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JRC SCIENCE AND POLICY REPORT

accreditation and conformity assessment in the field of breast cancer in Europe

Report of a survey on

Supporting information from the National Accreditation Bodies for the European Commission Initiative on Breast Cancer

Aslı Ulutürk, Silvia Deandrea, Donata Lerda, Jesús López Alcalde, Luciana Neamtiu, Zuleika Saz-Parkinson 2015

Report EUR 27382 EN

European Commission Joint Research Centre Institute for Health and Consumer Protection (IHCP) Contact information Donata Lerda Address: Joint Research Centre, IHCP, Public Health Policy Support Via Enrico Fermi 2749, TP 127, 21027 Ispra (VA), Italy E-mail: [email protected] Tel.: +39 0332 78 6201 Fax: +39 0332 78 9059 https://ec.europa.eu/jrc/en/institutes/ihcp https://ec.europa.eu/jrc/en Legal Notice This publication is a Science and Policy Report by the Joint Research Centre, the European Commission’s in-house science service. It aims to provide evidence-based scientific support to the European policy-making 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 which might be made of this publication. JRC92204 EUR 27382 EN ISBN 978-92-79-50318-4 (pdf) ISBN 978-92-79-50334-4 (print) ISSN 1831-9424 (online) ISSN 1018-5593 (print) doi:10.2788/15049 Luxembourg: Publications Office of the European Union, 2015 © European Union, 2015 Reproduction is authorised provided the source is acknowledged. Abstract Background: The objective of this survey was to collect information from the National Accreditation Bodies in collaboration with European Cooperation for Accreditation on the accreditation status of the countries. Methods: The survey included two questionnaires and a data protection form distributed by e-mail. The participants were the members of EA. Results: Twenty-five out of 35 contacted countries responded, corresponding to a response rate of 71%. The most applied standard resulted to be ISO 15189 and the most covered stage of care diagnosis. Conclusions: Accreditation status is diverse across Europe; some countries don’t harbor accredited/certified organisations on breast cancer care, and others use different standards in different stages of care. A harmonisation in quality benchmarking would enhance equality in patients’ care.

accreditation and conformity assessment in the field of breast cancer in Europe

Report of a survey on

Supporting information from the National Accreditation Bodies for the European Commission Initiative on Breast Cancer Aslı Ulutürk, Silvia Deandrea, Donata Lerda, Jesús López Alcalde, Luciana Neamtiu, Zuleika Saz-Parkinson 2015

Report EUR 27382 EN

Table of contents List of abbreviations Glossary Foreword Executive summary 1. Introduction to the European Commission Initiative on Breast Cancer 2. Introduction to the accreditation and conformity assessment terminology 3. Scope of the survey 4. Survey organisation Method Timeframe Participants 5. Survey results General overview 5.1. Section 1: Contact details and area of competence 5.2. Section 2: Gate questions 5.3. Section 3: The standards in use 5.3.1. ISO 15189:2012 5.3.2. ISO/IEC 17020:2012 5.3.3. ISO/IEC 17021:2011 5.3.4. ISO/IEC 17025:2005 5.3.5. Clinical Pathology Accreditation standard (CPA) 5.3.6. Imaging Services Accreditation Scheme (ISAS) 5.3.7. Quality Management System Standards 5.4. Section 4: The stages of breast cancer care and transversal items covered by the standards 5.4.1. The screening stage 5.4.2. The diagnosis stage 5.4.3. The treatment stage 5.4.4. The survivorship and management of recurrence stage 5.4.5. Transversal items 6. Conclusions 7. Acknowledgements 8. Bibliography 9. Useful links Annex I: Data protection form and questionnaire Annex II: E-mail communications Annex III: Tables

4 5 6 7 9 11 13 14 14 16 16 19 19 19 20 21 24 25 25 25 25 26 26 27 28 29 29 30 31 33 35 35 35 37 61 67

Table of contents | 3

List of abbreviations BCS Breast Cancer Service CPA Clinical Pathology Accreditation EA European co-operation for Accreditation EC European Commission ECIBC European Commission Initiative on Breast Cancer JRC Joint Research Centre JRC-IHCP Joint Research Centre - Institute for Health and Consumer Protection ISO International Organization for Standardization NAB National Accreditation Body QA Quality Assurance EUR Euratom, a number of JRC cataloguing, a series unique for JRC (JRC was formerly called)

4 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe

Glossary Breast Cancer Care: Any kind of healthcare intervention aimed at preventing, diagnosing or treating breast cancer, including the follow-up of any other condition caused by the disease or the treatment itself. It may include primary prevention when the intervention is specifically targeted to breast cancer (e.g. dietary recommendations for high-risk women). Breast Cancer Services: Comprises all services covering, in continuum, the full extent of management of breast cancer, from screening to follow-up and in some cases end-of-life care. These services may involve both primary care and a range of high speciality services including but not limited to screening, diagnostic imaging, pathology, surgery, radiation and medical oncology. Stages of Breast Cancer Care: These stages imply the steps of cancer care which a patient goes through in the pathway of cancer care. In ECIBC, breast cancer care is divided into five stages: (1) screening, (2) diagnosis, (3) treatment, (4) rehabilitation and (5) follow-up. These stages should be distinguished from clinical breast cancer stages defining the extent of disease which are usually expressed in numbers 0 through 4. In this report, rehabilitation and follow-up stages are combined into one stage (survivorship and management of recurrence) to make the data more easily conveyed and interpreted. Transversal items: This term refers to the horizontal aspects of breast cancer care that may be used in more than one stage or all through the care and for different diseases other than cancer (in other documents transversal items might be mentioned as ‘horizontal aspects’).

Glossary | 5

Foreword The European Commission’s Joint Research Centre (JRC) has been assigned the task of steering and coordinating the European Commission Initiative on Breast Cancer. This includes the development of a European quality assurance scheme underpinned by accreditation and the establishment of a platform of evidence-based guidelines, including a new version of the European guidelines for breast cancer screening and diagnosis. Developing a single European quality assurance scheme in order to assure competence and quality of European breast cancer services is very complex. In order to map out the situation in Europe and understand the differences in healthcare systems settings and quality assurance schemes within each country, a series of surveys were launched. The outcomes of the first survey were described in the Report of a European survey on the organisation of breast cancer care services.1 A second survey was conducted on the accreditation and conformity assessment standards in use in the Member States and other European countries and it was the first survey to be conducted among the National Accreditation Bodies in the healthcare area. The results are reported in this document. These two survey reports, along with the JRC report on review and analysis of external quality assessment of breast cancer services in Europe (soon to be published) allow us to map similarities and differences across coun1. http://bookshop.europa.eu/en/report-of-a-european-surveyon-the-organisation-of-breast-cancer-care-services-pbLBNA26593/.

tries and sometimes also highlighting discrepancies within countries (e.g. for data held by different entities like the Health Authorities and the National Accreditation Bodies). JRC also detected diverse interpretations of the term ‘accreditation’ depending on the respondent’s profile (healthcare service or accreditation service) and future reports will address these glossary divergences so as to create a common base of understanding for all stakeholders’ profiles. I highly value and support our coordination role in this initiative and its mandate to support countries and stakeholders in improving healthcare quality for all European citizens. This EUR report, being based on the information provided by many National Accreditation Bodies on several healthcare topics, is a reference for subsequent stages of the JRC project and provides publicly available information for other projects in the field. I warmly encourage all stakeholders to carefully read the report and to provide their feed-back on its potential use and impact. You are also invited to provide any additional information (not covered by this survey) as the JRC may organise further surveys. Last but not least, I wish to express my gratitude to all National Accreditation Bodies’ delegates, who contributed to the survey and we look forward to collaborating with them in the future. Krzysztof Maruszewski Director, JRC-IHCP


Executive summary The JRC, the European Commission’s inhouse science service, was assigned in December 2012 with the tasks of (i) developing a new version of the European guidelines for breast cancer screening and diagnosis (in the following mentioned as ‘the new European Guidelines’) and of (ii) developing a voluntary European Quality Assurance scheme for breast cancer services based on the European legislative framework on accreditation (defined in Regulation (EC) No 765/2008) (in the following mentioned as European QA scheme). Those tasks, among others, are part of the European Commission Initiative on Breast Cancer (ECIBC). With the scope of building up the knowledge base for the ECIBC and in view of designing a QA scheme flexible enough to adapt and embrace the differences in standards use in different countries, a survey was conducted to gather information about the use of standards issued by the International Organization for Standardization (ISO) and ISO CASCO, the ISO committee that develops standards and addresses issues related to conformity assessment. The survey targeted the National Accreditation Bodies (NAB), which are full members of the European co-operation for Accreditation (EA). The countries covered include European Union (EU) Member States plus Iceland, Montenegro, Norway, the former Yugoslav Republic of Macedonia, Turkey, Serbia and Switzerland. Contact persons for each NAB were identified with the support of EA.

Twenty-five of the 35 contacted countries responded to the survey, corresponding to a response rate of 71%. The primary findings are as follows: • Nineteen of the 25 responding countries (76 %) have at least one healthcare organisation in the breast cancer care pathway which includes accredited conformity assessment activities or which is holding an accredited conformity assessment certificate. • In 15 of these 19 countries (79%) the mentioned healthcare organisation(s) take part in the diagnosis or treatment of breast cancer at any stage of care (from screening to follow-up). • Four ISO standards are in place for either accrediting the laboratories within the mentioned organisations or for accreditation of Conformity assessment bodies to assess these organisations: ISO 15189:2012, ISO/IEC 17020:2012, ISO/IEC 17021:2011, and ISO/IEC 17025:2005. Only UK reports the use of national standards besides ISO standards, which are mapped on ISO standards. • ISO 15189:2012 and ISO/IEC 17021:2011 were the standards used in most countries (14 and 11, respectively). ISO 15189 can be applied directly in breast cancer services to accredit their laboratory (diagnostic activities) units. The ISO 17021 standard is instead used to accredit a certification body, which will as such certify the management system of the breast cancer service. • Among different stages of breast cancer care (hereinafter, those stages will be re-

Executive summary | 7

ferred to as stages of care), the diagnosis stage was most widely addressed with the standard in place. Laboratory tests, quality management and personal competence requirements were the items most addressed.

• Six countries do not have a healthcare organisation in the breast cancer pathway which is running accredited laboratory activities or holding an accredited certificate of conformity.


1

Introduction to the European Commission . Initiative on Breast Cancer

In 1987, the European Commission initiated the ‘Europe against cancer programme’. This programme was instrumental in funding the actions to develop the European guidelines for quality assurance in breast cancer screening and diagnosis.

In 2003, the European Council issued a re commendation 2 to the Member States to offer evidence-based cancer screening through a systematic population-based approach with quality assurance at all appropriate levels and in accordance with the European guidelines for quality assurance in breast cancer screening and diagnosis (now in their fourth edition since 2006). This was followed by the Council’s conclusions in 2008 which invited the European Commission to explore the potential for developing a European pilot quality assurance scheme for breast cancer screening and follow-up, based on European guidelines for breast cancer screening and diagnosis and on other evidence-based guidelines for the necessary follow-up (other stages of care). The ECIBC, underway at the Joint Research Centre’s Institute for Health and Consumer Protection (JRC-IHCP), is aimed at setting up one single system for defining, establishing and auditing/monitoring a minimum set of quality requirements for breast

2. Council Recommendation of 2 December 2003 on cancer screening (2003/878/EC): http://eur-lex.europa.eu/LexUriServ/ LexUriServ.do?uri=OJ:L:2003:327:0034:0038:EN:PDF.

cancer healthcare across Europe. The project has two main pillars: 1. to develop the new European Guidelines based on new knowledge and evidence; 2. to develop a voluntary European QA scheme, which will fulfil the European legal frame for Accreditation and therefore will be in fact a European QA scheme for Breast Cancer Services based on the EU legislative framework on accreditation, as defined in the Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance 3 and by a set of evidence-based guidelines. This initiative is in response to the Council Conclusions on reducing the burden of cancer 4 and it aims to minimize the risks connected to poor quality of care. Its concept foresees that all stages of care, i.e. screening, diagnosis, treatment, rehabilitation, and follow-up (including surveillance and, where necessary, management of recurrences); in addition, other aspects such as psychological support and palliative care, which are essential for a patient-centred concept of

3. Regulation (EC) No 765/2008, OJ L 218, 13.8.2008, p. 30: http:// eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218: 0030:0047:en:PDF. 4. Council of the European Union: Council Conclusions on reducing the burden of cancer, 2876 th Employment, Social Policy, Health and Consumer Affairs Council meeting, Luxembourg, 10 June 2008: http://www.eu2008.si/en/News_and_Documents/Council_ Conclusions/June/0609_EPSCO-cancer.pdf.

1. Introduction to the European Commission Initiative on Breast Cancer | 9

quality, are also covered. It foresees that a person’s centred and multidisciplinary approach will be applied. The processes involved in the development of this European QA scheme will rely on inforName of the report

mation gathered through bilateral meetings, workshops and a series of past, on-going and future surveys and studies. The reports partially or totally derived from surveys are listed below.

Scope of the report

Timing

Report of a European survey on the organi- To collect information from the countries involved sation of breast cancer care services in the ECIBC on the organisation of breast cancer services and to map out the organisation of breast cancer care and screening across Europe

Report published

Report of a survey on accreditation and conformity assessment in the field of breast cancer care in Europe (this one)

To understand the wide picture of accreditation and conformity assessment of breast cancer care pathway across Europe

Report published

Review and analysis of external quality assessment of breast cancer services in Europe

To describe current QA schemes in place in Europe that are affecting the breast cancer pathway

Report published

Project workshops report

Includes the narration of the two workshops, the conclusions derived and their impact on the planning of activities for meeting the requirements of the two tasks.

Report published

Events’ report

A summary of the meetings JRC embarked with a wide range of stakeholders, experts and concerned authorities at the national level.

Report published

The European QA scheme will be based on the new European Guidelines (and, if necessary, on the selection of existing guidelines and recommendations for other stages and

aspects of care not covered in the new Euro pean Guidelines). A more detailed description of the ECIBC is available on the JRC Science Hub. 5

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


2

Introduction to the accreditation . and conformity assessment terminology

In this document, the relevant terminology follows the strict European legislative framework in place for accreditation, which is detailed in Regulation (EC) No 765/2008 6 and Decision (EC) 768/2008 7 and might differ from the use of that terminology in healthcare or other areas. Healthcare organisations may undergo external assessments for various purposes such as improving safety and quality or demonstrating the achievement of certain requirements (Shaw 2013). These assessment modalities are normally outside the European legal framework for Accreditation (henceforth mentioned as the European legal framework) and may lead to an organisation obtaining a ‘certificate’ attesting their compliance with performance requirements which might contain the words ‘accreditation’, ‘certification’, ‘designation’ or others but with a different legal meaning than what is proposed in the European legal framework. To avoid confusion arising from possible different meanings, the definition of the terminology according to Regulation (EC) No 765/2008 was used in this report as given below.

6. OJ L 218, 13.8.2008, p. 30: http://eur-lex.europa.eu/LexUriServ/ LexUriServ.do?uri=OJ:L:2008:218:0030:0047:en:PDF. 7. OJ L 218, 13.8.2008, p. 82: http://eur-lex.europa.eu/LexUriServ/ LexUriServ.do?uri=OJ:L:2008:218:0082:0128:en:PDF.

• National accreditation body: the sole body in a Member State that performs accreditation with authority derived from the State (Regulation (EC) No 765/2008). It is agreed that each Member State will appoint one National accreditation body (NAB) or address the NAB of another Member State. The NABs operate on a non-profit basis and the Member State is expected to provide the appropriate financial and personnel resources. They are in charge of assessing, accrediting and monitoring conformity assessment bodies and are able to restrict, suspend or withdraw the given accreditation certificates in case of a breach. The NAB can accredit conformity assessment bodies. If a breast cancer service includes a laboratory or performs tests which can be considered as a laboratory activity, these activities can be accredited by the NAB. However a NAB is not allowed to provide certification or inspection services and they generally are not allowed to provide those services they accredit. Each NAB must be a member of the Euro pean cooperation for accreditation (list of members: http://www.european-accreditation.org/ea-members). • Accreditation: an attestation by a national accreditation body that a conformity assessment body meets the requirements set by harmonised standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a spe-

2. Introduction to the accreditation and conformity assessment terminology | 11

cific conformity assessment activities (Regulation (EC) No 765/2008). This term has gained different meanings among different professional groups (Shaw 2000). In this document, accreditation is strictly interpreted as defined above. The accreditation procedure, if the evaluated organisation is found to be competent, ends with an accreditation certificate being issued. This certificate is subject to be restricted, suspended or withdrawn. • Conformity assessment body: a body that performs conformity assessment activities including calibration, testing, certification and inspection (Regulation (EC) No 765/2008) upon accreditation from the NAB. As an example, a conformity assessment body (CAB) can verify compliance of radiotherapy services to specific requirements derived from healthcare guidelines. • Conformity assessment: the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled (Regulation (EC) No 765/2008). Conformity assessment can be applied to a product, a process (such as surgery, psychosocial care or survivorship support offered to cancer patients), a system, a body and includes activities such as testing, inspection and certification of management systems, products or services and persons. • Notified body: is a conformity assessment body which is granted an accreditation certificate and notified to the Commission by the relevant Member State its ability to carry out third-party conformity assessment services (Decision (EC) No 768/2008).

• Certification: it is the process of provision of a certificate by an independent body that the product, process, service or system in question meets specific requirements. • Inspection: inspection describes the regular checking of a product, a service or a system to make sure it meets specified criteria. For example some diagnostic equipment needs to be inspected regularly to ensure their efficacy and safety. • European co-operation for Accreditation (EA) (http://www.european-accreditation. org/home): according to Regulation (EC) No 765/2008, every NAB appointed by a Member State is required to be a member of EA, which is formally appointed as the body responsible for the European accreditation infrastructure in the same regulation. EA is given the task of coop eration with all stakeholders and the Euro pean Commission and provides peer eval uation services to its members.


3

. Scope of the survey

In 2012, a contact person responsible for coordinating responses at country level was identified for each of the full members of EA. The survey consisted of a data protection form and two questionnaires. The first questionnaire included gate questions about the presence of a healthcare organisation which is running an accredited laboratory or holding an accredited conformity assessment certificate for activities part of or relevant for breast cancer care. The second questionnaire (annexed to the first questionnaire) covered information on the standards used in the pathway, including details on the stages of care and transversal items (e.g. quality management) covered by each standard. The survey was organised primarily to understand the wide picture of accreditation and conformity assessment in the field of breast cancer care across Europe. The information requested is crucial to set-up a European QA scheme which will fulfil the European legal framework and therefore will be in fact an accreditation and conformity assessment scheme taking into account the significant experiences already built in the use of ISO standards for breast cancer care.

This report should be considered complementary with the JRC report Review and analysis of external quality assessment of breast cancer services in Europe in providing a better insight of the European situation in quality assurance. The two reports, together with the Report of a European survey on the organisation of breast cancer care services, will describe the origins of different data received from different sources and provide countries a better insight of the connections between the different involved authorities. It should be highlighted that the initiative aims to encourage application of evidencebased guidelines and harmonised operating procedures. The research JRC conducted so far, was functional for optimising the European QA scheme design and, consequently, enhancing impact of evidence-based healthcare on outcomes of women affected by breast cancer.

3. Scope of the survey | 13

4

. Survey organisation

Method

The Adobe LiveCycle Designer® tool was used to design, distribute and manage the information provided (using the distribute form and collect answers tools). This tool allows the creation of interactive forms with an automatic submission (e.g. via e-mail) and a functional mail-box ([email protected]), accessible to all group members, that was used to communicate with the designated respondents. In this way, full-time assistance and support could be provided to all participants.

1. Name of the ISO/ISO CASCO standard. 2. Where the standard ISO/IEC 17021 was mentioned, additional information about the quality management system standard used was asked. 3. The stages of care addressed by the standard. 4. Transversal items of breast cancer care addressed by the standard (e.g. safety, and other items covering the whole process of breast cancer care). 5. Additional comments.

Participants in the survey received three PDF forms: a data protection form and two questionnaires –the core form and the annex form. All documents used are visible in Annex I.

All the questions were mandatory, except for those in section 5 and the additional information part (free text) at the end of each section.

The core form included two sections, the contact and affiliation details and the gate questions. If the first gate question was replied positively, reflecting the presence of organisations accredited or holding accredited certificates of conformity for activities part of or relevant for breast cancer care in the country, the participants were asked to fill in the second questionnaire, the annex form. For each of the ISO/ISO CASCO standards in place, an annex form had to be filled in. It was divided into five sections:

Upon receipt of all the questionnaires, the data were collated into a database, a manual data cleaning procedure was performed and inconsistencies and/or missing data were reported for each participating country. The data protection form included a privacy statement and asked for consent to use the data provided in this survey for the development of the European QA scheme and for research purposes. As this report will be publicly available, a Request of Consent for Publication was sent to all participating countries which provided information (see e-mail in Annex II).


Countries Twere coded according to the International Organisation of Standardisation (ISO) 3166 standard (reported in Table 1 and

available at: (https://www.iso.org/obp/ui/# search).

Table 1: ISO codes of countries.

Country Name

ISO Code

Country Name

ISO Code

Austria

AT

Lithuania

LT

Belgium

BE

Luxembourg

LU

Bulgaria

BG

Latvia

LV

Switzerland

CH

Montenegro

ME

Cyprus

CY

The former Yugoslav Republic of Macedonia

MK

Czech Republic

CZ

Malta

MT

Germany

DE

Netherlands (the)

NL

Denmark

DK

Norway

NO

Estonia

EE

Poland

PL

Spain

ES

Portugal

PT

Finland

FI

Romania

RO

France

FR

Serbia

RS

Greece

GR

Slovenia

SI

Croatia

HR

Slovakia

SK

Hungary

HU

Sweden

SE

Ireland

IE

Turkey

TR

Iceland

IS

United Kingdom

UK

Italy

IT

4. Survey organisation | 15

Timeframe All nominated contact persons were contacted by e-mail via the functional mailbox. 1. The survey was launched on 9 August 2013 and the deadline for completion was 15 September 2013. 2. By the deadline, 16 countries had sent back a completed questionnaire. For all the others, an individual reminder e-mail was sent on 20 September 2013. 3. After an intense period of follow-up, the last questionnaire was received on 19 January 2014. 4. A request for clarifications was sent out starting from 4 March 2014. 5. Upon a second follow-up phase, the last clarifications were received on 2 June 2014. 6. On 5 June 2014 respondents were asked to approve the proposal of JRC for the summary tables of the individual data, as they would have been published (and appear in this document at Annex IV). Seventeen of the countries approved the data within the deadline. The last approval was received on 12 August 2014 after several communications.

7. Between 6 and 8 August 2014, participating countries, who already had approved their individual data, were asked to provide their consent for publication of the data with the information, that in the absence of a reply before August 15 th, the ‘Silence gives consent’ statement (consent is assumed when there’s no evidence of disagreement) would be applied and it would be recorded as a consent. The countries which had not sent the approval in time were sent a reminder mail to both approve their individual data and to provide their consent for publication of this data. 8. All the NABs finally approved their individual data. Participants In Table 2, the nominated contact persons from the 35 countries contacted are listed. Twenty-five of them responded and the nonresponding countries are shaded in grey. In two countries (BE and CY), the contact person was replaced between the questionnaire in 2013 and the follow-up in 2014.


Table 2: List of participants.

Country Nominated contacts

Other collaborators

Accreditation body

AT

Johanna STAMPLER

-

Akkreditierung Austria

BE

Veerle NOTEN (2013) Nicole VANLAETHEM (2014)

-

BELAC: Belgian Accreditation Organization

BG

Elza JANEVA

-

BAS: Bulgarian accreditation service

CH

Rolf STRAUB

-

SAS: Swiss Accreditation Service

CY

Kyriakos TSIMILLIS (2013) Antonis IOANNOU (2014)

-

CYS-CYSAB: Ministry of Health, Nicosia

CZ

Martina BEDNAROVA

-

CAI: Czech Accreditation Institute

DE

Uwe ZIMMERMANN

-

DAkkS: Germany’s National Accreditation Body

DK

Henrik Lykkegaard JØRGENSEN

-

DANAK: Danish Accreditation and Metrology Fund

EE

Kaire TÕUGU

-

EAK: Estonian Accreditation Centre

ES

Isabel de la VILLA

-

ENAC: Spanish National Accreditation Body

FI

Tuija SINERVO

-

FINAS: Finnish Accreditation Service

FR

Hélène MEHAY

-

COFRAC: French Accreditation Committee

GR

Aliki STATHOPOULOU

-

ESYD: Hellenic Accreditation System

HR

Dragica KRIZANEC

-

HAA: Croatian Accreditation Agency

HU

Rozsa RING

-

NAT: Hungarian Accreditation Board

IE

Marie O’MAHONY

-

INAB: Irish National Accreditation Board

IS

Sigurlinni SIGURLINNASON

-

ISAC: Icelandic Board for Technical Accreditation

IT

Filippo TRIFILETTI

-

ACCREDIA: Italian National Accreditation Body

LT

Danutė JANULIONIENĖ

-

LA: Lithuanian National Accreditation Bureau

LU

Ferrand DOMINIQUE

Monique JACOBY

OLAS: Luxembourg Accreditation and Surveillance Office

LV

Zinaida GORINA

-

LATAK: Latvian National Accreditation Bureau

MK

Dragan VELEVSKI

-

IARM: Institute for Accreditation of the Republic of Macedonia

MT

Claudio BOFFA

-

NAB-Malta: National Accreditation Board of Malta

ME

Ranko NIKOLIC

-

ATCG: Accreditation Body of Montenegro

4. Survey organisation | 17

Table 2: (cont.) Country Nominated contacts

Other collaborators

Accreditation body

NL

Jan C. van der POEL

-

RVA: Dutch Accreditation Council

NO

Cecilie LAAKE

-

NA: Norwegian Accreditation

PL

Eugeniusz ROGUSKI

Malgorzata OLCZAK-WASIK

PCA: Polish Centre for Accreditation

PT

Leopoldo CORTEZ

-

IPAC: Portugal Accreditation Institute

RO

Cristian NICHITA

-

RENAR: Romanian Association for Accreditation

RS

Ljubinka GLIGIC

-

ATS: Accreditation Body of Serbia

SE

Annika LYDÉN

-

SWEDAC: Swedish Board for Accreditation and Conformity Assessment

SI

Bostjan GODEC

-

SA: Slovenian Accreditation

SK

Tibor CZOCHER

-

SNAS: Slovak National Accreditation Service

TR

Gokhan BIRBIL

-

TURKAK- Turkish accreditation Agency

UK

Lorraine TURNER

Jane BEAUMONT

UKAS: United Kingdom Accreditation Service


5

. Survey results

Countries which did not respond to the survey were not included in the following tables, but they are visible on every map. In all the descriptions, response rates are rounded to the closest whole number and expressed in relation to the 25 countries responding (for instance, 84% of the countries means that this was the response of 21 countries out of 25).

The ideal response rate could be higher; however, taking into account that this was the first approach to the NABs for a survey on the healthcare system, the achieved 71% was considered as sufficient to draw a reliable picture of the current European situation in terms of accreditation and conformity assessment in breast cancer care. Figure 1: Country participation map. Responded

A standard may be applied to more than one stage of care or a stage of care may be addressed by more than one standard. For example when a stage of care is addressed by two different standards in a country, they are considered as two diverse applications. Therefore the total number of applications may exceeds the number of countries. To provide a clearer view, data will be displayed in terms of numbers of applications where needed.

Not responded FI

IS

NO EE LV DK IE

LT BY

UK

PL

NL DE BE LU FR

CZ

CH

Twenty-five countries out of the 35 contacted responded to the questionnaire, which corresponds to a response rate of 71%. HU, IS, LV, MT, NO, PT, RO, SK, CH and TR did not respond to the survey, therefore, no information is available for these countries. In Figure 1 the contacted countries are depicted in different colours according to their reaction to the questionnaire.

AD PT

ES

UA

SK

AT IT

General overview

RU

SE

HU

MD RO

SI HR BA RS BG ME MK AL GR

TR

CY MT

5.1. Section 1: Contact details and area of competence All the respondents were employed by the corresponding NABs. In all cases, due to the procedure applied for identifying respondents, they were the responsible staff mem-

5. Survey results | 19

bers within their organisations for the specific area of activity (healthcare). They were considered responsible for the information provided for the whole of their country. The fact that most of the persons responsible for the questionnaire compilation were employees of and nominated by the respective NABs provides a high degree of reliability to the information received. In the following, when a response typology is attributed to a country it means that the information was provided by the respective NAB.

Figure 2a: Existence of a healthcare organisation with accredited laboratories or holding accredited certificates of conformity in the breast cancer care pathway. Existing Not existing Not responded

FI

IS

RU

SE NO EE LV DK IE

LT BY

UK

NL DE BE LU FR AD

ES

CZ

UA

SK

AT

CH IT

PT

PL

HU

5.2. Section 2: Gate questions In this section, participants were firstly asked to report if in their country there is at least one healthcare organisation (such as a hospital, outpatient clinic, local health authority, laboratory, etc.), which is either accredited or holding an accredited certificate of conformity for all or part of the breast cancer care pathway. And, secondly, if such an organisation exists, they were asked whether that organisation is treating breast cancer patients before, during or after diagnosis (e.g. screening, biopsy, treatment). Nineteen of the 25 responding countries (76%) reported having an accredited laboratory in a healthcare organisation or having an organisation holding an accredited certificate of conformity. Out of these 19, one country stated that these healthcare organisations are not carrying out activities related to breast cancer care, two countries noted that this information is not known, one did not respond to this question and 15 countries stated that the organisation(s) take part in breast cancer care either before or after the diagnosis.

MD RO

SI HR BA RS BG ME MK AL GR

TR

The responses to the gate questions are mapped in Figure 2a and the aggregated data are shown in Figure 2b.

CY MT


Figure 2b: When such an organisation exists, involvement of this organisation in breast cancer treatment.

1

3

Involved in treatment of cancer Not involved in treatment of cancer Not known or not reported

15

5.3. Section 3: The standards in use The 19 countries which reported either having at least one healthcare organisation’s laboratory accredited and/or that at least one healthcare organisation held an accredited certificate of conformity in the first questionnaire, were asked to complete a second questionnaire (one per each of the standards applied). In the second questionnaire, the countries were asked to note all the standards in place in their country and give details for each standard, including the stages of care and transversal items addressed. Breast cancer care was divided into the following stages of care:

The individual answers of the countries are reported in Tables 1 to 7 in Annex III. Out of the 19 countries, 11 (52%) declared one standard running in the country, three countries (CZ, DE, FR) reported two standards, four countries (ES, FI, GR, SE) reported three and one country (UK) reported five accreditation standards in place. With the sole exception of UK, standards reported by the countries included only ISO or ISO CASCO. UK reported, besides three ISO standards, two national standards which are both based on ISO standards: Clinical Pathology Accreditation Standard and Imaging Services Accreditation Scheme. ISO 15189:2012, ISO/IEC 17020:2012, ISO/ IEC 17021:2011, and ISO/IEC 17025:2005 were used as accreditation standards. Where ISO/IEC 17021 is in place, ISO 9001:2008, ISO/IEC 27001:2013, ISO 13485:2003, ISO 14001:2004 and ISO/IEC TR 18001:2004 were reported as the management system standards. Details of the mentioned ISO standards’ scope are shown in Table 3.

1. The whole breast cancer pathway. 2. Screening. 3. Diagnosis. 4. Treatment. 5. Survivorship and follow-up.


Table 3: ISO standards used by the NABs in the covered countries. Standard name

Field (according to ICS*

Specifications

ISO 15189:2012

Laboratory medicine in general. Quality management and quality assurance

Medical laboratories – Requirements for quality and competence

ISO/IEC 17020:2012

Product and company certification. Conformity assessment

Conformity assessment – Requirements for the operation of various types of bodies performing inspection

ISO/IEC 17021:2011


Conformity assessment – Requirements for bodies providing audit and certification of management systems

ISO/IEC 17025:2005


General requirements for the competence of testing and calibration laboratories

ISO 9001:2008

Quality management and quality assurance

Quality management systems – Requirements

ISO/IEC 27001:2013

Character sets and information coding

Information technology– Security techniques– Information security management systems– Requirements

ISO 13485:2003

Quality management and quality assurance. Medical equipment in general

Medical devices – Quality management systems – Requirements for regulatory purposes

ISO 14001:2004

Environmental management

Environmental management systems – Requirements with guidance for use

ISO/IEC TR 18001:2004

Character sets and information coding

Information technology– Radio frequency identification for item management – Application requirements profiles

* ICS: International Classification for Standards.

In grey are the certification standards.

Number of countries using the standard

Figure 3: Number of NABs using each standard.

ISO 15189:2012

ISO/IEC 17020

ISO/IEC 17021:2011

ISO/IEC 17025:2005

Standard in use


Total number of applications

Figure 4: Total number of applications of each standard by all NABs and for all stages of care.

ISO 15189:2012

ISO/IEC 17020

ISO/IEC 17021:2011

ISO/IEC 17025:2005

Standard in use

Figure 5: Total number of applications of each standard by all NABS and per stage of care. Survivorship Treatment Diagnosis Screening The whole pathway

ISO

012

151

:2 89

20

/IE

ISO

11

20

70 C1

IS

EC O/I

1: 702

1

EC O/I

170

5

00

:2 25

IS


The most commonly used standard among countries was ISO 15189:2012, used by 14 countries out of 19 (74%) indicating the tendency of the NABs to directly audit the laboratories in healthcare organisations (ISO/ IEC 17025:2005 can be used in alternative). The second most common standard used by NABs was ISO/IEC 17021:2011 with 11 countries (58%); this is the standard used by NABs to accredit certification bodies. A brief explanation of the standard and an overview on how the countries applied each standard is reported below. Ratios are given with respect to the 19 countries using at least one standard. While discussing the standard, only the stage of care which it addresses most frequently is detailed. For all the other stages of care, details of individual answers are available in Tables 4-7, Annex IV. 5.3.1. ISO 15189:2012 ISO 15189:2012 is used by the accreditation bodies to assess and to accredit medical laboratories and provides recognition of the medical laboratory’s competence in both its management system and technical practice. It covers the requirements for medical laboratories to ensure the quality and competence of their services, and their consistency in delivering technically valid test results. It is the translation of ISO/IEC 17025:2005 for the medical field. This standard was the most addressed one, reported by 14 countries (74%). As the standard is to be used in the laboratory field, 13 of

these 14 (92%) countries addressed the diagnosis phase. Seven countries addressed the transversal items and each of the screening, treatment and survivorship and follow-up stages were addressed by three countries. The wide usage of this standard shows that in breast cancer care, the services most frequently seeking accreditation are linked to measurement and testing activities (e.g. laboratories and, more in general, diagnostics) and this may be explained by the fact that diagnostic activities were historically one of the first areas covered by accreditation in the medical field. Another important reason for targeting the diagnostic stage is the impact of diagnosis results for all the following stages of care and; hence the importance of a high degree of quality assessment implementation. Figure 6: Total number of applications of ISO 15189:2012 per stage. ISO 15189:2012

4

3

3

Screening Diagnosis Treatment

13

Survivorship

Of the 13 countries using this standard in the diagnosis phase, the aspiration of fluid and subsequent testing item was covered in eight; biopsy and tissue histology item in nine. Five countries declared that the standard was also used to address some molecular biology tests (such as HER2/neu tests).


5.3.2. ISO/IEC 17020:2012 ISO/IEC 17020:2012 is used to assess inspection bodies for the impartiality, competence and consistency of their inspection activities. Inspection bodies provide information to their clients about the conformity of inspected items with regulations, standards, specifications, inspection criteria or contracts.

Eleven countries out of 19 (58%) reported having this standard in place. Four of these countries (ES, IT, PL and SE) reported to address the whole breast cancer pathway. With this standard, the screening stage was addressed by five countries, the diagnosis and treatment stages by four countries, and the survivorship and follow-up stage by one country.

This standard was reported only by DE and FR. DE addressed the biopsy and tissue histology item of the diagnosis stage. FR reported addressing accreditation of inspection bodies for medical devices and external quality control by the standard.

Nine countries out of the 11 (82%) addressed some transversal items using this standard. The items mostly covered were quality management (nine countries), mammography (eight countries), ultrasonography, information systems and personal competence requirements (seven countries each).

5.3.3. ISO/IEC 17021:2011

5.3.4. ISO/IEC 17025:2005

This standard is intended for use by accreditation bodies to assess certification bodies which provide audit and certification of management systems (e.g. using ISO 9001). Accredited bodies will grant certification of applicants after a successful audit and provided that the criteria of the respective standard, as e.g. the ISO 9001 standard, are fulfilled.

This standard is applied to laboratories performing testing/calibration activities to recognize their competency in these activities. These also can include laboratories where testing and/or calibration are a part of inspection and product certification.

Figure 7: Total number of applications of ISO/IEC 17021:2011 per stage.

The whole pathway

9

8 8

ISO/IEC 17021:2011

4

5

Screening Diagnosis

Four countries had this standard in place: ES, FE, GR and SE. It addresses the diagnosis stage in three countries, treatment stage and transversal items in two, screening and survivorship and follow-up stages in only one country. 5.3.5. Clinical Pathology Accreditation standard (CPA)

Treatment Survivorship

This standard is a national one only reported by UK. It has been in use for accreditation of medical laboratories for over 20 years.


The laboratories are now undergoing transition to UKAS accreditation with ISO 15189. Diagnosis and survivorship and management of recurrence stages are covered by this standard as well as some transversal items. 5.3.6. Imaging Services Accreditation Scheme (ISAS) Similar to CPA, this standard is a national one and only reported by UK. It has been mapped on ISO 17020 and ISO 15189, designed to be applied to all current imaging modalities and to interventional radiology services. The standard covers items related to imaging studies in the diagnosis stage, the survivorship and management of recurrence stage and among the transversal items. Population based breast screening services are not covered by the standard. 5.3.7. Quality Management System Standards These standards are used by the accredited certification bodies to audit and certify the management systems of organisations. They provide a model to achieve more efficient use of resources and improved risk management.

In this survey, the following (quality) management system standards used by the certification bodies were reported: ISO 9001:2008, ISO/IEC 27001:2013, ISO 13485:2003, ISO 14001:2004 and ISO/IEC TR 18001:2004. • ISO 9001:2008: specifies requirements for a quality management system where an organization needs to demonstrate its ability to deliver products that meet the expected requirements. It is applicable to organizations of all types and size. • ISO/IEC 27001:2013: specifies the require ments for an organisation’s information security management system. It also includes requirements for the treatment of information security risks tailored to the needs of the organization. • ISO 13485:2003: sets out the requirements for a quality management system for an organization providing medical devices and related services. It aims to facilitate harmonized medical device regulatory requirements for quality management systems of producers of medical devices. • ISO 14001:2004: provides requirements for an environmental management system where an organization demonstrates that their policy takes into account legal requirements and company specific requirements to improve environmental aspects. • ISO/IEC TR 18001:2004: consists of the results of three surveys on the applications for radio frequency identification and provides classification of these applications and recommendations for areas of standardization based on these surveys.


5.4. Section 4: The stages of breast cancer care and transversal items covered by the standards While in section three the total frequency of standards application was reported, in this section, the standards used in healthcare systems are evaluated and reported in a stage-wise approach. The data included below are derived from the 19 countries which addressed breast cancer care with at least one standard.

For the ease of classifying, the stages of care are divided into screening, diagnosis, treatment and survivorship and management of recurrence. Each stage includes some substages which are discussed in the relevant sections below. The transversal items are also included in the questionnaire in addition to the stages of care.

Number of countries

Figure 8: Number of NABs addressing each stage.

The whole pathway

Screening

Diagnosis

Treatment

Breast cancer care stage

Survivorship and follow-up

Figure 9: Total number of applications of standards in each stage. ISO/IEC 17025:2005 ISO 15189:2012 ISO/IEC 17020 ISO/IEC 17021:2011

The whole pathway Screening

Diagnosis

Treatment

Survivorship


In general, the standards were mostly addressing the diagnosis stage. This is in correlation with the result that ISO 15189:2012 which is used to accredit medical laboratories such as pathology laboratories, is the most widely used standard.

Countries were asked whether the screening stage was addressed by a standard. The ones addressing this stage were further asked if the screening is an organised one and if not, to provide a detailed description of the screening.

The survivorship and follow-up stage was the least addressed by countries and least covered by a standard.

In 11 of the 19 countries (58%), this stage was addressed by at least one standard and in the remaining eight countries it was not addressed at all. The most widely used standard for this stage was ISO/IEC 17021:2011, reflecting that the management systems are crucial in screening programmes.

5.4.1. The screening stage Screening includes asymptomatic healthy women in a certain age range undergoing screening mammography at specified intervals for early diagnosis of breast cancer. Screening can be organised or opportunistic. In organised screening programmes, women are invited to attend a population breast cancer screening programme. If they are prescribed a screening mammography by their general practitioner or gynaecologist, it is defined as opportunistic screening.

Seven of the 11 countries (63%) addressing the screening stage declared that screening is an organised one, three informed that the situation was not known. The remaining country did not respond to this question.

Number of countries

Figure 10: Number of NABs addressing the screening stage by each standard.

ISO 15189:2012

ISO/IEC 17020

ISO/IEC 17021:2011 ISO/IEC 17025:2005

No standards

Standard in use


5.4.2. The diagnosis stage Women with signs or symptoms in their breast or women with a positive screening mammography undergo a diagnostic assessment in order to get a final diagnosis. This assessment can involve aspiration or a biopsy and the samples will then be assessed by subsequent tests. Diagnosis stage and its standardisation are of great importance as the future decisions and patterns of care depend on it.

This was the stage of care most covered by any standard, being addressed in 14 out of the 19 countries (74%). ISO 15189:2012 was the standard most used to cover this stage, used in 13 of these 14 (93%) countries. Among the 28 cases where this stage was addressed by a standard, the aspiration of fluid and subsequent testing item was addressed in 19 and biopsy and tissue histology item was addressed in 23. 5.4.3. The treatment stage

Countries were asked whether the diagnosis stage is addressed by a standard. If the stage was covered, they were further asked to specify if two items –aspiration and subsequent testing and biopsy and tissue histology – were covered.

Women diagnosed with breast cancer then undergo a treatment which may include, depending on multiple factors such as the stage of the disease, a surgical removal of the mass, a part of or the entire breast, radiotherapy, chemotherapy, hormonal therapy. Plastic reconstructive breast surgery is frequently proposed to these women.

Number of countries

Figure 11: Number of NABs addressing the diagnosis stage by each standard.

ISO 15189:2012

ISO/IEC 17020

ISO/IEC 17021:2011 ISO/IEC 17025:2005

No standards

Standard in use


When the country addressed this stage, it was asked to detail the inclusion of the items: surgery, breast reconstruction, radiotherapy and chemotherapy, and hormonal therapy. Eleven countries out of 19 (58%) addressed this stage and most of them (eight countries) applied ISO/IEC 17021:2011. Like in the screening stage, quality management systems were the first undergoing quality assessment. In the 13 applications of this stage, surgery was covered in nine, reconstruction in five, radiotherapy in nine and chemotherapy and hormonal therapy in eleven. 5.4.4. The survivorship and management of recurrence stage Women with a malignant lesion who undergo relevant treatment procedures are enrolled to follow-up in order to detect and manage possible recurrences and metastasis

at an early phase. During this stage, the survivors may also benefit from psychosocial and other support therapies. Palliative care can be provided at every step of the treatment (e.g. pain control) and in case of a negative outcome, end-of-life care could be delivered. Where the standards cover this stage, the country is asked to detail if it covers these four items: follow-up and management of recurrence, psychosocial care, survivorship support, palliative care and end-of-life care. This stage of care was covered in eight countries making it the stage least addressed by a standard. In the 10 cases where this stage is addressed, ISO/IEC 17021:2011 was utilized in five, ISO 15189:2012 was utilized in four and ISO/ IEC 17025:2005 in one.

Number of countries

Figure 12: Number of NABs addressing the treatment stage by each standard.

ISO 15189:2012

ISO/IEC 17020

ISO/IEC 17021:2011 ISO/IEC 17025:2005

No standards

Standard in use


Number of countries

Figure 13: Number of NABs addressing the survivorship and management of recurrence stage by each standard.

ISO 15189:2012

ISO/IEC 17020

ISO/IEC 17021:2011 ISO/IEC 17025:2005

No standards

Standard in use

Among these 10 cases, follow-up and management of recurrence was covered in eight, psychosocial care and palliative care and endof-life care in four, and survivorship support in three countries.

5.4.5. Transversal items

This data shows that this stage, especially psychosocial care, palliative care and endof-life care and survivorship support fields are highly neglected.

• Mammography. • Ultrasound. • Magnetic Resonance Imaging. • Pathology. • Laboratory tests. • Medication management. • Communication. • Information systems. • Quality management. • Proficiency testing. • Personnel competence requirements. • Hygiene. • Safety. • Research.

These aspects or items include elements of breast cancer care that are used in several stages of care throughout the pathway and cover:

Countries were asked to report whether these items were covered.


Sa fe ty Re se ar ch

un d so

Ul tra

M RI Pa t ho La lo bo gy ra to ry te st s M ed i ca Co tio m n m In u fo ni rm ca tio at ion n Qu al sy ity st em m an s ag Pr e ofi m cie en Pe n t rs cy on t es ne tin lc g om pe te nc e Hy gi en e

M

am m og

ra

ph

y

Number of applications

Figure 14: Number of applications of standards to each transversal item.

Transversal item addressed by the standard

Standards were applied to laboratory tests and quality management items in 20 cases and to personnel competence requirements

in 19 cases, making these three items the most addressed ones. Research, with seven cases, was the least covered item.


6

. Conclusions

Even if this survey does not cover the data from all the contacted NABs, a response rate of 71% can draw a reliable picture of the current European situation in terms of the accreditation and conformity assessment of breast cancer care. All the respondents are active within their respective NABs, ensuring a high level and up-to-date knowledge and therefore, reliable information. The data collected in this survey were very important and relevant to design a European QA scheme for Breast Cancer Services (BCS). The JRC report Review and analysis of external quality assessment of breast cancer services in Europe will help to provide a more detailed map of the European situation. The following conclusions can be derived from the results of the survey: • Nineteen of the 25 responding countries (76%) have at least one healthcare organisation in the breast cancer care pathway which is accredited or holding an accredited certificate of conformity. This leaves 24% having no such healthcare organisation and reflects the need for enhancement and unification of quality assurance in breast cancer care services throughout Europe. • Four ISO and ISO CASCO standards were applied for accrediting the mentioned organisations: ISO 15189:2012, ISO/ IEC 17020:2012, ISO/IEC 17021:2011, and

ISO/IEC 17025:2005. Only UK reported the use of national standards besides ISO standards. • ISO 15189:2012 and ISO/IEC 17021:2011 were the most used standards (14 and 11 times, respectively). ISO 15189:2012 specifies requirements for medical laboratories, and the wide usage of this standard is coherent with the result that the diagnosis stage is the one most addressed by a standard. ISO/IEC 17021:2011 addresses the certification bodies auditing the management systems and is mostly used in screening programs according to normative criteria; ISO 9001:2008 is the standard applied by certification bodies. • Among different stages of care, diagnosis was the most widely addressed with any standard. This is coherent with the importance of this stage for the following care decisions. • Laboratory tests, quality management and personal competence requirements were the transversal items most addressed. • None of the responding countries reported using the standard ISO/IEC 17065 for product or process certification, even though this standard could be envisioned to potentially address quality management within all the stages and aspects (or items) of breast cancer diagnosis and care. However, this would require the establishment of criteria that certification bodies, accredited according to ISO/IEC 17065, would have to apply when certifying BCS.

6. Conclusions | 33

These data reflect the heterogeneity in the accreditation status of breast cancer care services throughout Europe. The implementa tion of the European QA scheme would foster a unification of the accreditation and conformity assessment, and thus the implementation of the scheme by the BCS across Europe will have positive consequences on the quality of provided services.

Although this report provides detailed information about accreditation and conformity assessment of breast cancer care in Europe, the number of accredited/certified institutions is not discussed, therefore the information on the geographical prevalence and distribution of these standards cannot be derived through this survey.


7

. Acknowledgments

We would like to thank Thomas Facklam (EA chair) for his input and support in announcing the survey and in providing the list of contacts; Jane Beaumont (The United Kingdom Accreditation Service), for her accurate revision of the draft survey. We are also grateful to Hanspeter Ischi (former member of the Swiss NAB-SAS) for his very

8

valuable review and Manuel FlorensaMolist (JRC) for providing the design of the final product. Most of all, we would like to express our gratitude to all those responding to the survey and for the extremely valuable information they provided.

. Bibliography

1. Shaw CD, Braithwaite J, Moldovan M, Nicklin W, Grgic I, Fortune T, et al. Profiling health-care accreditation organizations: an international survey. Int J Qual Health Care. 2013 Jul;25(3):222-31.

9

2. Shaw C, Groene O, Mora N, Sunol R. Accreditation and ISO certification: do they explain differences in quality management in European hospitals? Int J Qual Health Care. 2010 Dec;22(6):445-51.

. Useful links

1. http://www.iso.org/iso/home.html 2. http://www.european-accreditation.org 3. http://www.cen.eu/Pages/default.aspx

4. http://www.iec.ch 5. https://standardsdevelopment.bsigroup. com

7. Acknowledgements | 8. Bibliography | 9. Useful links | 35

Annex I: Data protection form and questionnaire

Annex I: Data protection form and questionnaire | 37

1. Data protection form



2. Questionnaire Form 1–Core Form










3. Questionnaire Form 2 –Annex Form













Annex II: E-mail communications

Annex II: E-mail communications | 61

From: Sent: Subject: Attachments:

JRC CANCER POLICY SUPPORT 09 August 2013 12:02 Ares(2013)2784082: Survey on accreditation and certification of breast cancer care in Europe NABs_CORE FORM_distributed.pdf; NABs_ANNEX FORM_distributed.pdf; NABs_ DATA PROTECTION_distributed.pdf

Ares(2013)2784082 Dear Madam, dear Sir, you may already be aware of the discussions that have been taking place with the EA Chair, Dr Thomas Facklam, about the role of National Accreditation Bodies (NABs) in a very important project prompted by the European Council’s invitation to the Commission to explore the possibility of developing a voluntary accreditation scheme for breast cancer screening and care. As a follow up of an earlier survey to Member States on how breast cancer services are being delivered across Europe, now we are directly approaching NABs in order to go into more details in the identification of ISO accreditation and/or certification/inspection standards which have an impact on breast cancer care and might be in place in different countries. This survey is being carried out to ensure that all EA NABs have the opportunity to provide information to the project coordinators, European Commission Joint Research Centre (JRC) in Ispra (Italy). The information required concerns the accreditation work that has already been undertaken in each Member State and that may contribute to supporting any or all aspects of the breast cancer care pathway. The survey is enclosed (first two attachments) in this mail and the third attachment is the data privacy statement. As regards the survey, please note the following important points: 1) The survey consists in two different forms: CORE and ANNEX. CORE form should be filled in as first because it includes the gate questions that determine the necessity to compile the ANNEX one. The number of ANNEX forms to be filled in is variable and depends to the answers given in the CORE form. Further instructions are available in the form itself. 2) The survey can be saved at any stage of the process. It does not therefore need to be completed in one go. 3) The survey can be partially completed and then sent to someone else for further completion. The form will automatically save all the answers.


4) Once the form is completed, it can be submitted by clicking on the button Submit by Email (Please always use the option “Desktop Email application”): this will send the survey response directly to us. Note however that this operation will not succeed if any of the mandatory questions have been left unanswered. As regards the privacy statement and the agreement of consent of use of data, please check the appropriate box and then click on the button Submit by Email (Please always use the option “Desktop Email application”): this will send the data protection form directly to us. Note that you can change/revoke your choice at any time. All you need to do is to send us an e-mail informing us of your change and we will reply with confirmation. Please note that the deadline for submission of survey responses is 15/09/2013. If you should need any further information, please do not hesitate to contact us at this e-mail box or via the phone numbers listed in the questionnaire and/or visit our webpage: http://ihcp.jrc.ec.europa.eu/our_activities/public-health/cancer_policy_support. We would like to thank you and your collaborators in advance for dedicating your time to completing this questionnaire. Since the information you provide will be important to design the accreditation scheme that must be implementable in all EU Member States and in the other participating countries, we kindly ask you to provide as much information as possible. Best regards, Silvia DEANDREA on behalf of Healthcare Quality group _______________________________________ SILVIA DEANDREA MD, PhD European Commission DG Joint Research Centre (JRC) Institute for Health and Consumer Protection Public Health Policy Support Unit Via E. Fermi 2749 I-21027 Ispra (VA)/Italy Phone: +39 0332 786333 [email protected]


From: Sent: Subject:

JRC CANCER POLICY SUPPORT 05 June 2014 09:15 Approval of data in “Survey on accreditation and certification of Breast Cancer Care”

Dear Sir/Madam, Thanks to the efforts and cooperation of you and the other survey participants, we are finalising a report on Survey on accreditation and certification of Breast Cancer Care. In the file enclosed you can find the data that you have provided showed in a tabular representation; due to confidentiality issues, you see only the row corresponding to your country. As these tables correspond to what will be actually published in the final report, we suggest that you carefully check the content. An official request for consent to publication will immediately follow your data approval. In order to make this data available to European citizens and stakeholders as soon as possible, we would ask to provide an answer by June 17th. As for the previous step of the survey, we are fully available for any support or clarification needed. We would like to thank you again for the time you dedicated for contributing to such an important collection of information and to the final document derived. With grateful greetings by the JRC team on Healthcare Quality, Asli Uluturk

DG Joint Research Centre Institute for Health and Consumer Protection Public Health Policy Support Building 58A Via Enrico Fermi 2749 21027 Ispra (VA) ITALY +39 033278-3664 [email protected]


From: Sent: Subject:

JRC CANCER POLICY SUPPORT 06 August 2014 14:29 Publication of the “Survey on accreditation and certification of Breast Cancer Care”

Dear Sir/Madam, Thanks to the efforts and cooperation of you and other survey participants, we are now finalising the “Survey on accreditation and certification of Breast Cancer Care” and we envisage having it published within few weeks. We are coming back to you in order to ask your consent for the publication of the data that you provided last year and that you confirmed with your last e-mail on DD/MM/YYY: this can be done by simply replying YES to this e-mail. If we do not hear from you by 13/08/2014, we will apply the rule “Silence gives consent” (consensus is assumed when there’s no evidence of disagreement). With kindest regards, Asli ULUTURK We are recruiting: http://recruitment.jrc.ec.europa.eu/?type=GH.

DG Joint Research Centre Institute for Health and Consumer Protection Public Health Policy Support Building 58A Via Enrico Fermi 2749 21027 Ispra (VA) ITALY +39 033278-3664 [email protected]


Annex III: Tables

Annex III: Tables | 67

Table 1. ISO standards used in countries and stages of breast cancer care addressed by the standard. Gate questions: • Are there any organisations accredited or holding accredited certification/inspection for activities part of or relevant for breast cancer care? • Are these organisations treating breast cancer either before (e.g. screening, early diagnosis, biopsy, analysis) or after the diagnosis? Questions on the standards for Breast Cancer Care: • Name of the standard(s) used. • Breast cancer stages addressed by the standard in the healthcare institutions present in the country. • Transversal items addressed by the standard in the healthcare institutions present in the country.


Yes

Yes

No

Yes

BE

BG

CY

CZ

Yes

NR*

No

Yes

Screening –organised screen Mammography, ultrasounds, MRI, Information system, qualing for asymptomatic women, ity management screening of colorectal carcinoma, carcinoma cervicis uteri, carcinoma of the prostate gland Diagnosis – aspiration of fluid and subsequent testing, biopsy and tissue histology Treatment– surgery, breast reconstruction, radiotherapy, chemotherapy, PET centers Survivorship and management of recurrence–follow-up and management of recurrence, palliative care and end-of-life care

ISO/IEC 17021:2011 (under ISO 9001:2008, ISO 13485:2003, ISO/IEC 27001:2013)

Pathology, laboratory tests

–

Pathology, laboratory tests, medication management, quality management, personnel competence requirements

Diagnosis –biopsy and tissue histology

–

Screening Diagnosis Treatment Survivorship and management of recurrence

Diagnosis – biopsy and tissue histology, molecular testing to detect any mutations causing breast cancer or influencing treatment (for example: HER2/ neu FISH: if positive, a treatment with herceptin will be started).

Screening Diagnosis Treatment

Which breast cancer stages Which transversal items are addressed by the standard are addressed by the standard

ISO 15189:2012

–

ISO/IEC 17021:2011 (under ISO 9001:2008)

ISO 15189:2007

ISO/IEC 17021:2011 (under ISO 9001:2008)

Yes

AT

Yes

Is there an accredited/ Is this organisation Which standards are in place certified organisation diagnosing or treating breast cancer

Country

Table 1. (cont.)


No

Yes

Yes

EE

ES

Yes

Yes

NR*

The whole breast cancer pathway

Screening – organised screening for asymptomatic women Diagnosis – aspiration of fluid and subsequent testing, biopsy and tissue histology, molecular pathology: e.g.; HER2 Treatment–radiotherapy, there is one laboratory accredited for calibration of the standard used for therapy levels, Gamma radiation of Cobalt 60, 0,81 Gy/min, CMC=0,8 %

ISO 15189:2012

ISO/IEC 17025:2005

Diagnosis – aspiration of fluid and subsequent testing, biopsy and tissue histology, BRCA1 and 2 tests

–

ISO/IEC 17021:2011 (under ISO 9001:2008)

ISO 15189:2012

–

Diagnosis – biopsy and tissue histology

ISO/IEC 17020:2012

DK

Diagnosis – aspiration of fluid and subsequent testing

Pathology, laboratory testing, information systems, quality management, proficiency testing, personnel competence requirements, hygiene, safety

Mammography, ultrasound, MRI, pathology, laboratory tests, quality management, personnel competence requirements, hygiene, safety

–

–

Pathology

Laboratory tests


ISO 15189:2012

Yes

DE

Yes


Country

Table 1. (cont.)


Not known

Diagnosis–aspiration of fluid and subsequent testing, biopsy and tissue histology Screening – accreditation of inspection bodies for medical devices (mammography)

ISO 15189:2012

ISO/IEC 17020:2012

Screening – organised screening for asymptomatic women Treatment– surgery, breast reconstruction, radiotherapy, chemotherapy and hormonal therapy

ISO/IEC 17021:2011

Yes

Diagnosis – aspiration of fluid and subsequent testing, biopsy and tissue histology

ISO/IEC 17025:2005

FR**


Mammography

Pathology, laboratory tests

Mammography, medication management, communication, information systems, quality management, personnel competence requirements, hygiene, safety

Pathology, laboratory testing, communication, information systems, quality management, proficiency testing, personnel competence requirements, hygiene, safety

Pathology, laboratory testing, communication, information systems, quality management, proficiency testing, , personnel competence requirements, hygiene, safety


ISO 15189:2012

Yes

FI

Yes


Country

Table 1. (cont.)


Diagnosis – aspiration of fluid and subsequent testing, biopsy and tissue histology , blood marker tests for CA 15.3, CA125, CEA (carcinoembryonic antigen) Treatment– chemotherapy and hormonal therapy, blood cell counts: white blood cells, red blood cells, hemoglobin, hematocrit, platelets, blood chemistries : levels of liver enzymes , levels of potassium, chloride, and urea nitrogen levels, calcium levels, blood sugar levels, determination of drug levels in blood, blood marker tests for CA 15.3, CA125, CEA (carcinoembryonic antigen), FISH Test (Fluorescence In Situ Hybridization), molecular tests for mutation analysis (eg. real time PCR, ARMS PCR, NGS) Survivorship and management of recurrence – follow-up and management of recurrence Screening – organised screening for asymptomatic women Diagnosis – aspiration of fluid and subsequent testing, biopsy and tissue histology Diagnosis – Laboratory’s equipment calibration. Treatment–Molecular and cell biology tests for research use only (eg. cell viability test, gene expression analysis).

ISO 17021:2011 (ISO 9001:2008)

ISO 17025:2005

Laboratory tests, quality management, proficiency testing, personnel competence requirements, research, equipment calibration and metrological traceability

Mammography, ultrasound, MRI, laboratory tests, quality management, personnel competence requirements, hygiene, safety

Laboratory tests, communication, information systems, quality management, proficiency testing, personnel competence requirements, hygiene, safety


ISO 15189:2012

Yes

GR

Yes


Country

Table 1. (cont.)


Yes

Yes

Yes

No

No

No

Yes

IE

IT

LT

LU

ME

MK

NL

Yes

NR*

NR*

NR*

Not known

NR*

Yes

ISO 15189:2012

–

–

–

ISO/IEC 17021:2011 (under ISO 9001:2008)

ISO/IEC 17021:2011 (under ISO 9001:2008)

ISO 15189:2012

ISO 15189:2012

Yes

HR

Yes


Country

Diagnosis – biopsy and tissue histology

–

–

–

Screening –organised screening for asymptomatic women Diagnosis- aspiration of fluid and subsequent testing, biopsy and tissue histology Treatment– surgery, radiotherapy, chemotherapy and hormonal therapy



Treatment– chemotherapy and hormonal therapy

Proficiency testing

–

–

–

Mammography, ultrasound, MRI, laboratory tests, medication management, communication, information systems, quality management, personnel competence requirements

Mammography, ultrasound, MRI, pathology, laboratory tests, medication management, communication, information systems, quality management, proficiency testing, personnel competence requirements, hygiene, safety, research


Table 1. (cont.)


The whole breast cancer pathway– surgery, radiotherapy, chemotherapy and hormonal therapy, psychosocial care



ISO/IEC 17021:2011 (under ISO 14001:2004)

ISO/IEC 17021:2011 (under ISO/ IEC TR 18001:2004)

Mammography, ultrasound, MRI, pathology, laboratory tests, medication management, communication, information systems, quality management, personnel competence requirements, hygiene, safety, research




ISO/IEC 17021:2011 (under ISO 9001:2008)

Yes

PL

Yes


Country

Table 1. (cont.)


Yes

SE

Yes



Screening – organised screening for asymptomatic women Diagnosis – aspiration of fluid and subsequent testing, biopsy and tissue histology, Molecular biology methods, Immuno histolgy methods, Flow cytometry Survivorship and management of recurrence – follow-up and management of recurrences

ISO/IEC 17021:2011 (ISO 9001:2008)

ISO/IEC 17025:2005 and/or ISO 15189:2012

Screening–genetic studies–one lab is accreditation per ISO 15189: 2012 (examination of mutations in BRCA-1 and Brca-2 gene) Diagnosis – biopsy and tissue histology, Cytopathological examination of biopsy-monoclonal antibody (1 lab) ISO 15189:2012 Treatment– surgery, radiotherapy, chemotherapy and hormonal therapy Survivorship and management of recurrence

Mammography, pathology, laboratory tests, quality management, proficiency testing, , personnel competence requirements

Mammography, ultrasound, pathology, laboratory tests, medication management, information systems, quality management, personnel competence requirements, hygiene

Mammography, ultrasound, pathology, laboratory tests, medication management, information systems, quality management, personnel competence requirements, hygiene

Pathology, laboratory tests, proficiency testing , personnel competence requirements, hygiene, safety, research


ISO/IEC 17021:2011 (ISO/IEC 27001:2013)

ISO 15189:2012

Yes

RS

Yes


Country

Table 1. (cont.)


Yes

UK

Yes

Clinical Pathology Accreditation standard (laboratories are undergoing transition to UKAS accreditation to ISO 15189:2012)

Diagnosis – aspiration of fluid and subsequent testing, biopsy and tissue histology Survivorship and management of recurrence – follow-up and management of recurrences, the sampling and examination of aspirates and biopsies during follow-up surveillance activities.

Pathology, laboratory tests, communication, information systems, quality management, proficiency testing, personnel competence requirements, hygiene, safety

Information systems

ISO/IEC 17021:2011 (ISO/IEC 27001:2013)

Pathology, laboratory tests, communication, information systems, quality management, proficiency testing, , personnel competence requirements, hygiene, safety

–

Quality management

Diagnosis – aspiration of fluid and subsequent testing, biopsy and tissue histology Survivorship – follow-up and management of recurrences

–


ISO/IEC 17021:2011 (under ISO 9001:2008)

ISO 15189:2012

–

No

SI

NR*


Country

Table 1. (cont.)


Imaging Services Accreditation Scheme (ISAS) which has been ‘mapped’ against ISO/ IEC 17020:2012 and ISO 15189:2012

Is there an accredited/ Is this organisation Which standards are in place certified organisation diagnosing or treating breast cancer Diagnosis – Symptomatic screening, diagnostic mammo graphy, diagnostic ultrasound and other imaging and interventional radiology services. Survivorship and management of recurrence– Follow-up and management of recurrences, periodic imaging and interventional radiology screening to detect potential recurrence.

Mammography, ultrasound, MRI, communication, information systems, quality management, personnel competence requirements, hygiene, safety, research (The Standard is designed to be applied to all current imaging modalities and to interventional radiology services: general x-ray; ultrasound; computed tomography (CT); interventional radiology (IR); magnetic resonance imaging (MRI); dual energy x-ray absorption (DEXA); radionuclide imaging (RNI); symptomatic breast mammography. Non-imaging aspects of Nuclear Medicine (including radiopharmacy) and asymptomatic breast screening services are not currently included in the scope of this Standard.)


* NR: Not Reported. Relevant data was not provided or that the question was not relevant taking into consideration the answers to previous questions. ** ISO/IEC 17021:2011 and ISO/IEC 17065:2012 maybe in use but the respondent chose not to report the information due to uncertain/missing data.

UK (cont.)

Country

Table 1. (cont.)


Table 2. Overview of the breast cancer stages addressed by the standard. Questions: • ISO standard used for accreditation or accredited certification/inspection for activities part of or relevant for breast cancer care. • Countries using the standard. • The breast cancer stages covered by the standard.


DE, FR

AT¹, BG¹, CZ³, ES¹, FI, GR¹, IT¹, LT¹, PL⁴, SE², UK²

ES, FI, GR, SE

UK

UK

ISO/IEC 17020:2012

ISO/IEC 17021:2011

ISO/IEC 17025:2005

Clinical Pathology Accreditation standard

Imaging Services Accreditation Scheme

ES, IT, PL, SE

SE

AT, CZ, FI, GR,,LT

FR

ES, SE, RS

The whole breast Screening cancer pathway

UK

UK

FI, GR, SE

AT, CZ, FI, LT

DE

BE, CZ, DE, EE, ES, FI, FR, GR, IE, NL, RS, SE, UK

Diagnosis

ES, GR

AT, CZ, FI, LT

GR, HR, RS,

Treatment

UK

UK

SE

CZ

GR, SE, UK


These countries used the ISO/IEC 17021:2011 under the management system standard ISO 9001:2008. These countries used the ISO/IEC 17021:2011 under the management system standards ISO 9001:2008 and ISO/IEC 27001:2013. CZ used the ISO/IEC 17021:2011 under the management system standards ISO 9001:2008, ISO 13485:2003 and ISO/IEC 27001:2013. PL used the ISO/IEC 17021:2011 under the management system standards ISO 9001:2008, ISO 14001:2004 and ISO/IEC TR 18001:2004.

BE, CZ, DE, EE, ES, FI, FR, GR, HR, IE, NL, RS, SE, UK

ISO 15189:2012

1. 2. 3. 4.

Countries using the standard

ISO standard

UK

UK

SE

CZ, ES, FI, IT, LT, PL, SE, UK

DE, FR

BE, CZ, DE, ES, FR, GR, NL, RS, UK

Transversal Items

Table 2. (cont.)


Table 3. Detailed description of breast cancer stages addressed by standards in each country. Questions: • ISO standard used for accreditation or accredited certification/inspection for activities part of or relevant for breast cancer care. • Countries using the standard. • The breast cancer stages covered by the standard.


No No

No

No

DE

EE

ES

FI

No

No

CZ

FR

No

BE

ISO 15189:2012



ISO standard

No

No

Organised screening for asymptomatic women

No

No

No

No

Screening

Treatment

Aspiration of fluid and subsequent testing, biopsy and tissue histology


Aspiration of fluid and subsequent testing, biopsy and tissue histology, molecular pathology: e.g.; HER-2

Aspiration of fluid and subsequent testing, biopsy and tissue histology, BRCA1 and BRCA2 tests

Aspiration of fluid and subsequent testing

Biopsy and tissue histology

No

No

No

No

No

No

No

No

No

No

No


No

No

No Biopsy and tissue histology, molecular testing to detect any mutations causing breast cancer or influencing treatment (for example: HER2/ Neu FISH: if positive, a treatment with herceptin will be started).

Diagnosis

Table 3. (cont.)


No

No No

No No

No

No

GR

HR

IE

NL

RS

SE

UK

ISO 15189:2012 (cont.)



ISO standard

No


Genetic studies – one laboratory is accredited (examination of mutations in BRCA-1 and BRCA-2 gene)

No

No

No

No

Screening


Aspiration of fluid and subsequent testing, biopsy and tissue histology, molecular biology methods, immunohistology methods, flow cytometry

Follow-up and management of recurrence


No

No

Surgery , radiotherapy, See Table 7 chemotherapy and hormonal therapy, Immunochemical methods (CA 15-3; CEA) (7 labs), Cytopathological examination of biopsy-monoclonal antibody (1 lab) Aspiration of fluid and subsequent testing, biopsy and tissue histology, cytopathological examination of biopsy-monoclonal antibody (1 lab)

No

No

No

No

No


See Table 6

Chemotherapy and hormonal therapy


Treatment



No

Aspiration of fluid and subsequent testing, biopsy and tissue histology, blood marker tests for CA 15.3, CA125, CEA (carcinoembryonic antigen)

Diagnosis

Table 3. (cont.)


No

No

GR (under ISO 9001:2008)

LT (under ISO 9001:2008)

No

FI (under ISO 9001:2008)



ES (under ISO 9001:2008)

IT (under ISO 9001:2008)

Organised screening for asymptomatic women, colorectal cancer cervical cancer, prostate cancer

No

CZ (under ISO 9001:2008, ISO 13485:2003, ISO 27001:2013)


–



–

BAS have not information related

No

BG (under ISO 9001:2008)

See Table 4

No

Accreditation of inspection bodies for medical devices (mammography) external quality control

No

Screening

AT (under ISO 9001:2008)

No

FR

ISO/IEC 17021:2011

No

DE

ISO/IEC 17020:2012



ISO standard


–


No

–

– No

Surgery, radiotherapy, chemotherapy and hormonal therapy

No

–

No

Surgery, breast recon- No struction, radiotherapy, chemotherapy and hormonal therapy

–

Follow-up and management of recurrence, palliative care and end-of-life care

Surgery, breast reconstruction, radiotherapy, chemotherapy, PET centers

Aspiration of fluid and subsequent testing, biopsy and tissue histology –

BAS does not have information related to the topic


No

No

No



See Table 6

No

No

See Table 5

No

Treatment


Diagnosis

Table 3. (cont.)


No

No

No

No

ES

FI

GR

SE

No

UK (under ISO 9001:2008, ISO 27001:2013)

ISO/IEC 17025:2005

–


SE (under ISO 27001:2013, ISO 9001:2008)


No

No

No

No

–

The whole breast PL (under cancer pathway ISO 9001:2008, ISO14001:2004, ISO/IEC TR 18001:2004)

Screening

ISO/IEC 17021:2011 (c0nt.)



ISO standard

Aspiration of fluid and subsequent testing, biopsy and tissue histology, molecular biology methods, Immunohistology methods, flow cytometry

Laboratory’s equipment calibration.


No

No

–

–

Diagnosis

No

–

Psychosocial care


No

No

Follow-up and management of recurrences

No Molecular and cell biology tests for research use only (eg. cell viability test, gene expression analysis).

No

No Radiotherapy, there is one laboratory accredited for calibration of the standard used for therapy levels, Gamma radiation of Cobalt 60, 0,81 Gy/ min, CMC=0,8 %

No

–

Surgery, radiotherapy, chemotherapy and hormonal therapy

Treatment

Table 3. (cont.)


The whole breast cancer pathway No

No


UK

UK

ISO standard



No

No

Screening

Symptomatic screening, diagnostic mammography, diagnostic ultrasound and other imaging and interventional radiology services


Diagnosis

Survivorship and follow-up Follow-up and management of recurrences, The sampling and examination of aspirates and biopsies during follow-up surveillance activities Follow-up and management of recurrences, periodic imaging and interventional radiology screening to detect potential recurrence

Treatment No

No

Table 3. (cont.)


Table 4. Specific items of the screening stage addressed by the standard in place. Questions: • ISO standard used for accreditation or accredited certification/inspection for activities part of or relevant for breast cancer care. • Is the screening stage addressed by the standard. • Items of the screening stage addressed by the standard.


No No No No No No Yes

Yes No

FI

FR

GR

HR

IE

NL

RS

SE

UK

ISO/IEC 17021:2011

Yes No Yes Yes Yes Yes

AT

BG

CZ

ES

FI

GR

Yes

Yes

ES

No

No

EE

FR

No

DE

DE

No

CZ

ISO/IEC 17020:2012

No

BE

ISO 15189:2012

Yes

Yes

Yes

Yes

NR*

Not known

NR*

NR*

NR*

Yes

Not known

Not known

NR*

NR*

NR*

NR*

NR*

Yes

NR*

NR*

NR*

NR*

–

–

–

Colorectal cancer, cervical cancer, prostate cancer


–

Accreditation of inspection bodies for medical devices (mammography) external quality control

–

–

–

Genetic studies-one lab is accredited (examination of mutations in BRCA-1 and BRCA-2 gene)

–

–

–

–

–

–

–

–

–

Colorectal cancer, cervix cancer, prostate cancer

–

Is the screening stage addressed Are these items addressed by the standard by the standard Other Organised screening for asymptomatic women

Country using the standard

ISO standard

Table 4. (cont.)


88 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe No Yes No

No

GR

SE

UK

UK



NR*

NR*

Yes

NR*

NR*

NR*

NR*

Yes

Not known

Yes

–

–

–

–

–

There is one laboratory accredited for calibration of the standard used for therapy levels, Gamma radiation of Cobalt 60, 0,81 Gy/ min, CMC=0,8 %

–

–

–

–

* NR: Not Reported. Relevant data was not provided or that the question was not relevant taking into consideration the answers to previous questions.

No

FI

No

UK No

Yes

SE

ES

Yes

PL

ISO/IEC 17025:2005

Yes

LT

–

Yes

IT

ISO/IEC 17021:2011 (cont.)

Yes

Is the screening stage addressed Are these items addressed by the standard by the standard Organised screening Other for asymptomatic women


ISO standard

Table 4. (cont.)

Table 5. Specific items of the diagnosis stage addressed by the standard in place. Questions: • ISO standard used for accreditation or accredited certification/inspection for activities part of or relevant for breast cancer care. • Is the diagnosis stage addressed by the standard. • Items of the diagnosis stage addressed by the standard.


Yes Yes Yes No Yes Yes Yes Yes Yes

FI

FR

GR

HR

IE

NL

RS

SE

UK

ISO/IEC 17021:2011

Yes No Yes Yes No Yes

AT

BG

CZ

ES

FI

GR

No

Yes

ES

FR

Yes

EE

Yes

Yes

DE

DE

Yes

CZ

ISO/IEC 17020:2012

Yes

BE

ISO 15189:2012

Is the diagnosis stage addressed by the standard


ISO standard

90 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe Yes

NR*

Yes

Yes

Not known

Not known

NR*

NR*

Yes

Yes

NR*

Not known

Yes

NR*

Yes

Yes

Yes

Yes

Yes

Yes

No

Not known

Yes

NR*

Yes

Yes

Not known

Not known

NR*

Yes

Yes

Yes

Yes

Yes

Yes

NR*

Yes

Yes

Yes

Yes

Yes

NR*

Yes

Yes

Aspiration of fluid and Biopsy and tissue subsequent testing histology

–

–

Yes

–


–

–

–

–

Molecular biology methods– Immuno histolgy methods– Flow cytometry

Cytopathological examination of biopsymonoclonal antibody (1 lab)

–

–

–

Blood marker tests for CA 15.3, CA125, CEA (carcinoembryonic antigen)

–

–

Molecular Pathology: e.g.; HER2

BRCA1, BRCA2 tests

–

–

Molecular testing to detect any mutations causing breast cancer or influencing treatment (for example: HER2/Neu FISH: if positive, a treatment with herceptin will be started).

Other

Screening

Table 5. (cont.)

Yes Yes

Yes

SE

UK

UK



No

Yes

Yes

No

Yes

NR*

NR*

Yes

Not known

Yes

Yes

No

Yes

Yes

No

Yes

NR*

NR*

Yes

Not known

Yes

Yes

–

–

Molecular biology methods– Immuno histolgy methods– Flow cytometry

Laboratory’s equipment calibration.

–

–

–

–

–

–

–

Other

Screening Aspiration of fluid and Biopsy and tissue subsequent testing histology


Yes

GR

No

UK Yes

Yes

SE

FI

Yes

PL

No

Yes

LT

ES

Yes

IT

ISO/IEC 17021:2011 (cont.)

ISO/IEC 17025:2005

Is the diagnosis stage addressed by the standard


ISO standard

Table 5. (cont.)


Table 6. Specific items of the treatment stage addressed by the standard in place. Questions: • ISO standard used for accreditation or accredited certification/inspection for activities part of or relevant for breast cancer care. • Is the treatment stage addressed by the standard. • Items of the treatment stage addressed by the standard.


No No Yes

FI

FR

GR

NR*

No No

EE

ES

NR*

No

DE

NR*

No

NR*

NR*

NR*

NR*

No No

Surgery

BE

ISO 15189:2012

Is the treatment stage addressed by the standard

CZ


ISO standard

NR*

No

NR*

NR*

NR*

NR*

NR*

NR*

No

NR*

NR*

NR*

NR*

NR*

NR*

NR*

Radiotherapy

Yes

NR*

NR*

NR*

NR*

NR*

NR*

NR*

Blood cell counts: white blood cells, red blood cells, hemoglobin, hematocrit, platelets, blood chemistry, levels of liver enzymes , levels of potassium, chloride, and urea nitrogen levels, calcium levels, blood sugar levels, determination of drug levels in blood, blood marker tests for CA 15.3, CA125, CEA (carcinoembryonic antigen), FISH Test (Fluorescence In Situ Hybridization), molecular tests for mutation analysis (eg. real time PCR, ARMS PCR, NGS)

–

–

–

–

–

PET Centres

–

Chemotherapy and Other hormonal therapy

Are these items addressed by the standard Breast reconstruction

Table 6. (cont.)


ISO/IEC 17021:2011

ISO/IEC 17020:2012

Yes Yes

Yes Yes

CZ

ES

Not known

No

UK

Yes

Yes Yes

PL

Yes

LT

SE

Yes

Yes

IT

94 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe NR*

Yes

Yes

NR*

Yes No

FI

GR

Yes

Not known

Yes No

AT

NR*

NR*

NR*

NR*

BG

No

FR

No No

SE

UK No

NR*

Yes

RS

DE

Yes

No

NL

NR* NR*

Yes No

Surgery

HR

ISO 15189:2012 (cont.)

Is the treatment stage addressed by the standard

IE


ISO standard

NR*

Not known

Not known

Not known

Yes

NR*

Yes

Yes

Yes

Not known

Not known

NR*

NR*

NR*

NR*

Not known

NR*

NR*

NR*

Breast reconstruction

NR*

Not known

Yes

Yes

Yes

NR*

Yes

Yes

Yes

Not known

Not known

NR*

NR*

NR*

NR*

Yes

NR*

NR*

NR*

Radiotherapy

NR*

Yes

Yes

Yes

Yes

NR*

Yes

Yes

Yes

Not known

Not known

NR*

NR*

NR*

NR*

Yes

NR*

NR*

Yes

–

–

–

–

–

–

–

–

–


–

–

–

–

–

– Immunochemical methods (CA 15-3; CEA) (7 labs) – Cytopathological examination of biopsy-monoclonal antibody (1 lab)

–

–

–


Are these items addressed by the standard

Table 6. (cont.)

NR*

NR*

NR*

NR*

No

NR*

NR*

NR*

NR*

NR*

No

NR*

Yes

Radiotherapy

NR*

NR*

NR*

No

NR*

NR*

–

–

–

Molecular and cell biology tests for research use only (eg. Cell viability test, Gene expression analysis)

–

There is one laboratory accredited for calibration of the standard used for therapy levels, Gamma radiation of Cobalt 60, 0,81 Gy/min, CMC=0,8 %


Are these items addressed by the standard Breast reconstruction


No

UK


NR*

NR*

No No

SE

UK


NR* No

No Yes

FI

GR

Surgery NR*

ES

ISO/IEC 17025:2005

Is the treatment stage addressed by the standard Yes


ISO standard

Table 6. (cont.)


Table 7. Specific items of the survivorship and management of recurrence stage addressed by the standard in place. Questions: • ISO standard used for accreditation or accredited certification/inspection for activities part of or relevant for breast cancer care. • Is the survivorship and management of recurrence stage addressed by the standard. • Items of the survivorship and management of recurrence stage addressed by the standard.


ISO/IEC 17021:2011

ISO/IEC 17020:2012

NR* NR*

No

DE

NR*

NR* NR*

No

FI

No Yes No

LT

No

FI

GR

Yes

ES

IT

Yes

CZ

No No

AT

BG

No

FR

Yes

UK No

Yes

SE

DE

Yes

RS

NR*

No No

IE

NL

NR*

No

HR

Not known

Yes

NR*

NR*

Yes

Yes

Not known

NR*

NR*

NR*

Yes

Yes

Not known

NR*

Yes

No Yes

FR

GR

NR*

No No

EE

ES

NR*

No No

BE

ISO 15189:2012

Is the survivorship and management Follow-up of recurrence and management stage addressed of recurrence by the standard

CZ


ISO standard

NR*

Not known

Yes

NR*

NR*

Yes

Not known

Not known

NR*

NR*

NR*

No

No

No

NR*

NR*

NR*

No

NR*

NR*

NR*

NR*

NR*

NR*

Not known

Yes

NR*

NR*

Yes

Not known

Not known

NR*

NR*

NR*

No

No

No

NR*

NR*

NR*

No

NR*

NR*

NR*

NR*

NR*

NR*

NR*

Survivorship support

NR*

Not known

Yes

NR*

NR*

Yes

Yes

Not known

–

–

–

–

–

–


–

–

– NR*

– NR*

–

–

–

–

–

–

–

–

–

–

–

–

–

Other

No

No

No

NR*

NR*

NR*

No

NR*

NR*

NR*

NR*

NR*

NR*

NR*

Palliative care and end-of-life care

Are these items addressed by the standard Psychosocial care

Table 7. (cont.)


98 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe Yes

Yes

UK

UK



Yes

Yes

Yes

No

No

No

NR*

NR*

NR*

NR*

Not known

Yes

Psychosocial care

No

No

No

NR*

NR*

NR*

NR*

Not known

No

Survivorship support

No

No

No

NR*

NR*

NR*

NR*

Not known

No

Palliative care and end-of-life care

Are these items addressed by the standard


Yes

SE

NR*

NR*

No No

NR*

No

FI

ES

GR

ISO/IEC 17025:2005

Yes

Yes No

SE

UK

NR*

Not known

PL

ISO/IEC 17021:2011 (cont.)

Is the survivorship and management Follow-up of recurrence and management stage addressed of recurrence by the standard Yes


ISO standard

Periodic imaging and interventional radiology screening to detect potential recurrence

The sampling and examination of aspirates and biopsies during follow-up surveillance activities

–

–

–

–

–

–

–

Other

Table 7. (cont.)

Table 8. STransversal items of breast cancer addressed by the standard in place. Questions: • ISO standard used for accreditation or accredited certification/inspection for activities part of or relevant for breast cancer care. • Transversal items covered by the standard.


ISO/IEC 17021:2011

ISO/IEC 17020:2012

Yes No

SE

UK No

NR*

Communication NR*

No

NR*

No

Yes

NR*

NR*

No

No

Information systems

No

NR*

NR*

Yes

No

Yes

No

NR*

Yes

No

NR*

Yes

Not Yes known

No

No

NR*

NR*

Yes

No

Yes

Not Yes known

NR*

Not No known

No

NR*

NR*

No

No

No

No

NR*

NR*

Not No known

No

Quality management NR*

NR*

Yes

No

Yes

Yes

NR*

NR*

No

No

Proficiency testing

No

NR*

Yes

Yes

No

Yes

No

NR*

NR*

Yes

No

Yes

Yes

NR*

NR*

No

Yes

No

NR*

Yes

No

NR*

Yes

Not Yes known

Yes

Not Yes known

NR*

NR*

Yes

No

Yes

Yes

NR*

NR*

No

Yes

Personal competence requirements

No

No

NR*

NR*

NR*

Yes

No

Yes

Yes

NR*

NR*

NR*

NR*

No

No

No

No

NR*

–

–

–

–

No

No

–

–

No

No

No

NR*

Yes

Yes

Yes

Yes

–

No

NR*

Yes

No

NR*

No

No

–

No

Not Not No known known

Yes

Not Not Not No known known known

NR*

NR*

Yes

No

Yes

Yes

NR*

NR*


No

Other

Not Not Not Not Not Not Not Not Not Not Not Not Not Not BAS does not known known known known known known known known known known known known known known have information related to the topic

No

Yes

Medication management Yes

Hygiene

BG

No

NR*

Yes

Yes

No

Yes

No

NR*

NR*

Yes

Yes

Yes

Yes

NR*

Yes

Yes

Yes

Yes

No

NR*

NR*

No

Yes

Yes

Yes

NR*

NR*

Yes

Yes

Laboratory tests

Not Yes known

No

No

NR*

NR*

No

No

No

No

NR*

NR*

No

Pathology Yes

Safety

Not Not Not Not Not Not Not Not Not Not Not Not Not Not – known known known known known known known known known known known known known known

No

NR*

No

Yes

No

No

NR*

NR*

No

No

MRI No

Research

AT

Yes

No

RS

FR

NR*

NL

NR*

NR*

IE

DE

No NR*

No

FR

GR

No

No

FI

HR

No

No

ES

NR* NR*

NR*

No

NR*

CZ

No

DE

No

BE

ISO 15189:2012

Ultrasound

EE

No

Country using the standard Mammography

ISO standard

Table 8. (cont.)


No No

Yes

GR

SE

No

UK (under ISO 27001) NR*

Not Not Not Not Not Not Not Not Yes known known known known known known known known

UK (under ISO 9001)

FI

Yes

SE

ES

Yes

PL

ISO/IEC 17025:2005

Yes

No

No

No

NR*

No

Yes

Yes

Yes

No

No

No

NR*

No

Yes

No

Yes

NR*

No

Yes

Yes

Yes

NR*

No

Yes

Yes

No

No

No

NR*

No

Yes

Yes

Yes

Not Yes known Yes

Yes

No

Yes

Yes

Not Yes known

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

Yes

NR* No

Yes

Not No known

No

Yes

NR*

Not Yes known

Not Yes known

Yes

Yes

Yes

No

Yes

Yes

Yes

Yes

NR*

No

Yes

Yes

Yes

Yes

Yes

Yes

Not Not Not Yes known known known

Yes

LT

Yes

No

No

Yes

Yes

Yes

Yes

No

Yes

Not Not Not No known known known

IT

Yes

No

Yes

Yes

Yes

No

Yes

Yes

GR

Mammography Yes

Ultrasound

FI

MRI

Yes

Pathology

ES

Laboratory tests

Yes

Medication management

CZ

Communication

ISO/IEC 17021:2011 (c0nt.)

Information systems

Country using the standard Quality management

ISO standard Proficiency testing No

Personal competence requirements Yes

Yes

Yes

Safety

Hygiene Yes

Yes

Yes

Yes

Yes

No

No

No

No

No

Not – known

No

Yes

Yes

Yes

– Not Not No known known

Yes

Not Not Not – known known known

Yes

Yes

Yes

Yes


Research

Yes

Yes

Yes

NR*

No

Yes

Yes

Yes

NR*

No

No

No

Yes

NR*

No

Yes

No

NR*

No

Equipment calibration and metrological traceability

No

–

No


No

Yes

NR*

No

Not Not Not Not Not – known known known known known

Not Yes known

Not Yes known

Not Yes known

Yes

No

No

Not Yes known

No

Other

Table 8. (cont.)


Yes

UK

UK



Ultrasound

102 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe MRI Yes

No

Pathology No

Yes

Laboratory tests No

Yes

Medication management No

No

Communication Yes

Yes

Information systems Yes

Yes

Quality management Yes

Yes

Proficiency testing No

Yes

Personal competence requirements Yes

Yes

Hygiene Yes

Yes

Yes

Yes

Safety


Yes

No

Yes

No

Research Sampling and testing may be done specifically as a point-of care activity

Other

The standard is designed to be applied to all current imaging modalities and to interventional radiology services: general x-ray; ultrasound; computed tomography; interventional radiology; magnetic resonance imaging ; dual energy x-ray absorption; radionuclide imaging; symptomatic breast mammography. Non-imaging aspects of Nuclear Medicine (including radiopharmacy) and asymptomatic breast screening services are not currently included in the scope of this standard

No

Country using the standard Mammography

ISO standard

Table 8. (cont.)

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European Commission EUR 27382 EN – Joint Research Centre – Institute for Health and Consumer Protection Title: Report of a survey on accreditation and conformity assessment in the field of breast cancer in Europe Author(s): Aslı Ulutürk, Silvia Deandrea, Donata Lerda, Jesús López Alcalde, Luciana Neamtiu, Zuleika Saz-Parkinson Luxembourg: Publications Office of the European Union 2015 – 102 pp. – 21.0 x 29.7 cm EUR – Scientific and Technical Research series – ISSN 1831-9424 (online) – ISSN 1018-5593 (print) ISBN 978-92-79-50318-4 (pdf) ISBN 978-92-79-50334-4 (print) doi:10.2788/15049

LB-NA-27382-EN-N

JRC Mission As the Commission’s in-house science service, the Joint Research Centre’s mission is to provide EU policies with independent, evidence-based scientific and technical support throughout the whole policy cycle. Working in close cooperation with policy Directorates-General, the JRC addresses key societal challenges while stimulating innovation through developing new methods, tools and standards, and sharing its know-how with the Member States, the scientific community and international partners. Serving society Stimulating innovation Supporting legislation doi:10.2788/15049 ISBN 978-92-79-50318-4