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ESCMID Online Lecture Library © by Author The European Network of Biosafety Level-4 Laboratories Carla Nisii National Institute for Infectious Diseases© by ‘L. authorSpallanzani’ ESCMID Post-graduate Education course ESCMID OnlineMarseille, MarchLecture 19 2012 Library WHO Collaborating Center for clinical care, diagnosis, INMI L. Spallanzani response and training on Highly Infectious Diseases Rome The European Network of P4 laboratories, Marseille, 19th March 2012 1. Characteristics of biosafety laboratories 2. Why we need networks 3. Euronet-P4 (2004-2007), ENP4-Lab (2007- 2010) 4. Satellite activities,© by authorpresent and future (HEIBL, ERINHA, QUANDHIP, Mobile labs..). ESCMID Online Lecture Library Infectious agents: 4 risk groups The classification in four risk groups is based on the following criteria: • whether the agent is pathogenic for humans or animals; • whether the agent is a hazard to employees; © by author • whether the agent is transmissible to the community; •ESCMID whether there Onlineis effective treatmentLecture or prophylaxisLibrary available. WHO Laboratory Biosafety Manual, 3 Ed., 2004 Risk Groups: definitions (WHO Laboratory biosafety manual, 2004, Third edition) © by author ESCMID Online Lecture Library Risk groups and biosafety levels (WHO Laboratory biosafety manual, 2004, Third edition) © by author ESCMID Online Lecture Library Biosafety level 3 Procedures Controlled access (cardkey control) Sterilization of lab clothing, equipment, waste Clinical assessment, baseline serum of staff Biosafety manual Protective equipment Biosafety cabinets (BSC-II) PPE (wrap-around gown, scrub suit, shoe covers eye protection) © by author Respiratory protection may be used BuildingESCMID characteristics Online Lecture Library Anteroom (Double door) Sealable for decontamination Negative internal pressure Dedicated air treatment/conditioning system, no re-circulation[HEPA (high efficiency particulate air) filters for outgoing air] Biosafety level 4 Procedures As BSL-3, plus: Complete change of clothing Shower upon exit Protective Equipment As BSL-3, plus: All procedures performed in BSC-III (GLOVE BOX type), OR: BSC-II, wearing full body positive pressure suits (‘space suits’) (SUIT type) © by author Building characteristics As BSL-3, plus: ESCMID Separate from restOnline of lab Lecture Library Airlock entry with shower HEPA filters sia in entrata che in uscita Double ended, interlocked autoclave Why do we need networks of BSL-4 laboratories? The European Network of P4 ©laboratories by author ESCMID Online Lecture Library BSL4 laboratories in Europe Glovebox-system © by author Suits ESCMID Online Lecture Library BSL-3 BSL-4 BSL-4 UC/planned Needs at EU level Ensure a rapid and effective response to health threats deriving from natural infection by highly infectious agents or their deliberate release Stimulate complementarity and prevent duplication Promote exchange of information and international cooperation © by author Share good practice and protocols ESCMID Online Lecture Library Cooperation agreement for training, communication, and service availability to other Countries Needs of laboratories and scientists Few BSL-4 labs around the world Diagnostic methods are home-made Share materials and experience (External Quality Assurance Exercises) Share biosafety© by practicesauthor Offer support to other countries, rapid ESCMIDcommunication Online Lecture Library © by author ESCMID Online Lecture Library European Network of P4 laboratories First funded in 2005 (Euronet-P4, 2005- 2007, DG-SANCO) Second funding in 2007 (ENP4-Lab 2007-2010, PHEA) Became part© byof Quandhipauthor (2011-2014, PHE) ESCMID ERINHA Online Lecture Library Mobile laboratory initiative Euronet-P4 and ENP4-Lab: Partners INMI IRCCS L. Spallanzani, Italy Health Protection Agency, London and Porton Down, UK Philipps Universitat Marburg, Germany Bernhardt Nocht Institute of Tropical Medicine, Hamburg, Germany Swedish Institute for Infectious Disease Control, Solna, Sweden© by author Inserm, Lab. P3/P4 Jean Mérieux, Lyon, France (as of ESCMID2007) Online Lecture Library Euronet-P4 and ENP4-Lab: Observers Institut Pasteur, Lyon, France Robert Koch Institute, Berlin, Germany Bundeswehr Institute of Microbiology, Munich, Germany University of Marseille, France Austrian Agency for Health and Food Safety, Vienna, Austria Spiez Laboratory- Federal Office for Civil Protection, Spiez, Switzerland Centre International© deby Recherches author Médicales de Franceville – Gabon RIVM (National Institute for Public Health and the Environment ESCMID– The Netherlands Online Lecture Library Euronet-P4 and ENP4-Lab: Aims Aims 2005-2007 Development of a network of the existing P4 laboratories in Europe Improvement of diagnostic capabilities Training, communication, service availability Cooperation with other EC-funded networks and international activities © by author Aims 2007-2010 Harmonisation of biosafety procedures through establishment of a ‘checklist’ ESCMID Harmonisation Online of diagnostic Lecture procedures through Library External Quality Assurance exercises Mobile laboratory feasibility study Euronet-P4/ENP4-Lab: Results Web Site with public and restricted access areas (www.euronetp4.eu) Cooperation Agreement for sharing information, procedures, diagnostic samples and personnel for training Collection and evaluation of protocols for diagnostic procedures for risk group-4 agents Review of biosafety procedures in P4 labs Dissemination meeting on diagnostic and biosafety/biosecurity aspects (Rome, 21©-22 by May author2007) Definition of minimum training requirements for staff Checklist for Biosafety and Biosecurity aspects ESCMID Quality assurance Online exercises Lecture (Arena, Filoviruses, Library CCHF, Nipah, Hendra, Orthopoxviruses) Feasibility study for the establishment of a Mobile lab Present and future HEIBL, ERINHA, QUANDHIP, Mobile laboratory© by author initiative, other ESCMID Onlineresearch Lecture projects Library Satellite activities HEIBL Conference (Harmonising European Initiatives on Biocontainment Laboratories), Rome, 9-10 September 2010. Assessment of diagnostic capability through EQA and international exercises (GHSAG-LN: Global Health Security Action Group – Laboratory Network). EQA on: Smallpox© (2003,by author2006, molecular, CDC Atlanta); other Poxviruses (2003, molecular); (2003, 2005 EM, Berlin); VHF (2008 - Winnipeg, 2011 – Rome, molecular) ESCMID Transportation Online exercise: LectureAriel (Smallpox sample Library to CDC, 2007) HEIBL: Objectives To bring together key opinion leaders, membes or EU and international networks and institutions, representatives of member states. To provide lessons learned in the area of Biopreparedness and Research on high-risk biological agents© by author ESCMID To harmonise Online EU initiatives,Lecture stimulate Library future networking and capacity building HEIBL: Participants European Bodies (DG SANCO, DG ENTR, EAHC, ECDC) INMI Spallanzani (I), HPA (UK), SMI (Se), PUM Marburg (DE), BNI-TM (DE), Inserm (F), Rocky Mountain Laboratories (USA), Bundeswehr Institute of Microbiology (DE), Pasteur Institute (F), RKI (DE), Spiez Laboratory (CH), ISS (I), University Innsbruck, University Graz, Italian Army and Air Force, Stockholm International© by author Peace Research Institute (Se). ESCMID Astra Diagnostics Online Lecture Library Public Health Institutes from: Lithuania, Latvia, Portugal, Hungary. Networks: ENIVD, Biosafety-Europe HEIBL: Critical issues Sustainability (diagnostics, training, research) Avoiding proliferation and duplication Biosafety Training © by author Mobile laboratories (sample transport, ESCMIDincrease Online diagnostic Lecture capacity, Library research) Interoperability Many international initiatives DG SANCO, DG Research DG ENTR, DG Justice- DG RELEX ECDC WHO, GOARN GHSAG-LN (Global Health Security Action Group – Laboratory Network)© by author ENP4-Lab, ENIVD, EURONHID, ETIDE, QUANDHIP ESCMID(from EQADeBa Online and ENP4 Lecture-Lab), Epinorth, Library Episouth ERINHA (FP7) BBMRI Ongoing initiatives involving BSL4 labs • QUANDHIP (Quality Assurance Exercises and Networking on Detection of Highly Infectious Pathogens) • ERINHA (European Research Infrastructure on Highly Pathogenic Agents) © by author • Mobile laboratory initiative (DG DevCo) ESCMID Online Lecture Library • Disease specific and other research projects in EID field (CCHF, WNV, PreDemics, Antigone) QUANDHIP Coordinator: Roland Grunow/ Daniela Jacob Robert Koch-Institut Berlin, Germany Co-Coordinator: Giuseppe Ippolito/ Antonino Di Caro L. Spallanzani National Institute for Infectious Diseases (INMI), Rome, Italy © by author Additional staff involved: RKI – Uschi Sauer, Anna Rohleder, Anne Barduhn, Birgit Arnold, et al INMI – Maria R. Capobianchi, Ramona Iacovino, Francesco Maria ESCMIDFusco, Donatella Online Vincenti, Carla LectureNisii Library QUANDHIP: General Objectives To provide an integrated European laboratory infrastructure and strategy to protect European citizens against exposure to a panel of globally recognized high threat bacteria and viruses, which occur naturally and are potential bioterrorism agents. To link and consolidate two existing networks on highly infectious bacteria and viruses emerged from the EU funded projects EQADeBa/ENHPB, coordinated© by byauthor the Robert Koch-Institut (RKI), Germany (EAHC n° 2007 204) and the ENP4-Lab coordinated by National Institute for Infectious Diseases (INMI), Italy (EAHC n° ESCMID2006 208), Online Lecture
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