European Breast QA scheme Scope
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 Scope represents the first output in the development of the scheme and is meant to describe: 1) how the scheme will be implemented in the European context, according to the European legislation for accreditation; 2) the interventions and services that will be covered by the European QA scheme; and 3) the quality dimensions that will be included. All stakeholders and individual citizens were invited to provide their feedback on the draft document. The current Scope presents the results following the integration of the comments received. A second call for feedback will be launched once the scheme’s requirements are available, and thus in the final version of the scheme’s manual.
1. The accreditation legal framework of the European Breast QA scheme
The voluntary European Breast QA scheme will be developed, piloted and, in the future, run under Regulation (EC) No 765/2008 and associated acts.
2. Services, interventions, diseases, and care processes covered
The scheme applies to Breast Cancer Services (BCSs), defined as all healthcare services covering, in continuum, the full extent of breast cancer management, from screening to follow-up, and in some cases until the end-of-life care.
For each of the care processes within the care pathway, specific sub-processes can be identified. Some of them, such as breast imaging, concern more than one care process.
Organisation of the European Breast QA scheme requirements
A manual will be produced to present and explain the requirements that must be fulfilled by BCSs for certification and accreditation (of testing activities) to be granted.
The manual will specify:
- If applicable, the eligibility requirements a BCS would need to fulfil so that the accreditation/certification process could be started.
- The requirements against which the quality of the services will be judged in the accreditation/certification process, including the rationale and evidence on which they have been chosen.
- The quality domains to be addressed by process requirements.
In accordance with established practices for improving quality in European healthcare systems, the European Breast QA scheme will also assess whether requirements are being met by using quantitative indicators. Indicators will be associated with the requirements when the following criteria are fulfilled (NICE Healthcare Quality Standards Process Guide, Methodenpapier AQUA-Institut):
- There is significant variation in the delivery of (sub)-processes of care to persons between services and/or between Member States.
- The indicators measure key requirements for high-quality care or service provision with respect to improvements in the effectiveness, safety and experience of care.
- The performance of the (sub)-processes related to the requirements is quantitatively measurable.
- The BCS concerned has the power, within the respective country healthcare legal framework, to change the relevant care/services processes.
3. Quality domains
In the European Breast QA scheme, classification of requirements will be proposed according to the following domains:
- Clinical effectiveness
- Facilities, resources and workforce
- Personal empowerment and experience