|
|
| Zeile 80: |
Zeile 80: |
| | 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 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.<ref>Goldsmith, J.D., et al., “Reporting
| |
| − | guidelines for clinical laboratory reports in surgical pathology” Arch Pathol
| |
| − | Lab Med, 2008. 132(10): p. 1608-16</ref> 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<ref>http://www.cap.org/web/oracle/webcenter/portalapp/pagehierarchy/cancer_protocol_templates.jspx?_adf.ctrl-state=e1f4ltym4_4&_afrLoop=275425457234715#!</ref>, and by
| |
| − | the “comptes rendus d’anatomopathologie : données minimales à renseigner pour
| |
| − | une tumeur primitive” produced by the French society of pathology (SFP<ref> http://www.sfpathol.org</ref>)
| |
| − | for the French cancer institute (INCa <ref>http://www.e-cancer.fr</ref>), and by the German "Guideline Pathology / Neuropathology" (formerly TM-30) of the Sector Committee Pathology for the implementation of DIN EN ISO/EC 17020.
| |
| − |
| |
| − | 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=====
| |
| − | Dr. Eva Surgeon, PhD, takes a ultrasound guided core biopsy from a breast tumor from patient Eve Onewoman, born on Sept 21 1971, requests the procedure “breast core biopsy specimen - pathological examination” and sends the specimen to the anatomic pathology laboratory of the Cancer Institute.
| |
| − | One specimen (five cores) is accessioned by the anatomic pathology laboratory under the accession number A710240008. The staff performs a macroscopic examination of the specimen; gross imaging is performed if needed. The specimen with the specimen ID A710240008_A is 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 of the macroscopic and microscopic observations and some ancillary techniques, done by the pathologists Dr. Marcel Pathologist, PhD, and Dr. Jonas Jones, M.D., Dr. Marcel 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 Text Example=====
| |
| − | Macroscopic observation
| |
| − |
| |
| − | A. "RIGHT BREAST FIVE CORES 8-9:00" (ULTRASOUND GUIDED NEEDLE CORE BIOPSY):
| |
| − |
| |
| − | Microscopic observation
| |
| − |
| |
| − | INVASIVE ADENOCARCINOMA OF THE BREAST.<br/>
| |
| − | ICD-O-3-CLASSIFICATION: C50.3 M8500/33<br/>
| |
| − | HISTOLOGIC TYPE: DUCTAL.<br/>
| |
| − | NOTTINGHAM COMBINED HISTOLOGIC GRADE: 1 OF 3.<br/>
| |
| − | TUBULE FORMATION SCORE: 2.
| |
| − | NUCLEAR PLEOMORPHISM SCORE: 2.
| |
| − | MITOTIC RATE SCORE: 1.
| |
| − |
| |
| − | IN-SITU CARCINOMA: EQUIVOCAL.
| |
| − |
| |
| − | BREAST CANCER BIOMARKER STUDIES:<br/>
| |
| − | PARAFFIN BLOCK NUMBER: A1.<br/>
| |
| − | ER INTERPRETATION: POSITIVE ESTROGEN RECEPTOR ACTIVITY (ALLRED SCORE = 8, Percentage of positive cells = 85%, Staining Intensity score = 3).<br/>
| |
| − | PR INTERPRETATION: POSITIVE PROGESTERONE RECEPTOR ACTIVITY (ALLRED SCORE = 8).<br/>
| |
| − | DAKO EGFR PHARMDX IMMUNOHISTOCHEMISTRY: NEGATIVE (0) FOR EXPRESSION OF
| |
| − | EPIDERMAL GROWTH FACTOR RECEPTOR.<br/>
| |
| − | HER2/NEU IMMUNOHISTOCHEMISTRY: AMBIGUOUS(2+) FOR OVEREXPRESSION OF HER2/NEU
| |
| − | ONCOPROTEIN.<br/>
| |
| − | HER2/NEU FISH RESULT: NEGATIVE FOR AMPLIFICATION OF HER2/NEU.<br/>
| |
| − |
| |
| − | Diagnostic conclusion
| |
| − |
| |
| − | A. "RIGHT BREAST FIVE CORES 8-9:00" (ULTRASOUND GUIDED NEEDLE CORE BIOPSY):
| |
| − |
| |
| − | INVASIVE ADENOCARCINOMA OF THE BREAST.<br/>
| |
| − | ICD-O-3-CLASSIFICATION: C50.3 M8500/33<br/>
| |
| − | HISTOLOGIC TYPE: DUCTAL.<br/>
| |
| − | NOTTINGHAM COMBINED HISTOLOGIC GRADE: 1 OF 3.<br/>
| |
| − | TUBULE FORMATION SCORE: 2.
| |
| − | NUCLEAR PLEOMORPHISM SCORE: 2.
| |
| − | MITOTIC RATE SCORE: 1.
| |
| − |
| |
| − | IN-SITU CARCINOMA: EQUIVOCAL.
| |
| − |
| |
| − | BREAST CANCER BIOMARKER STUDIES:<br/>
| |
| − | PARAFFIN BLOCK NUMBER: A1.<br/>
| |
| − | ER INTERPRETATION: POSITIVE ESTROGEN RECEPTOR ACTIVITY (ALLRED SCORE = 8, Percentage of positive cells = 85%, Staining Intensity score = 3).<br/>
| |
| − | PR INTERPRETATION: POSITIVE PROGESTERONE RECEPTOR ACTIVITY (ALLRED SCORE = 8).<br/>
| |
| − | DAKO EGFR PHARMDX IMMUNOHISTOCHEMISTRY: NEGATIVE (0) FOR EXPRESSION OF
| |
| − | EPIDERMAL GROWTH FACTOR RECEPTOR.<br/>
| |
| − | HER2/NEU IMMUNOHISTOCHEMISTRY: AMBIGUOUS(2+) FOR OVEREXPRESSION OF HER2/NEU
| |
| − | ONCOPROTEIN.<br/>
| |
| − | HER2/NEU FISH RESULT: NEGATIVE FOR AMPLIFICATION OF HER2/NEU.<br/>
| |
| − |
| |
| − | ====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 identical to the actual 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 Intended Audience ==
| |
| − | The intended audience of IHE Technical Frameworks Volume 3 is:
| |
| − | * IT departments of healthcare institutions
| |
| − | * Technical staff of vendors participating in the IHE initiative
| |
| − | * Experts involved in standards development
| |
| − |
| |
| − | == 1.3 Overview of Technical Framework Volume 3 ==
| |
| − | Volume 3 is comprised of several distinct sections:
| |
| − | * Section 1 provides background and reference material.
| |
| − | * Section 2 presents the conventions used in this volume to define the content modules.
| |
| − | * Section 3 provides an overview of Content Modules and the terminology used.
| |
| − | * Section 4 is reserved for domain unique Content Module specifications.
| |
| − | * Section 5 lists the namespaces and identifiers defined or referenced and the vocabularies defined or referenced herein.
| |
| − | * Section 6 defines the PaLM domain’s HL7 V3 CDA Content Modules in detail.
| |
| − | * Section 7 defines the PaLM domain’s DICOM content modules in detail.
| |
| − | * Section 8 defines other types of content modules.
| |
| − | The appendices in Volume 3 provide clarification of technical details of the IHE data model and transactions. A glossary of terms and acronyms used in the IHE Technical Framework, including those from relevant standards, is provided in the [http://ihe.net/TF_Intro_Appendices.aspx IHE Technical Frameworks General Introduction]. Due to the length of the document, some domains may divide Volume 3 into smaller volumes labeled 3a, 3b, etc. In this case, the Volume 3 appendices are gathered in Volume 3x. Code and message samples may also be stored on the IHE ftp server. In this case, explicit links to the ftp server will be provided in the transaction text.
| |
| − |
| |
| − | == 1.4 Comment Process ==
| |
| − | IHE International welcomes comments on this document and the IHE initiative. They can be submitted by sending an email to the co-chairs and secretary of the Pathology and Laboratory Medicine domain committees at palm@ihe.net
| |
| − |
| |
| − | == 1.5 Copyright Licenses ==
| |
| − | IHE International hereby grants to each Member Organization, and to any other user of these documents, an irrevocable, worldwide, perpetual, royalty-free, nontransferable, nonexclusive, non-sublicensable license under its copyrights in any IHE profiles and Technical Framework documents, as well as any additional copyrighted materials that will be owned by IHE International and will be made available for use by Member Organizations, to reproduce and distribute (in any and all print, electronic or other means of reproduction, storage or transmission) such IHE Technical Documents.
| |
| − | The licenses covered by this Copyright License are only to those copyrights owned or controlled by IHE International itself. If parts of the Technical Framework are included in products that also include materials owned or controlled by other parties, licenses to use those products are beyond the scope of this IHE document and would have to be obtained from that other party.
| |
| − | === 1.5.1 Copyright of Base Standards ===
| |
| − | IHE technical documents refer to and make use of a number of standards developed and published by several standards development organizations. All rights for their respective base standards are reserved by these organizations. This agreement does not supersede any copyright provisions applicable to such base standards.
| |
| − | Health Level Seven, Inc. has granted permission to 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.
| |
| − |
| |
| − | == 1.6 Trademark ==
| |
| − | IHE® and the IHE logo are trademarks of the Healthcare Information Management Systems Society in the United States and trademarks of IHE Europe in the European Community. They may only be used with the written consent of the IHE International Board Operations Committee, which may be given to a Member Organization in broad terms for any use that is consistent with the IHE mission and operating principles.
| |
| − |
| |
| − | == 1.7 Disclaimer Regarding Patent Rights ==
| |
| − | Attention is called to the possibility that implementation of the specifications in this document may require use of subject matter covered by patent rights. By publication of this document, no position is taken with respect to the existence or validity of any patent rights in connection therewith. IHE International is not responsible for identifying Necessary Patent Claims for which a license may be required, for conducting inquiries into the legal validity or scope of Patents Claims or determining whether any licensing terms or conditions provided in connection with submission of a Letter of Assurance, if any, or in any licensing agreements are reasonable or non-discriminatory. Users of the specifications in this document are expressly advised that determination of the validity of any patent rights, and the risk of infringement of such rights, is entirely their own responsibility. Further information about the IHE International patent disclosure process including links to forms for making disclosures is available [http://www.ihe.net/Patent_Disclosure_Process here]. Please address questions about the patent disclosure process to the secretary of the IHE International Board: secretary@ihe.net
| |
| − |
| |
| − | == 1.8 History of Document Changes ==
| |
| − | Content Modules for the APSR 2.0 Profile:
| |
| − |
| |
| − | *Reconfiguration of the Document content module
| |
| − | *Reconfiguration of the Procedure step section content module
| |
| − | *Introduction of the Additionally Specified Observation section content module
| |
| − | *Reconfiguration 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.
| |
| − |
| |
| − | = 2 Conventions =
| |
| − | This document has adopted the following conventions for representing the framework concepts and specifying how the standards upon which the IHE Technical Framework is based shall be applied.
| |
| − |
| |
| − | == 2.1 Content Module Modeling and Profiling Conventions ==
| |
| − | In order to maintain consistent documentation, modeling methods for IHE content modules and profiling conventions for frequently used standards are maintained as an appendix in the [http://ihe.net/TF_Intro_Appendices.aspx IHE Technical Frameworks General Introduction]. Methods described include the standards conventions DICOM, HL7 v2.x, HL7 Clinical Document Architecture (CDA) Documents, etc. These conventions are critical to understanding this volume and should be reviewed prior to reading this text.
| |
| − |
| |
| − | == 2.2 Additional Standards Profiling Conventions ==
| |
| − | This section defines profiling conventions for standards which are not described in the IHE Technical Frameworks General Introduction.<br/>
| |
| − | Not Applicable.
| |
| − |
| |
| − | = 3 Content Modules Overview and Terminology =
| |
| − | In the future, an appendix to the IHE Technical Frameworks General Introduction will provide an overview of Content Modules. In the interim, information may be available [http://wiki.ihe.net/index.php?title=Profiles here].<br/>
| |
| − | The Pathology and Laboratory Medicine content modules are listed in the table below:<br/>
| |
| − | '''Table 3-1: Pathology and Laboratory Medicine Content Modules'''
| |
| − | {| class="hl7table"
| |
| − | !Content Module Acronym !! Type of Content Modules !! Semantic !! Status
| |
| − | |-
| |
| − | |XD-LAB || CDA R2 medical document || Clinical Laboratory Structured Report || Final Text
| |
| − | |-
| |
| − | |APSR || CDA R2 medical document || Anatomic Pathology Structured Report || Public Comment
| |
| − | |-
| |
| − | |}
| |
| − |
| |
| − | = 4 IHE Pathology and Laboratory Medicine Bindings =
| |
| − | == 4.1 Medical Document Binding to XDS, XDM and XDR ==
| |
| − | The bindings of the content modules of the PaLM domain leverage the bindings specified by the Patient Care Coordination domain, in [http://www.ihe.net/uploadedFiles/Documents/PCC/IHE_PCC_TF_Vol2.pdf PCC TF Volume 2], section 4, with the addition of the constraints specified below.
| |
| − | === 4.1.1 XDSDocumentEntry Metadata ===
| |
| − | ==== 4.1.1.1 XDSDocumentEntry.eventCodeList ====
| |
| − | <syntaxhighlight lang="xml">
| |
| − | Append this paragraph at the end of the section.</syntaxhighlight>
| |
| − | For the APSR content module, The XDSDocumentEntry.eventCodeList 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.
| |
| − |
| |
| − | ==== 4.1.1.2 XDSDocumentEntry.formatCode ====
| |
| − | <syntaxhighlight lang="xml">
| |
| − | Append this paragraph at the end of the section.</syntaxhighlight>
| |
| − | For the APSR content module, The XDSDocumentEntry.formatCode SHALL be urn:ihe:palm:apsr:2016<br/>
| |
| − | The associated codingScheme SHALL be 1.3.6.1.4.1.19376.1.2.3
| |
| − |
| |
| − | ==== 4.1.1.3 XDSDocumentEntry.parentDocumentRelationship ====
| |
| − | <syntaxhighlight lang="xml">
| |
| − | Append this paragraph at the end of the section.</syntaxhighlight>
| |
| − | For the APSR content module XDSDocumentEntry.parentDocumentRelationship is constrained to the "'''RPLC'''" value. When there is a parent document the current document is a new version of the parent document, replacing it.
| |
| − |
| |
| − | * Note 1: A non-final anatomic pathology 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.
| |
| − |
| |
| − | = 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, BUT THIS TEMPORARY VOCABULARY IS NO LONGER USED
| |
| − |
| |
| − | 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 of AP content built by the PaLM domain.
| |
| − |
| |
| − |
| |
| − | Notes on other IHE OIDs used in the AP domain:
| |
| − |
| |
| − | Branch 1.3.6.1.4.1.19376.1.3.4 is used to identify instances in the examples of AP content built by XD-LAB in the PaLM domain.
| |
| − |
| |
| − | == 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'''
| |
| − |
| |
| − | {|class="hl7table"
| |
| − | !codeSystem!!codeSystemName and Description!!Owner
| |
| − | |- valign=top
| |
| − | |2.16.840.1.113883.6.1
| |
| − | |LOINC<br/>''Logical Observation Identifier Names and Codes''
| |
| − | |Regenstrief Institute
| |
| − |
| |
| − | |- valign=top
| |
| − | |2.16.840.1.113883.6.8
| |
| − | |UCUM<br/>''Unified Code for Units of Measure''
| |
| − | |Regenstrief Institute, and the UCUM Organization
| |
| − |
| |
| − | |- valign=top
| |
| − | |2.16.840.1.113883.6.96
| |
| − | |SNOMED-CT<br/>''Systematized Nomenclature of Medicine – Clinical Terms''
| |
| − | |IHTSDO/Snomed International
| |
| − |
| |
| − | |- valign=top
| |
| − | |1.3.6.1.4.1.19376.1.5.3.2
| |
| − | |IHEActCode<br/>''Vocabulary defined by IHE PCC in PCC TF-2:5.1.2, used for representing annotation comments in the report''
| |
| − | |IHE PCC
| |
| − |
| |
| − | |- valign=top
| |
| − | |2.16.840.1.113883.5.4
| |
| − | |Act Code<br/>''Codesystem for Acts''
| |
| − | |HL7 International
| |
| − |
| |
| − | |- valign=top
| |
| − | |2.16.840.1.113883.5.6
| |
| − | |ActClass<br/>''Codesystem for Act Classes''
| |
| − | |HL7 International
| |
| − |
| |
| − | |- valign=top
| |
| − | |2.16.840.1.113883.5.1052
| |
| − | |Act Site<br/>''Codesystem for Act Sites''
| |
| − | |HL7 International
| |
| − |
| |
| − | |- valign=top
| |
| − | |2.16.840.1.113883.5.1065
| |
| − | |ProcedureMethod<br/>''Codesystem for Procedure Methods''
| |
| − | |HL7 International
| |
| − |
| |
| − | |- valign=top
| |
| − | |2.16.840.1.113883.5.111
| |
| − | |Role Code<br/>''Codesystem for Role Codes''
| |
| − | |HL7 International
| |
| − |
| |
| − | |- valign=top
| |
| − | |2.16.840.1.113883.5.129
| |
| − | |SpecimenType<br/>''Codesystem for Specimen Types''
| |
| − | |HL7
| |
| − |
| |
| − | |- valign=top
| |
| − | |2.16.840.1.113883.5.83
| |
| − | |ObservationInterpretation<br/>''One or more codes specifying a rough qualitative interpretation of the observation, such as "normal", "abnormal", "below normal", "change up", "resistant", "susceptible", etc.''
| |
| − | |HL7 International
| |
| − |
| |
| − | |- valign=top
| |
| − | |2.16.840.1.113883.5.84
| |
| − | |ObservationMethod<br/>''A code system that provides additional detail about the means or technique used to ascertain the observation''
| |
| − | |HL7 International
| |
| − |
| |
| − | |- valign=top
| |
| − | |2.16.840.1.113883.6.3
| |
| − | |ICD-10<br/>''International Classification of Diseases revision 10''
| |
| − | |WHO
| |
| − |
| |
| − | |- valign=top
| |
| − | |2.16.840.1.113883.6.43.1
| |
| − | |ICD-O-3<br/>''International Classification of Diseases for Oncology, 3rd edition, revision 1, 2013''
| |
| − | |WHO
| |
| − |
| |
| − | |- valign=top
| |
| − | | 1.2.840.10008.2.16.4
| |
| − | |DICOM controlled vocabulary<br/>''The meanings of codes defined in DICOM, either explicitly or by reference to another part of DICOM or an external reference document or standard <ref>DICOM controlled vocabulary http://nema.org/dicom/dicm]</ref>''
| |
| − | |DICOM
| |
| − |
| |
| − | |- valign=top
| |
| − | |2.16.840.1.113883.15.16
| |
| − | |TNM 8th edition<br/>''Internationally agreed-upon standards to describe and categorize cancer stages and progression <ref name="uicctnm">UICC TNM http://www.uicc.org/resources/tnm</ref>''
| |
| − | |Union for International Cancer Control (UICC) & American Joint Committee on Cancer (AJCC)
| |
| − |
| |
| − | |- valign=top
| |
| − | |2.16.840.1.113883.15.6
| |
| − | |TNM 7th edition<br/>''Internationally agreed-upon standards to describe and categorize cancer stages and progression <ref name="uicctnm">UICC TNM http://www.uicc.org/resources/tnm</ref>''
| |
| − | |Union for International Cancer Control (UICC) & American Joint Committee on Cancer (AJCC)
| |
| − |
| |
| − | |- valign=top
| |
| − | |2.16.840.1.113883.15.7
| |
| − | |TNM 6th edition<br/>''Internationally agreed-upon standards to describe and categorize cancer stages and progression <ref name="uicctnm"/>''
| |
| − | |Union for International Cancer Control (UICC) & American Joint Committee on Cancer (AJCC)
| |
| − |
| |
| − | |- valign=top
| |
| − | |2.16.840.1.113883.15.8
| |
| − | |TNM 5th edition<br/>''Internationally agreed-upon standards to describe and categorize cancer stages and progression <ref name="uicctnm"/>''
| |
| − | |Union for International Cancer Control (UICC) & American Joint Committee on Cancer (AJCC)
| |
| − |
| |
| − | |- valign=top
| |
| − | |2.16.840.1.113883.6.4
| |
| − | |ICD-10-PCS<br/>''International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS)''
| |
| − | |WHO
| |
| − |
| |
| − | |- valign=top
| |
| − | |1.2.276.0.76.5.464
| |
| − | |OPS 2017<br/>''Code lists to describe and categorize surgeries and procedures, adapted from WHO ICPM for Germany''
| |
| − | |DIMDI / (WHO)
| |
| − |
| |
| − | |- valign=top
| |
| − | |2.16.840.1.113883.6.174
| |
| − | |OMIM<br/>''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<ref> OMIM Johns Hopkins University School of Medicine http://www.omim.org</ref>
| |
| − |
| |
| − | |- valign=top
| |
| − | |1.2.276.0.76.3.1.131.1.5.1
| |
| − | |DKG Coding Scheme<br/>''Internationally agreed-upon code lists to describe and categorize cancer grading systems, adapted for Germany <ref>Coding Schemes German Cancer Society http://wiki.hl7.de/index.php?title=cdaonk:OID-Konzept</ref>''
| |
| − | |DKG (Deutsche Krebsgesellschaft)
| |
| − |
| |
| − | |- valign=top
| |
| − | |1.2.276.0.76.5.336
| |
| − | |Grading / Differentiation scheme<br/>''Code lists to describe and categorize Tumor grading according ICD-O-3, adapted for Germany''
| |
| − | ||HL7 Germany
| |
| − |
| |
| − | |- valign=top
| |
| − | |1.2.276.0.76.5.401
| |
| − | |Localization scheme for distant metastases<br/>''Code lists to describe and categorize localization of metastases according UICC, adapted for Germany''
| |
| − | |HL7 Germany
| |
| − | |}
| |
| − |
| |
| − | == 5.3 Value Sets ==
| |
| − |
| |
| − |
| |
| − | The value sets defined or referenced by this Volume 3 of the IHE PaLM TF Suppl. are listed and specified in Appendix A of this Volume.
| |
| − |
| |
| − | ==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 PaLM TF-3. This extension has been created by former 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
| |
| − |
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.3.3.1.1
| |
| − | ||CDA R2||Human Patient
| |
| − | ||IHE PaLM TF-3:6.3.2.11.1
| |
| − |
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.3.1.3
| |
| − | ||CDA R2||Specimen Received
| |
| − | ||IHE PaLM TF-3:6.3.4.6
| |
| − |
| |
| − | |-
| |
| − | |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
| |
| − |
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.3.1.6
| |
| − | ||CDA R2||Laboratory Observation
| |
| − | ||IHE PaLM TF-3:6.3.4.13
| |
| − |
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.3.3.1.4
| |
| − | ||CDA R2||Intended Recipient
| |
| − | ||IHE PaLM TF-3:6.3.2.14
| |
| − |
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.3.3.1.6
| |
| − | ||CDA R2||Ordering Provider (ordering physician)
| |
| − | ||IHE PaLM TF-3:6.3.2.17
| |
| − |
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.3.3.1.7
| |
| − | ||CDA R2||Laboratory Performer
| |
| − | ||IHE PaLM TF-3:6.3.2.20
| |
| − |
| |
| − | |}
| |
| − |
| |
| − | == 5.6 IHE code and formatCode for Anatomic Pathology Document Template ==
| |
| − | <syntaxhighlight lang="xml">
| |
| − | Merge the content of this section into the current section 5.1.1 of PaLM TF volume 3.
| |
| − | </syntaxhighlight>
| |
| − | Any AP structured report SHALL be associated with the metadata typeCode = “11526-1”, which is the LOINC code for “Pathology study”.
| |
| − |
| |
| − | The table below lists the format codes, template identifiers and media types used by the IHE Profiles specified in the PaLM Technical Framework.
| |
| − | Note that the code system for these codes is 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). For more information see [http://wiki.ihe.net/index.php?title=XDS_Coding_System_%281.3.6.1.4.1.19376.1.2.3%29 XDS Coding System (1.3.6.1.4.1.19376.1.2.3)].
| |
| − | <br/>
| |
| − | {| class="hl7table"
| |
| − | !Profile !! formatCode !! Media Type !! Template ID
| |
| − | |-
| |
| − | |XD-LAB || urn:ihe:lab:xd-lab:2008 || text/xml || 1.3.6.1.4.1.19376.1.3.3
| |
| − | |-
| |
| − | |APSR || urn:ihe:palm:apsr:2016 || text/xml || 1.3.6.1.4.1.19376.1.8.1.1.1
| |
| − | |}
| |
| − |
| |
| − | <div class="landscape">
| |
| − | =6 PaLM HL7 CDA Content Modules=
| |
| − |
| |
| − | ==6.1 Conventions==
| |
| − |
| |
| − | * HL7 CDA conventions are defined in the [http://ihe.net/TF_Intro_Appendices.aspx IHE Technical Frameworks General Introduction Appendix E]
| |
| − |
| |
| − | * In all Content Modules specified in this section, the abbreviation “'''AP'''” stands for “Anatomic Pathology”.
| |
| − |
| |
| − | ==6.2 Folder Modules==
| |
| − | Intentionally left blank
| |
| − |
| |
| − | ==6.3 Content Modules==
| |
| − | This section defines each IHE Pathology and Laboratory Medicine Content Module in detail, specifying the standards used and the information defined.
| |
| − |
| |
| − | ===6.3.1 CDA Document Content Modules===
| |
| − | All persons (including the patient) and organizations mentioned in the CDA Document Content Modules SHALL include the elements ''name'', ''addr'' and ''telecom''.
| |
| − |
| |
| − | ====6.3.1.1 Clinical Laboratory Report Content Module 1.3.6.1.4.1.19376.1.3.3====
| |
| − | <syntaxhighlight lang="xml">Section unchanged, as in PaLM TF-3</syntaxhighlight>
| |
| − |
| |
| − | ====6.3.1.2 Anatomic Pathology Structured Report Content Module 1.3.6.1.4.1.19376.1.8.1.1.1====
| |
| − | This Content Integration Profile describes a surgical pathology report as an electronic document to be published towards a document sharing resource such as an Electronic Health Record (EHR) or Personal Health Record (PHR) shared by a community of care providers, using one of the document sharing profiles defined in ITI-TF. <br/>
| |
| − | Such an electronic document contains the set of releasable results produced by an surgical pathology laboratory in fulfillment of an Order or an Order Group for a patient. The report is shared in a human-readable format. In addition, this electronic anatomic pathology report SHALL contain diagnostic conclusions in a machine-readable format, to facilitate the integration of these observations in the database of a consumer system. <br/>
| |
| − | This Document Content Module defines the base set of constraints that apply to all AP structured reports, related to any kind of lesion or diagnostic problem (cancers, benign neoplasms as well as non-neoplastic conditions) as well as for Cytopathology. <br/>
| |
| − | In other words, this is the generic template for any AP structured report.<br/> <br/>
| |
| − | This document content module is identified by templateId 1.3.6.1.4.1.19376.1.8.1.1.1. <br/>
| |
| − | 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. The only mandatory section is the Diagnostic Conclusion Section. And the only mandatory entry is the Problem Organizer Entry below this section. <br/><br/>
| |
| − |
| |
| − | The specification of this Document Content Module is built and published on Art-Decor [https://art-decor.org/art-decor/decor-project--psr- Pathology Structured Reporting], including schematron rules, code systems and value sets.
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.1.1/dynamic}}
| |
| − |
| |
| − | =====6.3.1.2.1 General constraints that apply to APSR=====
| |
| − | *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.
| |
| − | *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.
| |
| − |
| |
| − |
| |
| − | =====6.3.1.2.2 Common structure for CDA APSR=====
| |
| − |
| |
| − | Figure 6.3.1.2.2-1 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 6.3.1.2.2-1 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 6.3.1.2.2-2 shows the common structure of the Procedure Step Content Module specified here, too.
| |
| − |
| |
| − | [[Datei:6.2.1.3-2-FO_FM_GH.jpeg]]
| |
| − |
| |
| − | '''Figure 6.3.1.2.2-2 CDA APSR: common structure of machine-readable content for Procedure Step Content Module '''
| |
| − |
| |
| − | ===6.3.2 Place Holder===
| |
| − | Intentionally left blank
| |
| − |
| |
| − | ===6.3.3 Place Holder===
| |
| − | Intentionally left blank
| |
| − |
| |
| − | ===6.3.4 CDA R2 <section> Content Modules===
| |
| − |
| |
| − | ====6.3.4.1 Clinical Information <section> - 1.3.6.1.4.1.19376.1.8.1.2.1====
| |
| − |
| |
| − | =====6.3.4.1.1 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.
| |
| − |
| |
| − | =====6.3.4.1.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.2.1/dynamic}}
| |
| − |
| |
| − | ====6.3.4.2 Intraoperative Observation <section> - 1.3.6.1.4.1.19376.1.8.1.2.2====
| |
| − |
| |
| − | =====6.3.4.2.1 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.
| |
| − |
| |
| − | =====6.3.4.2.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.2.2/dynamic}}
| |
| − |
| |
| − | ====6.3.4.3 Macroscopic Observation <section> - 1.3.6.1.4.1.19376.1.8.1.2.3====
| |
| − |
| |
| − | =====6.3.4.3.1 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.
| |
| − |
| |
| − | =====6.3.4.3.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.2.3/dynamic}}
| |
| − |
| |
| − | ====6.3.4.4 Microscopic Observation <section> - 1.3.6.1.4.1.19376.1.8.1.2.4====
| |
| − |
| |
| − | =====6.3.4.4.1 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.
| |
| − |
| |
| − | =====6.3.4.4.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.2.4/dynamic}}
| |
| − |
| |
| − | ====6.3.4.5 Additional Specified Observation <section> - 1.3.6.1.4.1.19376.1.3.10.3.1====
| |
| − |
| |
| − | =====6.3.4.5.1 Definition and Purpose=====
| |
| − |
| |
| − | The Additional Specified Observation section includes additional pathologic finding(s) and the results of ancillary studies 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.
| |
| − |
| |
| − | =====6.3.4.5.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.3.1/dynamic}}
| |
| − |
| |
| − | ====6.3.4.6 Diagnostic Conclusion <section> - 1.3.6.1.4.1.19376.1.8.1.2.5====
| |
| − |
| |
| − | =====6.3.4.6.1 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 sample or group of specimen samples are reported separately. This section may include diagrams and still images or virtual slides, if taken. In case of cancer, this section may also include a cancer checklist. The only entry for this section is the Problem Organizer Entry module.
| |
| − |
| |
| − | =====6.3.4.6.2 Specification and Example=====
| |
| − |
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.2.5/dynamic}}
| |
| − |
| |
| − | ====6.3.4.7 Procedure steps <section> - 1.3.6.1.4.1.19376.1.8.1.2.6====
| |
| − |
| |
| − | =====6.3.4.7.1 Definition and Purpose=====
| |
| − |
| |
| − | The Procedure steps section contains the description of tissue sampling and 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.
| |
| − |
| |
| − | =====6.3.4.7.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.2.6/dynamic}}
| |
| − |
| |
| − | ===6.3.5 CDA R2 <entry> Content Modules===
| |
| − |
| |
| − | ====6.3.5.1 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 problem on one specimen or one group of specimens.
| |
| − |
| |
| − | ====6.3.5.2 Problem Organizer <entry> – 1.3.6.1.4.1.19376.1.8.1.3.6====
| |
| − |
| |
| − | =====6.3.5.2.1 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 on a group of specimens. If a Problem cannot be addressed specifically the Problem organizer allows also the grouping around one specimen. The problem type is coded by using a component with a generic CDA observation, not to confuse with the series of AP and other observations organized by this Organizer content module.
| |
| − |
| |
| − | =====6.3.5.2.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.3.6/dynamic}}
| |
| − |
| |
| − | ====6.3.5.3 Specimen Procedure Step <entry> - 1.3.6.1.4.1.19376.1.3.10.4.1====
| |
| − |
| |
| − | =====6.3.5.3.1 Definition and purpose=====
| |
| − | The Specimen Procedure Step <entry> Content Module contains in machine-readable form all the data 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, status, time intervals, performers, approach site, target site, etc.). <br/>
| |
| − | 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. <br/>
| |
| − | The resulting specimen is the participant in the procedure according to the CDA-RIM (fig. 6.2.5.3.2-1) with the typeCode="PRD", and the role of "SPEC". The specimen ID is the ParticipantRole.ID.<br/>
| |
| − | Additives to the specimen (e.g. fixatives) MAY be additional participants with the typeCode="CSM". <br/>
| |
| − | Each specimen is put in or on an appropriate container. The container is described through one or more EntryRelationship(s) to one or more Supply whose product is the container and possible container components (see this volume, 6.3.6.4).<br/>
| |
| − | The specimen reception in laboratory may be expressed through another EntryRelationship of typeCode "COMP", introducing the "specimen received" Act. <br/>
| |
| − | In case the procedure step produces a child specimen, the parent specimen is the specimen on which the procedure is performed. Thus the parent specimen is represented by a Specimen participation to the procedure. In this case, Specimen.SpecimenRole.Id is the id of the parent specimen. These parent specimens might be multiple, for instance in the case of TMA.Therefore, cardinalities of Specimen are [0..*]<br/>
| |
| − | Specimen and their containers carry IDs as well as further attributes, which are defined in the HL7 Specimen DAM.
| |
| − |
| |
| − | <ref>http://www.hl7.org/implement/standards/product_brief.cfm?product_id=331 HL7 DAM Specimen Release 1</ref>.
| |
| − |
| |
| − |
| |
| − | [[Datei:6.2.6.4.1-1_container_5.jpg|700px]]
| |
| − |
| |
| − | '''Figure 6.3.5.3.1-1 CDA-RMIM of the Specimen Procedure Steps <entry>'''
| |
| − |
| |
| − | 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). The
| |
| − |
| |
| − | The Code systems and Value sets MAY be organized organ-specific.
| |
| − |
| |
| − | =====6.3.5.3.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.4.1/dynamic}}
| |
| − |
| |
| − | '''Supportive template CDA Participant (Body) Procedure Steps APSR2 - 1.3.6.1.4.1.19376.1.3.10.9.20'''
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.20/dynamic}}
| |
| − |
| |
| − | '''Supportive template CDA PlayingEntitySpecimen APSR2 - 1.3.6.1.4.1.19376.1.3.10.9.21'''
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.21/dynamic}}
| |
| − |
| |
| − | ===6.3.6 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.
| |
| − |
| |
| − | ====6.3.6.1 Specimen Collector in Header – 1.3.6.1.4.1.19376.1.8.1.4.1====
| |
| − |
| |
| − | =====6.3.6.1.1 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)
| |
| − |
| |
| − | =====6.3.6.1.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.4.1/dynamic}}
| |
| − |
| |
| − | ====6.3.6.2 Author – 1.3.6.1.4.1.19376.1.8.1.4.2====
| |
| − |
| |
| − | =====6.3.6.2.1 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.
| |
| − |
| |
| − | =====6.3.6.2.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.4.2/dynamic}}
| |
| − |
| |
| − | ====6.3.6.3 Content Validator – 1.3.6.1.4.1.19376.1.8.1.4.3====
| |
| − |
| |
| − | =====6.3.6.3.1 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.
| |
| − |
| |
| − | =====6.3.6.3.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.4.3/dynamic}}
| |
| − |
| |
| − | ====6.3.6.4 Specimen Container in Specimen Procedure Step - 1.3.6.1.4.1.19376.1.3.10.9.22====
| |
| − |
| |
| − | =====6.3.6.4.1 Definition and purpose=====
| |
| − |
| |
| − | This Supporting Content Module is usable in the Specimen Procedure Steps <entry> (see 6.2.6.4) and is repeatable within one procedure step for describing container components, too. 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 specialized to Supporting Templates CDA ManufacturedProduct APSR2 (1.3.6.1.4.1.19376.1.3.10.9.24) and CDA Material Container APSR2 (1.3.6.1.4.1.19376.1.3.10.9.23).
| |
| − |
| |
| − | =====6.3.6.4.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.22/dynamic}}
| |
| − |
| |
| − | '''Supportive Template CDA ManufacturedProduct APSR2 - 1.3.6.1.4.1.19376.1.3.10.9.24'''
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.24/dynamic}}
| |
| − |
| |
| − | '''Supportive Template CDA Material Container APSR2 - 1.3.6.1.4.1.19376.1.3.10.9.23'''
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.23/dynamic}}
| |
| − |
| |
| − | ====6.3.6.5 Informant – 1.3.6.1.4.1.19376.1.8.1.4.6====
| |
| − |
| |
| − | =====6.3.6.5.1 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.
| |
| − |
| |
| − | =====6.3.6.5.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.4.6/dynamic}}
| |
| − |
| |
| − | ====6.3.6.6 Additional participant in an entry - 1.3.6.1.4.1.19376.1.8.1.4.7====
| |
| − |
| |
| − | =====6.3.6.6.1 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.
| |
| − |
| |
| − | =====6.3.6.6.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.4.7/dynamic}}
| |
| − |
| |
| − | ====6.3.6.7 Anatomic Pathology Observation template – 1.3.6.1.4.1.19376.1.8.1.4.9====
| |
| − |
| |
| − | =====6.3.6.7.1 Definition and purpose=====
| |
| − |
| |
| − | This Content Module is usable within a Problem Organizer.
| |
| − |
| |
| − | The “AP Observation” generic template is usable for all AP observations, including those on findings from ancillary
| |
| − | techniques.
| |
| − |
| |
| − | 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. For coding an AP observations LOINC codes SHOULD be used. For measurement results the UCUM system SHOULD be used.
| |
| − |
| |
| − | Each kind of AP observation SHALL have one or more content modules "X specimen identified"
| |
| − |
| |
| − | =====6.3.6.7.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.4.9/dynamic}}
| |
| − |
| |
| − | ====6.3.6.8 Embedded Image – 1.3.6.1.4.1.19376.1.8.1.4.10====
| |
| − |
| |
| − | =====6.3.6.8.1 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.
| |
| − |
| |
| − | =====6.3.6.8.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.8.1.4.10/dynamic}}
| |
| − |
| |
| − | ====6.3.6.9 X Specimen Identified - 1.3.6.1.4.1.19376.1.3.10.9.1 ====
| |
| − |
| |
| − | =====6.3.6.9.1 Definition and purpose=====
| |
| − |
| |
| − | This Specimen Identification <entry> provides the machine-readable links between any type of procedure or observation or embedded image or containers to the specimen, on that this procedure is performed (parent specimen), or 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, Specimen Procedure Steps, Observations, Embedded images, and Containers in Specimen Procedure Steps.
| |
| − |
| |
| − | =====6.3.6.9.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.1/dynamic}}
| |
| − |
| |
| − | ====6.3.6.10 UICC/AJCC TNM Staging and Grading - 1.3.6.1.4.1.19376.1.3.10.4.2====
| |
| − |
| |
| − | =====6.3.6.10.1 Definition and purpose=====
| |
| − | The UICC/AJCC TNM <entry> Content Modul is a template for a complex observation usable in tumor pathology contexts. It 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 6.3.6.10.1-1 CDA-RMIM of the UICC/AJCC TNM <entry>'''
| |
| − |
| |
| − | =====6.3.6.10.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.4.2/dynamic}}
| |
| − |
| |
| − | '''Supportive Template TNM T-Observation - 1.3.6.1.4.1.19376.1.3.10.9.25'''
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.25/dynamic}}
| |
| − |
| |
| − | '''Supportive Template TNM N-Observation - 1.3.6.1.4.1.19376.1.3.10.9.26'''
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.26/dynamic}}
| |
| − |
| |
| − | '''Supportive Template TNM Number of Nodes - 1.3.6.1.4.1.19376.1.3.10.9.37'''
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.37/dynamic}}
| |
| − |
| |
| − | '''Supportive Template TNM M-Observation - 1.3.6.1.4.1.19376.1.3.10.9.27'''
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.27/dynamic}}
| |
| − |
| |
| − | '''Supportive Template TNM Grading - 1.3.6.1.4.1.19376.1.3.10.9.28'''
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.28/dynamic}}
| |
| − |
| |
| − | '''Supportive Template TNM R-Status - 1.3.6.1.4.1.19376.1.3.10.9.29'''
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.29/dynamic}}
| |
| − |
| |
| − | '''Supportive Template TNM a - 1.3.6.1.4.1.19376.1.3.10.9.30'''
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.30/dynamic}}
| |
| − |
| |
| − | '''Supportive Template TNM r - 1.3.6.1.4.1.19376.1.3.10.9.31'''
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.31/dynamic}}
| |
| − |
| |
| − | '''Supportive Template TNM y - 1.3.6.1.4.1.19376.1.3.10.9.32'''
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.32/dynamic}}
| |
| − |
| |
| − | '''Supportive Template TNM Serum Tumor Markers - 1.3.6.1.4.1.19376.1.3.10.9.33'''
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.33/dynamic}}
| |
| − |
| |
| − | '''Supportive Template TNM Lymphatic Invasion - 1.3.6.1.4.1.19376.1.3.10.9.34'''
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.34/dynamic}}
| |
| − |
| |
| − | '''Supportive Template TNM Venous Invasion - 1.3.6.1.4.1.19376.1.3.10.9.35'''
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.35/dynamic}}
| |
| − |
| |
| − | '''Supportive Template TNM Perineurial Invasion - 1.3.6.1.4.1.19376.1.3.10.9.36'''
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.36/dynamic}}
| |
| − |
| |
| − | ====6.3.6.11 ICD-O-3 Typing and Grading - 1.3.6.1.4.1.19376.1.3.10.4.3====
| |
| − |
| |
| − | =====6.3.6.11.1 Definition and purpose=====
| |
| − | The ICD-O-3 Typing and Grading<entry> Content Modul is a template for a complex observation usable in tumor pathology contexts. It 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. The supporting template ICD-O-Differentiation is used for a more detailed descriptions of those elements of the ICD-O-3 system. The supporting template ICD-O-Behavior is only to use if the pathologists´ behavior classification is (rarely) deviant from the 5th digit in morphology and behavior code list, and is therefore overriding that digit.
| |
| − |
| |
| − | Morphology and topography axes of ICD-O-3 are not combined to a singular, common code, but used simultaneously. A complete ICD-O-3 coding consists always of topography ''and'' morphology and behavior codes, displayed together in on line in the human readable section. Therefore, the topography axis of ICD-O-3 SHOULD be coded in a supportive template ICD-O-Topography, specialized from a generic observation, within the same Problem Organizer <entry> Content Module.
| |
| − |
| |
| − | [[Datei:6.2.6.13.1-1_neu3.jpg]]
| |
| − |
| |
| − | '''Figure 6.3.6.11.1-1 CDA-RMIM of the ICD-O-3 <entry>'''
| |
| − |
| |
| − | =====6.3.6.11.2 Specification and Example=====
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.4.3/dynamic}}
| |
| − |
| |
| − |
| |
| − | '''Supportive Template ICD-O-Behavior - 1.3.6.1.4.1.19376.1.3.10.9.38'''
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.38/dynamic}}
| |
| − |
| |
| − |
| |
| − | '''Supportive Template ICD-O-Differentiation - 1.3.6.1.4.1.19376.1.3.10.9.39'''
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.39/dynamic}}
| |
| − |
| |
| − |
| |
| − | '''Supportive Template ICD-O-Topography - 1.3.6.1.4.1.19376.1.3.10.9.41'''
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.41/dynamic}}
| |
| − |
| |
| − | ====6.3.6.12 Assessment Scales for Scoring systems - 1.3.6.1.4.1.19376.1.3.10.4.4====
| |
| − |
| |
| − | =====6.3.6.12.1 Definition and purpose=====
| |
| − | The Assessment Scales <entry> Content Modul is a template for a complex observation, especially usable in tumor pathology contexts, within a Problem organizer or as sub-observation for grading observations. It 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_neu.jpg]]
| |
| − |
| |
| − | '''Figure 6.3.6.12.1-1 CDA-RMIM of an Assessment Scales <entry>'''
| |
| − |
| |
| − | =====6.3.6.12.2 Specification and Example=====
| |
| − |
| |
| − | '''Assessment Scales Observation for Scoring Systems APSR2 - 1.3.6.1.4.1.19376.1.3.10.4.4'''
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.4.4/dynamic}}
| |
| − |
| |
| − | '''Supportive Template Assessment Scoring System - 1.3.6.1.4.1.19376.1.3.10.9.42'''
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.42/dynamic}}
| |
| − |
| |
| − | '''Supportive Template Assessment Scoring Item - 1.3.6.1.4.1.19376.1.3.10.9.43'''
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.10.9.43/dynamic}}
| |
| − |
| |
| − | ===6.3.7 External Content Modules referenced by APSR 2.0 ===
| |
| − |
| |
| − | =====6.3.7.1 Definition and purpose=====
| |
| − | For some of the templates described above supportive templates are used, defined and specified by XD-LAB or PCC. They are listed in table 5.5-1 (see above), and shown here for better understanding only.
| |
| − |
| |
| − | =====6.3.7.2 Specifications and Examples=====
| |
| − |
| |
| − | '''IHE Reason for Referral Sub-Section - 1.3.6.1.4.1.19376.1.5.3.1.3.1'''
| |
| − | {{:1.3.6.1.4.1.19376.1.5.3.1.3.1/dynamic}}
| |
| − |
| |
| − | '''History of Present Illness Sub-Section - 1.3.6.1.4.1.19376.1.5.3.1.3.4'''
| |
| − | {{:1.3.6.1.4.1.19376.1.5.3.1.3.4/dynamic}}
| |
| − |
| |
| − | '''CDA Active Problems Sub-Section - 1.3.6.1.4.1.19376.1.5.3.1.3.6'''
| |
| − | {{:1.3.6.1.4.1.19376.1.5.3.1.3.6/dynamic}}
| |
| − |
| |
| − | '''Specimen Received Child element - 1.3.6.1.4.1.19376.1.3.1.3'''
| |
| − | {{:1.3.6.1.4.1.19376.1.3.1.3/dynamic}}
| |
| − |
| |
| − | '''Laboratory Observation Child element - 1.3.6.1.4.1.19376.1.3.1.6'''
| |
| − | {{:1.3.6.1.4.1.19376.1.3.1.6/dynamic}}
| |
| − |
| |
| − | '''Human Patient (recordTarget) Child element - 1.3.6.1.4.1.19376.1.3.3.1.1'''
| |
| − | {{:1.3.6.1.4.1.19376.1.3.3.1.1/dynamic}}
| |
| − |
| |
| − | '''Information Recipient Child element - 1.3.6.1.4.1.19376.1.3.3.1.4'''
| |
| − | {{:1.3.6.1.4.1.19376.1.3.3.1.4/dynamic}}
| |
| − |
| |
| − | '''Ordering Provider Child element - 1.3.6.1.4.1.19376.1.3.3.1.6'''
| |
| − | {{:1.3.6.1.4.1.19376.1.3.3.1.6/dynamic}}
| |
| − |
| |
| − | '''Laboratory Performer Child element - 1.3.6.1.4.1.19376.1.3.3.1.7'''
| |
| − | {{:1.3.6.1.4.1.19376.1.3.3.1.7/dynamic}}
| |
| − |
| |
| − | '''Annotation Comment Child element - 1.3.6.1.4.1.19376.1.5.3.1.4.2'''
| |
| − | {{:1.3.6.1.4.1.19376.1.5.3.1.4.2/dynamic}}
| |
| − |
| |
| − | ==Appendix A - Value Sets==
| |
| − |
| |
| − | ==A. APSR Value Sets==
| |
| − |
| |
| − | There are both extensional and intensional value sets specifically used for APSR.
| |
| − |
| |
| − | ===A.1 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}}
| |
| − |
| |
| − | ===A.2 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}}
| |
| − |
| |
| − | ===A.3 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}}
| |
| − |
| |
| − | ===A.4 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}}
| |
| − |
| |
| − | ===A.5 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}}
| |
| − |
| |
| − | ===A.6 UICC/AJCC stage 1.3.6.1.4.1.19376.1.3.11.46===
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.46/dynamic}}
| |
| − |
| |
| − | ===A.7 UICC/AJCC T category 1.3.6.1.4.1.19376.1.3.11.43===
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.43/dynamic}}
| |
| − |
| |
| − | ===A.8 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}}
| |
| − |
| |
| − | ===A.9 UICC/AJCC N category 1.3.6.1.4.1.19376.1.3.11.44===
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.44/dynamic}}
| |
| − |
| |
| − | ===A.10 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}}
| |
| − |
| |
| − | ===A.11 UICC/AJCC M category 1.3.6.1.4.1.19376.1.3.11.45===
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.45/dynamic}}
| |
| − |
| |
| − | ===A.12 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}}
| |
| − |
| |
| − | ===A.13 UICC/AJCC C-Factor 1.3.6.1.4.1.19376.1.3.11.19===
| |
| − |
| |
| − | This value set has values from TNM 7th edition only. There is no C-Factor in the 8th edition.
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.19/dynamic}}
| |
| − |
| |
| − | ===A.14 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}}
| |
| − |
| |
| − | ===A.15 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}}
| |
| − |
| |
| − | ===A.16 UICC/AJCC clinical/pathological 1.3.6.1.4.1.19376.1.3.11.22===
| |
| − |
| |
| − | This value set has values from TNM 8th edition. There is no difference to 7th edition.
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.22/dynamic}}
| |
| − |
| |
| − | ===A.17 UICC/AJCC Venous Invasion 1.3.6.1.4.1.19376.1.3.11.23===
| |
| − |
| |
| − | This value set has values from TNM 8th edition. There is no difference to 7th edition.
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.23/dynamic}}
| |
| − |
| |
| − | ===A.18 UICC/AJCC Lymphatic Invasion 1.3.6.1.4.1.19376.1.3.11.24===
| |
| − |
| |
| − | This value set has values from TNM 8th edition. There is no difference to 7th edition.
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.24/dynamic}}
| |
| − |
| |
| − | ===A.19 UICC/AJCC Perineurial Invasion 1.3.6.1.4.1.19376.1.3.11.25===
| |
| − |
| |
| − | This value set has values from TNM 8th edition. There is no difference to 7th edition.
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.25/dynamic}}
| |
| − |
| |
| − | ===A.20 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}}
| |
| − |
| |
| − | ===A.21 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}}
| |
| − |
| |
| − | ===A.22 UICC/AJCC Localization of distant metastases 1.3.6.1.4.1.19376.1.3.11.28===
| |
| − |
| |
| − | This value set has values from TNM 8th edition. There is no difference to 7th edition.
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.28/dynamic}}
| |
| − |
| |
| − | ===A.23 UICC/AJCC Grade 3 tiered 1.3.6.1.4.1.19376.1.3.11.29===
| |
| − |
| |
| − | This value set has values from TNM 8th edition. There is no difference to 7th edition.
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.29/dynamic}}
| |
| − |
| |
| − | ===A.24 UICC/AJCC Grade 2 tiered 1.3.6.1.4.1.19376.1.3.11.30===
| |
| − |
| |
| − | This value set has values from TNM 8th edition. There is no difference to 7th edition.
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.30/dynamic}}
| |
| − |
| |
| − | ===A.25 UICC/AJCC Grade 4 tiered 1.3.6.1.4.1.19376.1.3.11.31===
| |
| − |
| |
| − | This value set has values from TNM 8th edition. There is no difference to 7th edition.
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.31/dynamic}}
| |
| − |
| |
| − | ===A.26 UICC/AJCC Tumor Serum Markers 1.3.6.1.4.1.19376.1.3.11.32===
| |
| − |
| |
| − | This value set has values from TNM 8th edition. There is no difference to 7th edition.
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.32/dynamic}}
| |
| − |
| |
| − | ===A.27 ICD-O-3 Morphology and Behavior 1.3.6.1.4.1.19376.1.3.11.33===
| |
| − |
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.33/dynamic}}
| |
| − |
| |
| − | ===A.28 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}}
| |
| − |
| |
| − | ===A.29 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}}
| |
| − |
| |
| − | ===A.30 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}}
| |
| − |
| |
| − | ===A.31 UICC/AJCC Multiplicity 1.3.6.1.4.1.19376.1.3.11.37===
| |
| − |
| |
| − | This value set has values from TNM 8th edition. There is no difference to 7th edition.
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.37/dynamic}}
| |
| − |
| |
| − | ===A.32 UICC/AJCC Isolated Tumor Cells 1.3.6.1.4.1.19376.1.3.11.38===
| |
| − |
| |
| − | This value set has values from TNM 8th edition. There is no difference to 7th edition.
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.38/dynamic}}
| |
| − |
| |
| − | ===A.33 UICC/AJCC Recurrence 1.3.6.1.4.1.19376.1.3.11.39===
| |
| − |
| |
| − | This value set has values from TNM 8th edition. There is no difference to 7th edition.
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.39/dynamic}}
| |
| − |
| |
| − | ===A.34 UICC/AJCC Posttherapeutic 1.3.6.1.4.1.19376.1.3.11.40===
| |
| − |
| |
| − | This value set has values from TNM 8th edition. There is no difference to 7th edition.
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.40/dynamic}}
| |
| − |
| |
| − | ===A.35 UICC/AJCC Autopsy 1.3.6.1.4.1.19376.1.3.11.41===
| |
| − |
| |
| − | This value set has values from TNM 8th edition. There is no difference to 7th edition.
| |
| − | {{:1.3.6.1.4.1.19376.1.3.11.41/dynamic}}
| |
| − | </div>
| |
