Biosafety, Biosecurity and Biorisk Management Training

Background/ Introduction:
Module 1 covers the fundamental concepts of Biosafety. The topics include the brief history and principle of biosafety, containment, biosafety levels and introduction to the core requirements, heightened control measures and the maximum containment measures. This module also presents Laboratory Acquired Infections and the local and international biosafety guidelines and standards.

Objective/ Goals: 
This module aims to present the fundamental principles of laboratory biosafety, its vital role in keeping laboratory personnel, the community and environment safe, and the existing guidelines and standards governing the local implementation of biosafety. Specific objectives are enumerated in the succeeding submodules.

How the goals will be achieved/ manner or delivery: 
The methods in which the objectives of this module shall be achieved will be through lectures and quizzes.

Scope:

• Fundamental Principles of Biosafety
• Laboratory Acquired Infections
• Local and International Guidelines and Standards

Expectations:
Participants are expected to finish the lectures, answer the quizzes, and get a passing rate of 75% in the examination.

References:
I. Module 1.1 Fundamentals of Biosafety

• Bayot M, Limaiem F. Biosafety Guidelines. 2020 January [StatPearls Publishing]
• WHO Laboratory Biosafety Manual 4th Edition. 2020 December
• ISO 35001:2019. 2019 November
• WHO Laboratory Biosafety Manual 3rd Edition. 2004 August
• Biosafety in the Laboratory: Prudent Practices for the Handling and Disposal of Infectious Materials. 1989
• Biosafety in Microbiological and Biomedical Laboratories 5th Edition. 2009 December

II. Module 1.2 Laboratory Acquired Infections

• WHO Laboratory Biosafety Manual 4th Edition. 2020 December
• Belgian Biosecurity Server
• Center for Disease Control and Prevention: Morbidity and Mortality Weekly Report
• Laboratory – Associated Infectious and Biosafety Vol. 8 No. 3. 1995 July

III. Module 1.3 International and Local Policies, Guidelines and Standards

• The Millennium Project. 2023
• WHO Laboratory Biosafety Manual 4th Edition. 2020 December
• WHO Biorisk Management – Laboratory Biosecurity Guidance. 2006 September
• Biosafety in Microbiological and Biomedical Laboratories 5th Edition. 2009 December
• ISO 35001:2019. 2019 November
• Food and Agriculture Organization Biosecurity Toolkit. 2007
• Cartagena Protocol on Biosafety to the Convention on Biological Diversity. 2000
• United Nation Regional Center for Peace and Disarmament in Asia and the Pacific Server
• Halos. Biosafety Guidelines in the Philippines and their Implementation
• Executive Order No. 514, s. 2006: Establishing the Biosafety Framework
• Executive Order No. 430, s. 1990: National Committee on Biosafety of the Philippines
• Philippine Biosafety Guidelines. 1991
• Department of Health Laboratory Biosafety and Biosecurity Standards. 2023
• Republic Act 4688, s. 1966: Clinical Lab Law of the Philippines
• DOH Admin Order No. 2021 – 0037
• DOH Admin Order No. 2020 – 0014
• DOH Admin Order No. 2023 – 004
• RITM BRMO Interim Biosafety Guidelines for Laboratories Handling and Testing SARS – COV – 2 Specimen. 2020

• Fundamental Concepts

  17:29

• Laboratory Acquired Infections (LAI)

  08:42

• Local and International Guidelines and Standards

  16:19

• Evaluation

  00:00

• Module 1 Quiz

Background/ Introduction:
This module presents biorisk assessment in the context of a laboratory biorisk management system. It covers the fundamental biorisk management biorisk assessment concepts and principles and the step by step process of risk assessment following the WHO risk assessment framework.

Objective/ Goals: 
This module is intended to guide training participants to conduct its local biological risk assessment as the backbone of laboratory biosafety. The will further enhance the participant’s professional judgement in selecting mitigation control measures that commensurates the identified risk. Specific objectives are enumerated in the succeeding submodules.

How the goals will be achieved/ manner or delivery: 
The methods in which the objectives of this module shall be achieved will be through lectures, activities and quizzes.

Scope:

• Biorisk Management
• Biohazard and Biorisk
• Risk Identification, Characterization and Evaluation
• Risk Assessment - WHO Risk Assessment Framework

Expectations:
Participants are expected to finish the lectures, answer the quizzes, and get a passing rate of 75% in the examination.

References:
I. Module 2.1 Biorisk Management

• ISO 35001:2019. 2019 November
• WHO Laboratory Biosafety Manual 4th Edition. 2020 December
• CEN Workshop Agreement 15793. 2011 September
• Center for Disease Control and Prevention
• DOH Admin Order 2021 – 0037
• Sandia National Laboratories: Laboratory Biorisk Management, Biosafety and Biosecurity. 2015

II. Module 2.2 Biohazards and Biorisk

• OHSAS 18001:2007
• CEN Workshop Agreement 16393. 2012
• ISO/ IEC Guideline 51: 1999
• WHO Laboratory Biosafety Manual 4th Edition. 2020 December
• WHO Laboratory Biosafety Manual 3rd Edition. 2004 August
• ABSA International Risk Group Database
• Canada – Pathogen Safety Data Sheets Database

III. Module 2.3 Risk Identification, Characterization and Evaluation

• WHO Laboratory Biosafety Manual 4th Edition. 2020 December
• OHSAS 18001:2007
• Canada – Pathogen Safety Data Sheets Database
• WHO LBM 4th Ed. Risk Assessment Monograph

IV. Module 2.4 WHO Risk Assessment Framework

• WHO Laboratory Biosafety Manual 4th Edition. 2020 December
• WHO LBM 4th Ed. Risk Assessment Monograph
• DOH Admin Order 2021 – 0037

• Biorisk Management

  21:57

• Biohazards and Biorisk

  09:55

• Risk Identification, Risk Characterization and Risk Evaluation

  13:57

• WHO Risk Assessment Framework

  25:06

• Evaluation

  00:00

• Module 2 Quiz

Background/ Introduction:
Core requirements describe risk control measures that are both the foundation for, and an integral part of laboratory biosafety. This module discusses the set of minimum requirements and considerations necessary to work safely with biological agents even where associated risks are minimal. The measures detailed in this topic reflect international standards and best biosafety practices which are fundamental to all laboratory activities. It is emphasized that implementation of all risk control measures as part of the core requirements must be appropriately managed in order to help ensure a safe working environment.

Objective/ Goals: 
Generally, this module aims to define what core requirements are, and discuss each of the core requirements in detail. The specific objectives are indicated in the succeeding sessions as the training proceeds. Specific objectives are enumerated in the succeeding submodules.

How the goals will be achieved/ manner or delivery:
  The methods in which the objectives of this module shall be achieved will be through lectures and short interactive questionnaires and quizzes.

Scope:

• Good microbiological practices and procedures
• Personnel competence and training
• Facility design
• Specimen Receipt, Storage, Packaging and Transport
• Decontamination and waste management
• Personal protective equipment
• Laboratory equipment
• Emergency response
• Occupational Health

Expectations:
Participants are expected to finish the lectures, answer the quizzes, and get a passing rate of 75% in the examination. 

• Introduction to Core Requirements

  03:21

• Good Microbiological Practices and Procedures

  05:41

• Personnel Competence and Training

  09:07

• Facility Design

  09:40

• Specimen Receipt, Storage and Transport

  13:24

• Waste Management and Decontamination

  13:16

• Personal Protective Equipment

  08:44

• Laboratory Equipment

  15:18

• Emergency and Incident Response

  28:29

• Occupational Health

  08:25

• Evaluation

  00:00

• Module 3 Quiz

Background/ Introduction:
This module presents control measures to be implemented in facilities wherein the core requirements may not be enough to mitigate the identified risks. The submodule herein specified the heightened control measures and maximum containment measures when handling high risk pathogens and procedures.

Objective/ Goals:

• Describe heightened control measures and the maximum containment measures
• Describe the required facility design for laboratories employing heightened control measures and the maximum containment measures
• Describe the required safety equipment in laboratories employing heightened control measures and the maximum containment measures
• Describe specific operational practices in a maximum containment  facility and the maximum containment measures

How the goals will be achieved/ manner or delivery: 
The methods in which the objectives of this module shall be achieved will be through lectures and short scenario-based quizzes

Scope:

• Operational working practices and procedures
• Personnel competence and training
• Facility design
• Decontamination and waste management
• Personal protective equipment
• Laboratory equipment
• Emergency response

Expectations:
Participants are expected to finish the lectures, answer the quizzes, and get a passing rate of 75% in the examination. 

• Heightened Control and Maximum Containment Measures

  27:33

• Maximum Containment Measures

  18:26

• Evaluation

  00:00

• Module 4 Quiz

Background:
This module covers topics on fundamental concepts on biosecurity, its relevance and roles to the achievement of a good biorisk management in a laboratory, the pillars of a good biorisk management and the step by step procedure of performing a biosecurity risk assessment. Moreover, specific biosecurity events, needs and challenges in the Philippines will also be presented. 

Objectives: Generally, this module aims to discuss the fundamental concepts and principles of biosecurity, present biosecurity related events, needs and challenges in the Philippines and demonstrate the application of biosecurity risk assessment process. Specific objectives are enumerated in the succeeding submodules.

How the goals will be achieved/ manner or delivery: 
The methods in which the objectives of this module shall be achieved will be through lectures and short scenario-based quizzes.

Scope:

• Definition of Biosecurity,
• Bioterrorism Events
• Local and International Legislations
• The Biosecurity Assessment Team
• Biosecurity Events in the Philippines
• Pillars of Good Biosecurity Management,
• Components of Biosecurity
• Biosecurity needs and challenges in the Philippines.
• To present Risk Assessment Framework;
• To deliver Biosecurity Risk Assessment Guidelines, an;
• To describe the step by step procedures of Conducting
• Biosecurity Risk Assessment.

Expectations:
Participants are expected to finish the lectures, answer the quizzes, and get a passing rate of 75% in the final examination. 

• Introduction to Biosecurity

  17:23

• Components of Biosecurity

  14:57

• Biosecurity Risk Assesment

  14:28

• Evaluation

  00:00

• Module 5 Quiz

• Practical Exam 1

• Practical Exam 2

• Practical Exam 3

• Final Exam

• Evaluation

  00:00