BIORISK MANAGEMENT

Question 1

to ensure biosafety one must do what

Answer 1

must consider the practices & procedures on biocontainment

Question 2

necessary to carry out total safety of laboratory workers and patients.

Answer 2

proper management

Question 3

the risk associated to biological toxins or infectious agents.

Answer 3

biorisk

Question 4

examples of infectious agents

Answer 4

Bacteria, Fungi, Virus & Parasites

Question 5

Normal Flora is a biorisk

Answer 5

False

Question 6

sources of risks

Answer 6

Unintentional exposure to unauthorized access

Accidental release or loss

Theft

Misuse

Diversion

Intentional unauthorized release of biohazards

Question 7

is the integration of biosafety & biosecurity to manage risks when working with biological toxins and infectious agents

Answer 7

Biorisk management

Question 8

Biorisk management is the integration of biosafety & biosecurity to manage risks when working with biological toxins and infectious agents

Answer 8

(CWA 15793 Laboratory Biorisk Management Standard)

Question 9

Biorisk Management (BRM) is “a 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.”

Answer 9

CEN Workshop Agreement (CWA) 15793: 2011

Question 10

“a 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.”

Answer 10

Biorisk Management (BRM)

Question 11

three primary components of BRM

Answer 11

Assessment
Mitigation
Performance

Question 12

Identified risks can be

Answer 12

mitigated
avoided
limited
transferred to an outside entity

accepted

Question 13

Initial step in implementing a biorisk management

Answer 13

risk assessment

Question 14

refers to anything in the environment that has the
potential to cause harm.

Answer 14

hazard

Question 15

generally defined as the possibility that something
bad or unpleasant (injury or loss) will happen.

Answer 15

risk

Question 16

A sharp needle is a _____, but if no one is using it, the needle will not pose any risk.

Answer 16

hazard

Question 17

the likelihood that an adverse event involving a specific hazard or threat will occur followed by the consequences of that occurrence.

Answer 17

risk

Question 18

state the structured and repeatable process of performing risk assessment

Answer 18

1.Define the situation
2.Define the risks
3.Characterized the risks
4.Determine if risks are acceptable or not

Question 19

second fundamental component of the biorisk management

Answer 19

mitigation procedures

Question 20

are actions and control
measures that are put into place to reduce or eliminate the risks associated with biological agents and toxins

Answer 20

biorisk mitigation measures

Question 21

biorisk mitigation measures are actions and control
measures that are put into place to reduce or eliminate the risks associated with biological agents and toxins

Answer 21

Salerno (2015)

Question 22

state the five (5) major areas of control or measures that can be employed in mitigating the risks (from most effective to least)

Answer 22

Elimination
Substitution
Engineering Controls
Administrative controls
PPE

Question 23

Most difficult and most effective

Answer 23

Elimination

Question 24

Involves the total decision not to work with a specific biological agent or even not doing the intended work

Answer 24

Elimination

Question 25

Highest degree of risk reduction

Answer 25

Elimination

Question 26

Replacement of the procedures or biological agent with a similar entity in order to reduce the risks

Answer 26

Substitution

Question 27

Bacillus anthracis → [to what]

Answer 27

Bacillus thuringiensis

Question 28

can cause acute fatal disease anthrax

Answer 28

Bacillus anthracis

Question 29

less dangerous experimental surrogate; commonly used in biological pesticides worldwide

Answer 29

B. thuringiensis

Question 30

Includes physical changes in work stations, equipment, production facilities, or any other relevant aspect of the work environment that can reduce or prevent exposure to hazards.

Answer 30

engineering controls

Question 31

examples of engineering controls

Answer 31

1. Installation of biosafety cabinets 2. Safety equipment (centrifuge with cover, autoclave & machines with indicators) 3. Facility design enabling proper airflow 4. Ventilation system to ensure directional airflow 5. Air treatment systems to decontaminate or remove agents from exhaust air 6. Controlled access zones 7. Airlocks as laboratory entrances 8. Separate buildings or modules to isolate the laboratory

Question 32

the policies, standards, and guidelines used to control risks.

Answer 32

Administrative controls

Question 33

_____ and _____ _____ for lab staff is considered an administrative control.

Answer 33

proficiency and competency training

Question 34

-Displaying biohazard or warning signages, markings & labels -Controlling visitor and worker access -Documenting written standard operating procedures

Answer 34

administrative controls

Question 35

Devices worn by workers to protect them against chemicals, toxins, and pathogenic hazards in the laboratory.

Answer 35

PPE

Question 36

why are PPE labelled as least effective

Answer 36

it only protects the person who is wearing it, and only when it is used correctly

Question 37

the effectivity of mitigating risks relies on:

Answer 37

1. combination of all the different measures 2. proper utilization

Question 38

Last pillar of the biorisk management model

Answer 38

performance evaluation

Question 39

It involves a systematic process intended to achieve organizational objectives & goals.

Answer 39

performance evaluation

Question 40

performance evaluation ensures what

Answer 40

ensures that the implemented mitigation measures are indeed reducing or eliminating risks.

Question 41

helps to highlight biorisk strategies that are not working effectively & measures that are ineffective or unnecessary --> can be eliminated / replaced

Answer 41

performance evaluation

Question 42

Reevaluation of the overall mitigation strategy

Answer 42

performance management

Question 43

state the performance evaluation procedures

Answer 43

1. identify the key issues of concern 2. define OUTCOME indicators and metrics 3. define ACTIVITIES indicators and metrics 4. Collect data and report indicator results 5. provide findings from performance indicators 6. evaluate and refine performance indicators

Question 44

The result of a robust risk assessment must be properly

Answer 44

recorded documented communicated (to all stakeholders of the organization)