2. Resident Physics Series ACR Mammography Protocols

3. Mammography Quality Standards Act (MQSA) “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) 1992

4. MQSA Requirements Yearly physics surveys Yearly FDA inspections Georgia x-ray regulators on contract with FDA FY 2013 No violations: 87%

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

7. FDA Facility & Procedure Count June, 2006Late 2013% Change Total certified facilities 88508691-1.8 Total accredited units 1358812195-10.3 Certified facilities with FFDM units 10278004+679.4 Accredited FFDM units 145512195+738.1 Annual mammography procedures 33,940,03738,596,266+13.7

8. Number of Accredited FFDM Units Jun 11 Nov 03

9. Number of Accredited Units Jun 11 Nov 03

10. % FFDM Units Dec 2003 Jun 2011

11. FDA-Approved FFDM Units Last 5 Years DateManufacturerModel 6/15/11HologicSelenia EncoreDirect 4/28/11SectraMicroDose Mammography L30Photon Counting 2/11/11HologicSelenia Dimensions Digital Breast Tomosynthesis (DBT) Direct 2/11/11SiemensMammomat InspirationDirect 11/3/10CarestreamDirectview Computed Radiography (CR)CR 2/11/09HologicSelenia Dimensions 2DDirect 2/11/09HologicSelenia SDirect 2/11/09SiemensMammomat Novation SDirect 11/2007HologicSelenia with Tungsten targetDirect 07/10/06FujiComputed Radiography Mammography SuiteCR 04/11/06General ElectricSenographe EssentialIndirect

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

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

14. 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

15. Quality Control (QC) 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 QC is integral part of QA

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

17. Facility Responsibility Designate One Lead Interpreting Physician

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

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

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

21. 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

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

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

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

25. 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.”

26. The Proliferation of Digital Mammography Total mammography units in US (10/1/2010) 12,445 Total digital mammography units (10/1/2010 8748 (70.3%) Total digital mammography units (4/1/2010 or 6 months ago) 8195 (65.2%) Increase in digital units ~ 92/month

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

28. Physicist’s Responsibilities Note: All physicist’s tests are to be done annually or after tube replacement or major service Note: All physicist’s tests are to be done annually or after tube replacement or major service

29. 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 (see next slide)

30. Technique Chart Even though most mammo is phototimed, still need technique chart For given breast size, density, view specify machine set-up Phototimer mode (auto standard, contrast, dose, …) Density (-2, -1, 0, …)

31. Technique Chart Wrong (my opinion) Display kVp, mAs, target, filter calculated by machine for given image Correct (my opinion) Display machine settings selectable by technologist for this breast and view Should provide enough guidance to allow a technologist who has not worked in this room or facility to properly set up a study

32. Physicist’s Responsibilities: Mammography Unit Assembly Evaluation 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

33. 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 Many units by design will not do this

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

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

36. Physicist’s Responsibilities: Screen Uniformity compare O.D. of each cassette using phototimer AEC Reproducibility

37. Physicist’s Responsibilities Breast Entrance Exposure, Average Glandular Dose, RMI-156 “accreditation” phantom used for entrance exposure / average glandular dose

38. 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

39. Image Quality Evaluation use RMI-156 “accreditation” phantom record fibers speck groups masses optical densities technique

40. A Poor Phantom Image

41. Artifact Identification Artifact evaluation / description determination of artifact source processor other equipment Done with phantom film

42. Physicist’s Responsibilities Viewing conditions ambient light viewbox brightness My experience Ambient lighting often ignored

43. Technologist’s Responsibilities Daily darkroom cleanliness processor quality control sensitometric data Weekly screen cleanliness viewboxes and viewing conditions Phantom images All QC must not only be performed but must be documented!

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

45. Technologist’s Responsibilities Monthly: Visual Checklist cassette lock Is cassette held firmed in place when tubestand tilted Compression device & firm compression Smooth edges Holds pressure hand switch placement visibility switches/ lights/ meters cones/ collimators

46. Technologist’s Responsibilities Quarterly Fixer retention analysis Fixer affects archivability of films Repeat analysis breakdown by cause motion positioning technique static etc.

47. Semi-Annual Technologist’s Responsibilities: Darkroom Fog must use sensitized film partially cover previously exposed phantom film in darkroom for 2 minutes up to.05 O.D. increase acceptable

48. Semi-annual Technologist’s Responsibilities Screen Film Contact 40 lines/inch Copper mesh subjective results poor contact can result if time (15 minutes) not provided for air to bleed out of cassette after closing NOTE: 15 minutes between cassette loading & exposure must be provided for all clinical films to insure good contact

49. Semi-annual Technologist’s Responsibilities Screen Film Contact

50. Semi-Annual Technologist’s Responsibilities Compression can use bathroom scale covered with towel 25 - 40 pounds for automatic systems at least 25 pounds for manual compression

51. The End Questions?