Practical Experience of Implementing New Laboratory Biorisk Standards in Indonesia Presented in the 12 TH OIE SEMINAR during the 18 th WAVLD Symposium Sorrento Italy, 7-10 June 2017 Indrawati Sendow Indonesian Research Center for Veterinary Science Bogor, Indonesia Francois Diaz, OIE
Indonesia is an agricultural country 17,508 islands, 34 provinces, population of 260 million people, has 746 languages & dialects, great diversity of fauna & flora Migration of people and animals is increasing spreading of diseases, such as transboundary animal diseases (TADs) Indonesia has many veterinary laboratories Needs to implement biorisk management (BRM) compliance with the standards
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Laboratory Biorisk Analysis Biorisk Analysis is the process comprising biohazard identification, biorisk assessment, biorisk management and biorisk communication. What can go wrong? Biohazard Identification How likely is it to occur? How severe would be the consequence? Biorisk Assessment How can these risks be prevented? Biorisk Management Biorisk Communication How was the risk identified, characterised and controlled? Verification/continual improvement
Biohazard Identification Identification Nipah virus NIPAH ELISA Negligible (inactive virus) Serum neutralisation/viral Isolation Non-Negligible (live virus) Biorisk Assesment Likelihood of release Negligible Non-Negligible Likelihood of Exposure (H,A,E) Negligble Non-Negligible Consequences Low High Results Risk Low High Perform Low risk, performed in virology/zoonosis laboratory High risk, but can be performed in high biocontainment Biological Risk Management Control measures Microbiological practices, SOP Need: Engineering, Operational, Administrative Control and Personal Protective Equipment (PPE)
Example Risk Analysis Application to Biosafety at IRCVS Improve biosafety in BSL-2, Zoonosis lab, animal lab in zoonosis facility design lab, workflow, safety equipment, PPE, waste management, etc. Establish BSO, DBSO, IBC, Maintenance staff Conduct RA for all research proposals, including work in animal facilities Communicate RA results with the personnel Develop SOPs
Facility improvements
Biosecurity Improvements at IRCVS
Challenges Implementation of BRM 1. Changing culture 2. Building biosafety & biosecurity (BSS) capacity 3. Training & dissemination 4. Maintaining functional laboratories building capacity 5. Maintaining biorisk awareness in all workers 6. Commitment of Management
1. Changing Culture To Motivate staff to have the same perceptions of the importance of biosafety & biosecurity implementation To Create a sense of ownership to work safely in the laboratory (safety culture) To Update and continually train on biosafety and biosecurity and its implementation But Need a strong commitment from senior management
2. Building BSS Capacity Communicate & motivate staff to increase Biorisk awareness Collaborate with National & International Biorisk Associations. NIH, IFBA, A-PBA, IBA Internal training at IRCVS Involve: lab staff, technicians, maintenance staff, security guards & management TOT Apply Good Microbiological Practices (GMP), use of safety equipment, PPE, decontamination, waste management Capacity building and dissemination
3. Training and Dissemination
Simulation of Emergency Response & Assesment Practical drills address a variety of scenarios (loss or theft of materials) Emergency response to accidents & incidents Reporting and documentation Self assesment Training and Dissemination
4. Maintaining a functional laboratory Create a sense of ownership for working safely in the laboratory Train technical staff locally and abroad Training programmes on HVAC system Training on preventive maintenance for BSC, Autoclaves, incubators, etc. Training on BSC testing & troubleshoot Provide availibility of spare parts
WASTE MANAGEMENT 1. Solid waste: Solid waste should be autoclaved before being disposed All carcases should be incenerated. Autoclave routinely validated 2. Liquid waste: Improved the liquid waste dispossal with a central liquid waste treatment for all labs in IRCVS 3. Chemical waste: Seperated each chemical, labelled, stored and taken by the certified third party 4. Sharp waste: Provide the sharp container Disposed (Maintaining a functional laboratory)
INVENTORY AND ACCOUNTABILITY Biological Agent and Toxin Inventory and Information (IRCVS/Balitvet Culture Collection) (Maintaining a functional laboratory) Only authorised staff are responsible for the agent inventory & storage Track the inventory, storage, use, transfer, and destruction of dangerous biological agents and chemicals
Emergency Response & Contingency Plans Emergency exercises and simulation electricity power, fire, spills Backup system for power supply genset, UPS (Maintaining a functional laboratory) Communication with users for emergency plans spill in lab, BSC, centrifuge Emergency exit routes and assembly points designated. Coordination with external agencies ie. police, security services & training for security guards Specific to facility and infectious agents, toxins, and hazardous chemicals in laboratories
Verification and Corrective Action BRM is an ongoing process Must check and verify through an auditing process All the non-conformities related to BRM need to be corrected and verified Constant and never ending improvement is the BRM goal
Summary & Conclusions OIE provides capacity building allowing compliance with OIE Standards and strengthening of national Veterinary Services OIE Standard on Biorisk Management can be implemented by all countries from technologically advanced to transition or resource-limited countries FAO/OIE/WHO work together ( One Health approach) for a comprehensive Biological Risk Management framework on human and animal health Implementation of the OIE Standard in the laboratory is an integral part of the biorisk management agenda of veterinary laboratories that protects workers, co-workers, products, lab support personnel and the environment that ultimately leads to greater community confidence
OrganisationMondiale de la Santé Animale World Organisation for Animal Health Organización Mundial de Sanidad Animal 12 rue de Prony, 75017 Paris, France - www.oie.int oie@oie.int