EBSA19 Preconference Courses 2016

Day 1 – 19 April

 

 Day 2 – 20 April

A – Design and implementation of the biorisk management system

B – Emergencies happen – are you prepared?

D – Valuable biological material – treated to be used safely

C – Effective decontamination and decommissioning of equipment and facilities

E – Effective communication – internally and externally

F – They are trained, but are they competent?

 

 

 

 

G – Stopping/avoiding the little incidents before they lead to big accidents

H – Using risk assessment in investigating accidents to prevent recurrence  

I – Workshop - Animal By-Products in Research

J - “Beautiful” facility designs – are they useful and safe to operate?

K – How to decide - the border between contained use or deliberate release?

 

 

Course

Topic

Length

Dates

A

Design and implementation of the biorisk management system

Course description

Recent breaches of biosafety and biosecurity have emphasised that management failure is normally the root cause of accidents and incidents with biological agents and toxins. Implementation of a systematic biorisk management system, e.g. adopting the CWA 15793 can help organisations manage these risks. The CWA 15793:2011 "Laboratory Biorisk Management” is the first internationally recognized management document to specifically address hazards associated with laboratories where biological materials are handled at all containment levels. With respect to individual state legislation, CWA 15793 is a compendium of all biosafety issues irrespective 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 and by thus does not contradict any existing guidelines.

The 2-days-course will start with the introduction of the principles of a biorisk management and how the multiple components of a biorisk programme can be integrated into the management system(s) in place or to be developed in an institution. Participants will be asked to give a short presentation of their institution at the beginning of the course. The main emphasis of the two days will be the opportunity for the participants to work on a scheme for implementation of a biorisk management for their respective home institutes.

The course participants will be able to:

  • Identify the fundamentals of a biorisk management system
  • Understand the intent of the CWA 15793:2011 with emphasis on:
    • Plan-Do-Check-Act cycle
    • Policies
    • Documentation control
    • Hazard identification & risk assessment (incl. risk control)
    • Operational control
    • Emergency response and accident and incident investigation
    • Training, awareness and competence
  • Initiate or improve the implementation of the CWA 15793:2011 for their institution


To optimize the individual benefit, the course instructors will contact the participants in advance to recommend which information of their home institutions the participants should bring along (if available).

CWA 16335:2011 Biosafety professional competence references

The topic refers to competence 7.2.17 and training specifications C.2.1.2.15 of CWA 16335:2011 Biosafety professional competence.

 

Instructors:
Juergen Mertsching
Urs Pauli

2 days

19/20 April

B

 Emergencies happen – are you prepared?

Course description

From minor lab mishaps to large accidents, biosafety professionals have a pivotal 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 components (preparedness, response, contingency, crisis management, recovery and investigation). Assessment of credible emergency scenarios and integration of bio-risks in emergency plans should enable an organization to prepare (actors, infrastructure & equipment, procedures, business continuity and communication) for a reasonable response proportionate to the scale and nature of the emergency. Effective testing, communication and training approaches, including emergency exercises and simulations, will be discussed.

In the second part of the training, an introduction on how to set up an incident investigation process will be provided. Root cause analysis techniques and how they lead to corrective and preventive actions will be demonstrated. In addition to definitions, references and background information, examples will be developed on how a biosafety professional can prepare for such events, respond, keep records and identify effective corrective actions.

Participants will be able to practice the introduced tools on case studies covering minor as well as major emergency situations involving biological material. On this basis the participants shall be able to develop an emergency management plan, advise on its implementation and conduct an incident investigation. This makes the course of interest to biosafety professionals that will get involved in emergency preparedness and handling, as well as any handling emergency plans that include biosafety aspects

Main topics

  • Basic concepts, the legal framework and reference documents for (bio) emergency management
  • Emergency preparedness in the context of risk management, business continuity and corporate image
  • Development and implementation of a bio-emergency plan and its key components (preparedness, response, contingency, crisis management, recovery and investigation)
  • Introduction and application of incident investigation methods.

 

CWA16335:2011 Biosafety professional competence references:

7.2.15 Emergency preparedness and response
The biosafety professional shall be able to develop an emergency preparedness and response plan and advise on its implementation.

7.2.16 Incident and accident investigation
The biosafety professional shall understand methods of incident (including near misses) and accident investigation and shall be able to apply them and shall contribute to actions to prevent reoccurrence.

Instructors:
Patrick Rudelsheim
Walter Kempenaers

2 days

19/20 April

C

Effective decontamination and decommissioning of equipment and facilities

Course description:

Laboratory facilities can be rapidly evolving environments, as projects or techniques change, so do the requirements of the laboratories and equipment. This combined with the routine requirement for maintenance; servicing and calibration make the need for effective decontamination methods critical to the operation of laboratory facilities. The introduction of new, complex systems into the laboratories can further complicate these issues and understanding the risks associated with biological samples and the contamination or residues they may level will be considered.

When facilities come to the end of life or have to be returned or passed on to other parties, there will be a requirement to ensure that all the hazards have been identified and were removed. Issues surrounding the decommissioning of facilities, identification of hazards and selection of remediation methods will be discussed. As will the waste streams and disposal options. Much of this discussion will also relate to the refurbishment of existing facilities and the possible hidden or unexpected risks, often only found once physical building work has started, but which can lead to significant delays. Structure approaches to the decommissioning of facilities will be considered, in light of the requirements of legislation and guidance.

Rendering equipment safe to handle is still critical to ensure the safety of both operational and service staff. Decontamination strategies will be reviewed in light of the type and levels of contamination and the final end point (maintenance, re-used or disposal). The impact of ever more restrictive environmental controls, European legislation and safety concerns continue to restrict the use of some of the more traditional chemical disinfects, and it cannot be assumed that those you use today, will still be available in years to come. Advice and guidance will be given regarding the decontamination methods and the choice and suitability of disinfectants. This will include how to interpret externally generated validation data, including the limitation of such information, along with methods and techniques to undertake in-house validation of decontamination strategies.

Main topics

  • Identify and understand the relevant legislation
  • Understand the mode of action for different disinfectants
  • Identify the most appropriate decontamination methods and strategies for equipment
  • dentify appropriate biological and chemical decontamination methods for facilities, prior to change of use or decommissioning
  • Understand and advise on validation and test methods for decontamination

 

CWA16335:2011 Biosafety professional competence references:

7.2.13 Infection control, disinfection, decontamination and sterilisation
The biosafety professional shall be able to understand the most important elements of infection control, disinfection, decontamination and sterilisation, as well as their efficacy. The biosafety professional shall be able to advise on choice and the correct use of methods.

7.2.14 Biological waste management
The biosafety professional shall be able to develop a biological waste management plan, including validation and verification, and advise on implementation of the plan.

Instructors:
Simon Parks
Felix Gmunder

1½ days

 

19 April pm / 20 April

 

D

Valuable biological material - treated to be used safely

Course description:

Unlike decontamination, and disinfection where it is intended to damage and kill biological material there are situations where the material is valuable and needs to be taken from containment for further processing in a lower containment environment while retaining its important biological integrity/function/structures/elements but removing or reducing its hazard.

In this interactive workshop the participants will develop:

  • Examples of situations when this occurs: pcr, vaccine manufacture
  • Sources of information and types of processing
  • Decision making tool on the need for reduction and verification
  • Validation and assurance  criteria
  • Understanding of risk assessment and effort-benefit

 

CWA16335:2011 Biosafety professional competence references:

7.2.14 & C.2.1.2.12  Biological waste management

7.2.17 & C.2.1.2.15  Biorisk management

Instructors:
Heather Sheeley

½ day

19 April am

E

Effective communication – internally and externally

Topics to be covered:

Effective communication, persuasion, motivation in internal and external communication

  • Internal messages
  • Change in behaviour
  • Talking to authorities, press, etc.
  • Making the message clear and convincing
  • Reaching different groups in training, risk assessment, etc.
     

CWA16335:2011 Biosafety professional competence references:

7.2.21 Communication skills and information / knowledge systems
The biosafety professional shall be able to transfer information clearly and convincingly to an audience including management, laboratory workers, ancillary personnel and external parties. The biosafety professional shall be able to communicate with personnel at all levels with the proper degree of understanding and sensitivity.

Instructors:
Tim Trevan
Jeffrey Skiby– Copenhagen

1 day

19 April

F

They are trained, but are they competent?

Course description:

A lack of competence has contributed to a number of major accidents and has been identified as a key underlying cause of incidents in biocontainment facilities. Competence is a broad, multifaceted subject and most organisations will already have processes that can contribute to the provision of competence within their specific working environment. However, often the challenge still remains to harness these processes in order to underpin an overall effective competence management system. This one-day course aims to provide biosafety professionals, researchers and facility managers with an introduction to the human aspects of competence, leading to an understanding of different ways in which it can be assessed as part of an effective competence management system.

Through a combination of presentations by the course instructors, open plenary discussions and group exercises, by the end of the course participants will be able to:

  • Define what competence is and the elements that contribute to it
  • Understand and recognise the different stages of competence that a person passes through on the way to becoming skilled
  • Describe different types of human failure, why they might occur and identify which ones are directly linked to inadequate competence
  • Define what competence management is and what it should aim to achieve
  • Appreciate the need to assess competence and different ways in which this can be achieved and managed

 

Main topics:

  • What competence really is
  • The stages of competency
  • Types of human failure and why they happen
  • What competence management is
  • Features of an effective competence management system
  • Critical assessment of competency requirements for different tasks

 

CWA16335:2011 Biosafety professional competence references:

The topic refers in part to competence 7.2.20 training and training specifications C.2.1.2.16 of CWA 16335:2011 Biosafety professional competence.

 

Instructors:
Jonathan Gawn
Liz McMinn PhD

1 day

20 April

G

Stopping/avoiding the little incidents before they lead to big accidents

Course description:

Fortunately most laboratories never experience a significant incident (accident, ill-health or damage to property, equipment or the environment) but what about the less serious, apparently trivial incidents that may get ignored and/or not even reported.    Such events could potentially give rise to more significant outcomes under only slightly different circumstances, e.g. more hazardous material being handled.

This one-day course aims to provide biosafety professionals, researchers and managers with an introduction to those human factors/behaviours that could contribute to the occurrence of incidents.

Through a combination of presentations by the course instructors, open plenary discussions and group exercises based on case studies of real incidents, by the end of the course participants will be able to:

  • Understand what leading and lagging indicators are and how they can be used to measure safety performance
  • Appreciate the different types of human failure and through examination of case studies, understand how human failure can contribute to incidents occurring.
  • Apply this knowledge to:
    • analyse work practices and develop interventions to reduce the likelihood of incidents occurring

develop meaningful safety performance indicators

CWA16335:2011 Biosafety professional competence references:

7.2.5 Human factors

The biosafety professional shall be able to understand human factors (e.g. behaviour, reliability, ergonomics) leading to intentional and unintentional errors. The biosafety professional shall have the skills to influence behaviours and risk perception, and be persuasive in promoting good biosafety and biosecurity practices taking into account cultural and socio-economic considerations

7.2.11 Good microbiological techniques (GMT)
The biosafety professional shall be able to 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).

7.2.16 Incident and accident investigation

The biosafety professional shall understand methods of incident (including near misses) and accident investigation and shall be able to apply them and shall contribute to actions to prevent reoccurrence.

7.2.17 Biorisk management programme

The biosafety professional shall be able to develop and support the implementation of a biorisk management programme and understand how the elements (e.g. physical, personal and informational biosecurity measures) in such a programme are interrelated so as to achieve the objectives of the programme. The biosafety professional shall be able to understand and apply the core principles and practices associated with a management system approach that incorporates continual improvement and be able to communicate them.

Instructors:
Jillian Deans
Paul McDermot

1 day

20 April

H

Using risk assessment in investigating accidents to prevent recurrence  

Course description:

The value of risk analysis and assessment and the subsequent selection of adapted and most effective safety measures should not only be appreciated after an incident already happened, but also when evaluating new facilities and activities. Its use in investigation of an incident is crucial to determine where otherwise sensible measures failed.  All too often lessons are not learned.

The goal of this course is to discuss the type of methodologies to be applied to do a thorough incident investigation with which future incidents should be avoided.

This interactive course takes an example incident and uses it to look back at what led to it, directly and indirectly and to the adverse outcome. Participants will use their own knowledge on risk assessment methodologies to do root cause analysis and common risk rating and to assess these methods for their applicability to determine causal effect and refine controls.

Participants will:

  1. Explore plausible scenarios for flaws
  2. Apply different risk assessment methods and appreciate the value in learning lessons
  3. Gain an understanding of lessons learned and investigation

 

Prerequisite: Knowledge on different risk assessment methodologies.

CWA16335:2011 Biosafety professional competence references:

Section 7.2.7, Biorisk assessment and management, and Section 7.2.16, Incidents and accident intervention. The competence gained at this course is relevant to task B.2 (Biorisk assessment and management) and B.10 (Accident / incident reporting and investigation) of Annex B and can be fulfilled by training specification C.2.1.2.5 (Biorisk assessment and management) and C.2.1.2.14 (Incident and accident investigation) of  Annex

Instructors:
Heather Sheeley
Douwe Kuperus

1 day

20 April

I

 Animal by-products (ABP) are defined as entire bodies or parts of animals, products of animal origin or other products obtained from animals, which are not intended for human consumption. ABP and their derived products are a potential source of risks to public and animal health. Consequently, their use, transport and disposal are strictly regulated at EU level. The ABP regulation covers a wide range of ABP with varying risks (category 1, 2 and 3) and different purposes of use (e.g. animal food, clothing, scientific research). Consequently, not all its requirements apply to all users of ABP, making it sometimes difficult for users to find their way in the complex regulatory framework. Such is the case for ABP intended for diagnostic, research and/or educational activities (e.g. bodies and parts of animals used for scientific or educational purposes, serum produced for use in biotechnology, purified polyclonal antibodies). The workshop aims at an open discussion on experiences with ABP use and disposal by people working in a research environment. The results of the discussion will inform a guidance document  for our members on how to deal with their ABP.

Facilitators:
Karen van der Meulen, Perseus, Belgium
Annebel De Vleeschouwer

1/2 day

20 April

J

“Beautiful” facility designs - are they useful and safe to operate

Course description:

This course discusses the different lab layouts for BSL-1 and BSL-2 facilities. Particular attention is given to the personnel and material flows in different settings. The pros and cons of conventional and enclosed lab spaces versus open and multifunctional lab environments will be worked out. Additional emphasis is attributed to the role of the BSO and other HSE professionals in the planning and operation phase. This includes the consideration of user requirements as well as organisational, technical, ergonomical, and occupational hygiene aspects. Participants are invited to share their experience and engage in group work in order to find possible best-practice solutions.

The course is targeted towards BSOs and HSE professionals, as well as laboratory construction experts and architects.

CWA16335:2011 Biosafety professional competence references:

  • 7.2.9    Facility  (re)design,  construction, commissioning, decommissioning, validation, operation  and maintenance
  • Task B.15 (Facility planning, (re)design, commissioning, decommissioning, validation, operations and maintenance) of Annex B
  • Training specification C.2.1.2.7 (Facility design, construction, commissioning, decommissioning, validation, operation and maintenance) of Annex C.


Instructors:
Eric Dumermuth, Novartis Pharma Ltd., Basel, Switzerland
Guido Vogel, Mabritec Ltd., Riehen, Switzerland

½ day

20 April am

K

How to decide - the border between contained use or deliberate release?

Course description:

Did you ever ponder whether an activity with genetically modified organisms (GMO) would fulfil the requirements for contained use or whether you had to submit an authorisation application for deliberate release? On paper, the regulatory requirements and the distinction between contained use and deliberate release of GMO seems to be straight forward. In practice, there can be quite some uncertainty for which situations ‘contained use’ applies. A combination of biological, organisational and physical containment measures can either avoid or minimize the release of GMO into the environment. Under which setting and for which GMOs is ‘minimize’ sufficient with respect to the protection of people and the environment? Under which circumstances would an extended environmental risk assessment be necessary because, even though not deliberate, a minimal release of GMO cannot be avoided?

The workshop is suitable for all interested and involved in risk management of activities related to genetically modified organisms which might be slightly different from the usual contained use setting such as laboratories or production facilities and, foremost, for biosafety professionals facing new challenges regarding biocontainment related to, for instance, clinical trials or research with gm plants and animals in special settings.

The workshop will cover these aspects by discussing case studies, taking into account both the characteristics of the GMOs, the risks related to the activities, the safety measures taken and the context of regulatory requirements. Participants are asked to bring their own cases for discussion. Active participation in the discussion is expected.

The biosafety professional shall be able to:

  • understand the risks for the environment associated with work involving biological material;
  • evaluate the suitability of measures to prevent or minimize the escape of biological material into the environment;
  • design suitable monitoring strategies to evaluate prevention measures;
  • distinguish between contained use and deliberate release regulatory requirements and their implication.

 

CWA16335:2011 Biosafety professional competence references:

This competence is relevant to task B.21 (Environmental safety) of Annex B of CWA16335:2011 Biosafety Professional Competence and can be fulfilled by training specification C2.1.2.5, biorisk assessment and management, and C2.1.2.6, environmental safety. The course draws on CWA 15793:2011 Biorisk Management, specifically on section 4.3.1 on risk planning for hazard identification, risk assessment and risk control.
 

Instructor:
Ursula Jenal

½ day

20 April pm