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    Risk1

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    Risk1

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    colleges660
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    Risk1

    Uploaded by

    colleges660

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    Comprehensive Summary: Risk Management in Medical Laboratories (ISO 15189:2022)

    Learning Objectives:

    1. Understand the ISO 15189:2022 requirements for risk assessment and management.
    2. Analyze risks across laboratory phases:
    o Pre-analytical phase: Errors before testing.
    o Analytical phase: Errors during testing.
    o Post-analytical phase: Errors after testing.
    3. Explore tools like Failure Mode and Effects Analysis (FMEA) for risk evaluation.

    Key Concepts:

    1. Risk in ISO 15189:2022:


    o Risk management is a central requirement for accredited labs.
    o It focuses on identifying, mitigating, and monitoring risks that affect patient care.
    o Emphasizes patient-centered decision-making to reduce harm.
    2. Risk Management Framework:
    o Steps:
    1. Plan for risks.
    2. Identify potential risks.
    3. Analyze their impact.
    4. Develop mitigation strategies.
    5. Monitor and control outcomes.
    3. Definitions:
    o Risk: Probability and severity of harm.
    o Hazard: Potential source of harm.
    o Risk Analysis: Identifying hazards and estimating risks.
    o Risk Mitigation: Steps to reduce or prevent risks.

    Risk Across Laboratory Processes:

    1. Pre-analytical Risks:
    o Contributors: Mislabeling, incorrect storage, improper patient preparation, transportation issues.
    o Examples:
    ▪ Fasting instructions not followed.
    ▪ Improper temperature during sample shipment.
    o Mitigation:
    ▪ Clear guidelines for handling and transportation.
    ▪ Proper training for staff and transporters.
    2. Analytical Risks:
    o Contributors: Poor QC practices, lack of method validation, high staff turnover, unclear
    communication during shifts.
    o Examples:
    ▪ Neglecting manufacturer instructions for calibration.
    o Mitigation:
    ▪ Regular QC, effective communication, and staff training.
    ▪ Encouraging a culture of transparency to report errors without fear.
    3. Post-analytical Risks:
    o Contributors: Errors in result validation, manual transcription errors, delayed reporting.
    o Examples:
    ▪ Misinterpretation of oral results due to lack of confirmation.
    o Mitigation:
    ▪ Implementing IT systems for result management.
    ▪ Developing mechanisms for communicating critical results accurately.

    Tools for Risk Reduction:

    1. Failure Mode and Effects Analysis (FMEA):


    o Analyzes every process step to identify potential failures.
    o Creates safeguards to prevent errors.
    2. Risk Matrix:
    o Ranks risks based on severity and frequency.
    3. Severity Outcome Grid:
    o Evaluates how serious and frequent risks are to prioritize action.

    Risk Metrics:

    • Risk Priority Number (RPN):


    o A score combining severity, occurrence, and detectability to prioritize risks.
    o An RPN above 125 requires immediate action.
    • Critical Number (CN):
    o Focuses on severity and occurrence if detectability is hard to rank.

    Key Takeaways:

    1. Uncertainty is inevitable: Risk cannot be fully eliminated but can be significantly minimized.
    2. Importance of Strategy:
    o A risk management plan will help identify, prevent, and mitigate errors.
    o Testing processes must be reliable to ensure quality patient care.

    This summary captures all major points. Let me know if you want me to focus on a specific section or expand
    on anything!

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