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The Immunization section details a patient's current immunization status and pertinent immunization history. The section should include current immunization status, and may contain the entire immunization history that is relevant to the period of time being summarized. There is a separate Entry section for each immunization.

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

(R) - Required elements for the Immunization section and its sub-sections to be processed correctly in the Clinical:ImmunizationCCDA 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.

Immunization Section Details

Immunization 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=”2.16.840.1.113883.10.20.22.2.2.1”/>
        ...
    </section>
</component>
...
SectionElementAttributeValueNotes
ImmunizationtemplateIdrootMust be 2.16.840.1.113883.10.20.22.2.2.1The unique identifier for the CCDA R2.1 template that defines the requirements, format and structure for the entire Immunization section in Continuity of Care Documents (CCDs).

Immunization Section Code

component/section/code

Identifies that this section is detailing immunization status and history.

...
<component>
    <section>
        ...
        <templateId root=”2.16.840.1.113883.10.20.22.2.2.1”/>
		<code code="11369-6" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="History of immunizations"/>
        ...
    </section>
</component>
...
SectionElementAttributeValueNotes
Immunizationcode


codeMust be 11369-6Identifies that this section is detailing immunization status and history.
codeSystemMust be 2.16.840.1.113883.6.1Identifies the LOINC coding system used to translate the identifier provided 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.

Immunization Section Confidentiality Code

component/section/confidentialityCode

Indicates the level of security that should be applied to this Immunization 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=”2.16.840.1.113883.10.20.22.2.2.1”/>
		<code code="11369-6" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="History of immunizations"/>
		<confidentialityCode code="N" codeSystem="2.16.840.1.113883.5.25"/>
        ...
    </section>
</component>
...
SectionElementAttributeValueNotes
Immunization
confidentialityCode
codeMust 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.

Immunization Section Author

component/section/entry/author

Indicates the author of the section. Refer to Assigned Author Element for more details on what information can be available for the author section. 

...
<component>
    <section>
        ...
        <templateId root=”2.16.840.1.113883.10.20.22.2.2.1”/>
		<code code="11369-6" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="History of immunizations"/>
		<author>
			<assignedAuthor>
				...
			</assignedAuthor>
		</author>
		...
    </section>
</component>
...

Immunization Activity

component/section/entry/substanceAdministration

Describes immunization substance administrations that have actually occurred or are intended to occur.

...
<component>
    <section>
        ...
		<entry typeCode="DRIV">
			<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
				...
			</substanceAdministration>
		</entry>
        ...
    </section>
</component>
...
SubsectionElementAttributeValueNotes
Immunization ActivitysubstanceAdministrationclassCodeMust be SBADMUniquely identifies the immunization administrations that have occurred or are intended to occur.
moodCode

Must be one of the following:

  • INT
  • EVN
  • Immunization Activities in INT mood are reflections of immunizations a clinician intends a patient to receive.
  • Immunization Activities in EVN mood reflect immunizations actually received.
negationInd

Must be one of the following:

  • true
  • false
This attribute is optional. If true, the patient has no known immunization substances administered.

Immunization Activity Template ID

component/section/entry/substanceAdministration/templateId

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.

...
<component>
    <section>
        ...
		<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>
</component>
...
SubsectionElementAttributeValueNotes
Immunization ActivitytemplateIdrootMust be 2.16.840.1.113883.10.20.22.4.52Uniquely identifies the immunization administrations that have occurred or are intended to occur.

Immunization Activity Status Code

component/section/entry/substanceAdministration/statusCode

Indicates the current status of the immunization.

...
<component>
    <section>
        ...
		<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>
</component>
...
SubsectionElementAttributeValueNotes
Immunization ActivitystatusCodecode

Must be one of the following:

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

Indicates the current status of the immunization (whether it has been administered or not). The status value is not case-sensitive.

Immunization Activity Effective Time

component/section/entry/substanceAdministration/effectiveTime

Indicates the date and time that the immunization was administered. Refer to How Effective Time values are processed for details on the different ways effectiveTime information can be processed.

...
<component>
    <section>
        ...
		<entry typeCode="DRIV">
			<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
				<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
				<effectiveTime value="199911"/>
			</substanceAdministration>
		</entry>
        ...
    </section>
</component>
...

Immunization Activity Route Code

component/section/entry/substanceAdministration/routeCode

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

...
<component>
    <section>
        ...
		<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" codeSystemName="RouteOfAdministration" displayName="Intramuscular injection"/>
			</substanceAdministration>
		</entry>
        ...
    </section>
</component>
...
SubsectionElementAttributeValueNotes
Immunization ActivityrouteCodecode

Must be an alphanumeric string of any length

Identifies how the immunization was administered.

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 be a numeric string of any length in the following format: 2.16.840.1.113883.X.XXIdentifies the coding system used to translate the identifier provided 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 immunization method.

Immunization Activity Approach Site Code

component/section/entry/substanceAdministration/approachSiteCode

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

...
<component>
    <section>
        ...
		<entry typeCode="DRIV">
			<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
				<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
				<approachSiteCode code="302539009" codeSystem="2.16.840.1.113883.3.6.96" codeSystemName="SNOMED_CT" displayName="Entire Hand"/>
			</substanceAdministration>
		</entry>
        ...
    </section>
</component>
...
SubsectionElementAttributeValueNotes
Immunization Activity
approachSiteCode
code

Must be an alphanumeric string of any length

Identifies where the immunization was administered.

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 be a numeric string of any length in the following format: 2.16.840.1.113883.X.XXIdentifies the coding system used to translate the identifier provided 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 where the immunization was administered.

Immunization Activity Approach Dose Quantity

component/section/entry/substanceAdministration/doseQuantity

Indicates the amount substance given per immunization administration.

...
<component>
    <section>
        ...
		<entry typeCode="DRIV">
			<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
				<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
				<doseQuantity unit="g" value="50"/>
			</substanceAdministration>
		</entry>
        ...
    </section>
</component>
...
SubsectionElementAttributeValueNotes
Immunization ActivitydoseQuantityunit

Must be an alphanumeric string of any length that indicates a unit of measurement. For example:

  • min (minutes)
  • hour (hours)
  • % (percent)
  • cm (centimetres)
  • g (grams)
  • g/L (grams per litre)
  • mol (mole)

Identifies the unit in which the substance was administered in.

valueMust be an alphanumeric string of any lengthIdentifies the amount of products administered. For example, 50 (grams) or 2 (tablets).

Immunization Activity Approach Performer

component/section/entry/substanceAdministration/performer

Specifies the unique identifier of the person administering the immunization. Refer to Performer Element for more details on what information can be available for the performer section. 

...
<component>
    <section>
        ...
		<entry typeCode="DRIV">
			<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
				<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
				<performer>
					<assignedEntity>
						...
					</assignedEntity>
				</performer>
			</substanceAdministration>
		</entry>
        ...
    </section>
</component>
...

Immunization Medication Information

component/section/entry/substanceAdministration/consumable/manufacturedProduct/manufactureMaterial

Provides information about the immunization substance in a combined form, which includes its ingredients, strengths, and dose. Also includes the lot number of the immunization substance.

...
<component>
    <section>
        ...
		<entry typeCode="DRIV">
			<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
				<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
				<consumable>
					<manufacturedProduct>
						<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>
							<lotNumberText>1</lotNumberText>
						</manufacturedMaterial>
					</manufacturedProduct>
				</consumable>
			</substanceAdministration>
		</entry>
        ...
    </section>
</component>
...
SubsectionElementAttributeValueNotes
Immunization Medication

  • consumable
    • manufacturedProduct
      • manufacturedMaterial
        • code


code

Must be an alphanumeric string of any length

Identifies the medical substance used for the immunization.

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 be a numeric string of any length in the following format: 2.16.840.1.113883.X.XXIdentifies the coding system used to translate the identifier provided 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 immunization substance.
  • consumable
    • manufacturedProduct
      • manufacturedMaterial
        • lotNumberText
N/AMust be an alphanumeric string of any lengthThis element is optional.

Immunization Medication Organization

component/section/entry/substanceAdministration/consumable/manufacturedProduct/manufacturedOrganization/

Specifies the name of the organization responsible for manufacturing the immunization substance.

...
<component>
    <section>
        ...
		<entry typeCode="DRIV">
			<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
				<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
				<consumable>
					<manufacturedProduct>
						<manufacturedOrganization>
							<name>Immuno Inc.</name>
						</manufacturedOrganization>
					</manufacturedProduct>
				</consumable>
			</substanceAdministration>
		</entry>
        ...
    </section>
</component>
...
SubsectionElementAttributeValueNotes
Immunization Medication

  • consumable
    • manufacturedProduct
      • manufacturedOrganization
        • name
N/A

Must be an alphanumeric string of any length

This element is optional.

Immunization Refusal

component/section/entry/substanceAdministration/entryRelationship

This section specifies the rationale/reasoning for the patient declining an immunization.

...
<component>
    <section>
        ...
		<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">
						...
					</observation>
				</entryRelationship>
			</substanceAdministration>
		</entry>
        ...
    </section>
</component>
...
SubsectionElementAttributeValueNotes
Immunization Refusal

entryRelationship

typeCode

Must be RSON

Indicates that the information in this subsection provides reason (RSON) for a patient declining and immunization. Contains a child observation element.

  • entryRelationship
    • observation
classCodeMust be OBSSpecifies 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 has happened or is an ongoing activity, or was documented from a past activity.

Immunization Refusal Template ID

component/section/entry/substanceAdministration/entryRelationship/observation/templateId

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.

...
<component>
    <section>
        ...
		<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="2.16.840.1.113883.10.20.22.4.53"/>
					</observation>
				</entryRelationship>
			</substanceAdministration>
		</entry>
        ...
    </section>
</component>
...
SubsectionElementAttributeValueNotes
Immunization Refusal

templateId

root

Must be 2.16.840.1.113883.10.20.22.4.53

Uniquely identifies the immunization refusal template.

Immunization Refusal Code

component/section/entry/substanceAdministration/entryRelationship/observation/code

Specifies why a patient declined an immunization

...
<component>
    <section>
        ...
		<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="2.16.840.1.113883.10.20.22.4.53"/>
						<code code="PATOBJ" codeSystem="2.16.840.1.113883.11.19725" codeSystemName="HL7 ActNoImmunizationReason" displayName="Patient Objection"/>
					</observation>
				</entryRelationship>
			</substanceAdministration>
		</entry>
        ...
    </section>
</component>
...
SubsectionElementAttributeValueNotes
Immunization Refusal

code

code

Must include an alphanumeric string of any length

Identifies the reason for a patient declining an immunization.

codeSystemMust be a numeric string of any length in the following format: 2.16.840.1.113883.X.XXIdentifies the coding system used to translate the identifier provided 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 immunization refusal.

Immunization Instruction

component/section/entry/substanceAdministration/entryRelationship

This section specifies the instructions for the patient following an immunization administration.

...
<component>
    <section>
        ...
		<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">
						...
					</act>
				</entryRelationship>
			</substanceAdministration>
		</entry>
        ...
    </section>
</component>
...
SubsectionElementAttributeValueNotes
Immunization Instruction

entryRelationship

typeCode

Must be SUBJ

Indicates that the information in this subsection relates to the immunization itself (SUBJ). Contains a child act element.

  • entryRelationship
    • act
classCodeMust be ACTSpecifies the general nature of the entry, which in this case is an act (ACT).
moodCodeMust be INTIndicates that this entry is a clinical statement that is intended (INT) to happen.

Immunization Instruction Template ID

component/section/entry/substanceAdministration/entryRelationship/act/templateId

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.

...
<component>
    <section>
        ...
		<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="2.16.840.1.113883.10.20.22.4.20"/>
					</act>
				</entryRelationship>
			</substanceAdministration>
		</entry>
        ...
    </section>
</component>
...
SubsectionElementAttributeValueNotes
Immunization Instruction

templateId

root

Must be 2.16.840.1.113883.10.20.22.4.20

Uniquely identifies the immunization instruction template.

Immunization Instruction Text

component/section/entry/substanceAdministration/entryRelationship/act/templateId

Specifies the instructions for the patient following an immunization administration in free text.

...
<component>
    <section>
        ...
		<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="2.16.840.1.113883.10.20.22.4.20"/>
						<text>Possible flu-like symptoms for three days.</text>
					</act>
				</entryRelationship>
			</substanceAdministration>
		</entry>
        ...
    </section>
</component>
...
SubsectionElementAttributeValueNotes
Immunization Instruction

text

N/A

Must contain text of any type or length


Immunization Indication

component/section/entry/substanceAdministration/entryRelationship

This section specifies the reason/rationale for the administration of the immunization.

...
<component>
    <section>
        ...
		<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">
						...
					</observation>
				</entryRelationship>
			</substanceAdministration>
		</entry>
        ...
    </section>
</component>
...
SubsectionElementAttributeValueNotes
Immunization Indication

entryRelationship

typeCode

Must be RSON

Indicates that the information in this subsection provides reason (RSON) for the administration of the immunization. Contains a child observation element.

  • entryRelationship
    • observation
classCodeMust be OBSSpecifies 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 has happened or is an ongoing activity, or was documented from a past activity.

Immunization Indication Template ID

component/section/entry/substanceAdministration/entryRelationship/observation/templateId

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.

...
<component>
    <section>
        ...
		<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="2.16.840.1.113883.10.20.22.4.19"/>
					</observation>
				</entryRelationship>
			</substanceAdministration>
		</entry>
        ...
    </section>
</component>
...
SubsectionElementAttributeValueNotes
Immunization Indication

templateId

root

Must be 2.16.840.1.113883.10.20.22.4.19

Uniquely identifies the immunization indication template.

Immunization Indication Code

component/section/entry/substanceAdministration/entryRelationship/observation/code

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

...
<component>
    <section>
        ...
		<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="2.16.840.1.113883.10.20.22.4.19"/>
						<code code="31712002" codeSystem="2.16.840.1.113883.6.96" displayName="Primary Biliary Cirrhosis"/>
					</observation>
				</entryRelationship>
			</substanceAdministration>
		</entry>
        ...
    </section>
</component>
...
SubsectionElementAttributeValueNotes
Immunization Indication

code

code

Must be one of the the codes specified by the SNOMED CT coding system.

For example, 46635009 (Diabetes mellitus type 1) or 31712002 (Primary Biliary Cirrhosis).

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.

codeSystem

Must be 2.16.840.1.113883.6.96

This is the unique identifier for the SNOMED CT coding system. It will be used to translate the value provided in the code attribute.
displayNameCan be an alphanumerical string of any lengthThis attribute is optional. A human readable display name for immunization indication.

Reaction Observation

component/section/entry/substanceAdministration/entryRelationship

This section describes a response to an undesired symptom as a result of the administered immunization.

...
<component>
    <section>
        ...
		<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">
						...
					</observation>
				</entryRelationship>
			</substanceAdministration>
		</entry>
        ...
    </section>
</component>
...
SubsectionElementAttributeValueNotes
Reaction Observation

entryRelationship

typeCode

Must be CAUS

Indicates that the cause (CAUS) of the reaction observed is due to the administered immunization. Contains a child observation element.

  • entryRelationship
    • observation
classCodeMust be OBSSpecifies 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 has happened or is an ongoing activity, or was documented from a past activity.

Reaction Observation Template ID

component/section/entry/substanceAdministration/entryRelationship/observation/templateId

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.

...
<component>
    <section>
        ...
		<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="2.16.840.1.113883.10.20.22.4.9"/>
					</observation>
				</entryRelationship>
			</substanceAdministration>
		</entry>
        ...
    </section>
</component>
...
SubsectionElementAttributeValueNotes
Reaction Observation

templateId

root

Must be 2.16.840.1.113883.10.20.22.4.9

Uniquely identifies the reaction observation template.

Reaction Observation Effective Time

component/section/entry/substanceAdministration/entryRelationship/observation/effectiveTime

Indicates the date and time of when the reaction was observed. Refer to How Effective Time values are processed for details on the different ways effectiveTime information can be processed.

...
<component>
    <section>
        ...
		<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="2.16.840.1.113883.10.20.22.4.9"/>
						<effectiveTime xsi:type="IVL_TS">
							<low value="199812150805-0800"/>
							<high value="199812171205-0800"/>
						</effectiveTime>
					</observation>
				</entryRelationship>
			</substanceAdministration>
		</entry>
        ...
    </section>
</component>
...

Reaction Observation Code

component/section/entry/substanceAdministration/entryRelationship/observation/code

Specifies the type of reaction observed.

...
<component>
    <section>
        ...
		<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="2.16.840.1.113883.10.20.22.4.9"/>
						<code code="422587007" codeSystem="2.16.840.1.113883.6.96" displayName="Nausea"/>
					</observation>
				</entryRelationship>
			</substanceAdministration>
		</entry>
        ...
    </section>
</component>
...
SubsectionElementAttributeValueNotes
Reaction Observation

code

code

Must be one of the the codes specified by the SNOMED CT coding system.

For example, 247472004 (Hives) or 39579001 (Anaphylaxis).

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

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 be 2.16.840.1.113883.6.96This is the unique identifier for the SNOMED CT coding system. It will be used to translate the value provided in the code attribute.
displayNameCan be an alphanumerical string of any lengthThis attribute is optional. A human readable display name for reaction to the immunization administration.

Substance Administered Series Order

component/section/entry/substanceAdministration/entryRelationship

This particular entryRelationship section represents the immunization administration course in a series, showing the order of particular administration of substances.

...
<component>
    <section>
        ...
		<entry typeCode="DRIV">
			<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
				<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
				<entryRelationship typeCode="COMP">
					...
					<act classCode="ACT" moodCode="EVN">
						...
					</act>
				</entryRelationship>
			</substanceAdministration>
		</entry>
        ...
    </section>
</component>
...
SubsectionElementAttributeValueNotes
Substance Administered Act

entryRelationship

typeCode

Must be COMP

This particular entryRelationship is used to indicate a given immunization's order in a series.

The nested act identifies an administration in the series.

The nested sequenceNumber shows the order of this particular administration in that series.

  • entryRelationship
    • act
classCodeMust be ACTSpecifies the general nature of the entry, which in this case is an act (ACT).
moodCodeMust be EVNIndicates that this entry is an event (EVN) that has happened or is an ongoing activity, or was documented from a past activity.

Substance Administered Series Template ID

component/section/entry/substanceAdministration/entryRelationship/templateId

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

...
<component>
    <section>
        ...
		<entry typeCode="DRIV">
			<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
				<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
				<entryRelationship typeCode="COMP">
					<templateId root="2.16.840.1.113883.10.20.22.4.118"/>
					<act classCode="ACT" moodCode="EVN">
						...
					</act>
				</entryRelationship>
			</substanceAdministration>
		</entry>
        ...
    </section>
</component>
...
SubsectionElementAttributeValueNotes
Substance Administered Act

templateId

root

Must be 2.16.840.1.113883.10.20.22.4.118

Uniquely identifies the substance administered act template.

Substance Administered Sequence Number

component/section/entry/substanceAdministration/entryRelationship/sequenceNumber

Indicates a given immunization administration's order in a series.

...
<component>
    <section>
        ...
		<entry typeCode="DRIV">
			<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
				<templateId root="2.16.840.1.113883.10.20.22.4.52"/>
				<entryRelationship typeCode="COMP">
					<templateId root="2.16.840.1.113883.10.20.22.4.118"/>
					<sequenceNumber value="2"/>
					<act classCode="ACT" moodCode="EVN">
						...
					</act>
				</entryRelationship>
			</substanceAdministration>
		</entry>
        ...
    </section>
</component>
...
SubsectionElementAttributeValueNotes
Substance Administered Act

sequenceNumber

value

A numerical value

Indicates the order this immunization was administered in the series.



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