Preparing for an MQSA Inspection at Your Mammography Practice
A Comprehensive Manual for the Breast Imaging Community
- Publisher
- DoctrinaEdge Publishing
- Author
- Richard D. Lippert, Jr.
- Edition
- First Edition, 2025
- Pages
- 30 pages
- Added to library
- Added August 20, 2026
Overview
This 30-chapter manual is the definitive preparation guide for mammography facilities facing FDA MQSA inspections under the 2023 Final Rule (effective September 10, 2024). Written by Richard D. Lippert Jr. and published by DoctrinaEdge Publishing in June 2025, it walks every member of the breast imaging team -- lead interpreting physicians, technologists, medical physicists, and administrators -- through the exact documentation, qualification thresholds, and QC records an inspector will review. A comprehensive checklist is included for day-of-inspection readiness.
Key Contents
-Part I: MQSA Regulatory Framework and Organizational Structure (Ch. 1-2)
-Part II: Personnel Qualification Requirements -- physicians, technologists, physicists (Ch. 3-6)
-Part III: Equipment Standards and Quality Control, including QC testing schedules and phantom imaging (Ch. 7-11)
-Part IV: EQUIP Program and Quality Assurance Program Structure (Ch. 12-13)
-Part V: Medical Outcomes Audit Program and Peer Review Documentation (Ch. 14-15)
-Part VI: Patient and Healthcare Provider Communication Requirements, Additional Mammography Review and Density Notification (Ch. 16-18)
-Part VII: Accreditation, Certification, Recordkeeping, and Consumer Complaint Policies (Ch. 19-22)
-Part VIII: Inspection Day Preparation -- Comprehensive Documentation Checklist, Day-of Procedures, Understanding Inspection Outcomes (Ch. 23-25)
-12 Appendices: regulatory citation tables, Federal Register chronology, personnel quick-reference charts, QC schedules, documentation templates, breast density notification language, fee schedule, SAC contacts, FDA contacts, accreditation body contacts, MQSA glossary, 2023 Final Rule summary
How This Applies to Your Practice
Mammologix customers use MammoComply to organize and maintain the exact documentation categories this manual describes -- personnel credential files, QC logs, audit records, and communication files. The manual's chapter-by-chapter structure maps directly onto the MammoComply compliance framework: facilities can use this manual to understand what the inspector is looking for, then use Mammologix to ensure those records are organized, current, and retrievable at inspection time.
Practitioner Implications
Every mammography facility should have a copy of this manual in the hands of the Lead Interpreting Physician, QA technologist, and facility administrator before the next inspection cycle. The 2024 regulatory changes added new requirements around breast density notification language, PPV/CDR/recall rate calculation, and personnel records retention that are not covered in older preparation guides. Use Chapter 23 (Comprehensive Documentation Checklist) as an annual internal audit tool regardless of whether an inspection is scheduled.