1. In case of an updating of Eusoma referring standard for Certification how are managed the changes in the standard for the purpose of certification procedure?
In case of an updating of Eusoma reference standard is Eusoma itself to indicate to Breast Centres Certification how the new requirements and definitions has to be managed.
Usually a transitory period for the implementation of the new requirements is foreseen. The length of time of such transitory period is defined by Eusoma, taking into account the complexity for the implementation and satisfaction of the new requirements.
During the transitory period, all the new mandatory requirements introduced are considered as recommended for what concerns Certification process
2. What does it mean “service in outsourcing” and which are the services that can be externalized in a subcontract out of the Breast Centre?
It is a service not directly run/offered by the Breast Centre, for which a supply agreement is necessary. Within Breast Centres certification procedure, services that may be run outside the Breast Centre are:
- Magnetic resonance
- Core biopsy
- Clinical Genetic service
- Radiotherapy service
- Medical Oncology service
As indicated in Certification Rules and Regulation, if necessary, Breast Centres Certification can ask to verify an outsourcer in its headquarter. Such audit can be considered as “extraordinary audit” or be included in the scheduled audit at incontestable discretion of BCCert.The inability to carry out an outsourcer’s inspection can be considered as a sufficient motivation for a negative evaluation on Certification granting, or cause a certification suspension.
3. Which documents are requested to the Breast centre as evidence of the subcontract?
Agreement for magnetic resonance service:
the document has to contain the concept that the Breast Centre can send to the imaging service its patients that need to undergo a Magnetic Resonance
Agreement for core biopsy: the document should contain the concept that the Breast Centre can send to this diagnostic service the patients for which a core biopsy is needed.
Agreement for genetic service: document has to contain the concept that there is a collaboration with this service which will accept women sent by the Breast Centre with regard to genetics.
Agreement for radiotherapy service: the document should contain the concept of collaboration with the radiotherapy service to be available to treat patients sent by the Breast Centre. The participation of “external radiotherapists” in Breast Centre multidisciplinary meeting is requested.
Agreement medical oncology service: the document should contain the concept that the medical oncology service is available to treat the patients sent by the Breast Centre. The participation of “external medical oncologists” in Breast Centre multidisciplinary meeting is requested.
4. Which are the services that cannot be subcontracted out of the Breast Centre and, if so, has to be considered part of a MULTISITE Breast Centre?
- Breast Surgery
- Breast Radiology
- Breast Pathology
- Breast Care Nursing
5. In case of a non conformity on Quality Indicators, which are the aspects the Breast Centre has to consider in sending the corrective action proposal?
In sending the proposed corrective actions regarding the Quality Indicators the Breast Centre has to declare if the corrective action is regarding registration problems or problems of performance or both.
The proposal of corrective actions has to be sent by fax or e-mail to BCCert office using the Corrective Action Form, received by e-mail after the visit.
The acceptance of the proposed corrective actions will be evaluated by Eusoma Datacentre Director and by the visitors of the discipline involved, who carried out the visit.
If the non compliance for a quality indicator is due to registration or data transfer problems the Breast Centre has to make the appropriate corrections and perform a new data transfer to Eusoma database, within a maximum of 4 months following the audit visit.
If the non compliance regards a problem of performance, within 4 months following the audit visit, the Breast Centre has to send a new set of data of a 3 month period (after the implementation of the corrective actions), showing evidence. If necessary, in order to evaluate the Breast Centre performance, the Breast Centre may be requested to send all available data referring to the year of the audit visit.
In both cases the Breast Centre has to send a report describing in some detail actions that have been taken.
6. Which are the minimum contents of some specific documents requested to the Breast Centre
Breast Centre official document: document stating the set up and, if possible, the name of the Breast Centre (according to any National Regulation).
Letter of appointment for the Clinical Lead: document stating the name of the Clinical Lead of the Breast Centre.
Letter of appointment for the Data Manager: document stating the name of the data manager of the Breast Centre and his/her supervisor.
Letter of appointment for Clinical Geneticist: document stating the name of the designated psychologist of the Breast Centre.
Letter of appointment for the Psychologist: document stating the name of the designated clinical geneticist of the Breast Centre.