Transcript Presentation on Biorisk Management

Pakistan National Accreditation Council
Biorisk Management
Contents
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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
Basic Terminology
BIOSAFETY:
Describes the containment principles, technologies and
practices that are implemented to prevent the unintentional
exposure to 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, unauthorized access or
intentional release.
Ref: WHO/CDS/EPR/2006.6
Pakistan National Accreditation Council
Basic Terminology
BIORISK:
Pakistan National Accreditation Council
Biorisk Spectrum
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Naturally Occurring
Bio terror
Bio War
Lack of Awareness and Negligence
Pakistan National Accreditation Council
Global Biological Threats

Global outbreaks of emerging and reemerging infectious
disease
Morens, DM et. al. Nature. 8 Jul 2004
Pakistan National Accreditation Council
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
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
National Concerns
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Explosive increase in number of diagnostic
laboratories, blood banks and medical facilities in all
mega cities of Pakistan
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Estimated number: not known
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Work with infectious agents in public and private
research, animal care and agricultural facilities has
expanded enormously.
Pakistan National Accreditation Council
The Threat
Pakistan National Accreditation Council
Categories of Lab Services in Pakistan
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Public sector clinical diagnostic labs
 Located in tehsil, district, tertiary and teaching health units
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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
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
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Is taking effective administrative steps for mitigation of biological
risks

BWC Act is presently in the approval process
Pakistan National Accreditation Council
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
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
Measures
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Establishment of Inter-Agency Working Group (Task Force)
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Education and Awareness Raising for Bio-Risk Management
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Oversight of Biological Research and other Related Activities

Code of Conduct for Life Scientists
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National Core Group of Life Sciences (NCGLS)
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Pakistan Biological Safety Association (PBSA)
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Biological Safety Association of Pakistan (BSAP)
Pakistan National Accreditation Council
Work done
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Pak-US Bio Engagement Program meeting held in Cairo,
Egypt from 15-17 December 2010.
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A follow up meeting on the proposal was held in
Islamabad on March 2, 2011.
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Singapore Meeting 17-19 May 2011
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Train the Trainer Program
Pakistan National Accreditation Council
Specific
Guidelines &
Standards
Guidelines, Standards
GUIDELINES
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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
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ISO 15189:2007 – Medical Laboratories
ISO 15190:2003 - Medical laboratories - Requirements for safety
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CWA 15793:2011 - Laboratory biorisk management standard
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Pakistan National Accreditation Council
- International Laboratory Biorisk Management
Standard
CWA 15793:2011
Pakistan National Accreditation Council
International
Laboratory
Biorisk
Laboratory Biorisk Management
Standard
CWA 15793:2008
Management Standard
CWA 15793:2011

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
Pakistan National Accreditation Council
International
Laboratory
Biorisk
Laboratory Biorisk Management
Standard
CWA 15793:2008
Management Standard
CWA 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
International
Laboratory
Biorisk
Laboratory Biorisk Management
Standard
CWA 15793:2008
Management Standard
CWA 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 collaboration
and safety harmonization
• Basis for new or revised legislation or regulations
• Support laboratory certification/accreditation,
audits/inspections
Pakistan National Accreditation Council
International
Laboratory
Biorisk
Laboratory Biorisk Management
Standard
CWA 15793:2008
Management Standard
CWA 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
International
Laboratory
Biorisk
Laboratory Biorisk Management
Standard
CWA 15793:2008
Management Standard
CWA 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
International
Laboratory
Biorisk
Laboratory Biorisk Management
Standard
CWA 15793:2008
Management Standard
CWA 15793:2011
International Approach
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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
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
THANK YOU
Pakistan National Accreditation Council