FAQs on QA scheme

01. When the list of breast cancer services accredited by the European QA scheme will be published?

In 2018 the European QA scheme will be available to all interested breast cancer services (hospitals, clinics, diagnostic centres, etc.) in any Countries. The final version available in 2018 will be the result of a pilot phase to be conducted in 2017 in a maximum of 15 structures selected through an open call for pilot. The piloting phase will assess the functioning and feasibility of the draft scheme in different contexts and Countries and from the result we will be able to improve it, if necessary. The draft scheme manual may be made publicly available during the piloting phase. On this website you will eventually find all accredited breast cancer services as soon as they will implement the European QA scheme.

02. What does the European QA scheme require? Which are the provisions?

The European QA scheme is a collection of requirements and indicators. Its implementation guarantees that compliant breast cancer services can offer to users (women, patients and carers) top quality and most updated procedures for breast cancer screening and care. The requirements focus on the person’s needs and are based on the most updated evidence-based guidelines. The European QA scheme will also provide doctors, nurses and healthcare professionals with the most updated professional best practices, with proven validity and accepted by the ECIBC experts after a third party evaluation according to rigorous pre-set criteria.
All the requirements will strive to reflect a right balance between the continuous improvement of quality of care and local feasibility and applicability of the scheme.

 

03. What does it mean that the European QA scheme application is voluntary?

The application of the European QA scheme is not mandatory by law. Interested breast cancer services can implement it on the basis of their resources, programme and will.

04. Which type of entity can apply the European QA scheme?

Any breast cancer service which covers the full extent of breast cancer management: from screening to treatment until palliative care.

05. How does the Commission control the effective compliance of a Breast Cancer Service with the European QA scheme’s requirements?

The inspections will be carried out by representatives of the national accreditation bodies and the conformity assessment bodies. These entities function within the European accreditation framework [link: http://ec.europa.eu/growth/single-market/goods/building-blocks/accreditation/]. The breast cancer service will be audited to assess its compliance with the European QA scheme requirements. Those services will be asked to collect indicators (data) that will be centrally evaluated and, if need be, the QA scheme may be revised. In addition, feedback from users.

06. How are you developing the European QA scheme?

A wide team of experts, the Quality Assurance Development Group (QASDG), who work on a voluntary basis, without been remunerated, have been selected through an open call with a transparent procedure. These experts represent an inclusive range of competences; in fact, they include medical doctors, nurses, quality managers, healthcare managers, patients’ advocates, and legal experts. Under JRC co-ordination, they are all pulling together their competences, working both from remote and in face to face meetings usually held every three months. Their discussions are carried out using a method called “Delphi Round”. When consensus is reached and then the draft published on this website, anybody is invited to give feedback through a public open call for feedback. Overview of the methodology.

06. What is the Quality Assurance Scheme?

ECIBC is developing a Quality Assurance scheme for Breast Cancer services (European QA scheme) which will set the requirements covering every step of breast cancer (from screening to palliative care) based on the best available scientific evidence.

The European QA scheme puts the person’s need and sensitivity at the centre of its scope and therefore will be designed to include, beyond clinical recommendations, aspects such as patient values, communication needs and support. The European QA scheme will be piloted in 2017 in selected breast centres around Europe to undergo a deep assessment on its functioning in different context and circumstances to correct potential weakness. Then it will become available to all on voluntary basis. The breast cancer services wishing to adhere to it will have to demonstrate the capacity to attain its requirements.

Once the European QA scheme will be operative, you will find on this website an updated list of those breast cancer services compliant to the requirements.

07. How do I know if the service I go for screening is compliant with the European QA scheme?

If it appears in list/map on this website it means it applies the European QA scheme. Moreover you will be able to see in their site the certification of compliance (conformity assessment).

08. How the accredited European QA scheme breast centres differ from the others which are not? / If my hospital is not compliant with the European QA scheme mean is not good enough?

If a breast cancer service applies the European QA scheme means that it implements the most updated evidence-based requirements and protocols and that its compliance is regularly checked and evaluated by external entities. In addition, it means that it is able to offer to its users the best quality services currently available.
If your hospital does not apply it yet, it just means that its management did not yet take the strategic decision to implement it for any organisational reason or because the small size of the structure does not permit to develop such complete care pathway then it has decided to refer breast cancer patients to other accredited structures.

09. What is the added value of the European QA scheme accreditation?

  • For the users (women and patients) choosing a European QA scheme accredited breast cancer service means: (1) having the guarantee to be assisted according to the best quality evidence-based criteria, (2) having the possibility to follow a person centred care pathway completely designed to meet the woman/patient’s needs and (3) receiving all necessary information and support to take aware decision regarding own health.
  • For the breast cancer services being accredited with the European QA scheme means: (1) meeting patients’ expectations for the highest quality healthcare, (2) benefiting from frequent audits and peer reviews aiming to constant improvement of the services offered, (3) being framed into a scheme which guarantees adherence to most up-to-date evidence-based requirements.

 

10. Does the European QA scheme guarantee also the professional personnel is qualified?

The European QA scheme is supported by three pillars: (1) evidence-based guidelines on screening and diagnosis (European Breast Guidelines), (2) Platform of Guidelines covering every process of breast cancer care [link], (3) Digital Mammography Training template (DMT).This last one is being developed for the radiologists and radiographers in the screening programmes. It is meant to be a requirement in the European QA scheme.

11. What is the relation between ISO standards and the European QA scheme?

The European QA scheme will cover many healthcare processes, some of them will regard testing and examination activities. To ensure consistency along the processes, two main harmonised standards have been chosen: the ISO 15189:2012 (Medical laboratories -- Requirements for quality and competence) which specifies requirements for quality and competence in medical laboratories for the testing activities and the ISO/IEC 17065:2012 (Conformity assessment -- Requirements for bodies certifying products, processes and services). Both standards will be directly used by the National Accreditation Bodies: the first for accrediting testing activities (e.g. laboratories) associated to breast cancer services, and the second for accrediting certification bodies that should certify that that service fulfils all the specific requirements of the European QA Scheme. For more on ISO standards

12. If the European QA scheme is one, will its structure be too rigid to adapt to different women’s needs?

On the contrary: the European QA scheme is being developed with a person centred approach. While the medics and professional staff will be instructed by the scheme on the procedures, the women/patient will be informed at each step, empowering her of well-informed own decision-making.