|
|
| (296 dazwischenliegende Versionen von 4 Benutzern werden nicht angezeigt) |
| Zeile 4: |
Zeile 4: |
| | | | |
| | This is a supplement to the IHE Pathology | | This is a supplement to the IHE Pathology |
| − | and Laboratory Medicine Technical Framework V7.0. Each supplement undergoes a | + | and Laboratory Medicine Technical Framework V8.0. Each supplement undergoes a |
| | process of public comment and trial implementation before being incorporated | | process of public comment and trial implementation before being incorporated |
| | into the volumes of the Technical Frameworks. | | into the volumes of the Technical Frameworks. |
| | | | |
| − | This supplement is published on <Month XX, 2016> for | + | This supplement was published on September 27, 2017 for Public Comment, with a comment period extending to mid-November. The current content is the Trial Implementation version, which has taken in consideration the comments received. |
| − | 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 | | This supplement describes changes to the |
| Zeile 38: |
Zeile 35: |
| | The current version of the IHE Technical Framework (if applicable) can be found at: http://ihe.net/Technical_Frameworks. | | The current version of the IHE Technical Framework (if applicable) can be found at: http://ihe.net/Technical_Frameworks. |
| | | | |
| | + | ''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.'' |
| | | | |
| − | <''Comments may be submitted on IHE Technical Framework templates any time at http://ihe.net/ihetemplates.cfm. Please enter comments/issues as soon as they are found. Do not wait until a future review cycle is announced.''
| + | =Acknowledgements= |
| | + | |
| | + | Following authors mainly contributed to this document: |
| | + | *Francois Macary, PHAST, Paris |
| | + | *Dr. Gunter Haroske, Federal Association of German Pathologists, Berlin |
| | + | *Dr. Frank Oemig, Deutsche Telekom Healthcare Solutions GmbH, Bonn |
| | + | *Dr. Riki Merrick, APHL, San Francisco |
| | + | *Dr. Raj Dash, Duke University, Durham |
| | + | |
| | + | They have to acknowledge the contributions of Dr. Kai U. Heitmann, who managed the cooperation between PaLM and ART-DECOR. It was the very first time that a complete IHE TF document could be developed by means of the ART-DECOR tools and a media wiki. |
| | + | |
| | + | __TOC__ |
| | | | |
| | =Introduction to this Supplement= | | =Introduction to this Supplement= |
| Zeile 45: |
Zeile 54: |
| | This supplement complements volume 1 of | | This supplement complements volume 1 of |
| | the PaLM technical framework with the description of the APSR 2.0 content | | the PaLM technical framework with the description of the APSR 2.0 content |
| − | profile, and volumes 3 and 4 with the bindings, content modules and value sets, which specify | + | profile, and volume 3 with the bindings, content modules and value sets, which specify |
| | this profile. | | this profile. |
| − |
| |
| | | | |
| | ==Open Issues and Questions== | | ==Open Issues and Questions== |
| | | | |
| | ''None yet'' | | ''None yet'' |
| − |
| |
| | | | |
| | ==Closed Issues== | | ==Closed Issues== |
| Zeile 69: |
Zeile 76: |
| | the scope of this profile. The results produced on a derived specimen are | | the scope of this profile. The results produced on a derived specimen are |
| | attached to this specimen in the report. | | 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 [http://www.sfpathol.org])
| |
| − | 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.
| |
| − |
| |
| − |
| |
| − | [[Datei:fig.4.1.-1.jpg]]
| |
| − |
| |
| − | 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'''
| |
| − | {| class="hl7table"
| |
| − | !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'''
| |
| − |
| |
| − | {| class="hl7table"
| |
| − | !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'''
| |
| − | {| class="hl7table"
| |
| − | !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 a repeatable “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.
| |
| − |
| |
| − | [[Datei:10.4.1-1_FM.jpeg]]
| |
| − |
| |
| − | Figure 10.4.1-1
| |
| − | '''Common model for a digital anatomic pathology structured 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
| |
| − |
| |
| − | =====10.4.2.1.3 Single Report Example=====
| |
| − |
| |
| − | A. "RIGHT BREAST FIVE CORES 8-9:00" (ULTRASOUND GUIDED NEEDLE CORE BIOPSY):
| |
| − |
| |
| − | INVASIVE ADENOCARCINOMA OF THE BREAST.
| |
| − | HISTOLOGIC TYPE: DUCTAL.
| |
| − | NOTTINGHAM COMBINED HISTOLOGIC GRADE: 1 OF 3.
| |
| − | TUBULE FORMATION SCORE: 2.
| |
| − | NUCLEAR PLEOMORPHISM SCORE: 2.
| |
| − | MITOTIC RATE SCORE: 1.
| |
| − |
| |
| − | IN-SITU CARCINOMA: EQUIVOCAL.
| |
| − |
| |
| − | BREAST CANCER BIOMARKER STUDIES:
| |
| − | PARAFFIN BLOCK NUMBER: A1.
| |
| − |
| |
| − |
| |
| − | ER INTERPRETATION: POSITIVE ESTROGEN RECEPTOR ACTIVITY (ALLRED SCORE = 8).
| |
| − |
| |
| − | PR INTERPRETATION: POSITIVE PROGESTERONE RECEPTOR ACTIVITY (ALLRED SCORE = 8).
| |
| − |
| |
| − | DAKO EGFR PHARMDX IMMUNOHISTOCHEMISTRY: NEGATIVE (0) FOR EXPRESSION OF
| |
| − |
| |
| − | EPIDERMAL GROWTH FACTOR RECEPTOR.
| |
| − |
| |
| − | HER2/NEU IMMUNOHISTOCHEMISTRY: POSITIVE (3+) FOR OVEREXPRESSION OF HER2/NEU
| |
| − |
| |
| − | ONCOPROTEIN.
| |
| − |
| |
| − | ====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 =
| |
| − | The content of this entire section is copied from section 1 of [http://www.ihe.net/uploadedFiles/Documents/PaLM/IHE_PaLM_TF_Vol3.pdf Volume 3 of PaLM TF].
| |
| − |
| |
| − | == 1.1 Overview of the Anatomic Pathology Technical Framework ==
| |
| − | Integrating the Healthcare Enterprise (IHE) is an international initiative to promote the use of standards to achieve interoperability among health information technology (HIT) systems and effective use of electronic health records (EHRs). IHE provides a forum for care providers, HIT experts and other stakeholders in several clinical and operational domains to reach consensus on standards-based solutions to critical interoperability issues.
| |
| − | The primary output of IHE is system implementation guides, called IHE Profiles. IHE publishes each profile through a well-defined process of public review and trial implementation and gathers profiles that have reached final text status into an IHE Technical Framework, of which this volume is a part.
| |
| − | For more general information regarding IHE, refer to [http://ihe.net IHE International website]. It is strongly recommended that, prior to reading this volume, the reader familiarizes themselves with the concepts defined in the [http://ihe.net/TF_Intro_Appendices.aspx IHE Technical Frameworks General Introduction].
| |
| − |
| |
| − | == 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 Pathology and Laboratory Medicine 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 ==
| |
| − | <syntaxhighlight lang="xml">
| |
| − | Insert the text from the same section in volume 1 of the former PAT TF
| |
| − | </syntaxhighlight>
| |
| − |
| |
| − |
| |
| − |
| |
| − | == 1.4 Relationship to Standards ==
| |
| − | <syntaxhighlight lang="xml">
| |
| − | Insert a simplified version of the text from the same section in volume 1 of the former PAT TF
| |
| − | </syntaxhighlight>
| |
| − |
| |
| − |
| |
| − |
| |
| − |
| |
| − | == 1.5 Relationship to Real World Architecture ==
| |
| − | <syntaxhighlight lang="xml">
| |
| − | Insert the text from the same section in volume 1 of the former PAT TF
| |
| − | </syntaxhighlight>
| |
| − |
| |
| − |
| |
| − |
| |
| − | == 1.6 Conventions ==
| |
| − | <syntaxhighlight lang="xml">
| |
| − | Insert a simplified version of the text from the same section in volume 1 of the former PAT TF
| |
| − | </syntaxhighlight>
| |
| − |
| |
| − |
| |
| − |
| |
| − |
| |
| − | == 1.7 Scope Introduced in the Current Year ==
| |
| − |
| |
| − |
| |
| − | Content Modules for the APSR 2.0 Profile:
| |
| − |
| |
| − | *refiguration of the Document content module
| |
| − | *refiguration of the Procedure step section content module
| |
| − | *introduction of the Additionally Specified Observation section content module
| |
| − | *refiguration of the entry content modules "Problem organizer" and "Specimen procedure steps"
| |
| − | *introduction of child element content modules "X-specimen identified", "UICC/AJCC-TNM observation", "ICD-O-3 observation", "Assessment scales observation"
| |
| − | *renewal and completion of value sets.
| |
| − |
| |
| − | Transformation of a real-world use case into a valid APSR 2.0 xml instance.
| |
| − |
| |
| − | Finishing the Supplement ready to public comment.
| |
| − |
| |
| − | == 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 former PAT TF-1:1.12.
| |
| − |
| |
| − | = 2 Content Modules – Basic Principles =
| |
| − |
| |
| − | This Volume 3 of
| |
| − | the Suppl. APSR 2.0 to the PaLM TF organizes content modules categorically by the base standard. At
| |
| − | present, former 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 former 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 Pathology and Laboratory Medicine 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 former 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 former 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 chapter 5.6.
| |
| − |
| |
| − | 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 former IHE Anatomic Pathology domain, whereas 1.3.6.1.4.1.19376.1.81.3.6.1.4.1.19376.1.3 is the OID for PaLM domain :
| |
| − |
| |
| − | All exchangeable objects specified by these domains are identified by OIDs built on these roots:
| |
| − |
| |
| − |
| |
| − | Branch 1.3.6.1.4.1.19376.1.8.1 is dedicated to CDA Content Modules created by the AP domain
| |
| − |
| |
| − | Sub-branch 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 1.3.6.1.4.1.19376.1.8.1.3 is dedicated to Entry Content Modules.
| |
| − | Sub-branch 1.3.6.1.4.1.19376.1.8.1.3.6 is the OID of the Problem Organizer
| |
| − | Sub-branch 1.3.6.1.4.1.19376.1.8.1.4 is dedicated to Element Content Modules
| |
| − | Sub-branch 1.3.6.1.4.1.19376.1.8.1.4.9 is the OID of the generic anatomic pathology (AP) observation template
| |
| − |
| |
| − |
| |
| − | Branch 1.3.6.1.4.1.19376.1.8.2 is dedicated to terminologies defined by AP 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 AP domain.
| |
| − |
| |
| − | Branch 1.3.6.1.4.1.19376.1.3.10 is dedicated to Templates newly defined by PaLM domain.
| |
| − |
| |
| − | Sub-branch 1.3.6.1.4.1.19376.1.3.10.1 is dedicated to CDA Document Level Templates
| |
| − | Sub-branch 1.3.6.1.4.1.19376.1.3.10.2 is dedicated to CDA Header Level Templates
| |
| − | Sub-branch 1.3.6.1.4.1.19376.1.3.10.3 is dedicated to CDA Section Level Templates
| |
| − | Sub-branch 1.3.6.1.4.1.19376.1.3.10.4 is dedicated to CDA Entry Level Templates
| |
| − | Sub-branch 1.3.6.1.4.1.19376.1.3.10.9 is dedicated to CDA Template Fragments/Supporting Templates
| |
| − |
| |
| − | Branch 1.3.6.1.4.1.19376.1.3.11 is dedicated to Value Sets newly defined by PaLM domain.
| |
| − |
| |
| − | Branch 1.3.6.1.4.1.19376.1.8.9 is used to identify instances in the examples built by the AP domain.
| |
| − |
| |
| − |
| |
| − | Notes on other IHE OIDs used in the AP domain:
| |
| − |
| |
| − | nn
| |
| − |
| |
| − | == 5.2 Terminologies and controlled coded vocabularies ==
| |
| − |
| |
| − | This section lists the terminologies and the coded vocabularies referenced by this Volume 3.
| |
| − |
| |
| − | '''Table 5.2-1 Anatomic Pathology Terminologies and Coded Vocabularies'''
| |
| − |
| |
| − | {{FAQBox|
| |
| − | Could this be contributed by ArtDecor??? GH
| |
| − | }}
| |
| − |
| |
| − | {| class="hl7table"
| |
| − | !codeSystem !! codeSystemName !!Description!! Owner
| |
| − | |-
| |
| − | |2.16.840.1.113883.6.1
| |
| − | ||LOINC
| |
| − | ||Logical Observation Identifier Names and Codes
| |
| − | ||Regenstrief Institute
| |
| − |
| |
| − | |-
| |
| − | |2.16.840.1.113883.6.8
| |
| − | ||UCUM
| |
| − | ||Unified Code for Units of Measure
| |
| − | ||Regenstrief Institute, and the UCUM Organization
| |
| − |
| |
| − | |-
| |
| − | |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, used for representing annotation comments in the report
| |
| − | ||IHE PCC
| |
| − |
| |
| − | |-
| |
| − | |2.16.840.1.113883.5.4
| |
| − | ||Act Code||Codesystem for Acts
| |
| − | ||HL7
| |
| − |
| |
| − | |-
| |
| − | |2.16.840.1.113883.5.6
| |
| − | ||ActClass||Codesystem for Act Classes
| |
| − | ||HL7
| |
| − |
| |
| − | |-
| |
| − | |2.16.840.1.113883.5.1052
| |
| − | ||Act Site||Codesystem for Act Sites
| |
| − | ||HL7
| |
| − |
| |
| − | |-
| |
| − | |2.16.840.1.113883.5.1065
| |
| − | ||ProcedureMethod||Codesystem for Procedure Methods
| |
| − | ||HL7
| |
| − |
| |
| − | |-
| |
| − | |2.16.840.1.113883.5.111
| |
| − | ||Role Code||Codesystem for Role Codes
| |
| − | ||HL7
| |
| − |
| |
| − | |-
| |
| − | |2.16.840.1.113883.5.129
| |
| − | ||SpecimenType||Codesystem for Specimen Types
| |
| − | ||HL7
| |
| − |
| |
| − | |-
| |
| − | |2.16.840.1.113883.5.84
| |
| − | ||ObservationMethod||A code system that provides additional detail about the means or technique used to ascertain the observation
| |
| − | ||HL7
| |
| − |
| |
| − | |-
| |
| − | |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
| |
| − |
| |
| − | |-
| |
| − | | 1.2.840.10008.2.16.4
| |
| − | ||DICOM controlled vocabulary||The meanings of codes defined in DICOM, either explicitly or by reference to another part of DICOM or an external reference document or standard [http://nema.org/dicom/dicm]
| |
| − | ||DICOM
| |
| − |
| |
| − | |-
| |
| − | |1.2.250.1.213.2.11
| |
| − | ||ADICAP Thesaurus||French thesaurus of lesions in anatomic pathology - not used in APSR 2.0. Replaced by SNOMED CT
| |
| − | ||ADICAP
| |
| − |
| |
| − | |-
| |
| − | |1.2.250.1.213.2.12
| |
| − | ||SNOMED International (3.5)||Systematized Nomenclature of Medicine - no longer usable. Replaced by SNOMED CT, the only valid version.
| |
| − | ||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. No longer used. Replaced by SNOMED CT.
| |
| − | ||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)
| |
| − |
| |
| − | |-
| |
| − | |2.16.840.1.113883.6.4
| |
| − | ||ICD-10-PCS||International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS)
| |
| − | ||WHO
| |
| − |
| |
| − | |-
| |
| − | |1.2.276.0.76.5.464
| |
| − | ||OPS 2017||Code lists to describe and categorize surgeries and procedures, adapted from WHO ICPM for Germany
| |
| − | ||DIMDI (WHO)
| |
| − |
| |
| − | |-
| |
| − | |2.16.840.1.113883.6.174
| |
| − | ||OMIM||Code lists to describe and categorize human genes. OMIM is a comprehensive, authoritative compendium of human genes and genetic phenotypes that is freely available and updated daily.
| |
| − | ||OMIM Johns Hopkins University School of Medicine [http://www.omim.org]
| |
| − |
| |
| − | |-
| |
| − | |1.2.276.0.76.3.1.131.1.5.1
| |
| − | ||DKG Coding Scheme||Internationally agreed-upon code lists to describe and categorize cancer grading systems, adapted for Germany [http://wiki.hl7.de/index.php?title=cdaonk:Assessment_Scales_Entry_(Template)#aus_DKG-Labels_.28OID.3D1.2.276.0.76.3.1.131.1.5.1.29]
| |
| − | ||DKG (Deutsche Krebsgesellschaft)
| |
| − |
| |
| − | |-
| |
| − | |1.2.276.0.76.5.336
| |
| − | ||Grading / Differentiation scheme||Code lists to describe and categorize Tumor grading according ICD-O-3, adapted for Germany
| |
| − | ||HL7.de
| |
| − |
| |
| − | |-
| |
| − | |1.2.276.0.76.5.401
| |
| − | ||Localization scheme for distant metastases||Code lists to describe and categorize localization of metastases according UICC, adapted for Germany
| |
| − | ||HL7.de
| |
| − | |}
| |
| − |
| |
| − | == 5.3 Value Sets ==
| |
| − |
| |
| − |
| |
| − | The value sets defined or referenced by this Volume 3 of the IHE PaLM TF Suppl. are listed in Volume 4.
| |
| − |
| |
| − | ==5.4 Namespaces==
| |
| − |
| |
| − | ===5.4.1 Namespace protecting extensions to the CDA schema===
| |
| − |
| |
| − | There is currently one single extension to the CDA.xsd schema used in PAT TF-3. This extension has been created by IHE LAB and is protected by this particular namespace in document instances: '' xmlns:lab="urn:oid:1.3.6.1.4.1.19376.1.3.2"''
| |
| − |
| |
| − |
| |
| − | ==5.5 References to Content Modules built outside of IHE PAT TF==
| |
| − | The Content Modules specified in this Volume 3 of the PAT TF leverage a number of Content Modules (currently CDA templates) produced and maintained by other groups, including other domains of IHE. Table 5.5-1 lists them.
| |
| − |
| |
| − | '''Table 5.5-1 External Content Modules referenced by PAT TF-3'''
| |
| − |
| |
| − | {| class="hl7table"
| |
| − | !templateId !! Standard !!Definition!! Source of Specification
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.5.3.1.3.1||CDA R2
| |
| − | ||Reason for referral
| |
| − | ||IHE PCC TF-2:6.3.3.1.2
| |
| − |
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.5.3.1.3.4
| |
| − | ||CDA R2||History of present illness
| |
| − | ||IHE PCC TF-2:6.3.3.2.1
| |
| − |
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.5.3.1.3.6
| |
| − | ||CDA R2||Active Problems
| |
| − | ||IHE PCC TF-2:6.3.3.2.3
| |
| − |
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.5.3.1.4.2
| |
| − | ||CDA R2||Annotation Comment
| |
| − | ||IHE PCC TF-2:6.3.4.6
| |
| − |
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.3.3.1.7
| |
| − | ||CDA R2||Laboratory Performer
| |
| − | ||IHE PaLM TF-3:6.3.2.20
| |
| − |
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.3.3.1.6
| |
| − | ||CDA R2||Ordering Provider (ordering physician)
| |
| − | ||IHE PaLM TF-3:6.3.2.17
| |
| − |
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.3.3.1.4
| |
| − | ||CDA R2||Intended Recipient
| |
| − | ||IHE PaLM TF-3:6.3.2.14
| |
| − |
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.3.1.6
| |
| − | ||CDA R2||Laboratory Observation
| |
| − | ||IHE PaLM TF-3:6.3.4.13
| |
| − |
| |
| − | |}
| |
| − |
| |
| − | ==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:
| |
| − |
| |
| − | '''M (R in v2)'''
| |
| − |
| |
| − | A "'''Mandatory (Required in v2)'''" 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.
| |
| − |
| |
| − | '''R (R2 in v2)'''
| |
| − |
| |
| − | A "'''Required (Required if data present in v2)'''" data element is one that shall be provided when a value exists. If the information cannot be transmitted, the data element shall contain a value indicating the reason for omission of the data. If no such information is available to the content creator or if such information is not available in a well identified manner (e.g., buried in a free form narrative that contains additional information relevant to other sections) or if the content creator requires that information be absent, the R2 section shall be entirely absent. The Content Creator application must be able to demonstrate that it can populate all required if known elements, unless it does not in fact gather that data. This “R2” code is the equivalent of the HL7 standard “RE” usage code. The value “R2” has been chosen in harmonization with the IHE PCC TF, which is the source of a large number of CDA R2 content modules.
| |
| − |
| |
| − | '''O'''
| |
| − |
| |
| − | An "'''Optional'''" data element is one that may be provided, irrespective of whether the information is available or not. If the implementation elects to support this optional section, then its support shall meet the requirement set forth for the "Required if data present" or R2.
| |
| − |
| |
| − | '''C'''
| |
| − |
| |
| − | A "'''Conditional'''" data element is one that is required, required if known or optional depending upon other conditions. These will have further notes explaining when the data element is required, et cetera.
| |
| − |
| |
| − | ==6.2 HL7 CDA R2 Content Modules==
| |
| − |
| |
| − | ===6.2.1 Organization===
| |
| − |
| |
| − | ====6.2.1.1 Various Types of Content Modules====
| |
| − |
| |
| − | For the CDA Release 2.0 standard, the content modules are organized by:
| |
| − |
| |
| − |
| |
| − | *'''document''': The template for a whole document.
| |
| − |
| |
| − |
| |
| − | *'''section''': The template for a <section> element.
| |
| − |
| |
| − |
| |
| − | *'''entry''': The template for a <entry> element.
| |
| − |
| |
| − |
| |
| − | *'''child element''': An element of the CDA header or an element of a <section>, or an element nested at various depths below an <entry>, or an element appearing at some combination of these locations.
| |
| − |
| |
| − |
| |
| − | ====6.2.1.2 General constraints added by IHE PAT to a CDA R2 document====
| |
| − |
| |
| − | In the structured body of a CDA R2 document, a section has a narrative block (the text element), which presents the human-readable content of the section, and MAY have one entry or more. Sections MAY be nested within one another.
| |
| − |
| |
| − | The content modules designed by the PAT TF bring or highlight the following constraints:
| |
| − |
| |
| − | *When a section has a text element and one or more entry element, the content coded for machine-processing in the entries SHALL be completely transcribed into human-readable content in the text element.
| |
| − |
| |
| − | *Conversely the text element MAY contain pieces of information, which are not available in machine-readable format in any entry element of the section.
| |
| − |
| |
| − | *For a document of the Anatomic Pathology domain, the entry elements are instantiated per specimen or per group of specimens observed together. One entry contains in machine-readable format observations of the section related to the same specimen or group of specimens. Beneath an entry, the observations are organized per problem.
| |
| − |
| |
| − | *The text element of the section is supposed to be also laid out per specimen or group of specimens and per problem observed.
| |
| − |
| |
| − | *The APSR Content Profile leaves the layout of the text element up to the Content Creator applications, or to further constraints brought by national extensions of this profile. However, given that the text element is usually composed of free text (e.g. dictated text), assembled with the text generated from the set of data, machine-encoded in the entry elements below, the Content Creator application MUST handle these two kinds of content, and provide a user interface, which avoids risks of overwriting text automatically derived from the entries with free text typed in by the user (e.g., using forms with dedicated free text areas and distinct protected areas for text generated out of structured data).
| |
| − |
| |
| − | *Information that is sent SHALL clearly identify distinctions between:
| |
| − |
| |
| − | '''None'''
| |
| − |
| |
| − | It is known with complete confidence that there are none. This indicates that the sender knows that there is no relevant information of this kind that can be sent.
| |
| − |
| |
| − | '''None Known'''
| |
| − |
| |
| − | None known at this time, but it is not known with complete confidence that none exist.
| |
| − |
| |
| − | '''Asked but unknown'''
| |
| − |
| |
| − | The information was requested but could not be obtained. Used mainly in the context where an observation was made but the result could not be determined.
| |
| − |
| |
| − | '''Unknown'''
| |
| − |
| |
| − | The information is not known, or is otherwise unavailable.
| |
| − |
| |
| − | '''Other, not specified'''
| |
| − |
| |
| − | The actual value does not belong to the assigned value set and is not reported at all by the author.
| |
| − |
| |
| − | '''Other, specify'''
| |
| − |
| |
| − | The actual value does not belong to the assigned value set and the author of the report provides this ''foreign'' value anyway.
| |
| − |
| |
| − | '''Not applicable'''
| |
| − |
| |
| − | No proper value is applicable in this context.
| |
| − |
| |
| − | Sections that are required to be present but have no information should use one of the above phrases where appropriate in the ''text'' element.
| |
| − |
| |
| − | Structural elements that are required but have no information shall provide a “nullFlavor” attribute coding the reason why the information is missing.
| |
| − |
| |
| − | {| class="hl7table"
| |
| − | !Situation !! nullFlavor !!HL7 Definition
| |
| − | |-
| |
| − | |Asked but unknown||ASKU
| |
| − | ||Information was sought but not found
| |
| − |
| |
| − | |-
| |
| − | |Unknown
| |
| − | ||UNK||A proper value is applicable, but not known
| |
| − |
| |
| − | |-
| |
| − | |Other, not specified
| |
| − | ||OTH||The actual value is not an element in the value domain of a variable. (e.g., concept not provided by required code system).
| |
| − |
| |
| − | |-
| |
| − | |Not applicable
| |
| − | ||NA||No proper value is applicable in this context
| |
| − |
| |
| − | |-
| |
| − | |Temporarily not available
| |
| − | ||NAV||Information is not available at this time but it is expected that it will be available later.
| |
| − | |}
| |
| − |
| |
| − |
| |
| − | The two situations “None” and “None known” represent effective values, which are part of the related value sets.
| |
| − |
| |
| − | The situation “Other, specify” can be handled in two ways in a coded data element:
| |
| − | *Leaving empty the ''code'' attribute and providing the non-coded answer in the ''originalText'' attribute.
| |
| − | *Providing a value coded from a different coding scheme, when the coding strength of the element is “CWE” (coded with extensions). The attributes ''code'', ''displayName'', ''codeSystem'' and ''codeSystemName'' then describe the foreign code.
| |
| − |
| |
| − | For ancillary techniques, the situation “ not performed” or “none performed” is represented by nullFlavor = NAV.
| |
| − |
| |
| − |
| |
| − | ====6.2.1.3 Common structure for CDA APSR====
| |
| − |
| |
| − | Figure 6.2.1.3-1 summarizes the common structure of the first six 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.
| |
| − |
| |
| − |
| |
| − | [[Datei:6.2.1.3-1-FO_FM_GH.jpeg]]
| |
| − |
| |
| − | '''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'''
| |
| − |
| |
| − | 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 10.4.1-1 of Volume 1.
| |
| − |
| |
| − | Note 3: The possible sub sections are shown on figure 10.4.1-1 of Volume 1.
| |
| − |
| |
| − |
| |
| − | Figure 6.2.1.3-2 shows the common structure of the Procedure Step Content Module specified here, too.
| |
| − |
| |
| − | [[Datei:6.2.1.3-2-FO_FM_GH.jpeg]]
| |
| − |
| |
| − | '''Figure 6.2.1.3-2 CDA APSR: common structure of machine-readable content for Procedure Step Content Module '''
| |
| − |
| |
| − | ===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 Specification and example=====
| |
| − |
| |
| − | This section consists of a transclusion of an Art-Decor APSR 2.0 template for the content module, delivering a snippet, showing an example of the content module.
| |
| − |
| |
| − | 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.
| |
| − | *Within the tables appear notes providing additional information and detailing particular constraints on some elements or attributes.
| |
| − |
| |
| − | ===6.2.3 CDA R2 Document Content Modules===
| |
| − |
| |
| − | ====6.2.3.1 AP Structured Report (APSR) - 1.3.6.1.4.1.19376.1.8.1.1.1====
| |
| − |
| |
| − | =====6.2.3.1.1 Definition and purpose=====
| |
| − |
| |
| − | This Document Content Module defines the base set of constraints that apply to all AP structured report, related to any kind of lesion or diagnostic. In other words, this is the generic template for any AP structured report.
| |
| − |
| |
| − | The body of this Document Content Module has the hierarchy of sections and entries depicted by figure 4.1.2.1-1 in Volume 1.
| |
| − |
| |
| − | =====6.2.3.1.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.1.1/dynamic}}
| |
| − |
| |
| − | [http://art-decor.org/decor/services/RetrieveTemplate?prefix=psr-&version=&language=en-US&id=1.3.6.1.4.1.19376.1.8.1.1.1&effectiveDate=2014-05-13T11:57:57&format=html&collapsable=true on Art-Decor]
| |
| − |
| |
| − | ===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. The only entry for this section is the Problem Organizer Entry module.
| |
| − |
| |
| − | =====6.2.4.1.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.2.1/dynamic}}
| |
| − |
| |
| − | [http://art-decor.org/art-decor/decor-templates--psr-?id=1.3.6.1.4.1.19376.1.8.1.2.1&effectiveDate=2014-05-13T14:38:08&format=html&collapsable=true on Art-Decor]
| |
| − |
| |
| − | ====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). The only entry for this section is the Problem Organizer Entry module.
| |
| − |
| |
| − | =====6.2.4.2.2 Specification and Example=====
| |
| − |
| |
| − | {{FAQBox|
| |
| − | LOINC code has been ordered. GH
| |
| − | }}
| |
| − |
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.2.2/dynamic}}
| |
| − |
| |
| − | [http://art-decor.org/art-decor/decor-templates--psr-?id=1.3.6.1.4.1.19376.1.8.1.2.2&effectiveDate=2014-05-13T19:29:16 on Art-Decor]
| |
| − |
| |
| − | ====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. The only entry for this section is the Problem Organizer Entry module.
| |
| − |
| |
| − | =====6.2.4.3.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.2.3/dynamic}}
| |
| − |
| |
| − | [http://art-decor.org/art-decor/decor-templates--psr-?id=1.3.6.1.4.1.19376.1.8.1.2.3&effectiveDate=2014-05-13T11:57:09 on Art-Decor]
| |
| − |
| |
| − | ====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.The only entry for this section is the Problem Organizer Entry module.
| |
| − |
| |
| − | =====6.2.4.4.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.2.4/dynamic}}
| |
| − |
| |
| − | [http://art-decor.org/art-decor/decor-templates--psr-?id=1.3.6.1.4.1.19376.1.8.1.2.4&effectiveDate=2014-05-13T14:25:17 on Art-Decor]
| |
| − |
| |
| − | ====6.2.4.5 Additionally Specified Observation <section> - 1.3.6.1.4.1.19376.1.3.10.3.1====
| |
| − |
| |
| − | =====6.2.4.5.1 Definition and Purpose=====
| |
| − |
| |
| − | The Additionally Specified Observation section includes additional pathologic finding(s) and the results of ancillary study(yes) with non-morphological methods (e.g. flow cytometry, cytogenetics, molecular pathology, etc.) and may include diagrams and still images or virtual slides, if taken. The only entry for this section is the Problem Organizer Entry module.
| |
| − |
| |
| − | =====6.2.4.5.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.3.1/dynamic}}
| |
| − |
| |
| − | [https://art-decor.org/art-decor/decor-templates--psr-?section=templates&id=1.3.6.1.4.1.19376.1.3.10.3.1&effectiveDate=2016-11-13T14:28:08 on Art-Decor]
| |
| − |
| |
| − | ====6.2.4.6 Diagnostic Conclusion <section> - 1.3.6.1.4.1.19376.1.8.1.2.5====
| |
| − |
| |
| − | =====6.2.4.6.1 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 may also include a the cancer checklist. The only entry for this section is the Problem Organizer Entry module.
| |
| − |
| |
| − | =====6.2.4.6.2 Specification and Example=====
| |
| − |
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.2.5/dynamic}}
| |
| − |
| |
| − | [http://art-decor.org/art-decor/decor-templates--psr-?id=1.3.6.1.4.1.19376.1.8.1.2.5&effectiveDate=2014-05-13T19:31:26 on Art-Decor]
| |
| − |
| |
| − | ====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. This subsection does not contain any entries.
| |
| − |
| |
| − | =====6.2.4.7.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.2.7/dynamic}}
| |
| − |
| |
| − | [http://art-decor.org/art-decor/decor-templates--psr-?id=1.3.6.1.4.1.19376.1.8.1.2.7&effectiveDate=2016-06-13T17:54:42 on Art-Decor]
| |
| − |
| |
| − | ====6.2.4.8 Procedure steps <section> - 1.3.6.1.4.1.19376.1.8.1.2.6====
| |
| − |
| |
| − | =====6.2.4.8.1 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. The only entry for this section is the Specimen Procedure Steps Entry module.
| |
| − |
| |
| − | =====6.2.4.8.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.2.6/dynamic}}
| |
| − |
| |
| − | [http://art-decor.org/art-decor/decor-templates--psr-?id=1.3.6.1.4.1.19376.1.8.1.2.6&effectiveDate=2014-05-13T19:33:12 on Art-Decor]
| |
| − |
| |
| − | ===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 the Problem Organizer <entry>.
| |
| − |
| |
| − | The unique <entry> Content Module available in Procedure Steps <section> of the APSR template is Specimen Procedure Step <entry>.
| |
| − |
| |
| − | Each <entry> Content Module carries machine-readable data related to one Problem on one specimen or on a 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.
| |
| − |
| |
| − | ====6.2.5.2 Problem Organizer – 1.3.6.1.4.1.19376.1.8.1.3.6====
| |
| − |
| |
| − | =====6.2.5.2.1 Definition and purpose=====
| |
| − |
| |
| − | This Content Module is usable as only <entry> within any Section module except Procedure steps <section>.
| |
| − |
| |
| − | The problem organizer groups the battery of observations together with embedded images performed to investigate on a single problem identified on a specimen or group of specimens. If a Problem cannot be addressed specifically the Problem organizer allows also the grouping around one specimen.
| |
| − |
| |
| − | =====6.2.5.2.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.3.6/dynamic}}
| |
| − |
| |
| − | [https://art-decor.org/art-decor/decor-templates--psr-?section=templates&id=1.3.6.1.4.1.19376.1.8.1.3.6&effectiveDate=2015-08-13T10:24:55 on Art-Decor]
| |
| − |
| |
| − | ====6.2.5.3 Specimen Procedure Step <entry> - 1.3.6.1.4.1.19376.1.3.10.4.1====
| |
| − |
| |
| − | =====6.2.5.3.1 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 together with its container(s). 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 (identifiers and types, time intervals, performers, approach site, target site). By referencing the child procedure ID via an entryRelationship the entry is used in an iterative manner for each single step of specimen collection and 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). Specimen and their container carry IDs as well as further attributes, which are defined in the HL7 Specimen DAM.
| |
| − |
| |
| − | [http://www.hl7.org/implement/standards/product_brief.cfm?product_id=331 HL7 DAM Specimen Release 1].
| |
| − |
| |
| − | According to the CDA RIM in the Content Module further supporting Content Modules for Participant, and Playing Entity are needed, which have the (preliminary) OIDs 1.3.6.1.4.1.19376.1.3.10.9.20, 1.3.6.1.4.1.19376.1.3.10.9.21)
| |
| − |
| |
| − | [[Datei:6.2.6.4.1-1-container-2.jpg]]
| |
| − |
| |
| − | '''Figure 6.2.5.3.2-1 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.
| |
| − |
| |
| − | =====6.2.5.3.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.4.1/dynamic}}
| |
| − |
| |
| − | [http://art-decor.org/art-decor/decor-templates--psr-?id=1.3.6.1.4.1.19376.1.3.10.4.1&effectiveDate=2016-07-08T13:20:59 on Art-Decor]
| |
| − |
| |
| − | ===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)
| |
| − |
| |
| − | =====6.2.6.1.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.4.1/dynamic}}
| |
| − |
| |
| − | [http://art-decor.org/art-decor/decor-templates--psr-?id=1.3.6.1.4.1.19376.1.8.1.4.1&effectiveDate=2016-06-13T14:21:13 on Art-Decor]
| |
| − |
| |
| − | ====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.
| |
| − |
| |
| − | =====6.2.6.2.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.4.2/dynamic}}
| |
| − |
| |
| − | [http://art-decor.org/art-decor/decor-templates--psr-?id=1.3.6.1.4.1.19376.1.8.1.4.2&effectiveDate=2016-06-21T14:02:11 on Art-Decor]
| |
| − |
| |
| − | ====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.
| |
| − |
| |
| − | =====6.2.6.3.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.4.2/dynamic}}
| |
| − |
| |
| − | [http://art-decor.org/art-decor/decor-templates--psr-?id=1.3.6.1.4.1.19376.1.8.1.4.3&effectiveDate=2016-07-09T15:03:59 on Art-Decor]
| |
| − |
| |
| − | ====6.2.6.4 Container in Specimen Procedure Step - 1.3.6.1.4.1.19376.1.3.10.9.22====
| |
| − |
| |
| − | =====6.2.6.4.1 Definition and purpose=====
| |
| − |
| |
| − | This Supporting Content Module is usable in the Specimen Procedure Steps <entry> (see 6.2.6.4). It describes the properties of containers, in or on which the specimens are processed. The relations between container and specimen are described in the HL7 Specimen DAM.
| |
| − |
| |
| − | [http://www.hl7.org/implement/standards/product_brief.cfm?product_id=331 HL7 DAM Specimen Release 1].
| |
| − |
| |
| − | For Anatomic Pathology the CDA Content Modules "Material" and "ManufacturedMaterial" were modified under the (preliminary) OIDs 1.3.6.1.4.1.19376.1.3.10.9.23 and 1.3.6.1.4.1.19376.1.3.10.9.24
| |
| − |
| |
| − | =====6.2.6.4.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.22/dynamic}}
| |
| − |
| |
| − | [http://art-decor.org/art-decor/decor-templates--psr-?id=1.3.6.1.4.1.19376.1.3.10.9.22&effectiveDate=2016-07-29T12:09:33 on Art-Decor]
| |
| − |
| |
| − | ====6.2.6.5 Informant – 1.3.6.1.4.1.19376.1.8.1.4.6====
| |
| − |
| |
| − | =====6.2.6.5.1 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.
| |
| − |
| |
| − | =====6.2.6.5.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.4.6/dynamic}}
| |
| − |
| |
| − | [http://art-decor.org/art-decor/decor-templates--psr-?id=1.3.6.1.4.1.19376.1.8.1.4.6&effectiveDate=2016-07-08T11:22:58 on Art-Decor]
| |
| − |
| |
| − | ====6.2.6.6 Additional participant in an entry - 1.3.6.1.4.1.19376.1.8.1.4.7====
| |
| − |
| |
| − | =====6.2.6.6.1 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.
| |
| − |
| |
| − | =====6.2.6.6.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.4.7/dynamic}}
| |
| − |
| |
| − | [http://art-decor.org/art-decor/decor-templates--psr-?id=1.3.6.1.4.1.19376.1.8.1.4.7&effectiveDate=2016-07-12T18:44:06 on Art-Decor]
| |
| − |
| |
| − | ====6.2.6.7 AP Anatomic Pathology Observation template – 1.3.6.1.4.1.19376.1.8.1.4.9====
| |
| − |
| |
| − | =====6.2.6.7.1 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.
| |
| − |
| |
| − | =====6.2.6.7.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.4.9/dynamic}}
| |
| − |
| |
| − | [http://art-decor.org/art-decor/decor-templates--psr-?id=1.3.6.1.4.1.19376.1.8.1.4.9&effectiveDate=2014-05-14T17:09:54 on Art-Decor]
| |
| − |
| |
| − | ====6.2.6.8 Embedded Image – 1.3.6.1.4.1.19376.1.8.1.4.10====
| |
| − |
| |
| − | =====6.2.6.8.1 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.
| |
| − |
| |
| − | =====6.2.6.8.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.4.10/dynamic}}
| |
| − |
| |
| − | [http://art-decor.org/art-decor/decor-templates--psr-?id=1.3.6.1.4.1.19376.1.8.1.4.10&effectiveDate=2016-06-22T16:08:01 on Art-Decor]
| |
| − |
| |
| − | ====6.2.6.9 X Specimen Identified - 1.3.6.1.4.1.19376.1.3.10.9.1 ====
| |
| − |
| |
| − | {{FAQBox|
| |
| − | This is an addendum to the reference text of APSR 2.0 GH
| |
| − | }}
| |
| − |
| |
| − | =====6.2.6.9.1 Definition and purpose=====
| |
| − |
| |
| − | This Specimen Identification <entry> provides the machine-readable links between any type of observation or embedded image or containers to the specimen, from which this observation or image is obtained.
| |
| − | It is required when more than one specimen is documented at this level.
| |
| − | It is only used in PaLM templates for Problem Organizer, Observations, Embedded images, and Containers in Specimen Procedure Steps.
| |
| − |
| |
| − | =====6.2.6.9.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.1/dynamic}}
| |
| − |
| |
| − | [http://art-decor.org/art-decor/decor-templates--psr-?id=1.3.6.1.4.1.19376.1.3.10.9.1&effectiveDate=2014-12-22T15:54:30 on Art-Decor]
| |
| − |
| |
| − | ====6.2.6.10 UICC/AJCC TNM Staging and Grading - 1.3.6.1.4.1.19376.1.3.10.4.2====
| |
| − |
| |
| − | {{FAQBox|
| |
| − | This is an addendum to the reference text of APSR 2.0 GH
| |
| − | }}
| |
| − |
| |
| − | =====6.2.6.10.1 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 a constraint version of an AP Generic observation <entry> Content Module. 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. A series of supporting templates is used for all the detailed descriptions of the elements of the TNM system.
| |
| − |
| |
| − | [[Datei:6.2.6.12.1-1 1.jpeg]]
| |
| − |
| |
| − | '''Figure 6.2.6.10.1-1 CDA-RMIM of the UICC/AJCC TNM <entry>'''
| |
| − |
| |
| − | =====6.2.6.10.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.4.2/dynamic}}
| |
| − |
| |
| − | [http://art-decor.org/art-decor/decor-templates--psr-?id=1.3.6.1.4.1.19376.1.3.10.4.2&effectiveDate=2014-05-13T15:45:13 on Art-Decor]
| |
| − |
| |
| − | ====6.2.6.11 ICD-O-3 Typing and Grading - 1.3.6.1.4.1.19376.1.3.10.4.3====
| |
| − | {{FAQBox|
| |
| − | This is an addendum to the reference text of APSR 2.0 GH
| |
| − | }}
| |
| − |
| |
| − | =====6.2.6.11.1 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 a constraint version of an AP Generic observation <entry> Content Module. It is usable within a Problem Organizer <entry> Content Module only.
| |
| − |
| |
| − | This Content Module structures the machine-readable data, which characterize the typing and grading of a tumor or a systemic malignancy according the WHO regulations for the ICD-O-3 system. A series of supporting templates is used for all the detailed descriptions of the elements of the ICD-O-3 system.
| |
| − |
| |
| − | [[Datei:6.2.6.13.1-1 1.jpeg]]
| |
| − |
| |
| − | '''Figure 6.2.6.11.1-1 CDA-RMIM of the ICD-O-3 <entry>'''
| |
| − |
| |
| − | =====6.2.6.11.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.4.3/dynamic}}
| |
| − |
| |
| − | [http://art-decor.org/art-decor/decor-templates--psr-?id=1.3.6.1.4.1.19376.1.3.10.4.3&effectiveDate=2015-11-29T17:03:18 on Art-Decor]
| |
| − |
| |
| − | ====6.2.6.12 Assessment Scales for Scoring systems - 1.3.6.1.4.1.19376.1.3.10.4.4====
| |
| − | {{FAQBox|
| |
| − | This is an addendum to the reference text of APSR 2.0 GH
| |
| − | }}
| |
| − |
| |
| − | =====6.2.6.12.1 Definition and purpose=====
| |
| − | The Assessment Scales <entry> Content Modul contains in machine-readable form all the information concerning (semi)quantitative scoring systems often used for describing a tumor grading for a problem investigated. It is a constraint version of an AP Generic observation <entry> Content Module. 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.
| |
| − |
| |
| − | [[Datei:6.2.6.14.1-1.jpg]]
| |
| − |
| |
| − | '''Figure 6.2.6.12.1-1 CDA-RMIM of an Assessment Scales <entry>'''
| |
| − |
| |
| − | =====6.2.6.12.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.4.4/dynamic}}
| |
| − |
| |
| − | [http://art-decor.org/art-decor/decor-templates--psr-?id=1.3.6.1.4.1.19376.1.3.10.4.4&effectiveDate=2016-10-06T13:12:00 on Art-Decor]
| |
| − |
| |
| − | =VOLUME 4 - VALUE SETS=
| |
| − |
| |
| − | ==Generic AP Observation Codes 1.3.6.1.4.1.19376.1.3.11.11==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.11/dynamic}}
| |
| − |
| |
| − | [http://art-decor.org/art-decor/decor-valuesets--psr-?id=1.3.6.1.4.1.19376.1.3.11.11&effectiveDate=2015-11-22T12:20:34 on Art-Decor]
| |
| − |
| |
| − | ==Problem type 1.3.6.1.4.1.19376.1.3.11.7==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.7/dynamic}}
| |
| − |
| |
| − | ==Container Entity Class Type 1.3.6.1.4.1.19376.1.3.11.8==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.8/dynamic}}
| |
| − |
| |
| − | ==Procedure (target) site 1.3.6.1.4.1.19376.1.3.11.9==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.9/dynamic}}
| |
| − |
| |
| − | ==Specimen collection and processing 1.3.6.1.4.1.19376.1.3.11.10==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.10/dynamic}}
| |
| − |
| |
| − | ==UICC/AJCC stage 1.3.6.1.4.1.19376.1.3.11.18==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.18/dynamic}}
| |
| − |
| |
| − | ==UICC/AJCC T category 1.3.6.1.4.1.19376.1.3.11.15==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.15/dynamic}}
| |
| − |
| |
| − | ==UICC/AJCC T category (SCT) 1.3.6.1.4.1.19376.1.3.11.12==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.12/dynamic}}
| |
| − |
| |
| − | ==UICC/AJCC N category 1.3.6.1.4.1.19376.1.3.11.16==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.16/dynamic}}
| |
| − |
| |
| − | ==UICC/AJCC N category (SCT) 1.3.6.1.4.1.19376.1.3.11.13==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.13/dynamic}}
| |
| − |
| |
| − | ==UICC/AJCC M category 1.3.6.1.4.1.19376.1.3.11.17==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.17/dynamic}}
| |
| − |
| |
| − | ==UICC/AJCC M category (SCT) 1.3.6.1.4.1.19376.1.3.11.14==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.14/dynamic}}
| |
| − |
| |
| − | ==UICC/AJCC C-Factor 1.3.6.1.4.1.19376.1.3.11.19==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.19/dynamic}}
| |
| − |
| |
| − | ==UICC/AJCC C-Factor (SCT) 1.3.6.1.4.1.19376.1.3.11.20==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.20/dynamic}}
| |
| − |
| |
| − | ==UICC/AJCC Residual tumor (R) classification 1.3.6.1.4.1.19376.1.3.11.21==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.21/dynamic}}
| |
| − |
| |
| − | ==UICC/AJCC clinical/pathological 1.3.6.1.4.1.19376.1.3.11.22==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.22/dynamic}}
| |
| − |
| |
| − | ==UICC/AJCC Venous Invasion 1.3.6.1.4.1.19376.1.3.11.23==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.23/dynamic}}
| |
| − |
| |
| − | ==UICC/AJCC Lymphatic Invasion 1.3.6.1.4.1.19376.1.3.11.24==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.24/dynamic}}
| |
| − |
| |
| − | ==UICC/AJCC Perineurial Invasion 1.3.6.1.4.1.19376.1.3.11.25==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.25/dynamic}}
| |
| − |
| |
| − | ==UICC/AJCC Mucosa 1.3.6.1.4.1.19376.1.3.11.26==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.26/dynamic}}
| |
| − |
| |
| − | ==UICC/AJCC Submucosa 1.3.6.1.4.1.19376.1.3.11.27==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.27/dynamic}}
| |
| − |
| |
| − | ==UICC/AJCC Localization of distant metastases 1.3.6.1.4.1.19376.1.3.11.28==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.28/dynamic}}
| |
| − |
| |
| − | ==UICC/AJCC Grade 3 tiered 1.3.6.1.4.1.19376.1.3.11.29==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.29/dynamic}}
| |
| − |
| |
| − | ==UICC/AJCC Grade 2 tiered 1.3.6.1.4.1.19376.1.3.11.30==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.30/dynamic}}
| |
| − |
| |
| − | ==UICC/AJCC Grade 4 tiered 1.3.6.1.4.1.19376.1.3.11.31==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.31/dynamic}}
| |
| − |
| |
| − | == UICC/AJCC Tumor Serum Markers 1.3.6.1.4.1.19376.1.3.11.32==
| |
| − |
| |
| − | {{:2.16.840.1.113883.2.6.60.6.11.21/dynamic}}
| |
| − |
| |
| − | ==ICD-O-3 Morphology 1.3.6.1.4.1.19376.1.3.11.33==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.33/dynamic}}
| |
| − |
| |
| − | ==ICD-O-3 Behavior 1.3.6.1.4.1.19376.1.3.11.34==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.34/dynamic}}
| |
| − |
| |
| − | ==ICD-O-3 Differentiation 1.3.6.1.4.1.19376.1.3.11.35==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.35/dynamic}}
| |
| − |
| |
| − | ==ICD-O-3 Topography 1.3.6.1.4.1.19376.1.3.11.36==
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.36/dynamic}}
| |
