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|
| (555 dazwischenliegende Versionen von 4 Benutzern werden nicht angezeigt) |
| Zeile 4: |
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| | | | |
| | 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: |
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| | 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 47: |
Zeile 56: |
| | profile, and volume 3 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 61: |
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| | “Procedure Steps” section, which has a level 3 entry. | | “Procedure Steps” section, which has a level 3 entry. |
| | | | |
| − | '''APSR-10 – Observation related to multiple specimens''': For | + | '''APSR-10 – Observation related to multiple specimens''': For example tumor staging may require combining data from multiple specimens (e.g., a breast excision with positive margins followed by a re-excision with clear margins – in this case the tumor size may be a composite of measurements from both specimens. Another example is staging of ovarian carcinomas with multiple biopsies of pelvis, peritoneum, nodes, omentum, etc.). To accommodate these use |
| − | example tumor staging may require combining data from multiple specimens (e.g., | + | cases, each problem organizer as well as each observation may reference any number of specimens using the <specimen> child element. Each of these references may point to a detailed description of the specimen, in the "procedure steps" section. |
| − | a breast excision with positive margins followed by a re-excision with clear | |
| − | margins – in this case the tumor size may be a composite of measurements from | |
| − | both specimens. Another example is staging of ovarian carcinomas with multiple | |
| − | biopsies of pelvis, peritoneum, nodes, omentum, etc.). To accommodate these use | |
| − | cases, the specimen organizer is able to represent either a single specimen or | |
| − | a group of specimens investigated together.
| |
| | | | |
| | '''APSR-11 – Derivative specimens''':Specimens | | '''APSR-11 – Derivative specimens''':Specimens |
| Zeile 75: |
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| | 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 - INTEGRATION PROFILES=
| |
| − |
| |
| − | ==1.7 History of Annual Changes==
| |
| − |
| |
| − | <syntaxhighlight lang="xml">
| |
| − | Append the following at the end of section 1.7
| |
| − | </syntaxhighlight>
| |
| − |
| |
| − |
| |
| − | Scope of changes introduced in the current year:
| |
| − |
| |
| − |
| |
| − | *The Anatomic pathology Structured Reports (APSR) Content Profile extends the scope of the Pathology and Laboratory Medicine (PaLM) Technical Framework to the provision of persistent anatomic pathology and Cytopathology structured reports for various purposes such as care provision, care coordination, screening, and health surveillance.
| |
| − |
| |
| − | ==1.12 Glossary==
| |
| − |
| |
| − | <syntaxhighlight lang="xml">
| |
| − | Add the following terms to the Glossary in section 1.12:
| |
| − | </syntaxhighlight>
| |
| − |
| |
| − | '''APSR''' Anatomic Pathology Structured Reports Content Profile
| |
| − |
| |
| − | ==1.15 Scope of the Anatomic Pathology Technical Framework==
| |
| − |
| |
| − | <syntaxhighlight lang="xml">
| |
| − | Replace figure 1.15-1 by the one below
| |
| − | </syntaxhighlight>
| |
| − |
| |
| − |
| |
| − | [[Datei:Fig.1.15-1.001.jpeg||||APWorkflow ]]
| |
| − |
| |
| − | ==1.16 Anatomic Pathology Integration Profiles==
| |
| − | <syntaxhighlight lang="xml">
| |
| − | Replace figure 1.16-1by the new one below, taking the new profile(s) into account.
| |
| − | </syntaxhighlight>
| |
| − |
| |
| − | [[Datei:Fig.1.16-1.001.jpeg||||IntegrationProfiles ]]
| |
| − |
| |
| − | ==1.17 Dependencies among Integration Profiles==
| |
| − | <syntaxhighlight lang="xml">
| |
| − | Add the following lines to Table 1.17-1
| |
| − | </syntaxhighlight>
| |
| − | {| class="hl7table"
| |
| − | |-
| |
| − | |Anatomic Pathology Structured Reports to (APSR)
| |
| − | ||''Cross-Enterprise DocumentSharing (XDS)in ITI-TF''||
| |
| − | Implementers of APSR Content Profile may implement the XDS Profile to enable sharing of the pathology reports within an XDS Affinity Domain. In this case, the Content
| |
| − | Creator actor must be grouped with an XDS Document Source actor, and the Content Consumer actor must be grouped with an XDS Document Consumer actor.
| |
| − | ||
| |
| − | Ensure that the sharing of laboratory reports within an XDS Affinity Domain can co-exist with the sharing of other types of documents
| |
| − | |-
| |
| − | |Anatomic Pathology Structured Reports to (APSR)||''Cross-Enterprise DocumentMedia Interchange (XDM) in ITI-TF''||Implementers of APSR Content Profile may implement the XDM Profile to enable sharing of the laboratory reports using media. In this case, the Content Creator must be grouped with an XDM Portable Media Creator and the Content Consumer with an XDM Portable Media Consumer.||Ensure that the
| |
| − | sharing of laboratory reports on media can co-exist with the sharing of other types of documents
| |
| − | |-
| |
| − | |Anatomic Pathology Structured Reports to (APSR)||''Cross-Enterprise Document Reliable Interchange (XDR) in ITI-TF''|| Implementers of APSR Content Profile may implement the XDR Profile to enable sharing of the laboratory reports using reliable point-to-point network messages. In this case, the Content Creator must be grouped with an XDR Document Source, and the Content Consumer must be grouped with an XDR Document Recipient.||Ensure that the sharing of laboratory reports through reliable point-to-point messages can co-exist with the sharing of other types of documents
| |
| − | |}
| |
| − |
| |
| − | ==1.18 Profiles Overview==
| |
| − | <syntaxhighlight lang="xml">
| |
| − | Append sub-section 1.18.3 (takenfrom the current profile abstract) at the end of section 1.18.
| |
| − | </syntaxhighlight>
| |
| − |
| |
| − | === 1.18.3 Anatomic Pathology Structured Reports (APSR) ===
| |
| − | This Content profile describes an anatomic pathology structured report (APSR) as a CDA r2
| |
| − | document to be published towards a document sharing resource such as a shared electronic health record used by a community of care providers, relying on one of the infrastructure document sharing/exchanging profiles defined in IHE ITI TF.
| |
| − |
| |
| − | == 1.19 Actors Description ==
| |
| − | <syntaxhighlight lang="xml">
| |
| − | Add the following actors’ descriptions
| |
| − | </syntaxhighlight>
| |
| − |
| |
| − | '''Content Creator''': An application responsible for the creation of content and transmission to a Content Consumer. This actor is involved in the APSR profile to issue anatomic pathology structured reports.
| |
| − |
| |
| − | '''Content Consumer''': An application responsible for viewing, importing, or other processing of content created by a Content Creator Actor. This actor is involved in the APSR profile to consume anatomic pathology structured reports.
| |
| − |
| |
| − | <syntaxhighlight lang="xml">
| |
| − | Add Section 4 below, after the “ARPH integration profile” section.
| |
| − | </syntaxhighlight>
| |
| − |
| |
| − | =4 Anatomic Pathology Structured Reports (APSR Profile=
| |
| − |
| |
| − | This Content profile describes an anatomic pathology structured report (APSR) as a CDA r2 document to be published towards a document sharing resource such as a shared electronic health record used by a community of care providers, relying on one of the infrastructure document sharing/exchanging profiles defined in IHE ITI TF.
| |
| − |
| |
| − | Anatomicpathology reports (APR) document the pathologic findings in specimens removed from patients for diagnostic or therapeutic reasons. This information can be used for patient care, clinical research and epidemiology. Standardizing andcomputerizing APRs is necessary to improve the quality of reporting and the exchange of APR Information.
| |
| − |
| |
| − | This Content profile describes an anatomic pathology structured report (APSR) as a CDA r2 document to be published towards a document sharing resource such as a shared electronic health record used by a community of care providers, relying on one of the infrastructure document sharing/exchanging profiles defined in IHE ITI TF.
| |
| − |
| |
| − | Anatomic pathology reports (APR) document the pathologic findings in specimens removed from patients for diagnostic or therapeutic reasons. This information can be used for patient care, clinical research and epidemiology. Standardizing and computerizing APRs is necessary to improve the quality of reporting and the exchange of APR information.
| |
| − |
| |
| − | The current scope of this IHE content profile covers APSR for surgical pathology in all fields of anatomic pathology (cancers, benign neoplasms as well as non-neoplastic conditions) as well as for Cytopathology. The profile handles information of “traditional” pathology observation using light microscopy (including immunohistochemistry, FISH, etc.).
| |
| − |
| |
| − | Forensic pathology (autopsy, toxicology) will be addressed in further cycles as well as Special ancillary techniques (e.g., flow cytometry, cytogenetics, electron microscopy).
| |
| − |
| |
| − | Goldsmith provides recent recommendations that delineate the required, preferred, and optional elements which should be included in any APR for surgical pathology, regardless of report types.
| |
| − |
| |
| − | Several international initiatives intend to define standard structured templates for
| |
| − | specific types of APRs. In the cancer domain, in the United States, the CAP (College of American Pathologists) has published 80 cancer APSR templates (cancer checklists and background information)[http://www.cap.org]. In France, the SFP (French society of pathology) [http://www.sfpathol.org] and the INCa (French National Cancer Institute) [http://www.e-cancer.fr] have published 23 APSR templates of minimal set of data required for a primary tumor. In Australasia, the Royal College of Pathologists Australasia (RCPA) and the Cancer Australia developed an initial 6 reporting protocols (lung, melanoma, breast, colorectal, lymphoma and prostate) and a framework to guide development of the protocols, in partnership with national clinician and pathologist organizations. In some countries, the recommendations for generic and specific APSR requirements have become clinical guidelines, the use of which may be required by accrediting bodies.
| |
| − |
| |
| − | This profile has also benefited from the guidance on cancer AP reports provided by the North-American Association of Central Cancer Registries; some of the example snippets captured in the profile leverage the NAACCR Standards for Cancer Registries, Volume V, Pathology Laboratory Electronic Reporting.
| |
| − |
| |
| − | In addition to standardizing the cancer APR contents, it is necessary to computerize them. Several studies have focused on defining an appropriate IT standard comprising the structured and encoded clinical documents. Some of the implementation guides of APSRs proposed within these initiatives are not based on international healthcare IT standards (e.g., CAP eCC), other are based on either HL7 CDA r2 or CEN archetypes. HL7 CDA r2 is one of the most reliable standards that can support these needs. CDA allows the clinical data to be both machine and human-readable and provides a framework for incremental growth in the granularity of structured, codes-bound clinical information. This document takes into consideration current very few national CDA implementation guides
| |
| − | for the APSR developed in Netherlands (National IT Institute for Healthcare in the Netherlands [www.nictiz.nl] and in Germany.
| |
| − |
| |
| − | This Content profile describes an anatomic pathology report shared in a human-readable format, which may include images. In addition, this electronic AP report SHALL contain anatomic pathology observations in a machine-readable format, to facilitate the integration of these observations in the database of a consumer system.
| |
| − |
| |
| − | The Definition of required, preferred and optional elements in this content profile is mainly based on Goldsmith, for generic surgical pathology APSR (regardless of report
| |
| − | types) and, in the cancer domain, on standard structured templates provided by United States, the CAP (College of American Pathologists) [http://www.cap.org.], the SFP (French society of pathology) [http://www.sfpathol.org] and INCa (French National Cancer Institute) [http://www.e-cancer.fr] and the Royal College of Pathologists Australasia (RCPA).
| |
| − |
| |
| − | Structured reports are composed of a header, which provides the context of care (patient, care providers, pathologists, laboratories, order, act documented …), and a body. The latter provides the clinical information, which accompanied the order and specimens as well as the observations, findings and conclusions delivered by the pathologist after
| |
| − | examination.
| |
| − |
| |
| − | The anatomic pathology report described in this profile, with its set of anatomic pathology observations in a machine-readable format, MAY also be used to share
| |
| − | historical results with appropriate content anonymization and Patient identification pseudonymization to create shared distributed repositories of anatomic pathology information.
| |
| − |
| |
| − | Both the header and the body provide human-readable information. The body is a hierarchy of sections. Each section presents its
| |
| − | content in its ''text'' element, as human-readable text, possibly illustrated by some embedded images. This human-readable content, or a part of it, may also be present as machine-readable data coded with the appropriate terminologies (e.g., ICD-O-3, SNOMED CT, LOINC, ADICAP, etc.) in entry elements at the bottom of the section.
| |
| − |
| |
| − | There are zero or more ''entry'' elements in a section. Each ''entry'' element carries the machine-readable data related to a single specimen or to a group of specimens observed together. The entry is then subdivided per problem investigated.
| |
| − |
| |
| − | The ''text'' element of the section is supposed to reflect the same organization: per specimen, and then, per problem investigated on the specimen. The profile leaves the layout of the text element up to the Content Creator applications, or to further constraints brought by national extensions. However, given that the ''text'' element is usually composed of free text (e.g., dictated text), assembled with the text generated from the set of data, machine-encoded in the entry elements below, the Content Creator application MUST handle these two kinds of content, and provide a user interface, which precludes any confusion between them, both at creation time and update time (e.g., using forms with dedicated free text areas and distinct protected areas for coded fields).
| |
| − |
| |
| − | == 4.1 APSR Actors/Transactions ==
| |
| − |
| |
| − | This section references two other IHE Technical Frameworks:
| |
| − |
| |
| − | *IT Infrastructure Technical Framework (ITI TF)
| |
| − | *Patient Care Coordination Technical Framework (PCC TF)
| |
| − |
| |
| − | There
| |
| − | are two actors in this profile, the Content Creator and the Content
| |
| − | Consumer.
| |
| − |
| |
| − | '''Content Creator''': A
| |
| − | Content Creator Actor is responsible for the creation of content and transmission
| |
| − | to a Content Consumer.
| |
| − |
| |
| − | '''Content Consumer''': A Content
| |
| − | Consumer Actor is responsible for viewing, import, or other processing of
| |
| − | content created by a Content Creator Actor
| |
| − |
| |
| − | Content
| |
| − | (i.e., an anatomic pathology structured report) is created by a Content Creator and is to be consumed by a Content Consumer. The sharing or transmission of content from one actor to the other is addressed by the appropriate use of IHE profiles described below, and is out of scope of this profile. A Document Source or a Portable Media Creator may embody the Content Creator Actor. A Document Consumer, a Document Recipient or a Portable Media Importer may embody the Content Consumer Actor.
| |
| − |
| |
| − | The sharing or transmission of anatomic pathology structured reports from one actor to the other is addressed by the use of appropriate content bindings with XDS, XDM or XDR integration profiles as explained in section 4 of Volume 3 of the Anatomic Pathology Technical Framework.
| |
| − |
| |
| − | [[Datei:fig.4.1.-1.jpg]]
| |
| − |
| |
| − | Figure 4.1-1 APSR Actor Diagram
| |
| − |
| |
| − | === 4.1.1 Actor Descriptions and Requirements ===
| |
| − |
| |
| − | This section is intentionally empty.
| |
| − |
| |
| − | === 4.1.2 Document Content Modules ===
| |
| − |
| |
| − | ==== 4.1.2.1 Anatomic Pathology Structured Report (APSR) ====
| |
| − |
| |
| − | This document content module represents the generic set of constraints applied to any structured report for surgical pathology in all fields of anatomic pathology (cancers, benign neoplasms as well as non-neoplastic conditions) as well as for Cytopathology.
| |
| − |
| |
| − | This document content module is identified by templateId 1.3.6.1.4.1.19376.1.8.1.1.1
| |
| − |
| |
| − | The body of this document content module has the hierarchy of sections and entries depicted by figure 4.1.2.1-1. The only mandatory section is the Diagnostic Conclusion Section. And
| |
| − | the only mandatory entry is the Specimen Information Organizer Entry below this section.
| |
| − |
| |
| − | [[Datei:CDA APSR R2 (IHE) Hierarchy of the body for APSR document content module.PNG]]
| |
| − |
| |
| − | Figure 4.1.2.1-1 Hierarchy of the body for APSR document content module
| |
| − |
| |
| − | == 4.2 APSR Options ==
| |
| − |
| |
| − | Table 4.2-1 summarizes the options that actors may take for this content profile. Dependencies between options when applicable are specified in notes. These options are summarized below the table, and further detailed in PCC TF-2, as indicated in the right column of the table.
| |
| − |
| |
| − | '''Table 4.2-1 Actors and Options'''
| |
| − |
| |
| − | {| class="hl7table"
| |
| − | !Actor !! Options !! Domain, Vol & Section
| |
| − | |-
| |
| − | |Content
| |
| − | Consumer
| |
| − | ||''View Option (1)''
| |
| − | || PCC TF-2:3.1.1
| |
| − | |-
| |
| − | |Content
| |
| − | Consumer
| |
| − | ||''Document Import Option (1)''||PCC TF-2:3.1.2
| |
| − | |-
| |
| − | |Content
| |
| − | Consumer
| |
| − | ||''Section Import Option (1)''|| PCC TF-2:3.1.3
| |
| − | |}
| |
| − | ''Note 1: The Actor shall support at least one of these options.''
| |
| − |
| |
| − | == 4.3 APSR Actor Groupings and Profile Interactions ==
| |
| − |
| |
| − | It is expected that the sharing of anatomic pathology structured reports will occur in an environment where the physician offices and hospitals have a coordinated infrastructure that serves
| |
| − | the information sharing needs of this community of care. Several mechanisms are supported by IHE profiles:
| |
| − | *A registry/repository-based infrastructure is defined by the IHE Cross-Enterprise Document Sharing (XDS) and other IHE Integration Profiles such as patient identification (PIX & PDQ), and notification of availability of documents (NAV).
| |
| − | *A media-based infrastructure is defined by the IHE Cross-Enterprise Document Media Interchange (XDM) profile.
| |
| − | *A reliable messaging-based infrastructure is defined by the IHE Cross-Enterprise Document Reliable Interchange (XDR) profile.
| |
| − | *All of these infrastructures support Security and privacy through the use of the Consistent Time (CT) and Audit Trail and Node Authentication (ATNA) profiles.
| |
| − |
| |
| − | For more details on these profiles, see the IHE IT Infrastructure Technical Framework
| |
| − |
| |
| − | Such an infrastructure is assumed by the use cases described in this Profile.
| |
| − |
| |
| − | A content binding describes how the payloads used in IHE transactions are related to and/or constrained by the data elements contained within the content sent or received in those transactions. The APSR Content Profile applies one binding, which is used when grouping the Content Creator with the IHE ITI XDS, XDM or XDR Integration Profiles.
| |
| − |
| |
| − | The content and the binding are described in Volume 3 of the IHE Anatomic Pathology Technical Framework.
| |
| − |
| |
| − |
| |
| − |
| |
| − | == 4.4 APSR Process Flow ==
| |
| − |
| |
| − |
| |
| − |
| |
| − | === 4.4.1 Use Cases ===
| |
| − |
| |
| − | ==== 4.4.1.1 Use case 1: General case ====
| |
| − |
| |
| − |
| |
| − | Barbara Breast visits Sammy Surgeon for removal of a breast tumor. Sammy Surgeon orders the Requested Procedure “Breast surgical specimen - pathological examination” and sends the specimen(s) to the anatomic pathology department.
| |
| − |
| |
| − | Specimen(s) is (are) accessioned by the anatomic pathology department. The staff performs a macroscopic examination of the specimen(s); gross imaging is performed if needed. The specimen(s) are processed for microscopic examination and other special ancillary techniques or tissue banking if needed. During the imaging interpretation process, microscopic imaging is performed if needed. At the end of the interpretation process, pathologist queries the Content Creator application for the appropriate APSR template, fills the form, binds some relevant images and/or regions of interest to specific observation(s), validates and signs the document.
| |
| − |
| |
| − | ==== 4.4.1.2 Use case 2: Specimen collector is not the ordering physician ====
| |
| − |
| |
| − | Patricia Pathologist collects bone marrow from Peter Patient in the clinical ward.
| |
| − |
| |
| − | Specimen(s) is (are) accessioned by the anatomic pathology
| |
| − | department. The staff performs a macroscopic examination of the specimen(s);
| |
| − | gross imaging is performed if needed. The specimen(s) are processed for
| |
| − | microscopic examination and other special ancillary techniques or tissue
| |
| − | banking if needed. During the imaging interpretation process, microscopic
| |
| − | imaging is performed if needed. At the end of the interpretation process,
| |
| − | pathologist queries the '''Content Creator''' for
| |
| − | the appropriate APSR template, fills the form, binds some relevant images
| |
| − | and/or regions of interest to specific observation(s), validates and signs the
| |
| − | document.
| |
| − |
| |
| − | ==== 4.4.1.3 Use case 3: Multi-step reporting ====
| |
| − |
| |
| − | Barbara Breast
| |
| − | visits Sammy Surgeon for removal of a breast tumor. Sammy Surgeon orders the
| |
| − | Requested Procedure “Breast surgical specimen - Frozen sections &
| |
| − | pathological examination” and sends the specimen(s) to the anatomic pathology
| |
| − | department.
| |
| − |
| |
| − | Specimen(s) is (are) accessioned by the anatomic pathology
| |
| − | department. The staff performs a macroscopic examination of the specimen(s),
| |
| − | gross imaging is performed if needed. The specimen(s) are processed for
| |
| − | intraoperative observation if needed, and tissue banking if needed (e.g., for
| |
| − | research purpose). During the imaging interpretation process of frozen
| |
| − | sections, microscopic imaging is performed if needed. At the end of the
| |
| − | interpretation process, pathologist queries the '''Content Creator''' for the appropriate APSR template, fills the
| |
| − | intraoperative observation section, binds some relevant images and/or regions
| |
| − | of interest to specific observation(s) if needed, validates and signs (i.e.,
| |
| − | legally authenticates) the preliminary APSR.
| |
| − |
| |
| − | The day after, the specimen(s) are processed for microscopic
| |
| − | examination and other special ancillary techniques if needed. During the
| |
| − | imaging interpretation process, microscopic imaging is performed if needed. At
| |
| − | the end of the interpretation process, pathologist queries the '''Content Creator''' for the preliminary
| |
| − | APSR, fills the form, binds some relevant images and/or regions of interest to
| |
| − | specific observation(s), validates and signs (i.e., legally authenticates) the final
| |
| − | APSR.
| |
| − |
| |
| − | ==== 4.4.1.4 Use case 4: Opinion request ====
| |
| − |
| |
| − | There are various
| |
| − | situations in which an opinion request is issued: External expert consultation
| |
| − | (requested by Philip Pathologist, often before a final report is issued).
| |
| − | Second opinion request (usually made by a treating physician or patient/family,
| |
| − | or lawyer/court in malpractice cases). External slide review (usually routine
| |
| − | review of slides required by protocols in an outside treating institution).
| |
| − | These may vary in terms or workflow and even the materials accessed by the
| |
| − | outside lab.
| |
| − |
| |
| − | ''Requiring pathologist''
| |
| − | Philip Pathologist
| |
| − | asks for second opinion for the case of Peter Patient diagnosed as lymphoma. He
| |
| − | sends block(s) or slide(s) or shares/sends whole slide images to Patricia
| |
| − | pathologist, requesting her expertise on this material. He uses the '''Content Creator application''' to derive
| |
| − | the anatomic pathology opinion request document from the preliminary APSR of
| |
| − | Peter Patient.
| |
| − |
| |
| − | Philip Pathologist
| |
| − | later on uses his Content Consumer application
| |
| − | to view and import the APSR from Patricia Pathologist. He uses this report to
| |
| − | finalize and issue his own APSR in his application acting as a Content Creator.
| |
| − |
| |
| − | ''Requested pathologist''
| |
| − |
| |
| − | Patricia
| |
| − | Pathologist accepts to deliver second opinion about the case of Peter Patient
| |
| − | diagnosed as lymphoma.
| |
| − |
| |
| − | ''Block(s)''
| |
| − |
| |
| − | The specimen(s) are processed for microscopic examination and other
| |
| − | special ancillary techniques if needed. During the imaging interpretation
| |
| − | process, microscopic imaging is performed if needed. At the end of the
| |
| − | interpretation process, Patricia Pathologist queries the Content Creator for the appropriate APSR template, fills the form,
| |
| − | binds some relevant images and/or regions of interest to specific
| |
| − | observation(s), validates and signs the document.
| |
| − |
| |
| − | ''Slide(s)''
| |
| − |
| |
| − | During the imaging interpretation process, microscopic imaging is
| |
| − | performed if needed. At the end of the interpretation process, Patricia
| |
| − | Pathologist queries the Content Creator for
| |
| − | the appropriate APSR template, fills the form, binds some relevant images
| |
| − | and/or regions of interest to specific observation(s), validates and signs the
| |
| − | document.
| |
| − |
| |
| − | ''Whole slide image(s)''
| |
| − |
| |
| − | At the end of the interpretation process, Patricia Pathologist
| |
| − | queries the '''Content Creator''' for the
| |
| − | appropriate APSR template, fills the form, binds some relevant images and/or
| |
| − | regions of interest to specific observation(s), validates and signs the
| |
| − | document.
| |
| − |
| |
| − |
| |
| − | == 4.5 APSR Security considerations ==
| |
| − |
| |
| − | === 4.5.1Integrity ===
| |
| − |
| |
| − | The choice on whether
| |
| − | the digital signature is performed at the transaction level (XDS, XDM, XDR) or
| |
| − | at the content level is left up to national extensions. If the report is
| |
| − | digitally signed, the person having signed it SHALL be the person represented
| |
| − | in the ''legalAuthenticator'' element of
| |
| − | the CDA header.
| |
| − |
| |
| − |
| |
| − | === 4.5.2 Confidentiality ===
| |
| − |
| |
| − | In the
| |
| − | context of patient care coordination the anatomic pathology report described in
| |
| − | this profile contains patient personal data, and as such must be handled in
| |
| − | conformance to the local privacy policies.
| |
| − |
| |
| − | In other
| |
| − | contexts such as public health, surveillance, research, appropriate content
| |
| − | anonymization and patient identification pseudonymization may be required by
| |
| − | local policies.
| |
| − |
| |
| − |
| |
| − | === 4.5.3 Auditability ===
| |
| − |
| |
| − | Addressed by the CT
| |
| − | and ATNA profiles from ITI TF.
| |
| − |
| |
| − | = Volume 3 – Content Modules =
| |
| − |
| |
| − |
| |
| − |
| |
| − | = 1 Introduction =
| |
| − | <syntaxhighlight lang="xml">
| |
| − | Insert the text from the same section in volume 1 of the PAT TF
| |
| − | </syntaxhighlight>
| |
| − |
| |
| − |
| |
| − |
| |
| − |
| |
| − |
| |
| − | == 1.1 Overview of the Anatomic Pathology Technical Framework ==
| |
| − | <syntaxhighlight lang="xml">
| |
| − | Insert the text from the same section in volume 1 of the PAT TF
| |
| − | </syntaxhighlight>
| |
| − |
| |
| − |
| |
| − |
| |
| − |
| |
| − |
| |
| − | == 1.2 Overview of Volume 3 ==
| |
| − |
| |
| − |
| |
| − | The IHE Technical
| |
| − | Framework is based on actors that interact through transactions using some form
| |
| − | of content.
| |
| − |
| |
| − |
| |
| − | Actors are
| |
| − | information systems or components of information systems that produce, manage,
| |
| − | or act on information associated with operational activities in the enterprise.
| |
| − |
| |
| − |
| |
| − | Transactions are
| |
| − | interactions between actors that transfer the required information through
| |
| − | standards-based messages.
| |
| − |
| |
| − |
| |
| − | Content profiles
| |
| − | specify how the payload of a transaction fits into a specific use of that
| |
| − | transaction. A content profile has three main parts. The first part describes
| |
| − | the use case. The second part is binding to a specific IHE transaction, which
| |
| − | describes how the content affects the transaction. The third part is a Content
| |
| − | Module, which describes the payload of the transaction. A content module is
| |
| − | specified so as to be independent of the transaction in which it appears. This
| |
| − | overall content module is itself an assemblage of smaller content modules,
| |
| − | which in turn may assemble smaller content modules, conforming to the chosen
| |
| − | standard.
| |
| − |
| |
| − |
| |
| − | In particular,
| |
| − | the Anatomic Pathology Technical Framework provides a set of content profiles
| |
| − | for the sharing of persistent clinical document produced by the anatomic
| |
| − | pathology domain.
| |
| − |
| |
| − |
| |
| − | This Volume 3
| |
| − | specifies the content modules produced at various granularity levels (from a
| |
| − | whole clinical document to a tiny reusable piece of coded data) by the Anatomic
| |
| − | Pathology domain of IHE for its own content profiles.
| |
| − |
| |
| − |
| |
| − | Some of these
| |
| − | content modules produced here, may be used by content modules of higher
| |
| − | granularity from other domains (e.g., Patient Care Coordination).
| |
| − |
| |
| − |
| |
| − | Some of these
| |
| − | content modules produced here, may leverage content modules of lower
| |
| − | granularity from other domains (e.g., PCC, RAD, etc.).
| |
| − |
| |
| − |
| |
| − | == 1.3 Audience ==
| |
| − | <syntaxhighlight lang="xml">
| |
| − | Insert the text from the same section in volume 1 of the 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 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 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 PAT TF
| |
| − | </syntaxhighlight>
| |
| − |
| |
| − |
| |
| − |
| |
| − |
| |
| − | == 1.7 Scope Introduced in the Current Year ==
| |
| − |
| |
| − |
| |
| − | Content Modules for the APSR Profile
| |
| − |
| |
| − |
| |
| − | == 1.8 Copyright Permission ==
| |
| − |
| |
| − |
| |
| − | Health Level Seven, Inc. has granted permission to the IHE to reproduce tables from
| |
| − | the HL7 standard. The HL7 tables in this document are copyrighted by Health
| |
| − | Level Seven, Inc. All rights reserved. Material drawn from these documents is
| |
| − | credited where used.
| |
| − |
| |
| − |
| |
| − | == 1.9 Glossary ==
| |
| − |
| |
| − | The glossary of
| |
| − | the Anatomic Pathology Technical Framework is centralized in PAT TF-1:1.12.
| |
| − |
| |
| − | = 2 Content Modules – Basic Principles =
| |
| − |
| |
| − | This Volume 3 of
| |
| − | the PAT TF organizes content modules categorically by the base standard. At
| |
| − | present, PAT TF-3 uses only one base standard, CDA Release 2.0, but this is
| |
| − | expected to change over time. Underneath each standard, the content modules are
| |
| − | organized using a very coarse hierarchy inherent to the standard.
| |
| − |
| |
| − | Each content
| |
| − | module can be viewed as the definition of a "class" in software
| |
| − | design terms, and has associated with it a name. Like "class"
| |
| − | definitions in software design, a content module is a "contract", and
| |
| − | the PAT TF-3 defines that contract in terms of constraints that must be obeyed
| |
| − | by instances of that content module. Each content module has a name, also known
| |
| − | as its template identifier. The template identifiers are used to identify the
| |
| − | contract agreed to by the content module. The Anatomic Pathology Technical
| |
| − | Committee is responsible for assigning the template identifiers to each content
| |
| − | module.
| |
| − |
| |
| − | Like classes,
| |
| − | content modules may inherit features of other content modules of the same type
| |
| − | (e.g., Document, Section or Entry) by defining the parent content module that
| |
| − | they inherit from. They may not inherit features from a different type.
| |
| − |
| |
| − | Constraints that
| |
| − | apply to any content module will always apply to any content modules that
| |
| − | inherit from it. Thus, the "contracts" are always valid down the
| |
| − | inheritance hierarchy.
| |
| − |
| |
| − | The PAT TF-3 uses
| |
| − | the convention that a content module cannot have more than one parent (although
| |
| − | it may have several ancestors). This convention is not due to any specific
| |
| − | technical limitation of the technical framework, but does make it easier for
| |
| − | software developers to implement content modules.
| |
| − |
| |
| − | Each content
| |
| − | module has a list of data elements that are required (R), required if known
| |
| − | (R2), conditional (C) or optional (O).
| |
| − |
| |
| − | Other data
| |
| − | elements may be included in an instance of a content module over what is
| |
| − | defined by the PAT TF-3. Content consumers are not required to process these
| |
| − | elements, and if they do not understand them, must ignore them. Thus, it is not
| |
| − | an error to include more than is asked for, but it is an error to reject a
| |
| − | content module because it contains more than is defined by the framework. This
| |
| − | allows value to be added to the content modules delivered internationally in
| |
| − | this framework, through national extensions built by the national IHE
| |
| − | organizations in various countries. It further allows content modules to be
| |
| − | defined later by IHE that are refinements or improvements over previous content
| |
| − | modules.
| |
| − |
| |
| − |
| |
| − | = 3 IHE Transactions =
| |
| − |
| |
| − | This section
| |
| − | defines each IHE transaction in detail, specifying the standards used, and the
| |
| − | information transferred.
| |
| − |
| |
| − |
| |
| − | == 3.1 Cross Enterprise Document Content Transactions ==
| |
| − |
| |
| − |
| |
| − | At present, all
| |
| − | transactions used by the Anatomic Pathology Content Profiles appear in ITI TF-2a
| |
| − | and ITI TF-2b.
| |
| − |
| |
| − | General Options
| |
| − | defined in content profiles for a Content Consumer are listed below.
| |
| − |
| |
| − | === 3.1.1 View Option ===
| |
| − |
| |
| − | A Content
| |
| − | Consumer that supports the View Option shall be able to:
| |
| − |
| |
| − | 1. Use the appropriate XD* transactions to obtain the document along with associated
| |
| − | necessary metadata.
| |
| − |
| |
| − | 2. Render the document for viewing. This rendering shall meet the requirements defined
| |
| − | for CDA Release 2 content presentation semantics (See Section 1.2.4 of the CDA
| |
| − | Specification: Human readability and rendering CDA Documents). CDA Header
| |
| − | information providing context critical information shall also be rendered in a
| |
| − | human readable manner. This includes at a minimum the ability to render the
| |
| − | document with the stylesheet specifications provided by the document source, if
| |
| − | the document source provides a stylesheet. Content Consumers may optionally
| |
| − | view the document with their own stylesheet, but must provide a mechanism to
| |
| − | view using the source stylesheet.
| |
| − |
| |
| − | 3. Support traversal of links for documents that contain links to other documents managed
| |
| − | within the sharing framework.
| |
| − |
| |
| − | 4. Print the document to paper.
| |
| − |
| |
| − | === 3.1.2 Document Import Option ===
| |
| − |
| |
| − | This Option
| |
| − | requires that the View Option be supported. In addition, the Content Consumer
| |
| − | that supports the Document Import Option shall be able to support the storage
| |
| − | of the entire APSR document (as provided by the sharing framework, along with
| |
| − | sufficient metadata to ensure its later viewing). The machine-readable content
| |
| − | (from the entry elements) shall also be imported. This Option requires the
| |
| − | proper tracking of the document origin. Once a document has been imported, the
| |
| − | Content Consumer shall offer a means to view the document without the need to
| |
| − | retrieve it again from the sharing framework. When the document is used after
| |
| − | it was imported, a Content Consumer may choose to access the sharing framework
| |
| − | to find out if the related Document viewed has been deprecated or replaced.
| |
| − |
| |
| − | === 3.1.3 Section Import Option ===
| |
| − |
| |
| − | This Option
| |
| − | requires that the View Option be supported. In addition, the Content Consumer
| |
| − | that supports the Section Import Option shall be able to support the import of
| |
| − | one or more sections of the APSR document (along with sufficient metadata to
| |
| − | link the data to its source). The machine-readable content (from the entry
| |
| − | elements beneath the imported sections) shall also be imported. This Option
| |
| − | requires the proper tracking of the document section origin. Once sections have
| |
| − | been selected, a Content Consumer shall offer a means to copy the imported
| |
| − | section(s) into local data structures. When a section is used after it is
| |
| − | imported, a Content Consumer may choose to access the sharing framework to find
| |
| − | out if the related information has been updated.
| |
| − |
| |
| − |
| |
| − |
| |
| − |
| |
| − | = 4 IHE Anatomic Pathology Bindings =
| |
| − |
| |
| − | This section
| |
| − | describes how the payload used in a transaction of an IHE profile is related to
| |
| − | and/or constrains the data elements sent or received in those transactions.
| |
| − | This section is where any specific dependencies between the content and
| |
| − | transaction are defined.
| |
| − |
| |
| − | A content profile
| |
| − | can define multiple bindings. Each binding should identify the transactions and
| |
| − | content to which it applies.
| |
| − |
| |
| − | The source for
| |
| − | all required and optional attributes have been defined in the bindings below.
| |
| − | Three tables describe the three main XDS object types: XDSDocumentEntry,
| |
| − | XDSSubmissionSet, and XDSFolder. XDSSubmissionSet and XDSDocumentEntry are
| |
| − | required. Use of XDSFolder is optional. These concepts are universal to XDS,
| |
| − | XDR and XDM.
| |
| − |
| |
| − | The structure of
| |
| − | these three tables is presented in '''PCC TF-2:4'''
| |
| − |
| |
| − |
| |
| − | == 4.1 Anatomic Pathology Document Binding to XDS, XDM and XDR ==
| |
| − |
| |
| − | This binding
| |
| − | defines a transformation that generates metadata for the ''XDSDocumentEntry'' element of appropriate transactions from the XDS,
| |
| − | XDM and XDR profiles given a medical document and information from other
| |
| − | sources. The medical document refers to the document being stored in a
| |
| − | repository that will be referenced in the registry. The other sources of
| |
| − | information include the configuration of the Document Source actor, the
| |
| − | Affinity Domain, the site or facility, local agreements, other documents in the
| |
| − | registry/repository, and this content profile.
| |
| − |
| |
| − | In many cases,
| |
| − | the CDA document is created for the purposes of sharing within an affinity
| |
| − | domain. In these cases the context of the CDA and the context of the affinity
| |
| − | domain are the same, in which case the following mappings shall apply.
| |
| − |
| |
| − | In other cases,
| |
| − | the CDA document may have been created for internal use, and are subsequently
| |
| − | being shared. In these cases the context of the CDA document would not necessarily
| |
| − | coincide with that of the affinity domain, and the mappings below would not
| |
| − | necessarily apply.
| |
| − |
| |
| − |
| |
| − | === 4.1.1XDS DocumentEntry Metadata ===
| |
| − |
| |
| − | The general table
| |
| − | describing the ''XDSDocumentEntry Metadata'' requirements for IHE domains is shown in '''PCC TF-2:4.1.1'''
| |
| − |
| |
| − | The sub-sections
| |
| − | below list the only requirements which are specific to the Anatomic Pathology
| |
| − | Domain, and which supersede those from the general table mentioned above.
| |
| − |
| |
| − | ==== 4.1.1.1XDS DocumentEntry.formatCode ====
| |
| − |
| |
| − | The values of ''formatCode'' per document template are
| |
| − | listed in table 5.6-1.
| |
| − |
| |
| − | The associated'' codingScheme'' Slot SHALL be '''1.3.6.1.4.1.19376.1.2.3''' in all cases.
| |
| − |
| |
| − | == 4.1.1.2XDS DocumentEntry.eventCodeList ==
| |
| − |
| |
| − | This metadata
| |
| − | provides a means to index anatomic pathology reports by reportable conditions (e.g.,
| |
| − | certain types of tumors…) so as to facilitate later queries in a registry of
| |
| − | shared clinical documents. The conclusions coded in the ''entry'' element of the Diagnostic Conclusion section are good
| |
| − | candidates for this metadata.
| |
| − |
| |
| − | == 4.1.1.3XDS DocumentEntry.parentDocumentRelationship ==
| |
| − |
| |
| − | The Anatomic
| |
| − | Pathology document Content Modules only permit the “replace” relationship
| |
| − | between instances of APSR documents.
| |
| − |
| |
| − | Thus, XDSDocumentEntry.parentDocumentRelationship
| |
| − | is constrained to the "'''RPLC'''"
| |
| − | (replace) value. The new document issued replaces completely the parent one,
| |
| − | which will be considered as deprecated.
| |
| − |
| |
| − | === 4.1.2XDS SubmissionSet Metadata ===
| |
| − |
| |
| − | The submission
| |
| − | set metadata is as defined for XDS, and is not necessarily affected by the
| |
| − | content of the clinical document. Metadata values in an ''XDSSubmissionSet'' with names identical to those in the ''XDSDocumentEntry'' may be inherited from ''XDSDocumentEntry'' metadata, but this is
| |
| − | left to affinity domain policy and/or application configuration.
| |
| − |
| |
| − | This content
| |
| − | format uses the submission set to create a package of information to send from
| |
| − | one provider to another. All documents or images referenced by the Anatomic
| |
| − | Pathology Structured Report in this Package must be present (at least as
| |
| − | references in the case of images) in the submission set.
| |
| − |
| |
| − | === 4.1.3XDS Folder Metadata ===
| |
| − |
| |
| − | No specific requirements identified.
| |
| − |
| |
| − | === 4.1.4 Configuration ===
| |
| − |
| |
| − | The Anatomic
| |
| − | Pathology Content Profiles using this binding require that Content Creators and
| |
| − | Content Consumers be configurable with institution and other specific
| |
| − | attributes or parameters. Implementers should be aware of these requirements to
| |
| − | make such attributes easily configurable.
| |
| − |
| |
| − |
| |
| − | = 5 Namespaces and Vocabularies =
| |
| − |
| |
| − | == 5.1 OID tree of PAT TF ==
| |
| − |
| |
| − | 1.3.6.1.4.1.19376.1.81.3.6.1.4.1.19376.1.8 is the OID of the IHE Anatomic Pathology domain:
| |
| − |
| |
| − | All exchangeable objects specified by this domain are identified by OIDs built on this root:
| |
| − |
| |
| − |
| |
| − | Branch 1.3.6.1.4.1.19376.1.8.1 is dedicated to CDA Content Modules created by this domain
| |
| − |
| |
| − | 1.3.6.1.4.1.19376.1.8.1.1 is the OID of the generic Document Content Module
| |
| − |
| |
| − | Sub-branch 1.3.6.1.4.1.19376.1.8.1.2 is dedicated to Section Content Modules
| |
| − |
| |
| − | Sub-branch 1.3.6.1.4.1.19376.1.8.1.4 is dedicated to Element Content Modules
| |
| − |
| |
| − | 1.3.6.1.4.1.19376.1.8.1.4.4 is the OID of the Specimen Information Organizer
| |
| − |
| |
| − | 1.3.6.1.4.1.19376.1.8.1.4.8 is the OID of the Problem Organizer
| |
| − |
| |
| − | 1.3.6.1.4.1.19376.1.8.1.4.9 is the OID of the generic anatomic pathology (AP) observation template
| |
| − |
| |
| − | 1.3.6.1.4.1.19376.1.8.1.4.10 is the OID of the Procedure Steps template
| |
| − |
| |
| − |
| |
| − | Branch 1.3.6.1.4.1.19376.1.8.2 is dedicated to terminologies defined by this domain
| |
| − |
| |
| − | Sub-branch 1.3.6.1.4.1.19376.1.8.2.1 is dedicated to PathLex
| |
| − |
| |
| − | Branch 1.3.6.1.4.1.19376.1.8.5 is dedicated to Value Sets defined by this domain.
| |
| − |
| |
| − | Branch 1.3.6.1.4.1.19376.1.8.9 is used to identify instances in the examples built by the PAT TF.
| |
| − |
| |
| − | Notes on other IHE OIDs used in the AP domain:
| |
| − |
| |
| − | ''1.3.6.1.4.1.19376.1.3.1.2 is the OID of the Specimen Collection Procedure template''
| |
| − |
| |
| − |
| |
| − | == 5.2 Terminologies and controlled coded vocabularies ==
| |
| − |
| |
| − | This section lists the terminologies and the coded vocabularies referenced by this Volume 3 of the IHE PAT TF.
| |
| − |
| |
| − | '''Table 5.2-1 Anatomic Pathology Terminologies and Coded Vocabularies'''
| |
| − |
| |
| − | {{FAQBox|
| |
| − | Could this be contributed by ArtDecor??? GH
| |
| − | }}
| |
| − |
| |
| − | {| class="hl7table"
| |
| − | !codeSystem !! codeSystemName !!Description!! Owner
| |
| − | |-
| |
| − | |2.16.840.1.113883.6.1
| |
| − | ||LOINC
| |
| − | ||Logical Observation Identifier Names and Codes
| |
| − | ||Regenstrief Institute
| |
| − |
| |
| − | |-
| |
| − | |2.16.840.1.113883.6.96
| |
| − | ||SNOMED-CT||Systematized Nomenclature of Medicine – Clinical Terms
| |
| − | ||IHTSDO
| |
| − |
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.5.3.2
| |
| − | ||IHEActCode||Vocabulary defined by IHE PCC in PCC TF-2:5.1.2
| |
| − | ||IHE PCC
| |
| − |
| |
| − | |-
| |
| − | |2.16.840.1.113883.6.3
| |
| − | ||ICD-10||International Classification of Diseases revision 10
| |
| − | ||WHO
| |
| − |
| |
| − | |-
| |
| − | |2.16.840.1.113883.6.43
| |
| − | ||ICD-O-3||International Classification of Diseases for Oncology revision 3
| |
| − | ||WHO
| |
| − |
| |
| − | |-
| |
| − | |
| |
| − | ||PubCan||A Public Database of Human Cancers http://www.pubcan.org
| |
| − | ||WHO
| |
| − |
| |
| − | |-
| |
| − | |1.2.250.1.213.2.11
| |
| − | ||ADICAP Thesaurus||French thesaurus of lesions in anatomic pathology
| |
| − | ||ADICAP
| |
| − |
| |
| − | |-
| |
| − | |1.2.250.1.213.2.12
| |
| − | ||SNOMED International (3.5)||Systematized Nomenclature of Medicine
| |
| − | ||ASIP santé
| |
| − |
| |
| − |
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.8.2.1
| |
| − | ||PathLex||Temporary terminology covering the scope of anatomic pathology observation results and specimen collection procedure code
| |
| − | ||IHE-PAT
| |
| − |
| |
| − | |-
| |
| − | |2.16.840.1.113883.15.6
| |
| − | ||TNM 7th edition||Internationally agreed-upon standards to describe and categorize cancer stages and progression http://www.uicc.org/resources/tnm
| |
| − | ||Union for International Cancer Control (UICC) & American Joint Committee on Cancer (AJCC)
| |
| − |
| |
| − | |-
| |
| − | |2.16.840.1.113883.15.7
| |
| − | ||TNM 6th edition||Internationally agreed-upon standards to describe and categorize cancer stages and progression http://www.uicc.org/resources/tnm
| |
| − | ||Union for International Cancer Control (UICC) & American Joint Committee on Cancer (AJCC)
| |
| − |
| |
| − | |-
| |
| − | |2.16.840.1.113883.15.8
| |
| − | ||TNM 5th edition||Internationally agreed-upon standards to describe and categorize cancer stages and progression http://www.uicc.org/resources/tnm
| |
| − | ||Union for International Cancer Control (UICC) & American Joint Committee on Cancer (AJCC)
| |
| − |
| |
| − | |-
| |
| − | |1.2.276.0.76.3.1.131.1.5.1
| |
| − | ||DKG Coding Scheme||Internationally agreed-upon standards to describe and categorize cancer stages and progression, adapted for Germany
| |
| − | ||DKG (Deutsche Krebsgesellschaft)
| |
| − | |}
| |
| − |
| |
| − | == 5.3 Value Sets ==
| |
| − |
| |
| − |
| |
| − | The value sets defined or referenced by this Volume 3 of the IHE PAT TF are listed in the separate appendix spreadsheet “IHE_PAT_Suppl_APSR_AppendixValue_Sets”.
| |
| − |
| |
| − |
| |
| − | ==5.4 Namespaces==
| |
| − |
| |
| − | ===5.4.1 Namespace protecting extensions to the CDA schema===
| |
| − |
| |
| − | There is currently one single extension to the CDA.xsd schema used in PAT TF-3. This extension has been created by IHE LAB and is protected by this particular namespace in document instances: '' xmlns:lab="urn:oid:1.3.6.1.4.1.19376.1.3.2"''
| |
| − |
| |
| − |
| |
| − | ==5.5 References to Content Modules built outside of IHE PAT TF==
| |
| − | The Content Modules specified in this Volume 3 of the PAT TF leverage a number of Content Modules (currently CDA templates) produced and maintained by other groups, including other domains of IHE. Table 5.5-1 lists them.
| |
| − |
| |
| − | '''Table 5.5-1 External Content Modules referenced by PAT TF-3'''
| |
| − |
| |
| − | {| class="hl7table"
| |
| − | !templateId !! Standard !!Definition!! Source of Specification
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.5.3.1.3.1||CDA R2
| |
| − | ||Reason for referral
| |
| − | ||IHE PCC TF-2:6.3.3.1.2
| |
| − |
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.5.3.1.3.4
| |
| − | ||CDA R2||History of present illness
| |
| − | ||IHE PCC TF-2:6.3.3.2.1
| |
| − |
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.5.3.1.3.6
| |
| − | ||CDA R2||Active Problems
| |
| − | ||IHE PCC TF-2:6.3.3.2.3
| |
| − |
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.5.3.1.4.2
| |
| − | ||CDA R2||Annotation Comment
| |
| − | ||IHE PCC TF-2:6.3.4.6
| |
| − |
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.3.3.1.7
| |
| − | ||CDA R2||Performing laboratory
| |
| − | ||IHE LAB TF-3:2.3.3.22
| |
| − |
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.3.3.1.6
| |
| − | ||CDA R2||Ordering Provider (ordering physician)
| |
| − | ||IHE LAB TF-3:2.3.3.19
| |
| − |
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.3.3.1.4
| |
| − | ||CDA R2||Intended Recipient
| |
| − | ||IHE LAB TF-3:2.3.3.16
| |
| − |
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.3.1.6
| |
| − | ||CDA R2||Laboratory Observation
| |
| − | ||IHE LAB TF-3:2.3.5.11
| |
| − |
| |
| − |
| |
| − | |-
| |
| − | |1.3.6.1.4.1.19376.1.3.1.2
| |
| − | ||CDA R2||Specimen Collection Procedure
| |
| − | ||IHE LAB TF-3:2.3.5.5 (specification captured in this APSR supplement for easier readability)
| |
| − |
| |
| − | |}
| |
| − |
| |
| − | ==5.6 IHE Codes for Anatomic Pathology Document Templates==
| |
| − | Any AP structured report SHALL conform to the APSR generic Content Module Identified by templateId “1.3.6.1.4.1.19376.1.8.1.1.1” , and SHALL be associated with the following metadata:
| |
| − | *typeCode = “11526-1”, which is the LOINC code for “Pathology study”.
| |
| − | *formatCode = “urn:ihe:pat:apsr:all:2010”, with associated codingScheme = “1.3.6.1.4.1.19376.1.2.3” as assigned by the ITI Domain for codes used for the purposes of cross-enterprise document sharing (XDS).
| |
| − | *The media type SHALL be “text/xml”.
| |
| − |
| |
| − |
| |
| − | =6 Anatomic Pathology Content Modules=
| |
| − | ==6.1 Conventions==
| |
| − | In all Content Modules specified in this section, the abbreviation “'''AP'''” stands for “Anatomic Pathology”.
| |
| − |
| |
| − | Various tables used in this section will further constrain the content. Within this volume, the following conventions are used:
| |
| − |
| |
| − | '''R'''
| |
| − |
| |
| − | A "'''Required'''" data element is one that shall always be provided. If there is information available, the data element must be present. If there is no information available, or it cannot be transmitted, the data element must contain a value indicating the reason for omission of the data.
| |
| − |
| |
| − | '''R2'''
| |
| − |
| |
| − | A "'''Required if data present'''" data element is one that shall be provided when a value exists. If the information cannot be transmitted, the data element shall contain a value indicating the reason for omission of the data. If no such information is available to the content creator or if such information is not available in a well identified manner (e.g., buried in a free form narrative that contains additional information relevant to other sections) or if the content creator requires that information be absent, the R2 section shall be entirely absent. The Content Creator application must be able to demonstrate that it can populate all required if known elements, unless it does not in fact gather that data. This “R2” code is the equivalent of the HL7 standard “RE” usage code. The value “R2” has been chosen in harmonization with the IHE PCC TF, which is the source of a large number of CDA R2 content modules.
| |
| − |
| |
| − | '''O'''
| |
| − |
| |
| − | An "'''Optional'''" data element is one that may be provided, irrespective of whether the information is available or not. If the implementation elects to support this optional section, then its support shall meet the requirement set forth for the "Required if data present" or R2.
| |
| − |
| |
| − | '''C'''
| |
| − |
| |
| − | A "'''Conditional'''" data element is one that is required, required if known or optional depending upon other conditions. These will have further notes explaining when the data element is required, et cetera.
| |
| − |
| |
| − |
| |
| − | ==6.2 HL7 CDA R2 Content Modules==
| |
| − |
| |
| − | ===6.2.1 Organization===
| |
| − |
| |
| − | ====6.2.1.1 Various Types of Content Modules====
| |
| − |
| |
| − | For the CDA Release 2.0 standard, the content modules are organized by:
| |
| − |
| |
| − |
| |
| − | *'''document''': The template for a whole document.
| |
| − |
| |
| − |
| |
| − | *'''section''': The template for a <section> element.
| |
| − |
| |
| − |
| |
| − | *'''entry''': The template for a <entry> element.
| |
| − |
| |
| − |
| |
| − | *'''child element''': An element of the CDA header or an element of a <section>, or an element nested at various depths below an <entry>, or an element appearing at some combination of these locations.
| |
| − |
| |
| − |
| |
| − | ====6.2.1.2 General constraints added by IHE PAT to a CDA R2 document====
| |
| − |
| |
| − | In the structured body of a CDA R2 document, a section has a narrative block (the text element), which presents the human-readable content of the section, and MAY have one entry or more. Sections MAY be nested within one another.
| |
| − |
| |
| − | The content modules designed by the PAT TF bring or highlight the following constraints:
| |
| − |
| |
| − | *When a section has a text element and one or more entry element, the content coded for machine-processing in the entries SHALL be completely transcribed into human-readable content in the text element.
| |
| − |
| |
| − | *Conversely the text element MAY contain pieces of information, which are not available in machine-readable format in any entry element of the section.
| |
| − |
| |
| − | *For a document of the Anatomic Pathology domain, the entry elements are instantiated per specimen or per group of specimens observed together. One entry contains in machine-readable format observations of the section related to the same specimen or group of specimens. Beneath an entry, the observations are organized per problem.
| |
| − |
| |
| − | *The text element of the section is supposed to be also laid out per specimen or group of specimens and per problem observed.
| |
| − |
| |
| − | *The APSR Content Profile leaves the layout of the text element up to the Content Creator applications, or to further constraints brought by national extensions of this profile. However, given that the text element is usually composed of free text (e.g. dictated text), assembled with the text generated from the set of data, machine-encoded in the entry elements below, the Content Creator application MUST handle these two kinds of content, and provide a user interface, which avoids risks of overwriting text automatically derived from the entries with free text typed in by the user (e.g., using forms with dedicated free text areas and distinct protected areas for text generated out of structured data).
| |
| − |
| |
| − | *Information that is sent SHALL clearly identify distinctions between:
| |
| − |
| |
| − | '''None'''
| |
| − |
| |
| − | It is known with complete confidence that there are none. This indicates that the sender knows that there is no relevant information of this kind that can be sent.
| |
| − |
| |
| − | '''None Known'''
| |
| − |
| |
| − | None known at this time, but it is not known with complete confidence that none exist.
| |
| − |
| |
| − | '''Asked but unknown'''
| |
| − |
| |
| − | The information was requested but could not be obtained. Used mainly in the context where an observation was made but the result could not be determined.
| |
| − |
| |
| − | '''Unknown'''
| |
| − |
| |
| − | The information is not known, or is otherwise unavailable.
| |
| − |
| |
| − | '''Other, not specified'''
| |
| − |
| |
| − | The actual value does not belong to the assigned value set and is not reported at all by the author.
| |
| − |
| |
| − | '''Other, specify'''
| |
| − |
| |
| − | The actual value does not belong to the assigned value set and the author of the report provides this ''foreign'' value anyway.
| |
| − |
| |
| − | '''Not applicable'''
| |
| − |
| |
| − | No proper value is applicable in this context.
| |
| − |
| |
| − | Sections that are required to be present but have no information should use one of the above phrases where appropriate in the ''text'' element.
| |
| − |
| |
| − | Structural elements that are required but have no information shall provide a “nullFlavor” attribute coding the reason why the information is missing.
| |
| − |
| |
| − | {| class="hl7table"
| |
| − | !Situation !! nullFlavor !!HL7 Definition
| |
| − | |-
| |
| − | |Asked but unknown||ASKU
| |
| − | ||Information was sought but not found
| |
| − |
| |
| − | |-
| |
| − | |Unknown
| |
| − | ||UNK||A proper value is applicable, but not known
| |
| − |
| |
| − | |-
| |
| − | |Other, not specified
| |
| − | ||OTH||The actual value is not an element in the value domain of a variable. (e.g., concept not provided by required code system).
| |
| − |
| |
| − | |-
| |
| − | |Not applicable
| |
| − | ||NA||No proper value is applicable in this context
| |
| − |
| |
| − | |-
| |
| − | |Temporarily not available
| |
| − | ||NAV||Information is not available at this time but it is expected that it will be available later.
| |
| − | |}
| |
| − |
| |
| − |
| |
| − | The two situations “None” and “None known” represent effective values, which are part of the related value sets.
| |
| − |
| |
| − | The situation “Other, specify” can be handled in two ways in a coded data element:
| |
| − | *Leaving empty the ''code'' attribute and providing the non-coded answer in the ''originalText'' attribute.
| |
| − | *Providing a value coded from a different coding scheme, when the coding strength of the element is “CWE” (coded with extensions). The attributes ''code'', ''displayName'', ''codeSystem'' and ''codeSystemName'' then describe the foreign code.
| |
| − |
| |
| − | For ancillary techniques, the situation “ not performed” or “none performed” is represented by nullFlavor = NAV.
| |
| − |
| |
| − |
| |
| − | ====6.2.1.3 Common structure for CDA APSR====
| |
| − |
| |
| − | Figure 6.2.1.3-1 summarizes the common structure of the first five CDA APSR Section Content Modules specified here. Regarding the machine-readable part, the figure highlights the organization of entries within a section and of observations within an entry. Specific details such as the structure of sub-sections are not shown on this global picture.
| |
| − |
| |
| − | {{FAQBox|
| |
| − | Should these both figures better given in the HL7 Style??? GH
| |
| − | }}
| |
| − |
| |
| − | [[Datei:APSR_Common_Structure_Section1_5_neu.PNG]]
| |
| − |
| |
| − | '''Figure 6.2.1.3-1 CDA APSR: common structure of machine-readable content for CDA APSR Section Content Modules except Procedure Step Content Module'''
| |
| − |
| |
| − | Figure 6.2.1.3-2 shows the common structure of the Procedure Step Content Module specified here, too.
| |
| − |
| |
| − |
| |
| − | [[Datei:APSR_Common_Structure_Section6.PNG]]
| |
| − |
| |
| − | '''Figure 6.2.1.3-2 CDA APSR: common structure of machine-readable content for Procedure Step Content Module '''
| |
| − |
| |
| − |
| |
| − | Note 1: In order to facilitate a further de-identification process of CDA AP reports for some secondary use (biosurveillance, epidemiology…) the producer of an APSR SHOULD avoid populating any patient identification data (name, sex, birthdate, address …) into the body of the report (neither <entry> elements nor <text> elements). The appropriate location for patient identification data is the CDA header exclusively.
| |
| − |
| |
| − | Note 2: The AP sections are those shown on figure 4.1.2.1-1 of Volume 1.
| |
| − |
| |
| − | Note 3: The possible sub sections are shown on figure 4.1.2.1-1 of Volume 1.
| |
| − |
| |
| − | ===6.2.2 Common layout for the specification of a CDA Content Module===
| |
| − |
| |
| − | Each CDA R2 Content Module specified in this Volume is presented with this layout:
| |
| − |
| |
| − | ====6.2.2.1 Content Module Name – OID====
| |
| − |
| |
| − | Each Content Module is uniquely identified by a unique OID.
| |
| − |
| |
| − | =====6.2.2.1.1 Definition and purpose=====
| |
| − |
| |
| − | This section presents the content module and its purpose.
| |
| − |
| |
| − | In case this module is a specialization of a more generic one, the section references its parent template.
| |
| − |
| |
| − | =====6.2.2.1.2 Example=====
| |
| − |
| |
| − | This section delivers a snippet, showing an example of the content module.
| |
| − |
| |
| − | =====6.2.2.1.3 Specification=====
| |
| − |
| |
| − | The form of the specification depends upon the kind of CDA Content Module (document, section, entry, header and/or entry element). It respects the guidelines below:
| |
| − |
| |
| − | *The specification provides a table describing the structure of the content module, each element being located through an XPATH expression combined with indentation. The table provides cardinalities, meaning for each elements, references value sets described in section 5 for attributes, and provides the mapping with HL7 V2.5.1 relevant fields. The table also points the content modules nested in the current one, by showing their templateId, and locating their specification in the current PAT TF-3 or in the IHE TF they belong to (PCC, LAB, etc.).
| |
| − | *The table is simplified for section content modules: It only lists the content modules nested in the section template.
| |
| − | *Below the tables appear notes providing additional information and detailing particular constraints on some elements or attributes.
| |
| − |
| |
| − |
| |
| − |
| |
| − |
| |
| − | ===6.2.3 CDA R2 Document Content Modules===
| |
| − |
| |
| − | ====6.2.3.1 AP Structured Report (APSR) - 1.3.6.1.4.1.19376.1.8.1.1.1====
| |
| − |
| |
| − | =====6.2.3.1.1 Definition and purpose=====
| |
| − |
| |
| − | This Document Content Module defines the base set of constraints that apply to all AP structured report, related to any kind of lesion or diagnostic. In other words, this is the generic template for any AP structured report.
| |
| − |
| |
| − | The body of this Document Content Module has the hierarchy of sections and entries depicted by figure 4.1.2.1-1 in Volume 1.
| |
| − |
| |
| − |
| |
| − |
| |
| − | {{:2.16.840.1.113883.2.6.60.6.10.1/dynamic}}
| |
| − |
| |
| − | ===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.
| |
| − |
| |
| − | {{:2.16.840.1.113883.2.6.60.6.10.5}}
| |
| − |
| |
| − | ====6.2.4.2 Intraoperative Observation <section> - 1.3.6.1.4.1.19376.1.8.1.2.2====
| |
| − |
| |
| − | =====6.2.4.2.1 Definition and Purpose=====
| |
| − |
| |
| − | The Intraoperative Observation section contains an intraoperative diagnosis for each specimen examined, the specimen identification and description, intraoperative observation procedure description (frozen section, gross examination, intraoperative cytology) and derived specimen dissected for other ancillary procedures (flow cytometry, cytogenetics, molecular studies, and electron microscopy).
| |
| − |
| |
| − |
| |
| − | ====6.2.4.3 Macroscopic Observation <section> - 1.3.6.1.4.1.19376.1.8.1.2.3====
| |
| − |
| |
| − | =====6.2.4.3.1 Definition and Purpose=====
| |
| − |
| |
| − | The Macroscopic Observation section contains the description of the specimen(s) received or obtained by the laboratory (specimen type and state), the gross observation, links to gross images, if taken, processing information and tissue disposition (representative sampling and tissue submitted for additional studies or sent to biorepository.
| |
| − |
| |
| − |
| |
| − | ====6.2.4.4 Microscopic Observation <section> - 1.3.6.1.4.1.19376.1.8.1.2.4====
| |
| − |
| |
| − | =====6.2.4.4.1 Definition and Purpose=====
| |
| − |
| |
| − | The Microscopic Observation section contains optionally the histopathologic findings of the case and many laboratories use this section to record the results of histochemical and immunohistochemical stains.
| |
| − |
| |
| − |
| |
| − | ====6.2.4.5 Diagnostic Conclusion <section> - 1.3.6.1.4.1.19376.1.8.1.2.5====
| |
| − |
| |
| − | =====6.2.4.5.1 Definition and Purpose=====
| |
| − |
| |
| − | The Diagnostic Conclusion section contains diagnoses on all specimens that are delivered to the pathology department from one operation or patient visit to a single clinician on a particular day. The diagnoses for each specimen or group of specimens are reported separately. This section includes additional pathologic finding(s) and the results of ancillary study(ies) and may include diagrams and still images or virtual slides, if taken. In case of cancer, this section includes the cancer checklist.
| |
| − |
| |
| − |
| |
| − | ====6.2.4.6 Procedure steps <section> - 1.3.6.1.4.1.19376.1.8.1.2.6====
| |
| − |
| |
| − | =====6.2.4.6.1 Definition and Purpose=====
| |
| − |
| |
| − | The Procedure steps section contains the description of tissue dissection: representative specimens and derived specimens dissected for other ancillary procedures (flow cytometry, cytogenetics, molecular studies, electron microscopy, etc.) or biorepository.
| |
| − |
| |
| − |
| |
| − | ====6.2.4.7 Report Textual Summary <section> - 1.3.6.1.4.1.19376.1.8.1.2.7====
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| − |
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| − | =====6.2.4.7.1 Definition and Purpose=====
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| − |
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| − | 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.
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| − |
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| − |
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| − | ===6.2.5 CDA R2 <entry> Content Modules===
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| − |
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| − | ====6.2.5.1 Common Specification for all APSR Entry Content Modules====
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| − |
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| − | The unique <entry> Content Module available in all the sections except Procedure Steps <section> of the APSR template is Problem (Specimen Information) Organizer.
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| − |
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| − | The unique <entry> Content Module available in Procedure Steps <section> of the APSR template is Specimen Procedure Step
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| − |
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| − | Each <entry> Content Module carries machine-readable data related to one specimen or to one group of specimens observed for this section.
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| − |
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| − | 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.
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| − |
| |
| − |
| |
| − | 6.2.6 CDA R2 Child Element Content Modules
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| − |
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| − | 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.
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| − |
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| − | ====6.2.6.1 Specimen Collector in Header – 1.3.6.1.4.1.19376.1.8.1.4.1====
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| − |
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| − | =====6.2.6.1.1 Definition and purpose=====
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| − |
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| − | This Content Module is usable only in the CDA header.
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| − |
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| − | 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)
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| − |
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| − |
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| − | ====6.2.6.2 Author – 1.3.6.1.4.1.19376.1.8.1.4.2====
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| − |
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| − | =====6.2.6.2.1 Definition and purpose=====
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| − |
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| − | This Content Module is usable in the CDA header, in a <section> and at various depths of an <entry>.
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| − |
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| − | 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).
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| − |
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| − | A given document or any delimited portion of it may have more than one author.
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| − |
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| − | An author MAY be a person or a device (manufactured device or software system). In both cases the scoping organization MAY be described.
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| − |
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| − |
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| − |
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| − |
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| − | ====6.2.6.3 Content Validator – 1.3.6.1.4.1.19376.1.8.1.4.3====
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| − |
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| − | =====6.2.6.3.1 Definition and purpose=====
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| − |
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| − | This Content Module is usable only in the CDA header.
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| − |
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| − | 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.
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| − |
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| − | The report MAY have zero or more Content Validators.
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| − |
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| − |
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| − |
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| − | ====6.2.6.4 Specimen Information Organizer – 1.3.6.1.4.1.19376.1.8.1.4.4====
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| − |
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| − | =====6.2.6.4.1 Definition and purpose=====
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| − |
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| − | {{FAQBox|
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| − | Is this organizer really necessary? The updated AP Observation has direct relation to a specific specimen which is observed. The central organizer function should be fulfilled by the problem organizer. GH
| |
| − | }}
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| − |
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| − | This Content Module is the unique <entry> available for most of APSR sections (see figure 4.1.2.1-1 in Volume 1). The specimen information organizer organizes information related to the various acts (procedures, observations) performed on a single specimen or group of specimens investigated together.
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| − |
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| − |
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| − |
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| − | ====6.2.6.5 Specimen Collection Procedure generic template – 1.3.6.1.4.1.19376.1.3.1.2====
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| − |
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| − | =====6.2.6.5.1 Definition and purpose=====
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| − |
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| − | {{FAQBox|
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| − | Is this entry really necessary? Its function is better served by the Specimen Procedure Steps entry. GH
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| − | }}
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| − |
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| − | This Content Module is usable within an <entry> element.
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| − |
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| − | This Content Module structures the machine-readable data representing the characteristics of the specimen (identifiers and type) and the procedure that collected it: Type of procedure, time interval, performer (person and organization), approach site, target site.
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| − |
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| − | The “Specimen Collection Procedure” generic template is usable in all <entry> elements of all APSR Document Content Modules.
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| − |
| |
| − | Each organ-specific APSR Document Content Module mandates an organ-specific template, child of the “Specimen Collection Procedure” generic template. This organ-specific child template has exactly the same structure as the generic one, and brings only a number of vocabulary constraints related to this specific organ:
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| − | *The value set bound to the procedure/code element, consisting in a list of triplets (code, codeSystem, displayName) representing the various specimen collection procedures that can be performed on this specific organ.
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| − | *The value set bound to the procedure/targetSiteCode element, consisting in a list of triplets (code, codeSystem, displayName) representing the various precise locations for collecting specimens from this specific organ.
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| − |
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| − |
| |
| − | Thus, a specimen collection procedure in an <entry> within an organ-specific APSR Document Content Module declares conformance to two templates: The “Specimen Collection Procedure” generic template and the “Specimen Collection Procedure” child template constraining the vocabularies for the contextual organ.
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| − |
| |
| − | These specimen collection procedure child templates and their attached value sets are provided by the appendix “IHE_PAT_Suppl_APSR_AppendixValue_Sets.xlsx”
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| − |
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| − |
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| − |
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| − | ====6.2.6.6 Informant – 1.3.6.1.4.1.19376.1.8.1.4.6====
| |
| − |
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| − | =====6.2.6.6.1 Definition and purpose=====
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| − |
| |
| − | 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.
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| − |
| |
| − | A <ClinicalDocument> or a <section> or any kind of act below an <entry>, MAY have zero or more informant.
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| − |
| |
| − |
| |
| − |
| |
| − | ====6.2.6.7 Additional participant in an entry - 1.3.6.1.4.1.19376.1.8.1.4.7====
| |
| − |
| |
| − | =====6.2.6.7.1 Definition and purpose=====
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| − |
| |
| − | 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.
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| − |
| |
| − |
| |
| − |
| |
| − | ====6.2.6.8 Problem Organizer – 1.3.6.1.4.1.19376.1.8.1.4.8====
| |
| − |
| |
| − | =====6.2.6.8.1 Definition and purpose=====
| |
| − |
| |
| − | This Content Module is usable within (a Specimen Information Organizer) any Section module.
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| − |
| |
| − | The problem organizer groups the battery of observations performed to investigate on a single problem identified on a specimen or group of specimens.
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| − |
| |
| − |
| |
| − |
| |
| − | ====6.2.6.9 AP Anatomic pathology Observation template – 1.3.6.1.4.1.19376.1.8.1.4.9====
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| − |
| |
| − |
| |
| − | =====6.2.6.9.1 Definition and purpose=====
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| − |
| |
| − | 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.
| |
| − |
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| − |
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| − |
| |
| − |
| |
| − |
| |
| − | ====6.2.6.10 Embedded Image – 1.3.6.1.4.1.19376.1.8.1.4.10====
| |
| − | =====6.2.6.10.1 Definition and purpose=====
| |
| − |
| |
| − | This Content Module is usable within an <entry> element, in relationship with a
| |
| − | display anchor carried in the ''referencedObject'' attribute of a <renderMultimedia>
| |
| − | element in the <text> element of the <section> holding this <entry>.
| |
| − |
| |
| − |
| |
| − | The <observationMedia> element carries an image, embedded in B64. This element may be standalone, or encapsulated within a <regionOfInterest> element which defines an overlay
| |
| − | shape to focus on a part of the image.
| |
| − |
| |
| − | This <observationMedia> element embeds the image binary data, encoded in B64.
| |
| − |
| |
| − |
| |
| − | ====6.2.6.11 Specimen Procedure Step - 1.3.6.1.4.1.19376.1.8.1.4.11====
| |
| − | {{FAQBox|
| |
| − | This is an addendum to the reference text of APSR 2.0 GH
| |
| − | }}
| |
| − | =====6.2.6.11.1 Definition and purpose=====
| |
| − | The Specimen Procedure Step <entry> Content Modul contains in machine-readable form all the information concerning one specimen or a group of specimens. It is usable within a Procedure Steps <section> Content Module only.
| |
| − |
| |
| − | This Content Module structures the machine-readable data, which characterize the specimens and the procedures of their collection and processing. By nesting via an entryRelationship the entry is used in an iterative manner for each single step of specimen processing, which results in derived (child) specimen in and on the appropriate containers. The resulting specimen is the participant in the procedure according the CDA-RIM (fig. 6.2.6.11.1-1). It carries an ID as well as further attributes, which are defined in the HL7 Specimen DAM [http://www.hl7.org/implement/standards/product_brief.cfm?product_id=331 HL7 DAM Specimen Release 1].
| |
| − | [[Datei:6.2.6.11.1-1.jpg]]
| |
| − |
| |
| − | '''Figure 6.2.6.11.1-1 CDA-RMIM of the Specimen Procedure Steps <entry>'''
| |
| − |
| |
| − | The Code systems and Value sets MAY be organized organ-specific and represented e.g. by PathLex.
| |
| − |
| |
| − | ====6.2.6.12 UICC/AJCC TNM Staging and Grading====
| |
| − | {{FAQBox|
| |
| − | This is an addendum to the reference text of APSR 2.0 GH
| |
| − | }}
| |
| − |
| |
| − | =====6.2.6.12.1 Definition and purpose=====
| |
| − | The UICC/AJCC TNM <entry> Content Modul contains in machine-readable form all the information concerning a TNM formula for a problem investigated. It is usable within a Problem Organizer <entry> Content Module only.
| |
| − |
| |
| − | This Content Module structures the machine-readable data, which characterize the staging and grading of a malignant Tumor according the UICC/AJCC regulations for the TNM system.
| |
| − |
| |
| − | [[Datei:Fig.6.2.6.12.1-1.jpg]]
| |
| − |
| |
| − | '''Figure 6.2.6.12.1-1 CDA-RMIM of the UICC/AJCC TNM <entry>'''
| |
| − |
| |
| − | ====6.2.6.13 ICD-O-3 Typing and Grading====
| |
| − | {{FAQBox|
| |
| − | This is an addendum to the reference text of APSR 2.0 GH
| |
| − | }}
| |
| − | =====6.2.6.13.1 Definition and purpose=====
| |
| − | The ICD-O-3 Typing and Grading<entry> Content Modul contains in machine-readable form all the information concerning ICD-O-3 Typing and Grading for a problem investigated. It is usable within a Problem Organizer <entry> Content Module only.
| |
| − |
| |
| − | This Content Module structures the machine-readable data, which characterize the staging of a tumor or a systemic disease according the WHO regulations for the ICD-O-3 system.
| |
| − |
| |
| − |
| |
| − | '''Figure 6.2.6.13.1-1 CDA-RMIM of the ICD-O-3 <entry>'''
| |
| − |
| |
| − | ====6.2.6.14 Assessment Scales for Scoring systems====
| |
| − | {{FAQBox|
| |
| − | This is an addendum to the reference text of APSR 2.0 GH
| |
| − | }}
| |
| − | =====6.2.6.14.1 Definition and purpose=====
| |
| − | The Assessment Scales <entry> Content Modul contains in machine-readable form all the information concerning (semiquantitative) scoring systems often used for describing a tumor grading for a problem investigated. It is usable within the ICD-O-3 Typing and Grading <entry> or within a Problem Organizer <entry> Content Module.
| |
| − |
| |
| − | This Content Module structures the machine-readable data, which characterize the grading components of a tumor or a systemic disease according specific regulations.
| |
| − |
| |
| − |
| |
| − | '''Figure 6.2.6.14.1-1 CDA-RMIM of an Assessment Scales <entry>'''
| |
