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Radiation-Emitting Products
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Table of Contents
Introduction
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
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- 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
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- 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
STEP
Survey
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- 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
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
Interpreting Physician
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- 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
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- 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
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- 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
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- 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
Mammography Facility Survey and Medical Physicist Qualification Requirements
Response to Natural Disasters
States as Certifiers
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