EBSA15 Preconference Courses 2012

A) Emergency Preparedness and Contingency Planning (full day)

Instructors:
Walter Kempenaers, Perseus BVBA, Zwijnaarde/B
Patrick Rüdelsheim, Perseus BVBA Zwijnaarde/B

Description:
From minor lab mishaps to large accidents, the biosafety professional has a central role in minimizing unwanted effects of biological agents when normal biosafety or biosecurity operational controls fail.

The course introduces participants to Emergency Management and its key phases:

Preparedness, Response, Recovery and Mitigation. The Emergency Management scheme will be applied to incidents and accidents with limited impact. Examples will be developed on how a biosafety professional can prepare for such events, respond, keep records and identify effective corrective actions. The course will further develop on preventing and managing major emergency situations, e.g., major spills and other unintentional releases, fire, medical, power failures, security incidents, natural disasters, and any other emergency situations, involving biological material. Emphasizing the importance of the human factor, effective training programmes as well as principles of crisis communication will be discussed.

On this basis the participants shall be able to develop an Emergency Management plan and advise on its implementation.

B) Developing and sustaining behavioral-based safety programmes (full day)

Instructor:
Sean Kaufman, Emory University, Atlanta, GA/USA

Description:
You don't teach a child how to swim with PowerPoint, so why do we spend so much time training people with PowerPoint? We must acknowledge that training does not end with the transfer of a standard operating procedure. Laboratory safety is not just about what we know, it is about what we do. Doing is behavior and behavioral-based biosafety programmes must be included when preparing staff to work in laboratory environments. This program will utilize the model of behavioral evolution to discuss how behavioral-based safety programs benefit laboratory staff. We will discuss levels of learners, writing measurable training objectives, facilitating valid program evaluations - allowing us to capture valuable information needed to demonstrate course effectiveness of the behavioral-based training programs. Participants will be asked to engage in an interactive discussion with several practical-based exercises demonstrating behavioral training practices including modeling, shaping, and utilizing mental noise to increase behavior or cognitive engagement. After completing this program, participants will be able to discuss the profound differences between traditional training models and effective behavioral-based safety training programs.

C) Risk assessment of activities with genetically modified and pathogenic (micro)organisms (full day)

Instructors:

Ursula Jenal, Jenal & Partners Biosafety Consulting, Rheinfelden/CH
Otto Doblhoff-Dier, University of Veterinary Medicine Vienna/A

Description:
Management of risks related to activities with hazardous biological material, be it research, development, production or diagnostics, requires risk assessment at various stages of the activity.

To begin with, the hazards of the various biological materials need to be estimated. When genetic modification is involved methods and tools such as viral vectors, plasmids and types of inserts need to be considered.

At a second stage biosafety and biosecurity measures need to be evaluated for their ability to contain the biological material. These measures on their own, whether organizational or technical, have their weaknesses and might be vulnerable to failures which need to be taken into account in incident and accident prevention. To this aim, different types of risk assessment methodologies are available and can be applied.

The course will cover these aspects in introductory presentations and case studies. Participants are asked to actively participate in the course by bringing their own risk assessment questions and work situation up for discussion. Depending on these questions and situations the topics listed above will be delved into.

D) Biosafety aspects and management of the design and construction of biocontainment facilities (full day)

Instructors:
Simon Caidan, Medical Research Council National Institute of Medical Research, London/UK
Paul Jackett, TTASS Ltd, London/UK
Philippe Stroot, Xibios Biosafety Consulting, Tournai/B

Description:
This course will present the concepts, envisage technical options and examine the safety and project management issues related to planning of the construction of BSL2 and BSL3 facilities. The approach, starting from establishing the users' requirements, will emphasize the importance of an initial risk assessment, needed to define the scope and concept of the project.

Technical considerations will include: workflow and ergonomic considerations, basic construction requirements, materials for fit-out, work surfaces, selection of key equipment (including conforming to relevant European and National standards), schematic ventilation requirements and their control, pressure regimes, commissioning and validation, fumigation and the development of key operational policies and codes. Other issues include considerations on the role of the biosafety professional in a design and construction project, the structure of a project team and the involvement of regulatory authorities in the planning of facilities.

Some room will be left to discuss issues brought by the participants.

E) Personal protective equipment (half day)

Instructors:
Per Staugaard, Biosafety Training & Consultancy, Utrecht/NL
Jonas Hardestam, Swedish Institute for Infectious Disease Control, Stockholm/S

Description:
This course will give an overview of the use of personal protective equipment (PPE) in BSL2 and BSL3 laboratories. But will very much be focused on practical experience with different sorts of PPE. Thecourse will concentrate on how to choose adequate PPE (gloves, safety glasses, lab coats, respiratory protection, etc.) for different purposes. This day we will give the trainees an opportunity to try and to test hands-on various examples of PPE under the supervision of experienced trainers. We will also go through how to perform fit-testing of respirators.

This course is particularly suitable for laboratory managers responsible for supervision and for safety standards and training of personnel. Previous experience is not required.

F) Working safely in a biosafety cabinet

Instructors:
Per Staugaard, Biosafety Training & Consultancy, Utrecht/NL
Jonas Hardestam, Swedish Institute for Infectious Disease Control, Stockholm/S

Description:
The course will consist of a short theoretical introduction to design, maintenance, calibration and working.

In this course students will work according to a 'practical approach';

students are invited to work - as much as possible according to their own procedures The practical work will be video-taped during this work. Feed-back on basis of the recordings will be used in a discussion to improve procedures.

Do's and don'ts for working in a BSC will be discussed.

 Students are invited to bring their own PPE, materials ,and tools to be used in the training.

G) Biological waste management and decontamination (full day)

Instructors:
Evelien Kampert, National Institute of Public Health and the Environment Center for Infectious Disease Control, Bilthoven/NL
Joke Ederveen, Edra Services, Consultancy & Training, De Meern/NL

Description:

This one day course will give understanding of different aspects of decontamination. An interactive workshop combining theory and practical examples covering decon methods for micro-organisms of all risk groups, with particular focus on level 3, suitable for laboratory managers and biosafety officers in charge of microbiological labs or animal houses.

Legislation: Consequence of the biocides legislation in Europe (including REACH).

Disinfection: The pros and cons of several liquid disinfecting chemicals (ethanol, chlorines, etc) will be discussed. Allan Bennett of Health Protection Agency, Salisbury/UK will lead you through the different gaseous disinfection methods (formaldehyde, H2O2, ClO2).

Sterilization: Fundaments of sterilization (D-values) and several aspects of sterilization techniques. Technical information about the autoclave and the balance between autoclave loading and autoclave cycles.

Validation: What does validation mean? Discussion on the (im)possibilities of validation of the decon process.

Participants will perform risk assessments to decide for the best decon method and waste management program. There will be time to discuss questions and cases of participants.

H) Auditing - Beyond the basics (full day)

Instructors:
Helmut Bachmayer, Biosafety & Biosecurity Consultant, Maria Enzersdorf/A
Gary Burns, AstraZeneca PLC, Macclefield/UK

Description:

This 1-day course builds on the basic auditing workshop which has been delivered in connection with previous EBSA conferences although prior participation in that course is not essential. Participants will be assigned to groups which will be provided with a scenario from which they will be asked to elaborate pre-audit questionnaires, prepare introductory and closing sessions and draft a management summary of an audit report.

I) Biorisk management systems and the implementation of CWA 15793 - a practical approach (full day)

Instructors:
Toon De Kesel, Bayer CropScience, Gent/B
Juergen Mertsching, Hannover Medical School/D

Description:

Recent breaches of biosafety and biosecurity have emphasised that systematic management failure is normally the root cause of accidents and incidents with biological agents and toxins. Adopting the CWA 15793 can help organisations manage these risks.

The CWA 15793 - Laboratory Biorisk Management Standard - is the first internationally recognized management standard to specifically address hazards associated with laboratories where biological materials are handled at all containment levels. It sets out the requirements for a management system to enable organizations to effectively identify, monitor, and control risk associated with laboratory biosafety and biosecurity. It also provides a structured approach to managing risk associated with people, facilities and working procedures in laboratory environments.

With respect to individual state legislation, CWA 15793 is a compendium of all biosafety issues irrespectively of actual laws or administrative provisions. It defines key requirements encompassing all relevant laws and does not focus on the application of individual pieces of legislation. Therefore, the CWA 15793 document is deliberately general in order to accommodate national differences.

This interactive course aims to help you understand the fundamentals of the CWA 15793 and how it can be applied to your organization. It will present the principles of biorisk management, identify the multiple components of a biorisk programme and explore ways to integrate them into the management system(s) in place or to be developed in an institution. Some specific issues like the consideration of biosecurity aspects as part of biosafety management will be developed.

The course will be illustrated by examples of system implementation and a few exercises.