Post Inspection Summary Multiple Sites Conducted 4th Quarter 2025

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

What Themes or Focus Stood Out During the Inspection?

Inspectors continue to emphasize documentation completeness and binder organization as a major driver of inspection smoothness.
EQUIP processes remain a primary focus, especially random case selection methods, inclusion of all staff, and evidence of evaluations occurring throughout the year.
Credentialing and volume requirements for technologists and interpreting physicians are being checked carefully (licensure, CEUs, annual volumes, and read numbers).
Breast density and 'Final Rule' wording remains a high-risk review area, with inspectors spending significant time confirming required language is present.

Were There Any Unexpected Questions or Requests from the Inspector?

Requests for written policies covering BI-RADS 0 workflows, follow-up tracking for outside biopsies, and documentation of attempts to obtain outside results.
Requests for manufacturer and software manuals (monitor QC software manuals such as Barco/Medi-Cal QA, and equipment manuals), with expectation that they be retrievable immediately on-site.

What Findings or Feedback Were Provided During the Inspection?

Inspectors frequently move faster and ask fewer questions when documentation is standardized, clearly labeled, and easy to retrieve.
Some inspections involve detailed review of QC logs line-by-line, including close attention to dates, initials, and consistency across rooms.
Remote radiologist reading environments may trigger additional scrutiny if physicist reports lack home workstation location street address details.

How Well Did Mammologix's Documentation & Preparedness Meet Inspector's Expectations?

Maintain clean, complete QC records with consistent formats and ensure entries include required initials and full dates.
Standardize QC forms and processes across rooms to avoid drawing attention to mid-year format changes or inconsistencies.
Keep a readily accessible library (paper or digital) of equipment manuals and monitor QC software manuals.

Organization reduces inspection friction—inspectors dig less when everything is clearly laid out.
Do not wait until inspection time to compile EQUIP and credentialing documentation; inspectors want evidence it is maintained throughout the year.
Ensure remote reading QC documentation is complete and includes location/street address details for all interpretation monitors.
Audit QC logs routinely for small clerical issues that can become cite-able findings (missing initials, missing four-digit year, inconsistent logs between rooms).

Mammologix's Observations of Trends in Responses This Quarter

🔍 Breast Density / Final Rule Wording Remains a Key Area of Focus

Inspectors are spending significant time confirming required breast density and Final Rule wording is present in reports and lay letters. This continues to be one of the most scrutinized areas of compliance.

📋 QC Documentation Under the Microscope

QC logs are often reviewed line-by-line; inspectors may cite missing initials, incomplete entries, or missing full dates (including four-digit year). Consistency across rooms and systems is expected—differing forms or processes can draw unwanted attention.

📁 Organization Continues to Reduce Risk

Clear binder organization and standardized documentation reduces follow-up questions and shortens inspection time. The message is clear: invest time in organization before the inspector arrives.

🖥️ Remote Reading / Monitor QC Under Increased Scrutiny

Remote radiologist monitor QC documentation is a recurring friction point, especially when physicist reports do not include workstation location/street address. With remote reading becoming more common, this area deserves extra attention.

📚 Policies & Manuals: Be Ready

Inspectors are increasingly requesting written policies (BI-RADS 0 workflows, outside result tracking) and manufacturer/software manuals (monitor QC software and equipment). Having these readily accessible can significantly smooth the inspection process.

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.