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To accurately process the Header and Immunizations sections of a C-CDA CCD, in the Clinical:ImmunizationCcda 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.  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 Immunizations section, there are six elements that are required and sixteen elements that are optional

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

The immunizations section of a CCD will typically have several sub-sections to represent different immunization-related activities:

  • Immunization Activity
  • Immunization Medication Information
  • Immunization Refusal
  • Immunization Instruction
  • Immunization Indication
  • Reaction Observation
  • Substance Administration Act

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 ElementsImmunization SectiontemplateIdsection/templateID
codesection/code
Immunization ActivitytemplateIdsection/entry/substanceAdministration/templateId
statusCodesection/entry/substanceAdministration/statusCode
Immunization Medication InformationtemplateIdsection/entry/substanceAdministration/consumable/manufacturedProduct/templateId
codesection/entry/substanceAdministration/consumable/manufacturedProduct/manufacturedMaterial/code
Optional (but validated
if present) Elements
Immunization Activity



effectiveTimesection/entry/substanceAdministration/effectiveTime
routeCodesection/entry/substanceAdministration/routeCode
approachSiteCodesection/entry/substanceAdministration/approachSiteCode
doseQuantitysection/entry/substanceAdministration/doseQuantity
performersection/entry/substanceAdministration/performer
Immunization RefusaltemplateIdsection/entry/substanceAdministration/entryRelationship/observation/templateId
codesection/entry/substanceAdministration/entryRelationship/observation/code
Immunization InstructiontemplateIdsection/entry/substanceAdministration/entryRelationship/act/templateId
textsection/entry/substanceAdministration/entryRelationship/act/text
Immunization IndicationtemplateIdsection/entry/substanceAdministration/entryRelationship/observation/templateId
valuesection/entry/substanceAdministration/entryRelationship/observation/value
Reaction Observation

templateIdsection/entry/substanceAdministration/entryRelationship/observation/templateId
effectiveTimesection/entry/substanceAdministration/entryRelationship/observation/effectiveTime
valuesection/entry/substanceAdministration/entryRelationship/observation/value
Substance Administration ActsequenceNumbersection/entry/substanceAdministration/entryRelationship/sequenceNumber
templateId  section/entry/substanceAdministration/entryRelationship/act/templateId

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.

Immunization Section templateId

XPath:section/templateID
Purpose:

Specifies which CCDA R2.1 template is being used to structure the immunizations section. R2.1 templates define the requirements, format, and structure of a CCD section. This section defines a patient's current immunization status and relevant immunization history.

The templateID element must:

  • be present

  • contain a root attribute

    AttributeValuePurpose
    rootMust have a value of 2.16.840.1.113883.10.20.22.2.2Uniquely identifies the immunizations section template
Code Example of Immunization Section templateId
<section> 
	<templateID root=”2.16.840.1.113883.10.20.22.2.2”/> 
</section>

The entire immunizations section is ignored if the templateId element is not provided with a root attribute of 2.16.840.1.113883.10.20.22.2.2. The information provided in this section will not be processed and you will not receive any notification that this section was ignored.

 

Immunization Section code

XPath:section/code
Purpose:Identifies that this section is detailing immunization status and history.

The code element must:

  • be present

  • contain code and codeSystem attributes

    AttributeValuePurpose

    code

    Must have a value of 11369-6

    Identifies that this section is detailing immunization status and history

    codeSystem

    Must have a value of 2.16.840.1.113883.6.1

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

    displayName and codeSystemName are not required for processing.

Code Example of Immunization Section code
<section> 
	<templateID root=”2.16.840.1.113883.10.20.22.2.2”/> 
	<code code="11369-6" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="History of immunizations"/>
</section>

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

 

 

Immunization Activity templateId

XPath:section/entry/substanceAdministration/templateId
Purpose:Specifies which CCDA R2.1 template is being used to structure the immunizations activity sub-section. R2.1 templates define the requirements, format, and structure of a CCD section. This sub-section describes immunization administrations that have occurred or are intended to occur.

The templateId element must:

  • be present

  • contain a root attribute

    AttributeValuePurpose
    rootMust have a value of 2.16.840.1.113883.10.20.22.4.52Uniquely identifies the immunizations activity template
Code Example of Immunization Activity templateId
<section> 
	<templateID root="2.16.840.1.113883.10.20.22.2.2"/> 
	<entry typeCode="DRIV">	
		<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
			<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
		</substanceAdministration>
	</entry>
</section>

The entire immunization activity sub-section is ignored if the templateId element is not provided with a root attribute of 2.16.840.1.113883.10.20.22.4.52. The information provided in this sub-section will not be processed and you will not receive any notification that this sub-section was ignored.

 

 

Immunization Activity statusCode

XPath:section/entry/substanceAdministration/statusCode
Purpose:Indicates the current status of the immunization.

The statusCode element must:

  • be present
  • contain a code attribute
AttributeValuePurpose
code

Must be one of the following:

  • Normal
  • Aborted
  • Active
  • Cancelled
  • Completed
  • Held
  • New
  • Suspended
  • Nullified
  • Obsolete

Indicates the current status of the immunization (that is, whether it has been administered or not)

 

 

Code Example of Immunization Activity statusCode
<section> 
	<templateID root="2.16.840.1.113883.10.20.22.2.2"/> 
	<entry typeCode="DRIV">	
		<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
			<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
			<statusCode code="completed"/>
		</substanceAdministration>
	</entry>
</section>

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

 

 

Immunization Medication Information templateId

XPath:section/entry/substanceAdministration/consumable/manufacturedProduct/templateId
Purpose:Specifies which CCDA R2.1 template is being used to structure the immunization mediation information sub-section. R2.1 templates define the requirements, format, and structure of a CCD section. This sub-section represents product information about the immunization substance.

The templateId element must:

  • be present

  • contain a root attribute

    AttributeValuePurpose
    rootMust have a value of 2.16.840.1.113883.10.20.22.4.54Uniquely identifies the immunization medication information template
Code Example of Immunization Medication Information templateId
<section> 
	<templateID root="2.16.840.1.113883.10.20.22.2.2"/> 
	<entry typeCode="DRIV">	
		<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
			<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
			<statusCode code="completed"/>
			<consumable>
				<manufacturedProduct>
					<templateId root="2.16.840.1.113883.10.20.22.4.54"/>
				</manufacturedProduct>
			</consumable>
		</substanceAdministration>
	</entry>
</section>

The entire immunization medication information sub-section is ignored if the templateId element is not provided with a root value of 2.16.840.1.113883.10.20.22.4.54. You will not receive any notification that that this sub-section was ignored.

 

 

Immunization Medication Information code

XPath:section/entry/substanceAdministration/consumable/manufacturedProduct/manufacturedMaterial/code
Purpose:Provides information about the immunization substance in a combined form, which includes its ingredients, strengths, and dose.

The code element must:

  • be present

  • contain code and codeSystem attributes

    AttributeValuePurpose

    code

    Must include an alphanumeric string of any length

    Identifies the medical substance used for the immunization

    codeSystem

    Must include a numeric string of any length in the following format: 2.16.840.1.113883.X.XX

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

    displayName and codeSystemName are not required for processing.

    For accurate processing, we except to see code with code and codeSystem attributes, as documented above. However <code nullFlavor="UNK"/> or <code nullFlavor="OTH"/> is acceptable.

    If code is populated with nullFlavor="OTH", a child element of translation must be present and contain code and codeSystem attributes. Clinical Data Spaces will process the information provided here instead.

Code Example of Immunization Medication Information code
<section> 
	<templateID root="2.16.840.1.113883.10.20.22.2.2"/> 
	<entry typeCode="DRIV">	
		<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
			<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
			<consumable>
				<manufacturedProduct>
					<templateId root="2.16.840.1.113883.10.20.22.4.54"/>
					<manufacturedMaterial>
						<code code="88" codeSystem="2.16.840.1.113883.6.59" displayName="Influenza virus vaccine" codeSystemName="CVX">
									<originalText>Influenza virus vaccine</originalText>
									<translation code="111" displayName="influenza, live, intranasal" codeSystemName="CVX" codeSystem="2.16.840.1.113883.6.59"/>
						</code>
					</manufacturedMaterial>
				</manufacturedProduct>
			</consumable>
		</substanceAdministration>
	</entry>
</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). 

Immunization Activity effectiveTime

XPath:section/entry/substanceAdministration/effectiveTime
Purpose:

Indicates the time the immunization was administered

If present, the effectiveTime element must:

Contain an attribute of xsi:type, value 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 reaction was observed
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 reaction occurred
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 reaction occurred, but it was not recorded when.
Code Example of Immunization Activity effectiveTime
<entry typeCode="DRIV">	
		<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
			<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
			<effectiveTime xsi:type="IVL_TS" value="199911"/>
		</substanceAdministration>
</entry>

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

 

 

Immunization Activity routeCode

XPath:section/entry/substanceAdministration/routeCode
Purpose:

Specifies how the immunization was administered (for example, intramuscular, orally etc.)

If present, the routeCode element must:

contain code AND codeSystem attributes:

AttributeValuePurpose

code

Must include an alphanumeric string of any length

Identifies how the immunization was administered

codeSystem

Must include a numeric string of any length in the following format: 2.16.840.1.113883.X.XX

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

displayName and codeSystemName are not required for processing

For accurate processing, we except to see code with code and codeSystem attributes, as documented above. However <code nullFlavor="UNK"/> or <code nullFlavor="OTH"/> is acceptable.

If code is populated with nullFlavor="OTH", a child element of translation must be present and contain code and codeSystem attributes. Clinical Data Spaces will process the information provided here instead.

  

Code Example of Immunization Activity routeCode
<entry typeCode="DRIV">	
		<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
			<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
			<routeCode code="IM" codeSystem="2.16.840.1.113883.5.112" codeSystem=RouteOfAdministration" displayName="Intramuscular injection"/>
		</substanceAdministration>
</entry>

  

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

 

 

Immunization Activity approachSiteCode

XPath:section/entry/substanceAdministration/approachSiteCode
Purpose:

Specifies where the immunization was administered (for example, where on the body the intramuscular injection was administered - leg, arm etc.)

If present, the approachSiteCode element must:

contain code AND codeSystem attributes:

AttributeValuePurpose

code

Must include an alphanumeric string of any length

Identifies where the immunization was administered

codeSystem

Must include a numeric string of any length in the following format: 2.16.840.1.113883.X.XX

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

displayName and codeSystemName are not required for processing.

For accurate processing, we except to see code with code and codeSystem attributes, as documented above. However <code nullFlavor="UNK"/> or <code nullFlavor="OTH"/> is acceptable.

If code is populated with nullFlavor="OTH", a child element of translation must be present and contain code and codeSystem attributes. Clinical Data Spaces will process the information provided here instead.

Code Example of Immunization Activity approachSiteCode
 <entry typeCode="DRIV">	
		<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
			<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
<!----NEED THIS EXAMPLE--->
		</substanceAdministration>
</entry>

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

 

 

Immunization Activity doseQuantity

XPath:section/entry/substanceAdministration/doseQuantity
Purpose:

Indicates the number of products given per immunization administration

If present, the doseQuantity element must:

contain a value OR nullFlavor attribute, and optionally contain a unit attribute

AttributeValuePurpose

value

Must be alphanumerical 

Identifies the number of products administered (for example, "2" refers to 2x tablets)

unit

Must be alphanumerical 

Identifies the unit in with the product was administered in (for example, mg)

nullFlavor

Must be one of the following:

  • ASKU - asked but unknown
  • MSK - masked (sensitivity/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 needed, but was not provided, and gives a reason for why the information is not present. In this case, it suggests the immunization took place, but the value was not recorded.
Code Example of Immunization Activity doseQuantity
 <entry typeCode="DRIV">	
		<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
			<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
			<doseQuantity nullFlavor="UNK"/>
		</substanceAdministration>
</entry>

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

 

 

Immunization Activity performer

XPath:section/entry/substanceAdministration/performer
Purpose:Specifies the unique identifier of the person administering the immunization.
If an author element is present, it must:
  • have a child element of assignedEntity, 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: 2.16.840.1.113883.x.xx.x  or  UUID: 53459040-b1b4-49ed-ae1f-a52c8c502df4

    Uniquely identifies the author of the current medications entry

    extension

    Is optional and can include an alphanumeric string of any length

    Uniquely identifies the author of the current medications entry

Code Example of Immunization Activity performer
<entry typeCode="DRIV">	
		<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
			<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
			<performer>
            	<assignedEntity>
                	<id extension="56789" root="2.16.840.1.113883.19.5"/>
            	</assignedEntity>
        </performer>
		</substanceAdministration>
</entry>

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

 

 

Immunization Refusal templateId

XPath:section/entry/substanceAdministration/entryRelationship/observation/templateId
Purpose:

Specifies which CCDA R2.1 template is being used to structure the immunization refusal sub-section. R2.1 templates define the requirements, format, and structure of a CCD section. This sub-section documents the rationale for the patient declining an immunization.

If present, the xx element must:
  • be contained within an entryRelationship element with a typeCode attribute of "RSON"
  • have a parent element of observation
  • contain a root attribute

    AttributeValuePurpose
    rootMust have a value of 2.16.840.1.113883.10.20.22.4.53Uniquely identifies the immunization refusal template
Code Example of Immunization Refusal templateId
<entry typeCode="DRIV">	
		<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
			<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
				<entryRelationship typeCode="RSON">
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.113883.10.20.22.4.53"/>
					</observation>
				</entryRelationship>
		</substanceAdministration>
</entry> 

The entire immunization refusal sub-section is ignored if the templateId element is not provided with a root attribute of 2.16.840.1.113883.10.20.22.4.53. The information provided in this section will not be processed and you will not receive any notification that this section was ignored.

 

 

Immunization Refusal code

XPath:section/entry/substanceAdministration/entryRelationship/observation/code
Purpose:

Specifies why a patient declined an immunization

If present, the code element must:
  • be contained within an entryRelationship element with a typeCode attribute of "RSON", which has a templateId of 2.16.840.113883.10.20.22.4.53
  • have a parent element of observation
  • contain code AND codeSystem attributes
AttributeValuePurpose

code

Must include an alphanumeric string of any length

Identifies the reason for a patient declining an immunization

codeSystem

Must include a numeric string of any length in the following format: 2.16.840.1.113883.X.XX

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

displayName and codeSystemName are not required for processing.

Code Example of Immunization Refusal code
<entry typeCode="DRIV">	
		<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
			<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
				<entryRelationship typeCode="RSON">
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.113883.10.20.22.4.53"/>
						<code displayName="Patient Objection" code="PATOBJ" codeSystemName="HL7 ActNoImmunizationReason" codeSystem="2.16.840.113883.11.19725"/>
					</observation>
				</entryRelationship>
		</substanceAdministration>
</entry> 

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

 

 

Immunization Instruction templateId

XPath:section/entry/substanceAdministration/entryRelationship/act/templateId
Purpose:

Specifies which CCDA R2.1 template is being used to structure the immunization instruction sub-section. R2.1 templates define the requirements, format, and structure of a CCD section. This sub-section provides instructions for the patient following the immunization administration.

If present, the templateId element must:
  • be contained within an entryRelationship element with a typeCode attribute of "SUBJ"
  • have a parent element of act
  • contain a root attribute

    AttributeValuePurpose
    rootMust have a value of 2.16.840.1.113883.10.20.22.4.20Uniquely identifies the immunization instruction template
Code Example of Immunization Instruction templateId
<entry typeCode="DRIV">	
		<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
			<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
				<entryRelationship typeCode="SUBJ">
					<act classCode="ACT" moodCode="INT">
						<templateId root="2.16.840.113883.10.20.22.4.20"/>
					</act>
				</entryRelationship>
		</substanceAdministration>
</entry> 

The entire immunization instruction sub-section is ignored if the templateId element is not provided with a root attribute of 2.16.840.1.113883.10.20.22.4.20. The information provided in this section will not be processed and you will not receive any notification that this section was ignored.

 

 

Immunization Instruction text

XPath:section/entry/substanceAdministration/entryRelationship/act/text
Purpose:

Provides instructions for the patient following the immunization administration.

If present, the text element must:
  • be contained within an entryRelationship element with a typeCode attribute of "SUBJ", which has a templateId of: 2.16.840.1.113883.10.20.22.4.20
  • have a parent element of act
  • contain text of any type or length
Code Example of Immunization Instruction text
<entry typeCode="DRIV">	
		<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
			<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
				<entryRelationship typeCode="RSON">
					<act classCode="ACT" moodCode="INT">
						<templateId root="2.16.840.113883.10.20.22.4.20"/>
						<text>Possible flu-like symptoms for three days.</text>
					</act>
				</entryRelationship>
		</substanceAdministration>
</entry>

Processing of the text element will fail if it does not contain alphanumeric text. 

 

 

Immunization Indication templateId

XPath:section/entry/substanceAdministration/entryRelationship/observation/templateId
Purpose:

Specifies which CCDA R2.1 template is being used to structure the immunization mediation information sub-section. R2.1 templates define the requirements, format, and structure of a CCD section. This sub-section provides reason and/or rationale for the administration of the immunization.

If present, the templateId element must:
  • be contained within an entryRelationship element with a typeCode attribute of "RSON"
  • have a parent element of observation
  • contain a root attribute

    AttributeValuePurpose
    rootMust have a value of 2.16.840.1.113883.10.20.22.4.19Uniquely identifies the immunization indication template
Code Example of Immunization Indication templateId
 <entry typeCode="DRIV">	
		<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
			<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
				<entryRelationship typeCode="RSON">
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.113883.10.20.22.4.19"/>
					</observation>
				</entryRelationship>
		</substanceAdministration>
</entry>

The entire immunization indication sub-section is ignored if the templateId element is not provided with a root attribute of 2.16.840.1.113883.10.20.22.4.19. The information provided in this section will not be processed and you will not receive any notification that this section was ignored.

 

 

Immunization Indication value

XPath:section/entry/substanceAdministration/entryRelationship/observation/value
Purpose:

Specifies the reason and/or rationale for the administration of the immunization

If present, the value element must:
  • be contained within an entryRelationship element with a typeCode attribute of "RSON", which has a templateId of: 2.16.840.1.113883.10.20.22.4.19
  • have a parent element of observation
  • contain xsi:type, code, and codeSystem attributes

    AttributeValuePurpose
    xsi:typeCDIndicates that the value element is providing code and codeSystem information
    code

    Must include an alphanumeric string of any length.

    Identifies the specific reason and/or rationale for the administration of the immunization
    codeSystemMust include an alphanumeric string of any length, but typically in the following format: 2.16.840.1.113883.X.XX.X.XIdentifies the coding system used to translate the identifier provided in the code attribute

    displayName and codeSystemName are not required for processing

    For accurate processing, we except to see code with code and codeSystem attributes, as documented above. However <value nullFlavor="UNK"/> or <value nullFlavor="OTH"/> is acceptable.

    If value is populated with nullFlavor="OTH", a child element of translation must be present and contain code and codeSystem attributes. Clinical Data Spaces will process the information provided here instead.

Code Example of Immunization Indication value
<entry typeCode="DRIV">	
		<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
			<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
				<entryRelationship typeCode="RSON">
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.113883.10.20.22.4.19"/>
						<value nullFlavor="UNK"/> 
					</observation>
				</entryRelationship>
		</substanceAdministration>
</entry>

Processing of the value element will fail if it does not contain correctly populated xsi:type, code and codeSystem attributes.

 

 

Reaction Observation templateId

XPath:section/entry/substanceAdministration/entryRelationship/observation/templateId
Purpose:

Specifies which CCDA R2.1 template is being used to structure the reaction observation sub-section. R2.1 templates define the requirements, format, and structure of a CCD section. This sub-section describes a response to an undesired symptom as a result of the administered immunization.

If present, the templateId element must:
  • be contained within an entryRelationship element with a typeCode attribute of "CAUS"
  • have a parent element of observation
  • contain a root attribute

    AttributeValuePurpose
    rootMust have a value of 2.16.840.1.113883.10.20.22.4.9Uniquely identifies the reaction observation template
Code Example of Reaction Observation templateId
<entry typeCode="DRIV">	
		<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
			<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
				<entryRelationship typeCode="CAUS">
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.113883.10.20.22.4.9"/>
					</observation>
				</entryRelationship>
		</substanceAdministration>
</entry>  

The entire reaction observation sub-section is ignored if the templateId element is not provided with a root attribute of 2.16.840.1.113883.10.20.22.4.9. The information provided in this section will not be processed and you will not receive any notification that this section was ignored.

 

 

Reaction Observation effectiveTime

XPath:section/entry/substanceAdministration/entryRelationship/observation/effectiveTime
Purpose:

Specifies when a reaction occurred

If present, the effectiveTime element must:
  • be contained within an entryRelationship element with a typeCode attribute of "CAUS", which has a templateId of: 2.16.840.1.113883.10.20.22.4.9 
  • have a parent element of observation
  • contain a xsi:type OR value OR nullFlavor attribute

    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 reaction was observed
    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 reaction occurred
    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 reaction occurred, but it was not recorded when.
Code Example of Reaction Observation effectiveTime
<entry typeCode="DRIV">	
		<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
			<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
				<entryRelationship typeCode="CAUS">
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.113883.10.20.22.4.9"/>
							<effectiveTime>
			                       <low value="199812150805-0800" />
			                       <high value="199812171205-0800" />
			                </effectiveTime>
					</observation>
				</entryRelationship>
		</substanceAdministration>
</entry>  

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

 

 

Reaction Observation value

XPath:section/entry/substanceAdministration/entryRelationship/observation/value
Purpose:

Specifies the type of reaction observed.

If present, the value element must:
  • be contained within an entryRelationship element with a typeCode attribute of "CAUS", which has a templateId of: 2.16.840.1.113883.10.20.22.4.9
  • have a parent element of observation
  • contain xsi:type, code, and codeSystem attributes

    AttributeValuePurpose
    xsi:typeCDIndicates that the value element is providing code and codeSystem information

    code

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

    • 247472004 - Hives
    • 39579001 - Anaphylaxis
    • 129851009 - Alteration in comfort: pain 

    Identifies the specific reactive symptom (or problem) presented in the reaction to the immunization

    codeSystemMust have a value of 2.16.840.1.113883.6.96Identifies the SNOMED CT coding system used to translate the identifier provided in the code attribute

    displayName and codeSystemName are not required for processing

    For accurate processing, we except to see code with code and codeSystem attributes, as documented above. However <value nullFlavor="UNK"/> or <value nullFlavor="OTH"/> is acceptable.

    If value is populated with nullFlavor="OTH", a child element of translation must be present and contain code and codeSystem attributes. Clinical Data Spaces will process the information provided here instead.

Code Example of Reaction Observation value
<entry typeCode="DRIV">	
		<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
			<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
				<entryRelationship typeCode="CAUS">
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.113883.10.20.22.4.9"/>
						<value xsi:type="CD" code="422587007" codeSystem="2.16.840.1.113883.6.96" displayName="Nausea"/>
					</observation>
				</entryRelationship>
		</substanceAdministration>
</entry>  

Processing of the value element will fail if it does not contain correctly populated xsi:type, code, and codeSystem attributes.

 

 

Substance Administration Act sequenceNumber

XPath:section/entry/substanceAdministration/entryRelationship/sequenceNumber
Purpose:

Indicates a given immunization's order in a series.

If present, the sequenceNumber element must:
  • be contained within an entryRelationship element with a typeCode attribute of "COMP"
  • contain a value attribute
AttributeValuePurpose
valueA numerical valueIndicates the order number in a series
Code Example of Substance Administration Act sequenceNumber
<entry typeCode="DRIV">	
		<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
			<templateId root="2.16.840.1.113883.10.20.22.4.118"/>
				<entryRelationship typeCode="COMP" inversionInd="true">
					<sequenceNumber value="2"/>
				</entryRelationship>
		</substanceAdministration>
</entry>  

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

 

 

Substance Administration Act templateId

XPath:section/entry/substanceAdministration/entryRelationship/act/templateId
Purpose:

Specifies which CCDA R2.1 template is being used to structure the substance administration act sub-section. R2.1 templates define the requirements, format, and structure of a CCD section. This sub-section indicates a given immunization's order in a series.

If present, the templateId element must:
  • be contained within an entryRelationship element with a typeCode attribute of "COMP"
  • have a parent element of act
  • contain a root attribute

AttributeValuePurpose
root2.16.840.1.113883.10.20.22.4.118Uniquely identifies the substance administration act template
Code Example of Substance Administration Act templateId
<entry typeCode="DRIV">	
		<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
			<templateId root="2.16.840.1.113883.10.20.22.4.118"/>
				<entryRelationship typeCode="COMP">
					<act classCode="ACT" moodCode="INT">
						<templateId root="2.16.840.113883.10.20.22.4.118"/>
					</act>
				</entryRelationship>
		</substanceAdministration>
</entry> 

The entire substance administration act sub-section is ignored if the templateId element is not provided with a root attribute of 2.16.840.1.113883.10.20.22.4.118. The information provided in this section will not be processed and you will not receive any notification that this section was ignored.

 


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