Supplement 155 Imaging Reports using HL7 CDA Status Report to WG /04/01 Harry Solomon

Goals Foundational architecture for an evolving family of imaging reports Initial templates for radiology reports, aligned with RSNA RadLex and Reporting Initiative Primarily narrative, with some discrete data; evolving to more discrete data over time Diagnostic and screening; evolving to interventional, cardiac, anatomic path, etc. 4/1/2014Sup 155 review2

HL7 Clinical Document Architecture The scope of the CDA is the standardization of clinical documents for exchange. A clinical document is a record of observations and other services with the following characteristics: – Persistence – Stewardship – Potential for authentication – Wholeness – Human readability

4 / Harry Solomon / Module CDA/ Key Aspects of the CDA CDA documents are encoded in Extensible Markup Language (XML) CDA documents derive their meaning from the HL7 v3 Reference Information Model (RIM ) and use HL7 v3 Data Types A CDA document consists of a header and a body Header is consistent across all clinical documents - identifies and classifies the document, provides information on patient, provider, encounter, and authentication; allows document management, compilation of an individual patient's clinical documents into an electronic patient record Body contains narrative text / multimedia content (level 1), optionally structured into sections with coded titles and tagged narrative content (level 2), optionally augmented by coded equivalents to narrative (level 3) CDA documents for a particular use may be constrained by a Template

5 / Harry Solomon / Module CDA/ Core concepts of RIM Every happening is an Act Procedure, observation, medication, supply, registration, etc. Acts are related through an ActRelationship composition, preconditions, revisions, support, etc. Participation defines involvement in an Act author, performer, subject, location, etc. The participants are Roles patient, agent, responsible party. Roles are played and scoped by Entities persons, organizations, material, places, devices, etc.

6 / Harry Solomon / Module CDA/ … an administration of albuterol… RIM Classes and Color Coding Act 0..* 1 1 EntityParticipationRole * * Plays Scopes A person … Mr Joe Public … … playing the role patient … … participates as the subject of … … an observation Asthma … Act Relation- ship * 1 1 Source Target … which is the Reason for …

7 / Harry Solomon / Module CDA/ CDA Release 2 Information Model HeaderBody Participants Sections/ Headings Clinical Statements/ Coded Entries Extl RefsContext Doc ID &Type Start Here

8 / Harry Solomon / Module CDA/ CDA Structured Body Structured Body Section Text Section Text Section Text Section Text Section Text Section Text Entry Coded statement Entry Coded statement Entry Coded statement Arrows are Act Relationships Has component, Derived from, etc. Entries are coded clinical statements Observation, Procedure, Substance administration, etc. Entry Coded statement

9 / Harry Solomon / Module CDA/ Sample CDA

10 / Harry Solomon / Module CDA/ Narrative and Coded Info CDA structured body requires human-readable “Narrative Block”, all that is needed to reproduce the legally attested clinical content CDA allows optional machine-readable coded “Entries”, which drive automated processes Narrative may be flagged as derived from Entries Textual rendering of coded entries’ content, and contains no clinical content not derived from the entries General method for coding clinical statements is a hard, unsolved problem CDA allows incremental improvement to amount of coded data without breaking the model

11 / Harry Solomon / Module CDA/ Narrative and Coded Entry Example

Purposes of templates Reduce variability, improve interoperability Normalize best practice Support automation of report production Support validation of report content Sup 155 review4/1/201412

Multiple layers of constraint Sup 155 review HL7 v3 RIM Abstract Data Classes CDA r2 Refined Data Classes and structures for clinical documents DICOM (Sup 155) Additional requirements and templates for radiology reports Professional Content Specific content for specialized procedures 4/1/201413

Sup 155 as greenCDA greenCDA is the concept that CDA implementation can be simplified by abstractions bridging between use cases and CDA formal syntax requirements Defines data elements, using “business names”, that can be invoked by professional content specifications, without knowledge of CDA structures E.g., professional content can specify “impression:text”, or “contrast:name” and “contrast:volume”, and Sup 155 specifies how/where those are instantiated in a CDA structure Sup 155 review4/1/201414

Clinical Knowledge Report Authoring Template Report Authoring Process Imaging Study Data Clinician Interpretation CDA Report Instance Templates Element Public Interface Element CDA Structure Report Formatting Process CDA Imaging Report Document Authoring Template Element Structure IHE MRRT RSNA RadReport 4/1/2014Sup 155 review15

Sup 155 editorial style Following conventions of HL7 CDA implementation guides, including Consolidated CDA, and emerging HL7 Templates Standard (in ballot reconciliation) Library of document, section, and entry templates Templates specified as table aligned to XML, plus supplemental narrative conformance statements (conceptually similar to Part 3 module style) XML examples provided Not being generated from tooling (MDHT or Trifolia) Sup 155 review4/1/201416

Radiology Report Document Template NameXPathCard.VerbData Type Value Radiology Report ClinicalDocument Doc type code code1..1SHALLCD General header 1..1SHALL General Header Imaging header 1..1SHALL Imaging Header component1..1SHALL structuredBody1..1SHALL Current Procedure component1..1SHALL Current Imaging Procedure Description Clinical Information component0..1MAY Clinical Information Comparison Study component0..1MAY Comparison / Previous Findings Findingscomponent0..1MAY Findings Impressions component1..1SHALL Impressions Addendum component0..*MAY Addendum component0..1SHOULD DICOM Object Catalog 4/1/2014Sup 155 review17

Sup 155 review NameXPathCard.VerbData Type Value Comparison Study (HL7ActClass) = (ActMood) = EVN tbd id1..*SHALLII code1..1SHALLCD , LOINC, “Radiology Comparison study” text 0..1SHOULDED author 0..1MAY Observer Context procedure entry0..1MAY Imaging Procedure 4/1/201418

4/1/2014Sup 155 review19 NameXPathCard.VerbData Type Value Author (RoleClass) = ASSIGNED id1..1SHALL person0..1SHOULD Namename1..1SHALLPN authoringDevice0..1SHOULD DevicesoftwareName1..1SHALLST

Subsections Some defined in templates for specific uses – Contrast, Radiation Dose, Fetus Finding Requirements for user-labeled subsections – Content for an arbitrary topic (a particular organ or anatomic feature, a lesion, a tumor, etc.) – Required section.title with topic name – No section.code, hence no semantic post- coordination to section entries Sup 155 review4/1/201420

Why no section.code in user-labeled subsection? section.code uses LOINC codes with scale=NAR – i.e., its value in section.text is a narrative block – A concept that scopes a value (observable entity) The concepts used as user-labels (typically anatomy) are the wrong “part of speech” – Do not have formal semantics of scoping a value – Need something like a post-coordinated phrase: FindingsSection+FindingSite= (cf. DICOM) – CDA does not have section targetSiteCode or Participation for anatomic site Sup 155 review4/1/201421

22 / Harry Solomon / Module CDA/ Body and Narrative Sections

External Relations HL7 RSNA – Radiology Reporting – RadLex IHE – MRRT

Relationship to HL7 Builds on HL7 Diagnostic Imaging Report (DIR) CDA IG informative standard Leverages harmonization done for Consolidated CDA IG r2 (C-CDA) Public comment to be solicited in HL7 ballot cycle parallel to DICOM PC and LB periods May be balloted as HL7 standard (DIR r2), recognizing updates will be handled in DICOM continuous maintenance process Sup 155 review4/1/201424

Reuse of C-CDA Templates Intent is to be harmonized with C-CDA But C-CDA is US Realm only – DICOM needs to be Universal Realm Challenges to re-use based on shortcuts taken – Vocabulary bindings hard coded into templates – Vocabulary bindings US Realm only Sup 155 review4/1/201425

RSNA Reporting Initiative 4/1/2014Sup 155 review26 radreport.org

CT Brain (example) Clinical History * Medical history * Risk factors * Allergies, if relevant * Reason for exam, including medical necessity: [headache | stroke | dizziness | trauma] Imaging Technique * Time of image acquisition * Imaging device [MR, CT] * Image acquisition parameters, such as device settings, patient positioning, interventions (e.g., Valsalva) * Contrast materials and other medications administered (including name, dose, route, and time) * Radiation dose Comparison * Date and type of previous exams reviewed, if applicable Observations * Extra axial spaces: [normal in size and morphology for the patient's age* | widened] * Hemorrhage: [none* ; subdural ; subarachnoid; epidural, intraventricular, parenchymal] * Ventricular system: [normal in size and morphology for the patient's age* | enlarged | small] * Basal cisterns: [normal* | enlarged | small] * Cerebral parenchyma: [normal*; microvascular changes; infarction; encephalomalacia; gliosis; hemorrhage] * Midline shift: [none* | leftward shift | rightward shift] … Impressions

RadLex tagged content RadLex is an RSNA lexicon designed to tag concepts for subsequent indexing/retrieval Atomic concepts only – no compositional grammar Use CDA non-attested link in narrative block There is focal opacity at the right lung base most likely representing right lower lobe atelectasis.... Sup 155 review4/1/201428

Relationship to IHE MRRT Management of Radiology Report Templates is an IHE Profile that (inter alia) defines an HTML scheme for encoding report production templates Revisions needed for MRRT to use DICOM defined business names, supporting encoding of reports as CDA using Sup 155 Informative annex in DICOM about use of templates in report production, including MRRT Should we invite IHE Radiology to submit revised HTML scheme for standardization in Sup 155? 4/1/2014Sup 155 review29

DICOM Stuff 4/1/2014Sup 155 review30

What about Part 20? Designed for mapping SR to CDA Includes CDA structures also used in Sup 155 templates (e.g., DICOM Object Catalog, header structures, image references, etc.) Suggest general reworking combining current Part 20 with new material in Sup 155, to produce a replacement Part 20 How to handle new version of current Part 20 material? Sup 155 review4/1/201431

Conformance What needs to specified in Part 2 with respect to conformance? Creator claim of document level templates – That would just be one, for now – How about specific uses and/or RSNA templates? No expected receiver claims beyond general HL7 CDA receiver conformance – Not intended to be in the DICOM conformance world Sup 155 review4/1/201432

Schedule April 1: WG-06 – review overall strategy May-Jun: WG-06 webinars for line by line review Jun 23-27: WG-06 –Release for PC Mid July-mid Sept: Public Comment Sept 8-12: WG-06 – review comments and necessary revisions Nov 10-14: WG-06 – Release for LB Nov-Jan: Letter Ballot Jan 12-16: WG-06 – Final Text Draft ?? Publish FT May 5-9: HL7 – review with Structured Documents WG, and “clean draft” Supplement Aug 8-Sep 8: HL7 Comment Only ballot Sep 15-19: HL7 – review comments Dec 12-Jan 12:HL7 Comment Only ballot Jan 19-23: HL7 – review comments and Final Text Draft 4/1/2014 Sup 155 review 33

Should Sup155 be DSTU? DICOM generally has not found DSTU to be useful HL7 uses it regularly, especially for CDA IG’s 4/1/2014Sup 155 review34