Pakistan National Accreditation Council. Biorisk Management

Pakistan National Accreditation Council Pakistan National Accreditation Council

Biorisk Management


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


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


BIORISK:

Basic TerminologyBasic Terminology

Naturally Occurring Bio terror Bio War Lack of Awareness and Negligence

Biorisk SpectrumBiorisk Spectrum


Global Biological ThreatsGlobal Biological Threats

Global outbreaks of emerging and reemerging infectious disease

Morens, DM et. al. Nature. 8 Jul 2004


• 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


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


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.



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


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


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


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


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


Work done


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


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


- 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


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




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




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




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 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




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


THANK YOUTHANK YOU

Documents

Pakistan National Accreditation Council. Biorisk Management