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Inhaltsverzeichnis

1 Foreword
2 Introduction to this Supplement
- 2.1 Open Issues and Questions
- 2.2 Closed Issues
3 VOLUME 1 -PROFILES
4 Volume 3 – Content Modules
5 1 Introduction
6 2 Content Modules – Basic Principles
7 3 IHE Transactions
- 7.1 3.1 Cross Enterprise Document Content Transactions
8 4 IHE Anatomic Pathology Bindings
9 5 Namespaces and Vocabularies
10 6 Anatomic Pathology Content Modules
- 10.1 6.1 Conventions
- 10.2 6.2 HL7 CDA R2 Content Modules

Foreword

This is a supplement to the IHE Pathology and Laboratory Medicine Technical Framework V7.0. 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 on <Month XX, 2016> for Public Comment. Comments are invited and may be submitted at http://www.ihe.net/<domain>/<domain>comments.cfm. In order to be considered in development of the Trial Implementation version of the supplement, comments must be received by <Month XX, 201X>.

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:

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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.

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, the specimen organizer is able to represent either a single specimen or a group of specimens investigated together.

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.

VOLUME 1 -PROFILES

10 Anatomic Pathology Structured Report (APSR) Profile

This content profile describes an anatomic pathology structured report (APSR) as a digital document to be shared or exchanged between pathology laboratories and other care providers and institutions.

Anatomic pathology structured reports document the findings on specimens removed from patients for diagnostic or therapeutic reasons. This information can be used for patient care, clinical research and epidemiology. Standardizing and computerizing anatomic pathology reports is necessary to improve the quality of reporting and to facilitate the exchange the exchange and reuse of the content of these reports.

This content profile describes a digital anatomic pathology report shared in a human-readable format, which may include images, and which also contains findings and observations in a machine-readable format, to facilitate the integration of these into the database of a consumer system, and to enable the application of automated reasoning to this content.

The scope of this IHE content profile covers all fields of anatomic pathology (cancers, benign neoplasms as well as non-neoplastic conditions) as well as cytopathology.

Goldsmith, J.D., et al., “Reporting guidelines for clinical laboratory reports in surgical pathology” Arch Pathol Lab Med, 2008. 132(10): p. 1608-16, is the first source of specification for this content profile. This article delineates the required, preferred, and optional elements which should be included in any report of surgical pathology.

This source is complemented by the “cancer checklists” produced by the College of American Pathologists, and by the “comptes rendus d’anatomopathologie : données minimales à renseigner pour une tumeur primitive” produced by the French society of pathology (SFP [1]) for the French cancer institute (INCa [www.e-cancer.fr]).

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.

10.1 APSR Actors/Transactions

This section defines the actors, transactions, and/or content modules in this profile. General definitions of actors are given in the Technical Frameworks General Introduction Appendix A published here.

Figure 10.1-1 shows the actors directly involved in the APSR Profile and the direction that the content is exchanged.

A product implementation using this profile must group actors from this profile with actors from a workflow or transport profile to be functional. The grouping of the content module described in this profile to specific actors is described in more detail in the “Required Actor Groupings” section below.

Figure 10.1-1 APSR Actor Diagram

Table 10.1-1 lists the content module(s) defined in the APSR profile. To claim support with this profile, an actor shall support all required content modules (labeled “R”) and may support optional content modules (labeled “O”).

Table 10.1-1: <Profile Acronym>Profile - Actors and Content Modules

Actors	Content Modules	Optionality	Reference
Content Creator	Anatomic Pathology Structured Report 1.3.6.1.4.1.19376.1.8.1.1.1	R	PaLM TF-3: 6.3.1.2
Content Consumer	Anatomic Pathology Structured Report 1.3.6.1.4.1.19376.1.8.1.1.1	R	PaLM TF-3: 6.3.1.2

10.1.1 Actor Descriptions and Actor Profile Requirements

Most requirements are documented in Content Modules (Volume 3). This section documents any additional requirements on profile’s actors.

10.2 APSR Actor Options

Options that may be selected for each actor in this profile are listed in the table 10.2-1. These options are further detailed in PCC Technical Framework Volume 2 as indicated in the rightmost column.

Table 10.2-1 Anatomic Pathology Structured Report - Actors and Options

Actor

Option Name

Reference

Content

Creator

None

Content

Consumer

View Option (1)

Document Import Option (1)

Section Import Option (1)

PCC TF-2:3.1.1

PCC TF-2:3.1.2

PCC TF-2:3.1.3

Note 1: The Content Consumer Actor shall support at least one of these options.

10.3 APSR Required Actor Groupings

An Actor from this profile (Column 1) shall implement all of the required transactions and/or content modules in this profile in addition to all of the transactions required for the grouped actor (Column 2).

In some cases, required groupings are defined as at least one of an enumerated set of possible actors; this is designated by merging column one into a single cell spanning multiple potential grouped actors. Notes are used to highlight this situation.

Section 10.5 describes some optional groupings that may be of interest for security considerations and section 10.6 describes some optional groupings in other related profiles.

Table 10.3-1: Anatomic Pathology Structured Report - Required Actor Groupings

XD-LAB Actor

Actor to be grouped with

Reference

Content Bindings Reference

Content

Creator

ITI XDS.b Document Source

OR

ITI XDM Portable Media Creator

OR

ITI XDR Document Source

ITI TF-1:10

ITI TF-1:16

ITI TF-1:15

Content

Consumer

ITI XDS.b Document Consumer

OR

ITI XDM Portable Media Consumer

OR

ITI XDR Document Recipient

ITI TF-1:10

ITI TF-1:16

ITI TF-1:15

Note 1: Each actor of APSR SHALL be grouped with at least one of the ITI actors listed in its table row.

10.4 APSR Overview

10.4.1 Concepts

This content profile represents a common digital document model applicable to any structured report for surgical pathology in all fields of anatomic pathology (cancers, benign neoplasms, non-neoplastic conditions) as well as for cytopathology.

This common model is composed of a header conveying the context of care (patient, care providers, pathologists, laboratories, order, act documented …) and a body. The body organizes the human-readable content of the report in a number of sections. Each section may also provide machine-readable content in an “entry” embedded in the section. This common model defines the order of appearance, cardinalities and internal structure of each section, and of each entry embedded in each section.

Figure 10.4.1-1 shows this general model applicable to any pathology digital report.

Figure 10.4.1-1 Common model for a digital anatomic pathology report

Note 1: The only section that is mandatory is the Diagnostic Conclusion section.

10.4.2 Use Cases

10.4.2.1 Use case #1: Single Report

Anatomic pathology order fulfilled by a pathology laboratory produces a report.

10.4.2.1.1 Single Report Use Case Description

A surgeon removes a breast tumor from a patient, requests the procedure “breast surgical specimen - pathological examination” and sends the specimen(s) to the anatomic pathology laboratory. Specimens) are accessioned by the anatomic pathology laboratory. The staff performs a macroscopic examination of the specimens ; gross imaging is performed if needed. The specimens 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 the 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 observations, validates and signs the digital report.

10.4.2.1.2 Single Report Process Flow

Intentionally left blank

10.4.2.2 Use Case #2: Multi-step Report

Reporting includes multiple successive steps.

10.4.2.2.1 Multi-step Report Use Case Description

A surgeon removes a breast tumor from a patient, requests the procedure “breast surgical specimen - frozen sections & pathological examination”, and “breast surgical specimen - pathological examination” and sends the specimen(s) to the anatomic pathology laboratory.

Specimens are accessioned by the anatomic pathology department. The staff performs a macroscopic examination of the specimens, gross imaging is performed if needed. The specimens 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, the 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.

10.4.2.2.2 Multi-step Report Process Flow

Intentionally left blank

10.5 APSR Security Considerations

See Appendix A of PaLM TF-1.

10.6 APSR Cross Profile Considerations

Intentionally left blank

Volume 3 – Content Modules

1 Introduction

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1.1 Overview of the Anatomic Pathology Technical Framework

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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

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1.4 Relationship to Standards

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1.5 Relationship to Real World Architecture

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1.6 Conventions

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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

Could this be contributed by ArtDecor??? GH

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.

Should these both figures better given in the HL7 Style??? GH

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.

Id 1.3.6.1.4.1.19376.1.8.1.1.1 Effective Date valid from 2014‑05‑13 11:57:57

Status Draft Version Label 2.0

Name AnatomicPathologyStructuredReportContentModule Display Name Anatomic Pathology Structured Report Content Module

Description

Anatomic Pathology Structured Report Content Module.

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.

The body of this Document Content Module specifies a common hierarchy of sections and entries depicted by figure 10.4.1-1 in Volume 1 IHE_PaLM_Suppl_APSR 2.0. The only mandatory section is the Diagnostic Conclusion Section. And the only mandatory entry is the Problem Organizer Entry below this section.

Context Pathname /

Label PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

Classification CDA Document Level Template

Open/Closed Open (other than defined elements are allowed)

Used by / Uses

Used by 0 transactions and 0 templates, Uses 20 templates

Uses	as	Name	Version
1.3.6.1.4.1.19376.1.3.3.1.1	Include	Human Patient (2017)	2017‑06‑07
1.3.6.1.4.1.19376.1.8.1.4.2	Include	CDA author IHE	2016‑06‑21 14:02:11
2.16.840.1.113883.10.12.103	Include	CDA dataEnterer	2005‑09‑07
1.3.6.1.4.1.19376.1.8.1.4.6	Containment	CDA Informant(Header&Body) APSR2 (2.0)	2016‑07‑08 11:22:58
2.16.840.1.113883.10.12.104	Include	CDA custodian	2005‑09‑07
1.3.6.1.4.1.19376.1.3.3.1.4	Include	XD-LAB Information Recipient (2017)	2008‑08‑08
1.3.6.1.4.1.19376.1.3.10.2.4	Include	XD-LAB LegalAuthenticator (2017)	2016‑07‑05
1.3.6.1.4.1.19376.1.8.1.4.3	Include	CDA authenticator IHE	2016‑07‑09 15:03:59
1.3.6.1.4.1.19376.1.3.3.1.6	Include	Ordering Provider (2017)	2008‑08‑08
1.3.6.1.4.1.19376.1.8.1.4.1	Include	CDA Participant Specimen Collector	2016‑06‑13 14:21:13
1.3.6.1.4.1.19376.1.3.10.2.5	Include	CDA Participant Pertinent Insurance Information	2017‑11‑13 16:52:30
1.3.6.1.4.1.19376.1.3.3.1.7	Containment	Laboratory Performer (2017)	2008‑08‑08
2.16.840.1.113883.10.12.113	Include	CDA componentOf	2005‑09‑07
1.3.6.1.4.1.19376.1.8.1.2.1	Containment	Clinical Information Section (2.0)	2014‑05‑13 14:38:08
1.3.6.1.4.1.19376.1.8.1.2.2	Containment	Intraoperative Observation Section (2.0)	2014‑05‑13 19:29:16
1.3.6.1.4.1.19376.1.8.1.2.3	Containment	Macroscopic Observation Section (2.0)	2014‑05‑13 11:57:09
1.3.6.1.4.1.19376.1.8.1.2.4	Containment	Microscopic Observation Section (2.0)	2014‑05‑13 14:25:17
1.3.6.1.4.1.19376.1.3.10.3.1	Containment	Additional Specified Observation Section (2.0)	2016‑11‑13 14:28:08
1.3.6.1.4.1.19376.1.8.1.2.5	Containment	Diagnostic Conclusion Section (2.0)	2014‑05‑13 19:31:26
1.3.6.1.4.1.19376.1.8.1.2.6	Containment	Procedure Steps Section (2.0)	2014‑05‑13 19:33:12

Relationship Specialization: template 2.16.840.1.113883.10.12.1 (2005‑09‑07)

Example

example for use case #1

<ClinicalDocument xsi:schemaLocation="urn:hl7-org:v3 infrastructure/cda/CDA_extended.xsd"> <realmCode code="UV"/> <typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/> <templateId root="1.3.6.1.4.1.19376.1.8.1.1.1"/> <id root="1.3.6.1.4.1.19376.1.8.9.1" extension="A7102400008_1" assigningAuthorityName="IHE PaLM Technical Committee"/> <code code="60568-3" codeSystem="2.16.840.1.113883.6.1" displayName="Pathology Synoptic report"/> <title>Anatomic Pathology Structured Report - Breast Biopsy</title> <effectiveTime value="201001041605-0500"/> <confidentialityCode code="N" displayName="normal" codeSystem="2.16.840.1.113883.5.25"/> <languageCode code="en-US"/> <setId root="1.3.6.1.4.1.19376.1.8.9.1" extension="A7102400008" assigningAuthorityName="IHE PaLM Technical Committee"/> <versionNumber value="1"/>  <recordTarget> <patientRole> <id extension="0411886319605719371016" root="1.3.6.1.4.1.19376.1.8.9.2"/> <addr use="HP"> <streetAddressLine>39 East Street</streetAddressLine> <postalCode>69499</postalCode> <city>Appleton</city> <state>WI</state> <country>United States</country> </addr> <telecom nullFlavor="NASK"/> <patient> <name> <prefix>Miss</prefix> <given>EVE</given> <family qualifier="BR">ONEWOMAN</family> </name> <administrativeGenderCode code="F" codeSystem="2.16.840.1.113883.5.1"/> <birthTime value="19710921"/> </patient> </patientRole> </recordTarget>  <author> <templateId root="1.3.6.1.4.1.19376.1.8.1.4.2"/> <time value="20100104131933-0500"/> <assignedAuthor> <id root="1.3.6.1.4.1.19376.1.8.9.3" extension="801234567897"/> <addr nullFlavor="MSK"/> <telecom value="tel:+33-602030499"/> <assignedPerson> <name> <given>Marcel</given> <family>Pathologist</family> <suffix>Ph D</suffix> </name> </assignedPerson> <representedOrganization> <id root="1.3.6.1.4.1.19376.1.8.9.4" extension="1120456789"/> <name>CANCER INSTITUTE</name> <telecom nullFlavor="MSK"/> <addr nullFlavor="MSK"/> </representedOrganization> </assignedAuthor> </author>  <dataEnterer> <time value="20100104131720-0500"/> <assignedEntity> <id root="1.3.6.1.4.1.19376.1.8.9.3" extension="A32"/> <addr nullFlavor="MSK"/> <telecom nullFlavor="MSK"/> <assignedPerson> <name> <given>Adeline</given> <family>Medsecret</family> </name> </assignedPerson> </assignedEntity> </dataEnterer> <informant>  </informant>  <custodian> <assignedCustodian> <representedCustodianOrganization> <id root="1.3.6.1.4.1.19376.1.8.9.4" extension="1120456789"/> <name>CANCER INSTITUTE</name> <telecom use="PUB" value="0466666666"/> <addr> <streetAddressLine>38 Cramberry Street</streetAddressLine> <postalCode>69499</postalCode> <city>Appleton</city> <state>WI</state> </addr> </representedCustodianOrganization> </assignedCustodian> </custodian>  <informationRecipient> <templateId root="1.3.6.1.4.1.19376.1.3.3.1.4"/> <intendedRecipient> <id root="1.3.6.1.4.1.19376.1.8.9.3" extension="987"/> <addr> <streetAddressLine>1600 Clifton Road</streetAddressLine> <city>Atlanta</city> <state>GA</state> <postalCode>30333</postalCode> </addr> <telecom value="tel:404-639-3535"/> <informationRecipient> <name> <family>WOULDLIKETOKNOW</family> <given>Thomas</given> </name> </informationRecipient> </intendedRecipient> </informationRecipient>  <legalAuthenticator> <time value="20100104152503-0500"/> <signatureCode code="S"/> <assignedEntity> <id root="1.3.6.1.4.1.19376.1.8.9.3" extension="801234567897"/> <assignedPerson> <name> <given>Marcel</given> <family>Pathologist</family> </name> </assignedPerson> </assignedEntity> </legalAuthenticator>  <authenticator> <templateId root="1.3.6.1.4.1.19376.1.8.1.4.3"/> <time value="20100104142503-0500"/> <signatureCode code="S"/> <assignedEntity> <id root="1.3.6.1.4.1.19376.1.8.9.3" extension="801234567898"/> <addr nullFlavor="MSK"/> <telecom nullFlavor="MSK"/> <assignedPerson> <name> <given>Jonas</given> <family>Jones</family> <prefix>MD</prefix> </name> </assignedPerson> </assignedEntity> </authenticator>  <participant typeCode="REF"> <templateId root="1.3.6.1.4.1.19376.1.3.3.1.6"/> <time> <high value="20091231"/> </time> <associatedEntity classCode="PROV"> <id root="1.3.6.1.4.1.19376.1.8.9.3" extension="801234567892"/> <addr nullFlavor="NASK"/> <telecom value="tel:0147150000" use="EC"/> <associatedPerson> <name> <prefix>Doctor</prefix> <given>Eva</given> <family>Surgeon</family> <suffix>Ph D</suffix> </name> </associatedPerson> </associatedEntity> </participant>    <inFulfillmentOf> <order> <id root="1.3.6.1.4.1.19376.1.8.9.8" extension="12345"/> </order> </inFulfillmentOf>  <documentationOf> <serviceEvent> <id root="1.3.6.1.4.1.19376.1.8.9.9" extension="A7102400008"/> <code code="371528001" displayName="Pathology report (record artifact)" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"/> <lab:statusCode code="completed"/> <effectiveTime>  <low value="200912300922-0500"/>  <high value="201001041605-0500"/> </effectiveTime>  <performer typeCode="PRF"> <templateId root="1.3.6.1.4.1.19376.1.3.3.1.7"/> <time> <high value="201001041605-0500"/> </time> <assignedEntity> <id root="1.3.6.1.4.1.19376.1.8.9.3" extension="801234567897"/> <representedOrganization> <id root="1.3.6.1.4.1.19376.1.8.9.4" extension="1120456789"/> <name>CANCER INSTITUTE</name> <telecom nullFlavor="MSK"/> <addr nullFlavor="MSK"/> </representedOrganization> </assignedEntity> </performer> </serviceEvent> </documentationOf>   <componentOf> <encompassingEncounter> <id root="1.3.6.1.4.1.19376.1.8.9.7" extension="234567890"/> <code code="ACUTE" displayName="inpatient acute"/> <effectiveTime> <high value="2201001040735-0500"/> </effectiveTime> <location typeCode="LOC"> <healthCareFacility classCode="SDLOC"> <id root="1.3.6.1.4.1.19376.1.8.9.4" extension="11223344"/> <serviceProviderOrganization classCode="ORG" determinerCode="INSTANCE"> <name>Surgery theater</name> <asOrganizationPartOf> <wholeOrganization> <name>CANCER INSTITUTE</name> </wholeOrganization> </asOrganizationPartOf> </serviceProviderOrganization> </healthCareFacility> </location> </encompassingEncounter> </componentOf>  <component typeCode="COMP" contextConductionInd="true"> <structuredBody classCode="DOCBODY" moodCode="EVN"> <component typeCode="COMP" contextConductionInd="true">  </component> <component typeCode="COMP" contextConductionInd="true">  </component> <component typeCode="COMP" contextConductionInd="true">  </component> <component typeCode="COMP" contextConductionInd="true">  </component> <component typeCode="COMP" contextConductionInd="true">  </component> <component typeCode="COMP" contextConductionInd="true">  </component> <component typeCode="COMP" contextConductionInd="true">  </component> </structuredBody> </component></ClinicalDocument>

Item DT Card Conf Description Label

hl7:ClinicalDocument

1 … 1

M

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@classCode

cs

1 … 1

F

DOCCLIN

@moodCode

cs

1 … 1

F

EVN

hl7:templateId

II

1 … 1

M

This element is identifying the set of constraints applied to the CDA R2 standard by this IHE specification of a AP report. The following templateId SHALL be present and valued as follows to indicate compliance with the APSR 2.0 content module specification.

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@root

uid

1 … 1

F

1.3.6.1.4.1.19376.1.8.1.1.1

hl7:realmCode

CS (extensible)

1 … 1

M

This element SHALL be present and is valued from the RealmOfUse [2.16.840.1.113883.1.11.11050] subset, within the VocabularyDomainQualifier value set. In the international context of this profile used as it is without any further extension, the realm code SHALL be <realmCode code="UV"/> (universal).

Whenever a national extension has been defined and is used, the realm code SHALL identify this national extension.

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:typeId

II

1 … 1

M

This element is a technology-neutral explicit reference to the standard CDA R2. It SHALL be present and valued as follows:
ClinicalDocument/typeId@root = "2.16.840.1.113883.1.3" (which is the OID for HL7 Registered models);
ClinicalDocument.typeId@extension = "POCD_HD000040" (which is the unique identifier for the CDA, Release Two Hierarchical Description).

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@root

uid

1 … 1

F

2.16.840.1.113883.1.3

@extension

st

1 … 1

F

POCD_HD000040

hl7:id

II

1 … 1

M

ClinicalDocument/Id SHALL be present. It represents the unique instance identifier of the clinical document. The combination of the root and extension attributes SHALL provide a globally unique identifier, in accordance with CDA R2, without further constraints.

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@root

uid

1 … 1

R

Here the OID for PAT exemplary instances, in practice the OID of the LIS

@extension

st

1 … 1

R

Here a hypothetical document ID, most often derived from the accession number

Constraint

A report may have several successive revisions over time, in case corrections or complements are provided by the custodian after the initial release of the report.

The unique id of the current revision of the report is carried by the id element, and is composed of

id@root, which SHALL be an OID,
and optionally id@extension, which can be any string so that the concatenation of the two attributes root and extension provide a globally unique id, which identifies this release of the report.

Example

Report ID from use case #1

<id root="1.3.6.1.4.1.19376.1.8.9.1" extension="A7102400008_1" assigningAuthorityName="IHE PaLM Technical Committee"/>

hl7:code

CE (required)

1 … 1

M

ClinicalDocument/code SHALL be present. The document type of this content module is always
<code code="60568-3"
codeSystem="2.16.840.1.113883.6.1"
displayName="Pathology Synoptic report"
codeSystemName="LOINC"/>

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@code

CONF

1 … 1

F

60568-3

@codeSystem

1 … 1

F

2.16.840.1.113883.6.1 (Logical Observation Identifier Names and Codes)

@codeSystemName

1 … 1

F

LOINC

@displayName

1 … 1

F

Pathology Synoptic report

hl7:title

ST

1 … 1

M

The APSR <title> SHALL be present. It is the local translation of the code@displayName.

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

CONF

element content shall be "Anatomic Pathology Structured Report"

Example

Report title from use case #1

<title>ANATOMIC PATHOLOGY REPORT - BREAST BIOPSY</title>

hl7:effectiveTime

TS

1 … 1

M

ClinicalDocument/effectiveTime SHALL be present. It contains the creation date & time of the laboratory report as an electronic document. In case this is a new revision replacing a previous version (identified in parentDocument), this is the date & time of the new revision.

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:confidentialityCode

CE (required)

1 … 1

M

ClinicalDocument/confidentialityCode SHALL be present in accordance with the HL7 CDA R2 standard.

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

CONF

The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.16926 HL7 BasicConfidentialityKind (2014‑06‑09)

hl7:languageCode

CS (required)

1 … 1

M

ClinicalDocument/languageCode SHALL be present in accordance with the HL7 CDA R2 standard.

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

CONF

The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.11526 HumanLanguage (2014‑03‑26)

hl7:setId

II

1 … 1

M

ClinicalDocument/setId SHALL be present to enable further updates of the clinical document. It is an identifier that is common across all revisions of this AP report.

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@root

uid

1 … 1

R

@extension

st

1 … 1

R

Constraint A report may have several successive revisions over time, in case corrections or complements are provided by the custodian after the initial release of the report.
The setId element provides a globally unique identifier that is common across all successive revisions of the report. This identifier is similarly composed of setId@root, which SHALL be an OID, and optionally setId@extension.

Example

Report set ID from use case #1

<id root="1.3.6.1.4.1.19376.1.8.9.1" extension="A7102400008" assigningAuthorityName="IHE PaLM Technical Committee"/>

hl7:versionNumber

INT

0 … 1

R

ClinicalDocument/versionNumber MAY be present. As requested by the CDA standard, it is an integer value used as versioning.

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@value

int

1 … 1

R

Constraint

A report may have several successive revisions over time, in case corrections or complements are provided by the custodian after the initial release of the report.

The version number of the current revision of the report is a positive integer (1, 2 …) provided in the versionNumber element.

Example

Report version number for use case #1

<versionNumber value="1"/>

Included

1 … 1

M

from 1.3.6.1.4.1.19376.1.3.3.1.1 Human Patient (2017‑06‑07)
The Patient.

The anatomic pathology report is related to ONE SINGLE patient.

A patient SHALL be identified with at least one unique patientRole/Id.
The patient address and telecom SHALL be provided (or null flavored).
The patient identity SHALL provide AT LEASTthe patient full name, sex and date/time of birth.

hl7:recordTarget

1 … 1

M

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:patientRole

1 … 1

R

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:id

II

1 … *

R

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:addr

AD

1 … *

All persons (including the patient) and organizations mentioned in the document SHALL provide elements name, addr and telecom.

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:telecom

TEL

1 … *

All persons (including the patient) and organizations mentioned in the document SHALL provide elements name, addr and telecom.

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:patient

1 … 1

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:id

II

0 … 1

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:name

PN

1 … *

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:administrativeGenderCode

CE

1 … 1

R

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:birthTime

TS

1 … 1

R

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

Included

1 … *

M

from 1.3.6.1.4.1.19376.1.8.1.4.2 CDA author IHE (2016‑06‑21 14:02:11)
The Author Content Module represents an author of the report. This element is repeatable. The sub-element author/time carries the date/time of the authoring action.

   
       
At least one ClinicalDocument/author SHALL be present with a time in accordance with the HL7 CDA R2 standard and further constrained by this specification to require the presence of name, addr and telecom. The author/time element carries the date&time the AP report was produced. The AP report can be authored by a software system or by a person or by both.

Source: PaLM Suppl.APSR 2.0‑3: 6.3.6.2

hl7:author

1 … *

M

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@typeCode

cs

1 … 1

F

AUT

Example

author is a person

<author typeCode="AUT" contextControlCode="OP"> <time value="201306101654"/> <assignedAuthor classCode="ASSIGNED">  </assignedAuthor></author>

hl7:templateId

1 … 1

M

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@root

uid

1 … 1

F

1.3.6.1.4.1.19376.1.8.1.4.2

hl7:time

TS

1 … 1

M

The authoring time is the date & time that this author contributed to the document. It SHALL be provided.

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:assignedAuthor

0 … 1

C

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@classCode

cs

0 … 1

F

ASSIGNED

hl7:id

II

1 … *

M

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:addr

AD

1 … *

M

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:telecom

TEL

1 … *

M

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

Choice

1 … 1

The author is either an assigned person or an authoring device.

Elements to choose from:

hl7:assignedPerson
hl7:assignedAuthoringDevice

hl7:assignedPerson

0 … 1

C

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

Included 0 … * from 2.16.840.1.113883.10.12.152 CDA Person (2005‑09‑07)
The name(s) SHALL be given.

@classCode

0 … 1

F

PSN

@determinerCode

0 … 1

F

INSTANCE

hl7:name

PN

0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:assignedAuthoringDevice

0 … 1

C

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@classCode

cs

0 … 1

F

DEV

@determinerCode

cs

0 … 1

F

INSTANCE

hl7:manufacturerModelName

SC

0 … 1

R

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:softwareName

SC

0 … 1

R

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:code

CE

0 … 1

R

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:representedOrganization

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

Example

represented organization for author as a device

<representedOrganization classCode="ORG" determinerCode="INSTANCE"> <name>  </name></representedOrganization>

Included 0 … 1 from 2.16.840.1.113883.10.12.151 CDA Organization (2005‑09‑07)
The identifier(s) SHOULD, the name SHALL, the telecom(s) and the address(es) MAY be given.

@classCode

0 … 1

F

ORG

@determinerCode

0 … 1

F

INSTANCE

hl7:id

II

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:name

ON

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:telecom

TEL

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:addr

AD

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:standardIndustryClassCode

CE

0 … 1

SHALL be chosen from domain OrganizationIndustryClass

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:asOrganizationPartOf

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@classCode

0 … 1

F

PART

hl7:id

II

0 … *

R

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:code

CE

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@codeSystem

CONF

0 … 1

F

2.16.840.1.113883.5.111 (Role Code)

hl7:statusCode

CS

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

CONF

The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.15999 RoleStatus (DYNAMIC)

hl7:effectiveTime

IVL_TS

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:wholeOrganization

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@classCode

0 … 1

F

ORG

@determinerCode

0 … 1

F

INSTANCE

hl7:id

II

0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:name

ON

0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:telecom

TEL

0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:addr

AD

0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:standardIndustryClassCode

CE

0 … 1

SHALL be chosen from domain OrganizationIndustryClass

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

Included 0 … * R from 2.16.840.1.113883.10.12.103 CDA dataEnterer (2005‑09‑07)
Transcriptionist

hl7:dataEnterer

0 … *

R

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@typeCode

0 … 1

F

ENT

@contextControlCode

0 … 1

F

OP

hl7:time

TS

0 … 1

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:assignedEntity

1 … 1

Contains 2.16.840.1.113883.10.12.153 CDA AssignedEntity (DYNAMIC)

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:informant

0 … *

R

Zero or more informant MAY be mentioned in the header of the report. An informant is either an assignedEntity (a professional participating to the healthcare process, and who was assigned a defined role in that process) or a relatedEntity (a person who knows the patient and has provided relevant information concerning the patient). Hence the condition is either assignedEntity is present or relatedEntity is present. These two elements are defined in the content module “Informant”.

Source: PaLM Suppl. APSR 2.0-3: 6.3.6.5

Contains 1.3.6.1.4.1.19376.1.8.1.4.6 CDA Informant(Header&Body) APSR2 (2016‑07‑08 11:22:58)

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

where [hl7:templateId [@root='1.3.6.1.4.1.19376.1.8.1.4.6']]

Included 1 … 1 M from 2.16.840.1.113883.10.12.104 CDA custodian (2005‑09‑07)
ClinicalDocument/custodian SHALL be present with an id in accordance with the HL7 CDA R2 standard and further constrained by this specification to require the presence of name, addr and telecom. It represents the organization that is in charge of maintaining the AP report.

hl7:custodian

1 … 1

M

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@typeCode

0 … 1

F

CST

hl7:assignedCustodian

1 … 1

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@classCode

0 … 1

F

ASSIGNED

hl7:representedCustodianOrganization

1 … 1

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@classCode

0 … 1

F

ORG

@determinerCode

0 … 1

F

INSTANCE

hl7:id

II

1 … *

M

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:name

ON

0 … 1

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:telecom

TEL

0 … 1

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:addr

AD

0 … 1

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

Included

0 … *

R

from 1.3.6.1.4.1.19376.1.3.3.1.4 XD-LAB Information Recipient (2008‑08‑08)
The Intended Recipient Content Module represents a healthcare provider,

other than the ordering physician, expecting to receive a copy of the report. This repeatable element informationRecipient of the CDA header is used to list the intended recipients who were known at the time the report was created and issued.

Source: PaLM TF-3: 6.3.2.14

hl7:informationRecipient

0 … *

R

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:templateId

II

1 … 1

M

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@root

uid

1 … 1

F

1.3.6.1.4.1.19376.1.3.3.1.4

hl7:intendedRecipient

1 … 1

R

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:id

II

0 … *

R

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:addr

AD

1 … *

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:telecom

TEL

1 … *

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:informationRecipient

0 … 1

Contains 1.3.6.1.4.1.19376.1.3.10.9.18 PlayingEntity or person with Name (DYNAMIC)

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:receivedOrganization

0 … 1

Contains 1.3.6.1.4.1.19376.1.3.10.9.13 Organization with Name, Addr, Telecom (DYNAMIC)

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

Included

1 … 1

M

from 1.3.6.1.4.1.19376.1.3.10.2.4 XD-LAB LegalAuthenticator (2016‑07‑05)
The Legal authenticator Content Module describes a pathologist having verified the content of the report, using the element legalAuthenticator.

The report SHALL have one legal Authenticator

Source: PaLM TF-3: 6.3.2.15

hl7:legalAuthenticator

1 … 1

M

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:time

TS

1 … 1

R

The sub-element time carries the date&time this legal authentication took place.

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:signatureCode

CS

1 … 1

R

The sub-element signatureCode carries the “signed” (S) status

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@code

CONF

0 … 1

F

S

hl7:assignedEntity

1 … 1

R

All persons (including the patient) and organizations mentioned in the document SHALL provide elements name, addr and telecom.

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:addr

AD

1 … *

R

Constrained by this specification to require the presence of name, addr and telecom.

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:telecom

TEL

1 … *

R

Constrained by this specification to require the presence of name, addr and telecom.

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:assignedPerson

0 … 1

All persons (including the patient) and organizations mentioned in the document SHALL provide elements name, addr and telecom.

Contains 1.3.6.1.4.1.19376.1.3.10.9.18 PlayingEntity or person with Name (DYNAMIC)

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:representedOrganization

0 … 1

All persons (including the patient) and organizations mentioned in the document SHALL provide elements name, addr and telecom.

Contains 1.3.6.1.4.1.19376.1.3.10.9.13 Organization with Name, Addr, Telecom (DYNAMIC)

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

Included

0 … *

R

from 1.3.6.1.4.1.19376.1.8.1.4.3 CDA authenticator IHE (2016‑07‑09 15:03:59)

The Content validator Content Module 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.

Source: PaLM Suppl. APSR 2.0-3: 6.3.6.3

hl7:authenticator

0 … *

R

PaLM Suppl. APSR 2.0‑3: 6.3.6.3 Content validator

@typeCode

cs

1 … 1

F

AUTHEN

hl7:templateId

1 … 1

M

PaLM Suppl. APSR 2.0‑3: 6.3.6.3 Content validator

@root

uid

1 … 1

F

1.3.6.1.4.1.19376.1.8.1.4.3

hl7:time

TS

1 … 1

R

Time of validation

PaLM Suppl. APSR 2.0‑3: 6.3.6.3 Content validator

hl7:assignedEntity

0 … 1

C

AssignedPerson SHALL be given with name, representedOrganization MAY be given.
Contains 2.16.840.1.113883.10.12.153 CDA AssignedEntity (2005‑09‑07)

PaLM Suppl. APSR 2.0‑3: 6.3.6.3 Content validator

Included

1 … 1

R

from 1.3.6.1.4.1.19376.1.3.3.1.6 Ordering Provider (2008‑08‑08)

   The Ordering Provider Content Module represents the physician who has submitted the specimen examination order to the anatomic pathology laboratory. As specified in PaLM TF-3, this physician is represented in the CDA header as a participant element with the typeCode attribute valued “REF”. The sub-element participant/time carries the date/time of issuance of the
           order.

   
Source: PaLM TF-3: 6.3.2.17

hl7:participant

1 … 1

R

Referral Ordering Physician

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@typeCode

cs

1 … 1

F

REF

hl7:templateId

II

1 … 1

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@root

uid

1 … 1

F

1.3.6.1.4.1.19376.1.3.3.1.6

hl7:time

IVL_TS

1 … 1

R

This element represents the date and time the order was placed. Time MAY be present.

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:associatedEntity

1 … 1

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:addr

AD

1 … *

R

The address of this person (referral ordering physician) SHALL be present.

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:telecom

TEL.AT

1 … *

R

The telecom of this person (referral ordering physician) SHALL be present.

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

Schematron assert role error

test not(hl7:assignedPerson) or hl7:assignedPerson/hl7:name

Message The <name> sub-element SHALL be present when <assignedPerson> present.

hl7:associatedPerson

0 … 1

R

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:scopingOrganization

0 … 1

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

Included

0 … *

R

from 1.3.6.1.4.1.19376.1.8.1.4.1 CDA Participant Specimen Collector (2016‑06‑13 14:21:13)
The Specimen Collector Content Module is only used in case a specimen

provided as input to the AP act documented in this report, was collected by a different party than the ordering physician. In that case, this specimen collector is represented in the CDA header as a participant element with the typeCode attribute valued “DIST” and the sub-element participant/time carries the time period of the specimen collection.

Source: PAT TF-3: 6.2.6.1

hl7:participant

0 … *

R

The Specimen Collector Content Module is only used in case a specimen provided as input to the AP act documented in this report, was collected by a different party than the ordering physician. In that case, this specimen collector is represented in the CDA header as a participant element with the typeCode attribute valued “DIST” and the sub-element participant/time carries the time period of the specimen collection.

PaLM Suppl. APSR 2.0‑3:6.3.6.1 Specimen collector

@typeCode

cs

1 … 1

F

DIST

hl7:templateID

II

1 … 1

M

PaLM Suppl. APSR 2.0‑3:6.3.6.1 Specimen collector

@root

uid

1 … 1

F

1.3.6.1.4.1.19376.1.8.1.4.1

hl7:time

IVL_TS

1 … 1

M

Specimen collection time

The specimen collection time is an interval, which may be reduced to a point in time (see usage of data type IVL_TS).

PaLM Suppl. APSR 2.0‑3:6.3.6.1 Specimen collector

hl7:associatedEntity

0 … 1

R

At least one of the two elements

associatedPerson and scopingOrganization must be present. Both may be present.

PaLM Suppl. APSR 2.0‑3:6.3.6.1 Specimen collector

@classCode

cs

1 … 1

F

PROV

hl7:id

II

1 … *

R

PaLM Suppl. APSR 2.0‑3:6.3.6.1 Specimen collector

hl7:addr

AD

1 … *

R

PaLM Suppl. APSR 2.0‑3:6.3.6.1 Specimen collector

hl7:telecom

TEL.AT

1 … *

R

PaLM Suppl. APSR 2.0‑3:6.3.6.1 Specimen collector

hl7:associatedPerson

0 … *

C

Person who collected the specimen.
Only full name(s) SHALL be given.
Contains 2.16.840.1.113883.10.12.152 CDA Person (2005‑09‑07)

PaLM Suppl. APSR 2.0‑3:6.3.6.1 Specimen collector

hl7:scopingOrganization

0 … 1

C

Organization taking care for specimen collection.
Identifiers, name, telecom, and address SHOULD be given.
Contains 2.16.840.1.113883.10.12.151 CDA Organization (2005‑09‑07)

PaLM Suppl. APSR 2.0‑3:6.3.6.1 Specimen collector

Included 0 … 1 R from 1.3.6.1.4.1.19376.1.3.10.2.5 CDA Participant Pertinent Insurance Information (2017‑11‑13 16:52:30)
Key insurance information of the patient

hl7:participant

0 … 1

R

Insurance information of the patient in context for reporting to cancer registries (in Germany)

PaLM Suppl. 2.0‑3:6.3.6.13

@typeCode

cs

1 … 1

F

HLD

hl7:templateId

II

1 … *

M

PaLM Suppl. 2.0‑3:6.3.6.13

@root

uid

1 … 1

F

1.3.6.1.4.1.19376.1.3.10.2.5

hl7:time

IVL_TS

0 … 1

R

time shows the end of the current insurance period, e.g. end of the quartal

PaLM Suppl. 2.0‑3:6.3.6.13

Example <time> <high value="20171231"/></time>

hl7:associatedEntity

1 … 1

M

Data of the insured person

PaLM Suppl. 2.0‑3:6.3.6.13

@classCode

cs

1 … 1

F

POLHOLD

hl7:id

II

0 … *

R

ID(s) of the insured person (patient), e.g. ID of the insured, ID of the health card, etc.

PaLM Suppl. 2.0‑3:6.3.6.13

hl7:code

CE

0 … 1

R

status of the insured person

PaLM Suppl. 2.0‑3:6.3.6.13

@codeSystem

CONF

0 … 1

F

2.16.840.1.113883.5.111 (Role Code)

Example <code code="SELF" codeSystem="2.16.840.1.113883.5.111" displayName="self"> <translation code="1" codeSystem="2.16.840.1.113883.3.7.1.1" displayName="member"/></code>

hl7:translation

CV

0 … 1

R

further codes of the status of the insured person,

e.g. for Germany from value set S_KBV_VERSICHERTENSTATUS

1.2.276.0.76.11.162

PaLM Suppl. 2.0‑3:6.3.6.13

hl7:addr

AD

0 … 1

R

PaLM Suppl. 2.0‑3:6.3.6.13

hl7:telecom

TEL

0 … *

R

PaLM Suppl. 2.0‑3:6.3.6.13

hl7:associatedPerson

0 … 1

R

Data of the insured person, which may be different from the patient.
Contains 2.16.840.1.113883.10.12.152 CDA Person (2005‑09‑07)

PaLM Suppl. 2.0‑3:6.3.6.13

hl7:scopingOrganization

1 … 1

R

Data of the Insurance company, including the ID, the address data and the name.
In Germany the ID is formed by the ID itself (@extension = so-called IKNR) and the OID for IKNR (@root="1.2.276.0.76.4.5") in Germany.
Contains 2.16.840.1.113883.10.12.151 CDA Organization (2005‑09‑07)

PaLM Suppl. 2.0‑3:6.3.6.13

hl7:inFulfillmentOf

0 … 1

R

The inFulfillmentOf/order element MAY be present. It represents the Placer Order or the Placer Group that was fulfilled, the Id of which is carried by inFulfillmentOf/order/id.

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@typeCode

cs

1 … 1

F

FLFS

hl7:order

1 … 1

M

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@classCode

cs

1 … 1

F

ACT

@moodCode

cs

1 … 1

F

RQO

hl7:id

II

1 … *

R

Placer order group ID or Placer order ID

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:documentationOf

1 … 1

M

Documented act.

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@typeCode

cs

1 … 1

F

DOC

hl7:serviceEvent

1 … 1

M

The AP report is documenting a service (documentationOf/serviceEvent) performed by a surgical pathology laboratory. The Laboratory Performer Content Module represents this laboratory, and is fully described in the sub-element

documentationOf/serviceEvent/performer.
In case more than one laboratory contributed to a service, only the primary laboratory is in the CDA header, attached to the serviceEvent element, and the other (secondary) laboratories are described only in the sections of the report that they contributed to, in the body of the report.

Source: PaLM TF3: 6.3.2.19

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@classCode

cs

1 … 1

R

@moodCode

cs

1 … 1

R

hl7:id

II

1 … *

M

ID of the Act, i.e. Accession number

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:code

CE (extensible)

0 … 1

R

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

CONF

@code shall be "PATREPE"

@codeSystem shall be "2.16.840.1.113883.5.4"

@codeSystemName shall be "HL7 ActCode"

@displayName shall be "pathology report entry task"

or

@code shall be "371528001"

@codeSystem shall be "2.16.840.1.113883.6.96"

@codeSystemName shall be "SCT"

@displayName shall be "Pathology report (record artifact)"

hl7:effectiveTime

IVL_TS

0 … 1

R

Use of sub element documentationOf/serviceEvent/effectiveTime to document the time boundaries of events in the document is appropriate.

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

ihe-lab:statusCode

CS (required)

0 … 1

R

   The statusCode below documentationOf/serviceEvent is an extension to the CDA R2 standard, added by PaLM TF-3 to distinguish a preliminary report (statusCode@code="active") from a final report (statusCode@code="completed"). 
The statusCode sub element is  further described in section A.3 of PaLM TF-3. This sub-element is required. When it is not there, the documented Act is assumed to be completed and the report is assumed to be a final report.

This extension to the standard is protected by a dedicated namespace associated in the ClinicalDocument element to the prefix lab:

<Clinical Document xmlns:lab="urn:oid:1.3.6.1.4.1.19376.1.3.2" … >

Source: PaLM TF3: 6.3.2.19

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

Constraint The statusCode@code="completed" is only applicable, if ALL content modules of the Clinical Document have the statusCode@code="completed", too, or have the statusCode@code="aborted".

CONF

The value of @code shall be drawn from value set 1.3.6.1.4.1.19376.1.3.11.4 ActStatusActiveCompleted (2008‑08‑08)

Schematron assert role error

test hl7:serviceEvent/lab:statusCode[@code='completed']

Message Status code of all Content Modules SHALL be "complete" or "aborted"

hl7:performer

0 … *

R

Contains 1.3.6.1.4.1.19376.1.3.3.1.7 Laboratory Performer (2008‑08‑08)

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

where [hl7:templateId [@root='1.3.6.1.4.1.19376.1.3.3.1.7']]

hl7:relatedDocument

0 … 1

R

ClinicalDocument/relatedDocument/parentDocument

This element SHALL be present in case of an update replacement of a previous report. In this case relatedDocument@typeCode attribute SHALL be valued "RPLC", the new report replacing the parent one.

Note 1: A non-final AP structured report published in an XDS infrastructure will likely be replaced afterwards by the final report. When this event occurs, the Content Creator Actor SHALL apply the following rules:

ClinicalDocument/setId SHALL have the same value in the new report as in the replaced report.
ClinicalDocument/versionNumber SHALL be incremented in the replacing report (i.e., the final one).
ClinicalDocument/relatedDocument@typeCode attribute SHALL be valued ”RPLC”
ClinicalDocument/relatedDocument/parentDocument/id in the new report SHALL be equal to ClinicalDocument/ id of the replaced document.

The Document Source Actor SHALL apply the following rules on XDSDocumentEntry metadata:

The final report SHALL be associated with the previously published one, using RPLC relationship and the previous report SHALL be “Deprecated” as described in ITI TF-2:4.1.6.1.

Note 2: A non-final report can also be replaced by a more recent, albeit still non-final report. The rules above also apply in this case.

Note 3: A final report can also be replaced by a corrective final report. The rules above also apply in this case.

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@typeCode

cs

1 … 1

F

RPLC

relatedDocument@typeCode attribute SHALL be valued "RPLC"

hl7:parentDocument

ANY

1 … 1

M

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:id

II

1 … 1

M

SHALL be equal to ClinicalDocument/ id of the replaced document.

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:setId

II

1 … 1

M

SHALL have the same value in the new report as in the replaced report.

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:versionNumber

INT

0 … 1

R

SHALL have the same value as in the replaced report (when provided there).

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

Included

0 … 1

R

from 2.16.840.1.113883.10.12.113 CDA componentOf (2005‑09‑07)
The ClinicalDocument/componentOf/encompassingEncounter element MAY be present.

It describes the encounter during which the reported AP observations were ordered. When present the encounter SHALL:

be identified with an id element: encompassingEncounter/id
The encounter SHALL have an effective time that represents the time interval (possibly still running, e.g., an inpatient current stay) of the encounter or a point in time at which the encounter took place (e.g., an outpatient consultation): encompassingEncounter/ effectiveTime

The encounter MAY provide any number of encounter participants (encompassingEncounter/encounterParticipant/assignedEntity). When present, encounter participants SHALL be in accordance with the HL7 CDA R2 standard with a time and further constrained by this specification to require the presence of name, addr and telecom. Additionally, the encounter participant SHALL have a typeCode with one the values selected from the x_EncounterParticipant domain: The encounter MAY precise the patient location during this encounter. This is the healthcare facility in which the patient was located when the reported AP observations were ordered: encompassingEncounter/location/healthCareFacility. This healthcare facility can be represented as a physical place (e.g., room, floor, building, office) or as an organization (e.g., service, department, team) or both: healthCareFacility/location, healthCareFacility/serviceProviderOrganization.

hl7:componentOf

0 … 1

R

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@typeCode

0 … 1

F

COMP

hl7:encompassingEncounter

1 … 1

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@classCode

0 … 1

F

ENC

@moodCode

0 … 1

F

EVN

hl7:id

II

0 … *

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:code

CE

0 … 1

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

CONF

The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.13955 ActEncounterCode (DYNAMIC)

hl7:effectiveTime

IVL_TS

1 … 1

R

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:dischargeDispositionCode

CE

0 … 1

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

CONF

shall be drawn from concept domain "EncounterDischargeDisposition"

hl7:responsibleParty

0 … 1

Contains 2.16.840.1.113883.10.12.153 CDA AssignedEntity (DYNAMIC)

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@typeCode

0 … 1

F

RESP

hl7:encounterParticipant

0 … *

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@typeCode

cs

1 … 1

R

CONF

The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19600 x_EncounterParticipant (DYNAMIC)

hl7:time

IVL_TS

0 … 1

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:assignedEntity

1 … 1

Contains 2.16.840.1.113883.10.12.153 CDA AssignedEntity (DYNAMIC)

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:location

0 … 1

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@typeCode

0 … 1

F

LOC

hl7:healthCareFacility

1 … 1

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@classCode

0 … 1

F

SDLOC

hl7:id

II

0 … *

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:code

CE

0 … 1

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

CONF

The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.17660 ServiceDeliveryLocationRoleType (DYNAMIC)

hl7:location

0 … 1

Contains 2.16.840.1.113883.10.12.317 CDA Place (DYNAMIC)

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:serviceProviderOrganization

0 … 1

Contains 2.16.840.1.113883.10.12.151 CDA Organization (DYNAMIC)

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

hl7:component

1 … 1

R

Body of the CDA Clinical document

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@typeCode

cs

1 … 1

F

COMP

@contextConductionInd

bl

1 … 1

F

true

hl7:structuredBody

1 … 1

R

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

@classCode

cs

1 … 1

F

DOCBODY

@moodCode

cs

1 … 1

F

EVN

hl7:component

0 … 1

R

The Clinical Information section contains the information provided by the ordering physician: Clinical history, preoperative diagnosis, postoperative diagnosis, clinical laboratory data, specimen(s) description, collection procedure, reason for anatomic pathology procedure.
Contains 1.3.6.1.4.1.19376.1.8.1.2.1 Clinical Information Section (2014‑05‑13 14:38:08)

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

where [@typeCode='COMP'] [hl7:section [hl7:templateId [@root='1.3.6.1.4.1.19376.1.8.1.2.1']]]

@typeCode

cs

1 … 1

F

COMP

@contextConductionInd

bl

1 … 1

F

true

hl7:component

0 … 1

R

Contains 1.3.6.1.4.1.19376.1.8.1.2.2 Intraoperative Observation Section (2014‑05‑13 19:29:16)

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

where [@typeCode='COMP'] [hl7:section [hl7:templateId [@root='1.3.6.1.4.1.19376.1.8.1.2.2']]]

@typeCode

cs

1 … 1

F

COMP

@contextConductionInd

bl

1 … 1

F

true

hl7:component

0 … 1

R

The Macroscopic Observation section contains the description of the specimen 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.
Contains 1.3.6.1.4.1.19376.1.8.1.2.3 Macroscopic Observation Section (2014‑05‑13 11:57:09)

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

where [@typeCode='COMP'] [hl7:section [hl7:templateId [@root='1.3.6.1.4.1.19376.1.8.1.2.3']]]

@typeCode

cs

1 … 1

F

COMP

@contextConductionInd

bl

1 … 1

F

true

hl7:component

0 … 1

R

   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.

Contains 1.3.6.1.4.1.19376.1.8.1.2.4 Microscopic Observation Section (2014‑05‑13 14:25:17)

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

where [@typeCode='COMP'] [hl7:section [hl7:templateId [@root='1.3.6.1.4.1.19376.1.8.1.2.4']]]

@typeCode

cs

1 … 1

F

COMP

@contextConductionInd

bl

1 … 1

F

true

hl7:component

0 … 1

R

The Additional Specific Observation section includes additional pathologic finding(s) and the results of ancillary study(ies) with non-morphological methods (e.g. flow cytometry, cytogenetics, molecular pathology, etc.) and may include diagrams and still images or virtual slides, if taken.

Contains 1.3.6.1.4.1.19376.1.3.10.3.1 Additional Specified Observation Section (2016‑11‑13 14:28:08)

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

where [@typeCode='COMP'] [hl7:section [hl7:templateId [@root='1.3.6.1.4.1.19376.1.3.10.3.1']]]

@typeCode

cs

1 … 1

F

COMP

@contextConductionInd

bl

1 … 1

F

true

hl7:component

1 … 1

M

   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.

Contains 1.3.6.1.4.1.19376.1.8.1.2.5 Diagnostic Conclusion Section (2014‑05‑13 19:31:26)

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

where [@typeCode='COMP'] [hl7:section [hl7:templateId [@root='1.3.6.1.4.1.19376.1.8.1.2.5']]]

@typeCode

cs

1 … 1

F

COMP

@contextConductionInd

bl

1 … 1

F

true

hl7:component

0 … 1

R

   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.

Contains 1.3.6.1.4.1.19376.1.8.1.2.6 Procedure Steps Section (2014‑05‑13 19:33:12)

PaLM Suppl. APSR 2.0‑3: 6.3.1.1 APSR clinical document content module

where [@typeCode='COMP'] [hl7:section [hl7:templateId [@root='1.3.6.1.4.1.19376.1.8.1.2.6']]]

@typeCode

cs

1 … 1

F

COMP

@contextConductionInd

bl

1 … 1

F

true

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.

Id 1.3.6.1.4.1.19376.1.8.1.2.1 Effective Date valid from 2014‑05‑13 14:38:08

Status Draft Version Label 2.0

Name ClinicalInformationSection Display Name Clinical Information Section

Description

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, information about specimens collected in this case (including target site, performer, specimen type, specimen(s) clinical description, and tumor site in case of a cancer).

Context Parent nodes of template element with id 1.3.6.1.4.1.19376.1.8.1.2.1

Label PaLM Suppl. 2.0‑3: 6.3.4.1 Clinical information section

Classification CDA Section Level Template

Open/Closed Open (other than defined elements are allowed)

Used by / Uses

Used by 0 transactions and 1 template, Uses 5 templates

Used by	as	Name	Version
1.3.6.1.4.1.19376.1.8.1.1.1	Containment	Anatomic Pathology Structured Report Content Module (2.0)	2014‑05‑13 11:57:57
Uses	as	Name	Version
1.3.6.1.4.1.19376.1.8.1.3.6	Containment	Problem Organizer (2.0)	2015‑08‑13 10:24:55
1.3.6.1.4.1.19376.1.8.1.4.2	Include	CDA author IHE	2016‑06‑21 14:02:11
1.3.6.1.4.1.19376.1.5.3.1.3.1	Containment	IHE Reason for Referral Section (2014)	2016‑09‑26 07:58:18
1.3.6.1.4.1.19376.1.5.3.1.3.4	Containment	IHE History of Present Illness Section (2014)	2013‑01‑31
1.3.6.1.4.1.19376.1.5.3.1.3.6	Containment	IHE Active Problems Section (2014)	2015‑10‑05 16:02:07

Relationship Specialization: template 2.16.840.1.113883.10.12.201 (2005‑09‑07)

Example

generated example

<section classCode="DOCSECT" moodCode="EVN"> <templateId root="1.3.6.1.4.1.19376.1.8.1.2.1"/> <code code="22636-5" codeSystem="2.16.840.1.113883.6.1" displayName="Pathology report relevant history"/> <title>CLINICAL INFORMATION SECTION</title> <text/> <languageCode/> <entry xsi:type="ANY" typeCode="COMP" contextConductionInd="true">  </entry>  <component>  </component> <component>  </component> <component>  </component></section>

Item DT Card Conf Description Label

hl7:section

0 … 1

R

PaLM Suppl. 2.0‑3: 6.3.4.1 Clinical information section

@classCode

cs

0 … 1

F

DOCSECT

@moodCode

cs

0 … 1

F

EVN

Constraint

   This section SHALL contain a code element populated with these attributes:

@code="22636-5"

@codeSystem="'2.16.840.1.113883.6.1"

@displayName=" Pathology report relevant history”

This section SHALL contain a narrative block, represented by a text element, which renders the information to the human reader.

The section SHOULD contain as many Problem Organizer entry elements as there are problems (or groups thereof) to be described. These entries provide the machine-readable data corresponding to the narrative block.

This section MAY contain a number of elements component/section introducing sub-sections, each of these sub-sections providing a particular type of clinical information.

This section SHOULD contain author elements in case the authors of this section differ from those declared at a higher level in the document.

hl7:templateId

II

1 … 1

R

PaLM Suppl. 2.0‑3: 6.3.4.1 Clinical information section

@root

uid

1 … 1

F

1.3.6.1.4.1.19376.1.8.1.2.1

hl7:code

CE

1 … 1

M

PaLM Suppl. 2.0‑3: 6.3.4.1 Clinical information section

@code

CONF

1 … 1

F

22636-5

@codeSystem

1 … 1

F

2.16.840.1.113883.6.1 (Logical Observation Identifier Names and Codes)

@codeSystemName

1 … 1

F

LOINC

@displayName

1 … 1

F

Pathology report relevant history

hl7:title

ST

1 … 1

R

PaLM Suppl. 2.0‑3: 6.3.4.1 Clinical information section

CONF

element content shall be "CLINICAL INFORMATION SECTION"

Example <title>CLINICAL INFORMATION</title>

hl7:text

SD.TEXT

1 … 1

M

PaLM Suppl. 2.0‑3: 6.3.4.1 Clinical information section

Example <text> Tissue submitted: left breast biopsy and apical axillary tissue </text>

hl7:languageCode

CS

0 … 1

PaLM Suppl. 2.0‑3: 6.3.4.1 Clinical information section

CONF

The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.11526 HumanLanguage (2014‑03‑26)

hl7:entry

ANY

0 … *

R

Problem organizer
Contains 1.3.6.1.4.1.19376.1.8.1.3.6 Problem Organizer (2015‑08‑13 10:24:55)

PaLM Suppl. 2.0‑3: 6.3.4.1 Clinical information section

where [hl7:organizer [hl7:templateId [@root='1.3.6.1.4.1.19376.1.8.1.3.6']]]

@typeCode

cs

0 … 1

F

COMP

@contextConductionInd

bl

0 … 1

F

true

Included 0 … * C from 1.3.6.1.4.1.19376.1.8.1.4.2 CDA author IHE (2016‑06‑21 14:02:11)
Source: PaLM Suppl. APSR 2.0-3: 6.3.6.2

hl7:author

0 … *

C

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@typeCode

cs

1 … 1

F

AUT

Example

author is a person

<author typeCode="AUT" contextControlCode="OP"> <time value="201306101654"/> <assignedAuthor classCode="ASSIGNED">  </assignedAuthor></author>

hl7:templateId

1 … 1

M

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@root

uid

1 … 1

F

1.3.6.1.4.1.19376.1.8.1.4.2

hl7:time

TS

1 … 1

M

The authoring time is the date & time that this author contributed to the document. It SHALL be provided.

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:assignedAuthor

0 … 1

C

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@classCode

cs

0 … 1

F

ASSIGNED

hl7:id

II

1 … *

M

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:addr

AD

1 … *

M

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:telecom

TEL

1 … *

M

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

Choice

1 … 1

The author is either an assigned person or an authoring device.

Elements to choose from:

hl7:assignedPerson
hl7:assignedAuthoringDevice

hl7:assignedPerson

0 … 1

C

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

Included 0 … * from 2.16.840.1.113883.10.12.152 CDA Person (2005‑09‑07)
The name(s) SHALL be given.

@classCode

0 … 1

F

PSN

@determinerCode

0 … 1

F

INSTANCE

hl7:name

PN

0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:assignedAuthoringDevice

0 … 1

C

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@classCode

cs

0 … 1

F

DEV

@determinerCode

cs

0 … 1

F

INSTANCE

hl7:manufacturerModelName

SC

0 … 1

R

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:softwareName

SC

0 … 1

R

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:code

CE

0 … 1

R

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:representedOrganization

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

Example

represented organization for author as a device

<representedOrganization classCode="ORG" determinerCode="INSTANCE"> <name>  </name></representedOrganization>

Included 0 … 1 from 2.16.840.1.113883.10.12.151 CDA Organization (2005‑09‑07)
The identifier(s) SHOULD, the name SHALL, the telecom(s) and the address(es) MAY be given.

@classCode

0 … 1

F

ORG

@determinerCode

0 … 1

F

INSTANCE

hl7:id

II

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:name

ON

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:telecom

TEL

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:addr

AD

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:standardIndustryClassCode

CE

0 … 1

SHALL be chosen from domain OrganizationIndustryClass

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:asOrganizationPartOf

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@classCode

0 … 1

F

PART

hl7:id

II

0 … *

R

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:code

CE

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@codeSystem

CONF

0 … 1

F

2.16.840.1.113883.5.111 (Role Code)

hl7:statusCode

CS

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

CONF

The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.15999 RoleStatus (DYNAMIC)

hl7:effectiveTime

IVL_TS

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:wholeOrganization

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@classCode

0 … 1

F

ORG

@determinerCode

0 … 1

F

INSTANCE

hl7:id

II

0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:name

ON

0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:telecom

TEL

0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:addr

AD

0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:standardIndustryClassCode

CE

0 … 1

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:component

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Subsection

Source: PCC TF-2: 6.3.3.1.1
Contains 1.3.6.1.4.1.19376.1.5.3.1.3.1 IHE Reason for Referral Section (2016‑09‑26 07:58:18)

PaLM Suppl. 2.0‑3: 6.3.4.1 Clinical information section

where [hl7:section [hl7:templateId [@root='1.3.6.1.4.1.19376.1.5.3.1.3.1']]]

hl7:component

0 … 1

Subsection

Source: PCC TF-2: 6.3.3.2.1
Contains 1.3.6.1.4.1.19376.1.5.3.1.3.4 IHE History of Present Illness Section (2013‑01‑31)

PaLM Suppl. 2.0‑3: 6.3.4.1 Clinical information section

where [hl7:section [hl7:templateId [@root='1.3.6.1.4.1.19376.1.5.3.1.3.4']]]

hl7:component

0 … 1

Subsection

Source: PCC TF-2: 6.3.3.2.3
Contains 1.3.6.1.4.1.19376.1.5.3.1.3.6 IHE Active Problems Section (2015‑10‑05 16:02:07)

PaLM Suppl. 2.0‑3: 6.3.4.1 Clinical information section

where [hl7:section [hl7:templateId [@root='1.3.6.1.4.1.19376.1.5.3.1.3.6'] and hl7:templateId [@root='2.16.840.1.113883.10.20.1.11']]]

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).

Id 1.3.6.1.4.1.19376.1.8.1.2.2 Effective Date valid from 2014‑05‑13 19:29:16

Status Draft Version Label 2.0

Name IntraoperativeObservationSection Display Name Intraoperative Observation Section

Description

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).

Context Parent nodes of template element with id 1.3.6.1.4.1.19376.1.8.1.2.2

Label PaLM Suppl. 2.0‑3: 6.3.4.2 Intraoperative observation section

Classification CDA Section Level Template

Open/Closed Open (other than defined elements are allowed)

Used by / Uses

Used by 0 transactions and 1 template, Uses 2 templates

Used by	as	Name	Version
1.3.6.1.4.1.19376.1.8.1.1.1	Containment	Anatomic Pathology Structured Report Content Module (2.0)	2014‑05‑13 11:57:57
Uses	as	Name	Version
1.3.6.1.4.1.19376.1.8.1.4.2	Include	CDA author IHE	2016‑06‑21 14:02:11
1.3.6.1.4.1.19376.1.8.1.3.6	Containment	Problem Organizer (2.0)	2015‑08‑13 10:24:55

Relationship Specialization: template 2.16.840.1.113883.10.12.201 (2005‑09‑07)

Example

generated example

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hl7:section

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PaLM Suppl. 2.0‑3: 6.3.4.2 Intraoperative observation section

@classCode

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EVN

Constraint

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The section SHOULD contain as many Problem Organizer entry elements as there are problems or groups thereof observed. These entries provide the machine-readable data corresponding to the narrative block.

This section does not contain any subsection.

This section SHOULD contain author elements in case the authors of this section differ from those declared at a higher level in the document.

hl7:templateId

II

1 … 1

R

PaLM Suppl. 2.0‑3: 6.3.4.2 Intraoperative observation section

@root

uid

1 … 1

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1.3.6.1.4.1.19376.1.8.1.2.2

hl7:code

CE

1 … 1

M

PaLM Suppl. 2.0‑3: 6.3.4.2 Intraoperative observation section

@code

CONF

1 … 1

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83321-0

@codeSystem

1 … 1

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2.16.840.1.113883.6.1 (Logical Observation Identifier Names and Codes)

@codeSystemName

1 … 1

F

LOINC

@displayName

1 … 1

F

Pathology report intraoperative observation in Specimen Document

hl7:title

ST

1 … 1

R

PaLM Suppl. 2.0‑3: 6.3.4.2 Intraoperative observation section

CONF

element content shall be "INTRAOPERATIVE OBSERVATION SECTION"

hl7:text

SD.TEXT

1 … 1

M

PaLM Suppl. 2.0‑3: 6.3.4.2 Intraoperative observation section

Example

Intraoperative observation

<text>Frozen section diagnosis of infiltrating duct carcinoma, left breast</text>

hl7:languageCode

CS

0 … 1

PaLM Suppl. 2.0‑3: 6.3.4.2 Intraoperative observation section

CONF

The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.11526 HumanLanguage (2014‑03‑26)

Included

0 … *

C

from 1.3.6.1.4.1.19376.1.8.1.4.2 CDA author IHE (2016‑06‑21 14:02:11)
Author
Source: PaLM Suppl. APSR 2.0-3:

6.2.6.2

hl7:author

0 … *

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@typeCode

cs

1 … 1

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AUT

Example

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hl7:templateId

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M

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@root

uid

1 … 1

F

1.3.6.1.4.1.19376.1.8.1.4.2

hl7:time

TS

1 … 1

M

The authoring time is the date & time that this author contributed to the document. It SHALL be provided.

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:assignedAuthor

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:telecom

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

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Elements to choose from:

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hl7:assignedPerson

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

Included 0 … * from 2.16.840.1.113883.10.12.152 CDA Person (2005‑09‑07)
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@classCode

0 … 1

F

PSN

@determinerCode

0 … 1

F

INSTANCE

hl7:name

PN

0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:assignedAuthoringDevice

0 … 1

C

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@classCode

cs

0 … 1

F

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@determinerCode

cs

0 … 1

F

INSTANCE

hl7:manufacturerModelName

SC

0 … 1

R

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:softwareName

SC

0 … 1

R

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:code

CE

0 … 1

R

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:representedOrganization

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

Example

represented organization for author as a device

<representedOrganization classCode="ORG" determinerCode="INSTANCE"> <name>  </name></representedOrganization>

Included 0 … 1 from 2.16.840.1.113883.10.12.151 CDA Organization (2005‑09‑07)
The identifier(s) SHOULD, the name SHALL, the telecom(s) and the address(es) MAY be given.

@classCode

0 … 1

F

ORG

@determinerCode

0 … 1

F

INSTANCE

hl7:id

II

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:name

ON

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:telecom

TEL

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:addr

AD

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:standardIndustryClassCode

CE

0 … 1

SHALL be chosen from domain OrganizationIndustryClass

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:asOrganizationPartOf

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@classCode

0 … 1

F

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hl7:id

II

0 … *

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:code

CE

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@codeSystem

CONF

0 … 1

F

2.16.840.1.113883.5.111 (Role Code)

hl7:statusCode

CS

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

CONF

The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.15999 RoleStatus (DYNAMIC)

hl7:effectiveTime

IVL_TS

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:name

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0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:telecom

TEL

0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:addr

AD

0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:standardIndustryClassCode

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0 … 1

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:entry

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R

Source: PAT TF-3:6.2.6.8

Contains 1.3.6.1.4.1.19376.1.8.1.3.6 Problem Organizer (2015‑08‑13 10:24:55)

PaLM Suppl. 2.0‑3: 6.3.4.2 Intraoperative observation section

where [@typeCode='COMP'] [hl7:organizer [hl7:templateId [@root='1.3.6.1.4.1.19376.1.8.1.3.6']]]

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true

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.

Id 1.3.6.1.4.1.19376.1.8.1.2.3 Effective Date valid from 2014‑05‑13 11:57:09

Status Draft Version Label 2.0

Name MacroscopySection Display Name Macroscopic Observation Section

Description

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.

Context Parent nodes of template element with id 1.3.6.1.4.1.19376.1.8.1.2.3

Label PaLM Suppl. 2.0‑3: 6.3.4.3 Macroscopic observation section

Classification CDA Section Level Template

Open/Closed Open (other than defined elements are allowed)

Used by / Uses

Used by 0 transactions and 1 template, Uses 2 templates

Used by	as	Name	Version
1.3.6.1.4.1.19376.1.8.1.1.1	Containment	Anatomic Pathology Structured Report Content Module (2.0)	2014‑05‑13 11:57:57
Uses	as	Name	Version
1.3.6.1.4.1.19376.1.8.1.4.2	Include	CDA author IHE	2016‑06‑21 14:02:11
1.3.6.1.4.1.19376.1.8.1.3.6	Containment	Problem Organizer (2.0)	2015‑08‑13 10:24:55

Relationship Specialization: template 2.16.840.1.113883.10.12.201 (2005‑09‑07)

Example

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Item DT Card Conf Description Label

hl7:section

0 … 1

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Constraint

   This section SHALL contain a code element populated with these attributes:

@code ="22634-0"

@codeSystem ="2.16.840.1.113883.6.1"

@displayName ="Pathology report gross observation"

This section does not contain any subsection. The section SHALL contain a narrative block, represented by a text element, which renders the information to the human reader.

The section SHOULD contain as many Problem Organizer entry elements as there are problems or groups thereof to be described. These entries provide the machine-readable data corresponding to the narrative block.

This section SHOULD contain author elements in case the authors of this section differ from those declared at a higher level in the document.

hl7:templateId

II

1 … 1

M

PaLM Suppl. 2.0‑3: 6.3.4.3 Macroscopic observation section

@root

uid

1 … 1

F

1.3.6.1.4.1.19376.1.8.1.2.3

hl7:code

CE

1 … 1

M

PaLM Suppl. 2.0‑3: 6.3.4.3 Macroscopic observation section

@code

CONF

1 … 1

F

22634-0

@codeSystem

1 … 1

F

2.16.840.1.113883.6.1 (Logical Observation Identifier Names and Codes)

@codeSystemName

1 … 1

F

LOINC

@displayName

1 … 1

F

Pathology report gross observation

hl7:title

ST

1 … 1

R

PaLM Suppl. 2.0‑3: 6.3.4.3 Macroscopic observation section

CONF

element content shall be "MACROSCOPIC OBSERVATION SECTION"

Example <title>Macroscopic Observation</title>

hl7:text

SD.TEXT

1 … 1

M

PaLM Suppl. 2.0‑3: 6.3.4.3 Macroscopic observation section

Example

example for use case #1

<text>A. "RIGHT BREAST FIVE CORES 8-9:00" (ULTRASOUND GUIDED NEEDLE CORE BIOPSY)</text>

Included

0 … *

C

from 1.3.6.1.4.1.19376.1.8.1.4.2 CDA author IHE (2016‑06‑21 14:02:11)
Author

Source: PaLM Suppl. APSR 2.0-3: 6.3.6.2

hl7:author

0 … *

C

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@typeCode

cs

1 … 1

F

AUT

Example

author is a person

<author typeCode="AUT" contextControlCode="OP"> <time value="201306101654"/> <assignedAuthor classCode="ASSIGNED">  </assignedAuthor></author>

hl7:templateId

1 … 1

M

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@root

uid

1 … 1

F

1.3.6.1.4.1.19376.1.8.1.4.2

hl7:time

TS

1 … 1

M

The authoring time is the date & time that this author contributed to the document. It SHALL be provided.

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:assignedAuthor

0 … 1

C

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@classCode

cs

0 … 1

F

ASSIGNED

hl7:id

II

1 … *

M

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:addr

AD

1 … *

M

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:telecom

TEL

1 … *

M

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

Choice

1 … 1

The author is either an assigned person or an authoring device.

Elements to choose from:

hl7:assignedPerson
hl7:assignedAuthoringDevice

hl7:assignedPerson

0 … 1

C

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

Included 0 … * from 2.16.840.1.113883.10.12.152 CDA Person (2005‑09‑07)
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@classCode

0 … 1

F

PSN

@determinerCode

0 … 1

F

INSTANCE

hl7:name

PN

0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:assignedAuthoringDevice

0 … 1

C

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@classCode

cs

0 … 1

F

DEV

@determinerCode

cs

0 … 1

F

INSTANCE

hl7:manufacturerModelName

SC

0 … 1

R

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:softwareName

SC

0 … 1

R

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:code

CE

0 … 1

R

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:representedOrganization

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

Example

represented organization for author as a device

<representedOrganization classCode="ORG" determinerCode="INSTANCE"> <name>  </name></representedOrganization>

Included 0 … 1 from 2.16.840.1.113883.10.12.151 CDA Organization (2005‑09‑07)
The identifier(s) SHOULD, the name SHALL, the telecom(s) and the address(es) MAY be given.

@classCode

0 … 1

F

ORG

@determinerCode

0 … 1

F

INSTANCE

hl7:id

II

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:name

ON

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:telecom

TEL

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:addr

AD

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:standardIndustryClassCode

CE

0 … 1

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:asOrganizationPartOf

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@classCode

0 … 1

F

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hl7:id

II

0 … *

R

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:code

CE

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@codeSystem

CONF

0 … 1

F

2.16.840.1.113883.5.111 (Role Code)

hl7:statusCode

CS

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

CONF

The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.15999 RoleStatus (DYNAMIC)

hl7:effectiveTime

IVL_TS

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:wholeOrganization

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@classCode

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@determinerCode

0 … 1

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0 … *

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0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:telecom

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0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:addr

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0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:standardIndustryClassCode

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0 … 1

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:entry

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Source: PaLM Suppl. APSR 2.0-3: 6.2.5.2
Contains 1.3.6.1.4.1.19376.1.8.1.3.6 Problem Organizer (2015‑08‑13 10:24:55)

PaLM Suppl. 2.0‑3: 6.3.4.3 Macroscopic observation section

where [@typeCode='COMP'] [hl7:organizer [hl7:templateId [@root='1.3.6.1.4.1.19376.1.8.1.3.6']]]

@typeCode

cs

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@contextConductionInd

bl

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true

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.

Id 1.3.6.1.4.1.19376.1.8.1.2.4 Effective Date valid from 2014‑05‑13 14:25:17

Status Draft Version Label 2.0

Name MicroscopySection Display Name Microscopic Observation Section

Description

The Microscopic Observation section contains optionally the histopathologic findings of the case and of all of the derived specimens. This section should be used to record the results of histochemical and immunohistochemical stains and of image-based molecular methods.

Context Parent nodes of template element with id 1.3.6.1.4.1.19376.1.8.1.2.4

Label PaLM Suppl. 2.0‑3: 6.3.4.4 Microscopic observation section

Classification CDA Section Level Template

Open/Closed Open (other than defined elements are allowed)

Used by / Uses

Used by 0 transactions and 1 template, Uses 2 templates

Used by	as	Name	Version
1.3.6.1.4.1.19376.1.8.1.1.1	Containment	Anatomic Pathology Structured Report Content Module (2.0)	2014‑05‑13 11:57:57
Uses	as	Name	Version
1.3.6.1.4.1.19376.1.8.1.4.2	Include	CDA author IHE	2016‑06‑21 14:02:11
1.3.6.1.4.1.19376.1.8.1.3.6	Containment	Problem Organizer (2.0)	2015‑08‑13 10:24:55

Relationship Specialization: template 2.16.840.1.113883.10.12.201 (2005‑09‑07)

Example

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Item DT Card Conf Description Label

hl7:section

0 … 1

R

PaLM Suppl. 2.0‑3: 6.3.4.4 Microscopic observation section

Constraint

   This section SHALL contain a code element populated with these attributes:

@code ="22635-7"

@codeSystem ="2.16.840.1.113883.6.1"

@displayName ="Pathology report microscopic observation"

This section SHALL contain a narrative block, represented by a text element, which renders the information to the human reader.

The section SHOULD contain as many Problem Organizer entry elements as there are problems or groups thereof to be described. These entries provide the machine-readable data corresponding to the narrative block.

This section SHOULD contain author elements in case the authors of this section differ from those declared at a higher level in the document.

This section does not contain any subsections.

hl7:templateId

II

1 … 1

M

PaLM Suppl. 2.0‑3: 6.3.4.4 Microscopic observation section

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uid

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1.3.6.1.4.1.19376.1.8.1.2.4

hl7:code

CE

1 … 1

M

PaLM Suppl. 2.0‑3: 6.3.4.4 Microscopic observation section

@code

CONF

1 … 1

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22635-7

@codeSystem

1 … 1

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2.16.840.1.113883.6.1 (Logical Observation Identifier Names and Codes)

@codeSystemName

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LOINC

@displayName

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hl7:title

ST

1 … 1

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PaLM Suppl. 2.0‑3: 6.3.4.4 Microscopic observation section

CONF

element content shall be "MICROSCOPIC OBSERVATION SECTION"

Example <title>MICROSCOPIC OBSERVATION SECTION</title>

hl7:text

SD.TEXT

1 … 1

M

PaLM Suppl. 2.0‑3: 6.3.4.4 Microscopic observation section

Example

example from use case#1

<text> INVASIVE ADENOCARCINOMA OF THE BREAST. <br/> HISTOLOGIC TYPE: DUCTAL. <br/> NOTTINGHAM COMBINED HISTOLOGIC GRADE: 1 OF 3. <list> <item>TUBULE FORMATION SCORE: 2.</item> <item>NUCLEAR PLEOMORPHISM SCORE: 2.</item> <item>MITOTIC RATE SCORE: 1.</item> </list> IN-SITU CARCINOMA: EQUIVOCAL. <br/> <br/> BREAST CANCER BIOMARKER STUDIES: <list> <item>PARAFFIN BLOCK NUMBER: A1.</item> <item>ER INTERPRETATION: POSITIVE ESTROGEN RECEPTOR ACTIVITY (ALLRED SCORE = 8, Allred Percentage Score = 5, Allred Staining Score = 3).</item> <item>PR INTERPRETATION: POSITIVE PROGESTERONE RECEPTOR ACTIVITY (ALLRED SCORE = 8).</item> <item>DAKO EGFR PHARMDX IMMUNOHISTOCHEMISTRY: NEGATIVE (0) FOR EXPRESSION OF EPIDERMAL GROWTH FACTOR RECEPTOR.</item> <item>HER2/NEU IMMUNOHISTOCHEMISTRY: EQUIVOCAL (2+) FOR OVEREXPRESSION OF HER2/NEU ONCOPROTEIN.</item> <item>HER2/NEU FISH RESULTS: NOT AMPLIFIED.</item> </list></text>

Included

0 … *

C

from 1.3.6.1.4.1.19376.1.8.1.4.2 CDA author IHE (2016‑06‑21 14:02:11)
Author

Source: PaLM Suppl. APSR 2.0-3: 6.3.6.2

hl7:author

0 … *

C

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@typeCode

cs

1 … 1

F

AUT

Example

author is a person

<author typeCode="AUT" contextControlCode="OP"> <time value="201306101654"/> <assignedAuthor classCode="ASSIGNED">  </assignedAuthor></author>

hl7:templateId

1 … 1

M

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@root

uid

1 … 1

F

1.3.6.1.4.1.19376.1.8.1.4.2

hl7:time

TS

1 … 1

M

The authoring time is the date & time that this author contributed to the document. It SHALL be provided.

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:assignedAuthor

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C

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

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cs

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ASSIGNED

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II

1 … *

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:addr

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1 … *

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:telecom

TEL

1 … *

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

Choice

1 … 1

The author is either an assigned person or an authoring device.

Elements to choose from:

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hl7:assignedAuthoringDevice

hl7:assignedPerson

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C

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

Included 0 … * from 2.16.840.1.113883.10.12.152 CDA Person (2005‑09‑07)
The name(s) SHALL be given.

@classCode

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INSTANCE

hl7:name

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

Example

represented organization for author as a device

<representedOrganization classCode="ORG" determinerCode="INSTANCE"> <name>  </name></representedOrganization>

Included 0 … 1 from 2.16.840.1.113883.10.12.151 CDA Organization (2005‑09‑07)
The identifier(s) SHOULD, the name SHALL, the telecom(s) and the address(es) MAY be given.

@classCode

0 … 1

F

ORG

@determinerCode

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INSTANCE

hl7:id

II

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

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The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.15999 RoleStatus (DYNAMIC)

hl7:effectiveTime

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:addr

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

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Problem organizer entry

Source: PaLM Suppl. APSR 2.0-3:

6.2.5.2
Contains 1.3.6.1.4.1.19376.1.8.1.3.6 Problem Organizer (2015‑08‑13 10:24:55)

PaLM Suppl. 2.0‑3: 6.3.4.4 Microscopic observation section

where [@typeCode='COMP'] [hl7:organizer [hl7:templateId [@root='1.3.6.1.4.1.19376.1.8.1.3.6']]]

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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.

Id 1.3.6.1.4.1.19376.1.8.1.2.5 Effective Date valid from 2014‑05‑13 19:31:26

Status Draft Version Label 2.0

Name DiagnosticConclusionSection Display Name Diagnostic Conclusion Section

Description

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.

Context Parent nodes of template element with id 1.3.6.1.4.1.19376.1.8.1.2.5

Label PaLM Suppl. 2.0‑3: 6.3.4.6 Diagnostic conclusion section

Classification CDA Section Level Template

Open/Closed Open (other than defined elements are allowed)

Used by / Uses

Used by 0 transactions and 1 template, Uses 3 templates

Used by	as	Name	Version
1.3.6.1.4.1.19376.1.8.1.1.1	Containment	Anatomic Pathology Structured Report Content Module (2.0)	2014‑05‑13 11:57:57
Uses	as	Name	Version
1.3.6.1.4.1.19376.1.8.1.4.2	Include	CDA author IHE	2016‑06‑21 14:02:11
1.3.6.1.4.1.19376.1.3.10.4.5	Containment	CDA Update Information Organizer (2.0)	2017‑11‑14 15:22:14
1.3.6.1.4.1.19376.1.8.1.3.6	Containment	Problem Organizer (2.0)	2015‑08‑13 10:24:55

Relationship Specialization: template 2.16.840.1.113883.10.12.201 (2005‑09‑07)

Example

generated example

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Item DT Card Conf Description Label

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PaLM Suppl. 2.0‑3: 6.3.4.6 Diagnostic conclusion section

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DOCSECT

@moodCode

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EVN

Constraint

         This section SHALL contain a code element populated with these attributes:

@code ="22637-3"

@codeSystem ="2.16.840.1.113883.6.1"

@displayName ="Pathology report diagnosis"

This section SHALL contain a narrative block, represented by a text element, which renders the information to the human reader.

The section SHALL contain as many Problem Organizer entry elements as there are problems or groups thereof investigated. Each entry provides machine-readable data.

This section SHOULD contain author elements in case the authors of this section differ from those declared at a higher level in the document.

hl7:templateId

II

1 … 1

M

PaLM Suppl. 2.0‑3: 6.3.4.6 Diagnostic conclusion section

@root

uid

1 … 1

F

1.3.6.1.4.1.19376.1.8.1.2.5

hl7:code

CE

1 … 1

M

PaLM Suppl. 2.0‑3: 6.3.4.6 Diagnostic conclusion section

@code

CONF

1 … 1

F

22637-3

@codeSystem

1 … 1

F

2.16.840.1.113883.6.1 (Logical Observation Identifier Names and Codes)

@codeSystemName

1 … 1

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LOINC

@displayName

1 … 1

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'Pathology report diagnosis

hl7:title

ST

1 … 1

R

PaLM Suppl. 2.0‑3: 6.3.4.6 Diagnostic conclusion section

CONF

element content shall be "DIAGNOSTIC CONCLUSION SECTION"

hl7:text

SD.TEXT

1 … 1

M

PaLM Suppl. 2.0‑3: 6.3.4.6 Diagnostic conclusion section

Example

example for use case#1

<text> <paragraph> A1. "RIGHT BREAST FIVE CORES 8-9:00" (ULTRASOUND GUIDED NEEDLE CORE BIOPSY) </paragraph> INVASIVE ADENOCARCINOMA OF THE BREAST. <br/> HISTOLOGIC TYPE: DUCTAL. <br/> NOTTINGHAM COMBINED HISTOLOGIC GRADE: 1 OF 3. <list> <item>TUBULE FORMATION SCORE: 2.</item> <item>NUCLEAR PLEOMORPHISM SCORE: 2.</item> <item>MITOTIC RATE SCORE: 1.</item> </list> ICD-O-CLASSIFICATION: C50.3 M8500/31 <br/> IN-SITU CARCINOMA: EQUIVOCAL. <br/> <br/> BREAST CANCER BIOMARKER STUDIES: <list> <item>PARAFFIN BLOCK NUMBER: A1.</item> <item>ER INTERPRETATION: POSITIVE ESTROGEN RECEPTOR ACTIVITY (ALLRED SCORE = 8, Percentage stained tumor cells = 85%, Allred Staining Score = 3).</item> <item>PR INTERPRETATION: POSITIVE PROGESTERONE RECEPTOR ACTIVITY (ALLRED SCORE = 8).</item> <item>DAKO EGFR PHARMDX IMMUNOHISTOCHEMISTRY: NEGATIVE (0) FOR EXPRESSION OF EPIDERMAL GROWTH FACTOR RECEPTOR.</item> <item>HER2/NEU IMMUNOHISTOCHEMISTRY: EQUIVOCAL (2+) FOR OVEREXPRESSION OF HER2/NEU ONCOPROTEIN.</item> <item>HER2/NEU FISH RESULTS: NOT AMPLIFIED.</item> </list></text>

Included

0 … *

C

from 1.3.6.1.4.1.19376.1.8.1.4.2 CDA author IHE (2016‑06‑21 14:02:11)
Author

         
Source: PaLM Suppl. APSR 2.0-3: 
         6.3.6.2

hl7:author

0 … *

C

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@typeCode

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1 … 1

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AUT

Example

author is a person

<author typeCode="AUT" contextControlCode="OP"> <time value="201306101654"/> <assignedAuthor classCode="ASSIGNED">  </assignedAuthor></author>

hl7:templateId

1 … 1

M

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@root

uid

1 … 1

F

1.3.6.1.4.1.19376.1.8.1.4.2

hl7:time

TS

1 … 1

M

The authoring time is the date & time that this author contributed to the document. It SHALL be provided.

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:assignedAuthor

0 … 1

C

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@classCode

cs

0 … 1

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ASSIGNED

hl7:id

II

1 … *

M

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:addr

AD

1 … *

M

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:telecom

TEL

1 … *

M

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

Choice

1 … 1

The author is either an assigned person or an authoring device.

Elements to choose from:

hl7:assignedPerson
hl7:assignedAuthoringDevice

hl7:assignedPerson

0 … 1

C

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

Included 0 … * from 2.16.840.1.113883.10.12.152 CDA Person (2005‑09‑07)
The name(s) SHALL be given.

@classCode

0 … 1

F

PSN

@determinerCode

0 … 1

F

INSTANCE

hl7:name

PN

0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:assignedAuthoringDevice

0 … 1

C

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@classCode

cs

0 … 1

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DEV

@determinerCode

cs

0 … 1

F

INSTANCE

hl7:manufacturerModelName

SC

0 … 1

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:softwareName

SC

0 … 1

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:code

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R

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:representedOrganization

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

Example

represented organization for author as a device

<representedOrganization classCode="ORG" determinerCode="INSTANCE"> <name>  </name></representedOrganization>

Included 0 … 1 from 2.16.840.1.113883.10.12.151 CDA Organization (2005‑09‑07)
The identifier(s) SHOULD, the name SHALL, the telecom(s) and the address(es) MAY be given.

@classCode

0 … 1

F

ORG

@determinerCode

0 … 1

F

INSTANCE

hl7:id

II

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:name

ON

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:telecom

TEL

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:addr

AD

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:standardIndustryClassCode

CE

0 … 1

SHALL be chosen from domain OrganizationIndustryClass

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

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2.16.840.1.113883.5.111 (Role Code)

hl7:statusCode

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

CONF

The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.15999 RoleStatus (DYNAMIC)

hl7:effectiveTime

IVL_TS

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:wholeOrganization

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PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

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ORG

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INSTANCE

hl7:id

II

0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:name

ON

0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:telecom

TEL

0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:addr

AD

0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:standardIndustryClassCode

CE

0 … 1

SHALL be chosen from domain OrganizationIndustryClass

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:entry

0 … 1

C

Source: PaLM Suppl. APSR 2.0-3: 6.2.5.4

Contains 1.3.6.1.4.1.19376.1.3.10.4.5 CDA Update Information Organizer (2017‑11‑14 15:22:14)

PaLM Suppl. 2.0‑3: 6.3.4.6 Diagnostic conclusion section

where [@typeCode='COMP'] [hl7:organizer [hl7:templateId [@root='1.3.6.1.4.1.19376.1.3.10.4.5']]]

@typeCode

cs

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COMP

@contextConductionInd

bl

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true

Constraint if ClinicalDocument.versionNumber > 1

hl7:entry

1 … *

M

Source: PaLM Suppl. APSR 2.0-3: 6.2.5.2

Contains 1.3.6.1.4.1.19376.1.8.1.3.6 Problem Organizer (2015‑08‑13 10:24:55)

PaLM Suppl. 2.0‑3: 6.3.4.6 Diagnostic conclusion section

where [@typeCode='COMP'] [hl7:organizer [hl7:templateId [@root='1.3.6.1.4.1.19376.1.8.1.3.6']]]

@typeCode

cs

1 … 1

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true

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.

Id 1.3.6.1.4.1.19376.1.8.1.2.6 Effective Date valid from 2014‑05‑13 19:33:12

Status Draft Version Label 2.0

Name ProcedureStepsSection Display Name Procedure Steps Section

Description

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.

Context Parent nodes of template element with id 1.3.6.1.4.1.19376.1.8.1.2.6

Label PaLM Suppl. 2.0‑3: 6.3.4.7 Procedure steps section

Classification CDA Section Level Template

Open/Closed Open (other than defined elements are allowed)

Used by / Uses

Used by 0 transactions and 1 template, Uses 2 templates

Used by	as	Name	Version
1.3.6.1.4.1.19376.1.8.1.1.1	Containment	Anatomic Pathology Structured Report Content Module (2.0)	2014‑05‑13 11:57:57
Uses	as	Name	Version
1.3.6.1.4.1.19376.1.8.1.4.2	Include	CDA author IHE	2016‑06‑21 14:02:11
1.3.6.1.4.1.19376.1.3.10.4.1	Containment	Specimen Procedure Step (2.0)	2016‑07‑08 13:20:59

Relationship Specialization: template 2.16.840.1.113883.10.12.201 (2005‑09‑07)

Example

<section classCode="DOCSECT" moodCode="EVN"> <templateId root="1.3.6.1.4.1.19376.1.8.1.2.6"/> <code code="46059-2" codeSystem="2.16.840.1.113883.6.1" displayName="Special treatments and procedures section"/> <title>PROCEDURE STEPS SECTION</title> <text/>  <entry typeCode="COMP" contextConductionInd="false">  </entry></section>

Item DT Card Conf Description Label

hl7:section

0 … 1

R

PaLM Suppl. 2.0‑3: 6.3.4.7 Procedure steps section

@classCode

cs

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DOCSECT

@moodCode

cs

0 … 1

F

EVN

Constraint

   This section SHALL contain a code element populated with these attributes:

@code ="46059-2"

@codeSystem ="2.16.840.1.113883.6.1"

@displayName ="Special treatments and procedures section"

This section SHALL contain a narrative block, represented by a text element, which renders the information to the human reader.

This section SHOULD contain author elements in case the authors of this section differ from those declared at a higher level in the document.

The section SHOULD contain as many Specimen Procedure Steps entry elements as there are procedure steps or groups thereof to be described. These entries provide the machine-readable data corresponding to the narrative block.

hl7:templateId

II

1 … 1

M

PaLM Suppl. 2.0‑3: 6.3.4.7 Procedure steps section

@root

uid

1 … 1

F

1.3.6.1.4.1.19376.1.8.1.2.6

hl7:code

CE

1 … 1

M

PaLM Suppl. 2.0‑3: 6.3.4.7 Procedure steps section

@code

CONF

1 … 1

F

46059-2

@codeSystem

1 … 1

F

2.16.840.1.113883.6.1 (Logical Observation Identifier Names and Codes)

@codeSystemName

1 … 1

F

LOINC

@displayName

1 … 1

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Special treatments and procedures section

hl7:title

ST

1 … 1

R

PaLM Suppl. 2.0‑3: 6.3.4.7 Procedure steps section

CONF

element content shall be "PROCEDURE STEPS SECTION"

hl7:text

SD.TEXT

1 … 1

M

PaLM Suppl. 2.0‑3: 6.3.4.7 Procedure steps section

Example

example for use case#1

<text> RIGHT BREAST FIVE CORES 8-9:00" (ULTRASOUND GUIDED NEEDLE CORE BIOPSY) <br/> PARAFFIN BLOCK NUMBER: A1.:FOUR SECTIONS FOR EACH STAIN: <br/> <paragraph ID="A7102400008">RIGHT BREAST FIVE CORES 8-9:00</paragraph> <paragraph ID="block_A_1">PARAFFIN BLOCK NUMBER: A1</paragraph> <paragraph ID="slide_A_1_HE">slide from block A1 HE stained</paragraph> <paragraph ID="slide_A_1_ER">slide from block A1 ER Immunohistochemistry</paragraph> <paragraph ID="slide_A_1_PR">slide from block A1 PR Immunohistochemistry</paragraph> <paragraph ID="slide_A_1_EGFR">slide from block A1 EGFR (PharmDX) Immunohistochemistry</paragraph> <paragraph ID="slide_A_1_HER2">slide from block A1 HER2 Immunohistochemistry</paragraph> <paragraph ID="slide_A_1_HER2_FISH">slide block from A1 HER2 FISH</paragraph></text>

Included

0 … *

C

from 1.3.6.1.4.1.19376.1.8.1.4.2 CDA author IHE (2016‑06‑21 14:02:11)
Author

   
Source: PaLM Suppl.APSR 2.0‑3:6.3.6.2

hl7:author

0 … *

C

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@typeCode

cs

1 … 1

F

AUT

Example

author is a person

<author typeCode="AUT" contextControlCode="OP"> <time value="201306101654"/> <assignedAuthor classCode="ASSIGNED">  </assignedAuthor></author>

hl7:templateId

1 … 1

M

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@root

uid

1 … 1

F

1.3.6.1.4.1.19376.1.8.1.4.2

hl7:time

TS

1 … 1

M

The authoring time is the date & time that this author contributed to the document. It SHALL be provided.

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:assignedAuthor

0 … 1

C

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@classCode

cs

0 … 1

F

ASSIGNED

hl7:id

II

1 … *

M

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:addr

AD

1 … *

M

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:telecom

TEL

1 … *

M

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

Choice

1 … 1

The author is either an assigned person or an authoring device.

Elements to choose from:

hl7:assignedPerson
hl7:assignedAuthoringDevice

hl7:assignedPerson

0 … 1

C

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

Included 0 … * from 2.16.840.1.113883.10.12.152 CDA Person (2005‑09‑07)
The name(s) SHALL be given.

@classCode

0 … 1

F

PSN

@determinerCode

0 … 1

F

INSTANCE

hl7:name

PN

0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:assignedAuthoringDevice

0 … 1

C

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@classCode

cs

0 … 1

F

DEV

@determinerCode

cs

0 … 1

F

INSTANCE

hl7:manufacturerModelName

SC

0 … 1

R

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:softwareName

SC

0 … 1

R

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:code

CE

0 … 1

R

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:representedOrganization

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

Example

represented organization for author as a device

<representedOrganization classCode="ORG" determinerCode="INSTANCE"> <name>  </name></representedOrganization>

Included 0 … 1 from 2.16.840.1.113883.10.12.151 CDA Organization (2005‑09‑07)
The identifier(s) SHOULD, the name SHALL, the telecom(s) and the address(es) MAY be given.

@classCode

0 … 1

F

ORG

@determinerCode

0 … 1

F

INSTANCE

hl7:id

II

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:name

ON

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:telecom

TEL

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:addr

AD

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:standardIndustryClassCode

CE

0 … 1

SHALL be chosen from domain OrganizationIndustryClass

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:asOrganizationPartOf

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@classCode

0 … 1

F

PART

hl7:id

II

0 … *

R

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:code

CE

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@codeSystem

CONF

0 … 1

F

2.16.840.1.113883.5.111 (Role Code)

hl7:statusCode

CS

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

CONF

The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.15999 RoleStatus (DYNAMIC)

hl7:effectiveTime

IVL_TS

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:wholeOrganization

0 … 1

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

@classCode

0 … 1

F

ORG

@determinerCode

0 … 1

F

INSTANCE

hl7:id

II

0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:name

ON

0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:telecom

TEL

0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:addr

AD

0 … *

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:standardIndustryClassCode

CE

0 … 1

SHALL be chosen from domain OrganizationIndustryClass

PaLM Suppl.APSR 2.0‑3:6.3.6.2 Author

hl7:entry

0 … *

R

Specimen procedure steps

Source: PaLM Suppl.APSR 2.0‑3:6.2.5.3
Contains 1.3.6.1.4.1.19376.1.3.10.4.1 Specimen Procedure Step (2016‑07‑08 13:20:59)

PaLM Suppl. 2.0‑3: 6.3.4.7 Procedure steps section

where [@typeCode='COMP'] [hl7:procedure [hl7:templateId [@root='1.3.6.1.4.1.19376.1.3.10.4.1']]]

@typeCode

cs

1 … 1

F

COMP

@contextConductionInd

bl

0 … 1

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 all the sections except Procedure Steps <section> of the APSR template is Problem (Specimen Information) Organizer.

The unique <entry> Content Module available in Procedure Steps <section> of the APSR template is Specimen Procedure Step

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

Is this organizer really necessary? The updated AP Observation has direct relation to a specific specimen which is observed. The central organizer function should be fulfilled by the problem organizer. GH

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

Is this entry really necessary? Its function is better served by the Specimen Procedure Steps entry. GH

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

This is an addendum to the reference text of APSR 2.0 GH

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.

6.2.6.12 UICC/AJCC TNM Staging and Grading

This is an addendum to the reference text of APSR 2.0 GH

6.2.6.12.1 Definition and purpose

The UICC/AJCC TNM <entry> Content Modul contains in machine-readable form all the information concerning a TNM formula for a problem investigated. It is usable within a Problem Organizer <entry> Content Module only.

This Content Module structures the machine-readable data, which characterize the staging and grading of a malignant Tumor according the UICC/AJCC regulations for the TNM system.

Figure 6.2.6.12.1-1 CDA-RMIM of the UICC/AJCC TNM <entry>

6.2.6.13 ICD-O-3 Typing and Grading

This is an addendum to the reference text of APSR 2.0 GH

6.2.6.13.1 Definition and purpose

The ICD-O-3 Typing and Grading<entry> Content Modul contains in machine-readable form all the information concerning ICD-O-3 Typing and Grading for a problem investigated. It is usable within a Problem Organizer <entry> Content Module only.

This Content Module structures the machine-readable data, which characterize the staging of a tumor or a systemic disease according the WHO regulations for the ICD-O-3 system.

Figure 6.2.6.13.1-1 CDA-RMIM of the ICD-O-3 <entry>

6.2.6.14 Assessment Scales for Scoring systems

This is an addendum to the reference text of APSR 2.0 GH

6.2.6.14.1 Definition and purpose

The Assessment Scales <entry> Content Modul contains in machine-readable form all the information concerning (semiquantitative) scoring systems often used for describing a tumor grading for a problem investigated. It is usable within the ICD-O-3 Typing and Grading <entry> or within a Problem Organizer <entry> Content Module.

This Content Module structures the machine-readable data, which characterize the grading components of a tumor or a systemic disease according specific regulations.

Figure 6.2.6.14.1-1 CDA-RMIM of an Assessment Scales <entry>

Einleitung

Inhaltsverzeichnis

Foreword

Introduction to this Supplement

Open Issues and Questions

Closed Issues

VOLUME 1 -PROFILES

10 Anatomic Pathology Structured Report (APSR) Profile

10.1 APSR Actors/Transactions

10.1.1 Actor Descriptions and Actor Profile Requirements

10.2 APSR Actor Options

10.3 APSR Required Actor Groupings

10.4 APSR Overview

10.4.1 Concepts

10.4.2 Use Cases

10.4.2.1 Use case #1: Single Report

10.4.2.1.1 Single Report Use Case Description

10.4.2.1.2 Single Report Process Flow

10.4.2.2 Use Case #2: Multi-step Report

10.4.2.2.1 Multi-step Report Use Case Description

10.4.2.2.2 Multi-step Report Process Flow

10.5 APSR Security Considerations

10.6 APSR Cross Profile Considerations

Volume 3 – Content Modules

1 Introduction

1.1 Overview of the Anatomic Pathology Technical Framework

1.2 Overview of Volume 3

1.3 Audience

1.4 Relationship to Standards

1.5 Relationship to Real World Architecture

1.6 Conventions

1.7 Scope Introduced in the Current Year

1.8 Copyright Permission

1.9 Glossary

2 Content Modules – Basic Principles

3 IHE Transactions

3.1 Cross Enterprise Document Content Transactions

3.1.1 View Option

3.1.2 Document Import Option

3.1.3 Section Import Option

4 IHE Anatomic Pathology Bindings

4.1 Anatomic Pathology Document Binding to XDS, XDM and XDR

4.1.1XDS DocumentEntry Metadata

4.1.1.1XDS DocumentEntry.formatCode

4.1.1.2XDS DocumentEntry.eventCodeList

4.1.1.3XDS DocumentEntry.parentDocumentRelationship

4.1.2XDS SubmissionSet Metadata

4.1.3XDS Folder Metadata

4.1.4 Configuration

5 Namespaces and Vocabularies

5.1 OID tree of PAT TF

5.2 Terminologies and controlled coded vocabularies

5.3 Value Sets

5.4 Namespaces

5.4.1 Namespace protecting extensions to the CDA schema

5.5 References to Content Modules built outside of IHE PAT TF

5.6 IHE Codes for Anatomic Pathology Document Templates

6 Anatomic Pathology Content Modules

6.1 Conventions

6.2 HL7 CDA R2 Content Modules

6.2.1 Organization

6.2.1.1 Various Types of Content Modules

6.2.1.2 General constraints added by IHE PAT to a CDA R2 document

6.2.1.3 Common structure for CDA APSR

6.2.2 Common layout for the specification of a CDA Content Module

6.2.2.1 Content Module Name – OID

6.2.2.1.1 Definition and purpose

6.2.2.1.2 Example

6.2.2.1.3 Specification

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

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

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

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

6.2.4.4 Microscopic Observation <section> - 1.3.6.1.4.1.19376.1.8.1.2.4