digital mammography detector qc introduction introduction

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1 Slide 1 Digital Mammography Detector QC Eric A. Berns, Ph.D. Eric A. Berns, Ph.D. [email protected] [email protected] University of Colorado at Denver and HSC University of Colorado at Denver and HSC Denver, CO Denver, CO Slide 2 z What is FFDM QC and why is it What is FFDM QC and why is it important? important? z What to know before you start What to know before you start z Overview and compare QC tests Overview and compare QC tests z Key take home points Key take home points Introduction Introduction Slide 3 Total Certified Mammo Facilities -123 Difference 8,714 July 1, 2008 8,837 July 1, 2007 Certified Statistics – Past Year Introduction Introduction 5,911 SFM Units Slide 4 z MQSA MQSA Mammography Quality Standards Act Mammography Quality Standards Act z ACR ACR American College of Radiology American College of Radiology Introduction Introduction Slide 5 Screen Screen- Film Film Slide 6 FFDM FFDM z In FFDM, the manufacturer designs and mandates their In FFDM, the manufacturer designs and mandates their own QC program and action limits own QC program and action limits z In FFDM, you must the manufacturers In FFDM, you must the manufacturers’ QC program QC program

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Page 1: Digital Mammography Detector QC Introduction Introduction

1

Slide 1

Digital Mammography

Detector QC

Eric A. Berns, Ph.D.Eric A. Berns, Ph.D.

[email protected]@gmail.com

University of Colorado at Denver and HSCUniversity of Colorado at Denver and HSCDenver, CODenver, CO

Slide 2

What is FFDM QC and why is it What is FFDM QC and why is it

important?important?

What to know before you startWhat to know before you start

Overview and compare QC testsOverview and compare QC tests

Key take home pointsKey take home points

IntroductionIntroduction

Slide 3

Accredited FFDM units

Certified Facilities with FFDM units

Total Accredited Mammo Units

Total Certified MammoFacilities

+1,845

+1,293

-575

-123

Difference

6,964

4,659

12,875

8,714

July 1, 2008

5,119

3,366

13,450

8,837

July 1, 2007

Certified Statistics – Past Year

IntroductionIntroduction 5,911 SFM Units

Slide 4

MQSA MQSA

–– Mammography Quality Standards ActMammography Quality Standards Act

ACRACR

–– American College of RadiologyAmerican College of Radiology

IntroductionIntroduction

Slide 5

ScreenScreen--FilmFilm

Slide 6

FFDMFFDM

In FFDM, the manufacturer designs and mandates their In FFDM, the manufacturer designs and mandates their own QC program and action limitsown QC program and action limitsIn FFDM, you must the manufacturersIn FFDM, you must the manufacturers’’ QC programQC program

Page 2: Digital Mammography Detector QC Introduction Introduction

2

Slide 7

AGFA IMPAX MA3000AGFA IMPAX MA3000–– Clean monitor surfaceClean monitor surface–– Measure display white & blackMeasure display white & black–– Measure quality levelMeasure quality level–– Measure uniformityMeasure uniformity–– Calibrate displaysCalibrate displays–– View SMPTE patternView SMPTE pattern–– Viewing conditionsViewing conditions

GE Seno AdvantageGE Seno Advantage–– Viewing conditions check and settingViewing conditions check and setting–– Monitor calibrationMonitor calibration–– Image quality Image quality –– SMPTE patternSMPTE pattern–– Analysis of screen uniformityAnalysis of screen uniformity

Siemens Siemens MammoReportMammoReport PlusPlus–– Geometric distortionGeometric distortion–– Reflection Reflection –– Luminance ResponseLuminance Response–– Luminance UniformityLuminance Uniformity–– ResolutionResolution–– NoiseNoise–– Overall EvaluationOverall Evaluation

Slide 8

BarcoBarco–– II--Guard CheckGuard Check–– Quality LevelQuality Level–– Display WhiteDisplay White–– Calibration Settings CheckCalibration Settings Check

EizoEizo–– Pattern CheckPattern Check–– Luminance CheckLuminance Check–– GrayscaleGrayscale CheckCheck–– Uniformity CheckUniformity Check

PlanarPlanar–– Monitor CleaningMonitor Cleaning–– Viewing Conditions CheckViewing Conditions Check–– Monitor Calibration CheckMonitor Calibration Check–– Image Quality Image Quality –– SMPTESMPTE–– Visual Inspection for Display Visual Inspection for Display

DefectsDefects

Slide 9

Quality Control: Why?Quality Control: Why?

Reduce exposure to patients and Reduce exposure to patients and

personnelpersonnel

Consistent image qualityConsistent image quality

Detect and correct for potential problems, Detect and correct for potential problems,

before they impact image qualitybefore they impact image quality

Slide 10

What is Quality Control?What is Quality Control?

Determination of what is Determination of what is ““NormalNormal””

Detection of what is Detection of what is ““AbnormalAbnormal””

Understanding of how to return to Understanding of how to return to ““NormalNormal””from from ““AbnormalAbnormal””

In particular, in FFDM, how do you know In particular, in FFDM, how do you know what you are seeing is what it is supposed to what you are seeing is what it is supposed to be?be?

Slide 11

Golden Rules for FFDM QCGolden Rules for FFDM QC–– Must use manufacturerMust use manufacturer’’s QC proceduress QC procedures

•• Mandate action limitsMandate action limits

–– ManufacturersManufacturers’’ QC may refer to Monitor & Printer QC may refer to Monitor & Printer

ManufacturersManufacturers’’ QCQC

–– Multimodality Workstations have own separate QCMultimodality Workstations have own separate QC

–– Printers may have their own QCPrinters may have their own QC

–– Most failures result in stopping clinical imaging Most failures result in stopping clinical imaging

until failure can be correcteduntil failure can be corrected

Before You Begin QCBefore You Begin QCSlide 12

Obtain proper training & CE credits (8 hours)Obtain proper training & CE credits (8 hours)

–– HandsHands--on training on on training on actualactual unit:unit:

•• MechanicsMechanics

•• SoftwareSoftware

•• ArtifactsArtifacts

•• Learn vendor specific tests and tricks Learn vendor specific tests and tricks

Before You BeginBefore You Begin

Page 3: Digital Mammography Detector QC Introduction Introduction

3

Slide 13

Must have proper continuing experience:Must have proper continuing experience:

–– 2 facilities2 facilities

–– 6 units6 units

–– Within last 2 yearsWithin last 2 years

Before You BeginBefore You BeginSlide 14

Before You BeginBefore You Begin

Note:Note:––For new unitFor new unit: Must use most current : Must use most current

versionversion––For renewal unitFor renewal unit: Can use older : Can use older

version (version used when tested version (version used when tested previously)previously)

Slide 15

ACR AccreditationACR Accreditation -- www.acr.orgwww.acr.org–– Physics formsPhysics forms

•• http://acr.org/accreditation/mammography/mammo_qc_forms.aspxhttp://acr.org/accreditation/mammography/mammo_qc_forms.aspx

–– GEGE SenographeSenographe 2000D, DS, and Essential2000D, DS, and Essential–– Fischer Fischer SenoscanSenoscan–– LoradLorad SeleniaSelenia–– Siemens Siemens NovationNovation–– Fuji Fuji FCRmFCRm

•• NoteNote: if using unit for both screen: if using unit for both screen--film & CR, you must accredit for film & CR, you must accredit for bothboth

FDA AccreditationFDA Accreditation–– www.fda.gov/cdrh/mammographywww.fda.gov/cdrh/mammography//–– Other vendors when approvedOther vendors when approved

Before You BeginBefore You BeginSlide 16

Before You BeginBefore You Begin

Slide 17

Before You BeginBefore You BeginSlide 18

Before You BeginBefore You Begin

Page 4: Digital Mammography Detector QC Introduction Introduction

4

Slide 19

Before You BeginBefore You BeginSlide 20

Before You BeginBefore You Begin

Slide 21

ScreenScreen--Film MammoFilm Mammo–– Assure XAssure X--ray field aligns with the light fieldray field aligns with the light field

–– Collimator allows full coverage of receptorCollimator allows full coverage of receptor–– Chest wall edge of compression paddle aligns with chest Chest wall edge of compression paddle aligns with chest

wall of receptorwall of receptor

FFDMFFDM–– SameSame

–– Multiple target/filters and/or multiple paddle positionsMultiple target/filters and/or multiple paddle positions

–– Chest Wall Missed Tissue Chest Wall Missed Tissue –– Compression Plate Overlap on the Chest Wall SideCompression Plate Overlap on the Chest Wall Side

CollimationCollimationSlide 22

ScreenScreen--Film MammoFilm Mammo–– LineLine--pair test toolpair test tool

•• Focal spotFocal spot

FFDMFFDM–– LineLine--pair test toolpair test tool

•• Focal spotFocal spot

•• Detector & imaging chainDetector & imaging chain

Limiting Spatial ResolutionLimiting Spatial Resolution

Slide 23

Spatial ResolutionSpatial Resolution

XXXXMTFMTF

XXXXXXMeasure using LP Measure using LP phantom on top of phantom on top of acrylicacrylic

XXSame as ScreenSame as Screen--Film Film (Focal Spot (Focal Spot EvalEval))

Siemens Siemens NovationNovation

LoradLoradSeleniaSelenia

Fischer Fischer SenoscanSenoscan

GE GE 2000D, 2000D,

DS, DS, EssentialEssential

Fuji Fuji FCRmFCRm

Slide 24

ScreenScreen--Film MammoFilm Mammo–– Measure optical densitiesMeasure optical densities

•• Different thicknesses using clinical modesDifferent thicknesses using clinical modes

•• Different density settings (Different density settings (--2, 2, --1, 0, +1, +2, etc.)1, 0, +1, +2, etc.)

FFDMFFDM–– Measure resultant techniquesMeasure resultant techniques

–– Measure signal, exposure, & SNR valuesMeasure signal, exposure, & SNR values

AEC PerformanceAEC Performance

Page 5: Digital Mammography Detector QC Introduction Introduction

5

Slide 25

AECAEC

XXXXXXXXImage Mode TrackingImage Mode Tracking

XXACR ReproducibilityACR Reproducibility

XXXXXXSNRSNR

XXCNR CNR

XXXXXXDensity Control Density Control FunctionFunction

Same as ScreenSame as Screen--FilmFilm

Siemens Siemens NovationNovation

LoradLoradSeleniaSelenia

Fischer Fischer SenoscanSenoscan

GE GE 2000D, 2000D,

DS, DS, EssentialEssential

Fuji Fuji FCRmFCRm

Slide 26

AOP Mode and SNR CheckAOP Mode and SNR Check–– Variable thicknesses of acrylic Variable thicknesses of acrylic –– Std, AutoStd, Auto–– Evaluate:Evaluate:

•• Correct techniques?Correct techniques?•• Adequate SNR?Adequate SNR?

2.5 cm 2.5 cm AcrylicAcrylic

4.0 cm 4.0 cm AcrylicAcrylic

6.0 cm Acrylic6.0 cm Acrylic

Acrylic Thickness

Target-Filter

Selected kVp

Selected mAs

2.5 cm Mo-Mo 27 kVp 20-60

4.0 cm Mo-Rh 28 kVp 35-90

6.0 cm Rh-Rh 32 kVp 35-90

Each Each ““rawraw”” image must have a measured SNR of image must have a measured SNR of at least 50at least 50

GE 2000DGE 2000D

Slide 27

GE DS & EssentialGE DS & Essential

DS specific QC testsDS specific QC tests–– AOP Mode and SNR CheckAOP Mode and SNR Check

•• Use builtUse built--in software for image acquisitionin software for image acquisition

•• AOP: STD/AutoAOP: STD/Auto

31314545--9595Rh/RhRh/Rh606029294040--9090Rh/RhRh/Rh505026262020--6060Mo/MoMo/Mo2525kVkVmAsmAsTrack/FilterTrack/Filter

Exposure ParametersExposure ParametersFor AOP STD mode For AOP STD mode olyoly

Acrylic Thickness Acrylic Thickness (mm)(mm)

SNR must be > 50SNR must be > 50

Slide 28

LoradLorad SeleniaSelenia

Automatic Exposure Control Automatic Exposure Control –– AUTOAUTO--FILTER FILTER –– 2, 4, 6, 8 cm2, 4, 6, 8 cm

–– 4 cm (4 cm (--5 thru +5, or 5 thru +5, or --3 to +4)3 to +4)

–– Use ROI to measure mean pixel value Use ROI to measure mean pixel value

inside virtual AEC detectorinside virtual AEC detector

Performance CriteriaPerformance Criteria–– Pixel value should not vary by more Pixel value should not vary by more

than 10% of meanthan 10% of mean

–– Exposure compensation steps shall Exposure compensation steps shall

meet requirements in pixel value tablemeet requirements in pixel value table

Slide 29

AEC Image Stability and Reproducibility and SNRAEC Image Stability and Reproducibility and SNR

–– ACR Phantom ACR Phantom

–– Mo/Mo, 28 kV, Mo/Mo, 28 kV, ““HH””, sensor 1, sensor 1

–– Record Record mAsmAs, SNR, Mean, Entrance Exposure (5 times), SNR, Mean, Entrance Exposure (5 times)

Action Limits:Action Limits:

–– CoefCoef. of . of VarVar for for mASmAS and X < 5%and X < 5%

–– SNR and Mean shall not vary by SNR and Mean shall not vary by ++ 15% of Mean15% of Mean

Siemens Siemens NovationNovationSlide 30

AEC Thickness TrackingAEC Thickness Tracking

–– 2, 4, and 6 cm2, 4, and 6 cm

–– ““HH”” modemode

–– Max deviation = (Max difference / mean value ) * 100Max deviation = (Max difference / mean value ) * 100

Siemens Siemens NovationNovation DRDR

Page 6: Digital Mammography Detector QC Introduction Introduction

6

Slide 31

Density Control FunctionDensity Control Function

–– 4 cm acrylic, ACR phantom technique4 cm acrylic, ACR phantom technique

–– Repeat at Repeat at --2, 2, --1, 0, +1, +2 etc. density1, 0, +1, +2 etc. density

–– Record Record mAsmAs

–– mAsmAs change should be 5 to 15% per stepchange should be 5 to 15% per step

Fuji Fuji FCRmFCRmSlide 32

Reproducibility & Image Mode TrackingReproducibility & Image Mode Tracking–– 4 cm acrylic with clinical technique 4 cm acrylic with clinical technique –– Position ion chamber in beamPosition ion chamber in beam–– Record Record mAsmAs and Xand X–– Repeat 3 timesRepeat 3 times–– Repeat in each mode (small, large, Repeat in each mode (small, large, magmag, no grid), no grid)–– Action LimitsAction Limits: :

•• Coefficient of variation for Exposure or Coefficient of variation for Exposure or mAsmAs must not exceed must not exceed 0.050.05

•• No significant difference in exposure between small and large No significant difference in exposure between small and large buckybucky when using similar gridswhen using similar grids

Fuji Fuji FCRmFCRm

Slide 33

CNR Per Object ThicknessCNR Per Object Thickness

–– CNR using clinical technique for 2 cmCNR using clinical technique for 2 cm

–– Repeat for 4 and 6 cmRepeat for 4 and 6 cm

–– Action LimitsAction Limits::

•• CNR of 2 cm relative to 4 cm must be CNR of 2 cm relative to 4 cm must be >> 100%100%

•• CNR of 6 cm relative to 4 cm must be CNR of 6 cm relative to 4 cm must be >> 75%75%

Fuji Fuji FCRmFCRmSlide 34

ScreenScreen--Film MammoFilm Mammo

–– Measure if ODMeasure if OD’’s are consistents are consistent

–– Check for Check for artifactsartifacts

FFDMFFDM

–– FlatFlat--field uniformityfield uniformity

–– Detector calibrationDetector calibration

–– Pixel correction testPixel correction test

–– CR Reader Scanner PerformanceCR Reader Scanner Performance

Uniformity of Screen Speed & Uniformity of Screen Speed & Detector PerformanceDetector Performance

Slide 35

Detector PerformanceDetector Performance

XXPixel CorrectionPixel Correction

XXGeometric DistortionGeometric Distortion

XXDynamic RangeDynamic Range

XXCR Reader Scanner CR Reader Scanner PerformancePerformance

XXXXGhostingGhosting

XXInterInter--Plate Plate ConsistencyConsistency

XXPrimary ErasurePrimary Erasure

XXXXXXDetector CalibrationDetector Calibration

XXXXFlatFlat--Field UniformityField Uniformity

Same as ScreenSame as Screen--Film Film (Screen Uniformity)(Screen Uniformity)

Siemens Siemens NovationNovation

LoradLoradSeleniaSelenia

Fischer Fischer SenoscanSenoscan

GE GE 2000D, 2000D,

DS, DS, EssentialEssential

Fuji Fuji FCRmFCRm

Slide 36

ScreenScreen--Film MammoFilm Mammo–– ACR Phantom ScoresACR Phantom Scores

–– Optical Density & ContrastOptical Density & Contrast

FFDMFFDM–– ACR Phantom ScoresACR Phantom Scores

•• Pass/fail requirements differ by vendorPass/fail requirements differ by vendor

–– SignalSignal--toto--Noise Ratio (SNR)Noise Ratio (SNR)

–– ContrastContrast--toto--Noise Ratio (CNR)Noise Ratio (CNR)

Image QualityImage Quality

Page 7: Digital Mammography Detector QC Introduction Introduction

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Slide 37

Image QualityImage Quality

XXXXXXXXXXCNRCNR

PartialPartialXXXXClinical TechniqueClinical Technique

XXXXManual TechniquesManual Techniques

Same as ScreenSame as Screen--FilmFilm

Siemens Siemens NovationNovation

LoradLoradSeleniaSelenia

Fischer Fischer SenoscanSenoscan

GE GE 2000D, 2000D,

DS, DS, EssentialEssential

Fuji Fuji FCRmFCRm

Slide 38

ACR Phantom ImagingACR Phantom Imaging

4433MassesMasses

4433SpecksSpecks

5544FibersFibers

LoradLorad & & SiemensSiemens

GE & Fischer & GE & Fischer & Fuji Fuji

Image QualityImage Quality

Slide 39

ACR Phantom ImagingACR Phantom Imaging

–– Manual technique (Mo/Mo, 26 Manual technique (Mo/Mo, 26

kVp, 125 kVp, 125 mASmAS))

–– Score the Score the processedprocessed imageimage

–– Acquisition workstationAcquisition workstation

–– Each monitor of the RWSEach monitor of the RWS

–– Laser imagerLaser imager

GE 2000DGE 2000DSlide 40

ContrastContrast--toto--Noise Test (CNR)Noise Test (CNR)

–– To examine consistency of CNR To examine consistency of CNR

ratio measured over timeratio measured over time

–– Use the Use the rawraw imageimage

–– ++ 20% of baseline20% of baseline

Background ROIBackground ROI Mass ROIMass ROI

CNR = (CNR = (MeanMeanbackgroundbackground -- MeanMeanmassmass)/SD)/SDbackgroundbackground

GE 2000DGE 2000D

Slide 41

GE DSGE DS

DS specific QC testsDS specific QC tests

–– Phantom Image QualityPhantom Image Quality

•• Manual technique: Manual technique: Rh/RhRh/Rh, 29 kVp, 56 , 29 kVp, 56 mAsmAs

–– MTF and CNR MeasurementMTF and CNR Measurement

•• Use IQST test toolUse IQST test tool

•• Use builtUse built--in software for image acquisitionin software for image acquisition

•• Manual technique: Manual technique: Rh/RhRh/Rh 30 kVp, 56 30 kVp, 56 mAsmAs

•• Results are automatically displayed (pass/fail)Results are automatically displayed (pass/fail)

•• Same action limits as 2000DSame action limits as 2000D

Slide 42

Phantom Image QualityPhantom Image Quality–– Select clinical exposure mode (i.e. AUTOSelect clinical exposure mode (i.e. AUTO--FILTER)FILTER)–– Print film Print film –– Measure background OD and density difference Measure background OD and density difference ––

Plot on tech worksheetsPlot on tech worksheets•• Background must be Background must be >> 1.20 OD 1.20 OD ++ 0.200.20

•• DD must be DD must be >> 0.40 0.40 ++ 0.050.05

–– Score on each Soft Copy WorkstationScore on each Soft Copy Workstation•• 5 fibers5 fibers

•• 4 speck groups4 speck groups

•• 4 masses4 masses

LoradLorad SeleniaSelenia

Page 8: Digital Mammography Detector QC Introduction Introduction

8

Slide 43

Phantom Image QualityPhantom Image Quality–– Position phantom 1 cm Position phantom 1 cm

over chest wall edgeover chest wall edge

–– Select: 28 kV, AECSelect: 28 kV, AEC--Auto, Auto,

Mo/MoMo/Mo

–– Score on RWS or FilmScore on RWS or Film

–– Fiber Fiber >> 55

–– Specks Specks >> 44

–– Masses Masses >> 44

Siemens Siemens NovationNovation DRDRSlide 44

SNR and CNR MeasurementsSNR and CNR Measurements

–– SNRSNR at least at least >> 4040

–– CNRCNR should stay within should stay within ±±15% of baseline15% of baseline

•• Obtained during acceptance testingObtained during acceptance testing

LoradLorad & Siemens& Siemens

Slide 45

ContrastContrast--toto--Noise Test (CNR)Noise Test (CNR)–– To examine consistency of CNR ratio measured over timeTo examine consistency of CNR ratio measured over time

–– Use 4 cm acrylic & 0.2 mm AlUse 4 cm acrylic & 0.2 mm Al

–– Manual technique (Mo/Mo, 26 kVp, 125 Manual technique (Mo/Mo, 26 kVp, 125 mAsmAs))

–– Calculate CNR using softwareCalculate CNR using software

–– ++ 20% of baseline20% of baseline

Fuji Fuji FCRmFCRmSlide 46

ScreenScreen--Film MammoFilm Mammo–– Dose for single CC view of ACR phantom shall Dose for single CC view of ACR phantom shall

not exceed 3.0 not exceed 3.0 mGymGy per exposure per FDAper exposure per FDA

FFDMFFDM–– SameSame

DoseDose

Slide 47

ScreenScreen--Film MammoFilm Mammo

–– Measure optical densitiesMeasure optical densities

•• Density difference, midDensity difference, mid--density, density, base+fogbase+fog

•• Measures consistencyMeasures consistency

FFDMFFDM

–– ManufacturersManufacturers’’ recommendationsrecommendations

–– Some refer to printer manufacturersSome refer to printer manufacturers’’ recommendationsrecommendations

–– Typically identical to ACR SFM ManualTypically identical to ACR SFM Manual

Film ProcessingFilm ProcessingSlide 48

Film Processor QCFilm Processor QC

XXXXFollow Follow FFDMsFFDMs’’ QCQC

XXXXXXIf Not, Use TheirsIf Not, Use Theirs

XXXXXXFollow Printer Follow Printer Manufacturers QCManufacturers QC

Siemens Siemens NovationNovation

LoradLoradSeleniaSelenia

Fischer Fischer SenoscanSenoscan

GE GE 2000D, 2000D,

DS, DS, EssentialEssential

Fuji Fuji FCRmFCRm

Page 9: Digital Mammography Detector QC Introduction Introduction

9

Slide 49

MidMid--DensityDensity

Film ProcessingFilm Processing

Northwestern Memorial Hospital - Processor ID: 2 - MAR 2006 Mid-Density

1.30

1.40

1.50

1.60

1.70

1.80

1.90

2.00

2.10

2.20

2.30

1-Mar-0

6

2-Mar-0

6

3-Mar-

06

6-Mar-

06

7-Mar-

06

8-Mar-

06

9-Mar-

06

10-M

ar-06

13-M

ar-06

14-M

ar-06

servi

ce 3/14

15-M

ar-06

16-M

ar-06

17-M

ar-06

20-M

ar-06

21-Mar-

06

22-Mar-

06

23-M

ar-06

24-M

ar-06

27-M

ar-06

28-M

ar-06

29-M

ar-06

30-Mar-

06

31-M

ar-06

Date

Mid-Density Upper Control Limit = 2.06Mid-Density Daily ValueMid-Density Daily Value Operating Level = 1.91Mid-Density Lower Control Limit = 1.76

MD Step=12

Northwestern Memorial Hospital - Processor ID: Kodak 8900 - Oct 2006 Mid-Density

0.70

0.80

0.90

1.00

1.10

1.20

1.30

1.40

1.50

1.60

1.70

October

2, 20

06

October

3, 200

6

October 4,

2006

October

5, 20

06

October

6, 20

06

October

9, 200

6

October 10

, 200

6

October

11, 2

006

October

12, 2

006

October

13, 2

006

October 1

6, 20

06

October

17, 2

006

October

18, 2

006

October

19, 20

06

October 2

0, 20

06

October

23, 2

006

October

24, 2

006

October

25, 20

06

October 2

6, 20

06

October

27, 2

006

October

30, 2

006

Date

Mid-Density Upper Control Limit = 1.48

Mid-Density Daily Value

Mid-Density Daily Value Operating Level = 1.33

Mid-Density Lower Control Limit = 1.18

Wet Processing Laser Printer

Slide 50

Density DifferenceDensity Difference

Film ProcessingFilm Processing

Northwestern Memorial Hospital - Processor ID: 2 - MAR 2006 Density Difference

1.50

1.60

1.70

1.80

1.90

2.00

2.10

2.20

2.30

2.40

2.50

2.60

1-Mar-

06

2-Mar-

06

3-Mar-0

6

6-Mar-

06

7-Mar-0

6

8-Mar-0

6

9-Mar-

06

10-Mar-

06

13-Mar-

06

14-Mar-

06

service

3/14

15-M

ar-06

16-M

ar-06

17-Mar-

06

20-Mar-

06

21-Mar-

06

22-Mar-

06

23-M

ar-06

24-M

ar-06

27-M

ar-06

28-Mar-

06

29-Mar-

06

30-Mar-

06

31-Mar-

06

Date

Density Difference Upper Control Limit = 2.25

Density Difference Daily Value

Density Difference Daily Value Operating Level = 2.1

Density Difference Lower Control Limit = 1.95

HD Step=13 LD Step=10

Northwestern Memorial Hospital - Processor ID: Kodak 8900 - Oct 2006 Density Difference

1.00

1.10

1.20

1.30

1.40

1.50

1.60

1.70

1.80

1.90

2.00

October

2, 200

6

October 3, 2

006

October

4, 200

6

October 5,

2006

Octobe

r 6, 2

006

October 9,

2006

October 1

0, 2006

October 1

1, 200

6

October

12, 20

06

October 13, 2

006

October

16, 20

06

October 17, 2

006

October

18, 20

06

October 19

, 2006

October 2

0, 200

6

October 23

, 2006

October 2

4, 200

6

October 25

, 2006

October 2

6, 200

6

October

27, 20

06

October 3

0, 200

6

Date

Density Difference Upper Control Limit = 1.77

Density Difference Daily Value

Density Difference Daily Value Operating Level = 1.62

Density Difference Lower Control Limit = 1.47

Wet Processing Laser Printer

Slide 51

DDmaxmax

Film ProcessingFilm Processing

Northwestern Memorial Hospital - Processor ID: Kodak 8900 - Oct 2006 Dmax

2.60

2.70

2.80

2.90

3.00

3.10

3.20

3.30

3.40

3.50

3.60

3.70

3.80

3.90

4.00

Octobe

r 2, 2

006

Octobe

r 3, 2

006

Octobe

r 4, 2

006

October

5, 20

06

October

6, 20

06

October

9, 20

06

October

10, 2

006

October

11, 2

006

October

12, 2

006

Octobe

r 13, 2

006

Octobe

r 16,

2006

Octobe

r 17,

2006

Octobe

r 18, 2

006

Octobe

r 19,

2006

October

20, 2

006

October

23, 2

006

Octobe

r 24,

2006

October

25, 2

006

Octobe

r 26,

2006

Octobe

r 27,

2006

Octobe

r 30, 2

006

Octobe

r 31,

2006

Date

Dmax Daily Value

Dmax - Operating Level = 3.44

Dmax Action Limit = 3.19

Laser Printer

Slide 52

ScreenScreen--Film MammoFilm Mammo

–– Evaluate cassettes Evaluate cassettes

FFDMFFDM

–– Evaluate detectorEvaluate detector

–– CR: Imaging PlatesCR: Imaging Plates

ArtifactsArtifacts

Slide 53

XXXXXXXXXXExpose Using AcrylicExpose Using Acrylic

Same as ScreenSame as Screen--FilmFilm

Siemens Siemens NovationNovation

LoradLoradSeleniaSelenia

Fischer Fischer SenoscanSenoscan

GE GE 2000D, 2000D,

DS, DS, EssentialEssential

Fuji Fuji FCRmFCRm

ArtifactsArtifacts ArtifactsArtifacts

Page 10: Digital Mammography Detector QC Introduction Introduction

10

DescriptionDescription: :

GE Good FlatGE Good Flat--field field

ImageImage

ArtifactsArtifacts

DescriptionDescription: :

HologicHologic Good Flat Good Flat

FieldField

ArtifactsArtifacts

DescriptionDescription: Acceptable : Acceptable

ACR Phantom imageACR Phantom image

Raw imageRaw image

WW = 200WW = 200

ArtifactsArtifactsDescriptionDescription: Good : Good imageimage

ArtifactsArtifacts

Artifact evaluation Artifact evaluation –– Contact Mode GE 2000DContact Mode GE 2000D

Mo/MoMo/Mo Mo/Mo/RhRh Rh/RhRh/Rh

ArtifactsArtifactsArtifact evaluation Artifact evaluation -- windowingwindowing

Window width = 30Window width = 30 Window width = 200Window width = 200 Window width = 1000Window width = 1000

ArtifactsArtifacts

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DescriptionDescription: Non: Non--

uniform backgrounduniform background

Possible CausePossible Cause: :

Calibration fileCalibration file

SolutionSolution: Recalibrate: Recalibrate

ArtifactsArtifacts

DescriptionDescription: Low : Low

contrast overallcontrast overall

Possible CausePossible Cause: :

Window width too Window width too

wide wide –– (~750)(~750)

SolutionSolution: Re: Re--window window

ArtifactsArtifacts

DescriptionDescription: Poor : Poor

contrast, fibers and contrast, fibers and

masses failingmasses failing

Possible CausePossible Cause: Ultra low : Ultra low

dose dose –– Mo/Mo, 29 kVp, Mo/Mo, 29 kVp,

25 25 mAsmAs, 0.58 , 0.58 mGymGy

SolutionSolution: Increase : Increase

techniquestechniques

ArtifactsArtifacts

DescriptionDescription: Vertical : Vertical

and horizontal linesand horizontal lines

Possible CausePossible Cause: :

Gridlines, grid Gridlines, grid

artifacts in in cal fileartifacts in in cal file

SolutionSolution: Check grid : Check grid

mechanism, mechanism,

recalibraterecalibrate

ArtifactsArtifacts

ArtifactsArtifacts

DescriptionDescription::

White vertical bandsWhite vertical bands

Possible CausePossible Cause: :

Calibration fileCalibration file

SolutionSolution: :

Recalibrate detectorRecalibrate detector

ArtifactsArtifacts

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DescriptionDescription: : Magnification image, Magnification image, several small flecks, several small flecks, grayscale gradationgrayscale gradation

Possible CausePossible Cause: : Object calibrated into Object calibrated into Cal file, grayscale Cal file, grayscale gradation ~ normalgradation ~ normal

SolutionSolution: Clean : Clean detector and tube detector and tube head, recalibrate head, recalibrate detectordetector

ArtifactsArtifacts

DescriptionDescription: White : White

pixelspixels

Possible CausePossible Cause: :

Detector going badDetector going bad

SolutionSolution: New : New

DetectorDetector

ArtifactsArtifacts

2x2xArtifactsArtifacts 4x4xArtifactsArtifacts

6x6xArtifactsArtifacts 8x8xArtifactsArtifacts

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DescriptionDescription: :

Gridlines, black flecksGridlines, black flecks

Possible CausePossible Cause: Grid : Grid

failure, calibration filefailure, calibration file

SolutionSolution: Grid repair, : Grid repair,

clean the imaging clean the imaging

chain, and recalibratechain, and recalibrate

ArtifactsArtifacts

DescriptionDescription: Image : Image

processing around processing around

wax insertwax insert

Possible CausePossible Cause: :

Image processing Image processing

algorithmalgorithm

SolutionSolution: None: None

ArtifactsArtifacts

DescriptionDescription: Washed out Image: Washed out Image

CauseCause: Phantom not at chest wall edge : Phantom not at chest wall edge

SolutionSolution: Re: Re--position the phantomposition the phantom

ArtifactsArtifacts

DescriptionDescription: :

Linear and Linear and

rectangular rectangular

bandingbanding

Possible CausePossible Cause: :

Calibration fileCalibration file

SolutionSolution: Re: Re--

calibratecalibrate

ArtifactsArtifacts

DescriptionDescription: Shadows just : Shadows just

outside of breast skin lineoutside of breast skin line

Possible CausePossible Cause: Saturated : Saturated

detector due to overexposure detector due to overexposure

from dense breastfrom dense breast

SolutionSolution: Siemens : Siemens

recommends to increase kVp recommends to increase kVp

to reduce exposure time to reduce exposure time

ArtifactsArtifacts

DescriptionDescription: CR : CR --

Noisy Background, Noisy Background,

dark speckdark speck

Possible CausePossible Cause: :

Background Background

somewhat normalsomewhat normal

SolutionSolution: Check : Check

screen and system to screen and system to

identify black speckidentify black speck

ArtifactsArtifacts

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DescriptionDescription: : Horizontal, vertical, Horizontal, vertical, and curved lines and curved lines multiple density multiple density differences differences –– printed printed from from ““flatflat--fieldfield”” menu menu on on LoradLorad SeleniaSeleniaPossible CausePossible Cause: Dirty : Dirty spinner assembly in spinner assembly in optics casting optics casting shadowsshadowsSolutionSolution: Clean : Clean spinner assemblyspinner assembly

Printer

ArtifactsArtifacts

Collimator needs adjustment at chest wall edge

ArtifactsArtifacts

Readout Line Artifact

DescriptionDescription: :

Horizontal and Horizontal and

curving linescurving lines

Possible CausePossible Cause: :

Readout error, Readout error,

ghostingghosting

SolutionSolution: Recalibrate, : Recalibrate,

let detector sit idle, let detector sit idle,

replace detectorreplace detector

ArtifactsArtifactsProcessing Steps for Digital ImagesProcessing Steps for Digital Images

RawRaw ProcessedProcessedImage Detection

Image Correction

Image Processing

Image Display

Calibration File

ArtifactsArtifacts

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Summary on Artifacts•Most artifacts due to calibration file

•Window/level adjustments can appear as AEC and/or exposure problems

•Printers can cause fine, linear streaking artifacts - rare

•Look at technique factors, breast thickness, and breast density for clues

•Objects on bucky, mag stand, and up in tube head often make their way into the image – dust on accessories

•Detectors can, and do, fail

Slide 86

Obtain relevant handsObtain relevant hands--on trainingon training

Must perform manufacturer specific QC testsMust perform manufacturer specific QC tests

Artifacts Artifacts –– most problems can be seen heremost problems can be seen here

ReRe--booting and/or rebooting and/or re--calibrating fixes most calibrating fixes most problemsproblems

Laser PrinterLaser Printer–– DDmaxmax at least 3.5 ODat least 3.5 OD–– MidMid--density about 1.5 ODdensity about 1.5 OD

Key Take Home PointsKey Take Home Points

Slide 87

SAMsSAMs QuestionsQuestions

Slide 88

In digital mammography, who In digital mammography, who mandates the pass/fail criteria for site mandates the pass/fail criteria for site QC?QC?

20%

20%

20%

20%

20%

10

1.1. The American College of RadiologyThe American College of Radiology2.2. The FDAThe FDA3.3. The FFDM unit manufacturerThe FFDM unit manufacturer4.4. NEMANEMA5.5. MQSAMQSA

Slide 89

Answer: 3 Answer: 3 -- The FFDM unit The FFDM unit manufacturer manufacturer

ReferencesReferences

MQSA Regulations 900.12(e)(6)MQSA Regulations 900.12(e)(6)http://www.fda.gov/CDRH/MAMMOGRAhttp://www.fda.gov/CDRH/MAMMOGRAPHY/frmamcom2.html#s90012 PHY/frmamcom2.html#s90012

Slide 90

Answer 3: The FFDM unit Answer 3: The FFDM unit manufacturer manufacturer

ExplanationExplanation

““the quality assurance program shall be the quality assurance program shall be substantially the same as the quality substantially the same as the quality assurance program recommended by the assurance program recommended by the image receptor manufacturer, except that image receptor manufacturer, except that the minimum allowable dose for screenthe minimum allowable dose for screen--film systems in this sectionfilm systems in this section””

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Slide 91

How do you accredit a Fuji CR How do you accredit a Fuji CR Mammography system which uses Mammography system which uses both CR and screenboth CR and screen--film on the same film on the same xx--ray system?ray system?

25%

25%

25%

25%

10

1.1. As 1 mammography unit?As 1 mammography unit?

2.2. As 2 mammography units?As 2 mammography units?

3.3. You cannot use CR and film on the same You cannot use CR and film on the same unit.unit.

4.4. CR is exempt from accreditationCR is exempt from accreditation

Slide 92

Answer: 2 Answer: 2 –– As 2 mammography As 2 mammography units units

ReferencesReferences

http://www.acr.org/accreditation/mammography/http://www.acr.org/accreditation/mammography/mammo_faq/mammo_faq_mamac.aspx#8.0.1mammo_faq/mammo_faq_mamac.aspx#8.0.1

Slide 93

Answer: 2 Answer: 2 -- As 2 mammography As 2 mammography unitsunits

ExplanationExplanation

As of November 15, 2006 facilities using As of November 15, 2006 facilities using both screenboth screen--film and CR on the same film and CR on the same mammography units must accredit these mammography units must accredit these 2 systems as 2 separate units.2 systems as 2 separate units.

Slide 94

What are the minimum passing ACR What are the minimum passing ACR phantom scores for the Siemens phantom scores for the Siemens NovationNovationDR for weekly QC?DR for weekly QC?

20%20%

20%20%20%

10

1.1. 5 Fibers, 4 Speck Groups, 3 Masses5 Fibers, 4 Speck Groups, 3 Masses2.2. 4 Fibers, 3 Speck Groups, 3 Masses4 Fibers, 3 Speck Groups, 3 Masses3.3. 5 Fibers, 4 Speck Groups, 4 Masses5 Fibers, 4 Speck Groups, 4 Masses4.4. 4 Fibers, 4 Speck Groups, 3 Masses4 Fibers, 4 Speck Groups, 3 Masses5.5. 4 Fibers, 4 Speck Groups, 4 Masses4 Fibers, 4 Speck Groups, 4 Masses

Slide 95

Answer 3Answer 3: : 5 Fibers, 4 Speck Groups, 4 5 Fibers, 4 Speck Groups, 4 MassesMasses

ReferencesReferences

Siemens. Siemens Quality Control Siemens. Siemens Quality Control Manual Version 05, Manual Version 05, ErlanganErlangan, Germany. , Germany. 20072007

Slide 96

Answer 3Answer 3: : 5 Fibers, 4 Speck Groups, 4 5 Fibers, 4 Speck Groups, 4 MassesMasses

ExplanationExplanation

The Siemens The Siemens NovationNovation DR QC manual states that DR QC manual states that the ACR Phantom minimum passing scores the ACR Phantom minimum passing scores are as follows:are as follows:

5 Fibers5 Fibers4 Speck Groups 4 Speck Groups 4 Masses4 Masses

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Slide 97

For FFDM, the exposure for a single CC For FFDM, the exposure for a single CC view of the ACR Phantom shall not exceed?view of the ACR Phantom shall not exceed?

20%

20%

20%

20%

20%

10

1.1. 0.75 0.75 mGymGy/exposure/exposure2.2. 1.25 1.25 mGymGy/exposure/exposure3.3. 2.00 2.00 mGymGy/exposure/exposure4.4. 3.00 3.00 mGymGy/exposure/exposure5.5. 4.00 4.00 mGymGy/exposure/exposure

Slide 98

Answer 4Answer 4: 3.00 : 3.00 mGymGy/exposure/exposure

ReferencesReferences

900.12(e)(5)(vi): 900.12(e)(5)(vi): DosimetryDosimetry. The . The average glandular dose delivered during average glandular dose delivered during a single a single craniocaudalcraniocaudal view of an FDAview of an FDA--accepted phantom simulating a standard accepted phantom simulating a standard breast shall not exceed 3.0 breast shall not exceed 3.0 milligraymilligray((mGymGy) (0.3 ) (0.3 radrad) per exposure. The dose ) per exposure. The dose shall be determined with technique shall be determined with technique factors and conditions used clinically for factors and conditions used clinically for a standard breast. a standard breast.

Slide 99

Answer 4Answer 4: 3.00 : 3.00 mGymGy/exposure/exposure

ExplanationExplanation

The FDA requires:The FDA requires:

3.00 3.00 mGymGy/exposure/exposure

Slide 100

To meet the FDA requirement for continuing To meet the FDA requirement for continuing experience, how many mammography experience, how many mammography facilities and mammography unit surveys facilities and mammography unit surveys must be performed within the previous 24 must be performed within the previous 24 months?months?

20%

20%

20%

20%

20%

10

1.1. 6 Facilities and 2 mammography units6 Facilities and 2 mammography units2.2. 4 Facilities and 12 mammography units4 Facilities and 12 mammography units3.3. 2 Facilities and 6 mammography units2 Facilities and 6 mammography units4.4. 1 Facilities and 6 mammography units1 Facilities and 6 mammography units5.5. 2 Facilities and 12 mammography units2 Facilities and 12 mammography units

Slide 101

Answer 3Answer 3: : 2 Facilities and 6 Mammography 2 Facilities and 6 Mammography UnitsUnits

ReferencesReferences

http://www.fda.gov/CDRH/MAMMOGRAPHY/robohelp/http://www.fda.gov/CDRH/MAMMOGRAPHY/robohelp/START.HTMSTART.HTM900.12(a)(3)(iii)(B): Continuing experience. Following 900.12(a)(3)(iii)(B): Continuing experience. Following the second anniversary date of the end of the calendar the second anniversary date of the end of the calendar quarter in which the requirements of paragraphs quarter in which the requirements of paragraphs (a)(3)(i) and (a)(3)(ii) of this section were completed or (a)(3)(i) and (a)(3)(ii) of this section were completed or of April 28, 1999, whichever is later, the medical of April 28, 1999, whichever is later, the medical physicist shall have surveyed at least two physicist shall have surveyed at least two mammography facilities and a total of at least six mammography facilities and a total of at least six mammography units during the 24 months immediately mammography units during the 24 months immediately preceding the date of the facilitypreceding the date of the facility’’s annual MQSA s annual MQSA inspection or the last day of the calendar quarter inspection or the last day of the calendar quarter preceding the inspection or any date in between the preceding the inspection or any date in between the two. The facility shall choose one of these dates to two. The facility shall choose one of these dates to determine the 24determine the 24--month period. No more than one month period. No more than one survey of a specific facility within a 10survey of a specific facility within a 10--month period or month period or a specific unit within a period of 60 days can be a specific unit within a period of 60 days can be counted towards this requirement. counted towards this requirement.

Slide 102

Answer 3Answer 3: : 2 Facilities and 6 Mammography 2 Facilities and 6 Mammography UnitsUnits

ExplanationExplanation

The FDA requires:The FDA requires:

2 Facilities2 Facilities6 Mammography Units6 Mammography UnitsWithin past 24 monthsWithin past 24 months

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Slide 103

Thank YouThank You