10 Entry-level Templates
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# 10 Entry-level Templates

## 10.1 Coded Observation

Template ID | 2.16.840.1.113883.​10.20.6.2.13
Name | Coded Observation
Effective Date | 2015/03/24
Version Label | DICOM-20150324
Status | Active
Description | Qualitative or categorical observation using a value of type CD.
Classification | CDA Entry Level
Relationships | Included in all sections
Context | parent node
Open/Closed | open
Revision History | From Consolidated CDA r1.1 DICOM-20150324: Added optional negationInd, interpretationCode, targetSiteCode, and methodCode with Business Names; added optional subject Coded Observation

Business Name | Nest Level | Element/​Attribute | Card | Elem/Attr Conf | Data Type | Value Conf | Value | Subsidiary Template
--- | --- | --- | --- | --- | --- | --- | --- | ---
Coded​Observation[*] |  | observation |  |  |  |  |  |
| @ | @classCode | 1..1 | SHALL | CS | SHALL | OBS |
| @ | @moodCode | 1..1 | SHALL |  | SHALL | EVN |
Not | @ | @negationInd | 0..1 | MAY | BL | SHALL | true |
| > | template​Id | 1..1 | SHALL | II |  |  |
| >@ | @root | 1..1 | SHALL | UID | SHALL | 2.16.840.1.113883.​10.20.6.2.13 |
| > | id | 1..1 | SHALL | II |  |  |
Obs​Name | > | code | 1..1 | SHALL | CD |  | Concept​Domain ObservationType |
| > | text | 0..1 | SHOULD | ED |  |  |
Ref | >> | reference | 1..1 | SHALL | URL (XML IDREF) |  | # content​Ref |
| > | status​Code | 1..1 | SHALL | CS | SHALL | COMPLETED |
Time | > | effective​Time | 0..1 | SHOULD | TS |  |  |
Obs​Value | > | value | 1..1 | SHALL | CD |  | Concept​Domain ObservationValue |
| >@ | @xsi:type | 1..1 | SHALL | ST | SHALL | CD |
Interpretation​Code | > | interpretation​Code | 0..1 | MAY | CE | SHALL CNE | ValueSet ObservationInterpretation Value Set 2.16.840.1.113883.11.78 |
Actionable​Priority | >> | translation | 0..1 | MAY | CD | MAY CWE | ValueSet CID 7035 “Actionable Finding Classification” [See 10.1.3 interpretationCode and translation For Actionable Findings] |
Target​Site | > | target​Site​Code | 1..1 | COND | CD |  | Concept​Domain ObservationSite |
| >> | qualifier | 0..1 | COND |  |  |  |
| >>> | name | 1..1 | SHALL | CD | SHALL | (272741003, SNOMED CT, "laterality") |
Laterality | >>> | value | 1..1 | SHALL | CD | SHALL CNE | ValueSet CID 244 “Laterality” |
| >> | qualifier | 0..1 | COND |  |  |  |
| >>> | name | 1..1 | SHALL | CD | SHALL | (106233006, SNOMED CT, "topographical modifier") |
Topo​Modifier | >>> | value | 1..1 | SHALL | CD | SHALL CNE | ValueSet CID 2 “Anatomic Modifier” |
Method | > | method​Code | 0..1 | MAY | CD |  | Concept​Domain ObservationMethod |
| > | entry​Relationship | 0..* | MAY |  |  |  |
| >@ | @typeCode | 1..1 | SHALL | CS | SHALL | SPRT |
SOPInstance[*] | >> | observation | 1..1 | SHALL |  |  |  | 10.8 SOP Instance Observation 1.2.840.10008.9.18
| > | entry​Relationship | 0..* | MAY |  |  |  |
| >@ | @typeCode | 1..1 | SHALL | CS | SHALL | SPRT |
Quantity​Measurement[*] | > | observation | 1..1 | SHALL |  |  |  | 10.5 Quantity Measurement 2.16.840.1.113883.​10.20.6.2.14
| > | entry​Relationship | 0..* | MAY |  |  |  |
| >@ | @typeCode | 1..1 | SHALL | CS | SHALL | SUBJ |
Coded​Observation[*] | > | observation | 1..1 | SHALL |  |  |  | 10.1 Coded Observation 2.16.840.1.113883.​10.20.6.2.13

### 10.1.1 code and @negationInd

The Observation code element has an associated Concept Domain ObservationType. A representative binding for this Concept Domain is to the value (ASSERTION, actcode[2.16.840.1.113883.5.4], "Assertion"), providing an assertion of a finding concept in the value element.

The Observation may have @negationInd attribute "true", which together with the code "ASSERTION" indicates that the finding was not observed, e.g., to represent "No finding of stroke".

### Note

This is the pattern used in Consolidated CDA for negative findings.

### 10.1.2 text/reference and Related Narrative Block Markup

The Observation entry SHOULD include a text/reference element, whose value attribute (not to be confused with the value element of the Observation class) SHALL begin with a '#' and SHALL point to its corresponding narrative in the parent section (using the approach defined in CDA Release 2, section 4.3.5.1). See Section 9.1.1.1.

### 10.1.3 interpretationCode and translation For Actionable Findings

When an observation is unexpected or "actionable" (one type of which is denoted a "critical finding"), it may be flagged using the interpretationCode. For very abnormal findings the interpretationCode element SHALL be set to (AA, ObservationInterpretation, "abnormal alert"). Unexpected normal findings, e.g., no findings of disease when patient treatment had been planned on the presumption of disease, may also be flagged using interpretationCode (N, ObservationInterpretation, "normal").

The translation element of the interpretationCode may be used to provide a further classification as defined in a regionally- or professionally-specified value set. This template identifies an optional value set for the ACR Actionable Finding categories 1, 2, and 3, as defined by: Larson PA, et al. J Am Coll Radiol 2014; published online. DOI 10.1016/j.jacr.2013.12.016.

The narrative text associated with the actionable finding SHOULD be highlighted using styleCode Bold. See Section 9.5.1 and Section 9.1.1.1.

Actionable findings that require a specific follow-up action or procedure SHOULD be referenced from a recommendation in the 9.8.11 Recommendation section.

Communication of actionable findings SHOULD be documented in the 9.8.10 Communication of Actionable Findings section.

### 10.1.4 targetSiteCode

Each observation needs to fully specify its site/location.

COND: If the observation site is not pre-coordinated in the observation/code or observation/value, it SHALL be specified in the observation/targetSiteCode.

COND: The qualifier element for laterality SHALL be present if the targetSiteCode represents a paired body part and laterality is not pre-coordinated in the targetSiteCode.

Note that inclusion in a labeled subsection (see Section 9.8.9) does not imply a finding site for the observation from the title. The title is not semantically part of the post-coordination.

### 10.1.5 entryRelationship/@typeCode=SUBJ/observation - Coded

The Coded Observation entry MAY include an actRelationship of type SUBJ (has subject) to a subsidiary Coded Observation (recursively invoking this same template). This allows the constructions of complex clinical statements.

Example 10.1-1. Coded observation example

    <text>
        ...
        <content ID="fnd-1"> ...finding of a right hilar mass (abnormal - class 1) ...</content>
    </text>
    ...
    <entry>
        <observation classCode="OBS" moodCode="EVN">
            <templateId root="2.16.840.1.113883.10.20.6.2.13"/>
            <id root="1.2.840.10213.2.62.7044779.114265201"/>
            <code code="ASSERTION" codeSystem="2.16.840.1.113883.5.4"
                codeSystemName="actCode"
                displayName="Assertion"/>
            <text><reference value="#fnd-1"/></text>
            <statusCode code="completed"/>
            <effectiveTime value="20140914171504+0500"/>
            <value xsi:type="CD" code="309530007"
                codeSystem="2.16.840.1.113883.6.96"
                codeSystemName="SNOMED CT"
                displayName="Hilar mass"/>
            <interpretationCode code = "AA" codeSystem="2.16.840.1.113883.5.83"
                    codeSystemName="ObservationInterpretation"
                    displayName="Abnormal Alert">
                <translation code="RID49480" codeSystem="2.16.840.1.113883.6.256"
                    codeSystemName="RADLEX"
                    displayName="ACR Category 1 Actionable Finding"/>
            </interpretationCode>
            <!-- although "hilar mass" is by definition in the lung, the observation.value
                 does not describe right or left lung, so targetSite is required -->
            <targetSiteCode code="3341006"
                codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"
                displayName="right lung">
            </targetSiteCode>
            <!-- entryRelationship elements referring to SOP Instance Observations
                 or Quantity Measurement Observations may appear here -->
        </observation>
    </entry>

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