1. Resident Physics Series
ACR Mammography Protocols

2. Who Regulates Radiation in the United States?

3. Radioactive Material Regulation
Because of their potentially hazardous properties, the use of certain radioactive materials must be closely regulated to protect the health and safety of the public and the environment. Toward that end, the responsibility for licensing and regulating the use and handling of these materials is shared by the following governmental organizations:
The U.S. Environmental Protection Agency (EPA)
The Food and Drug Administration (FDA)
The U.S. Nuclear Regulatory Commission (NRC)
State Governments

4. X-Ray Manufacturer Regulation
X-ray imaging systems must comply with radiation safety performance standards in Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1010 and 1020:
Performance standards for electronic products: general
Diagnostic x-ray systems and their major components
Radiographic equipment
Fluoroscopic equipment
Computed Tomography (CT) equipment

5. X-Ray Usage Regulation
States regulate almost all medical usage of diagnostic x-ray
Regulations vary widely from state to state
Georgia requires a full 6 hours of training to take x-rays (unless you’re a physician or dentist in which case you’re assumed to have already gotten it)

6. X-Ray Usage Regulation: Mammography
Mammography controlled by federal government (FDA)
1992 Mammography Quality Standards Act (MQSA)

7. Mammography Quality Standards Act (MQSA)
1992
“to ensure the safety and reliability of mammography and help detect breast cancer in its earliest, most treatable stages”
Mammography practice under federal control (FDA)

8. MQSA Requirements Yearly physics surveys Yearly FDA inspections
Georgia x-ray regulators on contract with FDA
FY 2018
No violations: 84.9%

9. Facility Accreditation by “Accrediting Body”
American College of Radiology (ACR)
State of Arkansas
State of Iowa
State of Texas

11. Acronyms FFDM (also 2D) DBT (also 3D) Full Field Digital Tomography
Digital Breast Tomosynthesis

12. FDA Facility & Procedure Count
June, 2006
Mid-2018
% Change
Total certified facilities
8850
8726
-1.4
Total accredited units
13588
19242
+41.6
Certified facilities with FFDM units
1027
8622
+739
Accredited FFDM units
1455
12817
+781
Certified facilities with DBT
4526
Certified DBT units
6341
Annual mammography procedures
33,940,037
39,318,393
+15.8

13. Mammography QC Manual Sections Radiologist Clinical Image Quality
Revised Edition, 1999
Sections
Radiologist
Clinical Image Quality
Radiologic Technologist
Medical Physicist

14. New manual now out for FFDM; new manual coming for DBT
Mammography QC Manual
New manual now out for FFDM; new manual coming for DBT

15. Quality Assurance (QA)
QA should ensure
Every imaging procedure is necessary & appropriate to clinical problem at hand
images contain information critical to solution of that problem

16. Quality Assurance (QA)
recorded information is
correctly interpreted
made available to patient’s physician in a timely fashion
consistent with image quality objectives, examination results in lowest possible
radiation exposure
cost
inconvenience to the patient

17. QC is integral part of QA
Quality Control (QC)
QC is integral part of QA
Acceptance Testing
detection of defects in equipment that is newly installed or has undergone major repair
Baselines
Establishment of baseline equipment performance
quantitative data when system operating properly

18. Quality Control (QC) Diagnosis Verification
Diagnosis of changes in equipment performance before they become radiologically apparent
Verification
Verification of correction of causes of deterioration in equipment performance

19. Facility Responsibility
Designate One Lead Interpreting Physician

20. Lead Physician’s Responsibilities
Ensure technologists have adequate
orientation
based on procedure manual
training
continuing education
Ensure effective QC program

21. Radiologist’s Responsibilities
Designate one technologist responsible for QC
QC tech can delegate responsibilities

22. Radiologist’s Responsibilities
Ensure availability of appropriate test equipment
Arrange staffing / scheduling to allow time for QC

23. Radiologist’s Responsibilities
provide frequent consistent positive & negative feedback to technologists about film quality & QC
Review technologist’s test results
no less than every 3 months
more often if inconsistent results

24. Radiologist’s Responsibilities
Select a medical physicist
administers QC program
performs physicist’s tests
Review physicist’s test results

25. Radiologist’s Responsibilities
Oversee or designate qualified individual to oversee radiation protection program for
employees
patients
individuals in surrounding area

26. Radiologist’s Responsibilities
Ensure proper maintenance of records in QC procedures manual
employee qualifications
mammography technique / procedures
quality control / safety / protection
infection control

27. Radiologist’s Responsibilities
“The radiologist is ultimately responsible for the quality of films produced under his or her direction and bears ultimate responsibility for both proper QC testing and QA procedures in mammography.”

28. Physicists & Digital Mammography
Physicist must insure equipment meets manufacturer’s specifications
Equipment specs now defined by manufacturer, not ACR/FDA

29. Physicist’s Responsibilities
Note: All physicist’s tests required annually or after tube replacement or major service

30. Physicist’s Responsibilities: Mammography Unit Assembly Evaluation
mechanical stability / identification of sharp edges
receptor stability
locks / motions / detents
operator shielding
thickness scale accuracy
indicator lights working
technique chart posted

31. Physicist’s Responsibilities: Mammography Unit Assembly Evaluation
Film
Cassettes slide smoothly into/out of holder
Override available for auto-decompression
display must indicate when auto-decompression turned off
Manual release of compression if power lost CR

32. Collimation Assessment
x-ray light field alignment
beam does not exceed receptor by > 2% SID
compression paddle / receptor alignment at chest wall within 1% SID
paddle not visible on image
Image should fill film
Film

33. Physicist’s Responsibilities
Focal Spot Performance
limiting resolution pattern
kVp accuracy / reproducibility
Beam quality (HVL)
minimum & maximum
minimum: patient dose
maximum: image contrast

34. Automatic Exposure Control (AEC / Phototiming)
kVp tracking
Thickness tracking
image mode tracking (Mag, cassette sizes, w w/o grid)
automatic mode tracking
unit selects kVp, target, filter
density control
even steps of ~ 15-20%

35. Physicist’s Responsibilities:
Screen Uniformity
AEC Reproducibility
Film

36. Physicist’s Responsibilities
Breast Entrance Exposure, Average Glandular Dose,
Special “accreditation” phantom used for entrance exposure / average glandular dose / image quality

37. Breast Average Glandular Dose Limits
0.3 rad (300 mrads, 3 mGy) maximum per view for screen-film receptors using a grid
Same for film and digital
0.1 rad (100 mrads, 1 mGy) maximum per view for non-grid screen-film receptors
Radiation output rate > 800 mR/sec

38. Image Quality Evaluation
use “accreditation” phantom
record
fibers
speck groups
masses
optical densities
technique
New phantom available for FFDM

39. Phantom Image

40. Artifact Identification
Artifact evaluation / description
Done with phantom

41. Physicist’s Responsibilities
Monitor QC
Brightness
Often automated test
Viewing conditions
ambient lighting

42. Technologist’s Responsibilities
All QC must not only be performed but must be documented!

43. Technologist’s Responsibilities Monthly: Visual Checklist
SID indicator
angle indicator
locks
field light
smooth motions

44. Technologist’s Responsibilities Monthly: Visual Checklist
Compression device & firm compression
Smooth edges
Holds pressure
hand switch placement
visibility
switches/ lights/ meters
cones/ collimators

45. Technologist’s Responsibilities Quarterly
Repeat analysis
breakdown by cause
motion
positioning
technique
etc.

46. Semi-Annual Technologist’s Responsibilities
Compression
can use bathroom scale covered with towel
pounds for automatic systems
at least 25 pounds for manual compression

47. The End
Questions?