Radiation-Emitting Products
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Policy Guidance Help System
The Policy Guidance Help System was last updated March 20, 2013
The Policy Guidance Help System has useful information for mammography facilities and their personnel. It shows the Food and Drug Administration’s (FDA) current view on the final regulations implementing the Mammography Quality Standards Act (MQSA) (Pub. L.102-539). The FDA uses mandatory language, such as "shall", "must", and "require", when it refers to statutory or regulatory requirements. The FDA uses non-mandatory language, such as "should", "may", "can", and "recommend", when it refers to guidance. Each facility needs to follow the final regulations.
Under its own authority, a State may impose more requirements than those specified under MQSA and its implementing regulations. A facility should check with its State and local authorities about their requirements.
This system has several main topics:
Accreditation and Certification
Additional Mammography Review and Patient Notification
Approved Alternative Standards/Requirements
Alternative Requirements
Breast Implants
Clinical Image Quality
Consumer Complaints
Definitions
Equipment
CMS (Formerly HCFA)
Health Insurance Portability and Accountability Act (HIPAA)
Inspection
Inspector's Questions
Medical Outcomes Audit
Medical Records and Reports
Preparing for MQSA Inspections
Personnel
Quality Assurance
Topics have subtopics. A subtopic often starts with a citation of the regulation to which it relates. Then, there is a discussion and/or a series of questions and answers offering guidance about how FDA implements the regulation. Some topics end with a list of related topics. To see the contents of a subtopic, click on its title.
If you have comments or questions about the Policy Guidance Help System, please send them via e-mail to MQSAhotline@hcmsllc.com.
TOPIC AREAS
Accreditation and Certification
- Accreditation Body Regulations
- Accreditation and Certification Overview
- Appeal of Adverse Accreditation Decision
- Appeals of Denials of Certification
- Application for a Provisional Certificate
- Application for Extension of Provisional Certificate
- Application for Reinstatement of Accreditation and Certification
- Application to an Accreditation Body
- Definition of Certificate
- Full Field Digital Mammography (FFDM) Certification Extension Program
- MQSA Facility Certification Extension Requirements for CR FFDM Systems
- MQSA Facility Certification Extension Requirements for DR FFDM Systems
- Revocation of Accreditation
- Suspension or Revocation of Certificates
- Withdrawal of Accreditation Body Approval
Additional Mammography Review and Patient Notification
Approved Alternative Standards/Requirements
- Amendment to GE SenographeTM 2000D Full Field Digital Mammography (FFDM) system alternative standard originally approved on June 27, 2002.
- Assessment Category for Post Procedure Mammograms for Marker Placement
- Combined Mammography Medical Outcomes Audit for Multiple Mobile Mammography Units
- Conducting the Mammography Equipment Evaluation After a Software Upgrade Under Medical Physicist Oversight
- Continuous Display of Override Status
- Correction Period When Components of the Selenia Full Field Digital Mammography System Fail Quality Control Tests
- Corrective Action Period When Components of the Fuji Computed Radiography for Mammography (FCRm) Full Field Digital Mammography (FFDM) System Fail Quality Control Tests
- Daily Processor QC Tests
- Manufacturer's software modification of the AEC
- Modifications in the Assessment Categories Used in Medical Reports
- Post Exposure Focal Spot Indication
- Separate Assessment of Findings for Each Breast
- System Artifact Testing at Remote Mobile Mammography Sites Where Film Processing Takes Place Using Processors Permanently Located at the Site
- System Artifact Testing of Target Filter Combinations
- Weekly Phantom Image Test
Alternative Requirements
- Alternative Requirements Overview
- Amendment or Extension of an Alternative Standard
- Applicability of the Alternative Standards
- Applicants for Alternatives
- Applications for Approval of an Alternative Standard
- Approved Requests for an Alternative Standard
- Criteria for Approval of Alternative Standards
- Ruling on Applications for Alternative Standards
- Withdrawal of Approval of Alternative Requirements
Breast Implants
Clinical Image Quality
Consumer Complaints
Definitions
- Accreditation Body
- Action Limits or Action Levels
- Adverse Event
- Air Kerma
- Authorization
- Breast Implant
- Calendar Quarter
- Category I
- Certificate
- Certification
- Certification Agency
- Clinical Image
- CME or CEU
- Consumer
- Contact Configuration
- Contact Hour
- Direct Instruction
- Direct Supervision of Interpreting Physicians
- Direct Supervision of RTs and MPs
- Established Operating Level
- Facility
- FDA
- Final Interpretation
- First Allowable Time
- Interim Regulations
- Interpreting Physician
- Kerma
- Laterality
- Lead Interpreting Physician
- Levels of Non-Compliance (Observations)
- Lossless Compression
- Lossy Compression
- Mammogram
- Mammographic Modality
- Mammography
- Mammography Equipment Evaluation
- Mammography Medical Outcomes Audit
- Mammography Unit
- Mean Optical Density
- Medical Physicist
- Mobile Mammography Unit
- MQSA
- Multi-Reading of Mammograms by Interpreting Physicians
- Patient
- Performance Indicators
- Phantom
- Phantom Image
- Physical Science
- Positive Mammogram
- Provisional Certificate
- Qualified Instructor
- Quality Control Technologist
- Radiographic Equipment
- Radiologic Technologist
- Review Physician
- Serious Adverse Event
- Serious Complaint
- Standard Breast
- Survey
- Time Cycle
- Traceable to a National Standard
- Verification Test
- Within
Equipment
- Automatic Exposure Control (AEC) Performance Testing – Annual Physics Survey and Mammography Equipment Evaluation
- Application of Compression
- Compression Device
- Compression Paddle
- Film Masking Devices
- Film Processing Solutions
- Focal Spot Selection
- General Equipment Requirement
- Image Receptor Sizes
- Intensifying Screens
- Light Fields
- Lighting
- Magnification
- Motion of Tube Image Receptor Assembly
- Prohibited Equipment
- Technique Factor Selection and Display
- X-Ray Film
CMS (Formerly HCFA)
Health Insurance Portability and Accountability Act (HIPAA)
Inspection
General
- Facility Owner Responsibilities and Enforcement Actions Following Change in Ownership
- Facility Responsibility Regarding Inspection Observation(s) Follow-up
- Governmental Entity
- Governmental Entity Declaration Form
- Inspection Citation Levels
- Inspection Fees
- Inspection Fee Consolidation
- Inspections of Certified Facilities Currently Not Performing Mammography
- Mobile Mammography Facility Inspection Fee Reduction Fact Sheet
- Timing of Routine Annual Facility Inspections
Quality Control and Quality Assurance
- Artifact Test for Daylight Processing Systems
- Automatic Densitometers and Saving Data
- Charting of Quality Control Test Results
- Dose Calculations Using BR12 Rather than the RMI 156 Phantom
- Facility Use
- Fixer Retention Analysis Records
- Processing When Sensitometric Limits Are Out-of-Control
- QC Records Retention Requirement for Replaced Equipment
- Reestablishing Processor Operating Levels Over the 5-Day Period
- Repeat Analysis of the JCAHO Inspection
- Sensitometer Calibration
Report
- Responding to FDA after Inspections with Adverse Observations
- Inspection Findings Disputed by Facilities
- Recording State vs. MQSA Requirements
- Responding to FDA after Inspections with Adverse Observations
STEP
- Processing Cycle and the STEP Test
- Reference Information for Facilities - the STEP Test
- When the STEP Test Fails -- Actions By Facilities
Survey
- Extension of the 14 Month Limit for the Medical Physicist Survey
- kVp Values Used During Medical Physicist Survey Testing
- Medical Physicist Mammography Equipment Evaluation Testing Report
- Multiple Dates for the Medical Physicist Survey
- QC Testing Evaluation by Medical Physicist – Separate Reports
- Signature on Survey Report
X-Ray
- Phantom Images Exposed in a Fully Automatic Mode – Assigning a kVp
- Intensifying Screens with Poor Alignment
Inspector's Questions
Medical Outcomes Audit
- Audit Interpreting Physician
- Frequency of Medical Outcomes Audit Analysis
- Medical Outcomes Audit Program
Medical Records and Reports
- Communication of Results to Patients
- Communication of Results to Providers
- Contents of Records and Reports
- Mammographic Image Identification
- Recordkeeping
- Transfer of Records
Preparing for MQSA Inspections
Personnel
General
- Acceptable Subject Areas for the Continuing Education and Initial Training Requirements
- Attestation Form
- Attestation - Acceptable Uses for Personnel Requirements
- General Personnel
- Retention of Personnel Records
- Starting Dates
Interpreting Physician
- Interpreting Physician Overview
- Acceptable Documents for Interpreting Physicians
- Interpreting Physician Alternative to Board Certification
- Interpreting Physician Certification
- Interpreting Physician Continuing Education
- Interpreting Physician Continuing Experience
- Interpreting Physician Exemption from Initial Requirements
- Interpreting Physician Exemption from Reading Exams Within 6 Month Period Immediately Prior to Qualifying
- Interpreting Physician Initial Experience
- Interpreting Physician Initial Medical Education - 60 hours of CME
- Interpreting Physician License
- Interpreting Physician New Mammographic Modality Training
- Interpreting Physician Teaching a Specific Course
- Reestablishing the Interpreting Physician Continuing Education Requirement
- Reestablishing the Interpreting Physician Continuing Experience Requirement
- Sample Residency Letter Interim Regulations
- Samples Residency Letter Final Regulations
Medical Physicist
- Medical Physicist Overview
- Medical Physicist Approval Letter
- Acceptable Documents for Medical Physicists
- Medical Physicist Alternative Initial Qualifications
- Medical Physicist Continuing Education
- Medical Physicist Continuing Experience
- Medical Physicist Degree
- Medical Physicist Initial Experience
- Medical Physicist Initial Training
- Medical Physicist New Mammographic Modality Training
- Medical Physicist State License/Approval or Certification
- Reestablishing the Medical Physicist Continuing Education Requirement
- Reestablishing the Medical Physicist Continuing Experience Requirement
Radiologic Technologists
- Radiologic Technologist Overview
- Acceptable Documents for Radiologic Technologists
- Credit Hours for the Advanced ARRT Certificate in Quality Management
- Radiologic Technologist Continuing Education
- Radiologic Technologist Continuing Experience
- Radiologic Technologist License or Certification
- Radiologic Technologist Mammography Specific Training
- Radiologic Technologist New Mammographic Modality Training
- Radiologic Technologist Teaching A Specific Course
- Reestablishing the Radiologic Technologist Continuing Education Requirement
- Reestablishing the Radiologic Technologist Continuing Experience Requirement
Quality Assurance
Equipment
- Automatic Exposure Control (AEC) Performance Testing – Annual Physics Survey and Mammography Equipment Evaluation
- Air Kerma and AEC Reproducibility Annual Quality Control Test
- Alignment Annual Quality Control Tests
- Annual Equipment Quality Control Tests
- Annual Physics Survey
- Beam Quality and Half-Value Layer - Annual Quality Control Test
- Air Kerma Calibration
- Compression Device Performance- Semiannual Quality Control Tests
- Darkroom Fog Semiannual Equipment Quality Control Tests
- Decompression - Annual Quality Control Test
- Dosimetry - Annual Quality Control Test
- Equipment Failing to Meet Requirement
- Facility Cleanliness
- Focal Spot Condition/System Resolution – Annual Quality Control Test
- Infection Control
- Kilovoltage Peak Annual Quality Control Test
- Mammography Equipment Evaluations
- Mobile Units Equipment Quality Control
- Other Modalities Quality Control Tests
- Phantom Image - Weekly Equipment Quality Control Tests
- Processor Performance - Daily QC Tests
- Quality Control Tests Other Than Annual
- Radiation Output - Annual Quality Control Test
- Repeat Analysis and Fixer Retention - Quarterly Equipment Quality Control Tests
- Screen Film Contact - Semiannual Quality Control Tests
- Screen Speed Uniformity - Annual Quality Control Test
- System Artifacts - Annual Quality Control Test
- Use of Test Results
General
- Interpreting Physician Responsibilities
- Medical Physicist Responsibilities
- Quality Assurance Program
- Quality Assurance Records
- Quality Control Technologist Responsibilities
- Responsible Individuals For Quality Assurance Program
Mammography Facility Survey and Medical Physicist Qualification Requirements
Response to Natural Disasters
States as Certifiers
- Scope
- Application for Approval as a Certification Agency
- Standards for Certification Agencies
- Evaluation
- Withdrawal of Approval
- Hearings and Appeals
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