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

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

Melissa C. Martin, M.S., FACR, FAAPM, FACMP

AAPM Annual Meeting July 28, 2008

FDA Approval for Mammography

• Fuji FCRm System approved for Mammography on July 10, 2006 by the FDA as a FFDM Digital Mammography System

CR TechnologyCR TechnologyProtective LayerProtective LayerPhoto-stimuable phosphor layerPhoto-stimuable phosphor layer

SupportSupport

J. Ed Barnes, Ph.D. - MTMI

Fuji Fuji 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 enhance calcifications)


FCMFCM


１mm

１mm

Enlarged Images

Standard System (100 micron pixel)

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

Fuji System Components

ClearView-CSm

Breast Imaging Review Station

ClearView-1m Flash Plus IIPm


Fuji Clearview CSm Reader

• Four cassette stacker• Processes 20 screening exams/hour

(or 100 CR plates/hour)• Multi-objective Frequency Processing (MFP)

(enhances dense/peripheral tissue)• Pattern Enhancement Processing for

Mammography (PEM) (enhances calcifications)

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

Other CR Mammography Venders - World Wide

•Agfa

•Kodak

•Konica

•Canon


Kodak Mammography CR•Single sided plate•Thinner phosphor layer (improves resolution, reduces DQE)•Phosphor grain smaller and homogenous•BaFBr:Eu phospor•48.5 micron pixel•Read out speed reduced

•Twice as slow•Increases SNR•Use conventional reader (modified)


Agfa CR Mammography

•Single sided plate, flexible

•BaSrFBrI:Eu phosphor

•Smaller grain powdered phosphor

•50 micron pixel

•Scan slower than conventional CR

•Wider light collection guide

•Thinner plate to increase resolution


Konica CR Mammography

•Single sided plate, rigid

•BaFI:Eu phosphor

•43.75 micron pixel

•Utilize “Phased Contrast CR”

•Expose breast on a mag platform to a 14x17 cassette

•Demagnify to a 24x30 cm image(air grid)


CR Mammography Systems

for AGFA, FUJI, KODAK, KONICA

“ All measurements were equivalent to or exceeded the performance of a typical modern film/screen system”

From Centre for Evidence-based Purchasing Report 06047, October 2006


PSP Radiography (CR)

• Currently the major technology available for large field-of-view digital imaging

• Based upon the principles of photostimulated luminescence; 20+ years of experience

• Operation emulates the screen-film paradigm in use and handling.. (flexible but labor intensive)

• Manufacturing trends: – Smaller, faster, less expensive

J. Seibert - UC Davis

PSP Detector• Photostimulable Storage Phosphor (PSP)

Phosphor PlatePhosphor PlatePhosphor Plate Cassette HolderCassette HolderCassette Holder

• Coating thickness:– Standard resolution: ~100 μm BaFBr– High resolution: ~50-70 μm BaFBr

• Dual-side read; structured phosphor – CsBr

Laser Laser stimulationstimulation2 eV2 eV

ee

Incident xIncident x--rays rays

8 eV8 eV

F center trapF center trapee--PSLPSL

3 eV3 eVeeeeee

J. Seibert, Ph.D. - UC Davis

Computed Radiography Computed Radiography ““readerreader””

Information panelInformation panel

Plate Plate stackerstacker

FujiFuji


CRCRReaderReader

CR QC CR QC WorkstationWorkstation

Display / ArchiveDisplay / Archive

Laser film printerLaser film printer

DICOM / PACSDICOM / PACS

Image AcquisitionImage Acquisition

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

J. Seibert -UC Davis

Digital Image Networking

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

• Technologist QC Workstation– Image manipulation processing reconciliation– Reconciliation and image QA

• PACS and DICOM– Digital Imaging Communications in Medicine– Provides standard for modality interfaces, storage/retrieval, and

print

• DICOM image output


Photostimulated Luminescence

Incident Laser Incident Laser BeamBeam

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


CR PointCR Point--scan readoutscan readout

PMTPMT

Polygonal Polygonal MirrorMirror

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

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

PSP PSP

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 side readout

• Mammography applications

• High-speed line scan systems (<10 sec)

• Structured PSP

• Low cost table-top CR readers


MirrorMirrorTo imageTo imageprocessorprocessor

LightErasure

ADC

Light channeling guideLight channeling guide

Cylindrical mirrorCylindrical mirror

LaserLaserSourceSource

ReferenceReferencedetectordetector ff--θθ

lenslens

CR CR cassettecassette

ErasureErasureStageStageTransportTransport

PMTPMTOutput SignalOutput Signal

To imageTo imageprocessorprocessor

ADC


CR Mammography

• Dual-side readout capabilities (increased DQE)• Fine laser beam spot size, 50 μm (10 lp/mm)• Mammography-specific image processing

CR cassette

ConventionalMammo system CR reader

Two cassette sizes

QC workstation

18x2424x30

Scanning laser beam

50 μm spot

2 light guides

Transparent base

Low attenuation cassette, special IP

Fuji CRmSystem

CR Plate Reader

CR Plates

Section F = Medical Physicist’s QC Tests

Medical Physics Annual Tests• Mammographic Unit Assembly Evaluation• Collimation Assessment• S-Value Confirmation• System Resolution• kVp Accuracy and Reproducibility• HVL Measurement• Breast Entrance Exposure and Glandular Average

Dose• Radiation Output Rate• Phantom Image Quality Evaluation

- Printed Images- Softcopy

Medical Physics Annual Tests• AEC System Performance• System Artifact Evaluation• CR Reader Scanner Performance• Dynamic Range• Primary Erasure

- Additive and Multiplicative Lag Effects• Inter Plate Consistency• Viewing and Viewing Conditions• Review Workstation Tests• Printer Tests• Technologist’s QC

1. Mammographic Unit Assembly EvaluationPass/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 31 pounds.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 Auto-Filter mode.

FCRm Collimation

Test for Routinely Used:

Collimator, Compression Paddle, Bucky Combinations

Target Materials

Fuji CRm System

Measure Exposure Rate at Surface of Breast Support

S-Value Confirmation

FCRm S Value Confirmation

• Make exposure at 25 kVp with Mo/Moto give exposure > 20 mR

• Expose cassette at this technique- wait 10 minutes and process

• Record S value• Calculate the “corrected S value”Action Limit: Corrected S value should not exceed

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

1 - S Value Confirmation

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: 66.0 S 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

Description of Corrective Action:Corrective Action Taken? (Yes, No?)

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

Comments:

November 21, 2007

FCRm System Resolution

• Up to 10 lp/mm Test Pattern• 4 cm Acrylic Phantom• Parallel and Perpendicular to Tube with

3-5 degree angle

System limiting resolution must be 8 lp/mm +/- 2 lp/mm (6 to 10 lp/mm)

2. Evaluation of System Resolution

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

Visible black points: No NoAnode material Mo MoNominal kVp setting 27 25Nominal mA setting 30 100Density control setting 0 0mAs 57 124S Value (Digital) 58 63Magnification factor 1.80 CONTACTLimiting resolution 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 limiting resolution with the bars parallelto the anode-cathode axis is < 8 +/2 line-pairs/mm orperpendicular to the anode-cathode axis,then a more detailed investigation of the reasonshould be made and corrective action should betaken.

Fuji CRm

FCRm Density Control Function

4 cm Acrylic, Accreditation Phantom Technique

Repeat at -2, -1, 0, 1, 2, etc. density settings

Record mAs

mAs Changes should be 5 to 15% per step

Density Control Function:

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

Relative 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 Limit: 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

FCRm Reproducibility and Image Mode Tracking• 4 cm Acrylic with Clinical Technique• Position Ion Chamber in Beam• Record mAs and Exposure• Repeat 3 Times• Repeat in each Mode (small, large, mag and no grid)

Action Limits:Coefficient of Variation for Exposure must not exceed 0.05No Significant Difference in Exposure between small and

large bucky when using similar grid

4. Automatic Exposure Control (AEC) System PerformanceAEC position: #3 Density control: 0Small cassette ID: QC Large cassette ID: 24 x 30

Performance Capability:

CNR PER OBJECT THICKNESS Image 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 TrackingmA: 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

Fuji CRm System

Dynamic Range Test

FCRm Dynamic Range

• To confirm dynamic range of reader and plate

• Use 2 and 4 cm acrylic• Technique for 6 cm• View image to determine if 3 regions are

visible and discernable

Fuji CRm System - 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

Acceptable level

CNR (relative to 4cm

PMMA)CNRmAs

(Manual)mAs

(Auto)kVpFilterTargetPhantom Thickness

Auto TimeAEC Mode:

0Density Control:

3Focal Spot:

Auto TimeImage Mode:

CNR PER OBJECT THICKNESS

FCRm Reader Scanner Performance

• Establish that IP Reader and optics do not exhibit scan or print jitter

• Non-Grid Exposure• Position rulers in “T” formation• Expose and ProcessAction Limit:Image must have smooth borders free from jagged

edges or defects

3. CR Reader Scanner Performance 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

FCRm Primary Erasure

• To assess the erase performance of reader and plates

Additive: Shoot phantom, process, wait 1 minute, reprocess, change S value to 10X original, inspect for visibility of phantom image

Multiplicative: Shoot & process phantom, shoot 4 cm acrylic on same cassette, process and inspect for visibility of phantom image

LSG BH: FTarget Filter kVp mAs

Mo Mo 25 139 Printer:

Acceptable?CORRECTIVE ACTIVE NEEDED?CORRECTIVE ACTIVE DESCRIPTCORRECTIVE ACTIVE TAKEN?CORRECTIVE DATE:RESULTS OF NEW TEST:

Target Filter kVp mAsMo Mo 25 139Mo Mo 25 132

Acceptable?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:Acceptable?

A uniform 4 cm sheet imageACR MAPP

NA

Multiplicative Lag testExposure conditions

NA

PassNoNANA

ACR MAPP

52

520

Artifact Evaluation

S value of the ACR Phantom Image:S value applied to non-exposure image (10 Times Phantom Image S Value)

Cassette / IP Number A30389595C

Additive Lag testExposure conditions

Artifact EvaluationPassNoNA

Pass

NANANA

5.2%

FCRm Inter-Plate Consistency

• To confirm x-ray absorption & SNR consistency• Exposure plates with 4 cm acrylic using clinical

technique• Record mAs (must be within 10%)• Calculate SNR

(must be within 15%)

Yes69.662Yes133A777, #6

Yes69.521Yes132A111, #5

Yes70.166Yes132A222, #4

Yes70.152Yes132A123, #1

Yes70.952Yes132A234, #2

Yes70.946Yes132A456, #3

AcceptableSNRAcceptablemAsCassette ID

Group: Small Cassettes

25MoMoAuto TimeExposure conditions

kVpFilterTargetAEC-mode

Lorad M-IIIExposure Unite ID:

SNR limit is plus or minus 15 % from mean.

mAs limit is plus or minus 10 % from mean.

Inter PlateConsistency

FCRm CNR per Object Thickness• CNR using clinical techique for 2 cm• Repeat for 4 and 6 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 Filter kVp mAs (Auto)

mAs (Manual) CNR

CNR (relative to

4cm PMMA)

Acceptable level

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 THICKNESS Auto Time

L0

Auto Time

FCRm Contrast to Noise Ratio Test (CNR)• To examine consistency of CNR ratio

measured over time• Use 4 cm Acrylic and 0.2 mm Aluminum• Manual Technique (Mo/Mo, 26 kVp, 125 mAs)• Calculate CNR using softwareAction Limit:+/- 20% of baseline

4. Automatic Exposure Control (AEC) System PerformanceAEC position: #3 Density control: 0Small cassette ID: QC Large cassette ID: 24 x 30

Performance Capability:

CNR PER OBJECT THICKNESS Image 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 TrackingmA: 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

FCRm Viewing Conditions

• Hardcopy Interpretation: Same conditions as to be used for screen-film mammography images. Film masking devices and hot lights must be available to the radiologist.

• Softcopy Interpretations: Follow the monitor manufacturer’s QC procedures. If no monitor manufacturer’s QC procedures available, follow procedures outlined in Fuji QC Manual.

Fuji CRm - Monitor TestsSite: 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

Laser Printer -must be able to print images on mammography laser film

FCRm Printer Annual QC

• Follow the printer manufacturer’s QC program for test procedures, frequency, performance and corrective action.

• If no printer manufacturer’s QC program, follow the QC program outlined in Fuji QC Manual.

• Tests must be performed initially prior to interpreting hard copy mammograms and after major repairs and then annually.

OD Requirements for OD Requirements for HiHi--Resolution Laser ImagersResolution Laser Imagers

Dmax > 3.5 OD

Mid-density > 1.5 OD

10. Breast Entrance Exposure, AEC Reproducibility, Average GlanduDose, and Radiation 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 Exposure and AEC Reproducibility: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 limit: If coefficient of variation for either R or mAs exceeds 0.05, seek service.

Average Glandular Dose:Inv Sq corrected skin exp 1.525 1.480 1.231 0.705

153 159 164 217

233 235 202 153

Action limit: If average glandular dose exceeds 300 mrad (3 mGy) for 4.2 cm effective breastthickness, seek service or technique adjustment. Corrective action must be takenbefore further examinations are performed if the test results fail MQSA regulations.

Radiation Output Rate:

3 sec, kVp Anode Filter SID (cm)

Exp (mR) mAs Time

(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 limit: If output rate is less than 800 mR/sec (7.0 mGy air kerma/sec), seek service.

Coefficient of variation (CV)

Dose conversion factor from Tables 1-3 (mrad/R)Computed average glandular 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

Phantom Image Quality Check

Possible Items ( 6 )

( 5 )

( 5 )

Proper Scoring Techniques of the ACR Mammography Accreditation Phantom

Fibers• Full Point Score

- Full length of fiber visible (+/- 1 mm) -use first fiber as a reference for length- Correct location- Correct orientation

Fibers• Half Point Score

- Not all, but > 50% visible- Correct location- Correct orientation- Stop if orientation or borders not visible

Fibers - Artifacts• In Wrong Location of Phantom Insert

– Fiber-like– At least as apparent as last fiber scored– Diameter and length > last scored fiber

Fibers - Artifacts -Deductions

• Deduct 1.0 - last fiber is scored as whole and artifact is > 75% of full fiber length

• Deduct 0.5 - last fiber is scored as 1/2 and artifact is > 50% of full fiber length

• Only deduct from last fiber scoredAction Limits: Minimum of 4 fibers for all units

except Hologic and Siemens FFDM units. Minimum of 5 fibers for Hologic and Siemens FFDM units

Speck GroupsFull Point Score

- > 4 specks visible- Correct locations

Half Point Score- 2 or 3 specks visible- Correct locations

Speck Groups - Artifacts• Noise or speck-like• As apparent as last specks scored (i.e. - at

least as bright and > diameter)• Do not subtract bright artifacts caused by

dust or emulsion pickoff

Speck Groups - Deductions• Deduct 1-for-1 from scored specks• Only deduct from the specks(s) in the last

group scored (with either a 1.0 or 0.5 score)

Speck GroupsAction Limit:

Minimum score of 3 speck groups for all units except Hologic and Siemens FFDM unitsMinimum score of 4 speck groups for Hologic and Siemens FFDM units

Masses Score• Full Point

- Density difference visible- Generally circular

(> 75% circumference)- Correct location

Masses Score• Half Point

- Density difference visible- Not generally circular (< 75%

circumference)- Correct location

Masses Score - ArtifactsIn Wrong location of Phantom Insert

- Mass - like- As apparent as last mass scored

DeductionOnly deduct from last mass scored

Masses ScoresAction Limit:

Minimum score of 3 masses for all units except Hologic and Siemens FFDM unitsMinimum score of 4 masses for Hologic and Siemens FFDM units

Acceptable Phantom ImageWW = 200 (suggestion)

Description: AcceptableACR Phantom image

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

Image Quality Values

• The Phantom Image Quality on the Fuji CRm system will reflect very closely what was achieved previously on the film/screen system in use - expect no significant change in quality.

Site Name Report DateAddress Survey DateMedical Physicist's Name SignatureX-Ray Unit Manufacturer 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 Resolution (8 lp/mm + 2 lp/mm in both directions)

3. CR Reader Scanner Performance4. Imaging Plate (IP) Fog5. Mammography Unit Assembly Evaluation6. Collimation Assessment 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 Control (AEC) System Performance AssessmentAEC 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 Artifact 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. Dynamic Range11. Primary Erasure12. Inter-Plate Consistency (variation of mAs within + 10%; SNR within + 15%)

13. kVp Accuracy and Reproducibility 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 Quality Assessment & HVL Measurement 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 Conditions 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 Workstation (RWS) Tests** (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 Physicist'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. See FDA'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 substantially the same as that recommended by the image receptor manufacturer . If the RWS is FDA-approved, the RWS's QC manual is considered to be "substantially the same" and you may follow it. (Check with the RWS manufacturer for their FDA clearance status and QC manual.) If the RWS is not FDA-approved for FFDM, you must follow the QC 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 Technologist 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 Physicist's Recommendations 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 review the 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, continued)

Fuji Digital Mammography QCTechnologist’s Tests

TESTCNR-Contrast/NoisePhantom ImagePrinter/MonitorVisual ChecklistRepeat AnalysisCompressionIP Fog

FREQUENCYWeeklyWeekly

Per ManufacturerMonthly

QuarterlySemi-annualSemi-annual


Printer TestsNo film in cassetteImaging Plate should be erased after 8

hours of non-useImaging Plate should be processed or

erased after each exposurePrinters are monitored according to the

manufacturer’s approved QC program


Phantom Images TestConfirms image quality using ACR PhantomTools required - QC Cassette & ACR PhantomMethod - AEC Exposure, process IP using the

Physics, ACR MAPP MenuVisually inspect the image. Same scoring method

as MQSACorrection Period - Before any further

examinations are performed


CNR (Contrast/Noise Ratio) TestEvaluates Noise and Contrast using a fixed x-

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

examinations are performed


Tests in Accordance with ACR/MQSAVisual Checklist MonthlyRepeat Analysis QuarterlyCompression Test Semi-Annual

Same Action Limits and Corrective Action as MQSA

IP Fog replaces Darkroom Fog test - Semi Annual

Review Workstation QC

(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 QUALITY CONTROL CHECKLIST –FUJI FCRmDaily and Weekly Tests

Review Workstation QC

(See FDA guidance)

Printer QC (See FDA guidance)

Phantom Image (weekly)

CNR Weekly Check (weekly)

Initials

Date

Month

Year


Imaging Plate FogConfirm that the storage conditions of the exposure

room protects the IP cassettes from scatterTools required - IP CassetteMethod - Tape coin to front of cassette and place in

storage location during test exposuresVisually inspect image for visibility of coinCorrection Period - Before any further examinations

are performed


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

Screen Speed TestMust be performed when new IPs and/or

cassettes are introducedCan be performed by the QC technologist under

Qualified Medical Physicist oversight


Inter-Plate Consistency - As NeededConfirm that Imaging Plates used in the facility

are similar in sensitivity and image qualityTools Required - new and existing IPs and

Cassettes, 4 cm acrylic blockMethod - Expose cassettes using AEC (time)

ModeAcceptable results: mAs +/- 10$, SNR +/- 15%Correction Period - Within 30 days of the test

Thank You !!!

Melissa C. Martin, M.S., FACRTherapy Physics Inc.

879 West 190 St., Ste 419Gardena, CA 90248

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

e-mail: [email protected]

Documents

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