Risk Management in the Clinical Laboratory PDF

PRAYER BEFORE CLASS Holy Spirit, Divine Creator, true source of light and fountain of wisdom! Pour forth your brilliance upon my dense intellect, dissipate the darkness which covers me, that of sin and of ignorance. Grant me a penetrating mind to understand, a retentive memory, method and ease of le...

PRAYER BEFORE CLASS Holy Spirit, Divine Creator, true source of light and fountain of wisdom! Pour forth your brilliance upon my dense intellect, dissipate the darkness which covers me, that of sin and of ignorance. Grant me a penetrating mind to understand, a retentive memory, method and ease of learning, the lucidity to comprehend, and abundant grace in expressing myself. Guide the beginning of my work, direct its progress and bring it to successful completion. This I ask through Jesus Christ, true God, and true man, living and reigning with You and the Father, forever and ever. Amen.  UST General Santos Medical Technology Department RISK MANAGEMENT IN THE CLINICAL LABORATORY PRINCIPLES OF MEDICAL TECHNOLOGY PRACTICE 1 Outline Introduction AMP Model Risk Assessment Mitigation Procedures Performance Evaluation Learning Outcomes At the end of the unit, the student must be able to: Articulate the importance of biorisk management in the clinical laboratory  UST General Santos INTRODUCTION RISK MANAGEMENT IN THE CLINICAL LABORATORY  We all manage risk consciously or unconsciously - but rarely systematically  Biorisk - Risk associated to biological toxins or infectious agents Biorisk Management - Integration of biosafety and biosecurity to systematically manage risks when working with toxins and infectious agents REVIEW: _________ - safe working practices implemented to prevent exposure to pathogens and toxins ___________ - protection, control, and accountability for valuable biological materials within laboratories Biorisk Management CEN Workshop Agreement 15793:2011 “A system or process to control safety and security risks associated with the handling or storage and disposal of biological agents and toxins in laboratories and facilities” Biorisk Management - Encompasses identification, understanding, and management aspects of a system in interrelated processes - Primary components - Assessment - Mitigation - Performance  UST General Santos AMP Model RISK MANAGEMENT IN THE CLINICAL LABORATORY AMP Model Control measures must be: Based on robust risk assessment Undergo continuous evaluation of effectiveness and suitability AMP Model Identified risk can be managed thru: ○ Mitigation ○ Avoidance ○ Limitation ○ Transfer ○ Acceptance AMP Model  UST General Santos KEY COMPONENTS OF BIORISK MANAGEMENT RISK MANAGEMENT IN THE CLINICAL LABORATORY Risk Assessment - First step in implementing a biorisk management process - Includes: - Identification of hazards - Characterization of risks _ _ _ _ _ _ refers to anything in the environment that has the potential to cause harm _ _ _ _ defined as the possibility that something bad or unpleasant will happen Risk Assessment STEPS 1. Define the situation 2. Define the risks 3. Characterize the risks 4. Determine if risks are acceptable or not Risk Assessment 1. Define the situation - Identify the hazards and risks of the biological agents to be handled - At-risk hosts must be identified - Work activities and laboratory environment should be defined Risk Assessment 2. Define the risks - Review of how at-risk host may be exposed to the hazards EXAMPLE: Biological agent Which component of the Chain of Infection provides insights into the methods by which a pathogen can be transmitted to a susceptible host? Risk Assessment 3. Characterize the risks - Compare the likelihood and consequences of infection (quantitatively and qualitatively) 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 Risk Assessment ASSESSING CONSEQUENCES LEVEL DESCRIPTOR DESCRIPTION 1 NEGLIGIBLE Trivial incident or near miss requiring reporting and follow up 2 MINOR Incident with self-limiting consequences 3 MODERATE Incident that requires medical treatment and/or has insignificant environmental consequences 4 MAJOR Incident with potential lost time due to infection but non-permanent consequence and/or limited environmental impact 5 SEVERE Potential fatality or serious illness with potential disability and/or serious environmental impact Risk Assessment 4. Determine if risks are acceptable or not - Laboratories that work with biological agents can never eliminate all biological risks completely - Evaluate the risk arising from a biohazard - Adequacy of existing control measures - Determining whether the risk is acceptable or not - Risks are acceptable → work can proceed safely - Risks are too high → mitigate Risk Assessment 4. Determine if risks are acceptable or not - Acceptable risk varies and influenced by several factors - Factors involved: - Regulatory requirements overseeing risk - Availability and sustainability of resources - Measures for risk mitigation - Endemicity of the biological agent or disease in local population - Value of the work to the community - Risk perception of stakeholders Risk Assessment VERY LOW to LOW: ACCEPTABLE | MEDIUM to VERY HIGH: UNACCEPTABLE Mitigation Procedures Second component of biorisk management model Depend on the result of robust risk assessment Includes: ○ Actions ○ Controls Purpose ○ To reduce or eliminate the risks associated with biological agents or toxins Mitigation Procedures What is a good risk control strategy? A good risk control strategy should: ○ Provide a clear direction: outline the general types of measures needed to reduce risks ○ Be practical: strategy should be achievable using the available resources ○ Minimize resistance: consider the work being performed and secure support (ex. Approvals from national regulatory authorities) ○ Align with overall goals: contribute to the organization’s objectives and mission UST General Santos Can a single control measure effectively mitigate all risks? Performance Evaluation Last component of biorisk management model Involves a systematic process intended to achieve organizational objectives and goals Ensures implemented mitigation measures are effective in reducing or eliminating risks Performance Evaluation 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: https://www.who.int/publications/i/item/9789240011311 Dominican Blessing May God the Father bless us May God the Son heal us May God the Holy Spirit enlighten us Give us eyes to see with, ears to hear with, hands to do the work of God with, feet to walk with, and mouth to preach the word of salvation with; And may the angel of peace watch over us, and lead us at last by the Lord’s gift of the kingdom. Amen.