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FFDM in the Field: Physicist's Role in the QC of Mammography Laser Printers

May 2010Carl R. Keener, Ph.D., DABMP, DABR

keener@MARPinc.com

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

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FFDM laser printers

MQSA /FDA guidanceFFDM manufacturer guidanceprinter tests / laser printer manufacturer guidancesystem testsmedical physicist survey & documentationsummary

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we’re digital … why perform printer QC?

MQSA requires ithard copy used for

prior filmsarchivingfinal interpretation

• occasionally

ACR submission

without QC, things degrade

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FFDM laser printers

MQSA /FDA guidanceFFDM manufacturer guidanceprinter tests / laser printer manufacturer guidancesystem testsmedical physicist survey & documentationsummary

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caveat

This lecture involves MQSA.

Use with care.

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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

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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

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FFDM vendors

FujiFCRm

HologicSelenia

GESenographe 2000DSenographe DSEssential

SiemensNovation

FischerSenoscan

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laser printer vendors

AgfaDryStar 4500MDryStar 5500, 5503

Konica-MinoltaDryPro 793

FujiDryPix 4000DryPix 5000 / 7000

KodakDryView 8610

CarestreamDryView 6800

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available tests

laser printer testslow-contrast resolutionhigh-contrast spatial resolutionMAP phantomgray-scaleSMPTE patterngeometryartifactsmechanicalQC

FFDM & printer testsMAP phantomSMPTE patternartifacts

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FFDM laser printers

MQSA /FDA guidanceFFDM manufacturer guidanceprinter tests / laser printer manufacturer guidancesystem testsmedical physicist survey & documentationsummary

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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

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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

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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

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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. ? ? ? ?

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FFDM laser printers

MQSA /FDA guidanceFFDM manufacturer guidanceprinter tests / laser printer manufacturer guidancesystem testsmedical physicist survey & documentationsummary

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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

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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

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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

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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?

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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?

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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

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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?

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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

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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?

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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

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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

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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 ?

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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

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FFDM laser printers

MQSA /FDA guidanceFFDM manufacturer guidanceprinter tests / laser printer manufacturer guidancesystem testsmedical physicist survey & documentationsummary

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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

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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

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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

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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

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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

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FFDM laser printers

MQSA /FDA guidanceFFDM manufacturer guidanceprinter tests / laser printer manufacturer guidancesystem testsmedical physicist survey & documentationsummary

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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

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FFDM laser printers

MQSA /FDA guidanceFFDM manufacturer guidanceprinter tests / laser printer manufacturer guidancesystem testsmedical physicist survey & documentationsummary

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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

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FFDM in the Field: Physicist's Role in the QC of Mammography Laser Printers

May 2010Carl R. Keener, Ph.D., DABMP, DABR

keener@MARPinc.com

MARP &Medical Radiation Physics, Inc.