Risk Management in Clinical Laboratories

Prayer Before Class

• Holy Spirit, Divine Creator, true source of light and fountain of wisdom, pour forth your brilliance upon the speaker's dense intellect.
• Dissipate the darkness of sin and ignorance.
• Grant a penetrating mind to understand, a retentive memory, method, ease of learning, and lucidity to comprehend.
• Abundant grace in expressing oneself is asked for.
• Guide the beginning, direct progress, and bring work to successful completion.
• The prayer is made through Jesus Christ, true God and true man, living and reigning with the Father forever and ever. Amen.

Risk Management in the Clinical Laboratory

• Topic: Risk management in the clinical laboratory.
• Institution: UST General Santos Medical Technology Department.

Outline

• Introduction
• AMP Model
• Risk Assessment
• Mitigation Procedures
• Performance Evaluation

Learning Outcomes

• At the end of the unit, students must articulate the importance of biorisk management in the clinical laboratory.

Introduction

• Risk management in the clinical laboratory.

AMP Model

• This model is used for risk management.
• Control measures must be based on robust risk assessments.
• Ongoing evaluations of effectiveness and suitability are required.
• Identified risks can be managed through:
  • Mitigation
  • Avoidance
  • Limitation
  • Transfer
  • Acceptance

Biorisk Management

• Risk associated to biological toxins or infectious agents.
• Integration of biosafety and biosecurity to systematically manage risks.
• Safe working practices are implemented to prevent exposure to pathogens and toxins.
• Protection, control, and accountability for valuable biological materials within laboratories.
• A system or process to control safety and security risks associated with biological agents and toxins in laboratories.
• Biorisk Management
  • Entails the evaluation and control of safety and security risks when handling, storing and disposing biological agents and toxins in laboratories and facilities.
  • Primary components:
    • Assessment
    • Mitigation
    • Performance

Risk Assessment

• First Step: Identifying potential hazards and characterizing risks.
• Hazard: Anything in the environment with the potential to cause harm; possibility that something bad or unpleasant might happen.
• Four steps involved:
  • Defining the situation, including hazards and risks of the biological agents, at-risk hosts, and the work environment.
  • Defining the risks and review how at-risk hosts may be exposed to hazards (e.g. use the Chain of Infection to understand pathogen transmission).
  • Characterizing the risks in terms of likelihood and consequences. Use tables to quantify likelihood and consequences.
  • Determining if the identified risks are acceptable, evaluating whether the identified risks are acceptable (using factors relevant to risk assessment)

Assessing Likelihood

• Level | Descriptor | Description
• --- | --- | ---
• 1 | RARE | Almost impossible to occur
• 2 | UNLIKELY | Not very possible to occur
• 3 | POSSIBLE | Might occur
• 4 | LIKELY | Very possible to occur
• 5 | ALMOST CERTAIN | Highly probable to occur

Assessing Consequences

• Level | Descriptor | Description
• --- | --- | ---
• 1 | NEGLIGIBLE | Trivial incident
• 2 | MINOR | Self-limiting consequences
• 3 | MODERATE | Medical treatment needed; insignificant environmental consequences.
• 4 | MAJOR | Potential lost time; non-permanent consequences.
• 5 |SEVERE | Potential fatality; serious illness; disability or severe environmental impact.

Mitigation Procedures

• Second Component: The second component in the biorisk management model depending on the result of robust risk assessment.
• Includes:
  • Actions
    • To reduce or eliminate risks associated with biological agents or toxins
  • Controls
  • Purpose
• The strategy must be achievable using available resources and it should align with overall goals.

Performance Evaluation

• Last Component: The final component of the biorisk management model
• Involves: A systematic process for achieving organizational objectives and goals.
• Ensures: That implemented mitigation measures are effective in reducing or eliminating risks.