The European quality assurance scheme has been tested in real healthcare settings across the EU with the aim to assess and improve the practicability of the certification process before its final release.
Description
Feasibility checks of the requirements were completed before the pilot run. The summary of the results will be published soon. Read more.
The pilot run has been organised in collaboration with the European co-operation for Accreditation (EA) and with the voluntary participation of eight breast cancer services, eight certification bodies, and two national accreditation bodies from eight EU countries.
During the pilot run of the QA scheme, selected services and bodies have been testing the applicability of the accredited certification approach detailed in the Scheme Owner Manual.
Approach
The compliance of the breast cancer services with the requirements of the QA scheme is checked by independent certification bodies. To ensure a harmonised approach is used for the certification process, national accreditation bodies are involved through the EA multilateral agreement (MLA).
During the pilot run, each breast cancer service has collaborated with an allocated certification body, which has performed an audit to check the compliance.
Accredited and non-accredited certification bodies have participated in the pilot run. Some bodies have checked the accreditation process according to the requirements of the scheme, while others have offered information about the steps needed to obtain either accreditation or recognition of the certification scheme they already operate.
The pilot run did not lead to a formal certification of the services nor accreditation of certification bodies, but the feedback and data gathered have been analysed by the JRC and the EA to identify potential improvements to the accredited certification process.
The entities will, however, receive an official recognition of their participation in the pilot run of the scheme in the form of a certificate.
Note: The certification bodies seeking accreditation for the purpose of the QA scheme will be assessed by the respective national accreditation bodies according to ISO/IEC 17065.
Participating services and bodies
Breast cancer services and certification bodies were selected following a preliminary interest shown through open calls, while national accreditation bodies were selected considering the selected certification bodies.
Breast cancer services
| Country | Name | Certification module* |
|---|---|---|
| Germany | Brustzentrum der Charité Universitätsmedizin Berlin | Care pathway without screening |
| Italy | Breast Centre Humanitas Catania | Care pathway without screening |
| Lavia | Paula Stradiņa klīniskā universitātes slimnīca | Entire care pathway |
| Poland | Lower Silesian Oncology, Pulmonology and Hematology Center | Care pathway without screening |
| Romania | Piloting screening programme, The Oncology Institute „Prof. Dr. Ion Chiricuţă” | Screening programme only |
| Slovenia | DORA, Slovenian Breast Cancer Screening Programme, Institute of Oncology | Screening programme only |
| Spain | Breast Cancer Screening Programme: Southern Metropolitan Area of Barcelona, Catalan Institute of Oncology | Screening programme only |
| Spain | Hospital Universitario La Paz | Entire care pathway |
*As described in the Scheme Owner Manual
| Country | Name | Accreditation ISO/IEC 17065 |
|---|---|---|
| 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 | Name |
|---|---|
| Italy | L'Ente Italiano di Accreditamento - ACCREDIA |
| Spain | Entidad Nacional de Acreditación - ENAC |
| Country | Name |
|---|---|
| Germany | Deutsche Krebsgesellschaft - DKG |
| Italy | GISMA |
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.
Next steps
Implementation of the European QA scheme
Once the scheme and its manuals are updated, considering the results of the testing phase, the formal version of the scheme can be released.
Information on how the formal certification process will work in practice to allow breast cancer services to be formally certified will then be evaluated within the European Commission. Meanwhile, the Scheme Owner Manual explains in detail the type of certification process the QA scheme shall follow.
Note: Certification refers to formal recognition by an independent and impartial organisation (certification body) that the breast cancer service and its providers have been audited and have demonstrated to meet all the requirements of the QA scheme.