MARP FFDM in the Field: Physicist's Role in the
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MARP, Inc. FFDM in the Field: Physicist's Role in the QC of Third-Party Review Work Stations July 2009 Carl R. Keener, Ph.D., DABMP, DABR keener@MARPinc.com MARP Medical & Radiation Physics, Inc. Physicist's Role in the QC of Third-Party Review Work Stations MARP, Inc. consulting physics group with variety of clients FFDM: GE, Fischer, Hologic, Siemens RWS: GE, Hologic, Siemens Barco, Planar Sectra, Carestream, Agfa, McKesson how do we keep all of them in compliance? review of QC manuals, TG18 research of RWS vendors at RSNA incorporation of RWS requirements into database FFDM review workstations MARP, Inc. MQSA /FDA guidance TG18 guidance FFDM manufacturer guidance monitor manufacturer guidance PACS vendor guidance medical physicist survey & documentation summary caveat MARP, Inc. This lecture involves MQSA. Use with care. MQSA Guidance MARP, Inc. 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. allowed digital mammography in 2000 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 varies with manual version • & alternative standards FFDM vendors MARP, Inc. GE Senographe 2000D Senographe DS Essential Fischer Hologic Senoscan Selenia Siemens Novation Fuji FCRm third party vendors MARP, Inc. used for all studies not just mammography PACS (with manuals) Carestream • Totoku + Agfa • Barco 5 MP monitors NDS (Planar) EIZO WIDE Totoku Fimi Sectra • Barco, EIZO, Planar, Siemens Barco Richard Electronics • Image Systems (WIDE) Quest • Alphaview (Totoku) PACS (no manuals) Amicas • Barco, Planar McKesson • Barco MARP, Inc. scenario 1 MARP, Inc. soft copy workstation provided by FFDM manufacturer scenario 2 MARP, Inc. units at different sites share soft copy workstation by FFDM manufacturer scenario 3 MARP, Inc. FFDM units of different manufacturers share a single soft copy workstation scenario 4 MARP, Inc. single FFDM unit uses multiple soft copy workstations by various manufacturers FFDM RWS x 5 How do FFDM manufactures address 3rd party monitors? MARP, Inc. some defer to monitor manufacturer: Hologic • “If any workstation other than the (Hologic) SecurViewDX is used, the recommended QC of that workstation should be used” • weekly phantom must be scored on diagnostic workstation Fuji • “Follow monitor manufacturer’s QC program for test frequency, procedure, performance and corrective action” • For manufacturer’s w/out QC program, set up program using • TG18 QC or SMPTE RP133 • luminance response using gray scale images and photometer • weekly phantom scored on soft copy workstation How do FFDM manufactures address 3rd party monitors? MARP, Inc. some do not address it: GE • 2000D requires weekly phantom IQ on review workstation Siemens • phantom evaluated on RWS if it fails on AWS Fischer • requires weekly IQ on RWS How does FDA address 3rd party RWS? MARP, Inc. Printer and/or Monitors without QC Manuals Under the Mammography Quality Standards Act (MQSA) final regulation 900.12(e)(6), facilities using a mammographic modality other than screen-film must follow a quality control program that is “substantially the same as the quality assurance program recommended by the image receptor manufacturer…”. While all full field digital mammography (FFDM) manufacturers have quality control (QC) manuals, in some cases, the QC manual instructs the facility to test monitors and printers according to the component’s QC manual. In these cases, it is the responsibility of each facility to ensure that it obtains and follows the component’s QC manual for its monitors and printers. FDA Inspection News Update February 4, 2008 how does FDA address other RWS? MARP, Inc. Facilities Using the Same Printer or Monitor with FFDM Units from Different Manufacturers For facilities that are using FFDM units from different manufacturers, each with its own QC requirements for printers and monitors: Each FFDM manufacturer QC manual requires that the same or equivalent test be done, but at different time frequencies • facilities need to perform the test at the more stringent frequency. Each FFDM manufacturer QC manual requires that different but equivalent tests be done. • facilities may perform only one of the tests at the more stringent frequency. • medical physicist should provide a written statement for the facility’s quality control records, indicating that in his or her opinion, the two tests are equivalent. Each FFDM manufacturer QC manual requires that different tests (not equivalent) be done. • facilities need to perform each test at the frequency required in the respective FFDM manufacturer QC manual. FDA Inspection News Update February 4, 2008 How does FDA address laser printers? MARP, Inc. 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 TG18 tests MARP, Inc. monitor placement ambient light maximum & minimum luminance gray scale calibration geometric distortions reflections luminance response quantitative evaluations visual evaluations TG18 test patterns MARP, Inc. TG18-QC MARP, Inc. visual & quantitative resolution contrast luminance distortion artifacts TG18-CX MARP, Inc. visual resolution TG18-LN MARP, Inc. quantitative luminance DICOM grayscale calibration TG18-UN & UNL MARP, Inc. quantitative and visual luminance color uniformity 200 × ( Lmax − Lmin ) ≤ 30% ( Lmax + Lmin ) • TG18-UN80 • bright • TG18-UNL80 • bright, lined • TG18-UN10 • dark • TG18-UNL10 • dark, lined TG18-CT MARP, Inc. visual luminance response TG18-AFC MARP, Inc. visual noise TG18-MP MARP, Inc. visual luminance response • bit-depth resolution TG18-MM MARP, Inc. anatomical reference anatomical mammogram pattern FFDM manufacturer guidance MARP, Inc. GE Siemens Fischer Fuji Hologic FFDM manufacturer – GE MARP, Inc. Senographe 2000D RWS tasks in FFDM manual • 2277390-100 Rev 1, 2000 • 2371472-100 Rev 0, 2003 (postOnyx) CRT workstation • Siemens photometer • Dome • SMfit ACT SMfit no ACT software TG18 patterns technologist QC monitor cleaning • daily RWS viewing conditions • daily monitor calibration check • SMPTE pattern • monthly • fix immediately if fails FFDM manufacturer – GE MARP, Inc. physicist tests • 2277390-100 Rev 1, 2000 • 2371472-100 Rev 0, 2003 monitor calibration check Lmax & Lmin • L0 < 1.0 cd/m² • L255 = 240 ± 10 cd/m² viewing conditions • ambient < 50 lux & stable ± 5 lux • room drawing • fix immediately if fails gray scale vs baselines • • • • • • SMPTE pattern • smallest vertical bars do not need to be resolved • fix immediately if fails L0 L10 L60 L120 L180 L255 baseline ± 0.5 cd/m² baseline ± 0.5 cd/m² baseline ± 1.0 cd/m² baseline ± 2.0 cd/m² baseline ± 7 cd/m² baseline ± 10 cd/m² • background = L180 • fix within 30 days uniformity • visual check at L255 FFDM manufacturer – GE MARP, Inc. SenoAdvantage Workstation separate RWS QC manual physicist tests • ambient < 20 lux & stable ± 5 lux • room drawing • 2391082-4-1EN Rev 1 2007 usually LCD monitors • Siemens monitors • SMfit ACT software • Barco monitors • MediCal X software • TG18 test patterns SMPTE pattern • smallest vertical bars do not need to be resolved monitor calibration check • • • • • • • technologist QC • monitor cleaning • daily • RWS viewing conditions • daily • monitor calibration check • SMPTE pattern • monthly • fix immediately if fails viewing conditions L10 baseline ± 0.5 cd/m² L60 baseline ± 1.0 cd/m² L120 baseline ± 2.0 cd/m² L180 baseline ± 7 cd/m² L255 baseline ± 10 cd/m² background = L20% fix within 30 days uniformity • visual check at L255 FFDM manufacturer – Hologic MARP, Inc. SecureView Dx Barco Coronis monitor MediCal Pro software Technologist QC weekly open MediCal Pro software & run tests which are due • • • • white level quality level performance other tests for CRTs only preprogrammed limits Physicist tests viewing conditions • <50 lux • (<20 recommended) MediCal Pro software white level • 500 cd/m² ± 6% • 600 cd/m² ± 6% quality level performance • < 10% CRTs only • black level • uniformity < 15% FFDM manufacturer – Siemens MARP, Inc. syngo MammoReport VB22 technologist QC • • • • • • • daily monitor cleaning physicist tests monitor location specular reflections TG18-QC ambient light TG18-LN12-01 TG18-LN12-18 Lmin < 1.0 cd/m² Lmax > 250 cd/m² Lmax/Lmin > 250 ΔLmax < 10% physicist photometer uniformity • TG18-UNL10 • TG18-UNL80 • including CX scores luminance settings ( Lmax − Lmin ) ≤ 30% Lcenter resolution • TG18-QC (Cx scores) • < 10 cd/m² (recommended) noise • TG18-AFC monitor manufacturer guidance MARP, Inc. Barco WIDE NDS Totoku EIZO (Planar) Fimi available tests MARP, Inc. room layout • ambient light gray scale luminance TG18QC or SMPTE uniformity luminance response phantom technologist QC tests Barco MARP, Inc. Coronis 5MP monitor QC “manual” Version 7.0 29 August 2008 software: MediCal Pro MediCalX (more recent) most TG18 patterns built-in photometer at front Barco MARP, Inc. technologist QC: display • weekly • if MediCal QA Web is available compliance • monthly • weekly if MediCal QA Web not available • compares calibration to calibration curve autocalibration • annually • calibrates gray scale visual • TG18 QC • annually physicist tests display cleanliness viewing conditions • < 20 lux TG18QC • • • • ramps gray-scale patches 5% & 95% squares resolution NDS (Planar) MARP, Inc. DOME C5i & DOME E5 monitors QC manual MQSA QC Manual 020-0517-00 Rev:B software: Cxtra • RightLight Conformance external photometer most TG18 patterns NDS (Planar) MARP, Inc. technologist QC: monitor cleaning physicist tests • soft cloth or “mild cleanser” viewing conditions • drawing of room layout • < 20 lux • daily monitor calibration check • SMPTE pattern • monthly monitor calibration • “privileged user” • displays LUM, white level, graph Cxtra operation verification • daily • observe Windows taskbar for Cxtra icon viewing conditions SMPTE pattern visual inspection for defects EIZO MARP, Inc. RadiForce GS 520 monitor QC “manual” RadiForce QC management Revision 1.0 2007 software: RadiForce • guides user & writes report external sensor most TG18 patterns EIZO MARP, Inc. user QC pattern check & constancy physicist tests • daily • • • • technologist QC: constancy • monthly luminance • monthly Lmax/Lmin > 250 Lmax > 170 cd/m² ΔLmax < 10% Lamb < (Lmin-Lamb)/4 gray scale • target error rate < 10% GSDF gray scale pattern check • • • • • • • monthly luminance check uniformity • monthly TG18-QC TG18-CX TG18-AD TG18-UN80 TG18-AFC TG18-CT uniformity • bright & dark screens • < 30% WIDE MARP, Inc. IF2105MP monitor QC manual MQSA QC Manual OMI-1034 Rev 1.3 software: LumiCal • built-in internal photometer CFS • built-in internal photometer • or external phototimer some TG18 patterns? WIDE MARP, Inc. technologist QC: screen cleanliness • daily • soft cloth or special cleaning fluid viewing conditions physicist tests • drawing of room layout • < 20 lux • daily display luminance & gray scale calibration • black level (± 20% of target) • white level (± 10% of target) • JND root mean error < 20% image quality check • TG18-QC pattern • weekly viewing conditions image quality • TG18-QC Totoku MARP, Inc. ME511L & ME551i2 monitors QC manual MQSA Quality Control Manual Version 1.0 September 2007 software: Medivisor external photometer • DTP94 some TG18 patterns? Totoku MARP, Inc. technologist QC: cleaning physicist tests • drawing of room layout • < 20 lux • daily • cleaning agent & cloth viewing conditions • daily viewing conditions display calibration • • • • • image quality • SMPTE pattern • daily maximum (400 cd/m²) minimum (0.0 cd/m²) ambient (option) record gamma (displays calibration graph) SMPTE pattern visual uniformity • white pattern or TG18-UN80 PACS vendor guidance MARP, Inc. Carestream Richard Agfa Quest Sectra Electronics Carestream MARP, Inc. Quality Control Manual KODAK CARESTREAM Mammography Workstation Pub. #9F6423 May 17, 2007 Totoku monitors (relabeled) TG18 patterns Totoku technologist QC: Carestream technologist QC: cleaning • daily • daily viewing conditions image quality • SMPTE pattern • daily viewing conditions • daily • daily clean monitor image quality • SMPTE pattern • weekly Carestream MARP, Inc. physicist tests: viewing conditions • draw room layout • < 10 lux 200 × ( Lmax − Lmin ) ≤ 30% ( Lmax + Lmin ) chromaticity • TG18-UNL80 • nonuniformity between displays in same position <10% photometer (yours?) TG18-LN12-01 TG18-LN12-18 Lmax/Lmin >250 image quality • TG18-QC pixel defects • black & white • score pixels & subpixels luminance response • TG18-CT • TG18-MP • • • • luminance uniformity • TG18-UNL10 • visual & qualitative min & max luminance phantom • meets FFDM specs Agfa MARP, Inc. Quality Control Manual IMPAX 3000 Version 2.7 September 2005 Barco monitors (relabeled) MediCal Pro software Barco technologist QC: autocalibration Agfa (LCD) technologist QC: • daily display compliance visual • annually • TG18 QC measure display white • weekly calibration setting check • weekly • monthly (weekly) SMPTE • daily • weekly (or NA) viewing conditions • daily • annually clean monitor measure quality level • monthly automatic I-guard check • annually Afga MARP, Inc. Barco physicist tests Agfa physicist tests: display cleanliness clean monitor viewing conditions viewing conditions • < 20 lux • post room conditions • < 20 lux TG18QC • • • • ramps gray-scale patches 5% & 95% squares resolution measure display white • 600 cd/m² ± 6 black level • 1.0 cd/m² calibration settings check measure quality level • <10% calibrate displays SMPTE pattern auto I-guard Sectra MARP, Inc. Quality Control Procedures Sectra PACS for Breast Imaging Version 11.1 P3 September 2008 various monitors: Planar DOME E5i Eizo RadiForce GS520 Barco Coronis 5MP Siemens SMD 21500 Sectra technologist QC: daily: monitor cleaning viewing conditions display check • TG18-QC printer check Sectra technologist QC: monthly: contrast visibility • gray scale display function • visual (TG18-QC) & photometer display artifacts • photometer Lmin, Lmax Lmax/Lmin > 250 black level • photometer & calibration program monitor luminance range • • • TG18-QC stuck pixels printer test • print TG18-QC Sectra MARP, Inc. Sectra physicist tests: acceptance testing • 4-page chart signed by physicist • includes CAD annual testing viewing conditions • room drawing • Lamb < 0.25Lmin luminance • • • • • & grayscale Lmin Lmax Lmax/Lmin > 250 Lmax & Lmin match for all monitors GSDF passes phantom medical physicist surveys MARP, Inc. medical physicist surveys MARP, Inc. initial evaluations newly installed RWS annual surveys at least every 14 months MQSA does not require that all mammography tests be performed at same time evaluations RWS one moved or both monitors replaced if requested by FFDM service engineer following service or upgrade survey scenarios MARP, Inc. perform tests required by FFDM QC manual perform tests required by monitor or PACS QC manual perform tests as deemed appropriate by medical physicist perform all available tests including: • TG18 • FFDM manufacturer • monitor / PACS manufacturer for each 5 MP monitor used for final soft-copy interpretation survey caveats MARP, Inc. privileges most required QC applications do not require privileges to run many consoles require special privileges to access the menu which start the QC applications communicate with IT photometers calibrations gray vary scale specs based on a specific photometer medical physics survey MARP, Inc. common tests room layout • drawing • ambient light image quality • TG18-QC or SMPTE luminance values • Lmax • Lmin • Lmax/Lmin > 250 visual uniformity MAP phantom technologist QC other tests gray scale calibration uniformity • <30% other available TG18 tests room layout MARP, Inc. TG18 QC MARP, Inc. SMPTE pattern MARP, Inc. TG18 QC Cx MARP, Inc. TG18 CT, MP, AFC MARP, Inc. luminance calibration MARP, Inc. internal photometers behind screen in front of screen luminance calibration MARP, Inc. external photometers connected to RWS • supplied with RWS • referred to in QC manual and application • read by calibration program • values shown on monitor not connected to RWS • values on its on display • physicist or service engineer luminance calibration MARP, Inc. gray scale calibration - GE MARP, Inc. uniformity - visual MARP, Inc. bright screen (dark pixels) L255 TG18-UN80 TG18-UNL80 dark screen (white pixels) L0 TG18-UN10 TG18-UNL10 uniformity – measured on bright monitor MARP, Inc. bright screen L255 TG18-UN80 TG18-UNL80 uniformity – measured on dark monitor MARP, Inc. dark screen L0 TG18-UN10 TG18-UNL10 MAP phantom MARP, Inc. technologist QC MARP, Inc. technologist QC MARP, Inc. do the test intervals match the QC manual? automated test frequency may not be programmed correctly IT can change automated test frequency review workstation report MARP, Inc. part of FFDM survey report separate from FFDM survey report may be surveyed at different time • allowable under MQSA allows for: survey of monitor only • evaluation due to replacement or relocation multiple monitor surveys for single FFDM monitor survey for FFDM in another part of country monitor identification & recommendations MARP, Inc. 1 room layout MARP, Inc. 2 phantom MARP, Inc. 3 TG18 QC or SMPTE MARP, Inc. 3 gray-scale calibration MARP, Inc. 3 visual uniformity MARP, Inc. 4 measured uniformity MARP, Inc. 4 QC program MARP, Inc. 5 summary MARP, Inc. FFDM sites may use 5 MP monitors from manufacturers other than the FFDM unit manufacturer many different QC manuals may describe a FFDM unit / softcopy review workstation a comprehensive set of monitor tests may cover most or all of the MQSA required tests MARP, Inc. FFDM in the Field: Physicist's Role in the QC of Third-Party Review Work Stations July 2009 Carl R. Keener, Ph.D., DABMP, DABR keener@MARPinc.com MARP Medical & Radiation Physics, Inc.
