MQSA Compliance Checklist for Mammography Facilities: Complete Guide

The Mammography Quality Standards Act (MQSA) is the federal law that sets baseline quality standards for every facility in the United States that performs mammography. Enacted in 1992 and enforced by the FDA, MQSA ensures that every woman who receives a mammogram gets a reliable, high-quality examination regardless of where she is screened.

MQSA compliance is not optional. Any facility that performs mammography must hold a valid MQSA certificate and meet every requirement in the regulations. Failure to comply can result in corrective action plans, probation, or certificate revocation, any of which can shut down your mammography program.

This guide provides a comprehensive MQSA compliance checklist organized by category so your facility can verify that every requirement is met and identify gaps before an inspector does.

Who Must Comply with MQSA?

MQSA applies to every facility that offers mammography services in the United States and its territories, including hospitals, outpatient radiology clinics, mobile mammography units, physician offices, and federally operated facilities. There are no size-based exemptions. A single-room clinic faces the same standards as a multi-site health system.

MQSA Compliance Checklist: Personnel Qualifications

MQSA sets specific credential, training, and continuing education requirements for every person involved in the mammography process.

Interpreting Physician

• State licensure to practice medicine
• Board certification in diagnostic radiology (or equivalent qualifying pathway)
• Completion of at least 60 hours of documented medical education in mammography interpretation
• Minimum of 240 mammographic interpretations within the most recent 24-month period (ongoing requirement)
• At least 15 hours of continuing medical education in mammography within the most recent 36-month period
• Initial 8 hours of training specific to each new mammographic modality used (such as digital breast tomosynthesis)

Mammography Technologist

• State licensure or certification as a radiologic technologist (where applicable)
• Certification in mammography from an FDA-approved body (ARRT certification in mammography is the most common pathway)
• Completion of at least 40 contact hours of documented training in mammography
• Minimum of 200 mammographic examinations under direct supervision during training
• At least 25 mammographic examinations per year to maintain clinical competency
• Continuing education: 15 contact hours of mammography-specific CE within the most recent 36-month period
• Initial 8 hours of training for each new mammographic modality before clinical use

Medical Physicist

• State licensure or approval (where applicable)
• Master's degree or higher in a physical science relevant to medical physics
• Minimum of 20 contact hours of documented training specific to mammography equipment evaluation
• Experience conducting surveys of at least one mammographic facility and a total of at least 10 mammographic units
• Continuing education: 15 contact hours in mammography within the most recent 36-month period

MQSA Compliance Checklist: Equipment Standards

MQSA establishes minimum performance standards for all mammography equipment used clinically.

• System performance requirements: Equipment must be specifically designed for mammography and must be capable of meeting image quality standards as demonstrated through phantom testing
• Image quality: The system must produce images that meet ACR phantom scoring criteria, including fiber, speck group, and mass visibility thresholds
• Dose limits: The mean glandular dose for a standard breast (4.2 cm compressed thickness, 50% glandular/50% adipose composition) must not exceed 3.0 mGy (0.3 rad) per exposure
• Compression device: Must be capable of providing between 111 N (25 lbs) and 200 N (45 lbs) of compression force in power-driven mode
• Automatic exposure control (AEC): Must function properly across the clinical range of breast thicknesses and compositions
• Image labeling: Every mammographic image must include proper patient identification, examination date, facility identification, technologist identification, cassette or detector identification, and mammography unit identification

MQSA Compliance Checklist: Quality Assurance Program

Every MQSA-certified facility must maintain a QA program with regular QC testing following the manufacturer's QC manual or an FDA-approved alternative.

Daily QC Tests

• Flat field: Verify detector uniformity and identify artifacts before clinical imaging
• Artifact evaluation: Review flat-field images for artifacts that could interfere with diagnosis

Weekly QC Tests

• Phantom image quality: Image an ACR mammography phantom and score for fiber, speck, and mass visibility
• Visual checklist: Inspect equipment for physical damage, cleanliness, and mechanical integrity

Monthly and Quarterly QC Tests

• Compression force verification: Measure and document compression force monthly
• Repeat/reject analysis: Quarterly review of repeated and rejected exams to identify trends

Semi-Annual and Annual QC Tests

• Display monitor evaluation: Verify luminance and contrast standards
• Monitor cleaning: Maintain optimal display conditions

All QC results must be recorded, reviewed, and corrective actions taken when results fall outside acceptable limits.

Medical Physicist Annual Survey Requirements

MQSA requires an annual equipment evaluation performed by a qualified medical physicist. This survey must include, at minimum:

• Mammographic unit assembly evaluation
• Collimation assessment
• Focal spot performance evaluation
• kVp accuracy and reproducibility
• Beam quality assessment (half-value layer)
• AEC system performance evaluation
• Breast dose measurement (mean glandular dose calculation)
• Image quality evaluation using ACR phantom
• Artifact evaluation
• Radiation output rate
• Detector performance evaluation (for digital systems: uniformity, dead pixels, ghosting, signal-to-noise ratio)
• Viewbox or display monitor luminance evaluation

The physicist must provide a written survey report identifying any items that do not meet MQSA or manufacturer standards. The facility must correct deficiencies before continuing clinical mammography or within a timeframe specified by the severity of the finding.

Record Keeping and Documentation

MQSA mandates that facilities maintain detailed records available for inspection at all times.

• Personnel records: Current licensure, certification, training, and CE records for all interpreting physicians, technologists, and physicists
• QC records: Complete results of every QC test, including date, results, and corrective actions
• Physicist survey reports: Annual reports and documentation that deficiencies were corrected
• Equipment maintenance records: PM logs, repair records, and service reports
• Mammographic images: Retained for a minimum of 5 years, or 10 years if no subsequent mammograms were performed at the facility
• Patient reports: Retained for the same periods as corresponding images
• Outcome data: Correlation of mammographic findings with biopsy results

Patient Notification Requirements

MQSA requires that mammography results be communicated to patients and referring providers within specific timeframes.

• Written report to referring provider: Results within 30 days of the examination
• Lay summary to patient: A written summary in layperson terms within 30 days
• Urgent findings: Results highly suggestive of malignancy must be communicated as soon as possible
• Self-referred patients: The full written report goes directly to the patient
• Breast density notification: As of September 2024, standardized breast density information must be included in every patient lay summary

The MQSA Inspection Process

FDA-certified inspectors conduct annual inspections of every MQSA-certified facility. Inspections are typically unannounced.

What Inspectors Evaluate

• Current MQSA certificate displayed and valid
• Personnel qualifications documentation
• QC test records: completeness, frequency, results, and corrective actions
• Most recent physicist survey report and evidence that deficiencies were corrected
• Equipment performance (inspectors may perform phantom imaging and dose measurements)
• Clinical image quality (a sample of recent mammograms may be reviewed)
• Patient notification records
• Medical audit and outcome data
• Consumer complaint records

Common MQSA Violations and How to Avoid Them

Based on published FDA inspection data, the most frequently cited MQSA violations include:

• Incomplete or missing QC records: The single most common finding. Ensure QC tests are performed on schedule and documented completely, including dates, results, and corrective actions. Assign a lead mammography technologist as the QC coordinator with dedicated time for testing and documentation.
• Expired or inadequate personnel qualifications: Continuing education and volume requirements lapse without warning. Implement a tracking system that alerts staff 90 days before credential deadlines.
• Physicist survey deficiencies not corrected: Receiving the physicist's report is not enough. Every deficiency must be addressed and documented before the next clinical use or within the specified timeframe. Keep a log that tracks each finding through resolution.
• Patient notification delays: Results must reach patients within 30 days. Audit a sample of patient notifications quarterly to verify compliance with the timeline.
• Equipment maintenance gaps: Skipped preventive maintenance visits can lead to equipment performance drift that shows up as QC failures or physicist survey findings. Maintain a current PM service contract and keep complete service records.
• Medical audit not performed: Many facilities neglect the requirement to track outcomes. Establish a process for correlating mammographic assessments with pathology results.

Consequences of Non-Compliance

MQSA enforcement follows a structured escalation with serious consequences at every level.

• Level 1: Minor deficiencies requiring documented correction within a specified deadline
• Level 2: Significant deficiencies triggering a directed corrective action plan
• Level 3 (serious): Probation with mandatory notification to all patients and referring physicians — a public action with significant reputational damage
• Certificate revocation: Loss of the MQSA certificate means the facility cannot legally perform mammography
• Civil monetary penalties: FDA can impose fines for MQSA violations

Beyond regulatory consequences, non-compliance creates medical liability exposure. A malpractice claim involving a missed cancer is far more difficult to defend when the MQSA compliance record shows deficiencies.

How ARRAD's PM Service Supports MQSA Compliance

Maintaining MQSA compliance requires consistent equipment performance, and consistent equipment performance requires professional preventive maintenance. ARRAD's mammography PM service is specifically designed to support the compliance requirements outlined in this guide.

• PM protocols aligned with MQSA and manufacturer requirements: ARRAD's factory-trained engineers follow comprehensive PM protocols that address every equipment performance parameter evaluated during MQSA inspections and physicist surveys. Each PM visit includes mechanical inspection, calibration verification, detector performance testing, compression force measurement, and AEC performance evaluation.
• Complete documentation: Every ARRAD PM visit generates a detailed service report documenting all tests performed, measurements taken, parts replaced, and any findings that require follow-up. These reports become part of your MQSA compliance file and demonstrate a proactive equipment maintenance program to inspectors.
• Medical physicist coordination: ARRAD coordinates with your medical physicist to ensure that any equipment adjustments or component replacements are communicated before the annual survey. If your physicist identifies a deficiency, ARRAD responds promptly to correct the issue and documents the resolution.
• Proactive component monitoring: ARRAD tracks tube hours, detector performance trends, and mechanical wear indicators across PM visits. This allows us to identify components approaching end of life and plan replacements before they cause clinical failures or QC test failures.
• Emergency response: When equipment failures occur, ARRAD provides rapid response to minimize downtime. Extended downtime means missed QC tests and rescheduled patients, both of which create compliance risk.
• OEM parts sourcing: All replacement parts used during PM and repair are genuine OEM-specification components sourced through ARRAD's parts division at radmedparts.com, ensuring that equipment performance is maintained to manufacturer standards.

Keep Your Mammography Program Compliant

MQSA compliance is a continuous process, not a once-a-year checkbox. The facilities that consistently pass inspections without findings are the ones that build compliance into their daily operations through disciplined QC programs, proactive equipment maintenance, and meticulous documentation.

ARRAD partners with mammography facilities nationwide to keep equipment performing at the standards MQSA demands. Whether you need a comprehensive PM service contract, emergency repair support, or replacement parts, we are here to help.

Contact ARRAD today at 877.299.8303 or visit our contact page to discuss your mammography service needs. For OEM replacement parts, visit radmedparts.com.