FFDM -FCRm QC RequirementsWhat You REALLY Need to Know
Melissa C. Martin, M.S.,
FACR, FAAPM, FACMP
FDA Approval for Mammography
• Fuji FCRm System approved for
Mammography on July 10, 2006
by the FDA as a FFDM Digital
Mammography System
AAPM Annual Meeting July 28, 2008
CR Technology
Fuji Mammo CR
Protective Layer
Photo-stimuable phosphor layer
•Pixel size 50 micron
Support
•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
J. Ed Barnes, Ph.D. - MTMI
1
FCM
Enlarged Images
１mm
Standard System (100 micron pixel)
１mm
J. Ed Barnes, Ph.D. - MTMI
Fuji System
Components
ClearView-1m
FCRm (50 micron pixel)
Dual side scan
Fuji Clearview CSm Reader
Breast Imaging Review Station
ClearView-CSm
J. Ed Barnes, Ph.D. - MTMI
• 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)
Flash Plus IIPm
J. Ed Barnes, Ph.D. - MTMI
J. Ed Barnes, Ph.D., - MTMI
2
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)
J. Ed Barnes, Ph.D. - MTMI
Agfa CR Mammography
J. Ed Barnes, Ph.D. - MTMI
Konica CR Mammography
•Single sided plate, rigid
•Single sided plate, flexible
•BaFI:Eu phosphor
•BaSrFBrI:Eu phosphor
•Smaller grain powdered phosphor
•43.75 micron pixel
•50 micron pixel
•Utilize “Phased Contrast CR”
•Scan slower than conventional CR
•Expose breast on a mag platform to a 14x17
cassette
•Wider light collection guide
•Thinner plate to increase resolution
J. Ed Barnes, Ph.D. - MTMI
•Demagnify to a 24x30 cm image
(air grid)
J. Ed Barnes, Ph.D. - MTMI
3
PSP Radiography (CR)
CR Mammography Systems
• Currently the major technology available for large field-ofview digital imaging
for AGFA, FUJI, KODAK, KONICA
“ All measurements were equivalent to
or exceeded the performance of a typical
modern film/screen system”
• 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
From Centre for Evidence-based Purchasing Report 06047, October 2006
J. Ed Barnes, Ph.D. - MTMI
J. Seibert - UC Davis
Computed Radiography “reader”
reader”
PSP Detector
• Photostimulable Storage Phosphor (PSP)
Phosphor Plate
Fuji
Cassette Holder
Information panel
8 eV
PSL
e-
3 eV
F center trap
2 eV
ee
Laser
stimulation
Plate
stacker
Incident xx-rays
• Coating thickness:
– Standard resolution: ~100 µm BaFBr
– High resolution: ~50-70 µm BaFBr
• Dual-side read; structured phosphor – CsBr
J. Seibert, Ph.D. - UC Davis
J. Seibert - UC Davis
4
CR “system”
system”: more than the IP’
IP’s and the reader!!
Image Acquisition
Digital Image Networking
• Modality Worklist Input (from RIS via HL-7)
• Technologist QC Workstation
CR QC
Workstation
DICOM / PACS
Laser film printer
CR
Reader
• PACS and DICOM
– Digital Imaging Communications in Medicine
– Provides standard for modality interfaces, storage/retrieval, and
print
• DICOM image output
J. Seibert UC Davis
Display / Archive
J. Seibert - UC Davis
Photostimulated Luminescence
Incident Laser
Beam
Light guide
CR PointPoint-scan readout
PSL
Signal
PMT
Exposed
Imaging
Plate
– Image manipulation processing reconciliation
– Reconciliation and image QA
Light
Scattering
Photostimulated
Luminescence
Reference
detector
f-θ
lens
Laser
Source
Light channeling guide
Polygonal
Mirror
Output Signal
ADC
Protective Layer
Phosphor Layer
Cylindrical
mirror
Laser beam:
Scan direction
PMT
x= 1279
To image
y= 1333
processor
z= 500
Laser Light Spread
"Effective" readout diameter
Base Support
J. Seibert - UC Davis
Plate translation:
SubSub-scan direction
J. Seibert - UC Davis
ERASURE
Reuse
5
Phosphor Plate Cycle
PSP
SubSub-scan Direction
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)
Base support
x-ray exposure
Plate translation
plate exposure:
create latent image
reuse
laser beam scan
plate readout:
extract latent image
light erasure
Screen/film resolution:
Scan Direction
plate erasure:
remove residual signal
7-10 lp/mm (80 µm - 25 µm)
Laser beam deflection
J. Seibert - UC Davis
J. Seibert - UC Davis
CR Innovations
Reference
detector
Laser
Source
• Dual side readout
Mirror
• High-speed line scan systems (<10 sec)
Light
Erasure
• Low cost table-top CR readers
J. Seibert - UC Davis
Output Signal
To image
processor
ADC
To image
processor
• Structured PSP
PMT
ADC
CR
cassette
• Mammography applications
f-θ Cylindrical mirror
lens
Light channeling guide
Erasure
Stage
Transport
J. Seibert - UC Davis
6
CR Mammography
CR
Plates
• 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
Fuji CRm
System
Transparent base
CR Plate
Reader
50 µm
spot
24x30
18x24
2 light guides
CR cassette
Two cassette sizes
Scanning laser beam
Medical Physics Annual Tests
Section F = Medical
Physicist’s QC 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
7
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
FCRm Collimation
Test for Routinely Used:
Collimator, Compression
Paddle, Bucky
Combinations
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.
Fuji CRm System
S-Value Confirmation
Measure Exposure Rate at Surface of Breast Support
Target Materials
8
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
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)
FCRm System Resolution
kVp:
mAs:
Exposure 1 (mR):
Exposure 2 (mR):
Exposure 3 (mR):
Average Exposure:
25
3.0
37.0
37.1
37.0
37.0
IP Exposure Time 1:
IP Exposure Time 2:
IP Exposure Time 3:
2.0
2.0
2.0
S Value 1:
S Value 2:
S Value 3:
Average S Value:
66.0
68.0
65.0
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?)
System limiting resolution must be 8 lp/mm
+/- 2 lp/mm (6 to 10 lp/mm)
IP Read Time 1:
IP Read Time 2:
IP Read Time 3:
Yes
2 min
2 min
2 min
PASS
NO
Comments:
2. Evaluation of System Resolution
X-ray Tube Manufacturer:
• Up to 10 lp/mm Test Pattern
• 4 cm Acrylic Phantom
• Parallel and Perpendicular to Tube with
3-5 degree angle
Exposure readings within 5%?
Model #:
Varian (1/02)
B-115/M-113R
Fuji CRm
Visible black points:
Anode material
Nominal kVp setting
Nominal mA setting
Density control setting
mAs
S Value (Digital)
Magnification factor
Limiting resolution
in line-pairs per mm
Action Limit:
bars parallel to A-C axis
bars perpendicular to A-C axis
No
No
Mo
Mo
27
30
0
57
58
1.80
10
10
25
100
0
124
63
CONTACT
7
7
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.
9
FCRm Density Control Function
Density Control Function:
Imaging mode:
mA:
Phantom thickness:
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 Selector
Setting
5
4
3
2
1
0
-1
-2
-3
-4
-5
Action Limit:
FCRm Reproducibility and Image
Mode Tracking
Film/Screen Focal spot: 0.3 mm MO
kVp:
4 cm BR-12 Cassette ID: QC
Relative to Normal
% mAs
Density
mAs
Change
Change
255.0
227.0
201.0
187.0
166.0
146.0
125.0
109.0
98.3
86.3
75.4
11.0%
11.5%
7.0%
11.2%
12.0%
0%
14.4%
12.8%
9.8%
12.2%
12.6%
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Each step should result in a 5 to 15% change in mAs.
If not, seek service.
4. Automatic Exposure Control (AEC) System Performance
#3
QC
AEC position:
Small cassette ID:
Density control:
Large cassette ID:
0
24 x 30
Performance Capability:
•
•
•
•
•
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
CNR PER OBJECT THICKNESS
Image Mode:
Focal spot:
Density Control
Phantom thickness
2 cm
4 cm
6 cm
8 cm
Auto Time
Large
0
Target/Filter
kVp
mAs
(Auto)
CNR
CNR
(relative to
4cm PMMA)
Acceptable
Level
Mo/Mo
Mo/Mo
Mo/Rh
25
25
30
26.5
131
218
16.3
14.7
12.5
1.11
1.00
0.85
>100%
100%
>75%
PASS
Image Mode Tracking
mA:
Phantom thickness:
Anode/Filter:
Image Mode
small grid
large grid
Magnification/no grid
100
4 cm BR-12
Mo/Mo
AEC MODE
Target
Filter
kVp
mAs
Comments
Auto Filter
Auto Filter
Auto kV
Mo
Mo
Mo
Mo
Mo
Mo
26
25
27
146.0
113.0
57.7
HTC Grid
HTC Grid
No Grid
10
Fuji CRm System
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
Dynamic Range
Test
Fuji CRm System - CNR Test
FCRm Reader Scanner Performance
CNR PER OBJECT THICKNESS
Image Mode:
Auto Time
Focal Spot:
3
Density Control:
0
AEC Mode:
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%
• 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
PASS
11
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,
FCRm Primary Erasure
Parallel to Chest Wall
• 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
Acceptance Limits
Pass
No
Pass
No
NA
NA
NA
NA
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
Perpendicular to Chest Wall
Acceptance Limits
Pass
No
Pass
No
NA
NA
NA
NA
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
*If hard copy is used for final interpretation.
Cassette / IP Number
A30389595C
Additive Lag test
Exposure conditions
ACR MAPP
LSG BH: F
Target
Mo
Filter
Mo
kVp
25
S value of the ACR Phantom Image:
Acceptable?
CORRECTIVE ACTIVE NEEDED?
CORRECTIVE ACTIVE DESCRIPT
CORRECTIVE ACTIVE TAKEN?
CORRECTIVE DATE:
RESULTS OF NEW TEST:
FCRm Inter-Plate Consistency
520
Artifact Evaluation
Pass
No
NA
NA
NA
NA
Multiplicative Lag test
Exposure conditions
ACR MAPP
A uniform 4 cm sheet image
Printer:
52
S value applied to non-exposure image (10
Times Phantom Image S Value)
Acceptable?
CORRECTIVE ACTIVE NEEDED?
CORRECTIVE ACTIVE DESCRIPT
CORRECTIVE ACTIVE TAKEN?
CORRECTIVE DATE:
RESULTS OF NEW TEST:
mAs
139
Target
Mo
Mo
Filter
Mo
Mo
kVp
25
25
mAs
139
132
Artifact Evaluation
Pass
No
NA
NA
NA
NA
• 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%)
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
12
Inter Plate
Consistency
Lorad M-III
Exposure Unite ID:
Exposure conditions
AEC-mode
Target
Filter
kVp
Auto
Time
Mo
Mo
25
Group: Small
Cassettes
mAs limit is plus or minus
10 % from mean.
SNR limit is plus or minus
15 % from mean.
Cassette ID
mAs
Acceptable
SNR
Accept
able
A456, #3
132
Yes
70.946
Yes
A234, #2
132
Yes
70.952
Yes
A123, #1
132
Yes
70.152
Yes
Yes
A222, #4
132
Yes
70.166
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%
FCRm Contrast to Noise Ratio Test
(CNR)
CNR PER OBJECT THICKNESS
Image Mode:
Focal Spot:
Density Control:
AEC Mode:
Auto Time
L
0
Auto Time
Phantom Thickness
Target
Filter
kVp
mAs
(Auto)
mAs
(Manual)
CNR
CNR
(relative to
4cm PMMA)
Acceptable
level
2 cm
4 cm
6 cm
Mo
Mo
Mo
Mo
Mo
Rh
25.0
25.0
30.0
26.2
134.0
227.0
26.0
135.0
225.0
13.270
13.165
10.890
100.8%
100.0%
82.7%
>100%
100%
>75%
PASS
• 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
13
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.
Laser Printer must be able to
print images
on
mammography
laser film
Fuji CRm - Monitor Tests
Site:
Room #:
Date of Survey: 4/19/2007
Date of Installation: Apr-07
Med. Img Ctr of So Cal
Reading Room
DOME©E5
Serial Num bers
Luminance Value Setting (cd/sq-m)
Left M onitor
Right M onitor
703PNKN00011
703PNKN00028
499.2
500.88
Target Value = 500 cd/sq-m
Is the CXtra icon present in the
taskbar and shown as a green
check m ark?
Yes
No
Manual Conform ance report for
both displays attached?
Yes
No
Is DICOM calibration Graph for
both displays attached?
Yes
No
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.
14
OD Requirements for
HiHi-Resolution Laser Imagers
10. Breast Entrance Exposure, AEC Reproducibility, Average Glandu
Dose, and Radiation Output Rate
Digital
Fuji CR
CR
18 x 24
Collimators
Imaging mode:
Screen type:
Film type:
Cassette size (cm):
Field Restriction:
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
SID (cm):
Source-detector distance (cm):
Source-bucky distance (cm):
Dosimeter used:
Energy correction factor:
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
65
60
64
Keithley Triad
1.00
4.2
RMI 156-15914
28
Mo
Rh
Auto Time
0
0.43
Breast Entrance Exposure and AEC Reproducibility:
Dmax > 3.5 OD
Exposure #1
Exposure #2
Exposure #3
Exposure #4
Mean values
Standard deviations (SD)
Coefficient of
variation (CV)
Action limit:
R
mAs
R
mAs
R
mAs
R
mAs
1.581
1.498
1.521
1.501
1.525
0.039
147.0
139.0
142.0
140.0
142.0
3.56
1.480
121.0
1.231
89.1
0.705
75.2
1.480
121.0
1.231
89.1
0.705
75.2
0.025
0.025
If coefficient of variation for either R or mAs exceeds 0.05, seek service.
Average Glandular Dose:
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
Inv Sq corrected skin exp
Mid-density > 1.5 OD
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,
4.5 cm above
breast support
kVp
Anode
Filter
28
28
Mo
Mo
Mo
Mo
SID
(cm)
Exp
(mR)
mAs
Time
(sec)
65
4740
300
3
Kerma
Rate
(mR/s) (mGy/s)
1580
13.8
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)
Proper Scoring Techniques of the
ACR Mammography
Accreditation Phantom
(5)
15
Fibers
Fibers
• Full Point Score
- Full length of fiber visible (+/- 1 mm) use first fiber as a reference for length
- Correct location
- Correct orientation
• Half Point Score
- Not all, but > 50% visible
- Correct location
- Correct orientation
- Stop if orientation or borders not
Fibers - Artifacts
Fibers - Artifacts Deductions
• In Wrong Location of Phantom Insert
– Fiber-like
– At least as apparent as last fiber scored
– Diameter and length > last scored fiber
visible
• 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
16
Speck Groups
Speck Groups - Artifacts
Full Point Score
- > 4 specks visible
- Correct locations
• 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
Half Point Score
- 2 or 3 specks visible
- Correct locations
Speck Groups - Deductions
Speck Groups
• 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)
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
17
Masses Score
Masses Score
• Full Point
- Density difference visible
- Generally circular
(> 75% circumference)
- Correct location
• Half Point
- Density difference visible
- Not generally circular (< 75%
circumference)
- Correct location
Masses Score - Artifacts
Masses Scores
In Wrong location of Phantom Insert
- Mass - like
- As apparent as last mass scored
Deduction
Only deduct from last mass scored
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
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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
FFDM Model
Fuji
FFDM QC Manual Version: (check one; must use version applicable to system tested; contact mfr if questions)
1st edition, 07.2006 897N0602, 2006
Accessory Equipment:
Manufacturer
MEDICAL PHYSICIST'S MAMMOGRAPHY QC TEST SUMMARY
(Fuji, continued)
FCRm
OTHER (write in):
Model
Location
QC Manual Version
On-site
Off-site
Review Workstation*
Laser Film Printer*
On-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
Medical Physicist's QC Tests
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
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
PASS/FAIL
S Value Confirmation ( < 120 + 20% [96 < corrected S value < 144])
System Resolution (8 lp/mm + 2 lp/mm in both directions)
CR Reader Scanner Performance
Imaging Plate (IP) Fog
Mammography Unit Assembly Evaluation
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
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
System Artifact Evaluation
Phantom Image Quality Evaluation
Fibers
Specks
Masses (at least 4 fibers, 3 speck groups & 3 masses)
Phantom IQ (printed images)
Click in boxes to use
drop-down lists
Phantom IQ (softcopy)
Other tests meet Fuji performance criteria (mAs, OD & DD for hardcopy, S value for soft copy)
Dynamic Range
Primary Erasure
Inter-Plate Consistency (variation of mAs within + 10%; SNR within + 15%)
kVp Accuracy and Reproducibility
Test date if different from above:
Measured average kVp within +5% of indicated kVp
kVp coefficient of variation <0.02
Dose (average glandular dose for average breast is < 3 mGy [300 mrad])
mrad
Beam Quality Assessment & HVL Measurement
Test date if different from above:
HVL >kVp/100 mm Al
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
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
Review Workstation (RWS) Tests** (for all RWS, even if located offsite)
Overall Results ("Pass" means all tests pass; indicate "Fail" if any test fails)
1.
2.
3.
4.
5.
6.
7.
CNR Weekly Check
Phantom Image
Visual Checklist
Repeat Analysis
Compression
Printer QC*
Review Workstation QC-Overall*
Weekly
Weekly
Monthly
Quarterly
Semi-annually
See FDA guidance
See FDA guidance
Medical Physicist's Recommendations for Quality Improvement
**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 ***
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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
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
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
CNR (Contrast/Noise Ratio) Test
Evaluates Noise and Contrast using a fixed xray 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
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Fuji Digital Mammography QC
Technologist’s Tests
Tests in Accordance with ACR/MQSA
Visual Checklist
Repeat Analysis
Compression Test
Monthly
Quarterly
Semi-Annual
Same Action Limits and Corrective Action as
MQSA
IP Fog replaces Darkroom Fog test - Semi Annual
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)
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)
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
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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
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