Biorisk Management

1. Pakistan National Accreditation Council

2. Biorisk Management

3. Contents • Basic Terminology • Global Biological Threat • National Concerns • Measures • Combating the Threat • Way Forward • Biorisk Management Committee under NSC on Hospital & Health Care Facilities, SDC, PSQCA Pakistan National Accreditation Council

4. Basic Terminology BIOSAFETY: Describes the containment principles, technologies and practices that are implemented to prevent the unintentional exposureto Biological agents and toxins or their accidental release BIOSECURITY: Describes protection, control and accountability for valuable biological materials within laboratories, in order to prevent their loss, theft, misuse, diversion of, unauthorizedaccess or intentional release. Ref: WHO/CDS/EPR/2006.6 Pakistan National Accreditation Council

5. Basic Terminology BIORISK: Pakistan National Accreditation Council

6. Biorisk Spectrum • Naturally Occurring • Bio terror • Bio War • Lack of Awareness and Negligence Pakistan National Accreditation Council

7. Global Biological Threats • Global outbreaks of emerging and reemerging infectious disease Morens, DM et. al. Nature. 8 Jul 2004 Pakistan National Accreditation Council

8. Global Biological Threats • Global outbreaks of infectious disease • Natural outbreaks represent unpredictable sources of dangerous pathogens • Radical/Terrorist threat • Terrorist groups have established intent to do harm; use of BW represents a potential threat • Dual-use biotechnology • Increasing vulnerability of the legitimate bioscience sector for accidental release or intentional misuse Pakistan National Accreditation Council

9. The Threat – National Concerns Pakistan faces: - Communicable Diseases: TB, Hepatitis, Malaria, HIV/AIDS, Hemorrhagic Fevers, Polio, Measles and vaccine preventable diseases, water & food borne infections, Pandemic Influenza and other diseases Chronic Diseases: 25% adult population over 18 yrs suffers from chronic ailments like Diabetes, Heart Disease, Chronic Respiratory Disease, Cancers Pakistan National Accreditation Council

10. National Concerns • Explosive increase in number of diagnostic laboratories, blood banks and medical facilities in all mega cities of Pakistan • Estimated number: not known • Work with infectious agents in public and private research, animal care and agricultural facilities has expanded enormously. Pakistan National Accreditation Council

11. The Threat Pakistan National Accreditation Council

12. Categories of Lab Services in Pakistan Public sector clinical diagnostic labs Located in tehsil, district, tertiary and teaching health units Private sector clinical diagnostic labs Large number Clinical diagnostics Public health laboratories Two dedicated public health laboratories Public Health Laboratories Division, NIH, Islamabad Laboratory of Institute of Public Health, Lahore Pakistan National Accreditation Council

13. National Approach • Pakistan • shares the concerns of international community and is fully aware of its obligations • is concerned about the use of Biological Weapons or any Act of Bio-Terrorism • Is taking effective administrative steps for mitigation of biological risks • BWC Act is presently in the approval process Pakistan National Accreditation Council

14. Combating The Threat • Capacity-building of Organization • Awareness-raising and training of; • Laboratory managers and directors; • Bio-safety and Bio-security professionals • Bio-risk managers / Researcher / Lab Technicians • Development of national bio-risk management guidelines, based on international best practices Pakistan National Accreditation Council

15. Combating The Threat • Development of national accreditation plan for biological laboratories • Protection against misuse of bio wastage • Protection against bio terrorism • Reduce impact of chronic diseases due to mishandling of bio-wastage • Effective implementation of legislative measures Pakistan National Accreditation Council

16. Establishment of Inter-Agency Working Group (Task Force) Education and Awareness Raising for Bio-Risk Management Oversight of Biological Research and other Related Activities Code of Conduct for Life Scientists National Core Group of Life Sciences (NCGLS) Pakistan Biological Safety Association (PBSA) Biological Safety Association of Pakistan (BSAP) Measures Pakistan National Accreditation Council

17. Work done Pakistan National Accreditation Council Pak-US Bio Engagement Program meeting held in Cairo, Egypt from 15-17 December 2010. A follow up meeting on the proposal was held in Islamabad on March 2, 2011. Singapore Meeting 17-19 May 2011 Train the Trainer Program

18. SpecificGuidelines & Standards

19. Guidelines, Standards • GUIDELINES • Laboratory Safety Manual - WHO • Biosafety in Microbiological and Biomedical Laboratories (BMBL) - CDC • The Laboratory Biosafety Guidelines - Health Canada • Guidelines for Research Involving Recombinant DNA Molecules EC - NIH • Biorisk management. Laboratory biosecurity guidance - WHO • Biosafety risk assessment methodologies – Sandia Report • STANDARDS • ISO 15189:2007 – Medical Laboratories • ISO 15190:2003 - Medical laboratories - Requirements for safety • CWA 15793:2011 - Laboratory biorisk management standard Pakistan National Accreditation Council

20. - International - Laboratory Biorisk Management StandardCWA 15793:2011 Pakistan National Accreditation Council

21. International Laboratory Biorisk Management StandardCWA 15793:2011 • The documentwas adopted, and published as CWA 15793:2008 by CEN in 2008 • 76 participants from 24 countries developed a management system approach to biosafety and biosecurity in the laboratory • CEN in Brussels facilitated the process with funding by the European Commission Pakistan National Accreditation Council

22. International Laboratory Biorisk Management StandardCWA 15793:2011 CWA 15793:2011 is a Management System Standard Consistent with other international standards such as ISO 9001 / 14001 and OSHAS18001 Contains definitions, requirements and notes for guidance Pakistan National Accreditation Council

23. International Laboratory Biorisk Management StandardCWA 15793:2011 The Standard can be used for: • Improving overall laboratory biorisk performance • Increasing awareness of biosafety and biosecurity risks • Effective management of complex laboratory safety and security processes • Improving international laboratory collaborationand safety harmonization • Basis for new or revised legislation or regulations • Support laboratory certification/accreditation, audits/inspections Pakistan National Accreditation Council

24. International Laboratory Biorisk Management StandardCWA 15793:2011 • The Standard is not a technical document • The Standard is performance oriented • Describes what needs to be achieved • How to do it is up to the organization Pakistan National Accreditation Council

25. International Laboratory Biorisk Management StandardCWA 15793:2011 • The Standard is not intended to replace any national or sub-national regulatory requirements that may apply to the laboratory/facility • Compliance with regulatory requirements is mandatory Pakistan National Accreditation Council

26. International Laboratory Biorisk Management StandardCWA 15793:2011 • International Approach • Not country specific • Based on international, acceptable best practices • Local solutions possible • The Standard is based around the current WHO Biosafety and Biosecurity Guidelines Pakistan National Accreditation Council

27. Way Forward Medical Laboratories: Management System = CWA 15793 Technical System = ISO 15189 Microbiological / Non-Medical Laboratories: Management System = CWA 15793 Technical System = ISO/IEC 17025 Pakistan National Accreditation Council

28. THANK YOU Pakistan National Accreditation Council