BMS533

Biorisk Management

LABORATORY PRACTICAL FOLIO

Welcome to BMS533 Biorisk Management.

BMS533 is about biosafety and biosecurity – how to keep yourself safe and protect the
environment and people around you from potentially dangerous biological agents that may
be present in the laboratories.
In this document, you will find the schedule for our first four practical classes
i. For this semester, we are in hybrid, so T & L will be conducted via a series of lab
briefings, videos, guided self-learning and Face-to-face where permitted
ii. You will begin with a discussion, then watch some videos and then perform
certain tasks to reinforce your learning on risk assessment and risk management
iii. You may write all your observations and thoughts in this Folio.
iv. At the end of Week No 6 (or 7, depending on your tutor) submit the completed
Folio for assessment and marking.
v. The outcomes of this Folio addresses CLO2 -ability to analyse (risk assessment)
and apply the correct control (risk mitigation) and contribute 20% to your Final
Marks
Practical 1 is on risk assessment and reinforces your ability to identify and assess
risks in the laboratory. Practical 2 to 4 reinforce learning on risk mitigation and
their applications – administrative control, engineering control and PPE.
BMS533 Lesson Plan Semester 20232
Week
Wk Assess
of Lectures Practicals Outcome % CLO
ment

1 Principles of laboratory Biosafety &

20/3
Biosecurity. Importance. AMP.
2 27/3 Hazards identification and 1a. Hazard identification and
characterization characterization
3
3/4 Risk assessment 1b. Risk assessment (guided) Report

4 2. Good Laboratory Practice Set of

10/4 Risk assessment
(video) Guidelines
5 Risk Mitigation 3. Biological Safety Cabinet
17/4 SOP
Administrative controls (demo)
6
24/4 BREAK Aidil Fitri (22-23/4)

7 1/5 4. Donning & Doffing

Engineering controls Poster
(4/5) (practice)
8 Lab
8/5 Engineering controls 30 2
Report
9 5. ERP : Spill clean up Incidence
15/5 Personal Protective Equipment.
(simulation) report
10 6. Validation of Autoclave Validation
22/5 Personal Protective Equipment.
(simulation) record
11
29/5 BREAK Pesta Menuai, Gawai

12 Inspection
5/6 Disinfection & Waste management 7. Lab inspection (practice)
report
13 Case
12/6 Disinfection & Waste management 20 3
study
14
19/6 Biorisk management Performance Carry marks & Review

15
26/6 BREAK Aidil Adha (29/6)

16
3/7 Biosecurity. Concepts. DURC.

17
10/7 Review session TEST 50 1,2

18 17/7 STUDY BREAK

18 24/7
EXAMS
20 7/8

Yellow highlight = public holiday

Playlist of videos
The youtube link is provided. This is the preferred option.
Where the video no longer exist on youtube, or you cannot access, the link to a copy of the video in
google drive will be given. You can watch is there. Please do not download any videos.
Prac Title You tube link

1 A Biosafety Risk assessment https://www.youtube.com/watch?v=0QwJB1sH3Oc

2 A BSL 1 & BSL 2 Safety Intro to the https://www.youtube.com/watch?v=ge8I4fSdbPM

Lab Bench

B Lab Safety Training BSL2 https://www.youtube.com/watch?v=AtDiZB8FqIQ

C Biosafety mistakes

3 A Biosafety Cabinet Training at https://www.youtube.com/watch?v=q_C6xq7j-kg

Arizona State University

B Biological Safety Cabinet https://www.youtube.com/watch?v=96-aZLom340

4 A Donning doffing lab biosafety https://www.youtube.com/watch?v=ORhUis-0TSA

B Donning and doffing of PPE step by https://www.youtube.com/watch?v=WISzaCdJSQg

step

C Gloves donning and Doffing https://www.youtube.com/watch?v=PWrhmp3YAc0

D N95 mask donning and seal check https://www.youtube.com/watch?v=zoxpvDVo_NI

Case
Study

5 A Biological Spill Response Texas https://www.youtube.com/watch?v=VKIBNz4fHoU

Tech U

B Biological Spill Clean-up https://www.youtube.com/watch?v=l6uJvEQ-J9A

6 A In-office biological monitoring https://www.youtube.com/watch?v=YHj0rXxBulw

B Failed Spore Test What do you do https://www.youtube.com/watch?v=1576ElGWRRo

C 3M™ Attest™ 490M Auto Reader https://www.youtube.com/watch?v=LCQ8dFXwtoM

7 A Laboratory inspection exercise https://www.youtube.com/watch?v=ge8I4fSdbPM

*you will be given links to videos on a google drive for videos which are no longer on youtube.
 BMS533
Biorisk Management

GROUP : AS201 TEAM :

Practical 1 : Risk Assessment

LEADER :
Members :
:
:

Date :

Report writing :

This section was written by and reviewed by

Introduction :

Methods :

Results :

Discussion :
 BMS533 PRAC#1 : Risk Assessment

Objective

To identify possible biosafety risk in a laboratory.

Outcomes

I. Know - what is a biosafety risk.

II. Know - how to identify a biosafety risk
III. Do - make a list of possible biosafety risks for a biological agent
IV. Feel - confident in identifying biological risks

Introduction
Risk assessment is the first component of the AMP model for biorisk management, and also
an integral part of laboratory biosafety. In order to conduct a risk assessment, the first step is
to identify existing biosafety hazards. These can be agent-based or procedure -based. We
will then do a quick characterization of the identified hazards.

Instructions
1. Work in groups of 3 or 4.
2. Pick one of the following biological agents :
i. Bacillus subtilis
ii. Bacillus anthracis
iii. Shigella flexneri
iv. Staphylococcus aureus
v. Mycobacterium tuberculosis
vi. Streptococcus pneumoniae
vii. Salmonella typhimurium
viii. Rickettsia rickettsii

My agent = ................................................................................................

3. Assume that the lab will be used to do the following tasks with your selected bacteria:
a) diagnostic procedures e.g. gram staining, biochemical tests
b) culture in 1 litre volumes for growth studies
c) inoculating mice with the bacteria for pathogenic studies

PART A Hazard characterisation

4. Identify what are the possible biosafety hazards for your agent.
5. Complete the Hazard Characterisation Sheet attached. You will need to search
the internet or other sources for scientific data. This will provide the information for
the risk assessment in the next section.
6. Use the template on the next page. Use extra paper if you need.
Hazard characterisation sheet (tick where applicable)
Name of biological agent (genus/species etc.) :

1. Type of agent :
Bacterium Virus Fungus Parasite

Cell Culture Prion Biological toxin Others :

2. Risk Group 1 2 3 4 Unknown

3. Pathogenicity
Highly pathogenic Pathogenic

Opportunistic pathogen Potential pathogen

4. Infectious dose Unknown Known =

5. Host range
Human Animal Plants Others :

6. Communicability
Human to human Animal to human Human to animal Animal to animal

7. Route of infection
Respiratory tract/ inhalation Mucosal membranes/ eyes, nose, mouth

Percutaneous / break in skin Gastrointestinal tract/ ingestion

8. Mode of transmission
Direct contact Indirect contact Human-human Human-animal

Vector borne Inanimate objects Food, water Air, aerosols

9. Individual highly at risk

Pregnant woman Immunocompromised

Aged person/ children Others :

10. History of Laboratory –Acquired Infection (LAI)

Yes Rare No reports
11. Vaccine available? Yes No

12. Cure available? Yes No

For the procedures performed on this biological agent :

13. Will aerosols be produced in large amounts? Yes No

14. Will sharps be used? Yes No

15. Are spills/ splashes likely to happen? Yes No

Part B : Risk identification

7. Identify what risks can arise due to the hazard. One hazard can give risk to several
risks. The risk can be to the laboratory worker, people around the lab, or the
environment.
8. Identify under what conditions/ situations will the risk be manifested. Remember, just
by having a hazard doesn't mean that it will result in a risk.
9. Identify who will be at risk.

Table 1.1 : (Give me a title)

Hazard Risk Under what conditions can Who is at risk

this happen
What can happen

1 Mycobacterium Infection via respiratory Generation of infectious Lab workers

tuberculosis route aerosols when vortexing
samples.

2 ……..

3 …….

4 Mycobacterium Unintentional release Contaminated waste was Lab workers/

tuberculosis not properly autoclaved support workers/
community
Part C : Biorisk Assessment

10. Watch the video P1A on risk assessment (10 min)

11. Using the rubric below and the matrices given in the next page, identify how harm
can occur due to the risk you have identified, and assess the risk of each of these.

1 Hazard What can happen? How can it happen?

(Identify the Hazard) (Define the Risk as clearly as possible. This will help
greatly when you do Risk Mitigation in the next step)

What is the likelihood of it Why do you think so?

happening?
(You need to justify your evaluation based on
(Estimate the Likelihood) scientific facts)

If it DOES happen, how severe are the Why do you think so?
consequences?
(Quiz : what if there is no information for L or C?)
(Estimate the Consequence)

What is the level of risk? Is risk mitigation/ management required?

(Risk = Likelihood x Consequence)

12. Use the template and risk matrices provided below

13. Plot the risks on the quadrant graph below, using clear markers. Add to the legend.
Table 1.2 Risk Assessment Worksheet R = f(L,C) L = likelihood; C = consequence; R = Risk Level

Risk L Why C Why Risk

Level

1 Infection of lab 4 M.tuberculosis is known 3 TB is a chronic and High

users by to be highly infectious via severe disease.
Mycobacterium inhalation of aerosols. However, effective
tuberculosis through There are many reproted treatment is available.
inhalation of cases of LAIs.
aerosols

2 ……….
Figure 1.1. Quadrant Chart for risk assessment

Likelihood

High

Moderate

Low

Negligible

1 2 3 4 Consequence

Legend :

Risk Likelihood Consequence

Risk of infection through aerosol 4 3

Risk of .......
DISCUSSION :

< Discuss your results - is there any risk that will require mitigation?
Pick one of the high risk items and describe briefly what can be done to minimise the risk. It's OK if you
are not entirely sure. Make some suggestions >

CONCLUSION

< And a one sentence conclusion. >

REFERENCES

< two or three reference, probably formatted using a bibliography software >
APPENDIX 1 : LIKELIHOOD, CONSEQUENCES AND RISK MATRICES

Likelihood Likelihood assessment definitions

4 Highly likely Is expected to occur in most circumstances
3 Likely Could occur in many circumstances
2 Unlikely Could occur in some circumstances
1 Highly unlikely May occur only in very rare circumstances

Consequences Consequence assessment definitions

Adverse health effects that are severe, widespread and irreversible.
4 Major Extensive damage to the environment or extensive biological and physical disruption of
whole ecosystems, communities or an entire species that persists over time or is not
readily reversible.
Adverse health effects that are irreversible.
3 Intermediate Damage to the environment or disruption to biological communities that is widespread
but reversible or of limited severity.

Adverse health effects that are reversible.

2 Minor Damage to the environment or disruption to biological communities that is reversible
and limited in time and space or numbers affected.

Minimal adverse health effects.

1 Marginal
Minimal or no damage to the environment or disruption to biological communities.

RISK ESTIMATE
LI 4 Highly likely Low Moderate High High
KE
LI 3 Likely Low Low Moderate High
H 2 Unlikely Negligible Low Moderate Moderate
O
O 1 Highly unlikely Negligible Negligible Low Low
D
Marginal Minor Intermediate Major
1 2 3 4
CONSEQUENCE

Risk estimate Risk estimate definitions

Risk is unacceptable unless actions for mitigation are highly feasible and
4 High
effective.
Risk is of marked concern that will necessitate actions for mitigation that need
3 Moderate
to be demonstrated as effective.
Risk is minimal, but may invoke actions for mitigation beyond normal
2 Low
practices.
Risk is insubstantial and there is no present need to invoke actions for
1 Negligible
mitigation.
Lab Report Rubric PRAC # 1
 Exceeds
Attribute Meet Expectations Below Expectations Marks
Expectations
Marks 4-5 2-3 0-1
1. Hazard characterisation All information Most information Only some
sheet provided and correct provided and correct information
Is the sheet adequately provided
completed?
2. Risk identification > 3 risks correctly 1-3 risks correctly Risks were not
Did the student identify the identified identified correctly identified
risks associated with the
agent?
3. Likelihood evaluation Yes. Qualified by OK. Agreed. But No. Evaluation not
Is the likelihood well good comments weak comments well supported
evaluated?

4 Consequence evaluation Yes. Qualified by OK. Agreed. But No. Evaluation not
Is the consequence well good comments weak comments well supported
evaluated?

5. Risk level All assigned and Mostly assigned and Few or none
Are the risk levels correctly correct correct assigned
assigned based on the matrix?
6. Discussion and conclusion Results were well Some attempts. Lack of attempt to
Is a discussion included? discussed. mainly descriptive. discuss.
Correct conclusion, Conclusion is No conclusion/
related to the provided, but not conclusion not
objective directly related to the related to
objective objective(s)

SUM (30)

Evaluated by :_________________________________________ Date : ________________________

 BMS533
Biorisk Management

GROUP : AS201 TEAM :

Practical 2 : Good Microbiological Practises

LEADER :
Members :
:
:

Date :

Report writing :

This section was written by and reviewed by

Introduction :

Methods :

Results :

Discussion :
 BMS533 PRAC# 2 : Good Microbiological Practices (GMP)

Objective

To write set of GMPs for routine work in a BSL2 laboratory

Outcomes

I. Know - GMPs for work in a BSL2 laboratory

II. Know - What not to do in a BSL2 laboratory
III. Do - prepare a set of GMP guidelines for a BSL2 laboratory
IV. Feel - confident and committed practicing GMPs

Introduction
GMPs are central to any biorisk management programs. Most of you should have been taught
the basic GMP when you are first introduced to the Microbiology Lab. For this session, we will
attempt to write a set of GMP guidelines for routine work in a BSL2 laboratory, where microbes
that can cause infections are routinely handled. The purpose is for everyone to be on the same
page, as different lecturers may have taught you slightly different versions of GMPs. We will do
this by considering the 'correct' actions to take from the moment you want to enter the lab to the
point you leave the lab.

Exercise

1. Watch the videos on “Good Laboratory Practises” P2A, P2B, P2C (all in 27 mins)

2. P2A is a quick introduction to good microbiological practices

P2B is a good and comprehensive guide to practices in a BSL2 lab. Make sure you
watch this.
P2C is fun, watch this and try to pick put the various things that were done wrong.

3. Select the best practices to take, guided by your tutor, and document all these as a set
of guidelines

4. Use the template below.

Present your report as a set of guidelines and submit this for marking.
GOOD MICROBIOLOGICAL PRACTICES
Applicable for a BSL2 laboratory and handling of Risk Group 2 organisms and below.

1. BEFORE YOU ENTER THE LAB

1. Leave all personnel belongings outside

2. …..

3. ………

DO NOT

1. Bring in your mobile phone

2. ….

B. UPON ENTERING THE LAB

1. Put on your lab coat

2. ….

DO NOT

1. …...

C. WORKING IN THE LAB

……….
D. CLEANING UP AFTER YOU ARE DONE
………..
E. UPON EXITING THE LAB
……….

REFERENCES

Biosafety Committee
Faculty of Applied Sciences, UiTM Shah Alam
Tel. 0185122516 email : biosafety_fsg@uitm.edu.my
Lab Report Rubric PRAC # 2 (include this with your set of guidelines)

Exceeds Below
Attribute Meet Expectations Marks
Expectations Expectations
Marks 4-5 2-3 0-1
1. Organization of Guidelines Fully adhere to format Mostly adhere to Not organized
Is the prescribed format used? format

2. Originality of Guidelines Original, with creative Mostly written in own More than 50% of
Is the report original, or are insights words, attempts to report was
most parts duplicated from the summarise duplicated
manual? verbatim
3. How comprehensive are Full details for easy Details included, but Not enough
sections A and B. compliance still some ambiguity details

4. How comprehensive are Full details for easy Details included, but Not enough
sections C, D and E compliance still some ambiguity details

SUM (20)

Evaluated by :_________________________________________ Date : ________________________

Biosafety Committee
Faculty of Applied Sciences, UiTM Shah Alam
Tel. 0185122516 email : biosafety_fsg@uitm.edu.my
 BMS533
Biorisk Management

GROUP : AS201 TEAM :

Practical 3 : SOP for Biosafety Cabinet

LEADER :
Members :
:
:

Date :

Report writing :

This section was written by and reviewed by

Introduction :

Methods :

Results :

Discussion :
 BMS533 PRAC# 3 : SOP for Biosafety Cabinet

Objective

To draft SOP for the use of Type II Biosafety Cabinets

Outcomes

I. Know - the various types of Biosafety Cabinets

II. Know - how to use a Biosafety Cabinet correctly
III. Do - prepare a set of guidelines for using Biosafety Cabinets
IV. Feel - confident in using Biosafety Cabinets to carry out work of azardous nature

SOPs
An SOP is a set of instructions or steps someone follows to complete a job safely, with no
adverse impact on animals or the environment, and maximizes operational and production
requirements.

Tips for writing an SOP

In this exercise you will write a simple SOP. Follow these tips and principles :
Tip 1 : Begin each step with a single action verb e.g. “Open”
Tip 2 : Keep each step simple
Tip 3 : Identify the person who will perform the step
Tip 4 : Use quantitative information e.g. 5 ml
Tip 5 : List multiple objects
Tip 6 : Emphasize important information e.g. bold, italics or underline
Tip 7 : Most importantly, think like the USER
Tip8 : Use Behavorial Observation data (BODs) to monitor compliance

Exercise

1. Watch video P3A on the various types of Biosafety Cabinets and how they function.
The video also show the procedures for working safely in a BSC.
Watch video P3B for a a nother quick guide on the procedures for working in a BSC.
2. After the videos, discuss with your friends, summarise what you have learn and write
an SOP for the use of Class II Biosafety Cabinets.

Use the template below. Submit the guidelines as your report.

You may google for a copy of SOP, and follow the procedures. But DO NOT copy verbatim.
And you must also acknowledge the source of the SOP by proper citation and inclusion in
your reference.
__________________________________________________________________________________

SOP for Use of Type II Biological Safety Cabinets

__________________________________________________________________________________
This SOP is intended for personnel working with biological materials

__________________________________________________________________________________

1.0 Procedures

A. Preparation
1. Wear appropriate personal protective equipment like:
⚫ glove [ BOD : Is the user wearing gloves? ]
⚫ ......
⚫
2. ..............

B. Before you switch on the BSC

11. Check that the BSC is certified for use, and certification is not expired.
12. Check that the.......................

C. Turn on the BSC.....

D. Turn off the BSC.....

2.0 Biosafety
A. Personal Protective Equipment
General PPE e.g. lab coat, gloves, goggles and face mask if necessary.
Use heavy duty thick autoclave gloves when unloading hot material.

B. Clean up
● If there is water soillage on the floor, mop dry
 ● If there is material spillage in the autoclave, record in the logbook, inform the lab director
and carry out SOP # 1036
● If the control panel is wet, wipe dry with clean paper towel
● Periodically check and adjust the water level in the steam outlet container

If spill is large or unmanageable call Environmental Safety @ X-XXXX

3.0 Responsibility

3.1 Supervising personnel - to ensure that the laboratory personnel performing these tasks
are trained appropriately and that proper procedures are followed.
3.2 Laboratory personnel - to accurately record all required data and results.
3.3 Laboratory personnel - to document any deviation from these procedures, and consult
supervising personnel on the matter..

4.0 Reference

1. http://www.csbsju.edu/biology/chemical-inventory-and-safety/biosafety-plan/biosafety-
emergency-procedures
2. ......
3. ......
4. ......
Lab Report Rubric PRAC # 3 (include this with your SOP)

Exceeds Below
Attribute Meet Expectations Marks
Expectations Expectations
Marks 4-5 2-3 0-1
1. Organization of SOP Fully adhere to format Mostly adhere to Not organized
Is the prescribed format used? format

2. Originality of SOP Original, with creative Mostly written in own More than 50% of
Is the report original, or are insights words, attempts to report was
most parts duplicated from the summarise duplicated
manual? verbatim
3. Is the SOP detail enough Full details for easy Details included, but Not enough
compliance still some ambiguity details

4. Does every step starts with a Yes. Really helps A few steps are No.
proper verb? user to focus vague

5. Are BODs included Included and well Included, but placed Not included
placed at less useful steps

SUM(25)

Evaluated by :_________________________________________ Date : ________________________

 BMS533
Biorisk Management

GROUP : AS201 TEAM :

Practical 4 : Donning and Doffing PPEs

LEADER :
Members :
:
:

Date :

Report writing :

This section was written by and reviewed by

Introduction :

Methods :

Results :

Discussion :
 BMS533 PRAC# 4 : Donning and Doffing PPEs

Objective

To don and doff standard PPE safely

Outcomes

I. Know - the need to don and doff safely

II. Know - how to don and doff basic PPE safely
III. Do - don and doff basic PPE the correct and safe way
IV. Feel - confident in using PPE

Exercise
1. Watch the videos on donning and doffing – P4A, P4B, P4C and P4D
2. P4A is a good introduction for basic donning and doffing for the lab.
P4B is an extended version which is recommended by the MOH for frontliners that
will be handling potential Covid-19 patients
P4C is on the proper way to put-on and remove gloves. You MUST watch this.
P4D is on the correct way to wear and fit-test an N95 mask. You MUST watch this.
3. Following the instructions in the video P4A, design a poster donning and doffing of
PPEs for a BSL2 laboratory.
You can split donning / doffing to two posters if you want more space.

Use Powerpoint to create the poster of at least A3 size. Submit the poster together with this
report.
Also take snapshots of the poster at A4 size and append the images below :
EXAMPLES of POSTERS FOR PPE DONNING AND DOFFING (replace with your own)
OTHER EXAMPLES
Lab Report Rubric PRAC # 4 (include this with your poster)

Exceeds
Attribute Meet Expectations Below Expectations Marks
Expectations
Marks 5 3 1
1. Organization of poster Well presented and Pleasant and might Not organized,
attractive get people to read disorientating.

2. Is the poster detail enough Full details for easy Details included, but Not enough details
compliance still some ambiguity

3. Are the procedures correct All correctly shown One mistake More than one
mistake

4. Is the sequence of action All correctly shown One mistake More than one
correct mistake

5. Is the poster clear and easy to Clear and easy to Clear, but still a bit of Not clear.
follow ? follow gray areas

SUM(25)

Evaluated by :_________________________________________ Date : ________________________

PRACTCAL REPORTS ASSESSMENT

PRACTICAL # Marks Full marks

1 30

2 20

3 25

4 25

Total 100

% FINAL 30%