Capacity Building for Laboratory Biosecurity (for the 2010 ARF Workshop on Biorisk Management)

Transcription

1 Capacity Building for Laboratory Biosecurity (for the 2010 ARF Workshop on Biorisk Management) Peter Daniels, John Allen, Bagoes Poermadjaja, Greg Smith and Agus Wiyono 1. CSIRO Australian Animal Health Laboratory, Geelong - The AAHL Regional Program 2. Directorate of Animal Health, DGLS, Indonesia September, 2010

2 Preconditions for successful capacity building are: A clear and shared understanding of what is to be achieved A clear understanding and acceptance of who is responsible for what

3 What must be achieved? What s the specific objective today? An effective, comprehensive biorisk management system

4 Keys to a successful biorisk management system (CEN Workshop Agreement) CWA 15793:2008 Commitment by senior management Provision of resources, priorities Communicating the policy and its importance Integrating biorisk management throughout the organization (it s everyone s responsibility) Identifying opportunities for improvement And then focussing on continual improvement It s a responsibility of everyone With periodic reassessment Prevention activities Education and training Establishing goals and measures of improvement RECOGNIZING IMPROVEMENTS

5 Elements of a Biorisk Management System (How to we go about it?) There must be a system, with the intent that it works With a policy With planning risks identified, strategy defined With implementation Roles, responsibilities, authorities Personnel training, awareness, competence Consultation and communication Operational control Emergency response and contingency plans With checking and corrective action And with review CWA 15793:2008 CWA 15793:2008

6 Biorisk Management Policy (Stating the Objectives and the Commitment) Protecting staff and the interests of the community Reducing the risk of unintentional release Reducing the risk of unauthorized intentional release Complying with all legal measures Ensuring that effective biorisk management takes precedence over all other operations Effectively communicating the policy Continually improving biorisk management performance CWA 15793:2008

7 Hence the framework for capacity building has been defined Capacity building is a partnership That must involve and have a commitment from senior management (and all personnel) Will frequently involve an external source of advice External or specialized expertise not usually available in the facility Will have a focus on continual improvement (capacity building!)

8 The Australian Animal Health Laboratory A Biocontainment facility!

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10 AAHL Floor Plan

11 Effective building design involves complex engineering

12 Air handling systems - High Efficiency Particulate Air (HEPA) filters

13 Autoclaves, effluent sterilization systems

14 Biosecurity Level 4 Hendra virus, Nipah virus, Ebola Reston and SARS coronavirus

15 With a range of BSL 3 and 4 animal experimentation capacity

16 A range of site security measures and access restrictions

17 There is more to biocontainment than the building! Requirements for biocontainment: A suitably designed and constructed facility Staff and SOPs for managing the engineering functions Access to qualified engineers Trade staff on site Regular maintenance Staff and SOPs for laboratory procedures Regular training Incident reporting and review procedures Independent supervisory staff External oversight and review

18 Internal and External Oversight Laboratory Management Committees 1. CSIRO management processes 2. Bio-security, bio-safety and occupational health and safety 3. AAHL Support Services and Engineering Committees 4. AAHL Counter Terrorism and Risk Management Committee External Audit and Consultation 1. Management, quality and environmental management systems certified and accredited (ISO 9001, 14001, 17025) 2. AAHL Strategic Policy Group (ASPG) (Board of Governors) 3. AAHL Security Assessment Group (ASAG) detailed audit 4. Office of the Gene Technology Regulator (OGTR) audit 5. AQIS (quarantine service) audits 6. National Health Security Act (NHSA) audits 7. AAHL Medical Advisory Committee (AMAC) 8. Animal Welfare and Ethics Committee

19 AAHL s Regional Program Nepal Laos Taiwan Vietnam Thailand Malaysia The Australian Animal Health Laboratory (AAHL)* will serve the Australian and international communities by contributing to a prosperous and stable world through services in animal health relevant to food security, especially in the Asia Pacific region. This will be achieved by providing valued partnership and collaboration in the laboratory diagnosis and research of transboundary animal diseases, including emerging animal and zoonotic diseases, and associated laboratory capacity building. Indonisia * An OIE Collaborating Centre for Laboratory Capacity Building

20 Capacity Building: A people centered approach Science rarely achieves excellence where practiced in isolation Incremental advancement is an iterative process where people learn from and mutually support each other It follows that the one-off training course is not likely to be fully effective

21 Essential Elements of Laboratory Capability to Address in a Supported Regional Network Biocontainment and Biorisk Management Quality Assurance Management Health, Safety and Environment Management Physical Facilities and Equipment Management A defined scope of services, with standard test methods suitable for the various agreed purposes Staff Training Access to standard reagents, reference materials and QA panels Access to recognized national and regional reference laboratories with defined roles OIE, FAO and WHO monitoring and evaluation that objectives are being met

22 The Essential Elements of Laboratory Capacity Building The involvement of Top Management With a policy and a plan Communicating the desired outcomes to staff and stakeholders especially the relevant Directorates and Ministries With access to relevant expertise With criteria for internal assessment, and external audit and review

23 Components of a program of support: 1. Gap analyses Gap analyses of laboratories in the network are useful to identify areas in need of support or development Gap analyses are best conducted in a structured way (Think of them as similar to the PVS audits of veterinary services) They need not be as comprehensive as an audit for laboratory accreditation They should identify needs for support in any of the essential elements of laboratory capability as listed

24 Issues in conducting a Gap Analysis (1) It s a function of laboratory management! External expertise and advice can be used to help It starts with definition of the purpose of the laboratory It is conducted firstly in the context of national government legislation and regulations that cover the way delivery of these purposes will be conducted International benchmarking for good practice is also recognized

25 Issues in conducting a Gap Analysis (2) It is inseparable from evaluation of the management system of the laboratory Development of self knowledge But it may focus on a specific objective within the management system such as laboratory biosecurity The gap analysis should allow a plan of action to be developed The gap analysis should lead to a means of monitoring and evaluating progress

26 Components of a program of support: 2. What after the gap analysis? Evaluate within the context of Applicable legislation and regulations The purposes of the laboratory International benchmarking Costs of implementation Available resources The laboratory management system Which takes us back to CWA 15793:2008.

27 Elements of a Biorisk Management System There must be a system, with the intent that it works With a policy With planning risks identified, strategy defined With implementation Roles, responsibilities, authorities Personnel training, awareness, competence Consultation and communication Operational control Emergency response and contingency plans With checking and corrective action And with review

28 A practical example of a work in progress: Indonesian Veterinary Laboratory Biosecurity Project (Supported by DFAT, Counter-Terrorism Section) Biosecurity-Biosafety Gap Analysis & Risk Management Strategies for DICs, Jakarta. July 2010 CSIRO. Biosecurity AAHL: Diagnosis, Gap Analysis Surveillance and Response

29 The Overall Project Approach: Consultation with Top Management Several different Ministries Engagement of a source of international benchmarking expertise with a knowledge of the client s operating environment An opening workshop to scope the concepts and agree the work plan, Involving Top Management and the Laboratory Directors, the consultants and other international sources of expertise A training course at AAHL for the Laboratory Directors in Biorisk Management On site Gap Analyses Reporting A Review Workshop

30 The Approach to Gap Analysis on this Occasion A comprehensive engagement of laboratory management, as outlined Site visits by the consultants to facilitate site assessments Development of a list of questions/assessment points A walk through of each site, structured around the pathway of and support to a diagnostic specimen End of visit review with management Comprehensive overview in the end of project workshop

31 Aspects Reviewed in the Gap Analysis 1. Physical Security Perimeter security fencing, gates Availability of security staff Building security windows and doors, locking devices Access to keys and their control Site access, visitor control Alarms and surveillance aids Utilities and their reliability

32 Aspects Reviewed in the Gap Analysis 2. Other Laboratory Biosecurity Issues The purpose and function of the laboratory The enabling legislation The agents held and any requirements to report The appointment of a responsible person for biorisk management Documentation A written laboratory policy for biorisk management Specific SOPs for operations SOPs for transport of biological materials Incident reporting and corrective actions Staffing issues Selection Training Equipment Suitability Management and maintenance

33 Our focus tomorrow: a focus on HOW we manage biosecurity To develop an holistic perspective on laboratory biosecurity Risk assessments and gap analyses Establishment of best (good) practices With SOPs With documentation and review Beyond Physical Security Personnel reliability & integrity Material accountability Managing transport of risk materials Information security

34 Australian Animal Health Laboratory Dr Peter Daniels Assistant Director Phone: ) Cell Phone: peter.daniels@csiro.au Web: Thank you Contact Us Phone: or Enquiries@csiro.au Web: