Aim
The European quality assurance (QA) scheme for breast cancer services is a voluntary certification scheme in the context of organised, population-based breast cancer screening. It aims to support quality improvement and person-centred care in breast cancer services across Europe.
The scheme covers the entire breast cancer care pathway including screening, diagnosis, treatment and follow-up care and is available to all interested breast cancer services (i.e., hospitals, clinics, units, diagnostic centres, and other organisations) across diverse healthcare settings.
Description
The European QA scheme defines a common set of quality and safety requirements which, alongside evidence-based guidelines, aim to provide screening programmes, healthcare providers, as well as policymakers , with the instruments necessary to implement high-quality breast cancer care. Several tools are available to support the implementation of the scheme.
The multidisciplinary panel Quality Assurance Scheme Development Group (QASDG), with the support of selected experts from the Guideline Development Group (GDG), has defined the 'care pathway' from breast cancer screening to palliative care, the interventions and services to be considered, the quality domains to be included and how the scheme can be implemented at European level.
Certification to the scheme is underpinned by the European legislative framework on accreditation (defined in Regulation (EC) No 765/2008) and is recognised and accepted on a European and international level.
Approach
The requirements were defined and selected in a structured way by the QASDG expert panel.
The procedure consisted of the following essential steps:
1. Collection of requirements
Requirements for all breast cancer care processes (from screening to follow-up and palliative care) were researched in existing literature, guidelines, indicator databases, and existing quality assurance schemes, and were presented with reference to their evidence. In cases where the requirements retrieved did not address all the relevant quality potentials in the breast cancer care pathway, the QASDG developed new ones. Requirements that did not meet predefined inclusion criteria are excluded.
2. Panel process
In Delphi-style rounds, requirements were first rated for their understandability and relevance and subsequently for their feasibility. Relevance relates to the significance of the requirements for the desired health outcome. Feasibility relates to the potential for practical implementation of the requirements across services in Europe and to provide meaningful data at service-provider level.
Only requirements that are rated high for understandability, relevance and feasibility by the majority of the QASDG members were included in the European QA scheme.
3. Testing phase
The requirements were tested via feasibility checks in real settings and the scheme was evaluated in a pilot exercise. The testing phase took place between 2021 and 2023.
4. Publication
The feedback from the testing phase were considered in the final version of the scheme (Version 1.0), which, following endorsement by the European co-operation for Accreditation in November 2024, was officially published in February 2025.
Next steps
The first updating round of the scheme will be initiated to keep the scheme up-to-date.
The second version will be announced in advance for public consultation and with a transition plan.