PG-PCs Bio-Risk Mangement L4 Souzan PDF

Implementing a Biorisk Management System (II) Souzan Eassa Molecular and Microbiology Division SoM-UKH/ HSP-Follow  Fundamentals of Biorisk Management System Learning outcomes By the end of this lecture, students will be able to: 1. Apply risk m...

Implementing a Biorisk Management System (II) Souzan Eassa Molecular and Microbiology Division SoM-UKH/ HSP-Follow  Fundamentals of Biorisk Management System Learning outcomes By the end of this lecture, students will be able to: 1. Apply risk management strategies, including administrative controls and proper PPE procedures, in laboratory settings. 2. Evaluate biorisk management systems using monitoring, auditing, and continual improvement processes (PDCA cycle). 3. Understand how to identify, evaluate and manage incidents and non-conformities within the biorisk management system. 4. Describe how to analyze, evaluate and use performance indicators and data generated from accident/incident investigations, inspections & auditing to monitor and improve a biorisk management system 2  Fundamentals of Biorisk Management System Abbreviations SMART = Specific Measurable Achievable Relevant Timely CWA = CEN Workshop Agreement ISO = International Organization for Standardization GMPP = Good Microbiological Practices and Procedures. BMBL= Biosafety in Microbiological and Biomedical Laboratories EPA = Environmental Protection Agency CEN = ? CEN stands for the European Committee for Standardization (Comité Européen de Normalisation in French) 3  Dealing with Incidents and Nonconformities Identifying, evaluating, and managing incidents and non-conformities within the biorisk management system requires a systematic approach that includes regular monitoring and auditing, root cause analysis, risk assessment, and communication and documentation. Following are the important steps to address such incidents and non-conformities: ✓ Incident and Non-Conformity Identification ✓ Incident and Non-Conformity Evaluation ✓ Incident and Non-Conformity Management ✓ Incident and Non-Conformity Communication ✓ Incident and Non-Conformity Documentation 1.Both incidents and non-conformities are crucial for continuous improvement processes in organizations. They help in identifying weaknesses in systems and procedures, allowing for enhancements that can prevent future problems and improve overall safety and quality. 4  Continual Improvement Recommended model – PDCA Cyclical framework for conducting reviews of the management system. Identify who is responsible for implementation Conduct a risk assessment; identify needs and who will be affected; develop SOPs to fulfil and opportunities; set expectations; create objectives mentioned in the plan; develop and a plan; determine financial and personnel provide training; follow procedures, processes requirements; set a timeline and tools Do we need any changes to make our Have we met our expectations? plan more effective? Identify specific Gauge the performance of your procedures; did we meet our objectives and targets; determine if what you adjustments and decide whether to stay implemented worked as planned. If not, identify the with the current management plan or to root cause of the problem, reassess your plan and adjust and strengthen it. consider corrective actions 5  Recommended model – PDCA PDCA for an Incident/Accident Investigation Review the potential for or an actual nonconformity Determine the cause of nonconformities through an accident/incident investigation Evaluate the need for prevention or action to ensure no recurrence Determine and implement the action needed Record results of action taken Review corrective actions taken 6  Exercise A suspected increase in the number of needle-stick injuries among waste handlers. Apply the PDCA cycle to reduce this risk. 7  PDCA Cycle Findings: New lab staff is discarding the used syringes in biohazard waste bags. Biorisk officer begins a PDCA evaluation. Plan: set objective, conduct a risk assessment, and develop a risk mitigation plan i.e. training, review training content Do: implement a training plan to train new lab staff, review training content, any further accidents, injuries and incidents are fully investigated 8  PDCA Cycle Check: monitor injury report statistics; is the injury rate decreasing? Act: Continue if yes, Address if no, if the rate if the injury is increasing instead of decreasing, ask specific questions such as: If the perceived risk of injuries is due to a greater awareness of reporting requirements? Is injury recurring more than in the past? Is staff turnover possibly contributing to more injuries? 9  PDCA Cycle Act: Continue if yes, address if no, if the rate if the injury is increasing instead of decreasing, ask specific questions such as if the perceived risk of injuries is due to a greater awareness of reporting requirements? Is injury recurring more than in the past? Is staff turnover possibly contributing to more injuries? 10  Exercise - 2 There is a 30% increase in the size and scope of a BSL-2 laboratory project in your laboratory. The department was able to hire three new research team members. Apply the PDCA cycle to this situation. 11  Exercise – 2/ PDCA Cycle Context 1. The original biorisk management system ensured biosafety and biosecurity measures consistent with the program's scope and size at the time of implementation. 2. Annual inspections were conducted to verify that the BSL-2 program had adequate physical resources to support its work. Key Issues 3.Reassessment Needed: Is a new risk assessment required due to program expansion? Evaluate whether existing resources (e.g., staffing, equipment) are sufficient to support the larger research program. Determine if more frequent monitoring is necessary beyond the annual inspection. 4.New Research Members: Three new researchers were hired without undergoing the mandatory biorisk review. The biorisk officer was excluded from the hiring process and only met the new researchers post- 12 hiring.  Exercise – 2/ PDCA Cycle Plan: Develop a training plan for new team members. Provide additional support to the safety team for handling increased responsibilities. Do: Implement the training. Allocate additional staff to the safety team as needed. Check: Ensure all new labs have communicated with the safety group before initiating research activities. Act: If communication occurred, continue the current system. If not, remind all relevant parties of the policy to ensure compliance. 13 Objective 4 Describe how to analyse, evaluate and use performance indicators and data generated from accident/incident investigations, inspections & auditing to monitor and improve a biorisk management system 14 What is a performance indicator? Key performance indicators (KPIs) refer to a set of quantifiable measurements used to gauge a company's overall long-term performance. 15 Use of KPI & monitoring data for improvement Identifying relevant performance indicators Using data to inform Collecting and decision-making analyzing data Implementing and Evaluating the monitoring those effectiveness of the plans system Developing improvement plans 16 Analysis, evaluation, use of performance indicators and monitoring data Laboratory managers can continually improve the safety and effectiveness of their biorisk management system by following these steps to analyze, evaluate, and use performance indicators and data to monitor and improve a biorisk management system: 1. Identifying relevant performance indicators 2. Collecting and analyzing data 3. Evaluating the effectiveness of the system 4. Developing improvement plans 5. Implementing and monitoring those plans 6. Using data to inform decision-making, 17 1. Identify relevant performance indicators The first step is to identify relevant performance indicators that will be used to monitor and evaluate the effectiveness of the biorisk management system. This can include indicators related to incident rates, near-miss reports, corrective actions, and compliance with regulations and standards. 18 2. Collect and analyze data The next step is to collect and analyze data related to the identified performance indicators. This can include data from accident/incident investigations Inspections auditing training records incident reports The data should be analyzed to identify trends and areas for improvement. 19 3. Evaluate the effectiveness of a BRM system The data collected and analyzed should be used to evaluate the effectiveness of the biorisk management system. This can include identifying strengths of the BRM system weaknesses of the system areas for improvement 20 4. Develop improvement plans Based on the evaluation of the data, improvement plans should be developed to address any identified weaknesses or areas for improvement. These plans should include Specific actions to be taken Timelines Responsible individuals or teams. 21 5. Implement and monitor improvement plans The improvement plans should be implemented, and progress should be monitored regularly to ensure that the desired outcomes are being achieved. This can include collecting additional data and performance indicators to track progress and evaluate the effectiveness of the improvement plans. 22 6. Use data to inform decision-making: The data collected and analyzed should be used to inform decision- making related to the biorisk management system. This can include making changes to policies and procedures implementing new control measures allocating resources to address identified areas of weakness 23 Steps will help to create a culture of proactive biorisk management, ensuring sustainable improvements and prioritizing safety. Commitment from top management Focus on continual improvement 24  Steps will help to create a culture of proactive biorisk management, ensuring sustainable improvements and prioritizing safety. Top Management Commitment: Ensure that adequate resources are provided for biosafety and biosecurity. Clearly prioritize and communicate the organization's biosafety and biosecurity policies. Integrate biorisk management principles across all organizational levels. Regularly assess and identify areas for improvement and preventive measures. Investigate root causes of any system failures to prevent similar incidents in the future. 25  Steps will help to create a culture of proactive biorisk management, ensuring sustainable improvements and prioritizing safety. Continuous Improvement: Encourage employees at all levels to actively seek and implement improvement opportunities. Promote ongoing process refinement and support preventive activities. Require staff to participate in education and training focused on continuous improvement. Include training on how to measure progress toward goals and recognize positive changes. 26  Steps will help to create a culture of proactive biorisk management, ensuring sustainable improvements and prioritizing safety. Practical Steps for Improvement: Foster effective internal communication to keep everyone informed and aligned. Conduct meaningful performance reviews that focus on growth and improvement. Increase preventive actions to reduce risks. Implement beneficial follow-up activities to reinforce improvement efforts. Establish comprehensive training and awareness programs that build biosafety and biosecurity competencies. Document procedures and instructions thoroughly to ensure consistency and clarity across the organization. 27  References WHO Biorisk Management Advanced Trainer Program WHO Lab Biosafety Manual 4th Edition BMBL 5th Edition Bioprism Manual CWA 15793:2008 WHO Responsible Life Sciences Research for Global Health Security 28  References World Health Organization (WHO). Laboratory biosafety manual, 3rd ed. 2004. World Health Organization (WHO). Laboratory biosafety manual, 4th ed. 2020. Centers for Disease Control and Prevention (CDC). Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th edition. 2009. European Biosafety Network (EBN). Biorisk management: Laboratory biorisk management standard EN 16890. 2017. 29 Thank you! 30