Table 1 The DKG/DGS Requirements of Breast Centres (FAB): structure and general overview

1

General information on the breast centre

Structure of the network; tumour board/treatment planning; collaboration with doctors in private practice; access to support groups; psychosocial and psycho-oncological care; aftercare and follow-up; patient involvement; scientific research activities

2

Information on radiology services

Mammography equipment; stereotactic biopsy requirements; magnetic resonance imaging; breast ultrasound; radiography assistants; specialist radiologists (min. 2 names); basic and continuing medical education; quality circles (≥ 4 minuted meetings per year); number of mammograms read (> 2000/year (per breast)); specimen radiography; percutaneous biopsies (number); image-guided localisations (number); ductography (galactography) (images/year); description of techniques and procedures used; guidelines (fulfilment of requirements)

3

Information on nuclear medicine services

Medical laboratory assistant (min. 2 names); specialist doctors (min. 2 names); continuing education for medical and paramedical staff; quality circles (≥ 4 minuted meetings per year); number of bone scintigrams (1st/3rd year requirement: > 200/> 400); sentinel node biopsies (SNBs, (1st/3rd year requirement: > 20/> 30); SNB detection rate (1st/3rd year requirement: > 80%/> 90% (gamma probe guided)), (1st/3rd year requirement: > 80%/> 90% (scintigraphy; optional)); quality control testing of equipment; fulfilment of relevant level-3 guideline requirements

4

Information on surgical treatment – surgery – gynaecology – specialist breast services

Inpatient care; description; sufficient time for patients to consider treatment choices between core biopsy results and surgery (max. 14 days); operating theatre (OT) for breast surgery (min. 1 OT); continuing education of nursing staff; nursing staff (min. 2 full-time nurses/100 primary cases); specialist cancer nurse (min. 1); basic and continuing education for medical and paramedical staff; specialist doctors for the breast centre (min. 2 names); breast surgeons (min. 2 with specialist qualifications); details of breast surgeons' qualifications; quality circles (≥ 4 minuted meetings per year); number of primary breast cancers per surgeon: > 50 per year; total number of surgical procedures (axillary dissections (1st/3rd year requirement: > 85%/> 95%), revision procedures (< 5%), postoperative wound infections (2.5-max. 5%)); number of operations for breast tumours (benign, precancerous, primary, recurrences), primary carcinomas per centre per year (1st/3rd year requirement: > 100/> 150); number of pTis (1st/3rd year requirements: > 10%/> 15%); number of benign/malignant open biopsy findings; postoperative specimen radiography of microcalcifications after preoperative marker placement > 95%; rate of breast-conserving surgery (1st/3rd year requirement for pT1: > 50%/> 70%); mastectomy rate (1st/3rd year requirement for pT1: < 50%/< 30%); primary surgical treatment involving 1, 2, 3 or > 3 procedures, and rate of R1 resections; mean number of removed lymph nodes > 10 (in accordance with the guideline); breast reconstruction (responsibilities, details of collaboration if performed elsewhere, type of reconstruction procedure, surgeon's qualifications, general reconstructive surgery requirements); patient information and discussion of treatment options; breast clinics at least once weekly for early detection, treatment planning, advice to outpatients considering reconstruction, advice on benign breast disease, inflammation and impaired development (waiting times for clinic appointments/consultation < 2 weeks/1 hour); biopsies for histology (results after < 6 days); histological confirmation of tumour status (by core biopsy) in 90% of palpable and 70% of nonpalpable tumours; communication of tumour status diagnosis within < 1 week; documentation of the number of patient who refuse treatment; side-effects of treatment; knowledge and implementation of level-3 guideline.

5

Information on radiotherapy services

High energy radiotherapy equipment (minimum specifications, other requirements); description of radiotherapy techniques (guideline-concordant dose regimen); radiography assistants (min. 2); continuing education for medical and paramedical staff; quality circles (≥ 4 minuted meetings per year); specialist radio-oncologists (min. 2); aftercare and follow-up; documentation/tumour assessments, reactions to radiotherapy (acute, subacute, late); compliance with level-3 guideline for treatment; written patient information during and after radiotherapy; applicable level-3 radiotherapy guidelines

6

Information on pathology services

Specialist pathologists (min. 2 names); qualifications: details of expertise in breast histology and cytology; continuing education for medical and paramedical staff; external quality assurance; quality circles (≥ 4 minuted meetings per year); specialist experience: examination of 200 routine histological specimens from breast disease patients and 3000 histological specimens; rapid frozen sectioning (infrastructure, cryostat); number of rapid frozen sections performed per year; time to result; lymph node examination; specimen storage time: paraffin blocks ≥ 10 years, wet specimens ≥ 4; weeks; gross, microscopic and immunohistochemical examination and diagnosis; standardised processing for gross examination according to level-3 guideline; pathologist's report on breast specimens (except diagnostic core biopsies) must contain guideline-specified details for the gross pathology report microscopic examination; resection/safety margins; pT and pN status for > 95% of invasive tumours; measurable receptors (hormone receptors (> 95%), HER2/neu (> 95%), FISH analysis if necessary)

7

Information on oncology services (gynaecology, medical oncology, inpatient/outpatient services)

Specialist oncologist (internist or gynaecologist, experienced in chemotherapy (≥ 800 treatment cycles) and endocrine, immunological, adjuvant, palliative and supportive therapy and treatment of side effects); quality circles (≥ 4 minuted meetings per year); continuing education for medical and paramedical staff; ≥ 50 breast cancer chemotherapies/year per treatment unit or partner, or ≥ 200 chemotherapies/year for various cancers; provision of inpatient and outpatient chemotherapy; appropriate infrastructure; min. 2 chemotherapy rooms; description of facilities for supportive/palliative care; description of treatment phases during chemotherapy (initiation to termination); provision of information to patients and dialogue with patients; compliance with relevant level-3 guideline requirements

8

Tumour documentation/outcome quality

Details of tumour documentation system (TDS), which must contain complete patient and treatment details for ≥ 3 months prior to initial certification, details of treatment stage, data for cancer registries; guideline-compliant data sets; data collection by calendar year and certification period; responsible documentation manager; 50% position/breast centre for data collection-related tasks; data selection options must include by year, patient's name, diagnosis, type of treatment, date of recurrence/metastasis, survival data; outcome quality indicators: disease-free survival (DFS), overall survival (OAS), date and proportion of recurrence per stage and type of surgery (breast-conserving surgery (BCS) vs. mastectomy); date and location of metastasis; quality of life; Kaplan-Meier curves (local recurrence-free survival and OAS, by relevant prognostic groups, survival from progression); comparisons with other breast centres; multivariate analyses; appraisal of achievement of TDS objectives (transparency); DFS and OAS must be available at recertification every 3 years; 10-year recurrence rates for mastectomy/BCS: < 10%/< 15%; completed questionnaire and relevant process descriptions must be available at initial certification; documented data must be accessible; uses for TDS data: at least once-yearly in-house analysis of the data, centre-specific and comparative analyses, analysis-based improvements; archiving of results (data analysis, appraisal, actions); discussion of results with the main collaborating partners and the breast centre network as a whole; compliance of data with guideline requirements; responsible physicians' awareness of their data compared with other centres and the literature (quality of data, quality of care); appraisal of flexibility of documentation