This publication is a Technical report by the Joint Research Centre (JRC), the European Commission’s science and knowledge service. It aims to provide evidence-based scientific support to the European policymaking process. The scientific output expressed does not imply a policy position of the European Commission. Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use that might be made of this publication.

Contact information

Name: Donata Lerda

Address: Joint Research Centre, Directorate F–Health, Consumers and Reference Materials, Unit F.1–Health in Society Via Enrico Fermi 2749, TP 127, 21027 Ispra (VA), Italy

E-mail: jrc-cancer-policy-support@ec.europa.eu

Tel.: +39 0332 78 6201

Fax: +39 0332 78 9059

Web Site

http://ecibc.jrc.ec.europa.eu

JRC Science Hub

https://ec.europa.eu/jrc/

JRC Mission

As the science and knowledge service of the European Commission, the Joint Research Centre’s mission is to support EU policies with independent evidence throughout the whole policy cycle.

Europe Direct is a service to help you find answers to your questions about the European Union Free phone number (*): 00 800 6 7 8 9 10 11
(*) Certain mobile telephone operators do not allow access to 00 800 numbers or these calls may be billed.

A great deal of additional information on the European Union is available on the Internet. It can be accessed through the Europa server http://europa.eu

How to obtain EU publications

Our publications are available from EU Bookshop (http://publications.europa.eu/howto/index_en.htm), where you can place an order with the sales agent of your choice.

The Publications Office has a worldwide network of sales agents.
You can obtain their contact details by sending a fax to (352) 29 29-42758.

JRC106816

EUR 28621 EN

PDF | ISBN 978-92-79-69024-2 | ISSN 1831-9424 | doi:10.2760/070213 | KJ-NA-28621-EN-N
Print | ISBN 978-92-79-69023-5 | ISSN 1018-5593 | doi:10.2760/897944 | KJ-NA-28621-EN-C
EPUB | ISBN 978-92-79-75125-7 | ISSN 1831-9424 | doi:10.2760/462845 | KJ-NA-28621-EN-E

Luxembourg: Publications Office of the European Union, 2017

© European Union, 2017

The reuse of the document is authorised, provided the source is acknowledged and the original meaning or message of the texts are not distorted. The European Commission shall not be held liable for any consequences stemming from the reuse.

How to cite: Zuleika Saz Parkinson, Anke Bramesfeld, Silvia Deandrea, Jesús López-Alcalde, Luciana Neamtiu, Liisa Pylkkänen, Asli Ulutürk, Donata Lerda; Report of a European Survey on the Implementation of Breast Units; EUR EN; doi:10.2760/070213.

All images © European Union, 2017, except: cover image © tashatuvango.

KJ-NA-28-621-EN-E

Report of a European Survey on the Implementation of Breast Units

ECIBC–supporting information for breast cancer care policies and initiatives

Affiliations of the authors

Zuleika Saz Parkinson,a Anke Bramesfeld,a Silvia Deandrea,a Jesús López-Alcalde,b Luciana Neamțiu, b Liisa Pylkkänen,a Asli Ulutürk,a Donata Lerda.a

a European Commission, Directorate-General Joint Research Centre, Directorate F–Health, Consumers and Reference Materials, Unit F.1 – Health in Society, Ispra, Italy.

b Former JRC GH 30.

Foreword

The authors describe the state of implementation of the Breast Units as defined in 2006 in the European Guidelines for Quality Assurance in Breast Cancer Screening and Diagnosis. They provide updated information on how the requirements for those units have been followed in Member Staes and other European Countries.

Even though the 2006 breast units model is widely recognised as a valid and innovative instrument to address breast cancer care, the figures provided by the survey also show that its implementation remains a challenge, and different approaches have been followed. Of the numerous requirements defined in 2006 for breast units, some countries did not implement those which were mandatory, whilst others were prioritised. Implementation of 2006 breast units’ requirements was often voluntary and in very few cases by law.

Analysis of survey results on how the 2006 breast unit model was implemented vis-à-vis the approach proposed by the ongoing European Commission Initiative on Breast Cancer (ECIBC) and by other EU initiatives, e.g. the joint actions EPAAC and CanCon, highlights the importance of using an evidence-basis and deep knowledge about countries’ healthcare models and cancer plans when proposing requirements. This approach, besides making the EU added value evident, can provide Member States–and other concerned countries–and stakeholders with real-life examples, which can be of mutual interest. The report provides a useful input to ascertain the state of play on an important aspect of cancer prevention and control policies, allowing comparisons and providing basis for improvement across Europe. Moreover, it gives a vision for the implementation of the future European QA scheme.

John F. Ryan

Director

European Commission, DG Health and Food Safety, Directorate C–Public Health

List of Acronyms and Abbreviations

European Guidelines | European guidelines for quality assurance in breast Cancer screening and diagnosis, 4th edition (2006)
BU | Breast Unit
CME | Continued Medical Education
DG SANTE | Directorate General for Health and Food Safety (EC)
EC | European Commission
ECIBC | European Commission Initiative on Breast Cancer ED Europa Donna
EPAAC | European Partnership for Action Against Cancer
European QA scheme | European Quality Assurance scheme for Breast Cancer Services (currently under development as one of the objectives of the ECIBC)
European Breast Guidelines | European guidelines on breast cancer screening and diagnosis (currently under development as one of the objectives of the ECIBC)
JRC | Joint Research Centre (EC)

EXECUTIVE SUMMARY

The 4th edition of the European guidelines for quality assurance in breast cancer screening and diagnosis [1][6], issued in 2006, included a chapter providing indications for a model centralising breast cancer care in the so-called breast units and requirements for those units. Ten years after issuing that model and following-up the European Parliament (EP) resolution of 2006 on breast cancer in the enlarged European Union¹ (which called on Member States to ensure nationwide provision of interdisciplinary breast units by 2016 and on the Commission to deliver a progress report on this every two years), the survey described in this report was envisaged to provide up-to-date information on how and where these requirements have been implemented across Europe.

The aim of the report is to factually describe the implementation status of each requirement across Europe based on the results of the survey. No appraisal regarding the level or quality of care provided in each country is implied. The obtained results will also be used to inform the development and implementation of the voluntary European Quality Assurance scheme for Breast Cancer Services (the European QA scheme), one of the main pillars of the ECIBC.²

In order to capture the healthcare provider perspective and the patient perspective, the survey was conducted in parallel with two different groups of stakeholders:

1. ECIBC National Contacts, nominated via Members States’ Health Attachés, to ensure that the EC receives official information to support the ECIBC, and

2. ED National Representatives to take into account patient advocates’ feedback on the status of breast units in their respective countries.

Overall, 30 of 34 countries contacted responded to the survey. The main findings include:

• breast units are only required by law in a few countries, though they are recommended in 17 out of the 30 countries that responded to the survey;

• even if the 2006 breast unit model proved to be innovative and well known both by professionals and patients’ advocates, this report shows that the implementation of the model is not harmonised across all countries; in particular, a great diversity in the number and selection choices among the 25 requirements to be implemented was observed;

• of the 25 requirements listed in the 2006 European Guidelines, four were considered to be mandatory, although the implementation of these particular requirements was reported as compulsory in only two countries (IT and CZ). Of these four mandatory requirements, the volume requirement was implemented less frequently than the other three;

• among the remaining 21 requirements, those most implemented, in a compulsory manner, across Europe were the provision of adjuvant therapy, the provision of imaging equipment, the multidisciplinary case management meetings and provision of radiotherapy;

• regarding the two sets of responses (from ECIBC National Contacts and ED National Representatives), discrepancies were found in replies related to some key requirements–showing that there is room for improvement in the dissemination of breast cancer policies;

• differences in awareness about requirements implementation were observed between the two groups of respondents; this is of particular concern for countries where the replies of the ECIBC National Contact indicated that a requirement was compulsory, and the ED National Representative indicated the same requirement as not being in place.

A Europe-wide scheme, like the one being developed by the ECIBC, could take into account the 2006 breast unit model, as well as other existing schemes and sources, to develop its requirements. The European QA scheme is being developed in a harmonised, evidence-based and flexible way to grant equal and quality-benchmarked treatment to patients. In this respect, particular attention is devoted to substantiating, whenever possible and appropriate, proposed requirements with evidence; this ensures that any potential impact of quality requirements on outcomes is credible, reliable and valid.

1. Introduction

1.1. Background

Since 1987, the EC has supported cancer policies. In that same year, the ‘Europe Against Cancer’ Programme was launched and was instrumental in funding the actions to develop the series of European guidelines for quality assurance in breast cancer screening and diagnosis (European Guidelines).

Under the coordination of the EC, four editions of guidelines for breast cancer screening and diagnosis have been issued to support the implementation of screening programmes as indicated by the 2003 European Council recommendation [5].³ The 4th edition of the European Guidelines [1], issued in 2006, also included a chapter that provided indications for a model centralising breast cancer care in so-called breast units. The survey described in this report was envisaged to provide updated information on the implementation of breast units as defined in the 2006 (4th) edition of the European Guidelines.

1.2. The European Commission Initiative on Breast Cancer (ECIBC)

The ECIBC is a person-centred sustainable initiative aiming to improve and harmonise breast cancer care in Europe. The ECIBC is coordinated by the JRC under the auspices of DG SANTE. As the EC’s in-house science service, the JRC provides an inclusive and transparent platform for engaging all stakeholders while remaining independent of any national, commercial, and private interests. Within the JRC, the Healthcare Quality Team is dedicated to the fulfilment of the initiative.

Why the ECIBC?

Breast cancer is the most common type of cancer in Europe–accounting for approximately one in six cancer-related deaths. However, breast cancer incidence and mortality rates vary greatly between countries. This variation reflects large inequalities, which are also attributable to diversity in quality of care. Consequently, there is considerable potential to reduce the burden of breast cancer and inequalities in outcomes at European level.

Member States acknowledged the need for coordinated action against the burden of cancer through the Council conclusions of 2008;⁴ and in 2012 the EC launched the ECIBC. The ECIBC aims to ensure that all breast cancer care processes are appropriate, high quality (as defined by evidence) and accessible to all citizens. The ECIBC will work towards achieving this goal in collaboration with experts and the support of patients, including ECIBC working groups,⁵ ECIBC National Contacts,⁶ and other stakeholders.⁷

The primary objectives of the ECIBC are to establish:

1. a voluntary European Quality Assurance scheme for Breast Cancer Services (the European QA scheme) addressing all care processes, including screening, diagnosis, treatment, rehabilitation, survivorship care, and palliative care;⁸

2. evidence-based recommendations supporting the European QA scheme, including:

a. the European guidelines for breast cancer screening and diagnosis (the European Breast Guidelines);

b. the ECIBC Guidelines Platform⁹ covering all care processes;

3. a European training template for radiographers and radiologists on digital breast screening;

4. a web interface (the ECIBC web hub¹⁰) of complete and updated information and host to all ECIBC and ECIBC-related documents and materials, including the ECIBC concept, objectives and life-cycle processes, the first four recommendations on breast cancer screening, as well as a list of breast cancer services adhering to the European QA scheme. Key information, in particular information targeting women and patients, will also be made available in all official EU languages.

2. Scope of the survey

The survey was organised by the JRC in collaboration with the chair and co-chair of the 10th European Breast Cancer Conference (EBCC 10), Fatima Cardoso and Susan Knox, on behalf of ED, to provide an informative tool for breast cancer care policies, to complement the European Breast Units Manifesto launched at that conference,¹¹ and to follow-up the EP resolution of 2006 on breast cancer in the enlarged EU.¹² This resolution called on Member States: ‘to ensure nationwide provision of interdisciplinary breast units in accordance with the EU guidelines by 2016, since treatment in an interdisciplinary breast unit has been proved to raise chances of survival and to improve the quality of life, and calls on the Commission to deliver a progress report on this every two years’.

Member States are responsible for breast cancer services organisation, including planning and implementing Breast Units. The main scope of the survey was to map out in detail the implementation of 2006 breast unit model requirements within the diverse healthcare and breast care organisational models that have been adopted across Europe.

Such detailed mapping would complement other JRC findings¹³ on the status of breast cancer care in Europe and provide:

a. the basis of information for the development and implementation of the European QA scheme, in particular as regards the legal frameworks to be respected by the scheme, and

b. a resource for stakeholders, and particularly policy makers, for identifying which requirements were implemented more frequently and how.¹⁴

This mapping took into account:

a. results from previous JRC surveys and analyses,¹⁵ most notably the survey conducted with support from former EPAAC National Contacts,¹⁶ and

b. the realisation that, even if the concept of breast units has greatly evolved since 2006, the call of the EP clearly refers to definitions given in the 2006 European Guidelines.

Therefore, given the scope of the survey, the aim of this report is to present participants’ responses regarding the implementation of the requirements for breast units (as described in the 2006 European Guidelines and within the context of previous JRC findings)–with the goal of providing supporting information (a) to policy makers regarding breast cancer care and (b) towards the development of the European QA scheme and its future implementation.

The resulting map of responses shows the current status of implementation (i.e. which requirements have been implemented and where implementation has occurred) and is by no means an appraisal or valuation of a any country’s provision of breast cancer care services or quality of care.

The main limitations of the survey are:

• most country responses are based on the opinions and input of a single designated person deemed responsible for providing the health authority’s perspective and, as not all ECIBC National Contacts are part of an official health authority, their responses may not be a fully accurate depiction of implementation in their respective countries;

• survey questions are based on definitions found in the 2006 European Guidelines where, on some occasions, more than one concept was addressed in a single question; this may have introduced response bias as the respondent’s reply may refer to only part of the question; and

• many countries that have implemented the requirements did so not out of compliance with the 2006 European Guidelines but in response to common practices within those countries; therefore, implementation status may not be a true reflection of compliance in countries where implementation occurred before 2006 or as part of a national/regional mandate or recommendation unrelated to the guidelines (see Annex III, Tables 1-15).

3. Survey organisation

Methods

The survey was conducted in parallel with two different stakeholder profiles:

a. ECIBC National Contacts, who were nominated via Members States’ Health Attachés to ensure that the EC receives official information from each country in relation to the ECIBC, in particular with respect to the implementation status of the breast unit requirements included in the 2006 European Guidelines, and

b. ED National Representatives to take into account patient advocates’ feedback on the status of 2006 breast unit model in their respective countries.

Two questionnaires were developed for the survey. Each questionnaire offered similar content; however, the amount of detail and the number of mandatory questions differed. The more detailed questionnaire, which also included a greater number of mandatory questions, was sent to the ECIBC National Contacts, while the other, less detailed questionnaire was sent to the ED National Representatives. Survey participants received a single PDF document, which included the questionnaire and a data protection form–covering the consent for publication of the data (Annexes I a and I b).

The personal data protection section included a privacy statement and also requested consent for publication, which all participants agreed to. Further requests for consent will be made in the event of data publication in the future.

Each questionnaire was divided into seven sections:

1. Administrative details

a. Contact details

b. Geographical responsibility

2. Healthcare organisation

a. Changes that have occurred since 2012-2013

b. Brief description of healthcare organisation

3. References and definitions

Definitions reported in the 2006 European Guidelines

4. General questions on breast units

a. Existence of breast units

b. Existence required by law or recommended

c. National or regional/local accreditation/certification of breast units

d. Mandatory or voluntary accreditation/certification systems

5. Implementation stage of mandatory requirements for breast units

a. Critical mass

b. Core team composition, training and continuing medical education

6. Implementation stage of other requirements for breast units

a. Regulation of imaging equipment

b. Regulation of radiotherapeutic equipment

c. Regulation of new patient clinics

d. Regulation of communication of diagnosis and treatment plan

e. Regulation of multidisciplinary case management meetings

f. Regulation of provision of physiotherapy

g. Regulation of provision of adjuvant therapies

h. Regulation of management of advanced and recurrent breast cancer

i. Regulation of follow-up of primary breast cancer

j. Regulation of management of benign disease

k. Regulation of management of family history/genetics

l. Regulation of breast screening management

m. Regulation of patient information

n. Regulation concerning extra psychological support

o. Regulation of plastic surgery

p. Regulation of geneticist’s advice

q. Regulation of provision of palliative care

r. Regulation of provision of prosthesis

s. Regulation of provision of physiotherapy and lymphoedema treatment

t. Regulation of research management

u. Regulation of management of teaching

7. Personal data protection, consent to data publication and form submission.

Technical aspects

Adobe LiveCycle Designer® was used to design, distribute, collect and manage the information. This tool allows the creation of interactive PDF forms with automatic submission (e.g. e-mail) and the flexibility of a multiple user interface. Communication occurred via a functional mail-box (jrc-cancer-policy-support@ ec.europa.eu) accessible to all JRC Healthcare Quality Team members; thereby, allowing full-time assistance and support to all participants in the survey.

Data analysis

ECIBC National Contacts

30 of the 32 questions regarding breast units were mandatory (denoted by an asterisk on the form and controlled by the software used to ensure a response) and the remaining two questions were optional. However, countries were encouraged to report additional information, whenever possible.

ED National Representatives

None of the breast unit questions were mandatory. In addition, response options in the sections covering General questions on breast units, Implementation stage of mandatory requirements, and Implementation stage of other requirements differed slightly–with ECIBC National Contacts having more options to choose from.

ECIBC National Contacts’ response options:

1. YES, MANDATORY

2. YES, VOLUNTARY

3. NO, BUT PLANNED

4. NO and NOT PLANNED

5. I do not know

While the ED National Representatives had the following three options:

1. YES

2. NO

3. I do not have this information

However, when analysing the answers received by the ECIBC National Contacts and ED National Representatives, the JRC has assumed that a ‘YES’ for the ED National Representatives is equivalent to ECIBC National Contact options 1 or 2 (‘YES, MANDATORY’ AND ‘YES, VOLUNTARY’). Therefore, these two categories were combined in order to allow for comparisons. Once all of the data had been received and entered into the database, a manual data cleaning procedure was performed. Missing data and inconsistencies were crossed-checked with each respondent.

Countries were coded according to the International Organisation of Standardisation (ISO) 3166 standard (Table 1).

Table 1. ISO country codes.

Country Name | ISO Code
Austria | AT
Belgium | BE
Bulgaria | BG
Switzerland | CH
Cyprus | CY
Czech Republic | CZ
Germany | DE
Estonia | EE
Spain | ES
Denmark | DK
Finland | FI
France | FR
Greece | GR
Croatia | HR
Hungary | HU
Ireland | IE
Iceland | IS
Italy | IT
Lithuania | LT
Luxembourg | LU
Latvia | LV
Montenegro | ME
Malta | MT
Netherlands | NL
Norway | NO
Poland | PL
Portugal | PT
Romania | RO
Serbia | RS
Sweden | SE
Slovenia | SI
Slovakia | SK
Turkey | TR
United Kingdom | UK

Timeframe

All potential respondents (ECIBC National Contacts, ED National Representatives and possible delegated individuals) were contacted by e-mail via the JRC Cancer Policy Support functional mailbox. The same mailbox was used to correspond with participants for the duration of the survey.

1. On 21 January 2015, participants were informed about the survey and asked to confirm willingness to participate by 13 February 2015.

2. On 27 February 2015, a second email was sent to those countries confirming participation, including additional and more detailed information about the survey content and timeline.

3. The survey was launched on 8 April 2015 and the deadline for completion was 22 May 2015.

4. On 6 and 18 May 2015, participants that had not returned a questionnaire were contacted and offered support to complete it as well as being reminded of the upcoming deadline.

5. After a period of follow-up to ensure the highest possible response, the last questionnaire was received on 13 August 2015.

6. Countries providing inconsistent or incomplete responses were sent requests for clarification or more details on 17 December 2015. The last completed surveys were received on 10 February 2016.

7. All responses were harmonised and edited for language and style.

8. Aggregated results were presented at EBCC 10 on 9 March 2016.

9. On 3 August 2016, participants were asked to provide their final approval for publication of responses by 5 September 2016.

10. On 26 August 2016, participants received a reminder by email, which included a ‘silence gives consent’ clause to ensure that the final approval process could be terminated by the deadline.

Participants

Table 2 provides the list of 25 participating countries, the ECIBC National Contacts, and the collaborators responsible for completing the questionnaire. Table 3 includes the list of participating ED National Representatives and their respective countries of representation.

Table 2. List of ECIBC National Contact participants.

Country
Survey Respondent
Collaborator(s)
Affiliation

BE
Saskia VAN DEN BOGAERT

Federal Public Service of Public Health, Brussels

BG
Ivan GAVRILOV

National Hospital of Oncology

CH
Manfred LANGENEGGER

Federal Office of Public Health

CY
Myrto AZINA- CHRONIDES

Ministry of Health, Nicosia

CZ
Petra TESAROVA
Jan DANES
PT: Oncology Department. First Faculty of Medicine, Charles University, Prague JD: Radiology Department. First Faculty of Medicine, Charles University, Prague

DE
Simone WESSELMANN
Vanessa KÄAEB-SANYAL Andrea GILLES
SW: Bereichsleiterin Zertifizierung–Deutsche Krebsgesellschaft e.V., Berlin VKS: Kooperationsgemeinschaft Mammographie GbR; Berlin AG: ÄKzert Ärztekammer Westfalen-Lippe, Münster

FI
Minna TANNER

Tampere University Hospital, Tampere

FR
Emmanuelle SALINES

Department of health, Ministry of health, Paris

GR
Lydia IOANNIDOU-MOUZAKA

Nominated by the Hellenic Ministry of Health & President of the Hellenic Senologic Society, Athens

HU
Lajos DÖBRÖSSY

National Office of Chief Medical Officer, Budapest

IE
Michael CONROY

Department of Health, Dublin

IT
Antonio FEDERICI

Ministry of Health, Roma

LT
Rūta BRIEDIENĖ

National Cancer Institute, Vilnius

LU
Astrid SCHARPANTGEN

Ministère de la Santé, Luxembourg

LV
Alinta HEGMANE

Riga East University Hospital, Oncology Center of Latvia, Riga

MT
Miriam DALMAS

MD: Office of the Chief Medical Officer, Ministry for Energy and Health, Valletta

Richard ZAMMIT
RZ: DG Healthcare Regulation–Dpt. PH Regulation

Patricia GALEA
PG: Director Healthcare Standards–Dpt. PH Regulation

Stefan LASPINA
SL: Clinical Chair for Haematology & Oncology–Oncology Centre, Mater Dei Hospital

Christopher BARBARA
CB: Clinical Chair for Pathology–Mater Dei Hospital

Salvina ZRINZO
SZ: Clinical Chair for Radiology–Mater Dei Hospital

Joseph DEBONO
JD: Clinical Chair for Surgery–Mater Dei Hospital

Gordon CARUANA DINGLI
GCD: Breast Cancer Surgeon–Mater Dei Hospital

James DEGAETANO
JD: Lead Histopathologist–Mater Dei Hospital

Doreen PACE
DP: Lead Palliative Care consultant–Oncology Centre, Mater Dei Hospital

NO
Leif NORDBOTTEN

Norwegian Directorate of Health, Oslo

PL
Elzbieta SENKUS-KONEFKA

Medical University of Gdansk

PT
Nuno MIRANDA

General Directorate of Health, Lisbon

RO
Alexandru ENIU

Institute of Oncology
Prof. Dr. Ion Chiricuta–Cluj-Napoca

RS
Verica JOVANOVIC
Radan DZODIC
Zorica MILOSEVIC
Ana JOVICEVIC
Dragan ILIC
Institute for Public Health of the Republic of Serbia

SE
Göran ZETTERSTRÖM

The National Board of Health and Welfare, Stockholm

SI
Simona BORŠTNAR

Institute of Oncology, Ljubljana

SK
Kamil POHLODEK

University Hospital of Bratislava

UK*
Chris HOLCOMBE

Breast Clinical Reference Group, NHS England

*UK data refers to England only.

Table 3. List of ED National Representatives participants.

Country | Survey Respondents
AT | Walter NEUNTEUFEL
CH | Donatella CORBAT
CY | Stella KYRIAKIDES
CZ | Marta KOSTROVÁ
EE | Tiiu-Liis TIGANE
ES | Carmen BORONAT JIMÉNEZ
FR | Martine CASTRO
GR | Elizabeth Kay MEIER
IE | Tara BYRNE
IT | Elisabetta SESTINI
LU | Mariette FISCHBACH
MT | Doris FENECH
NL | Ellen VERSCHUUR-VAN DER VOORT
NO | Inger Margrethe HOLTER
SE | Elizabeth BERGSTEN NORDSTRÖM
SI | Mojca SENČAR
TR | Violet AROYO
UK | Margaret SPITTLE OBE

4. Survey results

The countries that did not respond to the survey are not included in Results tables but are reported in Annex III. Detailed participant responses are provided in Annex III and completed questionnaire forms are available upon request. Participants’ responses were expressed as a percentage and rounded to the nearest whole number.

General overview

The invitation to participate in the survey was sent to the 34 ECIBC National Contacts, 26 confirmed their willingness to participate, and 25 completed the survey (74% response rate). By comparison, 31 ED National Representatives were sent the invitation, 21 confirmed their willingness to participate, and 18 completed the survey (58% response rate). Overall the country coverage of the survey was 88% (in 30 countries out of the 34 contacted at least one respondent provided the requested information). However,

• Twelve countries provided information from both the ECIBC National Contact and the ED National Representative.

• The ECIBC National Contact for the UK provided information for only England, while the ED National Representative responses reflect the situation within the entire UK.

An overview of country level response is reported in Figure 1. All participants gave their consent for data publication.

In the following sections, responses for each of the seven parts of the survey are analysed, described and evaluated for their impact on policy decisions. Detailed responses are reported in Annex III.

Figure 1a. Country participation map. The magnified area corresponds to Malta.

Section 1: Contact details and geographical responsibility

As regards the ECIBC National Contacts geographical area of responsibility, 22 out of 25 participants had a national mandate and three had a regional mandate (BG, LT, and FI). 13 (52 %) participants were national ministry of health employees, while the remaining 12 participants were affiliated with research centres or hospitals. In all cases, due to the official nature of the nomination, they were responsible for the information provided regarding their own country. In the case of Germany, in addition to the National Contact’s response, they provided a regional perspective as well as a point of view from the national screening programme; however, with respect to the implementation status of the 2006 breast unit requirements, only responses provided by the ECIBC National Contact were considered.

Figure 1b. Country participation table. White cells correspond to participants that did not provide a response.

In addition to the ECIBC National Contacts, 15 collaborators were involved in the completion of the questionnaire (Table 2).

Section 2: Organisation of healthcare

Information on healthcare organisation was previously obtained in a JRC survey conducted with National Contacts regarding the organisation of breast cancer care services and is presented elsewhere.¹⁷ Responses to the present survey were received from an additional five countries (CH, GR, PL, PT, and RS); however, five countries that participated in the 2012 survey (AT, EE, ES, HR, and NL) did not provide input from an ECIBC National Contact in the current survey. Meanwhile, HU, SE, and UK noted that they had undergone changes in the geographical organisation/responsibility allocation of healthcare since the last survey.

Section 3: General questions on breast units

With regard to the general questions on breast units, ECIBC National Contacts’ responses are shown in Figure 2, while Figure 3 presents the responses for ED National Representatives.

The majority of countries reported having breast units in their geographical area; however, only two countries (CZ and IT) required them by law. Accreditation or certification systems for these breast units were reported as compulsory in a few countries and as voluntary in some others; this was reported at national and regional level throughout Europe (see Figures 2 and 3). With respect to these results, the 2012 survey asked ECIBC National Contacts about the status of accreditation and certification schemes (in development or implemented) for breast cancer services (those results are presented elsewhere for comparison).¹⁸ However, it should be noted that any inconsistencies between the results of the two surveys may be due to the fact that the 2012 survey covered breast cancer services, while the current survey focussed on the specific types of breast cancer services which are defined by the 2006 breast unit model.

Countries listed in boxes are those identified as having (green bordered box) or not having (red bordered box) BUs and a mandatory accreditation/certification scheme.

Figure 2. ECIBC National Contact responses to general breast unit questions.

Countries listed in boxes are those identified as having (green bordered box) or not having (red bordered box) BUs and a mandatory accreditation/certification scheme.

Figure 3. ED National Representative responses to general breast unit questions.

Section 4: Implementation stage of mandatory requirements for breast units

The mandatory requirements defined in the 2006 European Guidelines, include:

• A definition of the volume (critical mass) of cases necessary in order to set up breast units: ‘A Unit must be of sufficient size to have more than 150, newly diagnosed cases of primary breast cancer (at all ages and stages) coming under its care each year’.

• A definition of the composition of the core team working in the breast unit which should have ‘special training in breast cancer’; it includes a Clinical Director of Breast services, breast surgeons, breast radiologists, breast pathologists, breast oncologists, breast diagnostic radiographers, data managers, and patient support staff (such as breast care nurses). This core team was expected to also have a minimum experience (minimum surgeries performed, mammograms read per year, etc.).

• Each member of the core team must have special training in breast cancer, and

• each member of the breast unit core team must undertake continuing professional education (CME) on a regular basis.

Figure 4 shows the implementation status of these four mandatory requirements according to ECIBC National Contacts.

The responses from ED representatives are shown in Figure 5.

For each of the four mandatory requirements, detailed descriptions and maps are provided in the following sections.

Figure 4. Implementation of mandatory requirements according to ECIBC National Contacts.

Figure 5. Implementation of mandatory requirements according to ED National Representatives.

Volume requirement (150 newly diagnosed cases/year)

ECIBC National Contacts

Only CZ and IT reported this requirement as compulsory by law since 2010 and 2014, respectively. In CZ, this requirement has also been in use since 2002 at national and regional level as the basis for level of insurance reimbursement for breast care interventions, and as an institutional licencing requirement since 2003. This requirement has also been part of a non-public quality assurance scheme since 2010¹⁹ (Figure 6; only those countries were the volume requirement was implemented exactly at the 150 threshold are coloured). In BG, CY, IE, LT, LU, SE, SI, and SK, ECIBC National Contacts said the volume requirement was voluntary. The remaining countries reported that no volume requirement had been implemented to date.

Some countries have several implementation frameworks. In these cases, only one of the options is coloured, but further explanation is found in the text and in Annex III.

Figure 6. Implementation of mandatory volume requirement of 150 new cases/year according to ECIBC National Contacts.

ED National Representatives

Representatives from EE, IE, IT, MT, and SI reported the volume requirement was set at 150 new cases/year. No other information was provided.

A detailed overview of how the volume requirement has been implemented/not implemented and the use of other thresholds (e.g. 125 in BE and CH, 100 in AT, DE and NO) is provided in Annex III.

The map in Figure 7 summarises the responses of ECIBC National Contacts and ED National Representatives regarding the implementation of a volume requirement (thresholds differing from 150 are reported on the map). Minor discrepancies (i.e. the ECIBC National Contact reported that the requirement was voluntary and the ED National Representative replied that the requirement was not in place, or the ECIBC National Contact replied that implementation was planned and ED National Representative stated that the requirement was already in place) between respondents from same country were also highlighted.

Despite whether countries have implemented the volume requirement or not, Figure 8 shows that the majority of breast cancers in Europe are treated in centres whose volume is greater than 150 new cases/year. It should be noted that the 150 new cases/year minimum volume requirement was implemented in IT by law in 2014. Therefore, it would be interesting to see if in the future this leads to changes in the number of breast cancer cases treated per centre.²⁰ Detailed responses from all respondents are reported in Annex III.

The numbers on the map represent alternative volumes reported by respondents.

Figure 7. Implementation of volume requirement according to ECIBC National Contacts and ED National Representatives.

Core team requirement

ECIBC National Contacts

Twelve countries have implemented the requirement that regulates the composition of the core team: eight countries (BE, BG, CZ, DE, FI, IT, LT, and UK) have made it compulsory and four (CY, IE, LU, and SE) have implemented the requirement on a voluntary basis. ECIBC National Contacts from NO and SI stated that although the requirement had not been implemented, there were plans to do. It may also be worth mentioning that the ECIBC National Contact from RS reported that, while the requirement is not yet in place (but planned to be implemented), breast cancer treatment decisions are currently made by a breast cancer board, which is composed of a surgeon, radiologist, radiation oncologist, and chemotherapist, among others.

The ‘Most/all < 150’ category in the legend is the sum of two replies’ categories: (1) even though centres whose volume is higher than 150 new cases/year exist, most cases are treated in low-volume centres, and (2) virtually all primary breast cancer cases are treated in a centre whose volume is lower than 150 new cases/year.

Figure 8. Distribution of primary breast cancer cases in breast centres according to ECIBC National Contacts.

‘Minor discrepancy’ refers either to the fact that the ECIBC National Contact replied it was voluntary and the ED National Representative replied it was not in place, or that the ECIBC National Contact replied that implementation was planned and ED National Representative replied that the requirement was already in place.

Figure 9. Implementation of core team requirement: responses from ECIBC National Contacts and ED National Representatives.

ED National Representatives

In contrast to their ECIBC National Contact counterparts, ED National Representatives from AT, EE, and FR reported that the core team requirement was in place in their countries as well.

The status of implementation of the core team requirement is presented in Figure 9.

Some countries have several implementation frameworks; in these cases only one of the options is coloured, but further explanation is found in text and in Annex III.

Figure 10. Implementation framework of core team composition requirement according to ECIBC National Contacts.

In addition to the question regarding the core team requirement, ECIBC National Contacts were also asked about the implementation framework involved. Responses regarding the implementation framework of the core team requirement are presented in Figure 10.

Comparing Figures 9 and 10, it is evident that for BE, CZ, IT, and RS the core team requirement has been embedded in national/regional legislation since 2007, 2002, 2015 and 1980, respectively; however, not yet implemented but planned.

‘Minor discrepancy’ refers either to the fact that the ECIBC National Contact replied it was voluntary and the ED National Representative replied it was not in place, or that the ECIBC National Contact replied that implementation was planned and the ED National Representative replied that the requirement was already in place. ‘Serious discrepancy’ refers to an answer where the ECIBC National Contact replied that the requirement was implemented in a mandatory way and the ED National Representative replied that it was not in place.

Figure 11. Implementation of core team training requirement: responses from ECIBC National Contacts and ED National Representatives.

Core team training

ECIBC National Contacts

According to ECIBC National Contacts, a requirement regulating the training standards of the core team exists in 13 countries: compulsory in eight countries (BE, BG, CZ, DE, IT, LT, RS, and UK) and on a voluntary basis in five countries (CY, FI, IE, LU, and NO).

Some countries have several implementation frameworks. In these cases, only one of the options is coloured and further details are provided in the report and in Annex III.

Figure 12. Implementation framework of core team training requirement according to ECIBC National Contacts.

ED National Representatives

Representatives from AT, EE, FR, NL, and SI indicated that this requirement was in place in their countries as well. The status of implementation of the core team training requirement, it is presented in Figure 11. See Annex III for individual responses. With regard to the implementation framework, the ECIBC National Contacts had an additional question concerning this topic. This requirement is embedded in national/regional legislation in BE (since 2007), BG (since 1987), CZ (since 2010), IT (since 2014), LU (since 2003) and RS. It is used as a reference for insurance reimbursement at national/regional level in BG (since 2005), CZ (since 2002), and in LT, and it is used as an institutional licencing requirement at national/regional level in CZ (since 2002), in DE (since 2003), in FI, RS, and in the UK (since 2000). A summary of the responses is presented in Figure 12 and individual responses are reported in Annex III; it is however worth highlighting that the ECIBC National Contact reported on IT that the core team training requirement is embedded in legislation and mandatory, whilst the ED National Representative reported that this requirements is not implemented at all.

Continuing medical education

ECIBC National Contacts

The regulation regarding continuing medical education of the core team has been implemented in 12 countries; although, it is compulsory in only nine (CZ, DE, HU, IE, IT, PL, RO, RS, and UK).

ED National Representatives

According to ED National Representatives in AT, EE, FR, NL, and SI, the CME requirement has been implemented in their countries as well.

CME is present in most countries. However, only a few countries reported that it is formally or specifically regulated for the core team. This is perhaps one of the questions where it may not have been completely clear that the implementation of the CME requirement referred only to the core team. Therefore, some countries may have replied ‘NO’ with the understanding that there is no specific CME requirement for the core team; while some replied ‘YES’ with the clarification that it is not specific for the core team. The status of implementation of the CME requirement is presented in Figure 13. Individual responses are available in Annex III.

‘Minor discrepancy’ refers either to the fact that the ECIBC National Contact replied it was voluntary and the ED National Representative replied it was not in place, or that the ECIBC National Contact replied that implementation was planned and the ED National Representative replied that the requirement was already in place. ‘Serious discrepancy’ refers to an answer where the ECIBC National Contact replied that the requirement was implemented in a mandatory way and the ED National Representative replied that it was not in place.

Figure 13. Implementation of CME requirement: responses from ECIBC National Contacts and ED National Representatives.

The ECIBC National Contacts had an additional question regarding the implementation of CME. The CME requirement is part of national/regional legislation in BG (since 2000, although it is voluntary), CZ (since 2010), DE, HU (since 2005), IE, IT, PL (since 1997), RO (since 1995), and RS, and it is used as an institutional licencing requirement at national and regional level in IT (in addition to legislation) and UK (since 1995). Responses are summarised and presented in Figure 14.

Some countries have several implementation frameworks. In these cases, only one of the options is coloured and further details are provided in the report and in Annex III.

Figure 14. Implementation framework of CME requirement according to ECIBC National Contacts.

Individual responses are reported in Annex III.

Overview of the four mandatory requirements

Although there is some discrepancy in responses provided by ED National Representatives compared to ECIBC National Contacts regarding the status of implementation of the four mandatory requirements of the 2006 breast unit model, approximately one-third of countries reported implementation of the volume requirement, while the remaining three mandatory requirements, are reported to have been implemented in approximately half of the countries that responded (see Figures 4 and 5).

In order to provide an overview of the agreement between the responses from the ECIBC National Contact and the ED National Representative for the four mandatory requirements, responses received for a specific question by both types of participants for the same country were analysed (Figure 15).

Figure 15. Agreements (on YES or on NO replies) and discrepancies between responses from ECIBC National Contacts and ED National Representatives regarding the implementation of mandatory breast unit requirements.

The highest degree of disagreement between ECIBC National Contacts and ED National Representatives responses was for the question regarding the training requirement. In six out of 11 countries for which both ECIBC and ED participants responded (CY, FR, IT, LU, NO, and SI), discordant responses were provided. In four cases, the ECIBC National Contact reported that the requirement was present while the ED National Representative reported that it was not. Figures 16 and 17 present the implementation status of the four mandatory requirements of the 2006 breast unit model across Europe.

According to the responses received, the volume requirement is the least implemented of the four mandatory requirements across Europe. In fact, only two of 25 responding countries reported that implementation was compulsory (Figure 4).

Figure 16. Implementation of mandatory requirements: responses from ECIBC National Contacts.

Furthermore, due to the fact that this particular requirement showed the least amount of disagreement between ECIBC National Contacts and ED National Representatives (Figure 15), the result can be considered as an accurate reflection of the current status of implementation.

These results show that further enquiry is needed in order to consider possible inclusion of the volume requirement in the future European QA scheme. Indeed within the ECIBC, the JRC has examined the evidence regarding the definition of a minimum threshold requirement for breast cancer services and has found that, although women in need of diagnosis, cancer treatment or other breast services are recommended to be referred to high-volume hospitals, due to the diversity of studied thresholds, the cut-off values should be defined in accordance with local organisation and available resources [4].

Figure 17. Implementation of mandatory requirements: responses from ED National Representatives.

The implementation of the other three mandatory requirements of 2006 breast unit model (team composition, training and CME) was more balanced–with approximately half of the countries implementing them while the other half do not (Figures 4 and 5) and, in most cases, when they are implemented, they are compulsory. As regards training, the ECIBC is planning a prioritisation of core team competences and training requirements. In parallel, and in relation to screening programmes, the ECIBC includes the development of a harmonised training template for screening radiologists and radiographers. Given the population-based nature of the initiative, this was considered the most urgent action needed to ensure an essential level of competence that is compatible with both local and national legislation.

Section 5: Implementation stage of other requirements for breast units

The definitions used in this section and throughout the entire survey are in line with those used in the 2006 European Guidelines. These definitions were included in both versions of the questionnaire (Annex I).

In order to facilitate understanding of the overall status of implementation, the other requirements included in the 2006 breast unit model have been grouped by areas or topics and correspond to the relevant chapter in the 2006 European Guidelines. Results are summarised in the following figures and detailed responses listed by country are available in Annex III.

Three figures characterise each topic:

i. the first figure presents answers provided by the ECIBC National Contact (number of responses are directly reported on the bars and pie-charts of the figures);

ii. the second figure presents answers provided by the ED National Representative (number of responses are directly reported on the bars and pie-charts of the figures); and

iii. the last figure presents the amount of agreement and discordance (expressed as a percentage) between the ECIBC National Contacts and the ED National Representatives in response to the same question.

It should be noted that contradictory responses within one country, are often a case of the ECIBC National Contact indicating that a particular requirement has been implemented on a voluntary basis while their ED counterpart reported that the requirement was not in place. This contradiction may be due to the fact that voluntary implementation may mean that the requirement is not fulfilled in every breast unit and the perception from patient advocates maybe related to this partial implementation. This type of disagreement is considered minor; therefore, all requirements presented in Section 5 are not described on a country-by-country basis. In addition to a short possible interpretation of disagreement for the screening requirement, only serious disagreements are presented in this section. For more details, see participant response tables included in Annex III.

Equipment and facilities

• Equipment–imaging equipment (9.6.1); radiotherapy equipment (9.6.2).

• Facilities–new patient clinic establishment (9.7.1).

Figure 18. Implementation of requirements related to equipment and facilities: responses from ECIBC National Contacts.

Figure 19. Implementation of requirements related to equipment and facilities: responses from ED National Representatives.

Figure 20. Agreements (on YES or on NO replies) and discrepancies between responses from ECIBC National Contacts and ED National Representatives regarding the implementation of requirements related to equipment and facilities.

Breast screening

• Breast cancer screening management (9.7.11).

Figure 21. Implementation of the management of breast screening requirement: responses from ECIBC National Contacts.

Figure 22. Implementation of the management of breast screening requirement: responses from ED National Representatives.

Figure 23. Agreements (on YES or on NO replies) and discrepancies between responses from ECIBC National Contacts and ED National Representatives regarding the implementation of the management of breast screening requirement.

Regarding this requirement, part of the discrepancies could be the result of a misunderstanding of terminology, as the term ‘screening’ could have been understood to mean population-based screening by some and opportunistic screening by others.

Services (usually provided within the breast unit)

• Multidisciplinary case management Meetings (MDM) (9.7.3).

• Provision of appropriate adjuvant therapies (9.7.5).

• Management of advanced and recurrent breast cancer (9.7.6).

• Follow-up of primary breast cancer (9.7.7).

Figure 24. Implementation of requirements related to services usually provided within a breast unit: responses from ECIBC National Contacts.

Other services (usually provided outside breast units but they are closely connected to breast units)

• Provision of extra psychological support (9.8.1).

• Palliative care (9.8.4).

• Physiotherapy provision for post-operative recovery (9.7.4) together with Physiotherapy for treatment of lymphoedema (9.8.6).

• Plastic surgeon availability (9.8.2).

• Prosthesis (9.8.5).

• Management of benign disease (9.7.8).

Figure 25. Implementation of requirements related to services usually provided within a breast unit: responses from ED National Representatives.

Figure 26. Agreements (on YES or on NO replies) and discrepancies between responses from ECIBC National Contacts and ED National Representatives regarding the implementation of requirements related to services usually provided within a breast unit.

Figure 27. Implementation of requirements related to services usually provided outside a breast unit: responses from ECIBC National Contacts.

Figure 28. Implementation of requirements related to services usually provided outside a breast unit: responses from ED National Representatives.

Figure 29. Agreements (on YES or on NO replies) and discrepancies between responses from ECIBC National Contacts and ED National Representatives regarding the implementation of requirements related to services usually provided outside a breast unit.

With regard to the palliative care requirement, in addition to the usual minor discrepancies (the ECIBC National Contact reporting that a requirement is implemented in a voluntary manner and the ED National Representative reporting that that requirement is not in place), a serious discrepancy was detected for LU and NO, where ECIBC National Contacts reported that the requirement was compulsory, while the ED National Representative reported that it was not in place. These two discrepancies may be of great concern as despite it being a mandatory requirement, patients may not be benefitting from specialist palliative care service ‘for the referral of patients with advanced breast cancer’ and to ‘ensure that breakdowns in continuity of care do not occur’ (2006 European Guidelines).

Communication/advice

• Communication of diagnosis and treatment plan (9.7.2).

• Patient information (9.7.11).

• Family history/genetics (9.7.9).

• Geneticist-genetic risk communication (9.8.3).

Figure 30. Implementation of requirements related to communication and advice: responses from ECIBC National Contacts.

Figure 31. Implementation of requirements related to communication and advice: responses from ED National Representatives.

Figure 32. Agreements (on YES or on NO replies) and discrepancies between responses from ECIBC National Contacts and ED National Representatives regarding the implementation of requirements related to communication and advice.

Research and teaching (these are always linked together in hospitals and breast units)

• Research carried out (9.9).

• Provision of teaching for staff or students (9.10).

Figure 33: Implementation of research and teaching requirements: responses from ECIBC National Contacts.

Figure 34. Implementation of research and teaching requirements: responses from ED National Representatives.

Figure 35. Agreements (on YES or on NO replies) and discrepancies between responses from ECIBC National Contacts and ED National Representatives regarding the implementation of research and teaching requirements.

Overview of inconsistencies

Figure 36. Voluntary implementation of requirements according to ECIBC National Contacts vs implementation according to ED National Representatives.

5. Overview and discussion

Due to the complexity of the 2006 breast unit model, two simplifications were introduced in order to get a clearer picture of the overall implementation status of the model across Europe:

a. all the requirements of the 2006 breast unit model, in accordance with the 2006 European Guidelines, were considered as equally relevant (whether they were in the group of mandatory requirements or not); and

b. voluntary and mandatory implementation were considered as equivalent (which realistically may not be the case, at least in terms of population impact).

Figures 37 to 44 show the extent of implementation of the complete set of 25 requirements from the ECIBC National Contacts and ED National Representatives points’ of view.

There was quite a bit of variation across Europe with regard to the number of requirements implemented–from no requirements implemented in CH, FR, LV, and MT to the complete implementation of all 25 requirements in BG, CY, and CZ. FR indicated that the organisation of screening and diagnostics was distinct from the organisation of treatment. Therefore, it was not possible for French respondents to answer the questions as they were presented. The distribution of the number of requirements implemented on a compulsory basis is presented in Figure 38.

Based on the overall responses, it appears that DE, LT, and IT are the countries in which the greatest number of requirements (23, 21 and 19, respectively) have been implemented in a compulsory way, while none of the requirements are compulsory in GR, LV, MT, and SE.²¹

Figure 37. Overall implementation of the 25 breast unit requirements (voluntary or compulsory) across European countries according to ECIBC National Contacts.

According to the ED National Representatives, the majority of the requirements have been implemented in UK, IT, and EE and none of the requirements are implemented in ES or GR. The CH representative indicated that they did not have information in order answer all of the questions related to implementation of the 25 breast unit requirements within their country. CZ did not provide answers to these questions as they had replied ‘NO’ to all of the general questions related to breast units in Section 4 of the survey and thus, per the survey’s instructions, they did not complete Sections 5 and 6.

Figure 38. Number of breast unit requirements implemented on a compulsory basis across Europe according to ECIBC National Contacts.

Figure 39. Number of breast unit requirements implemented across Europe according to ED National Representatives.

Figure 40 presents the requirements that are implemented most frequently (compulsory or voluntary) across Europe.

The two most implemented requirements across all countries are the multidisciplinary case management (MDM) meetings and the provision of appropriate adjuvant therapy, present in 19 out of 25 countries (76%). Indeed, within the ECIBC, the JRC has examined the evidence regarding improvements in health outcomes for women whose breast cancer case has been discussed in a multi-disciplinary meeting [2]. The results from this review show that, although there is very low certainty in the evidence that ‘on-site’ multidisciplinary meetings (MDM) compared to non-MDM reduces 5-year mortality from breast cancer and breast-cancer specific survival, women assessed in MDM are more likely to be treated with standard best practices–thereby increasing equity of care. However, there is also uncertainty about the magnitude of the resources required and cost-effectiveness.

Figure 40. Most implemented breast unit requirements across Europe according to ECIBC National Contacts.

After MDM meetings and the provision of adjuvant therapy, the provision of extra psychological support, physiotherapy for treatment of lymphoedema, radiotherapy equipment, management of benign disease, training requirement for core team, communication of diagnosis and prosthesis were implemented in more than half of the reporting countries (Figure 41). Within this group of requirements, the training for core team requirement had been implemented in only 13 countries, although it is considered to be a mandatory requirement for breast units according to the 2006 European Guidelines.

Figure 41. Breast unit requirements implemented (compulsory or voluntary) in approximately half of the countries according to ECIBC National Contacts.

In contrast, the five requirements least frequently implemented were: management of advanced and recurrent BC, core team, continuing medical education, new patient clinics, and the volume requirement (Figure 42).

Figure 42. The least implemented breast unit requirements (compulsory or voluntary) across Europe according to ECIBC National Contacts.

It is interesting that three of the least implemented requirements (i.e. the volume requirement, the core team requirement and the CME requirement) are those that were considered mandatory for breast units in the 2006 European Guidelines.

Figure 43. Number of countries each of the breast unit requirements on a compulsory basis according to ECIBC National Contacts.

The lower implementation of these requirements could possibly be related to organisational, economic, and legislative factors. For example, in the case of the volume requirement, the infrastructure of breast cancer services varies greatly across Europe;²² while in the case of CME, many countries have general legislation for professionals but do not have a specific CME for the members of the core team. Compulsory implementation of the 25 breast unit requirements according to ECIBC National Contacts is presented in Figure 43.

Provision of adjuvant therapies and imaging equipment present in breast units are the requirements that are compulsory in approximately half of the participating countries, closely followed by the requirement concerning the multidisciplinary case management meetings and the requirement regarding radiotherapy equipment. Apparently, these four requirements are seen as most beneficial from the healthcare perspective as they are believed to impact health outcomes; thereby, assuring the proper provision of imaging equipment, multidisciplinary discussion of cases for diagnostic purposes and the provision of adequate therapies (e.g. adjuvant therapies); unlike the volume requirement which is compulsory in only two countries. However, due to the design of the ED National Representatives questionnaire, it is not possible, to know how many countries have implemented the requirements on a compulsory or voluntary basis. Figure 44 presents the status of implementation from an ED perspective.

Figure 44. Number of countries across Europe implementing breast unit requirements, compulsory or voluntary, according to ED National Representatives.

As with their ECIBC counterparts, ED National Representatives also reported that the requirement implemented less frequently is the one related to volume. Five out of 18 countries replied that the volume requirement was implemented (EE, IE, IT, MT, and SI) compared to the ECIBC National Contacts who reported implementation in SI and IE, planned implementation in MT and no response from the EE National Contact.

Provision of adjuvant therapies, the requirement concerning the radiotherapeutic and imaging equipment present in breast units, and the multidisciplinary case management meetings are among the requirements that are most frequently implemented across countries. This finding mirrored the responses provided by ECIBC National Contacts.

6. Conclusions

General considerations

Even though the results of this survey do not cover all of the invited countries, taking into account the two stakeholder’s responses (74% of ECIBC National Contacts and 58% of ED National Representatives), information was collected for 30 out of 34 countries (88% coverage)–the only countries not represented being DK, HR, IS, and ME. Furthermore, considering that the great majority of discrepancies between the two sets of responses were of minor importance, the overall response rate can be considered satisfactory and paints a reliable picture of the current European situation in terms of implementation.

The JRC considers the collected information as essential with respect to (a) how the 25 breast unit requirements (defined in the 2006 European Guidelines) have been implemented over the last ten years, and (b) how differences in knowledge between those responsible for the implementation of these requirements (e.g. Ministries of Health) and patient advocates can be improved to ensure that all those involved in the provision of quality healthcare are fully aware of which requirements are in place and which requirements are in need of implementation. Indeed, it would be particularly valuable for countries to focus on those requirements where the responses of the ECIBC National Contact indicated that the requirement was compulsory and the ED National Representative said that the requirement was not in place. This would be the case for the core team training and CME requirements in IT, the establishment of new patient clinics in CY, the management of advanced and recurrent breast cancer in SI, and the provision of palliative care in LU and NO.

Summary of results

Based on the responses provided, the results can be summarised as follows. Although only a few countries require breast units by law, 17 out of 30 responding countries reported that they are recommended.

• Compulsory implementation of the four mandatory requirements has only occurred in two countries (IT and CZ).

• In addition to the recommended threshold for the volume requirement, other thresholds ranging from 100 to 125 new cases per year have been reported in six countries (AT, BE, CH, DE, NO and UK).

• Countries that have implemented the majority of the requirements on a compulsory basis are: DE (23/25 requirements), LT (21/25 requirements) and IT (19/25 requirements).

• The most frequently implemented requirements, on a compulsory basis, include the provision of adjuvant therapy (13 countries), the provision of imaging equipment (13 countries), the multidisciplinary case management meetings (11 countries) and the provision of radiotherapy (11 countries).

• The least implemented requirement, on a compulsory basis, is the volume requirement (two countries)–which is considered by the 2006 European Guidelines as a mandatory requirement for a breast unit.

• Management of benign disease, the provision of extra psychological support and genetic risk communication are three requirements which are implemented on a compulsory basis in only five countries.

• The greatest discrepancies in responses between ECIBC National Contacts and ED National Representatives are with regard to the requirements concerning communication of diagnosis, patient information, physiotherapy for treatment of lymphoedema and the provision of extra psychological support. For these requirements, there was disagreement in 45% of the countries where both the ECIBC National Contact and the ED National Representative provided a response.

• The greatest concordance, on the other hand, was in the requirement for provision of teaching for staff or students; disagreement was recorded in only one out of eight countries where both the ECIBC National Contact and the ED National Representative provided a response.

From these results it can be concluded that adoption of the 2006 breast unit model appears to be somewhat of a challenge. On the one hand, it is very well known by both policy makers/professionals and patient advocates; however, as this report clearly shows, implementation of that model is not harmonised across all countries, and there is a great deal of diversity in the number and which of the 25 requirements are implemented.

Impact of the results– The European QA scheme perspective

A Europe-wide scheme, like the European QA scheme being developed under the auspices of the ECIBC, will need to take into account all existing schemes and models, certainly also the 2006 breast unit model. Developers of the European QA scheme should carefully examine the results of this report.

Looking at the scattered implementation of the 2006 breast unit model, and considering that the European QA scheme will be voluntary, it will be critical to ensure a consistent implementation across countries. For this reason it was decided (i) to work in close collaboration with countries in order to determine which models would be feasible for all countries involved in the ECIBC [3] and how they can be implemented; (ii) to embed the European QA scheme in the accreditation legal framework providing an existing European infrastructure–the National Accreditation Bodies–which will oversee the accreditation and certification process and ensure harmonised assessment of adherence of breast cancer services to the European QA scheme requirements; and (iii) to involve patients, experts, and all other stakeholders in all stages of the scheme’s development and implementation processes.

The results of this survey related to low implementation of some 2006 breast unit model mandatory requirements vis-à-vis higher implementation of other requirements not only triggered some targeted systematic reviews, e.g. about volumes impact on outcomes, but confirmed the need to substantiate with evidence, whenever possible and appropriate, the requirements to be included in the European QA scheme. For this reason, ECIBC incorporates guidelines (the evidence) and the QA scheme in the same initiative. Having a systematic methodology of evidence use to underpin the scheme, on one side ensures that any potential impact of quality requirements on outcomes is credible, reliable and valid and, from another perspective, that any quest to policy makers towards an increased adherence to the scheme is supported by data showing an improvement of outcomes.

The 2006 breast units unit model originated some collection of breast cancer care data that helped in obtaining new evidence; the European QA scheme wishes to start from that good example and therefore foresees a systematic collection of data related to its requirements. This will not only be an additional tool, beside the on-site audits, for assessing breast cancer services compliance to the requirements, but also a way to produce new evidence.

Impact of the results–The policy makers’ perspective

The 2006 breast unit model was, and still is, an innovative model for providing appropriate care to women. The model was translated in a set of recommendations, but without a country mandate. Therefore, the diversity about the model’s implementation status found in this survey should not be surprising.

Assuming that the most frequently implemented requirements were those considered the most feasible in relation to best practices and relevant for outcomes, the results can guide countries in prioritising implementation. Policy makers willing to implement the 2006 breast unit model (and possibly adhere to the European QA scheme in the future) may also wish to look at the evidence that is being produced within the ECIBC that will underpin the European QA scheme, to see which of the 2006 breast units model requirements would be in line with the future European QA scheme requirements and take this information under consideration when prioritising implementation of an appropriate set of breast unit model requirements. However, evidence may be weak or non-existent–making the choice on how to adopt some or all of 2006 breast unit requirements in national and local settings somewhat difficult.

Results can also be used by policy makers to see what other countries with similar organisational settings, population distribution, and level of investment in healthcare, prioritised for implementation and how the 2006 breast unit model requirements were actually implemented.

Acknowledgments

We would like to thank the co-organisers and 10th European Breast Cancer Conference (EBCC 10) chairs, Fatima Cardoso and Susan Knox on behalf of Europa Donna for their input and support in the development and launch of the survey, and in providing the list of contacts. We are indebted to Carmen Martos (JRC) for having revised the manuscript at internal level and to Manuel Florensa-Molist (JRC) for his editorial support. Most of all, we would like to express our gratitude to all who responded to the survey and for the extremely valuable information they provided.

Bibliography

[1] Perry N, Broeders M, de Wolf C, Törnberg S, Holland R, von Karsa L, editors. European guidelines for quality assurance in breast cancer screening and diagnosis. 4th ed. Luxembourg: European Commission, Office for Official Publications of the European Communities, 2006.

[2] Deandrea S, Bramesfeld A, Ambrosio M, Bocchi G, Dimitrova N, Lerda D, et al. Efficacy of multidisciplinary meetings on breast cancer outcomes: a systematic review and pooled analysis. ECIBC, Quality Assurance Scheme Development Group, and Iberoamerican Cochrane Centre contributed. 36th European Society of Surgical Oncology (ESSO) Conference, Krakow, 14-16 September 2016.

[3] Lerda D, Deandrea S, Freeman C, López-Alcalde J, Neamţiu L, Nicholl C, et al. Report of a European survey on the organisation of breast cancer care services. Ispra: European Commission, Joint Research Centre, 2014.

[4] Pylkkänen L, Deandrea S, Bramesfeld A, Neamţiu L, Saz Parkinson Z, Ulutürk A, et al. Can an annual minimum caseload for breast cancer services be determined? 2016 UICC World Cancer Congress, Paris, 31 October-3 November 2016.

[5] Von Karsa L, Anttila A, Ronco G. Cancer Screening in the European Union. Report on the implementation of the council recommendation on cancer screening. First report. Luxembourg: European Commission, Office for Official Publications of the European Communities, 2008.

[6] Wilson AR, Marotti L, Bianchi S, Biganzoli L, Claassen S, Decker T, et al. The requirements of a specialist breast centre. Eur J Cancer, 2013;49(17):3579-3587.

Annex Ia

ECIBC National Contact questionnaire

Annex Ib

ED National Representative questionnaire

Annex II

Communications

Interim (reminders) and individual communications are not included.

1.1. Initial invitation to participate e-mail (ECIBC National Contact)

Sent: 21 January 2015 13:59

Dear Madam, dear Sir, dear ECIBC National contacts,

We are planning to run a survey to follow-up the European Parliament resolution of 2006 on breast cancer in the enlarged European Union. It called on ‘Member States to ensure nationwide provision of interdisciplinary breast units in accordance with the EU guidelines by 2016, since treatment in an interdisciplinary breast unit has been proved to raise chances of survival and to improve the quality of life, and calls on the Commission to deliver a progress report on this every two years’.

The European Commission (EC) keeps a neutral position on how care is organised at Member States, and therefore does not in particular support Breast Units or any other form of organisation of breast cancer services. However, the EC wishes to fulfil the call of the European Parliament to provide a progress report to be available by beginning 2016, in correspondence with the deadline reported in the resolution. In this respect, we would need to map-out the situation in the European Countries, taking into account:

• the results of the previous survey which JRC ran with the support of EPAAC National Contacts (see the report at the link http://bookshop.europa.eu/en/report-of-a-european-survey-on-the-organisation-of-breast-cancer-care-services-pbLBNA26593/) and

• the fact that, even if the concept of Breast Units greatly evolved since 2006, the call of the European Parliament clearly refers to definitions given in the EU guidelines (their last edition is in fact dated back to 2006).

As for other previous and future information needs, for an accurate, factual and complete mapping, we would be grateful if we can count on your support and collaboration as experts in the area and as National Contact nominated for the European Commission Initiative for Breast Cancer (ECIBC).

This survey will be run in parallel with two stakeholders’ profiles:

1. Members States’ Health Authorities (via you as nominated ECIBC National Contact) to ensure that EC has the official information, and

2. Europa Donna National Representations so to take into account patients’ feed-back on the state of art of Breast Units in the respective countries.

The survey is organised in collaboration with Dr Fatima Cardoso, chair of the 2016 European Breast Cancer Conference–EBCC 10, and results will be presented in a dedicated session (European Breast Centres 2016–Impact in Mortality and Quality of Life) planned for 9 March 2016. Participating countries (YOU!) and Europa Donna will have the opportunity to present their results both orally and with posters.

You will also be involved as collaborating author in the publication of the EC report and possible other publications related to this survey.

We are convinced that, together with scientific evidence, reliable maps of what is in place are precious tools to support policies. Therefore, we would be grateful if you could confirm within 13 February 2015 your willingness to participate in this important survey project.

In order to facilitate your preparation to the survey, we will approach you again in few weeks with a time schedule and more details on the survey design and content. Please note that next communications will be sent via the mailbox jrc-cancer-policy-support@ec.europa.eu and we kindly ask you to ensure that this email address would not be classified as junk email.

Looking forward to receiving your feed-back, we would also like to anticipate our thankfulness for your participation.

Best regards,

Donata LERDA & the Healthcare Quality Team

European Commission

DG Joint Research Centre (JRC)

Institute for Health and Consumer Protection

Public Health Policy Support Unit–Healthcare Quality Team

Via E. Fermi 2749

I-21027 Ispra (VA)/Italy

Phone: +39 0332 786201

Fax: +39 0332 783858

donata.lerda@ec.europa.eu

jrc-cancer-policy-support@ec.europa.eu

and

Fatima Cardoso, MD

EBCC 10 Chair

Director Breast Unit, Champalimaud Clinical Center

Av. De Brasília s/n, 1400-038 Lisbon, Portugal

1.2. Initial invitation to participate e-mail (ED National Representative)

Sent: 21 January 2015 14:01

Dear Europa Donna National representatives,

We are planning to run a survey to follow-up the European Parliament resolution of 2006 on breast cancer in the enlarged European Union. It called on ‘Member States to ensure nationwide provision of interdisciplinary breast units in accordance with the EU guidelines by 2016, since treatment in an interdisciplinary breast unit has been proved to raise chances of survival and to improve the quality of life, and calls on the Commission to deliver a progress report on this every two years’.

The European Commission (EC) keeps a neutral position on how care is organised at Member States, and therefore does not in particular support Breast Units or any other form of organisation of breast cancer services: However, the EC wishes to fulfil the call of the European Parliament to provide a progress report to be available by beginning 2016, in correspondence with the deadline reported in the resolution. In this respect, we would need to map-out the situation in the European Countries, taking into account:

• the results of the previous survey which JRC ran with the support of EPAAC National Contacts (see the report at the link http://bookshop.europa.eu/en/report-of-a-european-survey-on-the-organisation-of-breast-cancer-care-services-pbLBNA26593/) and

• the fact that, even if the concept of Breast Units greatly evolved since 2006, the call of the European Parliament clearly refers to definitions given in the EU guidelines (their last edition is in fact dated back to 2006).

In order to ensure that the factual mapping provided by the National Contact nominated for the European Commission Initiative for Breast Cancer (ECIBC) is complemented by the point of view of those needing the service, we would like to ask you to complete a survey.

This survey will be run in parallel with two stakeholders’ profiles:

1. Members States’ Health Authorities (via the nominated ECIBC National Contacts) to ensure that EC has the official information, and

2. Europa Donna National Representations so to take into account patients’ feed-back on the state of art of Breast Units in the respective countries.

The survey is organised in collaboration with Dr Fatima Cardoso, chair of the 2016 European Breast Cancer Conference–EBCC 10, and results will be presented in a dedicated session (European Breast Centres 2016–Impact in Mortality and Quality of Life) planned for 9 March 2016. Europa Donna (YOU!) and participating countries will have the opportunity to present their results both orally and with posters.

You will also be involved as collaborating author in the publication of the EC report and possible other publications related to this survey.

We are convinced that, together with scientific evidence, reliable maps of what is in place are precious tools to support policies. Therefore, we would be grateful if you could confirm within 13 February 2015 your willingness to participate in this important survey project.

In order to facilitate your preparation to the survey, we will approach you again in few weeks with a time schedule and more details on the survey design and content. Please note that next communications will be sent via the mailbox jrc-cancer-policy-support@ec.europa.eu and we kindly ask you to ensure that this email address would not be classified as junk email.

Looking forward to receiving your feed-back, we would also like to anticipate our thankfulness for your participation.

Best regards,

Donata LERDA & the Healthcare Quality Team

European Commission

DG Joint Research Centre (JRC)

Institute for Health and Consumer Protection

Public Health Policy Support Unit–Healthcare Quality Team

Via E. Fermi 2749

I-21027 Ispra (VA)/Italy

Phone: +39 0332 786201

Fax: +39 0332 783858

donata.lerda@ec.europa.eu

jrc-cancer-policy-support@ec.europa.eu

and

Fatima Cardoso, MD

EBCC 10 Chair

Director Breast Unit, Champalimaud Clinical Center

Av. De Brasília s/n, 1400-038 Lisbon, Portugal

2.1. Follow-up email (ECIBC National Contact)

Sent: 27 February 2015 13:23

Dear ECIBC National Contacts,

As anticipated in the previous email, we are coming back to you with some more details, which we hope will facilitate your participation into the survey on breast units’ implementation in Europe. It is organised by JRC in collaboration with EBCC 10 chair, Fatima Cardoso and Europa Donna. The scope of the survey is to map out the degree of implementation of Breast Units in Europe with reference to the 2006 Resolution of the European Parliament on breast cancer in the enlarged European Union.

The reference document mentioned in the EP resolution is the European Guidelines for Quality Assurance in Breast Cancer Screening and Diagnosis, which last edition is dated 2006 (and herein after mentioned as European Guidelines 2006); you can find the full version of the guidelines at the link: http://bookshop.europa.eu/en/european-guidelines-for-quality-assurance-in-breast-cancer-screening-and-diagnosis-pbND7306954/.

In particular this survey will refer to chapter 9–The requirements of a specialist Breast Unit and, when referred to in chapter 9, to chapter 10–Guidelines for training. As specified in the previous communication, the survey will be run in parallel with two stakeholders’ profiles:

Members States’ Health Authorities and related entities (via the nominated ECIBC National Contacts) to ensure that EC has the official information, and

Europa Donna National Representations so to take into account patients’ feed-back on their awareness of state of art of Breast Units in the respective countries. Europa Donna National Representations will receive a similar questionnaire as for the ECIBC National Contacts, but questions on Breast Units will mostly be non-mandatory.

The questionnaire sections will be:

• CONTACT DETAILS

• REFERENCES AND DEFINITIONS

• THE ORGANISATION OF HEALTHCARE IN YOUR COUNTRY

• THE BREAST UNITS MANDATORY REQUIREMENTS (as listed and defined in the European Guidelines 2006) AND THEIR IMPLEMENTATION STATUS

• THE BREAST UNITS NON-MANDATORY REQUIREMENTS (as listed and defined in the European Guidelines 2006) AND THEIR IMPLEMENTATION STATUS

We are conscious of the effort that will be required in answering the questions. It is possible that it will require the input of several people but JRC as survey organiser needs to clearly identify the person responsible for the information provided in each questionnaire.

For the questionnaire, the PDF form tool will be used. You might not be familiar with it, but you just need to follow the instructions that will be included in the questionnaire. PDF forms make it possible:

To save a partially filled-in copy and send it later to us upon completion | You are responsible for the information provided
To save a partially filled-in copy and send it to other experts to complete it before sending it back to us | You are responsible for the information provided
To distribute the questionnaire to regional/local authorities asking them to send it back to you (in which case you will have to send all the forms back to JRC) | You are responsible for the information provided
To distribute the questionnaire to regional authorities asking them to send it directly back to us | Each respondent will be held responsible for the information provided

As regards the timing, we foresee to send out the questionnaire in the first half of March, in which case the deadline for sending it back will be end of April 2015.

We would highlight again the importance of receiving as many comprehensive responses as possible in order to ensure a complete overview of the situation in European countries (and regions). As we still hope to receive some additional participation, we still keep in the loop also those contacts that did not respond to the first communication. The survey will be sent only to those who explicitly confirmed their participation.

We wish to thank in advance the participants to this survey for the effort they engage in providing the information required.

Best regards,

Donata LERDA and the JRC Healthcare Quality Team

Scientific/Technical Project Officer

European Commission

DG Joint Research Centre (JRC)

Institute for Health and Consumer Protection

Public Health Policy Support Unit–Healthcare Quality Team

Via E. Fermi 2749

I-21027 Ispra (VA)/Italy

Phone: +39 0332 786201

Fax: +39 0332 783858

donata.lerda@ec.europa.eu

http://ihcp.jrc.ec.europa.eu/our_activities/public-health/cancer_policy_support/priority_activities/ECIBC

Fatima Cardoso, MD

EBCC 10 Chair

Director Breast Unit, Champalimaud Clinical Center

Av. De Brasília s/n, 1400-038 Lisbon, Portugal

Susan Knox

Executive Director

Europa Donna–The European Breast Cancer Coalition

Piazza Amendola 3

20149 Milan–Italy

2.2. Follow-up e-mail (ED National Representative)

Sent: 27 February 2015 13:45

Dear Europa Donna National representatives,

As anticipated in the previous email, we are coming back to you with some more details, which we hope will facilitate your participation into the survey on breast units’ implementation in Europe. It is organised by JRC in collaboration with EBCC 10 chair, Fatima Cardoso, and Europa Donna. The scope of the survey is to map out the degree of implementation of Breast Units in Europe with reference to the 2006 Resolution of the European Parliament on breast cancer in the enlarged European Union.

The reference document mentioned in the EP resolution is the European Guidelines for Quality Assurance in Breast Cancer Screening and Diagnosis, which last edition is dated 2006 (and herein after mentioned as European Guidelines 2006); you can find the full version of the guidelines at the link: http://bookshop.europa.eu/en/european-guidelines-for-quality-assurance-in-breast-cancer-screening-and-diagnosis-pbND7306954/.

In particular this survey will refer to chapter 9–The requirements of a specialist Breast Unit and, when referred to in chapter 9, to chapter 10–Guidelines for training.

As specified in the previous communication, the survey will be run in parallel with two stakeholders’ profiles:

1. Members States’ Health Authorities and related entities (via the nominated ECIBC National Contacts) to ensure that EC has the official information, and

2. Europa Donna National Representations so to take into account patients’ feed-back on the state of art of Breast Units in the respective countries.

Europa Donna National Representations will receive a similar questionnaire as for the ECIBC National Contacts, which covers many details you might not be aware of, but there will be no mandatory question (apart from the contact details) and you will always have the ‘non-applicable’ and ‘do not know’ options. Please note that the survey requires, as much as feasible, evidence-based information. In all cases where you should feel that you do not have the information required, just simply click on the option ‘do not know’. This response would be very useful in order to have an overview of the dissemination and information sharing aspects for breast units implementation.

The questionnaire sections will be:

• CONTACT DETAILS

• REFERENCES AND DEFINITIONS

• THE ORGANISATION OF HEALTHCARE IN YOUR COUNTRY

• THE BREAST UNITS MANDATORY REQUIREMENTS (as listed and defined in the European Guidelines 2006) AND THEIR IMPLEMENTATION STATUS

• THE BREAST UNITS NON-MANDATORY REQUIREMENTS (as listed and defined in the European Guidelines 2006) AND THEIR IMPLEMENTATION STATUS

For the questionnaire, the PDF form tool will be used. You might not be familiar with it, but you just need the basic Adobe software and to follow the instructions that will be included in the questionnaire.

As regards the timing, we foresee to send out the questionnaire in the first half of March in which case the deadline for sending it back will be end of April 2015.

We would highlight again the importance of receiving as many comprehensive responses as possible in order to ensure a complete overview of the situation in European countries (and regions). As we still hope to receive some additional participation, we still keep in the loop also those contacts that did not respond to the first communication. The survey will be sent only to those who explicitly confirmed their participation.

We wish to thank in advance the participants to this survey for the effort they engage in providing the information required.

Best regards,

Donata LERDA and the JRC Healthcare Quality Team

Scientific/Technical Project Officer

European Commission

DG Joint Research Centre (JRC)

Institute for Health and Consumer Protection

Public Health Policy Support Unit–Healthcare Quality Team

Via E. Fermi 2749

I-21027 Ispra (VA)/Italy

Phone: +39 0332 786201

Fax: +39 0332 783858

donata.lerda@ec.europa.eu

http://ihcp.jrc.ec.europa.eu/our_activities/public-health/cancer_policy_support/priority_activities/ECIBC

Fatima Cardoso, MD

EBCC 10 Chair

Director Breast Unit, Champalimaud Clinical Center

Av. De Brasília s/n, 1400-038 Lisbon, Portugal

Susan Knox

Executive Director

Europa Donna–The European Breast Cancer Coalition

Piazza Amendola 3

20149 Milan–Italy

3.1. E-mail for sending the PDF form with deadline to fill in questionnaire (ECIBC National Contact)

Sent: 08 April 2015 13:00

Dear Madam, dear Sir, dear ECIBC National Contacts,

We are with this email launching the survey on Breast Units in Europe. We kindly ask you to fill in the attached questionnaire to your best knowledge and submit it by the 22nd of May 2015.

We suggest that you carefully read the instructions before starting. In case you should need support, please do not hesitate to contact the survey helpdesk at this email or at the phone numbers listed in the form.

We wish to thank you in advance for having engaged in this survey and for the time you are going to spend for providing the information required.

Best regards,

Donata

Donata LERDA and the JRC Healthcare Quality Team

Group Leader

European Commission

DG Joint Research Centre (JRC)

Institute for Health and Consumer Protection

Public Health Policy Support Unit–Healthcare Quality Team

Via E. Fermi 2749

I-21027 Ispra (VA)/Italy

Phone: +39 0332 786201

Fax: +39 0332 783858

donata.lerda@ec.europa.eu

https://ec.europa.eu/jrc/en/research-topic/healthcare-quality?search

The call for Researchers at JRC is open! https://ec.europa.eu/jrc/en/working-with-us/jobs/vacancies/function-group-iv-researchers.

AND

Fatima Cardoso, MD

EBCC 10 Chair

Director Breast Unit, Champalimaud Clinical Center

Av. De Brasília s/n, 1400-038 Lisbon, Portugal

AND

Susan Knox

Executive Director

Europa Donna–The European Breast Cancer Coalition

Piazza Amendola 3

20149 Milan–Italy

3.2. E-mail for sending PDF form with deadline to fill in questionnaire (ED National Representative)

Sent: 08 April 2015 12:13

Dear Europa Donna National representatives,

We are with this email launching the survey on Breast Units in Europe. We kindly ask you to fill in the attached questionnaire to your best knowledge and submit it by the 22nd of May 2015.

We suggest that you carefully read the instructions before starting. In case you should need support, please do not hesitate to contact the survey helpdesk at this email or at the phone numbers listed in the form.

We wish to thank you in advance for having engaged in this survey and for the time you are going to spend for providing the information required.

Best regards,

Donata

Donata LERDA and the JRC Healthcare Quality Team

Group Leader

European Commission

DG Joint Research Centre (JRC)

Institute for Health and Consumer Protection

Public Health Policy Support Unit–Healthcare Quality Team

Via E. Fermi 2749

I-21027 Ispra (VA)/Italy

Phone: +39 0332 786201

Fax: +39 0332 783858

donata.lerda@ec.europa.eu

https://ec.europa.eu/jrc/en/research-topic/healthcare-quality?search

The call for Researchers at JRC is open! https://ec.europa.eu/jrc/en/working-with-us/jobs/vacancies/function-group-iv-researchers.

AND

Fatima Cardoso, MD

EBCC 10 Chair

Director Breast Unit, Champalimaud Clinical Center

Av. De Brasília s/n, 1400-038 Lisbon, Portugal

AND

Susan Knox

Executive Director

Europa Donna–The European Breast Cancer Coalition

Piazza Amendola 3

20149 Milan–Italy

4.1. E-mail for final approval of data (ECIBC National Contact)

Sent: 26 August 2016

Dear Mr/Ms ......,

We are coming back to you about last year’s Survey on breast units’ implementation along the 2006 European Guidelines that you so kindly filled in.

That survey was conducted by the JRC in collaboration with Europa Donna and Fatima Cardoso, in her role of EBCC-10 chair, and we are happy to announce that, thanks to your contribution, after a preliminary presentation of the results at the opening session of the EBCC-10 conference, we are ready to issue the report.

Before publishing the report, we wish to come back to you for the final approval of your responses as they will be published in the report. The responses may also be considered for future publications in peer reviewed journals, and in that case we will re-contact you and ask your contribution and endorsement as contributing author.

We may have proposed changes in the effort of harmonising text and language across the respondents, however doing our best for not changing the meaning; when we had doubts, we either highlighted or commented the text. Please have a look to the attached word file and come back to us.

Please be aware that these responses represent, under your responsibility, the situation in your country in a JRC publicly available report (and potentially in future papers), hence we wish to call your attention on the fact that this is not only the last approval step but also the last occasion for you to check that your responses are correct.

For your convenience, in addition to our proposal (doc), we also attach here the original form you submitted (PDF) and, when an interim check of responses occurred, we also attach the relative documentation (email).

Thanking you again for all the data you provided, we kindly ask you to provide the final approval by the 5.09.2016.

Kindest regards,

Donata LERDA and Zuleika SAZ-PARKINSON

Healthcare Quality/ECIBC Team

European Commission

Directorate General Joint Research Centre

Directorate F–Health, Consumers and Reference Materials

Unit F1 ‘Health in Society’

via E. Fermi, 2749, TP127

I-21027 Ispra (VA), Italy

+39 0332 786201

JRC-CANCER-POLICY-SUPPORT@ec.europa.eu

ecibc.jrc.ec.europa.eu

AND

Fatima Cardoso, MD

EBCC 10 Chair

Director Breast Unit, Champalimaud Clinical Center

Av. De Brasília s/n, 1400-038 Lisbon, Portugal

AND

Susan Knox

Executive Director

Europa Donna–The European Breast Cancer Coalition

Piazza Amendola 3

20149 Milan–Italy

4.2. E-mail for final approval of data (ED National Representative)

Sent: 03 August 2016

Dear Mr/Ms ......,

We are coming back to you about the year’s Survey on breast units’ implementation along the 2006 European Guidelines that you so kindly filled in.

That survey was conducted by the JRC in collaboration with Europa Donna and Fatima Cardoso, in her role of EBCC-10 chair, and we are happy to announce that, thanks to your contribution, after a preliminary presentation of the results at the opening session of the EBCC-10 conference, we are ready to issue the report.

Before publishing the report, we wish to come back to you for the final approval of your responses, as they will be published in a JRC publicly available report.

The responses may also be considered for future publications in peer reviewed journals, and in that case we will re-contact you and ask your contribution and endorsement as contributing author.

We attach here the original form you submitted (PDF) and the language-corrected version we propose (doc).

Thanking you again for all the data you provided, we kindly ask you to provide the final approval by the 5.09.2016.

Kindest regards,

Donata LERDA and Zuleika SAZ-PARKINSON

Healthcare Quality/ECIBC Team

European Commission

Directorate General Joint Research Centre

Directorate F–Health, Consumers and Reference Materials

Unit F1 ‘Health in Society’

via E. Fermi, 2749, TP127

I-21027 Ispra (VA), Italy

+39 0332 786201

JRC-CANCER-POLICY-SUPPORT@ec.europa.eu

ecibc.jrc.ec.europa.eu

AND

Fatima Cardoso, MD

EBCC 10 Chair

Director Breast Unit, Champalimaud Clinical Center

Av. De Brasília s/n, 1400-038 Lisbon, Portugal

AND

Susan Knox

Executive Director

Europa Donna–The European Breast Cancer Coalition

Piazza Amendola 3

20149 Milan–Italy

Annex III

Detailed replies from ECIBC National Contacts and ED National Representatives

Original responses were edited by the JRC and approved by the respondents before publication. The original responses will be available upon request.

Countries were coded according to the ISO 3166 standard (reported in Table 1 of the text and available at: https://www.iso.org/obp/ui/#search).

The following tables contain participants’ free-text responses to various survey questions. Individual responses have been only slightly modified to minimise grammatical errors. No details or information have been deleted or altered in any way.

Table 1: Survey Section 2.

The organisation of healthcare in your country

Questions:

i. ECIBC: Geographical responsibility/mandate of your affiliation * National; Regional; Local; Other

ED: Denomination of the country for which you provide the information required in this survey *

ii. ECIBC: Please specify if any change in the geographical organisation/responsibility allocation of healthcare occurred since 2012-2013; please indicate NOT APPLICABLE in case your country was not included in that report * YES; NO, NOT APPLICABLE

If YES or NOT APPLICABLE, please fill in the following fields:

• In your country, healthcare and breast cancer care in particular is organised: Nationally; Regionally; Regionally under National coordination; Locally; Locally under Regional/National coordination; Other (If you choose ‘Other’, please provide a more detailed description)

• In the geographical area under your organisation’s responsibility, healthcare and breast cancer care in particular is provided by: A–Public entities exclusively; B–Public entities mainly; C–Private entities mainly; Other

• If you choose ‘Other’, please provide a more detailed description

• If you choose B, are the public entities also responsible for the initial evaluation and the follow-up quality checks of external services provided by private entities? YES; NO

• If you choose C, Are the private entities supervised by public entities?; Are the private entities initially evaluated by public entities and then followed up for the quality of services provided?; Are the private entities required to be accredited/certified along defined National or European standards?; None of the previous

ED: Please specify if any change in the geographical organisation/responsibility allocation of healthcare occurred since 2012-2013; please indicate NOT APPLICABLE in case your country was not included in that report YES; NO; NOT APPLICABLE

If NO, skip the following two pages and just go to section 4

If YES or NOT APPLICABLE, please fill in the following fields:

• To the best of your knowledge, in your country, healthcare and breast cancer care in particular is organised: Nationally; Regionally; Regionally under National coordination; Locally; Locally under Regional/National coordination; Other; I do not have this information

• If you choose ‘Other’, please provide a more detailed description

• To the best of your knowledge, in your country, healthcare and breast cancer care in particular is provided by: A–Public entities exclusively; B–Public entities mainly; C–Private entities mainly; Other; I do not have this information

• If you choose ‘Other’, please provide a more detailed description

• If you choose B, to the best of your knowledge, are public entities also responsible for the initial evaluation and the follow-up quality checks of external services provided by private entities? YES; NO; I do not have this information

• If you choose C: Are the private entities supervised by public entities?; Are the private entities initially evaluated by public entities and then followed up for the quality of services provided?; Are the private entities required to be accredited/certified along defined National or European standards?; None of the previous; I do not have this information.

Country

1. Geographical mandate of ECIBC National Contact (responder to survey)
2.1. Healthcare organisation change since 2012 -2013
2.2. If response to question 2.1 is yes, then how is healthcare organised?
2.3. Clarification of ‘other’ healthcare organisation
2.4. Healthcare and breast cancer care is provided by
2.5. Clarification of ‘other’ healthcare provider
2.6. If Healthcare provided mainly by public entities, are the same public entities also responsible for the initial evaluation and the follow-up quality checks of external services provided by private entities?

AT
ECIBC National Contacts

ED National Representative
Not asked
NO
Regionally under National coordination

Public entities mainly

YES

BE
ECIBC National Contacts
National
NO

ED National Representative

BG
ECIBC National Contacts

NO

ED National Representative

CH
ECIBC National Contacts
National
NOT APPLICABLE
Regionally

Other
Mainly public and publicly subsidised
NO

ED National Representative

NOT APPLICABLE
Regionally
Switzerland has 26 cantons with 26 different healthcare systems.
Other
Private and public entities, depending on the canton.
I do not have this information.

CY
ECIBC National Contacts
National
NOT APPLICABLE
Nationally

Public entities mainly

NO

ED National Representative

Nationally

Other
There is no national health system. Health care is both private and public.

CZ
ECIBC National Contacts
National
NOT APPLICABLE
Nationally

Public entities mainly

YES

ED National Representative

NO

DE
ECIBC National Contacts
National
NO

ED National Representative

EE
ECIBC National Contacts

ED National Representative

NO

ES
ECIBC National Contacts

ED National Representative

NO

FI
ECIBC National Contacts
Regional
NO
Regionally

Public entities mainly

YES

ED National Representative

FR
ECIBC National Contacts
National
NO

Other
In France, healthcare and breast cancer care in particular are provided by both public and private entities.

ED National Representative

NO

GR
ECIBC National Contacts
National
NOT APPLICABLE
Nationally

Other
Public breast centres are under the responsibility of the Ministry of Health. Private breast centres are self-managed.
NO

ED National Representative

NO

HU
ECIBC National Contacts
National
YES
Nationally

Public entities exclusively
The responsibility of the Office of Chief Medical Officer (CMO) is national providing operating licences for all health care system units nationwide. However, patient care (including breast cancer care) has been organised at regional-local level. Professionally, the National Cancer Institute is in charge.

ED National Representative

IE
ECIBC National Contacts
National
NO
Nationally

Public entities mainly

NO

ED National Representative

NO
Regionally under National coordination

Public entities mainly

YES

IT
ECIBC National Contacts
National
NO

ED National Representative

NO

LT
ECIBC National Contacts
Regional
NO

ED National Representative

LU
ECIBC National Contacts
National
NO

ED National Representative

NO

LV
ECIBC National Contacts
National
NO
Nationally

Public entities mainly

NO

ED National Representative

MT
ECIBC National Contacts
National
NO

ED National Representative

NO

NL
ECIBC National Contacts

ED National Representative

NO

NO
ECIBC National Contacts
National
NO

ED National Representative

Locally under Regional / National coordination

Public entities exclusively

PL
ECIBC National Contacts
National
NOT APPLICABLE
Locally

Public entities mainly

NO

ED National Representative

PT
ECIBC National Contacts
National
NO

ED National Representative

RO
ECIBC National Contacts
National
NO

ED National Representative

RS
ECIBC National Contacts
National
NOT APPLICABLE
Nationally

Public entities mainly

NO

ED National Representative

SE
ECIBC National Contacts
National
YES
Locally under Regional / National coordination

Public entities mainly1

NO

ED National Representative

YES
Locally under Regional / National coordination

Public entities mainly

NO

SI
ECIBC National Contacts
National
NO
Regionally under National coordination

Public entities exclusively

ED National Representative

NO

SK
ECIBC National Contacts
National
NO

ED National Representative

TR
ECIBC National Contacts

ED National Representative

NO

UK
ECIBC National Contacts
National
YES
Nationally

Public entities mainly

NO

ED National Representative

NO

Note to Table 1: To Q2.1, several countries did not respond ‘YES or NOT APPLICABLE’, yet they went on to answer Q2.2. This is skipping error has likely introduced a certain degree of response bias to the results as the information that was provided was due to an error on the respondent’s part, otherwise, had the respondent followed the instructions correctly, the survey organiser would not have received these data. However, to ensure that all information respondents provided would be covered, the authors of this report decided to incorporate that additional information in Tables and Figures.

Table 2: Survey Section 4.

General questions on Breast Units

Questions:

ECIBC:

1. Are there any Breast Units as defined by the 2006 European Guidelines in the geographical area under your organisation’s responsibility? * YES; NO Comments/ Details

2. Are Breast Units required by law in the geographical area under your organisation’s responsibility? * YES; NO Comments/Details

3. Are Breast Units not required by law but just recommended in the geographical area under your organisation’s responsibility? * YES, NO Comments/ Details

ED:

i. Are there any Breast Units as defined by the 2006 European Guidelines in the geographical area under your organisation’s responsibility? YES; NO, I do not have this information Comments/Details

ii. Are Breast Units required by law in the geographical area under your organisation’s responsibility? YES; NO, I do not have this information Comments/Details

iii. Are Breast Units not required by law but just recommended in the geographical area under your organisation’s responsibility? YES, NO, I do not have this information Comments/Details

Country

4i. Are there BU in the geographical area under your organisation’s responsibility?
4i. Comments
4ii. Are BU required by law?
4ii. Comments
4iii. Are BU not required by law but just recommended?
4iii. Comments

AT
ECIBC National Contacts

ED National Representative
YES

NO

YES

BE
ECIBC National Contacts
YES
Breast clinics (specialised oncology care programmes) are recognised by regional authorities. The recognition criteria are regulated by royal decree, and all aspects do not conform to European Guideline requirements. Regional health authorities, and not the Federal Ministry of Health, are responsible for the recognition of breast units.
NO

YES

ED National Representative

BG
ECIBC National Contacts
YES
There is a breast department at the National Hospital of Oncology, which is equipped for complex treatment of breast cancer.
NO
In Bulgaria, health laws and laws regarding health establishments, regulating the work of the hospitals, are applicable as well.
NO
This is responsibility of the Ministry of Health.

ED National Representative

CH
ECIBC National Contacts
NO

NO

YES
They are recommended by professional associations.

ED National Representative
YES

NO

NO

CY
ECIBC National Contacts
YES
There has been a breast unit, operating since 2010. The Ministerial Board has recently (19 November 2014) decided to appoint an ad-hoc committee with the mandate to upgrade the breast unit according to the European standards and to prepare a proposal on how this can be achieved. The ad hoc committee has submitted the report to the Ministerial Council. The report included the requirements for further development and operation of the breast centre, according to European Guidelines. The Ministerial Board has approved the development of the centre on 16 February 2016 and appointed a steering committee with the mandate to coordinate the required actions and procedures for the operation of the centre. It is expected that the centre will be fully functional in September 2016.
NO
There is a decision from the Council of Ministers.
YES

ED National Representative
NO

NO

NO

CZ
ECIBC National Contacts
YES

YES

NO

ED National Representative
NO

I do not have this information.

I do not have this information.

DE
ECIBC National Contacts
YES

NO

YES

ED National Representative

EE
ECIBC National Contacts

ED National Representative
YES
There are two units without accreditation: one in Tallinn, one in Tartu.
YES
The medical centre is located in northern Estonia.
NO

ES
ECIBC National Contacts

ED National Representative
YES

NO

YES

FI
ECIBC National Contacts
YES

NO

YES

ED National Representative

FR
ECIBC National Contacts
NO
See comments 4vii on BU concept.
NO
See comments 4vii on BU concept.
NO
See comments 4vii on BU concept.

ED National Representative
YES

NO

NO

GR
ECIBC National Contacts
NO
Public breast centres are under the responsibility of the Ministry of Health. Private breast centres are self-managed.
NO

NO

ED National Representative
YES

NO

NO

HU
ECIBC National Contacts
YES
Yes, there is one in the National Cancer Institute.
NO

YES

ED National Representative

IE
ECIBC National Contacts
NO
The National Cancer Control Programme and Hospital Group Management are responsible for breast units.
NO

YES

ED National Representative
YES

NO

YES

IT
ECIBC National Contacts
YES

YES
State-regions agreement on breast units networking issued 18 December 2014.
NO

ED National Representative
YES

YES

NO

LT
ECIBC National Contacts
YES
The breast cancer care centre in the NCI was approved as a centre of excellence with SIS accreditation (accreditation in 2014).
NO

YES

ED National Representative

LU
ECIBC National Contacts
NO
The Ministry of Health adapted its first National Cancer Plan for 2014-2018. Breast cancer care is one of the topics.
NO
Luxembourg is a small country, with 5 hospitals, where all cancers are treated. In the framework of the Hospital Plan this might change in the coming years.
NO

ED National Representative
NO

NO

NO

LV
ECIBC National Contacts
NO

NO

NO

ED National Representative

MT
ECIBC National Contacts
NO
One breast care unit is present at the main hospital (Mater Dei Hospital - MDH) but it is not fully in line with the mandatory requirements as stipulated in the 2006 European Guidelines. This unit mainly caters to the diagnosis (patients diagnosed post-referral due to suspicious signs and symptoms), and surgical treatment and follow-up of most patients with breast cancer. Population-based organised mammography screening is carried out in a different set-up and patients diagnosed through the screening programme join the breast care unit after the initial MDT meeting in which their screening diagnosis is discussed and their cancer care pathway is planned. Oncological (chemotherapy, hormone therapy and radiotherapy) treatments and palliative care are managed at the oncology centre.
NO

NO
The breast unit at MDH was not mandated by law. It has been in operation since 2000.

ED National Representative
YES

I do not have this information.

I do not have this information.

NL
ECIBC National Contacts

ED National Representative
YES
Most breast units are part of a general hospital.
NO

YES

NO
ECIBC National Contacts
YES

NO

YES

ED National Representative
NO

NO

YES

PL
ECIBC National Contacts
YES
There are two ‘formal’ breast units in Poland.
NO

NO

ED National Representative

PT
ECIBC National Contacts
YES

NO

YES

ED National Representative

RO
ECIBC National Contacts
NO

NO

YES

ED National Representative

RS
ECIBC National Contacts
YES
In line with the regulation concerning the network of healthcare facilities in Serbia, as well as according to the healthcare law there are healthcare facilities established on secondary and tertiary level of healthcare which cover comprehensive cancer care, including breast cancer care as defined by the 2006 European Guidelines.
NO
The Ministry of Health issued a regulation on the network of healthcare facilities in Serbia in charge of oncological healthcare. Those oncology centres are obliged to provide healthcare services for diagnosis and therapy related to breast health. There are six institutions providing BU services: 1. Institute for Oncology and Radiology of Serbia -IORS, 2. Institute for Oncology and Radiology, Vojvodina, Sremska Kamenica, 3. Clinical Centre, Vojvodina, 4. Clinical Centre Nis, 5. Health Centre, Kladovo, 6. Military Hospital VMA, Belgrade.
NO
The healthcare law and regulation of the network of public healthcare facilities in Serbia as well as the law on health insurance are key documents regarding the legal framework concerning the functioning of diagnostic services and therapy for breast malignancies.

ED National Representative

SE
ECIBC National Contacts
YES
All of the university hospitals and most hospitals in the country have breast units. A follow up from the National Board of Health and Welfare showed that 70 % of breast units had more than 150 newly diagnosed cases per year (2013).
NO

YES
Recommended in The National Clinical Practice Guidelines for Breast Cancer (2014).

ED National Representative
YES
The interpretation of the definition given in the 2006 European Guidelines differs. There are no BU according to that definition but for every 250 000 to 300 000 inhabitants. As counties in Sweden are autonomous to the government they also tend to define recommendations/guidelines differently.
NO

YES
National guidelines are inspired to the recommendations from the Swedish Breast Cancer Group, which are continuously updated.

SI
ECIBC National Contacts
YES

NO

YES
See the National Cancer Control Programme.

ED National Representative
NO

NO

YES

SK
ECIBC National Contacts
NO

NO

NO

ED National Representative

TR
ECIBC National Contacts

ED National Representative
YES

NO

NO

UK
ECIBC National Contacts
YES
Most breast cancer diagnosis and treatment is performed in units as defined, this has been mandated since the start of the national peer review process in 2000.
NO
No, but hospital breast units have a defined set of peer review standards that have to be met and are measured. Compliance is assessed by visiting teams of external professional peer review assessors.
YES

ED National Representative
YES

YES

Table 3: Survey section 4.

General questions on Breast Units

Questions:

ECIBC:

4. Is there a national accreditation/certification system for Breast Units in the geographical area under your organisation’s responsibility? * YES; NO If YES, please provide details

5. Are there regional/local accreditation/certification systems for Breast Units in the geographical area under your organisation’s responsibility? * YES; NO If YES, please provide details

6. Are these accreditation/certification systems mandatory or voluntary in the geographical area under your organisation’s responsibility? * YES, NO If YES, please provide details

7. If you wish, please add below your comments/considerations on Breast Units organisational concept as defined in the 2006 European Guidelines

ED:

iv. Is there a national accreditation/certification system for Breast Units in the geographical area under your organisation’s responsibility? * YES; NO, I do not have this information

Comments/ Details

v. Are there regional/local accreditation/certification systems for Breast Units in the geographical area under your organisation’s responsibility? * YES; NO, I do not have this information

Comments/Details

vi. Are these accreditation/certification systems mandatory or voluntary in the geographical area under your organisation’s responsibility? * YES, NO, I do not have this information

Comments/Details

vii. If you wish, please add below your comments/considerations on Breast Units organisational concept as defined in the 2006 European Guidelines

Country

4iv. Is there a national accreditation/certification system for BU?
4iv. Comments
4v. Are there regional/local accreditation/certification systems for BU?
4v. Comments
4vi. Are these accreditation/certification systems mandatory or voluntary?
4vi. Comments regarding the question about whether the accreditation/certification systems are mandatory or voluntary

AT
ECIBC National Contacts

ED National Representative
YES
Certification system is private and based on professional association, no national responsibility.
NO

Voluntary

BE
ECIBC National Contacts
NO
Same as 4i comments.
YES
The certification system implies that there is recognition by regional health authorities.

NOT APPLICABLE: hospitals that wish to obtain recognition as a breast unit (in the framework of the hospital law) have to apply to regional health authorities and only obtain it if the criteria in the royal decree are fulfilled.

ED National Representative

BG
ECIBC National Contacts
YES
There is a general accreditation system for all hospitals, repeated every 3 to 5 years. It is also applicable to breast departments.
NO

Mandatory
The Ministry of Health requires regular accreditation of all health establishments, depending on their specialisation. The accreditation system of the Ministry of Health; Standards and guidelines for breast cancer treatment; Standards for general surgery; Standards for chemotherapy; Standards for radiotherapy.

ED National Representative

CH
ECIBC National Contacts
NO

NO

ED National Representative
NO

NO

I do not have this information.

CY
ECIBC National Contacts
NO
A breast unit was set up at Nicosia General Hospital. Since 2013, it has been part of the EUSOMA network.
NO

NOT APPLICABLE

ED National Representative
NO

NO

Voluntary
No accreditation

CZ
ECIBC National Contacts
YES
Ministry of Health and the Czech Radiological Society run the system.
NO

Mandatory
Only for the screening programme.

ED National Representative
I do not have this information.

I do not have this information.

I do not have this information.

DE
ECIBC National Contacts
YES
General information about the system: http://www.krebsgesellschaft.de/gcs/german-cancer-society/certification.html, Scientific publications and research: https://www.krebsgesellschaft.de/gcs/german-cancer-society/certification/publications_ii.html.
NO

Voluntary

ED National Representative

EE
ECIBC National Contacts

ED National Representative
NO

NO

I do not have this information.

ES
ECIBC National Contacts

ED National Representative
YES

NO

Voluntary

FI
ECIBC National Contacts
NO

NO

Voluntary

ED National Representative

FR
ECIBC National Contacts
NO
See comments 4vii on BU concept.
NO
See comments 4vii on BU concept.
Voluntary
See comments 4vii on BU concept.

ED National Representative
NO

NO

I do not have this information.

GR
ECIBC National Contacts
NO

NO

ED National Representative
YES

NO

Voluntary

HU
ECIBC National Contacts
NO

NO

Voluntary

ED National Representative

IE
ECIBC National Contacts
NO

NO

NOT APPLICABLE

ED National Representative
YES

YES

I do not have this information.

IT
ECIBC National Contacts
NO

YES
According to local (regional) initiatives and the state-regions agreement on Breast Units networking (Intesa Conferenza Stato-Regioni) issued 18 December 2014.
Mandatory
The state-regions agreement on breast units networking issued 18 December 2014 provides accreditation criteria and standards according to 2006 European Guidelines.

ED National Representative
NO
Breast centres can apply for voluntary certification (e.g. EUSOMA).
NO
A regional accreditation system is foreseen but not yet implemented (see document drawn by Italian Ministry of Health, December 2014 Rep. Atti 185/CSR).

According to the document mentioned above the regional accreditation system will become mandatory but at the same time the breast centres can undergo the voluntary certification process (e.g. EUSOMA).

LT
ECIBC National Contacts
NO

NO

Voluntary

ED National Representative

LU
ECIBC National Contacts
NO
In the framework of the Cancer Plan this might become an option.
NO

ED National Representative
NO

NO

Voluntary

LV
ECIBC National Contacts
NO

NO

ED National Representative

MT
ECIBC National Contacts
NO

NO

Voluntary

ED National Representative
NO

NO

I do not have this information.

NL
ECIBC National Contacts

ED National Representative
NO

NO

Voluntary
EUSOMA accreditation was recently obtained by one hospital. More will follow soon.

NO
ECIBC National Contacts
NO

NO

Voluntary

ED National Representative
NO

NO

PL
ECIBC National Contacts
NO

NO

NOT APPLICABLE

ED National Representative

PT
ECIBC National Contacts
YES
The accreditation system is starting now (2015).
NO

Voluntary

ED National Representative

RO
ECIBC National Contacts
NO

NO

Voluntary

ED National Representative

RS
ECIBC National Contacts
NO
In the Republic of Serbia there is a national agency for the accreditation of healthcare institutions (AZUS). In order to improve the quality of work of healthcare facilities majority of above listed institutions for oncology care are in the procedure of accreditation.
NO
In the Republic of Serbia there is a national agency for the accreditation of healthcare institutions (AZUS). Accreditation is not obligatory procedure for healthcare institutions in Serbia. Nevertheless, more than 50% of institutions are in the procedure of accreditation or are accredited.
Voluntary
They are not mandatory at the moment.

ED National Representative

SE
ECIBC National Contacts
NO

NO

Voluntary

ED National Representative
NO
Europa Donna is currently supporting a European quality assurance/accreditation through the European Commission and the JRC.
NO
There is no quality assurance system. Professionals have been looking at EUSOMA criteria, but not even the Swedish Breast Cancer Group has been working on this.
Voluntary
The University Hospital of Lund expressed interest regarding accreditation through EUSOMA. However, costs are high -due to compliance criteria, but also for the accreditation itself. As Swedish university hospitals are public entities, it is not within the policy to pay for a ‘diploma’.

SI
ECIBC National Contacts
NO

NO

ED National Representative
NO

NO

Voluntary

SK
ECIBC National Contacts
NO

NO

ED National Representative

TR
ECIBC National Contacts

ED National Representative
NO

NO

Voluntary

UK
ECIBC National Contacts
YES
A national peer review process for the symptomatic cancers, with defined criteria for assessment against these, is in place. A well-organised quality assurance programme for screen detected breast cancer is in place. Please see attached peer review documents.
YES
Peer review, which while not providing a certificate, assesses the % compliance and results are publicly available.
Mandatory
There are clear and detailed peer review measures published, each breast unit has to measure itself against these, and compliance is assessed by a visiting group of external peers.

ED National Representative
YES

YES

YES

Table 4: Survey section 5.

Breast Units mandatory requirements implementation stage.

Questions:

1. Critical mass

Definition from the 2006 European Guidelines

A Unit must be of sufficient size to have more than 150, newly diagnosed cases of primary breast cancer (at all ages and stages) coming under its care each year.

Note: these are newly diagnosed breast cancers. They may have been diagnosed elsewhere but if they have received any prior treatment and have been transferred, for example, to receive radiotherapy, they should not be counted.

All primary treatment must be carried out under the direction of the Unit (operation must be in the unit, adjuvant therapies must be directed by the unit but may have been received in other settings e.g. RT and chemotherapy). Follow up should be under the control of the Unit.

The reason for recommending a minimum number is to ensure a caseload sufficient to maintain expertise for each team member and to ensure cost-effective working of the Breast Unit: the establishment of a clinic staffed by experts is expensive and must have a high through-put of patients.

A number of Units will be recognised as teaching centres, nationally or internationally. They may be recognised for teaching over all breast cancer management or special aspects (e.g. screening, reconstruction, pathology).

ECIBC:

1. In the geographical area under your organisation’s responsibility is there any kind of requirement that regulates at more than 150 the number of newly diagnosed cases of primary breast cancer cases yearly treated in individual Breast Units? * YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. If you replied YES, MANDATORY or VOLUNTARY, please report below the implementation framework of the requirement and the respective year of implementation (more than one answer is possible). Embedded in national/regional legislation; Used as reference for reimbursement from insurances at national/regional level; Institutional licencing requirement at national/regional level; Used in a non-public quality assurance scheme under national/regional governance; Used in a non-public quality assurance scheme; NOT under national/regional governance

3. If you replied YES, please provide a more detailed description: name of legislation/ quality assurance scheme, link to the text or reference document

4. Please select the scenario that you think is better representing you country with respect to the critical mass at more than 150 the number of newly diagnosed cases of primary breast cancer cases yearly treated in individual Breast Units *: Virtually all primary breast cancer cases are treated in a centre whose volume is higher than 150 new cases/year; Most primary breast cancer cases are treated in a centre whose volume is higher than 150 new cases/year, but a small amount of cases are treated in centres with a lower volume; Primary breast cancer cases are equally divided in centres with more and less than 150 new cases/year; Even though centres whose volume is higher than 150 new cases/year exist, most cases are treated in low-volume centres; Virtually all primary breast cancer cases are treated in a centre whose volume is lower than 150 new cases/year

5. If you have requirements, but your threshold is different from 150, please provide the number

6. If you wish, please add below your comments/considerations on critical mass mandatory requirement

ED:

1. Is there in your country any kind of requirement that regulates at more than 150 the number of newly diagnosed cases of primary breast cancer cases yearly treated in individual Breast Units? YES; NO; I do not have this information

2. If you wish, please add below your comments/considerations on critical mass mandatory requirement

Country

5.1.1 Is there a requirement that regulates at more than 150 the number of newly diagnosed cases of primary breast cancer cases yearly treated in individual BU? [5.1 for ED Questionnaire]
5.1.2a Implementation framework of the requirement [Not included in ED Questionnaire]
5.1.3 Details [Not included in ED Questionnaire]
5.1.4 Which scenario better represents your country with respect to the critical mass at more than 150 the number of newly diagnosed cases of primary breast cancer cases yearly treated in individual BU? [Not included in ED Questionnaire]
5.1.5 If you have requirements, but your threshold is different from 150, please provide the number [Not included in ED Questionnaire]
5.1.6 Comments [5.1 Comments for ED Questionnaire]

AT
ECIBC National Contacts

ED National Representative
NO

The regulations require a minimum 100 primary breast cancer cases in a unit. Indeed, most units have more than 150 patients. The number ‘100’ was chosen due to the geographical (roads are determined by mountains) and political (the ‘Lander’ having their own hospitals) situation.

BE
ECIBC National Contacts
NO and NOT PLANNED

Even though centres whose volume is higher than 150 new cases per year exist, most cases are treated in low-volume centres.
125

ED National Representative

BG
ECIBC National Contacts
YES, VOLUNTARY
Institutional licencing requirement at national/regional level. Implemented in 2000. Used in a non-public quality assurance scheme under national/regional governance. Implemented in 2000.

Most primary breast cancer cases are treated in a centre whose volume is higher than 150 new cases per year, but a small number of cases are treated in centres with a lower volume.
120
The requirement of the National Hospital of Oncology is for every surgeon from the Breast Department to have at least 120 patients with primary breast cancer a year

ED National Representative

CH
ECIBC National Contacts
NO and NOT PLANNED

Primary breast cancer cases are equally divided in centres with more and less than 150 new cases per year.
125
For a non mandatory certification of Swiss BU’s, the requirement is 125 cases. For more details see http://www.krebsliga.ch/de/fachpersonen/qualitaetslabel_fuer_brustzentren/zertifizierte_zen-tren/.

ED National Representative
I do not have this information.

CY
ECIBC National Contacts
YES, VOLUNTARY
Institutional licencing requirement at national/regional level
The Ministry of Health refers to the 2006 European Guidelines. The Public Breast Unit follows the requirements, because there is no legislative framework. Private clinics act voluntarily.
Most primary breast cancer cases are treated in a centre whose volume is higher than 150 new cases per year, but a small number of cases are treated in centres with a lower volume.

Most women who are eligible for public health care services are treated in the centre that meets the above named requirements. The private clinics undergo the rules of free market and therefore the patients chose mainly centres whose volume is higher than 150 new cases per year.

ED National Representative
NO

CZ
ECIBC National Contacts
YES, VOLUNTARY
Embedded in national/regional legislation. Implemented in 2010. Used as reference for reimbursement from insurance at national/regional level. Implemented in 2002. Institutional licencing requirement at national/regional level. Implemented in 2003. Used in a non-public quality assurance scheme under national/regional governance. Implemented in 2010. Used in a non-public quality assurance scheme NOT under national/regional governance. Implemented in 1970.
The legislative framework in the Czech Republic is determined by decree of the Ministry of Health (MoH CR) no. 3/2010 Coll. It determines the content and intervals of preventive examinations and recommended standards. These were published in the Ministry of Health bulletin (April 2010).
Most primary breast cancer cases are treated in a centre whose volume is higher than 150 new cases per year, but a small number of cases are treated in centres with a lower volume.

Most breast cancer patients are treated in 13 comprehensive oncological centres associated with breast units.

ED National Representative

DE
ECIBC National Contacts
NO and NOT PLANNED

Virtually all primary breast cancer cases are treated in a centre whose volume is higher than 150 new cases per year.
100
There are good publications for some tumour sites (colorectal, lung, pancreatic) that show better outcome with higher volume, but this correlation is weak for breast cancer.However, from an economic point of view a critical mass can be useful. The median of the number of primary cases (no recurrences, no metastases) in breast cancer centres in Germany is 212 per year. (https://www.krebsgesellschaft.de/gcs/german-cancer-society/certification/documents.html?file=files/dkg/deutsche-krebsgesellschaft/content/pdf/Zertifizierung/Jahresberichte%2omit%20DOI%2ound%20ISBN/breast_annual%20report-2016-A3%28160721%29.pdf, page 3).

ED National Representative

EE
ECIBC National Contacts

ED National Representative
YES

Estonia is a very little country -population 1,31 million. In Estonia there are two breast units in major hospitals, one for the Northern part of the country, the other for the Southern part. Each year over 700 new breast cancers are diagnosed and treated.

ES
ECIBC National Contacts

ED National Representative
NO

FI
ECIBC National Contacts
NO and NOT PLANNED

Most primary breast cancer cases are treated in a centre whose volume is higher than 150 new cases per year, but a small number of cases are treated in centres with a lower volume.

ED National Representative

FR
ECIBC National Contacts
NO and NOT PLANNED

Most primary breast cancer cases are treated in a centre whose volume is higher than 150 new cases per year, but a small number of cases are treated in centres with a lower volume.

Question 1.4 is mandatory but doesn’t apply to France. See 4vii comments.

ED National Representative
NO

Thirty cases per year is the minimum requirement for surgeons.

GR
ECIBC National Contacts
NO and NOT PLANNED

Most primary breast cancer cases are treated in a centre whose volume is higher than 150 new cases per year, but a small number of cases are treated in centres with a lower volume.

Unfortunately, in Greece there are no breast centres that meet the 2006 European Guidelines. There is no official position on the threshold of cases even if 150 is the widely applied threshold. To date, there is no national breast cancer registry.

ED National Representative
NO

HU
ECIBC National Contacts
NO, BUT PLANNED

Most primary breast cancer cases are treated in a centre whose volume is higher than 150 new cases per year, but a small number of cases are treated in centres with a lower volume.

ED National Representative

IE
ECIBC National Contacts
YES, VOLUNTARY

Virtually all primary breast cancer cases are treated in a centre whose volume is higher than 150 new cases per year.

There is no mandatory minimum number but there are eight centres. So, all centres treat more than 150 women.

ED National Representative
YES

IT
ECIBC National Contacts
YES, MANDATORY
Embedded in national/regional legislation. Implemented in 2014.
State-regions agreement on breast units networking issued the 18 December 2014.
Even though centres whose volume is higher than 150 new cases per year exist, most cases are treated in low-volume centres.

ED National Representative
YES

LT
ECIBC National Contacts
YES, VOLUNTARY
Used as reference for reimbursement from insurance at national/regional level.
Since 1979, the National Cancer Institute (earlier Institute of Oncology, Vilnius University) has been one of many cancer treatment centres in Lithuania; all public hospitals are reimbursed from State patients funds and the Ministry. There are five main possible cancer treatment hospitals in major cities; three of them provide cancer diagnostics, surgery, radiotherapy and medical oncology; All patients are referred to these centres
Virtually all primary breast cancer cases are treated in a centre whose volume is higher than 150 new cases per year.

1 500 new breast cancer cases are diagnosed in Lithuania per year. There is no requirement on critical mass of breast cancer patients, but there are only three big centres in Lithuania (Vilnius National Cancer Institute, Kaunas and Klaipeda), where com prehensive breast cancer care is possible. In smaller cities as Klaipeda, Siauliai breast surgery and chemotherapy is possible, in Panevezys region only chemotherapy is possible.

ED National Representative

LU
ECIBC National Contacts
YES, VOLUNTARY

No legislation. The requirements for a ‘Competence Centre’ are defined but not implemented. The year of implementation might be 2017 within the framework of the National Cancer Plan.
Virtually all primary breast cancer cases are treated in a centre whose volume is lower than 150 new cases per year.

Yearly new diagnosed breast cancer cases: approximately 400. For the time being they are treated in five hospitals. The Ministry of Health together with the cancer registry is gathering data regarding all aspects of breast cancer care at national level. This might help policy makers decide whether to have a breast cancer unit in the future. The requirement of 150 new cases a year is a high number; the number of centres should be reduced to 2-3 for the whole country.

ED National Representative
NO

LV
ECIBC National Contacts
NO and NOT PLANNED

Most primary breast cancer cases are treated in a centre whose volume is higher than 150 new cases per year, but a small number of cases are treated in centres with a lower volume.

ED National Representative

MT
ECIBC National Contacts
NO, BUT PLANNED

Virtually all primary breast cancer cases are treated in a centre whose volume is higher than 150 new cases per year.

ED National Representative
YES

NL
ECIBC National Contacts

ED National Representative
NO

For this requirement, the Dutch Breast Cancer Society met a lot of resistance from professionals.

NO
ECIBC National Contacts
NO and NOT PLANNED

Most primary breast cancer cases are treated in a centre whose volume is higher than 150 new cases per year, but a small number of cases are treated in centres with a lower volume.

Our health authorities now suggest a minimum of 100 new patients each year at a Breast Cancer Surgery Unit (Report: Cancer Surgery in Norway).

ED National Representative
NO

PL
ECIBC National Contacts
NO and NOT PLANNED

Most primary breast cancer cases are treated in a centre whose volume is higher than 150 new cases per year, but a small number of cases are treated in centres with a lower volume.

ED National Representative

PT
ECIBC National Contacts
NO, BUT PLANNED

Most primary breast cancer cases are treated in a centre whose volume is higher than 150 new cases per year, but a small number of cases are treated in centres with a lower volume.

ED National Representative

RO
ECIBC National Contacts
NO and NOT PLANNED

Primary breast cancer cases are equally divided in centres with more and less than 150 new cases per year.

ED National Representative

RS
ECIBC National Contacts
NO and NOT PLANNED

Most primary breast cancer cases are treated in a centre whose volume is higher than 150 new cases per year, but a small number of cases are treated in centres with a lower volume.

The Republic Expert Committee for Oncology is in the process of developing criteria for an oncology accreditation system, including breast cancer management at national level.

ED National Representative

SE
ECIBC National Contacts
YES, VOLUNTARY

None of the alternatives given in question 1.2 are applicable. There is no formal regulation but most hospitals and county councils are aware of the recommendation, which is also fulfilled in most counties. The majority of hospitals in Sweden had more than 150 newly diagnosed cases of breast cancer per year (result from a follow up from 2013).
Most primary breast cancer cases are treated in a centre whose volume is higher than 150 new cases per year, but a small number of cases are treated in centres with a lower volume.

The National Clinical Practice Guidelines for Breast Cancer (2014) claim that there should be a breast unit per 250 000 inhabitants. The largest units have a population around 500 000 -800 000 individuals, the smallest one has just 57 000 individuals.

ED National Representative
I do not have this information.

As a member of the Swedish Breast Cancer Group, who initiates national guidelines/recommendations for the National Board of Health and Welfare, this has not been under scrutiny during my mandate period.

SI
ECIBC National Contacts
YES, VOLUNTARY
Used in a non-public quality assurance scheme under national/regional governance. Implemented in 2011.
More than 150 per breast unit (there are three in the country) are recommended by The National Cancer Control Programme of the Ministry of Health (http://www.dpor.si/en/).
Most primary breast cancer cases are treated in a centre whose volume is higher than 150 new cases per year, but a small number of cases are treated in centres with a lower volume.

ED National Representative
YES

SK
ECIBC National Contacts
YES, VOLUNTARY

Most primary breast cancer cases are treated in a centre whose volume is higher than 150 new cases per year, but a small number of cases are treated in centres with a lower volume.

ED National Representative

TR
ECIBC National Contacts

ED National Representative

UK
ECIBC National Contacts
NO and NOT PLANNED
Institutional licencing requirement at national/regional level. Implemented in 2000
Institutional assessment via the national peer review scheme. The vast majority of breast units in England would diagnose more than 150 new breast cancers per year even if the threshold is 100.
Virtually all primary breast cancer cases are treated in a centre whose volume is higher than 150 new cases per year.
100

ED National Representative
NO

Table 5: Survey section 5.

Breast Units mandatory requirements implementation stage.

Questions:

2. Core Team–(a) Composition

Definition from the 2006 European Guidelines

Each member of the core team must have special training in breast cancer; for standards see Chapter 10 (pages 356-365 http://bookshop.europa.eu/en/european-guidelines-for-quality-assurance-in-breast-cancer-screening-and-diagnosis-pbNDy306954/).

Each member of the breast unit core team must undertake continuing professional education on a regular basis. Breast Unit budgets must include provision for this.

9.5.2.1. The Breast Unit must have an identified Clinical Director of Breast Services.

9.5.2.2. Breast Surgeons (including Gynaecologists performing breast surgery)

Two or more nominated surgeons specially trained in breast disease, each of whom must personally carry out the primary surgery on at least 50 newly diagnosed cancers per annum and must attend at least one diagnostic clinic per week. For an average sized unit the surgeons will need at least eight identified ca. 4 hr sessions per week in Breast Disease. These sessions will allow for operating time, participation in diagnostic clinics, a follow-up clinic and, where appropriate, screening assessment clinics. A session must be allowed for attendance at a weekly team case management and audit meeting.

A Unit team must provide breast surgical reconstruction when required for those patients not suitable for breast conserving therapy and be able to apply special techniques for patients with extensive local disease. The breast surgeons in the team should be able to undertake basic reconstruction or recontouring and there should be a standard arrangement or joint reconstruction clinic with one or two nominated Plastic Surgeons (non-core team member) who take a special interest in breast reconstructive and recontouring techniques.

9.5.2.3. Breast Radiologists

There must be at least two nominated radiologists, fully trained and with continuing experience in all aspects of breast disease and associated imaging, tissue sampling and localisation procedures under image control. Ideally any radiologist investigating breast patients should participate in the screening programme in countries in which this is established and must participate in a national or regional QA scheme. They must fulfil the volume requirements as laid down for breast assessment in Chapter 5 and the previously published document ‘Quality Assurance in the Diagnosis of Breast Disease,’²³ reading a minimum of 1000 mammograms per year (5000 for those participating in a screening programme).

They must attend multidisciplinary meetings for case management and audit purposes.

They must be present in diagnostic assessment clinics with the surgeon. Each radiologist must attend at least one diagnostic clinic per week for symptomatic patients or screening assessment.

9.5.2.4. Breast Pathologists

A lead pathologist plus usually not more than one other nominated pathologist, specialising in Breast Disease, will be responsible for all breast pathology and cytology.

Pathologists carrying out these roles must have contractual sessions to attend team case management and audit meetings. They must be familiar with national and/or European performance quality standards and guidelines. They must take part in available European, National and Regional quality assurance schemes.

9.5.2.5. Breast Oncologists

(a) A nominated radiation oncologist must arrange the appropriate delivery of radiotherapy.²⁴ He/she must hold advanced disease clinics with other members of the breast team at the Breast Unit and must take part in the case management and audit meetings of the Unit. (b) In some countries, Clinical Oncologists carry out both radiation therapy and prescribe the chemotherapy. In centres in which a Medical Oncologist gives the chemotherapy he/ she should be a member of the core team and take a full part in case management and audit meetings.

9.5.2.6. Breast Diagnostic Radiographers (Technicians)

Radiographers with the necessary expertise and training in mammography are essential members of the team. They must fulfil the training and working practice recommendations as laid down in Chapters 3, 5, and 10. They must be responsible for taking the mammograms, which must not be performed by radiographic or nonradiographic personnel without the above training.

9.5.2.7. Data Managers

There must be a system covering audit. A data manager must enter data on diagnosis, treatment, pathology and clinical outcomes contemporaneously.

9.5.2.8. Patient Support staff

Regular support (advice, counselling, psychological help) is given by Breast Care Nurses in some countries and psychologically professionally trained persons with expertise in Breast Cancer in others. These persons must be members of the core team. They must be available to counsel and offer practical advice and emotional support to newly diagnosed patients at the time the diagnosis is given, so as to further explain treatment plans. They should also be available on demand from patients in the Primary Breast Cancer Follow up clinic and in the Advanced Breast Clinic. Particularly they must be present to support women when the diagnosis is given that the disease has become advanced. At least two Breast Care Nurses are needed per breast unit.

ECIBC:

1. Is there. in the geographical area under your organisation’s responsibility. any kind of requirement that regulates the composition of the core team as defined in the 2006 European Guidelines? * YES. MANDATORY; YES. VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. If you replied YES, please provide a more detailed description of the team (i.e. the clinical and radiation oncologist role, number of radiographers, additional members of the core team, e.g. higher numbers and/or additional professional profiles–e.g. plastic surgeons–than foreseen in the 2006 European Guidelines)

3. If you replied YES, please report below the implementation framework of the team composition requirements and the respective year of implementation (more than one answer is possible). Embedded in national/regional legislation; Used as reference for reimbursement from insurances at national/regional level; Institutional licencing requirement at national/regional level; Used in a non-public quality assurance scheme under national/regional governance; Used in a non-public quality assurance scheme NOT under national/regional governance

4. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

5. If you wish, please add below your comments/considerations on core team composition mandatory requirement.

ED:

1. Is there in your country any kind of requirement that regulates the composition of the core team as defined in the 2006 European Guidelines? YES; NO; I do not have this information

2. If you wish, please add below your comments/considerations on core team composition mandatory requirement

Country

2a.1 Is there a requirement that regulates the composition of the core team?
2a.2 Core team detailed description [Not included in ED Questionnaire]
2a.3a Implementation framework of the team composition [Not included in ED Questionnaire]
2a.4 Core team details [Not included in ED Questionnaire]
2a.5 Core team comments [2a.1 Comments for the ED Questionnaire]

AT
ECIBC National Contacts

ED National Representative
YES

The catalogue of requirements for breast cancer units ‘Anforderungskatalog für Brustgesundheitszentren in Österreich’ is based on the 2006 European Guidelines. The composition of the core team is mainly based on those guidelines.

BE
ECIBC National Contacts
YES, MANDATORY
Art. 3 of Royal Decree for specialised oncology care programmes for breast cancer defines: (1) identified clinical director of the breast unit; (2) two breast surgeons (general surgery or gynaecology with experience in breast surgery), who each perform surgery on at least 30 newly diagnosed cases; (3) two radiologists with experience in mammography and breast ultrasonography and in collecting breast tissue samples. They have to read a minimum of 1 000 mammograms per year for diagnostic or screening purposes. One has to have experience in other medical imaging techniques e.g. interventional imaging techniques useful for breast cancer and staging or MRI; (4) one pathologist with a minimum of three years’ experience in diagnosis of breast pathologies. They have to be available during surgery; (5) one radiation oncologist with a minimum of three years’ experience in breast cancer; (6) one oncologist with a minimum of three years’ experience in breast cancer treatment; (7) one plastic surgeon with experience in reconstructive surgery. They have to ensure that reconstructive procedures are available in the same surgery, that they are proposed to eligible patients, that waiting times for immediate reconstructive surgery don’t delay primary treatment, and must ensure follow-up during hospitalisation and ambulatory care. All these physicians work together in a structured and multidisciplinary way. Additional members of the multidisciplinary team are: breast nurse, psychologist, and data manager.
Embedded in national/regional legislation. Implemented in 2007.

ED National Representative

BG
ECIBC National Contacts
YES, MANDATORY
Pre- and post-surgical clinical conferences, which decide on the treatment plan for each patient, include:
1. Chairman (Director of the Breast Department)
2. Deputy chairman
3. Four surgeons (performing over 150 breast surgeries annually, each)
4. Two radiographers (physicians who read more than 1 000 mammograms annually, each)
5. Two radiotherapists
6. Two chemotherapists
7. One pathologist
8. One psychologist
9. Other specialists when needed - geneticist, cardiologist, endocrinologist, internal disease and plastic surgeon.
The meetings are held twice a week.
Used as reference for reimbursement from insurance at national/ regional level. Implemented in 2005. Used in a non-public quality assurance scheme under national/regional governance. Implemented in 2005.
Multidisciplinary breast cancer team has been in existence since more than 40 years, regulated by the guidelines of the National Oncology Institute. The guidelines for breast cancer standards are updated every four years. Since 2005, the National Health Insurance Fund introduced adherence to standards as a requirement for reimbursement.

ED National Representative

CH
ECIBC National Contacts
NO and NOT PLANNED

ED National Representative
I do not have this information.

CY
ECIBC National Contacts
YES, VOLUNTARY
The public breast unit includes a surgeon with main interest on breast cancer, a radiologist, a plastic surgeon, a histopathologist, a clinical oncologist. The programme also includes radiographers with special training that have worked in the screening programme since 2010.
Institutional licencing requirement at national/ regional level.

ED National Representative
NO

CZ
ECIBC National Contacts
YES, MANDATORY
Most multidisciplinary teams are complete, but some share, for example, a plastic surgeon or psychologist.
Embedded in national/ regional legislation. Implemented in 2002. Used as reference for reimbursement from insurance at national/regional level. Implemented in 2002. Institutional licencing requirement at national/regional level. Implemented in 2002.
The legislative framework for the project in the Czech Republic is determined by decree of the Ministry of Health (MoH CR) no. 3/2010 Coll. It determines the content and intervals of preventive examinations and recommended standards. These were published in the Ministry of Health bulletin (April 2010)
The Commission for the Screening of Breast Cancer at the Ministry of Health (Komda) - is composed by radiologists - breast radiologists, members of professional societies dealing with the diagnosis and treatment of breast diseases, the State Office for Nuclear Safety (SONS), General Health Insurance Company (VZP), the Association of Health Insurance Companies (associates other health insurers) and the Ministry of Health. Commission experts for Breast Radiology (Komda) - are represented mainly by specialists from the Radiological Society JEP, the Association of Non-State Outpatient Radiology and the Association of Czech Breast Radiologists (AMA-CZ).

ED National Representative

DE
ECIBC National Contacts
YES, MANDATORY
Enclosed in the ‘Catalogue of Requirements’ are the requirements and quality indicators for certified breast cancer centres in Germany with the definition of the core team and the needed qualification. The requirements 1.1.1/1.1.2 define the partners within the network and in the following chapters the expertise of the partners is described in more detail (1.1.1). Main cooperation partners include: surgeons, gynaecological oncologists, radiologists (with the exception of cooperating radiological facilities that only provide services for the breast cancer centre in conjunction with breast MRIs), pathologists, internal oncologists, radiation therapists and specialists in nuclear medicine. The following points must be regulated in the agreements with the main treatment partners: mandatory participation in tumour boards (with the exception of nuclear medicine); Assurance of availability; Description of the treatment processes relevant to the Breast Cancer Centre with a special focus on the interfaces; Obligation to implement established guidelines (S3 Guideline as a basic requirement); Description of the cooperation on the tumour documentation; Declaration of consent to cooperate with internal/external audits; Commitment to adhere to the relevant criteria of the requirements for breast cancer centres and to provide the relevant data annually; Agreement on the part of treatment partners to be publicly named as a part of the breast cancer centre (e.g. on the website); 24h access to the main clinical cooperation partners: surgeons, radiologists (with the exception of MRI), oncologic pharmaceutical therapist (gynaecological and/or internal), radiation therapists (1.1.2). Agreements with other treatment partners: written agreements in which willingness engage in cooperation is confirmed are to be signed with treatment partners for the following: Psycho-oncology; Social services; Self-help; Genetic counselling: Gene analysis, family anamnesis (BRCA-1, BRCA-2) and genetic counselling; Physiotherapy; Laboratory (with a round robin test certification); Hospice/palliative medicine; Medical aids supplier; see: ‘Catalogue of Requirements’: https://www.krebsgesellschaft.de/gcs/german-cancer-society/certification/documents.html?file=filesdkg/german-cancer-society/pdf/Certification/Catalogue%20of%20Req%20breast-H1%201%20%2814%2007%202016%29%20EN.pdf; ‘Indicator Sheet’: https://www.krebsgesellschaft.de/gcs/german-cancer-society/certification/documents.html?file=files/dkg/german-cancer-society/pdf/Certification/Indicator%20Sheet%20for%20Breast%20Cancer%20Centres%202017.pdf.
Institutional licencing requirement at national/ regional level. Implemented in 2003.
Detailed information in this PowerPoint-presentation: https://www.krebsgesellschaft.de/gcsgerman-cancer-society/certification.html?file=-files/dkg/deutsche-krebsgesellschaft/con-tent/pdf/ZertifizierungMaterialien%20fuer%20Zentren/160725%20CertificationOfCancerCen-tres_2016.pdf.

ED National Representative

EE
ECIBC National Contacts

ED National Representative
YES

Requirements are defined in the Standards of Cancer Treatment Quality, 2011.

ES
ECIBC National Contacts

ED National Representative
NO

FI
ECIBC National Contacts
YES, MANDATORY
The concept of core teams has been applied in all university hospitals for at least two decades. The university hospital areas (5) take care of treatment of almost all breast cancer cases in the country. This concept is also written in the national guidelines of breast cancer, which are regularly updated by the Finnish Breast Cancer Group. The guidelines are also voluntarily followed in the country.
Used in a non-public quality assurance scheme NOT under national/regional governance.
The concept of core teams has been applied in all university hospitals for at least two decades. The university hospital areas (5 in altogether) take care of treatment of almost all breast cancer cases in the country. This concept is also written in the national guidelines of breast cancer, which are regularly updated by the Finnish Breast Cancer Association. The guidelines are also voluntarily followed in the country.

ED National Representative

FR
ECIBC National Contacts
NO and NOT PLANNED

ED National Representative
YES

Core teams are submitted to six quality criteria, as defined in Cancer Plans 1 & 2, and stated by the Cancer National Institute (INCa).

GR
ECIBC National Contacts
NO and NOT PLANNED

The 2006 European Guidelines should become mandatory in everyday practice in all breast centres in Europe. This would be important even for a country that is undergoing severe economic crisis. An example of what was done in 1978 in Strasbourg under the direction of Charles Marie Gros, graduating the first Senologist (Breast Specialist) in Europe should be followed. The distribution of breast centres is unequal in the geographical area of Greece. A population of 10 million needs at least 30 breast centres applying the 2006 European Guidelines, but in Greece the majority of centres are concentrated in Athens with a total of 16 (both public and private). Protocols for diagnosis and management of breast cancer as well as quality control in mammography and in the general functioning of the breast centre are fundamental.

ED National Representative
NO

HU
ECIBC National Contacts
NO, BUT PLANNED

In Hungary, there are MDMs, and in between sub-specialised breast MDMs. This consists of surgeons, pathologists, radiotherapists and medical oncologists specialised in BC and sometimes radiologist and psychologist. The “breast nurse” is rarely involved.

ED National Representative

IE
ECIBC National Contacts
YES, VOLUNTARY
Each unit in this country has an appropriately trained core team.

This is not embedded in legislation or insurance but it complies with national guidelines that are monitored.

ED National Representative
YES

IT
ECIBC National Contacts
YES, MANDATORY
The members of the Breast Unit Core Team are:
- Clinical Director of Breast Services
- Breast surgeons (including gynaecologists performing breast surgery): two or more nominated surgeons specially trained in breast disease, each of whom must personally carry out primary surgery on at least 50 newly diagnosed cancers. The breast surgeons in the team should be able to undertake basic reconstruction or re-contouring and there should be an arrangement with one or two nominated plastic surgeons (non-core team member) specialised in breast reconstructive and re-contouring techniques. - Breast radiologists: there must be at least two nominated radiologists, fully trained and with continuing experience in all aspects of breast disease and associated imaging, tissue sampling and localisation procedures under image control. They must read a minimum of 1 000 mammograms per year (5 000 for those participating in a screening programme). - Breast pathologists: a nominated lead pathologist, trained in breast disease and cytology. - A nominated radiation oncologist and / or a clinical oncologists carrying out both radiation therapy and chemotherapy. - Breast diagnostic radiographers (Technicians): fully trained radiographers. - Data manager - Patient support staff: at least two breast care nurses and a psychologist well- trained in psycho-oncology.
Embedded in national/ regional legislation. Implemented in 2014.
State-regions agreement on breast units networking issued 18 December 2014.

ED National Representative
YES

LT
ECIBC National Contacts
YES, MANDATORY
In our NCI there is a director of breast unit (breast surgeon) as well as 4 breast surgeons, 6 radiologists working in breast screening as well as diagnostics, 10 radiographers trained in mammography, 3 medical oncologists in multidisciplinary team and mostly working with breast cancer patients, 5 radiation oncologists, 14 medical nurses in breast care, psycho-oncologists, a psychologist, 2 pathologists in MDT and consulting breast pathology cases.
Institutional licensing requirement at national/ regional level; Used in a non-public quality assurance scheme NOT under national/regional governance.
The team In breast cancer care Is defined at National Cancer Institute level, as well as SIS accreditation level. There Is no guidance for MDT from Ministry of Health or other institutions.
The Ministry of Health announced the National Cancer Programme on 24 November 2014 with main tasks for 2014-2025 (available on the Ministry of Health website). No accurate description of breast units and implementation guidance are included but there are more general tasks and objectives for cancer care improvement and assurance.

ED National Representative

LU
ECIBC National Contacts
YES, VOLUNTARY
According to the Breast Cancer Screening Programme (1992), all radiologists working in screening need an accreditation. All of them are doing assessment. The same for the radiographers. Most oncologists work primarily in breast cancer care, but it’s not mandatory. In Luxembourg a National Radiotherapy Centre exists, the radiotherapists who are delivering radiotherapy to breastcancer patient are specialised in breast cancer treatment. No requirement for surgeons, or plastic surgeons.

ED National Representative
NO

LV
ECIBC National Contacts
NO and NOT PLANNED

ED National Representative

MT
ECIBC National Contacts
NO, BUT PLANNED

Breast cancer care is mainly carried out by the following: (a) Two nominated surgeons specially trained in breast disease, each of whom carry out the primary surgery on at least 150 newly diagnosed cancers per year and attend three diagnostic clinics per week; (b) Three nominated radiologists, trained and with continuing experience in all aspects of breast disease and associated imaging, tissue sampling and localisation procedures under image control. Each radiologist reads more than 5 000 mammograms per year (these three radiologists are also responsible for the national organised screening programme). They all attend multidisciplinary meetings for case management and audit purposes; (c) Breast pathologist: the most senior histopathologist is responsible for reviewing the majority of breast pathology and cytology. This senior professional is a member of the EWGBSP (European Working Group on Breast Screening Pathology). The pathology laboratories at MDH participate in the UK NEQUAS (National External Quality Assurance Scheme) for Immunohistochemistry; (d) Breast oncologists: Breast cancer referrals are directed to two out of the four clinical oncologists working in Malta. These two oncologists attend breast MDT meetings. To date there is no medical oncologist engaged with health services in Malta; (e) Radiographers: The radiographers working in the Screening Unit are dedicated to the screening service and are trained specifically for this service. A core group are qualified with an MSc in mammography; (f) Data manager: BU at MDH does not have the services of a data manager to date. Some data management is performed by one of the breast unit nurses; (g) Patient support staff: presently there are 4.5 FTE (full-time equivalent) nurses working with the BU at MDH.

ED National Representative
NO

NL
ECIBC National Contacts

ED National Representative
NO

The organisation of breast cancer treatment is covered by the national guidelines. The organisation of breast cancer treatment has implemented some of the requirements of the 2006 European Guidelines, however on a voluntary basis. There is no legal requirement to comply with the National (and 2006 European Guidelines).

NO
ECIBC National Contacts
NO, BUT PLANNED

ED National Representative
YES

PL
ECIBC National Contacts
NO and NOT PLANNED

ED National Representative

PT
ECIBC National Contacts
NO, BUT PLANNED

ED National Representative

RO
ECIBC National Contacts
NO and NOT PLANNED

ED National Representative

RS
ECIBC National Contacts
NO, BUT PLANNED
Breast cancer patient treatment decisions are made by the Breast Cancer Board. Members of the Board include surgeons, radiologists, radiation oncologists, chemotherapists (medical oncologists), pathologists and others, if needed.
Embedded in national/ regional legislation. Used as reference for reimbursement from insurances at national/ regional level. Implemented in 1980.
Organisation of oncology healthcare since 1980 in Serbia: TQM system improvement. The legal framework consists of:
- Regulation on quality system improvement
- Regulation on content of healthcare services
- Law on Healthcare
- Law on Health Insurance

ED National Representative

SE
ECIBC National Contacts
YES, VOLUNTARY
National Guidelines for the Treatment of Breast Cancer (2014) and The National Clinical Practice Guidelines for Breast Cancer (2014) says: The core team should at least consist of breast surgeon, breast cancer oncologist, pathologist, radiologist and breast care nurse.

Question 2.3 is not applicable. There are National Guidelines for the Treatment of Breast Cancer (2014) provided by The National Board of Health and Welfare as well as National Clinical Practice Guidelines for Breast Cancer (2014).
When needed, most units having a specialist plastic surgeon and psycho-social competence available based on the individual needs.

ED National Representative
YES

Sweden has 21 autonomous counties each including a number of hospitals. The requirements are not mandatory; hence, despite National Recommendations/Guidelines issued by the National Board of Health and Welfare, requirements can be set aside locally/regionally for financial or other reasons. This also applies to core teams. The National Guidelines stipulate that within a core team there should be a breast pathologist, breast radiologist, breast surgeon, breast oncologist and a breast care nurse.

SI
ECIBC National Contacts
NO, BUT PLANNED

ED National Representative
YES

SK
ECIBC National Contacts
NO, BUT PLANNED

ED National Representative

TR
ECIBC National Contacts

ED National Representative

UK
ECIBC National Contacts
YES, MANDATORY
This is the detail of the defined core membership as per the peer review guidelines:
There should be a single named lead clinician for the breast MDT who is also a core team member. The lead clinician of the MDT should have agreed the responsibilities of the position with the lead clinician of the host trust (Note: The role of lead clinician of the MDT should not of itself imply chronological seniority, superior experience or superior clinical ability).
The MDT should provide the names of core team members for named roles in the team. The core team specific to the breast cancer MDT should include: two designated breast surgeons; a clinical oncologist; a medical oncologist (where the responsibility of chemotherapy is not undertaken by the clinical oncology core member); two imaging specialists; two histopathologists; two breast nurse specialist; MDT co-ordinator/secretary; an NHS-employed member of the core or extended team should be nominated as having specific responsibility for users’ issues and information for patients and carers; a member of the core team nominated as the person responsible for ensuring that recruitment into clinical trials and other well designed studies is integrated into the function of the MDT. Notes: • Each clinical core member should have sessions specified in the job plan for the care of patients with breast cancer and attendance at MDT meetings
• Where a medical specialty is referred to, the core team member should be a consultant. Where a medical skill rather than a specialty is referred to, this may be provided by one or more of the core members or by a career grade non-consultant medical staff member.
• The medically qualified core member(s) depend on the cancer site of the MDT.
• The co-ordinator/secretary role needs different amounts of time depending on team workload. See the appendix 2 for an illustration of the responsibilities of this role.
The co-ordinator and secretarial role may be filled by two different named individuals or the same one. It does not occupy the whole of an individual’s job description.
There may be additional core members agreed for the team besides those listed above.
Institutional licencing requirement at national/ regional level. Implemented in 2000.
Compliance is assessed by the national peer review team with local assessment by the hospital cancer team and external verification.

ED National Representative
YES

Table 6: Survey section 5.

Breast Units mandatory requirements implementation stage.

Questions:

2. Core Team–(b)Training

ECIBC:

1. Is there, in the geographical area under your organisation’s responsibility, any kind of requirement that regulates the training standards of the core team as defined in the 2006 European Guidelines? * YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. 

3. If you replied YES, please provide a more detailed description of the training standards, in particular of any deviation from those standards (e.g. training in imaging in mammography–both film-screen and digital)

4. If you replied YES, please report below the implementation framework of the team’s training standards and the respective year of implementation (more than one answer is possible). Embedded in national/regional legislation; Used as reference for reimbursement from insurances at national/regional level; Institutional licencing requirement at national/regional level; Used in a non-public quality assurance scheme under national/regional governance; Used in a non-public quality assurance scheme NOT under national/regional governance

5. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

6. If you wish, please add below your comments/considerations on core team’s training standards mandatory requirement.

ED:

1. Is there in your country any kind of requirement that regulates the training standards of the core team as defined in the 2006 European Guidelines? YES; NO; I do not have this information.

2. If you wish, please add below your comments/considerations on core team’s training standards mandatory requirement.

Country

2b.1 Is there a requirement that regulates the training standards of the core team?
2b.2 Detailed description of training standards [Not included in ED Questionnaire]
2b.3a Implementation framework for the team’s training standards [Not included in ED Questionnaire]
2b.4 Training details [Not included in ED Questionnaire]
2b.5 Training comments [2b.i Comments for ED Questionnaire]

AT
ECIBC National Contacts

ED National Representative
YES

Training and qualification for the core team members are defined in the catalogue of the ÖZK.

BE
ECIBC National Contacts
YES, MANDATORY

Embedded in national/ regional legislation. Implemented in 2007.

ED National Representative

BG
ECIBC National Contacts
YES, MANDATORY

Embedded in national/regional legislation. Implemented in 1987. Used as reference for reimbursement from insurance at national/regional level. Implemented in 2005.
National expert groups in oncology were established in 1987 following the Order of the Ministry of Health. In 2005, the National Health Insurance Fund introduced additional requirements. The Order of the Ministry of Health about the specialisation of the physicians regulates the mechanism for specialisation in various areas of oncology, including surgery, radiology, and chemotherapy.

ED National Representative

CH
ECIBC National Contacts
NO and NOT PLANNED

ED National Representative
I do not have this information.

CY
ECIBC National Contacts
YES, VOLUNTARY

ED National Representative
NO

CZ
ECIBC National Contacts
YES, MANDATORY
Training is supervised by the Czech Radiological Society and concludes with a test.
Embedded in national/ regional legislation. Implemented in 2010. Used as reference for reimbursement from insurance at national/regional level. Implemented in 2002. Institutional licencing requirement at national/regional level. Implemented in 2002.
The Commission for the Screening of Breast Cancer at the Ministry of Health (Komda) - is composed by radiologists - breast radiologists, members of professional societies dealing with the diagnosis and treatment of breast diseases, the State Office for Nuclear Safety (SONS), General Health Insurance Company (VZP), the Association of Health Insurance Companies (associates other health insurers) and the Ministry of Health. Commission experts for Breast Radiology (Komda) - are represented mainly by specialists from the Radiological Society JEP, the Association of Non-State Outpatient Radiology and the Association of Czech Breast Radiologists (AMA-CZ).
Training in accordance with EUSOMA and Europa Donna guidelines.

ED National Representative

DE
ECIBC National Contacts
YES, MANDATORY
For every member of the network we have requirements for qualification (at the beginning of every chapter) and further training (at the end of every chapter). In addition: requirements for attending tumour boards, morbidity-and-mortality-conferences, quality-circles. (see: https://www.krebsgesellschaft.de/gcsgerman-cancer-society/certification/documents.html?file=files/dkg/german-cancer-soci-ety/pdf/Certification/Catalogue%20of%20Req%20breast-H1%201%20%2814%2007%202016%29%20EN.pdf)
Institutional licencing requirement at national/ regional level. Implemented in 2003.
see 2b.2

ED National Representative

EE
ECIBC National Contacts

ED National Representative
YES

Requirements are defined in the Standards of Cancer Treatment Quality, 2011.

ES
ECIBC National Contacts

ED National Representative
NO

FI
ECIBC National Contacts
YES, VOLUNTARY

Institutional licencing requirement at national/ regional level.
The person responsible for providing breast services is expected to keep her/his skill up to date and it is also strongly recommended to participate in training (3-10 days each year). However, this is not mandatory.

ED National Representative

FR
ECIBC National Contacts
NO and NOT PLANNED
See 4vii comments

See 4vii comments.

ED National Representative
YES

Continuous training is foreseen.

GR
ECIBC National Contacts
NO and NOT PLANNED

Each member of the core team of the Breast Centre must have a specialisation and global education in Senology and should follow a continued Senologic education on a regular basis. Breast centres’ budgets should include this provision.

ED National Representative
NO

HU
ECIBC National Contacts
NO, BUT PLANNED

We consider international guidelines available in BC as core material for team training.

ED National Representative

IE
ECIBC National Contacts
YES, VOLUNTARY
Training is to a high standard but voluntary.

ED National Representative
YES

IT
ECIBC National Contacts
YES, MANDATORY
Training is expected at a central (regional level) with training targeted to individual job profiles. Multidisciplinary training (when appropriate) is strongly recommended. The training is aimed at achieving the stated standard professional skills as well as non-technical ones.
Embedded in national/ regional legislation. Implemented in 2014.
State-regions agreement on breast units networking issued 18 December 2014.

ED National Representative
NO

LT
ECIBC National Contacts
YES, MANDATORY
All standards are common for all medical personal in Lithuania and is regulated by Ministry of Health and the Accreditation Department.
Used as reference for reimbursement from insurance at national/ regional level.

ED National Representative

LU
ECIBC National Contacts
YES, VOLUNTARY
The Ministry of Health has to organise continuing medical accreditation for all physicians; but, it is has not been done. The Ministry also responsible for training radiologists and radiographers in digital mammography (films are no longer used), and in other aspects of breast imaging (e.g. MRI).
Embedded in national/regional legislation. Implemented in 2003.
Memorial A, 167, du 19 Novembre 2003: Convention entre l’Etat du Grand Duché de Luxembourg et l’Union des caisses de maladie portant organisation d’un programme permanent de dépistage précoce du cancer du sein par mammographie.

ED National Representative
NO

LV
ECIBC National Contacts
NO and NOT PLANNED
Board certification is mandatory to practice in Latvia.

Board certification is mandatory to practice in Latvia.

ED National Representative

NL
ECIBC National Contacts

ED National Representative
YES

MT
ECIBC National Contacts
NO, BUT PLANNED

ED National Representative
NO

NO
ECIBC National Contacts
YES, VOLUNTARY
Recommended for radiologists: reading 5000 screening exams annually and doing diagnostic mammography.

The radiologist’s interpretation scores, recall rate, etc. is continuously monitored and reported.

ED National Representative
NO

PL
ECIBC National Contacts
NO and NOT PLANNED

ED National Representative

PT
ECIBC National Contacts
NO and NOT PLANNED

ED National Representative

RO
ECIBC National Contacts
NO and NOT PLANNED

ED National Representative

RS
ECIBC National Contacts
YES, MANDATORY
In the Republic of Serbia, there are official training curricula for educating radiologists (training for future radiologists as defined by universities - medical faculties). In addition, the national screening programme defines standards for additional education of radiologists and radiographers (radiology technicians) for screening mammography. Eighty radiologists and 100 radiographers for screening mammography were trained via an EU-funded project.
According to the legal framework of the Republic of Serbia concerning quality improvement, continual medical education for radiologists/radiographers is required for obtaining and renewing licenses. The Serbian Medical Association and Serbian Medical Chamber (for radiologists) as well as the Serbian Chamber of Healthcare professionals (for radiographers) are legally in charge of monitoring and evaluation of this issue.
Embedded in national/ regional legislation; Institutional licencing requirement at national/ regional level.

ED National Representative

SE
ECIBC National Contacts
NO and NOT PLANNED

ED National Representative
NO

SI
ECIBC National Contacts
NO, BUT PLANNED

ED National Representative
YES

SK
ECIBC National Contacts
NO, BUT PLANNED

ED National Representative

TR
ECIBC National Contacts

ED National Representative

UK
ECIBC National Contacts
YES, MANDATORY
Most specialties complete a general training e.g. in surgery, oncology, radiology or radiography, but then undertake additional specialist training in breast cancer diagnosis and treatment. For some disciplines this is sub-specialisation at the end of training, but there are also more specific training programmes e.g. the national surgical oncoplastic fellowship scheme, and specific training for breast radiographers.
Now, doctors and other practitioners would not get appointed to a post in a breast unit without this sub-specialty training.
Institutional licencing requirement at national/regional level. Implemented in 2000.
Assessed in the national peer review process.

ED National Representative
YES

Table 7: Survey section 5.

Breast Units mandatory requirements implementation stage.

Questions:

A. Core Team–(c) Continuing medical education (CME)

ECIBC:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the CME of the core team as defined in the 2006 European Guidelines? * YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. If you replied YES, please provide a more detailed description of the continuing medical education contents/organisation (e.g. is CME outsourced to licenced trainers? How is licencing awarded?)

3. If you replied YES, please report below the implementation framework of the team’s CME and the respective year of implementation (more than one answer is possible). Embedded in national/regional legislation; Used as reference for reimbursement from insurances at national/regional level; Institutional licencing requirement at national/regional level; Used in a non-public quality assurance scheme under national/regional governance; Used in a non-public quality assurance scheme NOT under national/regional governance

4. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

5. If you wish, please add below your comments/considerations on core team’s CME mandatory requirement

ED:

1. Is there in your country any kind of requirement that regulates the CME of the core team as defined in the 2006 European Guidelines? YES; NO; I do not have this information

2. If you wish, please add below your comments / considerations on core team’s CME mandatory requirement

Country

2C.1 Is there a requirement that regulates the CME of the core team?
2C.2 Detailed description of CME contents/organisation [Not included in ED Questionnaire]
2C.3a Implementation framework of the team’s CME [Not included in ED Questionnaire]
2C.4 CME details [Not included in ED Questionnaire]
2C.5 CME comments [2C.1 Comments for ED Questionnaire]

AT
ECIBC National Contacts

ED National Representative
YES

The continuing medical education is regulated not only for the core team but for the nursing team, social workers and psycho-oncologist as well.

BE
ECIBC National Contacts
NO and NOT PLANNED

ED National Representative

BG
ECIBC National Contacts
YES, VOLUNTARY
The Bulgarian Society of Physicians has a system for CME. The Department for Specialisation of Medical Doctors regulates the training of specialists.
Embedded in national/regional legislation. Implemented in 2000.
Regulated by the Bulgarian Association of Physicians.

ED National Representative

CH
ECIBC National Contacts
NO and NOT PLANNED

ED National Representative
I do not have this information.

CY
ECIBC National Contacts
YES, VOLUNTARY
Please see above (continuous training).

ED National Representative
NO

CZ
ECIBC National Contacts
YES, MANDATORY
The condition for practicing medicine in the Czech Republic is to be involved in continuous medical education within the membership in the Czech Medical Chamber.
Embedded in national/ regional legislation. Implemented in 2010. Used as reference for reimbursement from insurance at national/regional level. Implemented in 2002. Institutional licencing requirement at national/regional level. Implemented in 2002.
The Czech Medical Chamber gives authorisation to work with a doctor specialising in radiotherapy, chief physician at the breast unit, etc. on the basis of compliance attestation exams and credits for educational courses.
Each specialist must annually complete a specified number of subsidised educational training hours.

ED National Representative

DE
ECIBC National Contacts
YES, MANDATORY
In Germany CME is obligatory for every medical doctor having contact with patients. They need a specific number of credit points per year in order to be able to issue invoices.
Embedded in national/ regional legislation
See: German Medical Association: “(Model) Speciality Training Regulations” ; http://www.bundesaerztekammer.defileadmin/user_upload/downloads/MFBO2013en.pdf

ED National Representative

EE
ECIBC National Contacts

ED National Representative
YES

Requirements are defined in the Standards of Cancer Treatment Quality, 2011.

ES
ECIBC National Contacts

ED National Representative
NO

FI
ECIBC National Contacts
YES, VOLUNTARY
For medical doctors, specialist training in his/her own field (3-10 days per year); Training is strongly recommended by the Finnish Medical Association. So this is a (strong) recommendation, not a requirement.

See above.
Education is recorded on each expert personal education registry, which can be inspected during audits etc., but there is no legal obligation for clinicians. Only for the personnel within mammography screening it is mandatory and in line with the European guideline requirements.

ED National Representative

FR
ECIBC National Contacts
NO and NOT PLANNED

ED National Representative
YES

Imaging equipment is regularly checked by competent authorities.

GR
ECIBC National Contacts
NO and NOT PLANNED
Each member of the ‘core team’ takes care of its own CME by attending congresses and seminars (national and international). In the majority of the cases, the registration fees are covered by the individual.

ED National Representative
NO

HU
ECIBC National Contacts
YES, MANDATORY
Regular postgraduate training of various aspects of clinical oncology; not limited to BC teamwork.
Embedded in national/ regional legislation. Implemented in 2005.
250 CME credit should be collected within 5 years’ time.

ED National Representative

IE
ECIBC National Contacts
YES, MANDATORY
Through the sub-speciality college
Embedded in national/ regional legislation

ED National Representative
YES

IT
ECIBC National Contacts
YES, MANDATORY
Continuing medical education refers to a more general body of laws: CME is planned and performed on an individual basis by each health operator.
Embedded in national/ regional legislation; Institutional licencing requirement at national/ regional level.
The National Programme for CME was launched in 2002, according to the Legislative Decree 502/1992 supplemented by Decree 229/1999, which had established the obligation of continuing education for health professionals. The State-Regions agreement of 1 August 2007 defines the reorganisation of the CME programme and establishes the new organisation and rules for its governance. It identifies the National Health Services Agency as the “common home “at national level for the management CME.

ED National Representative
NO

CME exists for all specialists.

LT
ECIBC National Contacts
NO and NOT PLANNED
There is a regulation for training and skills improvement every 5 years for medical doctors and nurses in Lithuania. CME credits are also possible for this purpose.

ED National Representative

LU
ECIBC National Contacts
NO, BUT PLANNED
In the framework of the cancer plan, a CME would be organised, but there is no handbook planned.

ED National Representative
NO

LV
ECIBC National Contacts
NO and NOT PLANNED

CME is mandatory for board certification and re-certification (takes place every 5 years for medical specialists)

ED National Representative

MT
ECIBC National Contacts
NO, BUT PLANNED

ED National Representative
NO

NL
ECIBC National Contacts

ED National Representative
YES

NO
ECIBC National Contacts
NO and NOT PLANNED

ED National Representative
NO

PL
ECIBC National Contacts
YES, MANDATORY
General requirements for CME are implemented by the Medical Board (applies to physicians only). There is no particular organisation responsible. There are a required number of points that are verified by the Medical Board.
Embedded in national/ regional legislation. Implemented in 1997

ED National Representative

PT
ECIBC National Contacts
NO and NOT PLANNED

ED National Representative

RO
ECIBC National Contacts
YES, MANDATORY
Every medical doctor has to acquire 40 CME points per year (200 every 5 years) to renew his professional accreditation. CME points can be obtained through several training programmes, which are all certified as “CME providers” (e.g. European UEMS/ACOE, and US AMA points are recognised). However, this is not specific for oncologists or breast cancer specialists; it is a general requirement for all MDs.
Embedded in national/ regional legislation. Implemented in 1995.

ED National Representative

RS
ECIBC National Contacts
YES, MANDATORY
As described above there is a system of CME in the country for radiologists, oncologists, surgeons and other medical doctors as well as continuing education for healthcare professionals (radiographers). The legal framework in Serbia for CME is as listed below: Law on Healthcare (Official Gazette 107/2005,) Law on Healthcare Chambers (Official Gazette 107/2005 i 99/2010), Regulation on licensing of healthcare professionals (Official Gazette 119/2997, 23/2009, 40/2010).
Embedded in national/ regional legislation.
CME is provided and organized by:
- Serbian Medical Society
- Serbian Medical Chamber
- Medical faculties
- Institute for Oncology and Radiology of Serbia
- Institute for Oncology of Vojvodina, Sremska Kamenica
- Clinical Centre Nis
- Clinical Centre Kragu-jevac

Key legal documents: You can find PDF files on the official website of the Cancer Screening Office
http://www.skriningsrbija.rs/srl/dokumenta/zakoni/

ED National Representative

SE
ECIBC National Contacts
NO and NOT PLANNED
It is of course very natural that the participants in the care team participate in CME activities, but there are no formal regulations.

ED National Representative
NO

SI
ECIBC National Contacts
NO, BUT PLANNED

In general, CME is mandatory for oncologists, but it is not specified for breast cancer.

ED National Representative
YES

SK
ECIBC National Contacts
NO, BUT PLANNED

ED National Representative

TR
ECIBC National Contacts

ED National Representative

UK
ECIBC National Contacts
YES, MANDATORY
Each specialty has to complete a defined amount of CME relevant to breast cancer diagnosis and treatment each year and for doctors; this is assessed at the annual appraisal and mandated by the General Medical Council.
Institutional licencing requirement at national/ regional level. Implemented in 1995.
Mandated by the General Medical Council.

ED National Representative
YES

Table 8: Survey section 6.

Breast Units non-mandatory requirements implementation stage.

Questions:

A. Equipment (9.6.1)

Definition from the 2006 European Guidelines

9.6.1. The unit must be in possession of all necessary imaging equipment for complete and adequate breast diagnosis.

ECIBC:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the imaging equipment requirement 9.6.1 as defined above? * YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

3. If you wish, please add below your comments/considerations on the imaging equipment voluntary requirement

ED:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the imaging equipment requirement 9.6.1 as defined above? YES; NO; I do not have this information

2. If you wish, please add below your comments/considerations on the imaging equipment voluntary requirement

B. Equipment (9.6.2)

Definition from the 2006 European Guidelines

9.6.2. The minimum equipment in a department giving radiotherapy must be two mega-voltage units, a brachytherapy unit, a simulator and a computerised planning system. The department must have a radiotherapeutic quality control programme for breast cases.

ECIBC:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the radiotherapeutic equipment requirement 9.6.2 as defined above? * YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

3. If you wish, please add below your comments/considerations on the radiotherapeutic equipment voluntary requirement

ED:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the radiotherapeutic equipment requirement 9.6.2 as defined above? YES; NO; I do not have this information

2. If you wish, please add below your comments/considerations on the radiotherapeutic equipment voluntary requirement

Country

A1. Is there a requirement that regulates the imaging equipment?
A2-A3 Imaging equipment details/comments
B1. Is there a requirement that regulates radiotherapeutic equipment?
B2-B3 Radiotherapeutic equipment details/comments

AT
ECIBC National Contacts

ED National Representative
YES
The ÖZK catalogue defines the imaging equipment required.
YES
The ÖZK catalogue defines the radiotherapeutic equipment required in accordance with the 2006 European Guidelines.

BE
ECIBC National Contacts
YES, MANDATORY
See previous questions, Royal Decree - 26 April 2007
NO and NOT PLANNED
The Hospital Law and Royal Decree on Radiation Oncology Services regulate radiotherapeutic equipment. The minimum technical equipment is specified for radiotherapy services in general, but not specifically for breast cancer. The Royal Decree for Specialised Oncology Care Programmes for Breast Cancer indicates, as recognition criteria for breast units, that there must be the provision of radiotherapy service or an agreement with a hospital that has a radiotherapy service.

ED National Representative

BG
ECIBC National Contacts
YES, MANDATORY
Regulation by the Ministry of Health and the National Health Insurance Fund.
YES, MANDATORY
There are Regulations of the Ministry of Health and the National Health Insurance Fund, and accreditation requirements of the National Hospital of Oncology.

ED National Representative

CH
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative
I do not have this information.

I do not have this information.

CY
ECIBC National Contacts
YES, MANDATORY
There is a medical devices department that regulates medical equipment in accordance with EU standards (digital mammographers etc.).
YES, MANDATORY
BOCOC (Bank of Cyprus Oncology Centre) is a partner of the Breast Centre Unit. The Centre meets all EU standards and is accredited.

ED National Representative
I do not have this information.
There is no breast unit in compliance with the 2006 European Guidelines; however, different centres have the necessary imaging equipment and it is regularly checked.
YES
The Oncology Centre meets all requirements.

CZ
ECIBC National Contacts
YES, MANDATORY
The Ministry of Health Decree no. 221/2010 Col specifies requirements for material and technical equipment of health facilities. The inspection of BU equipment is part of the accreditation process.
YES, MANDATORY
Radiotherapy is an essential part of a Comprehensive Cancer Centre. Checking radiotherapy equipment is part of the accreditation process of the Comprehensive Cancer Centre.

ED National Representative

DE
ECIBC National Contacts
YES, MANDATORY
For national mammography screening radiologists, legally mandatory requirements for the imaging equipment are in place. For the voluntary certification of Breast Cancer Centres there are mandatory requirements for imaging equipment: Excerpt from Chapter 3 Breast ultrasound; For breast diagnostics, only ultrasound equipment with a frequency of £7.5 MHz is to be used; Ultrasound equipment must correspond with DIN EN 61157; Requirement for performing breast ultrasound: Proof of a qualification in breast ultrasound (Fachkunde Mammasonografie [safeguarded], Ultrasound Agreement National Association of Statutory Health Insurance Physicians, DEGUM 1); Standardised documentation of the diagnostic findings according to the S3 guideline (e.g., use of US BI-RADS classification); Stereotaxis; The procedure should be digital and analogue only in exceptional cases; Marking and biopsies must be possible and this option should be employed; MRI: Access to MRI examinations must be ensured. In the event that an MRI cannot be performed directly on the site of the
YES, MANDATORY
The requirements regulating radiotherapeutic equipment are described in Chapter 7 (esp. 7.6) of the Catalogue of Requirements, see: https://www.krebsgesellschaft.de/gcs/german-cancer-society/certification/documents.html?file=files/dkg/german-cancer-society/pdf/Certification/Catalogue%20of%20Req%20breast-Hi%20i%20%2814%2007%202016%29%20EN.pdf. breast cancer centre, access must be regulated by a cooperation agreement. (see more detailed: https://www.krebsgesellschaft.de/gcs/german-cancer-society/certification/documents.html?file=-files/dkg/german-cancer-society/pdf/Certification/Catalogue%2oof%2oReq%20breast-Hi%20i%20%2814%2007%202016%29%2oEN.pdf)

ED National Representative

EE
ECIBC National Contacts

ED National Representative
YES
Requirements are defined in the Standards of Cancer Treatment Quality, 2011.
YES
Requirements are defined in the Standards of Cancer Treatment Quality, 2011.

ES
ECIBC National Contacts

ED National Representative
NO

NO

FI
ECIBC National Contacts
YES, MANDATORY
For breast screening units, the European Guidelines are followed (mandatory).
YES, MANDATORY
The Finnish Radiation and Nuclear Safety Authorisation (STUK) audits and provides requirements for the radiotherapy units. STUK supervises the number of radiotherapy equipment and the number of personnel required per each unit, these numbers are based on the number of patients treated. STUK can withdraw a radiotherapy permit when the unit does not comply with minimal requirements set by law.

ED National Representative

FR
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative
YES
Imaging equipment is regularly checked by competent authorities.
YES

GR
ECIBC National Contacts
YES, VOLUNTARY
On voluntary basis, a breast centre can be equipped with the following imaging equipment: 1. Mammographer (analog, CR mammographer, digital mammographer or tomosynthesis); 2. 3D U/S; 3. Elastography; 4. Stereotactic localisation of the non-palpable lesions; 5. MRI; A breast centre could have 2, 3 or all of the above types of equipment.
YES, VOLUNTARY
Out of the 13 hospitals that responded to the questionnaire, six reported that they have a radiotherapy department implementing quality control guidelines. In many hospitals radiotherapy equipment is old; an attempt to replace some of it is made through sponsorships from the private sector.

ED National Representative
NO

NO

HU
ECIBC National Contacts
YES, MANDATORY

YES, MANDATORY

ED National Representative

IE
ECIBC National Contacts
YES, VOLUNTARY

YES, VOLUNTARY

ED National Representative
YES

YES

IT
ECIBC National Contacts
YES, MANDATORY
State-regions agreement issued 18 December 2014.
YES, MANDATORY
State-regions agreement issued 18 December 2014.

ED National Representative
YES
See document from the Italian Ministry of Health (18 December 2014 Rep.Atti 185/CSR).
YES
See document from the Italian Ministry of Health (18 December 2014 Rep.Atti 185/CSR).

LT
ECIBC National Contacts
YES, MANDATORY
The NCI is following SIS requirements for a dedicated and accredited breast cancer centre as well as equipment. Digital mammography, digital tomosynthesis, stereotactic breast biopsy table, ultrasound units, and breast MRI are available at our institution. At this time we are implementing vacuum assisted US, stereo and MRI guided biopsy.
YES, MANDATORY
Our equipment : Clinac 2100 C/D – 2006; Clinac iX/2100 C/D – 2007; Clinac iX – 2011; Clinac 600 C/D – 2009; Brachytherapy Vari-source 200 – 2002 m.

ED National Representative

LU
ECIBC National Contacts
NO and NOT PLANNED
The Ministry of Health has a role as consultant. A hospital request for new equipment has to be approved by the health insurance company, but hospitals can also order new equipment with their own budgets. For breast care, all hospitals have the imaging equipment needed; the Ministry of Health controls mammographs.
YES, MANDATORY
The National Radiotherapy Centre fulfils all the international criteria

ED National Representative
YES

YES
Available in one national centre.

LV
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative

MT
ECIBC National Contacts
NO, BUT PLANNED
The imaging equipment available and planned includes: *two full field digital mammography machines with stereo guided equipment. “ultrasound equipment used for recalls and biopsies is equipped with 2D and 3D probes. *MRI used is a 3 Tesla with dedicated breast software. “currently seeking to acquire a dedicated vacuum assisted MRI stereotactic equipment.
NO, BUT PLANNED
The following is the radiotherapy equipment and capabilities available in Malta to date: *3 Linear Accelerators 2 of which are enabled for IMRT and IGRT (2 x Elekta Versa HD and 1 x Elekta Platform) “Planning Stations - XIO and MONACO systems *1 Large Bore CT Simulator *Patients requiring Brachytherapy are currently referred to a centre in the UK.

ED National Representative
NO

NO

NL
ECIBC National Contacts

ED National Representative
YES

YES

NO
ECIBC National Contacts
YES, MANDATORY
Regulated by the Norwegian Radiation Protection Authorities. http://www.nrpa.no/dav/a4e26fdc6c.pdf.
YES, MANDATORY
Regulated by the Norwegian Radiation Protection Authorities.

ED National Representative
YES

YES

PL
ECIBC National Contacts
YES, MANDATORY
Reference to the European guidelines for quality assurance in breast cancer and diagnosis (4th Edition).
YES, MANDATORY
As specified by the Minister of Health on 26 April 2013 (Journal of Laws pos. 874). The mandatory equipment includes two mega-voltage units, a simulator and a computerised planning system and a quality-control programme. Brachytherapy unit is not required.

ED National Representative

PT
ECIBC National Contacts
NO, BUT PLANNED

NO, BUT PLANNED

ED National Representative

RO
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative

RS
ECIBC National Contacts
YES, MANDATORY
There is a standard for imaging equipment within departments for radio-diagnostic procedures. The Republic Expert Committee is providing professional recommendations for innovations of technology including equipment concerning breast cancer screening. The Ministry of Health is obliged to provide equipment for public institutions.
NO, BUT PLANNED
There is a standard for the equipment for the departments giving radiotherapy. Departments do have a radio therapeutic quality control programme for breast diseases. A large amount of equipment is out of date, but the Ministry of Health is planning to procure new equipment for radiotherapy at republic level (procurement procedure has been started by Ministry of Health).

ED National Representative

SE
ECIBC National Contacts
NO and NOT PLANNED
Laws and regulations for radiation safety are written and governed by The Swedish Radiation Safety Authority.
NO and NOT PLANNED

ED National Representative
NO

NO

SI
ECIBC National Contacts
NO, BUT PLANNED
We have no requirement that regulates the imaging equipment requirement, but two breast units have the required equipment.
NO, BUT PLANNED
We have no requirement that regulates the radiotherapeutic equipment requirement, but one breast unit has the required equipment.

ED National Representative
YES

YES

SK
ECIBC National Contacts
i do not know

i do not know

ED National Representative

TR
ECIBC National Contacts

ED National Representative
YES

YES

UK
ECIBC National Contacts
YES, MANDATORY
Assessed via the National Health Service Breast Screening Programme Quality Assurance Programme with a three yearly review and check of the equipment.
NO and NOT PLANNED
There are however copious quality control processes around all radiotherapy planning. Most units would have more than the minimum requirements outlined above. There is no regulation regarding department size; although, there are recommendations that a department should have at least two Linacs.

ED National Representative
YES

YES

Table 9: Survey section 6.

Breast Units non-mandatory requirements implementation stage.

Questions:

C. Facilities/ Services (9.7.1)

Definition from the 2006 European Guidelines

Clinics (see definition in Section 9.4). Consultations for Breast patients should be held separately, i.e., not as part of general surgery.

New patient clinics

At least one clinic per week for newly referred symptomatic women must be held. A Unit diagnosing 150 new cancers per year must expect over 1500 new referrals of symptomatic women (= approximately 30 per week).

Suggested outcome measures for the waiting times are given in Chapter 5. A suggested good practice is that all newly referred women with breast symptoms should be offered an appointment within 10 working days of receipt of the referral.

Clinics to which patients are referred or self-referred must be staffed by a surgeon, a radiologist and radiographers from the breast care team. Multidisciplinary working must allow all standard investigations for triple assessment (clinical examination and all appropriate imaging and tissue diagnostic procedures) to be completed at one visit. Where possible the finding of no abnormality or a confirmed diagnosis of a benign lesion should be communicated to the patient at that visit.

ECIBC:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the new patient clinics as defined above? * YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do no know

2. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

3. If you wish, please add below your comments/considerations on the new patient clinics voluntary requirement

ED:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the new patient clinics as defined above? YES; NO; I do not have this information

2. If you wish, please add below your comments/considerations on the new patient clinics voluntary requirement

D. Facilities/Services (9.7.2)

Definition from the 2006 European Guidelines

Communication of the Diagnosis and Treatment Plan

It may not be possible (now that core biopsy is most often used) or may not be considered appropriate by the unit to give the diagnosis of cancer at the initial visit. Women found to have breast cancer should receive that diagnosis within 5 working days. The diagnosis should be ideally communicated personally by the surgeon: if it is communicated by the radiologist, then the surgeon (±) the oncologist must personally advice the patient on treatment. It is recommended that a breast care nurse (or) psychologically trained person (see 9.5.2.8) be present to discuss fully with the patient the options for treatment and to give emotional support.

If a patient has clear advanced breast cancer it may be more appropriate that an oncologist rather than a surgeon gives the diagnosis if the patient’s treatment does not involve surgery.

A suitable room with sufficient privacy must be available. In units in which preoperative irradiation or primary medical therapies are used, cases which might be suitable for these should be seen jointly by a surgeon and radiation or medical oncologist before treatment commences.

A diagnosis should not be given to a patient by letter or on the telephone, unless at the specific request of the patient given adequate and full informed choice.

ECIBC:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the communication of the diagnosis and treatment plan as defined above? * YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

3. If you wish, please add below your comments/considerations on the communication of the diagnosis and treatment plan voluntary requirement

ED:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the communication of the diagnosis and treatment plan as defined above? YES; NO; I do not have this information

2. If you wish, please add below your comments/considerations on the communication of the diagnosis and treatment plan voluntary requirement

E. Facilities/Services (9.7.3)

Definition from the 2006 European Guidelines

Multidisciplinary Case Management Meetings (MDM’s)

All members of the core team must attend the Multidisciplinary Meeting (MDM), which must be held at least weekly.

The following should be discussed:

cases in which the diagnosis is as yet uncertain e.g., following core biopsy cases in whom the diagnosis of cancer is confirmed and who may be considered for primary medical therapy

all cases following surgery on receipt of the histopathology for discussion of further care and

cases in follow-up who recently have undergone diagnostic investigations for possible symptoms of recurrent or advanced

disease It is possibly more convenient to have two MDM’s per week:

one for cases in diagnosis attended by surgeons, radiologists and pathologists and one for post-operative consideration of prognosis and adjuvant therapies and for cases investigated for disease recurrence (oncologists, surgeons, radiologists and pathologists).

ECIBC:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the MDMs as defined above? * YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

3. If you wish, please add below your comments/considerations on the MDMs voluntary requirement

ED:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the MDMs as defined above? YES; NO; I do not have this information

2. If you wish, please add below your comments/considerations on the MDMs voluntary requirement

Country

C1. Is there a requirement that regulates new patient clinics?
C1-C2 Patient clinics details/comments
D1. Is there a requirement that regulates the communication of the diagnosis and treatment plan?
D2-D3 Communication details/comments
E1. Is there a requirement that regulates Multidisciplinary case management meetings (MDM)?
E2-E3 MDM details/comments

AT
ECIBC National Contacts

ED National Representative
YES
The ÖZK catalogue defines all these requirements. The staff and waiting times are also defined and measured.
YES
These requirements are defined in accordance with the 2006 European Guidelines. Usually, times are short. All key figures are continuously measured and benchmarked annually.
YES
The ÖZK catalogue defines the requirements for MDMs in accordance with the 2006 European Guidelines. We call these meetings “boards” or “conferences”.

BE
ECIBC National Contacts
NO and NOT PLANNED

YES, MANDATORY
Royal Decree 26 April 2007. The breast unit has to be sufficiently equipped to provide diagnosis within five working days, and the diagnosis must be communicated by the lead physician. A nurse and psychologist have to be available at the time of the communication.
YES, MANDATORY
Royal Decree 26 April 2007. Multidisciplinary meetings are mandatory on a weekly basis.

ED National Representative

BG
ECIBC National Contacts
YES, MANDATORY
There are Ministry of Health and National Health Insurance Fund documents as well as accreditation requirements for the National Hospital of Oncology.
YES, MANDATORY
There are Ministry of Health and National Health Insurance Fund documents as well as accreditation requirements for the National Hospital of Oncology
YES, MANDATORY
There are Ministry of Health and National Health Insurance Fund documents as well as accreditation requirements for the National Hospital of Oncology.

ED National Representative

CH
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative
I do not have this information.

I do not have this information.

I do not have this information.

CY
ECIBC National Contacts
YES, MANDATORY
The policy of the MOH is to follow the EU guidelines. Currently, there is no legislative framework. Since November 2014, the Council of Ministers decided the gradual upgrading of the breast unit.
YES, VOLUNTARY
There are regulations regarding communication that are restricted by the capacity of our services.
YES, VOLUNTARY
We are in the process of turning this practice into a mandatory procedure.

ED National Representative
NO
There are no requirements regulating this; however, the oncology centre’s breast department meets all the guideline requirements, including number of cases, waiting times, number of new patients, etc. A breast team meets once a week.
NO
Diagnosis is not received within 5 working days due to histopathology delay. Diagnosis is communicated by surgeon or radiologist. There are no breast nurses.
NO
No requirement but the multidisciplinary team meets once a week to discuss all new cases. This has greatly improved services to women.

CZ
ECIBC National Contacts
YES, VOLUNTARY
New breast units in the Czech Republic are established based on the needs of the regions. Their number restricts the payment of insurance contracts.
YES, VOLUNTARY
Biopsy is communicated to patients within 5 business days individually. The patient may attend multidisciplinary team meetings as well as choose a surgeon and oncologist.
YES, MANDATORY
MDM is held every week. The team solves the indication of treatment for all new patients and patients with recurrence requiring other than oncological treatment. The patient may attend multidisciplinary team meetings as well as choose a surgeon and oncologist.

ED National Representative

DE
ECIBC National Contacts
YES, MANDATORY
In Germany we don’t follow the single entry port concept. The clinics must be held by a consultant. For breast cancer, in nearly all of the centres, it is the gynaecologist’s responsibility. All patients must be discussed interdisciplinary as soon as their diagnostic is finished and/or post-operative but not in the clinics. (see: Catalogue of Requirements: Chapter 2, page 17 et seq.)
YES, MANDATORY
The requirements regulating the communication of the diagnosis and treatment plan are described in Chapter 2.1.9, 2.1.10, 1.6.4 and 1.6.5, in addition more requirements in Chapter 1.4 and 1.5 of the Catalogue of Requirements, see: https://www.krebsgesellschaft.de/gcs/german-cancer-society/certification/documents.html?file=files/dkg/ german-cancer-soci-ety/pdf/Certification/Catalogue%2oof%20 Req%2obreast-H1%201%20%2814%20 07%202016%29%20EN.pdf.
YES, MANDATORY
The requirements regulating the MDM are described in Chapter 1.2 of the Catalogue of Requirements, see: https://www.krebsgesellschaft.de/gcs/german-cancer-society/certification/documents.html?file=files/dkg/german-cancer-soci-ety/pdf/Certification/Catalogue%20of%20Req%20breast-Hi%201%20%2814%2007%202016%29%20EN.pdf.

ED National Representative

EE
ECIBC National Contacts

ED National Representative
YES

YES

YES

ES
ECIBC National Contacts

ED National Representative
NO

NO

NO

FI
ECIBC National Contacts
YES, VOLUNTARY
The organisation of breast services is planned and executed regionally (in five university hospital areas). Organisation and tasks are agreed at upper management level (within the University Hospital’s management). Any decision on new breast services will be based on clear requirements and needs.
YES, VOLUNTARY
The over-mentioned recommendations are followed as much as possible, but this is not mandatory.
YES, VOLUNTARY
All breast cancer cases (and in case needed, also recurrences of breast cancers) should be and are being discussed in MDMs. MDMs are recommended in the national treatment guidelines written by the Finnish Breast Cancer Group. As far as I know, the recommendation is followed throughout Finland in all the units where breast cancer is treated.

ED National Representative

FR
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED
See 4vii comments
NO and NOT PLANNED

ED National Representative
NO

YES
An increasing number of public and private hospitals, and anti-cancer centres provide diagnosis in one day by the oncologist. Further communication is then given by an oncologic pivot nurse providing the patient with details and answers.
YES
MDM are mandatory at least twice a month (French Health Authority, INCa).

GR
ECIBC National Contacts
NO and NOT PLANNED

YES, VOLUNTARY
Communication to patients should be given by Senologist (Surgeon or Gynecologist) in a quiet environment.
YES, VOLUNTARY
The 2006 European Guidelines requirement on MDM is implemented in a few breast centres and only on a voluntary basis. Where MDMs exist (Tumour Board), it takes place for the cases where primary (new adjuvant) chemotherapy is given: Always takes place after surgery, the receipt of histopathology report, and after recurrence. The title of the Clinical-Surgical Physician should be adapted to either Senologist or Mastologist In this way, it can be ensured that only breast cancer-specialised surgeons can operate in breast centres. This would be an important point for discussion upon publication of the Survey report. Certainly in the locally advanced breast cancers or in a non-operable one, the priority of the treatment should be taken by a Tumour Board composed of the Senologist (Surgeon or Gynaecologist), Medical Oncologist and Radiotherapist.

ED National Representative
NO

NO

NO

HU
ECIBC National Contacts
NO, BUT PLANNED
We are reducing waiting time. We have a national plan for oncological diagnosis in 14 day.
NO, BUT PLANNED
Information and consent are mandatory for all patients, but this in not (always) a task for the MDM.
YES, MANDATORY
MDM for decision of diagnostic issues and treatment is mandatory in Hungary.

ED National Representative

IE
ECIBC National Contacts
YES, VOLUNTARY
The new patients with urgent symptoms must be seen within 2 weeks. All other new patients within 12 weeks. Extra clinics have to be organised, if necessary.
NO, BUT PLANNED
There are guidelines about how quickly a patient must be informed.
YES, VOLUNTARY
Minimum 50/year

ED National Representative
YES

YES

YES

IT
ECIBC National Contacts
YES, MANDATORY
State-regions agreement issued the 18 December 2014.
YES, MANDATORY
State-regions agreement issued the 18 December 2014.
YES, MANDATORY
The state-regions agreement issued the 18 December 2014 mandates MDMs frequency at one per week.

ED National Representative
YES
See document from the Italian Ministry of Health (18 December 2014 Rep. Atti 185/ CSR).
YES
See document from the Italian Ministry of Health (18 December 2014 Rep. Atti 185/ CSR).
YES
See document from the Italian Ministry of Health (18 December 2014 Rep. Atti 185/ CSR).

LT
ECIBC National Contacts
YES, MANDATORY
We are working in accordance with SIS accreditation standards and guidelines. Annually, we carry out: 23 000 patient consultations with breast pathology; 850 breast cancer patient consultations; 15 000 patients with benign breast diseases; 20 000 diagnostics mammographies; 32 000 screening mammograms (8 000 women for screening per year)
YES, MANDATORY
We have breast cancer diagnosis and treatment standards in Lithuania approved by the Ministry of Health and standards in our Institution
YES, MANDATORY
MDT meetings twice a week.

ED National Representative

LU
ECIBC National Contacts
NO, BUT PLANNED
The Ministry of Health will define the requirements for Competence Centres in accordance with the 2006 guidelines.
NO, BUT PLANNED
In the framework of the cancer plan there are no mandatory rules in place, but patients’ care is organised together with the surgeon (gynaecologist), the oncologist and a breast care nurse. Psychological support is also available.
NO, BUT PLANNED
All clinics organise MDMs, but mostly after surgery, and at different intervals. Some every two weeks, others once every three weeks. The core team includes a surgeon, an oncologist, a breast care nurse, a data nurse, occasionally a radiotherapist, and very rarely a pathologist. In recent years, there was a shortage of staff in one national pathology laboratory.

ED National Representative
NO

NO
No requirement
YES

LV
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative

MT
ECIBC National Contacts
NO, BUT PLANNED
Just over 300 new cases of breast cancer are seen and followed up at the BU at MDH
NO, BUT PLANNED
Communication of the diagnosis and treatment is done soon after the case discussion during MDT meetings
NO, BUT PLANNED
One MDM is held on a weekly basis. The following cases are discussed: cases in which the diagnosis is as yet uncertain e.g. following core biopsy cases after the triple assessment and all cases having a recall at screening; cases in which the diagnosis of cancer (and staging ) is confirmed and may be considered for primary medical therapy; all cases following surgery on receipt of the histopathology for discussion of further care and; cases in follow-up that have recently undergone diagnostic investigations for possible symptoms of recurrent or advanced disease.

ED National Representative
NO

NO

NO

NL
ECIBC National Contacts

ED National Representative
NO

NO
In most hospitals, the treatment plan is provided and discussed with the patient even if not mandated by a requirement.
NO
In most cases, even if not mandated, cases are discussed in a multidisciplinary setting at least when treatment is provided. In smaller hospitals, MDMs are held in cooperation with a specialised comprehensive cancer centre or a specialised cancer hospital.

NO
ECIBC National Contacts
YES, VOLUNTARY
According to standardised patient assessment and treatment processes (“package processes”) for breast cancer. (Together - against cancer. National Cancer Strategy 2013-2017).
YES, VOLUNTARY
The quality assurance manual for the Norwegian Breast Cancer Screening Programme includes recommendations on communication.
YES, VOLUNTARY
MDM was implemented as a part of the Norwegian Breast Cancer Screening Programme. Most breast units use MDM for all breast cancer patients.

ED National Representative
YES

YES

YES

PL
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

YES, MANDATORY
See Polish Parliament Act of 22 July 2014 (Journal of Laws No. 1138) on change of law on healthcare services financed by public resources.

ED National Representative

PT
ECIBC National Contacts
NO, BUT PLANNED

NO and NOT PLANNED

ED National Representative

RO
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

YES, VOLUNTARY
Local institutional protocols, such as http://jradonco.ro/upd/display_paper.php?idfile=V19_N02_2013_pp005

ED National Representative

RS
ECIBC National Contacts
YES, VOLUNTARY
National good clinical practice guidelines for diagnostics and treatment of breast cancer.
Available at: http://www.skriningsrbija.rssrl/dokumenta/nacion-alni-vodici-dobre-klin-icke-prakse/
YES, MANDATORY
Law on rights of patient (Official Gazette 45/13), Article 7 The patient has the right to all types of information about the state of his health, of health services and how to use them, as well as all the information on the basis of scientific research and technological innovations. A patient has a right to information about the rights of health care insurance and procedures in order to use those rights. A patient has a right for information concerning names and professional status of healthcare workers involved in diagnostics and treatment of the diseases, etc.
YES, MANDATORY
Law on healthcare; National Good Clinical Practice Guideline for Diagnostics and Treatment of Breast Cancer; Healthcare institutions procedures for work (diagnostic services and therapy) as per legal document called Statute of the Health Institution (specific for each institution).

ED National Representative

SE
ECIBC National Contacts
NO, BUT PLANNED
At the moment there is an ongoing investigation whether this process should be regulated in Sweden.
NO, BUT PLANNED
Work is ongoing to organise and standardise care with referring timelines (e.g. waiting time). For breast cancer this will be launched in 2016. Communication of the diagnosis and treatment plan is generally given as stated in the definition above.
YES, VOLUNTARY
The main requirement is that all patients should be discussed at MDM before and after surgery (See National Guidelines for the Treatment of Breast Cancer). Link: http:www.socialstyrelsen.se/Lists/Artikelkatalog/Attachments/19383/2014-4-2.pdf At page 22 it reads (translation): The MDM should include a breast surgeon, a breast oncologist, a radiologist, a pathologist and a contact nurses (or breast care nurse). Follow up from 2013 showed that before surgery 97 % had a MDM, and after surgery 98% of patients with newly diagnosed breast cancer.

ED National Representative
NO
A waiting time according to Chapter 5 (within 10 working days) is not at all applicable in Sweden - nor the communication of outcome at the same visit. Sweden is now planning to adopt the Danish system to reduce waiting time and recently analysed five diagnostic processes. For 2016 another ten are planned, including diagnosis of breast cancer.
NO
See comment in previous question (Cl)
YES
As for other requirements, non-harmonised application of guidelines is observed depending on the county, causing unequal care and services throughout Sweden.

SI
ECIBC National Contacts
NO, BUT PLANNED

NO, BUT PLANNED

YES, MANDATORY
The decision of proper diagnostic procedure and therapy is defined at the Multidisciplinary Case Management Meetings.

ED National Representative
YES
They are available at: http://www.dpor.si/en
YES

YES

SK
ECIBC National Contacts
YES, VOLUNTARY
Only at oncology institutes and university hospitals.
YES, MANDATORY
The National Guidelines for Breast Cancer Diagnosis and Treatment, issued by the Ministry of Health in 2009, and the National Guidelines for Screening Mammography, issued by the Ministry of Health in 2005.
YES, VOLUNTARY
MDM’s are only organised in oncology centres and in some university hospitals.

ED National Representative

TR
ECIBC National Contacts

ED National Representative
YES

YES

YES

UK
ECIBC National Contacts
YES, MANDATORY
Defined in the national peer review process as per the 2006 European Guidelines definition.
It is nationally mandated that all patients with a breast symptom are seen within 14 days (10 working days) of referral.
YES, MANDATORY
There are specific measures stated in the peer review guidelines on patient communication. The MDT should be offering patients the opportunity of a permanent record or summary of at least a consultation between patient and doctor when the following are discussed: diagnosis; treatment options and plan; relevant follow up (discharge) arrangements. The MDT should provide written material for patients and carers which includes: information specific to that MDT about local provision of the services offering treatment for that cancer site; information about patient involvement groups and patient self-help groups; information about the services offering psychological, social and spiritual/ cultural support, if available; information specific to the MDT’s cancer site or group of cancers about the disease and its treatment options (including names and functions/roles of the team treating them); information about services available to support the effects of living with cancer and dealing with its emotional effects. The core MDT, at their regular meetings should agree and record individual patient’s treatment plans which includes: the identity of patients discussed; the multidisciplinary treatment planning decision (i.e. to which modality(s) of treatment - surgery, radiotherapy, chemotherapy, hormone therapy or supportive care or combinations of the same, that are to be referred for consideration).
YES, MANDATORY
Mandated via the national peer review measures. There should be an operational policy for the team whereby it is intended that all new cancer patients will be reviewed by a multidisciplinary team for discussion of initial treatment plan. The policy should specify at what other stages in the patient pathway patients are referred back for discussion.

ED National Representative
YES

YES

YES

Table 10: Survey section 6.

Breast Units non-mandatory requirements implementation stage.

Questions:

F. Facilities/ Services (9.7.4)

Definition from the 2006 European Guidelines

Physiotherapy

Physiotherapy must be available for the post-operative recovery period to ensure good shoulder mobility, etc.

ECIBC:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the provision of physiotherapy as defined above? * YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

3. If you wish, please add below your comments/considerations on the provision of physiotherapy voluntary requirement

ED:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the provision of physiotherapy as defined above? YES; NO; I do not have this information

2. If you wish, please add below your comments/considerations on the provision of physiotherapy voluntary requirement

G. Facilities/ Services (9.7.5)

Definition from the 2006 European Guidelines

Adjuvant therapies

The multidisciplinary team (MDT) must decide on the appropriate adjuvant therapies in light of the pathology of the surgical specimen.

Radiotherapy may be delivered within the same hospital or patients may have to travel to a Radiotherapy Unit in another Hospital (at which the core team radiation oncologist must be able to supervise their treatment).

The administration of cytotoxic therapy as adjuvant therapy or for advanced disease must be by an accredited oncologist (member of the core team) with proper facilities. Cytotoxic therapies may be given in another hospital but the decisions regarding their application must be made by the MDT of the Unit.

ECIBC:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the provision of adjuvant therapies as defined above? * YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

3. If you wish, please add below your comments/considerations on the provision of adjuvant therapies voluntary requirement

ED:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the provision of adjuvant therapies as defined above? YES; NO; I do not have this information

2. If you wish, please add below your comments/considerations on the provision of adjuvant therapies voluntary requirement

H. Facilities / Services (9.7.6)

Definition from the 2006 European Guidelines

Advanced and recurrent Breast Cancer

There must be one Advanced Breast Cancer Clinic at least every 2 weeks at the Breast Unit, separate from the general oncology clinics (although sometimes combined with gynaecological oncology) and attended by the Clinical Oncologist ± Medical Oncologist (see 9.5.2.5 b). The surgeon must be available if required for consultation and must be in full attendance if the breast surgeons supervise the endocrine therapies. Patients with distant metastases locally advanced primary breast cancer and local or regional recurrence, must be managed in this clinic according to protocols agreed by the multidisciplinary team.

Patients who have received radiotherapy or chemotherapy at another Cancer Centre should normally be referred back to the Breast Team at their Breast Unit for further follow-up and decision making in the Advanced Breast Cancer Clinic. A palliative care/pain control service must be easily accessible.

ECIBC:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the management of advanced and recurrent breast cancer as defined above? * YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

3. If you wish, please add below your comments/considerations on the management of advanced and recurrent breast cancer voluntary requirement

ED:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the management of advanced and recurrent breast cancer as defined above? YES; NO; I do not have this information

2. If you wish, please add below your comments/considerations on the management of advanced and recurrent breast cancer voluntary requirement

Country

F1. Is there a requirement that regulates physiotherapy?
F2-F3 Physiotherapy details/comments
G1. Is there a requirement that regulates provision of adjuvant therapies?
G2-G3 Adjuvant therapy details/comments
H1. Is there a requirement that regulates management of advanced and recurrent breast cancer?
H2-H3 Advanced and recurrent breast cancer details/ comments

AT
ECIBC National Contacts

ED National Representative
YES
Every certified breast cancer unit has a physiotherapist and lymphologist specialised in treating breast cancer patients.
YES
The decisions are made during MDMs. Each unit has one or more radiotherapy and oncology departments. In special cases, the gynaecooncologists are responsible for chemotherapy.
YES
There are regular clinics for these patients with two core team members: radiotherapist and oncologist. For every patient, a responsible in charge of care is identified within the unit. Still manageable patients are discussed during the MDM. Otherwise, palliation and pain control are provided in the units.

BE
ECIBC National Contacts
YES, MANDATORY
Physiotherapy is included in the Royal Decree 26 April 2007 as a requirement for a breast unit.
YES, MANDATORY
It is a mandatory requirement included in the Royal Decree 26 April 2007, for recognition of a breast unit.
NO and NOT PLANNED

ED National Representative

BG
ECIBC National Contacts
YES, VOLUNTARY
Accreditation requirements of the National Hospital of Oncology
YES, MANDATORY
There are Ministry of Health and National Health Insurance Fund documents as well as accreditation requirements for the National Hospital of Oncology.
YES, MANDATORY
There are Ministry of Health and National Health Insurance Fund documents as well as accreditation requirements for the National Hospital of Oncology.

ED National Representative

CH
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative
I do not have this information.

I do not have this information.

I do not have this information.

CY
ECIBC National Contacts
YES, VOLUNTARY
Physiotherapy is regularly provide, though it is not regulated yet as a mandatory practice.
YES, VOLUNTARY
No legislative framework yet.
YES, VOLUNTARY
There is a breast cancer clinic operating once a week.

ED National Representative
NO

YES

NO

CZ
ECIBC National Contacts
YES, MANDATORY
Physiotherapy will begin after surgery. Physiotherapy is part of comprehensive cancer treatment, with emphasis on drainage to prevent lymphedema.
YES, MANDATORY
Adjuvant therapy is indicated under Czech standards of cancer care, the so-called “Blue Book”, based on the recommendations of ASCO, ESMO, NCCN.
YES, VOLUNTARY
Oncological therapy of advanced breast cancer is indicated under Czech standards of cancer care, the so-called blue book, based on the recommendations of ASCO, ESMO, NCCN.

ED National Representative

DE
ECIBC National Contacts
YES, MANDATORY
Agreements with other treatment partners: Written agreements in which willingness to engage in cooperation is confirmed are to be signed with treatment partners for the following: Psycho-oncology; Social services; Self-help; Genetic counselling; Gene analysis, family anamnesis (BRCA-1, BRCA-2) and genetic counselling; Physiotherapy; Laboratory (with a round robin test certification); Hospice/palliative medicine; Medical aids supplier; The following points can, for example, be regulated in the agreements with the treatment partners: Cooperation on further training measures and public relations work; Description of the cooperation and interfaces; Type of communication between the two parties; Confidentiality; (see Catalogue of Requirements, Chapter 1.1.2)
YES, MANDATORY
The requirements regulating the provision of adjuvant therapies are laid down in Chapter 6.2 (pages 29 et seq.) and 7 (pages 33 et seq.) of the Catalogue of Requirements, see: https://www.krebsgesellschaft.de/gcs/german-cancer-society/certification/documents.html?file=files/dkg/german-cancer-society/pdf/Certification/Catalogue%20of%20Req%20breast-H1%201%20%2814%2007%202016%29%20EN.pdf.
YES, MANDATORY
The requirements regulating the management of advanced and recurrent breast cancer are described in Chapter 1.2.4 and Chapter 9 of the Catalogue of Requirements, see: https://www. krebsgesellschaft. de/gcs/german-cancer-society/certification/documents.html?file=files/dkg/german-cancer-society/pdf/Certification/Catalogue%20of%20Req%20breast-H1%201%20%2814%20 07%202016%29%20EN.pdf.

ED National Representative

EE
ECIBC National Contacts

ED National Representative
YES

YES

YES

ES
ECIBC National Contacts

ED National Representative
NO

NO

NO

FI
ECIBC National Contacts
YES, MANDATORY
Physiotherapist should be available based on patients’ needs. Every patient receives personal guidance on how to reach normal mobility of the shoulder by a physiotherapist during their hospital stay for the primary surgical treatment.
YES, VOLUNTARY
The adjuvant therapy is decided during the MDM, and the primary oncologist (or her/his substitute) responsible for breast cancer will be the person ultimately deciding the treatment. The Finnish Breast Cancer Group (FBCG) consists of breast cancer specialists from all university areas in Finland; the FBCG also writes the national guidelines. Thus, people responsible of the breast cancer treatment in each region are also involved in writing the guidelines.
YES, VOLUNTARY
The recurrent breast cancer cases are discussed during the MDM (if needed) or in a meeting with several expert oncologists within the clinic. Otherwise, the person responsible for breast cancer treatment is at least consulted. National guidelines are followed similarly as in the case of adjuvant treatment (please see above).

ED National Representative

FR
ECIBC National Contacts
NO and NOT PLANNED
See 4vii comments
NO and NOT PLANNED

NO and NOT PLANNED
See 4vii comments

ED National Representative
NO
Support care is given by a number of hospitals (generally public). Some associations do offer it for free.
YES
As required by INCa and the French Health Authority.
I do not have this information.
Normally are managed during MDMs.

GR
ECIBC National Contacts
YES, VOLUNTARY
Out of the 13 breast centres that answered the questionnaire, only two responded that they have Physiotherapy section but they are not specialised in lymphoedema treatment. I totally agree with the 2006 European Guidelines requirement.
YES, VOLUNTARY
Regarding Radiotherapy: six out of the 13 hospital consulted for this questionnaire stated to have a Radiotherapeutic Department which is under “Quality Control” guidelines. Regarding the Cytotoxic Therapy: ten out of 13 hospitals have Cytotoxic Therapy Department. The majority of them follow St. Gallen consensus meetings and/or ASCO guidelines.
NO, BUT PLANNED
It is correct to distinguish the breast cancer clinic with metastatic breast cancer or locally advanced from local regional recurrence. The new case should be treated separately but such a procedure is not applied in breast centres. Furthermore, medical oncologists usually keep the patients that they treat in the same department, given that patients generally do not come back to the breast centre. The same attitude occurs with radiotherapists. There is no palliative care/pain service that is easily accessible in every hospital.

ED National Representative
NO

NO

NO

HU
ECIBC National Contacts
NO, BUT PLANNED

YES, MANDATORY
See as above on MDM decisions.
YES, MANDATORY
All changes in systemic or local therapies should be discussed during the MDM session

ED National Representative

IE
ECIBC National Contacts
YES, VOLUNTARY

YES, VOLUNTARY
There are guidelines with regard the waiting times for medical oncology.
NO and NOT PLANNED

ED National Representative
YES

YES

YES

IT
ECIBC National Contacts
YES, MANDATORY
The state-regions agreement issued 18 December 2014 considers physiotherapy as a component of general psycho-physical rehabilitation.
YES, MANDATORY
State-regions agreement issued 18 December 2014.
YES, VOLUNTARY
State-regions agreement issued 18 December 2014.

ED National Representative
YES
See document from the Italian Ministry of Health (18 December 2014 Rep. Atti 185/ CSR).
YES
See document from the Italian Ministry of Health (18 December 2014 Rep. Atti 185/ CSR).
YES
See document from the Italian Ministry of Health (18 December 2014 Rep. Atti 185/ CSR).

LT
ECIBC National Contacts
YES, MANDATORY
Regulated by breast cancer diagnosis and treatment standards in Lithuania and the NCI.
YES, MANDATORY
Every time approved during the MDT meeting (surgeons, radiologists, radiotherapy oncologists, medical oncologists, pathologists, and geneticist). Regulated by breast cancer diagnosis and treatment standards in Lithuania and the NCI. In some cases an individual approach to the case is possible.
YES, MANDATORY
Cases of advanced or recurrent disease are discussed either in the Department of Conservative Treatment (medical oncology and radiotheraphy - 1 time a week) or during the MDT as mentioned above.

ED National Representative

LU
ECIBC National Contacts
YES, VOLUNTARY
Physiotherapists are well trained, but no one is doing only breast cancer treatment due to low volume.
NO, BUT PLANNED
Will be adopted in the framework of the cancer plan guidelines on breast cancer management. Almost all breast cancer patients are treated at the National Radiotherapy Centre or in Germany (cross border- because the location is closer to the residence of the patients). All adjuvant treatments are delivered at the five hospitals. The health insurance company covers 100% of the costs.
NO, BUT PLANNED
Will be adopted in the framework of the cancer plan guidelines on breast cancer management.

ED National Representative
NO
There is no requirement but ED Luxembourg has coordinated the training of 200 physiotherapists to manual treatment of lymphoedema. Their addresses are published on the ED Luxembourg website.
NO

NO

LV
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative

MT
ECIBC National Contacts
NO, BUT PLANNED
Post-operative physiotherapy support is available at the acute hospital (MDH). A dedicated breast care team assess all patients prior to surgery and supports post-operatively. Cases are continually followed for any secondary mobility complications either at out-patient level within the acute hospital or at the Oncology Hospital.
NO, BUT PLANNED
Adjuvant therapies (radiotherapy and cytotoxic therapy) are given at the Oncology Department. This department presently resides in another hospital outside MDH. The Oncology Department is migrating to a new purposely built Oncology Centre (which is located adjacent to MDH), the Sir Anthony Mammo-Oncology Centre, which became fully operational in the summer of 2015. The new Centre has upgraded radiotherapy facilities.
NO, BUT PLANNED
Patients with advanced and recurrent breast cancer are seen and managed at the BU in MDH as well as at the Oncology Department. These cases are also discussed during MDT meetings. Patients who finished treatment and are ‘disease free’ are seen at minimum 6-month intervals (alternating between appointments at the breast unit and the Oncology Department).

ED National Representative
NO

NO

YES

NL
ECIBC National Contacts

ED National Representative
YES

YES

YES

NO
ECIBC National Contacts
YES, VOLUNTARY
There is a national action programme with guidelines for diagnostics, treatment and follow up of patients with breast cancer (Norwegian Breast Cancer Group): http://www.helsebiblioteket.no/retningslinjer/brystkreft/forord;jses-sionid=658DCBE466oD8D0FE08364EFEE27CBEE?hideme=true. Standardised patient assessment and treatment processes (“package processes”) for breast cancer.
YES, MANDATORY
The national action programme includes guidelines for diagnostics, treatment, and follow up of patients with breast cancer (Norwegian Breast Cancer Group). It standardised patient assessment and treatment processes (“package processes”) for breast cancer.
YES, MANDATORY
The national action programme includes guidelines for diagnostics, treatment, and follow up of patients with breast cancer (Norwegian Breast Cancer Group). It standardised patient assessment and treatment processes (“package processes”) for breast cancer.

ED National Representative
YES

YES

YES

PL
ECIBC National Contacts
i do not know

YES, MANDATORY
See Polish Parliament Act of 22 July 2014 (Journal of Laws No. 1138) on change of law on healthcare services financed by public resources.
NO and NOT PLANNED

ED National Representative

PT
ECIBC National Contacts
NO, BUT PLANNED

NO, BUT PLANNED

NO, BUT PLANNED

ED National Representative

RO
ECIBC National Contacts
NO and NOT PLANNED

YES, VOLUNTARY
http://jradonco.ro/upd/display_paper.php?id-file=V19_N02_2013_pp005.
NO and NOT PLANNED

ED National Representative

RS
ECIBC National Contacts
NO, BUT PLANNED
Some centres have a specialist for physiotherapy and physiotherapists, while the others refer their patients to specialised healthcare institutions for physiotherapy.
YES, MANDATORY
The MDT team is in charge of deciding the appropriate adjuvant therapies. Each institution is in charge of organising the work of the MDT. Usually there are more than one MDT in one institution. In our country, in institutions that provide oncology healthcare, the 2006 European Guidelines recommendation for composition of MDT is strictly followed.
All specialised oncology institutions have MDTs. Independent MDTs: IORS Serbia, Institute for Oncology of Vojvodina, Sremska Kamenica, Clinical Center Serbia, Clinical Center Nis, Clinical Center Kragu-jevac, Military Medical Academy.
Not fully independent MDTs with visiting experts from previously listed institutions: Hospital Bežanijska Kosa (KBC), general hospitals (Valjevo, Bor, Šabac, Cacak, Kladovo, Loznica, and Užice).
NO and NOT PLANNED
All breast cancer patients in all stages are treated and monitored in the same units. There is no Advanced Breast Cancer Clinics in Serbia defined as formally independent clinics.

ED National Representative

SE
ECIBC National Contacts
YES, VOLUNTARY
F2-F3 Physiotherapy details/comments: Physiotherapy is available at most breast units. Prophylactic programmes and educational sessions are also available at these units.
YES, VOLUNTARY
All radiotherapy is delivered at dedicated radiation units, often nearby most of the breast units. At a few of the smaller hospitals, chemotherapy is mostly delivered by oncologist from nearby bigger breast units.
YES, VOLUNTARY
At the major units patients with advanced and recurrent breast cancer are managed on weekdays by oncologists.

ED National Representative
YES
Depends on the county. In some of them patients have to find assistance within the private care.
YES
Depends on the county. Radiotherapy is mainly available at university hospitals and at other radiotherapy units.
Chemotherapy is delivered at university hospitals and at other hospitals - either linked to a university hospital where a “movable” oncology unit is present or available one to few days per week.
YES
Depends on the county. Patients with a recurrence, ABC or MBC are generally treated at the university clinics or related smaller units.

SI
ECIBC National Contacts
YES, VOLUNTARY
Post-operative physiotherapy is offered to all operated patients.
YES, MANDATORY
The decision of proper adjuvant therapy is defined at the Multi-disciplinary Case Management Meetings.
YES, MANDATORY
The decision of proper management of advanced and recurrent breast cancer is determined at the Multidisciplinary Case Management Meetings.

ED National Representative
NO

YES

NO

SK
ECIBC National Contacts
YES, VOLUNTARY
In oncology centres and university (teaching) hospitals.
YES, MANDATORY
The majority of patients are treated in special oncologic centres (adjuvant chemotherapy and radiotherapy).
i do not know

ED National Representative

TR
ECIBC National Contacts

ED National Representative
YES

YES

YES

UK
ECIBC National
YES, VOLUNTARY
The physiotherapist is considered to be a member of the extended multi-disciplinary team and is governed by the measure as outlined below:
The MDT should provide the names of members of the extended team for named roles in the team if they are not already offered as core team members.
The named extended team for the breast MDT should include:
• a core member of the specialist palliative care team;
• breast radiographer;
• psychiatrist or clinical psychologist;
• plastic/reconstructive surgeon;
•clinical geneticist/genetics counsellor;
•physiotherapist/lymphoedema/practitioner.
YES, MANDATORY
Mandated via the national peer review process, each region (network) of England has to have specific network wide guidelines for treatment, and all patients are discussed at a multi-disciplinary team meeting to decide adjuvant treatment. The Network Site Specific Group (NSSG) should agree network-wide clinical guidelines (how a given patient should be clinically managed), usually at the level of which modality of treatment is indicated. The NSSG, in consultation with the Network Chemotherapy Group (NCG) should agree a list of acceptable chemotherapy treatment algorithms. It should be updated bi-annually than detailed regimens or surgical techniques).
YES, VOLUNTARY
This would be a broad recommendation and would be the standard of care in most breast units, although this is not mandated or included as a measure in the peer review guidance.

ED National Representative
YES

YES

YES

Table 11: Survey section 6.

Breast Units non-mandatory requirements implementation stage.

Questions:

I. Facilities / Services (9.7.7)

Definition from the 2006 European Guidelines

Follow-up of primary breast cancer

All patients with primary breast cancer must be followed-up in a Clinic directly supervised by one of the surgeons. Any necessary imaging or other investigations should be carried out at the same visit.

Although the patient may have to visit a separate Hospital to receive radiotherapy or specialised chemotherapy, the decisions on the case management and the subsequent follow-up should be by the team members of her Breast Unit. The skills of the diagnostic breast team are then available for the detection and investigation of a possible recurrence.

ECIBC:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the follow-up of primary breast cancer as defined above? * YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

3. If you wish, please add below your comments/considerations on the follow-up of primary breast cancer voluntary requirement

ED:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the follow-up of primary breast cancer as defined above? YES; NO; I do not have this information

2. If you wish, please add below your comments/considerations on the follow-up of primary breast cancer voluntary requirement

J. Facilities/Services (9.7.8)

Definition from the 2006 European Guidelines

Benign disease

The Breast Unit must also advise and where necessary treat women with benign disease (e.g. cysts, fibroadenoma, mastalgia, inflammatory conditions, mammillary fistula and phyllodes tumour).

ECIBC:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the management of benign disease as defined above?* YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

3. If you wish, please add below your comments/considerations on the management of benign disease voluntary requirement

ED:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the management of benign disease as defined above? YES; NO; I do not have this information

2. If you wish, please add below your comments/considerations on the management of benign disease voluntary requirement

K. Facilities/Services (9.7.9)

Definition from the 2006 European Guidelines

Family History/genetics

Advice is best given in a multidisciplinary clinic, the specialists involved are a clinical geneticist and from the team a breast surgeon with reconstructive skills, radiologist and psychiatrist or clinical psychologist. Gene probing must be available when required and ideally a molecular geneticist should be accessible for consultation by the specialists in the clinic.

ECIBC:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the management of family history/genetics as defined above? * YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

3. If you wish, please add below your comments/considerations on the management of family history/genetics voluntary requirement

ED:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the management of family history/genetics as defined above? YES; NO; I do not have this information

2. If you wish, please add below your comments / considerations on the management of family history/genetics voluntary requirement

Country

I1. Is there a requirement that regulates the follow-up of primary breast cancer?
I2-I3 Primary breast cancer details/ comments
J1. Is there a requirement that regulates the management of benign disease?
J2-J3 Benign disease details/comments
K1. Is there a requirement that regulates the management of family history/genetics?
K2-K3 Family history/genetics details/comments

AT
ECIBC National Contacts

ED National Representative
YES
The follow up of each patient is secured in the units. One discipline, usually the surgeon / gynaecologist, is responsible, sometimes together with radiotherapist and / or oncologist.
YES
All breast units are able to treat women with benign disease as the surgeons and gynacologists are not only responsible for cancer patients but for all patients with breast diseases.
YES
The ÖZK catalogue defines the requirements for family history/genetics in accordance with the 2006 European Guidelines.

BE
ECIBC National Contacts
YES, MANDATORY

NO and NOT PLANNED

YES, MANDATORY
The Royal Decree of 26 April 2007 specifies that breast units must have an agreement with a centre for human genetics to provide genetic counselling.

ED National Representative

BG
ECIBC National Contacts
YES, MANDATORY
There are Ministry of Health and National Health Insurance Fund documents as well as accreditation requirements for the National Hospital of Oncology.
YES, MANDATORY
There are Ministry of Health and National Health Insurance Fund documents as well as accreditation requirements for the National Hospital of Oncology.
YES, VOLUNTARY
There are Ministry of Health and National Health Insurance Fund documents as well as accreditation requirements for the National Hospital of Oncology.

ED National Representative

CH
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative
I do not have this information.

I do not have this information.

I do not have this information.

CY
ECIBC National Contacts
YES, VOLUNTARY
The patients undergo follow up at regular intervals (e.g. monthly, every 3 months, 6 months, yearly).
YES, VOLUNTARY
See above.
YES, VOLUNTARY
The Institute of Neurology and Genetics is an associated partner and offers genetic counselling and gene probing services.

ED National Representative
NO

CZ
ECIBC National Contacts
YES, MANDATORY
Follow up of our breast cancer patients is governed by uniform rules of the Czech Oncological Society.
YES, VOLUNTARY
Patients with benign breast disease are followed in breast surgery clinics or in the department of gynaecology.
YES, MANDATORY
Genetic testing of patients is carried out under recommended conditions (ESMO). Carriers of genetic mutations and syndromes are observed in secondary prevention clinics in comprehensive centres.

ED National Representative

DE
ECIBC National Contacts
NO and NOT PLANNED
The Follow-up of primary breast cancer is described in Chapter 10 of the Catalogue of Requirements: https://www.krebsgesellschaft.de/gcs/german-cancer-society/certification/documents.html?file=files/dkg/german-cancer-soci-ety/pdf/Certification/Catalogue%2oof%20Req%2obreast-Hi%201%20%2814%2007%202016%29%20EN.pdf. This definition only focuses on the hospital (i.e. breast unit). In Germany, most therapies and follow-up of patients are performed through office-based doctors. They must be part of the certified network, must attend and present patients at the MDM.
YES, MANDATORY
The requirements regulating the management of benign disease are described in Chapter 2.1.3 of the Catalogue of Requirements, see: https://www.krebsgesellschaft.de/gcs/german-cancer-society/certification/documents.html?file=files/dkg/german-cancer-soci-ety/pdf/Certification/Catalogue%2oof%20Req%20breast-Hi%201%20%2814%20 07%202016%29%20EN.pdf.
YES, MANDATORY
The requirements regulating the management of family history/ genetics are described in Chapter 2.1.4 and Chapter 1.1.2 of the Catalogue of Requirements, see: https://www.krebsgesellschaft.de/gcs/german-cancer-society/certification/documents.html?file=files/dkg/german-cancer-society/pdf/Certification/Catalogue%20of%20 Req%20breast-Hi%201%20%2814%20 07%202016%29%20EN.pdf. The questionnaire must be used for patients in order to detect a hereditary carcinomas is available at: https://www.krebsgesellschaft.de/deutsche-krebsgesellschaft-wtrl/deutsche-krebsgesellschaft/zertifizierung/erhebungsboegen/dokumente-im-ue-berblick.html?file=-files/dkg/deutsche-krebsgesellschaft/content/pdf/Zertifizierung/Checklisten%20 und%20Algorithmen/checkliste_erbliche_belastung_brust-a5-160330.xlsx (in German).

ED National Representative

EE
ECIBC National Contacts

ED National Representative
YES

YES

YES

ES
ECIBC National Contacts

ED National Representative
NO

NO

NO

FI
ECIBC National Contacts
YES, VOLUNTARY
Each hospital area has own follow-up guidelines. In the majority of hospital areas, follow-up (up to 5 years) is organised in the oncological clinics; otherwise, it is organised in surgical units. The FBCG has included in the national guidelines the minimum requirements for follow-up.
NO and NOT PLANNED
Benign breast lesions are investigated in collaboration with the radiologist, surgeon and pathologist; the oncologist is also consulted. Unclear cases may be discussed at the MDM, if needed.
YES, VOLUNTARY
In case of strong family history (or other reason), the patient can be referred to a geneticist, available in all hospitals, by the doctor (family doctor, surgeon, oncologist, etc.). There is also a system organised by the Cancer Society of Finland, in which the healthy relatives of patients with strong family history can get genetic counselling and referral to a university hospital for genetic testing consideration. The FBCG has recommended clear criteria for family history for referring patients to genetic counselling

ED National Representative

FR
ECIBC National Contacts
NO and NOT PLANNED
See 4vii comments
NO and NOT PLANNED
See 4vii comments
NO and NOT PLANNED
See 4vii comments

ED National Representative
YES
It is supervised by surgeon or medical oncologist on a regular basis.
YES

YES

GR
ECIBC National Contacts
YES, VOLUNTARY
On voluntary basis the breast centre counts on the fact that the patient will remain in the same breast centre. A major problem arises with patients who are residents in counties far from Athens or other major cities like Thessaloniki or loannina where most of the breast centres are located. During their follow-up, patients may decide to be monitored by doctors who are nearby their home.
YES, VOLUNTARY
Usually patients visit at least two or three different doctors to receive other opinions regarding their case.
YES, VOLUNTARY
Six hospitals out of 13 reported to have a geneticist as a collaborator. Since the cost of a genetic laboratory is very high, a possible alternative would be to have a counselling geneticist or a skilled nurse specialised on hereditary breast cancer within every breast centre.

ED National Representative
NO

NO

NO

HU
ECIBC National Contacts
YES, VOLUNTARY

NO and NOT PLANNED

NO, BUT PLANNED
In case of familiarity, it is recommended to screen for genetic background.

ED National Representative

IE
ECIBC National Contacts
YES, VOLUNTARY
Follow-up for 5 years followed by annual mammography.
YES, VOLUNTARY
Patients seen within 12 weeks and imaged as appropriate.
YES, VOLUNTARY
There are national guidelines.

ED National Representative
YES
Follow up includes where possible imaging and other investigations.
I do not have this information.

YES

IT
ECIBC National Contacts
YES, MANDATORY
State-regions agreement issued 18 December 2014.
NO and NOT PLANNED
The state-regions Agreement issued 18 December 2014 does not cover treatment of benign diseases which is left to local management. The Italian screening guidelines do not recommend treatment of benign lesions.
YES, MANDATORY
State-regions agreement issued 18 December 2014.

ED National Representative
YES
See document from the Italian Ministry of Health (18 December 2014 Rep. Atti 185/CSR).
YES
See document from the Italian Ministry of Health (18 December 2014 Rep. Atti 185/CSR).
YES
See document from the Italian Ministry of Health (18 December 2014 Rep. Atti 185/CSR).

LT
ECIBC National Contacts
YES, MANDATORY
Patients for follow-up are supervised by medical oncologists or surgeons.
YES, MANDATORY
The NCI has separate recommendations for registration and waiting times as well as follow-up recommendations for different benign breast pathology cases.
YES, MANDATORY
Patients are referred to genetics consultation by medical oncologists, surgeons or MDT. All women with known BRCA 1-2 mutations are offered breast MRI for surveillance.

ED National Representative

LU
ECIBC National Contacts
NO, BUT PLANNED
Will be adopted in the framework of the cancer plan guidelines on breast cancer management.
NO and NOT PLANNED

NO, BUT PLANNED
Will be implemented for high risk women in the framework of the cancer plan guidelines on breast cancer management.

ED National Representative
NO

NO

NO
Working groups discussing this topic are in place.

LV
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative

MT
ECIBC National Contacts
NO, BUT PLANNED
Patients who finished treatment and are ‘disease free’ are seen at least at 6-month intervals (alternating between appointments at the Breast Unit and the Oncology Department).
NO, BUT PLANNED
Patients with benign breast disease are seen and managed at the BU in MDH
NO, BUT PLANNED
The BU at MDH has started a family history/genetics clinic which is led by a clinical geneticist. Patients are referred by surgeons to the geneticist who sees these cases during genetics clinic sessions.

ED National Representative
YES

YES

YES

NL
ECIBC National Contacts

ED National Representative
YES

YES

NO
In case of family history patients are normally referred to specialised centres for genetic testing, even if not mandated.

NO
ECIBC National Contacts
YES, MANDATORY
The national action programme includes guidelines for diagnostics, treatment, and follow up of patients with breast cancer (Norwegian Breast Cancer Group).
YES, MANDATORY
The national action programme includes guidelines for diagnostics, treatment, and follow up of patients with breast cancer (Norwegian Breast Cancer Group).
YES, MANDATORY
The national action programme includes guidelines for diagnostics, treatment, and follow up of patients with breast cancer (Norwegian Breast Cancer Group).

ED National Representative
YES

YES

YES

PL
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative

PT
ECIBC National Contacts
NO, BUT PLANNED

NO, BUT PLANNED

YES, MANDATORY
Portuguese law regulates genetic clinics, how they work, how they store the data and the need for clinical geneticists.

ED National Representative

RO
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative

RS
ECIBC National Contacts
YES, VOLUNTARY
Depending on the type of cancer, a patient is monitored by experts. Usually it is the same doctor that diagnosed the disease. Decisions regarding therapy are made by the MDT. Individual follow-up of the patient is done by one doctor - by the radiologist or by the oncologist or sometimes by the surgeon or more than one, if needed.
YES, VOLUNTARY
Legislation defines the same rights for patients for the treatment of benign diseases and malignant diseases (according to the legal framework in Serbia and in line with patients’ rights). In the guideline document developed by the experts (approved by MoH), there is a protocol/scheme for the treatment of benign diseases. It is used by experts on daily basis, but not mandatory by law.
YES, VOLUNTARY
Equipment for genetic analysis is available at the Institute for Oncology and Radiology of Serbia. This institution also provides genetic counselling for patients and their families.

ED National Representative

SE
ECIBC National Contacts
YES, VOLUNTARY
The follow up in Sweden is usually managed by the oncologist or by breast care nurses. In some units this is performed by a breast surgeon.
YES, VOLUNTARY
It is managed by the breast surgeon at the breast units.
YES, VOLUNTARY
At university hospitals, there are specific family history clinics which have separate MDMs with participation of clinical geneticists, breast surgeons, plastic surgeons, oncologists and psychologists.

ED National Representative
YES
Depends on the county. Follow-up is in most counties not in accordance with 2006 European Guidelines. The follow-up could sometimes be constituted by a letter from the health care provider.
YES
Depends on the county and even in BUs is not always implemented.
YES
At university hospitals, family history clinics/ genetic/hereditary investigators are available.

SI
ECIBC National Contacts
YES, MANDATORY
Follow-up is part of breast cancer management guidelines
YES, MANDATORY
Management of benign disease is part of breast cancer guidelines.
YES, MANDATORY
Genetic consultation is offered to all patients along the criteria described in breast cancer management guidelines in genetic clinic, which is present in one unit.

ED National Representative
YES

YES

YES

SK
ECIBC National Contacts
YES, MANDATORY
The majority of patients will be followed-up in specialised oncology centres and/or in specialised departments of some university hospitals.
YES, VOLUNTARY
The national guidelines for breast cancer diagnosis and treatment given by Ministry of Health defines specialists (specialised gynaecologists and /or surgeons) for treatment of breast diseases.
YES, VOLUNTARY
In oncology centres and some university hospitals.

ED National Representative

TR
ECIBC National Contacts

ED National Representative
YES

YES

I do not have this information.

UK
ECIBC National Contacts
YES, VOLUNTARY
The amount of clinical follow up is decreasing in England with a recommendation that patients should be discharged after 3 years of follow up (NICE guidance).
YES, VOLUNTARY
Not mandated but all breast units see the full range of benign disease which they diagnose and manage; most units would see approximately 20 patients with benign disease for every breast cancer diagnosed.
YES, VOLUNTARY
The family history provision is more mixed across the country with different patterns in different places - see NICE family history guidance.
For those at moderate risk these are commonly managed within the breast unit by the breast team, often an advanced nurse practitioner. Screening mammography for this group is performed within the local breast unit. Those at high risk are referred to the regional genetics service for counselling and genetic testing, and for possible consideration of risk reducing mastectomy for those who are gene positive. For those at high risk surveillance mammography and MRI are organised through the National Health Service Breast Screening Programme.

ED National Representative
YES

YES

YES

Table 12: Survey section 6.

Breast Units non-mandatory requirements implementation stage.

Questions:

L. Facilities/Services (9.7.11)

Definition from the 2006 European Guidelines

Breast Screening

Ideally breast screening centres should be a part of Breast Units and the same radiologists should be members of the Unit team and work in screen detection and the diagnosis of symptomatic disease. Assessment centres should be placed in Breast Units.

ECIBC:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the breast screening management as defined above? * YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

3. If you wish, please add below your comments/considerations on the breast screening management voluntary requirement

ED:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the breast screening management as defined above? YES; NO; I do not have this information

2. If you wish, please add below your comments/considerations on the breast screening management voluntary requirement

M. Facilities/Services (9.7.12)

Definition from the 2006 European Guidelines

Patient information

Women must be offered clear written and oral information regarding their diagnosis and/or treatment options. The Breast Unit should also provide written information concerning local out-patient support groups and advocacy organisations and should also respect the patients rights as outlined in the Breast Cancer Resolution of the European Parliament (OJ C 68 E (18.03.2004), p. 611). Patients should be provided with a list of their rights as outlined in the breast cancer resolution.

ECIBC:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the patient information as defined above? * YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

3. If you wish, please add below your comments/considerations on the patient information voluntary requirement

ED:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the patient information as defined above? YES; NO; I do not have this information

2. If you wish, please add below your comments/considerations on the patient information voluntary requirement

Country

L1. Is there a requirement that regulates breast screening management?
L2-L3 Breast screening management details/comments
M1. Is there a requirement that regulates the patient information?
M2-M3 Patient information details/comments

AT
ECIBC National Contacts

ED National Representative
NO
In Austria, only some of the screening and assessment centres are part of certified breast cancer units.
YES
All patients get information during the continuous process of informed consent.

BE
ECIBC National Contacts
NO and NOT PLANNED

YES, MANDATORY
Royal Decree on 26 April 2007. Breast units must have an agreement with patient organisations.

ED National Representative

BG
ECIBC National Contacts
YES, VOLUNTARY
There are Ministry of Health and National Health Insurance Fund documents as well as accreditation requirements for the National Hospital of Oncology
YES, MANDATORY
There are Ministry of Health and National Health Insurance Fund documents as well as accreditation requirements for the National Hospital of Oncology, and the Breast Department.

ED National Representative

CH
ECIBC National Contacts
YES

YES

ED National Representative
I do not have this information.

I do not have this information.

CY
ECIBC National Contacts
YES, VOLUNTARY
Mammography centres are satellites of the breast unit.
YES, VOLUNTARY
Oral information is provided.

ED National Representative
NO
We do not have a breast unit but have a national screening programme in accordance with the 2006 European Guidelines.
NO
Written information provided by NGOs.

CZ
ECIBC National Contacts
YES, VOLUNTARY
There is an integrated screening unit in the comprehensive cancer centre.
YES, MANDATORY
All therapeutic and diagnostic interventions are conditional upon signing an informed consent, which has a unified format.

ED National Representative

DE
ECIBC National Contacts
YES, MANDATORY
The requirements regulating breast screening management are described in Chapter 2.1.3 of the Catalogue of Requirements, see: https://www.krebsgesellschaft.de/gcs/german-cancer-society/certification/documents.html?file=files/dkg/german-cancer-society/pdf/Certification/Catalogue%20of%20Req%20breast-Hi%20i%20 %2814%2007%202016%29%20EN.pdf.
YES, MANDATORY
The requirements regulating the patient information are described in Chapter 2.1.1 and Chapter 1.6.3 et seq. of the Catalogue of Requirements, see: https://www.krebsgesellschaft.de/gcs/german-cancer-society/certification/documents.html?file=files/dkg/german-cancer-society/pdf/Certification/ Catalogue%20of%20Req%20breast-H1%201%20%2814%2007%202016%29%20EN.pdf. Patient information and shared decision making is mandatory but not with regard to the Resolution of the European Parliament.

ED National Representative

EE
ECIBC National Contacts

ED National Representative
YES
Mammography screening is organised, nationwide, age group 50-62, interval 2 years.
YES

ES
ECIBC National Contacts

ED National Representative
NO

NO

FI
ECIBC National Contacts
YES, MANDATORY
ISO standards are followed across Finland.
YES, MANDATORY
Both the doctors and nurses provide verbal and written information on all the topics previously mentioned.

ED National Representative

Which ISO?

FR
ECIBC National Contacts
NO and NOT PLANNED
As noted previously, in France the organisation for screening and diagnostics is distinct from the organisation of treatments. Screening and diagnostics are mainly performed in private radiology units for individual as well as organised mammography. The French organised breast cancer screening programme is established at national level and implemented at departmental level under the responsibility of regional health agencies (26). Agencies finance and control screening management structures in charge of the invitation of the target population, training, communication, evaluation of the programme etc. In case of positive screening, the screening structure shares information about the woman with the GP who will be in charge of her follow up in coordination with the oncology team.
NO and NOT PLANNED

ED National Representative
YES
France applies the 2006 European Guidelines but for age range. Screening is provided from women aged 50 to 74 every two years. The possibility to start screening at age 40 or 45 is now under evaluation.
YES
Usually (but not often) patients receive written information on diagnosis and treatment either directly from the hospital or through their medical doctor. To fully understand the discussions about treatment, the patient has to be educated on the topic. There is no rule foreseeing that patients have to be informed about NGOs (e.g. on advocacy). However, nurses provide this information when available.

GR
ECIBC National Contacts
YES, VOLUNTARY
It is very important for breast centres to have a separate section for a breast screening but in countries like Greece with a lot of islands and remote villages a national breast screening programme with mobile mammography units would be more appropriate.
NO and NOT PLANNED
The patient must receive full information regarding her diagnosis in writing and advice regarding her therapeutic treatment so to avoid any misunderstanding. Recently, some non-profit, non-governmental organisations have been involved with patient advocacy.

ED National Representative
NO

NO

HU
ECIBC National Contacts
YES, VOLUNTARY
This requirement is applied only by complex screening units to have proper diagnostic and therapeutic background.
NO, BUT PLANNED

ED National Representative

IE
ECIBC National Contacts
YES, VOLUNTARY

YES, VOLUNTARY

ED National Representative
YES

NO

IT
ECIBC National Contacts
YES, MANDATORY
Mammographie screening has been a Basic Healthcare Parameter (LEA) since 2001. Guidelines are provided by the Minister of Health - Department of Prevention in agreement with regional governments according to the state-regions Agreement on breast units networking issued 18 December 2014.
YES, MANDATORY
State-regions agreement on breast units networking issued 18 December 2014.

ED National Representative
YES
See document from the Italian Ministry of Health (18 December 2014 Rep. Atti 185/ CSR).
YES
See document from the Italian Ministry of Health (18 December 2014 Rep. Atti 185/ CSR).

LT
ECIBC National Contacts
YES, MANDATORY
All radiologists interpreting diagnostic mammograms also work in breast screening in the same NCI or outside the NCI in other screening units.
NO, BUT PLANNED
Oral information is given after every MDT meeting. Written information is mandatory before surgery, medical oncology, radiotherapy or interventional radiology procedures. There are separate information documents regarding different procedures or treatment modalities. There is no single document concerning all information about the disease, its type and all treatment possibilities. But usually the woman is offered information along international guidelines.

ED National Representative

LU
ECIBC National Contacts
YES, MANDATORY
The screening method is based on the 2006 EU guidelines. It is explained in the Guide des Bonnes Pratiques http://www.sante.public.lu/fr/catalogue-publications/rester-bonne-sante/cancer-prevention-depistage/guide-bonnes-pratiques-programme-mam-mographie-2014/index.html and in the Memorial A, num 167, 19 November 2003. All radiologists working in screening need an accreditation. All radiologists do assessment. Every radiologist is allowed to do breast imaging, and some of them know only some technics. All radiologists are working inside a hospital. Breast cancer screening and diagnosis activities are done in a general radiology centre because no breast unit with dedicated radiologists exists.
YES, VOLUNTARY
Legislation: loi du 24 juillet 2014, droits et obligations des patients, Memorial A num 140, 31 juillet 2014. Every physician should provide written information concerning diagnosis and treatment. All hospitals have for the time being their own printed material or distribute what developed by the Cancer Foundation and/or Europa Donna Luxembourg.

ED National Representative
YES

NO

LV
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative

MT
ECIBC National Contacts
NO, BUT PLANNED
Mammography screening is performed at a National Screening Unit which is located outside the MDH precincts. The radiologists working in the screening programme also perform the diagnosis of symptomatic diseases and are members of the multi-disciplinary team.
NO, BUT PLANNED
A breast cancer treatment booklet has been developed and tailored for both local women and men who are starting or having treatment for breast cancer. The aim is to provide patients with the appropriate information at an adequate point in the breast care pathway (i.e. at the initial point of contact prior to commencement of treatment). Such information is now available at the breast unit, Department of Oncology and Gozo General Hospital. Since it helps to know what to expect and where patients can get further support after diagnosis, this booklet has included relevant information about the various treatment options for breast cancer and other relevant information which the patient/relatives may find useful in their cancer journey. The information in this booklet focuses on early stage breast cancer. This booklet is available in both Maltese and English languages.
Advanced (metastatic) breast cancer treatment information is also available; the latter was written on behalf of Europa Donna France and translated into English by a member of Europa Donna Malta. This booklet is also being translated into the Maltese language. Breast screening information leaflets are also available at breast screening units. Moreover, the breast units are also developing information at the diagnostic stage of the pathway.

ED National Representative
YES

NO

NL
ECIBC National Contacts

ED National Representative
NO
In The Netherlands, a wide screening programme has been in place since 1990. It is not part of breast cancer units but organised separately. The quality of the breast cancer screening programme is assured by regular control of the Dutch Reference Centre for screening which also checks equipment, organisation and education of professionals involved.
NO
Almost every hospital has written information about diagnosis, treatment, and patient groups, even if not mandated.

NO
ECIBC National Contacts
YES, MANDATORY
The Norwegian Breast Cancer Screening Programme foresees coverage of women aged 50-69.
YES, VOLUNTARY
The national action programme includes guidelines for diagnostics, treatment, and follow up of patients with breast cancer.

ED National Representative
YES

YES

PL
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative

PT
ECIBC National Contacts
NO and NOT PLANNED

YES, MANDATORY
Informed consent is mandatory by law for all patients. There is not a specific law for breast cancer patients.

ED National Representative

RO
ECIBC National Contacts
NO, BUT PLANNED

NO and NOT PLANNED

ED National Representative

RS
ECIBC National Contacts
YES, VOLUNTARY
Organisation of breast cancer screening is defined by the Regulation on breast cancer screening in Serbia (Official Gazette 73/2013). In the implementation of organised screening, institutions from all three levels of healthcare are included. Specialised institutions only read mammography images as part of the screening programme, including additional diagnostic services and breast cancer therapy.
YES, MANDATORY
Law on patient rights - Written information provided by breast units/hospitals as well as by non-governmental organisations.

ED National Representative

SE
ECIBC National Contacts
YES, VOLUNTARY
National population-based screening in place since 1986 is recommended by The National Board of Health and Welfare from age 40-74, with screening intervals of 1824 months. All County Councils offer this. The screening units in rural areas are managed by mobile teams, while in urban areas it is often in collaboration with the clinical mammography unit and breast unit. There are also special screening units (sub-contracted) in urbanised areas) which refer patients to the breast units.
YES, VOLUNTARY
Written information is sent in advance before mammography screening.
Individual breast units have information about bio-banking.
Oral information is given at most surgery clinics. Some oncology units have written information about chemotherapy and radiotherapy. Leaflets (e.g. information about patient support groups/organisations) are available at most breast units.
Patient support groups/organisations have in most cases excellent contact with the breast units. Frequently, education sessions are arranged between breast units and patient support groups/organisations.

ED National Representative
YES
Population-based screening programmes have been in place since mid-1980s and the general recommendations are that all women between the ages of 40 - 74 are invited at intervals of 18 - 24 months. In remote areas, mobile screening units are available. There are recommendations about personnel competence, not always upheld as these services are sometimes contracted.
YES
Depends on the county. Written information is given in connection with mammography screening. Should a patient be diagnosed with breast cancer it is normally the breast surgeon - sometimes together with a breast care nurse - that informs the patient of the cancer diagnosis. If the patient is referred by a general practitioner in a primary ward - this could be done by letter. Written information about the process through surgery, radiotherapy to chemotherapy is given in quite a few clinics/hospitals. Patient support groups are working in some of the hospitals on a voluntary basis providing brochures and other information leaflets produced by the National Breast Cancer Association.

SI
ECIBC National Contacts
YES, MANDATORY
Defined in national breast screening programme – (DORA)
YES, VOLUNTARY
The patients are informed by the treating oncologist, information leaflets and the Cancer Patients’ Association of Slovenia.

ED National Representative
YES
Available only in some parts of Slovenia.
NO

SK
ECIBC National Contacts
NO, BUT PLANNED

NO, BUT PLANNED

ED National Representative

TR
ECIBC National Contacts

ED National Representative
YES

YES

UK
ECIBC National Contacts
YES, VOLUNTARY
It is recommended that breast units should be combined symptomatic and screening units, and most are, although this is not mandated.
YES, MANDATORY
Mandated via the National Peer Review Measures, see response to D2-D3.

ED National Representative
YES

YES

Table 13: Survey section 6.

Breast Units non-mandatory requirements implementation stage.

Questions:

N. S. Associated Services and non-core personnel (9.8.1)

Definition from the 2006 European Guidelines

These are services for which it cannot be expected that staff will spend the majority of their time on breast disease.

Extra Psychological Support

If the patient is experiencing psychological morbidity that cannot be dealt with effectively by members (usually breast care nurse or psycho-oncologist) of the Unit team, she should be referred to a psychiatrist with whom there are particular arrangements to see breast patients for the Breast Unit (non-core team member).

ECIBC:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the extra psychological support as defined above? * YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

3. If you wish, please add below your comments/considerations on the extra psychological support voluntary requirement

ED:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the extra psychological support as defined above? YES; NO; I do not have this information

2. If you wish, please add below your comments/considerations on the extra psychological support voluntary requirement

0. S. Associated Services and non-core personnel (9.8.2)

Definition from the 2006 European Guidelines

Plastic Surgeon

The Breast Unit should make arrangement with one or two nominated plastic surgeons with a special interest in breast reconstructive and recontouring techniques.

ECIBC:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the plastic surgery as defined above? * YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

3. If you wish, please add below your comments/considerations on the plastic surgery voluntary requirement

ED:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the plastic surgery as defined above? YES; NO; I do not have this information

2. If you wish, please add below your comments/considerations on the plastic surgery voluntary requirement

P. S.   Associated Services and non-core personnel (9.8.3)

Definition from the 2006 European Guidelines

Geneticists

Women seeking advice with regard to risk, e.g., family history, must be able to receive advice from the Breast team, which must include a clinical geneticist with a specialist interest in breast cancer (see 9.7.9).

ECIBC:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the genetist advice as defined above? * YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

3. If you wish, please add below your comments/considerations the genetist advice voluntary requirement

ED:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the genetist advice as defined above? YES; NO; I do not have this information

2. If you wish, please add below your comments/considerations on the genetist advice voluntary requirement

Country

N1. Is there a requirement that regulates the extra psychological support?
N2-N3 Extra psychological support details/comments
O1. Is there a requirement that regulates plastic surgery?
O2-O3 Plastic surgery details/comments
P1. Is there a requirement that regulates geneticist advice?
P2-P3 Geneticist advice details/comments

AT
ECIBC National Contacts

ED National Representative
YES
Every patient is offered psycho-oncological support. The psycho-oncologist is a member of the breast team; 10-50% of patients get support at least once during illness, some of them more.
YES
Every breast unit has at least one nominated plastic surgeon.
YES
Every unit has a nominated clinical geneticist.

BE
ECIBC National Contacts
YES, MANDATORY
Royal Decree on 26 April 2007. One of the recognition criteria for a breast unit is ensuring sufficient psychological support and follow-up of patients. A psychologist is included in the multidisciplinary team.
YES, MANDATORY
See previous questions on medical requirements.
YES, VOLUNTARY
The geneticist is not included in the breast unit team, but breast units must have a written agreement with a centre for human genetics to provide genetic counselling.

ED National Representative

BG
ECIBC National Contacts
YES, VOLUNTARY
There are Ministry of Health and National Health Insurance Fund documents as well as accreditation requirements for the National Hospital of Oncology. Patients are sent to a specialised psychological support centre.
YES, VOLUNTARY
There are Ministry of Health and National Health Insurance Fund documents as well as accreditation requirements for the National Hospital of Oncology. A plastic surgeon is included in the multidisciplinary team when necessary.
YES, VOLUNTARY
There are Ministry of Health and National Health Insurance Fund documents as well as accreditation requirements for the National Hospital of Oncology, and also requirements of the Breast Department

ED National Representative

CH
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative
I do not have this information.

I do not have this information.

I do not have this information.

CY
ECIBC National Contacts
YES, VOLUNTARY
Psychiatric help is provided but is not legally regulated.
YES, VOLUNTARY

YES, VOLUNTARY

ED National Representative
NO
Psychological support is offered through NGOs and a psychologist at the Oncology Centre.
NO

NO

CZ
ECIBC National Contacts
YES, VOLUNTARY
The psychologist is part of the multidisciplinary team or on call.
YES, VOLUNTARY
Each unit is connected to one or more of the clinics of plastic surgery.
YES, MANDATORY
Each unit has the opportunity to send patients to genetic testing and counselling.

ED National Representative

DE
ECIBC National Contacts
NO and NOT PLANNED
The psycho-oncologist is mandatory within the certification system and the psycho-oncologist could be a psychologist or a psychiatrist. (see Chapter 1.4.1, https://www.krebsgesellschaft.de/gcs/german-cancer-society/certification/documents.html?file=files/dkg/german-cancer-society/pdf/Certification/Catalogue%20of%20Req%20breast-Hi%201%20%2814%2007%202016%29%20EN.pdf) Why should there be an obligatory psychiatrist? Is there evidence that shows more psychiatric diseases in cancer patients than in normal population?
YES, MANDATORY
The requirements regulating plastic surgery are described in Chapter 5.2.21 et seq. and Chapter 1.1.1 / 1.1.2 of the Catalogue of Requirements, see: https://www. krebsgesellschaft. de/gcs/german-cancer-society/certification/documents.html?file=files/dkg/german-cancer-soci-ety/pdf/Certification/ Catalogue%2oof%20 Req%2obreast-Hi%201%20%2814%20 07%202016%29%20EN.pdf.
YES, MANDATORY
The requirements regulating genetist advice are described in Chapter 2.1.4 and Chapter 1.1.2 of the Catalogue of Requirements, see: https://www.krebsgesellschaft.de/gcs/german-cancer-society/certification/documents. html?file=files/dkg/german-cancer-society/pdf/Certification/ Catalogue°/o20of%20 Req%20breast-Hi%201%20%2814%2007%202016%29%20 EN.pdf.

ED National Representative

EE
ECIBC National Contacts

ED National Representative
YES
There are psychologists available for cancer patients (non-core team members).
YES

YES

ES
ECIBC National Contacts

ED National Representative
NO

NO

NO

FI
ECIBC National Contacts
YES, VOLUNTARY
All hospitals have psychosocial units that can be consulted. In addition, dedicated nurses with psychotherapy (or equivalent) education are available.
YES, VOLUNTARY
The FBCG recommends that each patient should be offered discussion about the timing of breast reconstruction (imminent or delayed). Plastic surgeons are taking part to the MDMs.
YES, VOLUNTARY
Referral to geneticist will be organised when needed. All university hospital areas have them in place. The FBCG recommendations are followed.

ED National Representative

FR
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative
NO
Extra psychological support is given by most of public entities. It’s mandatory in palliative care units. The Cancer Plan insists on giving this support to all patients, as needed.
YES
Provided for free in public hospitals and anti-cancer centres.
YES

GR
ECIBC National Contacts
YES, VOLUNTARY
In 2002, the Hellenic Senologic Society founded and operates the Centre for Psychosocial Support for women with breast cancer “Ellie Lambeti”. The Centre provides free of charge personalised services to women with breast cancer and to the members of their families. The existence of such centres is vital to patients’ wellbeing.
YES, VOLUNTARY
On voluntary basis, private hospitals cooperate with a plastic surgeon with special interest in breast reconstructive and re-contouring techniques. It is very important for the patient to know that a plastic surgeon is on her side. The hope that she could have a breast reconstruction facilitates the decision when mastectomy is proposed, raises their morale, and revives hope.
YES, VOLUNTARY
It is very important for women who wish to be informed about the risk to address to the specialised doctor to get a clear picture of their risk.

ED National Representative
NO

NO

NO

HU
ECIBC National Contacts
NO and NOT PLANNED

NO, BUT PLANNED
Patient should make own arrangements for plastic surgery.
NO and NOT PLANNED

ED National Representative

IE
ECIBC National Contacts
YES, VOLUNTARY

YES, VOLUNTARY

YES, VOLUNTARY
There is a national service separate from the breast units but they work together.

ED National Representative

IT
ECIBC National Contacts
YES, VOLUNTARY
State-regions agreement on breast units networking issued 18 December 2014.
YES, MANDATORY
State-regions agreement on breast units networking issued 18 December 2014.
YES, MANDATORY
State-regions agreement on breast units networking issued 18 December 2014.

ED National Representative
YES
See document from the Italian Ministry of Health (18 December 2014 Rep. Atti 185/ CSR).
YES
See document from the Italian Ministry of Health (18 December 2014 Rep. Atti 185/ CSR).
YES
See document from the Italian Ministry of Health (18 December 2014 Rep. Atti 185/ CSR).

LT
ECIBC National Contacts
YES, MANDATORY
The patient can be referred to psychologist by the MDT, medical oncologists, or surgeon.
YES, MANDATORY

YES, MANDATORY
Patient is referred to genetics by the MDT, medical oncologist, or surgeon. Geneticist could refer for further testing, if needed.

ED National Representative

LU
ECIBC National Contacts
NO, BUT PLANNED
Will be adopted in the framework of the Cancer Plan guidelines on breast cancer management.
NO, BUT PLANNED
Will be adopted in the framework of the Cancer Plan guidelines on breast cancer management.
NO, BUT PLANNED
The Social Security allows a genetic advice in some conditions described in: Memorial A, numb. 46, 31 mars 2014.

ED National Representative
NO
A law is being issued to regulate psycho-therapist in extra hospital areas.
NO

NO
Working groups discussing this topic are in place.

LV
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative

MT
ECIBC National Contacts
NO, BUT PLANNED
Due to lack of psychology professionals the presence of a psychologist whenever breast cancer patients are being given the bad news cannot be guaranteed. This situation is currently being evaluated. Plans are in place to provide for a psychologist both at the National Screening Unit and at the Breast Unit at MDH. More psychology professionals need to be employed within oncology, to be able to meet this need, as well as the needs pertaining to patients with other forms of cancer. Patient befriending and support is also provided by patient support groups. There are 2 non-governmental organisations providing these services: Europa Donna (Malta) and Action for Breast Cancer Foundation.
NO, BUT PLANNED
Breast care surgeons have started to perform both oncoplastic surgery as well as immediate reconstruction procedures. Patients requiring delayed reconstruction are referred and managed by a plastic surgeon.
NO, BUT PLANNED
The BU at MDH has started a family history/ genetics clinic which is led by a clinical geneticist. Patients are referred by the surgeons to the geneticist who sees these cases during the genetics clinic sessions.

ED National Representative
NO

NO

NO

NL
ECIBC National Contacts

ED National Representative
NO
Extra psychological support is always available if needed. As in the Netherlands psychological support is partly a health insurance issue and partly a municipal obligation, reimbursement may be complex.
NO
Not every hospital has a plastic surgeon with the required skills. The capacity of plastic surgeons specialised in this kind of surgery is a problem.
NO
See N, there are specialised genetic clinics so you are referred to that clinic, most are part of university hospitals

NO
ECIBC National Contacts
NO and NOT PLANNED

YES, VOLUNTARY
The national action programme includes guidelines for diagnostics, treatment, and follow up of patients with breast cancer.
YES, VOLUNTARY
The national action programme includes guidelines for diagnostics, treatment, and follow up of patients with breast cancer.

ED National Representative
YES

YES

YES

PL
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative

PT
ECIBC National Contacts
NO, BUT PLANNED

NO, BUT PLANNED

NO, BUT PLANNED

ED National Representative

RO
ECIBC National Contacts
NO and NOT PLANNED

YES, VOLUNTARY
Recently (two years ago [2013]), reconstructive surgery following interventions for breast cancer have been included in the reimbursement scheme. Voluntary arrangements have been made to create surgery teams that include plastic surgeons to allow patients to benefit from reconstruction techniques.
NO and NOT PLANNED

ED National Representative

RS
ECIBC National Contacts
YES, MANDATORY
Law on healthcare: Provide all necessary support to patients including psychological counselling and if needed to referral to psychiatrist.
YES, VOLUNTARY
Available at large centres as the Institute for Oncology and Radiology and the military medical academy.
YES, VOLUNTARY

ED National Representative

SE
ECIBC National Contacts
YES, VOLUNTARY
At some breast units, psychological support is available.
YES, VOLUNTARY
Plastic surgeons are available at all university hospitals and at other hospitals with breast units. The other units refer patients to these breast units or to a university hospital.
YES, VOLUNTARY
Please, see answer question K2 (on family history and genetics). At university hospitals there are specific family history clinics which have separate MDMs that include clinical geneticists, breast surgeons, plastic surgeons, oncologists and psychologists.

ED National Representative
YES
Depending on the county and according to recommendations from the Swedish Breast Cancer Group (which form the basis for the National Guidelines issued by the National Board of Health and Welfare). In most hospitals, including the university ones, this is not commonly at hand. Often, the patient has to ask for this service and not even then this is given.
YES
It Is Included In the National Guidelines, but mostly not fulfilled; It depends on the county. University hospitals have plastic surgeons. In addition, onco-plastic surgery is now performed at some university hospitals. Patients’ rights or possibilities to reconstruction and access to direct-reconstruction is being debated.
YES
It is included in the National Guidelines on Breast Cancer Treatment and available at university hospitals.

SI
ECIBC National Contacts
YES, VOLUNTARY
Psycho-oncology support is available in the frame of Department for Psycho-oncology (in one unit).
YES, MANDATORY
Plastic surgery is part of breast cancer management guidelines and is available for all breast cancer patients who need it.
YES, MANDATORY
Genetic consultation is offered to all patients in accordance with the criteria described in breast cancer management guidelines at our genetics clinic.

ED National Representative
NO

YES

YES

SK
ECIBC National Contacts
i do not know

YES, VOLUNTARY
In oncology centres and university hospitals.
YES, VOLUNTARY
In oncology centres and university hospitals.

ED National Representative

TR
ECIBC National Contacts

ED National Representative
NO

YES

I do not have this information.

UK
ECIBC National Contacts
YES, MANDATORY
Mandated via national peer review as a member of the extended multi-disciplinary team, (See response to F2-F3).
YES, MANDATORY
Mandated in the NICE guidance on early and locally advanced breast cancer (see below) and assessed via the national peer review measures; that the diagnosing and treating surgeon can either: offer breast reconstruction and re-contouring techniques or that there is a clear pathway defined for referral to a plastic surgeon who can offer immediate breast reconstruction. In practise many breast surgeons in England are trained in onco-plastic surgery and are able to offer immediate and delayed breast reconstruction. From the Early and locally advanced NICE guidance: 1.5.1 Discuss immediate breast reconstruction with all patients who are being advised to have a mastectomy, and offer it except where significant comorbidity or (the need for) adjuvant therapy may preclude this option. All appropriate breast reconstruction options should be offered and discussed with patients, irrespective of whether they are all available locally.
YES, VOLUNTARY
Those at moderate risk are usually assessed within the breast unit and counselled appropriately; those at high risk are referred to the regional genetics service.

ED National Representative
YES

YES

YES

Table 14: Survey section 6.

Breast Units non-mandatory requirements implementation stage.

Questions:

Q. S. Associated Services and non-core personnel (9.8.4)

Definition from the 2006 European Guidelines

Palliative Care

A specialist palliative care service must be available for the referral of patients with advanced breast cancer. A close working relationship must be established between members of the Breast Unit (especially the breast care nurse) and the palliative care service to ensure that breakdowns in continuity of care do not occur and also with the local network for home assistance.

ECIBC:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the provision of palliative care as defined above? * YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

3. If you wish, please add below your comments/considerations on the provision of palliative care voluntary requirement

ED:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the provision of palliative care as defined above? YES; NO; I do not have this information

2. If you wish, please add below your comments/considerations on the provision of palliative care voluntary requirement

R. S. Associated Services and non-core personnel (9.8.5)

Definition from the 2006 European Guidelines

Prosthesis

There must be provision for a Prosthesis fitting service within the unit.

ECIBC:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the provision of prosthesis as defined above? * YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

3. If you wish, please add below your comments/considerations on the provision of prosthesis voluntary requirement

ED:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the provision of prosthesis as defined above? YES; NO; I do not have this information

2. If you wish, please add below your comments/considerations on the provision of prosthesis voluntary requirement

S. S. Associated Services and non-core personnel (9.8.6)

Definition from the 2006 European Guidelines

Physiotherapy and Lymphoedema

An identified Physiotherapist or a Breast Care Nurse for the treatment of lymphoedema and late sequeale.

ECIBC:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the provision of physiotherapy and lymphoedema treatment as defined above? * YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

3. If you wish, please add below your comments/considerations the provision of physiotherapy and lymphoedema treatment voluntary requirement

ED:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the provision of physiotherapy and lymphoedema treatment as defined above? YES; NO; I do not have this information

2. If you wish, please add below your comments/considerations on the provision of physiotherapy and lymphoedema treatment voluntary requirement

Country

Q1. Is there a requirement that regulates the provision of palliative care?
Q2-Q3 Palliative care details/comments
R1. Is there a requirement that regulates provision of prosthesis?
R2-R3 Prosthesis details/comments
S1. Is there a requirement that regulates the provision of physiotherapy and lymphoedema treatment?
S2-S3 Physiotherapy and lymphoedema treatment details/ comments

AT
ECIBC National Contacts

ED National Representative
YES
Each unit has a nominated palliative care inpatient and outpatient service.
YES
Breast care nurse and prosthesis companies are part of the units.
YES
They are part of every breast unit team.

BE
ECIBC National Contacts
YES, VOLUNTARY
This is not specifically required in the Royal Decree on Breast Units, but a breast unit has to be part of an oncology care programme, and in this context there is a specific link with palliative care teams.
NO and NOT PLANNED

YES, MANDATORY
In the Royal Decree of 26 April 2007, specific attention is given to treatment of lymphoedema

ED National Representative

BG
ECIBC National Contacts
YES, VOLUNTARY
There are Ministry of Health and National Health Insurance Fund documents as well as accreditation requirements for the National Hospital of Oncology. There is a service for pain control.
YES, MANDATORY
There are Ministry of Health and National Health Insurance Fund documents as well as accreditation requirements for the National Hospital of Oncology.
YES, VOLUNTARY
There are Ministry of Health and National Health Insurance Fund documents as well as accreditation requirements for the National Hospital of Oncology.

ED National Representative

CH
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative
I do not have this information.

I do not have this information.

I do not have this information.

CY
ECIBC National Contacts
YES, VOLUNTARY

YES, VOLUNTARY

YES, VOLUNTARY

ED National Representative
NO

NO
Prosthesis provided by EUROPA DONNA Cyprus.
NO

CZ
ECIBC National Contacts
YES, MANDATORY
Each comprehensive cancer centre is usually associated with inpatient palliative care, hospice care, and mobile home hospice.
YES, MANDATORY
Patients’ breast units have the ability to get breast prostheses covered by insurance in the hospital shop or nearby.
YES, VOLUNTARY
Each BU is connected to a rehabilitation centre with the option of manual and instrumental lymph drainage, under the supervision of a lymphologist.

ED National Representative

DE
ECIBC National Contacts
YES, MANDATORY
The requirements regulating the provision of palliative care are described in Chapter 9 and Chapter 1.2.4 of the Catalogue of Requirements, see: https://www.krebsgesellschaft.de/gcs/german-cancer-society/certification/documents.html?file=files/dkg/german-cancer-society/pdf/Certification/Catalogue%200f%20Req%20breast-H1%201%20%2814%2007%202016%29%20EN.pdf.
YES, MANDATORY
The requirements regulating the provision of prothesis are described in Chapter 1.1.2 and 5.2.25 of the Catalogue of Requirements, see: https://www.krebsgesellschaft.de/gcs/german-cancer-society/certification/documents.html?file=files/dkg/german-cancer-soci-ety/pdf/Certification/Catalogue%2oof%20 Req%2obreast-Hi%201%20%2814%20 07%202016%29%20EN.pdf.
YES, MANDATORY
The requirements regulating the provision of physiotherapy and lymphoedema treatment are described in Chapter 1.1.2 of the Catalogue of Requirements, see: https://www.krebsgesellschaft.de/gcs/german-cancer-society/certification/documents. html?file=files/dkg/german-cancer-soci-ety/pdf/Certification/ Catalogue%20of%20 Req%20breast-H1%201%20%2814%2007%202016%29%20EN.pdf.

ED National Representative

EE
ECIBC National Contacts
YES

NO

YES

ED National Representative

ES
ECIBC National Contacts

ED National Representative
NO

NO

NO

FI
ECIBC National Contacts
YES, VOLUNTARY
EAPC guidelines for palliative care are followed. There is a three-level organisation of palliative care as recommended in the Cancer Control Plan.
YES, MANDATORY
This is outsourced in most cases to external service providers. All patients get referral and prosthesis free of charge. There is a law on prosthesis and other medical equipment.
YES, VOLUNTARY
Physiotherapy should be given according to patient need. Lymphatherapy as well, but the public service may be limited due to limited resources. However, it is partially reimbursed for BC patients by the Finnish government, so patients may also use private sector services.

ED National Representative

FR
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative
NO

NO
Patients are informed by surgeons about the prosthesis
NO
It is provided differently across hospitals.

GR
ECIBC National Contacts
YES, VOLUNTARY
Six out of the 13 hospitals that have answered, declare that they have protocols for palliative care service. There is a non-profit Centre of palliative care, called “Tzeni Karezi”, which provides its services to a certain number of patients.
NO and NOT PLANNED
Currently, none of the 13 hospitals can provide the patient with a prosthesis fitting service within the breast centre; although, such a service would be very helpful to patients.
YES, VOLUNTARY
Only two out of the 13 breast units responded that they have a physiotherapy section but they are not specialised in lymphoedema. In the past, physiotherapy was very important as the axillary dissection of lymph nodes provoked more often lymphoedema. Nowadays, biopsy of the sentinel lymph node during the operation, in case that it is negative- limits the cases of lymphoedema and consequently the need of physiotherapy.

ED National Representative
NO

NO

NO

HU
ECIBC National Contacts
YES, VOLUNTARY
Pain and palliative symptom control is managed on a case-by-case basis; hence, it is treated as a voluntary requirement.
NO and NOT PLANNED

YES, VOLUNTARY

ED National Representative

IE
ECIBC National Contacts
YES, VOLUNTARY

YES, VOLUNTARY

NO, BUT PLANNED

ED National Representative
YES

YES

NO
All cancer or DCIS patients get post-operative physiotherapy. It is not foreseen for benign disease.

IT
ECIBC National Contacts
YES, MANDATORY
State-regions agreement on breast units networking issued the 18 December 2014.
YES, MANDATORY
State-regions agreement on breast units networking issued the 18 December 2014.
YES, MANDATORY
State-regions agreement on breast units networking issued the 18 December 2014.

ED National Representative
YES
See document from the Italian Ministry of Health (18 December 2014 Rep. Atti 185/CSR).
YES
See document from the Italian Ministry of Health (18 December 2014 Rep. Atti 185/CSR).
YES
See document from the Italian Ministry of Health (18 December 2014 Rep. Atti 185/CSR).

LT
ECIBC National Contacts
YES, MANDATORY
Patients are usually referred by the medical oncologist or other MDT members
NO, BUT PLANNED
Reimbursement of outer prosthesis is regulated by the Lithuanian Ministry of Health, but there is no rule for reimbursement of implants after breast cancer surgery.
YES, MANDATORY
Regulated by breast cancer diagnosis and treatment standards in Lithuania and the NCI.

ED National Representative

LU
ECIBC National Contacts
YES, MANDATORY
Luxembourg has a law which regulates access to palliative care and to euthanasia: Memorial A, numb. 46, 16 mars 2009. Explanations available on: http://www.sante.public.lufr/actualites/2009/06/guide-soins-palliatifs/index.html
NO and NOT PLANNED
Some nurses are trained to provide explanations about the breast prosthesis during patient’s hospitalisation.
NO, BUT PLANNED
Will be adopted in the framework of the Cancer Plan guidelines on breast cancer management.

ED National Representative
NO

NO

NO
There is no requirement but ED Luxembourg has coordinated the training of 200 physiotherapists for manual treatment of lymphoedema. Their addresses are published on the ED Luxembourg website.

LV
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative

MT
ECIBC National Contacts
NO, BUT PLANNED
A specialist palliative care service and unit is located within the oncology department and it will also be migrating to the new oncology hospital within the MDH precincts. Referrals to the specialist palliative care services come from several sources that include the breast unit teams at MDH, other MDH departments, the oncology department, the rehabilitation hospital, long-term care residences, and family practice. Initial assessment is carried out by palliative care specialist at palliative care out-patients or at MDH for in-patients. Patients and their families are than referred to other team members as deemed necessary; occupational therapy, physiotherapy, psychology, social work, spiritual director, tissue viability unit and Hospice Malta (a non-governmental organisation). The latter also provide home care and loan of equipment. Patients continue attending outpatients follow ups until they are less well. This is complemented with visits by the hospice doctor at home as necessary. Patients are admitted to palliative in-patient unit for symptom control, palliative radiotherapy or end-of-life care as indicated and required.
NO, BUT PLANNED
The fitting and provision of prosthesis is performed at the BU at MDH and is led by the breast care nurses. This service is also supported by a breast cancer patients support group (a non-governmental organisation called Action for Breast Cancer Foundation).
NO, BUT PLANNED
A dedicated lymphoedema clinic, within the physiotherapy services at the oncology hospital has been supporting post-operative patients with secondary lymphoedema since 2003. Clinicians within the clinic are specifically trained in post-operative lymphoedema management observing current UK and European set modalities and practices.

ED National Representative
NO

YES

YES
The national guidelines have a paragraph physiotherapy and lymphoedemia (voluntary).

NL
ECIBC National Contacts

ED National Representative
YES

NO

NO

NO
ECIBC National Contacts
YES, MANDATORY
The national action programme includes guidelines for diagnostics, treatment, and follow up of patients with breast cancer.
YES, VOLUNTARY

NO and NOT PLANNED

ED National Representative
NO

YES

YES

PL
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative

PT
ECIBC National Contacts
NO, BUT PLANNED

YES, MANDATORY
Portuguese law states that the responsibility for prosthesis is on the treating hospital.
NO, BUT PLANNED

ED National Representative

RO
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative

RS
ECIBC National Contacts
YES, MANDATORY
Strategy of palliative care in Serbia. - Law on healthcare. -Plan for healthcare from 2015 this includes plan for provision of palliative healthcare in the Republic of Serbia financed by Health Insurance Fund and free of charge for users. -Now, the Ministry of Health has formed the network of hospitals within the public healthcare sector with hospital beds for palliative care. Thirty hospitals have capacities for palliative care.
YES, MANDATORY
Patients must attend the Institute for Oncology and Radiology of Serbia, the Military Medical Academy and the Institute of Oncology of Vojvodina, or Sremska Kamenica. They provide the prosthesis fitting services within their departments.
YES, MANDATORY
Physiotherapy and lymphoedema treatment is provided in Institute for Oncology and Radiology of Serbia, the Military Medical Academy and Institute of Oncology of Vojvodina, Sremska Kamenica. Patients from other healthcare institutions are referred to above mentioned institutions.

ED National Representative

SE
ECIBC National Contacts
YES, VOLUNTARY
The management of palliative care various throughout Sweden. Palliative Care is arranged by multiple institutions/units, and by both County Councils and Municipalities.
YES, VOLUNTARY
All patients with mastectomy and primary reconstruction can request a prosthesis. Single breast units have a very high rate of reconstructions.
YES, VOLUNTARY
Individuals who developed lymphoedema should be managed by a physiotherapist (according to the National Guidelines and the National Clinical Practice Guidelines for Breast Cancer); however, not all units have personnel that are educated in the treatment of lymphoedema. It should be emphasised that during the last decade, single units have reduced the problem with lymphoedema by the use of sentinel node and better use of surgery with or without radiotherapy.

ED National Representative
YES
Even if recommended by the National Guidelines, palliative care organisation differs depending on whether it is in the domain of the county council or municipality.
YES
Depends on the county. Generally a patient treated with a mastectomy will have access to a prosthesis.
NO
Depends on the county, but due to lack of lymphoedema therapists, it is rarely provided.

SI
ECIBC National Contacts
YES, VOLUNTARY
Palliative care is offered to all patients who need it (not separately for breast cancer patients only).
NO, BUT PLANNED
Prosthesis fitting service is currently located outside breast units; however, it is offered to all breast cancer patients.
NO, BUT PLANNED

ED National Representative
YES

YES

NO

SK
ECIBC National Contacts
NO, BUT PLANNED

YES, MANDATORY
In oncology centres and in some university hospitals.
YES, MANDATORY
In oncology centres and in some university hospitals.

ED National Representative

TR
ECIBC National Contacts

ED National Representative
NO

YES

YES

UK
ECIBC National Contacts
YES, MANDATORY
Defined by and mandated by the NICE Guidance on advanced disease, see below: Healthcare professionals involved in the care of patients with advanced breast cancer should ensure that the organisation and provision of supportive care services comply with advanced breast cancer (update) NICE clinical guideline 81.
The recommendations made in Improving outcomes in breast cancer: manual update (NICE) cancer service guidance [2002]) and Improving supportive and palliative care for adults with cancer (NICE cancer service guidance [2004]), in particular the following two recommendations: ‘Assessment and discussion of patients’ needs for physical, psychological, social, spiritual and financial support should be undertaken at key points (such as diagnosis; at commencement, during, and at the end of treatment; at relapse; and when death is approaching).’
‘Mechanisms should be developed to promote continuity of care, which might include the nomination of a person to take on the role of “key worker” for individual patients.’ [2009].
YES, VOLUNTARY
This is provided as standard by the breast care nurses in every breast unit in England.
YES, MANDATORY
Mandated through the national peer review measures and defined as one of the members of the extended MDT, which includes: a core member of the specialist palliative care team; breast radiographer; psychiatrist or clinical psychologist; plastic/reconstructive surgeon; clinical geneticist/genetics counsellor; physiotherapist/lymphoedema/ practitioner There is also advice and guidance on the management of lymphoedema in the NICE Advanced Breast Cancer Guidelines 2009, updated in 2014 as indicated: 1.5.1 Discuss with people who have or who are at risk of breast-cancer-related lymphoedema that there is no indication that exercise prevents, causes or worsens lymphoedema. [new 20l4]
1.5.2 Discuss with people who have or who are at risk of breast cancer-related lymphoedema that exercise may improve their quality of life. [new 20l4]
1.5.3 Assess patients with lymphoedema for treatable underlying factors before starting any lymphoedema management programme. [2009]
1.5.4 Offer all patients with lymphoedema complex decongestive therapy (CDT) as the first stage of lymphoedema management. [2009] l.5.5 Consider using multilayer lymphoedema bandaging (MLLB) for volume reduction as a first treatment option before compression hosiery. [2009] 1.5.6 Provide patients with lymphoedema with at least two suitable compression garments. These should be of the appropriate class and size, and a choice of fabrics and colours should be available. [2009]

1.5.7 Provide patients with lymphoedema clear, written information and the contact details of local and national lymphoedema support groups [2009].

ED National Representative
YES

YES

YES

Table 15: Survey section 6.

Breast Units non-mandatory requirements implementation stage.

Questions:

T. Research (9.9)

Definition from the 2006 European Guidelines

Research is one of the essential parts of training of specialists. As part of Audit Units must record numbers of patients entered into clinical trials and details of all other research. Units should be encouraged to provide research opportunities and this must be taken into account when assessing units for their suitability for accepting trainees.

ECIBC:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the management of research as defined above? * YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

3. If you wish, please add below your comments/considerations on the management of research voluntary requirement

ED:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the management of research as defined above? YES; NO; I do not have this information

2. If you wish, please add below your comments/considerations on the management of research voluntary requirement

U. Teaching (9.10)

Definition from the 2006 European Guidelines

The Unit must provide teaching, whether simply for junior staff or for students or on a national or international basis. Some units may particularly concentrate on certain areas (e.g. Reconstruction, Screening, Pathology, etc.).

ECIBC:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the management of teaching provision as defined above? * YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

3. If you wish, please add below your comments/considerations on the management of teaching provision voluntary requirement

ED:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the management of teaching provision as defined above? YES; NO; I do not have this information

2. If you wish, please add below your comments/considerations on the management of teaching provision voluntary requirement

V. Additional point (9.11)

Definition from the 2006 European Guidelines

The implementation of the suggested structure of Breast Units requires a reorganisation of time in each discipline, so that as a consultant spends more time in breast disease, his or her colleagues no longer treat breast cancer and specialise in other areas. Rationalisation of work patterns, in this way would provide sufficient staff for the Breast Units. Such a move would coincide with changes that are already occurring within all disciplines, for example, from General Surgery the emergence of specialist surgeons for urology, microinvasive techniques, vascular surgery, upper GI, hepatic and colon.

All work must be carried out or directly supervised by specialists specifically trained in breast disease. A service provided by a trained specialist is more efficient and more cost effective-diagnostic decisions are made earlier whereas junior staff are more likely to call a patient back several times unnecessarily and to carry out unnecessary investigations; operating by consultants gives better results for technical reasons; the interpretation of imaging techniques and the reading of histology is much more likely to produce definitive opinions if carried out by experts.

We [the guidelines authors] estimate that for a 10 million total population base 30-40 Breast Units are required for the ideal service and that reorganisation in this way will provide considerable financial savings. This could easily be achieved and should be attractive to many countries.

ECIBC:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the additional points as defined above? * YES, MANDATORY; YES, VOLUNTARY; NO, BUT PLANNED; NO and NOT PLANNED; I do not know

2. If you replied YES, please provide a more detailed description (i.e. name of legislation/quality assurance scheme, link to the text or reference document)

3. If you wish, please add below your comments/considerations the additional points voluntary requirement

ED:

1. In the geographical area under your organisation’s responsibility, is there any kind of requirement that regulates the additional points as defined above? YES; NO; I do not have this information

2. If you wish, please add below your comments/considerations on the additional points voluntary requirement

Country

T1. Is there a requirement that regulates the management of research?
T2-T3 Research details/comments
U1. Is there a requirement that regulates the management of teaching provision?
U2-U3 Teaching provision details/comments
V1. Is there a requirement that regulates additional points?
V2-V3 Additional points details/comments

AT
ECIBC National Contacts

ED National Representative
YES
Every unit must take part in clinical studies for at least 10% of patients.
NO
There are no “musts”, but most of the units provide teaching.
YES
In 2014, nearly 80% of all breast cancer patients were treated in certified breast cancer units.

BE
ECIBC National Contacts
YES, VOLUNTARY

NO and NOT PLANNED

YES, MANDATORY
See Royal Decree 26 April 2007.

ED National Representative

BG
ECIBC National Contacts
YES, MANDATORY
There are Ministry of Health and National Health Insurance Fund documents as well as accreditation requirements for the National Hospital of Oncology.
YES, VOLUNTARY
There are Ministry of Health and National Health Insurance Fund documents as well as accreditation requirements for the National Hospital of Oncology. The training is according to the yearly plan for specialisations in the National Hospital of Oncology
YES, VOLUNTARY
There are Ministry of Health and National Health Insurance Fund documents as well as accreditation requirements from the National Hospital of Oncology. If they wish, general surgeons can be trained in breast cancer according to the yearly plan of the Breast Department.

ED National Representative

CH
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative
I do not have this information.

I do not have this information.

I do not have this information.

CY
ECIBC National Contacts
YES, VOLUNTARY

YES, VOLUNTARY

YES, VOLUNTARY

ED National Representative

CZ
ECIBC National Contacts
YES, VOLUNTARY
In comprehensive oncological centres undergoing clinical studies (usually phase II and III), on the issue of breast cancer
YES, VOLUNTARY
Breast units provide training to postgraduate students, medics, and middle medical staff.
YES, VOLUNTARY
The Medical Chamber, professional societies, and insurance companies.

ED National Representative

DE
ECIBC National Contacts
YES, MANDATORY
The requirements regulating the management of research are described in Chapter 1.7 of the Catalogue of Requirements, see: https://www.krebsgesellschaft.de/gcs/german-cancer-society/certification/documents.html?file=files/dkg/german-cancer-soci-ety/pdf/Certification/Catalogue%2oof%20 Req%2obreast-Hi%201%20%2814%20 07%202016%29%20EN.pdf.
YES, MANDATORY
Training of new breast surgeons: The training of one breast surgeon must be organised for each location and for every 100 primary cases. Breast surgeons in training must provide evidence of at least 20 operations per year (not as a second surgeon). (see: Catalogue of Requirements, Chapter 5.2.8) Advanced training for every discipline/staff member: example: page 22 (3.16):
“Further/additional training: A qualification plan for physicians and other staff members (radiological technicians) must be submitted in which the qualification measures for the coming year are described.” Always at end of each Chapter of the Catalogue of Requirements). https://www.krebsgesellschaft.de/gcs/german-cancer-soci-ety/certification/documents.html?file=files/dkg/german-cancer-society/pdf/Certification/Catalogue%20of%20Req%20breast-H1%201%20%2814%2007%202016%29%20EN.pdf.
Teaching for students is performed through the university hospitals but they are only a small part of all certified Breast Cancer Centres.
Quality of scintigraphic marking/detection of the sentinel node (see Chapter 4.3 et seq.) Guideline-based quality indicators (e.g. Chapter 1.2.8 et seq.) Criteria for nursing care (see Chapter 1.8) Criteria for social workers (see Chapter 1.5) Self-help groups (see Chapter 1.6.8) (https://www.krebsgesellschaft.de/gcs/german-cancer-society/certification/documents.html?-file=files/dkg/german-cancer-society/pdf/Certification/Catalogue%20of%20Req%20breast-H1%201%20%2814%2007%202016%29%20EN.pdf)

ED National Representative

EE
ECIBC National Contacts

ED National Representative
NO

YES

YES

ES
ECIBC National Contacts

ED National Representative
NO

NO

NO

FI
ECIBC National Contacts
NO and NOT PLANNED

YES, VOLUNTARY
Teaching is provided in all university hospitals. MD specialisation is being carried out as well and specialising doctors follow the curriculum they have been given. The Board of Oncology professors in the Finnish Oncology Foundation yearly defines requirements for the oncology education.
NO and NOT PLANNED
Every university hospital has dedicated breast cancer specialists; in smaller central hospitals oncologists consult breast cancer specialists at university hospitals, when needed. According to Finnish law, patients have the freedom to choose their place of treatment inside Finland.

ED National Representative

FR
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative
YES

I do not have this information.

I do not have this information.
Breast units are not officially recognised, but rather it is based on the hospital initiative. Outpatient surgery is becoming more available, mostly in public hospitals and anti-cancer centres. The Cancer Plan insists on quality of life and high quality care affordable for all patients.

GR
ECIBC National Contacts
YES, VOLUNTARY
Unfortunately, as we do not have a National Cancer Registry, each doctor arranges his/her participation in research on personal basis. There is no organised participation in research.
YES, VOLUNTARY
Since 2009, the Hellenic Senologic Society operates under the auspices of the Senologic International Society (SIS) and the Hellenic Ministry of Health. It is dedicated to physicians who wish to work in the breast disease area. The school covers all relevant topics. At the end doctors undergo written exams based on 100 multiple choice questions.
NO and NOT PLANNED
In Greece, the majority (16) of breast centres are in Athens; they are both public and private.

ED National Representative
NO

NO

NO

HU
ECIBC National Contacts
YES, VOLUNTARY

YES, MANDATORY
Just in teaching hospitals.
YES, VOLUNTARY

ED National Representative

IE
ECIBC National Contacts
YES, VOLUNTARY
Some research is carried out.
YES, VOLUNTARY

YES, VOLUNTARY
There are national guidelines encompassing all the previous questions. They are monitored centrally and reviewed annually.

ED National Representative
YES

YES

YES

IT
ECIBC National Contacts
YES, VOLUNTARY
The state-regions agreement on breast units networking issued 18 December 2014 highlights the importance of the research and recommends BUs to join research programmes.
YES, VOLUNTARY
State-regions agreement on breast units networking issued 18 December 2014.
YES, MANDATORY
State-regions agreement on breast units networking issued 18 December 2014.

ED National Representative
YES
See document from the Italian Ministry of Health (18 December 2014 Rep.Atti 185/CSR).
YES
See document from the Italian Ministry of Health (18 December 2014 Rep.Atti 185/CSR).
YES
See document from the Italian Ministry of Health (18 December 2014 Rep.Atti 185/CSR).

LT
ECIBC National Contacts
YES, MANDATORY
In case breast cancer clinical trials are ongoing, medical oncologists, surgeons, or MDT members can refer patients to the principal investigator for information and possible participation in clinical trials.
YES, MANDATORY
Most MDT members are also personnel of Vilnius University, delivering lectures and workshops for students, residents, and other doctors.
NO and NOT PLANNED
Lithuania’s population is 3 million people; therefore, 10 breast units could be recommended for our country. Now, there is a possibility to get breast care in 5 units, some diagnostic procedures and breast cancer screening is available in more than 30 sites.

ED National Representative

LU
ECIBC National Contacts
NO, BUT PLANNED
In the framework of the Cancer Plan and through the National Cancer Institute.
NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative
I do not have this information.

I do not have this information.

NO
In Luxembourg, working groups are in place to tackle all above points. Requirements will be included in the hospital and cancer plans.

LV
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative

MT
ECIBC National Contacts
NO, BUT PLANNED
At the organisational level, research and audits are currently focusing on understanding the needs of cancer patients and their families, identify any service gaps that could be improved and to map out the holistic care pathway in various cancer sites, including breast cancer. A new director’s post on cancer care pathways was included in 2014. Internal audits are frequently performed by the surgical firms engaged in the BU at MDH. The Oncology Department participates in and manages patients involved in clinical trials particularly with regards to chemotherapy.
NO, BUT PLANNED
Teaching of junior staff is conducted internally by all the clinicians involved. Identified new expertise required is developed by supporting and sponsoring specialist medical trainees and young resident specialists to specialise and obtain new expertise in identified centres abroad. One recent example was the attainment of new local expertise in onco-plastic surgery.
NO and NOT PLANNED
Malta has one breast unit (which follows most of the requirements included in the 2006 Guidelines) for a population of just over 420,000 (2012 Demographic Review - National Statistics Office).

ED National Representative
NO

NO

NO

NL
ECIBC National Contacts

ED National Representative
I do not have this information.

I do not have this information.

I do not have this information.
I do not know whether there are additional requirements as stated above.

NO
ECIBC National Contacts
YES, MANDATORY
National Breast Cancer Registry.
YES, VOLUNTARY
Specialist training for doctors.
YES, MANDATORY
Specialist structure for doctors (i.e. breast and endocrine surgery).

ED National Representative
YES

YES

YES

PL
ECIBC National Contacts
NO and NOT PLANNED

NO and NOT PLANNED

NO and NOT PLANNED

ED National Representative

PT
ECIBC National Contacts
NO, BUT PLANNED

NO, BUT PLANNED

NO, BUT PLANNED

ED National Representative

RO
ECIBC National Contacts
YES, VOLUNTARY
Several centres participate in clinical research through international multi-centric clinical trials, including breast cancer trials. However, this is rather ‘tolerated’ than regulated; there is no regulation, voluntary or not, to support clinical research.
YES, VOLUNTARY
Larger centres, usually in connection with the university, provide training for students, residents, and also postgraduate courses for cancer specialists, covering different theoretic and practical subjects.
NO and NOT PLANNED

ED National Representative

RS
ECIBC National Contacts
YES, MANDATORY
Healthcare law defines obligation of tertiary healthcare institutions within the public healthcare system to conduct research in order to improve quality of healthcare.
YES, MANDATORY
On the basis of the Law on education, all healthcare institutions that are part of the university teaching centres are included in the process of teaching:
- undergraduate studies
- postgraduate studies
- continual medical education
i do not know
Experts from oncology centres in Serbia are within their departments already directed/ focused on particular types of tumours (e. g. breast cancer department within surgery, radiotherapy or medical oncology). Experts from those departments are collaborating through multidisciplinary meetings and making final treatment decisions. List of participants in the survey
prof. dr Radan Dzodic, : kabinet@ncrc.ac.rs, radan@ncrc.ac.rs prof. dr Zorica Milosevic, pipa011@ptt.rs, mr.sc Ana Jovicevic, anajovicevic@ncrc.ac.rs dr Verica Jovanovic, MSc, verica_jovano-vic@batut.org.rs prof.dr Dragan Ilic, kabinet@batut.org.rs

ED National Representative

SE
ECIBC National Contacts
YES, VOLUNTARY
All university hospitals have research activities. Other breast units are involved in research activities at different levels and interests.
The National Guidelines set as target that more than 25 per cent of the patients at the breast unit should be included in research (studies). The National Board have not done any follow up yet.
YES, VOLUNTARY
At all university hospitals there are associated medical schools providing education of medical students. in addition there are many hospitals associated with nurse training schools. There are national education and training courses for a variety of subjects, e.g. breast cancer surgeon, oncology with focus on breast cancer. Pathology and radiology normally have separate education programmes.
NO, BUT PLANNED
Please, see answers to question 1.6, C.2 and vii.
At the moment there is an ongoing investigation whether this process [new patient clinics] should be regulated in Sweden.

ED National Representative
NO
There should be mandatory criteria when staff are employed that research is part of the “job-description” in a breast unit. So far is being discussed, but not yet put in place.
YES
All university hospitals are associated with the medical schools and part of the training takes place at a university hospital (voluntary).
NO

SI
ECIBC National Contacts
YES, VOLUNTARY
Clinical trials in breast cancer are the important part of work of breast cancer specialists and are carried out according to GCP standards, the Declaration of Helsinki on biomedical research and the Directives and Recommendations of the European Commission (http://ec.europa.eu/health/documents/eudralex/vol-10/).
YES, MANDATORY
Two breast cancer units are part of teaching hospitals. These units carry out postgraduate education and specialisation of the profession such as medical oncology, surgery, radiotherapy, radiology and others.
NO, BUT PLANNED

ED National Representative
YES

YES

NO

SK
ECIBC National Contacts
YES, MANDATORY
In specialised oncology centres (e.g. National Cancer Institute, etc.).
YES, MANDATORY
In university hospitals and in some teaching departments of specialised oncology centres.
NO, BUT PLANNED

ED National Representative

TR
ECIBC National Contacts

ED National Representative
I do not have this information.

YES

I do not have this information.

UK
ECIBC National Contacts
YES, MANDATORY
Mandated by the National Peer Review Measures and assessed by them, and the regional network site-specific group, see below:
The NSSG should discuss at least annually, the report on clinical trials from each of its MDTs (see relevant MDT measures). The following should be present at the discussion: the Chair of the NSSG or a nominated ED National Representative; the NSSG research lead; the lead clinician of the MDT or nominated ED National Representative from that MDT; the clinical lead of the research network or a nominated ED National Representative from the research network.

A programme for improvement for clinical trial entry for the MDT should be agreed at the discussion.

The MDT should produce a report at least annually on clinical trials, for discussion with the NSSG. The report should include.

Details of the MDT’s trials portfolio including the extent of local provision of the national portfolio.

The MDT’s recruitment to the portfolio, including the extent of delivery against the locally agreed times-cales and targets.
The MDT’s programme for improvement for the above, as proposed to the NSSG. The MDT should agree a final programme for improvement at the NSSG discussion meeting.
YES, VOLUNTARY
Each breast unit would have attached junior staff, at the very least, which would be taught within the unit.
YES, VOLUNTARY
While this is not mandatory this has largely been implemented in England, with most clinicians and staff involved in the diagnosis and treatment of breast cancer doing only this, or the majority of their practise being in the diagnosis and treatment of breast cancer. The population of England is 53 million and there are approximately 180 breast units, which fit with the figures above and allows the necessary degree of specialisation.

ED National Representative
YES

YES

YES

23. Perry N, on behalf of EUSOMA Working Party. Quality Assurance in the diagnosis of breast disease. Eur J Cancer, 2001, 37. 159-172.

24. Kurtz J. for the EUSOMA Working Party. The curative role of radiotherapy in the treatment of operable breast cancer. Eur J Cancer. 2002. 38. 1961-1974.

Notes

1. http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52006IP0449.

2. http://ecibc.jrc.ec.europa.eu.

3. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:327:0034:0038:EN:PDF.

4. http://www.eu2008.si/en/News_and_Documents/Council_Conclusions/June/0609_EPSCO-cancer.pdf.

5. http://ecibc.jrc.ec.europa.eu/working-groups.

6. http://ecibc.jrc.ec.europa.eu/national-contacts.

7. http://ecibc.jrc.ec.europa.eu/stakeholders.

8. Embedded in the European accreditation legal framework.

9. See the dedicated chapter in the ECIBC Concept document (http://ecibc.jrc.ec.europa.eu/documents/20181/22500/ECIBC+Concept+Document.pdf/1940c19e-3935-4a54-9fc5-b66fo16c8b9e) for further details.

10. http://ecibc.jrc.ec.europa.eu/.

11. Available at http://www.ejcancer.com/article/S0959-8049(16)32527-8/fulltext.

12. http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52006IP0449.

13. http://ecibc.jrc.ec.europa.eu/-/report-lbna27382; http://ecibc.jrc.ec.europa.eu/-/report-lbna27382enn; http://ecibc.jrc. ec.europa.eu/-/report-lbna26591.

14. More frequently implemented requirements are likely to be considered more feasible and relevant. Consequently, given the diversity of healthcare settings in various countries, an updated definition e.g. via the European QA scheme may offer better support for patient-centred, quality care.

15. http://ecibc.jrc.ec.europa.eu/-/report-lbna27382; http://ecibc.jrc.ec.europa.eu/-/report-lbna27382enn; http://ecibc.jrc. ec.europa.eu/-/report-lbna26591.

16. http://bookshop.europa.eu/en/report-of-a-european-survey-on-the-organisation-of-breast-cancer-care-services-pbLB-NA26593/.

17. http://ecibc.jrc.ec.europa.eu/documents/20181/22500/Report+LBNA26593.pdf/cf44edb3-657c-4755-b62a-6442d06f2d30.

18. http://bookshop.europa.eu/en/report-of-a-european-survey-on-the-organisation-of-breast-cancer-care-services-pbLB-NA26593/.

19. The requirement has been in use in CZ since 1970 but not under national or regional governance until 2011.

20. At the time of this survey, IT stated that although ‘centres whose volume is higher than 150 new cases/year exist, most cases are treated in low-volume centres’.

21. As previously stated, the ECIBC National Contact from France indicated that the questions regarding the organisation of their breast units was different from that which has been defined in the 2006 European Guidelines.

22. http://bookshop.europa.eu/en/report-of-a-european-survey-on-the-organisation-of-breast-cancer-care-services-pbLB-NA26593/.