Why MQSA Regulations Matter in Mammography

Why MQSA Regulations Matter in Mammography

All mammography facilities must be certified according to the Mammography Quality Standards Act (MQSA) in order to legally operate.

MQSA guidelines are in place to:

  • Improve the quality of care delivered across all mammography facilities
  • Reduce the errors in clinical imaging mammography
  • Ensure all technologists and interpreting physicians are well-trained and practicing high standards for mammography delivery
  • Ensure mammography facilities have the proper procedures in place to consistently deliver high-quality patient care, evaluate radiologist performance, and effectively handle complaints.
Who do the MQSA Regulations Apply to?

Who do the MQSA Regulations Apply to?

MQSA regulations apply to all mammography facilities that take, process, or interpret mammograms. The impact on the radiologic technologists performing the mammograms, the physicians interpreting the images, the QA technologists monitoring quality standards for the facility, and the medical physicists surveying the equipment within the facility. The content below provides information on mammography facility procedures and quality assurance as they relate to MQSA Regulations. This content is not exhaustive, and it is recommended to review the official MQSA regulations page for a full understanding of the scope of the regulations.

Quality Assurance

Quality Assurance

Section (d) &(e) in MQSA Regulations Subpart B, Sec. 900.12

Each facility must assign the following roles to oversee quality assurance across the facility:

  • Lead interpreting physician
  • Interpreting physicians
  • Medical physicist
  • Quality control technologist

Facilities must also maintain comprehensive records regarding mammography techniques and procedures, quality control, safety, protection, and employee certification.

Quality assurance audit process:

Addressed in Section (f) in MQSA Regulations Subpart B, Sec. 900.12

Facilities are responsible for the establishment and maintenance of a mammography audit program to ensure reliability, clarity, and accuracy of the interpretation of mammograms.

  • Each facility must establish a system to collect and review outcome data for all mammograms performed, both individually and collectively for radiologists.
  • Medical outcomes audit data is to be reviewed by a designated interpreting physician (IP) at least once every 12 months.
    • It is the responsibility of the IP to determine whether the images are of poor quality and provide constructive feedback.


As of 2017, the FDA MQSA Enhancing Quality Using the Inspection Program (EQUIP) was established to emphasize high-quality clinical imaging in mammography. This program identified three main inspection priorities:

  1. Assessing facility procedures to ensure clinical images comply with accreditation body standards for quality and regular image quality reviews are conducted by technologists and interpreting physicians.
  2. Assessing the facility’s corrective procedures when image quality is poor, including a process for continual feedback to imaging personnel for performance improvements.
  3. Assessing procedures for ensuring LIP oversight of QA/QX recordkeeping, including assessing whether appropriate corrective actions have been taken when necessary.

How To Cost-Effectively Maintain MQSA Compliance Through Digitization and A.I. Automation

To receive accreditation status from the FDA, mammography facilities must comply with the regulations as outlined in the Mammography Quality Standards Act, and be accredited by the federally approved accreditation body.

Maintenance of MQSA compliance is a dynamic process that requires:

Radiology professionals are experiencing high levels of burnout as it is, amplified by the backlogs created by COVID-19. The main challenges that many facilities face with meeting and maintaining these standards is the lack of direction on how to implement the required procedures, and the administrative burden associated with MQSA EQUIP compliance.

A.I. automation of image quality assessment helps to minimize the administrative burden of FDA MQSA EQUIP compliance by automating and standardizing clinical image quality evaluation of all mammograms taken across mammography facilities and health systems. This enables the flagging of poor clinical image quality, identifying emerging trends, benchmarking performance, and tracking corrective actions.

The MQSA EQUIP does not provide a prescriptive methodology for implementing clinical image quality assurance procedures, but rather provides guidance regarding what the implementation process should address. The interpreting physician can use any tools available to accomplish such a process.

Modern A.I. solutions such as the densitas intelliMammo platform can provide automated and standardized assessments of clinical image quality and on-demand access to report generation and analytics functions for benchmarking performance.

Densitas intelliMammo is a solution powered by an A.I. engine, comprising three core sets of modern A.I. algorithms including densitas qualityai, densitas densityai and densitas riskai, that integrates into existing mammography clinical and reporting workflows. densitas intelliMammo streamlines and improves mammography facility MQSA inspection readiness by providing a comprehensive quality assurance platform for clinical image quality with actionable insights at point of care, continuous quality assurance, and clinical image quality auditing capacity.

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Learn more about how densitas intelliMammo can help your facility meet MQSA requirements.

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