European Commission Initiative on Breast Cancer (ECIBC) MEETING OF the TESTING SUBGROUP Varese, 22 November 2016 (4.30pm 6.30pm) Approved Minutes

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1 EUROPEAN COMMISSION DIRECTORATE GENERAL JOINT RESEARCH CENTRE Directorate F Health, Consumers and Reference Materials Unit F1 Health in Society European Commission Initiative on Breast Cancer (ECIBC) MEETING OF the TESTING SUBGROUP Varese, 22 November 2016 (4.30pm 6.30pm) Approved Minutes Document history Version Date Drafted by Comments 0 8/12/2016 Nicola DAVENPORT Initial draft version proposed by RETELL 1 12/12/2016 Donata LERDA JRC version 2 18/01/2017 Donata LERDA Version including inputs from participants - approved Page: 1 of 7

2 Presentations are available on the ECIBC web hub and/or on the CIRCABC dedicated space List of Participants is in Annex I The Agenda is available at The meeting was chaired by Aliki STATHOPOULOU Welcome The JRC welcomed participants, outlining three points for discussion: Pending questions on applying ISO in the context of ECIBC; The need for reference documents as a potential replacement for detailed technical references available in 2006 guidelines; The use of ISO standards for testing aspects. Questions on applying ISO in the context of the ECIBC No questions were raised. Reference documents The JRC gave a brief presentation covering the need for a harmonised methodology on retrieving reference documents (can include technical protocols, standard operating procedures, methods, etc.), and for agreement on whether they are needed if so, how should they be used. The workflow agreed in June on how to proceed about reference documents is posted on CIRCABC and so far fulfilled. The importance of feasibility was underlined: it would not be feasible to provide every ECIBC user with a reference document for every single procedure. The JRC suggested that: Only the testing activities included in accreditation requirements should be covered by reference documents. The JRC referred to the co-coordinators of the testing subgroup for decisions on which techniques should be included/not included. The scope of the reference documents should be breast cancer. If a technique is not covered by the ECIBC recommendations, it will not be necessary to look for reference documents. The JRC proposed focusing initially on identifying reference documents for techniques backed by a strong recommendation in the guidelines. The JRC also highlighted how, in some EU Member States, the previous European guidelines are referred to in legislation (particularly for imaging). As the new guidelines will not contain all the technical details present in the previous guidelines, these gaps will need to be filled with reference documents. To determine what is needed, it will first be necessary to look into national legislative provisions. Page: 2 of 7

3 The JRC also considers that instead of providing a full detailed protocol on how to work in lab (for example), it may be necessary to provide some criteria, for example on the upper limit for false positives or the minimum content for certain reports. Participants remarked that if you work in a laboratory, you already have standard operating procedures. Guiding documents are only needed if you are setting up new testing activities. So the options are: Reference documents and a workflow on how to prioritise them, or General requirements for those working in laboratories to demonstrate to auditors that requirements are being met through the lab s general operating procedures. A participant asked whether it would be feasible to have a combination of the two options because if you have specific minimum performance requirements for some of the reference documents, there may be no evidence that those reference documents that are cited in legislation meet those performance requirements. In response to a request for a recap on the aim of collecting the reference documents, the JRC responded that different laboratories in different countries work in different ways. The aim is to have minimum/ essential standards respected by all. So, to also combine the two options, a plan could be: a. Agree on requirements for collecting and accepting reference documents (scope, performance levels possibly granted by inter-laboratory validation, year of production, validation needs, language-only English?, etc.) b. Agree on techniques and processes to be considered for reference documents (based on techniques mentioned in recommendations, processes that are key in ISO15189 and/or considered as key by the experts, references embedded in legislations) If it is found that no standard operating procedure exists (along point b) or meets requirements (listed at point a), the subgroup may opt to develop a document (within the group or through contractors) fulfilling the same requirements reported at point a. Participants suggested the following: Assessing all guidelines across Europe would be a huge project, and suggested focusing on a few specific sets of guidelines or creating a new set of guidelines but avoiding a piecemeal approach. Good guidelines exist already, and there is no point in reinventing the wheel. Reference documents are needed, and performance requirements must be stipulated. But don t need to create new day-to-day guidelines. Starting by identifying existing reference documents to see where there are gaps before deciding how to proceed. Page: 3 of 7

4 Most evidence-based docs exclude pathology. Best practice statements are instead used for many pathology recommendations because of a lack of studies directly comparing results obtained with different techniques. The group agreed that for very detailed procedures, no detailed reference documents are needed. However, as the interpretation phase can be accredited, reference documents and/or performance requirements should cover interpretation. The JRC explained that where reference documents are deemed as not necessary by the subgroup, minimum acceptable performance requirements will need to be agreed so that these can be used in the application of the accreditation standard (ISO or equivalent) for pathology activities providing results to the breast cancer service wishing to adhere to the European QA scheme. Laboratories should see the reference documents as supporting information, not an obligation. If other documents are used, the laboratory must be able to provide validation data to prove to auditors that their documented operating procedures meet the required performance levels. In the meantime, the JRC proposes that, once a decision on documents needed and respective requirements is taken, the search for public documents could be contracted out, while the subgroup can help retrieving the non-public ones (or a call can be launched). The documents used by assessment bodies when assessing a pathology lab were also proposed as relevant for collection. One member was nominated to contact subgroup members to collect their criteria for reference documents. It was clarified that many existing documents cover operating procedures, not performance. Performance criteria are however important to demonstrate that operating procedures are reliable and repeatable. It was suggested that both aspects are covered. It was agreed to start with a core set of documents, once the subgroup has specified what these are. If this appears a huge task, the JRC suggested that members of other groups could be asked to help. The JRC reminded subgroup experts that any plan for work, given also the limited time and resources, should be prioritised based on their knowledge of what is currently available to laboratories. For instance, if they believe all laboratories already have good standard operating procedures, the reference documents issue can be closed simply by declaring that no need of reference document was detected (still keeping in mind the need to identify and specify documents embedded in legislation). It may however be necessary to agree on the minimum acceptable performance criteria for key operating procedures. The workflow proposed to the pathology part of the testing subgroup is in line with the one proposed and agreed by the imaging part. The group agreed that the reference documents are needed some countries still need good guidelines on how to report things, minimum data sets, etc. Page: 4 of 7

5 ISO standards for testing activities The JRC reminded participants that the standards and accreditations at present used vary from country to country (a JRC report was produced on this 1 ). A consistent approach should be proposed by the ECIBC along the scope approved. If a national authority has already implemented certain requirements that are different to those the ECIBC proposes, the laboratories in that country may not be able to meet the ECIBC requirements. The approach proposed in the scope speaks of equivalency to the ISO 15189; however, to facilitate the inclusion in the European QA scheme of those countries having an historical application of other standards, the proposal is to agree on a core set of ISO requirements that should be fulfilled by all and include in the scheme that set to be audited during the accreditation of testing (or inspection) services not applying ISO This would possibly grant the desired level of consistency across all countries. It was confirmed that the geographical scope for this exercise covers all ECIBC countries. One participant noted that it may be useful to check whether anything has changed since the JRC report 1. It was agreed that by the next meeting, two members would indicate the key elements of ISO that would need to be covered by alternative standards. One member explained the historical background and rationale of the German pathologists to use ISO instead of ISO for accreditation of German pathology laboratories. They selected ISO instead of ISO because in their opinion the target parameter of ISO standard is the correct measured value of a single examination or of a test, while they consider ISO as targeting the medical quality of the diagnosis of the disease which is made up of a varying number of investigation results and which also expressly includes medical interpretation or evaluation of the individual investigation results in the overall context of a disease. According to the perception of the German pathologists and the German national accreditation board ISO completely includes ISO and goes beyond it. Another member of the Testing subgroup asked if same flexibility on ISO standards is going to be applied also for imaging. The meeting was reminded that accreditation bodies use two different types of scope: flexible scope and fixed scope. More accreditation bodies use the latter and it is more detailed than a flexible scope. There was a proposal to use the fixed scope approach as it could help services in all countries to achieve accreditation. Further discussions will however be needed to determine which of the two approaches would be more useful and feasible for the European QA scheme. A combination of both scopes could also be used. Finally, one member suggested that quality assurance of the interfaces between the disciplines (i. e. radiology pathology; pathology surgery; pathology treatment) is important for the outcome of the women/patients. Therefore, it was proposed to consider the development of quality indicators for the interfaces in the planning of next activities. 1 Page: 5 of 7

6 Closing remarks It was agreed that the subgroup will be co-coordinated by an expert in accreditation (Aliki STATHOPOULOU) and by a clinical profile (Francesco SARDANELLI for the imaging; Cecily QUINN accepted to co-coordinate for pathology). The meeting was closed with a review of the action points (see table below). Action points Action Timeline Who Collect criteria that reference documents must meet. Collect a list of topics to be covered by the reference documents (Scope) Collect National legislation to check if reference to European Guidelines about pathology is embedded Search for reference documents already developed and validated by a representative entity For those organisations using a standard other than ISO 15189, indicate the core elements of ISO that would need to be covered and audited Discuss on how to seek evidence for addressing interfaces, in particular between the breast centre and the testing activities services Discuss on whether a common approach to ISO standards equivalency is in place between imaging and pathology ASAP ASAP ASAP After the criteria and scope are defined Before the next meeting During February meeting During February meeting Subgroup members (Cecily Quinn and Aliki Stathopoulou) To be drafted by Aliki Stathopoulou and Jane Beaumont JRC JRC Subgroup members (Aliki Stathopoulou and Jane Beaumont) JRC includes the point in the agenda JRC includes the point in the agenda Page: 6 of 7

7 ANNEX I: List of subgroup members present ANDRÉ-ROBERT GRIVEGNEE, ANNETTE LEBEAU, CECILY QUINN, ALIKI STATHOPOULOU, FRANCESC TRESSERRA Testing subgroup members (pathology) absent TIBOR TOTI Other participants Jane BEAUMONT (JRC Contractor for supporting the Testing Subgroup about accreditation, Nicola DAVEMPORT (JRC Contractor for minutes-taking and reports), Miranda LANGENDAM (GDG External Expert Methodologist), Donata LERDA (JRC) Management of conflicts of interest All participants could participate in the discussion. Stathopoulou was asked to abstain in case of voting about accreditation of imaging activities due to her employment at the Greek National Accreditation Body. Beaumont could not vote due to her role as JRC Contractor. Tresserra could not vote due to his role of External Expert in the QASDG. No voting took place. Page: 7 of 7