WHO Laborat ator ory y Biosaf safety ty Manual ual (LBM) M) - - PowerPoint PPT Presentation

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WHO Laborat ator ory y Biosaf safety ty Manual ual (LBM) M) - - PowerPoint PPT Presentation

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WHO Laborat ator ory y Biosaf safety ty Manual ual (LBM) M) Revi visio sion n Update Dr Kazunobu nobu KOJIMA IMA World ld Healt lth h Organ anizat ization on (WHO) HO) Pr Present esentation ation over overview view Ba

slide-1
SLIDE 1

Dr Kazunobu nobu KOJIMA IMA World ld Healt lth h Organ anizat ization

  • n (WHO)

HO)

WHO Laborat ator

  • ry

y Biosaf safety ty Manual ual (LBM) M) Revi visio sion n Update

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SLIDE 2

Pr Present esentation ation over

  • verview

view

  • Ba

Backgr ground

  • und
  • Key

ey co conce cepts pts

  • Aim

imin ing g to achie ieve ve

  • Ris

isk k (hazar zard) d) gr group ups

  • Bi

Biosaf afety ty le level els

  • Core

re Req equir uiremen ements, ts, He Heig ightened ened Contr ntrol

  • l Mea

easures, ures, Hi High gh Cont ntainment ainment

  • Way forwar

ard

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SLIDE 3

WHO HO La Labor

  • rat

ator

  • ry

y Bi Bios

  • saf

afety ty Man anua ual l (LB LBM)

  • LBM has

s se served ved th the e global bal biosaf safety ty communi munity ty for r more re th than an 30 ye year ars s with th practica tical guidance ance on biosaf safety ty

  • WHO

O Manual nual (1st

st editi

tion

  • n,

, 1983) – Risk sk Grou

  • up:

: I, II, , III and IV – “Laboratory Classification”: Basic, Containment and Maximum Cont ntainmen ainment

  • “BSL” yet to be defined
  • Techn

hnology

  • logy

– Comm

  • mmon
  • n diagnos

gnostic tic metho thods – e.g.

  • g. viru

rus s iso solati ation,

  • n, electr

tron

  • n microscope
  • scope

 PCR CR PCR

CR first t demo mons nstr trat ated ed in 198 983

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SLIDE 4

LB LBM Evol

  • lution

ution

  • BSL 1-4

4

  • Rapidly

ly adva vancin ing technol nolog

  • gy
  • The current

nt 3rd

rd edition

ion has s been trans nslat lated into

  • >10 UN
  • fficial

icial and other r lang ngua uages es and WHO continu tinues s to receive ve requests ts for translat nslation ion into

  • other

r lang nguage uages

  • Published

ished in 2004, , 13 yea years have ve passed in this is fast- evo volving ving field ld

  • http

http://ww www.w .who ho.in .int/csr/re t/csr/resou source ces/ s/publi ublication ations/ s/biosa

  • safety/WH

ty/WHO_ O_CDS_ DS_CSR_L R_LYO_2004 O_2004 _11/ 1/en/

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SLIDE 5

WHO Ext xtended nded Biosaf safety ty Advi visor sory y Group p (BAG) G) Meeti tings, ngs, Geneva, va, 24-25 25 Nove

  • vember

ber 2014, and 13-15 December ber 2016

  • Ke

Key y Recom Recomme mendati ation

  • n 2014

– Revisio sion n to the WHO O Biosaf afety Manual al is both h a necessar essary y and d a priori iority

  • Ke

Key y Recom Recomme mendati ation

  • n 2016

– Gener eral al agreem eement ent for the propos

  • posed

ed modif dificati ications

  • ns to the

manual, ual, the revisio sion n of which h rema mains ins a prior

  • rit

ity

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SLIDE 6

Our audience varies…

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SLIDE 7

Pr Pragmatism? agmatism?

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SLIDE 8

Is Issu sues es in in sp space ace an and d wo work k flow low

Laboratory Biosafety Manual Revision

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SLIDE 9

Is Issu sues es in in sp space ace an and d wo work k flow low

Laboratory Biosafety Manual Revision

slide-10
SLIDE 10
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SLIDE 11

Pat Pathog

  • gen

en (Ha Haza zard) d) ve

versu sus

Pr Process

  • cess (Likelih

ikelihood)

  • od)

Laboratory Biosafety Manual Revision

Pathogen Process

[Likelihood + severity of harm]

+

Risk

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SLIDE 12

“Risk Group = Biosafety Level” ?? ??

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SLIDE 13

Bi Bios

  • safe

afety ty Le Level vel 3? 3?

Laboratory Biosafety Manual Revision

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SLIDE 14

Fac acility ility

Laboratory Biosafety Manual Revision

  • Sustainability:

– Funding for construction

  • vs. operational costs

– Staff – Scientific programme

  • Technical challenges
slide-15
SLIDE 15

Go Good d Mic icrobiolog

  • biological

ical Practice ctices s and d Procedure cedures s (GM GMPP) P)

  • Emph

phasis is on ris isk k assess essment ment and d train ining ing rather than engi gineering neering co controls ls in in GMPP

  • The be

best de desig igned ned and m d most engi gineered neered la labo boratory y is is only ly as good d as it its le least train ined ed worker er

  • Human fact

ctors s are gener nerall lly y the ca cause e of LA LAIs Is rather than malfu lfunction ctions s of engineer gineering ing co controls ls

slide-16
SLIDE 16

Pr Proposed

  • posed Way

y Fo Forwar ard

Laboratory Biosafety Manual Revision

  • Ensure a practical, risk- and evidence-based

approach to biosafety

  • Flexibility
  • Uphold good microbiological practices/procedures
  • Encourage sustainable facilities
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SLIDE 17

Ho How? w?

Laboratory Biosafety Manual Revision

  • Refocusing on good microbiological

practices and procedure

  • Emphasising the importance of

competence and on-going on-the-job training

  • Highlighting what risk assessment is and

how it should be performed

  • To remove Risk Groups and Biosafety

Levels at the global level to allow appropriate and practical measures are in place to mitigate the risk(s) identified

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SLIDE 18

Con

  • ncept

cept

Laboratory Biosafety Manual Revision

Risk (Hazard) groups Biosafety level

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SLIDE 19

Fac actor

  • rs

s af affecti ecting ng co consequen nsequence ce

Laboratory Biosafety Manual Revision

High severity or mortality plus:

  • Low infectious dose
  • High communicability
  • Airborne route of transmission
  • No preventive or therapeutic treatment

available

  • History of laboratory-acquired infection
  • Exotic epidemiology (non-endemic)
  • Highly susceptible population (e.g.

immunocompromised, naïve)

  • Increasing virulence
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SLIDE 20

Procedu

  • cedures

res wi with h hi high gh likeliho kelihood

  • d of
  • f ex

expos

  • sur

ure

Laboratory Biosafety Manual Revision

  • Producing and using large volumes and high titres
  • Procedures that might have the potential to

generate aerosols e.g. sonication, or deliberate generation of aerosols

  • Infecting animals
  • Using sharps
  • Necropsy where infection is

suspected

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SLIDE 21

Procedu

  • cedures

res wi with h low

  • w likeliho

kelihood

  • d of
  • f ex

expos

  • sur

ure

Laboratory Biosafety Manual Revision

  • Use of agar plates (e.g. streaking, spreading)
  • Serial dilution
  • Preparing/staining slides
  • Nucleic acid extraction
  • Inactivation
  • Use of autoanalysers
  • ELISA
  • PCR
  • Rapid diagnostic tests
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SLIDE 22

Ris isk k as assessment sessment

Laboratory Biosafety Manual Revision

Likelihood of exposure Consequence of exposure or release

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SLIDE 23

Cor

  • re

e Require quirements ments

Laboratory Biosafety Manual Revision

  • “Core requirements” refers to a combination of

elem ements ents to be implem emented ented and use sed as s a minimu imum m re requ quirement irement for r sa safe e wo working ing du duri ring g th the majority jority of laborat ator

  • ry

y proced edures. ures.

– codes des of cond nduct uct – compet mpetent ent and d app ppropri

  • priat

ately ely trained ned staff – the labo borat ator

  • ry

y facil ilit ity/eq y/equipm uipment ent – good

  • d micr

icrobiologi

  • biological

cal practices actices and d procedure

  • cedures.

.

  • Core

re re requirem rements ents will be be fundam ament ental al to sa safe e working ing practice tices s of any ny facility ity.

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SLIDE 24

He Height ightened ened Con

  • ntr

trol

  • l Measures

asures

Laboratory Biosafety Manual Revision

Control Measures to be increased with… …increased risk

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SLIDE 25

He Height ightened ened Contr trol

  • l Measures:

asures: Ex Examples amples

Laboratory Biosafety Manual Revision Pathogen Process Routes of exposure Example controls Mycobacterium tuberculosis Diagnostic via PCR

  • Aerosol
  • Splash
  • Contact
  • Gloves, (RPE)
  • Work within a BSC prior to inactivation

using validated methods

  • BSC work surface disinfection post use

Brucellosis Culture

  • Splash
  • Aerosol
  • Double gloves, facial protection, RPE
  • Work within a BSC
  • Work surface disinfection on test

completion

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SLIDE 26

Maxi aximum mum Con

  • ntai

ainment nment

Laboratory Biosafety Manual Revision

Highest control Example of when maximum containment might be required:

  • Eradicated diseases such as smallpox
  • Procedures with high likelihood of exposure and

impact of release to the environment:

– Unknown agents of potential high consequence – Known pathogens of high consequence

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SLIDE 27

Pla Plan n of

  • f Ac

Action ion

  • To
  • creat

ate e a ce a cent ntral al cor

  • re

e do docum ument ent wi with

  • Add

dditional tional mon

  • nogr
  • graphs

aphs tha hat go

  • int

nto

  • de

detail ail on

  • n seve

veral al ke key y as aspe pects cts inc nclud luding ing

– Risk sk asse ssessment, ssment, – Biosafe safety ty program amme me mana nage gement ent, , – Labor

  • rat

ator

  • ry

y desi sign gn and maint ntena enance nce, – Bio iolog logic ical al sa safety ty cabi bine nets ts and d is isolat lator

  • rs,

s, – PPE, E, – Decont

  • ntaminati

amination

  • n and wa

waste te mana nageme gement, t, and – Emer ergency ency/outbrea /outbreak re resp spon

  • nse

se

  • Publ

blicat ication ion of

  • f a pos

a position tion pa pape per r pr prior

  • r to re
  • release

ease of

  • f the

he LBM to

  • u
  • utline

ine the he rat ationale

  • nale for
  • r the

he cha hanges nges

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SLIDE 28

Ac Acknowledgements knowledgements

Editori rial al Commit itte tee: e:

Maria ianne nne Heisz sz, , Public ic Healt lth h Agency cy, , Canada Allan an Bennett, tt, Public ic Healt lth h Engla land, nd, UK St Stuart t Blac acksel ksell, , Mahidol dol-Oxf Oxfor

  • rd Tropical

pical Medicine cine Resear earch h Unit, t, Thail iland and Michelle elle McKinne inney, , National

  • nal Insti

titut tute e of Health, th, USA Kathrin rin Summe mermatt rmatter er, , Institu titute e of Virology

  • logy and Immun

unology

  • logy,

, Switzerlan tzerland Catherine erine Makison son Booth, h, Healt lth & S Safety ty Laborat ator

  • ry,

, UK UK

Global bal Pa Partne tnership ship Progr gram am (GPP), PP), Glob

  • bal

al Affair airs s Canada nada Bio iosec security urity Engagem gagemen ent t Progr

  • gram

am (BEP), P), U. U.S. . De Depa partmen tment t of St State te

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SLIDE 29

Dr r Kazunob nobu u KOJI JIMA MA WHO O HQ, Geneva neva ko kojimak@ mak@who.int who.int

Th Than ank k you you