafety cabinet Chemical fume hood
Petridish Using forceps to pick up sharps
N96 mask Handwashing posters
ATCC 25922 (Escherichia coli) Reporting injuries/accidents
No eating policy in the lab Negative pressure lab
HEPA filter installed in the lab Creation of biosafety committee
Use of absorbent pads for spills Training of personnel
Lab gown Using aerosol-free pipettors
Ante-room Installing biohazard signage
Using bactecinerator Waste segregation policy
Automated plate streaker Decontaminating work surfaces
Double-gloving Autoclaving
Do not work at all Giving awards to persons with best practices
E S En A P PPE
DO NOT ATCC *BSC *Creation of *Using N95 mask
WORK AT ALL 25922 *Chemical fume Biosafety bactecinerator Lab gown
hood committee *Use of aerosol-
*Petridish *Training free pipettors
*Anteroom *Handwashing *Using forceps
*HEPA filter installed posters to pick up
in the lab *Installing sharps
*Neg pressure biohazard *Decon of work
lab/room signage surfaces
*Automated plate *Reporting *Autoclaving
streaker accidents/injuri *Double-gloving
es *Use of
*No eating absorbent pads
policy for spills
*Waste
segregation
policy
*Giving
incentives to
employees for
best safety
practices
 RISK MITIGATION
CONTROL MEASURES
Elimination Removing the risk

Substitution Substitution of a serious pathogen with

one this is much less pathogenic
Controls: Physical changes to work stations,
Engineering equipment, materials, production
facilities, or any other relevant aspect of
the work environment that reduce or
prevent exposure to hazards
Administrative Policies, standards and guidelines

Practices and Procedures Processes and activities

PPE Devices worn by the worker to protect

against hazards
 Implementing Mitigation Measures

Ideally, you should first consider elimination or

substitution

A combination of control measures should be

used based on their effectiveness and your
ability to implement them
UNDERSTANDING MITIGATION CONTROLS:
Car safety vs. motorcycle safety

Engineering control vs. use of PPE

 Advantages/Disadvantages
Control Measures* Advantages Disadvantages
Engineering Efficient, eliminates hazard Cost, complexity
Significantly reduces the
potential and the level of
exposure to pathogens.
Administrative Authority approach Indirect approach,
addresses the human
factor
Practices and SOP based (standardized Training and supervision
Procedures approach) requirements

PPE Ease of use, relative cost Does not eliminate hazard:

if PPE fails exposure
happens, uncomfortable,
limits ability

* A combination of different measures is needed to be effective

 RISK MITIGATION
PERSONAL PROTECTIVE EQUIPMENT (PPE)
• Last control in the hierarchy of controls
• Should be used with other controls.
• However, in many laboratories it is the first control
implemented, and sometimes the only control

• Eye protection
• Gloves
• Face shields
• Hair nets
• Ear plugs (when sonicating)
• Protective clothing (gowns)
• Footwear
• Respiratory Protection
 Points to consider

• Breaking the chain to manage the risk

• Pathogen: substitute a non pathogen (avirulent
strain)
• Reservoir of pathogen: eliminate reservoir (treat
cooling tower for algae, Legionella)
• Portal of escape: prevent splashes, aerosols
• Transmission: sharps precautions
• Route of entry/infectious dose: block with PPE; use in
low concentration/volume
• Susceptible host: immunize, enhance immune system
 Remember: “Acceptable Risk”

The "Wow" Effect

• A robust methodological approach to risk

mitigation gives you the ability to:
• Justify decisions
• Evaluate the impact of certain risk mitigation
decisions
• Compare the cost effectiveness of various risk
mitigation decisions
EXAMPLE OF RA + MITIGATION
 RISK ANALYSIS
HAZARD RISK CONSEQUENCE
SOPs in place and
complied with. Work
inside BSC. PPE used.

LIKELIHOOD CONSEQUENCES
Insignificant Minor Moderate Major Catastrophic
(1) (2) (3) (4) (5)
(5) Almost M M H H H
Certain
(4) Likely M M M H H
(3) Possible L M M H H
(2) Unlikely L L M M H
(1) Rare L L M M H
 RISK ANALYSIS
HAZARD RISK CONSEQUENCE
Access to labs SOP-Buddy system, Another Amerithrax
pathogen inventory.

LIKELIHOOD CONSEQUENCES
Insignificant Minor Moderate Major Catastrophic
(1) (2) (3) (4) (5)
(5) Almost M M H H H
Certain
(4) Likely M M M H H
(3) Possible L M M H H
(2) Unlikely L L M M H
(1) Rare L L M M
 Proposal for Solution!

PLANT
BIOSAFETY CULTURE !
• BioSafety CULTURE by organic and systemic
operation & management.
• Thus, it requires multilateral approaches to
- Executive
- BioSafety Manager
- End-user (Researcher)
 Planting BioSafety culture
in Executive
• Why required ?
: Impossible to build & manage BSL-2/3 without
continuous financial support from institute
based on deep understanding what BioSafety is for.

Because BSL-3 /high containment Lab facilities means….

- Construction of building & facility
- Purchasing equipment like BSCs, Autoclave etc.
- Validation & Maintenance of Equip. & Facility
- Education & Training cost
- Running cost
- Reorganizing or newly preparing internal organization & regulations
- Closing BSL- 3 experiment periodically for revalidation
 How to plant BioSafety in Executive?

• By Laws & Regulations

• By Deep understanding of BioSafety

• Encouraging the institute or company equipping

BSL-2/3 facility and good BioSafety system by
government
Ex.1 Giving merits on research grant application
Ex.2 Financial or Technical support
• International cooperation etc.
Planting BioSafety culture in Researcher

• Why required?
: Meaningless for BSL-2/3 facility without end-users’
practical compliance with BioSafety system
based on deep understanding what BioSafety is for.
Researcher can have…
- Less priority for BioSafety than Research
- Too much confidence
→ Ignore BioSafety regulations
- Too much fear
→ Lose confidence of working @ BSL-3
- Too many worries about punishment from supervisor
→ Hide accident, incident & doubtful cases
 How to Plant it in Researcher?
:By Training
• Providing BioSafety Training
- To Principle Investigators
- To IBC members
• Inviting BioSafety Trainer /Consultant
• Visual education (DVD)
• BioSafety open lecture
• BSL-3 specific training
- Theoretical training
- Practical training
- Emergency training including spill clean up, evacuation
thrill, fire etc.
 How to Plant it in Researcher?
:By Good Communication
• Prepare various communication routes
- BSL-3 Specific website or intranet
- E-mail
- Poster & Notice board : frequent exposure
- Face to face : Listen to voice from field!

• Induce researchers’ interest

- Simple & Clear contents
- Utilize Photo, Safety Sign & Color
- Fun approach
 How to Plant BioSafety culture to
Researcher?
APPROACH with SCIENTIFIC LOGIC!

PUNISHMENT is NOT SOLUTION !

OPEN TRANSPARENT/ COMMUNICATION!

BUILD UP TRUST RELATIONSHIP!

SIMPLE, CLEAR & INTERESTING APPROACH!

The shared commitment of management &
employees to ensure the safety of work
environment.

It encourages every individual in an org. to

project a level of awareness and accountability
for safety.

A culture of safety permeates all

aspects of work environment
 this serve to communicate the org. commitment to safety

Action taken by management to improve safety.

Worker’s participations in Safety Planning

Availability of written safety guidelines and policies.

Availability of appropriate safety devices and protective
equipment

Influence of group norms regarding acceptable safety

practices; and
Socialization processes around safety that personnel experience
when they first join an organization
:
 Include safety related • Eg. zero tolerance for unsafe
statements in org. conditions and practices in the
missions,visions, values health care environment.
goals, & objectives

Give high priority & visibility to

• Eg. occupational health, infections
safety committees, teams &
control, quality assurance, pharmacy,
work groups; ensure direct mgt
and therapeutics and waste care
involvement in evaluation of
management;
com process and impact

Require action plans for • Eg. action plan for improving culture of
safety in ongoing planning safety for sharps injury prevention
processes; modelling safe could be one element in an overall
attitudes & practices safety culture initiative.
Example 1. Safety label/sign
Example 2. Photo
Example 3. Poster & Notice
Example 4. Campaign poster
Example 5. Create Characters
 TAKE HOME LEARNING
• BRM= Assessment, MITIGATION, Performance
• Mitigation decisions is most often the job of
managers/administrators after careful
evaluation and deliberation
• Robust mitigation depends on robust risk
assessment
• However, different factors influence mitigation
decisions
 TAKE HOME LEARNINGS
• There are different mitigation measures to
choose from: elimination, substitution, engineering,
administrative, practices/procedures, PPE
• What works is usually a combination of these
mitigation measures/controls
• No “one size fits all”
 TAKE HOME LEARNING
• “Acceptable risk” depends on the perception
of risk (tolerant or averse)
• Risk perception is multi-factorial
• A sustainable solution: plant biosafety culture
• Culture of safety= permeates all over the
environment
• Culture of safety needs organizational
commitment at all levels
 BE SAFE, BE BIOSAFE
BE SECURE,BE BIOSECURE

REACH ME!
Email: jpcalayo2014@gmail.com
Mobile: 09053667092
Office: 7323777 local 152