More than 87 percent of the 8,700 or so FDA-certified mammography facilities in the U.S. are in complete compliance with the Mammography Quality Standards Act (MQSA) of 1992. And, of those that have fallen short on any MQSA measure, fewer than 1 percent have a serious violation.
The agency reported the good news for public health in an MQSA Insights article posted online Oct. 4.
To earn MQSA certification—which is required to legally practice mammography—a facility has to pass inspection on equipment performance, quality assurance, quality control, personnel qualifications, medical records, and medical audit and outcome analysis.
Some telling numbers FDA gleaned from the MQSA National Statistics web page and reported in the Oct. 4 announcement:
- MQSA-certified facilities use around 18,000 mammography machines and collectively perform more than 39 million mammograms a year.
- Certified MQSA inspectors have performed more than 175,000 MQSA inspections during the program’s history.
- More than 68,000 patients and their referrers have been notified through the patient and provider notification (PPN) system, which requires facilities flagged for serious MQSA noncompliance to issue such alerts.
- The largest single PPN notified more than 12,000 patients.
“The MQSA program continues to adapt and evolve as mammography technology advances,” FDA writes in the article. “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.”
To read the full article, click here.