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MINUTES
DICOM WORKING GROUP TWENTY-SIX
Joint meeting together with IHE (AP) and HL7 (sig AP)
(Pathology)
June 18th, 2014
Called to order: 09.00
Meeting closed: 17:30
Location: Room 100, Collège des Bernardins” (18-24 Rue de Poissy, 75005 Paris)
Presiding Officer: Mikael Wintell
Voting Members Represented
ADICAP, ADHP, INSERM
Omnyx
Philips Healthcare
JAHIS
Servicio de Anatomia Patologia
Vastra Gotalandsregionen
Daniel Christel
Khal Rai
Hans van Wijngaarden
Megumi Kondo
Marcial Garcia Rojo
Mikael Wintell
Voting Members Not Represented
ALCON Research
British Columbia Provincial Lab.
Coordinating Office
CAP
Corista, LLC
DMetrix, Inc.
Mass General Hospital
Nikon Instruments
Objective Pathology Services
Panasonic
Simin Shoari
Joanne Philley
Bruce Beckwith
Eric Wirch
Michael Descour
John Gilbertson
Stanley Schwartz
Kemp Watson
Thomas Wedi
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DICOM WG-26 – Pathology
June 18th, 2014
Ohio State University
TRIBVN
Takasaki Univ.
Leica Biosystems
3DHISTECH
CAP
Tony Pan
Jacques Klossa
Ikuo Tofukuji
Dave Toomey
Viktor Varga
Mark Whitsitt
Alternate Voters, Observers, Guests Present
Mary Kennedy
Thomas Schrader
Yves Sucaet
Frank van Apeldoorn
Wim Waelput
Bikash Sabata
Frédrique Capron
Laura Pomarjanschi
Yannick Kergosien
Alhamany Zautouna
André Huisman
Francois Macary
Gunter Haroske
Ras Dash
Lanine Traoré
Lika Svanadze
CAP
Charité, Berlin
HistoGeneX
Philips healthcare
Histodig
Ventana Medical System
Assistance Publique Hopistal de Paris
Euroimmun AG
LIMICS INSERM
Rabat Norocio Pathology
Medical PHIT
ASIP Santé
BDT
CAP/IHE-AP/Duke University
AP-HP
Göttingen University
Acknowledgements
(Thanks to Jacques Klossa for helping us arranging this room and meeting facilities)
o
ASSIGNMENTS SUMMARY:
Work Items assigned and remaining since earlier meetings:
1. JD Nolen and Michael to see if somebody from HL7 AP could present and overview of
LAW
2. Mary to work with IHE, making sure the VGR digital pathology workflow is reviewed
and integration profiles potentially be latered to account for that workflow
3. Dan to share the information on the 2nd Aperio/Leica patent
4. Ann to follow-up whether the “license at no fee” applies to both Aperio/Leica DICOM
patents
5. Ann to follow-up whether there are any potential copyright issues around that / those
patent(s)
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DICOM WG-26 – Pathology
June 18th, 2014
6. Michael to re-share strategy document of WG26
Work item(s) from previous meeting(s):
1. Michael to publish link to IHE conference calendar
2. Michael to ask WG26 for participants in a trial implementation of LIS, stainer, and
imaging device
3. On hold: Bas H to work with Bas R and translate multi-spectral proposal into DICOM
4. On hold: Bas H to check with WG26 listserve who would be interested in a trial
implementation of multi-spectral presentation state.
·


o
Agenda:
Welcome & Introductions
Purpose of this joint meeting with IHE and HL7, AP
Co-chair situation and the upcoming election.
1. Opening:
The meeting began with a welcome and brief introduction to the planned agenda of the meeting.
We welcomed those present, asked people to introduce themselves, and re-stated the antitrust
rules, book keeping. The Agenda was approved.
o Workflow:
Dr Dash, IHE AP presented a “standard workflow” in AP and started from the beginning
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DICOM WG-26 – Pathology
June 18th, 2014
Where are we?
AP WSI Im
Specimen/Container
Identification
• 2D Barcode
Standardization (CLSI)
• Unique Identifier
(HL7)
APSR (IHE)
LAW
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June 18th, 2014
Where can we go?
Unique Identifiers
Structured Repo
Standard Formats
Standard Mod
Complete Case
Interoperability
Standard Interfaces
Instruments and Systems
Standard Task and Pr
Workflows and D
.
But this is not the whole story we need to focus on the complete chain of stakeholders
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June 18th, 2014
Where can we go?
Clinician – Lab
Structured Reporting
Communication
Standard Model
Complete Case
Interoperability
Specimen Processing
Workflow
Image Acquisition and
Interpretation
But we have Supple 145, but we need a unified standard around the storage of whole slide
images and this standard powers the digital workflow. But without a standardized, interoperable
workflow prior to that, we will struggle!
So as a proposed plan we need harmonization of Unique ID (HL7) and 2D Barcode (CLSI), and
this work already started.
AP/O&O HL7 harmonizing Unique ID with Specimen Model….possible informative ballot in
September.
Potential “real estate” issue with small format of 2D standard and information in Unique
Joint workflow project (HL7, DICOM, IHE), result from this meeting, hopefully
Leverage LAW profile to define standard workflows in AP, we will come back to LAW later
during this meeting
Use APSR 2.0 (via HL7 Germany) to build a generic structured report and also consider CDA.
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DICOM WG-26 – Pathology
June 18th, 2014
Have the ability to handle eCC-like data and also define a standard data format and vocabulary to
capture all of the data in the workflow (Processing, tasks, tracking, etc. )
So in summary of this topic, where we are now!
•All parties (IHE, DICOM, HL7) want this to be an IHE AP project
•HL7 APWG approval for project complete (last WGM)
•Formal HL7 project approval pending IHE approval
•First focus (project)
–Stainer workflow in LAW
•IHC-based seems more likely since interfaces exist with most LIS/LIMS
•“Simple” workflow/data set to start.
More detailed workflow dialogue, IHE AP.
Dr Daniel provided some information and background from IHE. From their technical
framework you can read
Current Technical Framework - Revision 2.0
July 23, 2010. Copyright © 2010: IHE International, Inc.Trial Implementation
Vol. 1 (PAT TF-1): Integration Profiles
Vol. 2 (PAT TF-2): Transactions
These volumes provide specification of the following profile:
Anatomic Pathology Workflow (APW)
Supplements for Trial Implementation
To be tested at subsequent IHE Connectathons.
Supplements extend the IHE Anatomic Pathology Technical Framework, Rev. 2.0 for Trial
Implementation.
Anatomic Pathology Reporting to Public Health (ARPH) - Published 2010-07-23
Anatomic Pathology Structured Reports (APSR) - Published 2011-03-31
APSR Value Sets Appendix - Published 2011-03-31
From this the current work with the workflow AP looks like this
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DICOM WG-26 – Pathology
June 18th, 2014
IHE Anatomic Pathology
Existing and planned profiles
IT Infrastructure
profiles
ATNA
Care
Ward
Anatomic Pathology
Laboratory
CT
Order mgmt.
Image mgmt
Securit
PAM
Report mgmt. Aut
APW: AP workflow
PDQ
Enhanced
Imaging
workflow
Patient
mgmt.
ARW:AP
reporting
workflow
AP
AP de
autom
IAPW:
Inter AP
labs
workflow
APOR:
AP opinion request
XDS
XDS-I
APSR: AP Struct
Report
XDM
Docs./Image
sharing
ARPH: AP Report
And important to realize is that Structure Report here is not the same as DICOM SR, this was
kind of confusing for some of the participants. Before this was sorted out some of us didn´t
understand the gap as the DICOM SR has all the necessary tag information to feed the workflow
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DICOM WG-26 – Pathology
June 18th, 2014
engine. But now we need to work in a joint venture together with IHE and HL7 to have those
metadata available, and used to manage the workflow we want to achieve within AP.
IHE has also come to the same conclusion as WG26 to start with the basic need for a workflow
in AP, otherwise we will drown in details, and below there´s a suggestion to start with.
Anatomic Pathology Workflo
(APW)
Patient
mgmt.
Care
Ward
Anatomic
Pathology
Laboratory
Im
M
Modality
worklist
Patient
Adm
Mgmt
Acquisition Modality
(gross imaging/microscopic imaging)
Acquisition completed
Order
Mgmt
Re
Mg
ADT
Registration
Order Placer
Orders Placed
Order Filler
Orders accepted
Report created
This profile introduces 8 actors :
2 in the care unit (OP, OrderResult Tracker, Image Display) OP, ORT may be implemented by
diff systems or grouped in the by the CIS or EMR
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DICOM WG-26 – Pathology
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Order Placer: A hospital or enterprise-wide system that generates orders for various
departments and distributes those orders to the correct department, and appropriately manages all
state changes of those orders. In some cases the Order Placer is responsible for collecting and
identifying the specimens. Therefore, the transaction between Order Placer and Order Filler may
carry specimen related information. There may be several Order placer actors in the same
enterprise
Order Result Tracker – A system that stores pathology observations obtained for the patients
of the healthcare institution, registers all state changes in the results notified by Order Fillers.
This actor stores observations in the context of their Order or Order Group. This actor also stores
reports outside the Pathology department.
Image Display: A system that offers browsing of patient’s studies including anatomic pathology
image folders. In addition, it may support the retrieval and display of selected evidence objects
including sets of images, presentation states and Evidence Documents.
2 in the PAT (OF (usually implemented by PIS: scheduling of orders and result delivery to
clinical unit), Acquisitio modality & evidence Creator)
Order Filler: A pathology department-based information system that provides functions related
to the management of orders received from external systems or through the department system’s
user interface. The system receives orders from Order Placer actors, collects or controls the
related specimens, accepts or rejects the order, schedules work orders, and sends them to
processing room, receives the results of gross study (specimen status and adequacy), controls the
status of each specimen, and appropriately manages all state changes of the order. In some cases,
the Order Filler will create test orders itself (e.g. a paper order received from a department not
connected to an Order Placer, or a paper order was received from a physician external to the
organization). In some cases the Order Filler is responsible for collecting and identifying the
specimens. An Order Filler may receive orders from various Order Placers.
Acquisition Modality: A system that acquires and creates medical images from a specimen, e.g.
gross imaging station, a digital camera mounted on a microscope or a virtual slide scanner. A
modality may also create other evidence objects such as Presentation States for the consistent
viewing of images or Evidence Documents containing measurements.
Evidence Creator: A system that creates additional evidence objects such as images,
presentation states, Key Image Notes, and/or Evidence Documents and transmits them to an
Image Archive. It also makes requests for storage commitment to the Image Manager for the data
previously transmitted.
The 2 last actors usually grouped in the same system are
Image Archive: A system that provides long term storage of evidence objects such as images,
presentation states, Key Image Notes and Evidence Documents.
Image Manager: A system that provides functions related to safe storage and management of
evidence objects. It supplies availability information for those objects to the Department System
Scheduler.
From the work within WG26 in a simplified way, view of how a basic workflow could look like.
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DICOM WG-26 – Pathology
June 18th, 2014
Simple Workflow
Area
Clinical
Pre-Prep
Activity
Obtain Specimen
Receive Specimen
Order Test
Register Order
Step
• Surgery/Oncology
• Accessioning
System
HIS / EMR
• HL7
Standard
•Patient ID
•Demographics
• Proprietary
• EDIFACT
• DICOM UPS
Prep
Processing
• Staining
• Scanning
LIS
• HL7
•Case ID
•Test
• XML
• Paper
• DICOM UPS
LIS/Instrument/Tracking
•
•
•
•
HL7
DICOM
ASTM
DICOM UPS
During this presentation we had a good dialogue where all the participating vendors spoke their
mind and in my conclusion I didn´t hear anyone disagree to this approach. We need to provide a
high quality input with the suggested information/tag that needs to be a part om the workflow for
the vendor to consider in the future, but this is a joint work, vendor – users - academia.
IHE Clinical Lab, LDA (lab device automation) and LAW (lab analytic workflow) profiles
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• Re
• Re
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DICOM WG-26 – Pathology
June 18th, 2014
•
•
•
•
IH
DI
HL
XD
We had a presentation done by Francois Macary (ASIP) where he presented the integration
profiles and their part in the overall workflow. And after a good dialogue we all agreed on that
the best profile to start with will be LDA, this to get the information necessary for the workflow,
out from the instrument and into the “workflow engine.
Automation Actors
in the clinical laborato
LIS
Order Filler
Middleware
systems
Work
Order
Analyzer Manager
Au
M
AWOS
AWOS Scheduler
Lab
Analytical
Workflow
(LAW)
Automated
Devices
AWOS
Assay
Availability
AWOS
Assignments
Analyzer
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Sample
Handoff
Sample Transport
Controller
SWOS
Assignments
Sample
Handoff
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DICOM WG-26 – Pathology
June 18th, 2014
Labora
Combined imaging and lab device
workflow
Automated processes on images : Could you perform
Specimen and Suppl 122 (G Haroske)
To create an opportunity for high level automatizing we need to look into the specimen process
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DICOM supp 122: Specimen
tracking
Specimen description:
Short/detailed
textual
description of
both specimen &
ancestry
1
2
4
3
5
To be able to track and trace specimen is a major requirement for the future automated lab
workflow to be able to perform with high value for the stakeholders.
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DICOM WG-26 – Pathology
June 18th, 2014
1
 Specimen model
applicable to each
use case
 Specimen can be
identified by
containers’ ID
An imaging procedure corresponding to an order is performed on one or more specimen (part,
tissue samples, tissue section, , etc) this object is on or inside or comes from a container (block, ,
slide, etc) identified by the Pathology Information System.
In most cases, a specimen in is identified by the identifier of the container in or on which the
physical object is at the time of the imaging procedure.
In many laboratories that have 1 specimen per container,
the value of the specimen identifier (ID) and container ID will be same
When the specimen is a part the specimen identification requires the box identifier.
When the specimen is a tissue section the specimen identification requires the slide identifier,
and optionally the box identifier(s) of the corresponding part(s), and the cassette identifier of the
corresponding block
However, there are use cases in which more than 1 specimen is present in a container.
Slides created from tissue microarray (TMA) blocks have small fragments of many different
tissues coming from different patients, all of which may be processed at the same time, under the
same conditions, by a desired technique. These are typically used in research. Tissue items
(spots) on the TMA slide come from different tissue items (cores) in TMA blocks (from different
donor blocks, different parts, and different patients) (Figure 6). Each specimen (spot) must have
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DICOM WG-26 – Pathology
June 18th, 2014
its own ID and Images created for each spot should be assigned to the real patients or research
subjects
 Specimen can NOT be
identified by containers’ ID
 TMA : More than one
tissue item (spots) per
slide (from different
blocks and different
patients)
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DICOM Sup 122 Specimen Identification
IHE/HL7/DICOM Specimen imaging model
Patient
1
1
 Disambiguates specim
Is
source
of
Has
n
Study


n
1
Contains

n
Equipment
1
Modality
n
Creates
Series
1

Contains
n
Image
1
Is
acquired
on
1
Component
Base, Coverslip
1
n
Has
Container
Box, Block, Slide, etc.
1
n
Specimen
Contains
Physical object
n
1
container
Container is target of
Container may have m
one specimen
Specimens have a ph
derivation (preparatio
parent specimens
When more than one
specimen in an image
container, each speci
distinguished (e.g., b
or color-coding)
n
Has
Preparation
Step
Collect, Sample,
Stain, Process
1
Is child of
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DICOM WG-26 – Pathology
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After this session with the overall workflow we took it to the next level and focused on reports
and images. To my help came Dr Cristel that presented some work around the AP Structure
Report.
Joint IHE and HL7 anatomic pathology initiative
Content profile providing templates for building Anatomic Pathology Structured Reports in all
fields of anatomic pathology (cancers, benign neoplasms as well as non-neoplastic conditions)
CDA documents including Anatomic Pathology observations bound to images or regions of
interest
Shared or exchanged within a community of care providers using existing integration profiles
defined by IHE Information Technology Infrastructure
We need usercases to work with that kind of highlight the daily routines performed everyday in
the pathology process.
This profile supports 5 major use cases:
Use case 1: Surgical pathology – Operative specimen
Use case 2: Surgical pathology – Biopsies
Use case 3: Cytology
Use case 4: Autopsy
Use case 5: Tissue Micro Array (more than one specimen from more than one patient per
container)
Anatomic pathology reports (APR) document the pathologic findings in specimens removed
from patients for diagnostic or therapeutic reasons. This information can be used for patient care,
clinical research and epidemiology. Standardizing and computerizing APRs is necessary to
improve the quality of reporting and the exchange of APR information.
As part of joint IHE and HL7 anatomic pathology activities, our objective is to provide a
methodology and tools that facilitate the development of consensus-based APR templates and to
publish an HL7 “Clinical Document Architecture” (CDA) implementation guide for these
templates.
Glodsmith08 [Goldsmith, J.D., et al., Reporting guidelines for clinical laboratory reports in
surgical pathology. Arch Pathol Lab Med, 2008. 132(10): p. 1608-16] provides recent
recommendations that delineate the required, preferred, and optional elements which should be
included in any APR, regardless of report types.
Several international initiatives intend to define standard structured templates for specific types
of APRs. For example, in the cancer domain, in the United States, the CAP (College of
American Pathologists) has published 67 cancer APR templates (cancer checklists and
background information) [http://cap.org.]. In France, the SFP (French society of pathology) has
published 23 APR templates (cancer checklists associated to Comptes Rendus Fiches
Standardisées, CRFS) that cover the main cancer domains [http://SFpathol.org]. Together, the
recommendations for generic and specific APR reporting requirements have become clinical
guidelines, the use of which may be required by accrediting bodies.
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June 18th, 2014
In addition to standardizing the cancer APR contents, it is necessary to computerize them.
Several studies have focused on defining an appropriate IT standard comprising the structured
and encoded clinical documents (e.g. CAP eCC). HL7 CDA is one of the most reliable standards
that can support these needs. CDA allows the clinical data to be both machine and humanreadable and provides a framework for incremental growth in the granularity of structured,
codes-bound clinical information. This document takes into consideration currently very few
national initiatives of CDA implementation guides for the APR, one example being developed at
the National IT Institute for Healthcare in the Netherlands
[http://www.nictiz.nl/uploaded/FILES/Publicaties/ 2003-10-07.pdf.].
Discussion
Will be especially considered the following issues and barriers :
Medical consensus is not easy to achieve at regional/national/international level about important
features that should be reported as well as the vocabulary and/or code system to use.
Standard information models (templates) are not available.
"International" code systems are mainly available in English and ther content coverage with
regards to the content of anatomic pathology reports has not been formally evaluated
Structured reports may be built from different sources(APIS, post processing station ("evidence"
creation), etc). A crucial issue is to identify a technical solution to handle templates of structured
reports including findings and their evidences. It should be possible to link each observation or
finding to the specimen source (part(s) (Box ID) for macroscopic findings, tissue item (Slide ID)
for microscopic findings)).
Moreover it must be possible to link each observation or finding to the image(s) or region of
interest of image(s) acquired from the specimen source. Complex diagnostic structured reports
include numeric quantitative measurement, images or graphs, image annotation and links
between image (and/or evidence) information and textual information.
Structured reports may be designed for multple uses : patient care but also "secondary use"
(clinical research, cancer registries, cancer multi(disciplinary meetings, etc). We have to
carefully analyse these different contexts of producing structured reports (workflow) in order to
define both templates and IT solution to support these different uses.
In this joint venture we also need to look into Dicom SR and see how that could fit, ad some
value if so.
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DICOM WG-26 – Pathology
June 18th, 2014
APSR
Observation t
Procedure tem
Organizers
33
After this busy morning session with very good and informative presentations and dialogue we
recessed for lunch. And the topic after lunch will be the Workshop covering the use cases.
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June 18th, 2014
In conclusion of this joint IHE, HL7 and WG26 meeting, WG26 is in favor of having a joint
group effort together with HL7 AP, J-D Nolen coordinates this effort.
If you´re interested in this work please send an email to co-chair Mikael Wintell ASAP.

We need to educate folks on IHE-LAW at Pathology at one of our next
meetings! Do we know someone suitable for this mission?
.

Upcoming Meetings:
o Next F2F meeting DICOM WG26, Pathology Visions in Oct in San Francisco.
Get back to you when date, time and location is finalized.
Will be very grateful for any help to provide a room, AV-equipment and
refreshments. Pls send me an email.
Reported by:
Mikael Wintell, Chair
Reviewed by legal counsel:
Clark Silcox
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