cdapath:Einleitung

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Einleitung / Introduction

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.

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.

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.

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.

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.

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.

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.

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.

Introduction

This supplement is written for Trial Implementation.

This supplement prepares a new volume, Volume 3, of the IHE Pathology and Laboratory Medicine (PaLM) Technical Framework.

This supplement references other documents the reader should be aware of:

1. IHE IT Infrastructure Technical Framework Volume 1

2. IHE IT Infrastructure Technical Framework Volume 3

3. IHE PCC Technical Framework Volume 2

4. IHE LAB Technical Framework Volume 3

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

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.

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

APSR-01 – List of potential sections of an AP structured report: - Clinical information (content supposedly provided by the ordering physician)

- Intraoperative observations (in case of intraoperative consultation, which may be macroscopic only or may include cytology and/or frozen section)

- 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.

APSR-04 – Linking AP observations to images/evidence documents: It is sometimes useful to present to the reader of the report the images related to the observations. The CDA AP report provides the CDA R2 standard means to embed images at the observation level or at the organizer level in an entry, using the observationMedia element and potentially the regionOfInterest element. These images can only be small illustrations. Big images – like whole slide images or evidence documents – will stay in their own storage infrastructure, accessible via the DICOM standard protocol, and may be associated with the APSR document, via a DICOM KOS list of references (as described in the XDS-I profile from the Radiology domain), issued in the same submission set.

APSR-05 – Coding of the TNM: The value sets for the TNM of various tumors will be created into the PathLex terminology built by IHE PAT, based on the reference material of this profile. PathLex is a temporary code system, which may be used in an AP structured report, but is not mandated by this APSR content Profile. Alternatively for TNM coding as well as for ICD-O-Typing and Grading specific templates built by IHE PaLM should be used.

APSR-06 – Two (or more) distinct problems observed on the same specimen: In this case, the AP report template should provide a means to group the observations per problem. The solution consists in inserting a battery organizer grouping all observations related to the same problem below the specimen information organizer. See also APSR-03 above.

APSR-07 – Representing the hierarchy of specimens in an entry : This APSR supplement does not represent the hierarchy of specimens at the CDA level 3 (within an entry). The operations on specimen and production of child specimens are tracked in the “Procedure Steps” section, which does not have a level 3 entry, in this current release of the profile.

APSR-08 – Human authors and/or authoring devices: Do we have use cases for recording authoring devices as “author” in the report or a part of it? Or do we allow only human authors? The answer is “Both”: Image modalities may be authoring devices in some situations.

APSR-09 – Transcriptionist: A transcriptionist may appear in the CDA report in the header as a dataEnterer element, or within an entry (organizer or observation) as a participant element. In both cases the element uses a participationType “ENT” whose definition in HL7 V3 vocabulary is: “A person entering the data into the originating system. The data entry person is collected optionally for internal quality control purposes. This includes the transcriptionist for dictated text.”

VOLUME 1 - INTEGRATION PROFILES

Grundlage / Basics

Grundlage dieses Konzeptes ist der Implementierungsleitfaden des Bundesverbands der Hersteller von IT-Lösungen für das Gesundheitswesen, e.V. (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, [CDAr2Arztbrief], 2012
• 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.