Adrian A Sanchez, Heather V Garrett, Ria Dave, Debbie L Bennett, Michelle V Lee
The Mammography Quality Standards Act (MQSA), enacted by Congress in 1992, established nationwide requirements to ensure the safety, consistency, and diagnostic quality of mammography in the United States. Compliance encompasses equipment performance, personnel qualifications, quality assurance and quality control activities, reporting standards, patient notification, and facility certification. Although individual MQSA components are straightforward, the cumulative responsibilities, particularly for the Lead Interpreting Physician (LIP), can be complex. This article provides a comprehensive overview of the MQSA regulatory framework, including the roles of federal and state entities, accreditation bodies, and key personnel essential to maintaining a compliant mammography program. We outline qualification and ongoing training requirements for interpreting physicians, technologists, and medical physicists; describe expectations for annual U.S. Food and Drug Administration (FDA) inspections; and summarize required processes for patient and provider communication, record retention, equipment evaluation, and the facility's annual outcomes audit. The article also reviews the FDA's Enhancing Quality Using the Inspection Program (EQUIP) initiative, which emphasizes continuous clinical image quality improvement, and highlights common reasons for inspection deficiencies. Key considerations for teleradiology, including diagnostic display testing and documentation standards, are discussed, as are updates introduced by the 2023 FDA rule, including mandatory breast density notification. By synthesizing regulatory requirements and practical operational strategies, this article aims to support LIPs and multidisciplinary breast imaging teams in developing efficient, sustainable systems that ensure high-quality mammographic care and ongoing MQSA compliance.