LECTURE 9/ LECTURER: Ms. Mariel Angela N.

Velasquez, RMT, MLS (ASCPi)/TRANSCRIBED BY: ESPINOSA, TAN, & BRANZUELA MT-1F

LABORATORY BIORISK MANAGEMENT ● If something should be

COURSE OUTLINE
1 Recap (Lab Biosafety and Security)
2 Biorisk
3 Working with Biological Materials
4 Laboratory acquired infections
5 3 Primary Components of LBR
LEARNING OBJECTIVES
• Define Biorisk management and determine how it is
related to Biosafety and Biosecurity
• Explain the reasons why Biorisk management is being
practiced
• Provide a real-life scenario that shows importance of
Biorisk management
• Discuss the AMP model
• Identify risk assessment, mitigation and performance
evaluation procedures
I. RECAP ON LAB BIOSAFETY VS LAB
BIOSECURITY
Table 1: Recap
Lab Biosafety
● Contain principles,
technologies and
practices
● Prevent unintentional
release or exposure to
pathogens and toxins
● Main goal: Protect people ●
from dangerous
pathogens
→ Support VS Not support
→ Prioritize VS Not prioritize
→ Implement Vs Not Implement
● Diagrams are a cycle
→ When something is accepted, there should be
follow up, as to maintain its status of being
accepted
→ If it is rejected, there should be mitigation strategies
● Diagram explanation
→ Identify biothreats
▪ By determining the risks
→ Remember: If process is acceptable
▪ Proceed with the work and monitoring controls
→ Remember: If process is not acceptable
▪ Terminate the project
▪ or revise the project
→ Prepare risk control plan
▪ Check still if acceptable or not
→ Implementing control measures
▪ Check still if acceptable or not
→ Reviewing adequacy of plan
▪ Check still if acceptable or not
→ This is a cycle (Lab biorisk management)
Lab Biosecurity
● Institutional and personal
security measures
● Prevents loss, theft,
misuse, diversion, or
intentional release of
pathogens and toxins
Main goal: Protect
pathogens from
dangerous people (ex:
anthrax)

II. LABORATORY BIORISK MANAGEMENT

● Biorisk
→ Application of both biosafety and biosecurity Fig. Biorisk management Diagram
● Integration of biosafety and biosecurity
→ to manage risks when working with biological toxins B. IMPORTANCE OF BIORISK MANAGEMENT
and infectious agents
● System or process to control safety and security risks ● Is a way for science to show we care for the future
associated ● To conform to prudent biosafety/biosecurity practices
→ with the handling or storage; ● Expand the research community's awareness of the
→ and disposal of biological agents and toxins in the importance of biological safety
laboratories and facilities → In the conduct of good science through effective
● Defined according to the World Health Organization
communication
(WHO) as
→ “The analysis of ways and development of → Every new discovery must be credited well,
strategies to minimize the likelihood of the meaning there is communication between
occurrence of biorisks” researchers
● To prevent employees and their families from acquiring
A. BIORISK MANAGEMENT AS SYSTEM/PROCESS laboratory-associated (Nosocomial) infectious diseases
→ Nosocomial diseases - hospital acquired
● It deals with decisions
diseases
 ● To prevent contamination of the environment and promote
environmental quality
● To comply with all the applicable National, International,
and Local guidelines and regulations
→ for the use of biohazards
● Prevent loss, theft, or misuse of microorganisms,
biological materials, and research-related information
→ Only belongs to researchers
● Protect proprietary materials and information
● Protect the reputation and mission of the institute
● Enhance emergency preparedness and response
● Added info
→ Pathogens and toxins have been used even in the
recent past to
▪ Threaten and harm people
▪ Disrupt society, economies, and political status
quo
→ Because of those
▪ They show no regard for ethical values
▪ Do not respect the right of people to safe and
peaceful life
▪ Do not recognize global treaties and
conventions
→ Several regulatory approaches are made
▪ To limit unauthorized access to biological
agents and toxins available in biological
laboratories
▪ They are now carefully considered and
implemented worldwide
Real Life Scenario (SARS)
● AKA Severe Acute Respiratory Syndrome (SARS)
● A talk in the whole world on 2003
● Case (SEPTEMBER 2003)
→ 27 year old
→ Microbiology graduate student
→ Singapore
→ Working with a non-attenuated strain of West Nile
virus
▪ In Level 3 BSL 3
▪ Evaluated for flu like symptoms
Non-attenuated ● Not weakened or strained
Level 3 BSL ● Since virus is really contagious
→ Patient denied any exposure to SARS
→ Had no travel history
▪ Quite understandable since symptoms for
these viruses are indistinguishable early on
→ Inappropriate lab procedures and cross
contamination of
▪ West nile virus and SARS-CoV
→ Big difference from 2
▪ Coughing and difficulty in breathing does not
come with west nile
→ Was discharge in emergency department
▪ But returned 5 days later because of persistent
fever
→ Because Singapore remained in a heightened state
of alert for SARS at 2003
▪ PCR was performed with the sputum
specimen
▪ And return a positive result for SARS
→ Additional epidemiologic investigation revealed that
▪ Laboratory where he worked was also involved
in research on SARS-coronavirus
▪ One of the cell cultures of West Nile virus was
contaminated with the same infecting strain of
sars coronavirus
→ Although this represent an exceptional event
▪ Serves to highlight the inherent risk posed to
laboratory workers by virtue of their occupation
● DECEMBER 2003
→ Male laboratory scientist
→ Working in Level 4 BSL
▪ Identified to have contracted the virus
→ Happened when manually disinfecting a spillage
▪ He may not have practice precautionary
measures
▪ May not have worn a mask and gloves while
doing so
▪ Resulting to him testing positive for SARS
● MARCH 25, 2004
→ Female research student was admitted
→ A’s mother (died)
→ Nursing attending A
→ C’s mother
→ C’ aunt
→ C’ father
→ Retired doctor sharing hospital room with C
→ G’s daughter in-law
APRIL 17, 2004
→ Male laboratory Researcher
→ Female Labworker in BSL3
→ Female Labworker developed pneumonia
→ Male lab worker (A’s supervisor)
● Economic consequences and scientific concerns resulting
from the laboratory acquired SARS-CoV infection in
Singapore, Taipei, and Beijing
→ Not only raised biosafety awareness
→ Also, promoted review by the concerned scientific
community and national regulatory bodies
● These incidents triggered the improvement of national
biosafety policies
Real Life Scenario (COVID-19)
● Work related infections of health workers from news
● Contributing factor
→ Relaxed biorisk management
● As part of medical field
→ Follow correct procedures as to not harm others
and ourselves
III. WORKING WITH BIOLOGICAL MATERIALS
A. RISKS INCLUDE:
1. Accidental infection
● E.g accidental contraction of biothreat UN through an
exposure
● 2001 anthrax attacks proved infectious agents and toxins
can be misused to intentionally harm individuals and
populations
 ● Anthrax attack
→ Several people in US received mail in envelope
→ No content but inside those were spores of anthrax
→ A lot of them contracted anthracis (disease)
→ A lot died
→ Bioterrorism is a real threat
2. Accidental release of toxic chemicals
3. Intentional theft and/or misuse
4. Physical injuries
● E.g accidental needle stick injuries from sharps, animal
bites, slips or falls, burns, and ergonomic injuries
(repetitive strain, prolonged exposure to abnormal
temperatures or vibrations, prolonged awkward positions)

● Where does work with biological materials occur

1. Laboratories
2. Hospital Fig. Most frequent laboratory acquired infections (LAI’s)
3. Field work
4. Transport/ shipping B. MOST FREQUENT LAI’s
5. Practically everywhere
1. Brucellosis (Brucella spp.)
● Risks are unpredictable and practically everywhere
● Minimize risks
● Has reported that it is the most important LAIs.
→ By implementing biorisk management
● One of the Top 10 Laboratory-Acquired Bacterial
Infections
IV. LABORATORY ACQUIRED INFECTIONS ● Caused by a group of bacteria from the genus and brucella
→ Which belongs to risk group level 3.
● Laboratories are used for ● These bacteria infect both humans and animals.
→ clinical medicine ● So, brucellosis is often spread when people eat
→ research and development of pharmaceutical contaminated food which can include raw meat and
products pasteurized milk
→ diagnosis of diseases ● Bacteria can spread through air contact with an open
→ confirmation of biological findings wound
● Laboratory workers frequently become infected through ● But in laboratory required brucellosis it is not always
unexpected modes of transmission associated with occupational accident
● This was illustrated by the first laboratory acquired case of → but due to direct contact and contamination of skin,
Severe Acute Respiratory Syndrome SARS splashing in mucous membrane, conjunctiva or
→ which occurred 4 months after the end of the SARS needle stick injuries
epidemic ● Outbreaks have been mainly associated with
● Lab infections due to variety of bacteria, viruses, ricochet, → improper use of biological safety cabinets or UPSC;
fungi, and parasites and
→ Have been describe in different literature → deficient recognition of brucellosis species
→ Their symptoms are often general. Not easy to
Table: Laboratory Acquired Infections recognize if the patient has this infection.
20% = Causative of Defined Top 4 Accidents Resulting in
Event Infection 2. Hepatitis (HAV, HBV, HCV)
• 80% Human Factors • Spillages & splashes
• 20% Equipment failure • Needle & syringe ● The most frequent laboratory-acquired infections
• Sharp objects & broken ● These bloodborne viruses are more likely to infect people
glass working in serology or hematology laboratories
• Bite or scratch from → Rather than microbiologists
animals or ectoparasites ● Hepatitis B has been responsible for the most known LAIs
● Since the vaccine has been available A & B the number
laboratory acquired hepatitis significantly decreased
● Accidents cannot be full prevented, unless you do: ● Interns are required to get vaccinated in Hepatitis B
→ Regular management of system → Because it is common in Laboratory to have needle
→ Correct processes used stick injuries
→ Regular check ups → This serves as prophylaxis or preventive measure
→ Regular maintenance to have Hepatitis B.
● In laboratories, there are tasks that involved numerous 3. Psittacosis (Chlamydia psittaci)
risks for laboratory staff
→ Thus, any accident associated with a given ● From a group of birds known as cystines (parrots)
microbiological hazard is most likely to happen in ● Infections of man from birds
the microbiology lab ● Do not frequently occur, but not so uncommon in LAI.
● Chlamydia psittaci is a type of bacteria that often infects
birds
● Less commonly, these bacteria can infect people and
cause a disease called psittacosis.
 ● Psittacosis
→ can cause mild illness or pneumonia or lung
infection
4. Q Fever (Coxiella burnetii)
● Most reports concerning laboratory Q fever are from the
1950s
→ where the most cases of LAIs were observed
among members of the US armed forces after the
Second World War
● Despite its high infectivity
→ Only second place in the Top 10 LAI’s nowadays
● Most commonly found in cattle, sheep, goats around the
world.
● Humans typically get Q Fever when they breathe the dust
that was contaminated with the infected animals.
C. PREVENTION OF INFECTION FROM LAIs
● To control the ambient conditions and procedures that are
practiced by the staff in manipulation of these organisms
● They should be in accordance with biosafety and
biosecurity rules
→ to avoid potentially dissemination in the
environment (the bacteria and viruses)
● Identify and characterize the potential hazard related with
the manipulation techniques or research
→ Which the risks are still unknown
● Avoid occupational infections
→ Know which things you should do and not do
● Knowledge of the application of correct microbiological
procedures and techniques, and the use of containment
devices, facilities, and protective barriers
→ Very necessary when working in a laboratory

5. Tuberculosis (Mycobacterium Tuberculosis) IV. LABORATORY ACQUIRED INFECTIONS

● Very common A. AMP MODEL
● Mycobacterium Tuberculosis
→ Disease causing bacteria ● Like a 3-legged stool, a Biorisk management system fails
● These bacteria usually attack the lungs, if one of the three components is overlooked or if not
→ but they can also damage the other parts of the addressed
body. ● In contrast to other risk management model, which is
● Tuberculosis is not only people coughing blood typically focused on mitigation measures
→ Sometimes the bacteria travel to other parts of the → AMP focuses on all components with equal
body. attention
→ Systemic tuberculosis is acquired when that
happens
● Generation of aerosols
→ The greatest risk of LAI for laboratory personnel
who handle M Tuberculosis
● Spreads through air when a person coughs, sneezes, or
talks.
● M. Tuberculosis is one of the most important life-
threatening bacterial diseases and remains a well
characterized hazard to diagnostic laboratories
● To avoid M Tuberculosis
→ Mycobacteria must be handled in Class 2 or Class
3 Biosafety Cabinets
● Sputum
→ What you examine in the lab if there is tuberculosis Fig. AMP Model
bacteria in the specimen and is placed in a slide,
coil the sputum and stain to see if there is a TB Assessment Mitigation Performance
bacteria What are the How can I reduce How can I confirm
→ Since this is coiled, possible inhalation the bacteria risks? the level of risk? that I have actually
so this is processed in a BSC reduced the level of
● In Laboratory the risk?
→ Treat every specimen, as potentially infectious
● Risk identification
6. Tularemia (Fransisella Tularensis) Assessment ● Hazard/threat identification
● Likelihood evaluation
● AKA Rabbit fever, Deer fly fever ● Consequences evaluation
● Rare infectious disease that can attack your skin, lung,
eyes and lymph nodes ● Elimination or substitution
● Fransisella tularensis Mitigation ● Engineering controls
→ High infectivity via aerosols ● Administrative controls
→ Severity in disease in humans ● Practices and procedures
● LIA’s by this bacteria have been reported in literatures ● Personal protective equipment
→ Are more frequently associated with cultures than ● Control
with clinical materials or infected animals Performance ● Assurance
● Since antibiotic therapy treatment presents some adverse ● Improvement
effects
→ Combination of vaccination and correct biosafety
measures have been referred to as the most
valuable control tool
 B. RISK ASSESSMENT ● Other considerations:
→ Ability of an infectious agent or toxin to cause
● Risk disease
→ combination of the likelihood of the occurrence of a → Way in which the infectious agent or toxin causes
harm and the severity of that harm disease
→ The likelihood that a hazard will actually cause its → Activities performed in the laboratory
adverse effects, together with a measure of the → Safety equipment and design elements present in
effect the laboratory
→ Combination of both harm and likelihood → Health and training of the laboratory worker
→ A two-part concept and you have both parts to
make sense of it ● Risk group levels do not always correspond to
→ Likelihood can be expressed as: biosafety levels
▪ Probabilities (1 in 1000) → E.g. specific research projects biological risk
▪ Frequencies (900 cases per year) assessment with the use of Human
▪ Qualitative (negligible or significant) Immunodeficiency Virus (HIV)
● Likelihood → This is a risk group's reagent and correctly
→ The chance of something happening determines the HIV can be handled in biosafety
level 2.
Example of Risk Assessment
● The annual risk of a worker in Great Britain Table: Biosafety levels
1 experiencing a fatal accident at work is less than Level Definitions
one in 100,000 ● Lowest risk
1 ● No or low individual and community risk
● About 1500 workers each year in Great Britain ● Microorganism unlikely to cause human or
2 suffer a non-fatal major injury from contact with animal disease
moving machinery. ● Moderate individual risk, Low community risk
● Pathogens can cause human or animal
disease but
● The lifetime risk of an employee developing
→ Unlikely to be a serious hazard to
3 asthma from exposure to substance X is
2 laboratory workers, community,
significant
livestock, etc
● Laboratory exposures may cause serious
● Legend infection but effective treatment and
→ Hazard preventive measures are available
→ Effect → Risk of spreading infection is limited
→ Likelihood
● High individual risk, low community risk
(opposite of 2)
● Factors that influence the degree or likelihood of risk
3 ● Pathogens cause serious disease
→ Nature of exposure
→ But it doesn't spread from one infected
▪ How much the person is exposed to hazardous
individual to another.
thing/ condition
4 ● Highest risk
▪ E.g Several times a day, Once a year
● High individual and community risk
→ How the person is exposed
● Pathogens cause serious disease in both
▪ Breathing and vapor would take faster
humans and animals
compared to skin contact
→ and can be readily transmitted from
→ Severity of effect
one individual to another, directly or
▪ One substance may cause skin cancer while
indirectly
another may cause skin irritation only
● Effective treatment and measures are not
→ Defined as “Process of identifying the hazards and
usually available
evaluating risks associated with biological agents
and toxins, taking into account the adequacy of any
existing controls, and deciding whether or not the Biological Hazard Biological Risk
risks are acceptable” ● Relates to intrinsic ● Likelihood that a
▪ Method of looking at our work activities characteristics of the biological agent will
considering what could go wrong, deciding on agents cause harm under certain
control measures, or to prevent the loss or ● Independent from the circumstances
damage or injury in workplace environment or ● Combination of
▪ Continuous improvement cycle which can be conditions of use probability of occurrence
implemented in management process and the ● Biological agent may and the severity of harm
company constitute as the hazard ● Relates to the
→ THE HARM environment and
C. RISK GROUPS conditions of use
● Working with biological
● Classifications agent poses as a risk
→ Describe the relative hazard posed by infectious → LIKELIHOOD +
agents or toxins in the laboratory HARM
● Primary Consideration
→ Used in a biological risk assessment to determine
the appropriate biosafety level
 D. MITIGATION
● actions and control measures that are put into place to
reduce or eliminate the risks associated with biological
agents and toxins”
Fig. Hierarchy of Controls
● Risk should be avoided and eliminated and if not
possible, must be reduced by taking preventive
measures
→ In order of priority (aka hierarchy of control- used
in all times when implementing controls)
● Inverted pyramid: Those at the top are potentially more
effective and protective than those at the bottom
1. Elimination
● Physically remove the hazard
● Total removal of the hazards
→ Effectively making all the identified and possible
accidents in health impossible
● A permanent solution
→ should be attempted at first instance
● If the hazard is removed
→ all the other management controls will no longer
be required
● Risk is reduced to 0 without shifting it elsewhere (Top of
the hierarchy)
2. Substitution
● Replace the hazard with lesser hazard
● Replacing the hazard by one that presents a lower risk
→ Immediately combined with shift to another but a
much lower risk
● With chemicals, substitution with a safer form of the same
chemical is a safer option
→ If products cannot be changed, find ways to make
the product less hazardous
→ Eg. substitute the same chemical but in a safer form
(if you cannot change the chemical, use pellets
instead of powder because airborne dust can be
hazardous)
→ Purchase those with larger particle size; Larger
products can substitute smaller products (eg. use
of acrylic instead of lead based paint)
● The new product must not produce another hazard
Both elimination and substitution
● Tend to be the most difficult to implement in an existing
process
● Because you either change everything or a part of that
thing
If the process is still at design/development stage
● They may be both inexpensive and simple to implement
● Hence, they are the highest in the hierarchy of control
3. Engineering Controls
● Do not eliminate hazards but rather
→ Isolate workers from the hazard
● Physical means that limit the hazard
● Structural changes
● Erecting a barrier
● Eg. Local exhaust ventilation
→ Control risk from dust and fumes
● Enclosing or guarding dangerous items of
machinery/equipment
● Cost is higher than administrative and PPE at first
→ But over long term, it becomes lower
→ Provides cost saving in other areas of the process
4. Administrative Controls
● Change the way the work is performed
● Aka Organizational measures
● Reduce or eliminate exposure to a hazard
→ by adherence to established procedures or
instructions
● Includes: Job Scheduling, Posting Hazard Signs,
Restricting access, Training
● Documentation
5. PPE
● Protect the worker with personal protective equipment
● Should used only as last resort since least effective
● Devices worn by the worker to protect against hazards
● Includes: gloves, respirators, hard hats, safety glasses,
high visibility, and safety footwear
Is it possible to use more than one control?
● YES
● Many times you can completely control hazards by using
just one of the controls
● In most situations, the actual method for controlling the
risk is a combination of options in the hierarchy
→ For example, the use of substitution to remove a
very hazardous chemical with the last hazardous
chemical
→ But it may still be necessary to create
administrative controls that limit the type of work
or is near the chemical
→ Even then it may be necessary to provide the
worker with PPEs
Quick summary of the hierarchy

● As you go down the hierarchy, the controls become

→ Less reliable
→ More costly
→ More work to ensure they are maintained

E. PERFORMANCE

● “Implementation of the entire biorisk management system,

including evaluating and ensuring that the system is
working with the way it was designed; the process of
continually improving the system”

● Process of improving biorisk management by

→ Recording
→ Measuring
→ And evaluating organizational actions and
outcomes to reduce biorisk
● If your system works, CONTROL
● If your system is sustainable, ASSURE THAT IT IS
● If the risk is accessible, IMPROVE THE WORK
ENVIRONMENT

1. Control

● Done through
→ Validation/verification, QC, proficiency testing,
Specimen management
● Procedures undertaken by the laboratory staff
→ For the continuous and immediate monitoring of
laboratory work
→ In order to decide whether the results are reliable
enough to be released.

2. Assurance

● Done through checking

→ Audits and Inspections
● Includes the internal QC, External QA, preanalytical
phase, test standardization, post analytical phase,
performance evaluations, management and organization

3. Improvement

● Setting and achieving management goals

→ based on internal and external feedback
● Continuous cycle and an ongoing process
→ Between different measures