Risk Management in Clinical Laboratory - Medical Technology
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Questions and Answers

What is the primary factor that influences whether a risk is considered acceptable?

  • Regulatory requirements overseeing risk (correct)
  • The personal preference of the stakeholders
  • The availability of technology
  • The economic benefits of the project

Which of the following best describes an effective risk control strategy?

  • It should be theoretical and not constrained by resources
  • It should prioritize the interests of stakeholders above all else
  • It should be aimed solely at eliminating all risks entirely
  • It should minimize resistance and secure support (correct)

What classification defines risks that are considered acceptable?

  • Unacceptable to High
  • Very High to Medium
  • Very Low to Low (correct)
  • Medium to High

Which of the following is NOT a component of the biorisk management model?

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

What should a robust risk assessment primarily lead to?

<p>Development of effective mitigation procedures (D)</p> Signup and view all the answers

How does performance evaluation in biorisk management operate?

<p>It is a systematic ongoing process evaluating effectiveness (A)</p> Signup and view all the answers

Which factor is least likely to influence the acceptability of a risk?

<p>The personal experiences of laboratory personnel (D)</p> Signup and view all the answers

Which is a key purpose of implementing mitigation procedures?

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

What is the first step in the risk assessment process related to biological agents?

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

Which of the following best describes the descriptor 'MAJOR' in assessing consequences?

<p>Incident causing potential lost time due to infection but with non-permanent consequences (D)</p> Signup and view all the answers

When characterizing risks, what must be compared?

<p>Likelihood and consequences of infection (B)</p> Signup and view all the answers

What does the assessment level 'UNLIKELY' indicate in terms of risk occurrence?

<p>Might occur but not very possible (B)</p> Signup and view all the answers

In determining if risks are acceptable, what should be evaluated first?

<p>The existing control measures (A)</p> Signup and view all the answers

Which level of likelihood corresponds to 'almost impossible to occur'?

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

What action should be taken if risks are deemed too high in a laboratory setting?

<p>Implement mitigation strategies (B)</p> Signup and view all the answers

Which descriptor indicates an incident with trivial consequences requiring reporting?

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

What is the primary goal of biorisk management in the clinical laboratory?

<p>To systematically manage risks associated with biological toxins and infectious agents (D)</p> Signup and view all the answers

Which component is NOT part of the AMP Model for risk management?

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

What does the term 'biorisk' refer to?

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

Which of the following is a step in risk assessment in the biorisk management process?

<p>Identification of hazards (B)</p> Signup and view all the answers

Which of the following best describes the concept of 'performance evaluation' in biorisk management?

<p>An ongoing check of the effectiveness and suitability of control measures (C)</p> Signup and view all the answers

What type of control measure is 'avoidance' classified as in the AMP Model?

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

What does the term 'hazard' refer to in the context of risk assessment?

<p>Anything in the environment that has the potential to cause harm (C)</p> Signup and view all the answers

What is a key feature of the CEN Workshop Agreement 15793:2011 related to biorisk management?

<p>It outlines safety and security risk control systems for biological agents (C)</p> Signup and view all the answers

What role does 'mitigation' play within the AMP Model?

<p>It is a step taken to minimize potential impacts of identified risks (B)</p> Signup and view all the answers

Which of the following aspects does NOT fall under biorisk management?

<p>Enhancing laboratory productivity (C)</p> Signup and view all the answers

Flashcards

Risk Assessment Step 1

Identifying hazards and risks associated with biological agents, at-risk hosts, and the work environment.

Risk Assessment Step 2

Analyzing how at-risk hosts might be exposed to hazards.

Risk Assessment Step 3

Evaluating the likelihood and severity of infection by comparing them quantitatively and qualitatively.

Likelihood Level 1

Rare: Almost impossible to occur.

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Likelihood Level 5

Almost Certain: Highly probable to occur.

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Consequence Level 1

Negligible: Trivial incident or near miss requiring reporting and follow up.

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Consequence Level 5

Severe: Potential fatality or serious illness with potential disability and/or serious environmental impact.

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Risk Assessment Step 4

Determining if risks are acceptable by evaluating existing control measures and deciding whether to proceed safely or mitigate the risk.

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What is biorisk management?

Biorisk management is a systematic approach to controlling safety and security risks associated with handling, storing, and disposing of biological agents and toxins in labs.

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What's the core concept of biorisk management?

Biorisk management aims to integrate biosafety and biosecurity practices to effectively manage risks within labs.

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What is biosafety?

Biosafety refers to safe working practices implemented to prevent exposure to pathogens and toxins.

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What is biosecurity?

Biosecurity focuses on the protection, control, and accountability for valuable biological materials within laboratories.

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Risk Assessment

The first step in implementing a biorisk management process, it involves identifying potential hazards and characterizing their risks.

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Hazard

Anything in the environment that has the potential to cause harm.

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Risk

The possibility that something bad or unpleasant will happen.

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Amp Model

A model for managing risk that focuses on assessment, mitigation, and performance.

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Mitigation

Actions taken to lessen the impact of a risk.

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Performance Evaluation

A process to assess the effectiveness of biorisk management controls and measure their impact.

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Risk Acceptance

Determining whether identified risks are tolerable or unacceptable.

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Factors Influencing Risk Acceptance

These factors determine whether a risk is considered acceptable, including legal obligations, resources, mitigation measures, local disease prevalence, project value, and stakeholder concerns.

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Mitigation Procedures

Actions, such as controls, taken to reduce or eliminate risks associated with biological agents.

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Good Risk Control Strategy

A well-defined plan that is practical, minimizes resistance, and aligns with organizational goals, ensuring effective risk reduction.

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Dynamic Risk

Risks can change as lab activities, personnel, processes, or technology evolve.

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Mitigation Procedures Role

They depend on a thorough risk assessment and aim to reduce risks associated with handling biological agents.

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Single Control Measure and Risk

A single control measure may not be enough to mitigate all risks.

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Study Notes

Prayer Before Class

  • Holy Spirit, Divine Creator, is the true source of light and wisdom.
  • Students seek brilliance, dispelling darkness of sin and ignorance.
  • A penetrating mind to understand, a retentive memory, and ease of learning are requested.
  • Students ask for clarity in expression, successful completion of work, and guidance in their progress.
  • This prayer is made through Jesus Christ.

Risk Management in the Clinical Laboratory

  • Course: Principles of Medical Technology Practice 1
  • Department: Medical Technology
  • University: UST General Santos
  • Topics include Introduction, AMP Model, Risk Assessment, Mitigation Procedures, and Performance Evaluation.

Learning Outcomes

  • Students will be able to articulate the importance of biorisk management in the clinical laboratory.

Introduction

  • Risk Management in the Clinical Laboratory is the topic of the introduction.

Risk Management

  • Risk is managed consciously or unconsciously, rarely systematically.
  • Biorisk is the risk associated with biological toxins and infectious agents.

Biorisk Management

  • Biosafety and biosecurity integration to manage risks.
  • Safe working practices to prevent exposure to pathogens and toxins.
  • Protection, control, and accountability for valuable biological materials in laboratories.
  • A system or process to control safety and security risks.

AMP Model

  • Biorisk management encompasses risk identification, understanding, and management, system aspects in interrelated processes.
  • Three primary components: assessment, mitigation, and performance.
  • Control measures must be based on robust risk assessment and undergo continuous evaluation of effectiveness and suitability.
  • Identified risks can be managed through mitigation, avoidance, limitation, transfer, or acceptance.

Risk Assessment

  • First step in implementing a biorisk management process.
  • Includes hazard identification and risk characterization.
  • Risk is defined as the possibility that something bad or unpleasant will happen.
  • Steps in risk assessment: define the situation, the risks, characterize the risks, and determine if risks are acceptable or not.
  • Defining the situation entails identifying hazards and risks of biological agents, identifying at-risk hosts, and defining work activities and laboratory environment.
  • Defining the risks involves reviewing how at-risk hosts may be exposed to hazards. Example: a biological agent component of the chain of infection.
  • Characterizing the risks involves comparing the likelihood and consequences of infection quantitatively and qualitatively.
  • Determining if risks are acceptable or not depends on factors including regulatory requirements, resource availability and sustainability, risk mitigation measures, local endemism, community value, stakeholder perception, and risk matrix analysis.

Mitigation Procedures

  • The second component of the biorisk management model.
  • Depends on risk assessment results.
  • Includes actions and controls.
  • Purpose: To reduce or eliminate risks associated with biological agents or toxins.
  • Good risk control strategies: provide a clear direction, be practical, minimize resistance, align with overall goals.

Performance Evaluation

  • The last component of the biorisk management model.
  • Involves a systematic process to achieve organizational goals.
  • Ensures implemented mitigation measures are effective in mitigating or eliminating risks.
  • The process includes identifying key issues, evaluating and refining performance indicators, providing findings from indicators, collecting data, reporting indicator results, defining outcome indicators and metrics, and defining activities indicators and metrics.
  • Laboratory activities, personnel, processes, and technology changes affect 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: [URL removed]

Dominican Blessing

  • Prayer for blessings from God the Father, Son, and Holy Spirit.
  • Guidance, eyes to see, ears to hear, hands to do God's work, feet to walk the path of salvation, and a mouth to preach the Word of God.
  • Guardian angel's protection and the Lord's gift of the kingdom.

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Description

This quiz covers risk management principles specifically tailored for clinical laboratories as part of the Medical Technology course. Students will explore key topics including the AMP Model, risk assessment, mitigation procedures, and performance evaluation. Enhance your understanding of biorisk management and its significance in ensuring safety and effectiveness in laboratory practices.

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