European guidelines for quality assurance in breast cancer screening and diagnosis. Fourth edition—summary document

Abstract

Breast cancer is a major cause of suffering and death and is of significant concern to many women. Early detection of breast cancer by systematic mammography screening can find lesions for which treatment is more effective and generally more favourable for quality of life. The potential harm caused by mammography includes the creation of unnecessary anxiety and morbidity, inappropriate economic cost and the use of ionising radiation. It is for this reason that the strongest possible emphasis on quality control and quality assurance is required. Development of the European Guidelines for Quality Assurance in Breast Cancer Screening and Diagnosis has been an initiative within the Europe Against Cancer Programme. The fourth edition of the multidisciplinary guidelines was published in 2006 and comprises approximately 400 pages divided into 12 chapters prepared by >200 authors and contributors. The multidisciplinary editorial board has prepared a summary document to provide an overview of the fundamental points and principles that should support any quality screening or diagnostic service. This document includes a summary table of key performance indicators and is presented here in order to make these principles and standards known to a wider scientific community.

Columnar cell lesions associated with breast calcifications on vacuum-assisted core biopsies: clinical, radiographic, and histological correlations

“…Lesions with complex architectural patterns such as cribriform spaces or micropapillae, according to the extent and degree of these, were placed within the atypical ductal hyperplasia or low-grade ductal in situ carcinoma. According to the European Guideline for breast screening pathology, 16 samples with benign lesions but without calcifications on the core biopsy specimens were classified as inadequate B1; columnar cell lesions without atypia as B2; flat epithelial atypia and columnar cell lesions without atypia associated with lobular intraepithelial neoplasia or atypical ductal hyperplasia or papillomas as B3; and any columnar cell lesions associated with carcinoma in situ or invasive carcinoma were classified as B5a or B5b, respectively. We decided to classify flat epithelial atypia involving more than four vacuum-assisted core biopsy samples as B4.…”

“…The benign nature of all of these lesions was confirmed at definitive surgery. Following the European Guideline, 16 surgical biopsy was recommended for all B3 cases, with the exception of one woman, with columnar cell lesions without atypia associated with a benign papilloma, who was recommended for follow-up because all calcifications were harvested during the biopsy procedure. Nine women with B3 lesions refused surgical excision.…”

Evaluation of the New DIN Standard for Quality Assurance of Diagnostic Displays – Technical Review DIN 6868-157

“…It is not clear why these requirements were so significantly raised. Thus, for example, EUREF (European Reference Organisation for Quality Assured Breast Screening and Diagnostic Services) does not require legibility of the entire lettering, but that the number of observed characters remains constant [8].…”

A retrospective audit of the first screening round of the Maltese breast screening programme

“…3,4 Key to achieving this aim were high levels of quality within the entire screening process. 4 The MNBSP strives to protect the dignity and privacy of women, while offering an effective service at the highest levels of quality to diagnose and treat breast cancers at the earliest possible stage, and also meeting the European clinical standards. 4 The first MNBSP round commenced in October 2009 and ended in February 2013.…”

“…This could be achieved by early monitoring of screening performance parameters of the unit, potentially optimising the use of resources and ultimately producing an observable reduction in mortality. 4 Strict adherence to quality assurance and quality control guidelines must be practised in all mammography facilities to ensure accurate diagnosis, thus minimising false positive mammograms. 8,9 Falsepositive rate refers to recalls for further assessment which turn out to be normal or benign.…”