printer

MARP, Inc.

FFDM in the Field: Physicist's Role in the QC of Mammography Laser Printers May 2010

Carl R. Keener, Ph.D., DABMP, DABR [email protected]

MARP Medical & Radiation Physics, Inc.

Physicist's Role in the QC of Third-Party Review Work Stations MARP, Inc.

X

X X X X

consulting physics group with variety of clients X

FFDM:

GE, Fischer, Hologic, Siemens

X

laser printers:

Agfa, Konica, Fuji, Kodak

how do we keep all of them in compliance? review of QC manuals development of laser printer evaluation survey incorporation of laser printer requirements into database

FFDM laser printers MARP, Inc.

X X

X

X X

X

MQSA /FDA guidance FFDM manufacturer guidance printer tests / laser printer manufacturer guidance system tests medical physicist survey & documentation summary

we’re digital … why perform printer QC? MARP, Inc.

X X

MQSA requires it hard copy used for X

prior films

X

archiving

X

final interpretation • occasionally

X

X

ACR submission

without QC, things degrade


X X

X

X X

X


caveat MARP, Inc.

This lecture involves MQSA. Use with care.

MQSA Guidance MARP, Inc.

X

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.

FDA Guidance MARP, Inc.

X

allowed digital mammography in 2000 X X

X

X

FFDM manufacturer supplied QC manual to FDA initially allowed final interpretation from laser film only later allowed soft copy mammography interpretation

requires MP to follow QC program in FFDM manufacturer’s QC manual X

varies with manual version • & alternative standards

how does FDA address laser printers? MARP, Inc.

X

X

X

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

FFDM vendors MARP, Inc.

X

Hologic X

X

X

GE X

Senographe 2000D

X

Senographe DS

X

Essential

Siemens X

X

Selenia

Novation

Fischer X

Senoscan

X

Fuji X

FCRm

laser printer vendors MARP, Inc.

X

X

Agfa

X

Fuji

X

DryStar 4500M

X

DryPix 4000

X

DryStar 5500, 5503

X

DryPix 5000 / 7000

Konica-Minolta X

X

DryPro 793

Kodak X

X

DryView 8610

Carestream X

DryView 6800

available tests MARP, Inc.

X

FFDM & printer tests

X

laser printer tests

X

MAP phantom

X

X

SMPTE pattern

X

X

artifacts

low-contrast resolution high-contrast spatial resolution

X

MAP phantom

X

gray-scale

X

SMPTE pattern

X

geometry

X

artifacts

X

mechanical

X

QC


X X

X

X X

X


Hologic printer tests MARP, Inc. X

MAN-00093 rev 006

X

artifact test X

tech (weekly) & MP

X

digital flat field •

X

SMPTE pattern X

tech (weekly)

X

small film • • •

X

both film sizes (if supported)

LD (90%) +/- 0.15 MD (40%) +/- 0.15 DD (40%- 10%) +/- 0.15

MAP phantom X

laser printer and RWS

X

tech (weekly) & MP

X

small film

X

score • •

X

5 fibers / 4 specks / 4 masses 4.5 fibers / 4 specks / 3.5 masses if SNR >40

background OD> 1.20

Hologic printer tests MARP, Inc. X

MAN-00093 rev 006

X

X

artifact test

X

X

tech (weekly) & MP

X

tech (weekly) & MP

X

digital flat field

X

digital flat field

• X

•


SMPTE pattern

X


SMPTE pattern

X

tech (weekly)

X

tech (weekly)

X

small film

X

small film

• • • X

MAN-00093 rev 008 MAN-01476 rev 001 MAN-00523 rev 003 artifact test

• • •

LD (90%) +/- 0.15 MD (40%) +/- 0.15 DD (40%- 10%) +/- 0.15

MAP phantom

X

LD (90%) +/- 0.15 MD (40%) +/- 0.15 DD (40%- 10%) +/- 0.15

MAP phantom

X

laser printer and RWS

X

laser printer or RWS

X

tech (weekly) & MP

X

tech (weekly) & MP

X

small film

X

small film

X

score

X

score

• • X

• •


background OD> 1.20

X


no OD requirements

other FFDM manufacturers defer to printer manufacturer MARP, Inc.

X

GE X

X

Senographe 2000D

Siemens Novation X

• 2371472-100 rev 0 X

GE Senographe DS

X

• 5122453-4-1EN X

X

follow printer manufacturer QC manual

X

•

4 fibers / 3 specks / 3 masses

• no disk • no OD requirements

follow printer manufacturer QC manual MAP phantom • tech does not print • MP prints if AWS fails

print MAP phantom • tech (weekly) & MP • score

SPB7-250.623.50.05.24 ver 05

X

printer check • daily when printer used • SMPTE pattern • plot 11 ODs • 3 LUTs • Dmin = 0.20 • Dmax = 3.50

other FFDM manufacturers defer to printer manufacturer MARP, Inc.

X

Fischer X X

X

Senoscan follow printer manufacturer QC manual

X

Fuji FCRm X X

X

no printed phantom requirement

3rd edition Feb 2007 follow printer manufacturer QC manual if no printer manufacturer QC manual: • set up weekly program like film/screen • us TG18-QC or TG18-PQC

X

weekly MAP phantom • if printer used for final interpretation • background OD > 1.20 +/-0.20 • DD +/- 0.05

FFDM printer requirements MARP, Inc.

Hologic small MAP phantom (score)

large

D?

GE small

D

Siemens large

small

D?

MAP phantom (OD) SMPTE pattern artifact follow printer manu.

D D

Fischer

large small large

Fuji CRm small large

D D

D D D? D

D? D D? D D?


X X

X

X X

X


gray-scale display function MARP, Inc.

1

N N

based on film/screen sensitometry base+fog N

N

9 10

12

N

lowest step (OD=~0.20)

mid-density N

speed index

N

step closest to (but greater than) 1.20 OD

density-difference N

contrast index

N

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

film-screen processor QC action limits MARP, Inc.

1

N N

establish baselines with 5-day average MQSA limits: N

base+fog • > 0.03 over baseline → do not use processor

N

mid-density • ± 0.10 from baseline → contact service • ± 0.15 from baseline → do not use processor

9 10

N

density-difference • ± 0.10 from baseline → contact service • ± 0.15 from baseline → do not use processor

12 N

developer temperature • typically 95.0°F • ± 0.5°F from baseline → do not use processor

N

if out of limits → repeat N

if still out of limits → do not use processor

laser printer sensitometry MARP, Inc.

X

X

X

gray scale pattern generated internally in laser printer may use internal photometer to read and report ODs printers uses different calibration strip for self-calibration

gray-scale – Agfa MARP, Inc.

X

5-step gray-scale X

X

Base + Fog, Low, Mid, High, Dmax

establish aim values X

must meet Agfa operating levels • • • •

X

B+F = MD = DD = Dmax =

0.22 ± 0.03 1.40 ± 0.15 HD-LD = 1.90 ± 0.15 3.70 ± 0.25

daily test image X

must meet aim values • • • •

B+F = MD = DD = Dmax =

aim ± 0.03 aim ± 0.15 aim ± 0.15 aim ± 0.25

X

uses internal photometer

X

one film size only?

gray-scale – Konica MARP, Inc.

X

6-step gray-scale X

X

X

1, 2 (LD), 3, 4 (MD), 5 (HD), 6

establish benchmarks X

all 6 steps

X

Contrast = HD – LD (5 – 2)

daily test image X

action / control limits 1 2 (LD) 3 4 (MD) 5 (HD) 6 Contrast

aim ± 0.03 / 0.03 aim ± 0.10 / 0.15 aim ± 0.10 / 0.15 aim ± 0.10 / 0.15 aim ± 0.10 / 0.15 aim ± 0.20 / 0.20 aim ± 0.15

X

uses external photometer

X

one film size only?

gray-scale – Fuji MARP, Inc.

X

X X

17-step gray-scale X

uses 4 steps only

X

1, 5, 10, 15

control limits set by Fuji weekly test images 1 5 10 15 X X

≤ 0.23 0.48 ± 0.07 1.38 ± 0.10 2.40 ± 0.15

uses external photometer all film sizes used for mammo

gray-scale – Carestream MARP, Inc.

X

X

21-step gray-scale X

edge - automatic densitometer

X

center - manual densitometer

establish operating levels • • • •

X

Dmin = LD = MD = HD =

step 1 step closest & ≥ 0.45 step closest & ≥ 1.20 step closest & ≥ 2.20

weekly test image X

must meet aim values • • • •

Dmin = LD = MD = HD =

operating level ± 0.03 operating level ± 0.07 operating level ± 0.15 operating level ± 0.15

X

uses external photometer

X

all film sizes used for mammo?

gray-scale response function - Carestream MARP, Inc.

X X

annual physicist test 21-step gray-scale X

Dmin = 0.17 – 0.27

X

densities 2-20 • target & tolerances based on Dmin

X

Dmax = 3.60 ± 0.16

Agfa QC mammo test image MARP, Inc.

X

weekly X

spatial resolution • resolve each set of smallest dots • magnifier & bright view box

X

no artifacts

X

low-contrast • resolve 0%/5% & 95%/100% ovals • 5500 & 5503 only

X

annual geometric X

horizontal (A) & vertical (B) distances • ± 1% of reference • A/B ratio ≤ 0.01

X

one film size only?

Konica mammo QC image MARP, Inc.

X

daily sharpness X

X

horizontal & vertical line pairs

SMPTE pattern X

recommended at setup

X

generated from FFDM 90 % 40% 10% 0%

0.42 ± 0.08 1.55 ± 0.15 2.54 ± 0.15 3.60 ± 0.15

Fuji QC images MARP, Inc.

X

annual X

resolution • spatial resolution test pattern • 50 micron lp resolved in both directions • mammo set to “high resolution”

X

geometry • geometry test pattern • horizontal (H) & vertical (J) dimensions • within 1% of standard • all mammo film sizes

X

artifacts

X

mechanical • no transport errors • no abnormal noises

Carestream multipurpose QC test image MARP, Inc.

semiannual (tech) annual (MP) low-contrast

6 fibers

5 speck groups

5 masses

all must be resolved

spatial resolution

all line pairs visible

all mammo films sizes?

Carestream QC images MARP, Inc.

X

gray QC test images X

light gray & dark

X

annual artifact

X

annual geometry • horizontal & vertical • ± 1% of reference • straight ± 2%

• all mammo films sizes? X

phantom image X

must pass FFDM requirements • GE , Fischer, Fuji 4 fibers 3 speck groups 3 masses • Hologic, Siemens 5 fibers 4 speck groups 4 masses • Hologic if SNR > 40 4.5 fibers 4 speck groups 3.5 masses

laser printer manufacturer QC requirements MARP, Inc.

Carestream 6800

gray scale LCD HCR geometry artifacts

small

large

small

D D D D D

D? D? D? D? D?

D

mechanical

large

5500

5500

D D D

D D

Fuji 40005000-7000

Konica 793

small

large

small

D

D

D

D?

D D D D

D D D D

D

D?

D

Hologic

large small large

D D

SMPTE pattern MAP phantom

Agfa 4500/5500

D?

D D?

D

laser printer QC manuals MARP, Inc.

X

Agfa X

X

DryStar 4500M

Fuji X

• 4th Edition Oct 2008

• 2811B EN 20030415 X

DryStar 5500, 5503

X

Konica-Minolta X

DryPro 793 • Version 1.1 Feb 06

DryPix 5000 / 7000 • 1st Edition Mar 2005 • 3rd Edition Dec 2006 • 4th Edition Oct 2008

• 2901D EN 20050909

X

DryPix 4000

X

Kodak X

DryView 8610 • V 1.0 (5/01)

X

Carestream X

DryView 6800 • QC Manual 2007


X X

X

X X

X


printing films MARP, Inc.

X

X

X

multiple FFDM sources X

AWS(s)

X

RWS(s)

X

PACS

multiple DICOM sources X

CT, MR, US, CR, etc.

X

different film sizes

X

different LUTs

X

different Dmax

X

different resolution

printing file vs. image X

default vs. WL

system tests MARP, Inc.

X

most tests only test the printer X

gray-scale

X

printer test patterns • • • • •

resolution low-contrast geometry OD artifacts

X

very few system tests X

Carestream requires MAP phantom • score only, no ODs

X

Fuji FCRm requires MAP phantom • minimum OD

X

Hologic requires uniform image • artifacts only

X

Hologic requires SMPTE • constancy only, no aim values

X

Konica DryPro recommends SMPTE • OD aim values

SMPTE pattern suggestions MARP, Inc.

X

generate SMPTE pattern at FFDM console X

origin, WL, high-resolution caveats

X

send to printer (all film sizes)

X

observe LCD squares: • 0% / 5% & 95% / 100

X X

observe gray levels use Konica DryPro OD recommendations: 90 % 40% 10% 0%

X

0.42 ± 0.08 1.55 ± 0.15 2.54 ± 0.15 3.60 ± 0.15

note: Dmax > 3.45

MAP phantom suggestions MARP, Inc.

X

image MAP phantom on both receptor sizes X

send to printer (all film sizes)

X

does it print?

X

correct size? • •

ACR recommends “true size” phantom ± 25%

X

score?

X

Dmax > 3.45? • • • •

X

Agfa Carestream Konica (SMPTE) Siemens

3.70 ± 0.25 3.60 ± 0.16 3.60 ± 0.15 3.50 ± 0.10

phantom background OD 1.6-1.9? •

ACR recommendation

X

artifacts?

X

note: sending file vs. sending image

mammogram suggestion MARP, Inc.

X

observe printed mammograms X

contrast & densities correct?

X

Dmax > 3.45?

X

Dmin> 1.0? • old film/screen recommendation

X

true size? • ACR digital mammo standard recommends true size

X

artifacts?

uniform image suggestion MARP, Inc.

X X

Hologic artifact test other FFDM may need to be sent from PACS X

TG18 UN 10 & UN80

test multiple sources MARP, Inc.

X

send phantoms, SMPTE patterns and test patterns from various AWS, RWS and PACS used to print digital mammograms X

check Dmax

X

check Dmin

X

check MD


X X

X

X X

X


survey scenarios MARP, Inc.

X

perform tests required by FFDM QC manual X X

X

perform all available tests X

what if Hologic FFDM shares the printer?

perform tests as deemed appropriate by medical physicist

including: • all available printer QC test patterns • all available film sizes • artifacts • SMPTE pattern from FFDM • MAP phantom • look at printed mammogram

what if other FFDM shares the printer?

perform tests required by printer QC manual X

X

acceptable for Hologic

X

X

for each laser printer used for mammography

MARP laser printer evaluation sample MARP, Inc.

printer info MARP, Inc.

gray scale MARP, Inc.

SMPTE pattern MARP, Inc.

artifacts MARP, Inc.

low contrast detectability MARP, Inc.

high contrast resolution MARP, Inc.

geometric accuracy MARP, Inc.

mechanical checks MARP, Inc.

MAP phantom MARP, Inc.

technologist QC MARP, Inc.

laser printer report MARP, Inc.


X X

X

X X

X


summary MARP, Inc.

X

X

X

X

X

MQSA requires that physicist survey laser printers used for FFDM required tests vary based on FFDM manufacturer & printer manufacturer required tests may miss QC problems, especially incorrect film densities site 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 2010

Carl R. Keener, Ph.D., DABMP, DABR [email protected]

MARP Medical & Radiation Physics, Inc.