Post Inspection Summary Multiple Sites Conducted 3rd Quarter 2025

Objective: The goal of this report is to collect information from Mammologix clients after a MQSA inspection and share the information in an anonymized format with Mammologix clients that are preparing for future inspections.

What Themes or Focus Stood Out During the Inspection?

• Strong emphasis on new MQSA regulations (Sept 2024 update), especially wording for breast density categories and ensuring density is included in all Mammography exam reports.
• Many inspectors checked QC (quality control) books line by line, with special attention to phantom documentation and monitor QC logs.
• Some inspectors were especially detailed, spending most of the day reviewing QC binders and reports.

Were There Any Unexpected Questions or Requests from the Inspector?

• Requests for equipment manuals surprised several sites.
• One inspector scrutinized whether phantom images were documented even if performed and the image was in PACS checking to see that each phantom was in the QC log sheet.
• Who is notified if QC failure occurs and is it documented.

What Findings or Feedback were Provided During the Inspection?

• Most sites reported no citations. Concerns were usually minor:
  • Missing or poorly documented phantom entries.
  • Small clerical/documentation errors.
• Inspectors emphasized the importance of clear organization – well-tabbed binders and cover sheets appeared to reduce inspectors digging into individual items.

How Well Did Mammologix's Documentation & Preparedness for Your Facility Meet the Inspector's Expectations?

• Facilities with organized binders, cover sheets, and flagged pages had smoother inspections.
• Mammologix-provided reports and audits were consistently described by inspectors as complete and easy to review.

Lessons Learned from Clients They Wanted to Share with Others

• Organization is key – inspectors dig less when everything is clearly laid out.
• Be proactive in checking QC entries and phantom documentation to avoid minor findings.
• If a new technologist takes over QC, extra oversight and internal audits are critical.
• Review the lay summary letter wording carefully and be prepared to discuss it during inspections. Misunderstandings can occur, but facilities that fully understand and could confidently explain their lay letter content experienced no issues when clarifying with inspectors. 
• Implement protocols for immediate notification if QC failures occur.

Mammologix's Observations of Trends in Responses During Interviews This Quarter

1. Breast Density Wording was a Key Area of Focus in Most Every Post-Inspection we Performed Repeated emphasis across facilities on exact MQSA breast density language in reports and lay summaries. Inspectors are scrutinizing this closely.
2. QC Documentation Review was another Key Area of Focus Mentioned Frequently
   • Multiple sites mentioned phantom test documentation lapses (phantom performed but not recorded).
   • Inspectors expect perfectly maintained QC binders and often review them in detail.
3. Organization Reduces Risk - Sites taking the time to organize reported having a less documents challenged by the inspector
   • Sites with well-organized binders, tabs, and cover sheets reported smoother inspections and fewer questions.
   • Inspectors often commented that organization made their job easier.
4. Inspector Variability
   • Some inspectors are extremely meticulous (line-by-line QC checks, long on-site presence).
   • Others are quicker and less demanding, sometimes working independently in a separate room.
5. Mammologix Service Feedback
   • Users consistently noted positive value of:
     • Automated recall and overdue notices.
     • Pathology upload features.
     • Responsive support from Teri and team.

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.