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The Results domain in Clinical Data Spaces (CDS) collates information from both Results and Vital Signs sections in a CCD. There are two separate validation checklists, one for Results and another for Vital Signs, to align with the two separate CCD sections.

The Vitals Sign section contains relevant vital signs for the context and use case of the document type, such as blood pressure, heart rate, respiratory rate, height, weight, body mass index, head circumference, pulse oximetry, temperature, and body surface area. There is a separate Entry section for each vital signs organizer and a Component section for each vital sign observation.

Vital Signs are represented in the same way as other results, but are aggregated into their own CCD section to follow clinical conventions. When processed in Clinical Data Spaces, Results and Vital Signs CCD information merge into one CDS domain - Results. 

This topic details the data elements that must be present in the Vital Signs section of a Continuity of Care Document (CCD) for it to be processed in the Clinical:ResultsCcda data space (hosted in Data Engine).

(R) - Required elements for the Results Vitals section and its sub-sections to be processed correctly in the Clinical:ResultsCCDA data space.

(O) - Optional elements that are processed if provided in correct format.

Required (R) elements that are children of an Optional (O) element are only required for the immediate parent element to be processed.

Results Vital Signs Section Details

Vital Signs Section Template ID

component/section/templateId

Specifies which CCDA R2.1 template is being used to determine the requirements, format and structure of the information this subsection.

...
<component>
	<section>
		<templateId root=”2.16.840.1.113883.10.20.22.2.4.1”/>
	</section>
</component>
...
SectionElementAttributeValueNotes
Vital SignstemplateIdrootMust be 2.16.840.1.113883.10.20.22.2.4.1The unique identifier for the CCDA R2.1 template that defines the requirements, format and structure for the entire Vital Signs section in Continuity of Care Documents (CCDs).

Vital Signs Section Code

component/section/code

Indicates that this section is detailing vital signs information.

...
<component>
	<section>
		<templateId root=”2.16.840.1.113883.10.20.22.2.4.1”/>
		<code code=”8716-3” codeSystem=”2.16.840.1.113883.6.1” codeSystemName=”LOINC” displayName=”VITAL SIGNS”/>
	</section>
</component>
...
SectionElementAttributeValueNotes
Vital SignscodecodeMust be 8716-3In the Logical Observation Identifiers Names and Codes (LOINC) coding system this alphanumeric string (or 'code') represents the Vital Signs document.
codeSystemMust be 2.16.840.1.113883.6.1The unique numerical identifier for the Logical Observation Identifiers Names and Codes (LOINC) coding system. This system will be used to resolve the value in the code attribute.
codeSystemNameCan be an alphanumerical string of any lengthThis attribute is optional. A human readable display name for the code system.
displayNameCan be an alphanumerical string of any lengthThis attribute is optional. A human readable display name for the template section.

Vital Signs Section Confidentiality Code

component/section/confidentialityCode

Indicates the level of security that should be applied to this Vital Signs section. The level of security that should be applied is typically driven by the guidelines of the system that generated the CCD.

...
<component>
	<section>
		<templateId root=”2.16.840.1.113883.10.20.22.2.4.1”/>
		<confidentialityCode code="N" codeSystem="2.16.840.1.113883.5.25"/>
	</section>
</component>
...
SectionElementAttributeValueNotes
Vital SignsconfidentialityCodecodeMust include an alphanumeric string of any length. The HL7-supported confidentiality coding system is typically used, where security levels are indicated as:
  • U - unrestricted
  • L - low
  • N - normal
  • - moderate
  • R - restricted
  • V - very restricted

If no code attribute is present, a nullFlavor attribute MUST be present instead. Otherwise, the code element will not be processed. Refer to How nullFlavor Values are Processed in Coded Elements for details on nullFlavor attributes.

codeSystemMust include an alphanumeric string of any length, typically in the following format: 2.16.840.1.113883.X.XX.X. The HL7-supported confidentiality coding system is indicated by 2.16.840.1.113883.5.25A numerical string that specifies which system will be used to translate the identifier provided in the code attribute.

Vital Signs Organizer

component/section/entry/organizer

This sub-section provides a structure for grouping vital signs observations. It contains information applicable to all of the observations in the vital signs section.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="CLUSTER" moodCode="EVN">
				...
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Vital Signs Organizer

organizer

classCode

Must be CLUSTER

The value "CLUSTER" is used for more complex organizer constructs with nested organizer elements.

moodCodeMust be EVNIndicates that this entry is an event (EVN) that has happened or is an ongoing act, or was documented from a past act.

Vital Signs Organizer Template ID

component/section/entry/organizer/templateId

Specifies which CCDA R2.1 template is being used to structure the vital signs organizer sub-section. R2.1 templates define the requirements, format, and structure of a CCD section. 

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="CLUSTER" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.26"/>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Vital Signs Organizer

templateId

root

Must be 2.16.840.1.113883.10.20.22.4.26

Uniquely identifies the vital signs organizer sub-section.

Vital Signs Organizer ID

component/section/entry/organizer/id

Specifies the unique identifier for the organization responsible for organizing the vital signs contained within this sub-section.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="CLUSTER" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.26"/>
				<id root="c6f88320-67ad-11db-bd13-0800200c9a66"/>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Vital Signs Organizer

id

root

Must be an alphanumeric string in an OID (object identifier) or UUID (universally unique identifier) format. 

For example, OID: 2.16.840.1.113883.x.xx.x or UUID: 53459040-b1b4-49ed-ae1f-a52c8c502df4

Uniquely identifies the vital signs organizer sub-section.


extension Can be an alphanumeric string of any length.This attribute is optional. Part of the information that uniquely identifies the organization.

Vital Signs Organizer Code

component/section/entry/organizer/code

Categorizes the vital signs contained in the Vital Signs Observation sub-section into one of several commonly accepted values.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="CLUSTER" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.26"/>
				<code code="46680005" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" displayName="Vital Sign"/>
			</organizer>
		</entry>
	</section>
</component>
...

Vital Signs Organizer Status Code

component/section/entry/organizer/statusCode

Indicates the current status of the vital signs grouping.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="CLUSTER" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.26"/>
				<statusCode code="completed"/>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Vital Signs Organizer

statusCode

code

Must be one of the following:

  • aborted
  • active
  • cancelled
  • completed
  • held
  • suspended
 

Vital Signs Organizer Effective Time

component/section/entry/organizer/effectiveTime

Specifies the date and time the group of vital signs was obtained. Refer to How Effective Time values are processed for details on the different ways effectiveTime information can be processed.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="CLUSTER" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.26"/>
				<effectiveTime xsi:type="IVL_TS">
					<low value="200803190830-0800"/>
					<high value="200803190830-0800"/>
				</effectiveTime>
			</organizer>
		</entry>
	</section>
</component>
... 

Vital Signs Organizer Author

component/section/entry/organizer/author

Specifies information of the person responsible for grouping the vital signs observation. Refer to Assigned Author Element for more details on what information can be available for the author section. 

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="CLUSTER" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.26"/>
				<author>
					<time value="200803190830-0800"/>
					<assignedAuthor>
						<id root="1.3.6.1.4.1.22812.4.10025422.0" extension="10007"/>
					</assignedAuthor>
				</author>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Vital Signs Organizer
  • author
    • time
value

Must be populated with a date in the following format:

YYYY[MM[DD[HHMM[SS[.S[S[S[S]]]]]]]][+/-ZZZZ] where +/-ZZZZ specifies the offset from Coordinated Universal Time (UTC).

Indicates the specific time the author grouped the vital signs results.
  • author
    • assignedAuthor
      • id
root

Must be an alphanumeric string in an OID (object identifier) or UUID (universally unique identifier) format. 

For example:

  • OID: 2.16.840.1.113883.x.xx.x or 
  • UUID: 53459040-b1b4-49ed-ae1f-a52c8c502df4
 
extensionCan be an alphanumeric string of any length.This attribute is optional. Part of the information that uniquely identifies the person documenting the Vital Signs Organizer section.

Vital Signs Observation

component/section/entry/organizer/component/observation

This sub-section represents measurement of common vital signs. Vital signs are represented with additional vocabulary constraints for type of vital sign and unit of measure.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="CLUSTER" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.26"/>
				<component>
					<observation classCode="OBS" moodCode="EVN">
						...
					</observation>
				</component>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Vital Signs Observation

observation

classCode

Must be OBS

Specifies the general nature of the entry, which in this case is an observation (OBS).
moodCodeMust be EVNIndicates that this entry is an event (EVN) that actually happens, has happened or is an ongoing activity, or was documented from a past activity.

Vital Signs Observation Template ID

component/section/entry/organizer/component/observation/templateId

Specifies which CCDA R2.1 template is being used to structure the vital signs observation sub-section. R2.1 templates define the requirements, format, and structure of a CCD section.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="CLUSTER" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.26"/>
				<component>
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.1.113883.10.20.22.4.27"/>
					</observation>
				</component>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Vital Signs Observation

templateId

root

Must be 2.16.840.1.113883.10.20.22.4.27

Uniquely identifies the vital signs observation sub-section.

Vital Signs Observation ID

component/section/entry/organizer/component/observation/id

Specifies the unique identifier for the organization responsible for the vital signs observation contained within this sub-section.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="CLUSTER" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.26"/>
				<component>
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.1.113883.10.20.22.4.27"/>
						<id root="c6f88321-67ad-11db-bd13-0800200c9a66" extension="8902-1"/>
					</observation>
				</component>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Vital Signs Observation

id

root

Must be an alphanumeric string in an OID (object identifier) or UUID (universally unique identifier) format. 

For example, OID: 2.16.840.1.113883.X.XX.X or UUID: 53459040-b1b4-49ed-ae1f-a52c8c502df4

 
extensionCan be an alphanumerical string of any lengthUniquely identifies the organization responsible for the vital signs observation contained within this sub-section

Vital Signs Observation Code

component/section/entry/organizer/component/observation/code

Specifies the type of vital signs result observed.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="CLUSTER" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.26"/>
				<component>
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.1.113883.10.20.22.4.27"/>
						<code code="8302-2" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Height">
					</observation>
				</component>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Vital Signs Observation

code

code

Must be an alphanumerical value.

Must be a code from the Logical Observation Identifiers Names and Codes (LOINC) code system that identifies the vital signs observation.
codeSystemMust be 2.16.840.1.113883.6.1The unique numerical identifier for the LOINC coding system. This system will be used to resolve the value in the code attribute.
codeSystemNameCan be an alphanumerical string of any lengthThis attribute is optional. A human readable display name for the code system.
displayNameCan be an alphanumerical string of any lengthThis attribute is optional. A human readable display name for the template section.

Vital Signs Observation Status Code

component/section/entry/organizer/component/observation/statusCode

Indicates the current status of the vital signs observation.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="CLUSTER" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.26"/>
				<component>
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.1.113883.10.20.22.4.27"/>
						<statusCode code="completed"/>
					</observation>
				</component>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Vital Signs Observation

statusCode

code

Must be one of the following:

  • aborted
  • active
  • cancelled
  • completed
  • held
  • suspended
 

Vital Signs Observation Effective Time

component/section/entry/organizer/component/observation/effectiveTime

Specifies the date and time the vital signs observation was obtained. Represents the biologically relevant time of the measurement (for example, the time a blood pressure reading was obtained or the time a blood sample was obtained). Refer to How Effective Time values are processed for details on the different ways effectiveTime information can be processed.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="CLUSTER" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.26"/>
				<component>
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.1.113883.10.20.22.4.27"/>
						<effectiveTime value="200803190830-0800"/>
					</observation>
				</component>
			</organizer>
		</entry>
	</section>
</component>
...

Vital Signs Observation Value

component/section/entry/organizer/component/observation/value

Indicates the value of the vital sign results observed.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="CLUSTER" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.26"/>
				<component>
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.1.113883.10.20.22.4.27"/>
						<value xsi:type="PQ" value="177" unit="cm"/>
					</observation>
				</component>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Vital Signs Observation

value

xsi:type

Must be one of the following:

  • IVL_PQ
  • CD
  • SC
  • ST
  • PQ
  • INT
  • REAL
  • RTO_PQ_PQ
  • ED
  • IVL_TS
  • TS

 

Vital Signs Observation Interpretation Code

component/section/entry/organizer/component/observation/interpretationCode

Indicates how the observed vital sign was interpreted.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="CLUSTER" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.26"/>
				<component>
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.1.113883.10.20.22.4.27"/>
						<interpretationCode code="A" codeSystem="2.16.840.1.113883.5.83"/>
					</observation>
				</component>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Vital Signs Observation

interpretationCode

code

Must be an alphanumeric string from ValueSet Observation Interpretation (HL7). For example:

  • A - abnormal
  • B - better
  • C - carrier
  • D - decreased
  • HX - above high threshold
  • IND - indeterminate
  • MS - moderately susceptible

 

codeSystemMust be an alphanumeric string of any length in the following format: 2.16.840.1.113883.X.XXUnique identifier for the Coding System that should be used to resolve the value specified in the code attribute.

Vital Signs Observation Method Code

component/section/entry/organizer/component/observation/methodCode

Indicates the method used to observe the vital sign results.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="CLUSTER" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.26"/>
				<component>
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.1.113883.10.20.22.4.27"/>
						<methodCode code="1404" codeSystem="2.16.840.1.113883.5.84"/>
					</observation>
				</component>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Vital Signs Observation

methodCode

code

Must be an alphanumeric string of any length

 

codeSystemMust be an alphanumeric string of any length in the following format: 2.16.840.1.113883.X.XXUnique identifier for the Coding System that should be used to resolve the value specified in the code attribute.

Vital Signs Observation Target Site Code

component/section/entry/organizer/component/observation/targetSiteCode

Indicates the specific site where the vital sign result was observed.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="CLUSTER" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.26"/>
				<component>
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.1.113883.10.20.22.4.27"/>
						<targetSiteCode code="302539009" codeSystem="2.16.840.1.113883.6.96"/>
					</observation>
				</component>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Vital Signs Observation

targetSiteCode

code

Must be an alphanumeric string of any length

 

codeSystemMust be an alphanumeric string of any length in the following format: 2.16.840.1.113883.X.XXUnique identifier for the Coding System that should be used to resolve the value specified in the code attribute.

Vital Signs Observation Author

component/section/entry/organizer/component/observation/author

Details information about the person documenting the vital signs observation. Refer to Assigned Author Element for more details on what information can be available for the author section. 

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="CLUSTER" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.26"/>
				<component>
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.1.113883.10.20.22.4.27"/>
						<author>
							<assignedAuthor>
								...
							</assignedAuthor>
						</author>
					</observation>
				</component>
			</organizer>
		</entry>
	</section>
</component>
...

Vital Signs Observation Reference Range

component/section/entry/organizer/component/observation/referenceRange/observationRange

Indicates the range of values for the observed vital sign result if applicable.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="CLUSTER" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.26"/>
				<component>
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.1.113883.10.20.22.4.27"/>
						<referenceRange>
							<observationRange>
								<text>90/min; 120/min</text>
							</observationRange>
						</referenceRange>
					</observation>
				</component>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Vital Signs Observation
  • referenceRange
    • observationRange
      • text
N/A

Must contain text of any type or length

This attribute is optional. The specification suggests value is an acceptable child element (with low and high values) however for the purposes of correct processing in Clinical Data Spaces, we accept a completed text element instead.



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