Non-Normative Content The Normative content for these specifications may be found on the HL7, IHE, and HITSP web sites.

Immunization Activity

[SubstanceAdministration: templateId 2.16.840.1.113883.10.20.22.4.52]

An Immunization Activity describes immunization substance administrations that have actually occurred or are intended to occur. 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.

An Immunization Activity is very similar to a Medication Activity with some key differentiators. The drug code system is constrained to CVX codes. Administration timing is less complex. Patient refusal reasons should be captured. All vaccines administered should be fully documented in the patient's permanent medical record. Healthcare providers who administer vaccines covered by the National Childhood Vaccine Injury Act are required to ensure that the permanent medical record of the recipient indicates:

  1. Date of administration
  2. Vaccine manufacturer
  3. Vaccine lot number
  4. Name and title of the person who administered the vaccine and the address of the clinic or facility where the permanent record will reside
  5. Vaccine information statement (VIS)
    1. date printed on the VIS
    2. date VIS given to patient or parent/guardian.
  1. SHALL contain exactly one [1..1] templateId ( CONF:10498 ) such that it
    1. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.52"
  2. SHALL contain exactly one [1..1] @classCode="SBADM" (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) (CONF:8826)
  3. SHALL contain exactly one [1..1] @moodCode, where the @code SHALL be selected from ValueSet MoodCodeEvnInt 2.16.840.1.113883.11.20.9.18 STATIC 2011-04-03 (CONF:8827)
  4. SHALL contain exactly one [1..1] @negationInd (CONF:8985)
    • Use negationInd="true" to indicate that the immunization was not given.

  5. SHALL contain at least one [1..*] id (CONF:8829)
  6. MAY contain zero or one [0..1] code (CONF:8830)
  7. SHALL contain exactly one [1..1] statusCode (CONF:8833)
  8. SHALL contain exactly one [1..1] effectiveTime (CONF:8834)
  9. MAY contain zero or one [0..1] routeCode, where the @code SHALL be selected from ValueSet Medication Route FDA Value Set 2.16.840.1.113883.3.88.12.3221.8.7 STATIC 1 (CONF:8839)
  10. MAY contain zero or one [0..1] approachSiteCode, where the @code SHALL be selected from ValueSet Body Site Value Set 2.16.840.1.113883.3.88.12.3221.8.9 STATIC 2 (CONF:8840)
  11. SHOULD contain zero or one [0..1] doseQuantity (CONF:8841)
  12. MAY contain zero or one [0..1] participant (CONF:8850, CONF:8851, CONF:15547)
    1. Contains exactly one [1..1] Drug Vehicle (templateId: 2.16.840.1.113883.10.20.22.4.24)
  13. MAY contain zero or one [0..1] entryRelationship (CONF:8853, CONF:8854, CONF:15537)
    1. Contains @typeCode="RSON" RSON
    2. Contains exactly one [1..1] Indication (templateId: 2.16.840.1.113883.10.20.22.4.19)
  14. MAY contain zero or one [0..1] entryRelationship (CONF:8856, CONF:8857, CONF:15538)
    1. Contains @typeCode="SUBJ" SUBJ
    2. Contains exactly one [1..1] Instructions (templateId: 2.16.840.1.113883.10.20.22.4.20)
  15. MAY contain zero or one [0..1] entryRelationship (CONF:8863, CONF:8864, CONF:15540)
    1. Contains @typeCode="REFR" REFR
    2. Contains exactly one [1..1] Medication Dispense (templateId: 2.16.840.1.113883.10.20.22.4.18)
  16. MAY contain zero or one [0..1] entryRelationship (CONF:8866, CONF:8867, CONF:15541)
    1. Contains @typeCode="CAUS" CAUS
    2. Contains exactly one [1..1] Reaction Observation (templateId: 2.16.840.1.113883.10.20.22.4.9)
  17. MAY contain zero or one [0..1] precondition (CONF:8869, CONF:8870, CONF:15548)
    1. Contains exactly one [1..1] Precondition For Substance Administration (templateId: 2.16.840.1.113883.10.20.22.4.25)
  18. MAY contain zero or one [0..1] entryRelationship (CONF:8988, CONF:8989, CONF:15542)
    1. Contains @typeCode="RSON" RSON
    2. Contains exactly one [1..1] Immunization Refusal Reason (templateId: 2.16.840.1.113883.10.20.22.4.53)
  19. SHALL contain exactly one [1..1] consumable (CONF:8847)
    1. This consumable SHALL contain exactly one [1..1] manufacturedProduct, where its type is Immunization Medication Information (CONF:15546)
      1. Contains exactly one [1..1] Immunization Medication Information (templateId: 2.16.840.1.113883.10.20.22.4.54)
  20. SHOULD contain zero or one [0..1] text (CONF:8831)
  21. MAY contain zero or one [0..1] repeatNumber (CONF:8838)
    • In "INT" (intent) mood, the repeatNumber defines the number of allowed administrations. For example, a repeatNumber of "3" means that the substance can be administered up to 3 times. In "EVN" (event) mood, the repeatNumber is the number of occurrences. For example, a repeatNumber of "3" in a dispense act means that the current dispensation is the 3rd. A repeatNumber of "3" in a substance administration event means that the current administration is the 3rd in a series. (CONF:8987).

  22. MAY contain zero or one [0..1] administrationUnitCode (CONF:8846), where the @code SHALL be selected from ValueSet Medication Product Form Value Set 2.16.840.1.113883.3.88.12.3221.8.11 STATIC 1
  23. SHOULD contain zero or one [0..1] performer (CONF:8849)
    1. Contains exactly one [1..1] CDA Performer2
  24. MAY contain zero or one [0..1] entryRelationship (CONF:8860, CONF:8861, CONF:15539)
    1. Contains @typeCode="REFR" REFR
    2. Contains exactly one [1..1] Medication Supply Order (templateId: 2.16.840.1.113883.10.20.22.4.17)
  25. This text, if present, SHOULD contain zero or one [0..1] reference (CONF:15543)
  26. reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15544)
  27. This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1. (CONF:15545)
  28. doseQuantity, if present, SHOULD contain zero or one [0..1] @unit, which SHALL be selected from ValueSet UCUM Units of Measure (case sensitive) 2.16.840.1.113883.1.11.12839 DYNAMIC (CONF:8842)
  29. entryRelationship with target entry Instructions SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:8858)
  30. participant with target entry Drug Vehicle SHALL contain exactly one [1..1] @typeCode="CSM" (CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90) (CONF:8851)
  31. Precondition for Substance Adminstration SHALL contain exactly one [1..1] @typeCode="PRCN" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:8870)

Immunization Activity example

<substanceadministration xmlns="urn:hl7-org:v3">
  <id root="MDHT" extension="1748175814"/>
  <code code="335631200"/>
  <text>Text Value</text>
  <statusCode code="completed"/>
  <effectiveTime value="20130627"/>
  <repeatNumber value="1"/>
  <routeCode code="398655745"/>
  <approachSiteCode code="1733009301"/>
  <doseQuantity/>
  <administrationUnitCode code="302553653"/>
  <consumable>
    <manufacturedProduct>
      <id root="MDHT" extension="974325640"/>
      <manufacturedMaterial>
        <code codeSystem="2.16.840.1.113883.12.292" codeSystemName="Vaccines administered (CVX)"/>
      </manufacturedMaterial>
      <manufacturerOrganization/>
    </manufacturedProduct>
  </consumable>
  <performer/>
  <entryRelationship>
    <observation>
      <id root="MDHT" extension="109581967"/>
      <code code="853689711"/>
      <text>Text Value</text>
      <statusCode code="completed"/>
      <effectiveTime>
        <low value="2013"/>
        <high value="2013"/>
      </effectiveTime>
      <repeatNumber value="1"/>
    </observation>
  </entryRelationship>
  <entryRelationship>
    <act>
      <id root="MDHT" extension="2065040719"/>
      <code code="1300503965"/>
      <text>Text Value</text>
      <statusCode code="completed"/>
      <effectiveTime>
        <low value="2013"/>
        <high value="2013"/>
      </effectiveTime>
    </act>
  </entryRelationship>
  <entryRelationship>
    <supply>
      <id root="MDHT" extension="1463994974"/>
      <code code="600390680"/>
      <text>Text Value</text>
      <statusCode code="completed"/>
      <effectiveTime value="20130627"/>
      <repeatNumber value="1"/>
      <performer>
        <assignedEntity/>
      </performer>
      <entryRelationship>
        <supply>
          <id root="MDHT" extension="1344738139"/>
          <code code="1089112090"/>
          <text>Text Value</text>
          <statusCode code="completed"/>
          <effectiveTime value="20130627"/>
          <repeatNumber value="1"/>
          <author/>
          <entryRelationship>
            <act/>
          </entryRelationship>
        </supply>
      </entryRelationship>
    </supply>
  </entryRelationship>
  <entryRelationship>
    <observation>
      <id root="MDHT" extension="1645737970"/>
      <code code="1863116578"/>
      <text>Text Value</text>
      <statusCode code="completed"/>
      <effectiveTime>
        <low value="2013"/>
        <high value="2013"/>
      </effectiveTime>
      <repeatNumber value="1"/>
      <entryRelationship>
        <observation>
          <id root="MDHT" extension="361474313"/>
          <code code="424717258"/>
          <text>Text Value</text>
          <statusCode code="completed"/>
          <effectiveTime>
            <low value="2013"/>
            <high value="2013"/>
          </effectiveTime>
          <repeatNumber value="1"/>
        </observation>
      </entryRelationship>
      <entryRelationship>
        <procedure>
          <id root="MDHT" extension="1368943685"/>
          <code code="904546694"/>
          <text>Text Value</text>
          <statusCode code="completed"/>
          <effectiveTime>
            <low value="2013"/>
            <high value="2013"/>
          </effectiveTime>
          <approachSiteCode code="643837628"/>
          <specimen/>
          <performer/>
          <entryRelationship typeCode="COMP" inversionInd="true"/>
          <entryRelationship>
            <observation/>
          </entryRelationship>
          <entryRelationship>
            <substanceAdministration/>
          </entryRelationship>
          <entryRelationship>
            <act/>
          </entryRelationship>
        </procedure>
      </entryRelationship>
      <entryRelationship>
        <substanceAdministration>
          <id root="MDHT" extension="1001857135"/>
          <code code="137352747"/>
          <text>Text Value</text>
          <statusCode code="completed"/>
          <effectiveTime value="20130627"/>
          <repeatNumber value="1"/>
          <routeCode code="511179707"/>
          <approachSiteCode code="1825849270"/>
          <doseQuantity/>
          <administrationUnitCode code="1017565226"/>
          <consumable/>
          <performer/>
          <entryRelationship>
            <supply/>
          </entryRelationship>
          <entryRelationship>
            <observation/>
          </entryRelationship>
          <entryRelationship>
            <act/>
          </entryRelationship>
          <entryRelationship>
            <observation/>
          </entryRelationship>
          <entryRelationship>
            <supply/>
          </entryRelationship>
          <precondition/>
        </substanceAdministration>
      </entryRelationship>
    </observation>
  </entryRelationship>
  <entryRelationship>
    <observation>
      <id root="MDHT" extension="1221243388"/>
      <code code="399723103"/>
      <text>Text Value</text>
      <statusCode code="completed"/>
      <effectiveTime>
        <low value="2013"/>
        <high value="2013"/>
      </effectiveTime>
      <repeatNumber value="1"/>
    </observation>
  </entryRelationship>
  <entryRelationship>
    <supply>
      <id root="MDHT" extension="143774022"/>
      <code code="979681898"/>
      <text>Text Value</text>
      <statusCode code="completed"/>
      <effectiveTime value="20130627"/>
      <repeatNumber value="1"/>
      <author/>
      <entryRelationship>
        <act>
          <id root="MDHT" extension="1763459622"/>
          <code code="669809951"/>
          <text>Text Value</text>
          <statusCode code="completed"/>
          <effectiveTime>
            <low value="2013"/>
            <high value="2013"/>
          </effectiveTime>
        </act>
      </entryRelationship>
    </supply>
  </entryRelationship>
  <precondition>
    <criterion/>
  </precondition>
</substanceadministration>