CDA+-+Immunizations+Section

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Immunizations-1: entry_substanceAdministration
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 * **Element [clinicalDocument/component**
 * /structuredBody/component/section/]** || *entry/substanceAdministration* ||
 * || Immunization section SHOULD [1..*] medication activity clinical statement. CCD CONF-276 ||
 * || The Immunizations Section SHALL [1..*] immunization entries. HITSP C83-[CT-117-2] ||
 * || SHALL [1..*] medication administration entry model IHE 6.3.4.13.5 ||
 * **Proposal** || **SHALL [1..*] substanceAdministration[templateId/@root='immunization _substanceAdministration_template'].** ||

Immunizations-2: code
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 * **Element [clinicalDocument/component**
 * /structuredBody/component/section/]** || **substanceAdministration[templateId/root='immunization_ substanceAdministration_template’]** ||
 * || Not specified in CCD ||
 * || Not specified in HITSP ||
 * || SHALL [1..1] code. The code SHALL [1..1] @code, SHALL [1..1] @codeSystem. If no available code, a default code SHALL be used as following: code/@code SHALL be 'IMMUNIZ', @codeSystem SHALL be '2.16.840.1.113883.5.4' from HL7 ActCode. IHE 6.3.4.17.5 ||
 * **Old Proposal** || SHALL [1..1] code. The code SHALL [1..1] @code, SHALL [1..1] @codeSystem. If standard code is not available, a default code SHALL be used as following: code/@code SHALL be 'IMMUNIZ', @codeSystem SHALL be '2.16.840.1.113883.5.4' from HL7 ActCode. ||
 * **New Proposal** || **Updated on 3/25/2011: SHALL [1..1] code, which indicates the substanceAdministration was an immunization. The code SHALL [1..1] @code, and @codeSystem. The @code SHALL be 'IMMUNIZ', the @codeSystem SHALL be '2.16.840.1.113883.5. ' (HL7 ActCode).** ||

Immunizations-3: text
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 * **Element [clinicalDocument/component**
 * /structuredBody/component/section/]** || **substanceAdministration[templateId/root='immunization_substanceAdministration_template’]** ||
 * || Not specified in CCD ||
 * || Not specified in HITSP C83. ||
 * || SHALL [1..1] text/reference. The reference/@value SHALL be URI pointing to the corresponding narrative immunization description. IHE 6.3.4.17.6. ||
 * **Proposal** || **SHOULD [1..1] text/reference, the reference/@value SHALL have an URI pointing to the immunization narrative description.** ||

Immunizations-4: statusCode
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 * **Element [clinicalDocument/component**
 * /structuredBody/component/section/]** || **substanceAdministration[templateId/root='immunization_substanceAdministration_template’]** ||
 * || SHOULD [1..1] statusCode CCD CONF-307 ||
 * || Not specified in HITSP ||
 * || SHALL [1..1] statusCode. The value SHALL be 'completed' IHE6.3.4.17.7 ||
 * **Proposal** || **SHALL [1..1] statusCode with value 'completed'.** ||

Immunizations-5: effectiveTime
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 * **Element [clinicalDocument/component**
 * /structuredBody/component/section/]** || **substanceAdministration[templateId/root='immunization_substanceAdministration_template’]** ||
 * || SHOULD [1..*] effectiveTime. CCD CONF-308 ||
 * || Not specified in HITSP ||
 * || SHALL effectiveTime (cardinality not specified). If the date is unknown, this shall be recorded using the nullFlavor attribute, with the reason that the information is unknown being specified. Otherwise, the date shall be recorded, and should have precision of at least the day. IHE 6.3.4.17.8 ||
 * **Proposal** || **SHALL [1..1] effecttiveTime. If the date is unknown, the effectiveTime SHALL [1..1] @nullFlavor.**
 * The effectiveTime/@value SHOULD have precision of at least the day.** ||

Immunizations-6: routeCode
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 * **Element [clinicalDocument/component**
 * /structuredBody/component/section/]** || **substanceAdministration[templateId/root='immunization_substanceAdministration_template’]** ||
 * || SHOULD [1..1] routeCode from HL7 RouteOfAdministration codeSystem. CCD CONF-309, 310. ||
 * || SHOULD [1..1] routeCode, SHALL be coded as specified in HITSP/C80 Section 2.2.3.3.4.1 Medication Route FDA. HITSP C83-[DE-8.07\-CDA-1 ] ||
 * || SHALL [1..1] routeCode if known. SHALL NOT [1..1] if unknown. SHALL be selected from HL7 RouteOfAdministration codeSystem. IHE 6.3.4.16.13 ||
 * **Proposal** || **SHOULD [1..1] routeCode, which SHALL be selected from routeCode value set xxxx (HITSP/C80 Section 2.2.3.3.4.1 Medication Route FDA).** ||

Immunizations-7: approachSiteCode
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 * **Element [clinicalDocument/component**
 * /structuredBody/component/section/]** || **substanceAdministration[templateId/root='immunization_substanceAdministration_template’]** ||
 * || Not specified in CCD ||
 * || Not specified in HITSP ||
 * || SHOULD approachSiteCode (cardinality is not specified). If present, SHALL [1..1] originalText/reference, which SHALL [1..1] @value having an URI pointing to the body site narrative description. IHE 6.3.4.16.14. ||
 * **Old Proposal** || SHOULD [0..1] approachSiteCode. If present, SHOULD [1..1] originalText. The originalText SHOULD [1..1] reference, which SHOULD [1..1] @value with an URI pointing to corresponding body site narrative description. ||
 * **New Proposal** || **Updated on 3/28/2011:**
 * MAY [0..1] approachSiteCode.**
 * The value of @code SHALL be a value descending from SNOMED CT Anatomical Structure (91723000), or Acquired body structure (body structure) (280115004) or Anatomical site notations for tumor staging (body structure)(258331007), or Body structure, altered from its original anatomical structure (morphologic abnormality) (118956008), or Physical anatomical entity (body structure) (91722005) Source constraint: C154-[DE-8.09-1] / C80 Section 2.2.3.2.1 Body Site.** ||

Immunizations-8: doseQuantity
Units MAY be present when needed. If present it SHALL be coded as specified in HITSP/C80 Section 2.2.3.6.6 Units of Measurement. HITSP C154-[DE-8.08-1] When the coded product or brand name describes the strength or concentration of the medication, and the dosing is in administration units (e.g., 1 tablet, 2 capsules), units SHOULD contain the preferred name of the presentation units within braces { } using the units of presentation from the NCI Thesaurus HITSP C154-[DE-8.08-2] ||    If a dose range is given (e.g., 1-2 tablets, or 325-750mg), then the and bounds are specified in their respective elements, otherwise both and have the same value. If the dose is in countable units (tablets, caplets, "eaches"), then the unit attribute is not sent. Otherwise the units are sent. The unit attribute should be derived from the HL7 UnitsOfMeasureCaseSensitive vocabulary. IHE 6.3.4.16.15 Any and elements used for  or  should contain a element that provides a to the  found in the narrative body of the document. IHE 6.3.4.16.16 || The low or high SHOULD [1..1] translation/originalText/reference, which SHOULD [1..1] @value pointing to the narrative description for doseQuantity. The doseQuantity SHOULD [1..1] @unit. For doses in countable units, the value of @unit SHOULD be selected from units of presentation from NCI Thesaurus (http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162049.htm), or otherwise be selected from value set xxxx (HITSP/C80 Section 2.2.3.6.6 Units of Measurement). || (Back to the top)
 * **Element [clinicalDocument/component**
 * /structuredBody/component/section/]** || **substanceAdministration[templateId/root='immunization_substanceAdministration_template’]** ||
 * || SHOULD [1..1] doseQuantity or rateQuantity. CCD CONF-311 ||
 * || SHOULD [0..*] doseQuantity HITSP table 2-12
 * || SHALL doseQuantity (cardinality not specified) if known. doseQuantity SHALL [1..1] low, and [1..1] high. If dose is in countable unit, SHALL NOT [1..1] @unit, otherwise, SHALL [1..1] @unit, which SHOULD be selected from HL7 UnitsOfMeasureCaseSensitive. IHE 6.3.4.16.15
 * **Old Proposal** || SHALL [1..1] doseQuantity. If the dose is unknown, the doseQuantity SHALL [1..1] @nullFlavor. The doseQuantity SHALL [1..1] low, and [1..1] high.
 * **New Proposal** || **Updated on 3/28/2011:**
 * SHALL [1..1] doseQuantity. If the dose is unknown, the doseQuantity SHALL [1..1] @nullFlavor.**
 * When doses in strength/concentration, the doseQuantity SHALL [1..1] @unit, whose value SHALL be selected from value set (HITSP/C80 Section 2.2.3.6.6 Units of Measurement) . Example: **
 * When doses in countable units, the doseQuantity SHOULD [1..1] @unit, whose value SHALL be selected from NCI Thesaurus ([]), surrounded by "{}". Example: ** ||

Immunizations-9: consumable_manufacturedProduct_ manufacturedMaterial_code (comments)
The code SHALL [1..1] originalText. (HITSP table 2-18) The code SHALL [1..1] @code. HITSP C83-[DE-13.06\-CDA-1 ] The code/@code SHALL be selected from value set xxxx (HITSP/C80 Section 2.2.3.5.1 Vaccines Administered). HITSP C154-[DE-13.06-1] || Cardinality is not specified (i.e. 1..1, CDA default is 0..1) If present, the code SHALL [1..1] @code, and [1..1] @codeSystem, SHOULD [1..1] @displayName. IHE 6.3.4.19.3 If present, the code SHALL [1..1] originalText/reference, whose URI value points to the generic name and strength of the medication, or just the generic name alone if strength is not relevant. IHE 6.3.4.19.3 || If the vaccination code does not exist, the code SHALL [1..1] @nullFlavor='OTH'. If code exists, SHALL [1..1] @code, [1..1] @codeSystem, SHOULD [1..1] @displayName. The value of code SHALL be selected from value set xxxx (HITSP/C80 Section 2.2.3.5.1 Vaccines Administered) The code SHALL [1..1] originalText, which contains free text product name. || (Back to the top)
 * **Element [clinicalDocument/component**
 * /structuredBody/component/section/]** || **substanceAdministration[templateId/root='immunization_substanceAdministration_template']/consumable/manufacturedProceduct/manufacturedMaterial** ||
 * || Not specified in CCD ||
 * || SHALL [1..1] code if known (HITSP table 2-18)
 * || Conformance strength is not specified (i.e. shall, should, may).
 * **Old Proposal** || SHALL [1..1] code.
 * **New Proposal** || **Updated on 3/25/2011:**
 * SHALL [1..1] code. The value of code SHALL be selected from value set "HITSP/C80 Section 2.2.3.5.1 Vaccines Administered”. Both code/@code, and code/@codeSystem SHALL present. If code is not available from the value set, @nullFlavor="UNK" SHALL present.**
 * The code SHOULD [0..1] originalText, which contains free text product name.** ||

Immunizations-10: performer
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 * **Element [clinicalDocument/component**
 * /structuredBody/component/section/]** || **substanceAdministration[templateId/root='immunization_substanceAdministration_template’]** ||
 * || MAY [1..*] performer CCD CONF-313 ||
 * || MAY [1..1] performer HITSP table 2-18 ||
 * || Not specified in IHE ||
 * **Proposal** || **MAY [1..1] performer** ||

Immunizations-11: medication series number (entryRelationship_observation)
The observation SHALL conform to CCD medication series number observation template (2.16.840.1.113883.10.20.1.46) IHE 6.3.4.17.14. The observation SHALL [1..1] code. The code SHALL [1..1] @code with value '30973-2', SHALL [1..1] @codeSystem with value '2.16.840.1.113883.6.1'. IHE 6.3.4.17.15 The observation SHALL [1..1] statusCode/@code, the @code SHALL be 'completed'. IHE 6.3.4.17.16 The observation SHALL [1..1] value with data type INT (xsi:type='INT'), the value/@value SHALL be assigned. IHE 6.3.4.17.17 || (Back to the top)
 * **Element [clinicalDocument/component**
 * /structuredBody/component/section/]** || **substanceAdministration[templateId/root='immunization_substanceAdministration_template’]** ||
 * || Not specified in CCD. ||
 * || Not specified in HITSP ||
 * || SHOULD [0..1] entryRelationship[@typeCode='SUBJ']/observation [@classCode='OBS'][@moodCode='EVN'] to indicate the position of this immunization in a series of immunizations. IHE 6.3.4.17.14.
 * **Proposal** || **SHOULD [0..1] entryRelasitonship[@typeCode='SUBJ']/observation to indicate the position of this immunization in a series of immunization.**
 * The observation SHALL conform to CCD medication series number observation template (2.16.840.1.113883.10.20.1.46).**
 * The observation/statusCode SHALL be 'completed'.** ||

Immunizations-12: adverse reaction observation (entryRelationship_observation)
The observation SHALL conform to problem observation template. IHE 6.3.4.17.18. || (Back to the top)
 * **Element [clinicalDocument/component**
 * /structuredBody/component/section/]** || **substanceAdministration[templateId/root='immunization_substanceAdministration_template’]** ||
 * || Not specified in CCD ||
 * || SHOULD [0..*] entryRelationship [@typeCode='CAUS']/observation. HITSP table 2-18 ||
 * || SHOULD [0..*] entryRelationship [@typeCode='CAUS']/observation.
 * **Proposal** || **SHOULD [0..*] entryRelationship[@typeCode='CAUS']/observation to identify adverse reaction caused by the immunization.**
 * The observation SHALL conform to problem observation template.** ||

Immunizations-13: prescription activity (entryRelationship_supply)
The supply SHALL conform to supply template. IHE 6.3.4.17.13 || (Back to the top)
 * **Element [clinicalDocument/component**
 * /structuredBody/component/section/]** || **substanceAdministration[templateId/root='immunization_substanceAdministration_template’]** ||
 * || Not specified in CCD ||
 * || Not specified in HITSP ||
 * || SHOULD [0..1] entryRelationship[@typeCode='REFR']/supply to provide prescription activity.
 * **Proposal** || **SHOULD [0..1] entryRelationship[@typeCode='REFR']/supply to provide related prescription activity.**
 * The supply SHALL conform to supply activity template.** ||

Immunizations-14: refusal reason (entryRelationship_act)
The reason for refusal SHALL be coded as specified in HITSP/C80 Section 2.2.3.5.3 No Immunization Reason. HITSP C154-[DE-13.10-1] || An immunization entry can have negationInd set to true to indicate that an immunization did not occur. In this case, it shall have at least one comment that provides an explaination for why the immunization did not take place. Other comments may also be present. IHE 6.3.4.17.22 || (Back to the top)
 * **Element [clinicalDocument/component**
 * /structuredBody/component/section/]** || **substanceAdministration[templateId/root='immunization_substanceAdministration_template’]** ||
 * || Not specified in CCD ||
 * || If substanceAdministration[@negationInd='true'], SHALL [1..1] entryRelationship[@typeCode=’RSON’] / act[templateId/@root='problem_act_template'] to specify refusal reason. HITSP table 2-18
 * || If substanceAdministration[@negationInd='true'], SHALL [1..*] entryRelationship [@typeCode='SUBJ'][@inversionInd='true'] /act[templateId/@root='comment_template']
 * **Proposal** || **If substanceAdministration[@negationInd='true'],**
 * SHALL [1..1] entryRelationship[@typeCode='RSON]/ act[templateId/@root='problem_act_template'] to provide refusal reason.**
 * The act SHALL conform to problem act template.**
 * The act/code SHALL be selected from value set xxxx (HITSP/C80 Section 2.2.3.5.3 No Immunization Reason)** ||