MQSA Inspection Insights Project Introduction
Real-World Data. National Trends. Smarter Compliance.
With over 30 years of experience supporting breast imaging facilities nationwide, Mammologix understands that MQSA inspections can be a source of uncertainty—even for well-prepared teams. While regulations provide the framework, real-world inspection experiences often reveal evolving trends, shifting areas of focus, and surprising requests from inspectors.
That's why we're proud to introduce the MQSA Inspection Insights Project—a quarterly intelligence report created exclusively for Mammologix clients.
What Is the MQSA Inspection Insights Project?
This initiative is designed to reduce ambiguity and increase preparedness for your facility's next MQSA inspection by sharing anonymized, aggregated feedback from Mammologix-supported inspections nationwide.
Each quarter, our team conducts structured post-inspection interviews with clients, gathers firsthand insights, and analyzes recurring themes, inspector behavior, and documentation pitfalls. The result is a practical, real-time view of the inspection landscape—grounded in the experiences of facilities like yours.
Why We Built It
- ✅ To demystify MQSA inspections by showing what's happening on the ground, not just what's written in the regulations
- 📊 To track national trends and inspector behavior patterns across regions, settings, and inspection styles
- 📚 To help our clients prepare smarter—with tips, reminders, and strategies based on honest post-inspection feedback
- 🛠️ To elevate operational readiness using tools, templates, and insights that streamline documentation and reduce inspection risk
Backed by our involvement in over 4,500 MQSA inspections, this project is a natural extension of Mammologix's commitment to helping breast imaging centers not only meet compliance standards but thrive within them.
What You'll Find in Each Quarterly Report
Every MQSA Inspection Insights report includes:
- 🔎 Top Inspection Focus Areas — Including newly emphasized regulations and quality control checkpoints
- ❗ Unexpected Questions or Documentation Requests — What caught facilities off guard
- ⚠️ Common Gaps or Minor Citations — Patterns you can proactively address
- 💡 Best Practices & Lessons Learned — From facilities with smooth, successful inspections
- 📈 National Trends & Inspector Variability — Insight into how inspection styles differ
An Exclusive from Mammologix
This value-added feature is provided at no additional cost as part of our commitment to excellence in compliance and service. It's one more way Mammologix empowers small and mid-sized breast imaging facilities with tools built for real-world success.
Stay Prepared. Stay Informed. Stay Confident—with Mammologix.
Now Available: Q3 2025 Report
Our inaugural edition highlights the impact of the September 2024 MQSA regulation updates, with a strong emphasis on breast density language, QC documentation, and the value of meticulous binder organization. See how facilities are adapting—and what you can do today to stay ahead.
Disclaimer:
The information contained in the MQSA Inspection Insights Report is provided for informational purposes only and is based on anonymized feedback voluntarily shared by Mammologix clients following their MQSA inspections. This report is not intended to replace official rules, regulations, or guidance issued by the U.S. Food and Drug Administration (FDA), state regulatory agencies, or other governing bodies.
While the content reflects real-world observations and common inspection experiences, it should not be interpreted as a comprehensive or authoritative source of regulatory requirements. Inspection practices may vary, and interpretations of compliance standards are subject to change.
Users are strongly encouraged to consult the official MQSA regulations and seek guidance directly from the FDA or appropriate state authorities regarding any specific compliance questions or interpretations.
Mammologix makes no representations or warranties regarding the completeness, accuracy, or applicability of this information to any individual facility’s circumstances. Use of this report is at your own discretion and risk.