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Definition:Within a CDA document, the following information maps to the HITSP/C154 Data Dictionary. See the HL7 Continuity of Care Document Section 3.11 for constraints applicable to these data elements. This module contains data describing the patient's immunization history. The HL7 Continuity of Care (CCD) Implementation Guide defines Immunizations using the same data objects and constraints as for Medications. See the HL7 Continuity of Care Document, Sections 3.9 Medications and 3.11 Immunizations; and also the Medication module Section of this construct for constraints applicable to this module.
CDA Data Location HITSP Data Element Identifier and Name O/R Additional Specification
cda:substanceAdministration[cda:templateId/@root = '2.16.840.1.113883.'] Immunization Event Entry See Below22
negationInd 13.01 - Refusal R/N
cda:effectiveTime 13.02 - Administered Date O/N
cda:entryRelationship [@typeCode='SUBJ']/ cda:observation/cda:value 13.03 - Medication Series Number O/N
cda:entryRelationship[@typeCode='CAUS']/ cda:observation[cda:templateId/@root= '2.16.840.1.113883.'] 13.04 - Reaction O/Y
cda:performer/cda:assignedEntity 13.05 - Performer O/N
cda:consumable/cda:manufacturedProduct Medication Information R/Y
cda:manufacturedMaterial/cda:code/@code 13.06 - Coded Product Name R2/Y
cda:originalText 13.07 - Free Text Product Name R/N
cda:manufacturerOrganization 13.08 - Drug Manufacturer O/N
cda:manufacturedMaterial/ cda:lotNumberText 13.09 - Lot Number R2/N
cda:entryRelationship[@typeCode='RSON']/ cda:act[cda:templateId/@root= '2.16.840.1.113883.'] 13.10 - Refusal Reason R2/N

Optionality Legend: “R” for Required, “R2” for Required if known, “O” for Optional and Repeat = “Y” for Yes or “N” for No

Immunization Example

<!-- These examples assume the default namespace is 'urn:hl7-org:v3' -->
<substanceAdministration classCode='SBADM' moodCode='EVN'>
<templateId root='2.16.840.1.113883.'/>
<templateId root='2.16.840.1.113883.'/>
<templateId root=''/>
<code code='11369-6' displayName=' History of immunizations ' codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'>
<entryRelationship typeCode='SUBJ'> <!-- medication series -->
<value xsi:type='INT' value='2'/>
<entryRelationship typeCode='CAUS'> <!-- reaction -->
<performer typeCode='PRF'>
<manufacturedProduct classCode='MANU'>
<templateId root='2.16.840.1.113883.'/>
<code code='...' displayName='...' codeSystem='...' codeSystemName='...'/>
</substanceAdministration >

Section ID Constraint ID Definition
C83-[DE-13-CDA-1] A CDA Document SHALL declare conformance for the Immunization module by including a <templateID> element with the root attribute set to the value 2.16.840.1.113883.
C83-[DE-13-CDA-2] Immunization data elements SHALL declare conformance to the IHE Immunization entry by including a <templateID> element with the root attribute set to the value Coded Product Name Constraints Not Provided
C154-[DE-13.06-1] Immunizations SHALL be coded using CVX as specified in HITSP/C80 Section Vaccines Administered.
C83-[DE-13.06-CDA-1] The code SHALL appear in the code attribute of the <code> or <translation> element Refusal Reason Constraints Refusal Reason Constraints
C154-[DE-13.10-1] The reason for refusal SHALL be coded as specified in HITSP/C80 Section No Immunization Reason
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