Podcast
Questions and Answers
What is defined as the possibility that something bad or unpleasant will happen in the context of biorisk management?
What is defined as the possibility that something bad or unpleasant will happen in the context of biorisk management?
Which component is NOT a primary aspect of biorisk management?
Which component is NOT a primary aspect of biorisk management?
What is the first step in the biorisk management process?
What is the first step in the biorisk management process?
Which of the following is NOT a method to manage identified risk according to the AMP model?
Which of the following is NOT a method to manage identified risk according to the AMP model?
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What is meant by 'biorisk'?
What is meant by 'biorisk'?
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Which statement about safe working practices in biorisk management is correct?
Which statement about safe working practices in biorisk management is correct?
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Continuous evaluation of effectiveness relates to which of the following in the AMP model?
Continuous evaluation of effectiveness relates to which of the following in the AMP model?
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What does the term 'biosecurity' refer to in the context of biorisk management?
What does the term 'biosecurity' refer to in the context of biorisk management?
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Which approach to biorisk management involves eliminating potential threats?
Which approach to biorisk management involves eliminating potential threats?
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What does the acronym CEN stand for in the context of biorisk management guidelines?
What does the acronym CEN stand for in the context of biorisk management guidelines?
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What is the first step in conducting a risk assessment for biological agents?
What is the first step in conducting a risk assessment for biological agents?
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Which of the following best describes a risk that is categorized as 'POSSIBLE'?
Which of the following best describes a risk that is categorized as 'POSSIBLE'?
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In risk characterization, which descriptor reflects an incident that may result in serious illness or potential fatality?
In risk characterization, which descriptor reflects an incident that may result in serious illness or potential fatality?
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What is the primary goal of determining if risks are acceptable during risk assessment?
What is the primary goal of determining if risks are acceptable during risk assessment?
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Which of the following aspects is NOT considered in the definition phase of risk assessment?
Which of the following aspects is NOT considered in the definition phase of risk assessment?
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How is 'LIKELY' defined on the scale of likelihood assessment?
How is 'LIKELY' defined on the scale of likelihood assessment?
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Which consequence descriptor indicates an incident that requires medical treatment?
Which consequence descriptor indicates an incident that requires medical treatment?
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When evaluating the adequacy of existing control measures, which of the following should NOT be a consideration?
When evaluating the adequacy of existing control measures, which of the following should NOT be a consideration?
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Which component of risk assessment provides insights into the methods of pathogen transmission?
Which component of risk assessment provides insights into the methods of pathogen transmission?
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What level of risk descriptor denotes an incident that is almost impossible to occur?
What level of risk descriptor denotes an incident that is almost impossible to occur?
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Which factor does NOT influence the acceptability of risk?
Which factor does NOT influence the acceptability of risk?
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What is categorized as an unacceptable risk level?
What is categorized as an unacceptable risk level?
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What is a critical characteristic of a good risk control strategy?
What is a critical characteristic of a good risk control strategy?
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Which aspect is NOT part of the mitigation procedures in biorisk management?
Which aspect is NOT part of the mitigation procedures in biorisk management?
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In the performance evaluation stage, why is it essential to reassess risk?
In the performance evaluation stage, why is it essential to reassess risk?
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Which option is NOT a purpose of mitigation procedures?
Which option is NOT a purpose of mitigation procedures?
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What is the expected outcome of a robust risk assessment?
What is the expected outcome of a robust risk assessment?
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Which of the following is a common misconception regarding risk control measures?
Which of the following is a common misconception regarding risk control measures?
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What should be avoided in the creation of a risk control strategy?
What should be avoided in the creation of a risk control strategy?
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Which of the following best describes the relationship between mitigation procedures and risk assessment?
Which of the following best describes the relationship between mitigation procedures and risk assessment?
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Which of the following options best describes a situation that should be defined during risk assessment?
Which of the following options best describes a situation that should be defined during risk assessment?
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What is the first step in characterizing risks according to the risk assessment process?
What is the first step in characterizing risks according to the risk assessment process?
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Which risk descriptor indicates that an incident might occur but is not very likely?
Which risk descriptor indicates that an incident might occur but is not very likely?
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In the context of assessing consequences, which descriptor represents a potentially severe incident?
In the context of assessing consequences, which descriptor represents a potentially severe incident?
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What should be assessed to determine if risks are acceptable after evaluating a biohazard?
What should be assessed to determine if risks are acceptable after evaluating a biohazard?
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When assessing likelihood of infection, which level indicates a situation that is highly probable to occur?
When assessing likelihood of infection, which level indicates a situation that is highly probable to occur?
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What is a common characteristic of laboratories working with biological agents?
What is a common characteristic of laboratories working with biological agents?
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Which of the following correctly defines a situation where an incident has trivial consequences?
Which of the following correctly defines a situation where an incident has trivial consequences?
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How should the characterization of risks be approached according to the risk assessment process?
How should the characterization of risks be approached according to the risk assessment process?
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In which situation would risks be deemed unacceptable during the risk assessment process?
In which situation would risks be deemed unacceptable during the risk assessment process?
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Which of the following factors does NOT influence the acceptability of risk?
Which of the following factors does NOT influence the acceptability of risk?
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What characterizes a risk that falls within the 'MEDIUM' to 'VERY HIGH' category?
What characterizes a risk that falls within the 'MEDIUM' to 'VERY HIGH' category?
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What is a key purpose of the mitigation procedures in biorisk management?
What is a key purpose of the mitigation procedures in biorisk management?
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Which of the following describes a quality of a good risk control strategy?
Which of the following describes a quality of a good risk control strategy?
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Why is performance evaluation critical in the biorisk management process?
Why is performance evaluation critical in the biorisk management process?
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What must be considered when evaluating the adequacy of existing control measures?
What must be considered when evaluating the adequacy of existing control measures?
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What happens to risk when laboratory activities or technology change?
What happens to risk when laboratory activities or technology change?
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Which of the following is NOT a component of the mitigation procedures?
Which of the following is NOT a component of the mitigation procedures?
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What characterizes 'acceptable risk' in the context of risk assessment?
What characterizes 'acceptable risk' in the context of risk assessment?
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Which option outlines a characteristic of a robust risk assessment?
Which option outlines a characteristic of a robust risk assessment?
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What is the primary focus of biorisk management in clinical laboratories?
What is the primary focus of biorisk management in clinical laboratories?
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Which of the following best describes risk assessment in biorisk management?
Which of the following best describes risk assessment in biorisk management?
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What is the role of the AMP model in risk management?
What is the role of the AMP model in risk management?
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Which step occurs after risk identification in the risk assessment process?
Which step occurs after risk identification in the risk assessment process?
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What does the term 'mitigation' refer to in the context of the AMP model?
What does the term 'mitigation' refer to in the context of the AMP model?
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In what ways can identified risks be managed according to the AMP model?
In what ways can identified risks be managed according to the AMP model?
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What is a critical component of a successful risk management process?
What is a critical component of a successful risk management process?
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Which characteristic is NOT part of effective biorisk management?
Which characteristic is NOT part of effective biorisk management?
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What is the ultimate goal of implementing biorisk management strategies in laboratories?
What is the ultimate goal of implementing biorisk management strategies in laboratories?
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What best represents the concept of 'biorisk'?
What best represents the concept of 'biorisk'?
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Study Notes
Prayer Before Class
- Holy Spirit, true source of light and wisdom, dispell darkness of sin and ignorance.
- Grant a penetrating mind, retentive memory, ease of learning and clarity in comprehending.
- Guide the beginning and progress of work and bring it to successful completion, through Jesus Christ.
Risk Management in the Clinical Laboratory
- Course: Principles of Medical Technology Practice 1
- Department: UST General Santos Medical Technology Department
- Topic Outline: Introduction, AMP Model, Risk Assessment, Mitigation Procedures, Performance Evaluation
Learning Outcomes
- At the end of the unit, students will articulate the importance of biorisk management in the clinical laboratory.
Introduction to Risk Management in the Clinical Laboratory
- People manage risk consciously or unconsciously, but rarely systematically.
Biorisk
- Biological toxins or infectious agents pose a risk.
Biorisk Management
- Integrating biosafety and biosecurity is essential for systematically managing risks from toxins and infectious agents.
- Safe working practices are needed to prevent exposure to pathogens and toxins.
- Protection, control, and accountability are essential practices concerning valuable biological materials within laboratories.
- Control system or process for safety and security risks related to handling, storing and disposing of biological/toxic agents.
AMP Model
- An acronym for assessment, mitigation and performance, that encompasses the identification, understanding, and management of risk.
AMP Model (Control measures)
- Control measures must be based on robust risk assessment.
- Control measures must undergo continuous evaluation of effectiveness and suitability.
AMP Model (Risk Management)
- Identified risks can be managed through mitigation, avoidance, limitation, transfer, or acceptance.
Key Components of Biorisk Management
- Core components of biorisk management, used in risk management in clinical laboratories
Risk Assessment
- First step in biorisk management, it's about identifying hazards and characterizing risks.
Risk Assessment (Steps)
- Define the situation, define the risks, characterize the risks, and determine if risks are acceptable or not.
Risk Assessment (Define Situation)
- Identify hazards and risks of biological agents
- Identify at-risk hosts (people)
- Define the laboratory environment and work activities
Risk Assessment (Define Risks)
- Review how at-risk hosts may be exposed to hazards. (e.g. Biological agent and chain of infection)
Risk Assessment (Characterize Risks)
- Quantitatively and qualitatively compare likelihood and consequences of infection.
Risk Assessment (Assessing Likelihood)
- A numerical scale determining the occurrence possibility of risk.
Risk Assessment (Assessing Consequences)
- A numerical scale assessing the impact of a risk.
Risk Assessment (Acceptable/Not Acceptable)
- Determine if risks are acceptable or not based on various factors such as regulatory requirements, resource availability, risk mitigation strategies and stakeholder perception.
- Risks that are too high require mitigation.
Mitigation Procedures
- Second component of the biorisk management model; depends on thorough risk assessments.
- Includes the steps for mitigating identified hazards and risks ( actions, controls and purpose).
- It aims at reducing or eliminating risks associated with biological agents or toxins.
Mitigation Procedures (Risk Control Strategy)
- Provide a clear direction outlining measures to reduce risk.
- Be practical to be achievable with available resources.
- Minimize resistance by securing support and considering the work being performed.
- Align with overall organizational objectives and mission.
Performance Evaluation
- Last component of the biorisk management model that ensures effectiveness of implemented mitigation measures.
- It involves a systematic process to achieve organizational objectives.
- Use data to determine if performance indicators are successful.
Performance Evaluation (Procedures)
-
Identify key issues, evaluate and refine performance indicators, provide findings from performance indicators, collect data and report indicator results, define outcome, activities indicators and metrics.
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When laboratory activities, personnel, processes, and technology change, so does the risk
References
-
Benitez, P., Dumaoal, O., Estrella, F., Mortel, F., Nava, M. (2019). Principles of Medical Laboratory Science 1. C and E Publishing, Inc.
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WHO 2020 Laboratory Biosafety Manual 4th Edition.
Dominican Blessing
- A formal blessing from the Dominican order, asking God's blessings on people and their work.
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Description
Explore the essentials of risk management in clinical laboratories through this quiz. Understand the AMP Model, risk assessment techniques, and the significance of biorisk management. This quiz is designed for students of Medical Technology Practice 1 for a comprehensive understanding of managing biological risks.
