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=Einleitung / Introduction=
 
 
Dieses Dokument ist ein Entwurf für die Umsetzung von Pathologie-Berichten mit Hilfe von HL7 CDA R2. Diese Entwicklung soll die Pathologieintegration innerhalb Deutschlands, im deutschsprachigen Raum und auch international fördern. Sie wird vom Bundesverband Deutscher Pathologen e.V. unterstützt.
 
 
Ausgehend vom HL7 V3 Arztbrief-Leitfaden der bvitg (ehemals VHitG) stützt sich der Pathologiebefund auf die IHE-Dokumente "IHE Anatomic Pathology, Technical Framework Supplement, Anatomic Pathology Structured Reports - Trial Implementation, Rev.2.0" vom 06.08.2013, "APSR Value Sets Appendix, Rev. 2.0" vom 06.08.2013, "IHE Anatomic Pathology (PAT), Technical Framework, Volume 1, Revision 2.0 1, Trial Implementation" vom 23.7.2010, "IHE Anatomic Pathology (PAT), Technical Framework, Volume 2 15, Revision 2.0, Trial Implementation" vom 23.7.2010.
 
 
Die spezifisch deutschen Belange werden als National Extensions für IHE entwickelt und mit den Aktivitäten von ELGA, Österreich, abgestimmt. Darüber hinaus wird eine enge Kooperation mit IHE-AP und HL7-AP gesucht, um die in Deutschland erarbeiteten Details international einzubringen.
 
 
Orientiert wird dabei auf eine möglichst vollständige Berücksichtigung des "Leitfadens Pathologie/Neuropathologie (ehem. TM-30)" des Sektorkomitees Pathologie für die Anwendung der DIN EN ISO/IEC 17020 in der Pathologie/Neuropathologie.
 
 
Weiterhin wird angestrebt, die durch den Bundesverband Deutscher Pathologen und die Deutsche Gesellschaft für Pathologie veröffentlichten "Empfehlungen zur pathologisch-anatomischen Diagnostik von Kolorektalen Karzinomen, Mammakarzinomen und Prostatakarzinomen" in HL7 CDA R2 kompatible Templates zur Integration als Checklisten in Pathologie-Management-Systeme umzusetzen.
 
 
Auf dieser Basis soll der Import von HL7 CDA R2 Dokumenten von der Pathologie in KIS-Systeme sowie in Tumormeldungen und Qualitätssicherungs- und Tumordokumentationssysteme (z.B. AQUA, MaSC, ix.mid etc.) umgesetzt werden.
 
 
 
 
This document is a proposal for Anatomical Pathology Structured Reports (APSR)in HL7 CDA R2. It should help to integrate Anatomic and Clinical Pathology in German speaking countries into clinical and research environments by enabling interoperability between a variety of LIS, HIS, and cancer registries as well as elctronic health records. The specific German aspects are constraints of the IHE Anatomic Pathology profiles. They will be developed in close collaboration with the Austrian ELGA initiative. On the other hand, there is a close cooperation with IHE-AP and HL7-AP as to bring in the national demands into international standard development.
 
 
For the German APSR the "Guideline Pathology / Neuropathology" (formerly TM-30) of the Sector Committee Pathology for the implementation of DIN EN ISO/EC 17020 shall be regarded. Furthermore, the recommendations of the German Society of Pathology for pathologic-anatomical reporting of colorectal, breast, and prostate cancers should be enabled by CDA compatible codes and value sets.
 
  
 
=Foreword=
 
=Foreword=
This is a supplement to the forthcoming IHE Pathology and Laboratory Technical Framework. Each supplement undergoes a process of public comment and trial implementation before being incorporated into the volumes of the Technical Frameworks.
 
  
 +
This is a supplement to the IHE Pathology
 +
and Laboratory Medicine Technical Framework V8.0. Each supplement undergoes a
 +
process of public comment and trial implementation before being incorporated
 +
into the volumes of the Technical Frameworks.
  
This supplement is published as Final Text on xxx, 2016 and may be available for testing at subsequent IHE Connectathons. The supplement may be amended based on the results of testing. It will be incorporated into the Pathology and Laboratory Technical Framework. Comments are invited and may be submitted at http://ihe.net/PaLM_Public_Comments.  
+
This supplement was published on September 27, 2017 for Public Comment, with a comment period extending to mid-November. The current content is the Trial Implementation version, which has taken in consideration the comments received.
  
This supplement describes changes to the existing technical framework documents and where indicated amends text by addition ('''bold underline''') or removal ('''bold strikethrough'''), as well as addition of large new sections introduced by editor’s instructions to "add new text" or similar, which for readability are not bolded or underlined.  
+
This supplement describes changes to the
 +
existing technical framework documents.  
  
 +
“Boxed” instructions like the sample
 +
below indicate to the Volume Editor how to integrate the relevant section(s)
 +
into the relevant Technical Framework volume.
  
"Boxed" instructions like the sample below indicate to the Volume Editor how to integrate the  relevant section(s) into the relevant Technical Framework volume:  
+
<syntaxhighlight lang="xml">
 +
Replace Section X.X by the following:
 +
</syntaxhighlight>
  
 
+
Where the amendment adds text, make the added
Replace Section X.X by the following:
+
text '''bold underline'''. Where the amendment removes
 +
text, make the removed text '''bold strikethrough'''.
 +
When entire new sections are added, introduce with editor’s instructions to
 +
“add new text” or similar, which for readability are not bolded or underlined.
  
 
General information about IHE can be found at: http://www.ihe.net.  
 
General information about IHE can be found at: http://www.ihe.net.  
Zeile 43: Zeile 35:
 
The current version of the IHE Technical Framework (if applicable) can be found at: http://ihe.net/Technical_Frameworks.
 
The current version of the IHE Technical Framework (if applicable) can be found at: http://ihe.net/Technical_Frameworks.
  
=Introduction=
+
''Comments may be submitted on IHE Technical Framework templates any time at http://ihe.net/ihetemplates.cfm. Please enter comments/issues as soon as they are found. Do not wait until a future review cycle is announced.''
  
This supplement is written for Trial Implementation.
+
=Acknowledgements=
  
 +
Following authors mainly contributed to this document:
 +
*Francois Macary, PHAST, Paris
 +
*Dr. Gunter Haroske, Federal Association of German Pathologists, Berlin
 +
*Dr. Frank Oemig, Deutsche Telekom Healthcare Solutions GmbH, Bonn
 +
*Dr. Riki Merrick, APHL, San Francisco
 +
*Dr. Raj Dash, Duke University, Durham
  
This supplement prepares a new volume, Volume 3, of the [http://www.ihe.net/Technical_Frameworks/#palmIHE Pathology and Laboratory Medicine (PaLM) Technical Framework].  
+
They have to acknowledge the contributions of Dr. Kai U. Heitmann, who managed the cooperation between PaLM and ART-DECOR. It was the very first time that a complete IHE TF document could be developed by means of the ART-DECOR tools and a media wiki.
  
This supplement references other documents the reader should be aware of:
+
__TOC__
  
1. [http://www.ihe.net/Technical_Frameworks/#IT IHE IT Infrastructure Technical Framework Volume 1]
+
=Introduction to this Supplement=
  
2. [http://www.ihe.net/Technical_Frameworks/#IT IHE IT Infrastructure Technical Framework Volume 3]
+
This supplement complements volume 1 of
 +
the PaLM technical framework with the description of the APSR 2.0 content
 +
profile, and volume 3 with the bindings, content modules and value sets, which specify
 +
this profile.
  
3. [http://www.ihe.net/Technical_Frameworks/#PCC IHE PCC Technical Framework Volume 2]
+
==Open Issues and Questions==
  
4. [http://www.hl7.org/implement/standards/product_brief.cfm?product_id=7 HL7 CDA r2 normative edition 2005]
+
''None yet''
 
 
5. Goldsmith, J.D., et al., Reporting guidelines for clinical laboratory reports in surgical pathology. Arch Pathol Lab Med, 2008. 132(10): p. 1608-16
 
 
 
6. [http://www.cap.org/web/home/resources/cancer-reporting-tools/cancer-protocol-templates?_afrLoop=647933738303260#!%40%40%3F_afrLoop%3D647933738303260%26_adf.ctrl-state%3D19runu8bt4_17 CAP Cancer Protocols and Checklists 2010]
 
 
 
==Profile Abstract==
 
 
 
 
 
<nowiki>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.
 
 
 
 
 
This Content Profile is the result of a joint initiative from IHE and HL7 anatomic pathology workgroups who brought along a methodology and tools to facilitate the development of consensus-based anatomic pathology structured reports (APSR) and to publish an HL7 Clinical Document Architecture (CDA) implementation guide for these APSR. </nowiki>
 
 
 
==Open Issues and Questions==
 
'''APSR-13 – Missing LOINC code for intraoperative section:''' This code does not seem to be available in LOINC. The creation will be submitted to the Regenstrief Institute.
 
  
 
==Closed Issues==
 
==Closed Issues==
  
'''APSR-01 List of potential sections of an AP structured report: '''
+
'''APSR-07 Representing the hierarchy of specimens in an entry''' : This APSR
*Clinical information (content supposedly provided by the ordering physician)
+
supplement enables to represent the hierarchy of specimens at the CDA level 3.
*Intraoperative observations (in case of intraoperative consultation, which may be macroscopic only or may include cytology and/or frozen section)
+
The operations on specimen and production of child specimens are tracked in the
*Macroscopic observations
+
“Procedure Steps” section, which has a level 3 entry.
*Microscopic observations
 
*Diagnosis
 
*Procedure steps (this technical section is also useful for tracking the sequence of operations performed on the specimen at the work area), which does not preclude some of this information from appearing in one of the other sections (e.g., the Macroscopic observations section).
 
 
 
 
 
'''APSR-02 – Content of sections: '''
 
*Each section SHALL contain a text element presenting the content to the human reader. The profile does not constrain the layout of this narrative block.
 
*The Diagnostic Conclusion section SHALL contain an ''entry'' element with the corresponding machine-readable data.
 
*The other sections SHOULD contain an ''entry'' element with the corresponding machine-readable data.
 
*The Clinical information section MAY contain other sections.
 
 
 
'''APSR-03 – Handling the mix of coded content and free unstructured text: ''' AP reports are often composed of free text (which can be dictated), assembled with a set of coded information (e.g., some AP observations). The Content Creator application must handle these two kinds of content, and provide a user interface, which avoids any confusion between these two kinds of content, both at creation time and update time (e.g., using forms with dedicated free text areas and distinct areas for coded fields).
 
 
 
The body of the report is a hierarchy of sections. Each section presents its content in its text element, as human-readable text, possibly illustrated by some embedded images. This human-readable content of the section, or a part of it, may also be present as machine-readable data coded with the appropriate terminologies (e.g., ICD-O-3, PATHLEX, SNOMED CT, LOINC, ADICAP, or any other terminology admitted by this profile or a national extension of it …) in ''entry'' elements at the bottom of the section.
 
 
 
There are zero or more ''entry'' elements in a section. Each ''entry'' element carries the machine-readable data related to a specimen or to a group of specimens (see APSR-10). The ''entry'' is then subdivided per problem investigated on the specimen(s) (see closed issue APSR-06 below).
 
 
 
The ''text'' element of the section is supposed to reflect the same organization: per specimen or group of specimens, and then, per problem investigated. However, this APSR Content Profile does not explicitly describe the structure of this text element, and leaves it up to the Content Creator applications, or to further constraints brought by national extensions of this profile. The ''text'' element of a section in an APSR instance may be a mix of paragraphs, tables, diagrams and images, composed by the author of the report with the sole purpose of clarity and comprehensiveness for the reader.
 
 
 
'''APSR-04 – Linking AP observations to images/evidence documents''': It is sometimes useful to present to the reader of the report the images related to the observations. The CDA AP report provides the CDA R2 standard means to embed images at the observation level or at the organizer level in an entry, using the ''observationMedia'' element and potentially the ''regionOfInterest'' element. These images can only be small illustrations. Big images – like whole slide images or evidence documents – will stay in their own storage infrastructure, accessible via the DICOM standard  protocol, and may be associated with the APSR document, via a DICOM KOS list of references (as described in the XDS-I profile from the Radiology domain), issued in the same submission set.
 
 
 
'''APSR-05 – Coding of the TNM''': The value sets for the TNM of various tumors will be created into the PathLex terminology built by IHE PAT, based on the reference material of this profile. PathLex is a temporary code system, which may be used in an AP structured report, but is not mandated by this APSR content Profile. Alternatively for TNM coding as well as for ICD-O-Typing and Grading specific templates built by IHE PaLM should be used.
 
 
 
'''APSR-06 – Two (or more) distinct problems observed on the same specimen''': In this case, the AP report template should provide a means to group the observations per problem. The solution consists in inserting a battery organizer grouping all observations related to the same problem below the specimen information organizer. See also APSR-03 above.
 
 
 
'''APSR-07 – Representing the hierarchy of specimens in an entry''' : The operations on specimen and production of child specimens are tracked in the “Procedure Steps” section, which has a level 3 ''entry'' element for that purpose.
 
 
 
'''APSR-08 – Human authors and/or authoring devices''': Do we have use cases for recording authoring devices as “author” in the report or a part of it? Or do we allow only human authors? The answer is “Both”: Image modalities may be authoring devices in some situations.
 
 
 
'''APSR-09 – Transcriptionist''': A transcriptionist may appear in the CDA report in the header as a ''dataEnterer'' element, or within an ''entry'' (organizer or observation) as a ''participant'' element. In both cases the element uses a ''participationType'' “ENT” whose definition in HL7 V3 vocabulary is: “A person entering the data into the originating system. The data entry person is collected optionally for internal quality control purposes. This includes the transcriptionist for dictated text.”
 
 
 
'''APSR-10 – Observation related to multiple specimens''': For example tumor staging requiring combining data from multiple specimens (e.g., a breast excision with positive margins followed by a re-excision with clear margins – in this case the tumor size may be a composite of measurements from both specimens. Another example – staging of ovarian carcinomas with multiple biopsies of pelvis, peritoneum, nodes, omentum, etc.). To accommodate these use cases, the specimen organizer is able to represent either a single specimen or a group of specimens investigated together. The specimen collection procedure nested in this organizer is repeatable to give the possibility to describe each of the specimens of the group.
 
 
 
'''APSR-11 – Derivative specimens'''. Specimens derived from primary specimens for ancillary studies, which may be sent to a reference lab or done in another part of the same institution, are included in the scope of this profile. The results produced on a derived specimen are attached to this specimen in the report. However the hierarchy of specimens is not explicitly represented in the report (see APSR-07), apart from being tracked in the “Procedure steps section” (see APSR-01).
 
 
 
'''APSR12 – Multipart report'''. In some cases the pathologist may create report(s) or report contents in a third-party application and embed, link, or refer to that separate report in the report produced by the LIS. This use case is natively taken care of by the underlying document sharing infrastructure: The profiles “Cross Enterprise Document Sharing” (XDS), “Cross Enterprise Document Media Interchange” (XDM) and “Cross Enterprise Document Reliable Interchange” (XDR) enable the sharing of a “submission set” which groups the collection of documents issued from a particular healthcare act. The APSR could be grouped with a DICOM Key Object Selection list (DICOM KOS) referring to the whole slide images representing the specimens investigated. It could also be grouped with a related report produced in some format by a third-party application. In addition to being in the same “submission set” these related documents or references to images can also be explicitly referred from within an entry of the CDA APSR, as a reference to an ''externalDocument'', ''externalObservation'', ''externalProcedure'' or ''externalAct'' element.
 
 
 
'''APSR-14 – Gaps in SNOMED CT''': It is not straightforward to encode Anatomic Pathology observations and AP ancillary technique observations and their corresponding value sets described in Volume IV (Value Sets for APSR) using SNOMED CT concepts (missing concepts, issues of postcoordination versus precoordination). Moreover, SNOMED CT cannot be mandated by an IHE profile since the usage in production of this terminology is conditioned by a license, and many countries have not contracted this license yet. Thus these observations are identified with LOINC codes. Their value sets MAY be encoded using a temporary coding system built by the IHE Anatomic Pathology domain (PathLex - OID: 1.3.6.1.4.1.19376.1.8.2.1), or by any other locally agreed upon vocabulary.
 
 
 
'''APSR15 – Preadopting codes from upcoming releases of terminologies or value sets.''' For some AP observations, the value sets are changing regularly, which may bring the need for APSR producers to encode some observations using new codes approved by the source organization in a future version not available yet. This process is enabled by the ''other, specify'' mechanism described in volume 3.
 
 
 
'''APSR16 – Exportable human-readable summary of an AP report'''. Need for a "summary version" of the anatomic pathology report intended to be subsequently extracted for use in other medical documents. Thus when authors of other medical documents feel the need to include a segment such as "...the pathology report states '[...]'", the "summary version" of the report would ideally be included in the square brackets instead of the entire report including all of its sections. In the future it may be possible to generate and populate the summary version using the controlled vocabulary and discrete data elements used in the report. However, in order to allow the pathologist to control how the report is summarized, should we introduce an optional (free text) "summary version" section into the standard? This would encourage those who are interested to control concise versions of their reports, and on the flip side help the natural language processing algorithm developers. This need of a free text summary is addressed by an optional “Report Textual Summary” sub-section nested in the mandatory Diagnostic Conclusion section. This Report Textual Summary sub-section does not contain any entry.
 
 
 
=VOLUME 1 - INTEGRATION PROFILES=
 
 
 
==1.7 History of Annual Changes==
 
 
 
''Append the following at the end of section 1.7''
 
 
 
Scope of changes introduced in the current year:
 
 
 
 
 
*The Anatomic pathology Structured Reports (APSR) Content Profile extends the scope of the Pathology and Laboratory Medicine (PaLM) Technical Framework to the provision of persistent anatomic pathology and Cytopathology structured reports for various purposes such as care provision, care coordination, screening, and health surveillance.
 
 
 
 
 
 
 
==1.12 Glossary==
 
 
 
''Add the following terms to the Glossary in section 1.12:''
 
 
 
'''APSR''' Anatomic Pathology Structured Reports Content Profile
 
 
 
 
 
==1.15 Scope of the Anatomic Pathology Technical Framework==
 
 
 
''Replace figure 1.15-1 by the one below''
 
 
 
[[Datei:Fig.1.15-1.001.jpeg||||APWorkflow ]]
 
 
 
==1.16 Anatomic Pathology Integration Profiles==
 
''Replace figure 1.16-1by the new one below, taking the new profile(s) into account. ''
 
 
 
 
 
[[Datei:Fig.1.16-1.001.jpeg||||IntegrationProfiles ]]
 
 
 
==1.17 Dependencies among Integration Profiles==
 
 
 
''Add the following lines to Table 1.17-1''
 
 
 
{| class="hl7table"
 
|-
 
|Anatomic Pathology Structured Reports to (APSR)
 
||''Cross-Enterprise DocumentSharing (XDS)in ITI-TF''||
 
Implementers of APSR Content Profile may implement the XDS Profile to enable sharing of the pathology reports within an XDS Affinity Domain. In this case, the Content
 
Creator actor must be grouped with an XDS Document Source actor, and the Content Consumer actor must be grouped with an XDS Document Consumer actor.
 
||
 
Ensure that the sharing of laboratory reports within an XDS Affinity Domain can co-exist with the sharing of other types of documents
 
|-
 
|Anatomic Pathology Structured Reports to (APSR)||''Cross-Enterprise DocumentMedia Interchange (XDM) in ITI-TF''||Implementers of APSR Content Profile may implement the XDM Profile to enable sharing of the laboratory reports using media.  In this case, the Content Creator must be grouped with an XDM Portable Media Creator and the Content Consumer with an XDM Portable Media Consumer.||Ensure that the
 
sharing of laboratory reports on media can co-exist with the sharing of other types of documents
 
|-
 
|Anatomic Pathology Structured Reports to (APSR)||''Cross-Enterprise Document Reliable Interchange (XDR) in ITI-TF''|| Implementers of APSR Content Profile may implement the XDR Profile to enable sharing of the laboratory reports using reliable point-to-point network messages.  In this case, the Content Creator must be grouped with an XDR Document Source, and the Content Consumer must be grouped with an XDR Document Recipient.||Ensure that the sharing of laboratory reports through reliable point-to-point messages can co-exist with the sharing of other types of documents
 
|}
 
 
 
==1.18 Profiles Overview==
 
 
 
 
 
''Append sub-section 1.18.3 (takenfrom the current profile abstract) at the end of section 1.18.''
 
 
 
 
 
 
 
=== 1.18.3 Anatomic Pathology Structured Reports (APSR) ===
 
This Content profile describes an anatomic pathology structured report (APSR) as a CDA r2
 
document to be published towards a document sharing resource such as a shared electronic health record used by a community of care providers, relying on one of the infrastructure document sharing/exchanging profiles defined in IHE ITI TF.
 
 
 
 
 
 
 
== 1.19 Actors Description ==
 
 
 
''Add the following actors’ descriptions''
 
 
 
 
 
 
 
 
 
'''Content Creator''': An application responsible for the creation of content and transmission to a Content Consumer. This actor is involved in the APSR profile to issue anatomic pathology structured reports.
 
 
 
'''Content Consumer''': An application responsible for viewing, importing, or other processing of content created by a Content Creator Actor. This actor is involved in the APSR profile to consume anatomic pathology structured reports.
 
 
 
 
 
 
 
''Add Section 4 below, after the “ARPH integration profile” section.''
 
 
 
 
 
 
 
=4 Anatomic Pathology Structured Reports (APSR Profile=
 
 
 
This Content profile describes an anatomic pathology structured report (APSR) as a CDA r2 document to be published towards a document sharing resource such as a shared electronic health record used by a community of care providers, relying on one of the infrastructure document sharing/exchanging profiles defined in IHE ITI TF.
 
 
 
Anatomicpathology 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 andcomputerizing APRs is necessary to improve the quality of reporting and the exchange of APR Information.
 
 
 
This Content profile describes an anatomic pathology structured report (APSR) as a CDA r2 document to be published towards a document sharing resource such as a shared electronic health record used by a community of care providers, relying on one of the infrastructure document sharing/exchanging profiles defined in IHE ITI TF.
 
 
 
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.
 
 
 
The current scope of this IHE content profile covers APSR for surgical pathology in all fields of anatomic pathology (cancers, benign neoplasms as well as non-neoplastic conditions) as well as for Cytopathology. The profile handles information of “traditional” pathology observation using light microscopy (including immunohistochemistry, FISH, etc.).
 
 
 
Forensic pathology
 
(autopsy, toxicology) will be addressed in further cycles as well as special
 
ancillary techniques (e.g., flow cytometry, cytogenetics, electron microscopy).
 
 
 
Goldsmith provides recent recommendations that delineate
 
the required, preferred, and optional elements which should be included in any
 
APR for surgical pathology, regardless of report types.
 
 
 
Several
 
international initiatives intend to define standard structured templates for
 
specific types of APRs. In the cancer domain, in the United States, the CAP
 
(College of American Pathologists) has published 80 cancer APSR templates
 
(cancer checklists and background information)[http://www.cap.org]. In
 
France, the SFP (French society of pathology) [http://www.sfpathol.org] and the INCa (French National Cancer Institute) [http://www.e-cancer.fr] have published 23 APSR templates of minimal
 
set of data required for a primary tumor. In
 
Australasia, the Royal College of Pathologists Australasia (RCPA) and the
 
Cancer Australia developed an initial 6 reporting protocols (lung, melanoma,
 
breast, colorectal, lymphoma and prostate) and a framework to guide development
 
of the protocols, in partnership with national clinician and pathologist
 
organizations. In some countries, the recommendations
 
for generic and specific APSR requirements have become clinical guidelines, the
 
use of which may be required by accrediting bodies.
 
 
 
This
 
profile has also benefited from the guidance on cancer AP reports provided by
 
the North-American Association of Central Cancer Registries; some of the
 
example snippets captured in the profile leverage the NAACCR Standards for
 
Cancer Registries, Volume V, Pathology Laboratory Electronic Reporting.
 
 
 
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. Some of the
 
implementation guides of APSRs proposed within these initiatives are not based
 
on international healthcare IT standards (e.g., CAP eCC), other are based on
 
either HL7 CDA r2 or CEN archetypes. HL7 CDA r2 is one of the most reliable
 
standards that can support these needs. CDA allows the clinical data to be both
 
machine and human-readable and provides a framework for incremental growth in
 
the granularity of structured, codes-bound clinical information. This document
 
takes into consideration current very few national CDA implementation guides
 
for the APSR developed in Netherlands (National IT Institute for Healthcare in
 
the Netherlands [www.nictiz.nl] and in Germany.
 
 
 
This content
 
profile describes an anatomic pathology report shared in a human-readable
 
format, which may include images. In addition, this electronic AP report SHALL
 
contain anatomic pathology observations in a machine-readable format, to
 
facilitate the integration of these observations in the database of a consumer
 
system.
 
 
 
The definition
 
of required, preferred and optional elements in this content profile is mainly
 
based on Goldsmith, for generic surgical pathology APSR (regardless of report
 
types) and, in the cancer domain, on standard structured templates provided by
 
United States, the CAP (College of American Pathologists) [http://www.cap.org.], the
 
SFP (French society of pathology) [http://www.sfpathol.org] and INCa (French National
 
Cancer Institute) [http://www.e-cancer.fr] and the Royal
 
College of Pathologists Australasia (RCPA).
 
 
 
Structured reports are composed of a header, which provides
 
the context of care (patient, care providers, pathologists, laboratories,
 
order, act documented …), and a body. The latter provides the clinical
 
information, which accompanied the order and specimens as well as the
 
observations, findings and conclusions delivered by the pathologist after
 
examination. 
 
 
 
The
 
anatomic pathology report described in this profile, with its set of anatomic
 
pathology observations in a machine-readable format, MAY also be used to share
 
historical results with appropriate content anonymization and patient
 
identification pseudonymization to create shared distributed repositories of
 
anatomic pathology information.
 
 
 
Both the header and the body provide human-readable
 
information. The body is a hierarchy of sections. Each section presents its
 
content in its ''text'' element, as
 
human-readable text, possibly illustrated by some embedded images. This
 
human-readable content, or a part of it, may also be present as machine-readable
 
data coded with the appropriate terminologies (e.g., ICD-O-3, SNOMED CT, LOINC,
 
ADICAP, etc.) in entry elements at
 
the bottom of the section.
 
 
 
There are zero or more ''entry''
 
elements in a section. Each ''entry'' element carries the machine-readable
 
data related to a single specimen or to a group of specimens observed together.
 
The entry is then subdivided per
 
problem investigated.
 
 
 
The ''text'' element of
 
the section is supposed to reflect the same organization: per specimen, and
 
then, per problem investigated on the specimen. The profile leaves the layout of the text element up to the Content Creator
 
applications, or to further constraints brought by national extensions.
 
However, given that the ''text'' element is usually composed of free text (e.g., dictated text),
 
assembled with the text generated from the set of data, machine-encoded in the entry elements below, the Content
 
Creator application MUST handle these two kinds of content, and provide a user
 
interface, which precludes any confusion between them, both at creation time
 
and update time (e.g., using forms with dedicated free text areas and distinct
 
protected areas for coded fields).
 
 
 
== 4.1 APSR Actors/Transactions ==
 
 
 
This section references two other IHE Technical Frameworks:
 
 
 
*IT Infrastructure Technical Framework (ITI TF)
 
*Patient Care Coordination Technical Framework (PCC TF)
 
 
 
There
 
are two actors in this profile, the Content Creator and the Content
 
Consumer. 
 
 
 
'''Content Creator''':      A
 
Content Creator Actor is responsible for the creation of content and transmission
 
to a Content Consumer.
 
 
 
'''Content Consumer''':    A Content
 
Consumer Actor is responsible for viewing, import, or other processing of
 
content created by a Content Creator Actor
 
 
 
Content
 
(i.e., an anatomic pathology structured report) is created by a Content Creator
 
and is to be consumed by a Content Consumer.
 
The sharing or transmission of content from one actor to the other is
 
addressed by the appropriate use of IHE profiles described below, and is out of
 
scope of this profile.  A Document Source
 
or a Portable Media Creator may embody the Content Creator Actor.  A Document Consumer, a Document Recipient or
 
a Portable Media Importer may embody the Content Consumer Actor.
 
 
 
The
 
sharing or transmission of anatomic pathology structured reports from one actor
 
to the other is addressed by the use of appropriate content bindings with XDS,
 
XDM or XDR integration profiles as explained in section 4 of Volume 3 of the
 
Anatomic Pathology Technical Framework.
 
 
 
[[Datei:fig.4.1.-1.jpg]]
 
 
 
Figure 4.1-1  APSR Actor Diagram
 
 
 
=== 4.1.1 Actor Descriptions and Requirements ===
 
 
 
This section is intentionally empty.
 
 
 
=== 4.1.2 Document Content Modules ===
 
 
 
==== 4.1.2.1 Anatomic Pathology Structured Report (APSR) ====
 
 
 
This document content module represents the generic set of constraints applied to any
 
structured report for surgical pathology in all fields of anatomic pathology
 
(cancers, benign neoplasms as well as non-neoplastic conditions) as well as for
 
Cytopathology.
 
 
 
This document content module is identified by templateId 1.3.6.1.4.1.19376.1.8.1.1.1
 
 
 
The body of this document
 
content module has the hierarchy of sections and entries depicted by figure
 
4.1.2.1-1. The only mandatory section is the Diagnostic Conclusion Section. And
 
the only mandatory entry is the Specimen Information Organizer Entry below this
 
section.
 
 
 
[[Datei:CDA APSR R2 (IHE) Hierarchy of the body for APSR document content module.PNG]]
 
 
 
Figure 4.1.2.1-1  Hierarchy of the body for APSR document content module
 
 
 
== 4.2 APSR Options ==
 
 
 
Table 4.2-1 summarizes the options that actors may take for this content profile. Dependencies between options when applicable are specified in notes. These options are summarized below the table, and further detailed in PCC TF-2, as indicated in the right column of the table.
 
 
 
'''Table 4.2-1  Actors and Options'''
 
 
 
{| class="hl7table"
 
!Actor !! Options !! Domain, Vol & Section
 
|-
 
|Content
 
Consumer
 
||''View Option (1)''
 
|| PCC TF-2:3.1.1
 
|-
 
|Content
 
Consumer
 
||''Document Import Option (1)''||PCC TF-2:3.1.2
 
|-
 
|Content
 
Consumer
 
||''Section Import Option (1)''|| PCC TF-2:3.1.3
 
|}
 
''Note 1: The Actor shall support at least one of these options.''
 
 
 
== 4.3 APSR Actor Groupings and Profile Interactions ==
 
 
 
It is expected that the sharing of
 
anatomic pathology structured reports will occur in an environment where the
 
physician offices and hospitals have a coordinated infrastructure that serves
 
the information sharing needs of this community of care.  Several mechanisms are supported by IHE
 
profiles:
 
*A registry/repository-based infrastructure is defined by the IHE Cross-Enterprise Document Sharing (XDS)
 
and other IHE Integration Profiles such as patient identification (PIX & PDQ), and notification of availability of documents (NAV).
 
*A media-based infrastructure is defined by the IHE Cross-Enterprise Document Media Interchange (XDM) profile.
 
*A reliable messaging-based infrastructure is defined by the IHE Cross-Enterprise Document Reliable
 
Interchange (XDR) profile.
 
*All of these infrastructures support Security and privacy through the use of the Consistent Time (CT) and
 
Audit Trail and Node Authentication (ATNA) profiles.
 
 
 
For more details on these profiles, see the IHE IT Infrastructure Technical Framework
 
 
 
Such an infrastructure is assumed by the use cases described in this Profile.
 
 
 
A content binding describes how the payloads used in IHE transactions are related
 
to and/or constrained by the data elements contained within the content sent or
 
received in those transactions.  The APSR
 
Content Profile applies one binding, which is used when grouping the Content
 
Creator with the IHE ITI XDS, XDM or XDR Integration Profiles.
 
 
 
The content and the binding are described in Volume 3 of the IHE Anatomic Pathology Technical
 
Framework.
 
 
 
 
 
 
 
== 4.4 APSR Process Flow ==
 
 
 
 
 
 
 
=== 4.4.1 Use Cases ===
 
 
 
==== 4.4.1.1 Use case 1: General case ====
 
 
 
Barbara Breast
 
visits Sammy Surgeon for removal of a breast tumor. Sammy Surgeon orders the
 
Requested Procedure “Breast surgical specimen - pathological examination” and
 
sends the specimen(s) to the anatomic pathology department.
 
 
 
Specimen(s) is (are) accessioned by the anatomic pathology
 
department. The staff performs a macroscopic examination of the specimen(s);
 
gross imaging is performed if needed. The specimen(s) are processed for
 
microscopic examination and other special ancillary techniques or tissue
 
banking if needed. During the imaging interpretation process, microscopic
 
imaging is performed if needed. At the end of the interpretation process,
 
pathologist queries the Content Creator application
 
for the appropriate APSR template, fills the form, binds some relevant
 
images and/or regions of interest to specific observation(s), validates and
 
signs the document.
 
 
 
==== 4.4.1.2 Use case 2: Specimen collector is not the ordering physician ====
 
 
 
Patricia
 
Pathologist collects bone marrow from Peter Patient in the clinical ward.
 
 
 
Specimen(s) is (are) accessioned by the anatomic pathology
 
department. The staff performs a macroscopic examination of the specimen(s);
 
gross imaging is performed if needed. The specimen(s) are processed for
 
microscopic examination and other special ancillary techniques or tissue
 
banking if needed. During the imaging interpretation process, microscopic
 
imaging is performed if needed. At the end of the interpretation process,
 
pathologist queries the '''Content Creator''' for
 
the appropriate APSR template, fills the form, binds some relevant images
 
and/or regions of interest to specific observation(s), validates and signs the
 
document.
 
 
 
==== 4.4.1.3 Use case 3: Multi-step reporting ====
 
 
 
Barbara Breast
 
visits Sammy Surgeon for removal of a breast tumor. Sammy Surgeon orders the
 
Requested Procedure “Breast surgical specimen - Frozen sections &
 
pathological examination” and sends the specimen(s) to the anatomic pathology
 
department.
 
 
 
Specimen(s) is (are) accessioned by the anatomic pathology
 
department. The staff performs a macroscopic examination of the specimen(s),
 
gross imaging is performed if needed. The specimen(s) are processed for
 
intraoperative observation if needed, and tissue banking if needed (e.g., for
 
research purpose). During the imaging interpretation process of frozen
 
sections, microscopic imaging is performed if needed. At the end of the
 
interpretation process, pathologist queries the '''Content Creator''' for the appropriate APSR template, fills the
 
intraoperative observation section, binds some relevant images and/or regions
 
of interest to specific observation(s) if needed, validates and signs (i.e.,
 
legally authenticates) the preliminary APSR.
 
 
 
The day after, the specimen(s) are processed for microscopic
 
examination and other special ancillary techniques if needed. During the
 
imaging interpretation process, microscopic imaging is performed if needed. At
 
the end of the interpretation process, pathologist queries the '''Content Creator''' for the preliminary
 
APSR, fills the form, binds some relevant images and/or regions of interest to
 
specific observation(s), validates and signs (i.e., legally authenticates) the final
 
APSR.
 
 
 
==== 4.4.1.4 Use case 4: Opinion request ====
 
 
 
There are various
 
situations in which an opinion request is issued: External expert consultation
 
(requested by Philip Pathologist, often before a final report is issued).
 
Second opinion request (usually made by a treating physician or patient/family,
 
or lawyer/court in malpractice cases). External slide review (usually routine
 
review of slides required by protocols in an outside treating institution).
 
These may vary in terms or workflow and even the materials accessed by the
 
outside lab.
 
 
 
''Requiring pathologist''
 
Philip Pathologist
 
asks for second opinion for the case of Peter Patient diagnosed as lymphoma. He
 
sends block(s) or slide(s) or shares/sends whole slide images to Patricia
 
pathologist, requesting her expertise on this material. He uses the '''Content Creator application''' to derive
 
the anatomic pathology opinion request document from the preliminary APSR of
 
Peter Patient.
 
 
 
Philip Pathologist
 
later on uses his Content Consumer application
 
to view and import the APSR from Patricia Pathologist. He uses this report to
 
finalize and issue his own APSR in his application acting as a Content Creator.
 
 
 
''Requested pathologist''
 
 
 
Patricia
 
Pathologist accepts to deliver second opinion about the case of Peter Patient
 
diagnosed as lymphoma.
 
 
 
''Block(s)''
 
 
 
The specimen(s) are processed for microscopic examination and other
 
special ancillary techniques if needed. During the imaging interpretation
 
process, microscopic imaging is performed if needed. At the end of the
 
interpretation process, Patricia Pathologist queries the Content Creator for the appropriate APSR template, fills the form,
 
binds some relevant images and/or regions of interest to specific
 
observation(s), validates and signs the document.
 
 
 
''Slide(s)''
 
 
 
During the imaging interpretation process, microscopic imaging is
 
performed if needed. At the end of the interpretation process, Patricia
 
Pathologist queries the Content Creator for
 
the appropriate APSR template, fills the form, binds some relevant images
 
and/or regions of interest to specific observation(s), validates and signs the
 
document.
 
 
 
''Whole slide image(s)''
 
 
 
At the end of the interpretation process, Patricia Pathologist
 
queries the '''Content Creator''' for the
 
appropriate APSR template, fills the form, binds some relevant images and/or
 
regions of interest to specific observation(s), validates and signs the
 
document.
 
 
 
 
 
== 4.5 APSR Security considerations ==
 
 
 
=== 4.5.1Integrity ===
 
 
 
The choice on whether
 
the digital signature is performed at the transaction level (XDS, XDM, XDR) or
 
at the content level is left up to national extensions. If the report is
 
digitally signed, the person having signed it SHALL be the person represented
 
in the ''legalAuthenticator'' element of
 
the CDA header.
 
 
 
 
 
=== 4.5.2 Confidentiality ===
 
 
 
In the
 
context of patient care coordination the anatomic pathology report described in
 
this profile contains patient personal data, and as such must be handled in
 
conformance to the local privacy policies.
 
 
 
In other
 
contexts such as public health, surveillance, research, appropriate content
 
anonymization and patient identification pseudonymization may be required by
 
local policies.
 
 
 
 
 
=== 4.5.3 Auditability ===
 
 
 
Addressed by the CT
 
and ATNA profiles from ITI TF.
 
 
 
 
 
 
 
 
 
 
 
= Volume 3 – Content Modules =
 
 
 
 
 
 
 
= 1 Introduction =
 
 
 
 
 
 
 
''Insert the text from the same section in volume 1 of the PAT TF''
 
 
 
 
 
 
 
== 1.1 Overview of the Anatomic Pathology Technical Framework ==
 
 
 
 
 
''Insert the text from the same section in volume 1 of the PAT TF''
 
 
 
 
 
 
 
== 1.2 Overview of Volume 3 ==
 
 
 
 
 
The IHE Technical
 
Framework is based on actors that interact through transactions using some form
 
of content.
 
 
 
 
 
Actors are
 
information systems or components of information systems that produce, manage,
 
or act on information associated with operational activities in the enterprise.
 
 
 
 
 
Transactions are
 
interactions between actors that transfer the required information through
 
standards-based messages.
 
 
 
 
 
Content profiles
 
specify how the payload of a transaction fits into a specific use of that
 
transaction. A content profile has three main parts. The first part describes
 
the use case. The second part is binding to a specific IHE transaction, which
 
describes how the content affects the transaction. The third part is a Content
 
Module, which describes the payload of the transaction. A content module is
 
specified so as to be independent of the transaction in which it appears. This
 
overall content module is itself an assemblage of smaller content modules,
 
which in turn may assemble smaller content modules, conforming to the chosen
 
standard.
 
 
 
 
 
In particular,
 
the Anatomic Pathology Technical Framework provides a set of content profiles
 
for the sharing of persistent clinical document produced by the anatomic
 
pathology domain.
 
 
 
 
 
This Volume 3
 
specifies the content modules produced at various granularity levels (from a
 
whole clinical document to a tiny reusable piece of coded data) by the Anatomic
 
Pathology domain of IHE for its own content profiles.
 
 
 
 
 
Some of these
 
content modules produced here, may be used by content modules of higher
 
granularity from other domains (e.g., Patient Care Coordination).
 
 
 
 
 
Some of these
 
content modules produced here, may leverage content modules of lower
 
granularity from other domains (e.g., PCC, RAD, etc.).
 
 
 
 
 
== 1.3 Audience ==
 
 
 
 
 
 
 
''Insert the text from the same section in volume 1 of the PAT TF''
 
 
 
 
 
 
 
== 1.4 Relationship to Standards ==
 
 
 
 
 
 
 
 
 
''Insert a simplified version of the text from the same section in volume 1 of the PAT TF''
 
 
 
 
 
== 1.5 Relationship to Real World Architecture ==
 
 
 
 
 
 
 
''Insert the text from the same section in volume 1 of the PAT TF''
 
 
 
 
 
== 1.6 Conventions ==
 
 
 
 
 
''Insert a simplified version of the text from the same section in volume 1 of the PAT TF''
 
 
 
 
 
 
 
== 1.7 Scope Introduced in the Current Year ==
 
 
 
 
 
Content Modules for the APSR Profile
 
 
 
 
 
== 1.8 Copyright Permission ==
 
 
 
 
 
Health Level Seven, Inc. has granted permission to the IHE to reproduce tables from
 
the HL7 standard. The HL7 tables in this document are copyrighted by Health
 
Level Seven, Inc. All rights reserved. Material drawn from these documents is
 
credited where used.
 
 
 
 
 
== 1.9 Glossary ==
 
 
 
The glossary of
 
the Anatomic Pathology Technical Framework is centralized in PAT TF-1:1.12.
 
 
 
 
 
 
 
= 2 Content Modules – Basic Principles =
 
 
 
This Volume 3 of
 
the PAT TF organizes content modules categorically by the base standard. At
 
present, PAT TF-3 uses only one base standard, CDA Release 2.0, but this is
 
expected to change over time. Underneath each standard, the content modules are
 
organized using a very coarse hierarchy inherent to the standard.
 
 
 
Each content
 
module can be viewed as the definition of a "class" in software
 
design terms, and has associated with it a name. Like "class"
 
definitions in software design, a content module is a "contract", and
 
the PAT TF-3 defines that contract in terms of constraints that must be obeyed
 
by instances of that content module. Each content module has a name, also known
 
as its template identifier. The template identifiers are used to identify the
 
contract agreed to by the content module. The Anatomic Pathology Technical
 
Committee is responsible for assigning the template identifiers to each content
 
module.
 
 
 
Like classes,
 
content modules may inherit features of other content modules of the same type
 
(e.g., Document, Section or Entry) by defining the parent content module that
 
they inherit from. They may not inherit features from a different type.
 
 
 
Constraints that
 
apply to any content module will always apply to any content modules that
 
inherit from it. Thus, the "contracts" are always valid down the
 
inheritance hierarchy.
 
 
 
The PAT TF-3 uses
 
the convention that a content module cannot have more than one parent (although
 
it may have several ancestors). This convention is not due to any specific
 
technical limitation of the technical framework, but does make it easier for
 
software developers to implement content modules.
 
 
 
Each content
 
module has a list of data elements that are required (R), required if known
 
(R2), conditional (C) or optional (O).
 
 
 
Other data
 
elements may be included in an instance of a content module over what is
 
defined by the PAT TF-3. Content consumers are not required to process these
 
elements, and if they do not understand them, must ignore them. Thus, it is not
 
an error to include more than is asked for, but it is an error to reject a
 
content module because it contains more than is defined by the framework. This
 
allows value to be added to the content modules delivered internationally in
 
this framework, through national extensions built by the national IHE
 
organizations in various countries. It further allows content modules to be
 
defined later by IHE that are refinements or improvements over previous content
 
modules.
 
 
 
 
 
= 3 IHE Transactions =
 
 
 
This section
 
defines each IHE transaction in detail, specifying the standards used, and the
 
information transferred.
 
 
 
 
 
== 3.1 Cross Enterprise Document Content Transactions ==
 
 
 
 
 
At present, all
 
transactions used by the Anatomic Pathology Content Profiles appear in ITI TF-2a
 
and ITI TF-2b.
 
 
 
General Options
 
defined in content profiles for a Content Consumer are listed below.
 
 
 
=== 3.1.1 View Option ===
 
 
 
A Content
 
Consumer that supports the View Option shall be able to:
 
 
 
1. Use the appropriate XD* transactions to obtain the document along with associated
 
necessary metadata.
 
 
 
2. Render the document for viewing. This rendering shall meet the requirements defined
 
for CDA Release 2 content presentation semantics (See Section 1.2.4 of the CDA
 
Specification: Human readability and rendering CDA Documents). CDA Header
 
information providing context critical information shall also be rendered in a
 
human readable manner. This includes at a minimum the ability to render the
 
document with the stylesheet specifications provided by the document source, if
 
the document source provides a stylesheet. Content Consumers may optionally
 
view the document with their own stylesheet, but must provide a mechanism to
 
view using the source stylesheet.
 
 
 
3. Support traversal of links for documents that contain links to other documents managed
 
within the sharing framework.
 
 
 
4. Print the document to paper.
 
 
 
=== 3.1.2 Document Import Option ===
 
 
 
This Option
 
requires that the View Option be supported. In addition, the Content Consumer
 
that supports the Document Import Option shall be able to support the storage
 
of the entire APSR document (as provided by the sharing framework, along with
 
sufficient metadata to ensure its later viewing). The machine-readable content
 
(from the entry elements) shall also be imported. This Option requires the
 
proper tracking of the document origin. Once a document has been imported, the
 
Content Consumer shall offer a means to view the document without the need to
 
retrieve it again from the sharing framework. When the document is used after
 
it was imported, a Content Consumer may choose to access the sharing framework
 
to find out if the related Document viewed has been deprecated or replaced.
 
 
 
=== 3.1.3 Section Import Option ===
 
 
 
This Option
 
requires that the View Option be supported. In addition, the Content Consumer
 
that supports the Section Import Option shall be able to support the import of
 
one or more sections of the APSR document (along with sufficient metadata to
 
link the data to its source). The machine-readable content (from the entry
 
elements beneath the imported sections) shall also be imported. This Option
 
requires the proper tracking of the document section origin. Once sections have
 
been selected, a Content Consumer shall offer a means to copy the imported
 
section(s) into local data structures. When a section is used after it is
 
imported, a Content Consumer may choose to access the sharing framework to find
 
out if the related information has been updated.
 
 
 
 
 
 
 
 
 
= 4 IHE Anatomic Pathology Bindings =
 
 
 
This section
 
describes how the payload used in a transaction of an IHE profile is related to
 
and/or constrains the data elements sent or received in those transactions.
 
This section is where any specific dependencies between the content and
 
transaction are defined.
 
 
 
A content profile
 
can define multiple bindings. Each binding should identify the transactions and
 
content to which it applies.
 
 
 
The source for
 
all required and optional attributes have been defined in the bindings below.
 
Three tables describe the three main XDS object types: XDSDocumentEntry,
 
XDSSubmissionSet, and XDSFolder. XDSSubmissionSet and XDSDocumentEntry are
 
required. Use of XDSFolder is optional. These concepts are universal to XDS,
 
XDR and XDM.
 
 
 
The structure of
 
these three tables is presented in '''PCC TF-2:4'''
 
 
 
 
 
== 4.1 Anatomic Pathology Document Binding to XDS, XDM and XDR ==
 
 
This binding
 
defines a transformation that generates metadata for the ''XDSDocumentEntry'' element of appropriate transactions from the XDS,
 
XDM and XDR profiles given a medical document and information from other
 
sources. The medical document refers to the document being stored in a
 
repository that will be referenced in the registry. The other sources of
 
information include the configuration of the Document Source actor, the
 
Affinity Domain, the site or facility, local agreements, other documents in the
 
registry/repository, and this content profile.
 
 
 
In many cases,
 
the CDA document is created for the purposes of sharing within an affinity
 
domain. In these cases the context of the CDA and the context of the affinity
 
domain are the same, in which case the following mappings shall apply.
 
 
 
In other cases,
 
the CDA document may have been created for internal use, and are subsequently
 
being shared. In these cases the context of the CDA document would not necessarily
 
coincide with that of the affinity domain, and the mappings below would not
 
necessarily apply.
 
 
 
 
 
=== 4.1.1XDS DocumentEntry Metadata ===
 
 
 
The general table
 
describing the ''XDSDocumentEntry Metadata'' requirements for IHE domains is shown in '''PCC TF-2:4.1.1'''
 
 
 
The sub-sections
 
below list the only requirements which are specific to the Anatomic Pathology
 
Domain, and which supersede those from the general table mentioned above.
 
 
 
==== 4.1.1.1XDS DocumentEntry.formatCode ====
 
 
 
The values of ''formatCode'' per document template are
 
listed in table 5.6-1.
 
 
 
The associated'' codingScheme'' Slot SHALL be '''1.3.6.1.4.1.19376.1.2.3''' in all cases.
 
 
 
== 4.1.1.2XDS DocumentEntry.eventCodeList ==
 
 
 
This metadata
 
provides a means to index anatomic pathology reports by reportable conditions (e.g.,
 
certain types of tumors…) so as to facilitate later queries in a registry of
 
shared clinical documents. The conclusions coded in the ''entry'' element of the Diagnostic Conclusion section are good
 
candidates for this metadata.
 
 
 
== 4.1.1.3XDS DocumentEntry.parentDocumentRelationship ==
 
 
 
The Anatomic
 
Pathology document Content Modules only permit the “replace” relationship
 
between instances of APSR documents.
 
 
 
Thus, XDSDocumentEntry.parentDocumentRelationship
 
is constrained to the "'''RPLC'''"
 
(replace) value. The new document issued replaces completely the parent one,
 
which will be considered as deprecated.
 
 
 
=== 4.1.2XDS SubmissionSet Metadata ===
 
 
 
The submission
 
set metadata is as defined for XDS, and is not necessarily affected by the
 
content of the clinical document. Metadata values in an ''XDSSubmissionSet'' with names identical to those in the ''XDSDocumentEntry'' may be inherited from ''XDSDocumentEntry'' metadata, but this is
 
left to affinity domain policy and/or application configuration.
 
 
 
This content
 
format uses the submission set to create a package of information to send from
 
one provider to another. All documents or images referenced by the Anatomic
 
Pathology Structured Report in this Package must be present (at least as
 
references in the case of images) in the submission set.
 
 
 
=== 4.1.3XDS Folder Metadata ===
 
 
 
No specific requirements identified.
 
 
 
=== 4.1.4 Configuration ===
 
 
 
The Anatomic
 
Pathology Content Profiles using this binding require that Content Creators and
 
Content Consumers be configurable with institution and other specific
 
attributes or parameters. Implementers should be aware of these requirements to
 
make such attributes easily configurable.
 
 
 
 
 
= 5 Namespaces and Vocabularies =
 
 
 
== 5.1 OID tree of PAT TF ==
 
 
 
1.3.6.1.4.1.19376.1.81.3.6.1.4.1.19376.1.8 is the OID of the IHE Anatomic Pathology  domain:
 
 
 
All exchangeable objects specified by this domain are identified by OIDs built on this root:
 
 
 
 
 
Branch 1.3.6.1.4.1.19376.1.8.1 is dedicated to CDA Content Modules created by this domain
 
 
 
1.3.6.1.4.1.19376.1.8.1.1 is the OID of the generic Document Content Module
 
 
 
Sub-branch 1.3.6.1.4.1.19376.1.8.1.2 is dedicated to Section Content Modules
 
 
 
Sub-branch 1.3.6.1.4.1.19376.1.8.1.4 is dedicated to Element Content Modules
 
 
 
1.3.6.1.4.1.19376.1.8.1.4.4 is the OID of the Specimen Information Organizer
 
 
 
1.3.6.1.4.1.19376.1.8.1.4.8 is the OID of the Problem Organizer
 
 
 
1.3.6.1.4.1.19376.1.8.1.4.9 is the OID of the generic anatomic pathology (AP) observation template
 
 
 
1.3.6.1.4.1.19376.1.8.1.4.10 is the OID of the Procedure Steps template
 
 
 
 
Branch 1.3.6.1.4.1.19376.1.8.2 is dedicated to terminologies defined by this domain
 
 
 
Sub-branch 1.3.6.1.4.1.19376.1.8.2.1 is dedicated to PathLex
 
 
 
Branch 1.3.6.1.4.1.19376.1.8.5 is dedicated to Value Sets defined by this domain.
 
 
 
Branch 1.3.6.1.4.1.19376.1.8.9 is used to identify instances in the examples built by the PAT TF.
 
 
 
Notes on other IHE OIDs used in the AP domain:
 
 
 
''1.3.6.1.4.1.19376.1.3.1.2 is the OID of the Specimen Collection Procedure template''
 
 
 
 
 
== 5.2 Terminologies and controlled coded vocabularies ==
 
 
 
This section lists the terminologies and the coded vocabularies referenced by this Volume 3 of the IHE PAT TF.
 
 
 
'''Table 5.2-1  Anatomic Pathology Terminologies and Coded Vocabularies'''
 
 
 
{{FAQBox|
 
Could this be contributed by ArtDecor??? GH
 
}}
 
 
 
{| class="hl7table"
 
!codeSystem !! codeSystemName !!Description!! Owner
 
|-
 
|2.16.840.1.113883.6.1
 
||LOINC
 
||Logical Observation Identifier Names and Codes
 
||Regenstrief Institute
 
 
 
|-
 
|2.16.840.1.113883.6.96
 
||SNOMED-CT||Systematized Nomenclature of Medicine – Clinical Terms
 
||IHTSDO
 
 
 
|-
 
|1.3.6.1.4.1.19376.1.5.3.2
 
||IHEActCode||Vocabulary defined by IHE PCC in PCC TF-2:5.1.2
 
||IHE PCC
 
 
 
|-
 
|2.16.840.1.113883.6.3
 
||ICD-10||International Classification of Diseases revision 10
 
||WHO
 
 
 
|-
 
|2.16.840.1.113883.6.43
 
||ICD-O-3||International Classification of Diseases for Oncology revision 3
 
||WHO
 
 
 
|-
 
|
 
||PubCan||A Public Database of Human Cancers http://www.pubcan.org
 
||WHO
 
 
 
|-
 
|1.2.250.1.213.2.11
 
||ADICAP Thesaurus||French thesaurus of lesions in anatomic pathology
 
||ADICAP
 
 
 
|-
 
|1.2.250.1.213.2.12
 
||SNOMED International (3.5)||Systematized Nomenclature of Medicine
 
||ASIP santé
 
 
 
 
 
|-
 
|1.3.6.1.4.1.19376.1.8.2.1
 
||PathLex||Temporary terminology covering the scope of anatomic pathology observation results and specimen collection procedure code
 
||IHE-PAT
 
 
 
|-
 
|2.16.840.1.113883.15.6
 
||TNM 7th edition||Internationally agreed-upon standards to describe and categorize cancer stages and progression http://www.uicc.org/resources/tnm
 
||Union for International Cancer Control (UICC) & American Joint Committee on Cancer (AJCC)
 
 
 
|-
 
|2.16.840.1.113883.15.7
 
||TNM 6th edition||Internationally agreed-upon standards to describe and categorize cancer stages and progression http://www.uicc.org/resources/tnm
 
||Union for International Cancer Control (UICC) & American Joint Committee on Cancer (AJCC)
 
 
 
|-
 
|2.16.840.1.113883.15.8
 
||TNM 5th edition||Internationally agreed-upon standards to describe and categorize cancer stages and progression http://www.uicc.org/resources/tnm
 
||Union for International Cancer Control (UICC) & American Joint Committee on Cancer (AJCC)
 
 
 
|-
 
|1.2.276.0.76.3.1.131.1.5.1
 
||DKG Coding Scheme||Internationally agreed-upon standards to describe and categorize cancer stages and progression, adapted for Germany
 
||DKG (Deutsche Krebsgesellschaft)
 
|}
 
 
 
== 5.3 Value Sets ==
 
 
 
 
 
The value sets defined or referenced by this Volume 3 of the IHE PAT TF are listed in the separate appendix spreadsheet “IHE_PAT_Suppl_APSR_AppendixValue_Sets”.
 
 
 
 
 
==5.4 Namespaces==
 
 
 
===5.4.1 Namespace protecting extensions to the CDA schema===
 
 
 
There is currently one single extension to the CDA.xsd schema used in PAT TF-3. This extension has been created by IHE LAB and is protected by this particular namespace in document instances: '' xmlns:lab="urn:oid:1.3.6.1.4.1.19376.1.3.2"''
 
 
 
 
 
==5.5 References to Content Modules built outside of IHE PAT TF==
 
The Content Modules specified in this Volume 3 of the PAT TF leverage a number of Content Modules (currently CDA templates) produced and maintained by other groups, including other domains of IHE. Table 5.5-1 lists them.
 
 
 
'''Table 5.5-1  External Content Modules referenced by PAT TF-3'''
 
 
 
{| class="hl7table"
 
!templateId !! Standard !!Definition!! Source of Specification
 
|-
 
|1.3.6.1.4.1.19376.1.5.3.1.3.1||CDA R2
 
||Reason for referral
 
||IHE PCC TF-2:6.3.3.1.2
 
 
 
|-
 
|1.3.6.1.4.1.19376.1.5.3.1.3.4
 
||CDA R2||History of present illness
 
||IHE PCC TF-2:6.3.3.2.1
 
 
 
|-
 
|1.3.6.1.4.1.19376.1.5.3.1.3.6
 
||CDA R2||Active Problems
 
||IHE PCC TF-2:6.3.3.2.3
 
 
 
|-
 
|1.3.6.1.4.1.19376.1.5.3.1.4.2
 
||CDA R2||Annotation Comment
 
||IHE PCC TF-2:6.3.4.6
 
 
 
|-
 
|1.3.6.1.4.1.19376.1.3.3.1.7
 
||CDA R2||Performing laboratory
 
||IHE LAB TF-3:2.3.3.22
 
 
 
|-
 
|1.3.6.1.4.1.19376.1.3.3.1.6
 
||CDA R2||Ordering Provider (ordering physician)
 
||IHE LAB TF-3:2.3.3.19
 
 
 
|-
 
|1.3.6.1.4.1.19376.1.3.3.1.4
 
||CDA R2||Intended Recipient
 
||IHE LAB TF-3:2.3.3.16
 
 
 
|-
 
|1.3.6.1.4.1.19376.1.3.1.6
 
||CDA R2||Laboratory Observation
 
||IHE LAB TF-3:2.3.5.11
 
 
 
 
 
|-
 
|1.3.6.1.4.1.19376.1.3.1.2
 
||CDA R2||Specimen Collection Procedure
 
||IHE LAB TF-3:2.3.5.5 (specification captured in this APSR supplement for easier readability)
 
 
 
|}
 
 
 
==5.6 IHE Codes for Anatomic Pathology Document Templates==
 
Any AP structured report SHALL conform to the APSR generic Content Module Identified by templateId “1.3.6.1.4.1.19376.1.8.1.1.1” , and SHALL be associated with the following metadata:
 
*typeCode = “11526-1”, which is the LOINC code for “Pathology study”.
 
*formatCode = “urn:ihe:pat:apsr:all:2010”, with associated codingScheme = “1.3.6.1.4.1.19376.1.2.3” as assigned by the ITI Domain for codes used for the purposes of cross-enterprise document sharing (XDS).
 
*The media type SHALL be “text/xml”.
 
 
 
 
 
=6 Anatomic Pathology Content Modules=
 
==6.1 Conventions==
 
In all Content Modules specified in this section, the abbreviation “'''AP'''” stands for “Anatomic Pathology”.
 
 
 
Various tables used in this section will further constrain the content. Within this volume, the following conventions are used:
 
 
 
'''R'''
 
 
 
A "'''Required'''" data element is one that shall always be provided. If there is information available, the data element must be present. If there is no information available, or it cannot be transmitted, the data element must contain a value indicating the reason for omission of the data.
 
 
 
'''R2'''
 
 
 
A "'''Required if data present'''" data element is one that shall be provided when a value exists. If the information cannot be transmitted, the data element shall contain a value indicating the reason for omission of the data. If no such information is available to the content creator or if such information is not available in a well identified manner (e.g., buried in a free form narrative that contains additional information relevant to other sections) or if the content creator requires that information be absent, the R2 section shall be entirely absent. The Content Creator application must be able to demonstrate that it can populate  all required if known elements, unless it does not in fact gather that data. This “R2” code is the equivalent of the HL7 standard “RE” usage code. The value “R2” has been chosen in harmonization with the IHE PCC TF, which is the source of a large number of CDA R2 content modules.
 
 
 
'''O'''
 
 
 
An "'''Optional'''" data element is one that may be provided, irrespective of whether the information is available or not. If the implementation elects to support this optional section, then its support shall meet the requirement set forth for the "Required if data present" or R2.
 
 
 
'''C'''
 
 
 
A "'''Conditional'''" data element is one that is required, required if known or optional depending upon other conditions. These will have further notes explaining when the data element is required, et cetera.
 
 
 
 
 
==6.2 HL7 CDA R2 Content Modules==
 
 
 
===6.2.1 Organization===
 
 
 
====6.2.1.1 Various Types of Content Modules====
 
 
 
For the CDA Release 2.0 standard, the content modules are organized by:
 
 
 
 
 
*'''document''': The template for a whole document.
 
 
 
 
 
*'''section''': The template for a <section> element.
 
 
 
 
*'''entry''': The template for a <entry> element.
 
 
 
 
 
*'''child element''': An element of the CDA header or an element of a <section>, or an element nested at various depths below an <entry>, or an element appearing at some combination of these locations.
 
 
 
 
 
====6.2.1.2 General constraints added by IHE PAT to a CDA R2 document====
 
 
 
In the structured body of a CDA R2 document, a section has a narrative block (the text element), which presents the human-readable content of the section, and MAY have one entry or more.  Sections MAY be nested within one another.
 
 
 
The content modules designed by the PAT TF bring or highlight the following constraints:
 
 
 
*When a section has a text element and one or more entry element, the content coded for machine-processing in the entries SHALL be completely transcribed into human-readable content in the text element.
 
 
 
*Conversely the text element MAY contain pieces of information, which are not available in machine-readable format in any entry element of the section.
 
 
 
*For a document of the Anatomic Pathology domain, the entry elements are instantiated per specimen or per group of specimens observed together. One entry contains in machine-readable format observations of the section related to the same specimen or group of specimens. Beneath an entry, the observations are organized per problem.
 
 
 
*The text element of the section is supposed to be also laid out per specimen or group of specimens and per problem observed.
 
 
 
*The APSR Content Profile leaves the layout of the text element up to the Content Creator applications, or to further constraints brought by national extensions of this profile. However, given that the text element is usually composed of free text (e.g. dictated text), assembled with the text generated from the set of data, machine-encoded in the entry elements below, the Content Creator application MUST handle these two kinds of content, and provide a user interface, which avoids risks of overwriting text automatically derived from the entries with free text typed in by the user  (e.g., using forms with dedicated free text areas and distinct protected areas for text generated out of structured data).
 
 
 
*Information that is sent SHALL clearly identify distinctions between:
 
 
 
'''None'''
 
 
 
It is known with complete confidence that there are none. This indicates that the sender knows that there is no relevant information of this kind that can be sent.
 
 
 
'''None Known'''
 
 
 
None known at this time, but it is not known with complete confidence that none exist.
 
 
 
'''Asked but unknown'''
 
 
 
The information was requested but could not be obtained. Used mainly in the context where an observation was made but the result could not be determined.
 
 
 
'''Unknown'''
 
 
 
The information is not known, or is otherwise unavailable.
 
 
 
'''Other, not specified'''
 
 
 
The actual value does not belong to the assigned value set and is not reported at all by the author.
 
 
 
'''Other, specify'''
 
 
 
The actual value does not belong to the assigned value set and the author of the report provides this ''foreign'' value anyway.
 
 
 
'''Not applicable'''
 
 
 
No proper value is applicable in this context.
 
 
 
Sections that are required to be present but have no information should use one of the above phrases where appropriate in the ''text'' element.
 
 
 
Structural elements that are required but have no information shall provide a “nullFlavor” attribute coding the reason why the information is missing.
 
 
 
{| class="hl7table"
 
!Situation !! nullFlavor !!HL7 Definition
 
|-
 
|Asked but unknown||ASKU
 
||Information was sought but not found
 
 
 
|-
 
|Unknown
 
||UNK||A proper value is applicable, but not known
 
 
 
|-
 
|Other, not specified
 
||OTH||The actual value is not an element in the value domain of a variable. (e.g., concept not provided by required code system).
 
 
 
|-
 
|Not applicable
 
||NA||No proper value is applicable in this context
 
 
 
|-
 
|Temporarily not available
 
||NAV||Information is not available at this time but it is expected that it will be available later.
 
|}
 
 
 
 
 
The two situations “None” and “None known” represent effective values, which are part of the related value sets.
 
 
 
The situation “Other, specify” can be handled in two ways in a coded data element:
 
*Leaving empty the ''code'' attribute and providing the non-coded answer in the ''originalText'' attribute.
 
*Providing a value coded from a different coding scheme, when the coding strength of the element is “CWE” (coded with extensions). The attributes ''code'', ''displayName'', ''codeSystem'' and ''codeSystemName'' then describe the foreign code.
 
 
 
For ancillary techniques, the situation “ not performed” or “none performed”  is represented by nullFlavor = NAV.
 
 
 
==Grundlage / Basics==
 
Grundlage dieses Konzeptes ist der Implementierungsleitfaden des Bundesverbands der Hersteller von IT-Lösungen für das Gesundheitswesen, e.V. ([http://www.bvitg.de bvitg]), Berlin, für den Arztbrief des deutschen Gesundheitswesens sowie der Diagnose- und Datentypleitfaden.
 
 
 
The APSR Germany is based on the trial implementation of the Bundesverband der Hersteller von IT-Lösungen für das Gesundheitswesen, e.V. (bvitg), Berlin, for the Discharge letter ("Arztbrief") of the German Health System, as well as the guidelines for diagnosis and data types.
 
 
 
* bvitG Arztbrief, v2.x, <nowiki>[CDAr2Arztbrief]</nowiki>, 2012
 
* [http://www.hl7.de/download/documents/diagnosen/Diagnoseleitfaden-v1.1_20110622.pdf Diagnoseleitfaden] v0.99b, 13.12.09
 
* Datentypleitfaden (HL7 V3)
 
 
 
 
 
 
 
==Disclaimer==
 
Dieses Dokument enthält keine komplette Spezifikation eines HL7 CDA R2 Arztbriefes bzw. Dokumentes. Es werden Teile eines Arztbriefes spezifiziert.
 
 
 
This document does not show a complete specification of a HL7 CDA R2 Discharge Letter. Parts of the Discharge letter are constrained.
 
  
 +
'''APSR-10 – Observation related to multiple specimens''': For example tumor staging may require combining data from multiple specimens (e.g., a breast excision with positive margins followed by a re-excision with clear margins – in this case the tumor size may be a composite of measurements from both specimens. Another example is staging of ovarian carcinomas with multiple biopsies of pelvis, peritoneum, nodes, omentum, etc.). To accommodate these use
 +
cases, each problem organizer as well as each observation may reference any number of specimens using the <specimen> child element. Each of these references may point to a detailed description of the specimen, in the "procedure steps" section.
  
[[Kategorie:cdapath|Einleitung]]
+
'''APSR-11 – Derivative specimens''':Specimens
 +
derived from primary specimens for ancillary studies, which may be sent to a
 +
reference lab or done in another part of the same institution, are included in
 +
the scope of this profile. The results produced on a derived specimen are
 +
attached to this specimen in the report.

Aktuelle Version vom 7. Februar 2018, 11:17 Uhr

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Foreword

This is a supplement to the IHE Pathology and Laboratory Medicine Technical Framework V8.0. Each supplement undergoes a process of public comment and trial implementation before being incorporated into the volumes of the Technical Frameworks.

This supplement was published on September 27, 2017 for Public Comment, with a comment period extending to mid-November. The current content is the Trial Implementation version, which has taken in consideration the comments received.

This supplement describes changes to the existing technical framework documents.

“Boxed” instructions like the sample below indicate to the Volume Editor how to integrate the relevant section(s) into the relevant Technical Framework volume.

Replace Section X.X by the following:

Where the amendment adds text, make the added text bold underline. Where the amendment removes text, make the removed text bold strikethrough. When entire new sections are added, introduce with editor’s instructions to “add new text” or similar, which for readability are not bolded or underlined.

General information about IHE can be found at: http://www.ihe.net.

Information about the IHE Pathology and Laboratory Medicine domain can be found at: http://ihe.net/IHE_Domains.

Information about the structure of IHE Technical Frameworks and Supplements can be found at: http://ihe.net/IHE_Process and http://ihe.net/Profiles.

The current version of the IHE Technical Framework (if applicable) can be found at: http://ihe.net/Technical_Frameworks.

Comments may be submitted on IHE Technical Framework templates any time at http://ihe.net/ihetemplates.cfm. Please enter comments/issues as soon as they are found. Do not wait until a future review cycle is announced.

Acknowledgements

Following authors mainly contributed to this document:

  • Francois Macary, PHAST, Paris
  • Dr. Gunter Haroske, Federal Association of German Pathologists, Berlin
  • Dr. Frank Oemig, Deutsche Telekom Healthcare Solutions GmbH, Bonn
  • Dr. Riki Merrick, APHL, San Francisco
  • Dr. Raj Dash, Duke University, Durham

They have to acknowledge the contributions of Dr. Kai U. Heitmann, who managed the cooperation between PaLM and ART-DECOR. It was the very first time that a complete IHE TF document could be developed by means of the ART-DECOR tools and a media wiki.

Introduction to this Supplement

This supplement complements volume 1 of the PaLM technical framework with the description of the APSR 2.0 content profile, and volume 3 with the bindings, content modules and value sets, which specify this profile.

Open Issues and Questions

None yet

Closed Issues

APSR-07 – Representing the hierarchy of specimens in an entry : This APSR supplement enables to represent the hierarchy of specimens at the CDA level 3. The operations on specimen and production of child specimens are tracked in the “Procedure Steps” section, which has a level 3 entry.

APSR-10 – Observation related to multiple specimens: For example tumor staging may require combining data from multiple specimens (e.g., a breast excision with positive margins followed by a re-excision with clear margins – in this case the tumor size may be a composite of measurements from both specimens. Another example is staging of ovarian carcinomas with multiple biopsies of pelvis, peritoneum, nodes, omentum, etc.). To accommodate these use cases, each problem organizer as well as each observation may reference any number of specimens using the <specimen> child element. Each of these references may point to a detailed description of the specimen, in the "procedure steps" section.

APSR-11 – Derivative specimens:Specimens derived from primary specimens for ancillary studies, which may be sent to a reference lab or done in another part of the same institution, are included in the scope of this profile. The results produced on a derived specimen are attached to this specimen in the report.