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 Backgr ground ound • 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 ol Mea easures, ures, Hi High gh Cont ntainment ainment • Way forwar ard
WHO HO La Labor orat ator ory y Bi Bios osaf 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 (1 st st editi tion on, , 1983) – Risk sk Grou oup: : I, II, , III and IV – “Laboratory Classification”: Basic, Containment and Maximum Cont ntainmen ainment • “BSL” yet to be defined • Techn hnology ology – Comm ommon on diagnos gnostic tic metho thods – e.g. g. viru rus s iso solati ation, on, electr tron on microscope oscope PCR CR PCR CR first t demo mons nstr trat ated ed in 198 983
LB LBM Evol olution ution • BSL 1-4 4 • Rapidly ly adva vancin ing technol nolog ogy • The current nt 3 rd rd edition ion has s been trans nslat lated into o >10 UN official icial and other r lang ngua uages es and WHO continu tinues s to receive ve requests ts for translat nslation ion into o 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 osafety/WH ty/WHO_ O_CDS_ DS_CSR_L R_LYO_2004 O_2004 _11/ 1/en/
WHO Ext xtended nded Biosaf safety ty Advi visor sory y Group p (BAG) G) Meeti tings, ngs, Geneva, va, 24-25 25 Nove ovember ber 2014, and 13-15 December ber 2016 • Ke Key y Recom Recomme mendati ation on 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 on 2016 – Gener eral al agreem eement ent for the propos oposed ed modif dificati ications ons to the manual, ual, the revisio sion n of which h rema mains ins a prior orit ity
Our audience varies…
Pr Pragmatism? agmatism?
Is Issu sues es in in sp space ace an and d wo work k flow low Laboratory Biosafety Manual Revision
Is Issu sues es in in sp space ace an and d wo work k flow low Laboratory Biosafety Manual Revision
Pat Pathog ogen en (Ha Haza zard) d) ve sus Pr Process ocess (Likelih ikelihood) ood) versu + Pathogen Process Risk [Likelihood + severity of harm] Laboratory Biosafety Manual Revision
“Risk Group = Biosafety Level” ?? ??
Bi Bios osafe afety ty Le Level vel 3? 3? Laboratory Biosafety Manual Revision
Fac acility ility • Sustainability: – Funding for construction vs. operational costs – Staff – Scientific programme • Technical challenges Laboratory Biosafety Manual Revision
Go Good d Mic icrobiolog obiological 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 controls co 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
Pr Proposed oposed Way y Fo Forwar ard • Ensure a practical, risk- and evidence-based approach to biosafety • Flexibility • Uphold good microbiological practices/procedures • Encourage sustainable facilities Laboratory Biosafety Manual Revision
Ho How? w? • 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 Laboratory Biosafety Manual Revision
Con oncept cept Biosafety level Risk (Hazard) groups Laboratory Biosafety Manual Revision
Fac actor ors s af affecti ecting ng co consequen nsequence ce 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 Laboratory Biosafety Manual Revision
Procedu ocedures res wi with h hi high gh likeliho kelihood od of of ex expos osur ure • 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 Laboratory Biosafety Manual Revision
Procedu ocedures res wi with h low ow likeliho kelihood od of of ex expos osur ure • 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 Laboratory Biosafety Manual Revision
Ris isk k as assessment sessment Consequence of exposure or release Likelihood of exposure Laboratory Biosafety Manual Revision
Cor ore e Require quirements ments • “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 ory y proced edures. ures. – codes des of cond nduct uct – compet mpetent ent and d app ppropri opriat ately ely trained ned staff – the labo borat ator ory y facil ilit ity/eq y/equipm uipment ent – good od micr icrobiologi obiological cal practices actices and d procedure ocedures. . • 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. Laboratory Biosafety Manual Revision
He Height ightened ened Con ontr trol ol Measures asures Control Measures to be increased with… …increased risk Laboratory Biosafety Manual Revision
He Height ightened ened Contr trol ol Measures: asures: Ex Examples amples Pathogen Process Routes of Example controls exposure Mycobacterium Diagnostic - Aerosol - Gloves, (RPE) tuberculosis via PCR - Splash - Work within a BSC prior to inactivation - Contact using validated methods - BSC work surface disinfection post use Brucellosis Culture - Splash - Double gloves, facial protection, RPE - Aerosol - Work within a BSC - Work surface disinfection on test completion Laboratory Biosafety Manual Revision
Maxi aximum mum Con ontai ainment nment 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 Laboratory Biosafety Manual Revision
Pla Plan n of of Ac Action ion • To o creat ate e a ce a cent ntral al cor ore e do docum ument ent wi with • Add dditional tional mon onogr ographs aphs tha hat go o int nto o de detail ail on on 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 orat ator ory 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 ors, s, – PPE, E, – Decont ontaminati amination on and wa waste te mana nageme gement, t, and – Emer ergency ency/outbrea /outbreak re resp spon onse se • Publ blicat ication ion of of a pos a position tion pa pape per r pr prior or to re o release ease of of the he LBM to o ou outline ine the he rat ationale onale for or the he cha hanges nges
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