Consolidated CDA Release 2.1 StructureDefinition Publication
2.1 - CI Build

Consolidated CDA Release 2.1 StructureDefinition Publication, published by Health Level Seven. This is not an authorized publication; it is the continuous build for version 2.1). This version is based on the current content of https://github.com/HL7/CDA-ccda-2.1-sd/ and changes regularly. See the Directory of published versions

## Logical Model: Sex Observation

Official URL: http://hl7.org/cda/us/ccda/StructureDefinition/SexObservation | Version: 2.1
Draft as of 2023-09-29 | Computable Name: SexObservation
Other Identifiers: id: urn:hl7ii:2.16.840.1.113883.10.20.22.4.507:2023-07-01

This Sex Observation template is used to reflect the documentation of a person’s sex. Systems choosing to record the source of information should include the Provenance participation.

USCDI v3 includes a data element for sex, intended to support the exchange of a sex value that is not characterized as sex assigned at birth or birth sex. This version of the C-CDA companion guide supports USCDI v3 Sex data element. Sex assigned at birth or birth sex must be recorded using the Birth Sex Observation which falls under the broader category of a ‘Sex observation’. A Data Absent Reason (DAR) code value of ‘asked-declined’ may be used when a person has chosen not to disclose their sex.

Future versions of the template may be informed by the content of the HL7 Cross Paradigm IG: Gender Harmony - Sex and Gender Representation, which may include additional guidance on this Sex observation and the relationship to administrative gender (administrativeGenderCode).

It is recommended systems include the Sex Observation in the Social History section.

Usage:

- This Logical Model is not used by any profiles in this Implementation Guide

### Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

- Differential Table
- Key Elements Table
- Snapshot Table
- Statistics/References
- All

This structure is derived from CDAR2.Observation

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation |  | 1..1 | CDAR2.Observation | XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @classCode, @moodCode, @negationInd, realmCode, typeId, templateId, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, referenceRange Base for all types and resources
classCode |  | 1..1 | cs | Fixed Value: OBS
moodCode |  | 1..1 | cs | Fixed Value: EVN
Slices for templateId |  | 1..* | II | Slice: Unordered, Open by value:root, value:extension
templateId:templateId1 |  | 1..1 | II | templateId
root |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.10.20.22.4.507
extension |  | 1..1 | st | Required Pattern: 2023-07-01
code |  | 1..1 | CD |
code |  | 1..1 | cs | Required Pattern: 46098-0
codeSystem |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.6.1
statusCode |  | 1..1 | CS |
code |  | 1..1 | cs | Fixed Value: completed
effectiveTime |  | 1..1 | IVL_TS |
low |  | 0..0 |  |
center |  | 0..0 |  |
width |  | 0..0 |  |
high |  | 0..0 |  |
value |  | 1..1 | CD |
nullFlavor |  | 0..0 |  |
code |  | 1..1 | cs | Binding: VSAC 2.16.840.1.113762.1.4.1240.3 (required)
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet
Observation.value.code | required | http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1240.3

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation |  | 1..1 | CDAR2.Observation | XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @classCode, @moodCode, @negationInd, realmCode, typeId, templateId, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, referenceRange Base for all types and resources
@classCode |  | 1..1 | cs | Binding: ActClassObservation (required) Fixed Value: OBS
@moodCode |  | 1..1 | cs | Fixed Value: EVN
Slices for templateId |  | 1..* | II | Slice: Unordered, Open by value:root, value:extension
templateId:templateId1 |  | 1..1 | II | templateId
@root |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.10.20.22.4.507
@extension |  | 1..1 | st | Required Pattern: 2023-07-01
code |  | 1..1 | CD | Binding: ObservationType (extensible)
@code |  | 1..1 | cs | Required Pattern: 46098-0
@codeSystem |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.6.1
statusCode |  | 1..1 | CS | Binding: ActStatus (required)
@code |  | 1..1 | cs | Fixed Value: completed
effectiveTime |  | 1..1 | IVL_TS |
value |  | 1..1 | CD |
@code |  | 1..1 | cs | Binding: VSAC 2.16.840.1.113762.1.4.1240.3 (required)
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code
Observation.classCode | required | Fixed Value: OBS
Observation.code | extensible | ObservationType
Observation.statusCode | required | ActStatus
Observation.value.code | required | http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1240.3

#### Constraints

Id | Grade | Path(s) | Details | Requirements
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation |  | 1..1 | CDAR2.Observation | XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @classCode, @moodCode, @negationInd, realmCode, typeId, templateId, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, referenceRange Base for all types and resources
@classCode |  | 1..1 | cs | Binding: ActClassObservation (required) Fixed Value: OBS
@moodCode |  | 1..1 | cs | Fixed Value: EVN
@negationInd |  | 0..1 | bl |
realmCode |  | 0..* | CS |
typeId |  | 0..1 | II |
Slices for templateId |  | 1..* | II | Slice: Unordered, Open by value:root, value:extension
templateId:templateId1 |  | 1..1 | II | templateId
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
@assigningAuthorityName |  | 0..1 | st |
@displayable |  | 0..1 | bl |
@root |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.10.20.22.4.507
@extension |  | 1..1 | st | Required Pattern: 2023-07-01
id |  | 0..* | II |
code |  | 1..1 | CD | Binding: ObservationType (extensible)
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
@code |  | 1..1 | cs | Required Pattern: 46098-0
@codeSystem |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.6.1
@codeSystemName |  | 0..1 | st |
@codeSystemVersion |  | 0..1 | st |
@displayName |  | 0..1 | st |
@sdtcValueSet |  | 0..1 | oid | XML Namespace: urn:hl7-org:sdtc XML: valueSet (urn:hl7-org:sdtc)
@sdtcValueSetVersion |  | 0..1 | st | XML Namespace: urn:hl7-org:sdtc XML: valueSetVersion (urn:hl7-org:sdtc)
originalText |  | 0..1 | ED |
qualifier |  | 0..* | CR |
translation |  | 0..* | CD |
derivationExpr |  | 0..1 | ST |
text |  | 0..1 | ED |
statusCode |  | 1..1 | CS | Binding: ActStatus (required)
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
@code |  | 1..1 | cs | Fixed Value: completed
@sdtcValueSet |  | 0..1 | oid | XML Namespace: urn:hl7-org:sdtc XML: valueSet (urn:hl7-org:sdtc)
@sdtcValueSetVersion |  | 0..1 | st | XML Namespace: urn:hl7-org:sdtc XML: valueSetVersion (urn:hl7-org:sdtc)
effectiveTime |  | 1..1 | IVL_TS |
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
@value |  | 0..1 | ts | Date Format: YYYYMMDDHHMMSS.UUUU[+|-ZZzz]
@operator |  | 0..1 | cs | Binding: SetOperator (required)
priorityCode |  | 0..1 | CE | Binding: ActPriority (extensible)
repeatNumber |  | 0..1 | IVL_INT |
languageCode |  | 0..1 | CS | Binding: HumanLanguage (required)
value |  | 1..1 | CD |
@code |  | 1..1 | cs | Binding: VSAC 2.16.840.1.113762.1.4.1240.3 (required)
@codeSystem |  | 0..1 | oid, uuid, ruid |
@codeSystemName |  | 0..1 | st |
@codeSystemVersion |  | 0..1 | st |
@displayName |  | 0..1 | st |
@sdtcValueSet |  | 0..1 | oid | XML Namespace: urn:hl7-org:sdtc XML: valueSet (urn:hl7-org:sdtc)
@sdtcValueSetVersion |  | 0..1 | st | XML Namespace: urn:hl7-org:sdtc XML: valueSetVersion (urn:hl7-org:sdtc)
originalText |  | 0..1 | ED |
qualifier |  | 0..* | CR |
translation |  | 0..* | CD |
interpretationCode |  | 0..* | CE | Binding: ObservationInterpretation (required)
methodCode |  | 0..* | CE | Binding: ObservationMethod (extensible)
targetSiteCode |  | 0..* | CD |
subject |  | 0..1 | Subject |
specimen |  | 0..* | Specimen |
performer |  | 0..* | Performer2 |
author |  | 0..* | Author |
informant |  | 0..* | Informant |
participant |  | 0..* | Participant2 |
entryRelationship |  | 0..* | EntryRelationship |
reference |  | 0..* | Reference |
precondition |  | 0..* | Precondition |
referenceRange |  | 0..* | InfrastructureRoot |
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
realmCode |  | 0..* | CS |
typeId |  | 0..1 | II |
templateId |  | 0..* | II |
@typeCode |  | 0..1 | cs | Binding: ActRelationshipPertains (required) Fixed Value: REFV
observationRange |  | 1..1 | ObservationRange |
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code
Observation.classCode | required | Fixed Value: OBS
Observation.templateId:templateId1.nullFlavor | required | NullFlavor
Observation.code | extensible | ObservationType
Observation.code.nullFlavor | required | NullFlavor
Observation.statusCode | required | ActStatus
Observation.statusCode.nullFlavor | required | NullFlavor
Observation.effectiveTime.nullFlavor | required | NullFlavor
Observation.effectiveTime.operator | required | SetOperator
Observation.priorityCode | extensible | ActPriority
Observation.languageCode | required | HumanLanguage (a valid code from `http://terminology.hl7.org/CodeSystem/ietf3066`)
Observation.value.code | required | http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1240.3
Observation.interpretationCode | required | ObservationInterpretation
Observation.methodCode | extensible | ObservationMethod
Observation.referenceRange.nullFlavor | required | NullFlavor
Observation.referenceRange.typeCode | required | Fixed Value: REFV

#### Constraints

Id | Grade | Path(s) | Details | Requirements
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |

This structure is derived from CDAR2.Observation

Summary

Mandatory: 11 elements
Fixed Value: 3 elements
Prohibited: 5 elements

Slices

This structure defines the following Slices:

- The element Observation.templateId is sliced based on the values of value:root, value:extension

Differential View

This structure is derived from CDAR2.Observation

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation |  | 1..1 | CDAR2.Observation | XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @classCode, @moodCode, @negationInd, realmCode, typeId, templateId, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, referenceRange Base for all types and resources
classCode |  | 1..1 | cs | Fixed Value: OBS
moodCode |  | 1..1 | cs | Fixed Value: EVN
Slices for templateId |  | 1..* | II | Slice: Unordered, Open by value:root, value:extension
templateId:templateId1 |  | 1..1 | II | templateId
root |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.10.20.22.4.507
extension |  | 1..1 | st | Required Pattern: 2023-07-01
code |  | 1..1 | CD |
code |  | 1..1 | cs | Required Pattern: 46098-0
codeSystem |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.6.1
statusCode |  | 1..1 | CS |
code |  | 1..1 | cs | Fixed Value: completed
effectiveTime |  | 1..1 | IVL_TS |
low |  | 0..0 |  |
center |  | 0..0 |  |
width |  | 0..0 |  |
high |  | 0..0 |  |
value |  | 1..1 | CD |
nullFlavor |  | 0..0 |  |
code |  | 1..1 | cs | Binding: VSAC 2.16.840.1.113762.1.4.1240.3 (required)
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet
Observation.value.code | required | http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1240.3

Key Elements View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation |  | 1..1 | CDAR2.Observation | XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @classCode, @moodCode, @negationInd, realmCode, typeId, templateId, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, referenceRange Base for all types and resources
@classCode |  | 1..1 | cs | Binding: ActClassObservation (required) Fixed Value: OBS
@moodCode |  | 1..1 | cs | Fixed Value: EVN
Slices for templateId |  | 1..* | II | Slice: Unordered, Open by value:root, value:extension
templateId:templateId1 |  | 1..1 | II | templateId
@root |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.10.20.22.4.507
@extension |  | 1..1 | st | Required Pattern: 2023-07-01
code |  | 1..1 | CD | Binding: ObservationType (extensible)
@code |  | 1..1 | cs | Required Pattern: 46098-0
@codeSystem |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.6.1
statusCode |  | 1..1 | CS | Binding: ActStatus (required)
@code |  | 1..1 | cs | Fixed Value: completed
effectiveTime |  | 1..1 | IVL_TS |
value |  | 1..1 | CD |
@code |  | 1..1 | cs | Binding: VSAC 2.16.840.1.113762.1.4.1240.3 (required)
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code
Observation.classCode | required | Fixed Value: OBS
Observation.code | extensible | ObservationType
Observation.statusCode | required | ActStatus
Observation.value.code | required | http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1240.3

#### Constraints

Id | Grade | Path(s) | Details | Requirements
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |

Snapshot View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation |  | 1..1 | CDAR2.Observation | XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @classCode, @moodCode, @negationInd, realmCode, typeId, templateId, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, referenceRange Base for all types and resources
@classCode |  | 1..1 | cs | Binding: ActClassObservation (required) Fixed Value: OBS
@moodCode |  | 1..1 | cs | Fixed Value: EVN
@negationInd |  | 0..1 | bl |
realmCode |  | 0..* | CS |
typeId |  | 0..1 | II |
Slices for templateId |  | 1..* | II | Slice: Unordered, Open by value:root, value:extension
templateId:templateId1 |  | 1..1 | II | templateId
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
@assigningAuthorityName |  | 0..1 | st |
@displayable |  | 0..1 | bl |
@root |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.10.20.22.4.507
@extension |  | 1..1 | st | Required Pattern: 2023-07-01
id |  | 0..* | II |
code |  | 1..1 | CD | Binding: ObservationType (extensible)
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
@code |  | 1..1 | cs | Required Pattern: 46098-0
@codeSystem |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.6.1
@codeSystemName |  | 0..1 | st |
@codeSystemVersion |  | 0..1 | st |
@displayName |  | 0..1 | st |
@sdtcValueSet |  | 0..1 | oid | XML Namespace: urn:hl7-org:sdtc XML: valueSet (urn:hl7-org:sdtc)
@sdtcValueSetVersion |  | 0..1 | st | XML Namespace: urn:hl7-org:sdtc XML: valueSetVersion (urn:hl7-org:sdtc)
originalText |  | 0..1 | ED |
qualifier |  | 0..* | CR |
translation |  | 0..* | CD |
derivationExpr |  | 0..1 | ST |
text |  | 0..1 | ED |
statusCode |  | 1..1 | CS | Binding: ActStatus (required)
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
@code |  | 1..1 | cs | Fixed Value: completed
@sdtcValueSet |  | 0..1 | oid | XML Namespace: urn:hl7-org:sdtc XML: valueSet (urn:hl7-org:sdtc)
@sdtcValueSetVersion |  | 0..1 | st | XML Namespace: urn:hl7-org:sdtc XML: valueSetVersion (urn:hl7-org:sdtc)
effectiveTime |  | 1..1 | IVL_TS |
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
@value |  | 0..1 | ts | Date Format: YYYYMMDDHHMMSS.UUUU[+|-ZZzz]
@operator |  | 0..1 | cs | Binding: SetOperator (required)
priorityCode |  | 0..1 | CE | Binding: ActPriority (extensible)
repeatNumber |  | 0..1 | IVL_INT |
languageCode |  | 0..1 | CS | Binding: HumanLanguage (required)
value |  | 1..1 | CD |
@code |  | 1..1 | cs | Binding: VSAC 2.16.840.1.113762.1.4.1240.3 (required)
@codeSystem |  | 0..1 | oid, uuid, ruid |
@codeSystemName |  | 0..1 | st |
@codeSystemVersion |  | 0..1 | st |
@displayName |  | 0..1 | st |
@sdtcValueSet |  | 0..1 | oid | XML Namespace: urn:hl7-org:sdtc XML: valueSet (urn:hl7-org:sdtc)
@sdtcValueSetVersion |  | 0..1 | st | XML Namespace: urn:hl7-org:sdtc XML: valueSetVersion (urn:hl7-org:sdtc)
originalText |  | 0..1 | ED |
qualifier |  | 0..* | CR |
translation |  | 0..* | CD |
interpretationCode |  | 0..* | CE | Binding: ObservationInterpretation (required)
methodCode |  | 0..* | CE | Binding: ObservationMethod (extensible)
targetSiteCode |  | 0..* | CD |
subject |  | 0..1 | Subject |
specimen |  | 0..* | Specimen |
performer |  | 0..* | Performer2 |
author |  | 0..* | Author |
informant |  | 0..* | Informant |
participant |  | 0..* | Participant2 |
entryRelationship |  | 0..* | EntryRelationship |
reference |  | 0..* | Reference |
precondition |  | 0..* | Precondition |
referenceRange |  | 0..* | InfrastructureRoot |
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
realmCode |  | 0..* | CS |
typeId |  | 0..1 | II |
templateId |  | 0..* | II |
@typeCode |  | 0..1 | cs | Binding: ActRelationshipPertains (required) Fixed Value: REFV
observationRange |  | 1..1 | ObservationRange |
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code
Observation.classCode | required | Fixed Value: OBS
Observation.templateId:templateId1.nullFlavor | required | NullFlavor
Observation.code | extensible | ObservationType
Observation.code.nullFlavor | required | NullFlavor
Observation.statusCode | required | ActStatus
Observation.statusCode.nullFlavor | required | NullFlavor
Observation.effectiveTime.nullFlavor | required | NullFlavor
Observation.effectiveTime.operator | required | SetOperator
Observation.priorityCode | extensible | ActPriority
Observation.languageCode | required | HumanLanguage (a valid code from `http://terminology.hl7.org/CodeSystem/ietf3066`)
Observation.value.code | required | http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1240.3
Observation.interpretationCode | required | ObservationInterpretation
Observation.methodCode | extensible | ObservationMethod
Observation.referenceRange.nullFlavor | required | NullFlavor
Observation.referenceRange.typeCode | required | Fixed Value: REFV

#### Constraints

Id | Grade | Path(s) | Details | Requirements
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |

This structure is derived from CDAR2.Observation

Summary

Mandatory: 11 elements
Fixed Value: 3 elements
Prohibited: 5 elements

Slices

This structure defines the following Slices:

- The element Observation.templateId is sliced based on the values of value:root, value:extension

Other representations of profile: CSV, Excel