Jan 21, 2024

Time to Get Ready for These Modernizations Coming to Your Mammography Practice

Time to Get Ready

Mammography remains a gold standard for the detection of breast cancer detection. For the over 8,800 certified mammography facilities in the United States, the Mammography Quality Standards Act (MQSA) establishes federal standards to ensure patients nationwide have access to quality mammography services.

MQSA was enacted on October 27, 1992, and is codified, as amended in 1998 and 2004, under section 354 of the Public Health Service (PHS) Act. Public Law 102–539, 2, 106 (1992), codified as amended at 42 U.S.C. 263b.

The United States Food and Drug Administration (FDA) has issued a final rule to update these mammography regulations. These directives modernize and improve the information provided by mammography facilities, including breast density information. These updates become effective September 10, 2024.

What Updates Are Coming?

FDA is making three categories of improvements: technology, enforcement, and categorization/reporting of results.

  • The amendments include updates to equipment and quality control provisions, enforcement enhancements, and categorization improvements.
  • Improvements in reporting include changes in assessment categories, the inclusion of facility information, required timeframes for sending reports, and assessment of breast density.
  • The lay summary is revised to provide clear breast density notification statements for dense and non-dense breast tissue.
  • The healthcare provider’s report includes an overall breast density assessment in four categories.
  • Policies and procedures are required to minimize the loss of mammography images and reports.
  • Timeframes for transferring records to patients, healthcare providers, and others are specified.
  • Facilities must collect minimum information for mammography medical outcomes audits to evaluate the accuracy and enable quality improvement.

Want to Learn More?

When such updates get finalized, they are published in the Federal Register. You can find all the regulation updates with 21 CFR Part 900 Mammography Quality Standards Act; Final Rule, published in the Federal Register Volume 88, No. 47, pages 15126 -15171 (pdf version).Mammologix also invites you to join us for our FREE Info Video designed to help mammography practices plan for these 7 critical updates.

View the video here.

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