RADIOLOGY

RESEARCH

Current IHE Topics:

1. PDI,

Portable Data Imaging Integration Profile

2. MAMMO,

Mammography Image Integration Profile

Michael Flynn, PhD

Donald Peck, PhD

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IHE

IHE: Integrating the Healthcare Enterprise

• “IHE is an initiative by healthcare professionals andindustry to improve the way computer systems inhealthcare share information.”

• “IHE promotes the coordinates use of establishedstandards such as DICOM and HL7 to address specificclinical need in support of optimal patient care.”

• “Systems developed in accordance with IHEcommunicate with one another better, are easier toimplement, and enable care providers to useinformation more effectively.”

http://www.ihe.net/

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IHE Member Organizations

IHE: Member Organizations

• 27 Healthcare Professional Associations

AAPM, ASTRO, RSNA, SNM …

• 104 Healthcare companies

• 8 Government Agencies

CDC, NIST, VA …

• 7 Standards Organizations

• 8 Healthcare provider organizations

• 8 Healthcare education & research orgs.

http://www.ihe.net/

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IHE Domains

IHE: Active Domains

• Cardiology

• Eye Care

• IT Infrastructure

• Laboratory

• Patient CareCoordination

• Patient Care Devices

• Quality

http://wiki.ihe.net/

• Radiation Oncology

• Radiology

• Mammography

• Nuclear Medicine

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Recent IHE Profiles

IHE Profiles relevant to Medical Physics

• [NTPL-S] Normal Treatment Planning-Simple

• [MMR-RO] Multimodality Registration, RadiationOncology

• [TRWF] RT Treatment Workflow

• [PWF] Post-Processing Workflow

• [NM] Nuclear Medicine Image

• [FUS] Image Fusion (in Trial)

• [REM] Radiation Exposure Management (in Trial)

• [MAMMO] Mammography Image

• [PDI] Portable Data for Imaging

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Part I

• [PDI] Portable Data for Imaging:

“provides reliable interchange of imagedata and diagnostic reports on CDs forimporting, printing, or optionally, displayingin a browser.”

Part II

• [MAMMO] Mammography Image:

“Specifies how Mammography images andevidence objects are created, exchanged,used and displayed.”

Outline

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Learning Objectives

1. Understand from two examples how the IHEprofiles impact diagnostic radiology PACS.

2. Understand how to avoid problems whenexchanging image data between institutions.

3. Learn how recent mammography profiles canbe used when specifying systems for digitalmammography reading.

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Topics

• AMA & patient safety

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AMA A-06-539, 2006

AMA House of Delegates2006 Resolution 539

Development of Standards for MRI Equipment and Interpretationto Improve Patient Safety

• Whereas, Patients’ MRI data in CD format are not all compatibleCD format are not all compatiblewith physicians’ computers; and

• Whereas, The MRI CD data is usually without a master key, legendsusually without a master key, legendsor localizing imagesor localizing images so that the consultant cannot determine theimage sequence or the level of interest, creating significant patientsafety issues; and

• Whereas, Different MRI software arranges images in oppositearranges images in oppositeplanes of view, left to right, superior to inferiorplanes of view, left to right, superior to inferior, and vice versa; and

• Whereas, Errors can and do occur, potentially harming a patient,when there is confusion as to the localization of pathology; and

• Whereas, Physicians must have the most reliable and standardizeddata for best possible patient safety and outcomes; therefore be it

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AMA A-06-539, 2006

AMA House of Delegates2006 Resolution 539

Development of Standards for MRI Equipment and Interpretationto Improve Patient Safety

• RESOLVED, That our American Medical Association convene aconvene ameeting(smeeting(s) with representatives from MRI manufacturers, radiology) with representatives from MRI manufacturers, radiologyand other interested medical specialties, and imaging facilitiesand other interested medical specialties, and imaging facilities, withthe goals of:

• (1) agreeing to standards in electronic imaging formats (e.g., leftto right, axial, coronal, sagittal);

• (2) developing standards of data manipulation and localizationconsistent throughout all units for best interpretation of thedata; and

• (3) ensuring that each electronic format is equipped with thecapability of loading and launching its contained images on thephysician’s computer

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AMA Board of Trustees, 2007

AMA B of T Report 30-A-07

Development of Standards for MRI .. to Improve Patient Safety

• CONCLUSION

• The lack of standardization of MRI information has importantpatient safety, ethical, and liability implications for physiciansin a wide array of specialties and practice settings. …, the useof nonstandardized imaging systems is a current threat tohigh quality, medically appropriate, efficient, and safe care.

• Although the AMA-convened meeting of stakeholders wasproductive, it was not conclusive. Meeting attendeesidentified additional issues that must be addressed in orderto expedite standards setting for MRIs. Attendees alsoidentified other relevant stakeholders that should be a partof future discussions.

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AMA Board of Trustees, 2007

AMA B of T Report 30-A-07

Development of Standards for MRI .. to Improve Patient Safety

• RECOMMENDATIONS

• Recommend that stakeholders agree to a voluntary system ofMRI standardization and accreditation, and focus ondeveloping solutions across professional, payer, and industrypartners that promote interoperability and use of MRI dataand presentation and urge the development of a timetablethat would result in 50% interoperatibility within one year.

• If voluntary efforts fail and/or vendors and others arereticent to act, advocate for mandated change throughlegislative channels.

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AMA A-08-523, 2008

AMA House of Delegates

2008 Resolution 523

MRI Safety and Standardization

•Whereas, This product is now becoming known as thebecoming known as the ““AMA StandardAMA Standard””digital imaging format for use by clinical care providers such ascardiologists, orthopedists, neurologists, and neurosurgeons; and

•Whereas, This standard is seen as a model for creating betterpatient safety by eliminating the current plethora of variable andconfusing programs; and

•Whereas, This effort, when adopted by software vendors, will stillallow for innovation and competition with expandable toolbars forspecial features unique to themselves as well as for specialty needs;and

•Whereas, Adoption will significantly eliminate the need for duplicativestudies by specialists who currently are unable to open and learn themore than 70 variations of formatting data, creating delays andinaccurate treatment plans; and

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AMA A-08-523, 2008

AMA House of Delegates2008 Resolution 523MRI Safety and Standardization

•RESOLVED, That our American Medical Association continueto promote and fund this successful effort for the next 18months, convening key industry and specialty providers toadopt this groundbreaking accomplishment (Directive to TakeAction); and be it further

•RESOLVED, That the results of this safety initiative beThat the results of this safety initiative bereported back to the House of Delegates by the 2009 Interimreported back to the House of Delegates by the 2009 InterimMeetingMeeting, or sooner if goals are met prior to the 2009 AnnualMeeting. (Directive to Take Action)

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Topics

• AMA & patient safety

• DICOM Media Standards

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DICOM PS 3.10

DICOM Part 10

Media Storage and File Format for Media Interchange

• Defines a file format with a preamble containingessential information normally exchanged duringassociation prior to DICOM image networkcommunication.

• Defines a directory file, DICOMDIR, thatindexes all images stored on the media.

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DICOM Part 10 file format

The file metaheader contains10 dicom tags (group 0002)

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DICOM Part 10 DICOMDIR

“A single File with a File ID, DICOMDIR, shall existas a member of every File-set”

• It contains the DICOM Media Storage Directory(see PS 3.3) which includes general informationabout the whole File-set.

• Defines how to organize records to find imagesof series of studies of patients.

• However, not mandatory and content ambiquous.

• Structured Documents as defined by an HL7standard may be stored on DICOM InterchangeMedia, and may be referenced from within theDICOMDIR.

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DICOM PS 3.11

DICOM Part 11

Media Storage Application Profiles

• This part of the DICOM Standard specifiesapplication specific subsets of the DICOMStandard to which an implementation may claimconformance.

• Such a conformance statement applies to theinteroperable interchange of medical imagesand related information on storage media forspecific clinical uses.

• It follows the framework, defined in PS 3.10,for the interchange of various types ofinformation on storage media.

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DICOM PS 3.11

DICOM Part 11

Media Storage Application Profiles

Annex D - General Purpose CD-R and DVDInterchange Profiles

Annex E - CT and MR Image Application Profiles

Annex H - General Purpose DVD with CompressionInterchange Profiles

Annex J - General Purpose USB and Flash Memorywith Compression Interchange Profiles

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DICOM PS 3.11, CT & MR

DICOM Part 11

CT and MR Image Application Profiles

STD-CTMR-MOD41 CT/MR Studies on 4.1GB MOD

STD-CTMR-CD CT/MR Studies on CD-R

STD-CTMR-DVD-RAM CT/MR Studies on DVD-RAM

STD-CTMR-DVD CT/MR Studies on DVD

Handles single frame 8, 12 or 16 bit grayscaleand 8 bit palette color, uncompressed andlossless compressed images.

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DICOM PS 3.11, CT & MR

DICOM Part 11

General Purpose DVD with Compression Interchange

STD-GEN-DVD-JPEG General Purpose DVDInterchange with JPEG

STD-GEN-DVD-J2K General Purpose DVDInterchange with JPEG 2000

STD-GEN-SEC-DVD-JPEG General Purpose Secure DVDInterchange with JPEG

STD-GEN-SEC-DVD-J2K General Purpose Secure DVDInterchange with JPEG 2000

Handles interchange of Composite SOP Instances suchas Images, Structured Reports, Presentation Statesand Waveforms, either uncompressed or with losslessor lossy JPEG[2000]

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DICOM PS 3.12

DICOM Part 12

Media Formats and Physical Media for Media Interchange

Annex F - 120mm CD-R Medium (ISO-9660, level 1)

Annex J – UDF on 120 mm DVD-RAM Medium

Annex P – 120 mm DVD Medium

DVD-ROM/-R/-RW/+R/+RW, UDF or ISO-9660

Annex R – USB Connected Removeable Devices

FAT 16, USB 1.1 or 2.0

Annex V – ZIP File Media (PKWARE ZIP specs)

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Topics

• AMA & patient safety

• DICOM Media Standards

• IHE PDI

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IHE PDI

IHE Technical Framework

Volume III Transactions (Continued)

Revision 8, 30-Aug-2007

..

4.47 Distribute Imaging Information on Media

This section corresponds to Transaction RAD-47 of theIHE Technical Framework. Transaction RAD-47 is used bythe Portable Media Creator and by media reading actors(Portable Media Importer, Image Display, Report Reader,Display and Print Composer).

..

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IHE PDI

IHE Technical Framework

Volume III Transactions (Continued)

Revision 8, 30-Aug-2007

..

4.47.3 Referenced Standard

DICOM 2007 PS 3.10:Media Storage and File Format for Data Interchange

DICOM 2007 PS 3.11:Media Storage Application Profiles

DICOM 2007 PS 3.12:Media Formats and Physical Media for Data Interchange

..

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IHE PDI

IHE Technical FrameworkVolume III Transactions (Continued)

Revision 8, 30-Aug-2007..4.47.4.1.2.1 Media File system and File Naming Restrictions

Since the DICOM content on the media is required to conform tothe DICOM standard, some of the requirements specified in PS3.10, 3.11 and 3.12 are reiterated here for emphasis:

• Strict ISO 9660 Level 1 compliance• No packet writing• File and folder names referenced by the DICOMDIR file

restricted to 8 characters, uppercase letters, digits andunderscore only, with no extension

..

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IHE PDI Added Value

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IHE PDI Example

DICOM Directory file referencing all DICOM instances:

all DICOM images

the PS object

the SR object

/DICOMDIR

links to XHTML report and to another page (THUMBS.HTM)with thumbnails that link the full resolution JPEG images

link to a launch point for the DICOM viewer in /VIEWERS

link to the list of importable data

/INDEX.HTM

File with content per 4.47.4.1.2.2/README.TXT

Marker with content per 4.47.4.1.2.2:

patient name

creation date

name of the institution that created the media

Identification Marking

DescriptionContent element(s)

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IHE PDI Example

Directory with content per 4.47.4.1.2.2:

Image object 1

Image object 2

.

.

.

Image object N

DICOM Presentation State object

Basic Text DICOM Structured Report object

/ DICOM/

/DICOM /12296

/DICOM /12297

.

.

.

/DICOM /NNNNN

/DICOM /98732

/DICOM /12312

DescriptionContent element(s)

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IHE PDI Example

Optional directory:

executable viewer

/VIEWERS/

/VIEWERS/VIEWER.EXE

IHE PDI Web Content directory

XHTML report

navigation page that displays T_12296.JPG, T_12297.JPG

thumbnail of Image object 1

thumbnail of Image object 2

full resolution JPEG image for view within browser

full resolution JPEG image for view within browser

/IHE_PDI

/IHE_PDI /REPORT.HTM

/IHE_PDI /THUMBS.HTM

/IHE_PDI /T_12296.JPG

/IHE_PDI /T_12297.JPG

/IHE_PDI /I_12296.JPG

/IHE_PDI /I_12297.JPG

DescriptionContent element(s)

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IHE PDI Changes

Change proposals to PDI are now beingprepared that aim to support the end userexperience in managing digital imagingdelivered via portable media.

They concern:

1. Expanding the supported media to includeDVDs and media with USB interface

2. Supporting compression of image files

3. Supporting the addition of file formatsthat support video

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Topics

• AMA & patient safety

• DICOM Media Standards

• IHE PDI

• Validation

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DRG specifications

• CD media exchangespecifications similar toIHE-PDI.

• Difference between theDRG and IHE-PDIspecifications arespecifically described.

• IHE-PDI conformantmedia meet DRGspecifications. Thereverse is not true.

• A harmonization effortis in progress.

www.dicom-cd.de/index.php.en

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DRG Vaidation DICOM WG10 Meeting, BerlinMichael Onken , OFFIS

Order

Data Acquisition

Initial Test?ShortTest

Report Short Test

Intensive Test

Interoperability Test

Certification Abort

OK? Repeat?

yes no

no

yes

yes

no

FullTest

Report

Interop.Report

Certifi-cate

Phase

1:

Evalu

atio

nfre

e

Phase

2:

short

test

Phase

3:

Full

test

Order

Data Acquisition

Initial Test?ShortTest

Report Short Test

Intensive Test

Interoperability Test

Certification Abort

OK? Repeat?

yes no

no

yes

yes

no

FullTest

Report

Interop.Report

Certifi-cate

Phase

1:

Evalu

atio

nfre

e

Phase

2:

short

test

Phase

3:

Full

test

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DRG CD: Current status

• April 2007, registration for DRG CD validation began

• OFFIS performs tests on behalf of DRG

• Company signs contracts with OFFIS

• OFFIS performs short/full test (phase 2 and 3)

• Certificates granted jointly by OFFIS and DRG

• Five companies already entered phase 2 and 3

• Another six companies in phase 1 (evaluation)

• First certified products expected by mid-2007

• Expiring of a DRG certificate

• Certificates granted for two full calendar years(i. e. all certificates from 2008 will expire in 2010)

DICOM WG10 Meeting, Berlin

Michael Onken , OFFIS

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Part I

• [PDI] Portable Data for Imaging:

“provides reliable interchange of imagedata and diagnostic reports on CDs forimporting, printing, or optionally, displayingin a browser.”

Part II

• [MAMMO] Mammography Image:

“Specifies how Mammography images andevidence objects are created, exchanged,used and displayed.”

Outline

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[MAMMO] Mammography Image

• Outlined in the IHE Radiology:Mammography User’s Handbook

• Published March 2007

• Describes how to “solve” different aspectsof implementing digital mammography

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MAMMO Profile

• Minimum contents for DICOM instances

• Image Data

• “for processing” and “for presentation” SOP Classes

• CAD data

• CAD SR

• Mammography Workflow

• Managing the process of creating, storing and usingMammography Image content

• Basic display capabilities to suit specificmammography review requirements

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Mammography Image Profile

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Mammo Image Profile

• Acquisition Modality

• FFDM & CR are required to create MG objects

• MG objects have 40 Attributes with specificrequirements that are mandatory in order tocomply with the Profile

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Required Attributes of interest to Physicist

Acquisition

• KVP

• Exposure

• Exposure Time

• Filter Material

• Anode Target Material

• Body Part Thickness

• Position Angle

• Relative X-ray Exposure

• Entrance Dose in mGy

• Organ Dose

• Date of Last DetectorCalibration

Display

• VOI LUT Sequence

• LUT Explanation

• VOI LUT Function

• Implant Present

• Pixel Padding Value

• Pixel Padding Value Range

• Estimated RadiographicMagnification Factor

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Scheduled Workflow Profile

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Scheduled Workflow Profile

• Image Manager/Archive

• Support both Modality Images and EvidenceDocument Stored with Storage Commitment

• Support Query/Retrieve of both Images andEvidence Documents

AcquisitionModality

EvidenceCreator

ImageManager

↓ [RAD 18] Evidence Document Stored↓ [RAD 10] Storage Commitment

↓ [RAD 14] Query Images↓ [RAD 16] Retrieve Images↓ [RAD 44] Query Evidence Documents↓ [RAD 45] Retrieve Evidence Documents

ImageArchive

[RAD 8] Modality Images Stored ↓[RAD 10] Storage Commitment ↓

ImageDisplay

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Portable data for Imaging Profile

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Consistent Presentation of Images Profile

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Mammography Images – “The Problem”

• Mammography image review relies on comparisonwith prior image sets• increases the occurrence of simultaneous review of

images from different systems

• Multi-vendor Mammography Systems• Vary with detector technologies and sizes resulting

in varying image matrices sizes.• Vary with contrast presentation methods resulting

in varying image presentation

• Mammography Image Review requires a minimal setof display features• zoom, LUT rendering, hanging protocols

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Hanging Protocol – Incorrect

* adapted from D. Clunie, SCAR 2005

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Hanging Protocols - Correct

* adapted from D. Clunie, SCAR 2005

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Hanging Protocol

* adapted from D. Clunie, SCAR 2005

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Hanging Protocol

* adapted from D. Clunie, SCAR 2005

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Hanging Protocol

* adapted from D. Clunie, SCAR 2005

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Hanging Protocol

* adapted from D. Clunie, SCAR 2005

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Orientation of images

• The necessary DICOM attributes are mandatory

• Always present and correct - safety related issue

• Dependent on correct user input of laterality

• Technologist may need to verify correct lateralityafter acquisition

• Should not try and setup the acquisition system toencode the header to force the correct hanging

• Need to have vendor compliance with this IHEMammo Profile

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Justification of images

• Radiologists like mammograms displayed“back to back”

• Non-Mammography default layout is tocenter image, rather than justify to one sideor the other

• Knowledge of desired layout, view andorientation is encoded in image

• this should allow automatic justification

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Image Justification

* adapted from D. Clunie, SCAR 2005

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Image Justification

* adapted from D. Clunie, SCAR 2005

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Image size

• Available display size may be differentthan image pixel data size

• Images from different vendors or fromdifferent detector modes in the sameproduct will have different pixel sizes

• All images need to display at their “true”size, regardless of the image pixel size

• DICOM Imager Pixel Spacing attributespecifies size of pixels in image

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Example of different image sizes

Current

Prior Prior

Current

* adapted from D. Clunie, SCAR 2005

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Image size synchronization

* adapted from D. Clunie, SCAR 2005

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Image Contrast Adjustment

VOI LUT

Linear LUT

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Image Contrast Adjustment

• “For Presentation” Images shall have thecapability to apply all transformationsavailable, i.e.:

• VOI LUT Sequence (0028,3010)

• VOI LUT Function (0028,1056)

• Window Width (0028,1051)

• Window Center(0028,1050)

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Image Display Functions

• Zoom• Adjust zoom accounting for varying acquisition pixel sizes• True size zoom accounting for display (monitor) pixel size

• Background unattenuated region suppression (termed “air gap”)• When windowing the image, the detected background stays

black

• Image orientation• Flipping according to Patient Orientation

• CAD rendering (using CAD SR)

• Annotations• Set of required annotations to be displayed is defined• ACR requires annotation be available on the PDI media

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Film Print

• Print Composer/Server

• Support Print Request with Presentation LUT

• including the LIN-OD presentation LUT shape

• Use Requested Image Size to achieve “true size”printing

• Support 12 bits printing

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Questions?

?