cdapath:Einleitung

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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

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 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 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.

"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:

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.

Introduction

This supplement is written for Trial Implementation.

This supplement prepares a new volume, Volume 3, of the Pathology and Laboratory Medicine (PaLM) Technical Framework.

This supplement references other documents the reader should be aware of:

1. IHE IT Infrastructure Technical Framework Volume 1

2. IHE IT Infrastructure Technical Framework Volume 3

3. IHE PCC Technical Framework Volume 2

4. HL7 CDA r2 normative edition 2005

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. CAP Cancer Protocols and Checklists 2010

Profile Abstract

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.

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

APSR-01 – List of potential sections of an AP structured report:

• Clinical information (content supposedly provided by the ordering physician)
• Intraoperative observations (in case of intraoperative consultation, which may be macroscopic only or may include cytology and/or frozen section)
• Macroscopic observations
• 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

1.16 Anatomic Pathology Integration Profiles

Replace figure 1.16-1by the new one below, taking the new profile(s) into account.

1.17 Dependencies among Integration Profiles

Add the following lines to Table 1.17-1

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)[1]. In France, the SFP (French society of pathology) [2] and the INCa (French National Cancer Institute) [3] 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) [4], the SFP (French society of pathology) [5] and INCa (French National Cancer Institute) [6] 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.

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.

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

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.

1 Introduction

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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

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

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.

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.

6.2.1.3 Common structure for CDA APSR

Figure 6.2.1.3-1 summarizes the common structure of the first five CDA APSR Section Content Modules specified here. Regarding the machine-readable part, the figure highlights the organization of entries within a section and of observations within an entry. Specific details such as the structure of sub-sections are not shown on this global picture.

Figure 6.2.1.3-1 CDA APSR: common structure of machine-readable content for CDA APSR Section Content Modules except Procedure Step Content Module

Figure 6.2.1.3-2 shows the common structure of the Procedure Step Content Module specified here, too.

Figure 6.2.1.3-2 CDA APSR: common structure of machine-readable content for Procedure Step Content Module

Note 1: In order to facilitate a further de-identification process of CDA AP reports for some secondary use (biosurveillance, epidemiology…) the producer of an APSR SHOULD avoid populating any patient identification data (name, sex, birthdate, address …) into the body of the report (neither <entry> elements nor <text> elements). The appropriate location for patient identification data is the CDA header exclusively.

Note 2: The AP sections are those shown on figure 4.1.2.1-1 of Volume 1.

Note 3: The possible sub sections are shown on figure 4.1.2.1-1 of Volume 1.

6.2.2 Common layout for the specification of a CDA Content Module

Each CDA R2 Content Module specified in this Volume is presented with this layout:

6.2.2.1 Content Module Name – OID

Each Content Module is uniquely identified by a unique OID.

6.2.2.1.1 Definition and purpose

This section presents the content module and its purpose.

In case this module is a specialization of a more generic one, the section references its parent template.

6.2.2.1.2 Example

This section delivers a snippet, showing an example of the content module.

6.2.2.1.3 Specification

The form of the specification depends upon the kind of CDA Content Module (document, section, entry, header and/or entry element). It respects the guidelines below:

• The specification provides a table describing the structure of the content module, each element being located through an XPATH expression combined with indentation. The table provides cardinalities, meaning for each elements, references value sets described in section 5 for attributes, and provides the mapping with HL7 V2.5.1 relevant fields. The table also points the content modules nested in the current one, by showing their templateId, and locating their specification in the current PAT TF-3 or in the IHE TF they belong to (PCC, LAB, etc.).
• The table is simplified for section content modules: It only lists the content modules nested in the section template.
• Below the tables appear notes providing additional information and detailing particular constraints on some elements or attributes.

6.2.3 CDA R2 Document Content Modules

6.2.3.1 AP Structured Report (APSR) - 1.3.6.1.4.1.19376.1.8.1.1.1

6.2.3.1.1 Definition and purpose

This Document Content Module defines the base set of constraints that apply to all AP structured report, related to any kind of lesion or diagnostic. In other words, this is the generic template for any AP structured report.

The body of this Document Content Module has the hierarchy of sections and entries depicted by figure 4.1.2.1-1 in Volume 1.

6.2.4 CDA R2 <section> Content Modules

6.2.4.1 Clinical Information <section> - 1.3.6.1.4.1.19376.1.8.1.2.1

6.2.4.1.1 Definition and Purpose

The Clinical Information section contains the information provided by the ordering physician: Clinical history, preoperative diagnosis, postoperative diagnosis, reason for anatomic pathology procedure, clinical laboratory data, specimen collection procedure including target site, performer, specimen type, specimen(s) clinical description, and tumor site in case of a cancer.

6.2.4.2 Intraoperative Observation <section> - 1.3.6.1.4.1.19376.1.8.1.2.2

6.2.4.2.1 Definition and Purpose

The Intraoperative Observation section contains an intraoperative diagnosis for each specimen examined, the specimen identification and description, intraoperative observation procedure description (frozen section, gross examination, intraoperative cytology) and derived specimen dissected for other ancillary procedures (flow cytometry, cytogenetics, molecular studies, and electron microscopy).

6.2.4.3 Macroscopic Observation <section> - 1.3.6.1.4.1.19376.1.8.1.2.3

6.2.4.3.1 Definition and Purpose

The Macroscopic Observation section contains the description of the specimen(s) received or obtained by the laboratory (specimen type and state), the gross observation, links to gross images, if taken, processing information and tissue disposition (representative sampling and tissue submitted for additional studies or sent to biorepository.

6.2.4.4 Microscopic Observation <section> - 1.3.6.1.4.1.19376.1.8.1.2.4

6.2.4.4.1 Definition and Purpose

The Microscopic Observation section contains optionally the histopathologic findings of the case and many laboratories use this section to record the results of histochemical and immunohistochemical stains.

6.2.4.5 Diagnostic Conclusion <section> - 1.3.6.1.4.1.19376.1.8.1.2.5

6.2.4.5.1 Definition and Purpose

The Diagnostic Conclusion section contains diagnoses on all specimens that are delivered to the pathology department from one operation or patient visit to a single clinician on a particular day. The diagnoses for each specimen or group of specimens are reported separately. This section includes additional pathologic finding(s) and the results of ancillary study(ies) and may include diagrams and still images or virtual slides, if taken. In case of cancer, this section includes the cancer checklist.

6.2.4.6 Procedure steps <section> - 1.3.6.1.4.1.19376.1.8.1.2.6

6.2.4.6.1 Definition and Purpose

The Procedure steps section contains the description of tissue dissection: representative specimens and derived specimens dissected for other ancillary procedures (flow cytometry, cytogenetics, molecular studies, electron microscopy, etc.) or biorepository.

6.2.4.7 Report Textual Summary <section> - 1.3.6.1.4.1.19376.1.8.1.2.7

6.2.4.7.1 Definition and Purpose

The Report Textual Summary section is an optional sub-section of the Diagnostic Conclusion section. This section contains a textual summary of the AP report, which can be extracted from the document and inserted into other clinical documents. It addresses the use case where authors of other medical documents feel the need to include a segment such as "...the pathology report states '[...]'", the text content of this section filling the brackets.

6.2.5 CDA R2 <entry> Content Modules

6.2.5.1 Common Specification for all APSR Entry Content Modules

The unique <entry> Content Module available in the sections of the APSR template is Specimen Information Organizer.

Each <entry> Content Module carries machine-readable data related to one specimen or to one group of specimens observed for this section.

Each <entry> Content Module is repeatable below its section, so as to support the use cases where a section reports on more than one specimen or more than one group of specimens.

6.2.6 CDA R2 Child Element Content Modules

This section specifies the Content Modules designed for child elements. A child element is a child of the CDA header or a child of a <section>, or an element nested at various depths below an <entry>, or an element appearing at some combination of these locations.

6.2.6.1 Specimen Collector in Header – 1.3.6.1.4.1.19376.1.8.1.4.1

6.2.6.1.1 Definition and purpose

This Content Module is usable only in the CDA header.

This Content Module is used only in the situation where the specimen was not collected by the ordering physician. (See use cases in volume 1)

6.2.6.2 Author – 1.3.6.1.4.1.19376.1.8.1.4.2

6.2.6.2.1 Definition and purpose

This Content Module is usable in the CDA header, in a <section> and at various depths of an <entry>.

It describes an author having contributed to the document wholly or to a portion of it (e.g., a section, an observation, a group of observations).

A given document or any delimited portion of it may have more than one author.

An author MAY be a person or a device (manufactured device or software system). In both cases the scoping organization MAY be described.

6.2.6.3 Content Validator – 1.3.6.1.4.1.19376.1.8.1.4.3

6.2.6.3.1 Definition and purpose

This Content Module is usable only in the CDA header.

It describes a pathologist having verified the content of the report, using the element authenticator. This element authenticator is used when the pathologist having verified the content of the report is distinct from the pathologist assuming the legal responsibility for this report, described in the legalAuthenticator element.

The report MAY have zero or more Content Validators.

6.2.6.4 Specimen Information Organizer – 1.3.6.1.4.1.19376.1.8.1.4.4

6.2.6.4.1 Definition and purpose

This Content Module is the unique <entry> available for most of APSR sections (see figure 4.1.2.1-1 in Volume 1). The specimen information organizer organizes information related to the various acts (procedures, observations) performed on a single specimen or group of specimens investigated together.

6.2.6.5 Specimen Collection Procedure generic template – 1.3.6.1.4.1.19376.1.3.1.2

6.2.6.5.1 Definition and purpose

This Content Module is usable within an <entry> element.

This Content Module structures the machine-readable data representing the characteristics of the specimen (identifiers and type) and the procedure that collected it: Type of procedure, time interval, performer (person and organization), approach site, target site.

The “Specimen Collection Procedure” generic template is usable in all <entry> elements of all APSR Document Content Modules.

Each organ-specific APSR Document Content Module mandates an organ-specific template, child of the “Specimen Collection Procedure” generic template. This organ-specific child template has exactly the same structure as the generic one, and brings only a number of vocabulary constraints related to this specific organ:

• The value set bound to the procedure/code element, consisting in a list of triplets (code, codeSystem, displayName) representing the various specimen collection procedures that can be performed on this specific organ.
• The value set bound to the procedure/targetSiteCode element, consisting in a list of triplets (code, codeSystem, displayName) representing the various precise locations for collecting specimens from this specific organ.

Thus, a specimen collection procedure in an <entry> within an organ-specific APSR Document Content Module declares conformance to two templates: The “Specimen Collection Procedure” generic template and the “Specimen Collection Procedure” child template constraining the vocabularies for the contextual organ.

These specimen collection procedure child templates and their attached value sets are provided by the appendix “IHE_PAT_Suppl_APSR_AppendixValue_Sets.xlsx”

6.2.6.6 Informant – 1.3.6.1.4.1.19376.1.8.1.4.6

6.2.6.6.1 Definition and purpose

This Content Module is usable in the CDA header, in a <section> and within an <entry>.

It describes a person having provided some piece of relevant information for the document.

A <ClinicalDocument> or a <section> or any kind of act below an <entry>, MAY have zero or more informant.

6.2.6.7 Additional participant in an entry - 1.3.6.1.4.1.19376.1.8.1.4.7

6.2.6.7.1 Definition and purpose

This Content Module is usable only within an <entry> element.

Additional participants MAY take part in any organizer as well as in any observation of an APSR. These participants MAY be any of these 4:

• Validator: This is the same participation as Content Validator in the header of the report: a pathologist having verified the content (of this particular subset of results).
• Device: A device used to produce this particular subset of results.
• Responsible: The director of a laboratory (described in a performer element at the same level) who produced this particular subset of results.
• Transcriptionist: This is the same participation as dataEnterer in the header of the report: a staff who entered, possibly from dictation, this particular subset of results.

6.2.6.8 Problem Organizer – 1.3.6.1.4.1.19376.1.8.1.4.8

6.2.6.8.1 Definition and purpose

This Content Module is usable within (a Specimen Information Organizer) any Section module.

The problem organizer groups the battery of observations performed to investigate on a single problem identified on a specimen or group of specimens.

6.2.6.9 AP Anatomic pathology Observation template – 1.3.6.1.4.1.19376.1.8.1.4.9

6.2.6.9.1 Definition and purpose

This Content Module is usable within a Problem Organizer.

The “AP Observation”generic template is usable for all AP observations, including ancillary techniques.

Each specific AP observation is associated to a specific template, child of the “AP Observation”generic template. This specific child template has exactly the same structure as the generic one, and brings only a number of vocabulary constraints related to the type of observation and to the type of organ source of the specimen observed:

• The code for the specific observation, defined as a value set bound to the observation/code element, containing a single triplet (code,

codeSystem, displayName) representing this specific observation.

• The cardinalities and default type for the observation/value element carrying the results of this observation.
• The domain of values for this observation in case these values are coded. This domain of coded values is defined as a value set bound to the

observation/value element, containing as many triplets (code, codeSystem, displayName) as there are admissible result values for this specific observation performed on a specimen taken from this specific organ.

An AP Observation has a status and an effective time, may describe various participants (persons, devices, organizations), may have a number of additional properties (method, interpretation, text), and may contain embedded images, comments, and sub-observations, which are also AP observations.

6.2.6.10 Embedded Image – 1.3.6.1.4.1.19376.1.8.1.4.10

6.2.6.10.1 Definition and purpose

This Content Module is usable within an <entry> element, in relationship with a display anchor carried in the referencedObject attribute of a <renderMultimedia> element in the <text> element of the <section> holding this <entry>.

The <observationMedia> element carries an image, embedded in B64. This element may be standalone, or encapsulated within a <regionOfInterest> element which defines an overlay shape to focus on a part of the image.

This <observationMedia> element embeds the image binary data, encoded in B64.

6.2.6.11 Specimen Procedure Step - 1.3.6.1.4.1.19376.1.8.1.4.11

6.2.6.11.1 Definition and purpose

The Specimen Procedure Step <entry> Content Modul contains in machine-readable form all the information concerning one specimen or a group of specimens. It is usable within a Procedure Steps <section> Content Module only.

This Content Module structures the machine-readable data, which characterize the specimens and the procedures of their collection and processing. By nesting via an entryRelationship the entry is used in an iterative manner for each single step of specimen processing, which results in derived (child) specimen in and on the appropriate containers. The resulting specimen is the participant in the procedure according the CDA-RIM (fig. 6.2.6.11.1-1). It carries an ID as well as further attributes, which are defined in the HL7 Specimen DAM HL7 DAM Specimen Release 1.

Figure 6.2.6.11.1-1 CDA-RMIM of the Specimen Procedure Steps <entry>

The Code systems and Value sets MAY be organized organ-specific and represented e.g. by PathLex.

Grundlage / Basics

Grundlage dieses Konzeptes ist der Implementierungsleitfaden des Bundesverbands der Hersteller von IT-Lösungen für das Gesundheitswesen, e.V. (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, [CDAr2Arztbrief], 2012
• 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.