To read the Summary Report, click here.
Breast cancer is the most common cancer among women in the European Union. Statistics from the European Cancer Information System (ECIS) indicate that in 2020, more than 355,000 women were estimated to be diagnosed with breast cancer (13.3% of all cancer diagnoses). Moreover, in some countries, there are inconsistencies between incidence and mortality rates, where mortality is higher than the European average, despite a lower incidence. This may depend on various factors, including the quality and access to care. The European Parliament and Council aim to support Member States in their efforts to combat cancer.
A joint project between the European Commission and EA was initiated to ensure the quality and safety of the patient’s journey through the breast cancer care pathway and to improve the quality of care offered to women. This mission was accomplished in April 2023.
Now, let’s delve further into this project and its outcomes.
The European Quality Assurance Scheme for Breast Cancer Services
The European Quality Assurance (QA) Scheme for breast cancer services has been established under the auspices of the European Commission Initiative on Breast Cancer (ECIBC). The ECIBC project was launched by the European Commission’s Directorate-General for Health and Food Safety, with oversight by the Commission’s Joint Research Centre (JRC). The European Commission owns the European QA Scheme.
The European QA Scheme defines a common set of quality and safety requirements for Breast Cancer Services (BCSs) in Europe, which should be followed by any entity providing BCSs to women. The fulfillment of these requirements is demonstrated through accredited certification.
The European QA Scheme is applicable to all healthcare services covering the entire breast cancer care pathway. The breast cancer care pathway defined and covered by the scheme outlines the journey followed by a patient, including possible entry and end points and the services involved. This approach ensures that the European QA Scheme follows a patient-centered perspective.
What are the requirements of the scheme?
The requirements in the European QA Scheme are defined, where possible, based on evidence-based recommendations from high-quality guidelines, best professional practices, and relevant legislation. Detailed descriptions of these requirements can be found in the the Manual of the European Quality Assurance Scheme for Breast Cancer Services and the European QA Scheme Owner Manual.
The requirements of the scheme are specific, measurable, and actionable. They directly pertain to the maintenance, restoration, or improvement of health and are related to one or more of the following quality domains:
- clinical effectiveness;
- safety;
- facilities, resources, and workforce;
- personal empowerment and experience.
The European QA Scheme has been developed as a modular scheme, allowing different legal entities or geographically separated services to participate according to the range of breast cancer services they provide.
Adopting the European QA Scheme is voluntary and not mandatory for health services/BCSs to implement. However, if a BCS entity chooses to implement it and seeks certification under the scheme, it must adhere to the scheme’s requirements and criteria.
The role of certification and accreditation
Certification is the formal recognition by an independent, impartial organization (Certification Body – CB) that a BCS and its providers have been audited and have demonstrated compliance with all the European QA Scheme requirements. A BCS provider that adopts the European QA Scheme and achieves accredited certification can provide formal assurance that a woman using its services, for any aspect of breast cancer care, will benefit from services meeting the requirements of an EU-wide protocol.
Through accreditation, conducted by a National Accreditation Body (NAB), a CB obtains recognition and affirmation that it competently and impartially carries out its duties following the relevant harmonized standard (EN ISO/IEC 17065) when certifying BCSs. In addition to the harmonized standard, the scheme owner’s requirements, as described in the Manual for Breast Cancer Services and the Scheme Owner Manual, must also be applied.
Diagnostic services, including pathology and imaging services, are integral parts of breast cancer services, and the competence of the bodies providing these services can be demonstrated through accreditation.
To read the Summary Report, click here.