Rationale
The European quality assurance (QA) scheme has been tested in real healthcare settings across the EU with the aim to assess and improve the applicability and practicability of the requirements or certification process before its final release.
It included the:
- Feasibility checks
- Pilot run
The testing phase took place with the voluntary participation of, in total, 20 breast cancer services, associated entities, certification bodies and national accreditation bodies from 9 EU countries.
Feasibility checks
By using supporting tools, the breast cancer services assessed the applicability and practicability of the requirements and indicators listed in the Manual for Breast Cancer Services, organised according to the modules of the breast cancer pathway and respective coverage by the individual healthcare settings, as follows:
- Services covering the entire breast cancer pathway (screening, diagnosis, treatment, rehabilitation, follow-up/ survivorship, and palliative/end-of-life care)
- Services covering the screening programme only, and, where applicable, diagnosis for referrals following screening
- Services covering the breast cancer pathway from diagnosis to follow-up and palliative care
The feasibility checks took place between September 2021 and March 2022.
Pilot run
Following the feasibility checks, a pilot run was carried out in collaboration with the European co-operation for Accreditation (EA), to test the applicability of the accredited certification approach (ISO/IEC 17065), as detailed in the Scheme Owner Manual.
Each breast cancer service collaborated with an allocated certification body, which performed an audit to check the compliance. Accredited and non-accredited certification bodies participated in the pilot run. Some checked the accreditation process according to the requirements of the scheme, while others offered information about the steps needed to obtain accreditation or to evaluate how best to integrate with a certification scheme they already operate.
The pilot run took place between April 2022 and February 2023.
The testing phase did not lead to a formal certification of the services nor accreditation of certification bodies. The entities have, however, received an official recognition of their participation in the testing phase of the European QA scheme in the form of a certificate.
Participating entities
Breast cancer services and certification bodies were selected following a preliminary interest shown through open calls, while national accreditation bodies were selected considering the participating certification bodies.
| Country | Certification Body | Accreditation |
|---|---|---|
| Belgium | Organisation of European Cancer Institutes - OECI | Non accredited |
| Germany | OnkoZert GmbH | Non accredited |
| Italy | BUREAU VERITAS ITALY SPA | More details |
| Italy | ITALCERT S.R.L. | More details |
| Spain | Agencia de Calidad Sanitaria de Andalucía - ACSA | More details |
| Spain | Sociedad Española de Senología y Patología Mamaria - SESPM | Non accredited |
| Country | National Accreditation Body |
|---|---|
| Italy | L'Ente Italiano di Accreditamento - ACCREDIA |
| Spain | Entidad Nacional de Acreditación - ENAC |
| Country | Additional entities collaborating |
|---|---|
| Germany | Deutsche Krebsgesellschaft - DKG |
| Italy | GISMA |
| Netherlands | Netherlands Comprehensive Cancer Organisation |
Disclaimer: The list of participating entities and their respective websites are included for information only. The Commission is not responsible for the information available on the websites.
Conclusion
The testing phase of the European QA scheme has been concluded in March 2023 with the participation of 20 entities in total: breast cancer services, associated entities, certification bodies and national accreditation bodies from 9 EU countries.
Feedback was collected from all entities regarding the practicality and applicability of requirements in the context of their settings. Barriers for implementation and requisites that would support the application of the scheme within services were identified.
The European QA scheme was found:
- to be clearly described and the requirements representative and useful.
- to have the potential, through implementation of the service requirements, to support quality assessments of processes and leading to improvements of the management of the services themselves, such as, ensuring continuity of care through enhanced communication among service units, as well as, improving the timeliness and consistency of quality care.
Importantly, the scheme was found to be:
'fit-for-purpose'
by the EA and generally compliant with the requirements of the relevant accreditation standards and certification scheme framework.
Subsequently, in November 2024, EA endorsed the scheme to be applied for the accreditation of certification bodies wishing to certify breast cancer services. This represents the formal scheme validation by the EA.