Risk Management in Clinical Laboratories
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Questions and Answers

What is defined as the possibility that something bad or unpleasant will happen in the context of biorisk management?

  • Hazard
  • Threat
  • Peril
  • Risk (correct)

Which component is NOT a primary aspect of biorisk management?

  • Performance
  • Response (correct)
  • Assessment
  • Mitigation

What is the first step in the biorisk management process?

  • Mitigation Strategies
  • Implementation of control measures
  • Performance Evaluation
  • Risk Assessment (correct)

Which of the following is NOT a method to manage identified risk according to the AMP model?

<p>Combination (D)</p> Signup and view all the answers

What is meant by 'biorisk'?

<p>Risk associated with biological toxins or infectious agents (B)</p> Signup and view all the answers

Which statement about safe working practices in biorisk management is correct?

<p>They should be implemented consistently to prevent exposure. (B)</p> Signup and view all the answers

Continuous evaluation of effectiveness relates to which of the following in the AMP model?

<p>Control Measures (A)</p> Signup and view all the answers

What does the term 'biosecurity' refer to in the context of biorisk management?

<p>Protection and accountability for biological materials (C)</p> Signup and view all the answers

Which approach to biorisk management involves eliminating potential threats?

<p>Avoidance (C)</p> Signup and view all the answers

What does the acronym CEN stand for in the context of biorisk management guidelines?

<p>European Committee for Standardization (A)</p> Signup and view all the answers

What is the first step in conducting a risk assessment for biological agents?

<p>Define the situation (A)</p> Signup and view all the answers

Which of the following best describes a risk that is categorized as 'POSSIBLE'?

<p>Might occur (A)</p> Signup and view all the answers

In risk characterization, which descriptor reflects an incident that may result in serious illness or potential fatality?

<p>SEVERE (B)</p> Signup and view all the answers

What is the primary goal of determining if risks are acceptable during risk assessment?

<p>To mitigate risks that are considered too high (A)</p> Signup and view all the answers

Which of the following aspects is NOT considered in the definition phase of risk assessment?

<p>Reviewing mode of transmission of hazards (A)</p> Signup and view all the answers

How is 'LIKELY' defined on the scale of likelihood assessment?

<p>Very possible to occur (A)</p> Signup and view all the answers

Which consequence descriptor indicates an incident that requires medical treatment?

<p>MODERATE (A)</p> Signup and view all the answers

When evaluating the adequacy of existing control measures, which of the following should NOT be a consideration?

<p>Financial implications of control measures (C)</p> Signup and view all the answers

Which component of risk assessment provides insights into the methods of pathogen transmission?

<p>Defining the risks (B)</p> Signup and view all the answers

What level of risk descriptor denotes an incident that is almost impossible to occur?

<p>RARE (D)</p> Signup and view all the answers

Which factor does NOT influence the acceptability of risk?

<p>Emotional wellbeing of the staff (A)</p> Signup and view all the answers

What is categorized as an unacceptable risk level?

<p>MEDIUM (A)</p> Signup and view all the answers

What is a critical characteristic of a good risk control strategy?

<p>It must garner support from national regulatory authorities (C)</p> Signup and view all the answers

Which aspect is NOT part of the mitigation procedures in biorisk management?

<p>Formulate a robust risk assessment (C)</p> Signup and view all the answers

In the performance evaluation stage, why is it essential to reassess risk?

<p>When laboratory activities and technologies change (D)</p> Signup and view all the answers

Which option is NOT a purpose of mitigation procedures?

<p>To outline the roles of stakeholders (B)</p> Signup and view all the answers

What is the expected outcome of a robust risk assessment?

<p>Designation of risk mitigation measures (A)</p> Signup and view all the answers

Which of the following is a common misconception regarding risk control measures?

<p>One measure can mitigate all risks (D)</p> Signup and view all the answers

What should be avoided in the creation of a risk control strategy?

<p>Overcomplicating the risk assessment process (B)</p> Signup and view all the answers

Which of the following best describes the relationship between mitigation procedures and risk assessment?

<p>Mitigation procedures depend on risk assessment outcomes (B)</p> Signup and view all the answers

Which of the following options best describes a situation that should be defined during risk assessment?

<p>Identifying the hazards and risks of biological agents (C)</p> Signup and view all the answers

What is the first step in characterizing risks according to the risk assessment process?

<p>Comparing likelihood and consequences of infection (D)</p> Signup and view all the answers

Which risk descriptor indicates that an incident might occur but is not very likely?

<p>Unlikely (A)</p> Signup and view all the answers

In the context of assessing consequences, which descriptor represents a potentially severe incident?

<p>Severe (D)</p> Signup and view all the answers

What should be assessed to determine if risks are acceptable after evaluating a biohazard?

<p>Adequacy of existing control measures (C)</p> Signup and view all the answers

When assessing likelihood of infection, which level indicates a situation that is highly probable to occur?

<p>Likely (C)</p> Signup and view all the answers

What is a common characteristic of laboratories working with biological agents?

<p>They must balance risk management and scientific progress (A)</p> Signup and view all the answers

Which of the following correctly defines a situation where an incident has trivial consequences?

<p>Negligible (A)</p> Signup and view all the answers

How should the characterization of risks be approached according to the risk assessment process?

<p>Using both qualitative and quantitative comparisons (A)</p> Signup and view all the answers

In which situation would risks be deemed unacceptable during the risk assessment process?

<p>When potential risks threaten public health (C)</p> Signup and view all the answers

Which of the following factors does NOT influence the acceptability of risk?

<p>Public opinion on environmental issues (C)</p> Signup and view all the answers

What characterizes a risk that falls within the 'MEDIUM' to 'VERY HIGH' category?

<p>It is generally seen as unacceptable. (B)</p> Signup and view all the answers

What is a key purpose of the mitigation procedures in biorisk management?

<p>To reduce or eliminate risks associated with biological agents (C)</p> Signup and view all the answers

Which of the following describes a quality of a good risk control strategy?

<p>It should provide clear direction and be practical. (A)</p> Signup and view all the answers

Why is performance evaluation critical in the biorisk management process?

<p>To ensure that implemented measures effectively reduce risks (A)</p> Signup and view all the answers

What must be considered when evaluating the adequacy of existing control measures?

<p>The specific risks associated with the biological agents in use (B)</p> Signup and view all the answers

What happens to risk when laboratory activities or technology change?

<p>Risk evolves alongside the changes in processes. (C)</p> Signup and view all the answers

Which of the following is NOT a component of the mitigation procedures?

<p>Evaluations (B)</p> Signup and view all the answers

What characterizes 'acceptable risk' in the context of risk assessment?

<p>It typically falls in the 'VERY LOW' to 'LOW' range. (A)</p> Signup and view all the answers

Which option outlines a characteristic of a robust risk assessment?

<p>It needs to encompass various influencing factors. (C)</p> Signup and view all the answers

What is the primary focus of biorisk management in clinical laboratories?

<p>Integration of biosafety and biosecurity to manage biological risks (D)</p> Signup and view all the answers

Which of the following best describes risk assessment in biorisk management?

<p>The process of identifying hazards and characterizing risks (B)</p> Signup and view all the answers

What is the role of the AMP model in risk management?

<p>To provide a systematic approach for managing identified risks (B)</p> Signup and view all the answers

Which step occurs after risk identification in the risk assessment process?

<p>Risk characterization (C)</p> Signup and view all the answers

What does the term 'mitigation' refer to in the context of the AMP model?

<p>Strategies to reduce the impact of identified risks (B)</p> Signup and view all the answers

In what ways can identified risks be managed according to the AMP model?

<p>Through mitigation, avoidance, limitation, transfer, and acceptance (D)</p> Signup and view all the answers

What is a critical component of a successful risk management process?

<p>Robust risk assessment and continuous evaluation (B)</p> Signup and view all the answers

Which characteristic is NOT part of effective biorisk management?

<p>Ignoring low-level risks (B)</p> Signup and view all the answers

What is the ultimate goal of implementing biorisk management strategies in laboratories?

<p>To safeguard against risks associated with biological materials (B)</p> Signup and view all the answers

What best represents the concept of 'biorisk'?

<p>Risk from biological toxins or infectious agents (C)</p> Signup and view all the answers

Flashcards

Biorisk Management

A system to control safety and security risks associated with biological agents and toxins in labs

Biosafety

Safe working practices to prevent exposure to pathogens and toxins

Biosecurity

Protection, control, and accountability for valuable biological materials

Risk Assessment

Identifying hazards and characterizing risks, the first step of biorisk management

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Hazard

Anything in the environment that could cause harm

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Risk

The possibility of something bad or unpleasant occurring

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Mitigation

Actions to reduce the likelihood and severity of a risk

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AMP Model

A model for managing risks by mitigation, avoidance, limitation, transfer, or acceptance

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Hazard Identification

The step toward identifying the elements that could cause harm

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Risk Characterization

Understanding the risks by analyzing the likelihood and potential effects of a hazard

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Risk Assessment

A systematic process for identifying, analyzing, and evaluating potential hazards and risks associated with handling biological agents in a laboratory setting

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Define the Situation

The initial risk assessment step; identify hazards and risks from biological agents, at-risk hosts, and lab environment

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Define the Risks

Analyzing how at-risk hosts might be exposed to hazards from biological agents; understanding exposure methods.

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Characterize the Risks

Evaluating the likelihood and consequences of infection, both qualitatively (descriptive) and quantitatively (using scales).

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Assessing Likelihood

Categorizing the probability of a risk occurring; using a scale (1-5) with descriptors like "rare" to "almost certain".

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Assessing Consequences

Evaluating the potential impact of a risk, using a scale (1-5) to measure severity, from negligible to severe consequences.

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Acceptable Risk

A risk level deemed low enough to allow work to proceed safely.

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Mitigate Risk

Actions taken to reduce or eliminate unacceptable risks.

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Chain of Infection

The process by which a pathogen can be transmitted to a susceptible host.

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Biological Agents

Living organisms capable of causing harm or infection (e.g., bacteria, viruses, fungi)

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Acceptable Risk

A risk level deemed acceptable based on factors like regulatory requirements, resource availability, mitigation measures, local disease prevalence, community benefit, and stakeholder perception.

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Risk Assessment

The process of evaluating risks associated with biological agents or toxins.

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Risk Mitigation Procedures

Actions and controls put in place to reduce or eliminate risks related to biological agents or toxins.

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Risk Control Strategy

A plan of measures to lower biological risk, featuring clear goals, achievable steps, support, and alignment with overall objectives.

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Performance Evaluation

A systematic process to ensure risk mitigation procedures are effective in achieving organizational goals.

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Single Control Measure

A single action or step to mitigate a risk.

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Risk Factors

Influencing elements that determine if a risk is acceptable, including regulatory requirements, resource availability and sustainability, mitigation procedures, endemicity of biological agents, community value, and stakeholder perceptions.

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Biorisk Management Model

A model comprised of risk assessment, risk mitigation, and performance evaluation to manage biorisks (biological risks).

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Unacceptable Risk

A risk level that necessitates further action or management to reduce risk to acceptable levels.

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Laboratory Changes

Modifications to laboratory activities, personnel, processes or technology that subsequently impacts the levels of biosafety risk.

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Prayer Before Class

A prayer asking for divine guidance and wisdom to aid learning during a class, asking the Holy Spirit for insight and clarity.

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Biorisk Management

Systematically controlling biosafety and biosecurity risks from biological toxins and infectious agents.

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Biosafety

Safe practices to prevent exposure to pathogens.

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Biosecurity

Protecting and controlling biological materials' safety.

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Risk Assessment

Identifying hazards and evaluating risk possibilities.

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Hazard

Potential source of harm in the environment.

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Risk

Possibility of harm or something bad happening.

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AMP Model

Framework for managing risks using strategies (avoidance, limitation, etc.).

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Mitigation

Actions to reduce risk severity.

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Risk Assessment Steps

Identifying hazards, evaluating risks using a process. Examples include identifying and characterizing risks.

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Define the Situation

The first step in risk assessment; identify hazards and risks from biological agents, at-risk individuals, and the lab environment.

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Define the Risks

Analyzing how at-risk individuals might be exposed to hazards from biological agents; understanding exposure methods.

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Characterize the Risks

Evaluating the likelihood and consequences of infection, both qualitatively (descriptive) and quantitatively (using scales).

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Assessing Likelihood

Categorizing the probability of a risk occurring; using a scale (1-5) with descriptors like "rare" to "almost certain".

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Assessing Consequences

Evaluating the potential impact of a risk, using a scale (1-5) to measure severity, from negligible to severe.

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Acceptable Risk

A risk level deemed low enough to allow work to proceed safely.

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Mitigate Risk

Actions taken to reduce or eliminate unacceptable risks.

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Chain of Infection

The process by which a pathogen can be transmitted to a susceptible host.

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Biological Agents

Living organisms capable of causing harm or infection

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Risk Assessment

A process for evaluating the potential risks related to biological agents in laboratories.

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Acceptable Risk

A risk level low enough to allow safe work procedures.

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Risk Assessment

Evaluating potential hazards and risks of handling biological agents.

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Risk Mitigation Procedures

Actions to reduce or eliminate risks from biological agents.

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Risk Control Strategy

Plan of measures to lower biological risks.

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Performance Evaluation

Checking if risk mitigation works to meet goals.

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Single Control Measure

One action to lower a risk.

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Risk Factors

Elements determining if risk is acceptable.

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Unacceptable Risk

A risk that needs more attention for lowering.

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Laboratory Changes

Modifications to lab procedures, staff, or tools affecting biosafety risk levels.

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Risk Assessment Factors

Influences on whether a risk is acceptable or not (e.g., safety regulations, available resources, risk mitigation, biological agent presence, community impact, stakeholder opinions).

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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.

  • 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.

  • 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.

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