The Implementation of Biorisk compliance with International Standard

Transcription

1 The Implementation of Biorisk compliance with International Standard Presentation to Regional Seminar for OIE National Focal Points for Veterinary Laboratories Jeju, RO Korea, 5-7 April 2016 Indrawati Sendow Research Institute for Veterinary Science Bogor, Indonesia Francois Diaz, OIE Peter Daniels, OIE

2 OIE vision for the management of biological risks A world that is safe and secure from the accidental or deliberate release of animal pathogens, including zoonoses.

3 OIE Biosafety and Biosecurity Resources - OIE Health Standards - Manual of Diagnostic Tests for Aquatic Animals Manual of Diagnostic Tests and Vaccines for Terrestrial Animals

4 OIE Biosafety and Biosecurity Resources - OIE Standards - A new chapter in the Terrestrial Manual was adopted as the current standard for member countries during the May 2015 General Session of the OIE: Chapter : Biosafety and Biosecurity: Standard for Managing Biological Risk in the Veterinary Laboratory and Animal Facilities. TY.pdf Chapter , Biosafety and biosecurity in the veterinary diagnostic microbiology laboratory and animal facilities. Chapter a. Standard for managing biorisk in the veterinary laboratory and animal facilities (adopted by the World Assembly of OIE Delegates in May 2014)

5 OIE Biosafety and Biosecurity Resources - OIE Standards - A new chapter in the Terrestrial Manual was adopted as the current standard for member countries during the May 2015 General Session of the OIE: Chapter : Biosafety and Biosecurity: Standard for Managing Biological Risk in the Veterinary Laboratory and Animal Facilities. Appendix : Steps in Biological Risk Analyses Appendix : Consideration used in evaluating and implementing biological risk control measures.

6 OIE Biosafety and Biosecurity Resources - OIE Standards - Guideline 3.5. Managing Biorisks: Examples of aligning risk management strategies with assessed biorisks: Provide working examples of the risk assessment process to help in implementing Chapter SPECIF_RA.pdf

7 The new Chapter provides: 1. Principles for managing biological risks based on risk assessment and steps to be followed in biological risk analysis; 2. Essential basic standards to be followed for all laboratory work; 3. Illustrative examples of risk assessments

8 DEFINITIONS Laboratory Biosafety describes the containment principles, technologies, and practices that are implemented to prevent the unintentional exposure to biological agents and toxins, and to prevent their accidental release. Laboratory Biosecurity describes the protection, control and accountability for biological agents and toxins within laboratories, in order to prevent their loss, theft, misuse, diversion of, unauthorized access or intentional unauthorized release.

9 Laboratory Biorisk Analysis Biorisk Analysis is the process comprised of biohazard identification, biorisk assessment, biorisk management and biorisk communication. What can go wrong? Biohazard Identification How likely is it to occur? How sever would be the consequence? Biorisk Assessment How can these risks be prevented? Biorisk Management Biorisk Communication How was the risk identified, characterized and controlled? Verification/continual improvement

10 Biohazard Identification Identify the biologic agent or toxin, including: The amount (volume, concentration) of the agent expected to be handled in the laboratory. The laboratory procedures to be used (e.g. centrifugation, sonication, isolation and amplification in culture, animal inoculation). Storage and archive volumes of the agent or toxin expected for the laboratory.

11 Biorisk Assessment 1) Identify the likelihood and the potential consequences (severity of harm) associated with exposure to or release of the biologic agent identified as a hazard: human disease (probability and severity) animal disease (probability and severity) susceptible species in the vicinity environmental factors in the vicinity (routes of transmission) economic consequences of the disease and associated disease control costs. potential for theft, misuse, or deliberate release. 2) Decide if the risk of handling the agent in the laboratory can be controlled and is the cost justifiable.

12 Biorisk Management Strengthening laboratory biosafety and biosecurity to protect laboratory capacity and safely combat infectious diseases implementation, evaluation and improvement Ensure the sustainability of maintenance and management commitment of Top Management Maximize existing resources and facilities to enhance effectiveness and efficiencies The laboratory manager works with a biorisk management advisor to identify which control measures are appropriate and feasible for use in their laboratory in order to prevent exposure to and release of the agent.

13 Engeenering Control Directional Airflow HEPA Filtration Biosafety Cabinets Alarms Autoclaves Administrative Control Background Check Security clearance Training Medical surveillance Vaccinations SOP compliance Biosafety and Biosecurity E Implementation Personal Protective Equipment (PPE) Respiratory Protection, PAPR Gloves, goggle and ear protection Scrubs/tyvek suit Booties Standard Operating Procedure (SOP How to use PPE Emergency Responce Working in Biosafety Cabinets (BSC) Decontamination Handling Sharps Waste Management

14 Biorisk Communication Biorisk communication is the interactive transmission and exchange of information and opinions throughout the risk analysis process concerning risk, risk-related factors and risk perceptions among risk assessors, risk managers, risk communicators, the general public, and other interested parties. The format and language is tailored to the intended audience, whether policymakers, disease control authorities, animal care providers, or the public, in order to provide the information in a clear and understandable manner, including; the identification of the biohazard (agent or toxin) the benefits to the stakeholder gained by the laboratory working with the biohazard information indicating that a biorisk analysis was performed and is documented information indicating that the laboratory has control measures in place to mitigate against accidental or intentional release of the biological agent or toxin.

15 Summary and Conclusions OIE sets international standards for animal health adopted by the World Assembly of Delegates (180 Member Countries) OIE provides capacity building allowing compliance with OIE standards and strengthening national veterinary services OIE Standard on Biorisk management can be implemented by all countries from advanced technology to transition or resources limited countries. FAO/OIE/WHO work together (one health approach) for a comprehensive Biological Risk Management framework on human and animal health

16 How to implement biorisk compliance within the standard?

17 Capacity Building & Outreach Veterinary Laboratory Facilities in Indonesia: BSL 3 (10) Bogor (3); Jakarta (4); Bandung 2), Surabaya (1) BSL2 (8) (Diseases Investigation Center): Java (2), Sumatera (3), Sulawesi (1), Kalimantan (1), Bali (1) >150 small labs (type B and C).

18 Jakarta, Bogor, Bandung, Surabaya BSL3 FACILITIES IN INDONESIA

19 MAP OF DIC AREAS IN INDONESIA I II V III VIII IV VI VII

20 Challenges of establishing the safe and secure lab/implementing the BRM 1. Building BBS capacity: limited expertise of personel 2. Changing the culture 3. Maintaining functional laboratories building capacity 4. Maintaining biorisk awareness in all workers 5. Commitment Management

21 1. Limited expertise of personel Limited expertise on BBS for staff, technician, Maintenance, IT Working in biosafety is not full time no full time personnel on BSO, Safety officer, IBC, IACUC and Maintenance staff to implement and maintain for continual improvement. It is also no recognition for carrier promotion. Language problems ( for maintenance and technician; Most labs have no engineer) Maintenance and operational of BSL3 is different to BSL2. Maintenance equipment: spare parts (still imported), human resources for calibration/ certification( BSC), validation (waste, autoclaves) etc funding constraint Training in house training, abroad and dissemination, for all employees (staff, Maintenance, security, management)

22 2. Changing the culture People are used to working in old ways Motivated them to have one perception on the importance of Biosafety and biosecurity implementation Create a sense of ownership for working safety in the laboratory (safety culture). Continuous and updated training on biosafety and biosecurity. Strong commitment from Top Management

23 3. Maintaining a function laboratory Some Technical staffs had training locally and abroad, preconferences (APBA, AAHL Australia, Eagleson USA, IBA, Hawaii, others ) limited staffs should disseminate to other staffs and applied in the lab based on our resources multilayer training program Training program on HVAC system, preventive maintenance, BSC testing, troubleshoot of equipment (BSC, Autoclaves, incubators etc) The availibility of spare parts (Imported) BSC Testing training Maintenance training

24 Maintenance Training program

25 4. Training and Dissemination

26 Improving building Capacity

27 Simulation of Emergency Respons and Assesment Practice drills: address a variety of scenarios (loss or theft of materials) Emergency response to accidents and injuries, reporting and documentation Self assesment

28 ELEMENTS OF A BIOSECURITY PROGRAM Physical Protection Access Control and Monitoring

29 INVENTORY AND ACCOUNTABILITY To know what agents exist at a facility, where they are located, and who is responsible To track the inventory, storage, use, transfer, and destruction of dangererous biological agents and chemicals

30 TRANSPORT OF BIOLOGICAL AGENTS Material transport policies: accountability measures for the movement of materials within an institution and outside of the facility Personnel should be adequately trained and familiar with regulatory and institutional procedures for proper containment, packaging, labeling, documentation and transport of biological materials. Category A 602 package Labels: UN 2814 UN 2900 Biohazard

31 INFORMATION SECURITY Development of policies for handling sensitive information Development of policies that govern the identification, marking and handling of sensitive information Control of the access of sensitive information.

32 Verification and corrective action BRM is an ongoing process Must check and verify that it is working through an auditing process All the non conformities related to BRM, need to be corrected and verified as working. Constant and never ending improvement is the BRM goal

33 Let us work together to achieve our common goals One Health

34 OrganisationMondiale de la Santé Animale World Organisation for Animal Health Organización Mundial de Sanidad Animal 12 rue de Prony, Paris, France - oie@oie.int