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 Technology Protective Layer Photo-stimuable phosphor layer Support J. Ed Barnes, Ph.D. - MTMI

Fuji Mammo CR 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) J. Ed Barnes, Ph.D. - MTMI

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

Enlarged Images 1mm Standard System (100 micron pixel) 1mm J. Ed Barnes, Ph.D. - MTMI FCRm (50 micron pixel) Dual side scan

Fuji System Components Breast Imaging Review Station ClearView-CSm ClearView-1m Flash Plus IIPm J. Ed Barnes, Ph.D. - MTMI

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 J. Ed Barnes, Ph.D. - MTMI

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

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 J. Ed Barnes, Ph.D. - MTMI

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

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 J. Ed Barnes, Ph.D. - MTMI

PSP Radiography (CR) Currently the major technology available for large field-ofview 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 Plate Cassette Holder 8 ev PSL 3 ev e - e 2 ev F center trap Laser stimulation Coating thickness: Standard resolution: ~100 μm BaFBr High resolution: ~50-70 μm BaFBr Incident x-rays x Dual-side read; structured phosphor CsBr J. Seibert, Ph.D. - UC Davis

Computed Radiography reader Fuji Information panel Plate stacker J. Seibert - UC Davis

CR system :: more than the IP s s and the reader!! Image Acquisition DICOM / PACS CR QC Workstation CR Reader J. Seibert - UC Davis Laser film printer Display / Archive

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 J. Seibert - UC Davis

Photostimulated Luminescence Incident Laser Beam Light guide PMT PSL Signal Exposed Imaging Plate Light Scattering Photostimulated Luminescence Laser Light Spread Protective Layer Phosphor Layer "Effective" readout diameter Base Support J. Seibert - UC Davis

CR Point-scan readout Reference detector Laser Source Polygonal Mirror Laser beam: Scan direction f-θ lens Cylindrical mirror Light channeling guide Output Signal PMT ADC x= 1279 To image processor y= 1333 z= 500 Plate translation: Sub-scan direction J. Seibert - UC Davis ERASURE Reuse

Sub-scan Direction Plate 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) Scan Direction Laser beam deflection Screen/film resolution: 7-10 lp/mm (80 μm - 25 μm) J. Seibert - UC Davis

Phosphor Plate Cycle PSP reuse x-ray exposure laser beam scan light erasure Base support plate exposure: create latent image plate readout: extract latent image plate erasure: remove residual signal J. Seibert - UC Davis

CR Innovations Dual side readout Mammography applications High-speed line scan systems (<10 sec) Structured PSP Low cost table-top CR readers J. Seibert - UC Davis

Reference detector Laser Source f-θ lens Cylindrical mirror Light channeling guide CR cassette Mirror PMT Output Signal ADC To image processor ADC To image processor Light Erasure Erasure Stage Transport J. Seibert - UC Davis

CR Mammography Dual-side readout capabilities (increased DQE) Fine laser beam spot size, 50 μm (10 lp/mm) Mammography-specific image processing Conventional Mammo system CR reader QC workstation Low attenuation cassette, special IP Transparent base 50 μm spot 24x30 18x24 CR cassette Two cassette sizes 2 light guides Scanning laser beam

CR Plates Fuji CRm System CR Plate Reader

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 Evaluation Free-standing unit is mechanically stable All moving parts move smoothly, without obstructions to motion All locks and detents work properly Image receptor holder assembly is free from vibrations Image receptor slides smoothly into holder assembly Image receptor is held securely by assembly in any orientation Compressed breast thickness scale is accurate to +/-0.5 cm, reproducible to +/-2 mm Patient or operator is not exposed to sharp or rough edges, or other hazards Operator technique control charts are posted Operator protected during exposure by adequate radiation shielding All indicator lights working properly Auto decompression can be overridden to maintain compression (status displayed) Manual emergency compression release can be activated in the event of a power failure Pass/Fail/NA Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass 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 S-Value Confirmation Measure Exposure Rate at Surface of Breast Support

FCRm S Value Confirmation Make exposure at 25 kvp with Mo/Mo to 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: November 21, 2007 Exposure Unit ID: Lorad M-IV Image Reader ID: Fuji ClearView CSm Is the 95%uji ClearView CS kvp: 25 mas: 3.0 Exposure 1 (mr): 37.0 Exposure 2 (mr): 37.1 Exposure 3 (mr): 37.0 Average Exposure: 37.0 Exposure readings within 5%? Yes IP Exposure Time 1: 2.0 IP Read Time 1: 2 min IP Exposure Time 2: 2.0 IP Read Time 2: 2 min IP Exposure Time 3: 2.0 IP Read Time 3: 2 min S Value 1: 66.0 S Value 2: 68.0 S Value 3: 65.0 Average S Value: 66.3 Corrected S Value: 122.8 Corrected S Value Pass/Fail? Corrective Action Needed? Description of Corrective Action: Corrective Action Taken? (Yes, No?) Date of Corrective Action: Results of New Test: (Pass, Fail?) PASS NO Comments:

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 Fuji CRm Visible black points: No No Anode material Mo Mo Nominal kvp setting 27 25 Nominal ma setting 30 100 Density control setting 0 0 mas 57 124 S Value (Digital) 58 63 Magnification factor 1.80 CONTACT Limiting resolution bars parallel to A-C axis 10 7 in line-pairs per mm bars perpendicular to A-C axis 10 7 Action Limit: For Fuji FCRm, if the limiting resolution with the bars parallel to the anode-cathode axis is < 8 +/2 line-pairs/mm or perpendicular to the anode-cathode axis, then a more detailed investigation of the reason should be made and corrective action should be taken.

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 MO ma: kvp: Phantom thickness: 4 cm BR-12 Cassette ID: QC Relative to Normal Density Selector % mas Density Setting mas Change Change 5 255.0 11.0% Pass 4 227.0 11.5% Pass 3 201.0 7.0% Pass 2 187.0 11.2% Pass 1 166.0 12.0% Pass 0 146.0 0% Pass -1 125.0 14.4% Pass -2 109.0 12.8% Pass -3 98.3 9.8% Pass -4 86.3 12.2% Pass -5 75.4 12.6% Pass Action Limit: Each step should result in a 5 to 15% change in mas. If not, seek service.

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 0.05 No Significant Difference in Exposure between small and large bucky when using similar grid

4. Automatic Exposure Control (AEC) System Performance AEC position: #3 Density control: 0 Small cassette ID: QC Large cassette ID: 24 x 30 Performance Capability: Image Mode: Auto Time Focal spot: Large Density Control 0 CNR PER OBJECT THICKNESS mas (Auto) CNR (relative to 4cm PMMA) Acceptable Level Phantom thickness Target/Filter kvp CNR 2 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 Tracking ma: 100 Phantom thickness: 4 cm BR-12 Anode/Filter: Mo/Mo Image Mode AEC MODE Target Filter kvp mas Comments small grid Auto Filter Mo Mo 26 146.0 HTC Grid large 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 CNR PER OBJECT THICKNESS Image Mode: Focal Spot: Density Control: AEC Mode: Auto Time 3 0 Auto Time Phantom Thickness Target Filter kvp mas (Auto) mas (Manual) CNR CNR (relative to 4cm PMMA) Acceptable level 2 cm Mo Mo 25.0 27.2 28.0 17.197 114.4% >110% 4 cm Mo Mo 25.0 135.0 130.0 15.030 100.0% 100% 6 cm Mo Rh 30.0 282.0 280.0 13.765 91.6% >75% PASS

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 Process Action Limit: Image must have smooth borders free from jagged edges or defects

3. CR Reader Scanner Performance Test Date: November 21, 2007 Image Reader ID: Fuji ClearView CSm # 5722213 (Required for Annual Surveys; not required for Mammography Equipment Evaluations of new units. However, Parallel to Chest Wall Acceptance Limits Workstation Monitor Corrective Action Needed? Laser Film Printer* Corrective Action Needed? Corrective Action Description? Corrective Action Taken? Date of Corrective Action Results of New Test Pass No Pass No NA NA NA NA Perpendicular to Chest Wall Acceptance Limits Workstation Monitor Corrective Action Needed? Laser Film Printer* Corrective Action Needed? Corrective Action Description? Corrective Action Taken? Date of Corrective Action Results of New Test Pass No Pass No NA NA NA NA *If hard copy is used for final interpretation.

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

Cassette / IP Number Additive Lag test Exposure conditions ACR MAPP A30389595C LSG BH: F Target Filter kvp mas Mo Mo 25 139 Printer: S value of the ACR Phantom Image: S value applied to non-exposure image (10 Times Phantom Image S Value) 52 520 Acceptable? CORRECTIVE ACTIVE NEEDED? CORRECTIVE ACTIVE DESCRIPT CORRECTIVE ACTIVE TAKEN? CORRECTIVE DATE: RESULTS OF NEW TEST: Artifact Evaluation Pass No NA NA NA NA Multiplicative Lag test Exposure conditions ACR MAPP A uniform 4 cm sheet image Acceptable? CORRECTIVE ACTIVE NEEDED? CORRECTIVE ACTIVE DESCRIPT CORRECTIVE ACTIVE TAKEN? CORRECTIVE DATE: RESULTS OF NEW TEST: Target Filter kvp mas Mo Mo 25 139 Mo Mo 25 132 Artifact Evaluation Pass No NA NA NA NA The mas noted on the generator read-out must not change by more than ±15% from the previous test. Percent Change in mas: Acceptable? 5.2% Pass

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%)

Inter Plate Exposure Unite ID: Lorad M-III Consistency AEC-mode Target Filter kvp Exposure conditions Auto Time Mo Mo 25 Group: Small Cassettes mas limit is plus or minus 10 % from mean. Cassette ID A456, #3 mas 132 Acceptable Yes SNR 70.946 Accept able Yes SNR limit is plus or minus 15 % from mean. A234, #2 A123, #1 132 132 Yes Yes 70.952 70.152 Yes Yes A222, #4 132 Yes 70.166 Yes A111, #5 132 Yes 69.521 Yes A777, #6 133 Yes 69.662 Yes

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 CNR PER OBJECT THICKNESS Auto Time L 0 Auto Time 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

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 software Action Limit: +/- 20% of baseline

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 Tests Site: Med. Img Ctr of So Cal Date of Survey: 4/19/2007 Room #: Reading Room Date of Installation: Apr-07 DOME E5 Left Monitor Right Monitor Serial Numbers 703PNKN00011 703PNKN00028 Luminance Value Setting (cd/sq-m) 499.2 Target Value = 500 cd/sq-m 500.88 Is the CXtra icon present in the taskbar and shown as a green check mark? Manual Conformance report for both displays attached? Is DICOM calibration Graph for both displays attached? Yes Yes Yes No 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 Hi-Resolution Laser Imagers D max > 3.5 OD Mid-density > 1.5 OD

10. Breast Entrance Exposure, AEC Reproducibility, Average Glandu Dose, and Radiation Output Rate Imaging mode: Digital SID (cm): Screen type: Fuji CR Source-detector distance (cm): Film type: CR Source-bucky distance (cm): Cassette size (cm): 18 x 24 Dosimeter used: Field Restriction: Collimators Energy correction factor: 65 60 64 Keithley Triad 1.00 Breast thickness (cm) Phantom Nominal kvp setting Anode material Filter AEC mode AEC density control setting Measured HVL (mm Al) 4.2 RMI 156-15914 25 Mo Mo Auto Filter 0 0.3 4.2 RMI 156-15914 26 Mo Mo Auto Time 0 0.31 4.2 RMI 156-15914 27 Mo Mo Auto Time 0 0.32 4.2 RMI 156-15914 28 Mo Rh Auto Time 0 0.43 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 75.2 Exposure #2 1.498 139.0 Exposure #3 1.521 142.0 Exposure #4 1.501 140.0 Mean values 1.525 142.0 1.480 121.0 1.231 89.1 0.705 75.2 Standard deviations (SD) 0.039 3.56 Coefficient of variation (CV) 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 Dose conversion factor from Tables 1-3 (mrad/r) 153 159 164 217 Computed average glandular dose (mrad) 233 235 202 153 Action limit: If average glandular dose exceeds 300 mrad (3 mgy) for 4.2 cm effective breast thickness, seek service or technique adjustment. Corrective action must be taken before 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 13.8 breast 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.

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 scored Action 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 Groups Full 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 Groups Action Limit: Minimum score of 3 speck groups for all units except Hologic and Siemens FFDM units Minimum 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 - Artifacts In Wrong location of Phantom Insert - Mass -like - As apparent as last mass scored Deduction Only deduct from last mass scored

Masses Scores Action Limit: Minimum score of 3 masses for all units except Hologic and Siemens FFDM units Minimum score of 4 masses for Hologic and Siemens FFDM units

Acceptable Phantom Image WW = 200 (suggestion) Description: Acceptable ACR Phantom image Minimum Acceptable Phantom Image Score for the Fuji FCRm system is: 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.

MEDICAL PHYSICIST'S MAMMOGRAPHY QC TEST SUMMARY Full-Field Digital Fuji Site Name Report Date Address Survey Date Medical Physicist's Name Signature X-Ray Unit Manufacturer Model Date of Unit Installation Room ID FFDM Image Receptor Mfr Fuji FFDM Model FCRm FFDM QC Manual Version: (check one; must use version applicable to system tested; contact mfr if questions) 1st edition, 07.2006 897N0602, 2006 OTHER (write in): Accessory Equipment: Manufacturer Model Location QC Manual Version Review Workstation* Laser Film Printer* On-site On-site Off-site Off-site *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 Survey Type: Mammo Eqpt Evaluation of new unit (include MQSA Rqmts for Mammo Eqpt checklist) Annual Survey PASS/FAIL 1. 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 Performance 4. Imaging Plate (IP) Fog 5. Mammography Unit Assembly Evaluation 6. Collimation Assessment Test date if different from above: Chest wall edge of X-ray field extends to edge of IR Deviation between X-ray field and light field <2% of SID X-ray field does not extend beyond any side of the IR by more than 2% of SID Paddle chest wall edge not beyond IR by more than 1% of SID or appear on the image 7. Automatic Exposure Control (AEC) System Performance Assessment AEC density control function meets Fuji performance criteria Reproducibility (CV) for either exposure or mas is <0.05 Image mode tracking meets Fuji performance criteria CNR per object thickness meets Fuji performance criteria 8. System Artifact Evaluation 9. Phantom Image Quality Evaluation Fibers Specks Masses (at least 4 fibers, 3 speck groups & 3 masses) Phantom IQ (printed images) Phantom IQ (softcopy) Medical Physicist's QC Tests Click in boxes to use drop-down lists Other tests meet Fuji performance criteria (mas, OD & DD for hardcopy, S value for soft copy) 10. Dynamic Range 11. Primary Erasure 12. 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 kvp kvp coefficient of variation <0.02 14. Dose (average glandular dose for average breast is < 3 mgy [300 mrad]) mrad 15. Beam Quality Assessment & HVL Measurement Test date if different from above: HVL >kvp/100 mm Al 16. Radiation Output Test date if different from above: Radiation output rate is >800 mr/sec (7.0 mgy/sec) at 28 kvp with Mo/Mo 17. 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) **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.) *** YOUR MEDICAL PHYSICIST MUST SUMMARIZE HIS/HER RESULTS ON THIS FORM ***

MEDICAL PHYSICIST'S MAMMOGRAPHY QC TEST SUMMARY (Fuji, continued) Evaluation of Site's Technologist QC Program (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.) PASS/FAIL MQSA Regs 1. CNR Weekly Check Weekly 2. Phantom Image Weekly 3. Visual Checklist Monthly 4. Repeat Analysis Quarterly 5. Compression Semi-annually 6. Printer QC* See FDA guidance 7. Review Workstation QC-Overall* See FDA guidance Medical Physicist's Recommendations for Quality Improvement

Fuji Digital Mammography QC Technologist s Tests TEST CNR-Contrast/Noise Phantom Image Printer/Monitor Visual Checklist Repeat Analysis Compression IP Fog FREQUENCY Weekly Weekly Per Manufacturer Monthly Quarterly Semi-annual Semi-annual

Fuji Digital Mammography QC Technologist s Tests Printer Tests No film in cassette Imaging Plate should be erased after 8 hours of non-use Imaging Plate should be processed or erased after each exposure Printers are monitored according to the manufacturer s approved QC program

Fuji Digital Mammography QC Technologist s Tests Phantom Images Test Confirms image quality using ACR Phantom Tools required - QC Cassette & ACR Phantom Method - AEC Exposure, process IP using the Physics, ACR MAPP Menu Visually inspect the image. Same scoring method as MQSA Correction Period - Before any further examinations are performed

Fuji Digital Mammography QC Technologist s Tests CNR (Contrast/Noise Ratio) Test Evaluates Noise and Contrast using a fixed x- ray exposure Tools needed - 4 cm acrylic block & 0.2 mm Al Method - Fixed manual technique CNR Measurement must be within +/- 20% Correction Period - Before any further examinations are performed

Fuji Digital Mammography QC Technologist s Tests Tests in Accordance with ACR/MQSA Visual Checklist Monthly Repeat Analysis Quarterly Compression Test Semi-Annual Same Action Limits and Corrective Action as MQSA IP Fog replaces Darkroom Fog test - Semi Annual

Visual Checklist - Technologist QC Year Month JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC Visual Checklist (monthly) Repeat Analysis ( 2% change) (quarterly) Compression (25-45 lb) (semi-annually) Review Workstation QC (See FDA guidance)

FULL-FIELD DIGITAL MAMMOGRAPHY QUALITY CONTROL CHECKLIST FUJI FCRm Daily and Weekly Tests Year Month Date Initials CNR Weekly Check (weekly) Phantom Image (weekly) Printer QC (See FDA guidance) Review Workstation QC (See FDA guidance)

Fuji Digital Mammography QC Technologist s Tests Imaging Plate Fog Confirm that the storage conditions of the exposure room protects the IP cassettes from scatter Tools required - IP Cassette Method - Tape coin to front of cassette and place in storage location during test exposures Visually inspect image for visibility of coin Correction Period - Before any further examinations are performed

Fuji Digital Mammography QC Technologist s Tests Inter-Plate Consistency - As Needed The Inter-plate Consistency Test replaces the Screen Speed Test Must be performed when new IPs and/or cassettes are introduced Can be performed by the QC technologist under Qualified Medical Physicist oversight

Fuji Digital Mammography QC Technologist s Tests Inter-Plate Consistency - As Needed Confirm that Imaging Plates used in the facility are similar in sensitivity and image quality Tools Required - new and existing IPs and Cassettes, 4 cm acrylic block Method - Expose cassettes using AEC (time) Mode Acceptable results: mas +/- 10$, SNR +/- 15% Correction Period - Within 30 days of the test

Thank You!!! Melissa C. Martin, M.S., FACR Therapy Physics Inc. 879 West 190 St., Ste 419 Gardena, CA 90248 Office Phone: 310-217-4114 Cell Phone: 310-612-8127 e-mail: Melissa@TherapyPhysics.com