BMS533

Biorisk Management

CASE STUDY 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 case studies designed to teach and assess the ‘P’
Performance in our AMP model for biorisk management
i. For this semester, we are in hybrid mode, 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 video and then perform certain tasks to reinforce your
learning on using assessment, mitigation and performance to manage and
improve risk situations
iii. You may write all your observations and thoughts in this Folio.
iv. At the end of Week No 10 (or depending on your tutor) submit the completed
Folio for assessment and marking.
v. The outcomes of this Folio addresses CLO8 - ability to apply managerial decision
for improving the biorisk performance in the lab; and contribute 20% to your
Final Marks

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BMS533 Lesson Plan Semester 20224
Week
Wk Assess CL
of Lectures Practicals Outcome %
ment O

1 Principles of laboratory Biosafety &

10/10
Biosecurity. Importance. AMP.
2 17/10 Hazards identification and 1a.Hazard identification
characterization and characterization
3 24/10 Risk assessment 1b. Risk assessment
Report
(24) (guided)
4 2. Good Laboratory Set of
31/10 Risk assessment
Practice (video) Guidelines
5 Risk Mitigation 3. Biological Safety
7/11 SOP
Administrative controls Cabinet (demo)
6 4. Donning & Doffing
14/11 Engineering controls Poster
(practice)
7
21/11 BREAK

8 Lab
28/11 Engineering controls 30 2
Report
9 5. ERP : Spill clean up Incidence
5/12 Personal Protective Equipment.
(simulation) report
10 12/12 6. Validation of Autoclave Validation
Personal Protective Equipment.
(12) (simulation) record
11 7. Lab inspection Inspection
19/12 Disinfection & Waste management
(practice) report
12 26/12
BREAK (XMAS)
(26)

13 2/1 Case
Disinfection & Waste management 20 3
(2) study
14
9/1 Biorisk management Performance

15
16/1 Biosecurity. Concepts. DURC.

16 23/1
Biosecurity. Concepts. DURC. TEST 50 1,2
(23&24)
17 30/1 STUDY BREAK

6/2
18
(6)

19 13/2

20 20/2

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Playlist of videos
The youtube link is provided. This is the prefer 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.
Practic Title You tube link
al
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.

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 BMS533
Biorisk Management

GROUP : AS201 TEAM :

Case study 5 : Emergency Response Plan -

Biohazard spill clean-up

LEADER :
Members :
:
:

Date :

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 BMS533 PRAC#5 : Emergency Response

Objective

To identify improvements for clean-up of biological spillage

Outcomes

I. Know - how to clean up a low-risk biological spill

II. Know - identify possible improvements
III. Do - analyse the performance of spillage incident reports
IV. Feel - confident in managing biohazard spills

Exercise
1. Watch video 5A on cleaning up a small low-risk biological spill
(Also watch video 5B in your free time)
2. Take note that all spillage, big or small, low risk and otherwise, must be reported to
the proper authority.
3. Study the Biohazard Incident Report Form on Page 6. This is an example of a
incident form that you may need to fill up when a spill occur.
What are the important information to capture so that such incidents can be better
prevented in the future?

Information to capture Justification (how will this information

help to prevent spill incidences?)

..

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4. Anne the biosafety manager is looking worried as she stared at the reports on her
desk. In the first six months of this year, there has been 4 spillage accidents in her
laboratories. The department has four labs and provide diagnostic and antibiotic
resistance testing for the hospital. They have a low record of spills. The sudden
increase in frequency of incidents points to the possibility that something they are
doing is not right.
Anne dived deeper into the reports, looking for similarities and noticed a pattern
where all the accidents happened near the shaker-incubator that is used to grow
bacterial cultures prior to antibiotic resistance test. As a result of a change in the test
protocol six months ago, the technicians are now required to inoculate three flasks of
medium instead of one, bring them to the shaker for incubation and take them back
to the BSC after the 24 hours growth period. All the reported incidents involved
accidental dropping of a flask of cultured bacteria. Anne interviewed the technicians
involved in the spills, and in all cases, the technicians were carrying 3 flasks of
cultures as they attempt to open the incubator door, and dropped one of the flasks in
the process.
Suggest two improvements that can help to reduce similar incidents in the future.

Improvements How will this help to reduce similar

incidents
1

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EXAMPLE - BIOHAZARD INCIDENT REPORT FORM

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 BMS533
Biorisk Management

GROUP : AS201 TEAM :

Case study 6 : Autoclave validation

LEADER :
Members :
:
:

Date :

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 BMS533 PRAC# 6 : Autoclave validation

Objective

To validate the performance of an autoclave

Outcomes

I. Know - how to validate and autoclave using biological indicators

II. Know - how to prepare documentation for autoclave validation
III. Do - validate an autoclave using biological indicators
IV. Feel - confident and committed to perform validation regularly

Introduction
The autoclave is perhaps the most important piece of equipment in the microbiology
laboratory. It is used to sterilised medium, solutions etc. to ensure correct results. It is also
used to disinfect/ decontaminate all laboratories waste that has been in contact with
biological agents. It the autoclave is not functioning properly; the results can be disastrous
where infectious biological material can leave the laboratory in the waste stream. To ensure
that this does not happen, autoclaves should be validated on a regular basis. Validation is
the process where a chemical or biological indicator is used to test the autoclave’s
performance cycle. The biological indicator commonly used are endospores from
Geobacillus stearothermophilus which are highly resistant to heat. These spores are
included in a routine autoclave cycle, and recovered for culturing. If the autoclave is
functioning properly, then the biological indicator will be inactivated and show no growth after
autoclaving. As always, the validation process should be diligently documented.

Exercise

1. Watch the video P6A and P6B on biological indicators for validation and what to do if
your autoclave FAIL a validation. Video P6C introduces a semi-automated system.

2. Design a record sheet for autoclave validation ot be filled in by the personnel in

charge after every cycle of autoclave validation.
(A simple, half page form will do. Google for examples)
(If you cannot find any, there is a sample on the next page)

3. Anne has another problem. One of the autoclaves was not functioning properly,
resulting in a batch of waste material containing viable foot-and-mouth virus to be
released accidentally, and infected several cleaning staff. Jim, the technician who
disposed the waste, thought that Alfred (the lab manager) had validated the
autoclave, while Alfred thought that Jim has done it. The confusion led to Jim using a
non-validated autoclave for decontamination.
Suggest two improvements to the laboratory SOP that will prevent this incident.

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 Improvements to SOP How will this help to reduce similar
incident
1

___________________________________________________________________
EXAMPLE OF A RECORD SHEET/ FORM FOR AUTOCLAVE VALIDATION

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AUTOCLAVE VALIDATION FORM/ SHEET
All autoclaves must be validated weekly. Please check validation status before using.

{ Design your sheet/ form here. }

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 BMS533
Biorisk Management

GROUP : AS201 TEAM :

Case Study 7 : Laboratory Inspection

LEADER :
Members :
:
:

Date :

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 BMS533 PRAC# 7 : Laboratory Inspection

Objective

To conduct a self inspection of a BSL-1 Laboratory

Outcomes

V. Know - the requirements for a BSL-1 lab

VI. Know - how to improve the safety in a BSL-1 lab
VII. Do - self-inspect a BSL-1 lab
VIII. Feel - confident in using a checklist for self -inspection

Exercise

1. Using the checklist attached, conduct a self -inspection of the laboratory that you use
for this course.
2. Based on the outcomes, complete the report.

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Laboratory Inspection Checklist : BSL1
Faculty of Applied Sciences, UiTM. Version 2017/1

Laboratory : Inspector:

Premise: Date:

Principal Investigator: Time:

Check ( ) in the appropriate box that best describes the laboratory

A. Laboratory Facilities Yes No NA Details/Comment

1 Is a universal biohazard symbol for BSL 1 posted at the
entrance of the laboratory?
2 Do the sign include name, and phone number of the /
laboratory supervisor or other responsible personnel?
3 Is there a sink for hand washing in the laboratory? /

4 Is furniture in the laboratory capable of supporting

anticipated loads and uses?
5 Are spaces between benches, cabinets, and equipment
accessible for cleaning?
6 Are bench tops impervious to water and resistant
to heat, organic solvents, acids, alkalis, and other
chemicals?
7 Is furniture including bench tops covered with a
non-porous material that can be easily cleaned?
8 Are laboratory windows that are open to the
exterior fitted with screens?
9 Is an autoclave for pre-treatment of laboratory wastes
is available?
10 Is an eyewash fountain available in the laboratory?

11 Is an effective integrated pest management

programme in place and managed appropriately?
12 Is there a good housekeeping in the laboratory?

B. Safety Equipment Yes No NA Details/Comment

13 Is there first aid kit available?

14 Is there a fume hood for working with hazardous

chemicals?
15 Are suitable PPE and used by laboratory personnel?

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 16 Is there any storage equipment to keep biological
materials? (e.g. refrigerator)
17 Are the equipment regularly maintained?

C. Work Practices Yes No NA Details/Comment

18 Is there any biohazardous materials handled in the

laboratory?
19 Do personnel wash their hands before leaving the lab?
20 Are mechanical pipetting devices used?
21 Is there a signage available for prohibiting from
eating, drinking, smoking, handling contact lenses,
applying cosmetics, and storing food for human
consumption in the lab?
22 Are work surfaces decontaminated with an effective
disinfectant on completion of work especially after
spills or splashes of biohazardous materials?
23 Is a sharp bin available for disposal of and all
syringes/ needles/sharps?
24 Are re-usable sharps properly cleaned and disinfected?
25 Is there a biological spill kit available?
26 Are all wastes that are contaminated with bio
hazardous materials autoclaved or decontaminated?
27 Have all personnel been provided information about
hazards and risk about their work activity?
28 Are laboratory waste segregated into dedicated
waste bins and labelled properly?
29 Is there a Laboratory Biosafety Guidelines or Biosafety
Manual in the laboratory?
30 Is there an Emergency Response Plan?

D. Records and Documents For : Yes No NA Details/Comment

31 Procurement and transfers of biological agents
32 Biological material /LMO inventory /
33 SOPs for contained use activity
34 Staff training and competency
35 Equipment maintenance
36 Decontamination and validation

Additional comments/observations and recommendation : (use extra paper if required)

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Report

1. List two areas that will require immediate attention to improve the safety performance of this
Lab.

Area that needs immediate attention What needs to be done

Example : No signage at door Attached signage with required information

3. If you are asked to upgrade this Lab to BSL-2, what will be the three most important areas to
upgrade?

Area to upgrade What action to take

Example : No signage at door Attached signage with required information

Inspector’s Signature: Date

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Case Study Rubric

Exceeds
Attribute Meet Expectations Below Expectations Marks
Expectations
Marks 4-5 2-3 0 -1
1. Punctuality Submitted early Submitted on time Submitted late
Was the report submitted on
time?
2. Organization of report Well-presented and Pleasant and might Not organized
Is the prescribed format used? attractive get people to read

3. Originality of report
Is the report original, or are
most parts duplicated from the
manual?
Biological spills
Original, with creative Mostly written in own More than 50% of
insights words, attempts to report was
summarise duplicated verbatim

4. Were the important points Yes. Points were Missed a point Only one or less
correctly identified? correctly identified. points

5. Are the recommendations for
improvement logical and
workable?
6. Are the recommendations
sufficiently detailed?
Logical and workable. Logical, but not Not very useful and
Will lead to entirely feasible, or little improvement.
improvements not many
improvements
expected
Full details for easy Details included, but Not enough details
compliance still some ambiguity

Autoclave Validation

7. Form design - Is the language Clear and easy to Clear, but still some Not clear.
and design clear? follow gray areas

8. Are the recommendations for
improvement logical and
workable?
9. Are the recommendations
sufficiently detailed?
Logical and workable. Logical, but not Not very useful and
Will lead to entirely feasible, or little improvement.
improvements not many
improvements
expected
Full details for easy Details included, but Not enough details
compliance still some ambiguity

Lab Inspection Clearly detailed out, Clear, but not well- Not clear, lab
focused on the focused on the manager will be
10. Inspection report – are issues problems, and will problems unsure of what
clearly communicated? help the lab manager needs to be
to improve safety corrected

11. Are the recommendations for
improvement logical and
workable?
12. Are the recommendations
sufficiently detailed?
Logical and workable. Logical, but not Not very useful and
Will lead to entirely feasible, or little improvement.
improvements not many
improvements
expected
Full details for easy Details included, but Not enough details
compliance still some ambiguity

SUM(60)

Evaluated by :_________________________________________ Date : ________________________

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