Diagnostic Imaging Report

CDAR2_II_BIMGRPTS_R1

Implementation Guide for CDA Release 2 – Diagnostic Imaging Report

Editor/Co-Chair: / Fred M. Behlen, PhD
American College of Radiology

Co-Chair: / Helmut Koenig, MD

(Committee Draft for) 1st Informative Ballot
August 28September 12, 2007

Revision History

0.3.14 September 30, 2006 Committee draft from Boca Raton Meeting

0.3.15 January 10, 2007 Committee draft

0.4.17 April 29, 2007 Committee draft

0.4.18 July 8, 2007 Committee Draft

0.4.19 July 15, 2007 Committee Draft

0.4.20 August 28, 2007 Committee Draft

0.4.21 September 12, 2007 Committee Draft

0.x.00 December xx, 2007 1st Informative Ballot

Open Issues

Update Appendix B with current CDA ample
Update figures with snips from current CDA sample
Others TBD in Committee Review (July 11 Conference Call)
Specify Level 2 constraints
Specify Level 3 description with measurements, annotation and image references.
Level 1-2 example (Appendix B, C)
Level 3 example (Appendix D)
Describe transformation of SR to CDA (Appendix E)

Table of Contents

1 Diagnostic Imaging Report 7

1 Introduction 7

1.1 Purpose 7

1.2 Audience 7

1.3 Approach 7

1.4 Conventions Used in this Guide 7

1.4.1 Explanatory Statements 7

1.4.2 Conformance Requirements 7

1.4.3 XPath Notation 8

1.4.4 Key Words 8

1.4.5 XML Samples 8

1.4.6 DICOM Samples 8

1.4.7 Content of the Ballot Package 8

1.5 Scope 9

2 CDA Header 10

2.1 ClinicalDocument 10

2.1.1 General Constraints 11

2.1.2 Rendering Information from the CDA Header for Human Presentation 11

2.1.3 ClinicalDocument/realmCode 11

2.1.4 ClinicalDocument/typeId 12

2.1.5 ClinicalDocument/templateId 12

2.1.6 ClinicalDocument/id 12

2.1.7 ClinicalDocument/code 13

2.1.8 ClinicalDocument/title 14

2.1.9 ClinicalDocument/effectiveTime 14

2.1.10 ClinicalDocument/confidentialityCode 15

2.1.11 ClinicalDocument/languageCode 15

2.1.12 ClinicalDocument/setId and ClinicalDocument/versionNumber 15

2.1.13 ClinicalDocument/copyTime 15

2.2 Participants 15

2.2.1 recordTarget 16

2.2.2 author 16

2.2.3 dataEnterer 17

2.2.4 informant 18

2.2.5 custodian 18

2.2.6 informationRecipient 18

2.2.7 legalAuthenticator 19

2.2.8 authenticator 19

2.2.9 participant 20

2.2.10 inFullfillmentOf 20

2.2.11 documentationOf 21

2.2.12 authorization 22

2.2.13 relatedDocument 22

2.2.14 componentOf 23

3 Body 24

3.1 LOINC Section Type Codes 24

3.2 Required Sections 26

3.2.1 Findings – LOINC 18782-3 26

3.3 Conditionally-Required Sections 28

3.3.1 DICOM Object Catalog – DCM 121181 28

3.4 Optional Sections 30

3.4.1 Reason for Study – LOINC 18785-6 30

3.4.2 History of Present Illness – LOINC 10164-2 30

3.4.3 Impressions – LOINC 19005-8 30

3.5 Level 3 Content 31

3.5.1 Text Elements 31

3.5.2 Code Elements 32

3.5.3 Report Observations 32

4 References 37

Appendix A — Validation 38

Introduction 38

Administrative Gender 38

Ethnicity & Race 38

Null Flavor 38

Participation Function 40

Appendix B — Sample Conforming CDA Document 41

1 Diagnostic Imaging Report 7

1 Introduction 7

1.1 Purpose 7

1.2 Audience 7

1.3 Approach 7

1.4 Conventions Used in this Guide 7

1.4.1 Explanatory Statements 7

1.4.2 Conformance Requirements 7

1.4.3 XPath Notation 8

1.4.4 Key Words 8

1.4.5 XML Samples 8

1.4.6 DICOM Samples 8

1.4.7 Content of the Ballot Package 8

1.5 Scope 9

2 CDA Header 10

2.1 ClinicalDocument 10

2.1.1 General Constraints 11

2.1.2 Rendering Information from the CDA Header for Human Presentation 11

2.1.3 ClinicalDocument/realmCode 11

2.1.4 ClinicalDocument/typeId 12

2.1.5 ClinicalDocument/templateId 12

2.1.6 ClinicalDocument/id 12

2.1.7 ClinicalDocument/code 13

2.1.8 ClinicalDocument/title 14

2.1.9 ClinicalDocument/effectiveTime 14

2.1.10 ClinicalDocument/confidentialityCode 15

2.1.11 ClinicalDocument/languageCode 15

2.1.12 ClinicalDocument/setId and ClinicalDocument/versionNumber 15

2.1.13 ClinicalDocument/copyTime 15

2.2 Participants 15

2.2.1 recordTarget 16

2.2.2 author 16

2.2.3 dataEnterer 17

2.2.4 informant 18

2.2.5 custodian 18

2.2.6 informationRecipient 18

2.2.7 legalAuthenticator 19

2.2.8 authenticator 19

2.2.9 participant 20

2.2.10 inFullfillmentOf 20

2.2.11 documentationOf 21

2.2.12 authorization 22

2.2.13 relatedDocument 22

2.2.14 componentOf 23

3 Body 24

3.1 LOINC Section Type Codes 24

3.2 Required Sections 26

3.2.1 Findings – LOINC 18782-3 26

3.3 Optional Sections 29

3.3.1 Reason for Study – LOINC 18785-6 29

3.3.2 History of Present Illness – LOINC 10164-2 29

3.3.3 Impressions – LOINC 19005-8 29

3.3.4 DICOM Object Catalog – DCM 121181 29

3.4 Level 3 Content 33

4 References 34

Appendix A — Validation 35

Introduction 35

Administrative Gender 35

Ethnicity & Race 35

Null Flavor 35

Participation Function 37

Appendix B — Sample Conforming CDA Document 38

Figures

Figure 1 Use of the templateId element to indicate use of this guide. 11

Figure 2 ClinicalDocument Example 12

Figure 3 ClinicalDocument/realmCode Example 12

Figure 4 ClinicalDocument/typeId Example 13

Figure 5 ClinicalDocument/templateId Example conforming to Level 1 only 13

Figure 6 ClinicalDocument/id Example 13

Figure 7 ClinicalDocument/code Example 14

Figure 8 Use of the translation element to include local codes for document type. 14

Figure 9 ClinicalDocument/title Example 15

Figure 10 CinicalDocument/effectiveTime Example 15

Figure 11 CinicalDocument/confidentialityCode Example 16

Figure 12 ClinicalDocument/languageCode Example with language only 16

Figure 13 ClinicalDocument/languageCode Example with language and country. 16

Figure 14 recordTarget Example 17

Figure 15 author Example 18

Figure 16 dataEnterer Example 18

Figure 17 custodian Example 19

Figure 18 informationRecipient Example 20

Figure 19 legalAuthenticator Example 20

Figure 20 authenticator Example 21

Figure 21 participant Example 21

Figure 22 inFulfillmentOf Example 22

Figure 23 documentationOf Example 23

Figure 24 componentOf example 24

Figure 25 Findings Example including Level 3 content 28

Figure 26 DICOM Object Catalog Example 30

Figure 27 Reason for Study Example 31

Figure 28 History Example 31

Figure 29 Impressions Example 31

Figure 30 Text Element example 33

Figure 31 Code Element example 33

Figure 32 Report Observation as an Entry 34

Figure 33 Report Observation as a support for an inferred finding 34

Figure 34 Image Reference Report Observation example 35

Figure 34 Linear Measurement Report Observation example 35

Figure 34 Linear Measurement Report Observation example 36

Figure 34 Volume Measurement Report Observation example 36

Figure 34 Numeric Measurement Report Observation example 37

Figure 1 Use of the templateId element to indicate use of this guide. 10

Figure 2 ClinicalDocument Example 11

Figure 3 ClinicalDocument/realmCode Example 11

Figure 4 ClinicalDocument/typeId Example 12

Figure 5 ClinicalDocument/templateId Example conforming to Level 1 only 12

Figure 6 ClinicalDocument/id Example 12

Figure 7 ClinicalDocument/code Example 13

Figure 8 Use of the translation element to include local codes for document type. 13

Figure 9 ClinicalDocument/title Example 14

Figure 10 CinicalDocument/effectiveTime Example 14

Figure 11 CinicalDocument/confidentialityCode Example 15

Figure 12 ClinicalDocument/languageCode Example with language only 15

Figure 13 ClinicalDocument/languageCode Example with language and country. 15

Figure 14 recordTarget Example 16

Figure 15 author Example 17

Figure 16 dataEnterer Example 17

Figure 17 custodian Example 18

Figure 18 informationRecipient Example 19

Figure 19 legalAuthenticator Example 19

Figure 20 authenticator Example 20

Figure 21 participant Example 20

Figure 22 inFulfillmentOf Example 21

Figure 23 documentationOf Example 22

Figure 24 componentOf example 23

Figure 25 Findings Example 28

Figure 26 Reason for Study Example 29

Figure 27 History Example 29

Figure 28 Impressions Example 29

Figure 29 DICOM Object Catalog Example 32

Tables

Table 1 Contents of the Ballot Package 10

Table 2 LOINC Document Type Codes 15

Table 3 LOINC Section Type Codes 25

Table 4 Administrative Gender 39

Table 5 Null Flavor 40

Table 6 Participating Function Codes 41

Table 1 Contents of the Ballot Package 9

Table 2 LOINC Document Type Codes 14

Table 3 LOINC Section Type Codes 24

Table 4 Administrative Gender 35

Table 5 Null Flavor 36

Table 6 Participating Function Codes 37

1 Diagnostic Imaging Report

1 Introduction

1.1 Purpose

The purpose of this document is to describe constraints on the CDA Header and Body elements for Diagnostic Imaging Reports. A Diagnostic Imaging Report contains a consulting specialist’s interpretation of image data. It is intended to convey the interpretation to the referring (ordering) physician, and becomes part of the patient’s medical record. It is intended for use in Radiology, Endoscopy, Cardiology, and other imaging specialties.

1.2 Audience

The audience for this document is software developers and consultants responsible for implementation of Radiology Information Systems, Radiology Reporting systems, Picture Archiving and Communications Systems (PACS), and other image and imaging management systems, that are expected to transmit results to of Electronic Health Record (EHR) systems or health information exchange networks as CDA documents created according to this specification.

1.3 Approach

The approach taken in the development of this specification was to review existing relevant DICOM Standards and IHE Implementation Profiles, and to review CDA Header and Body elements and attributes with domain experts, and on that basis, constrain the CDA Header and Body elements.

1.4 Conventions Used in this Guide

This guide is a conformance profile, as described in the Refinement and Localization section of the HL7 Version 3 standards. As defined in that document, this guide is both an annotation profile and a constraint profile. The base standard for this guide is the HL7 Clinical Document Architecture, Release 2.0.

The mapping profile for SR to CDA is based on DICOM Template 2000 Basic Diagnostic Imaging Report, NEMA PS3.16-2007.

1.4.1 Explanatory Statements

As an annotation profile, portions of this guide summarize or explain the base standard.

Explanatory statements will appear in this style.

1.4.2 Conformance Requirements

Conformance requirements within this guide are sequentially numbered, and appear in the format illustrated below:

CONF-1: This is an example conformance requirement for conformance to level 1 requirements.

1.4.3 XPath Notation

Instead of the traditional dotted notation used by HL7 to represent RIM classes, this guide uses XPath notation in conformance statements and elsewhere to identify the XML elements and attributes within the CDA document instance to which various constraints are applied. The implicit context of these expressions is the root of the document. The purpose of using this notation is to provide a mechanism which will be familiar to developers for identifying parts of an XML document.

1.4.4 Key Words

The key words "shall", "shall not", "should", "should not", "may", and "need not" in this document are to be interpreted as described in the HL7 Version 3 Publishing Facilitator's Guide.

1.4.5 XML Samples

XML Samples appear in various figures in this document in a fixed font. Portions of the XML content may be suppressed for brevity. These are marked by a vertical ellipses, as shown in the example below.

</ClinicalDocument>

Within the narrative, XML element and attribute names in the text will appear in this font. Literal attribute values will appear in this font.

XPath expressions are used in the narrative and conformance requirements to identify elements. These were chosen because they are familiar to many XML implementers.

1.4.6 DICOM Samples

DICOM Samples appear in the table format used in the DICOM Standard, listing each DICOM Attribute as a single line with columns denoting the Attribute Tag, Name, Value Representation and usage description.

Examples of DICOM SR documents are presented in the notation used in Clunie, David, DICOM Structured Reporting, PixelMed Publishing, Bangor, PA, 2000. Available at: http://www.pixelmed.com (link checked ____,__, 2007).

DICOM Images referenced in the samples may be presented herein a header in DICOM tabular form followed by a rendering of the pixel data into the publishing format of this document. The DICOM binary encoded form in included in the ballot package.

1.4.7 Content of the Ballot Package

The ballot package contains the following files:

Filename / Description
Diagnostic Imaging Report for CDA Release 2 Level 1-3 v1.0.pdf / This guide
DICOM SR “Basic Diagnostic Imaging Report” to HL7 CDA Release 2 “Diagnostic Imaging Report” Transformation Guide / The transformation guide specifying the mapping of constrained DICOM SR “Basic Diagnostic Imaging Reports” (DICOM PS 3.16-2007: Template 2000) to CDA Release 2 “Diagnostic Imaging Reports” as described by this guide.
EnhancedSR.xml / The sample CDA document found in Appendix B.
voc.xml / A vocabulary data file used by both the Schematron schema and the display stylesheet.
IMPL_CDAR2.xsl / A stylesheet for displaying the content of the sample document in HTML.
EnhancedSR.dcm / The sample DICOM SR document found in Appendix C.
SampleChestXR_PA.dcm
SampleChestXR_Lat.dcm / Sample DICOM images referenced within the DICOM SR document EnhancedSR…dcm

Table 1 Contents of the Ballot Package

1.4.7.1 Sample DICOM SR Basic Diagnostic Imaging Report

The Sample DICOM SR report conforms to DICOM Template 2000 for a diagnostic imaging report including image annotation and references. This SR report is equivalent in content to the Sample CDA document, according to the mapping described on Appendix B.

The Report example is based on a chest radiography examination, the images from whick are included in two DICOM Image files, SampleChestXR_PA.dcm and SampleChestXR_Lat.dcm. The report examples include references to these images.

1.4.7.2 Constrained CDA Diagnostic Imaging Report XML Schema

Also included in this ballot package is a CDA XML Schema constrained to the elements allowed in this Implementation Guide. This Schema is informative, and implementers should be cautioned that not all constraints in this guide are represented in the XML Schema.

1.4.7.3 Sample XML

A sample document is provided which conforms to the level 1 and level 2 constraints of this guide. This document is the source of many of the examples provided in this guide.

1.5 Scope

This specification defines additional constraints on CDA Header and Body elements used in a Diagnostic Imaging Report, and provides examples of conforming fragments in the body of the document and an example of a conforming XML instance as an appendix.

This Guide specifies three levels of conformance requirements. Level 1 requirements specify constraints upon the CDA Header and the content of the document. Level 2 requirements specify constraints upon the structuredBody of the ClinicalDocument element of the CDA document. Level 3 requirements describe a limited set of structured entries for the purpose of referencing and annotating images from within the report.

This specification is intended for global use (Universal Realm). The specification of workflows, messages, or procedures used in performing imaging procedures is outside the scope of this specification.

CDA provides a mechanism to reference a template or implementation guide that has been assigned a unique identifier. The following example shows how to formally assert the use of this implementation guide. Use of the templateId indicates that the CDA instance not only conforms to the CDA specification, but in addition, conforms to the constraints specified in this implementation guide.