Recommendations for good practice in pandemic preparedness for National Influenza Centres

Transcription

1 Recmmendatins fr gd practice in pandemic preparedness fr Natinal Influenza Centres Evaluatin f hw pandemic preparedness activities aided Natinal Influenza Centres in the WHO Eurpean Regin in the respnse t pandemic (H1N1) 2009

2 page 1 ABSTRACT T assist Member States with the revisin f their pandemic plans with respect t labratry activities after the 2009 influenza H1N1 pandemic, WHO/Eurpe perfrmed an evaluatin f the usefulness f pandemic plans and preparedness activities undertaken by labratry netwrks and WHO in the respnse t the pandemic. Using a systematic apprach, Natinal Influenza Centres and natinal influenza reference labratries in six Member States were interviewed by telephne. Six majr themes cnsidered essential t pandemic preparedness fr labratries were identified: cmmunicatin; crdinatin/cllabratin; capacity; adaptatin; leadership; and supprt. Key issues and recmmendatins fr gd practice in pandemic preparedness fr Natinal Influenza Centres and WHO were subsequently identified. Pandemic preparedness had generally been successful, with clse cllabratin between labratry netwrks in cuntries, frmal plan apprval, labratry accreditatin prcess and internatinal/natinal infrmatin surcing emerging as imprtant success factrs. Future preparedness activities shuld cntinue t emphasize these areas, as well as imprve planning fr: diagnstic capacity building; cntrl n high diagnstic demands; clinical-labratry feedback mechanisms; management f media requests t labratry staff; and real-time mnitring f antiviral resistance. Keywrds LABORATORY NETWORKS NATIONAL INFLUENZA CENTRES DISASTER PLANNING rganizatin and administratin DISEASE OUTBREAKS preventin and cntrl INFLUENZA, HUMAN INFLUENZA A VIRUS, H1N1 SUBTYPE EVIDENCE-BASED PRACTICE PUBLIC HEALTH PRACTICE GUIDELINES EUROPE Address requests abut publicatins f the WHO Reginal Office fr Eurpe t: Publicatins WHO Reginal Office fr Eurpe Scherfigsvej 8 DK-2100 Cpenhagen Ø, Denmark Alternatively, cmplete an nline request frm fr dcumentatin, health infrmatin, r fr permissin t qute r translate, n the Reginal Office web site ( Wrld Health Organizatin 2011

3 page 2 All rights reserved. The Reginal Office fr Eurpe f the Wrld Health Organizatin welcmes requests fr permissin t reprduce r translate its publicatins, in part r in full. The designatins emplyed and the presentatin f the material in this publicatin d nt imply the expressin f any pinin whatsever n the part f the Wrld Health Organizatin cncerning the legal status f any cuntry, territry, city r area r f its authrities, r cncerning the delimitatin f its frntiers r bundaries. Dtted lines n maps represent apprximate brder lines fr which there may nt yet be full agreement. The mentin f specific cmpanies r f certain manufacturers prducts des nt imply that they are endrsed r recmmended by the Wrld Health Organizatin in preference t thers f a similar nature that are nt mentined. Errrs and missins excepted, the names f prprietary prducts are distinguished by initial capital letters. All reasnable precautins have been taken by the Wrld Health Organizatin t verify the infrmatin cntained in this publicatin. Hwever, the published material is being distributed withut warranty f any kind, either express r implied. The respnsibility fr the interpretatin and use f the material lies with the reader. In n event shall the Wrld Health Organizatin be liable fr damages arising frm its use. The views expressed by authrs, editrs, r expert grups d nt necessarily represent the decisins r the stated plicy f the Wrld Health Organizatin.

4 page 3 Authrs: WHO Reginal Office fr Eurpe (WHO/Eurpe) Lucie Jean-Gilles Dmitriy Pereyaslv Carline Sarah Brwn Natinal Influenza Centres Natalja Kuznetsva (Estnia) Marin Kpmans, Adam Meijer, Ab Osterhaus (the Netherlands) Radu Cjcaru (Republic f Mldva) Virel Alexandrescu, Alina Baetel, Emilia Lupulescu (Rmania) Selim Badur, Meral Ciblak, Fatma Gulay Krukluglu (Turkey) Iryna Demchishina, Oleksandr Grynevych, Alla Mirnenk (Ukraine) WHO cllabrating centre fr reference and research n influenza, NIMR, Lndn, United Kingdm Rd Daniels Eurpean Centre fr Disease Preventin and Cntrl (ECDC) Eeva Brberg Methdlgy: WHO cllabrating centre fr pandemic influenza and research, University f Nttingham, United Kingdm Ahmed Hashim Jnathan Nguyen-Van-Tam

5 page 4 Table f Cntents Backgrund... 5 Experience f Natinal Influenza Centres during the respnse t pandemic (H1N1) Pst-Pandemic (H1N1) 2009 NIC Activities... 7 Evaluatin bjectives... 7 Evaluatin methdlgy... 8 Pririty issues and recmmendatins fr gd practice in pandemic preparedness... 8 Cnclusins Annex 1. Summary f findings Annex 2. Evaluatin Interview Guide... 15

6 page 5 Backgrund Natinal Influenza Centres (NICs) frm the backbne f the Wrld Health Organizatin (WHO)- crdinated Glbal Influenza Surveillance Netwrk (GISN). As described in the WHO terms f reference fr NICs 1, these natinal institutins serve as key pints f cntact between the WHO and its Member States, and they prvide virus islates fr influenza vaccine strain selectin, risk assessment and antiviral susceptibility mnitring. These activities sustain natinal, reginal and glbal virlgical and epidemilgical surveillance that is required fr the rutine surveillance f influenza epidemics, as well as fr respnding effectively t unusual utbreaks r influenza pandemics. Cuntry-t-cuntry variatin in NIC rles and capacities exists and the successful implementatin f pandemic preparedness activities by NICs depends largely n the availability f resurces and the cmmitment f natinal authrities. Hence, cntinued gvernment supprt is required t ensure the sustainability f the rles f NICs in influenza surveillance and respnse, including their participatin in natinal pandemic preparedness planning. The prpsed rles f NICs in pandemic preparedness have been described in a WHO guidance dcument 2. During the inter-pandemic perid (r influenza seasn), this rle invlves islating and characterizing antigenically influenza viruses and sending representative virus islates t WHO cllabrating centres fr reference and research n influenza (WHO CC) 3 fr further antigenic and genetic analysis. In the Eurpean Regin, NICs 4 prvide surveillance data n a weekly basis t WHO thrugh either Tessy, the surveillance platfrm f the Eurpean Centre fr Disease Preventin and Cntrl (ECDC), fr EU and EEA Member States, r thrugh EurFlu, the WHO/Eurpe reginal influenza surveillance platfrm. The data are published weekly in an electrnic bulletin 5 and are simultaneusly transferred t the WHO glbal platfrm FluNet where it is incrprated in glbal updates. Depending n the cuntry and NIC capacities, NICs may als crdinate and supprt natinal netwrks f influenza labratries (including labratries within health care facilities). At the start f each seasn they prvide supprt t sentinel netwrks, including the prvisin f sampling materials. They als assist natinal authrities in integrating labratry-related cmpnents int natinal pandemic plans. As part f early warning and respnse activities, NICs alert natinal authrities and WHO (using cmmunicatin channels agreed upn natinally and accrding t Internatinal Health Regulatins, where apprpriate) t unusual utbreaks f influenza r influenza-like illness, and/r any virus islates that are nt readily identifiable, ther indicatins f the emergence f influenza viruses with pandemic ptential, ccurrences f antiviral resistance and ther findings that may be f public health cncern. All such viruses are shared immediately with the WHO CC 6. Shuld the emergence f a virus with pandemic ptential be suspected, cllabratin with epidemilgists t undertake early risk assessment is imprtant and sufficient capacity and resurces need t be made available t meet the high demands that may ensue frm enhanced surveillance. Once the virus is widespread and a pandemic has been declared, NICs mnitr further spread and, where capacities allw, characteristics f the pandemic virus including antiviral susceptibility, antigenic drift and virulence. They cntinue t share representative viruses with the WHO CC t assist in the prcess f vaccine prductin and t supprt the effective clinical management f pandemic infectin NIC in EU/EEA cuntries frm the Cmmunity Netwrk f Reference Labratries fr Human Influenza in Eurpe (CNRL) a_surveillance_overview.aspx 6 shipment_frm_nic_t_wh_cllabrating_center.pdf

7 page 6 In view f the imprtance and vlume f activities undertaken by NICs between and during pandemics, cllabratin with and supprt frm the natinal health authrities is crucial fr ensuring that surge capacity and sustainability planning is develped t meet new and increased demands fr labratry testing during a pandemic and t ensure that natinal preparedness plans are develped, functinal and implemented. Supprt frm internatinal rganizatins is als imprtant: WHO/Eurpe, in crdinatin with the WHO CC, NIMR, United Kingdm, WHO headquarters and with ECDC, prvides NICs with tls fr capacity building and labratry netwrking. The imprtance f such cllabrative effrts is illustrated by the pandemic preparedness activities that were undertaken by NICs within the WHO Eurpean Regin and by the prminent rle f NICs in the respnse t pandemic influenza A (H1N1) Experience f Natinal Influenza Centres during the respnse t pandemic (H1N1) 2009 On 27 April 2009, tw days after WHO declared a Public Health Emergency f Internatinal Cncern (PHEIC) upn the advice f the Emergency Cmmittee called under the Internatinal Health Regulatins (IHR), WHO raised the glbal pandemic alert level frm phase 3 t phase 4. Tw days later phase 4 was raised t phase 5, prviding the signal f an imminent pandemic. A new influenza virus was identified and the netwrk f labratries arund the wrld began the vital and challenging wrk f investigating and reprting cases. NICs in the Eurpean Regin, as elsewhere in the wrld, played a frntline rle in the respnse t the pandemic; their first task was t ensure that they culd detect cases infected with the new virus. Mlecular detectin assays (plymerase chain reactin; PCR) were develped as sn as the genetic sequence f the virus was made available by the WHO CC, CDC, Atlanta, which als supplied NICs with PCR kits. Marina Vlas at the Natinal Influenza Labratry, Natinal Virlgy Centre, Natinal Centre fr Public Health, Ministry f Health, Republic f Mldva The first cases in the Eurpean Regin were reprted in the week f 27 April 2009 by 11 cuntries. By 11 June 2009, nearly cases had been cnfirmed in 74 cuntries, 30 f which were in the Eurpean Regin. Based n the glbal gegraphical spread f the new H1N1 virus, WHO fficially raised the glbal alert level t phase 6, declaring that a glbal pandemic f nvel influenza A (H1N1) was underway. By 24 August 2009, 48 ut f 53 Eurpean Member States had reprted their first cases. In mst Eurpean cuntries the majrity f cases were in travellers frm Nrth America and Mexic, the first affected cuntries. By Octber 2009, mst Eurpean Member States experienced increased influenza activity in the cmmunity reflected in increased rates f ILI and/r ARI, as well as increases in the number f severe cases, which cntinued int early January By the end f the pandemic, mre than 214 cuntries wrldwide reprted labratry-cnfirmed cases f H1N1, including at least related-deaths. During the summer f 2009, WHO/Eurpe interviewed NICs in fur cuntries and published a summary f the challenges faced n WHO/Eurpe web site 8. On the ne hand, NICs within the Eurpean Regin gained significant experience frm the pandemic (H1N1) 2009, particularly in labratries just starting t

8 page 7 perfrm PCR. On the ther hand, the rapid spread f the H1N1 virus and the enhanced surveillance perfrmed in many cuntries during the summer f 2009 caused increased pressure n the testing capacities f labratries. As the virus spread in the cmmunity, many NICs became respnsible fr testing hspitalized cases in cuntries that intrduced mandatry natinal ntificatin f severe cases, in additin t perfrming testing as part f rutine ILI/ARI surveillance, which substantially increased their wrklad. Typically, the vlume f samples received fr testing increased abut 5 10 fld, and during the seasn abut 10 times mre influenza virus detectins were reprted t EurFlu cmpared with the winter seasn 9. Due t limited human resurces available, labratry persnnel wrked duble shifts t meet the demands f increased testing, reprting t health authrities and respnding t media requests. Althugh cllabratin (e.g. sample exchange, surveillance data) was reprted t be gd between labratries acrss Eurpean cuntries, sme labratries experienced the requests fr methdlgical advice as a further increase t the pressure. Sme f the pressure experienced by NICs (and affiliated reference labratries) in the Eurpean Regin during the pandemic was relieved by multi-faceted supprt prvided by WHO. In additin t guidance n labratry testing, bisafety and sample transprt prcedures, WHO als facilitated the shipment f PCR kits and ther reagents prvided by CDC, as well as sampling materials t labratries that lacked sustainable resurces. WHO cntinued t prvide prficiency panels thrugh the WHO External Quality Assessment Prgramme (EQAP) 10, which was updated t include the pandemic (H1N1) virus. Surveillance infrmatin and situatin updates were prvided thrugh the EurFlu bulletin and the WHO/Eurpe web site. Glbal and reginal telecnferences n virlgical issues were held, which were deemed extremely useful by labratries fr sharing experience and gd practice. Pst-Pandemic (H1N1) 2009 NIC Activities As described abve, NICs played a critical frnt-line rle during the pandemic respnse. Thus, the develpment and implementatin f pandemic preparedness and respnse plans must be an integral part f NIC activities. After entering the pst-pandemic phase n 10 August 2010, WHO recmmended that Member States assess and, if necessary, revise their pandemic plans. This includes planning fr virlgical surveillance and respnse perfrmed by NICs. The valuable experience gained by NICs during the pandemic can be used as a learning framewrk upn which future pandemic preparedness activities necessary fr effective respnse can be imprved. Therefre, t supprt these effrts, WHO/Eurpe perfrmed an evaluatin n hw pandemic preparedness undertaken by NICs within the Eurpean Regin aided the respnse t the 2009 pandemic. The utcme f this evaluatin is a set f recmmendatins fr gd practice fr the labratry aspects f pandemic preparedness. This is expected t assist NICs and WHO in the revisin f their pandemic plans. These recmmendatins cmplement the in-depth evaluatin perfrmed by WHO/Eurpe in seven Member States, which fcused n key stakehlder grups ther than the NICs 11. Evaluatin bjectives The aim f this evaluatin was t prvide recmmendatins t assist NICs and Member States in the WHO Eurpean Regin in the revisin f their pandemic plans. This was dne by evaluating hw pandemic preparedness activities aided the respnse f NICs t the 2009 pandemic. Subsequently, the evaluatin was used t identify gd practices fr future pandemic planning. The evaluatin als addressed ways in which WHO can imprve its supprt t NICs

9 page 8 The fllwing specific bjectives were targeted: a) t describe the prcess f labratry pandemic planning in Member States; b) t describe hw well the labratry preparedness crrespnded t the respnse needed by identifying activities that were cnsidered adequate r inadequate fr the respnse; b) t determine what culd have been dne differently t imprve the usefulness f these activities during the respnse; and c) t determine future supprt required frm WHO. Evaluatin methdlgy The usefulness f pandemic preparedness activities undertaken by NICs in cuntries f the WHO Eurpean Regin and the WHO supprt prvided fr respnding effectively t the pandemic (H1N1) 2009 was evaluated qualitatively amng nine NICs and natinal influenza reference labratries in six cuntries, which were cnsidered t prvide gd representatin f the diversity f cuntries in the WHO Eurpean Regin. These included Estnia, the Netherlands, Republic f Mldva, Rmania, Turkey and Ukraine. The Ministries f Health f these cuntries received a frmal request frm WHO/Eurpe t participate. Infrmatin was btained by cnducting telephne interviews using a questinnaire with pen-ended questins that cvered the bjectives described abve. The head f the Natinal Influenza Centre and ther relevant labratry staff frm each participating Member State were asked a set f key questins frm a frmatted guide questinnaire cvering the stages f the planning prcess, implementatin f activities befre the pandemic and use f the plan during the pandemic respnse. Reflectins n what culd have been dne differently during these stages and expectatins frm WHO fr future supprt were als addressed. In ttal, 6 interviews were cnducted, cnstituting 36 hurs f recrded material. Recrding facilitated data analysis, which was cnducted thrugh transcriptin, as well as cmmn cntent rganizatin using a matrix and cding t allw themes t emerge. The NIC data analysis was then aggregated acrss the Member States, and six themes in pandemic preparedness were identified. The pandemic preparedness activities that wrked well r did nt wrk well were categrized under these six themes: capacity; cmmunicatin; crdinatin/cllabratin; supprt; leadership; and adaptatin. A summary table cntaining the results was generated (Annex 1) which frmed the basis fr discussin during the secnd stage f the evaluatin, namely a wrkshp fr participants frm the six cuntries held at the Reginal Office n 15 Nvember Participants wrked in a grup and made additins t the summary table based n presentatins made during the wrkshp. Participants then identified frm the summary table a list f pririty issues and develped recmmendatins. Fr a mre detailed descriptin f the methdlgy and results, please cntact the Reginal Office (influenza@eur.wh.int). Pririty issues and recmmendatins fr gd practice in pandemic preparedness The evaluatin shwed that all f the participants had taken part in natinal pandemic planning activities. All participants cnsidered that pandemic planning activities had been useful in the respnse t the 2009 pandemic. Hwever, a number f areas fr imprvement were identified. During the evaluatin prcess, a list f issues cnsidered imprtant fr gd pandemic preparedness and respnse was develped, as well as recmmendatins fr gd practice and areas in which WHO supprt is needed.

10 page 9 Issues imprtant fr gd pandemic preparedness and respnse: 1. Plitical cmmitment t cntinuus capacity building 2. Invlvement f NICs in utbreak management and multi-labratry crdinatin mechanism 3. Priritizatin f testing t avid verlad 4. Real-time antiviral resistance mnitring system 5. Surveillance system fr severe acute respiratry infectins (SARI) 6. Early implementatin f 24/7 infrmatin htline fr health prfessinals 7. Opprtunities fr sharing experiences between cuntries 8. WHO supprt Recmmendatins fr gd practice 1. Plitical cmmitment t cntinuus capacity building T undertake pandemic preparedness effectively and t be able t detect emerging pandemic viruses early, strng gvernment cmmitment t building capacity in NICs and labratry netwrks is needed. The fllwing is required: gvernment funding fr pandemic preparedness, including training, purchase f equipment and rapid access t reagents and ther supplies; a labratry preparedness plan that includes early evaluatin, different pssible scenaris (e.g. varius clinical attack rates) and prcedures fr scaling up labratry capacity; labratry capacity scaled up thrugh appinting additinal labratries (e.g. ther public health labratries r labratries lcated in universities/hspitals) t supprt NICs; Such cllabratin with a labratry netwrk needs t be established in the preparedness phase t ensure rapid activatin during a pandemic. standardized prtcls fr the unifrm sampling f patients and handling f specimens used by all labratries in the netwrk; Stcks f sampling materials shuld be available in case a pandemic ccurs. sampling and transprt capacity established by training f persnnel at additinal labs and testing transprt mechanisms befre the pandemic; prtcls t validate virus detectin kits (PCR) and rapid external quality assurance prgrammes in place at the natinal and internatinal level (such as the WHO EQAP); and enhanced cmmunicatin capacity f NICs t deal with questins frm general practitiners and hspitals. 2. Invlvement f NICs in utbreak management and multi-labratry crdinatin mechanism Fr NICs t undertake pandemic preparedness activities effectively, multi-grup activities will need t be crdinated. These include: the implementatin f an utbreak management team, which includes participatin f the NIC (if there is a labratry netwrk, ther labratries may als be included). 3. Priritizatin f testing t avid verlad Althugh the pandemic was relatively mild, there was a high diagnstic demand frm hspitals, general practitiners and in sme cases frm the public, upn which NICs and ther labratries had little r n cntrl. An effective priritizatin mechanism fr testing samples needs t be established at the natinal level and cmmunicated t relevant stakehlders t ensure the ratinal use f diagnstic capacity and avid verlad f the labratries. T d this: A natinal labratry preparedness plan must address this priritizatin issue; the principles fr priritizatin shuld be described, as well as the lgistics plan and the rle

11 page 10 f the NIC and ther labratries. Epidemilgists and clinicians shuld be invlved in the develpment f the plan. The primary task f the NIC is surveillance; during a pandemic, there will be an increase in demands n virlgical analyses fr surveillance, as well as diagnstic, purpses. NICs must cntinue their surveillance activities during all stages f a pandemic and plans fr the priritizatin f testing shuld take this int accunt, especially within a limited resurce envirnment. The natinal plan fr the priritizatin f testing shuld include guidance n hw many samples are t be sent fr surveillance and testing purpses t the different labratries invlved in the respnse. The number (and pssibly type) f samples sent fr testing will differ accrding t the different stages f the pandemic. Belw is an example f such stages: In the perid f first intrductin f the virus t the cuntry, the fcus will be n detectin and characterizatin f the first cases and pssibly cntacts, as well as testing f cases frm utbreaks. This enhanced surveillance will place strains n NIC capacities and shuld be supprted by ther labratries, where pssible. Later, if the virus starts t spread in the cmmunity, where pssible, existing rutine sentinel cmmunity and hspital surveillance will be relied n using the same sampling strategies (and number f samples cllected) as thse fr seasnal influenza. Shuld new surveillance systems be intrduced, such as natinal ntificatin and testing f severe cases, this will likely als lead t verlad and must be planned fr befrehand. Plans must be flexible, allwing fr adjustments t be made accrding t the lcal situatin during an actual pandemic. Cmmunicatin channels with relevant institutins and prfessinals must be in place befre the pandemic, s that plans can be develped tgether, shared and adjusted in a timely fashin, shuld a pandemic ccur. 4. Real-time antiviral resistance mnitring system Antiviral drugs are crucial early in a pandemic, particularly when specific influenza vaccines are nt yet available. The incidence f anti-viral resistance, hwever, is likely t increase with increased utilizatin. This leads t a decrease in antiviral drugs effectiveness fr treating patients and this is f particular significance in immuncmprmised individuals. It is therefre imprtant fr Member States t be able t rapidly detect and mnitr antiviral susceptibility and the emergence f resistance. This can be achieved thrugh: NICs having a real-time antiviral resistance mnitring system in place prir t the pandemic; NICs having basic capacity levels t implement the mnitring system during a pandemic (e.g. at least having PCR in place t detect a knwn mutatin); NICs that will intrduce antiviral resistance mnitring receiving training in assays, validatin (EQA) and interpretatin f results; NICs that d nt have the capacity t perfrm antiviral resistance mnitring shipping all viruses frm patients suspected f harburing a resistant virus t a WHO CC, as well as representative viruses frm rutine surveillance 12 ; and NICs pssibly establishing an agreement with anther labratry in the regin t perfrm rutine antiviral resistance mnitring. 5. Surveillance system fr severe acute respiratry infectins (SARI) During the pandemic, the lack f rutine sentinel surveillance systems fr severe disease caused by influenza was highlighted. During the past tw years, a number f cuntries have implemented sentinel 12 shipment_frm_nic_t_wh_cllabrating_center.pdf

12 page 11 SARI surveillance in hspitals 13. The NIC staff participating in this evaluatin cnsidered that such a system wuld imprve the effectiveness f the virlgical surveillance and made the fllwing recmmendatins: Member States shuld cnsider having in place sentinel SARI surveillance. This will require additinal human resurces and funding made available by health authrities t the sentinel site hspitals, clinicians, nurses, epidemilgists and virlgists invlved in this surveillance. In additin, testing wuld need t be perfrmed t determine respiratry pathgens ther than influenza causing SARI. A natinal plan r prtcl describing the sentinel SARI surveillance wuld need t be established (cvering staff invlved, including fcal pints and respnsibilities, sentinel sites, sampling strategies, selectin f labratries fr testing, transprt, testing algrithms, etc., as described in WHO/Eurpe guidance fr sentinel influenza surveillance in humans 14 ). 6. Early implementatin f 24/7 infrmatin htline fr health prfessinals During the first few weeks r mnths f the pandemic, a system fr addressing labratry-related questins shuld be available t avid verburdening the capacity f NICs. The fllwing is needed: The natinal pandemic plan shuld include prvisins fr a natinal 24/7 htline fr health prfessinals (e.g. general practitiners, hspitals) and public health specialists t btain infrmatin n, fr example, case definitins, priritizatin f sampling and testing, where t send samples, etc. Health care prfessinals shuld be aware f the htline and shuld be infrmed f its activatin as sn as the emergence f a pandemic virus is suspected. 7. Opprtunities fr sharing experiences between cuntries T create an efficient platfrm fr sharing experience amng cuntries: netwrks need t be built with neighburing cuntries; infrmal discussin lists can be used n the EurFlu platfrm; increased use f the cuntry cmments sectin in the ECDC WISO/EurFlu bulletin shuld be encuraged; and regular meetings shuld be held (in additin t the annual reginal netwrk meetings rganized by WHO/Eurpe and ECDC 15, a meeting befre seasn t infrm the netwrks f new develpments shuld be planned). 8. WHO Supprt Labratry netwrks in the Eurpean Regin requested WHO supprt in varius aspects f pandemic preparedness. These include supprt in capacity building, pandemic preparedness simulatin exercises and guidance n cntainment measures at the labratry level. Fr this supprt t be effective, the fllwing is necessary: During a pandemic, WHO shuld infrm NICs which WHO guidance is in the pipeline t avid duplicatin and s that newly develped guidelines can be cmmunicated in a timely fashin t ther labratries in natinal netwrks. Rapid translatin f WHO guidance int Russian is needed

13 page 12 Clear statements n bisafety requirements fr handling pandemic viruses need t be prvided. WHO shuld facilitate mre pprtunities fr sharing infrmatin and experiences during a pandemic. Supprt frm WHO with labratry diagnstics, labratry quality and surveillance system imprvement, especially SARI, needs t be cntinued in the inter-pandemic perid. WHO shuld prvide recmmendatins fr priritizatin f sampling fr testing and surveillance purpses during a pandemic. Cnclusins This evaluatin demnstrated the usefulness f pandemic preparedness activities undertaken by NICs in respnse t the 2009 pandemic. Supprt frm WHO was cnsidered t have been wrthwhile and t have imprved the pandemic respnse in The brad range f preparedness tasks undertaken by NICs was deemed imprtant and influential. As labratry services and netwrks require significant investments and resurces in a rapidly changing field, plitical and financial cmmitments are needed fr NICs t remain effective in their multi-faceted rle, particularly t sustain capacity fr a high level f alert in influenza. Clear strengths in the cuntries included: clse cllabratin between labratry netwrks; frmal apprval prcess f plans; labratry certificatin prcess; and internatinal/natinal infrmatin surcing. Based n the interviews, cmmn thematic elements shuld be viewed by individual NICs f the Member States as essential factrs t cnsider when revising, re-frmulating r rejuvenating natinal pandemic plans (and assciated preparedness activities) during the pst-pandemic evaluatin perid. These are: cmmunicatin crdinatin/cllabratin capacity adaptatin leadership supprt In terms f the respnse by NICs in the Eurpean Regin, the mst prblematic areas and thse where preparedness activities in the pst-pandemic recvery perid require strnger emphasis, as well as imprvement in planning, are: plitical cmmitment fr diagnstic capacity building cntrl n high diagnstic demands clinicians-labratry feedback system utbreak management teams that include NICs shielding labratry staff frm media demands real-time antiviral resistance mnitring The findings frm this exercise shuld be used t strengthen Eurpean pandemic planning during the pst pandemic recvery perid.

14 Labratry Netwrks Capacity Crdinatin/ Cllabratin Planning: Wrked well training f lab persnnel (imprved skills) early evaluatin and prtcl fr scaling up f lab capacity (e.g. PPE, staff, diagnstics) related experience (H5N1) cntact tracing hspital access t lab services crdinatin f planning prcess with MH, PH and NIC specialists inter-sectral cllabratin lab netwrk fr assistance in utbreaks standardized prtcl fr handling f specimens Didn t wrk well requirements fr additinal persnnel nt specified Implementatin f plan befre pandemic: Wrked well diagnstic equipment and lab materials/cnsumables surveillance fr early detectin fllw up cntent f plan (after disseminatin) multi-grup crdinated actins, utbreak management team implementatin, establish cllabratin with external labs Didn t wrk well lacking technical capacity, lab infrastructure, PPE, vaccines and AV prvisin f real-time AV resistance mnitring system difficulties setting up system fr sample cllectin, transprt & testing verlad strategy fr rapid respnse system implementatin cmplicated sampling lgistics Evaluatin f hw pandemic preparedness activities aided Eurpean NIC in the respnse t pandemic (H1N1) 2009 page 13 Annex 1. Summary f findings Leadership Cmmunicatin Supprt Adaptatin delegatin f respnsibilities t relevant rganizatins by MH fr plan develpment apprval f plan by MH r NIC labratry certificatin prgramme fr secndary labs e.g. at universities and hspitals natinal & internatinal wrkshps & seminars upfrnt agreements between labs/hspitals detailed cmmunicatin strategies multi-stakehlder discussins (e.g. pharmaceuticals, reginal, hspitals, labs, etc.), table tp exercises internatinal rganizatin(s) and natinal gvernment fr financing PPA, training & purchase f diagnstic material & equipment appintment f additinal labs WHO Guidelines adapting planning fcus frm H5N1 t H1N1 diagnstics nging evaluatin f planning prcess preparatin fr different scenaris, e.g. varius attack rates reference status f nly sme labs apprved internatinally appintment f persns fr implementatin f PPA measures gvernment set implementatin deadlines rapid authrizatin frm natinal medicine agency N/A specific rles need clearer definitin internatinal supprt fr desktp exercise and feedback reprting system f implementatin status t gvernment, seminars, lab service centres & epidemilgists, rapid sharing f data within lab netwrk, alert system cmmitment in capacity building cmplicated implementatin f cmmunicatin lines n agreement n sampling lgistics and AV resistance/ virulence markers cntainment measures, between-lab quality assurance system implementatin surveillance system fr severe cases nt in place N/A revisin and evaluatin f plan befre pandemic lessns learnt frm H5N1 experience applied t H1N1 pandemic, e.g. PPE, sample transprtatin, strage, virus cntainment, case islatin and ntificatin system tested fr identifying required changes

15 page 14 Labratry Netwrks Capacity Crdinatin/ Cllabratin Leadership Cmmunicatin Supprt Adaptatin Use f plan in respnse: Wrked well early case detectin rapid acquirement f lab materials, reagents and diagnstic equipments fr service reinfrcement, new lab data lgging tls increased sample handling capacity by utbreak assistance labs efficient multistakehlder respnse cllabratin (different levels and rganizatins) lab netwrk wrking clsely tgether emergency cmmissin directing plan revisin wrking grup, rapid mechanism fr apprval f revised plan infrmatin surces frm natinal & internatinal channels, meeting with natinal emergency cmmittee, inter-lab and relevant parties infrmatin disseminatin ntificatin channels fr ppulatin discussins and feedback pprtunity, infrmatin disseminatin thrugh free mbile netwrk, regular meetings 24/7 htline WHO, CDC, ECDC & MH recmmendatins internatinal supprt in lab diagnstics, quality and surveillance system imprvement reprting cases t WHO/ EurFlu MH mandate n revisin f surveillance system, revisin f case definitin & situatin evaluatin criteria rerganizatin f emergency service and hspital infrastructure plan adaptatin t natinal situatin using WHO & CDC guidance develpment f new guidance fr clinical AV resistance testing Didn t wrk well insufficient diagnstic capacity t meet demand (management, number f staff) real-time surveillance Expectatins frm WHO: mre training prvisin new methds facilitatin cnferences mre universal mechanism fr respnse crdinatin measures at natinal level n active mnitring f virlgical changes cllecting fllw-up specimens n mandate/cntrl n high diagnstic demand frm hspitals, GPs and ppulatin when pandemic mild (i.e. human behaviural factr) respnding t requests frm press and media mass media cntrl insufficient data t allw rbust cnclusins n severity late translatin f internatinal data/guidelines lack f lab specialist representatin in media N/A N/A get mre infrmatin and data at early stage f pandemic clearer pandemic severity criteria mre infrmatin n viral resistance t better infrm the public f the risk financial resurce mbilizatin link between clinical and virlgical data nt cmmunicated (e.g. feedback system) lack f natinal plan guidance n hw many samples t be sent fr testing creating pprtunity fr experience sharing between cuntries discussins & supprt n real-time diagnstics and sentinel surveillance raise issue f need fr dedicated budget lines fr lab cmpnent f PPA adaptatin f new H1N1 recmmendatins t natinal requirements and epidemilgical situatin adaptatin f clinical prtcl fr pregnant wmen, children and yung adults revise definitin f pandemic phases

16 page 15 Annex 2. Evaluatin Interview Guide Interview guide: evaluatin f hw pandemic preparedness aided the respnse t the pandemic (H1N1) 2009 Natinal Influenza Labratries Versin 14 July 2010

17 page 16 Sectin A: The planning prcess (25 minutes) 1) Were yu familiar with the natinal pandemic plan befre the pandemic (H1N1) 2009? 2) Des the natinal pandemic plan include a sectin n labratry and if yes, culd yu tell us hw was this develped: a. Did yu give input t develpment f the labratry sectin f the natinal pandemic plan? If yes, what input was given? b. Were ther persns invlved in the actual writing prcess and if s, hw did yu wrk tgether, hw frequently did yu meet? c. When was develpment f the labratry cmpnent f the plan initiated and finalized and what was the apprval prcess? d. Were the necessary finances t implement the labratry cmpnent f the plan identified? e. Which factrs were imprtant fr develping the labratry cmpnent f the natinal pandemic plan? 3) Hw did yu prepare fr a pandemic in yur labratry? Was a pandemic plan fr the labratry develped? When was develpment f the plan initiated/finalized and what was the apprval prcess? What was the status f the plan as f March 2009? Were necessary finances identified fr implementatin? What was imprtant fr develping the labratry plan? 4) Was the labratry plan develped n initiative f yur labratry r institute r in respnse t a request frm the natinal level? The fllwing questins apply t bth the labratry sectin f the natinal plan as well as the labratry plan, if available 5) Was guidance sught frm WHO, ther internatinal rganizatins r ther labs? If WHO guidance was used, which exactly and which WHO guidance was mst useful (eg. WHO glbal plan r checklist; NIC dcument, ther)? 6) Has the plan been revised r evaluated befre the pandemic? What were triggers fr revisin f the plan? 7) Was a specific scenari used as a basis fr the pandemic plan? 8) T which stakehlders was the plan disseminated? Prmpts/details fr the abve questins: (Q 1) Range f persns and prfessinal grups invlved (Q 3) eg. necessary finances rganized, surge capacity

18 page 17 (Q 5) WHO, ther rganizatins; was the guidance r input useful and why? (Q 7) Planning assumptins: attack rate, case fatality rate, hspitalizatin (Q 2e/3) What were the critical issues: e.g. time, expert input, external supprt etc

19 page 18 Sectin B: Implementatin f the plan befre the pandemic (25 minutes) 9) Did the plan identify actins that required putting in place befre the pandemic? a. Which were they? What gt implemented? What specifically facilitated their implementatin? Where these things implemented because the natinal plan r WHO guidance (WHO Glbal plan/checklist) said they shuld be r what determined their implementatin? b. Were things implemented befre the pandemic that with hindsight need nt have been implemented? 10) Were there things needed/implemented in the respnse that shuld have been implemented befrehand? What were they? Why were they nt implemented befre the pandemic? 11) Was the pandemic plan tested in exercises? a. Which elements were tested and with whm? b. Hw were lessns learned incrprated int the pandemic plan/pandemic preparedness activities (Q 10/11) Implemented: e.g. stckpiles f reagents and ther labratry materials; PPE; prcedures fr dealing with large number/sudden increase in samples; surge capacity planning; Tamiflu fr staff; (Q 10a) what were the critical issues: e.g. time, specific input frm experts, external supprt, ring-fencing f staff duties etc (Q 10b) D yu think it was the right decisin t implement these things, e.g. were (such large/small) stckpiles f reagents needed r wuld a smaller/bigger stckpile have been better?

20 page 19 Sectin C: Use f the plan in the respnse t the pandemic (H1N1) 2009 (40 minutes) 12) Did yu use the plan yu had written in the respnse t the pandemic (please answer fr bth the labratry sectin f the natinal plan and fr the specific lab plan, if available)? Did yu use ther dcuments? Which? 13) At the start f the pandemic, what was the trigger t implement/activate the plan? What exactly did yu d t implement/activate the plan? a. What did yu disseminate and t whm? 14) Which parts f the plan were used? If the plan, r cmpnents f the plan, were nt used, why nt? a. What was used/implemented instead? b. What culd have been in the plan t make it mre useful? c. Culd anything have made the WHO guidance/dcuments mre useful? 15) Did yu need t develp any new dcuments r respnse strategies that were nt envisaged in the plan? Hw were these develped? Were they disseminated and t whm? 16) Were triggers fr actin/de-escalatin during the pandemic clear t yu? 17) Where did yur infrmatin cme frm? Were yu able t distil the available infrmatin? Were yu able t make timely decisins? 18) Was there any infrmatin r supprt that yu needed frm the natinal/reginal level during the pandemic that yu did nt get? 19) Was it clear what was expected frm yu at different stages f the pandemic? 20) Were there mechanisms in place that allwed yu t feed back prblems frm the frnt line t relevant authrities at reginal/natinal level? 21) Were there cmmunicatin channels that did nt wrk? Were there cmmunicatin channels that were nt anticipated but that prved imprtant? 22) Thinking abut yur expected rle during a pandemic, hw did yur actual rle play ut in cmparisn? 23) What were the main things that were dne differently in the respnse than envisaged in the planning prcess? Prmpts/details fr the abve questins: (Q 13) sent s, held a meeting, sent ut the plan etc. (Q14b and c) Technical vs. plicy dcument; WHO dcuments refers t dcuments develped befre the pandemic and after the start f the pandemic (Q 15) If n, refer t gaps in plan. E.g. did yu miss a clearly defined list f respnsibilities in the plan, r divisin f tasks amng ther labs in the cuntry

21 page 20 (Q 16) Triggers culd be in the natinal plan r in the lab-specific plan, they culd be the first case in the cuntry, first death in the cuntry, mre than x number f cases, declaratin f new phase by WHO, directive t the lab frm the public health authrity r MH (Q 17) If there is n mentin f WHO phases/recmmendatins: D yu knw what WHO recmmended fr each phase? Was this what yu did? (Q 18) Internal: within the lab/instituteutside gvernment. External: WHO, ECDC (Q19) Technical, scientific, plitics, lgistic, financial

22 page 21 Sectin D: Reflectin n what culd have been dne differently in the planning phase (30 minutes) 25) Which pandemic preparedness activities were the mst useful t yur respnse t the pandemic? Why? 26) Which pandemic preparedness activities were the least useful t yur respnse t the pandemic? Why? 27) Hw culd the plan/pandemic preparedness activities have been mre useful/hw culd it have better served the respnse? 28) If yu had t start again, what wuld yur plan/ pandemic preparedness activities include/lk like? Wh wuld yu engage with/invlve? 29) What are yur next steps (evaluatin, revisin f plan)? 30) What d yu expect frm WHO fr future pandemic preparedness activities? Prmpts/details fr the abve questins: (Q 25) Was it mst useful t have a detailed plan, frequent meetings, exercises, stckpiles, surge capacity, training etc (Q 25) Natinal as well as WHO pandemic preparedness activities (wrkshps, missins, guidance dcuments, training, surveillance platfrm) (Q 30) What WHO (EURO) did related t pandemic preparedness: shipped CDC PCR kits fr pandemic (H1N1) and ther reagents during the respnse; missins, trainings, wrkshps, reginal meetings, guidance dcuments, EurFlu surveillance platfrm.