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 | |
The FAB of 2006 encompass 185 items from eight main areas. Applicant breast centres need to (1) describe existing facilities, resources and procedures and (2) meet specified requirements in order to attain initial or full certification and recertification.