CR Technology Fuji Mammo CR - AAPM

1

FFDM -FCRm QC Requirements-What You REALLY Need to Know

M elissaC. Martin , M.S.,FACR, FAAPM, FACMP

AAPM Annual Meeting July 28,2008

FDA Appr oval for Mammography

• Fuji FCRmSystemapprovedforMammographyon July 10,2006by theFDA asa FFDM DigitalMammographySystem

CR TechnologyCR Technology

ProtectiveLayerProtective LayerPhoto-stimuablephosphor layerPhoto-stimuablephosphor layer

SupportSupport

J.Ed Barnes,Ph.D.- MTMI

FujiFuji MammoMammo CRCR

•Pixel size 50 micron

•Use dual sided reading to DQE

•Imaging Plate has thicker phosphor layer

•Results in 40-50% increase in NEQ (DQE)

•Post processing enhances image

(e.g. filtering to recognize and enhancecalcifications)

J. Ed Barnes,Ph.D.- MTMI

2

FCMFCM

J.Ed Barnes,Ph.D. - MTMI

１mm

１mm

EnlargedImages

Standard System (100 micron pixel)

FCRm (50 micron pixel)Dual side scanJ. Ed Barnes, Ph.D.- MTMI

Fuji SystemComponents

ClearView -CSm

Breast Imagi ng Review Statio n

ClearView -1mFlash Plus IIPm

J.Ed Barnes, Ph.D.- MTMI

Fuji ClearviewCSm Reader

• Four cassettestacker

• Processes20 screeningexams/hour(or 100CR plates/hour)

• Multi -objectiveFrequencyProcessing(MFP)(enhancesdense/peripheral tissue)

• PatternEnhancement ProcessingforMammography (PEM)(enhancescalcifications)

J.Ed Barnes, Ph.D.,- MTMI

3

OtherCR MammographyVenders- World Wide

•Agfa

•Kodak

•Konica

•Canon

J. Ed Barnes,Ph.D.- MTMI

KodakMammography CR•Singlesidedplate•Thinnerphosphorlayer (improvesresolution,reducesDQE)•Phosphorgrain smallerandhomogenous•BaFBr:Eu phospor•48.5micron pixel•Readout speed reduced

•Twice asslow•IncreasesSNR•Useconventional reader(modified)

J.Ed Barnes,Ph.D.- MTMI

Agfa CR Mammography

•Single sidedplate, flexible

•BaSrFBrI:Eu phosphor

•Smaller grain powdered phosphor

•50 micron pixel

•Scanslower thanconventional CR

•Wider light collection guide

•Thinner plateto increaseresolution


KonicaCR Mammography

•Single sidedplate, rigid

•BaFI:Eu phosphor

•43.75micronpixel

•Utilize “PhasedContrastCR”

•Exposebreaston a mag platformto a 14x17cassette

•Demagnify to a 24x30cm image(air grid)

J. Ed Barnes,Ph.D. - MTMI

4

CR MammographySystems

for AGFA, FUJI,KODAK, KONICA

“ All measurements wereequivalenttoor exceeded theperformanceof a typicalmodernfilm/screensystem”

FromCentre for Evidence-basedPurchasingReport 06047, October2006


PSPRadiography(CR)

• Currently the majortechnologyavailable for largefield-of-view digital imaging

• Basedupon theprinciplesof photostimulatedluminescence;20+ yearsof experience

• Operationemulatesthescreen-film paradigm in useandhandling.. (flexible but laborintensive)

• Manufacturingtrends:– Smaller,faster, lessexpensive

J. Seibert - UC Davis

PSPDetector

• PhotostimulableStoragePhosphor (PSP)

Phosphor PlatePhosphor PlatePhosphor Plate Cassette HolderCassette HolderCassette Holder

• Coating thickness:– Standardresolution: ~100µm BaFBr

– High resolution: ~50-70 µm BaFBr

• Dual-sideread; structured phosphor – CsBr

LaserLaserstimulationstimulation

2 eV2 eVee

Incident xIncident x--raysrays

8 eV8 eV

F center trapF center trapee--PSLPSL

3 eV3 eVeeeeee

J.Seibert, Ph.D. - UC Davis

Computed RadiographyComputed Radiography ““readerreader””

Information panelInformation panel

PlatePlatestackerstacker

FujiFuji

J. Seibert- UC Davis

5

CRCRReaderReader

CR QCCR QCWorkstationWorkstation

Display / ArchiveDisplay / Archive

Laser film printerLaser film printer

DICOM / PACSDICOM / PACS

Image AcquisitionImage Acquisition

CRCR ““systemsystem””: more than the IP: more than the IP’’s and the reader!!s and the reader!!

J.Seibert-UC Davis

Digital ImageNetworking

• Modality Worklist Input (from RIS via HL-7)

• TechnologistQC Workstation– Imagemanipulation processingreconciliation

– ReconciliationandimageQA

• PACS andDICOM– Digital ImagingCommunicationsin Medicine

– Providesstandardfor modality interfaces, storage/retrieval,andprint

• DICOM image output


Photostimulated Luminescence

Incident LaserIncident LaserBeamBeam

PMTPMT

Protective LayerProtective Layer

Phosphor LayerPhosphor Layer

Base SupportBase Support

LightLightScatteringScattering

Laser Light SpreadLaser Light Spread

PhotostimulatedPhotostimulatedLuminescenceLuminescence

"Effective" readout diameter"Effective" readout diameter

ExposedExposedImagingImaging

PlatePlate

Light guideLight guidePSLPSLSignalSignal

J.Seibert - UC Davis

CR PointCR Point--scan readoutscan readout

PMTPMT

PolygonalPolygonalMirrorMirror

LaserLaserSourceSource

Light channeling guideLight channeling guide

Output SignalOutput Signal

ReferenceReferencedetectordetector

CylindricalCylindricalmirrormirrorff--θθ

lenslens

ADCADC

Laser beam:Laser beam:Scan directionScan direction

Plate translation:Plate translation:SubSub--scan directionscan direction

To imageTo imageprocessorprocessor

ADCADC

x= 1279x= 1279y= 1333y= 1333z= 500z= 500

ERASURE → ReuseJ. Seibert- UC Davis

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Scan DirectionScan Direction

SubSub--scan Directionscan Direction

Laser beam deflectionLaser beam deflection

Plate translationPlate translation

Typical CR resolution:35 x 43 cm -- 2.5 lp/mm (200 µm)24 x 30 cm -- 3.3 lp/mm (150 µm)18 x 24 cm -- 5.0 lp/mm (100 µm)

Screen/film resolution:7-10 lp/mm (80 µm - 25 µm)


Phosphor Plate CyclePhosphor Plate Cycle

PSPPSP

Base supportBase support

reusereuse

plate erasure:plate erasure:remove residual signalremove residual signal

light erasurelight erasure

plate exposure:plate exposure:create latent imagecreate latent image

xx--ray exposureray exposure

plate readout:plate readout:extract latent imageextract latent image

laser beam scanlaser beam scan


CR Innovations

• Dual sidereadout

• Mammographyapplications

• High-speedline scan systems(<10sec)

• StructuredPSP

• Low costtable-top CR readers


MirrorMirror


LightErasure

ADC

Light channeling guideLight channeling guide

Cylindrical mirrorCylindrical mirror

LaserLaserSourceSource

ReferenceReferencedetectordetector ff--θθ

lenslens

CRCRcassettecassette

ErasureErasureStageStageTransportTransport

PMTPMTOutput SignalOutput Signal


ADC


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CR Mammography

• Dual-side readout capabilities (increasedDQE)• Fine laser beam spotsize,50µm (10 lp/mm)• Mammography-specificimageprocessing

CR cassette

ConventionalMammo system CR reader

Two cassette sizes

QC workstation

18x2424x30

Scanning laser beam

50 µmspot

2 light guides

Transparent base

Low attenuationcassette, special IP

Fuji CRmSystem

CR PlateReader

CRPlates

SectionF = MedicalPhysicist’s QC Tests

Medical PhysicsAnnual Tests• MammographicUnit AssemblyEvaluation• Collimation Assessment• S-ValueConfirmation• SystemResolution• kVp AccuracyandReproducibility• HVL Measurement• BreastEntranceExposureand GlandularAverage

Dose• RadiationOutputRate• PhantomImageQuality Evaluation

- PrintedImages- Softcopy

8

MedicalPhysicsAnnual Tests• AEC SystemPerformance• SystemArtifact Evaluation• CR ReaderScannerPerformance• Dynamic Range• Primary Erasure

- Additive andMultiplicative Lag Effects• Inter PlateConsistency• Viewing andViewingConditions• ReviewWorkstationTests• Printer Tests• Technologist’s QC

1. Mammographic Unit Assemb ly Evaluatio nPass/Fail/ NA

Free-standing unit is mechanically stable PassAll moving parts move smoothly, without obstructions to motion PassAll locks and detents work properly PassImage receptor holder assembly is free from vibrations PassImage receptor slides smoothly into holder assembly PassImage receptor is held securely by assembly in any orientation PassCompressed breast thickness scale is accurate to +/-0.5 cm, reproducible to +/-2 mm PassPatient or operator is not exposed to sharp or rough edges, or other hazards PassOperator technique control charts are posted PassOperator protected during exposure by adequate radiation shielding PassAll indicator lights working properly PassAuto decompression can be overridden to maintain compression (status displayed) PassManual emergency compression release can be activated in the event of a power failure Pass

Comments: The following four items satisfy MQSA Final Regulations:1.) Upon power interruption, the gantry remains stationary and stable.2.) Under compression, the paddle deflection was: 18x24 cm: 3 mm; 24x30 cm: 4 mm.3.) The collimator light illuminance was 420 lux.4.) The compression paddle indicates the location of the AEC sensor. Compression is set at 31pounds.The technique chart above reflects the results of our measurements and should be posted on the unit.The unit will be used clinically in the Au to-Filter mode.

FCRm Collimati on

Testfor Routinely Used:

Collimator,CompressionPaddle,BuckyCombinations

Target Materials

Fuji CRm System

MeasureExposureRate at Surface of Breast Support

S-Value Confir mation

9

FCRmS ValueConfirmation

• Makeexposureat 25 kVp with Mo/Moto giveexposure> 20 mR

• Exposecassetteat this technique- wait 10 minutesandprocess

• RecordS value

• Calculatethe“ corrected S value”

Action Limit:Corrected S value should not exceed

the range of 120 +/- 20% (96 to 144)

1 - S Value Confirmati on

Date:Exposure Unit ID: Lorad M-IVImage Reader ID: Fuji ClearView CSm

Is the 95%uji ClearView CS

kVp: 25mAs: 3.0

Exposure 1 (mR): 37.0Exposure 2 (mR): 37.1Exposure 3 (mR): 37.0

Average Exposure: 37.0 Exposure readings within 5%? Yes

IP Exposure Time 1: 2.0 IP Read Time 1: 2 minIP Exposure Time 2: 2.0 IP Read Time 2: 2 minIP Exposure Time 3: 2.0 IP Read Time 3: 2 min

S Value 1: 66.0S Value 2: 68.0S Value 3: 65.0

Average S Value: 66.3

Corrected S Value: 122.8

Corrected S Value Pass/Fail? PASSCorrective Action Needed? NO

Descriptio n of Correctiv e Action:Cor rective Act io n Taken? (Yes, No?)

Date of Corrective Action:Resu lts of New Test: (Pass, Fail?)

Comments:

November 21, 2007

FCRmSystemResolution

• Up to 10 lp/mm Test Pattern

• 4 cm Acrylic Phantom

• Parallel andPerpendicular to Tubewith

3-5 degreeangle

Systemlimi ting resolutionmustbe8 lp/mm

+/- 2 lp/mm (6 to 10 lp/mm)

2. Evaluation of System Resol uti on

X-ray Tube Manufacturer: Varian (1/02) Model #: B-115/M-113R

Visible black points: No NoAnode material Mo Mo

Nominal kVp setting 27 25

Nominal mA setting 30 100

Density control setting 0 0mAs 57 124S Value (Digital) 58 63Magnification factor 1.80 CONTACTLimitin g resol ution bars parallel to A-C axis 10 7in line -pairs per mm bars perpendicular to A-C axis 10 7

Action Limit: For Fuji FCRm, if the limi ting resolu tion with the bars paralle lto the anode-cathode axis is < 8 +/2 line-pairs/m m orperpendicul ar to the anode -cathode axis,then a more detailed inve stiga tion of the reasonshould be made and corre ct ive action sho uld betaken.

Fuji CRm

10

FCRmDensityControl Function

4 cm Acrylic, Accreditation PhantomTechnique

Repeatat -2, -1, 0, 1, 2, etc. densitysettings

Record mAs

mAs Changesshouldbe5 to 15%perstep

Densi ty Control Function :

Imaging mode: Film/Screen Focal spot: 0.3 mm MOmA: kVp:Phantom thickness: 4 cm BR-12 Cassette ID: QC

Relati ve to NormalDensity Selector % mAs Density

Setting Change Change5 11.0% Pass4 11.5% Pass3 7.0% Pass2 11.2% Pass1 12.0% Pass0 0% Pass-1 14.4% Pass-2 12.8% Pass-3 9.8% Pass-4 12.2% Pass-5 12.6% Pass

Action Lim it: Each step should result in a 5 to 15% change in mAs.If not, seek service.

75.4

125.0109.098.386.3

201.0187.0166.0146.0

mAs255.0227.0

FCRmReproducibility andImageModeTracking

• 4 cm Acrylic with Clinical Technique

• PositionIon Chamberin Beam

• RecordmAs andExposure

• Repeat3 Times

• Repeatin eachMode(small,large,magandno grid)

Action Limits:

Coefficient of Variationfor Exposuremustnot exceed0.05

No Significant Differencein Exposure betweensmall andlargebucky whenusingsimilar grid

4. Automat ic Exposur e Contro l (AEC) System Perfo rmanceAEC position: #3 Density control: 0Small cassette ID: QC Large cassette ID: 24 x 30

Performance Capabil ity:

CNR PER OBJECT THICKNESSImage Mode: Auto TimeFocal spot: LargeDensity Control 0

Phantom thickness Target/Filter kVpmAs

(Auto) CNR

CNR(relative to

4cm PMMA)Acceptable

Level2 cm Mo/Mo 25 26.5 16.3 1.11 >100%4 cm Mo/Mo 25 131 14.7 1.00 100%6 cm Mo/Rh 30 218 12.5 0.85 >75%8 cm

PASS

Image Mode Trackin gmA: 100Phantom thickness: 4 cm BR-12Anode/Filter: Mo/Mo

Image Mode AEC MODE Target Filter kVp mAs Commentssmall grid Auto Filter Mo Mo 26 146.0 HTC Gridlarge grid Auto Filter Mo Mo 25 113.0 HTC Grid

Magnification/no grid Auto kV Mo Mo 27 57.7 No Grid

11

Fuji CRm System

Dynamic RangeTest

FCRmDynamicRange

• To confirm dynamicrangeof readerandplate

• Use2 and 4 cm acrylic

• Techniquefor 6 cm

• View imageto determineif 3 regionsarevisible anddiscernable

Fuji CRmSystem- CNR Test

PASS

>75%91.6%13.765280.0282.030.0RhMo6 cm

100%100.0%15.030130.0135.025.0MoMo4 cm

>110%114.4%17.19728.027.225.0MoMo2 cm

Acceptablelevel

CNR(relativ e to 4cm

PMMA)CNRmAs

(Manua l)mAs

(Auto )kVpFilterTargetPhantom Thickness

Auto Tim eAEC Mode:

0Density Control:

3Foca l Spot:

Auto Tim eImage Mode:

CNR PER OBJECT THICKNESS

FCRmReader ScannerPerformance

• Establish thatIP Readerandoptics

donot exhibit scanor print ji tter

• Non-Grid Exposure

• Positionrulers in “T” formation

• ExposeandProcess

Action Limit :

Imagemusthavesmoothbordersfree from jaggededges or defects

12

3. CR Reader Scanner Performan ce Test

Date:

Parallel to Chest Wall

Workstation MonitorCorrective Action Needed?Laser Film Printer*Corrective Action Needed?Corrective Action Description?Corrective Action Taken?Date of Corrective ActionResults of New Test

Perpendicular to Chest Wall

Workstation MonitorCorrective Action Needed?Laser Film Printer*Corrective Action Needed?Corrective Action Description?Corrective Action Taken?Date of Corrective ActionResults of New Test

*If hard copy is used for final interpretation.

November 21, 2007

Image Reader ID: Fuji ClearView CSm # 5722213(Required for Annual Surveys; not required for Mammography Equipment Evaluations of new units. However,

Pass

NoNA

NA

NANANA

NA

Acceptance Limits

Acceptance Limits

NANA

NoPass

PassNo

PassNo

FCRmPrimary Erasure

• To assesstheeraseperformanceof reader andplates

Additive: Shoot phantom, process,wait 1 minute,reprocess,changeS value to 10X original, inspectfor visibility of phantomimage

Multiplicative: Shoot& processphantom,shoot 4cm acrylic on samecassette, processand inspectfor visibility of phantomimage

LSG BH: F

Target Filter kVp mAsMo Mo 25 139 Printer:

Accep tabl e?CORRECTIVE ACTIVE NEEDED?CORRECTIVE ACTIVE DESCRIPTCORRECTIVE ACTIVE TAKEN?CORRECTIVE DATE:RESULTS OF NEW TEST:

Target Filter kVp mAsMo Mo 25 139Mo Mo 25 132

Accep tabl e?CORRECTIVE ACTIVE NEEDED?CORRECTIVE ACTIVE DESCRIPTCORRECTIVE ACTIVE TAKEN?CORRECTIVE DATE:RESULTS OF NEW TEST:

The mAs noted on the generator read-out must not change by more than ±15% from the previous test.

Percent Change in mAs:Accep tabl e?

A unif orm 4 cm sheet imageACR MAPP

NA

Multiplicative Lag testExposure con ditio ns

NA

PassNoNANA

ACR MAPP

52

520

Artif act Evaluation

S valu e of the ACR Phanto m Image:

S valu e applied to non-expos ure image (10Times Phantom Image S Value)

Cassette / IP Numb er A30389595C

Additive Lag testExposure con ditio ns

Artif act EvaluationPassNoNA

Pass

NANANA

5.2%

FCRmInter-PlateConsistency

• To confirm x-ray absorption & SNRconsistency

• Exposureplateswith 4 cm acrylic usingclinicaltechnique

• RecordmAs (mustbewithin 10%)

• CalculateSNR

(mustbewithin 15%)

13

Yes69.662Yes133A777, #6

Yes69.521Yes132A111, #5

Yes70.166Yes132A222, #4

Yes70.152Yes132A123, #1

Yes70.952Yes132A234, #2

Yes70.946Yes132A456, #3

Acceptabl eSNRAccept ablemAsCassett e ID

Group: SmallCasset tes

25MoMoAutoTimeExposu re conditions

kVpFil terTargetAEC-mode

Lorad M-IIIExposure Unite ID:

SNR limit is plus or minus15 % from mean.

mAs limit is plus or minus10 % from mean.

Inter PlateConsistency

FCRmCNR perObjectThickness• CNR usingclinical techiquefor 2 cm

• Repeatfor 4 and6 cm

Action Limits:CNR of 2 cm relative to 4 cm must be > 100%

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

Image Mode:Focal Spot:Density Control:AEC Mode:

Phantom Thickness Target Filt er kVpmAs

(Auto)mAs

(Manual)CNR

CNR(relat ive to

4cm PMMA)

Acceptablelevel

2 cm Mo Mo 25.0 26.2 26.0 13.270 100.8% >100%4 cm Mo Mo 25.0 134.0 135.0 13.165 100.0% 100%6 cm Mo Rh 30.0 227.0 225.0 10.890 82.7% >75%

PASS

CNR PER OBJECT THICKNESSAuto Time

L0

Auto Time

FCRmContrastto NoiseRatio Test(CNR)

• To examineconsistencyof CNR ratiomeasuredover time

• Use4 cm Acrylic and0.2mm Aluminum

• ManualTechnique(Mo/Mo, 26 kVp, 125 mAs)

• CalculateCNR using software

Action Limit:+/- 20% of baseline

14

FCRmViewing Conditions

• HardcopyInterpretation: Sameconditionsasto beusedfor screen-film mammography images.Filmmaskingdevicesandhot lights mustbeavailableto theradiologist.

• Softcopy Interpretations: Follow themonitormanufacturer’s QC procedures.If no monitormanufacturer’s QC proceduresavailable, followproceduresoutlined in Fuji QC Manual.

Fuji CRm - Monitor Tests

Site: Med. Img Ctr of So Cal Date of Survey: 4/19/2007

Room #: Reading Room Date of Installation: Apr-07

DOME©E5

Target Value = 500 cd/sq-m

499.2

Serial Numbers

Luminance Value Setting (cd/sq-m)

Left Monitor Right Monitor

703PNKN00028

500.88

703PNKN00011

Is the CXtra icon present in thetaskbar and shown as a green

check mark?

Manual Conformance report forboth displays attached?

Is DICOM calibration Graph forboth displays attached?

NoYes

Yes

Yes

No

No

LaserPrinter-mustbeabletoprint imagesonmammographylaserfilm

FCRmPrinter AnnualQC

• Follow theprinter manufacturer’s QC programfortestprocedures,frequency,performanceandcorrectiveaction.

• If noprinter manufacturer’s QC program,followtheQC programoutlinedin Fuji QC Manual.

• Testsmustbeperformedinitially prior tointerpretinghardcopymammogramsandaftermajor repairsandthenannually.

15

OD Requirements forOD Requirements forHiHi--Resolution Laser ImagersResolution Laser Imagers

Dmax > 3.5 OD

Mid-density > 1.5 OD

10. Breast Entranc e Exposure, AEC Repro duc ibilit y, Average Gland uDose, and Radiat ion Output Rate

Imaging mode: SID (cm):Screen type: Source-detector distance (cm):Film type: Source-bucky distance (cm):Cassette size (cm): Dosimeter used:Field Restriction: Energy correction factor:

Breast thickness (cm)PhantomNominal kVp settingAnode materialFilterAEC modeAEC density control settingMeasured HVL (mm Al)

Breast Entrance Exposur e and AEC Reprodu cibility:

R mAs R mAs R mAs R mAs

Exposure #1 1.581 147.0 1.480 121.0 1.231 89.1 0.705 75.2Exposure #2 1.498 139.0Exposure #3 1.521 142.0Exposure #4 1.501 140.0

Mean values 1.525 142.0 1.480 121.0 1.231 89.1 0.705 75.2Standard deviations (SD) 0.039 3.56

0.025 0.025

Action l imi t: If coe ffic ient of variation for either R or mAs exceeds 0.05, seek service.

Aver age Glandular Dose:

Inv Sq corrected skin exp 1.525 1.480 1.231 0.705

153 159 164 217

233 235 202 153

Action l imi t: If average glandular dose exceeds 300 mrad (3 mGy) for 4.2 cm effec tiv e breas tthickness, seek service or technique adjust ment. Corre cti ve action must be takenbefore furth er examina tions are performed if the test results fail MQSA regulations.

Radiation Output Rate:

3 sec,kVp Anode Filter

SID(cm)

Exp(mR)

mAsTime(sec)

Rate(mR/s)

Kerma(mGy/s)

4.5 cm above 28 Mo Mo 65 4740 300 3 1580 13.8breast support 28 Mo Mo

Air Kerma (mGy/sec) = Exp Rate (mR/s) x 0.00873 mGy/mR

Action l imi t: If output rate is less tha n 800 mR/sec (7.0 mGy air kerma/sec), seek service.

Coeffi cient ofvariati on (CV)

Dose conversion factorfrom Tables 1-3 (mrad/R)Comput ed averagegland ular dose (mrad)

MoAuto Filter

00.3

1.00

DigitalFuji CR

CR18 x 24

656064

Keithley TriadCollimators

RhAuto Time

00.43

4.2RMI 156-15914

28Mo

MoAuto Time

00.32

4.2RMI 156-15914

27Mo

MoAuto Time

00.31

25Mo

4.2RMI 156-15914

26Mo

RMI 156-159144.2

PhantomImageQuality Check

PossibleItems

( 6 )

( 5 )

( 5 )

ProperScoringTechniquesof theACR MammographyAccreditationPhantom

16

Fibers

• Full PointScore

- Full lengthof fiber visible (+/- 1 mm) -usefirst fiber as a referencefor length

- Correct location

- Correct orientation

Fibers

• Half Point Score

- Not all, but > 50%visible

- Correct location

- Correct orientation

- Stop if orientation or bordersnot visible

Fibers- Artifacts

• In WrongLocation of PhantomInsert

– Fiber-like

– At leastasapparent aslastfiber scored

– Diameter andlength> lastscoredfiber

Fibers- Artifacts -Deductions

• Deduct1.0- lastfiber is scoredas wholeandartifact is > 75%of full fiber length

• Deduct0.5- lastfiber is scoredas 1/2 andartifact is > 50%of full fiber length

• Only deductfrom last fiber scored

Action Limits: Minimum of 4 fibersfor all unitsexceptHologic andSiemensFFDM units.Minimumof 5 fibers for Hologic andSiemensFFDM units

17

Speck Groups

Full PointScore

- > 4 specksvisible

- Correctlocations

Half Point Score

- 2 or 3 specks visible

- Correctlocations

SpeckGroups- Artifacts

• Noiseor speck-like

• As apparentaslast specks scored(i.e. - atleastasbright and > diameter)

• Do not subtract bright artifactscausedbydustor emulsion pickoff

Speck Groups- Deductions

• Deduct1-for-1 from scoredspecks

• Only deductfrom thespecks(s) in thelastgroup scored (with eithera 1.0or 0.5score)

SpeckGroups

Action Limit:

Minimumscoreof 3 speck groupsfor all unitsexcept Hologic andSiemensFFDM units

Minimumscoreof 4 speck groupsfor Hologic andSiemensFFDM units

18

MassesScore

• Full Point

- Density differencevisible

- Generally circular(> 75% circumference)

- Correct location

MassesScore

• Half Point

- Density differencevisible

- Not generally circular (< 75%circumference)

- Correctlocation

MassesScore- Arti facts

In Wronglocationof PhantomInsert

- Mass- like

- As apparentaslast mass scored

Deduction

Only deduct from last massscored

MassesScores

Action Limit:

Minimumscoreof 3 massesfor all units exceptHologic andSiemensFFDM units

Minimumscoreof 4 massesfor Hologic andSiemensFFDM units

19

Acceptable PhantomImage

WW = 200 (suggestion)

Description: AcceptableACR Phantom image

Minimum AcceptablePhantom Image Scorefor the Fuji FCRm systemis:4 fibers, 3 speck groups,3 masses

ImageQuality Values

• ThePhantomImageQuality on theFujiCRmsystemwil l reflect very closelywhatwasachievedpreviouslyon thefilm/screensystemin use- expectno significantchangein quality.

Site Name Report DateAddress Survey DateMedic al Physicist's Name Signa tur eX-Ray Unit Manuf acturer ModelDate of Unit Installation Room IDFFDM Image Receptor Mfr FFDM ModelFFDM QC Manual Version: (check one; must use version applicable to system tested; contact mfr if questions)

Accessory Equipment:

Review Workstation*

Laser Film Printer*

Survey Type: Mammo Eqpt Evaluation of new unit (include MQSA Rqmts for Mammo Eqpt checklist) Annual Survey

PASS/FAIL1. S Value Confirmation ( < 120 + 20% [96 < corrected S value < 144])

2. System Resolu tion (8 lp/mm + 2 lp/mm in both directions)

3. CR Reader Scanner Performance4. Imaging Plate (IP) Fog5. Mamm ography Unit Assembly Evaluation6. Collimation Assessmen t Test date if different from above:

Chest wall edge of X-ray field extends to edge of IRDeviation between X-ray field and light field <2% of SIDX-ray field does not extend beyond any side of the IR by more than 2% of SIDPaddle chest wall edge not beyond IR by more than 1% of SID or appear on the image

7. Automatic Exposure Contr ol (AEC) System Perfo rmance Ass essmentAEC density control function meets Fuji performance criteriaReproducibility (CV) for either exposure or mAs is <0.05Image mode tracking meets Fuji performance criteriaCNR per object thickness meets Fuji performance criteria

8. System Artif act Evaluation9. Phantom Image Quality Evaluation Fibers Specks Masses (at least 4 fibers, 3 speck groups & 3 masses)

Phantom IQ (printed images)Phantom IQ (softcopy)Other tests meet Fuji performance criteria (mAs, OD & DD for hardcopy, S value for soft copy)

10. Dynam ic Range11. Primar y Erasure12. Inter -Plate Consistency (variation of mAs within + 10%; SNR within + 15%)

13. kVp Accur acy and Repro ducibil ity Test date if different from above:

Measured average kVp within +5% of indicated kVpkVp coefficient of variation <0.02

14. Dose (average glandular dose for average breast is < 3 mGy [300 mrad]) mrad15. Beam Qualit y Assessment & HVL Measureme nt Test date if different from above:

HVL >kVp/100 mm Al16. Radiation Output Test date if different from above:

Radiation output rate is >800 mR/sec (7.0 mGy/sec) at 28 kVp with Mo/Mo17. Viewing and Viewing Condition s Test date if different from above:

Mammographic viewbox luminance >3000 cd/m^2 (nit)Room illuminance (viewbox surface & seen by observer) <50 lux

18. Review Work station (RWS) Test s** (for all RWS, even if located offsite)

Overall Results ("Pass" means all tests pass; indicate "Fail" if any test fails)

Fuji FCRm

MEDICAL PHYSICIST'S MAMMOGRAPHY QC TEST SUMMARYFull -Field Digital – Fuji

Model QC Manual Version

Medical Phys icist's QC Tests

Manufacturer Location

*FDA recommends that only monitors and printers specifically cleared for FFDM use by FDA’s Office of Device Evaluation (ODE) be used. SeeFDA's Policy Guidance Help System www.fda.gov/CDRH/MAMMOGRAPHY/robohelp/START.HTM

*** YOUR MEDICAL PHYSICIST MUST SUMMARIZE HIS/HER RESULTS ON THIS FORM ***

**FDA requires that all RWS comply with a QC program that is subst antially the same as that recommended by the image receptormanufacture r . If the RWS is FDA-approved, the RWS's QC manual is considered to be "substantially the same" and you may follow it. (Checkwith the RWS manufacturer for their FDA clearance status and QC manual.) If the RWS is not FDA-approved for FFDM, you must follow theQC manual provided by the image receptor manufacturer. (Check with the image receptor manufacturer for their required tests.)

1st edition, 07.2006 897N0602, 2006

On-site Off-site

On-site Off-site

OTHER (write in):

Click in boxes to use drop-down lists

Evaluation of Site's Technolog ist QC Program

PASS/FAILMQSA Regs

1. CNR Weekly Check Weekly2. Phantom Image Weekly3. Visual Checklist Monthly4. Repeat Analysis Quarterly5. Compression Semi-annually6. Printer QC* See FDA guidance7. Review Workstation QC-Overall* See FDA guidance

Medical Physic ist' s Recomm endations for Quality Improvement

MEDICAL PHYSICIST'S MAMMOGRAPHY QC TEST SUMMARY

(Required for Annual Surveys; not required for Mammography Equipment Evaluations of new units. However, medical physicists must reviewthe site's technologist QC program within 45 days and complete this section so that the facility may submit this form along with the entire

Mammography Equipment Evaluation report with their phantom and clinical images to the ACR.)

(Fuji, cont inued)

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Fuji Digital Mammography QCTechnologist’s Tests

TESTCNR-Contrast/NoisePhantom ImagePrinter/Moni torVisual ChecklistRepeatAnalysisCompressionIP Fog

FREQUENCYWeeklyWeekly

Per ManufacturerM onthly

QuarterlySemi-annualSemi-annual


Printer TestsNo film in cassetteImaging Plate should be erased after 8

hours of non-useImaging Plate should be processedor

erased after eachexposurePrin ters are monitored according to the

manufacturer ’s approved QC program


Phantom ImagesTestConfi rms imagequality using ACR PhantomToolsrequired - QC Cassette& ACR Phantom

Method - AEC Exposure,processIP using thePhysics,ACR MAPP Menu

Visually inspect the image. Samescoring methodasMQSA

Correction Period - Before any fur therexaminationsare performed


CNR (Contrast/NoiseRatio) TestEvaluatesNoiseand Contrast using a fixed x-

ray exposureTools needed- 4 cm acrylic block & 0.2mm AlM ethod - Fixed manual techniqueCNR Measurementmust be within +/- 20%Correction Period - Before any further

examinations are performed

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Testsin Accordancewith ACR/MQSAVisual Checklist Monthl yRepeatAnalysis Quarterl y

Compression Test Semi-Annual

Same Action Lim its and Corrective Action asMQSA

IP Fog replacesDarkroom Fog test - SemiAnnual

Review WorkstationQC

(See FDA guidance)

Compression(25-45 lb)

(semi-annually)

Repeat Analysis(≤2% change)

(quarterly)

Visual Checklist(monthly)

DECNOVOCTSEPAUGJULJUNMAYAPRMARFEBJANMonth

Year

Visual Checklist - Technologist QC

FULL-FIELD DIGITAL MAMMOGRAPHY QUALIT Y CONTROL CHECKLIST –FUJI FCRmDaily and Weekly Tests

ReviewWorkstation QC

(See FDAguidance)

Printer QC(See FDAguidance)

Phantom Image(weekly)

CNR WeeklyCheck (weekly)

Initial s

Date

Month

Year


Imaging Plate FogConfirm that the storageconditions of the exposure

room protects the IP cassettes fr om scatter

Tools required - IP CassetteMethod - Tape coin to front of cassetteand place in

storagelocation dur ing test exposures

Visually inspectimagefor visibil ity of coinCorrection Period - Before any fur ther examinations

are performed

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Inter -Plate Consistency- As NeededThe Inter -plate Consistency Test replaces the

ScreenSpeedTest

Must be performedwhen new IPs and/orcassettesare introduced

Can be performed by the QC technologist underQualified Medical Physicist oversight


Inter-Plate Consistency- As NeededConfirm that Imaging Platesusedin the facility

are similar in sensitivity and imagequality

Tools Required - new and existing IPs andCassettes,4 cm acrylic block

Method - ExposecassettesusingAEC (time)Mode

Acceptable results: mAs +/- 10%, SNR +/- 15%

Correction Period - Wi thin 30 daysof the test

Thank You !! !

MelissaC. Martin, M.S., FACRTherapyPhysicsInc.

879West190St., Ste419Gardena,CA 90248

Office Phone:310-217-4114Cell Phone:310-612-8127

e-mail: [email protected]

Documents

CR Technology Fuji Mammo CR - AAPM