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  1. Mammography Quality Standards Act and Program

Good News for Public Health: Most Mammography Facilities are in Full Compliance with MQSA Regulations

On October 27th, 1992, President George H. W. Bush signed into law the Mammography Quality Standards Act (MQSA), thereby establishing national quality standards for mammography. A quality mammogram is a major factor in the ability to detect breast cancer in its earliest, most treatable stages. Under the MQSA, mammography facilities must meet specific standards and abide by regulations promulgated by the U.S. Food and Drug Administration (FDA), to help ensure that patients across the United States and its territories have access to high-quality mammography. In order to perform mammograms, a facility must participate in a two-step process: each mammography unit that is going to be used to provide mammography services must be accredited by an FDA- approved accrediting body, and the facility must hold an active MQSA certificate to legally practice mammography.

Today there are approximately 8,700 MQSA certified mammography facilities. These facilities collectively perform over 39 million mammograms a year, using approximately 18,000 mammography units. The good news for public health is that over 87% of mammography facilities have no violations of the MQSA, and of those with violations, less than 1% have a serious violation. These and other aggregate statistics about mammography facilities are posted monthly on the MQSA National Statistics web page.

Each mammography facility is inspected annually against the quality standards set by the MQSA’s implementing regulations. An MQSA inspection focuses on the following mammography components: equipment performance, quality assurance records, quality control testing, personnel qualifications, medical records, and medical audit and outcome analysis records. In 2016, the Division of Mammography Quality Standards (DMQS), the part of FDA that administers the MQSA program, launched an initiative to further promote image quality as a primary goal. To mark the beginning of the 25th year of MQSA, DMQS announced the Enhancing Quality Using the Inspection Program (EQUIP) initiative last October. EQUIP added inspection questions related to already existing quality assurance regulations. These questions emphasize the need for ongoing facility review of image quality to ensure continued compliance with image quality standards. If you would like to learn more about the EQUIP initiative, please read our MQSA Insights article, EQUIP: Enhancing Quality Using the Inspection Program, and visit the MQSA Inspection News, which has more articles and videos about EQUIP.

Certified MQSA inspectors have performed over 175,000 MQSA inspections during the program’s history. In order to ensure that mammography facilities and their equipment are operating in compliance with the MQSA regulations, the FDA established a rigorous training program to certify inspectors to conduct MQSA facility inspections. If during a facility’s MQSA inspection an inspector discovers that a facility did not maintain compliance with the regulations, the inspector cites the noncompliance, and the facility is required to respond with its corrective action.

If a facility has violated the regulations or failed to meet the image quality standards set by its accreditation body, FDA or an accrediting body can request an Additional Mammography Review (AMR). An AMR is conducted by sampling a random selection of mammography images performed by a facility and having them reviewed by experts in mammography. If the AMR reveals that the quality of mammography performed at the facility was so inconsistent with the quality standards established by the MQSA as to pose a serious risk to human health, the FDA can require the facility to conduct a patient and provider notification (PPN). A facility under a PPN order is required to notify patients and their referring health care providers of the serious concerns regarding the quality of mammography performed by the facility. To date, over 68,000 patients and their referring healthcare providers have been notified through the PPN process. The largest PPN notified over 12,000 patients.

Over the past 25 years, the main focus and goal of the MQSA has remained the same: To ensure that all patients have access to high quality mammography so breast cancer can be detected and treated in its earliest stages. Many advances in mammography technology came to fruition during this time; first there was full field digital mammography, FDA- cleared for marketing in 2000, and then FDA’s marketing approval in 2011 of the first digital breast tomosynthesis unit. The MQSA program continues to adapt and evolve as mammography technology advances. Congratulations to the vast majority of mammography facilities for providing a quarter of a century of quality mammography to its patients, and Happy 25th Anniversary to the MQSA, which, with the help of its many partners and supporters, protects and promotes the public health by helping facilities to provide that all-so-important quality mammography.