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Slide 1

DigitalMammography

Detector QC

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

[email protected] meric.bern [email protected]

Denver Health Medical CenterDenver Health Medical CenterUniversity of Colorad o at Denver and HSCUniv ersit y of Colorado at Denver and HSC

Denver, CODenver , CO

Slide 2

�� What is FFDM QC and why is itWhat 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

AccreditedFFDM units

CertifiedFacilities withFFDM units

Total AccreditedMammo Units

Total CertifiedMammoFacilities

+2,193

+1,375

+45

+5

Difference

5,119

3,366

13,450

8,837

July 1, 2008

2,926

1,991

13,405

8,832

July 1, 2007

Certified Statistics – Past Year

IntroductionIntroduction 8,331 SFM Units

Slide 4

FFDM vs. Date

0%

2%

4%

6%

8%

10%

12%

Ju l-98 Dec-99 Apr-01 Sep-02 Jan-04 May-05 Oct-06

% Fac w Dig

% Units FFDM

GE 2000DGE 2000DApp: Jan 2000App: Jan 2000

FischerFischer SenoscanSenoscanApp: SeptApp: Sept ‘‘0101

LoradLorad CCDCCDApp: MarApp: Mar ‘‘0202

LoradLorad SeleniaSeleniaApp: OctApp: Oct ‘‘0202

SiemensSiemens NovationNovationApp: AugApp: Aug ‘‘0404

GE DSGE DSApp: Feb 2004App: Feb 2004

GE EssentialGE EssentialApp: AprApp: Apr ‘‘0606

FujiFuji FCRmFCRmApp: JulApp: Jul ‘‘0606

2

Slide 5

�� MQSAMQSA

–– Mammography Quality Standards ActMammography Quality Standards Act

�� ACRACR

–– American College of RadiologyAmerican College of Radiology

IntroductionIntroductionSlide 6

ScreenScreen--FilmFilm

Slide 7


Slide 8


3

Slide 9


Slide 10


Slide 11


Slide 12

FFDMFFDM

�� In FFDM, the manufacturer designs and mandates theirIn FFDM, the manufacturer designs and mandates theirown QC programown QC program

�� In FFDM, you must the manufacturersIn FFDM, you must the manufacturers’’ QC programQC program

4

Slide 13

RWSRWS

Slide 14

Vs.Vs.

Slide 15

Quality Control: Why?Quality Control: Why?

�� Reduce exposure to patients andReduce 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 16

What is Quality Control?What is Quality Control?

�� Determination of what isDetermination of what is ““NormalNormal””

�� Detection of what isDetection of what is ““AbnormalAbnormal””

�� Understanding of how to return toUnderstanding of how to return to ““NormalNormal””

fromfrom ““AbnormalAbnormal””

�� In particular, in FFDM, how do you knowIn particular, in FFDM, how do you know

what you are seeing is what it is supposed towhat you are seeing is what it is supposed to

be?be?

5

Slide 17

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

•• Mandate action limitsMandate action limits

–– ManufacturersManufacturers’’ QC may refer to Monitor & PrinterQC 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 imagingMost failures result in stopping clinical imaging

until failure can be correcteduntil failure can be corrected

Before You Begin QCBefore You Begin QCSlide 18

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

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

•• MechanicsMechanics

•• SoftwareSoftware

•• ArtifactsArtifacts

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

Before You BeginBefore You Begin

Slide 19

�� 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 20


��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 testedversion (version used when tested

previously)previously)

6

Slide 21

�� 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–– FischerFischer SenoscanSenoscan–– LoradLorad SeleniaSelenia–– SiemensSiemens NovationNovation–– FujiFuji FCRmFCRm

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

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



PersonnelEquipmentTestingTech QC FormsEquipment EvaluationAnn ual Survey Form s

Slide 23


GE Fischer Fuji

Lorad Siemen s Film

Slide 24

Summary FormsSummary Forms

7

Slide 25


Site Report DateSurvey Date

X-Ray Unit Manufacturer GE Medical Systems ModelDate of Installation Room ID

Medical Physicist Signatu re

GE QC manual version(s) at facility (check all that apply):? 2277390-100 Rev 1, 2000 ? 2277390-100 Rev 3, 2001 ? 2277390-100 Rev 3+ Addendum 2354312-100, 2003? 2371472-100 Rev 0, 2003 ? Mobile 2371698-100Rev 0, 2003 ? SenoAdvantage 2391082-100 Rev 1, 2003

1. Flat Field (as described in radiologic technologist tests)2. Image Quality (Phantom) (as described in radiologic technologist tests)

CNR (required)Change in CNR =0.2 (NA for Equipment Evaluations)

Fibers Specks MassesPhantom IQ Test on AWSPhantom IQ Test on RWS – Left* (* NA for units with SenoPhantom IQ Test on RWS – Right* Advantage workstations)Phantom IQ Test on Printer

3. MTF Measurement (as described in radiologic technologist tests)4. AOP Mode and Signal-to-Noise (SNR) (as described in radiologic technologist tests)5. Collimation Assessment

Deviation between X-ray field and light field is less than 2% of SIDX-ray field does not extend beyond any side of the IR by more than 2% of SIDChest wall edge of compression paddle doesn't extend beyond IR by more than 1% of SID

6. Evaluation of Focal Spot Performa nceMeasured performance within acceptable limits for large focal spotMeasured performance within acceptable limits for small focal spot

7. Breast Entrance Exposure, Average Glandular Dose and Reproduci bil ityAverage glandular dose for average breast is below 3 mGy (300 mrad)Average glandular dose to a 4.2-cm-thick breast on your unit is mradExposure reproducibility (CV) for R and mAs must be less than 0.05

8. Artifact Evaluation and Flat Field Uniform ity9. Viewing Condition Check and Setting10. Monit or Calibration11. Image Quality – SMPTE Pattern12. Analysis of Review Work Station (RWS) or Seno Advantage Screen Uniformit y

(required for Equipment Evaluations and as necessary)13. kVp Accuracy and Reproducibility

Measured average kVp within ±5% of indicated kVpkVp coefficient of variation =0.02

14. Beam Quality Assessment (Half-Value Layer Measurement)15. Radiation Output

Radiation output is =800 mR/s mR/s16. Mammographic Unit Assembly Evaluati on

MEDICAL PHYSICIST'S MAMMOGRAPHY QC TEST SUMMARYFull -Field Digital – GE Medical Systems

Medical Physicist's QC Tests

PASS/FAIL/NA

Senograp he 2000D


X-Ray Unit Manufacturer Model

Date of Installation Room IDMedical Physicist Signature

Fischer QCmanual version ? P-55943-OMIssue 1, Rev. 000 (2002) ? P-55943-OM Issue 1, Rev. 1 (April 2003)? P-55943-OMIssue 1, Rev. 3 (July 2003) ? P-55943-OM Issue 1, Rev. 7 (March 2004)

1. X-Ray Field Size Al ignment and Chest Wall Missed Tissue ChecksX-ray field size aligns with field area indicated onbreast support within =2% SIDChest wall edge of the digital image to the ruler reference mark of breast support is =8.5 mm

2. Compression Paddl e Al ignme ntCompression paddle edges not visible within field of viewChest wall edge of compression paddle extends beyondimage by =1% SID

3. kVp Accuracy TestMeasured average kVp within ±5% of indicated kVpkVp coefficient of variation =0.02

4. Linearity, Reproducibi lit y and AccuracyLinearity <0.08Reproducibility <0.035 for each technique

5. Half-Value Layer and OutputHVL =0.33 mmAl at 30 kVp, 100 mA

6. Dosimetry – Average Glandul ar Dose and OutputAverage glandular dose for average breast is below 3 mGy (300 mrad)Average glandular dose to a4.2-cm-thick breast on your unit is mrad

7. Phantom Image Acquis ition TestNo obvious artifacts(ADU values required for both QCand Equipment Evaluations; P/F results are NA for Equipment Evaluations)Background StDev within +50/-0 ADUcounts of baselineBackground mean within ±100 ADUcounts of baselineADU level difference within ±300 ADUcounts of baseline

8. Image QualityLargest 4 fibers, 3 speck groups and 3 masses Fibers Specks MassesPhantom IQ Test on Review Work Station

9. System Resolution/Scan Speed Uniformit yStandard imaging mode @7 lp/mm: =5 transitions, =10% modulationHigh resolution imaging mode @ 11.1 lp/mm: =5 transitions, =5% modulation

10. Flat Field TestFlat field testDeviations betweencorner ROIs and center within ±20%

11. Geometric Distorti on and Resolut ion Uniformity12. Automatic Decompres sion Control13. System Artifacts14. Image Display Monitor(s) Check (review daily log)15. Image Viewing Room Illumi nance Test (=50 lux)

at facility (check one) :

MEDICAL PHYSICIST'S MAMMOGRAPHY QC TEST SUMMARYFull-Field Digita l - Fisch er


PASS/FAIL/NA

Fischer SenoScan


X-Ray Unit Manufacture r ModelDate of Installation Room IDMedical Physicist Signature

Lorad QC manual version at facil ity (check one) : ? June 11, 2002 ? 9-500-0285, Rev. 002 (2003)

? 9-500-0285, Rev. 003 (2003) ? 9-500-0285, Rev. 004 (2004)

1. Mammographic Unit Assembly EvaluationAutodecompression can be overidden to maintain compression (& status maintained)Manual emergency compression release can be activated in the event of power failure

2. Collimation Assess mentDeviation between X-ray field and light field is less than 2%of SIDX-ray field does not extend beyond any side of the IRby more than 2% of SIDChest wall edge of compression paddle doesn't extend beyond IRby more than 1%of SID

3. Artifact Evaluati onArtifacts were not apparent or not significant

4. kVp Accura cy and Reproduci bil ityMeasured average kVp within ±5% of indicated kVpkVp coefficient of variation =0.02

5. Beam Quality Assessm ent - HVL MeasurementHalf-value layer is within acceptable lower and upper limits at all kVp values tested

6. Evaluation of System Resolut ionMeasured performance within acceptable limits

7. Breast Entrance Exposure and Averag e Glandular DoseAverage glandulardose for average breast is below 3 mGy (300 mrad)Average glandulardose to a 4.2-cm-thick breast on your unit is mrad

8. Radiation Output RateRadiation output rate is greater than 800 mR/sec mR/sec

9. Phantom Image Quality Evaluat ion5 largest fibers, 4 largest speck groups and 4 largest masses are visiblePhantom image quality scores: Fibers Background Optical Density

Specks Disk Optical DensityMasses Disk Contrast

Hard copy background density must be =1.20 (with operating level =1.40)Hard copy density difference over acrylic disk must be =0.35 (with operating level =0.40)

10. Signal-To-Nois e Ratio and Contrast-To-Noi se Ratio Measuremen tSignal-To-Noise Ratio should be equal or greater to 40 SNRContrast-To-Noise Ratio should not vary by more than ±15% CNR

11. Viewbox Lumin ance and Room Illumin anceMammographic viewbox is capable of a luminance of at least 3000 cd/sq m (nit)Room illuminance (viewbox surface as seen by observer) is 50 lux or lessRoom illuminance (monitor surface) is 20 lux or less

12. Softcopy Workstat ion QCWhite level performanceBlack level performanceQuality level performanceUniformity performance

Selenia

MEDICAL PHYSICIST'S MAMMOGRAPHY QC TEST SUMMARYFull-F ield Digital – Lorad

Lorad


PASS/FAIL

••ACR AccreditationACR Accreditation –– Equipment Evaluation FormsEquipment Evaluation Forms


Slide 27


�� ScreenScreen--FilmFilm MammoMammo

–– Ensure locks, detents,Ensure locks, detents, angulationangulation indicators, andindicators, and

mechanical support devices operate properlymechanical support devices operate properly

�� FFDMFFDM

–– SameSame

MammoMammo Unit EvaluationUnit Evaluation

8

Slide 29

�� ScreenScreen--FilmFilm MammoMammo–– 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 chestChest wall edge of compression paddle aligns with chest

wall of receptorwall of receptor

�� FFDMFFDM

–– SameSame

–– MultipleMultiple targetarge/filters and/or multiple paddle positions/filters and/or multiple paddle positions

–– Chest Wall Missed TissueChest Wall Missed Tissue

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

CollimationCollimationSlide 30

CollimationCollimation

XXCompression PlateCompression PlateOverlap on ChestOverlap on ChestWallWall

XXXXChest Wall & MissedChest Wall & MissedTissueTissue

XXXXXXMultiple paddleMultiple paddlepositionspositions

XXXXXXMultiple target/filterMultiple target/filtercombocombo’’ss

XXXXXXXXXXSame as ScreenSame as Screen--FilmFilm

SiemensSiemensNovationNovation

LoradLoradSeleniaSelenia

FischerFischerSenoscanSenoscan

GEGE2000D,2000D,

DS,DS,EssentialEssential

FujiFuji FCRmFCRm

Slide 31


–– 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 ResolutionSlide 32

Spatial ResolutionSpatial Resolution

XXXXMTFMTF

XXXXXXMeasure using LPMeasure using LPphantom on top ofphantom on top ofacrylicacrylic

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




GEGE2000D,2000D,


FujiFuji FCRmFCRm

9

Slide 33

�� Focal Spot EvaluationFocal Spot Evaluation

••Mo/MoMo/Mo

••Rh/RhRh/Rh

••Large & Small SpotsLarge & Small Spots

(1.5(1.5 magmag))

GE 2000D, DS, & EssentialGE 2000D, DS, & EssentialSlide 34

�� MTF MeasurementMTF Measurement –– MonthlyMonthly –– Raw ImageRaw Image

MTF (% ) = (Std. Dev.)x 222/ (Mean Dark ROIMT F (%) = (Std. Dev.)x 222/ (Mean Dark ROI –– Mean Light ROI)Mean Light ROI)

MTF (%) @M TF (%) @ 22 lplp/mm > 58% MTF (%) @/mm > 58% MTF (%) @ 44 lplp/mm > 25%/mm > 25%

GE 2000DGE 2000D

Slide 35

GE 2000DGE 2000D

�� 2000D Addendum: Sub2000D Addendum: Sub--system MTFsystem MTF–– Optional replacement for MTF & Focal spotOptional replacement for MTF & Focal spot

–– No need for filmNo need for film

•• Use specific bar pattern & 4.5 cm acrylic blockUse specific bar pattern & 4.5 cm acrylic block

•• Use ROI tools to calculate subUse ROI tools to calculate sub--system MTFsystem MTF

•• Repeat at 1.8Repeat at 1.8 magmag

Slide 36

�� MTF and CNR MeasurementMTF and CNR Measurement -- WeeklyWeekly–– Test consistency of CNR and ensureTest consistency of CNR and ensure

contrast is adequatecontrast is adequate•• IQST Test toolIQST Test tool

�� Action Limit:Action Limit:–– MTF @ 2MTF @ 2 lplp/mm > 58%, MTF @ 4/mm > 58%, MTF @ 4 lplp/mm > 25%/mm > 25%

–– Change in CNR must not exceed 0.2Change in CNR must not exceed 0.2

GE DS & EssentialGE DS & Essential

10

Slide 37

�� Evaluation of System ResolutionEvaluation of System Resolution–– 55--1515 lplp/mm Test Pattern/mm Test Pattern

�� The system limiting spatial resolution must be:The system limiting spatial resolution must be:> 7> 7 lplp/mm/mm

LoradLorad & Siemens& SiemensSlide 38

�� System ResolutionSystem Resolution

–– Up to 10Up to 10 lplp/mm Test Pattern/mm Test Pattern

–– 4 cm acrylic4 cm acrylic

–– Parallel & Perpendicular to tube with 3Parallel & Perpendicular to tube with 3--55

degree angledegree angle

�� The system limiting spatial resolution must be:The system limiting spatial resolution must be:

> 8> 8 lplp/mm/mm ++ 22 lplp/mm (6 to 10/mm (6 to 10 lplp/mm)/mm)

FujiFuji FCRmFCRm

Slide 39


–– 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 PerformanceSlide 40

AECAEC

XXXXXXXXImage Mode TrackingImage Mode Tracking

XXACR ReproducibilityACR Reproducibility

XXXXXXSNRSNR

XXCNRCNR

XXXXXXDensity ControlDensity ControlFunctionFunction

Same as ScreenSame as Screen--FilmFilm




GEGE2000D,2000D,


FujiFuji FCRmFCRm

11

Slide 41

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

•• Correct techni ques?Correct techni ques ?

•• Adequate SNR?Adequate SNR?

2.5 cm2.5 cmAcrylicAcrylic

4.0 cm4.0 cmAcryli cAcryli c

6.0 cm Acryl ic6.0 cm Acrylic

AcrylicThickness

Target-Filter

SelectedkVp

SelectedmAs

2.5cm Mo-Mo 27 kVp 20-60

4.0 cm Mo-Rh 28 kVp 35-90

6.0cm Rh-Rh 32 kVp 35-90

EachEach ““ rawraw ”” image must have a measured SNR ofimage must have a measured SNR ofat least 50at least 50

GE 2000DGE 2000DSlide 42


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

•• Use builtUse built --in softw are for image acquis itionin softw are for image acqu is ition

•• AOP: STD/AutoAOP: STD/Auto

31314545--9595Rh/RhRh/Rh6060

29294040--9090Rh/RhRh/Rh5050

26262020--6060Mo/MoMo/Mo2525

kVkVmAsmAsTrack/FilterTrack/Filter

Exposure ParametersExposure ParametersFor AOP STD modeFor AOP STD mode olyoly

Acrylic ThicknessAcrylic Thickness(mm)(mm)

SNR must be > 50SNR must be > 50

Slide 43

LoradLorad SeleniaSelenia

�� Automatic Exposure ControlAutomatic Exposure Control

–– AUTOAUTO--FILTERFILTER –– 2, 4, 6, 8 cm2, 4, 6, 8 cm

–– 4 cm (4 cm (--5 thru +5, or5 thru +5, or --3 to +4)3 to +4)

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

inside virtual AEC detectorinside virtual AEC detector

�� Performance CriteriaPerformance Criteria

–– Pixel value should not vary by morePixel value should not vary by more

than 10% of meanthan 10% of mean

–– Exposure compensation steps shallExposure compensation steps shall

meet requirements in pixel value tablemeet requirements in pixel value table

Slide 44

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

–– ACR PhantomACR Phantom

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

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

�� Action Limits:Action Limits:

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

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

SiemensSiemens NovationNovation

12

Slide 45

�� AEC Thickness TrackingAEC Thickness Tracking

–– 2, 4, and 6 cm2, 4, and 6 cm

–– ““ HH”” modemode

–– Max deviat ion = (Max difference / mean value ) * 100Max deviat ion = (Max differenc e / mean value ) * 100

SiemensSiemens NovationNovation DRDRSlide 46

�� Density Control FunctionDensity Control Function

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

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

–– RecordRecord mAsmAs

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

FujiFuji FCRmFCRm

Slide 47

�� Reproducibility & Image Mode TrackingReproducibility & Image Mode Tracking–– 4 cm acrylic with clinical technique4 cm acrylic with clinical technique

–– Position ion chamber in beamPosition ion chamber in beam

–– RecordRecord 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 orCoefficient of variation for Exposure or mAsmAs must not exceedmust not exceed

0.050.05

•• No significant difference in exposure between small and largeNo significant difference in exposure between small and large

buckybucky when using similar gridswhen using similar grids

FujiFuji FCRmFCRmSlide 48

�� 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 beCNR of 2 cm relative to 4 cm must be >> 100%100%

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

FujiFuji FCRmFCRm

13

Slide 49


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

–– Check forCheck 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 50

Detector PerformanceDetector Performance

XXPixel CorrectionPixel Correction

XXGeometric DistortionGeometric Distortion

XXDynamic RangeDynamic Range

XXCR Reader ScannerCR Reader ScannerPerformancePerformance

XXXXGhostingGhosting

XXInterInter--PlatePlateConsistencyConsistency

XXPrimary ErasurePrimary Erasure

XXXXXXDetector CalibrationDetector Calibration

XXXXFlatFlat--Field UniformityField Uniformity

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




GEGE2000D,2000D,


FujiFuji FCRmFCRm

Slide 51

�� Dynamic RangeDynamic Range

–– To confirm the dynamic range of reader and plateTo confirm the dynamic range of reader and plate

–– Use 2 & 4 cm acrylicUse 2 & 4 cm acrylic

–– Technique for 6 cmTechnique for 6 cm

–– View image to determine if 3 regions are visibleView image to determine if 3 regions are visible

and discernableand discernable


�� CR Reader Scanner PerformanceCR Reader Scanner Performance

–– Establish that IP reader & optics do not exhibit scan orEstablish that IP reader & optics do not exhibit scan or

print jitterprint jitter

–– NonNon--grid exposuregrid exposure

–– Position rulers inPosition rulers in ““TT”” formationformation

–– Expose & processExpose & process

–– Action Limit:Action Limit: Image must have smooth borders freeImage must have smooth borders free

from jagged edges or defectsfrom jagged edges or defects

FujiFuji FCRmFCRm

14

Slide 53

�� Primary Erasure (Additive & Multiplicative)Primary Erasure (Additive & Multiplicative)–– To assess the erasure performance of reader andTo assess the erasure performance of reader and

platesplates

–– Additive:Additive: Shoot phantom, process, wait 1 minute,Shoot phantom, process, wait 1 minute,

reprocess, change S value to 10X original,reprocess, change S value to 10X original,

inspect for visibility of phantom imageinspect for visibility of phantom image

–– Multiplicative:Multiplicative: Shoot & process phantom, shoot 4Shoot & process phantom, shoot 4

cm acrylic on same cassette, process and inspectcm acrylic on same cassette, process and inspect

for visibility of phantom imagefor visibility of phantom image


�� InterInter--Plate ConsistencyPlate Consistency

–– To confirm xTo confirm x--ray absorption & SNR consistencyray absorption & SNR consistency

–– Expose plates using clinical technique with 4cmExpose plates using clinical technique with 4cm

acrylicacrylic

–– RecordRecord mASmAS (must be within(must be within ++10%)10%)

–– Calculate SNR (must be withinCalculate SNR (must be within ++15%)15%)

FujiFuji FCRmFCRm

Slide 55

�� FlatFlat--field uniformityfield uniformity

–– Test to ensure detector performance acceptableTest to ensure detector performance acceptable

•• Measures detector uniformity (signal & noise)Measures detector uniformity (signal & noise)

•• Measures bad pixelsMeasures bad pixels

–– System automatically calculates pass/failSystem automatically calculates pass/fail

QAPQAP

GE 2000D, DS, & EssentialGE 2000D, DS, & EssentialSlide 56

�� Detector CalibrationDetector Calibration –– WeeklyWeekly

–– 4 cm acrylic block4 cm acrylic block –– no paddleno paddle

–– Built in Calibration softwareBuilt in Calibration software

–– Follow onFollow on--screen instructionsscreen instructions

•• Review image for artifactsReview image for artifacts

•• Repeat until you have 8 imagesRepeat until you have 8 images

•• End calibrationEnd calibration

•• Calibration is performed automaticallyCalibration is performed automatically


15

Slide 57

�� Detector UniformityDetector Uniformity

–– Make exposure: 28 kV, 50Make exposure: 28 kV, 50 mASmAS ,,

Mo/MoMo/Mo

–– Select ROI 128 x 128 pixelsSelect ROI 128 x 128 pixels

–– Record measurem ents in cornersRecor d measur ements in corners

and centerand center

–– Pixel value insi de each of 5Pixel value insi de each of 5 ROIROI’’ss

shall not diff er by more than 10%shall not diff er by more than 10%

of meanof mean


�� Detector Calibration TestDetector Calibration Test

–– Objective: to determine if systemObjective: to determine if system

was correctly gain calibratedwas correctly gain calibrated

–– Must be done weeklyMust be done weekly

(technologist)(technologist)


–– Acquire 8 imagesAcquire 8 images

–– Images should be free of artifactsImages should be free of artifacts

SiemensSiemens NovationNovation

Slide 59

�� Pixel Correction TestPixel Correction Test

–– Calibration modeCalibration mode

–– Create new pixel mapCreate new pixel map


–– Acquire imageAcquire image

–– Evaluate image is free fromEvaluate image is free from

collimator or debris artifactscollimator or debris artifacts

–– System compiles new pixel mapSystem compiles new pixel map

–– System display resultsSystem display results –– mustmust

meet requirementsmeet requirements



–– Evaluate cassettesEvaluate cassettes

�� FFDMFFDM

–– Evaluate detectorEvaluate detector

–– CR: Imaging PlatesCR: Imaging Plates

ArtifactsArtifacts

16

Slide 61

ArtifactsArtifacts

XXXXXXXXXXExpose Using AcrylicExpose Using Acrylic





GEGE2000D,2000D,


FujiFuji FCRmFCRm

Slide 62

ArtifactsArtifacts

Slide 63

Artifact evaluationArti fact evaluati on

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

ArtifactsArtifactsSlide 64


–– 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

17

Slide 65


XXXXXXXXXXCNRCNR

PartialPartialXXXXClinical TechniqueClinical Technique

XXXXManual TechniquesManual Techniques





GEGE2000D,2000D,


FujiFuji FCRmFCRm

Slide 66

ACR Phantom ImagingACR Phantom Imaging

4433MassesMasses

4433SpecksSpecks

5544FibersFibers

LoradLorad &&SiemensSiemens

GE & Fischer &GE & Fischer &FujiFuji


Slide 67

�� ACR Phantom ImagingACR Phantom Imaging

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

kVpkVp, 125, 125 mASmAS ))

–– Score theScore the process edproc essed imageimage

–– Acquisition workstationAcquisition work stati on

–– Each monitor of the RWSEach monitor of the RWS

–– Laser imagerLaser imager

GE 2000DGE 2000DSlide 68

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

–– To examine consistency of CNRTo examine consistency of CNR

ratio measured over timeratio measured over time

–– Use theUse the rawraw imageimage

–– ++ 20% of baseline20% of baseline

Backg roun d ROIBackg roun d ROI Mass ROIMass ROI

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

GE 2000DGE 2000D

18

Slide 69


�� Phantom Image QualityPhantom Image Quality

–– Manual technique:Manual technique: Rh/RhRh/Rh , 29, 29 kVpkVp, 56, 56 mAsmAs

�� MTF and CNR MeasurementMTF and CNR Measurement

–– Use IQST test toolUse IQST test tool

–– Use builtUse built --in software for image acq uisitionin software for image acq uisition

–– Manual technique:Manual technique: Rh/RhRh/Rh 3030 kVpkVp, 56, 56 mAsmAs

–– Results are autom atically displaye d (pass/fail )Result s are autom atically displayed (pass/fai l)

–– Same action li mits as 2000DSame acti on limits as 2000D

Slide 70

�� Phantom Image Qual ityPhantom Image Quali ty–– Select clinical exposu re mode (i.e. AUTOSelect clinic al exposu re mode (i.e. AUTO--FILTER)FILTER)

–– Print filmPrint film

–– Measure backgrou nd OD and density diff erenceMeasure backgroun d OD and density diff erence ––

Plot on tech worksheet sPlot on tech work sheets

•• Backgroun d must beBackgr oun d must be >> 1.20 OD1.20 OD ++ 0.200.20

•• DD mus t beDD mus t be >> 0.400.40 ++ 0.050.05

–– Score on each Sof t Copy Workstatio nScore on each Soft Copy Workstation

•• 5 fibers5 fibers

•• 4 speck groups4 speck gro ups

•• 4 masses4 masses


Slide 71

�� Phantom Image Qualit yPhantom Image Quality

–– Position phantom 1 cmPosition phantom 1 cm

over chest wall edg eover chest wall edge

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

Mo/MoMo/Mo

–– Score on RWS or FilmScore on RWS or Film

–– FiberFiber >> 55

–– Speck sSpecks >> 44

–– MassesMasses >> 44


�� SNR and CNR MeasurementsSNR and CNR Measurements

–– SNRSNR at leastat least >> 4040

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

•• Obtained during acceptance testingObtained during acceptance testing

LoradLorad & Siemens& Siemens

19

Slide 73

�� 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, 26Manual technique (Mo/Mo, 26 kVpkVp, 125, 125 mAsmAs))

–– Calculate CNR using softwareCalculate CNR using software

–– ++ 20% of baseline20% of baseline



–– Assure that actualAssure that actual kVpkVp isis

•• Accurate (Accurate (++ 5% of indicated)5% of indicated)

•• Reproducible (Reproducible (CoeffCoeff. Var.. Var. << 2%)2%)

�� FFDMFFDM

–– SameSame

kVpkVp

Slide 75


–– Assure HVL is adequate to minimize patientAssure HVL is adequate to minimize patient

dosedose

–– HVL shall meetHVL shall meet FDAFDA’’ss Performance StandardsPerformance Standards

�� FFDMFFDM

–– SameSame

HVLHVL

Note the lead sheetNote the lead sheet

Slide 76


–– Dose for single CC view of ACR phantom shallDose for single CC view of ACR phantom shall

not exceed 3.0not exceed 3.0 mGymGy per exposureper exposure

�� FFDMFFDM

–– SameSame

DoseDose

20

Slide 77


–– System shall be capable of producing aSystem shall be capable of producing a

minimum output of 7.0minimum output of 7.0 mGymGy/sec @ 28/sec @ 28 kVpkVp

Mo/Mo over 3.0 second periodMo/Mo over 3.0 second period

�� FFDMFFDM

–– SameSame

–– S value confirmationS value confirmation

–– Exposure LinearityExposure Linearity

Radiation OutputRadiation OutputSlide 78


–– Luminance (Luminance (>> 3000 cd/m3000 cd/m22))

–– RoomRoom illuminanceilluminance ((<< 5050 luxlux))

–– ViewboxViewbox cleaningcleaning

�� FFDMFFDM

–– SameSame

Viewing & Viewing ConditionsViewing & Viewing Conditions

Slide 79


–– Assess siteAssess site’’s QC programs QC program

–– Check that QC tests are properly performedCheck that QC tests are properly performed

–– Independent checks of tech QC testsIndependent checks of tech QC tests

�� FFDMFFDM

–– SameSame

Assessing Tech QCAssessing Tech QCSlide 80


–– 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 Processing

21

Slide 81

Film Processor QCFilm Processor QC

XXXXFollowFollow FFDMsFFDMs’’ QCQC

XXXXXXIf Not, Use TheirsIf Not, Use Theirs

XXXXXXFollow PrinterFollow PrinterManufacturers QCManufacturers QC




GEGE2000D,2000D,


FujiFuji FCRmFCRm

Slide 82

�� MidMid--DensityDensity

Film ProcessingFilm Processing

Northwestern Memorial Hospital - Proce ssor ID: 2 - MAR 2006Mid-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-M

ar-0

6

3-M

ar-06

6-Mar-0

6

7-M

ar-0

6

8-Mar-0

6

9-M

ar-0

6

10-Mar-0

6

13-M

ar-0

6

14-Mar-0

6

serv

i ce3/1

4

15-M

ar-0

6

16-M

ar-06

17-M

ar-0

6

20-Mar-0

6

21-M

ar-0

6

22-Mar-0

6

23-M

ar-06

24-M

ar-0

6

27-M

ar-06

28-M

ar-0

6

29-Mar-0

6

30-M

ar-06

31-M

ar-0

6

Date

Mid-D ensi ty Upper Contr ol Limit = 2.06

Mid-D ensi ty Daily Value

Mid-D ensi ty Daily Value Oper ating Lev el = 1.91

Mid-D ensi ty Lower Control Limit = 1.76

MD Step=12

Nor thwester n Memorial Hospital - Proces sor ID: Kodak 8900 - Oct 2006Mid-Density

0.70

0.80

0.90

1.00

1.10

1.20

1.30

1.40

1.50

1.60

1.70

Oct

ober 2, 200

6

Oct

ober 3, 200

6

Oct

ober4,

2006

Oct

ober5,

2006

Oct

ober6,

2006

Oct

ober9,

2006

October 10,

2006

October 11,

2006

October 12,

2006

October 13,

2006

October 16,

2006

October 17,

2006

October 18,

2006

October 19,

2006

October 20,

2006

October

23,20

06

October

24,20

06

October

25,20

06

October

26,20

06

October

27, 2

006

October

30, 2

006

Date

Mid-Density Upper Control Limit = 1.48

Mid-Density Daily Valu e

Mid-Density Daily Valu e Operating Level = 1.33

Mid-Density Lower Control Limi t = 1.18

Wet Processing Laser Printer

Slide 83

RWS QCRWS QC

XXXXUse FFDMUse FFDMmanufacturersmanufacturers’’ss QCQC

XXXXXXIf Not, UseIf Not, Use FFDMFFDM’’ss

XXXXXXFollow monitorFollow monitormanufacturers QCmanufacturers QC




GEGE2000D,2000D,


FujiFuji FCRmFCRm

Slide 84

�� AGFA IMPAX MA3000AGFA IMPAX MA3000–– Clean monitor surf aceClean monitor surfa ce–– Measure display white & bla ckMeasure display white & black–– Measure quality levelMeasure quality leve l–– Measure uniformi tyMeasure uniformity–– Calibrate displaysCalibrate displays–– View SMPTE patternView SMPTE pattern–– Viewing conditionsViewing conditions

�� GE Seno AdvantageGE Seno Ad vantage–– Viewing con ditions check and sett ingViewing conditions check and setting–– Monitor calibr ationMonitor calibrati on–– Image qualityImage quali ty –– SMPTE patter nSMPTE pattern–– Anal ysis of scr een uniformi tyAnalysis of scr een unifo rm ity

�� SiemensSiemens Mammo ReportMammoReport PlusPlus–– Geometr ic distortio nGeometric distorti on–– ReflectionReflec tion–– Luminance ResponseLuminance Respons e–– Luminance Uniformit yLuminance Uniformi ty–– ResolutionResolution–– NoiseNoise–– Overall EvaluationOverall Evaluation

22

Slide 85

�� BarcoBarco–– II--Guard CheckGuard Check–– Quality LevelQuality Level–– Display WhiteDisplay White–– Calibr ation Setti ngs CheckCalibration Setti ngs Check

�� EizoEizo–– Pattern CheckPattern Check–– Lumina nce CheckLuminance Check–– Graysca leGrays cale CheckCheck–– Unifor mity CheckUniformity Check

�� PlanarPlanar–– Monitor CleaningMonitor Cleanin g–– Viewing Cond itions CheckViewing Conditi ons Check–– Monitor Calibration CheckMonitor Calibrati on Check–– Image QualityImage Quality –– SMPTESMPTE–– Visual Insp ecti on for DisplayVisual Inspection for Display

DefectsDefec ts

Slide 86

�� Tungsten w/ Silver or RhodiumTungsten w/ Silver or Rhodium

–– CalibrationCalibration: FDA requires all air: FDA requires all air kermakerma measuringmeasuring

instruments be calibrated to NISTinstruments be calibrated to NIST--traceabletraceable

standard for at least one targetstandard for at least one target--filter combination infilter combination in

thethe mammomammo xx--ray rangeray range……,,

–– Do not require such a calibration for W/Ag or W/Do not require such a calibration for W/Ag or W/RhRh

–– May require corrections for solid state instrumentsMay require corrections for solid state instruments

New FDA Hot TopicsNew FDA Hot Topics

Slide 87


–– kVpkVp MeasurementsMeasurements::

•• Scenario 1Scenario 1: If using: If using kVpkVp meter certified for W/Ag ormeter certified for W/Ag or

W/W/RhRh and aand a mammomammo calibrated ion chamber, then okcalibrated ion chamber, then ok

•• Scenario 2Scenario 2: If not, you need to include a correction: If not, you need to include a correction

factor infactor in kVpkVp measurements obtained frommeasurements obtained from kVpkVp metermeter

manufacturer, or, by working with service engineermanufacturer, or, by working with service engineer

and comparing measurementsand comparing measurements

•• Scenario 3Scenario 3: If not W certified and using a separate: If not W certified and using a separate

solidsolid--state probe, then follow scenario 2.state probe, then follow scenario 2.

New FDA Hot TopicsNew FDA Hot TopicsSlide 88


–– HVL MeasurementsHVL Measurements::

•• Scenario 1Scenario 1: If using integrated solid: If using integrated solid--state instrumentstate instrument

that is manufactured for W/Ag or W/that is manufactured for W/Ag or W/RhRh, then ok., then ok.

•• Scenario 2:Scenario 2: If using integrated solidIf using integrated solid--state instrumentstate instrument

that isthat is notnot manufactured for W/Ag or W/manufactured for W/Ag or W/RhRh, then, then

obtain necessary correction factors.obtain necessary correction factors.


23

Slide 89

�� Use of Foam Cushions on FFDMUse of Foam Cushions on FFDM

––FDA recommends using pads for QCFDA recommends using pads for QC

if used clinicallyif used clinically

––Required if manufacturerRequired if manufacturer’’s QCs QC

manuals specifies the pad be presentmanuals specifies the pad be present

during QCduring QC

New FDA Hot TopicsNew FDA Hot TopicsSlide 90

�� QC testing for PrintersQC testing for Printers

–– Follow FFDM manufacturerFollow FFDM manufacturer’’s QC Manuals QC Manual

–– Then, follow printerThen, follow printer’’s QC manuals QC manual

–– To determine the appropriate testingTo determine the appropriate testing


Slide 91

�� The current ACR QC Manual was written forThe current ACR QC Manual was written for

screenscreen--filmfilm–– Most does not apply to digitalMost does not apply to digital

�� Subcommittee on QA is writing new manualSubcommittee on QA is writing new manual–– ChairChair -- EricEric BernsBerns, Ph.D., Ph.D.

–– MembersMembers –– Radiologists, technologists, medical physicists, MITARadiologists, technologists, medical physicists, MITA

repsreps

�� Standardize QC tests, performance criteria andStandardize QC tests, performance criteria and

frequencies across all systemsfrequencies across all systems

�� Clinical section specific to digital issuesClinical section specific to digital issues

ACR FFDM QC Manual ProjectACR FFDM QC Manual ProjectSlide 92

�� QC testsQC tests–– Will apply to all manufacturers and modelsWill apply to all manufacturers and models

–– Fewer tests and written to beFewer tests and written to be ““tech friendlytech friendly””

–– New phantom to be more applicable to digital (but usable withNew phantom to be more applicable to digital (but usable with

screenscreen--film)film)

–– When ready, draft will be sent to manufacturers for their inputWhen ready, draft will be sent to manufacturers for their input beforebefore

it is finalit is final

�� When final, ACR will apply for FDA alternativeWhen final, ACR will apply for FDA alternative

standardstandard

�� Hope to have draft completed by end of 2008Hope to have draft completed by end of 2008

ACR FFDM QC Manual ProjectACR FFDM QC Manual Project

24

Slide 93

�� Archive QC images periodically on a CDArchive QC images periodically on a CD

�� Perform flatPerform flat--field imaging before phantomfield imaging before phantom

imaging testsimaging tests

�� Perform testing in the morningPerform testing in the morning

�� Have a system for monitoring theHave a system for monitoring the ““AutoAuto

Print/Auto PushPrint/Auto Push”” functionsfunctions

SuggestionsSuggestionsSlide 94

�� Repeat testRepeat test–– CleanClean plexiglassplexiglass & move slightly& move slightly

�� Questions to ask yourself:Questions to ask yourself:–– Are you using the correct image? Raw vs.Are you using the correct image? Raw vs.

Processed?Processed?

–– Are theAre the ROIROI’’ss in the correct location?in the correct location?

�� ReRe--boot systemboot system

�� Call serviceCall service–– ReRe--calibration solves most image quality problemscalibration solves most image quality problems

Troubleshooting QCTroubleshooting QC

Slide 95

�� Obtain relevant handsObtain relevant hands--on trainingon training

�� Must perform manufacturer specific QC testsMust perform manufacturer specific QC tests

�� ArtifactsArtifacts –– most problems can be seen heremost problems can be seen here

�� ReRe--booting and/or rebooting and/or re--calibrating fixes mostcalibrating 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 PointsSlide 96

�� Review workstation monitorsReview workstation monitors –– look at thelook at the

clinical images!clinical images!–– Do they match?Do they match?

–– Appropriate dark and light levelsAppropriate dark and light levels

�� Be aware of separate QC for printers &Be aware of separate QC for printers &

monitorsmonitors

�� Know, and be involved with, your site QCKnow, and be involved with, your site QC

programprogram

Key Take Home PointsKey Take Home Points

25

Slide 97

SAM QuestionsSAM Quest ions

Digital Mammography QCDigital Mammography QC

EricEric BernsBerns, PhD, PhD

Slide 98

In digital mammography, whoIn digital mammography, whomandates the pass /fail criteria for sitemandates the pass/fail crit eria for siteQC?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 99

Answer: 3Answer: 3 -- The FFDM uni tThe FFDM uni tmanufac turermanufacturer

ReferencesReferences

�� MQSA Regulations 900.12(e)(6)MQSA Regulations 900.12(e)(6)�� http://www.fda.gov/CDRH/MAMMOGRAhttp://www.fda.gov/CDRH/MAMMOGRA

PHY/frmamcom2.html#s90012PHY/frmamcom2.html#s90012

Slide 100

Answe r 3: The FFDM unitAnswer 3: The FFDM unitmanufacturermanufa cturer

ExplanationExplanation

““the quality assurance program shall bethe quality assurance program shall besubstantially the same as the qualitysubstantially the same as the qualityassurance program recommended by theassurance program recommended by theimage receptor manufacturer, except thatimage receptor manufacturer, except thatthe minimum allowable dose for screenthe minimum allowable dose for screen--film systems in this sectionfilm systems in this section””

26

Slide 101

How do you accredit a Fuji CRHow do you accredit a Fuji CRMammograph y system which usesMammograp hy system which usesboth CR and screenboth CR and screen --film on the samefilm on the samexx--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 theYou cannot use CR and film on the

same unit.same unit.4.4. CR is exempt from accreditationCR is exempt from accreditation

Slide 102

Answer: 2Answer: 2 –– As 2 mammograph yAs 2 mamm ographyunitsuni ts


�� 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 103

Answe r: 2Answer: 2 -- As 2 mammographyAs 2 mammographyunitsunits


As of November 15, 2006 facilities usingAs of November 15, 2006 facilities usingboth screenboth screen--film and CR on the samefilm and CR on the samemammography units must accredit thesemammography units must accredit these2 systems as 2 separate units.2 systems as 2 separate units.

Slide 104

What are the min imum passi ng ACRWhat are the mini mum passin g ACRphantom scores for thephantom scores for the Lora dLorad SeleniaSelenia forforweekly QC?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

27

Slide 105

Answer 3Ans wer 3:: 5 Fibers, 4 Speck Grou ps, 45 Fibers, 4 Speck Group s, 4MassesMasses


�� HologicHologic.. LoradLorad SeleniaSelenia Quality ControlQuality ControlManual MANManual MAN--00093, Revision 003,00093, Revision 003,Bedford (MA):Bedford (MA): HologicHologic, 2005, 2005

Slide 106

Answer 3Answe r 3:: 5 Fibers, 4 Speck Grou ps, 45 Fibers , 4 Speck Groups, 4MassesMasses


TheThe LoradLorad SeleniaSelenia QC manual states that the ACRQC manual states that the ACRPhantom minimum passing scores are asPhantom minimum passing scores are asfollows:follows:

�� 5 Fibers5 Fibers�� 4 Speck Groups4 Speck Groups�� 4 Masses4 Masses

Slide 107

To meet the FDA requirement for continuingTo meet the FDA requiremen t for continuingexperienc e, how many mammo grap hyexperience , how many mammog raphyfacilities and mammography uni t surveysfacilities and mammo grap hy unit surveysmust be performed wi th in the previous 24must be per for med with in the previous 24months?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 108

Answer 3Answe r 3:: 2 Facilities and 6 Mammography2 Facilities and 6 MammographyUni tsUni ts


�� http://www.fda.gov/CDRH/MAMMOGRAPHY/robohelp/http://www.fda.gov/CDRH/MAMMOGRAPHY/robohelp/START.HTMSTART.HTM

�� 900.12(a)(3)(iii)(B): Continuing experience. Following900.12(a)(3)(iii)(B): Continuing experience. Followingthe second anniversary date of the end of the calendarthe second anniversary date of the end of the calendarquarter in which the requirements of paragraphsquarter 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 orof April 28, 1999, whichever is later, the medicalof April 28, 1999, whichever is later, the medicalphysicist shall have surveyed at least twophysicist shall have surveyed at least twomammography facilities and a total of at least sixmammography facilities and a total of at least sixmammography units during the 24 months immediatelymammography units during the 24 months immediatelypreceding the date of the facilitypreceding the date of the facility’’s annual MQSAs annual MQSAinspection or the last day of the calendar quarterinspection or the last day of the calendar quarterpreceding the inspection or any date in between thepreceding the inspection or any date in between thetwo. The facility shall choose one of these dates totwo. The facility shall choose one of these dates todetermine the 24determine the 24--month period. No more than onemonth period. No more than onesurvey of a specific facility within a 10survey of a specific facility within a 10--month period ormonth period ora specific unit within a period of 60 days can bea specific unit within a period of 60 days can becounted towards this requirement.counted towards this requirement.

28

Slide 109

Answer 3Ans wer 3:: 2 Facilities and 6 Mammo grap hy2 Facilities and 6 Mammo graphyUnitsUnits


The FDA requires:The FDA requires:

�� 2 Facilities2 Facilities�� 6 Mammography Units6 Mammography Units�� Within past 24 monthsWithin past 24 months

slid e 2 introduction digital mammography what is ffdm qc ... · aver ag egla nd ula rd ose to a 4....

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