carl r. keener, ph.d., dabmp, dabr … · drypix 4000 x drypix 5000 / 7000 x kodak x dryview 8610 x...
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MARP, Inc.
FFDM in the Field: Physicist's Role in the QC of Mammography Laser Printers
May 2010Carl R. Keener, Ph.D., DABMP, DABR
MARP &Medical Radiation Physics, Inc.
MARP, Inc.
Physicist's Role in the QC of Third-Party Review Work Stations
consulting physics group with variety of clientsFFDM: GE, Fischer, Hologic, Siemenslaser printers: Agfa, Konica, Fuji, Kodak
how do we keep all of them in compliance?review of QC manualsdevelopment of laser printer evaluation surveyincorporation of laser printer requirements into database
MARP, Inc.
FFDM laser printers
MQSA /FDA guidanceFFDM manufacturer guidanceprinter tests / laser printer manufacturer guidancesystem testsmedical physicist survey & documentationsummary
MARP, Inc.
we’re digital … why perform printer QC?
MQSA requires ithard copy used for
prior filmsarchivingfinal interpretation
• occasionally
ACR submission
without QC, things degrade
MARP, Inc.
FFDM laser printers
MQSA /FDA guidanceFFDM manufacturer guidanceprinter tests / laser printer manufacturer guidancesystem testsmedical physicist survey & documentationsummary
MARP, Inc.
caveat
This lecture involves MQSA.
Use with care.
MARP, Inc.
MQSA Guidance
21 CFR 900.12(e)(6)Quality control tests—other modalities. For systems with image receptor modalities other than screen-film, the quality assurance program shall be substantially the same as the quality assurance program recommended by the image receptor manufacturer, except that the maximum allowable dose shall not exceed the maximum allowable dose for screen-film systems in paragraph (e)(5)(vi) of this section.
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FDA Guidance
allowed digital mammography in 2000FFDM manufacturer supplied QC manual to FDAinitially allowed final interpretation from laser film onlylater allowed soft copy mammography interpretation
requires MP to follow QC program in FFDM manufacturer’s QC manual
varies with manual version• & alternative standards
MARP, Inc.
how does FDA address laser printers?
To avoid unnecessary follow-ups by MQSA inspectors, we urge all medical physicists to review the FFDM manufacturer’s QC manual and, where necessary, the laser printer QC or operator’s manual to determine the appropriate testing. They then need to clearly document the testing of the laser printer in their reports.FDA Inspection News Update February 4, 2008
MARP, Inc.
FFDM vendors
FujiFCRm
HologicSelenia
GESenographe 2000DSenographe DSEssential
SiemensNovation
FischerSenoscan
MARP, Inc.
laser printer vendors
AgfaDryStar 4500MDryStar 5500, 5503
Konica-MinoltaDryPro 793
FujiDryPix 4000DryPix 5000 / 7000
KodakDryView 8610
CarestreamDryView 6800
MARP, Inc.
available tests
laser printer testslow-contrast resolutionhigh-contrast spatial resolutionMAP phantomgray-scaleSMPTE patterngeometryartifactsmechanicalQC
FFDM & printer testsMAP phantomSMPTE patternartifacts
MARP, Inc.
FFDM laser printers
MQSA /FDA guidanceFFDM manufacturer guidanceprinter tests / laser printer manufacturer guidancesystem testsmedical physicist survey & documentationsummary
MARP, Inc.
Hologic printer tests
MAN-00093 rev 006
artifact testtech (weekly) & MPdigital flat field
• both film sizes (if supported)
SMPTE patterntech (weekly)small film
• LD (90%) +/-
0.15• MD (40%) +/-
0.15• DD (40%-
10%) +/-
0.15
MAP phantomlaser printer and RWStech (weekly) & MPsmall filmscore
• 5 fibers / 4 specks / 4 masses• 4.5 fibers / 4 specks / 3.5 masses
if SNR >40
background OD> 1.20
MARP, Inc.
Hologic printer tests
MAN-00093 rev 006
artifact testtech (weekly) & MPdigital flat field
• both film sizes (if supported)
SMPTE patterntech (weekly)small film
• LD (90%) +/-
0.15• MD (40%) +/-
0.15• DD (40%-
10%) +/-
0.15
MAP phantomlaser printer and RWStech (weekly) & MPsmall filmscore
• 5 fibers / 4 specks / 4 masses• 4.5 fibers / 4 specks / 3.5 masses
if SNR >40
background OD> 1.20
MAN-00093 rev 008MAN-01476 rev 001MAN-00523 rev 003artifact test
tech (weekly) & MPdigital flat field
• both film sizes (if supported)
SMPTE patterntech (weekly)small film
• LD (90%) +/-
0.15• MD (40%) +/-
0.15• DD (40%-
10%) +/-
0.15
MAP phantomlaser printer or RWStech (weekly) & MPsmall filmscore
• 5 fibers / 4 specks / 4 masses• 4.5 fibers / 4 specks / 3.5 masses
if SNR >40
no OD requirements
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other FFDM manufacturers defer to printer manufacturer
GE Senographe 2000D
• 2371472-100 rev 0
GE Senographe DS• 5122453-4-1EN
follow printer manufacturer QC manualprint MAP phantom
• tech (weekly) & MP• score
• 4 fibers / 3 specks / 3 masses
• no disk• no OD requirements
Siemens NovationSPB7-250.623.50.05.24 ver 05follow printer manufacturer QC manualMAP phantom
• tech does not print• MP prints if AWS fails
printer check• daily when printer used• SMPTE pattern• plot 11 ODs
• 3 LUTs• Dmin
= 0.20• Dmax
= 3.50
MARP, Inc.
other FFDM manufacturers defer to printer manufacturer
Fischer Senoscanfollow printer manufacturer QC manualno printed phantom requirement
Fuji FCRm3rd edition Feb 2007follow printer manufacturer QC manualif no printer manufacturer QC manual:
• set up weekly program like film/screen
• us TG18-QC or TG18-PQC
weekly MAP phantom• if printer used for final
interpretation• background OD > 1.20 +/-0.20• DD +/-
0.05
MARP, Inc.
FFDM printer requirements
Hologic GE Siemens Fischer Fuji CRm
small large small large small large small large small large
MAP phantom (score) ? ?
MAP phantom (OD)
SMPTE pattern
artifact
follow printer manu. ? ? ? ?
MARP, Inc.
FFDM laser printers
MQSA /FDA guidanceFFDM manufacturer guidanceprinter tests / laser printer manufacturer guidancesystem testsmedical physicist survey & documentationsummary
MARP, Inc.
gray-scale display function
� based on film/screen sensitometry
� base+fog
� lowest step (OD=~0.20)
� mid-density
� speed index
� step closest to (but greater than) 1.20 OD
1
9� step closest to (but greater than) 1.20 OD
� density-difference
� contrast index
� difference between
• step closest to 2.20 OD
• step closest to (but greater than) 0.45 OD
• top & bottom of linear portion of characteristic curve
10
9
12
MARP, Inc.
film-screen processor QC action limits
� establish baselines with 5-day average
� MQSA limits:
� base+fog
• > 0.03 over baseline →→→→ do not use processor
� mid-density
• ±±±± 0.10 from baseline →→→→ contact service
• ±±±± 0.15 from baseline →→→→ do not use processor
1
9 • ±±±± 0.15 from baseline →→→→ do not use processor
� density-difference
• ±±±± 0.10 from baseline →→→→ contact service
• ±±±± 0.15 from baseline →→→→ do not use processor
� developer temperature
• typically 95.0°F
• ±±±± 0.5°F from baseline →→→→ do not use processor
� if out of limits →→→→ repeat
� if still out of limits →→→→ do not use processor
10
9
12
MARP, Inc.
laser printer sensitometry
gray scale pattern generated internally in laser printermay use internal photometer to read and report ODsprinters uses different calibration strip for self-calibration
MARP, Inc.
gray-scale – Agfa
5-step gray-scaleBase + Fog, Low, Mid, High, Dmax
establish aim valuesmust meet Agfa operating levels
• B+F = 0.22 ±
0.03• MD = 1.40 ±
0.15• DD = HD-LD = 1.90 ±
0.15• Dmax
= 3.70 ±
0.25
daily test imagemust meet aim values
• B+F = aim ±
0.03• MD =
aim ±
0.15• DD = aim ±
0.15• Dmax
= aim ±
0.25
uses internal photometerone film size only?
MARP, Inc.
gray-scale – Konica
6-step gray-scale1, 2 (LD), 3, 4 (MD), 5 (HD), 6
establish benchmarksall 6 stepsContrast = HD – LD (5 – 2)
daily test imageaction / control limits
1
aim ±
0.03 / 0.032 (LD)
aim ±
0.10 / 0.153
aim ±
0.10 / 0.154 (MD)
aim ±
0.10 / 0.155 (HD)
aim ±
0.10 / 0.156
aim ±
0.20 / 0.20Contrast
aim ±
0.15
uses external photometerone film size only?
MARP, Inc.
gray-scale – Fuji
17-step gray-scaleuses 4 steps only 1, 5, 10, 15
control limits set by Fujiweekly test images
1 ≤
0.235 0.48 ±
0.0710 1.38 ±
0.1015 2.40 ±
0.15uses external photometerall film sizes used for mammo
MARP, Inc.
gray-scale – Carestream
21-step gray-scaleedge - automatic densitometercenter - manual densitometer
establish operating levels• Dmin
= step 1• LD = step closest & ≥
0.45• MD = step closest & ≥
1.20• HD = step closest & ≥
2.20
weekly test imagemust meet aim values
• Dmin
= operating level ±
0.03• LD =
operating level ±
0.07• MD = operating level ±
0.15• HD = operating level ±
0.15
uses external photometerall film sizes used for mammo?
MARP, Inc.
gray-scale response function - Carestream
annual physicist test21-step gray-scale
Dmin = 0.17 – 0.27densities 2-20
• target & tolerances based on Dmin
Dmax = 3.60 ± 0.16
MARP, Inc.
Agfa QC mammo test image
weekly spatial resolution
• resolve each set of smallest dots• magnifier & bright view box
no artifactslow-contrast
• resolve 0%/5% & 95%/100% ovals
• 5500 & 5503 only
annual geometrichorizontal (A) & vertical (B) distances
• ±
1% of reference• A/B ratio ≤
0.01
one film size only?
MARP, Inc.
Konica mammo QC image
daily sharpnesshorizontal & vertical line pairs
SMPTE patternrecommended at setupgenerated from FFDM
90 % 0.42 ±
0.0840% 1.55 ±
0.1510% 2.54 ±
0.150% 3.60 ±
0.15
MARP, Inc.
Fuji QC images
annualresolution
• spatial resolution test pattern• 50 micron lp
resolved in both directions
• mammo set to “high resolution”
geometry• geometry test pattern• horizontal (H) & vertical (J)
dimensions • within 1% of standard• all mammo film sizes
artifactsmechanical
• no transport errors • no abnormal noises
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Carestream multipurpose QC test image
semiannual (tech)annual (MP)low-contrast
6 fibers 5 speck groups 5 masses all must be resolved
spatial resolutionall line pairs visible
all mammo films sizes?
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Carestream QC images
gray QC test imageslight gray & darkannual artifactannual geometry
• horizontal & vertical• ±
1% of reference• straight ±
2%• all mammo films sizes?
phantom imagemust pass FFDM requirements
• GE , Fischer, Fuji4 fibers 3 speck groups 3 masses
• Hologic, Siemens5 fibers 4 speck groups 4 masses
• Hologic if SNR > 404.5 fibers 4 speck groups 3.5 masses
MARP, Inc.
laser printer manufacturer QC requirements
Carestream
6800 Agfa 4500/5500 Fuji 4000-
5000-7000 Konica 793 Hologic
small large small large small large small large small large
gray scale ? ?
LCD ? 5500 5500
HCR ? ?
geometry ?
artifacts ?
mechanical
SMPTE pattern ?
MAP phantom ?
MARP, Inc.
laser printer QC manuals
AgfaDryStar 4500M
• 2811B EN 20030415
DryStar 5500, 5503• 2901D EN 20050909
Konica-MinoltaDryPro 793
• Version 1.1 Feb 06
FujiDryPix 4000
• 4th
Edition Oct 2008
DryPix 5000 / 7000• 1st
Edition Mar 2005• 3rd
Edition Dec 2006• 4th
Edition Oct 2008
KodakDryView 8610
• V 1.0 (5/01)
CarestreamDryView 6800
• QC Manual 2007
MARP, Inc.
FFDM laser printers
MQSA /FDA guidanceFFDM manufacturer guidanceprinter tests / laser printer manufacturer guidancesystem testsmedical physicist survey & documentationsummary
MARP, Inc.
printing films
multiple FFDM sourcesAWS(s)RWS(s)PACS
multiple DICOM sourcesCT, MR, US, CR, etc.different film sizesdifferent LUTsdifferent Dmaxdifferent resolution
printing file vs. imagedefault vs. WL
MARP, Inc.
system tests
most tests only test the printer
gray-scaleprinter test patterns
• resolution• low-contrast• geometry• OD• artifacts
very few system testsCarestream requires MAP phantom
• score only, no ODs
Fuji FCRm requires MAP phantom
• minimum OD
Hologic requires uniform image
• artifacts only
Hologic requires SMPTE• constancy only, no aim values
Konica DryProrecommends SMPTE
• OD aim values
MARP, Inc.
SMPTE pattern suggestions
generate SMPTE pattern at FFDM console
origin, WL, high-resolution caveatssend to printer (all film sizes)observe LCD squares:
• 0% / 5% & 95% / 100
observe gray levelsuse Konica DryPro OD recommendations:
90 % 0.42 ±
0.0840% 1.55 ±
0.1510% 2.54 ±
0.150% 3.60 ±
0.15note: Dmax > 3.45
MARP, Inc.
MAP phantom suggestions
image MAP phantom on both receptor sizessend to printer (all film sizes)does it print?correct size?• ACR recommends “true size”• phantom ±
25%
score?Dmax > 3.45?• Agfa
3.70 ±
0.25• Carestream
3.60 ±
0.16• Konica (SMPTE)
3.60 ±
0.15• Siemens
3.50 ±
0.10
phantom background OD 1.6-1.9?• ACR recommendation
artifacts?note: sending file vs. sending image
MARP, Inc.
mammogram suggestion
observe printed mammograms
contrast & densities correct?Dmax > 3.45?Dmin> 1.0?
• old film/screen recommendation
true size?• ACR digital mammo standard
recommends true size
artifacts?
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uniform image suggestion
Hologic artifact testother FFDM may need to be sent from PACS
TG18 UN 10 & UN80
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test multiple sources
send phantoms, SMPTE patterns and test patterns from various AWS, RWS and PACS used to print digital mammograms
check Dmaxcheck Dmincheck MD
MARP, Inc.
FFDM laser printers
MQSA /FDA guidanceFFDM manufacturer guidanceprinter tests / laser printer manufacturer guidancesystem testsmedical physicist survey & documentationsummary
MARP, Inc.
survey scenarios
perform tests required by FFDM QC manual
acceptable for Hologicwhat if other FFDM shares the printer?
perform tests required by printer QC manual
what if Hologic FFDM shares the printer?
perform tests as deemed appropriate by medical physicist
perform all available tests
including:• all available printer QC
test patterns• all available film sizes• artifacts• SMPTE pattern from FFDM• MAP phantom• look at printed
mammogram
for each laser printer used for mammography
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MARP laser printer evaluation sample
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printer info
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gray scale
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SMPTE pattern
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artifacts
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low contrast detectability
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high contrast resolution
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geometric accuracy
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mechanical checks
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MAP phantom
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technologist QC
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laser printer report
MARP, Inc.
FFDM laser printers
MQSA /FDA guidanceFFDM manufacturer guidanceprinter tests / laser printer manufacturer guidancesystem testsmedical physicist survey & documentationsummary
MARP, Inc.
summary
MQSA requires that physicist survey laser printers used for FFDMrequired tests vary based on FFDM manufacturer & printer manufacturerrequired tests may miss QC problems, especially incorrect film densitiessite may be better served by performing all available tests instead of minimum required“system tests” (sent from FFDM to printer) are particularly useful
MARP, Inc.
FFDM in the Field: Physicist's Role in the QC of Mammography Laser Printers
May 2010Carl R. Keener, Ph.D., DABMP, DABR
MARP &Medical Radiation Physics, Inc.