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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.

To accurately process the Header, Results and Vital Signs sections of a C-CDA CCD, in the Clinical:ResultsCcda Data Space, certain elements are required and must contain valid information. There are also certain elements that are optional but, if present, must also contain valid information. 

In the Header section, there are eight elements that are required and three elements that are optional. For more information see CCDA Header: Data Preparation Checklist.

In the Results section, there are two elements that are required and seventeen elements that are optional. For more information see ResultsCCDA: Data Preparation Checklist - Results Section.

In the Vital Signs section, there are two elements that are required and fifteen elements that are optional

This checklist provides a description of the Vital Signs elements and how they should be validated prior to processing in CDS.  

The vital signs section of a CCD will typically have several sub-sections to represent different Vital Signs and reports for a patient:

  • Vital Sign Organizer
  • Vital Sign Observation

Each sub-section is uniquely identified by its templateId. When elements occur in multiple sub-sections (for example, value, code, effectiveTime), the templateId helps differentiate validation requirements.

 Section or Sub-SectionElementXPath
Required ElementsVital Signs SectiontemplateIdsection/templateId
codesection/code
Optional (but validated
if present) Elements
Vital Sign OrganizertemplateIdsection/entry/organizer/templateId
idsection/entry/organizer/id
codesection/entry/organizer/code
statusCodesection/entry/organizer/statusCode
effectiveTimesection/entry/organizer/effectiveTime
authorsection/entry/organizer/author
Vital Sign ObservationtemplateIdsection/entry/organizer/component/observation/templateId
idsection/entry/organizer/component/observation/id
codesection/entry/organizer/component/observation/code
statusCodesection/entry/organizer/component/observation/statusCode
effectiveTimesection/entry/organizer/component/observation/effectiveTime
valuesection/entry/organizer/component/observation/value
interpretationCodesection/entry/organizer/component/observation/interpretationCode
methodCodesection/entry/organizer/component/observation/methodCode
targetSiteCodesection/entry/organizer/component/observation/targetSiteCode
authorsection/entry/organizer/component/observation/author
observationRangesection/entry/organizer/component/observation/observationRange

A full copy of the sample Continuity of Care Document (CCD) used in this section is attached.

 


Required Elements

This section details the elements that are required for processing in Clinical Data Spaces, that is, they must be present, contain certain information, and be correct.

Vital Signs Section templateId

XPath:section/templateId
Purpose:

Specifies which CCDA R2.1 template is being used to structure the vital signs section. R2.1 templates define the requirements, format, and structure of a CCD section. This section contains relevant vital signs such as blood pressure, heart rate, respiratory rate, heigh, weight, body mass index, pulse oximetry, and temperature.

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.

The templateId element must:
  • be present
  • contain a root attribute

    AttributeValuePurpose
    rootMust have a value of 2.16.840.1.113883.10.20.22.2.4.1Uniquely identifies the vital signs section of a CCD
Code Example of Vital Signs Section templateId
 <section>
	<templateId root="2.16.840.1.113883.10.20.22.2.4.1"/>
</section>

The entire vital signs section is ignored if the templateId element is not provided with a root attribute of 2.16.840.1.113883.10.20.22.4.1. The information provided in this section will not be processed and you will not receive any notification that this section was ignored.

 

Vital Signs Section code

XPath:section/templateId
Purpose:Identifies that this section is detailing vita signs information
The code element must:
  • be present
  • contain code and codeSystem attributes

    AttributeValuePurpose

    code

    Must have a value of 8716-3

    Identifies that this section is detailing vital signs information.

    codeSystem

    Must have a value of 2.16.840.1.1113883.6.1

    Identifies the LOINC coding system used to translate the identifier provided in the code attribute.
Code Example of Vital Signs Section code
<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> 

Processing of the code element will fail if it does not contain correctly populated code AND codeSystem attributes.

 

 


Optional Elements

This section details elements that are not required but if present, must contact certain information and be correct for accurate processing in Clinical Data Spaces (CDS).

Vital Sign Organizer templateId

XPath:section/entry/organizer/templateId
Purpose:Specifies which CCDA R2.1 template is being used to structure the vital sign organizer sub-section. R2.1 templates define the requirements, format, and structure of a CCD section. This sub-section provides a structure for grouping vital sign observations.
If present, the templateId element must:

contain a root attribute

AttributeValuePurpose
rootMust have a value of 2.16.840.1.113883.10.20.22.4.26Uniquely identifies the vital sign organizer sub-section
Code Example of Vital Sign Organizer templateId
<section>
	<templateId root="2.16.840.1.113883.10.20.22.2.4.1"/>
	<entry typeCode="DRIV">
		<organizer classCode="CLUSTER" moodCode="EVN">
			<templateId root="2.16.840.1.113883.10.20.22.4.26"/>
		</organizer>
	</entry>
</section>  

The entire vital sign organizer sub-section is ignored if the templateId element is not provided with a root attribute of 2.16.840.1.113883.10.20.22.4.26. The information provided in this section will not be processed and you will not receive any notification that this section was ignored.

 

 

Vital Sign Organizer id

XPath:section/entry/organizer/id
Purpose:Provides a unique identifier for the organization responsible for the vital sign contained within this sub-section.
If present, the id element must:

contain a root attribute and optionally contain an extension attribute, OR contain a nullFlavor attribute

AttributeValuePurpose
root

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

For example, OID: 2.16.840.1.1113883.x.xx.x  or  UUID: 53459040-b1b4-49ed-ae1f-a52c8c502df4

Uniquely identifies the organization responsible for the vital signs contained within this sub-section

extension

Is optional and can include an alphanumeric string of any length

Uniquely identifies the organization responsible for the vital signs contained within this sub-section

nullFlavor

Must be one of the following:

  • ASKU - asked but unknown
  • MSK - masked (for sensitivity or confidentiality reasons)
  • NA - not available, system down
  • NASK - not asked
  • NAV - not available
  • NI - no information
  • OTH - other
  • UNK - unknown
Indicates that an attribute was required, but was not provided, and gives a reason for why the information is not present.
Code Example of Vital Sign Organizer id
<section>
	<templateId root="2.16.840.1.113883.10.20.22.2.4.1"/>
	<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>  

Processing of the id element will fail if it does not contain a correctly populated root OR nullFlavor attribute.

 

 

Vital Sign Organizer code

XPath:section/entry/organizer/code
Purpose:Provides information about the type of vital sign presented in this sub-section
If present, the code element must:

contain code and codeSystem attributes

AttributeValuePurpose

code

Must include an alphanumeric string of any length

Identifies the type of result presented in this sub-section

codeSystemMust include a numeric string of any length in the following format: 2.16.840.1.1113883.X.XXIdentifies the coding system used to translate the identifier provided in the code attribute

displayName and codeSystemName are not required for processing.

Code Example of Vital Sign Organizer code
<section>
	<templateId root="2.16.840.1.113883.10.20.22.2.4.1"/>
	<entry typeCode="DRIV">
		<organizer classCode="CLUSTER" moodCode="EVN">
			<code code="46680005" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED -CT" displayName="Vital signs"/>
		</organizer>	
	</entry>
</section>  

Processing of the code element will fail if it does not contain correctly populated code AND codeSystem attributes.

 

 

Vital Sign Organizer statusCode

XPath:section/entry/organizer/statusCode
Purpose:Indicates the current status of the vital sign
If present, the statusCode element must:

contain a code attribute

AttributeValuePurpose
code

Must be one of the following:

  • Aborted
  • Active
  • Cancelled
  • Completed
  • Held
  • Suspended
Indicates the current status of the result
Code Example of Vital Sign Organizer statusCode
<section>
	<templateId root="2.16.840.1.113883.10.20.22.2.4.1"/>
	<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>  

Processing of the statusCode element will fail if it does not contain a correctly populated code attribute.

 

 

Vital Sign Organizer effectiveTime

XPath:section/entry/organizer/effectiveTime
Purpose:Indicates the time a vital sign was obtained
If present, the effectiveTime element must:

Contain an attribute of xsi:typevalue OR nullFlavor

AttributeValuePurpose
xsi:type

Must be populated with IVL_TS and effectiveTime must:

  1. have a low child element, which can be:
    • empty
    • have a nullFlavor attribute
    • have a value attribute indicating a specific date and time
  2. optionally have a high child element which can be:
    • empty
    • have a nullFlavor attribute
    • have a value attribute indicating a specific date and time
Indicates the period over which the vital sign was obtained
valueMust be populated with a date in the format YYYY[MM[DD[HHMM[SS[.S[S[S[S]]]]]]]][+/-ZZZZ] where +/-ZZZZspecifies the offset from Coordinated Universal Time. Indicates the specific time the vital sign was obtained
nullFlavor

Must be one of the following:

  • ASKU - asked but unknown
  • MSK - masked (for sensitivity or confidentiality reasons)
  • NA - not available, system down
  • NASK - not asked
  • NAV - not available
  • NI - no information
  • OTH - other
  • UNK - unknown
Indicates that an attribute was required, but was not provided, and gives a reason for why the information is not present. In this case, it suggests a vital sign was obtained, but it was not recorded when.
Code Example of Vital Sign Organizer effectiveTime
<section>
	<templateId root="2.16.840.1.113883.10.20.22.2.4.1"/>
	<entry typeCode="DRIV">
		<organizer classCode="CLUSTER" moodCode="EVN">
			<templateId root="2.16.840.1.113883.10.20.22.4.26"/>
			<effectiveTime value="19991114"/>
		</organizer>
	</entry>
</section>

Processing of the effectiveTime element will fail if it does not contain a correctly populated xsi:typevalue or nullFlavor attribute.

 

 

Vital Sign Organizer author

XPath:section/entry/organizer/component/observation/templateId
Purpose:Indicates the unique identifier of the person responsible for grouping the result observations
If present, the author element must:
  • have a child element of assignedAuthor, which must
  • have a child element of id, which must
  • contain a root attribute and optionally contain an extension attribute

AttributeValuePurpose
root

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

For example, OID: 2.16.840.1.1113883.x.xx.x  or  UUID: 53459040-b1b4-49ed-ae1f-a52c8c502df4

Uniquely identifies the author of the vital sign organizer sub-section
extensionIs optional and can include an alphanumeric string of any length Uniquely identifies the author of the vital sign organizer sub-section
Code Example of Vital Sign Organizer author
<section>
	<templateId root="2.16.840.1.113883.10.20.22.2.4.1"/>
	<entry typeCode="DRIV">
		<organizer classCode="CLUSTER" moodCode="EVN">
			<templateId root="2.16.840.1.113883.10.20.22.4.26"/>
    		<author>
                <assignedAuthor>
                    <id extension="10007" root="1.3.6.1.4.1.22812.4.10025422.0"/>
                </assignedAuthor>
            </author>
		</organizer>
	</entry>
</section>

The author element and its contents will be ignored if the id element does not contain a correctly populated root attribute. Information provided within the author element in the document header will be processed instead.

 

 

 

Vital Sign Observation templateId

XPath:section/entry/organizer/component/observation/templateId
Purpose:Specifies which CCDA R2.1 template is being used to structure the vital sign observation sub-section. R2.1 templates define the requirements, format, and structure of a CCD section. This sub-section represents measurements of common vital signs. Vital signs are represented with additional vocabulary constraints for type of vital sign and unit of measure.
If present, the templateId element must:

contain a root attribute

AttributeValuePurpose
rootMust have a value of 2.16.840.1.113883.10.20.22.4.27Uniquely identifies the vital sign observation sub-section
Code Example of Vital Sign Observation templateId
<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> 

The entire vital sign observation sub-section is ignored if the templateId element is not provided with a root value of 2.16.840.1.113883.10.20.22.4.27. You will not receive any notification that that this sub-section was ignored.

 

 

Vital Sign Observation id

XPath:section/entry/organizer/component/observation/id
Purpose:Provides a unique identifier for the organization responsible for the vital sign observation contained within this sub-section.
If present, the id element must:

contain a root attribute and optionally contain an extension attribute, OR contain a nullFlavor attribute

AttributeValuePurpose
root

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

For example, OID: 2.16.840.1.1113883.x.xx.x  or  UUID: 53459040-b1b4-49ed-ae1f-a52c8c502df4

Uniquely identifies the organization responsible for the result observation contained within this sub-section

extension

Is optional and can include an alphanumeric string of any length

Uniquely identifies the organization responsible for the result observation contained within this sub-section

nullFlavor

Must be one of the following:

  • ASKU - asked but unknown
  • MSK - masked (for sensitivity or confidentiality reasons)
  • NA - not available, system down
  • NASK - not asked
  • NAV - not available
  • NI - no information
  • OTH - other
  • UNK - unknown
Indicates that an attribute was required, but was not provided, and gives a reason for why the information is not present.
Code Example of Vital Sign Observation id
<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"/>
                    </observation>
            </component>
        </organizer>
</entry> 

Processing of the id element will fail if it does not contain a correctly populated root OR nullFlavor attribute.

 

 

Vital Sign Observation code

XPath:section/entry/organizer/component/observation/code
Purpose:Provides information about the type of vital sign presented in this sub-section
If present, the code element must:

contain code and codeSystem attributes

AttributeValuePurpose

code

Must include an alphanumeric string of any length

Identifies the type of vital sign presented in this sub-section

codeSystemMust include a numeric string of any length in the following format: 2.16.840.1.1113883.X.XXIdentifies the coding system used to translate the identifier provided in the code attribute

displayName and codeSystemName are not required for processing.

Code Example of Vital Sign Observation code
 <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> 

Processing of the code element will fail if it does not contain correctly populated code AND codeSystem attributes.

 

 

Vital Sign Observation statusCode

XPath:section/entry/organizer/component/observation/statusCode
Purpose:Indicates the current status of the vital sign observation
If present, the statusCode element must:

contain a code attribute

AttributeValuePurpose
code

Must be one of the following:

  • aborted
  • active
  • cancelled
  • completed
  • held
  • suspended
Indicates the current status of the result observation
Code Example of Vital Sign Observation statusCode
 <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>

Processing of the statusCode element will fail if it does not contain a correctly populated code attribute.

 

 

Vital Sign Observation effectiveTime

XPath:section/entry/organizer/component/observation/effectiveTime
Purpose:Indicates the time a observation was obtained. Represents the biologically relevant time of the measurement (for example, the time a blood pressure reading was obtained)
If present, the effectiveTime element must:

Contain an attribute of xsi:typevalue OR nullFlavor

AttributeValuePurpose
xsi:type

Must be populated with IVL_TS and effectiveTime must:

  1. have a low child element, which can be:
    • empty
    • have a nullFlavor attribute
    • have a value attribute indicating a specific date and time
  2. optionally have a high child element which can be:
    • empty
    • have a nullFlavor attribute
    • have a value attribute indicating a specific date and time
Indicates the period over which the measurement was obtained
valueMust be populated with a date in the format YYYY[MM[DD[HHMM[SS[.S[S[S[S]]]]]]]][+/-ZZZZ] where +/-ZZZZspecifies the offset from Coordinated Universal Time. Indicates the specific time the measurement was obtained
nullFlavor

Must be one of the following:

  • ASKU - asked but unknown
  • MSK - masked (for sensitivity or confidentiality reasons)
  • NA - not available, system down
  • NASK - not asked
  • NAV - not available
  • NI - no information
  • OTH - other
  • UNK - unknown
Indicates that an attribute was required, but was not provided, and gives a reason for why the information is not present. In this case, it suggests a measurement was obtained, but it was not recorded when.
Code Example of Vital Sign Observation effectiveTime
<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="19991114"/>
                    </observation>
            </component>
        </organizer>
</entry>

Processing of the effectiveTime element will fail if it does not contain a correctly populated xsi:typevalue or nullFlavor attribute.

 

 

Vital Sign Observation value

XPath:section/entry/organizer/component/observation/value
Purpose:Indicates actual value of the observation
If present, the value element must:

contain a xsi:type attribute

AttributeValuePurpose
xsi:type

Must have a value of one of the following:

  • CD
  • IVL_PQ
  • SC
  • ST
  • PQ 
Indicates what type of information the value element is providing
Code Example of Vital Sign Observation value
<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> 

Processing of the value element will fail if it does not contain a correctly populated xsi:type attribute.

 

 

Vital Sign Observation interpretationCode

XPath:section/entry/organizer/component/observation/interpretationCode
Purpose:Indicates how the observed vital sign was interpreted
If present, the interpretationCode element must:

contain code AND codeSystem attributes

AttributeValuePurpose

code

Must include an alphanumeric string of any length. Could be one of the following:

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

Identifies how the observed vital sign was interpreted in the coding system.

codeSystem

Must include an alphanumeric string of any length, but typically in the following format: 2.16.840.1.1113883.X.XX.X.X

Identifies the coding system used to translate the identifier provided in the code attribute

Code Example of Vital Sign Observation interpretationCode
<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="N" codeSystem="2.16.840.1.113883.5.83"/>
                    </observation>
            </component>
        </organizer>
</entry>  

Processing of the interpretationCode element will fail if it does not contain correctly populated code and codeSystem attributes.

 

 

Vital Sign Observation methodCode

XPath:section/entry/organizer/component/observation/methodCode
Purpose:Indicates the method in which the vital sign was observed
If present, the methodCode element must:

contain code AND codeSystem attributes

AttributeValuePurpose

code

Must include an alphanumeric string of any length

Identifies the method in which the vital sign was observed in the coding system.

codeSystem

Must include an alphanumeric string of any length, but typically in the following format: 2.16.840.1.1113883.X.XX.X.X

Identifies the coding system used to translate the identifier provided in the code attribute

Code Example of Vital Sign Observation methodCode
<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/>
                    </observation>
            </component>
        </organizer>
</entry>   

Processing of the methodCode element will fail if it does not contain correctly populated code and codeSystem attributes.

 

 

Vital Sign Observation targetSiteCode

XPath:section/entry/organizer/component/observation/targetSiteCode
Purpose:Indicates where the vital sign was observed
If present, the targetSiteCode element must:

contain code AND codeSystem attributes

AttributeValuePurpose

code

Must include an alphanumeric string of any length

Identifies where the vital sign was observed in the coding system.

codeSystem

Must include an alphanumeric string of any length, but typically in the following format: 2.16.840.1.1113883.X.XX.X.X

Identifies the coding system used to translate the identifier provided in the code attribute

Code Example of Vital Sign Observation targetSiteCode
<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/>
                    </observation>
            </component>
        </organizer>
</entry>    

Processing of the targetSiteCode element will fail if it does not contain correctly populated code and codeSystem attributes.

 

 

Vital Sign Observation author

XPath:section/entry/organizer/component/observation/author
Purpose:Indicates the unique identifier of the person providing the vital sign observation
If present, the author element must:
  • have a child element of assignedAuthor, which must
  • have a child element of id, which must
  • contain a root attribute and optionally contain an extension attribute

AttributeValuePurpose

root

Must include an alphanumeric string in the following OID (object identifier) format. It is not constrained by length: 2.16.840.1.1113883.x.xx.x

Uniquely identifies the author of the vital sign observation

extension

Is optional and can include an alphanumeric string of any length

Uniquely identifies the author of the vital sign observation

Code Example of Vital Sign Observation author
<entry typeCode=”DRIV”> 
        <organizer classCode="CLUSTER" moodCode="EVN">
            <templateId root="2.16.840.1.113883.10.20.22.4.26"/>
            <component>
                    <observation>
                        <templateId root="2.16.840.1.113883.10.20.22.4.27"/>
                        <author>
                            <assignedAuthor>          
                                <id root="2.16.840.1.113883.19.5"/>
                            </assignedAuthor>
                        </author>
                    </observation>
            </component>
        </organizer>
</entry>  

The author element and its contents will be ignored if the id element does not contain a correctly populated root attribute. Information provided within the author element in the document header will be processed instead.

 

 

 

Vital Sign Observation observationRange

XPath:section/entry/organizer/component/observation/referenceRange/observationRange
Purpose: 
If present, the observationRange element must:

contain a child element of text which contains text of any type or length

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 except a completed text element.

Code Example of Vital Sign Observation observationRange
<entry typeCode=”DRIV”> 
        <organizer classCode="CLUSTER" moodCode="EVN">
            <templateId root="2.16.840.1.113883.10.20.22.4.26"/>
            <component>
                    <observation>
							<observationRange>
								<text>xxx</text>
							</observationRange>
						</referenceRange>
                    </observation>
            </component>
        </organizer>
</entry>    

Processing of the observationRange/text element will fail if it is not populated with text of some type.

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