BASIC CONCEPTS OF BIORISK MANAGEMENT

Summary

This lecture introduces the foundational principles of biorisk management, emphasizing biosafety and biosecurity. Dr. Kenneth explains that biosafety focuses on preventing unintentional release of pathogens, while biosecurity addresses intentional misuse. The session covers key concepts such as risk assessment, mitigation, performance evaluation, and containment, highlighting primary and secondary controls. It also introduces biological agents, including bacteria, viruses, yeast, and prions, and outlines the importance of adhering to international guidelines and national laws, referencing manuals like ISO 35001, WHO Laboratory Biosafety Manual, and CDC BMBL. The lecture establishes a framework for safe, responsible laboratory practices and continuous quality improvement in managing biological risks.

Takeaways

• 😀 Biosafety and biosecurity are key areas of bio risk management, focusing on the unintentional and intentional release of biological agents, respectively.
• 😀 Biosafety management involves controlling the accidental release of pathogens in laboratory settings, while biosecurity deals with preventing unauthorized or intentional releases (e.g., bioterrorism).
• 😀 Bio risk management is a process designed to mitigate risks posed by biological agents, ensuring the safety of research and lab personnel while advancing scientific knowledge.
• 😀 Risk management follows a management systems approach that emphasizes continuous quality improvement through a cyclical process of planning, doing, checking, and acting.
• 😀 Top management has a critical role in setting the bio risk policy, defining roles and responsibilities, and ensuring the safety of laboratory operations.
• 😀 Containment is a key principle, consisting of primary containment (protecting workers) and secondary containment (protecting the environment), to prevent the spread of biological agents.
• 😀 A breach of containment refers to the failure of controls that limit the spread of biological agents, which can lead to public health and safety threats.
• 😀 Bio risk management involves three key phases: risk assessment (identifying risks), risk mitigation (reducing risks with controls), and performance assessment (evaluating the effectiveness of those controls).
• 😀 International and national guidelines, such as the WHO and ISO 35001, provide comprehensive frameworks for establishing biosafety and biosecurity protocols in labs.
• 😀 Biological agents include bacteria, viruses, prions, and genetically modified organisms, each posing varying levels of risk depending on their characteristics and the processes involved.
• 😀 The success of bio risk management depends on the effective implementation of controls, proper training, and ongoing monitoring and audits to ensure safety and compliance.

Q & A

What is the main focus of the first lecture in this bio risk management MOOC?

The first lecture introduces the fundamental principles of fire risk management, focusing specifically on the management of risks posed by biological agents, including biosafety, biosecurity, containment, biological agents, and laboratory processes.

What is the difference between biosafety and biosecurity management?

Biosafety management focuses on preventing accidental release of pathogens from laboratories or containment facilities, while biosecurity management deals with the intentional, unauthorized release of biological agents, often involving malicious intent like bioterrorism.

Why is bio risk management important?

Bio risk management is essential because biological agents themselves do not pose a significant risk, but when handled or cultured in laboratories, they can increase the risk of accidents. Proper risk management helps mitigate these risks while allowing important research to continue.

What does the term 'containment' mean in the context of bio risk management?

Containment refers to the system of controls designed to confine biological agents within a defined space, typically in a laboratory setting, to prevent their accidental or intentional release. It is divided into primary containment (protecting the lab users) and secondary containment (protecting the environment and the public).

What is the difference between primary and secondary containment?

Primary containment involves controls such as personal protective equipment (PPE) and biological safety cabinets that protect the laboratory workers. Secondary containment includes measures like secure laboratory facilities, waste disposal systems, and facility design to protect the surrounding environment and community.

What is the role of top management in bio risk management?

Top management is responsible for driving the bio risk policy across the organization, setting goals, monitoring implementation, and ensuring continuous quality improvement in bio risk practices.

How does the management systems approach work in bio risk management?

The management systems approach in bio risk management is a cyclical process that involves planning, doing, checking, and acting. For instance, after developing a standard operating procedure (SOP), you implement it, assess its effectiveness, and make necessary adjustments to improve it continuously.

What is the 'AMP' model in bio risk management?

The AMP model stands for Risk Assessment, Risk Mitigation, and Performance Assessment. It is a cyclical process in bio risk management that helps assess the potential risks, apply mitigation strategies, and evaluate the effectiveness of the controls to reduce exposure to biological agents.

What are some examples of biological agents mentioned in the lecture?

Examples of biological agents discussed include bacteria (e.g., Bacillus anthracis), viruses, yeast (e.g., Candida albicans), and prions, which are misfolded proteins capable of causing infections or diseases.

What are some important international manuals and guidelines mentioned in the lecture?

Some important guidelines include the ISO 35001:2019 for bio risk management in laboratories, the WHO Laboratory Biosafety Manual, the CDC's Biosafety in Microbiological and Biomedical Laboratories (BMBL), and the NIH guidelines for research involving recombinant or synthetic nucleic acid molecules.