Biosafety Principles and Practices for Laboratory professionals

By

Eilu Roggers Michael

Laboratory systems Specialist

Global health security program, Infectious Diseases Institute

Biohazard awareness and Risk Assessment

• Biological laboratories are special work environments that can pose infectious disease or toxin exposure risks to persons working or entering these laboratories
• In fact, there is a clear historical record of infections having been acquired in laboratory settings.
• More than 4,000 laboratory-acquired infections (LAIs) have been reported since the 1920s and many others have likely occurred.
• Some LAIs have been associated with morbidity & mortality, expensive remediation costs, and/or damaging publicity.

Biohazard awareness and Risk Assessment

• There may be instances where agent or procedural characteristics create unique hazards such as the potential for aerosolization of pathogens cultured in concentrations higher than found in nature, inadvertent contamination of surfaces, etc.
• Given the microscopic nature of most biological hazards, it is difficult-to-impossible to directly evaluate the risk in real time. Consequently, only ~15% of all LAIs are attributable to a known or identifiable accident or exposure

Biological Hazards

• Biological hazards are any agents, materials, or conditions that pose a threat to human, animal, plant, or environmental health. They Include;

1. Biological agents, including bacteria, viruses, fungi, protozoa, helminths, and prions. These are also referred to as infectious agents, etiological agents or pathogens.  Biological agents are propagative, cause a broad range of diseases (asymptomatic-to-fatal), and may take hours-to-years to manifest as disease in the host.

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Biological Hazards

2. Recombinant or synthetic nucleic acid molecules. While nucleic acids do not pose an explicit risk, the macromolecules they encode (or interact with) and resulting phenotypes.  Recombinant or synthetic constructs that encode toxins, viruses, oncogenes, antibiotic resistance (of clinical relevance), or any other molecule that contributes to disease are of particular concern.  Host cells/systems, method/control of gene expression, potential for horizontal/vertical transfer, and/or research procedures may contribute to the risk of recombinant/synthetic nucleic acid molecules.

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Biological Hazards

3. Biological toxins, venoms or other molecules derived from biological systems that may cause or contribute to disease. These are non-propagative, but often have acute and serious-to-fatal effects.

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4. Blood, blood products, tissues, secretions, excretions, or cell lines derived from humans or animals. The risk profile is generally: human > primate/simian > other mammals > avian > reptile/amphibian > arthropods (other invertebrates)

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Biological Hazards

5. Novel nanoparticles conjugated to biologically active or cell-modifying molecules (e.g. siRNA, antibodies, effector proteins, etc.).

6. Environmental specimens, particularly plant, soil, or water samples that are likely reservoirs of high-risk biological agents or toxins

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Routes of transmission

Routes of transmission

1. Injection (percutaneous)

• Contaminated sharp objects (e.g. needle, scalpel)
• Animal bites, scratches
• Through broken or abraded skin (including rashes, eczema, split cuticles, etc.)

2. Absorption (Mucous membrane contact)

• Splashes to the eyes, nose, mouth
• Hand to face movements (i.e itching body part, cell phone use etc)

3. Ingestion

• Eating/drinking
• Applying cosmetics
• Contact with tear ducts

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Routes of transmission

4.Inhalation (aerosols)

• Liquid disturbance
• Syringe preparation
• Dried animal excretions
• Leakage from injection site

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Host Factors

Host factors play an important role in the outcome of an exposure/infection. Factors that can increase susceptibility include:

• Underlying diseases, particularly those affecting the immune system
• Age (children and elderly are at higher risk)
• Treatment with antimicrobials, steriods, or anticancer drugs
• Vaccination status
• Type of pathogen/agent exposure
• Opportunistic pathogens can cause disease only when introduced into an unusual location or an immunocompromised host (e.g. normal flora, most environmental yeasts/molds, etc.).
• A primary pathogen (also known as true or frank pathogen) can cause disease in an otherwise healthy individual (e.g. Staphylococcus aureus, Streptococcus pyogenes, hepatitis B virus, influenza virus, etc.).

Risk Assessment

• A thorough biological risk assessment determines the proper safety and containment precautions given the intrinsic risk of the biohazard(s), procedures, and health of laboratory workers
• The risk assessment is a guide for the selection of appropriate controls and microbiological practices, safety equipment, and facility safeguards.
• The risk assessment will be used to alert others to the hazards of working in the lab and to the need for developing proficiency in the use of safe practices and containment equipment.

Risk Assessment

• Successful control of hazards in the laboratory also protects persons not directly associated with the laboratory, such as other occupants in the building, infrequent visitors (e.g., facilities services), and the public.
• Risk assessments generally begin with the question, “Is the biological material that I’m working with capable of causing human disease or environmental harm?”  If so, determine the best safety practices and level of containment to reduce the chance of accidental exposure or release of infectious agents, recombinant agents/organisms, or other relevant biohazard

Risk groups

• Infectious agents are grouped according to their intrinsic biological properties, particularly their pathogenicity and virulence in humans.
• Similar principles are used to categorize the risk of recombinant materials, which could impact human (or animal or plant) health and/or the environment if released.
• Risk groups consider the following:
• Pathogenicity of the organism
• Virulence of the organism
• Mode of transmission and host range
• Availability of effective preventive measures (e.g., vaccines)
• Availability of effective treatment (e.g., antibiotics, antivirals)
• For recombinant materials: type/pathogenicity of host, gene/transgene products, gene expression, targeted effects (and consideration of off-target effects), phenotypes, biological/environmental impacts

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Risk Groups

Risk Reduction for Biological Agents

• Once the RG and other procedural factors are determined, basic considerations for risk reduction include:

Risk awareness

• Risk assessments are performed and communicated
• Materials and procedures are reviewed by the IBC as required
• Containment recommendations are implemented
• Standard Operating Procedures (SOPs) are developed and communicated

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Risk Reduction for Biological Agents

Control of materials

• Containment requirements per the risk assessment are followed
• Materials are labeled and securely stored per risk assessment
• Biohazard inventory is documented, maintained and controlled
• Secondary containment is used for storage and transport of biohazards

Restriction of Access

• Follow prescribed laboratory security procedures per institutional policy
• Secure storage equipment in common areas and placard with content owners name and contact information

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Risk Reduction for Biological Agents

Good Practices

• Follow prescribed personal & lab hygiene principles, also known as Standard Microbiological Practices
• Wear and maintain personal protective equipment (PPE) per the risk assessment and manufacturers recommendations
• Communicate hazards via door placard, biohazard labels, etc.
• Segregate and dispose biohazardous wastes per Biosafety Office guidelines
• Decontamination must be routine and effective based on the risk assessment and prudent practices
• Communicate and follow emergency response procedures (spills, personal exposures, injuries, etc.)

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Introduction to Biorisk Management

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Introduction

• The increasing threats and hazards from biological agent arising from emerging and re-emerging infectious diseases have become a global concern.
• The rapid advancement in Technology, Biotechnology, synthetic Biology and the emergence of AI poses new Biosafety and Biosecurity challenges that require to be regulated.
• The nature of work in facilities is potentially risky and often exposes service providers to harm
• The recent COVID-19 and Ebola outbreak have highlighted a very urgent need for establishment of robust biorisk management system (BRM) and enhance awareness and preparedness across all one health implementing entities

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1.3.4 RATIONALE FOR BIOSAFETY BIOSECURITY INTERVENTIONS

Emerging biological risks

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• Biorisk management involves principles techniques and measures put in place for the safety of personnel, community and environment and for the security of valuable biological materials(VBM) and information

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• Laboratory Biorisk Management is a set of Coordinated activities to direct and control an organization with regard to biorisk. (ISO 35001:2019 clause 3.6)

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Slide Title

1.3.2 Definitions of key terms

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• Biorisk- These are risks associated with biological materials
• Biorisk : Effect of uncertainty expressed by the combination of the consequences of an event (including changes in circumstances) and the associated “likelihood” of occurrence, where biological materials is the source of harm.
• Biorisk = Biosafety + Biosecurity Risks

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Slide Title

1.3.2 Definitions of key terms continued

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• Biorisk management system: Is the organization management system or part of an organization’s management system used to establish biorisk management policies, objectives and processes to achieve those objectives.

(ISO 35001:2019 clause 3.7)

• BRM system is built on the concept of continual improvement through PDCA principle

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Slide Title

1.3.2 Definitions of key terms continued

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Definition of key terms

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Biosafety: Application of knowledge, techniques and equipment to prevent personal exposure to potentially infectious agents or biohazards. Biosafety defines the containment conditions under which laboratory workers can safely manipulate infectious agents.

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Containment principles, technologies and practices that are implemented to prevent unintentional exposure to biological agents or their inadvertent release.

(WHO Biosafety Manual 4^th Edition)

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Laboratory biosafety: Practices and controls that reduce the risk of unintentional exposure or release of biological materials.

(ISO 35001:2019 clause 3.22)

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Definition of key terms

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Biosecurity: Containment principles, technologies and practices that are implemented to prevent intentional exposure to pathogens, toxins or their intentional release (WHO Biosafety Manual 4^th Edition)

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Laboratory biosecurity describes the protection, control and accountability for valuable biological materials (VBM) within laboratories, in order to prevent their unauthorized access, loss, theft, misuse, diversion or intentional release.

Laboratory biosecurity: Practices and controls that reduce the risk of loss , theft, misuse, diversion of, or intentional unauthorized release of biological materials (ISO 35001:2019 clause 3.23).

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Biosafety

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To Keep Bad Bugs From People

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Biosecurity

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To Keep Bad People From Bugs.

Biosafety Vs Biosecurity Measures

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Physical security

Personnel security

Material control and Accountability

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Information security

Transport security

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Each component implemented based on results of risk assessment

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Components of a Biosecurity Program

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Slide Title

1.3.3 Key Components of Biorisk Management

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Slide Title

1.3.3 Key Components of Biorisk Management Continued

Biorisk Assessment

Process of identifying the hazards and evaluating the risks associated with biological agents and toxins, taking into account the adequacy of any existing controls, and deciding whether or not the risks are acceptable (ISO 35001: 2019 clause 6.1.2)

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The organization shall ensure that suitable methodologies for assessing and prioritizing biorisks are identified, implemented, maintained, and documented (ISO 35001: 2019 clause 6.1.2)

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Risk: Effect of uncertainty.

• Risk is the likelihood of an undesirable event happening, that involves a specific hazard or threat and has consequences

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Risk = f (likelihood, consequences)

or, more simply R=f(L&C)

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Risk is a function of both the Likelihood

of something happening and

Consequences of that occurrence

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Slide Title

1.3.2 Definitions of key terms continued

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1.3.3 Key Components of Biorisk Management Continued

Biorisk Mitigation

• Actions and control measures that are put into place to reduce or eliminate the risks associated with biological agents and toxins

(ISO 35001:2019 clause 6.1.3)

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• The identification and implementation of control measures shall be based on the results of the biorisk assessment (ISO 35001:2019 clause 6.1.3).

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Slide Title

Hierarchy of Controls

• Elimination or Substitution
• Engineering Controls
• Administrative Controls
• Practices and Procedures
• Personal Protective Equipment

Control methods at the top of the list are, in general, more effective and protective than those at the bottom.

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Slide Title

1.3.3 Key Components of Biorisk Management Continued

Performance

• Implementation of the entire biorisk management system, including evaluating the effectiveness of the controls implemented to mitigate biorisks.

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• Another aspect of performance is the process of continually improving the system (ISO 35001:2019 clause 6.1.4

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Slide Title

1.3.3 Key Components of Biorisk Management Continued

Performance

The performance of all of the control measures shall be evaluated on a routine basis, and the results of that evaluation shall be documented.(ISO 35001:2019 clause 6.1.4

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Measurement is the first step that leads to control and eventually to improvement. If you can't measure something, you can't understand it. If you can't understand it, you can't control it. If you can't control it, you can't improve it.”

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H. James Harrington

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Performance evaluation

9.1 Monitoring, measurement, analysis, and evaluation

• continuously evaluate the performance and effectiveness of the biorisk management system.
• Determine:

— what needs to be monitored and measured;

— the methods for monitoring, measurement, analysis, and evaluation, as applicable, to ensure valid results;

— when the monitoring and measuring is performed;

— when the results from monitoring and measurement are analysed and evaluated.

• Retain records of the results.
• establish and maintain documented procedures to report, define, document, analyse, and learn from incidents that involve biorisks.

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Performance evaluation

9.2 Internal audit

9.2.1 conduct internal audits and inspections at planned intervals to provide information on whether the biorisk management system:

a) conforms to:

— the organization’s own requirements for its biorisk management system, and

— the requirements of this document;

b) is effectively implemented and maintained.

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Performance evaluation

9.2.2 The organization:

a) plan, establish, implement, and maintain an audit programme(s), including the frequency, methods, responsibilities, planning requirements and reporting.

consider the importance of the processes concerned and previous audits

b) define the audit criteria and scope for each audit;

c) elect auditors and conduct audits to ensure objectivity and the impartiality of the audit process;

d) ensure that the results of the audits are reported to relevant management

e) retain documented information for implementation of the audit programme and the audit results.

Exercise: Develop BRM audit program template

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Performance evaluation

9.3 Management review

• Top management reviews BRM, at planned intervals, to ensure its continuing suitability, adequacy, and effectiveness.

The MR makes consideration of:

a) biorisk management objectives progress;

b) Previous MR actions status;

c) changes in external and internal issues that are relevant to BRM system. E.g.;

— the organization’s activities, biological hazards and/or threats, and associated biorisks;

— legal and other requirements; and

— standards and guidelines relevant to the organization’s biorisk management system;

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Performance evaluation

— follow-up actions from previous management reviews; and

— other factors deemed appropriate for consideration by top management, such as trends in relevant benchmarks in comparison to other organizations; and

— opportunities for continual improvement.

MR outputs: decisions related to continual improvement opportunities and any need for changes to the BRM, allocated resources, procedures, policies, and objectives.

Records of results of MR are maintained.

communicate all relevant outputs of the MR to internal and, if appropriate, external interested parties.

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5. Leadership �5.1 Leadership and commitment

Top management shall demonstrate leadership and commitment with respect to the biorisk management system by:

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• Ensuring BRM Policy & Objectives

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• Integrating BRMS into Processes

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• Availing resources needed for BRMS

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5. Leadership �5.1 Leadership and commitment

Top management shall demonstrate leadership and commitment with respect to the biorisk management system by:

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• Define, document and Communicate Roles, responsibilities and authorities

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• Direct and support persons who implement BRM

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• Communication of actions to be taken

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• Promote continual improvements

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• Support other management roles

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5.3 Roles, Responsibilities and �Authorities.

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• Responsible for overall BRM including Policy
• Demonstrate commitment by
• Availing Resources(Human, infrastructure) E I M I

• 5.3.2 Operational Responsibility
• Oversee the BRM

• 5.3.3 Chaired by appointed Senior/Top Management
• 5.3.3 Have a plan for what will happen they meet
• 5.3.4 Provide advise, guidance and assurance on BRM

• 5.3.5 Individual(s) responsible for all or part of the Biosafety and Biosecurity program at health facility

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5.3 Roles, Responsibilities and �Authorities

• 5.3.1 Top Management

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• Ultimate responsibility BRM system.

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• Must not delegate it’s ultimate responsibility,

• May delegate authority.

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• Demonstrate commitment for provision of resources to establish, implement, Maintain and Improve the BRM system

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5.3 Roles, Responsibilities and �Authorities

• 5.3.2 Senior Management

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• Operational Responsibility to oversee BRMS

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• Ensure appropriate & adequate workers, facilities

• Report to mag’t on performance of BRMS

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• Promotion of BRMS throughout the organization
• Institute review, audit and reporting measures

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5.3 Roles, Responsibilities and �Authorities

• 5.3.3 BRM Committee

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• Consist of members independent of reviewed for Biorisk issues

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• Report to senior/top management

• Chaired by someone appointed by senior/top management

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• Meet at defined and appropriate frequency (plan/program)

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5.3 Roles, Responsibilities and �Authorities

• 5.3.3 BRM Committee

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Alternative name

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• Biosafety Committee

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• Laboratory Safety Committee

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• Hospital Infection Control Committee
• Occupational health & safety committee
• Institution Biosafety Committee
• Infection control committee

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5.3 Roles, Responsibilities and �Authorities

• 5.3.4 BRM Advisor

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• Competent individual(s) to provide guidance, advise and assurance on BRM
• Report to senior management with delegated authority to prohibit work

• Ensure up-to-date information (MSDS)

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• Advise on BRM issues

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• Contribute to development &/ delivery of BRM training (Must be trained)

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5.3 Roles, Responsibilities and �Authorities

• 5.3.4 BRM Advisor

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Alternative names

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• Biosafety professionals

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• Biological officers

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• Biosafety practitioners

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• Biosafety coordinators

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• See ISO 35001:2019;5.3.4 Note

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5.3 Roles, Responsibilities and �Authorities

• 5.3.5 Scientific Management
• Individual(s) with responsibility for the BRM

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• Ensure adequate staffing

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• Planning and coordinating activities

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• Supervising workers

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• Ensuring required authorization at work

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• Ensure compliance to established policies and guidelines
• See ISO 15190;2020; 5.3.2 & 5.5

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Why BRM Committees are important ?

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• Assist the institution Management in identifying, developing and reaching biorisk management goals

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Slide Title

1.6 References

• ISO 35001:2019(en), Biorisk management for laboratories and other related organisations.
• ISO 15190:2020(en), Medical laboratories — Requirements for safety
• ISO 45001:2018(en), Occupational health and safety management systems — Requirements with guidance for use
• ISO 9000:2015(en), Quality management systems — Fundamentals and vocabulary
• Laboratory biosafety manual, 4th edition (who.int)
• Biorisk management: laboratory biosecurity guidance (who.int)

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Infection Prevention and Control

Infectious Diseases Institute

College of Health Sciences, Makerere University, Uganda

Investing In The Future – Impacting Real Lives

Overview

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• Infection Prevention and Control is the cornerstone of epidemics’ and case management

Goal of Infection Prevention and Control

IPC is a set of practices, protocols, and procedures that are put in place to prevent transmission of infections

Modes of disease transmission

Chain of Infection

• For infection to spread, all links must be connected

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• IPC goal is to break a link in the chain to prevent the transfer of the pathogen

Chain of infection

Breaking the chain of transmission(Apply standard precautions at all times)

Standard Precautions

• Meant to reduce the risk of transmission of pathogens from both recognized and unrecognized sources

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• They are the basic level of infection control precautions to be used as minimum in all patient care settings at all times

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• Risk assessment is key to determine the precaution necessary

Components of Standard Precautions

Hand hygiene

Decontamination and disinfection of patient care equipment, surfaces, linen, patient environment

Personal Protective Equipment (PPE)

Respiratory & cough hygiene

Sharps safety

And Prevention of needle stick injuries

1. Standard precautions

To be used in care of all patients at all times

Safe waste management

Components of Transmission based precautions

Additional standard precautions

To prevent transmission of known infectious disease spread by specific route.

2. Transmission based precautions

Steps to Improve IPC practices in Hospitals and Communities

• Establishment of active IPC Structures (committees and focal Persons at District and Facility Level)

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• Developing clear IPC policies and protocols

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• Regularly discussing IPC initiatives with HCWs

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• Providing tools to help monitor IPC activities at Hospitals

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• Providing trainings and reorientation for HCWs on IPC

Thank you for participating.��For further questions or comments, please contact:� office@idi.co.ug | http://idi.mak.ac.ug��Visit us on social media: ��

Infectious Diseases Institute

College of Health Sciences, Makerere University, Uganda

Investing In The Future – Impacting Real Lives