THE BIOSAFETY OFFICER
Assoc. Prof. Dr. Kenneth F. Rodrigues Biotechnology Research Institute
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INTRODUCTION
The Biosafety officer (BSO) represents the human component of the
biosafety system of an organization. He or she is expected to be cognizant of, uphold and implement the principles, policies of the organization
within the framework of biorisk management.
A BSO must be aware of the key concepts associated with biological systems and should be cognizant of biosafety guidelines, laws and practices.
This module has been developed with the intention of facilitating the process of understanding the practices, roles and responsibilities of the BSO and the way these can be implemented.
Objectives
This module has been designed to deliver the following concepts:
1. The culture of bio-safety.
2. Compliance.
3. Overview of roles and responsibilities.
Learning Outcomes
Upon completion of this module, you should be able to:
1. Describe the roles and responsibilities of a Biosafety officer.
2. Provide an overview of the guidelines which are the driving principles of biosafety.
3. Develop the first component of your biosafety manual which is the
“Roles and Responsibilities of a Biosafety Officer”.
4. Apply what you have learnt to inculcate a culture of biosafety at your respective institutions.
THE CULTURE OF BIOSAFETY
Culture of Biosafety
“A culture is a way of life of a group of people--the behaviors, beliefs, values, and symbols that they accept, generally without thinking
about them, and that are passed along by communication and imitation from one generation to the next”
Citation: Texas A&M University
Culture
Beliefs
Values
Symbols Behaviors
“If we could change ourselves, the tendencies in the world would also change. As a man (or woman) changes
his (or her) own nature, so does the attitude of the world change towards him (her) ... We need not wait to
see what others do.”
– M. K. Gandhi
THE CULTURE OF COMPLIANCE
COMPLIANCE
“Compliance means conforming to a rule, such as a specification, policy, standard or law.
Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws and regulations.”
What does my organization comply with?
• International Laws
• National Laws
• Guidelines
• Code of Ethics
• Good Laboratory Practices.
• Globally Accepted Standards.
• Specifications
• Standards
How does my organization ensure that it is compliant?
AWARENESS ACTION INTROSPECTION
Translates into…
PLAN DO CHECK ACT
SETTING THE AGENDA
Where do I begin?
How can you set the agenda?
1. The Policy: the institutional biosafety policy must be integrated into the vision and mission of the institution.
2. The Law: Institutions do not to be perceived as being in non- compliance of laws.
3. Corporate Social Responsibility: Institutions favor projecting an image that is accepted by society in general.
4. Identifying agents of change: People are the key.
FOSTERING CHANGE
Scenario
“ The biosafety act has been amended and every research institution involved with biological research is now required to employ a certified BSO.
You have been newly appointed by an institution which does not practice biorisk management.
The management perceives BRM as a financial burden and the researchers employed at the institution view BRM as an additional task that they would like to do without.”
How will you as address this challenge as a newly appointed BSO?
How can you foster change?
AWARENESS COMMUNICATION IMPLEMENTATION
ROLES & RESPONSIBILITIES
THE BIOSAFETY OFFICER / BIORISK MANAGER
RESPONSIBILITY
“The state or fact of having a duty to deal with something or of having control over someone.”
“The state or fact of being accountable or to blame for something.”
“The opportunity or ability to act independently and make decisions without authorization.”
ROLE #1
Understanding the basic principles of
microbiology and cell
biology.
Scenario I
“One of the principle investigators at your institute intends culturing a pathogen in the general microbiology laboratory”
What necessary actions will you take in order to mitigate the risk posed by the activity?
What key questions will you ask?
ROLE #2
Awareness of the
basic principles of
genetic engineering
and biotechnology.
ROLE #3
Understand the risks associated with working with biological agents and be aware of other hazards and their
associated risks.
Key
Question?
“What is a biological agent and how are biological agents classified?Scenario II
“Six of the ten researchers working with the biological agent X have been diagnosed with an infection. The biological agent in question is
associated with the environment. How can you assess the likelihood that the researchers were infected within the laboratory premises?”
‘Could they have been infected prior to commencing their research work with agent X?
ROLE #4
Understand the role of the occupational health provider and be able to work with the
occupational health
provider to ensure that suitable preventive and surveillance measures are in place to keep laboratory workers healthy.
ROLE #5
Understand the human factors related to human behavior, human reliability and human failure (intentional and
unintentional errors). The biosafety professional shall be able to influence behaviors and risk perception, and be
persuasive in promoting good biosafety and biosecurity
practices taking into account cultural and socio-economic considerations.
ROLE #6
Understand the concept of containment and its limitations, and to
discuss the most important types of containment.
How many types of containment are you aware of?
ROLE #7
Carry out a risk assessment for a given situation and decide on mitigation strategies taking into account the hierarchy of controls.
The biosafety professional shall be able to provide guidance on
biological hazard identification and biological risk assessment to
management, project leaders, principal investigator and other relevant personnel.
ROLE #8
Environmental safety:
(a) Understand the risks to the environment associated with working with biological agents and biological materials
(b) Design suitable measures and surveillance to prevent the escape of biological hazards into the
environment
(c) Decide when expert help is needed to address a specific issue
ROLE #9
Identify facility design and constructionissues that are relevant to biosafety and biosecurity.
(a) Read and understand technical drawings, and the basic systems (e.g. Heating Ventilation Air Conditioning (HVAC), etc.) and design features of a typical facility;
(b) Understand the construction, commissioning and validation processes;
(c) Possess a knowledge on basic (re)design features of the most important types of facilities.
(d) Identify and describe the biosafety issues in preventive and corrective maintenance, operations and decommissioning.
Scenario III
“Your employer has decided to build, plan, operate and lease a biological safety level 3 laboratory for the purpose of animal containment. The management decides that you as a BSO will represent the company during meetings with the Engineering Consultants and the Local
Authorities”
1. What pertinent questions will you pose to the Engineering Consultants with regard to facility design?
2. How will you address the concerns of the Local Authorities?
3. Are both (1) and (2) the responsibilities of the BSO?
ROLE #10
Understand the biosafety and biosecurity implications of equipment in the facility and to advise on choice, correct use, installation, validation, certification and maintenance.
Key Concepts
Choice
Correct Use
Installation
Validation
Certification
Maintenance
ROLE #11
Understand and apply good microbiological techniques in order to guide staff to enable them to create and maintain a safe working
environment (workplace and workflow).
ROLE #12
Advise on the appropriate types of PPE required for a given situation, based on theoretical and practical experience, and discuss potential problems and solutions when the
equipment is introduced and used.
ROLE #13
Describe the most
important elementsof infection, control,
disinfection,
decontamination and
sterilization, as well as their efficacy.
The biosafety professional shall be able to advise on the choice and the correct use of all methods.
ROLE #14
Develop and implement a biological waste
management plan including validation.
ROLE #15
Develop and implement an emergency
preparedness and
response plan.
ROLE #16
Understand methods of accident and
incident
investigation and
shall be able to
apply them.
ROLE #17
Develop and support the implementation of a biosafety and
biosecurity program and understand how the
elements in such a program are
interrelated so as to achieve the objectives of the program.
ROLE #18
Have sufficient
knowledge on training principles in order to understand training needs and to develop, deliver and validate an internal biosafety and biosecurity (re)training programs tailored to different audiences.
ROLE #19
Be able to transfer
information clearly and convincingly to an
audience including
management, laboratory workers and external parties. The biosafety professional shall be able to communicate with
personnel at all levels with the proper degree of
understanding and sensitivity.
ROLE #20
Demonstrate the ability to carry out relevant audits and inspections, identify failures, non- conformities and areas for improvement.
ROLE #21
Be able to identify and
understand the application of relevant regulations and guidelines on transport,
import and export, including correct packaging, labeling and means of transport for biological materials and be able to support those with assignments for the
transport of those materials.
ROLE #22
Be able to demonstrate understanding and
applicability of national and international regulatory frameworks, including standards, guidelines and conventions, in all areas of biosafety and biosecurity to ensure compliance.
ROLE #23
Be aware of bioethical issues applicable to
his/her field of activities and able to
demonstrate familiarity with applicable
bioethics legislation and codes of conduct.
Role #24
Be aware of different or more complex and/or higher risk
environments that require demonstration of additional specialized competences, such as:
(a) Laboratory experiments with small animals (e.g. rodents, fish); large animals (e.g cattle, swine, equine); and nonhuman primates;
(b) Working with plants;
(c) Working with insects;
(d) Transmissible Spongiform Encephalopathies (TSE);
(e) Large scale production (bioprocessing);
(f) Biosafety and Good Manufacturing Practices (GMP);
(g) Clinical / diagnostic activities;
(h) Gene therapy activities.
ROLE #25
Demonstrate
continuous professional development.
SUMMARY
The role of the BSO is critical to the efficient implementation of the
policies and practices associated with the management of biological risk at an institution, however this is dependent upon:
1. Administrative support.
2. Sound knowledge of biological processes.
3. Awareness of guidelines and regulations.
4. Working knowledge of engineering controls and PPEs.
5. Ability to develop and to implement training programs.
6. Amenability to change and continuous professional development.
