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BADAN PENELITIAN DAN PENGEMBANGAN KESEHATAN KEMENTERIAN KESEHATAN RI

BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

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Page 1: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

BADAN PENELITIAN DAN PENGEMBANGAN KESEHATAN

KEMENTERIAN KESEHATAN RI

Page 2: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,
Page 3: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,
Page 4: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

More than infectious disease hazards: 1980-2009

Page 5: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,
Page 6: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,
Page 7: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

NATIONAL ISSUE : BIODIVERSITY

INDONESIA BIODIVERSITY :

• 17.500 Island and coverage of ± 4.500 KM²

• Country with Highest Biodiversity after Brazil and Congo

• Indonesia has more than 17% of the world species

• Potential to be a good source for food and drug.

• Attract people from around the world to do

researches

• Potential to be misuse as a biological weapon

Ratification of UN Convention on Biodiversity UU No. 5 / 1994

Ratification of Cartagena Protocol on Biosafety and Biosecurity of

UN convention on Biodiversity UU No. 21 / 2004

Page 8: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

BUKU PENUNJANG LABORATORIUM BSL-3

Page 9: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

BIORISK

MANAGEMENT

Page 10: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

TERMINOLOGY

BIOSAFETY

BIOSECURITY

• Protect lab workers and

community,

• Unintentionally exposure,

• Accidental releases of

Biohazard

• Protect Biological agent from

lost, theft and Intentional

Misuse

• Bioterrorism vocal point

Page 11: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

BIORISK MANAGEMENT

What is Biorisk Management?

Biorisk encompasses biosafety and

biosecurity, where the hazards are

biological agents and their products

Establishes systems and policies to

manage the laboratory biorisk

Integral poin the day-to-day operations

of the institute / organization, both in

normal times and times of emergency

Page 12: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

ASSESSMEN MITIGATION PERFORMANCE

What is my risk What will I do about it How did I do it

Page 13: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

Biosafety Risk Management

BIOSAFETY RISK

MITIGATION

Elimination or

Substitution

Engineering Control (EC)

Administrative

Control (AC)

Personal Protective Equipment

(PPE)

Procedure Practices

(PP)

Page 14: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

Biosecurity Risk Management

Page 15: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,
Page 16: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

MORE CHALLENGES

National Concern

Emerging and re-emerging Diseases

Chronic Diseases

Increases of working with pathogen

agents in private and research

laboratory.

Dual Use Research

Page 17: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

NATIONAL STRATEGY

Awareness raising and training of Laboratory management –manager and directors, laboratory worker, researchers and laboratory engineers

Capacity buildings

Formalizing the national guidelines of Biorisk

Formalizing regulation of pathogen agents use in research.

Page 18: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

NATIONAL STRATEGY

Development of national accreditation

for biological laboratories

Development of National regulation on

biosecurity

Reduce impact of chronic diseases

due to mishandling of bio-wastage

Effective implementation of legislative

measures

Page 19: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

International Guideline on

Biorisk Management

CWA 15793:2008

Page 20: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

International 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

Page 21: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

CWA 15793:2008

• Consist of 16 element :

– Biorisk Management System

– Risk Assessment

– Pathogen and toxin inventory and information

– Personel and competency

– Good Microbiological Technique

– Clothing and PPE

– Human Factors

– Healthcare

– Emergency Response and Contingency planning

– Accident/incident Investigation

– Facility Physical Requirement

– Equipment and maintenance

– Decontamination, disinfection and sterilisation

– Security

Page 22: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

CWA 15793:2008

The standard is designed to

complement other management

standards

ISO9001 (Quality)

ISO14001 (Environmental)

OHSAS18001 (Occupational

Health and Safety)

Page 23: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

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

• CWA 15793:2008 has a life-cycle of 3 years

– Renewal, change, termination

• Learning experience for the community

– Implementation by laboratories

Page 24: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

Cek Tekanan

Pompa

Penggantian Filter

Luar

Cek Atap Lab. BSL-3 Cleaning Lab BSL-

3

Cek Temp, RH,

Tekanan Ruangan

Cek Inverter Cek Tekanan

CO2

Cek Water Treatmen

Page 25: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

Ganti Filter Air Cek Fungsi & Isi

Solar Genset

Penggantian

Filter dalam

Cek Kompresor

Autoclave

Cek Autoclave Cek Baterai UPS Cek Level Air

Page 26: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

Ganti Fan Belt Ganti Filter Oli,

udara & Oli

Genset

Tes Fungsi Hand

Shower

Cuci Indoor AC

Cuci Outdoor AC Cek Tekanan

Freon AC

Cek Tegangan

Outdoor AC

Ganti Baterai

UPS

Page 27: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

DEKONTAMINASI RUANGAN RE-PROGRAM SYSTEM

SERTIFIKASI

Page 28: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,
Page 29: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

PELATIHAN - PELATIHAN

TRAINING BIOSAFETY PRACTITIONERS

- GEDUNG EIJKMAN JAKARTA

WORKSHOP OPERATION &

MAINTENANCE PRINCIPLES

BIOCONTAINMENT LABORATORIES –

IHVCB UI JAKARTA

IBA INAUGURAL CONFERENCE –

HOTEL BOROBUDUR JAKARTA

BSL3 Science and Safety Training di

Universitas Emory, Atlanta

Page 30: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

Pelatihan Tanggap

Darurat Kebakaran

Rutin Setahun Sekali

Page 31: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

Pelatihan Tanggap

Darurat K3

Page 32: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

Vaksinasi bagi Petugas

Laboratorium dan Staff

Pendukung

Page 33: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

Medical Check Up

Page 34: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

Penerimaan

Spesien (LIMS)

Page 35: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,
Page 36: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,
Page 37: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,
Page 38: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,
Page 39: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,
Page 40: BADAN PENELITIAN DAN PENGEMBANGAN ... › acsel › lister › Panel Discussions...International Laboratory Biorisk Management Standard CWA 15793:2008 •The document was adopted,

TERIMAKASIH