The FDA Enhancing Quality Using the Inspection Program (EQUIP) Breast Imaging Quality Initiative. 5-Year Clinical Experience.

Abstract

Objectives: To evaluate the effects of the Enhancing Quality Using the Inspection Program (EQUIP) on quality control (QC) and quality assurance (QA) at an academic medical center.

Methods: EQUIP audit logs for technologist image quality review as well as mammography unit QA and QC formed the basis for study data. One randomly selected screening mammogram was evaluated by the lead interpreting physician (LIP) using EQUIP criteria for each technologist for each imaging site worked, initially semiannually and then monthly. One randomly selected screening mammogram interpreted by each interpreting physician (IP) for each imaging site was evaluated on a semiannual basis. Quarterly, the LIP reviewed QA and QC logs for each mammography unit with deficiencies further investigated.

Results: Of 214 965 eligible screening mammograms performed, 5955 (2.8%) underwent EQUIP image quality review. Five were found to be technically inadequate (0.08%, 5955/214 965). The LIP identified 20 significant interpretive differences compared with the clinical interpretation resulting in 10 biopsies and 7 previously undetected malignancies, with supplemental cancer detection rate of 1.2/1000 cases reviewed. Two hundred ninety mammography unit QA/QC reviews identified 31 potential deficiencies, 29 of which were due to human documentation error (93.4%).

Conclusion: EQUIP review of both IP and technologists' quality and mammography unit QA/QC logs as performed identified few deficiencies. EQUIP policies should be evaluated at each institution and modified to best utilize resources and provide opportunities for meaningful quality improvement. Although not an EQUIP focus, supplemental cancer detection was observed as might be expected with double reading.