pakistan national accreditation council. biorisk management
TRANSCRIPT
Pakistan National Accreditation Council Pakistan National Accreditation Council
Biorisk Management
Pakistan National Accreditation Council Pakistan National Accreditation Council
ContentsContents
1. Basic Terminology
2. Global Biological Threat
3. National Concerns
4. Measures
5. Combating the Threat
6. Way Forward
7. Biorisk Management Committee under NSC on Hospital & Health Care Facilities, SDC, PSQCA
Pakistan National Accreditation Council Pakistan National Accreditation Council
Basic TerminologyBasic Terminology
BIOSAFETY:
Describes the containment principles, technologies and practices that are implemented to prevent the unintentional unintentional exposureexposure to Biological agents and toxins or their accidental accidental releaserelease
BIOSECURITY:
Describes protection, control and accountability for valuable biological materials within laboratories, in order to prevent their lossloss, thefttheft, misusemisuse, diversiondiversion of, unauthorizedunauthorized accessaccess or intentional releaseintentional release.
Ref: WHO/CDS/EPR/2006.6
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BIORISK:
Basic TerminologyBasic Terminology
Naturally Occurring Bio terror Bio War Lack of Awareness and Negligence
Biorisk SpectrumBiorisk Spectrum
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Global Biological ThreatsGlobal Biological Threats
Global outbreaks of emerging and reemerging infectious disease
Morens, DM et. al. Nature. 8 Jul 2004
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• 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
Global Biological ThreatsGlobal Biological Threats
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The Threat – National ConcernsThe 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
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National ConcernsNational 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 Pakistan National Accreditation Council
Pakistan National Accreditation Council Pakistan National Accreditation Council
The ThreatThe Threat
Categories of Lab Services in PakistanCategories 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
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National ApproachNational ApproachPakistan
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 Pakistan National Accreditation Council
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
Combating The ThreatCombating The Threat
Pakistan National Accreditation Council Pakistan National Accreditation Council
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
Combating The ThreatCombating The Threat
Pakistan National Accreditation Council Pakistan National Accreditation Council
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)
MeasuresMeasures
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Work done
Pakistan National Accreditation Council 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
SpecificGuidelines &
Standards
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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 standardCWA 15793:2011 - Laboratory biorisk management standard
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- International - Laboratory Biorisk Management
Standard CWA 15793:2011CWA 15793:2011
Laboratory Biorisk Management Standard CWA 15793:2008
The document was 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
International Laboratory Biorisk Management Standard CWA 15793:2011CWA 15793:2011
Pakistan National Accreditation Council
Laboratory Biorisk Management Standard CWA 15793:2008
CWA 15793:2011
is a
Management System Standard
Consistent with other internationalstandards such as ISO 9001 /14001 and OSHAS18001
Contains definitions, requirementsand notes for guidance
International Laboratory Biorisk Management Standard CWA 15793:2011CWA 15793:2011
Pakistan National Accreditation Council
Laboratory Biorisk Management Standard CWA 15793:2008
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 collaboration
and safety harmonization• Basis for new or revised legislation or regulations• Support laboratory certification/accreditation,
audits/inspections
International Laboratory Biorisk Management Standard CWA 15793:2011CWA 15793:2011
Pakistan National Accreditation Council
Laboratory Biorisk Management Standard CWA 15793:2008
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
International Laboratory Biorisk Management Standard CWA 15793:2011CWA 15793:2011
Pakistan National Accreditation Council
Laboratory Biorisk Management Standard CWA 15793:2008
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
International Laboratory Biorisk Management Standard CWA 15793:2011CWA 15793:2011
Pakistan National Accreditation Council
Laboratory Biorisk Management Standard CWA 15793:2008
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
International Laboratory Biorisk Management Standard CWA 15793:2011CWA 15793:2011
Pakistan National Accreditation Council
Pakistan National Accreditation Council Pakistan National Accreditation Council
Medical Laboratories:Medical Laboratories:Management System = CWA 15793Technical System = ISO 15189
Microbiological / Non-Medical Laboratories:Microbiological / Non-Medical Laboratories:Management System = CWA 15793Technical System = ISO/IEC 17025
Way Forward Way Forward
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THANK YOUTHANK YOU