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1. What does it mean “service in outsourcing” and which are the services that can be externalized?

It is a service not directly run/offered (completely or partially) 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:

  • Vacuum-assisted biopsy under mammographic or MRI guidance
  • Lesion localisation and bracketing under ultrasound, mammography and MRI guidance
  • Clinical Genetic
  • Radiation Oncology
  • Nucleare Medicine
  • Palliative care

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.

2. Which documents are requested to the Breast centre as evidence of the subcontract?

An agreement is needed


Agreement for vacuum-assisted biopsy (under mammographic or MRI guidance): the document should contain the concept that the Breast Centre can send to this diagnostic service the patients for which a vacuum-assisted biopsy is needed.

Agreement for radiation oncology service: the document should contain the concept of collaboration with the radiation oncology service to be available to treat patients sent by the Breast Centre. The participation of “external radiotherapists” in Breast Centre multidisciplinary meeting is requested.

3. 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 Medical Oncology
  • Breast Care Nursing

4. Which are the minimum contents of some specific documents requested to the Breast Centre

Breast Centre official document (according to any National Regulation): document stating the set up of the breast centre, including if possible description of the breast centre

Letter of appointments for the Clinical Lead, geneticist and psychologist: each document has to indicate name, role and start date of the appointment. If appointment has an expiration date, new letters following the expiring date have to be available

Letter of appointment for the Data Manager: document stating the name, role and datamanager’s supervisor.