Quality standards of breast cancer services differ across Europe

A JRC survey on the use of ISO standards in breast cancer care services in Europe finds that in 76% of the countries examined at least one healthcare organisation is accredited or holds an accredited certificate of conformity to the respective standard. This reflects the need to consider what is already in place when developing a European quality assurance scheme for breast cancer services, aimed at improving quality of care. The survey shows that ISO standards most widely used are applied in breast cancer diagnosis and screening.

Breast cancer is the biggest cause of death by cancer of women in Europe. Most European countries acknowledge the importance of quality in breast cancer services but use different standards to cover the various stages of care. The JRC’s report on the use of ISO standards in breast cancer care portrays the situation in 25 – out of the 35 contacted – countries that participated in the survey via their national accreditation bodies. The findings, which reflect the heterogeneity of certification and accreditation tools applied by breast cancer care services, will contribute to the European quality assurance scheme for breast cancer services in the framework of the European Commission Initiative on Breast Cancer (ECIBC).

The report of a survey on accreditation and conformity assessment in the field of breast cancer in Europe highlights the diversity across Europe showing that:

Diagnosis through laboratory tests is the transversal item most addressed, followed by quality management and personal competence requirements.
In the majority of participating countries (76%), at least one healthcare organisation is accredited or holds an accredited certificate of conformity. This leaves 24% having no such healthcare organisation and reflects the need for enhancement and unification of quality assurance in breast cancer care services throughout Europe.
Four ISO and ISO CASCO standards were applied for accrediting (and conformity-assessing) the mentioned organisations: ISO 15189:2012, ISO/ IEC 17020:2012, ISO/IEC 17021:2011, and ISO/IEC 17025:2005. The UK reported the use of national standards in addition to ISO standards
ISO 15189:2012 and ISO/IEC 17021:2011 are the most used standards (14 and 11 times, respectively). ISO 15189:2012 specifies requirements for medical laboratories, and the wide usage of this standard reflects the fact that the diagnosis stage is the one most addressed by a standard. ISO/IEC 17021:2011 addresses the certification bodies auditing the management systems and is mostly used in screening programmes.