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Quality assurance

The quality standards laid down for the German mammography screening programme are contained in Section B No. III of the Early Detection of Breast Cancer Guideline (KFE-RL) and in Annex 9.2 of the Federal Framework Agreement for Physicians (BMV-Ä). The standards are based on the stipulations laid down in the European Guidelines on Quality Assurance in Breast Cancer Screening and, in the sense of a learning system, they support continuous quality control and optimisation.

This quality management concept comprises all levels of quality assurance:

  • Quality of structures: requirements regarding the rooms and the equipment used at mammography and assessment units, technical quality assurance qualification of the staff involved in the programme
  • Quality of processes: interdisciplinary collaboration in performing work, as well as internal quality assurance
  • Quality of results: presentation of quality and programme evaluation, using standardised indicators, as evidence of the effectiveness of the programme

Physicians and radiology specialists must provide evidence of their professional qualification before starting their work in screening. They must also take part in regular training to maintain and further develop their professional competence.

Quality Assurance

Structures

  • Facilities, equipment and infrastructure
  • Technical quality
  • Professional qualification: evidence, maintenance and further development of professional competence
    • minimum number of cases (lead programme radiologist (LPR), diagnostician, pathologist, hospital physician)
    • Guided activities (LPR, diagnostician, radiology specialist)
    • Supervision phases (LPR, diagnostician, pathologist)
    • Further training (LPR, diagnostician, pathologist, radiology specialist)
    • casebook inspection (LPR, diagnostician)
    • Random checks (diagnostic image quality, assessment diagnostics)

Processes

  • Double reading
  • Case conferences for continuous control and improvements to diagnostics and assessments
    • Consensus conference
    • Multidisciplinary pre- and post-operative case conferences
  • Internal review processes (incl. expert discussions)
    • Diagnostic image quality
    • Quality of reading
    • Quality of biopsy
    • Quality of histopathology assessment
    • Cross-analytical quality assurance

Results

  • Cancer registry comparison for identifying interval carcinomas
  • Regular re-certification (performance parameters) of screening units every 30 months
  • Certification of Reference Centres by EUREF
  • Evaluation of quality assurance measures by KoopG ➔ parties to the Federal Framework Agreement for Physicians
  • Evaluation of the programme by KoopG, report to General Joint Committee