Diagnostic Imaging Report - dicom

CDAR2_II_BIMGRPTS_R1
Implementation Guide for CDA Release 2 –
Diagnostic Imaging Report
Editor/Co-Chair:
Fred M. Behlen, PhD
American College of Radiology
fbehlen@laitek.com
Co-Chair:
Helmut Koenig, MD
helmut.koenig@siemens.com
(Committee Draft for) 1st Informative Ballot
September 16, 2007
© 2007 Health Level Seven, Inc.
Ann Arbor, MI
All rights reserved.
Revision History
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1st Informative Ballot
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Open Issues
1. Update Appendix B with current CDA ample
2. Update figures with snips from current CDA sample
3. Specify Detailed Level 3 description of measurements, annotation and image
references.
4. Data enterer not in sample document
5. Information recipient not in sample document
6. ComponentOf/EncompassingEncounter not in sample document
7. Section 3.3.2 Rendering of Coded Observations into Section.text needs to be
specified.
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Table of Contents
CDAR2_II_BIMGRPTS_R1 ........................................................................................... 1
IMPLEMENTATION GUIDE FOR CDA RELEASE 2 – DIAGNOSTIC IMAGING REPORT ........ 1
REVISION HISTORY ......................................................................................................... 2
OPEN ISSUES
3
TABLE OF CONTENTS ...................................................................................................... 4
FIGURES .............................................................................................................................. 6
FIGURES .............................................................................................................................. 6
TABLES................................................................................................................................ 6
1
1
2
DIAGNOSTIC IMAGING REPORT ................................................................................ 8
INTRODUCTION ............................................................................................................... 8
1.1
Purpose .......................................................................................................................... 8
1.2
Audience ........................................................................................................................ 8
1.3
Approach ....................................................................................................................... 8
1.4
Conventions Used in this Guide .................................................................................... 8
1.4.1
1.4.2
1.4.3
1.4.4
1.4.5
1.4.6
1.4.7
Explanatory Statements ................................................................................................ 8
Conformance Requirements .......................................................................................... 8
XPath Notation.............................................................................................................. 9
Key Words..................................................................................................................... 9
XML Samples ................................................................................................................ 9
DICOM Samples............................................................................................................ 9
Content of the Ballot Package........................................................................................ 9
2.1.1
2.1.2
2.1.3
2.1.4
2.1.5
2.1.6
2.1.7
2.1.8
2.1.9
2.1.10
2.1.11
2.1.12
2.1.13
General Constraints .................................................................................................... 12
Rendering Information from the CDA Header for Human Presentation ......................... 12
ClinicalDocument/realmCode ..................................................................................... 12
ClinicalDocument/typeId ............................................................................................ 13
ClinicalDocument/templateId ..................................................................................... 13
ClinicalDocument/id ................................................................................................... 13
ClinicalDocument/code ............................................................................................... 14
ClinicalDocument/title ................................................................................................ 15
ClinicalDocument/effectiveTime ................................................................................. 15
ClinicalDocument/confidentialityCode ........................................................................ 16
ClinicalDocument/languageCode ................................................................................ 16
ClinicalDocument/setId and ClinicalDocument/versionNumber .................................. 16
ClinicalDocument/copyTime ....................................................................................... 16
1.5
Scope ........................................................................................................................... 10
CDA HEADER .............................................................................................................. 11
2.1
ClinicalDocument ......................................................................................................... 11
2.2
Participants ................................................................................................................. 17
2.2.1
2.2.2
2.2.3
2.2.4
2.2.5
2.2.6
2.2.7
2.2.8
2.2.9
2.2.10
recordTarget............................................................................................................... 17
author ........................................................................................................................ 18
dataEnterer ................................................................................................................ 18
informant ................................................................................................................... 19
custodian .................................................................................................................... 19
informationRecipient .................................................................................................. 19
legalAuthenticator ...................................................................................................... 20
authenticator .............................................................................................................. 20
participant .................................................................................................................. 21
inFullfillmentOf ........................................................................................................... 21
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2.2.11
2.2.12
2.2.13
2.2.14
3
BODY ......................................................................................................................... 25
3.1
Section Type Codes ..................................................................................................... 25
3.2
Sections ....................................................................................................................... 27
3.2.1
3.2.2
3.2.3
3.2.4
3.2.5
DICOM Object Catalog – DCM 121181 ........................................................................ 27
Findings – LOINC 18782-3 .......................................................................................... 28
Reason for Study – LOINC 18785-6 ............................................................................. 29
History of Present Illness – LOINC 10164-2 ................................................................. 30
Impressions – LOINC 19005-8 ..................................................................................... 30
3.3.1
3.3.2
3.3.3
Text Observations ....................................................................................................... 31
Code Observations ...................................................................................................... 32
Report Observations.................................................................................................... 32
3.3
4
documentationOf ........................................................................................................ 22
authorization .............................................................................................................. 23
relatedDocument ........................................................................................................ 23
componentOf .............................................................................................................. 24
Level 3 Content ............................................................................................................ 31
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
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Figures
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1 Use of the templateId element to indicate use of this guide. ........................ 11
2 ClinicalDocument Example ..........................................................................12
3 ClinicalDocument/realmCode Example ........................................................ 12
4 ClinicalDocument/typeId Example .............................................................. 13
5 ClinicalDocument/templateId Example conforming to Level 1 only ..............13
6 ClinicalDocument/id Example ......................................................................13
7 ClinicalDocument/code Example .................................................................14
8 Use of the translation element to include local codes for document type. .....14
9 ClinicalDocument/title Example...................................................................15
10 CinicalDocument/effectiveTime Example ..................................................16
11 CinicalDocument/confidentialityCode Example .........................................16
12 ClinicalDocument/languageCode Example with language only ..................16
13 ClinicalDocument/languageCode Example with language and country. .....16
14 recordTarget Example ...............................................................................17
15 author Example ......................................................................................... 18
16 dataEnterer Example .................................................................................19
17 custodian Example ....................................................................................19
18 informationRecipient Example ...................................................................20
19 legalAuthenticator Example .......................................................................20
20 authenticator Example ..............................................................................21
21 participant Example ...................................................................................21
22 inFulfillmentOf Example.............................................................................22
23 documentationOf Example ........................................................................23
24 componentOf example ...............................................................................24
25 DICOM Object Catalog Example .................................................................28
26 Findings Example including Level 3 content ..............................................29
27 Reason for Study Example .........................................................................30
28 History Example ........................................................................................ 30
29 Impressions Example .................................................................................30
30 Text Element example ................................................................................32
31 Code Element example ...............................................................................32
32 Report Observation as an Entry .................................................................33
33 Report Observation as a support for an inferred finding ............................. 33
34 Image Reference Report Observation example ............................................34
35 Linear Measurement Report Observation example .....................................35
36 Linear Measurement Report Observation example .....................................35
37 Volume Measurement Report Observation example....................................35
38 Numeric Measurement Report Observation example ..................................36
Tables
Table
Table
Table
Table
Table
1
2
3
4
5
Contents of the Ballot Package .....................................................................10
LOINC Document Type Codes ........................................................................15
Section Type Codes ....................................................................................... 25
Administrative Gender ...................................................................................38
Null Flavor ....................................................................................................39
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Table 6 Participating Function Codes.........................................................................40
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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:
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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 xmlns='urn:hl7-org:v3'>
:
.
</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:
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Filename
Description
Diagnostic Imaging Report
for CDA Release 2 Level 13 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
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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.
<ClinicalDocument xmlns="urn:hl7-org:v3" xmlns:voc="urn:hl7-org:v3/voc"
xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="urn:hl7-org:v3
CDA.xsd">
<typeId root="2.16.840.1.113883.1.3" extension="POCD_HD000040"/>
<templateId root="2.16.840.1.113883.10" extension="CDAR2_II_BIMGRPTS_R1"/>
:
.
:
</ClinicalDocument>
Figure 1 Use of the templateId element to indicate use of this guide.
Within this guide, the required and optional content within the body are identified.
This guide describes the information content of each section, but this cannot be verified
by software.
2
CDA Header
2.1
ClinicalDocument
The namespace for CDA Release 2.0 is urn:hl7-org:v3. Appropriate namespace declarations SHALL be
used in the XML instance of the Clinical Document. In the examples in this specification, all elements are
shown un-prefixed, assuming that the default namespace is declared to be urn:hl7-org:v3. This guide
does not require use of any specific namespace prefix. Transmitted instances SHOULD NOT include the
xsi:schemaLocation1 element.
The root of a Diagnostic Imaging Report SHALL be a ClinicalDocument element from the urn:hl7org:v3 namespace.
The xsi:schemaLocation element is not recommended by the XML ITS because of security
risks. Receivers who choose to perform validation should use a locally cached schema.
1
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<ClinicalDocument xmlns="urn:hl7-org:v3" xmlns:voc="urn:hl7-org:v3/voc"
xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="urn:hl7-org:v3
CDA.xsd">
<typeId root="2.16.840.1.113883.1.3" extension="POCD_HD000040"/>
<templateId root="2.16.840.1.113883.10" extension="CDAR2_II_BIMGRPTS_R1"/>
<id root="1.2.840.113619.2.62.994044785528.20060828170821659"/>
<code code="18782-3" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"
displayName="Diagnostic Imaging Report"/>
<title>Chest X-Ray, PA and LAT View</title>
<effectiveTime value="20060828170821"/>
<confidentialityCode code="N" codeSystem="2.16.840.1.113883.5.25"/>
<languageCode code="en-US"/>
:
.
:
</ClinicalDocument>
Figure 2 ClinicalDocument Example
2.1.1
General Constraints
All telephone numbers SHALL be encoded using a restricted form of the tel: URL
scheme, described in the section on Error! Reference source not found. below.
2.1.2
Rendering Information from the CDA Header for Human Presentation
Rendering the information in the header for human presentation is optional. However, un-rendered
information cannot be assumed to be authenticated information. Therefore, the judgment of whether to
render or not render information in the header should recognize the business need to authenticate the
information as well as other business needs.
Recommendations for rendering information from the header include:
2.1.3

Document title and document dates

Service and encounter types and date ranges as appropriate

All persons named along with their roles, participations, participation date
ranges, identifiers, address and telecom information

Selected organizations named along with roles, participations, identifiers or
names,

Record Target(s) date-of-birth

Any other minimal context information that is available
ClinicalDocument/realmCode
This value identifies the realm2.
The ClinicalDocument/realmCode element MAY be present. If present, it SHALL use the
fixed value UV.
<realmCode code='UV'/>
Figure 3 ClinicalDocument/realmCode Example
2
This guide is for the Universal realm. A future guide may define national localizations.
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2.1.4
ClinicalDocument/typeId
The ClinicalDocument/typeId element SHALL be present. It identifies the constraints imposed by CDA
Release 2.0 on the content, essentially acting as a version identifier. The @root and @extension values
of this element SHALL be specified as shown below in Figure 4.
<typeId root="2.16.840.1.113883.1.3" extension="POCD_HD000040"/>
Figure 4 ClinicalDocument/typeId Example
CONF-1: The extension attribute of the typeId element SHALL be POCD_HD000040.
2.1.5
ClinicalDocument/templateId
The ClinicalDocument/templateId elements identify the templates that impose constraints on the
content.
At least one ClinicalDocument/templateId of SHALL be present with the content shown
below in Figure 5. This indicates conformance to the level one features of this guide.
CONF-2: A ClinicalDocument/templateId element SHALL be present where the value
of @extension is CDAR2_II_BIMGRPTS_R1 and the value of @root is
2.16.840.1.113883.10.
<templateId root="2.16.840.1.113883.10" extension="CDAR2_II_BIMGRPTS_R1"/>
Figure 5 ClinicalDocument/templateId Example conforming to Level 1 only
2.1.6
ClinicalDocument/id
The ClinicalDocument/id element SHALL be present.. It SHALL be an II data type where the root is an
OSI Object Identifier (OID). The root uniquely identifies the scope of the extension. The root and
extension uniquely identifies the document.
CONF-3: The ClinicalDocument/id/@root attribute SHALL be a syntactically correct
OID.
CONF-4: OIDs SHALL be represented in dotted decimal notation, where each decimal
number is either 0, or starts with a non-zero digit. More formally, an OID SHALL
be in the form ([0-2])(.([1-9][0-9]*|0))+.
CONF-5: OIDs SHALL be no more than 64 characters in length.
<id root="1.2.840.113619.2.62.994044785528.20060828170821659"/>
Figure 6 ClinicalDocument/id Example
Organizations that use OIDs SHALL properly register their OID root, and ensure uniqueness of the OID
roots used in identifiers. There are a large number of mechanisms to obtain OID roots for free, or for a
reasonable fee. HL7 Maintains an OID registry page, from which organizations may request an OID root
under the HL7 OID root. This page can be accessed at: http://hl7.amg-hq.net/oid/frames.cfm
Another useful resource lists the many ways to obtain a registered OID Root for free or a small fee,
anywhere in the world, located at:
http://www.dclunie.com/medical-image-faq/html/part8.html#UIDRegistration
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The manner in which the OID root is obtained is not constrained by this
implementation guide.
When a DICOM SR report is transformed to a CDA Diagnostic imaging Report, the
ClinicalDocument/id/@root identifier is equivalent to the DICOM Attribute (0008,0018)
SOP Instance UID and the ClinicalDocument/id/@extension identifier is not present.
For compatibility with DICOM SR documents, ClinicalDocument/id/@extension SHALL
NOT be present in Diagnostic Imaging Reports authored as CDA Documents.
CONF-6: The ClinicalDocument/id/@extension attribute SHALL NOT be present.
2.1.7
ClinicalDocument/code
The ClinicalDocument/code element SHALL be present and specifies the type of the clinical document.
The LOINC Diagnostic Imaging Report document type (LOINC Document Code 18748-4)
SHOULD be used as the value for ClinicalDocument/code in the CDA Header.
<code code="18782-3" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"
displayName="Diagnostic Imaging Report"/>
Figure 7 ClinicalDocument/code Example
CDA Release 2.0 states that LOINC is the preferred vocabulary for document type
specification.
2.1.7.1
Use of Local Document Type Codes
Implementations MAY use local codes in translation elements to further refine the document type. An
example of this is shown below in Figure 8.
<code code="18782-3" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"
displayName="Diagnostic Imaging Report
<translation code='XRPEDS' displayName='Pediatric Radiography Report'
codeSystem='2.16.840.1.123456.78.9'/>
</code>
Figure 8 Use of the translation element to include local codes for document type.
2.1.7.2
Precoordinated Document Type Codes
The LOINC document hierarchy listed in Table 2 is a list of document type codes
supported under this specification. Some of these codes (those not marked in boldface
type), are pre-coordinated with either the imaging modality, body part examined or
specific imaging method such as the view. Use of these codes is not recommended, as
this duplicates information potentially present with the CDA document header. When
these codes are used, they SHALL NOT conflict with the other information present in the
document. These codes are shown below in Table 2.
LOINC Code
Display Name
Modality
Diagnostic Imaging Report
Any
18747-6
CT Report
Cumputed Tomography
18755-9
MRI Report
Magnetic Resonance Imaging
18748-4
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18760-9
Ultrasound Report
Ultrasoound
18757-5
Nuclear Medicine Report
Nuclear Medicine
18758-3
PET Scan Report
Positron Emission Tomography
18745-0
Cardiac Catheterization Report
Cardiac Radiography/Fluoroscopy
11522-0
Echocardiography Report
Cardiac Ultrasound
18782-3
X-ray Report
18752-6
Exercise stress test report
18754-2
Holter Study
18750-0
Cardiac Electrophysiology
11524-0
ECG Report
38269-7
Bone Mineral Densitometry Report
Bone Densitometry
18748-4
Breast Imaging Report
Mammography
18750-0
Cardiac Electrophysiology Report
11524-0
ECG Report
18752-6
Exercise Stress Test Report
18754-2
Holter Study Report
Projection Radiography
Table 2 LOINC Document Type Codes
These codes are drawn from LOINC version 2.16, December 2005 and equal the subset
of LOINC whose scale is DOC and which refer to reports for diagnostic imaging
procedures.
CONF-7: If pre-coordinated document type codes are used, values used in imaging
procedure code ClinicalDocument/documentationOf/serviceEvent/code SHALL
NOT conflict with ClinicalDocument/code.
2.1.8
ClinicalDocument/title
The title element MAY be present and specifies the local name used for the document. Many provider
organizations will desire to have document titles more specific than the generic Display Name of the
Document Type Code. For example, instead of Diagnostic Imaging Report, one may wish to have the title
be “Chest CT Report”. Implementers may generate this automatically from available information
specifying procedure, modality, body part, etc. The method of such derivation is not specified in this
specification.
<title>Chest X-Ray, PA and LAT View</title>
Figure 9 ClinicalDocument/title Example
2.1.9
ClinicalDocument/effectiveTime
The ClinicalDocument/effectiveTime element SHALL be present and specifies the creation time of the
content of the document.
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All Diagnostic Imaging Reports authored by direct input to a computer system SHOULD
record an effectiveTime that is precise to the second. When authored in other ways, for
example, by dictation and transcription, the precision of effectiveTime may be less.
<effectiveTime value="20060828170821"/>
Figure 10 CinicalDocument/effectiveTime Example
2.1.10
ClinicalDocument/confidentialityCode
The ClinicalDocument/confidentialityCode SHALL be present. It specifies the confidentiality
assigned to the document. This implementation guide provides no guidance on documents with respect to
the vocabulary used for confidentialityCode, nor treatment or implementation of confidentiality. A
Fixed Value of “N” (normal) is used when the CDA document is transformed from DICOM SR. A CDA
Release 2.0 conforming example is shown below.
<confidentialityCode code="N" codeSystem="2.16.840.1.113883.5.25"/>
Figure 11 CinicalDocument/confidentialityCode Example
2.1.11
ClinicalDocument/languageCode
The ClinicalDocument/languageCode element SHALL be present. It specifies the
language of the Diagnostic Imaging Report. The encoding of the language SHALL be
present, and SHALL be in the form nn (see Figure 12) or nn-CC (see Figure 13), where nn
is a two letter ISO-639-1 language code in lower case, and CC is a two letter ISO-3166
Country code in upper case. This is a subset of the values defined by RFC 3066.
CONF-8: The languageCode element SHALL be present.
CONF-9: The language code SHALL be in the form nn, or nn-CC.
CONF-10: The nn portion SHALL be a legal ISO-639-1 language code in lower case.
CONF-11: The CC portion, if present SHALL be an ISO-3166 country code in upper
case.
<languageCode code="en"
Figure 12 ClinicalDocument/languageCode Example with language only
<languageCode code="en-US"
Figure 13 ClinicalDocument/languageCode Example with language and country.
2.1.12
ClinicalDocument/setId and ClinicalDocument/versionNumber
The ClinicalDocument/setId and ClinicalDocument/versionElements, SHALL be absent.
CONF-12: Both ClinicalDocument/setId and ClinicalDocument/versionNumber SHALL
be absent.
2.1.13
ClinicalDocument/copyTime
The ClinicalDocument/copyTime element has been deprecated in CDA Release 2,
therefore it SHALL NOT be present in conforming instances of a Diagnostic Imaging
Report.
CONF-13: A ClinicalDocument/copyTime element SHALL NOT be present.
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2.2
Participants
This section describes the constraints placed upon CDA Participants described in the
CDA Header.
In the HL7 Clinical Document Architecture, Release 2.0 specification, section 4.2.2.13
describes various Participant Scenarios, where a single person can participate in several
roles. In these cases, the person SHOULD be listed for each role, as described in the CDA
Release 2.0 specification.
2.2.1
recordTarget
The recordTarget element SHALL be present. It SHALL be the patient in whose medical record the report
is to be placed.
CONF-14: At least one recordTarget/patientRole element SHALL be present.
The birthTime and administrativeGenderCode SHALL be present as this information is
needed by users of a Diagnostic Imaging Report. If unknown, it SHALL be represented
using a flavor of null. Values for administrativeGenderCode SHOULD be drawn from the
HL7 AdministrativeGender vocabulary.
CONF-15: A patient/birthTime element SHALL be present.
CONF-16: A patient/administrativeGenderCode element SHALL be present.
The maritalStatusCode, religiousAffiliationCode, raceCode and ethnicGroupCode elements
MAY be present.
CONF-17: If maritalStatusCode, religiousAffiliationCode, raceCode and
ethnicGroupCode elements are present, they SHOULD be encoded using
appropriate HL7 vocabularies.
CONF-18: The guardian element SHOULD be present when the patient is a minor
child.
The providerOrganization element MAY be present.
<recordTarget>
<patientRole>
<id root="1.2.840.113619.2.62.994044785528.10" extension="0000680029"/>
<!-- (0010,0020)
{root}.10 = patient ID list -->
<patient>
<name>
<given>John</given>
<!-- (0010,0010)
-->
<family>Doe</family>
</name>
<administrativeGenderCode codeSystem="2.16.840.1.113883.5.1" code="M"/>
<!-- (0010,0040)
-->
<birthTime value="19641128"/>
<!-- (0010,0030)
-->
</patient>
</patientRole>
</recordTarget>
Figure 14 recordTarget Example
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2.2.2
author
The author element SHALL be present. It represents the creator of the document. If the role of the actor is
the entry of information from his or her own knowledge or application of skills, that actor SHOULD be
represented as the author. If one actor provides information to another actor, who filters, reasons, or
algorithmically creates new information, then that second actor is also an author, having created
information from his or her own knowledge or skills. However, that determination is independent from the
determination of the first actor's authorship.
<author>
<time value="20060823224352"/>
<assignedAuthor>
<id extension="121008" root="2.16.840.1.113883.19.5"/>
<assignedPerson>
<name>
<given>Richard</given>
<family>Blitz</family>
<suffix>MD</suffix>
</name>
</assignedPerson>
</assignedAuthor>
</author>
Figure 15 author Example
The time element SHALL be present. It SHALL be the starting time of the author's participation in the
creation of the document.
CONF-19: The author/time element SHALL be present.
The assignedAuthor/id element SHALL be present.
CONF-20: The assignedAuthor/id element SHALL be present.
An assignedAuthor/assignedPerson or assignedAuthor/assignedAuthoringDevice
element SHALL be present. This is the person or device authoring the document.
CONF-21: An assignedAuthor element SHALL contain at least one assignedPerson or
assignedAuthoringDevice elements.
2.2.3
dataEnterer
This element MAY be present. It represents the person, usually a transcriptionist, who transferred the
information from other sources into the Diagnostic Report. A person can participate as both author and
dataEnterer.
If the role of the actor is to transfer information from one source to another (e.g., transcription, or transfer
from paper form to electronic system), that actor SHOULD be recorded as dataEnterer.
CONF-22: When dataEnterer is present, an assignedEntity/assignedPerson element
SHALL be present.
The time element MAY be present. If present, it represents the starting time of entry of the data.
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<dataEnterer>
<time value='20050329222451+0500'/>
<assignedEntity>
<id extension='2' root='1.3.6.4.1.4.1.2835.2'/>
<assignedPerson>
<name>
<prefix>Mrs.</prefix>
<given>Bernice</given>
<family>Wiseman</family>
</name>
</assignedPerson>
</assignedEntity>
</dataEnterer>
Figure 16 dataEnterer Example
2.2.4
informant
The informant element SHALL NOT be present.
2.2.5
custodian
The custodian element SHALL be present. This SHALL be the custodian of the Diagnostic Imaging
Report document. The Custodian is optional in DICOM SR documents. When transforming from SR to
CDA and Custodian is not present in the source document, it shall be set according to organizational
policies.
<custodian>
<assignedCustodian>
<representedCustodianOrganization>
<id root="1.2.840.113619.2.62.994044785528"/>
<name>World University Hospital</name>
</representedCustodianOrganization>
</assignedCustodian>
</custodian>
Figure 17 custodian Example
2.2.6
informationRecipient
The ClinicalDocument/informationRecipient element MAY be present3. This element records the
intended recipient of the information at the time the document is created. The Referring Physician, if
present, SHALL be recorded as an informationRecipient. When no referring physician is preesnt, as in the
case of self-referred screening examinations allowed by law, the intendedRecipient may be null with a
nullFlavor of “OTH”. The intended recipient MAY also be the health chart of the patient, in which case the
receivedOrganization SHALL be the scoping organization of that chart.
CONF-23: When informationRecipient is used, at least one
informationRecipient/intendedRecipient/informationRecipient or
informationRecipient/intendedRecipient/recievedOrganization SHOULD be
present.
Note that there are two elements in the CDA Release 2.0 schema that are named
informationRecipient. The outermost of these elements is what is being discussed here. The
second element with the same name may appear as a descendent of this one.
3
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<informationRecipient>
<intendedRecipient>
<id extension='4' root='1.3.6.4.1.4.1.2835.2'/>
<addr>
<streetAddressLine>21 North Ave</streetAddressLine>
<city>Burlington</city>
<state>MA</state>
<postalCode>01803</postalCode>
<country>USA</country>
</addr>
<telecom value='tel:(999)555-1212' use='WP'/>
<informationRecipient>
<name>
<prefix>Dr.</prefix>
<given>Phil</given>
<family>Green</family>
</name>
</informationRecipient>
<receivedOrganization>
<name>Good Health Clinic</name>
</receivedOrganization>
</intendedRecipient>
</informationRecipient>
Figure 18 informationRecipient Example
2.2.7
legalAuthenticator
The legalAuthenticator element SHALL be present if the document has been legally authenticated. It
SHALL identify the legal authenticator of the document. Diagnostic Imaging Reports MAY be released
before legal authentication, based on local practice. This implies that a Diagnostic Imaging Report that
does not contain this element has not been legally authenticated.
CDA Release 2 allows only one Legal Authenticator. In the case of diagnostic reports that are double read
by physicians with authenticating privilege, one of the physicians is recorded as the legalAuthenticator, and
the other is recorded as an Authenticator. Institutional policy may dictate which physician is the
legalAuthenticator.
CONF-24: The assignedEntity/assignedPerson element SHALL be present in
legalAuthenticator.
<legalAuthenticator>
<time value="20060827141500"/>
<signatureCode code="S"/>
<assignedEntity>
<id extension="08150000" root="1.2.840.113619.2.62.994044785528.33"/>
<assignedPerson>
<name>
<given>Richard</given>
<family>Blitz</family>
<suffix>MD</suffix>
</name>
</assignedPerson>
</assignedEntity>
</legalAuthenticator>
Figure 19 legalAuthenticator Example
2.2.8
authenticator
An authenticator MAY be present. The authenticator SHALL identify a participant who verified the
accuracy of the information in the document.
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In radiology reporting environments, the authenticator would typically be a resident who dictated the initial
report and reviewed and approved the transcribed version, but the report would still need to be legally
authenticated by an attending radiologist.
CONF-25: The assignedEntity/assignedPerson element SHALL be present in an
authenticator element.
<legalAuthenticator>
<time value="20060827134500"/>
<signatureCode code="S"/>
<assignedEntity>
<id extension="1234567" root="1.2.840.113619.2.62.994044785528.33"/>
<assignedPerson>
<name>
<given>Robert</given>
<family>Resident</family>
<suffix>MD</suffix>
</name>
</assignedPerson>
</assignedEntity>
</legalAuthenticator>
Figure 20 authenticator Example
participant
2.2.9
The participant element MAY be present. The participant SHALL identify the physician requesting the
imaging procedure (the referring physician).
CONF-26: The assignedEntity/assignedPerson element SHALL be present in an
participant element.
<participant typeCode="REF">
<associatedEntity classCode="PROV">
<id nullFlavor="UNK"/>
<associatedPerson>
<name>
<given>John</given>
<family>Smith</family>
<suffix>MD</suffix>
</name>
</associatedPerson>
</associatedEntity>
</participant>
Figure 21 participant Example
.
2.2.10
inFullfillmentOf
The inFullfillmentOf elements MAY be present. They represent the Placer Order that was fulfilled in by
the imaging procedure(s) covered by this report document.
The Placer Order is either a group of of order (modeled as PlacerGroup in the Placer Order RMIM of the
Orders & Observations domain) or a single order item (modeled as ObservationRequest in the same
RMIM). This optionality reflects two major approaches to the grouping of procedures as implemented in
the installed base of imaging information systems. These approaches differ in their handling of grouped
procedures and how they are mapped to identifiers in the DICOM image and structured reporting data.
The example of a CT examination covering chest, abdomen and pelvis will be used in the discussion below:
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
In the IHE Scheduled Workflow model, the Chest CT, Abdomen CT and Pelvis CT each represent a
Requested Procedure, and all three procedures are grouped under a single Filler Order. The
Filler Order number maps directly to the DICOM Accession Number in the DICOM imaging and
report data.

A widely deployed alternative approach maps the requested procedure identifiers directly to the
DICOM Accession Number. The Requested Procedure ID in such implementations may or may
not be different from the Accession Number but is of little identifying importance because there is
only one Requested Procedure per Accession Number. There is no identifier that formally
connects the requested procedures ordered in this group.
In both cases, inFullfillmentOf/order/id is mapped to the DICOM Accession Number in the imaging
data.
<inFulfillmentOf>
<order>
<id extension="10523475" root="1.2.840.113619.2.62.994044785528.27"/>
<!-- {root}.27= accession number list *-->
</order>
</inFulfillmentOf>
Figure 22 inFulfillmentOf Example
2.2.11
documentationOf
One or more documentationOf elements SHALL be present. Each
documentationOf/ServiceEvent SHALL indicate an imaging procedure that the provider
describes and interprets in the content of the Diagnostic Imaging Report. The main
activity being described by this document is the interpretation of the imaging
procedure. This is shown by setting the value of the @classCode attribute of the
serviceEvent element to ACT, and indicating the duration over which care was provided
in the effectiveTime element. Within the documentationOf element, there is one
serviceEvent element. This event is the unit imaging procedure corresponding to a
billable item. The type of imaging procedure MAY be further described in the
serviceEvent/code element. This guide makes no specific recommendations about the
vocabulary to use for describing this event.
CONF-27: One or more ClinicalDocument/documentationOf elements SHALL be
present.
CONF-28: The value of the serviceEvent/@classCode attribute SHALL be ACT (a
Healthcare Service).
CONF-29: One or more serviceEvent/id elements SHALL be present. In IHE
Scheduled Workflow environments, one serviceEvent/id element contains the
DICOM Study Instance UID from the Modality Worklist, and the second
serviceEvent/id element contains the DICOM Requested Procedure ID from the
from the Modality Worklist,
CONF-30: If present, the value of serviceEvent/code SHALL NOT conflict with the
ClininicalDocument/code.
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The effectiveTime for the serviceEvent covers the duration of the imaging procedure being reported.
This event SHOULD have one or more performers, which MAY participate at the same or different periods of
time.
Service events map to DICOM Requested Procedures. That is
documentationOf/ServiceEvent/id is ID of the Requested Procedure.
CONF-31: The effectiveTime element of the serviceEvent element SHOULD be present.
CONF-32: The effectiveTime element SHOULD contain both a low and a high element.
CONF-33: A serviceEvent SHOULD have at least one performer. There are cases
where no performers might be listed, for example, in cases where the information
is not available.
CONF-34: The performer elements SHOULD list the persons performing the
procedure(s) being reported. This would normally be the technologist performing
the imaging procedure.
The specific type of performer MAY be described in performer/assignedEntity/code.
CONF-35: If present, the values for performer/assignedEntity/code SHALL be drawn
from SNOMED CT, using concepts that descend from the healthcare professional
subtype hierarchy (SNOMED CT Concept ID: 223366009).
CONF-36: The performer/assignedEntity/code if present SHALL have a value drawn
from the SNOMED CT healthcare professional subtype hierarchy.
CONF-37: Every performer/assignedEntity element SHALL have at least one
assignedPerson or representedOrganization.
The time element of the performer element MAY be present. If present, it indicates the
time span over which healthcare services are provided, if different from that of the
service event.
<documentationOf>
<serviceEvent classCode="ACT">
<id root="1.2.840.113619.2.62.994044785528.114289542805"/>
<!-- study instance UID -->
<id extension="123453" root="1.2.840.113619.2.62.994044785528.26"/>
<!-- requested procedure ID , {root}.26 = procedure ID Namespace-->
</serviceEvent>
</documentationOf>
Figure 23 documentationOf Example
2.2.12
authorization
The authorization elements MAY be present. This document provides no guidance on the encoding of
authorization elements.
2.2.13
relatedDocument
relatedDocument elements MAY be present. A Diagnostic Imaging Report may have three types of
parent document:

A superseded version that the present document wholly replaces (typeCode = RPLC).
Diagnostic Imaging Reports may go through stages of revision prior to being legally
authenticated. Such early stages may be drafts from transcription, or those created by residents,
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or other pleliminary versions. Policies not covered by this specification may govern requirements
for retention of such earlier versions, but except for forensic purposes, the latest version in a chain
of revisions represents the complete and current report.

An original version that the present document appends (typeCode = APND). When a
Diagnostic Imaging Report is legally authenticated, it cannot thereafter be replaced, but is only
amended by a separate addendum document that references the original.

A source document from which the present document is transformed (typeCode = XFRM). A
Diagnostic Imaging Report may be created by transformation from a DICOM SR document or
from another Diagnostic Imaging Report. An example of the latter case is the creation of a
derived document for use in a claims attachment.
When the parent document legally authenticated, it SHALL NOT be replaced. It may
only be appended or transformed.
2.2.14
componentOf
When the Diagnostic imaging procedure is performed in the context of a hospital stay or
and outpatient visit for which there is an Encounter Number, that number SHOULD be
is present in as the id of the encompassingEncounter.
EncompassingEncounter.id is not available from DICOM SR documents, if Physian’s
Reading Studies shall be mapped as Encounter participant (Performer), the null flavor
UNK (unknown) shall be used
The id element of the encompassingEncounter SHALL be present and represents the
identifier for the encounter.
CONF-38: The encompassingEncounter element SHALL have an id element.
The effectiveTime MAY be present, and represents the time interval or point in time in which the
encounter took place. The encompassing encounter might be that of the office visit in which the Diagnostic
Imaging procedure was ordered.
CONF-39: The encompassingEncounter element MAY have an effectiveTime
element.
The responsibleParty element MAY be present. If present, it represents only the party
responsible for the encounter, not necessarily the entire episode of care.
CONF-40: The responsibleParty/assignedEntity element SHALL have at least one
assignedPerson or representedOrganization element present.
<componentOf>
<encompassingEncounter>
<id extension='9937012' root='1.3.6.4.1.4.1.2835.12'/>
<effectiveTime>
<low value='20050329'/>
<high value='20050329'/>
</effectiveTime>
</encompassingEncounter>
</componentOf>
Figure 24 componentOf example
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3
Body
A Diagnostic Imaging Report SHALL have a structuredBody element. The content of this
element makes up the human readable text of the document. This information SHALL
be organized into sections and MAY have sub-sections.
CONF-41: A nonXMLBody/text SHOULD not contain both a reference element and
character data.
3.1
Section Type Codes
The Section Type codes used in this guide are described below in Table 3. All section
codes shown in this table describe narrative document sections4.
The column headings of this table are described below:
DCM Code:
DCM Code Meaning:
LOINC Code:
LOINC Component Name:
Use:
DCM
Code
The code of the section in DICOM (Context Group CID 7001).
The display name of the section in DICOM (Context Group CID 7001)..
The code of the section in LOINC.
The display name of the section in LOINC.
The use column indicates that a section in a Diagnostic Imaging Report is:
R – required
C – conditionally required
O – optional
DCM Code meaning
LOINC Code
121181 DICOM Object Catalog
121060 History
121062 Request
121064 Current Procedure Descriptions
121066 Prior Procedure Descriptions
121068 Previous Findings
121070 Findings
121072 Impressions
121074 Recommendations
LOINC Component Name
Use
C
O
O
O
O
18834-2
RADIOLOGY COMPARISON STUDY OBSERVATION
O
18782-3
RADIOLOGY STUDY OBSERVATION
R
19005-8
RADIOLOGY - IMPRESSION
O
18783-1
RADIOLOGY STUDY RECOMMENDATION
O
121076 Conclusions
121078 Addendum
O
O
121109 Indications for Procedure
121110 Patient Presentation
121113 Complications
121111 Summary
121180 Key Images
18785-6
RADIOLOGY REASON FOR STUDY
O
O
O
O
O
Table 3 Section Type Codes
The DICOM Object Catalog section (see § 3.3.1), if present, SHALL be the first section in
the document body.
4
SCALE_TYP = 'NAR' in the LOINC tables.
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Subsequent sections SHOULD appear in the order shown above. Sections within the
Diagnostic Imaging Report content SHOULD have a title. A section element in a level 2
conforming Diagnostic Imaging Report SHOULD have a non-empty title element.
The remainder of the examples in this section all show sample content that would
appear in the structuredBody element.
For level 2 conformance, all section elements that are present in the body of the
document SHALL have a code and some non-blank text or one or more subsections, even
if the purpose of the text is only to indicate that information is unknown.
CONF-42: A section element SHALL have a code element.
CONF-43: A section SHALL contain at least one text element or one or more
component elements.
CONF-44: All text or component elements SHALL contain content.
For compatibility with DICOM SR reports, which do not have section titles apart from
the Code Meaning of the section container’s Concept Name code, the CDA Section title
SHALL be identical to the displayName of the Section Code.
CONF-45: A Section/title element SHALL be present and SHALL have content equal to
the content of Section/code@displayName.
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3.2
Sections
Required and optional sections are described below. The sections “Reason for Study”,
“History of Present Illness” and “Impressions”, detailed below, are three examples of
optional sections. Others, as set forth in Table 2, may also be present.
3.2.1
DICOM Object Catalog – DCM 121181
A DICOM Object Catalog SHALL be present if the document contains references to
DICOM Images, and if present SHALL be the first section in the CDA document body,
Structured Reports or other DICOM composite objects. The DICOM Object Catalog lists
all referenced objects and their parent Series and Studies, plus other DICOM
attriburtes required for retrieving the objects.
DICOM Object Catalog sections are not intended for viewing, and contain empty section
text.
CONF-46: A DICOM Object Catalog SHALL be present if the document contains
references to DICOM Images.
CONF-47: If present, the DICOM Object Catalog section SHALL be the first section in
the CDA document body,
CONF-48: A DICOM Object Catalog section SHALL have an empty or absent
section/text element.
Error! Reference source not found. Figure 26, below, shows a sample of an Object
Catalog section.
<component>
<section classCode="DOCSECT" moodCode="EVN">
<code code="121181" codeSystem="1.2.840.10008.2.16.4" codeSystemName="DCM"
displayName="DICOM Object Catalog"/>
<text/>
<entry>
<!-- **** Study **** -->
<act classCode="ACT" moodCode="EVN">
<id root="1.2.840.113619.2.62.994044785528.114289542805"/>
<code code="113014" codeSystem="1.2.840.10008.2.16.4" codeSystemName="DCM"
displayName="Study"/>
<!-- **** Series **** -->
<entryRelationship typeCode="COMP">
<act classCode="ACT" moodCode="EVN">
<id root="1.2.840.113619.2.62.994044785528.20060823223142485051"/>
<code code="113015" codeSystem="1.2.840.10008.2.16.4" codeSystemName="DCM"
displayName="Series">
<qualifier>
<name code="121139" codeSystem="1.2.840.10008.2.16.4"
codeSystemName="DCM" displayName="Modality"> </name>
<value code="CR" codeSystem="1.2.840.10008.2.16.4" codeSystemName="DCM"
displayName="Computed Radiography"> </value>
</qualifier>
</code>
<!-- **** SopInstance UID **** -->
<!-- 2 References (chest PA and LAT) -->
<entryRelationship typeCode="COMP">
<observation classCode="DGIMG" moodCode="EVN">
<id root="1.2.840.113619.2.62.994044785528.20060823.200608232232322.3"/>
<code code="1.2.840.10008.5.1.4.1.1.1" codeSystem="1.2.840.10008.2.6.1"
codeSystemName="DCMUID" displayName="Computed Radiography Image Storage">
<originalText>
<reference value="#finding3"/>
</originalText>
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</code>
<text xsi:type="ED" mediaType="application/DICOM">
<reference
value="http://www.example.org/wado?requestType=WADO&studyUID=1.2.840.113619.2.62.9940
44785528.114289542805&seriesUID=1.2.840.113619.2.62.994044785528.20060823223142485051
&objectUID=1.2.840.113619.2.62.994044785528.20060823.200608232232322.3&contentTyp
e=application/DICOM"/>
<!--reference to image 1 (PA) -->
</text>
<effectiveTime value="20060823223232"/>
</observation>
</entryRelationship>
<entryRelationship typeCode="COMP">
<observation classCode="DGIMG" moodCode="EVN">
<id root="1.2.840.113619.2.62.994044785528.20060823.200608232231422.3"/>
<code code="1.2.840.10008.5.1.4.1.1.1" codeSystem="1.2.840.10008.2.6.1"
codeSystemName="DCMUID" displayName="Computed Radiography Image Storage">
<originalText>
<reference value="#finding4"/>
</originalText>
</code>
<text xsi:type="ED" mediaType="application/DICOM">
<reference
value="www.example.org/wado?requestType=WADO&studyUID=1.2.840.113619.2.62.99404478552
8.114289542805&seriesUID=1.2.840.113619.2.62.994044785528.20060823223142485051&ob
jectUID=1.2.840.113619.2.62.994044785528.20060823.200608232231422.3&contentType=appli
cation/DICOM"/>
<!--reference to image 2 (LAT) -->
</text>
<effectiveTime value="20060823223142"/>
</observation>
</entryRelationship>
</act>
</entryRelationship>
</act>
</entry>
</section>
</component>
Figure 25 DICOM Object Catalog Example
3.2.2
Findings – LOINC 18782-3
A Findings Section SHALL be present. The Findings section contains the main
narrative body of the report. This section SHOULD contain only the direct observations
in the report, with topics such as Reason for Study, History, and Impression placed in
separate sections. However, in cases where the source of report content provides a
single blob of text not separated into these sections, that text SHALL be placed in the
Findings section.
<component>
<section>
<code code="18782-3" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"
displayName="Study observation"/>
<text>
<content ID="finding1">The cardiomediastinum is within normal limits. The
trachea is midline. The previously described opacity at the medial right lung base has
cleared. There are no new infiltrates. There is a new round density at the left hilus,
superiorly (diameter about 45mm). A CT scan is recommended for further evaluation. The
pleural spaces are clear. The visualized musculoskeletal structures and the upper abdomen
are stable and unremarkable.</content>
<content ID="finding2"> 45 mm diameter</content>
<content ID="finding3"> Image</content>
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<linkHtml
href="http://www.example.org/wado?requestType=WADO&studyUID=1.2.840.113619.2.62.99404
4785528.114289542805&seriesUID=1.2.840.113619.2.62.994044785528.20060823223142485051&
amp;objectUID=1.2.840.113619.2.62.994044785528.20060823.200608232232322.3&contentType
=application/DICOM" name="Computed Radiography Image Storage"/>
</text>
<entry>
<observation classCode="OBS" moodCode="EVN">
<code code="18782-3" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"
displayName="Study observation">
</code>
<text>
<reference value="#finding1"/>
</text>
<!-- inferred from measurement -->
<entryRelationship typeCode="SPRT">
<observation classCode="OBS" moodCode="EVN">
<code code="M-02550" codeSystem="2.16.840.1.113883.6.96"
codeSystemName="SNM3" displayName="Diameter">
<originalText>
<reference value="#finding2"/>
</originalText>
</code>
<statusCode code="completed"/>
<effectiveTime value="20060823223912"/>
<value xsi:type="PQ" value="45" unit="mm">
<translation code="mm" codeSystem="2.16.840.1.113883.6.8"
codeSystemName="UCUM" codeSystemVersion="1.5"/>
</value>
</observation>
</entryRelationship>
<!-- inferred from image -->
<entryRelationship typeCode="SUBJ">
<observation classCode="DGIMG" moodCode="EVN">
<id root="1.2.840.113619.2.62.994044785528.20060823.200608232232322.3"/>
<!-- (0008,1155) Referenced SOP Instance UID-->
<code code="1.2.840.10008.5.1.4.1.1.1" codeSystem="1.2.840.10008.2.6.1"
codeSystemName="DCMUID" displayName="Computed Radiography Image Storage">
<!-- (0008,1150) Referenced SOP Class UID -->
<originalText>
<reference value="#finding3"/>
</originalText>
</code>
<text xsi:type="ED" mediaType="application/DICOM">
<reference
value="http://www.example.org/wado?requestType=WADO&studyUID=1.2.840.113619.2.62.9940
44785528.114289542805&seriesUID=1.2.840.113619.2.62.994044785528.20060823223142485051
&objectUID=1.2.840.113619.2.62.994044785528.20060823.200608232232322.3&contentTyp
e=application/DICOM"/>
<!--reference to image 1 (PA view) -->
</text>
<effectiveTime value="20060823223232"/>
</observation>
</entryRelationship>
</observation>
</entry>
</section>
</component>
Figure 26 Findings Example including Level 3 content
3.2.3
Reason for Study – LOINC 18785-6
The indication for the imaging procedure SHOULD be present as a separate section.
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<component>
<section>
<code code="18785-6" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"
displayName="Reason for study"/>
<text>Suspected lung tumor</text>
</section>
</component>
Figure 27 Reason for Study Example
3.2.4
History of Present Illness – LOINC 10164-2
Relevant patient history MAY be present as a separate section.
<component>
<section>
<code code="10164-2" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"
displayName="History of present illness"/>
<text>Sore throat.</text>
</section>
</component>
Figure 28 History Example
3.2.5
Impressions – LOINC 19005-8
Radiologist’s impression SHALL be present unless the Impression content is embedded
in the FINDINGS section.
<component>
<section>
<code code="19005-8" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"
displayName="X-ray impression"/>
<text>No acute cardiopulmonary process. Round density in left superior hilus,
further evaluation with CT is recommended as underlying malignancy is not
excluded.</text>
</section>
</component>
Figure 29 Impressions Example
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3.3
Level 3 Content
A Diagnostic Imaging Report MAY contain CDA Entries that represent in coded form
findings, image references, annotation and numeric measurements, equivalent to the
body content in DICOM Structured Reporting documents as constrained in the IHE
Simple Image and Numeric report (SINR) profile). IHE SINR is based on DICOM Basic
Diagnostic Imaging Report (Template 2000), with the additional constraint that only the
Enhanced SR Information Object Definition may be used.
DICOM Template 2000 defines imaging report documents comprising a number of
optional sections, including those defined above under “Level 2 Content”. Each section
contains,

Text Observations [Text Elements in DICOM SR], optionally inferred from
“Report Observations” (as defined below)

Code Observations [Code Elements in DICOM SR], optionally inferred from
Report Observations

Report Observations
Template 2000 does not constrain the number or order of the Observations.
Each Report Observation is ONE of the following:

An Image reference (purpose of reference is Baseline, Best Illustration of
Finding, Source of Measurement, or user extension),

A Linear Measurement, optionally inferred from a RegionOFInterest [Spatial
Coordinates (SCOORD) in DICOM SR] referencing an image,

An Area Measurement, optionally inferred from a RegionOFInterest [Spatial
Coordinates (SCOORD) in DICOM SR] referencing an image,

A Volume Measurement, optionally inferred from a RegionOFInterest [Spatial
Coordinates (SCOORD) in DICOM SR] referencing an image, or

A Numeric measurement with a coded measurement type optionally inferred
from either
o
an Image Reference, or
o
a RegionOFInterest [Spatial Coordinates (SCOORD) in DICOM SR]
referencing an image
In all cases, the Level 3 content take the place of <entry> elements immediately
following the Section/text closing bracket as illustrated in Figure 25.
3.3.1
Text Observations
Text entries MAY be present, and if present, shall contain the same text content as the
Section.text. A Text entry is required if the findings in the section text are represented
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as inferred from Report Observations. This is required in CDA because if an
observation is to be the source of an SPRT entryRelationship (equivalent to INFERRED
FROM in DICOM SR), the source Observation must be an entry. That is, a whole
section cannot be inferred from an Observation entry.
If Text Entries are present the Section.text must represent faithfully the concatenation
of the all such text entries. The entry’s observation.text element SHOULD avoid
replication of the text content by including it as a <reference> to tagged <content> in
the Section.text.
<entry>
<observation classCode="OBS" moodCode="EVN">
<code code="18782-3" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"
displayName="Study observation">
</code>
<text>
<reference value="#finding1"/>
</text>
<!— zero or more <entryRelationship> observations may appear here -->
</observation>
</entry>
</section>
</component>
Figure 30 Text Element example
3.3.2
Code Observations
Code Observations may be present, and may obtionally be inferred from Report
Observations, and if present, shall contain the same text content as the Section.text.
Code Observations shall be rendered into Section.text in separate paragraphs.
<entry>
<observation classCode="OBS" moodCode="EVN">
<code code="18782-3" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"
displayName="Study observation">
</code>
<statusCode code='completed'/>
<value xsi:type="CD" code="248649006" codeSystem="2.16.840.1.113883.6.96"
codeSystemName="SNOMED CT" displayName="Hilar mass"/>
<!— zero or more <entryRelationship> observations may appear here -->
</observation>
</entry>
</section>
</component>
Figure 31 Code Element example
3.3.3
Report Observations
Report Observations may be present as Entries, enclosed in <entry> … </entry> or as
supporting observations in Text or Code entries, enclosed in <entryRelationship
typeCode="SPRT"> … </entryRelationship>. Figures 25 and 25, below, illustrate these
two placements, respectively.
<entry>
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<observation classCode="DGIMG" moodCode="EVN">
<id root="1.2.840.113619.2.62.994044785528.20060823.200608232232322.3"/>
<!-- (0008,1155) Referenced SOP Instance UID-->
<code code="1.2.840.10008.5.1.4.1.1.1" codeSystem="1.2.840.10008.2.6.1"
codeSystemName="DCMUID" displayName="Computed Radiography Image Storage">
<!-- (0008,1150) Referenced SOP Class UID -->
<originalText>
<reference value="#finding3"/>
</originalText>
</code>
<text xsi:type="ED" mediaType="application/DICOM">
<reference
value="http://www.example.org/wado?requestType=WADO&studyUID=1.2.840.113619.2.62.9940
44785528.114289542805&seriesUID=1.2.840.113619.2.62.994044785528.20060823223142485051
&objectUID=1.2.840.113619.2.62.994044785528.20060823.200608232232322.3&contentTyp
e=application/DICOM"/>
<!--reference to image 1 (PA view) -->
</text>
<effectiveTime value="20060823223232"/>
</observation>
</entry>
</section>
</component>
Figure 32 Report Observation as an Entry
<entry>
<observation classCode="OBS" moodCode="EVN">
<code code="18782-3" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"
displayName="Study observation">
</code>
<text>
<reference value="#finding1"/>
</text>
<!-- inferred from image -->
<entryRelationship typeCode="SUBJ">
<observation classCode="DGIMG" moodCode="EVN">
<id root="1.2.840.113619.2.62.994044785528.20060823.200608232232322.3"/>
<!-- (0008,1155) Referenced SOP Instance UID-->
<code code="1.2.840.10008.5.1.4.1.1.1" codeSystem="1.2.840.10008.2.6.1"
codeSystemName="DCMUID" displayName="Computed Radiography Image Storage">
<!-- (0008,1150) Referenced SOP Class UID -->
<originalText>
<reference value="#finding3"/>
</originalText>
</code>
<text xsi:type="ED" mediaType="application/DICOM">
<reference
value="http://www.example.org/wado?requestType=WADO&studyUID=1.2.840.113619.2.62.9940
44785528.114289542805&seriesUID=1.2.840.113619.2.62.994044785528.20060823223142485051
&objectUID=1.2.840.113619.2.62.994044785528.20060823.200608232232322.3&contentTyp
e=application/DICOM"/>
<!--reference to image 1 (PA view) -->
</text>
<effectiveTime value="20060823223232"/>
</observation>
</entryRelationship>
</observation>
</entry>
</section>
</component>
Figure 33 Report Observation as a support for an inferred finding
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3.3.3.1
Report Observation – Image Reference
Image References indicate the image from which an observation was inferred or which a
finding mentions.
<!-- inferred from image -->
<entryRelationship typeCode="SUBJ">
<observation classCode="DGIMG" moodCode="EVN">
<id root="1.2.840.113619.2.62.994044785528.20060823.200608232232322.3"/>
<!-- (0008,1155) Referenced SOP Instance UID-->
<code code="1.2.840.10008.5.1.4.1.1.1" codeSystem="1.2.840.10008.2.6.1"
codeSystemName="DCMUID" displayName="Computed Radiography Image Storage">
<!-- (0008,1150) Referenced SOP Class UID -->
<originalText>
<reference value="#finding3"/>
</originalText>
</code>
<text xsi:type="ED" mediaType="application/DICOM">
<reference
value="http://www.example.org/wado?requestType=WADO&studyUID=1.2.840.113619.2.62.9940
44785528.114289542805&seriesUID=1.2.840.113619.2.62.994044785528.20060823223142485051
&objectUID=1.2.840.113619.2.62.994044785528.20060823.200608232232322.3&contentTyp
e=application/DICOM"/>
<!--reference to image 1 (PA view) -->
</text>
<effectiveTime value="20060823223232"/>
</observation>
</entryRelationship>
Figure 34 Image Reference Report Observation example
3.3.3.2
Report Observation – Linear Measurement
Linear Measurements represent distance between two points in the image.
<!-- inferred from measurement -->
<entryRelationship typeCode="SPRT">
<observation classCode="OBS" moodCode="EVN">
<code code="M-02550" codeSystem="2.16.840.1.113883.6.96"
codeSystemName="SNM3" displayName="Diameter">
<originalText>
<reference value="#finding2"/>
</originalText>
</code>
<statusCode code="completed"/>
<effectiveTime value="20060823223912"/>
<value xsi:type="PQ" value="45" unit="mm">
<translation code="mm" codeSystem="2.16.840.1.113883.6.8"
codeSystemName="UCUM" codeSystemVersion="1.5"/>
</value>
</observation>
</entryRelationship>
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Figure 35 Linear Measurement Report Observation example
3.3.3.3
Report Observation – Area Measurement
Area Measurements represent area within a region of interest in a image.
<!-- inferred from measurement -->
<entryRelationship typeCode="SPRT">
<observation classCode="OBS" moodCode="EVN">
<code code="M-02550" codeSystem="2.16.840.1.113883.6.96"
codeSystemName="SNM3" displayName="Diameter">
<originalText>
<reference value="#finding2"/>
</originalText>
</code>
<statusCode code="completed"/>
<effectiveTime value="20060823223912"/>
<value xsi:type="PQ" value="45" unit="mm">
<translation code="mm" codeSystem="2.16.840.1.113883.6.8"
codeSystemName="UCUM" codeSystemVersion="1.5"/>
</value>
</observation>
</entryRelationship>
Figure 36 Linear Measurement Report Observation example
3.3.3.4
Report Observation – Volume Measurement
Volume Measurements represent physical volumes within anatomical structures, as
inferred from measurement s on the image or groups of images.
<!-- inferred from measurement -->
<entryRelationship typeCode="SPRT">
<observation classCode="OBS" moodCode="EVN">
<code code="M-02550" codeSystem="2.16.840.1.113883.6.96"
codeSystemName="SNM3" displayName="Diameter">
<originalText>
<reference value="#finding2"/>
</originalText>
</code>
<statusCode code="completed"/>
<effectiveTime value="20060823223912"/>
<value xsi:type="PQ" value="45" unit="mm">
<translation code="mm" codeSystem="2.16.840.1.113883.6.8"
codeSystemName="UCUM" codeSystemVersion="1.5"/>
</value>
</observation>
</entryRelationship>
Figure 37 Volume Measurement Report Observation example
3.3.3.5
Report Observation – Numeric Measurement
Numeric Measurements may be derived from image characteristics, other than spatial
measurements.
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<!-- inferred from measurement -->
<entryRelationship typeCode="SPRT">
<observation classCode="OBS" moodCode="EVN">
<code code="M-02550" codeSystem="2.16.840.1.113883.6.96"
codeSystemName="SNM3" displayName="Diameter">
<originalText>
<reference value="#finding2"/>
</originalText>
</code>
<statusCode code="completed"/>
<effectiveTime value="20060823223912"/>
<value xsi:type="PQ" value="45" unit="mm">
<translation code="mm" codeSystem="2.16.840.1.113883.6.8"
codeSystemName="UCUM" codeSystemVersion="1.5"/>
</value>
</observation>
</entryRelationship>
Figure 38 Numeric Measurement Report Observation example
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4
References
CDA Release 2.0 Clinical Document Architecture, Release 2.0, 2005, Health Level
Seven, Inc.
ISO-3166-1
Codes for the representation of names of countries and their
subdivisions -- Part 1: Country codes, 1997, International
Organization for Standardization
ISO-639-1
Codes for the representation of names of languages--Part 1: Alpha-2
code, 2002, International Organization for Standardization
LOINC®
Logical Observation Identifiers Names and Codes, Regenstrief
Institute
RFC 2806
URLs for Telephone Calls, 2000, A. Vaha-Sipila, The Internet Society
RFC 2119
Key words for use in RFCs to Indicate Requirement Levels
RFC 3066
Tags for the Identification of Languages, 2001, H. Alvestrand, The
Internet Society
Schematron
The Schematron Assertion Language 1.5, 2002, Rick Jelliffe,
Academia Sinica Computing Centre
SNOMED CT
SNOMED Clinical Terms, 2002, SNOMED International Organization
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Appendix A — Validation
Introduction
This appendix describes the vocabularies used or defined by this specification, and the
Schematron schema that may be used to validate the content of the CDA Header for
Diagnostic Imaging Report documents.
Administrative Gender
Administrative Gender codes used to describe the gender of the patient SHOULD come
from the HL7 AdministrativeGender vocabulary. The OID for this vocabulary domain is
2.16.840.1.113883.5.1.
Code
Display Name
Description
F
Female
Female
M
Male
Male
UN
Undifferentiated
The gender of a person could not be uniquely defined as male or female, such as hermaphrodite.
Table 4 Administrative Gender
Ethnicity & Race
Ethnicity codes used to describe the ethnicity of the patient SHOULD come from the HL7
Ethnicity vocabulary. The OID for this vocabulary domain is 2.16.840.1.113883.5.50.
This vocabulary is listed below. DICOM’s Patient Sex attribute is mapped to
Administrative Gender.
Race codes used to describe the race of the patient SHOULD come from the HL7 Race
vocabulary. This vocabulary is too extensive to list in this document. The OID for this
vocabulary domain is 2.16.840.1.113883.5.104.
In the diagnostic reporting context, Race or Ethnicity as a CDA header component is a
confirming demographic attribute usually inherited from information systems providing
orders or ADT information. In any circumstance where race or ethnicity is clinically
relevant to report content, Race or Ethnicity SHALL be explicitly mentioned in the report
narrative.
Null Flavor
Null Flavors are used to indicate why a required data element does not contain any
information. Only the UNK null flavor is used in the Diagnostic Imaging Report. The
complete list is shown below for reference.
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Code
Display Name
Description
NI
NoInformation
No information whatsoever can be inferred from this
exceptional value. This is the most general
exceptional value. It is also the default exceptional
value.
OTH
other
The actual value is not an element in the value
domain of a variable. (e.g., concept not provided by
required code system).
NINF
negative infinity
Negative infinity of numbers.
PINF
positive infinity
Positive infinity of numbers.
UNK
unknown
A proper value is applicable, but not known.
ASKU
asked but unknown
Information was sought but not found (e.g., patient
was asked but didn't know)
NAV
temporarily unavailable
Information is not available at this time but it is
expected that it will be available later.
NASK
not asked
This information has not been sought (e.g., patient
was not asked)
TRC
trace
The content is greater than zero, but too small to be
quantified.
MSK
masked
There is information on this item available but it has
not been provided by the sender due to security,
privacy or other reasons. There may be an alternate
mechanism for gaining access to this information.
Note: using this null flavor does provide information
that may be a breach of confidentiality, even though
no detail data is provided. Its primary purpose is for
those circumstances where it is necessary to inform
the receiver that the information does exist without
providing any detail.
NA
not applicable
No proper value is applicable in this context (e.g., last
menstrual period for a male).
NP
not present
Value is not present in a message. This is only
defined in messages, never in application data! All
values not present in the message must be replaced
by the applicable default, or no-information (NI) as
the default of all defaults.
Table 5 Null Flavor
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Participation Function
Participating function codes used to describe the exact function of a healthcare
providers SHOULD come from the HL7 ParticipatingFunction vocabulary. This
vocabulary is listed below. The OID for this vocabulary domain is
2.16.840.1.113883.5.88.
Code
Display Name
Description
ADMPHYS
admitting physician
A physician who admitted a patient to a hospital or other care unit that is the context of
this service.
ANRS
anesthesia nurse
In a typical anesthesia setting the nurse principally assisting the anesthesiologist
during the critical periods.
ANEST
anesthesist
In a typical anesthesia setting an anesthesiologist or anesthesia resident in charge of
the anesthesia and life support, but only a witness to the surgical procedure itself. To
clarify responsibilities anesthesia should always be represented as a separate service
related to the surgery.
ATTPHYS
attending physician
A physician who is primarily responsible for a patient during the hospitalization, which
is the context of the service.
DISPHYS
discharging physician
A physician who discharged a patient from a hospital or other care unit that is the
context of this service.
FASST
first assistant surgeon
In a typical surgery setting the assistant facing the primary surgeon. The first assistant
performs parts of the operation and assists in others (e.g., incision, approach,
electrocoutering, ligatures, sutures).
MDWF
midwife
A person (usually female) helping a woman deliver a baby. Responsibilities vary
locally, ranging from a mere optional assistant to a full required participant, responsible
for (normal) births and pre- and post-natal care for both mother and baby.
NASST
nurse assistant
In a typical surgery setting the non-sterile nurse handles material supply from the
stock, forwards specimen to pathology, and helps with other non-sterile tasks (e.g.,
phone calls, etc.).
PCP
primary care physician
The healthcare provider that holds primary responsibility for the overall care of a
patient.
PRISURG
primary surgeon
In a typical surgery setting the primary performing surgeon.
RNDPHYS
rounding physician
A physician who made rounds on a patient in a hospital or other care center.
SNRS
scrub nurse
In a typical surgery setting the nurse in charge of the instrumentation.
SASST
second assistant surgeon
In a typical surgery setting the assistant who primarily holds the hooks.
TASST
third assistant
In a typical surgery setting there is rarely a third assistant (e.g., in some Hip operations
the third assistant postures the affected leg).
Table 6 Participating Function Codes
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Appendix B — Sample Conforming CDA Document
The document below is a non-normative example of a Diagnostic Imaging Report that
conforms to this specification. The file sampleDiagnosticImagingReport.xml included
in this distribution is equivalent in content to this appendix.
[paste sample document, as pretty-printed by XML Spy, in final text]
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