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| − | =Einleitung / Introduction= | + | =Foreword= |
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| − | Dieses Dokument ist ein Entwurf für die Umsetzung von Pathologie-Berichten mit Hilfe von HL7 CDA R2. Diese Entwicklung soll die Pathologieintegration innerhalb Deutschlands, im deutschsprachigen Raum und auch international fördern. Sie wird vom Bundesverband Deutscher Pathologen e.V. unterstützt.
| + | This is a supplement to the IHE Pathology |
| | + | and Laboratory Medicine Technical Framework V8.0. Each supplement undergoes a |
| | + | process of public comment and trial implementation before being incorporated |
| | + | into the volumes of the Technical Frameworks. |
| | | | |
| − | Ausgehend vom HL7 V3 Arztbrief-Leitfaden der bvitg (ehemals VHitG) stützt sich der Pathologiebefund auf die IHE-Dokumente "IHE Anatomic Pathology, Technical Framework Supplement, Anatomic Pathology Structured Reports - Trial Implementation, Rev.2.0" vom 06.08.2013, "APSR Value Sets Appendix, Rev. 2.0" vom 06.08.2013, "IHE Anatomic Pathology (PAT), Technical Framework, Volume 1, Revision 2.0 1, Trial Implementation" vom 23.7.2010, "IHE Anatomic Pathology (PAT), Technical Framework, Volume 2 15, Revision 2.0, Trial Implementation" vom 23.7.2010.
| + | 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. |
| | | | |
| − | Die spezifisch deutschen Belange werden als National Extensions für IHE entwickelt und mit den Aktivitäten von ELGA, Österreich, abgestimmt. Darüber hinaus wird eine enge Kooperation mit IHE-AP und HL7-AP gesucht, um die in Deutschland erarbeiteten Details international einzubringen.
| + | This supplement describes changes to the |
| | + | existing technical framework documents. |
| | | | |
| − | Orientiert wird dabei auf eine möglichst vollständige Berücksichtigung des "Leitfadens Pathologie/Neuropathologie (ehem. TM-30)" des Sektorkomitees Pathologie für die Anwendung der DIN EN ISO/IEC 17020 in der Pathologie/Neuropathologie.
| + | “Boxed” instructions like the sample |
| | + | below indicate to the Volume Editor how to integrate the relevant section(s) |
| | + | into the relevant Technical Framework volume. |
| | | | |
| − | Weiterhin wird angestrebt, die durch den Bundesverband Deutscher Pathologen und die Deutsche Gesellschaft für Pathologie veröffentlichten "Empfehlungen zur pathologisch-anatomischen Diagnostik von Kolorektalen Karzinomen, Mammakarzinomen und Prostatakarzinomen" in HL7 CDA R2 kompatible Templates zur Integration als Checklisten in Pathologie-Management-Systeme umzusetzen.
| + | <syntaxhighlight lang="xml"> |
| | + | Replace Section X.X by the following: |
| | + | </syntaxhighlight> |
| | | | |
| − | Auf dieser Basis soll der Import von HL7 CDA R2 Dokumenten von der Pathologie in KIS-Systeme sowie in Tumormeldungen und Qualitätssicherungs- und Tumordokumentationssysteme (z.B. AQUA, MaSC, ix.mid etc.) umgesetzt werden.
| + | Where the amendment adds text, make the added |
| | + | text '''bold underline'''. Where the amendment removes |
| | + | text, make the removed text '''bold strikethrough'''. |
| | + | When entire new sections are added, introduce with editor’s instructions to |
| | + | “add new text” or similar, which for readability are not bolded or underlined. |
| | | | |
| | + | General information about IHE can be found at: http://www.ihe.net. |
| | | | |
| | + | Information about the IHE Pathology and Laboratory Medicine domain can be found at: http://ihe.net/IHE_Domains. |
| | | | |
| − | This document is a proposal for Anatomical Pathology Structured Reports (APSR)in HL7 CDA R2. It should help to integrate Anatomic and Clinical Pathology in German speaking countries into clinical and research environments by enabling interoperability between a variety of LIS, HIS, and cancer registries as well as elctronic health records. The specific German aspects are constraints of the IHE Anatomic Pathology profiles. They will be developed in close collaboration with the Austrian ELGA initiative. On the other hand, there is a close cooperation with IHE-AP and HL7-AP as to bring in the national demands into international standard development.
| + | Information about the structure of IHE Technical Frameworks and Supplements can be found at: http://ihe.net/IHE_Process and http://ihe.net/Profiles. |
| | | | |
| − | For the German APSR the "Guideline Pathology / Neuropathology" (formerly TM-30) of the Sector Committee Pathology for the implementation of DIN EN ISO/EC 17020 shall be regarded. Furthermore, the recommendations of the German Society of Pathology for pathologic-anatomical reporting of colorectal, breast, and prostate cancers should be enabled by CDA compatible codes and value sets.
| + | The current version of the IHE Technical Framework (if applicable) can be found at: http://ihe.net/Technical_Frameworks. |
| | | | |
| − | =Introduction=
| + | ''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.'' |
| | | | |
| − | This supplement is written for Trial Implementation.
| + | =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 |
| | | | |
| − | This supplement prepares a new volume, Volume 3, of the IHE Pathology and Laboratory Medicine (PaLM) Technical Framework.
| + | 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. |
| | | | |
| − | This supplement references other documents the reader should be aware of:
| + | __TOC__ |
| | | | |
| − | 1. IHE IT Infrastructure Technical Framework Volume 1
| + | =Introduction to this Supplement= |
| | | | |
| − | 2. IHE IT Infrastructure Technical Framework Volume 3 | + | This supplement complements volume 1 of |
| | + | the PaLM technical framework with the description of the APSR 2.0 content |
| | + | profile, and volume 3 with the bindings, content modules and value sets, which specify |
| | + | this profile. |
| | | | |
| − | 3. IHE PCC Technical Framework Volume 2
| + | ==Open Issues and Questions== |
| | | | |
| − | 4. IHE LAB Technical Framework Volume 3
| + | ''None yet'' |
| − | | |
| − | 5. HL7 CDA r2 normative edition 2005
| |
| − | | |
| − | 6. Goldsmith, J.D., et al., Reporting guidelines for clinical laboratory reports in surgical pathology. Arch Pathol Lab Med, 2008. 132(10): p. 1608-16
| |
| − | | |
| − | 7. CAP Cancer Protocols and Checklists 2010
| |
| − | | |
| − | ==Profile Abstract==
| |
| − | | |
| − | | |
| − | <nowiki>Anatomic pathology reports (APR) document the pathologic findings in specimens removed from patients for diagnostic or therapeutic reasons. This information can be used for patient care, clinical research and epidemiology.
| |
| − | | |
| − | | |
| − | This Content Profile is the result of a joint initiative from IHE and HL7 anatomic pathology workgroups who brought along a methodology and tools to facilitate the development of consensus-based anatomic pathology structured reports (APSR) and to publish an HL7 Clinical Document Architecture (CDA) implementation guide for these APSR. </nowiki>
| |
| − | | |
| − | ==Open Issues and Questions==
| |
| − | '''APSR-13 – Missing LOINC code for intraoperative section:''' This code does not seem to be available in LOINC. The creation will be submitted to the Regenstrief Institute. | |
| | | | |
| | ==Closed Issues== | | ==Closed Issues== |
| | | | |
| − | '''APSR-01 – List of potential sections of an AP structured report: ''' | + | '''APSR-07 – Representing the hierarchy of specimens in an entry''' : This APSR |
| − | - Clinical information (content supposedly provided by the ordering physician)
| + | supplement enables to represent the hierarchy of specimens at the CDA level 3. |
| − | | + | The operations on specimen and production of child specimens are tracked in the |
| − | - Intraoperative observations (in case of intraoperative consultation, which may be macroscopic only or may include cytology and/or frozen section)
| + | “Procedure Steps” section, which has a level 3 entry. |
| − | | |
| − | - Macroscopic observations
| |
| − | | |
| − | - Microscopic observations
| |
| − | | |
| − | - Diagnosis
| |
| − | | |
| − | - Procedure steps (this technical section is also useful for tracking the sequence of operations performed on the specimen at the work area), which does not preclude some of this information from appearing in one of the other sections (e.g., the Macroscopic observations section).
| |
| − | | |
| − | | |
| − | '''APSR-02 – Content of sections: '''
| |
| − | - Each section SHALL contain a text element presenting the content to the human reader. The profile does not constrain the layout of this narrative block.
| |
| − | | |
| − | - The Diagnostic Conclusion section SHALL contain an ''entry'' element with the corresponding machine-readable data.
| |
| − | | |
| − | - The other sections SHOULD contain an ''entry'' element with the corresponding machine-readable data.
| |
| − | | |
| − | - The Clinical information section MAY contain other sections.
| |
| − | | |
| − | '''APSR-03 – Handling the mix of coded content and free unstructured text: ''' | |
| − | | |
| − | AP reports are often composed of free text (which can be dictated), assembled with a set of coded information (e.g., some AP observations). The Content Creator application must handle these two kinds of content, and provide a user interface, which avoids any confusion between these two kinds of content, both at creation time and update time (e.g., using forms with dedicated free text areas and distinct areas for coded fields).
| |
| − | | |
| − | The body of the report is a hierarchy of sections. Each section presents its content in its text element, as human-readable text, possibly illustrated by some embedded images. This human-readable content of the section, or a part of it, may also be present as machine-readable data coded with the appropriate terminologies (e.g., ICD-O-3, PATHLEX, SNOMED CT, LOINC, ADICAP, or any other terminology admitted by this profile or a national extension of it …) in entry elements at the bottom of the section.
| |
| − | | |
| − | There are zero or more entry elements in a section. Each entry element carries the machine-readable data related to a specimen or to a group of specimens (see APSR-10). The entry is then subdivided per problem investigated on the specimen(s) (see closed issue APSR-06 below).
| |
| − | | |
| − | The text element of the section is supposed to reflect the same organization: per specimen or group of specimens, and then, per problem investigated. However, this APSR Content Profile does not explicitly describe the structure of this text element, and leaves it up to the Content Creator applications, or to further constraints brought by national extensions of this profile. The text element of a section in an APSR instance may be a mix of paragraphs, tables, diagrams and images, composed by the author of the report with the sole purpose of clarity and comprehensiveness for the reader.
| |
| − | | |
| − | ==Grundlage / Basics==
| |
| − | Grundlage dieses Konzeptes ist der Implementierungsleitfaden des Bundesverbands der Hersteller von IT-Lösungen für das Gesundheitswesen, e.V. ([http://www.bvitg.de bvitg]), Berlin, für den Arztbrief des deutschen Gesundheitswesens sowie der Diagnose- und Datentypleitfaden.
| |
| − | | |
| − | The APSR Germany is based on the trial implementation of the Bundesverband der Hersteller von IT-Lösungen für das Gesundheitswesen, e.V. (bvitg), Berlin, for the Discharge letter ("Arztbrief") of the German Health System, as well as the guidelines for diagnosis and data types.
| |
| − | | |
| − | * bvitG Arztbrief, v2.x, <nowiki>[CDAr2Arztbrief]</nowiki>, 2012
| |
| − | * [http://www.hl7.de/download/documents/diagnosen/Diagnoseleitfaden-v1.1_20110622.pdf Diagnoseleitfaden] v0.99b, 13.12.09
| |
| − | * Datentypleitfaden (HL7 V3)
| |
| − | | |
| − | | |
| − | | |
| − | ==Disclaimer==
| |
| − | Dieses Dokument enthält keine komplette Spezifikation eines HL7 CDA R2 Arztbriefes bzw. Dokumentes. Es werden Teile eines Arztbriefes spezifiziert.
| |
| − | | |
| − | This document does not show a complete specification of a HL7 CDA R2 Discharge Letter. Parts of the Discharge letter are constrained.
| |
| | | | |
| | + | '''APSR-10 – Observation related to multiple specimens''': For example tumor staging may require combining data from multiple specimens (e.g., a breast excision with positive margins followed by a re-excision with clear margins – in this case the tumor size may be a composite of measurements from both specimens. Another example is staging of ovarian carcinomas with multiple biopsies of pelvis, peritoneum, nodes, omentum, etc.). To accommodate these use |
| | + | cases, 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. |
| | | | |
| − | [[Kategorie:cdapath|Einleitung]]
| + | '''APSR-11 – Derivative specimens''':Specimens |
| | + | derived from primary specimens for ancillary studies, which may be sent to a |
| | + | reference lab or done in another part of the same institution, are included in |
| | + | the scope of this profile. The results produced on a derived specimen are |
| | + | attached to this specimen in the report. |
Dieses Material ist Teil des Leitfadens Pathologiebefund.
- Direkt im Wiki geändert werden sollten Schreibfehler, ergänzende Hinweise.
- Offene Fragen, die der Diskussionen bedürfen, sollten auf der Diskussionsseite aufgenommen werden.
- Liste der Seiten dieses Leitfadens: hier, Liste der Seiten, in denen dieses Material verwendet (transkludiert) siehe hier .
|
Foreword
This is a supplement to the IHE Pathology
and Laboratory Medicine Technical Framework V8.0. Each supplement undergoes a
process of public comment and trial implementation before being incorporated
into the volumes of the Technical Frameworks.
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.
This supplement describes changes to the
existing technical framework documents.
“Boxed” instructions like the sample
below indicate to the Volume Editor how to integrate the relevant section(s)
into the relevant Technical Framework volume.
Replace Section X.X by the following:
Where the amendment adds text, make the added
text bold underline. Where the amendment removes
text, make the removed text bold strikethrough.
When entire new sections are added, introduce with editor’s instructions to
“add new text” or similar, which for readability are not bolded or underlined.
General information about IHE can be found at: http://www.ihe.net.
Information about the IHE Pathology and Laboratory Medicine domain can be found at: http://ihe.net/IHE_Domains.
Information about the structure of IHE Technical Frameworks and Supplements can be found at: http://ihe.net/IHE_Process and http://ihe.net/Profiles.
The current version of the IHE Technical Framework (if applicable) can be found at: http://ihe.net/Technical_Frameworks.
Comments may be submitted on IHE Technical Framework templates any time at http://ihe.net/ihetemplates.cfm. Please enter comments/issues as soon as they are found. Do not wait until a future review cycle is announced.
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.
Introduction to this Supplement
This supplement complements volume 1 of
the PaLM technical framework with the description of the APSR 2.0 content
profile, and volume 3 with the bindings, content modules and value sets, which specify
this profile.
Open Issues and Questions
None yet
Closed Issues
APSR-07 – Representing the hierarchy of specimens in an entry : This APSR
supplement enables to represent the hierarchy of specimens at the CDA level 3.
The operations on specimen and production of child specimens are tracked in the
“Procedure Steps” section, which has a level 3 entry.
APSR-10 – Observation related to multiple specimens: For example tumor staging may require combining data from multiple specimens (e.g., a breast excision with positive margins followed by a re-excision with clear margins – in this case the tumor size may be a composite of measurements from both specimens. Another example is staging of ovarian carcinomas with multiple biopsies of pelvis, peritoneum, nodes, omentum, etc.). To accommodate these use
cases, 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.
APSR-11 – Derivative specimens:Specimens
derived from primary specimens for ancillary studies, which may be sent to a
reference lab or done in another part of the same institution, are included in
the scope of this profile. The results produced on a derived specimen are
attached to this specimen in the report.
