Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
| Active as of 2024-12-04 |
XML representation of the ectd-composition-32p32 resource profile.
<StructureDefinition xmlns="http://hl7.org/fhir">
<id value="ectd-composition-32p32"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: StructureDefinition ectd-composition-32p32</b></p><a name="ectd-composition-32p32"> </a><a name="hcectd-composition-32p32"> </a><a name="ectd-composition-32p32-en-US"> </a><table border="0" cellpadding="0" cellspacing="0" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top"><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="The logical name of the element">Name</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Information about the use of the element">Flags</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Minimum and Maximum # of times the element can appear in the instance">Card.</a></th><th style="width: 100px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Reference to the type of the element">Type</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Additional information about the element">Description & Constraints</a><span style="float: right"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_resource.png" alt="." style="background-color: white; background-color: inherit" title="Resource" class="hierarchy"/> <a href="StructureDefinition-ectd-composition-32p32-definitions.html#Composition">Composition</a><a name="Composition"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/composition.html">Composition</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-ectd-composition-32p32-definitions.html#Composition.identifier">identifier</a><a name="Composition.identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span>..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#Identifier">Identifier</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Version-independent identifier for the Composition</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-ectd-composition-32p32-definitions.html#Composition.status">status</a><a name="Composition.status"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">final</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-ectd-composition-32p32-definitions.html#Composition.type">type</a><a name="Composition.type"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Kind of composition (LOINC if possible)</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding">coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Code defined by a terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">(complex)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system">system</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Identity of the terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Symbol in syntax defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">32P32</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Representation defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">Product Batch Formula</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: white; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="StructureDefinition-ectd-composition-32p32-definitions.html#Composition.author">author</a><a name="Composition.author"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span>..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-literal-reference.html" title="Literal Reference">LiteralReference</a>(<a href="StructureDefinition-cmc-organization.html">Basic Organization</a>)<a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html"> {</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html" title="When the resource is in a Bundle, the resource the reference points to will be found in the same bundle as the resource that includes the reference.">b</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html">}</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Who and/or what authored the composition</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck03.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Definition" class="hierarchy"/> <a style="font-style: italic" href="StructureDefinition-ectd-composition-32p32-definitions.html#Composition.section">Slices for section</a><a name="Composition.section"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic"/><span style="font-style: italic">1</span><span style="font-style: italic">..</span><span style="opacity: 0.5; font-style: italic">*</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; font-style: italic" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5; font-style: italic">Composition is broken into sections</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Open by value:code</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck033.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> section:All Slices<a name="Composition.section.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Content/Rules for all slices</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0320.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-ectd-composition-32p32-definitions.html#Composition.section.code">code</a><a name="Composition.section.code"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Classification of section (recommended)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck025.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-ectd-composition-32p32-definitions.html#Composition.section:BatchFormulaMedicinalProduct" title="Slice BatchFormulaMedicinalProduct: Product Batch Formula to be included under the 3.2.P.3.2 eCTD heading.">section:BatchFormulaMedicinalProduct</a><a name="Composition.section.3"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Composition is broken into sections</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0250.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-ectd-composition-32p32-definitions.html#Composition.section:BatchFormulaMedicinalProduct.title">title</a><a name="Composition.section.title"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Label for section (e.g. for ToC)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0251.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-ectd-composition-32p32-definitions.html#Composition.section:BatchFormulaMedicinalProduct.code">code</a><a name="Composition.section.code.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Classification of section (recommended)</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck02501.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding">coding</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Code defined by a terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">(complex)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck025010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system">system</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Identity of the terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck025010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code">code</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Symbol in syntax defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">ich_3.2.p.3.2</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck025000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Representation defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">Batch Formula</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0240.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="StructureDefinition-ectd-composition-32p32-definitions.html#Composition.section:BatchFormulaMedicinalProduct.entry">entry</a><a name="Composition.section.entry"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-literal-reference.html" title="Literal Reference">LiteralReference</a>(<a href="StructureDefinition-pqcmc-batch-formula-product.html">Batch Formula Drug Product Identification</a>)<a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html"> {</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html" title="When the resource is in a Bundle, the resource the reference points to will be found in the same bundle as the resource that includes the reference.">b</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html">}</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">A reference to data that supports this section</span></td></tr>
<tr><td colspan="5" class="hierarchy"><br/><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAABmJLR0QA/wD/AP+gvaeTAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3goXBCwdPqAP0wAAAldJREFUOMuNk0tIlFEYhp9z/vE2jHkhxXA0zJCMitrUQlq4lnSltEqCFhFG2MJFhIvIFpkEWaTQqjaWZRkp0g26URZkTpbaaOJkDqk10szoODP//7XIMUe0elcfnPd9zsfLOYplGrpRwZaqTtw3K7PtGem7Q6FoidbGgqHVy/HRb669R+56zx7eRV1L31JGxYbBtjKK93cxeqfyQHbehkZbUkK20goELEuIzEd+dHS+qz/Y8PTSif0FnGkbiwcAjHaU1+QWOptFiyCLp/LnKptpqIuXHx6rbR26kJcBX3yLgBfnd7CxwJmflpP2wUg0HIAoUUpZBmKzELGWcN8nAr6Gpu7tLU/CkwAaoKTWRSQyt89Q8w6J+oVQkKnBoblH7V0PPvUOvDYXfopE/SJmALsxnVm6LbkotrUtNowMeIrVrBcBpaMmdS0j9df7abpSuy7HWehwJdt1lhVwi/J58U5beXGAF6c3UXLycw1wdFklArBn87xdh0ZsZtArghBdAA3+OEDVubG4UEzP6x1FOWneHh2VDAHBAt80IbdXDcesNoCvs3E5AFyNSU5nbrDPZpcUEQQTFZiEVx+51fxMhhyJEAgvlriadIJZZksRuwBYMOPBbO3hePVVqgEJhFeUuFLhIPkRP6BQLIBrmMenujm/3g4zc398awIe90Zb5A1vREALqneMcYgP/xVQWlG+Ncu5vgwwlaUNx+3799rfe96u9K0JSDXcOzOTJg4B6IgmXfsygc7/Bvg9g9E58/cDVmGIBOP/zT8Bz1zqWqpbXIsd0O9hajXfL6u4BaOS6SeWAAAAAElFTkSuQmCC" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
<valueCode value="brr"/>
</extension>
<url
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p32"/>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:oid:2.16.840.1.113883.4.642.40.36.42.38"/>
</identifier>
<version value="2.0.0-ballot"/>
<name value="EctdComposition32P32"/>
<title value="eCTD Batch Formula"/>
<status value="active"/>
<date value="2024-12-04T20:50:29+00:00"/>
<publisher value="HL7 International / Biomedical Research and Regulation"/>
<contact>
<name value="HL7 International / Biomedical Research and Regulation"/>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/rcrim"/>
</telecom>
<telecom>
<system value="email"/>
<value value="brr@lists.HL7.org"/>
</telecom>
</contact>
<description
value="The fields needed to represent the Product Batch Formula to be included under the eCTD. References Sponsor Organization and Batch Formula"/>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="US"/>
<display value="United States of America"/>
</coding>
</jurisdiction>
<fhirVersion value="5.0.0"/>
<mapping>
<identity value="workflow"/>
<uri value="http://hl7.org/fhir/workflow"/>
<name value="Workflow Pattern"/>
</mapping>
<mapping>
<identity value="w5"/>
<uri value="http://hl7.org/fhir/fivews"/>
<name value="FiveWs Pattern Mapping"/>
</mapping>
<mapping>
<identity value="rim"/>
<uri value="http://hl7.org/v3"/>
<name value="RIM Mapping"/>
</mapping>
<mapping>
<identity value="cda"/>
<uri value="http://hl7.org/v3/cda"/>
<name value="CDA (R2)"/>
</mapping>
<mapping>
<identity value="fhirdocumentreference"/>
<uri value="http://hl7.org/fhir/documentreference"/>
<name value="FHIR DocumentReference"/>
</mapping>
<kind value="resource"/>
<abstract value="false"/>
<type value="Composition"/>
<baseDefinition
value="http://hl7.org/fhir/StructureDefinition/Composition"/>
<derivation value="constraint"/>
<snapshot>
<element id="Composition">
<path value="Composition"/>
<short
value="A set of resources composed into a single coherent clinical statement with clinical attestation"/>
<definition
value="A set of healthcare-related information that is assembled together into a single logical package that provides a single coherent statement of meaning, establishes its own context and that has clinical attestation with regard to who is making the statement. A Composition defines the structure and narrative content necessary for a document. However, a Composition alone does not constitute a document. Rather, the Composition must be the first entry in a Bundle where Bundle.type=document, and any other resources referenced from Composition must be included as subsequent entries in the Bundle (for example Patient, Practitioner, Encounter, etc.)."/>
<comment
value="While the focus of this specification is on patient-specific clinical statements, this resource can also apply to other healthcare-related statements such as study protocol designs, healthcare invoices and other activities that are not necessarily patient-specific or clinical."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Composition"/>
<min value="0"/>
<max value="*"/>
</base>
<constraint>
<key value="dom-2"/>
<severity value="error"/>
<human
value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/>
<expression value="contained.contained.empty()"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-3"/>
<severity value="error"/>
<human
value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource"/>
<expression
value="contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-4"/>
<severity value="error"/>
<human
value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/>
<expression
value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-5"/>
<severity value="error"/>
<human
value="If a resource is contained in another resource, it SHALL NOT have a security label"/>
<expression value="contained.meta.security.empty()"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">
<valueMarkdown
value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."/>
</extension>
<key value="dom-6"/>
<severity value="warning"/>
<human
value="A resource should have narrative for robust management"/>
<expression value="text.`div`.exists()"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map
value="Entity, Role, or Act,Document[classCode="DOC" and moodCode="EVN" and isNormalAct()]"/>
</mapping>
<mapping>
<identity value="workflow"/>
<map value="Event"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="infrastructure.documents"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value="ClinicalDocument"/>
</mapping>
<mapping>
<identity value="fhirdocumentreference"/>
<map value="when described by DocumentReference"/>
</mapping>
</element>
<element id="Composition.id">
<path value="Composition.id"/>
<short value="Logical id of this artifact"/>
<definition
value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes."/>
<comment
value="Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="id"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="Composition.meta">
<path value="Composition.meta"/>
<short value="Metadata about the resource"/>
<definition
value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.meta"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Meta"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="Composition.implicitRules">
<path value="Composition.implicitRules"/>
<short value="A set of rules under which this content was created"/>
<definition
value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc."/>
<comment
value="Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.implicitRules"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="uri"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="true"/>
<isModifierReason
value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation"/>
<isSummary value="true"/>
</element>
<element id="Composition.language">
<path value="Composition.language"/>
<short value="Language of the resource content"/>
<definition
value="The base language in which the resource is written."/>
<comment
value="Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.language"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="Language"/>
</extension>
<strength value="required"/>
<description value="IETF language tag for a human language"/>
<valueSet value="http://hl7.org/fhir/ValueSet/all-languages|5.0.0"/>
<additional>
<purpose value="starter"/>
<valueSet value="http://hl7.org/fhir/ValueSet/languages"/>
</additional>
</binding>
</element>
<element id="Composition.text">
<path value="Composition.text"/>
<short value="Text summary of the resource, for human interpretation"/>
<definition
value="A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety."/>
<comment
value="Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later."/>
<alias value="narrative"/>
<alias value="html"/>
<alias value="xhtml"/>
<alias value="display"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="DomainResource.text"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Narrative"/>
</type>
<condition value="dom-6"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="Act.text?"/>
</mapping>
</element>
<element id="Composition.contained">
<path value="Composition.contained"/>
<short value="Contained, inline Resources"/>
<definition
value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning."/>
<comment
value="This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels."/>
<alias value="inline resources"/>
<alias value="anonymous resources"/>
<alias value="contained resources"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.contained"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Resource"/>
</type>
<condition value="dom-2"/>
<condition value="dom-4"/>
<condition value="dom-3"/>
<condition value="dom-5"/>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Composition.extension">
<path value="Composition.extension"/>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Composition.modifierExtension">
<path value="Composition.modifierExtension"/>
<short value="Extensions that cannot be ignored"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Composition.url">
<path value="Composition.url"/>
<short
value="Canonical identifier for this Composition, represented as a URI (globally unique)"/>
<definition
value="An absolute URI that is used to identify this Composition when it is referenced in a specification, model, design or an instance; also called its canonical identifier. This SHOULD be globally unique and SHOULD be a literal address at which an authoritative instance of this Composition is (or will be) published. This URL can be the target of a canonical reference. It SHALL remain the same when the Composition is stored on different servers."/>
<comment
value="Can be a urn:uuid: or a urn:oid: but real http: addresses are preferred. Multiple instances may share the same URL if they have a distinct version."/>
<requirements
value="Allows the Composition to be referenced by a single globally unique identifier."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Composition.url"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="uri"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="w5"/>
<map value="FiveWs.identifier"/>
</mapping>
</element>
<element id="Composition.identifier">
<path value="Composition.identifier"/>
<short value="Version-independent identifier for the Composition"/>
<definition
value="A version-independent identifier for the Composition. This identifier stays constant as the composition is changed over time."/>
<comment
value="Similar to ClinicalDocument/setId in CDA. See discussion in resource definition for how these relate."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Composition.identifier"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Identifier"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="workflow"/>
<map value="Event.identifier"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.identifier"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Document.id / Document.setId"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".setId"/>
</mapping>
<mapping>
<identity value="fhirdocumentreference"/>
<map value="DocumentReference.identifier"/>
</mapping>
</element>
<element id="Composition.version">
<path value="Composition.version"/>
<short
value="An explicitly assigned identifer of a variation of the content in the Composition"/>
<definition
value="An explicitly assigned identifer of a variation of the content in the Composition."/>
<comment
value="While each resource, including the composition itself, has its own version identifier, this is a formal identifier for the logical version of the Composition as a whole. It would remain constant if the resources were moved to a new server, and all got new individual resource versions, for example."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Composition.version"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="w5"/>
<map value="FiveWs.version"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".versionNumber"/>
</mapping>
<mapping>
<identity value="fhirdocumentreference"/>
<map value="DocumentReference.version"/>
</mapping>
</element>
<element id="Composition.status">
<path value="Composition.status"/>
<short
value="registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown"/>
<definition
value="The workflow/clinical status of this composition. The status is a marker for the clinical standing of the document."/>
<comment
value="If a composition is marked as withdrawn, the compositions/documents in the series, or data from the composition or document series, should never be displayed to a user without being clearly marked as untrustworthy. The flag "entered-in-error" is why this element is labeled as a modifier of other elements.
Some reporting work flows require that the original narrative of a final document never be altered; instead, only new narrative can be added. The composition resource has no explicit status for explicitly noting whether this business rule is in effect. This would be handled by an extension if required."/>
<requirements
value="Need to be able to mark interim, amended, or withdrawn compositions or documents."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Composition.status"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<patternCode value="final"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="true"/>
<isModifierReason
value="This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="CompositionStatus"/>
</extension>
<strength value="required"/>
<description
value="The workflow/clinical status of the composition."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/composition-status|5.0.0"/>
</binding>
<mapping>
<identity value="workflow"/>
<map value="Event.status"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.status"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="interim: .completionCode="IN" & ./statusCode[isNormalDatatype()]="active"; final: .completionCode="AU" && ./statusCode[isNormalDatatype()]="complete" and not(./inboundRelationship[typeCode="SUBJ" and isNormalActRelationship()]/source[subsumesCode("ActClass#CACT") and moodCode="EVN" and domainMember("ReviseComposition", code) and isNormalAct()]); amended: .completionCode="AU" && ./statusCode[isNormalDatatype()]="complete" and ./inboundRelationship[typeCode="SUBJ" and isNormalActRelationship()]/source[subsumesCode("ActClass#CACT") and moodCode="EVN" and domainMember("ReviseComposition", code) and isNormalAct() and statusCode="completed"]; withdrawn : .completionCode=NI && ./statusCode[isNormalDatatype()]="obsolete""/>
</mapping>
<mapping>
<identity value="cda"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="fhirdocumentreference"/>
<map value="DocumentReference.docStatus"/>
</mapping>
</element>
<element id="Composition.type">
<path value="Composition.type"/>
<short value="Kind of composition (LOINC if possible)"/>
<definition
value="Specifies the particular kind of composition (e.g. History and Physical, Discharge Summary, Progress Note). This usually equates to the purpose of making the composition."/>
<comment
value="For Composition type, LOINC is ubiquitous and strongly endorsed by HL7. Most implementation guides will require a specific LOINC code, or use LOINC as an extensible binding."/>
<requirements
value="Key metadata element describing the composition, used in searching/filtering."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Composition.type"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<patternCodeableConcept>
<coding>
<system
value="http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use"/>
<code value="32P32"/>
<display value="Product Batch Formula"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="DocumentType"/>
</extension>
<strength value="preferred"/>
<description value="Type of a composition."/>
<valueSet value="http://hl7.org/fhir/ValueSet/doc-typecodes"/>
</binding>
<mapping>
<identity value="workflow"/>
<map value="Event.code"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.class"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="./code"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".code"/>
</mapping>
<mapping>
<identity value="fhirdocumentreference"/>
<map value="DocumentReference.type"/>
</mapping>
</element>
<element id="Composition.category">
<path value="Composition.category"/>
<short value="Categorization of Composition"/>
<definition
value="A categorization for the type of the composition - helps for indexing and searching. This may be implied by or derived from the code specified in the Composition Type."/>
<requirements
value="Helps humans to assess whether the composition is of interest when viewing an index of compositions or documents."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Composition.category"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="DocumentCategory"/>
</extension>
<strength value="example"/>
<description
value="High-level kind of a clinical document at a macro level."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/referenced-item-category"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.class"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value=".outboundRelationship[typeCode="COMP].target[classCode="LIST", moodCode="EVN"].code"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="fhirdocumentreference"/>
<map value="DocumenttReference.category"/>
</mapping>
</element>
<element id="Composition.subject">
<path value="Composition.subject"/>
<short value="Who and/or what the composition is about"/>
<definition
value="Who or what the composition is about. The composition can be about a person, (patient or healthcare practitioner), a device (e.g. a machine) or even a group of subjects (such as a document about a herd of livestock, or a set of patients that share a common exposure)."/>
<comment value="For clinical documents, this is usually the patient."/>
<requirements
value="Essential metadata for searching for the composition. Identifies who and/or what the composition/document is about."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Composition.subject"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Resource"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="workflow"/>
<map value="Event.subject"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.subject[x]"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value=".participation[typeCode="SBJ"].role[typeCode="PAT"]"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".recordTarget"/>
</mapping>
<mapping>
<identity value="fhirdocumentreference"/>
<map value="DocumentReference.subject"/>
</mapping>
</element>
<element id="Composition.encounter">
<path value="Composition.encounter"/>
<short value="Context of the Composition"/>
<definition
value="Describes the clinical encounter or type of care this documentation is associated with."/>
<requirements
value="Provides context for the composition and supports searching."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Composition.encounter"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Encounter"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="workflow"/>
<map value="Event.encounter"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.context"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="unique(highest(./outboundRelationship[typeCode="SUBJ" and isNormalActRelationship()], priorityNumber)/target[moodCode="EVN" and classCode=("ENC", "PCPR") and isNormalAct])"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".componentOf.encompassingEncounter"/>
</mapping>
<mapping>
<identity value="fhirdocumentreference"/>
<map value="DocumentReference.context"/>
</mapping>
</element>
<element id="Composition.date">
<path value="Composition.date"/>
<short value="Composition editing time"/>
<definition
value="The composition editing time, when the composition was last logically changed by the author."/>
<comment
value="The Last Modified Date on the composition may be after the date of the document was attested without being changed. This means that the date on an amended document is the date of the amendment, not the date of original authorship."/>
<requirements
value="dateTime is used for tracking, organizing versions and searching. Note that this is the time of authoring this version of the Composition. When packaged in a document, [Bundle.timestamp](http://hl7.org/fhir/R5/bundle-definitions.html#Bundle.timestamp) is the date of packaging."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Composition.date"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="dateTime"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="workflow"/>
<map value="Event.occurrence[x]"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.done[x]"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".effectiveTime[type="TS"]"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".effectiveTime"/>
</mapping>
<mapping>
<identity value="fhirdocumentreference"/>
<map
value="DocumentReference.content.attachment.date, DocumentReference.date"/>
</mapping>
</element>
<element id="Composition.useContext">
<path value="Composition.useContext"/>
<short value="The context that the content is intended to support"/>
<definition
value="The content was developed with a focus and intent of supporting the contexts that are listed. These contexts may be general categories (gender, age, ...) or may be references to specific programs (insurance plans, studies, ...) and may be used to assist with indexing and searching for appropriate Composition instances."/>
<comment
value="When multiple useContexts are specified, there is no expectation that all or any of the contexts apply."/>
<requirements value="Assist in searching for appropriate content."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Composition.useContext"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="UsageContext"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="Composition.author">
<path value="Composition.author"/>
<short value="Who and/or what authored the composition"/>
<definition
value="Identifies who is responsible for the information in the composition, not necessarily who typed it in."/>
<requirements value="Identifies who is responsible for the content."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Composition.author"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference"/>
<targetProfile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"/>
<aggregation value="bundled"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="workflow"/>
<map value="Event.performer"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.author"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value=".participation[typeCode="AUT"].role[classCode="ASSIGNED"]"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".author.assignedAuthor"/>
</mapping>
<mapping>
<identity value="fhirdocumentreference"/>
<map value="DocumentReference.author"/>
</mapping>
</element>
<element id="Composition.name">
<path value="Composition.name"/>
<short value="Name for this Composition (computer friendly)"/>
<definition
value="A natural language name identifying the {{title}}. This name should be usable as an identifier for the module by machine processing applications such as code generation."/>
<comment
value="The name is not expected to be globally unique. The name should be a simple alphanumeric type name to ensure that it is machine-processing friendly."/>
<requirements value="Support human navigation and code generation."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Composition.name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="Composition.title">
<path value="Composition.title"/>
<short value="Human Readable name/title"/>
<definition value="Official human-readable label for the composition."/>
<comment
value="For many compositions, the title is the same as the text or a display name of Composition.type (e.g. a "consultation" or "progress note"). Note that CDA does not make title mandatory, but there are no known cases where it is useful for title to be omitted, so it is mandatory here. Feedback on this requirement is welcome during the trial use period."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Composition.title"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="./title"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".title"/>
</mapping>
<mapping>
<identity value="fhirdocumentreference"/>
<map
value="DocumentReference.description, DocumentReference.content.attachment.title"/>
</mapping>
</element>
<element id="Composition.note">
<path value="Composition.note"/>
<short value="For any additional notes"/>
<definition value="For any additional notes."/>
<comment
value="A comment, general note or annotation not coded elsewhere."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Composition.note"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Annotation"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="Composition.attester">
<path value="Composition.attester"/>
<short value="Attests to accuracy of composition"/>
<definition
value="A participant who has attested to the accuracy of the composition/document."/>
<comment value="Only list each attester once."/>
<requirements
value="Identifies responsibility for the accuracy of the composition content."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Composition.attester"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map
value=".participation[typeCode="AUTHEN"].role[classCode="ASSIGNED"]"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".authenticator/.legalAuthenticator"/>
</mapping>
<mapping>
<identity value="fhirdocumentreference"/>
<map value="DocumentReference.attester"/>
</mapping>
</element>
<element id="Composition.attester.id">
<path value="Composition.attester.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<condition value="ele-1"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Composition.attester.extension">
<path value="Composition.attester.extension"/>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Composition.attester.modifierExtension">
<path value="Composition.attester.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Composition.attester.mode">
<path value="Composition.attester.mode"/>
<short value="personal | professional | legal | official"/>
<definition value="The type of attestation the authenticator offers."/>
<requirements
value="Indicates the level of authority of the attestation."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Composition.attester.mode"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="CompositionAttestationMode"/>
</extension>
<strength value="preferred"/>
<description
value="The way in which a person authenticated a composition."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/composition-attestation-mode"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="unique(./modeCode)"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value="implied by .authenticator/.legalAuthenticator"/>
</mapping>
<mapping>
<identity value="fhirdocumentreference"/>
<map value="DocumentReference.attester.mode"/>
</mapping>
</element>
<element id="Composition.attester.time">
<path value="Composition.attester.time"/>
<short value="When the composition was attested"/>
<definition value="When the composition was attested by the party."/>
<requirements
value="Identifies when the information in the composition was deemed accurate. (Things may have changed since then.)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Composition.attester.time"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="dateTime"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="./time[type="TS" and isNormalDatatype()]"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".authenticator.time"/>
</mapping>
<mapping>
<identity value="fhirdocumentreference"/>
<map value="DocumentReference.attester.time"/>
</mapping>
</element>
<element id="Composition.attester.party">
<path value="Composition.attester.party"/>
<short value="Who attested the composition"/>
<definition value="Who attested the composition in the specified way."/>
<requirements
value="Identifies who has taken on the responsibility for accuracy of the composition content."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Composition.attester.party"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Patient"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/RelatedPerson"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Practitioner"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="w5"/>
<map value="FiveWs.witness"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="./role[classCode="ASSIGNED" and isNormalRole]/player[determinerCode="INST" and classCode=("DEV", "PSN") and isNormalEntity()] or ./role[classCode="ASSIGNED" and isNormalRole and not(player)]/scoper[determinerCode="INST" and classCode="ORG" and isNormalEntity()]"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".authenticator.assignedEnttty"/>
</mapping>
<mapping>
<identity value="fhirdocumentreference"/>
<map value="DocumentReference.attester.party"/>
</mapping>
</element>
<element id="Composition.custodian">
<path value="Composition.custodian"/>
<short value="Organization which maintains the composition"/>
<definition
value="Identifies the organization or group who is responsible for ongoing maintenance of and access to the composition/document information."/>
<comment
value="This is useful when documents are derived from a composition - provides guidance for how to get the latest version of the document. This is optional because this is sometimes not known by the authoring system, and can be inferred by context. However, it is important that this information be known when working with a derived document, so providing a custodian is encouraged."/>
<requirements
value="Identifies where to go to find the current version, where to report issues, etc."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Composition.custodian"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map
value=".participation[typeCode="RCV"].role[classCode="CUST"].scoper[classCode="ORG" and determinerCode="INST"]"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".custodian.assignedCustodian"/>
</mapping>
<mapping>
<identity value="fhirdocumentreference"/>
<map value="DocumentReference.custodian"/>
</mapping>
</element>
<element id="Composition.relatesTo">
<path value="Composition.relatesTo"/>
<short value="Relationships to other compositions/documents"/>
<definition
value="Relationships that this composition has with other compositions or documents that already exist."/>
<comment
value="To reference (using relatesTo) a Bundle of type "document" or another Composition where you only have the identifier, use a resourceReference with an identifier.\
When a Composition is an alternate representation of another type of document e.g. CDA, the other document could be referenced in a DocumentReference resource.
Here is an example of using relatesTo to reference another Bundle of type "document" or Composition where you only have the identifier:
```
"relatesTo": [{
"type": "replaces",
"resourceReference": {
"identifier": {
"system": "...",
"value": "..."
}
}
}]
```"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Composition.relatesTo"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="RelatedArtifact"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value=".outboundRelationship"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".relatedDocument"/>
</mapping>
<mapping>
<identity value="fhirdocumentreference"/>
<map value="DocumentReference.relatesTo"/>
</mapping>
</element>
<element id="Composition.event">
<path value="Composition.event"/>
<short value="The clinical service(s) being documented"/>
<definition
value="The clinical service, such as a colonoscopy or an appendectomy, being documented."/>
<comment
value="The event needs to be consistent with the type element, though can provide further information if desired."/>
<requirements
value="Provides context for the composition and creates a linkage between a resource describing an event and the composition created describing the event."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Composition.event"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map
value="outboundRelationship[typeCode="SUBJ"].target[classCode<'ACT']"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".documentationOf.serviceEvent"/>
</mapping>
</element>
<element id="Composition.event.id">
<path value="Composition.event.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<condition value="ele-1"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Composition.event.extension">
<path value="Composition.event.extension"/>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Composition.event.modifierExtension">
<path value="Composition.event.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Composition.event.period">
<path value="Composition.event.period"/>
<short value="The period covered by the documentation"/>
<definition
value="The period of time covered by the documentation. There is no assertion that the documentation is a complete representation for this period, only that it documents events during this time."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Composition.event.period"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Period"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value=".effectiveTime"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".effectiveTime"/>
</mapping>
<mapping>
<identity value="fhirdocumentreference"/>
<map value="DocumentReference.period"/>
</mapping>
</element>
<element id="Composition.event.detail">
<path value="Composition.event.detail"/>
<short
value="The event(s) being documented, as code(s), reference(s), or both"/>
<definition
value="Represents the main clinical acts, such as a colonoscopy or an appendectomy, being documented. In some cases, the event is inherent in the typeCode, such as a "History and Physical Report" in which case the procedure being documented is necessarily a "History and Physical" act. The events may be included as a code or as a reference to an other resource."/>
<comment
value="An event can further specialize the act inherent in the typeCode, such as where it is simply "Procedure Report" and the procedure was a "colonoscopy". If one or more events are included, they SHALL NOT conflict with the values inherent in the classCode, practiceSettingCode or typeCode, as such a conflict would create an ambiguous situation. This short list of codes is provided to be used as key words for certain types of queries."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Composition.event.detail"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableReference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Resource"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="DocumentEventType"/>
</extension>
<strength value="example"/>
<description
value="This list of codes represents the main clinical acts being documented."/>
<valueSet value="http://terminology.hl7.org/ValueSet/v3-ActCode"/>
</binding>
<mapping>
<identity value="rim"/>
<map value=".outboundRelationship[typeCode="SUBJ"].target"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="fhirdocumentreference"/>
<map value="DocumentReference.event"/>
</mapping>
</element>
<element id="Composition.section">
<path value="Composition.section"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="code"/>
</discriminator>
<description
value="Slice on ICH code. only one slice is defined but slicing is left open for interoperability"/>
<ordered value="false"/>
<rules value="open"/>
</slicing>
<short value="Composition is broken into sections"/>
<definition
value="The root of the sections that make up the composition."/>
<min value="1"/>
<max value="*"/>
<base>
<path value="Composition.section"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<constraint>
<key value="cmp-1"/>
<severity value="error"/>
<human
value="A section must contain at least one of text, entries, or sub-sections"/>
<expression
value="text.exists() or entry.exists() or section.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Composition"/>
</constraint>
<constraint>
<key value="cmp-2"/>
<severity value="error"/>
<human value="A section can only have an emptyReason if it is empty"/>
<expression value="emptyReason.empty() or entry.empty()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Composition"/>
</constraint>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map
value="./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".component.structuredBody.component.section"/>
</mapping>
</element>
<element id="Composition.section.id">
<path value="Composition.section.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<condition value="ele-1"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Composition.section.extension">
<path value="Composition.section.extension"/>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Composition.section.modifierExtension">
<path value="Composition.section.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Composition.section.title">
<path value="Composition.section.title"/>
<short value="Label for section (e.g. for ToC)"/>
<definition
value="The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents."/>
<comment
value="The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element."/>
<requirements
value="Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized."/>
<alias value="header"/>
<alias value="label"/>
<alias value="caption"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Composition.section.title"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="./title"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".title"/>
</mapping>
</element>
<element id="Composition.section.code">
<path value="Composition.section.code"/>
<short value="Classification of section (recommended)"/>
<definition
value="A code identifying the kind of content contained within the section. This must be consistent with the section title."/>
<comment
value="The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document.
If the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code."/>
<requirements
value="Provides computable standardized labels to topics within the document."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Composition.section.code"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="CompositionSectionType"/>
</extension>
<strength value="example"/>
<description
value="Classification of a section of a composition/document."/>
<valueSet value="http://hl7.org/fhir/ValueSet/doc-section-codes"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="./code"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".code"/>
</mapping>
</element>
<element id="Composition.section.author">
<path value="Composition.section.author"/>
<short value="Who and/or what authored the section"/>
<definition
value="Identifies who is responsible for the information in this section, not necessarily who typed it in."/>
<requirements value="Identifies who is responsible for the content."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Composition.section.author"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Practitioner"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Device"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Patient"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/RelatedPerson"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="w5"/>
<map value="FiveWs.author"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value=".participation[typeCode="AUT"].role[classCode="ASSIGNED"]"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".author.assignedAuthor"/>
</mapping>
</element>
<element id="Composition.section.focus">
<path value="Composition.section.focus"/>
<short
value="Who/what the section is about, when it is not about the subject of composition"/>
<definition
value="The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources)."/>
<comment
value="Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Composition.section.focus"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Resource"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="cda"/>
<map
value=".subject? (CDA did not differentiate between subject and focus)"/>
</mapping>
</element>
<element id="Composition.section.text">
<path value="Composition.section.text"/>
<short value="Text summary of the section, for human interpretation"/>
<definition
value="A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative."/>
<comment
value="Document profiles may define what content should be represented in the narrative to ensure clinical safety."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Composition.section.text"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Narrative"/>
</type>
<condition value="cmp-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value=".text"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".text"/>
</mapping>
</element>
<element id="Composition.section.orderedBy">
<path value="Composition.section.orderedBy"/>
<short value="Order of section entries"/>
<definition
value="Specifies the order applied to the items in the section entries."/>
<comment
value="Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order."/>
<requirements
value="Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Composition.section.orderedBy"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="SectionEntryOrder"/>
</extension>
<strength value="preferred"/>
<description value="What order applies to the items in the entry."/>
<valueSet value="http://hl7.org/fhir/ValueSet/list-order"/>
</binding>
<mapping>
<identity value="rim"/>
<map
value=".outboundRelationship[typeCode=COMP].sequenceNumber > 1"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Composition.section.entry">
<path value="Composition.section.entry"/>
<short value="A reference to data that supports this section"/>
<definition
value="A reference to the actual resource from which the narrative in the section is derived."/>
<comment
value="If there are no entries in the list, an emptyReason SHOULD be provided."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Composition.section.entry"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Resource"/>
</type>
<condition value="cmp-1"/>
<condition value="cmp-2"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map
value=".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".entry"/>
</mapping>
</element>
<element id="Composition.section.emptyReason">
<path value="Composition.section.emptyReason"/>
<short value="Why the section is empty"/>
<definition
value="If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason."/>
<comment
value="The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases."/>
<requirements
value="Allows capturing things like "none exist" or "not asked" which can be important for most lists."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Composition.section.emptyReason"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<condition value="cmp-2"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="SectionEmptyReason"/>
</extension>
<strength value="preferred"/>
<description value="If a section is empty, why it is empty."/>
<valueSet value="http://hl7.org/fhir/ValueSet/list-empty-reason"/>
</binding>
<mapping>
<identity value="rim"/>
<map
value=".inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Composition.section.section">
<path value="Composition.section.section"/>
<short value="Nested Section"/>
<definition value="A nested sub-section within this section."/>
<comment
value="Nested sections are primarily used to help human readers navigate to particular portions of the document."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Composition.section.section"/>
<min value="0"/>
<max value="*"/>
</base>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Composition#Composition.section"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map
value="./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".component.section"/>
</mapping>
</element>
<element id="Composition.section:BatchFormulaMedicinalProduct">
<path value="Composition.section"/>
<sliceName value="BatchFormulaMedicinalProduct"/>
<short value="Composition is broken into sections"/>
<definition
value="Product Batch Formula to be included under the 3.2.P.3.2 eCTD heading."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Composition.section"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<constraint>
<key value="cmp-1"/>
<severity value="error"/>
<human
value="A section must contain at least one of text, entries, or sub-sections"/>
<expression
value="text.exists() or entry.exists() or section.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Composition"/>
</constraint>
<constraint>
<key value="cmp-2"/>
<severity value="error"/>
<human value="A section can only have an emptyReason if it is empty"/>
<expression value="emptyReason.empty() or entry.empty()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Composition"/>
</constraint>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map
value="./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".component.structuredBody.component.section"/>
</mapping>
</element>
<element id="Composition.section:BatchFormulaMedicinalProduct.id">
<path value="Composition.section.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<condition value="ele-1"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Composition.section:BatchFormulaMedicinalProduct.extension">
<path value="Composition.section.extension"/>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="Composition.section:BatchFormulaMedicinalProduct.modifierExtension">
<path value="Composition.section.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Composition.section:BatchFormulaMedicinalProduct.title">
<path value="Composition.section.title"/>
<short value="Label for section (e.g. for ToC)"/>
<definition
value="The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents."/>
<comment
value="The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element."/>
<requirements
value="Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized."/>
<alias value="header"/>
<alias value="label"/>
<alias value="caption"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Composition.section.title"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="./title"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".title"/>
</mapping>
</element>
<element id="Composition.section:BatchFormulaMedicinalProduct.code">
<path value="Composition.section.code"/>
<short value="Classification of section (recommended)"/>
<definition
value="A code identifying the kind of content contained within the section. This must be consistent with the section title."/>
<comment
value="The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document.
If the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code."/>
<requirements
value="Provides computable standardized labels to topics within the document."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Composition.section.code"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<patternCodeableConcept>
<coding>
<system
value="http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use"/>
<code value="ich_3.2.p.3.2"/>
<display value="Batch Formula"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="CompositionSectionType"/>
</extension>
<strength value="example"/>
<description
value="Classification of a section of a composition/document."/>
<valueSet value="http://hl7.org/fhir/ValueSet/doc-section-codes"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="./code"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".code"/>
</mapping>
</element>
<element id="Composition.section:BatchFormulaMedicinalProduct.author">
<path value="Composition.section.author"/>
<short value="Who and/or what authored the section"/>
<definition
value="Identifies who is responsible for the information in this section, not necessarily who typed it in."/>
<requirements value="Identifies who is responsible for the content."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Composition.section.author"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Practitioner"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Device"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Patient"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/RelatedPerson"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="w5"/>
<map value="FiveWs.author"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value=".participation[typeCode="AUT"].role[classCode="ASSIGNED"]"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".author.assignedAuthor"/>
</mapping>
</element>
<element id="Composition.section:BatchFormulaMedicinalProduct.focus">
<path value="Composition.section.focus"/>
<short
value="Who/what the section is about, when it is not about the subject of composition"/>
<definition
value="The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources)."/>
<comment
value="Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Composition.section.focus"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Resource"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="cda"/>
<map
value=".subject? (CDA did not differentiate between subject and focus)"/>
</mapping>
</element>
<element id="Composition.section:BatchFormulaMedicinalProduct.text">
<path value="Composition.section.text"/>
<short value="Text summary of the section, for human interpretation"/>
<definition
value="A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative."/>
<comment
value="Document profiles may define what content should be represented in the narrative to ensure clinical safety."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Composition.section.text"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Narrative"/>
</type>
<condition value="cmp-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value=".text"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".text"/>
</mapping>
</element>
<element id="Composition.section:BatchFormulaMedicinalProduct.orderedBy">
<path value="Composition.section.orderedBy"/>
<short value="Order of section entries"/>
<definition
value="Specifies the order applied to the items in the section entries."/>
<comment
value="Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order."/>
<requirements
value="Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Composition.section.orderedBy"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="SectionEntryOrder"/>
</extension>
<strength value="preferred"/>
<description value="What order applies to the items in the entry."/>
<valueSet value="http://hl7.org/fhir/ValueSet/list-order"/>
</binding>
<mapping>
<identity value="rim"/>
<map
value=".outboundRelationship[typeCode=COMP].sequenceNumber > 1"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Composition.section:BatchFormulaMedicinalProduct.entry">
<path value="Composition.section.entry"/>
<short value="A reference to data that supports this section"/>
<definition
value="A reference to the actual resource from which the narrative in the section is derived."/>
<comment
value="If there are no entries in the list, an emptyReason SHOULD be provided."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Composition.section.entry"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference"/>
<targetProfile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-batch-formula-product"/>
<aggregation value="bundled"/>
</type>
<condition value="cmp-1"/>
<condition value="cmp-2"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map
value=".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".entry"/>
</mapping>
</element>
<element
id="Composition.section:BatchFormulaMedicinalProduct.emptyReason">
<path value="Composition.section.emptyReason"/>
<short value="Why the section is empty"/>
<definition
value="If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason."/>
<comment
value="The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases."/>
<requirements
value="Allows capturing things like "none exist" or "not asked" which can be important for most lists."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Composition.section.emptyReason"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<condition value="cmp-2"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="SectionEmptyReason"/>
</extension>
<strength value="preferred"/>
<description value="If a section is empty, why it is empty."/>
<valueSet value="http://hl7.org/fhir/ValueSet/list-empty-reason"/>
</binding>
<mapping>
<identity value="rim"/>
<map
value=".inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Composition.section:BatchFormulaMedicinalProduct.section">
<path value="Composition.section.section"/>
<short value="Nested Section"/>
<definition value="A nested sub-section within this section."/>
<comment
value="Nested sections are primarily used to help human readers navigate to particular portions of the document."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Composition.section.section"/>
<min value="0"/>
<max value="*"/>
</base>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Composition#Composition.section"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map
value="./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]"/>
</mapping>
<mapping>
<identity value="cda"/>
<map value=".component.section"/>
</mapping>
</element>
</snapshot>
<differential>
<element id="Composition.identifier">
<path value="Composition.identifier"/>
<max value="1"/>
<mustSupport value="true"/>
</element>
<element id="Composition.status">
<path value="Composition.status"/>
<patternCode value="final"/>
</element>
<element id="Composition.type">
<path value="Composition.type"/>
<patternCodeableConcept>
<coding>
<system
value="http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use"/>
<code value="32P32"/>
<display value="Product Batch Formula"/>
</coding>
</patternCodeableConcept>
</element>
<element id="Composition.author">
<path value="Composition.author"/>
<max value="1"/>
<type>
<code value="Reference"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference"/>
<targetProfile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"/>
<aggregation value="bundled"/>
</type>
<mustSupport value="true"/>
</element>
<element id="Composition.section">
<path value="Composition.section"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="code"/>
</discriminator>
<description
value="Slice on ICH code. only one slice is defined but slicing is left open for interoperability"/>
<ordered value="false"/>
<rules value="open"/>
</slicing>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="Composition.section.code">
<path value="Composition.section.code"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="Composition.section:BatchFormulaMedicinalProduct">
<path value="Composition.section"/>
<sliceName value="BatchFormulaMedicinalProduct"/>
<definition
value="Product Batch Formula to be included under the 3.2.P.3.2 eCTD heading."/>
<min value="1"/>
<max value="1"/>
<mustSupport value="true"/>
</element>
<element id="Composition.section:BatchFormulaMedicinalProduct.title">
<path value="Composition.section.title"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="Composition.section:BatchFormulaMedicinalProduct.code">
<path value="Composition.section.code"/>
<patternCodeableConcept>
<coding>
<system
value="http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use"/>
<code value="ich_3.2.p.3.2"/>
<display value="Batch Formula"/>
</coding>
</patternCodeableConcept>
</element>
<element id="Composition.section:BatchFormulaMedicinalProduct.entry">
<path value="Composition.section.entry"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Reference"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference"/>
<targetProfile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-batch-formula-product"/>
<aggregation value="bundled"/>
</type>
<mustSupport value="true"/>
</element>
</differential>
</StructureDefinition>
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-04
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