We aimed to design and develop a comprehensive mammography database system (CMDB) to collect clinical datasets for outcome assessment and development of decision support tools. A Health Insurance Portability and Accountability Act (HIPAA) compliant CMDB was created to store multi-relational datasets of demographic risk factors and mammogram results using the Breast Imaging Reporting and Data System (BI-RADS) lexicon. The CMDB collected both biopsy pathology outcomes, in a breast pathology lexicon compiled by extending BI-RADS, and our institutional breast cancer registry. The audit results derived from the CMDB were in accordance with Mammography Quality Standards Act (MQSA) audits and national benchmarks. The CMDB has managed the challenges of multi-level organization demanded by the complexity of mammography practice and lexicon development in pathology. We foresee that the CMDB will be useful for efficient quality assurance audits and development of decision support tools to improve breast cancer diagnosis. Our procedure of developing the CMDB provides a framework to build a detailed data repository for breast imaging quality control and research, which has the potential to augment existing resources.
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