Lesson 7

Question 1



In working with infectious agents and toxins in laboratories, one must consider the practices and procedures on biocontainment to ensure biosafety and biosecurity. Proper management is necessary to carry out total safety of laboratory workers and patients.

1) ________ is the risk associated to biological toxins or infectious agents. The source of risk may be unintentional exposure to unauthorized access, accidental release or loss, theft, or intentional unauthorized release of biohazards. Biorisk management is the integration of biosafety and biosecurity to manage risks when working with biological toxins and infectious agents (CWA 15793 Laboratory Biorisk Management Standard).

According to the CEN Workshop Agreement (CWA) 15793:2011, 2) _______ (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.” BRM encompasses the identification, understanding, and management aspects of a system in interrelated processes. It is divided into three primary components:

AMP= 3)____________

These components are collectively captured by what is called the AMP model (World Health Organization, 2010). The model requires that control measures be based on a robust risk assessment, and a continuous evaluation of effectiveness and suitability of the control measures. Identified risks can be either mitigated, avoided, limited, transferred to an outside entity, or accepted.
Like a three-legged stool, a biorisk management system fails if one of the components, or legs, is overlooked or is not addressed. In contrast to other risk management models, which typically focus heavily on mitigation measures, AMP focuses on all components with equal attention.

Answer 1

1) Biorisk
2) Biorisk Management
3) assessment (A), mitigation (M), and performance (P).

Question 1



1. It refers to anything in the environment that has the potential to cause harm.
   a. risk
   b. hazard
   c. biosafety
   d. biosecurity
2. It refers to the possibility that something bad or unpleasant (such as an injury or loss) will happen.
   a. risk
   b. hazard
   c. biosafety
   d. biosecurity
   faits
3. It is the least effective mitigation measure according to the hierarchy of controls.
   a. elimination
   b. administrative controls
   c.personal protective equipment.
   d. engineering controls
4. It is the process of identifying the hazards and characterizing the risks.
   a. risk assessment
   b. mitigations
   c. performance evaluation
   d. communication
5. It refers to a system or process of controlling safety and security risks associated with the handling, storage, and disposal of biological agents and toxins in laboratories and facilities.
   a. biosafety guidelines
   c. biosecurity standards
   b. biorisk management
   d. mitigation control measures

Question 2



Key Components of Biorisk Management leomapapel deisole
Risk Assessment
The initial step in implementing a biorisk management process relies on risk assessment which includes the identification of hazards and characterization of risks that are possibly present in the laboratory. Hazard refers to anything in the environment that has the potential to cause harm while risk is generally defined as the possibility that something bad or unpleasant (such as an injury or loss) will happen. In order for a risk to occur, there must be a situation for the hazard to cause harm (ISO/IEC Guide 51:1999). For example, a sharp needle is a hazard, but if no one is using it, the needle will not pose any risks. More specifically, risk is the likelihood that an adverse event involving a specific hazard or threat will occur followed by the consequences of that occurrence. In performing risk assessment, a structured and repeatable process is followed. It consists of the following steps:

1. _________ - the risk assessment team must identify the hazards and risks of the biological agents to be handled. Next, at-risk hosts, who could be humans or animals inside and outside the laboratory, must be identified. The work activities and laboratory environment including location, procedures, and equipment should also be defined. gitidasine a
2. __________ - defining the risks must include a review of how individuals inside and outside the laboratory may be exposed to the hazards. It could either be through droplets, inhalation, ingestion, or inoculation in case a biological agent has been identified as the hazard.
3. __________- to characterize the overall biosafety risks, the risk assessment team needs to compare the likelihood and the consequences of infection-either qualitatively or quantitatively.
4. __________ - this process of evaluating the biorisk arising from a biohazard takes into account the adequacy of any existing controls, and deciding whether or not the biorisk is acceptable.

Answer 2

1) Define the situation
2) Define the risks
3) Characterize the risks
4) Determine if risks are acceptable or not

Question 3

Mitigation Procedures
The second fundamental component of the biorisk management model is ______.

_______ measures are actions and control measures that are put into place to reduce or eliminate the risks associated with biological agents and toxins (Salerno, 2015). There are five major areas of control or measures that can be employed in mitigating the risks.

1.
2.
3.
4.
5.

Answer 3

mitigation
Biorisk mitigation

1. Elimination
2. Substitution
3. Engineering controls
4. Administrative Control
5. PPE

Question 4



Elimination, the most difficult and most effective control measure, involves the total decision not to work with a specific biological agent or even not doing the intended work. Definitely, elimination provides the highest degree of risk reduction.

Substitution, the second control measure, is the replacement of the procedures or biological agent with a similar entity in order to reduce the risks. For example, a laboratory conducting research with the pathogen Bacillus anthracis, responsible for causing the acute fatal disease anthrax, could potentially substitute a less dangerous experimental surrogate, such as the Bacillus thuringiensis, an organism most commonly used in biological pesticides worldwide.

The third control measure, setting of engineering controls, 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. Examples are installation of biosafety cabinets, safety equipment (centrifuge with cover, autoclave, and machines with indicators), facility design enabling proper airflow, ventilation system to ensure directional airflow, and air treatment systems to decontaminate or remove agents from exhaust air,

The fourth measure, the setting of administrative controls, refers to the policies, standards, and guidelines used to control risks. Proficiency and competency training for laboratory staff is considered an administrative control. The displaying of biohazard or warning signages, markings, and labels, controlling visitor and worker access, and documenting written standard operating procedures are some examples. Practices and procedures of administrative controls comprise minimizing splashes, sprays, and aerosols to avoid laboratory-acquired infections or following standard operating procedures (SOPs).

The last mitigation control measure is the use of personal protective equipment (PPE). These are devices worn by workers to protect them against chemicals, toxins, and pathogenic hazards in the laboratory. Gloves, gowns, and respirators are all examples of PPE. PPE is considered the least effective measure because it only protects the person who is wearing it, and only when it is used
correctly.

Question 5

The last pillar of the biorisk management model is ___________ that involves a systematic process intended to achieve organizational objectives and goals. The model ensures that the implemented mitigation measures are indeed reducing or eliminating risks. It also helps to highlight biorisk strategies that are not working effectively and measures that are ineffective or unnecessary. These can be eliminated or replaced. Performance management is simply a reevaluation of the overall mitigation strategy. The diagram below shows the specific procedures in conducting performance evaluation.

Answer 5

performance evaluation

Question 6



KEY POINTS
. Biorisk Management (BRM) is an integral part in the implementation of the concept of biosafety and biosecurity in a laboratory. It involves the process of assessment, mitigation, and performance evaluation.
. The AMP model illustrates the balanced role among the components of BRM.
. A robust risk assessment is the heart of BRM. It ensures safety and security of the people working in the laboratory as well as all the stakeholders in an organization.
. The different mitigation procedures to be employed depend on the result of a robust risk assessment. It is recommended not to overdo or underdo the measures.
. Performance evaluation is not a linear process, rather, it is a continuous process to monitor the implementation of existing biosafety procedures and practices. It provides direction for decision-makers to be able to come up with reasonable and justifiable biosafety guidelines.
. Most importantly, communicating BRM among the members of the organization, especially to the top management paves the way for interactive transmission and exchange of information and opinions throughout the analysis process about risk, risk- related factors, and risk perceptions among risk managers, risk communicators, the general public, and other impacted parties.

Question 7



1. It refers to anything in the environment that has the potential to cause harm.
2. It refers to the possibility that something bad or unpleasant (such as an injury or loss) will happen.
3. It is the least effective mitigation measure according to the hierarchy of control.
4. It is a process of identifying the hazards and characterizing the risks.
5. It refers to a system or process of controlling safety and security risks associated with the handling, storage, and disposal of biological agents and toxins in laboratories and facilities.

Answer 7

1. Hazard
2. Risk
3. PPE
4. Risk Assessment
5. Biorisk Management