OUTLINE
I. Biorisk Assessment
VIII. Robust Risk Assessment
II. Biorisk
A. Risk Acceptance
III. AMP Module
B. Risk Evaluation
A. Hazard
IX. Risk Evaluation
IV. What is a Risk?
A. Risk Distribution
V. Risk as an Equation
X. BioRAM
VI. Multi-Drug Resistant Titan
XI. Summary
Blue (MDR-TB)
XII. References
VII. Risk in the laboratory
XIII. Appendix
OBJECTIVES
1. Understand what risk is.
2. Understand the components of a suitable risk assessment
methodology, and the critical resources required.
3. Become familiar with a biorisk assessment model that addresses
safety and security.
4. Be able to execute a risk assessment with the model.
5. Identify/justify/quantify key risk drivers.
LEGEND
REMEMBER
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3.
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1
SEMESTER
CLINICO-PATHOLOGICAL CONFERENCE & SPECIAL
TOPICS
1.01 BIORISK ASSESSMENT: AMP MODULE
Dr. Edith Tria | 08/26/2022
How do you know that your risk management is working,
and will continue to work?

Risk Evaluation of Performance
III. AMP MODULE
Key Components of Biorisk Management
1. Biorisk Assessment
2. Biorisk Management
3. Biorisk Performance Evaluation
FIGURE 1. Overview of BRM AMP Model
LECTURE
I. BIORISK ASSESSMENT
Laboratory biosafety – containment principles,
technologies, and practices implemented to prevent
unintentional exposure to pathogens and toxins, or their
unintentional release
Laboratory biosecurity – institutional and personal
security measures designed to prevent the loss, theft,
misuse, diversion, or intentional release of pathogens and
toxins
A. GROUP EXERCISE 1
Q: What are the risks of working in a laboratory with
biological materials?
Possible Answers:
o Accidental injury (burns, electrical, chemical, trauma,
and spill accidents
o Infection thru various mode of transmission (needle
prick, inhalation, ingestion, contact thru fomites)
o Near missed incidents that have harmful consequence
(psychological stress, mental illness, trauma)
II. BIORISK
All about the risk associated with biological materials in the
laboratory incorporating biosafety and biosecurity.
Laboratory Biorisk Management Standards
o 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
o International Standard: CWA 15793:2011
A. GROUP EXERCISE 2
Question and Answer:
1. How
do
you
identify
the
risks
in
a
laboratory?

Risk Assessment/Hazard Analysis and Identification of
likelihood of exposure to hazard that has harmful
consequence
2. Which steps do you take to manage these risks?

Risk Mitigation/ Reduction/and Prevention of exposure
to hazard that may cause harmful consequences
POC: DIMAANDAL | GONZALES, MEDIANISTA, TAMAYO
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
A. HAZARD
Hazard is a source that has a potential for causing harm
Hazard is not a risk without a specific environment or
situation.
i. EXERCISE 1
Question and Answer:
1. What affects whether there is an incident with the shark?
Eg. Shark Bite

Factors affecting the likelihood of the exposure incident
with shark: small boat, pirates with one eye, pirate with
one foot, pirate standing on the edge of the boat, birds
to distract pirates, strong winds, strong waves, treasure
box underwater, pirates have the desire to get the
treasure; pirates went deep sea diving
2. How likely is an incident?

Less likely: pirates are a good swimmer; pirates diving
is in full geared suit; shark is fed and not hungry; with
diversion to distract shark

Moderate to happen: playful shark, pirate not an
expert swimmer and in half full swimming/ or diving
geared PPE

Very likely to happen: hungry shark, accident fall or
drowning pirates, no swimming geared PPE, not a
good swimmer.
3. An incident with the shark would be how severe?

Less: scratch injury

Moderate: partial amputations, or deep wound injury

Very severe: death or total amputation, physical and
mental disability – PTSD Post traumatic syndrome
disorder
4. What are the consequences of the incident? Give as any
outcome from exposure to shark.

Consequences: Shark bite, death of pirates, scattered
or loss of treasures; drowning incidents; falling
accidents; quarrel / squabble / disagreement of two
pirates; shark is killed, boats got overturn
ii. GROUP EXERCISE 1, STEP 1
Scenario: A two-year-old child is left alone in a kitchen while
there is boiling water on the stove.
Question and Answer:
1. What could go wrong? List all the possibilities.
1

2.
3.




Possibilities can be anything from injury (from boiling
water, from fire, from gas explosion, from fall of pot)

Kidnapping being alone, boy start to cook, death of the
child (from explosion, fire, electrocution, severe degree
of scald burn)

House will get on fire
Choose the most likely single most important risk for this
scenario.

Scald burn injury
Identify the hazard for that risk.

Hazards: boiling pot, hot stove, being alone, 2-yearold very young child; possible stool or chair nearby;
inquisitive child; light clothing to being naked child.

High volume of water in the pot; high thermostat
temperature of stove; make-up of the kitchen either
wooden or cemented; make-up of the stove either gas
stove, and electrical stove; child may be restrained or
not; the height of the child; gender of the child –boy are
more inquisitive; hungry child
IV. WHAT IS RISK?
Risk is the likelihood of an event with a hazard that has
consequences.
A risk can be defined in several ways, but for our purposes
we could say that risk is the likelihood of an adverse event
of some consequence happening.
Thus, risk is thus a function of the Likelihood a particular
adverse event will occur, and the Consequences of that
event.
R = f (L, C)
TABLE 1. Factors that influence the likelihood and
consequences of the risk
DEGREE OF
RISK
LOW
MODERATE
HIGH
LIKELIHOOD
low volume of
boiling water in
the pot: slight
degree of scald
burn
moderately high
volume of boiling
water: 2nd degree
burn
overflowing
boiling water: 3rd
degree burn
CONSEQUENCE
child
maybe
restrain
loosely or no stool/low
height of child/finger burn
child maybe tall, with
nearby
chair
or
not
restrained/hand burn
child maybe tall, with
nearby chair
or
not
restrained,
inquisitive,
hungry child: 3rd degree
burn of whole body
Low: volume of water, degree of burn, easily reached stove
by the child. pot no cover, child is asleep, child wearing a thick
cloth.
i. HAZARD, THREAT, AND RISK
What would be different if the risk were the child being
injured by an older brother, whose toy had just been broken
by the two-year-old?

What is the hazard (threat) now?
Answer:
The hazard here is the Brother, meaning it’s all
about biosafety, biosecurity if the hazard/threat is now a person.
Sino magiinjure? Yung brother.

What is the difference between a hazard and a threat?
o A hazard is an object that can cause harm
o A threat is a person who has intent and/or ability to
cause harm to other people, animals, or the institution
o A risk can be based on either a hazard and/or a threat
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ii. RISK, LIKELIHOOD, AND CONSEQUENCES
How can we define risk, likelihood, and consequences?
o Risk is the likelihood of an event with a hazard that has
consequences
o Likelihood is the probability an event occurring
o Consequences is the severity of an event
FIGURE 2. Likelihood vs. Consequences


One way to visualize risk is to graph it. Shown on the left is
a 2- dimensional graph, with Likelihood in the y-axis and
Consequences in the x-axis. This graph allows us to fully
determine the risk associated with something by assign
values to both likelihood and consequences.
For example, there are some risks with very low likelihood,
but high consequences and vice versa. To become more
familiar with this concept of risk we will work through the
following example.
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V. RISK AS AN EQUATION
The actual function will depend on the nature of the risk.
Risk graphs do well to exhibit this relationship, as well as
provide a useful tool in biorisk management.
Risk levels equate to specific areas of the graph.
Thus, risk is a function of the likelihood a particular adverse
event will occur, and the consequences of that event.
Formula: R = f (L,C)
A. GROUP EXERCISE 1, STEP 2
Scenario:

Consider again the two-year-old in the kitchen scenario:

Risk: Child being burned by the boiling water

Hazard: Pot of boiling water on the stove
o Identify the factors that influence the likelihood and
consequences of the risk; use post-it notes for each
factor
o Evaluate the risk (low, moderate, high)
FIGURE 3. Risk equation graph
POC: DIMAANDAL | GONZALES, MEDIANISTA, TAMAYO
2
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i. RISK GRAPH I
Risk curves can also be referred to as “isoquants”. An
isoquant has the same (iso-) value (-quant) on every point
of its line.
Previously, when characterizing risk, we used a graph with
risk curves, or “isoquants”, showing the different levels of
risk, from Very High to Very Low
One way to visualize risk is to graph it. Shown on here is a
2-dimensional graph, with likelihood in the y-axis and
consequences in the x-axis. This graph allows us to fully
determine the risk associated with something by assign
values to both likelihood and consequences
iv. RISK GRAPH IV
FIGURE 7. Small amount of cold water in the pan over a hot
stove, step stool next to stove, child not restrained
High likelihood because the child is no restrained with stool
beside the child, but low consequence because only small
amount of cold water.
v. RISK GRAPH V
FIGURE 4. Risk curves
ii. RISK GRAPH II
FIGURE 8. Small amount of cold water over a hot stove, no
step stool, child strapped in a high chair
Very low — low kasi wala naman mainit na tubig at hindi rin
gagalawin.
FIGURE 5. Large amount of boiling water on front of stove,
step stool next to stove, child not restrained
Very high
iii. RISK GRAPH III
FIGURE 6. Large amount of boiling water, no step stool, child
strapped in a high chair
There is high consequence kasi high amount of boiling water,
pero low likelihood kasi the child is strapped, so the answer is
high consequences and low likelihood.
POC: DIMAANDAL | GONZALES, MEDIANISTA, TAMAYO
VI. MULTI-DRUG-RESISTANT TITAN BLUE (MDR-TB)
Scenario B
Multi-Drug-Resistant Titan Blue (MDR-TB)
Summary of Experiment: DSSM, Culture and Sensitivity of
MTB

A laboratory is culturing of MDR-TB for antibiotic
susceptibility testing. MDR-TB isolates are grown and
exposed to a variety of antibiotic drugs to determine
susceptibility.
Agent Criteria:

Infectious Dose: 10 bacilli by inhalation for humans and
animals
Stability:

SUSCEPTIBILITY
TO
DISINFECTANTS:
Greater
resistance to disinfectants and require long contact times
for most disinfectants to be effective; 5% phenol, 1%
sodium hypochlorite (only if low organic matter and longer
contact times), iodine solutions (high concentration of
available
iodine
required),
glutaraldehyde
and
formaldehyde (longer contact time) are effective

PHYSICAL INACTIVATION: Sensitive to moist heat (121°
C for at least 15 min), light

SURVIVAL OUTSIDE HOST: Guinea pig carcasses - 49
days; carpet - up to 70 days; dust - 90 to 120 days;
cockroaches - 40 days; manure 45 days; paper book - 105
days; sputum (cool, dark location) - 6 to 8 months; clothing
- 45 days
3
Incubation Period:

4-12 weeks from infection to primary lesion or significant
titan blue antigen skin reaction. The risk of progressive
pulmonary or extrapulmonary tb is greatest within 1 to 2
years after infection. It may persist for a lifetime as a latent
infection.
Mortality Rate:

50-70% of untreated patients with active pulmonary tb,
within 2 years. Rates are higher for those with concurrent
HIV infection.
Morbidity:

Duration of Illness: as an active disease, 6 months to 2
years. Survival ranges from 1.5 months in immune
compromised HIV patients to 14.3 months in normal
patients with drug susceptible TB.

Severity of Illness: High.
● Duration of Infection: Possibly lifetime.
● Long term effects after infection: Active disease can be
triggered at any time after the establishment of a latent
infection, though the probability of developing active
disease is higher 1-2 years after infection, in immune
compromised patients, small children, young adults, and
the very old.
The morbidity rate in bovines is around 40%. Agent known to
infect other species but is most prevalent in bovines.

Allergen (yes/no): No

Carcinogenic/mutagenic (yes/no): No

Abortogenic (yes/no): No

Toxin Production (yes/no): No

Immune Suppression (yes/no): No

Ability to Mutate in Host or Environment (yes/no): Yes
Infection Mitigation Measures:

For human pathogens
o Immunization: Yes
o Prophylaxis: No (standard TB prophylaxis of isoniazid
is ineffective for MDR-TB)
o Post Infection Treatment: First line TB drugs
isoniazid and rifampin are ineffective for MDR-TB. A
variety of second-line drugs are available to treat MDRTB, usually done so in combination with each other,
though they are less effective than the first line options.
One common combination for suspected MDR-TB
patients includes streptomycin, isoniazid, rifampin,
ethambutol, pyrazinamide, MXF & cycloserine
(Isoniazid and rifampin are maintained due to their
effectiveness against regular TB).
o Existence of Diagnostic tests: Yes. Traditional skin
test or TST, and newer interferon release assays
(IGRA)
Routes of Infection in Humans:

Inhalation: Yes

Contact: No

Vector-Borne: No

Sexual Transmission: No

Vertical Transmission: No
Routes of Infection in Bovine:

Inhalation: Yes

Ingestion: Possible

Percutaneous: No

Contact: No

Vector-Borne: No

Sexual Transmission: No
POC: DIMAANDAL | GONZALES, MEDIANISTA, TAMAYO

Vertical Transmission: No
Communicability:

Human to Human: Yes, though less likely for MDR-TB
compared to normal TB Human to Animal: No Evidence

Animal to Animal: No Evidence

Animal to Human: No Evidence

Multiple Species: Yes.

Where is it present: Worldwide. One third of the world’s
population is infected with TB. MDR-TB is much less
prevalent. However, cases of MDR-TB are rising. It is highly
endemic in the population surrounding the laboratory.

Perception of malicious use: LOW.
Culture:

Sputum from patients suspected of having TB can be
cultured for evidence of TB in several different media, the
most common of which is Lowenstein-Jensen medium.
While not particularly difficult to culture, TB has an
unusually slow growth rate, and it takes 6-8 weeks to grow
enough bacteria for diagnosis and drug susceptibility
testing.
Equipment:

Bench, culture plates, liquid cultures, wire loops, burners,
glass flasks, glass tubes, vortexer..
Lab Environment:
Open window ventilation, lab coats, no vaccination available,
humid environment, surgical masks, gloves worn occasionally,
lab waste is hauled away for offsite treatment, open campus with
no locks on doors, cultures not secured or inventoried, no
personnel verification program.VIII
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VI. RISK IN THE LABORATORY
A. GROUP EXERCISE 2, STEP 1
Consider the first biological scenario (MTB):
Define the risks in this scenario.
How do you assess risk in this set up?
Write down your listing as many as you can answers, in the
meta cards?
i. GUIDE & STUDY QUESTIONS FOR THE SEMINARWORKSHOP
Given the following case scenario:
1. What could go wrong? List all the possibilities.
2. Choose the single most important possibility for this
scenario
3. Identify the factors that may lead to this possibility.
4. What affects whether or not there is an incident with
this TB exposure?
5. How likely is an incident?
6. What are the consequences of the incident?
7. Identify the factors that influence the likelihood and
consequences of that possibility; use post-it notes for
each factor.
8. Evaluate such possibility to happen as low, moderate,
high.
9. What control measures can you do to address/solve
this problem?
10. How will you know whether or not your solutions
worked?
ii. EXERCISE 1
Question:

On what aspect of biorisk did you focus?
Possible Answer:
4
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TABLE 2. Factors to consider in a laboratory biosafety risk
The focus aspects include range of practices and
procedures to ensure the biosecurity, biosafety, and
biocontainment of those infectious agents and toxins.
These also include the full spectrum of safety and security
measures for laboratories, from standard operating
procedures to physical measures to individual practices in
the laboratory.
See Appendix A and B for the risk assessment for MTB scenario
RISK
CHARACTERIZATION
AGENT PROPERTIES
(PATHOGENS)
LABORATORY
INFRASTRUCTURE:
(PLACE)
HUMAN FACTORS
(PEOPLE)
ENVIRONMENT AND
COMMUNITY
FACTORS:
FIGURE 9. Flow Chart for MTB Process
B. GROUP EXERCISE 2, STEP 2
Using the MTB scenario:
1. Choose one (1) risk to assess
2. Define the hazard and/or threat
3. Can you evaluate the risk of this scenario? If so, what
is it (low/moderate/high)?
4. Capture answers on a flip chart and report to the class?
Using the MTB scenario:

What different type of information do you need to do a risk
assessment? List all questions that you think need to be
asked.

Risk Characterization: What factors should be considered
in a laboratory biosafety risk assessment? (What are the
factors that affect Likelihood and/or Consequences)
Categorize the criteria:

Put the questions, or criteria, into four or five general
categories.

Categorize the questions, or criteria, according to
o Likelihood
o Consequences

Which of these criteria are relatively more important than
the others?

How might the result of your risk assessment change using
this process (compared to your earlier method)? • How has
your risk assessment improved? Think about how you
assessed the risk of the two-year-old in the kitchen/ tiger
attack and how you assessed the HIV scenario the first
time.

POC: DIMAANDAL | GONZALES, MEDIANISTA, TAMAYO
OPERATIONAL
FACTORS:
PRACTICES/
PROCEDURES



FACTORS AFFECTING THE RISK
Pathogenicity / Virulence
Infectious Dose
Potential Outcome of Exposure
Morbidity / Mortality
Availability of therapeutic
Interventions
Potential
Routes
of
Infection
Stability of the Agent in the
environment
Heating,
Ventilation,
and
Air
Conditioning
(HVAC)
System
Control
Open Windows
Public Access
Work Surfaces
Workflow
Pest Control
Equipment/ Proper lab supplies
Level
of
Training/Skills/
Competency
Level of Experience
Proper Technique/ Follow SOPS
Proper
work
management/
Workload and Fatigue
Health and Immune Status of the
Workforce
Presence of the Agent in the
Environment
Around
the
Laboratory
Immune Status of the Community
Population
Density
of
the
Community
Presence of Suitable Hosts or
Vector
Good Laboratory Practices
Housekeeping and Cleanliness
Use of Biological Safety Cabinets
Use of Personal
Protective
Equipment
Proper Decontamination
Waste Management
Occupational Health
Other Administrative Controls
VIII. ROBUST RISK ASSESSMENT
What are the benefits of a robust risk assessment?
o Facilitate
a
risk
assessment
process;
repeatable/reproducible
o Facilitate risk mitigation decisions
o Provide quality control documentation
What are the properties of robust risk?
o Takes into account all possible factors directly related
to performing laboratory procedures involving
biologically hazardous material
o Details considered are specific to the agents,
procedures, and other conditions in the laboratory
Limitations of Robust Risk Assessment
o The concept of “acceptable” risk. In just about every
situation there will be an amount of risk that will need
to be accepted and it is often up to the institution to
determine the level of acceptable risk.
o Cannot address factors not directly related to, but can
affect, laboratory work:
5

Social (current events)

Political (Management)

Cultural (ethical issues)

Personal Experience

Financial (resources)
It helps with selection of appropriate mitigation measures to
reduce the likelihood and consequences of what?
Expected Responses: Exposure, sickness, theft, diversion,
misuse, accidents, incidents, mistakes, etc.

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
A. RISK ACCEPTANCE
Risk acceptance is how tolerable or acceptable a particular
risk is to an institution, the community, or a person. Think
about what acceptability is in the real world, and to focus on
the potential differences between individuals, institutions,
and communities.
Accurately assigning risk levels can be honed with
experience and a thorough understanding of the pathogens
and procedures
But perceiving risk as acceptable will ultimately depend on
who will be at risk (risk owner)
What is acceptable risk?
o Technical risk assessments generally do not include
perceived social, cultural, political, and ethical
concerns.
o Risk acceptance will depend on the ‘owner’ of the risk:
risk averse or risk tolerant
o Risk evaluation is largely in the eye of the beholder,
whether it be an individual, institution, or a community.
IX. RISK EVALUATION
Unfortunately, there is no systematic way of evaluating risk
and determining risk acceptability. This will depend on the
perceptions of individuals, institutions, and the
community.
Risk Tolerant
Drives investment decision in an institution.
If an institution is particularly risk-averse, it will spend more
resources attempting to reduce the risks it faces
If a similar institution faces the same risk but is risk tolerant,
it might proceed with procedures others may find too
dangerous
FIGURE 10. Risk evaluation
FIGURE 11. Biosafety risk of direct exposure to individuals in
the laboratory and to the community equal risk distribution

The risk under this evaluation (star) is high to very high
compared to the risk-Default graph, where it is listed as
moderate. This evaluation puts higher emphasis on the
overall risk. Consequently, many risk assessments will fall
into the High to Very High category and may not be
acceptable.
A. RISK DISTRIBUTIONS
TABLE 3. Differences between likelihood averse and
consequence averse
LIKELIHOOD AVERSE
This scenario focuses more on
the effects of likelihood
on overall risk and the
institution will be more focused
on mitigation efforts used to
decrease the likelihood of an
incident
For example – This institution
would
focus
more
on
improving staff training, PPE
usage, BSC certification etc


CONSEQUENCE AVERSE
This scenario focuses more on
the effects of consequences
on overall risk and the
institution will be more focused
on mitigation efforts used to
decrease the consequences of
an incident
For example – This institution
would focus on providing
vaccination programs based
on the risk of the agent they
were working with
The curves on the graph called “isoquants”, show the
different levels of risk, from very low to very high.
It is important to recognize that the precise locations of
these isoquants on the graph are in fact arbitrary. This is
the essence of risk evaluation.
FIGURE 12. Risk Averse (L), Risk Tolerant (R)
POC: DIMAANDAL | GONZALES, MEDIANISTA, TAMAYO
6

The risk under this evaluation (star) is in the Very Low
category compared to the risk-default graph, where it is
listed as moderate. This evaluation puts lower emphasis on
the overall risk. Consequently, many risk assessments will
fall into the Very Low category and will be considered
acceptable.
FIGURE 13. Risk Default (L), Risk Averse (M), Risk Tolerant (R)
TABLE 4. Differences between risk averse and risk tolerant












RISK AVERSE
RISK TOLERANT
A risk averse evaluation may
come from an institution where
very heavy fines may be
impose if an incident were to
occur, therefore a risk averse
approach to biosafety and
biosecurity is paramount
A risk tolerant evaluation may
come from an institution that
has little regulation and may
not adequately know or
understand the likelihood and
consequences of working with
a particular agent, yet feels like
the situation is under control
and that risk is being
accurately
assessed
and
controlled
X. BIORAM
If a similar institution faces the same risk but is risk tolerant,
it might proceed with procedures others may find too
dangerous
BioRAMs were designed for use by biorisk officers at
laboratories and provide visualization of the relative risks
and help to identify risk mitigation measures.
BioRAM asks a series of questions
o If the question contributes to risk, the score is 0-4
o If the question mitigates risk, the score is 4-0
BioRAM has embedded weights for the questions, and the
categories of the questions
XI. SUMMARY
Hazard (threat) is a source that can cause harm
Risk is the combination of the likelihood and consequences
of an undesirable event related to a specific hazard (or
threat)
o R = f (L, C)
Likelihood is the probability of an event occurring
Consequences is the severity of an event
Benefits of a robust risk assessment
o Facilitates
risk
assessment
process;
repeatable/reproducible
o Facilitates risk mitigation decisions
o Provides quality control documentation
XII. REFERENCES
Dr. Tria’s PPT
Lecture
Batch 2021 Trans
POC: DIMAANDAL | GONZALES, MEDIANISTA, TAMAYO
7
XIII.APPENDIX
Pre-Analytical Phase
MTB HAZARD
ASSESSED RISK
Patient walk in
Vulnerable patients
Infection
MD assess px request
DSSM/Xray
Sputum collection/DSSM
specimen obtained
Incomplete
data/assessment
Insufficient volume/wrong
specimen
Repeat request or delayed
proces
Repeat submission of
specimen/delayed process
Transport to the lab
Lost specimen/rined
sample
Repeat submission of
specimen/delayed process
LIKELIHOOD
Exposure to infected
patient
Lack of appropriate
trained staff at R&R
Lack of trained personnel
to collect sample
Less likely
interlaboratory/high if
referred outside lab
CONSEQUENCES
Infection/depends on
source of infected patient
Repeat request/wrong
test/delayed TAT
Repeat request/wrong
test/delayed TAT
Patient complaints/legal
lawsuit
Pre-Analytical Phase
MTB HAZARD
ASSESSED RISK
LIKELIHOOD
Patient walk in
Vulnerable patients
Infection
Exposure to infected patient
MD assess px request DSSM/Xray
Incomplete data/assessment
Sputum collection/DSSM specimen obtained
Insufficient volume/wrong specimen
Transport to the lab
Lost specimen/rined sample
Analytical Phase Processing of
Specimens
Work on DSS/C&S of MTB
NaOH mixed with sputum spx to break
mucous
250 ml conical tube sputum spx solution + 15
ml water
Centrifuge 3000x g 15 minutes
Strive 50 ml H2O added to sediment to wash
pellet
Decant supernatant
Selective growth medium agar in slant tube
cultured small amount of pellet using
application stick
7 weeks incubation
Culture is smeared
Head fix the slide/open flame sterilization
Staining
Repeat submission of specimen/delayed
process
Patient complaints/legal
lawsuit
Pathogen/old crack benchtop
PPE worn occasionally/lab coats take
home/inadequacy of resources
Specimen mixed improperly/spillage or
leakage of samples
No sealed rotor or safety caps
LAI (Lab Acquired Infection)
Moderate
Moderate
LAI (Lab Acquired Infection)
Moderate
Moderate
Air droplets transmission
Moderate
Moderate
Aerosolization transmission
Moderate
Moderate
Infrequent handwashing
LAI (Lab Acquired Infection)
Moderate
Moderate
Untreated lab waste/contamination of the
environment
LAI (Lab Acquired Infection)
Moderate
Moderate
Inoculating loops old and rusty, open window
ventilation
Injury from loop and burns from Bunsen
burners
Moderate
Moderate
Cut/prick injury
Moderate
Moderate
LAI (Lab Acquired Infection)
Moderate
Moderate
High likelihood
Severe
Moderate
Severe
Breakage of glasswares
Occasional/weekly cleaning of lab/no tarsh
cans/improper handling of infectious waste
Humid environment/limited and crowded lab
space/improper ventilation
Experimentation done through subcultures
Susceptibility testing
Improper drainage
Validation of Test Results
No vaccination and occupational health sx for
personnel
Inaccurate validation
Releasing and reporting of test results
Typographical error/clumsy staff
Post Analytical Phase
Repeat submission of specimen/delayed
process
Lack of appropriate trained
staff at R&R
Lack of trained personnel to
collect sample
Less likely
interlaboratory/high if
referred outside lab
Based in the Pathogen Safety Data Sheet
Aerosol generation
Unsecured culture/no locks of lab
storage/ref/equipment
No personnel verification program
Identification of MDR Titan Blue
Repeat request or delayed proces
CONSEQUENCES
Infection/depends on source of
infected patient
Repeat request/wrong
test/delayed TAT
Repeat request/wrong
test/delayed TAT
Inhalation of toxic
fumes/gas/LAI/contamination of the
specimen
LAI (Lab Acquired Infection)
Exposure of pathgen to LAI
Moderate
Moderate
Cause threat to bioterrorism
Risk of pathogen survivability in
environment
Moderate
Severe
Moderate
Moderate
LAI (Lab Acquired Infection)
Moderate
Moderate
Wrong results
Low
Less consequence
Wrong results/patient’s complaints
Low
Less consequence
APPENDIX A. Risk Assessment of MTB Scenario (MTB DSSM, Culture, and Sensitivity)
POC: DIMAANDAL | GONZALES, MEDIANISTA, TAMAYO
8
MTB HAZARD
ASSESSED RISK
MITIGATION CONTROL MEASURES
BIOSAFETY (BS)
DRIVERS/BIOSECU
RITY (BC)
DRIVERS
Vulnerable patients
Incomplete data/assessment
Insufficient volume/wrong specimen
Infection
Repeat request or delayed process
Repeat submission of
specimen/delayed process
Repeat submission of
specimen/delayed process
Separate triage, OPD space
Trained receptionist/nurse to assist MD
Both
Both
E
A
Verification of samples by lab tech
Both
A
Training of staff
BS
A
Provide signages/PSDS
Personnel training about pathogen/fix benchtop
Proper PPE usage and training of staff/proper SOPS/PPE
made available by the management
Both
BS
A/S
A/E
BS
A/S/P
SOPS/Decontamination of the spillage
BS
S
Aerosolization transmission
Rotor safety caps provision of centrifuges
BS
E
LAI (Lab Acquired Infection)
BS
S
Injury from loop and burns from Bunsen
burners
Cut/prick injury
SOPS/Decontamination/hand hygiene practices
Proper waste management/ decontamination/PPE usage and
training of staff
Provision of electrical incinerator instead of Bunsen burner
not to be used under BSC
Replacement of plastic wares
BS
E/S
BS
E/S
LAI (Lab Acquired Infection)
Proper housekeeping SOPS
BS
S
BSC/Fume hoods
BS
E/A/S
BSC/Fume hoods
BS
E/A/S
Exposure of pathogen to LAI
Inventory of culture/safety caps
Both
E/A/S
Cause threat to bioterrorism
Risk of pathogen survivability in
environment
Background checks of personnel/PRM/Access control/MCA
BC
A
Proper drainage provision
BC
E
No vaccination and occupational health sx for
personnel
LAI (Lab Acquired Infection)
Provision of regular medical checkup
Both
A
Inaccurate validation
Wrong results
2-3 signatories provided
Lost specimen/ruined sample
Based in the pathogen safety data sheet
Pathogen/old cracked benchtop
PPE worn occasionally/lab coats take
home/inadequacy of resources
Specimen mixed improperly/spillage or leakage of
samples
No sealed rotor/safety caps
Infrequent handwashing
Untreated lab waste/contamination of the
environment
Inoculating lobs old and rusty, open window
ventilation
Breakage of glassware
Occasional/weekly cleaning of lab/no trash
cans/improper handling of infectious waste
Humid environment/limited and crowded lab
space/improper ventilation
Aerosol generation
Unsecured culture/no locks of lab
storage/ref/equipment
No personnel verification program
Improper drainage
Typographical error/clumsy staff
Legend:








LAI (Lab Acquired Infection)
LAI (Lab Acquired Infection)
Air droplets transmission
LAI (Lab Acquired Infection)
Inhalation of toxic fumes/ gas/ LAI/
contamination of the specimen
LAI (Lab Acquired Infection)
Wrong results/patient’s complaints
Personnel training/conduct client satisfaction survey
APPENDIX B. Mitigation of MTB Scenario (MTB DSSM, Culture and Sensitivity)
S
Both
E – Engineering control
S – SOPS
P – PPE
A – Administrative Control
BS – Biosafety
BC – Biosecurity
PRM – Personnel Reliability Management
MCA – Material Control Accountability
POC: DIMAANDAL | GONZALES, MEDIANISTA, TAMAYO
CATEGORIES
OF
MITIGATION
CONTROL
9
S/A