Annex X Template structure for ECDC reports on laboratory external quality assessment schemes

Transcription

1 Annex X Template structure fr ECDC reprts n labratry external quality assessment schemes Versin 1, 18 March Please nte that the template may be revised slightly during the duratin f the framewrk cntract. The template shuld be used as a guide t the cntent f the EQA reprt. Nte that if nn EU/EEA cuntries participate in the EQA, the results and cnclusins may have t be presented in the reprt separately, e.g. EU/EEA, nn EU/EEA, all participating labratries. Reprt Objectives A starting pint in writing the reprt is defining the bjectives f the dcument. T guide the definitin f the bjectives the fllwing questins culd be used: Why is it needed t prduce a reprt n the cnducted EQA scheme? Wh is this reprt intended fr, i.e. wh shuld be the reader f the reprt? What wuld be the desired effect n the reader? What is expected t be achieved with this reprt? The answers f these questins might identify bjectives which invlve different target audiences fr the reprt. The latter might impact n the way the reprt is written, the way the data is presented and type f the disseminatin channels used. The bjectives f the EQA reprt are related t the bjectives f the EQA scheme althugh they might be brader since these culd differ depending n the utcme and results f the EQA scheme. An EQA reprt shuld nt be seen as merely a final dcumentatin f an activity but rather as an infrmatin resurce t be used fr actin (infrmatin fr actin by ECDC, by the labratries taking part in the EQA scheme, by natinal surveillance bdies and ther natinal public health authrities, etc.). It is wrth discussing alternative ways f reprting EQA results in rder t increase the impact f findings and cnclusins made. This is nt necessarily t substitute the technical reprt frmat but rather t cmplement it and make the effrts put in prducing such a reprt mre effective. Reprt Structure Title Shuld be cncise and infrmative, reflecting as clsely as pssible the cntent f reprt. Ideally n lnger than 15 wrds. Avid abbreviatins and acrnyms. Indicate the timeline f the EQA the reprt describes. Credits These g n the imprint (page 2, after the title page). Keep it shrt and straightfrward. Example: This reprt was cmmissined by ECDC (reference t the specific prcurement dcuments), crdinated by [ECDC prject manager] and prduced by [authr, institutin]. If there is a team f authrs, names and institutins can be included in a table.

2 Acknwledgements, if necessary, must be kept as shrt as pssible (n mre than a shrt paragraph). Example: This reprt was cmmissined by ECDC, crdinated by [ECDC prject manager] and prduced by [authr, institutin] n behalf f the netwrk participants Table f cntents Just a simple table f cntents. The editrs will frmat and update it. List f figures, tables and abbreviatins List f the figures and tables in the reprt. Only used if there are many. List f abbreviatins used in the reprt in alphabetical rder. With the use f the terminlgy server at ECDC and the Dcument Management System, it shuld be easier t be cnsistent with the use f terms and abbreviatins. Executive summary It shuld stress the key messages frm the reprt and crrectly reflect n: The public health prblem the study is addressing Objectives f the EQA scheme perfrmed in relatin t ECDC s surveillance bjectives Ratinale f the study design, participants, time perid Results btained Key cnclusins linked t the bjectives, i.e. t what extent these were achieved and the impact n cmmunicable disease surveillance Prpsed actins and next steps The executive summary must be a stand alne piece as each year the summaries f key ECDC publicatins are cmpiled and published as a separate dcument. The language must be clear and straightfrward t facilitate translatin int ther languages than English. Tip: When reviewing the executive summary f yur EQA reprt, ask yurself if yu are targeting the bjectives f the reprt. If needed, cnsult with ECDC s Cmmunicatin experts t address this issue jintly. Intrductin Shuld include brief explanatin f the fllwing cmpnents: Public health impact f the disease/pathgen in questin Imprtance f surveillance f this disease/pathgen and hw this is addressed by ECDC s surveillance bjectives, the disease surveillance bjectives Intrductin t the labratry netwrk in questin, its bjectives The rle f the clinical micrbilgy labratries and natinal reference micrbilgy labratries in supprting the disease surveillance by prviding relevant data. The current situatin f micrbilgy fr surveillance f that disease In the cntext f the current situatin, what prblem is the described EQA scheme addressing and hw this it link t similar n ging initiatives (e.g. by ther agencies,

3 Cmmissin, WHO). List clearly the specific bjectives f the EQA. D nt make the bjectives with scpe brader than what an EQA scheme can achieve. If the EQA cvers schemes which are cmmercially available, shrtly state why ECDC is rganising such an activity Study Design Cntent and pssible sub headings: Organisatin f the scheme (Wh rganised it and fr whm? Hw were the participants selected? Hw were they apprached? List f participants with cuntry, institutin and city (where needed) as annex. It culd be useful t include a brief sentence stating the number f labratries the survey was sent t, the number f thse wh replied psitively, f thse participating and f thse cmpleting the scheme (if differences exist). It is wrth discussing whether the annex listing the names f participants shuld nt include als thse wh were invited t participate but did nt reply t the invitatin. Descriptin f specimens and time frame (i.e. Sample, islate, strain, etc. Hw have the strains been selected? Descriptin f the verificatin prcedures and traceability t the reference strain (if applicable). Present table with strain characteristics.) Methds f handling and transprtatin. Reprting sheet including questinnaire Summary f the main questins, e.g. n lab capacity, methds used, media and ther key elements. Put the full questinnaire in the annex Standards (e.g. ISO, CLLS) used fr preparatin and implementatin f the EQA scheme and interpretatin Indicatrs used fr assessing perfrmance Statistical methds Cst and time breakdwn include in an annex Results Cntent and pssible sub headings: Results f questinnaire (if relevant) Overview f the EQA results (table) expected vs. actual Results per each EQA blck/test Expected results Actual perfrmance (i.e. numbers r percentage) at aggregated level. Results fr individual labratries shuld preferably be put in annex t the reprt. If the scheme is repeated ver several years, the labratry cdes shuld remain the same in rder

4 t facilitate cmparisn ver time, as lng as the annymity can be kept. Cncrdance value and errrs (separately fr each specimen/islate and fr labs (individual annymised lab results presented in annex f the reprt)) Cnclusin The gal f this sectin is t briefly summarise the majr inferences that can be drawn frm the infrmatin presented in the reprt. State in brief the utcme f the EQA scheme, the significance f the findings reprted. This culd be dne in sub sectins as per the different bjectives f the EQA. Evaluate the EQA itself using criteria such as apprpriateness f the study design, participatin rates, frequency f testing, number f samples, analysis f results, reprting f data, etc. Discussin Cmment n verall perfrmance, discuss the pssible reasns fr the failure rates bserved, variatin between methds r prcedures Cmpare the results t previus EQA schemes perfrmed with the respective labratry netwrk. Discuss hw these fit in the cntext f the state f art, ther similar studies, and current effrts t address t imprve perfrmance, cmment n the success f specific actins taken t fill in previusly identified gaps State briefly the study limitatins; highlight any specific issues r prblems encuntered in the study that wuld have had an impact n the utcmes, e.g. limitatins f the test methd, transprt f samples, sample preparatin in the rganising labratry Briefly discuss what the bservatins mean in the cntext f surveillance bjectives, disease preventin and cntrl Identify the critical factrs determining individual labratry as well as netwrk perfrmance success rates; If pssible, cmment n time and cst fr EQA schemes vs. achieved utcmes fr capacity building and cmpliance with surveillance bjectives (value fr mney, impact). Recmmendatins Based n the identified critical factrs, prpse specific actins t address the identified errrs, gaps, etc. Link prpsed actins t key players, i.e. whether the actin is fr individual labratries, fr the labratry netwrk, fr ECDC, etc. Put yur prpsal in the cntext f identified bjectives (EQA, netwrk, ECDC) If key elements t imprve the EQA rganisatin itself were identified, state these here (e.g. hw t cllect questinnaires, hw and when t send testing material, hw t prcure EQA activities). List f references Entries shuld be listed numerically and in the same rder that they have been cited in the text, in Vancuver style.

5 When referring t ECDC s surveillance bjectives and disease specific surveillance bjectives, it is imprtant t include apprpriate references. Similarly, it wuld be infrmative t include references t mre infrmatin n the labratry netwrk in questin. Annexes Questinnaires used, terms f references, extra tables f data, etc.