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 pqcmc-quality-specification resource profile.
<StructureDefinition xmlns="http://hl7.org/fhir">
<id value="pqcmc-quality-specification"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: StructureDefinition pqcmc-quality-specification</b></p><a name="pqcmc-quality-specification"> </a><a name="hcpqcmc-quality-specification"> </a><a name="pqcmc-quality-specification-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-pqcmc-quality-specification-definitions.html#PlanDefinition">PlanDefinition</a><a name="PlanDefinition"> </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/plandefinition.html">PlanDefinition</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_bck13.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_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a href="StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.extension">Slices for extension</a><a name="PlanDefinition.extension"> </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..<span style="opacity: 0.5">*</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/extensibility.html#Extension">Extension</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">Extension</span><br/><span style="font-weight:bold">Slice: </span>Unordered, Open by value:url</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_bck134.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_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-pqcmc-quality-specification-definitions.html#PlanDefinition.extension:ApprovalStatus" title="Extension URL = http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension">ApprovalStatus</a><a name="PlanDefinition.extension.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"><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 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">Specification Status</span><br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-pq-specification-status-extension.html">http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension</a><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-specification-status-terminology.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-status-terminology">Specification Status Terminology</a> (<a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</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_bck124.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_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.extension:spec-additional-info" title="Extension URL = http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension">spec-additional-info</a><a name="PlanDefinition.extension.3"> </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">0..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#markdown">markdown</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Specification Additional Information<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-pq-additional-info-extension.html">http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension</a></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-pqcmc-quality-specification-definitions.html#PlanDefinition.identifier">identifier</a><a name="PlanDefinition.identifier"> </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">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</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#Identifier">Identifier</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">Additional identifier for the plan definition</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_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-pqcmc-quality-specification-definitions.html#PlanDefinition.version" title="The alphanumeric text assigned by the sponsor to a particular edition of a specification. [Source: SME Defined] Examples: 2.1, 13.2, ST1, 00001, 00002, companyname-001.
Note: This value should be unique across all specifications for a given material, not just those with the same name">version</a><a name="PlanDefinition.version"> </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">Specification Version</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-pqcmc-quality-specification-definitions.html#PlanDefinition.title" title="The textual identification for the specification. [Source: SME Defined]
Example: &lt;drug name> 75 mg chewable tablets
Note: This may include the name of the drug substance, product or the raw material/excipients">title</a><a name="PlanDefinition.title"> </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..<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#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">Specification Title</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_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-pqcmc-quality-specification-definitions.html#PlanDefinition.subtitle" title="An additional textual identification for the specification [Source: SME Defined].">subtitle</a><a name="PlanDefinition.subtitle"> </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><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#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">Specification Subtitle</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_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: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.type" title="A classification of specification related to the kind of entity it is referencing. [Source: SME Defined]
Examples: Drug product, Drug substance. ">type</a><a name="PlanDefinition.type"> </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..<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">Specification Type</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_bck103.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_slice.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Definition" class="hierarchy"/> <a style="font-style: italic" href="StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.type.coding">Slices for coding</a><a name="PlanDefinition.type.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"><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">2</span><span style="font-style: italic">..</span><span style="font-style: italic">2</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/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"><span style="opacity: 0.5; font-style: italic">Code defined by a terminology system</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Closed by value:$this</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_bck1035.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_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-pqcmc-quality-specification-definitions.html#PlanDefinition.type.coding:DefinitionType" title="Slice DefinitionType">coding:DefinitionType</a><a name="PlanDefinition.type.coding.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"><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/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"><span style="opacity: 0.5">Code defined by a terminology system</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_bck10350.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_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.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/CodeSystem/plan-definition-type</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_bck10350.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_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.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">workflow-definition</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_bck10340.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_vline_slicer.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_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">Workflow Definition</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_bck1024.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_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-pqcmc-quality-specification-definitions.html#PlanDefinition.type.coding:SpecType" title="Slice SpecType: A classification of specification related to the kind of the entity it is referencing.">coding:SpecType</a><a name="PlanDefinition.type.coding.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/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">Specification Type<br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-specification-type-terminology.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-type-terminology">Specification Type Terminology</a> (<a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</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_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-pqcmc-quality-specification-definitions.html#PlanDefinition.status">status</a><a name="PlanDefinition.status"> </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">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#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"><span style="opacity: 0.5">draft | active | retired | unknown</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-pqcmc-quality-specification-definitions.html#PlanDefinition.subject[x]">subject[x]</a><a name="PlanDefinition.subject_x_"> </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..<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 href="StructureDefinition-literal-reference.html" title="Literal Reference">LiteralReference</a>(<a href="StructureDefinition-pqcmc-drug-product-handle.html">Drug Product Handle</a> | <a href="StructureDefinition-pqcmc-routine-drug-substance.html">Drug Substance Handle</a> | <a href="StructureDefinition-pqcmc-excipient.html">Excipient Drug Substance</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">Type of individual the plan definition is focused on</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_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-pqcmc-quality-specification-definitions.html#PlanDefinition.date" title="The date when the sponsor assigned a date to a specific version. [Source: SME Defined]
Note: This is the date a particular version of the specification was internally accepted by the submitter.">date</a><a name="PlanDefinition.date"> </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#dateTime">dateTime</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Specification Version Date</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-pqcmc-quality-specification-definitions.html#PlanDefinition.approvalDate" title="The date on which the FDA approval status for a specification became effective. [Source: SME Defined]
Note: If the application is not yet approved, then this is the date of the current submission OR the date of the complete response (CR).
Note: This is not the application approval status date.">approvalDate</a><a name="PlanDefinition.approvalDate"> </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">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#date">date</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Specification Status Date</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-pqcmc-quality-specification-definitions.html#PlanDefinition.goal">goal</a><a name="PlanDefinition.goal"> </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><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</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/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">Acceptance Criteria</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_bck113.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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a href="StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.extension">Slices for extension</a><a name="PlanDefinition.goal.extension"> </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">*</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/extensibility.html#Extension">Extension</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">Extension</span><br/><span style="font-weight:bold">Slice: </span>Unordered, Open by value:url</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_bck1124.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_vline.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: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.extension:ac-additional-info" title="Extension URL = http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension">ac-additional-info</a><a name="PlanDefinition.goal.extension.2"> </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">0..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#markdown">markdown</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Acceptance Criteria Additional Information<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-pq-additional-info-extension.html">http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension</a></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_bck110.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.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-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.description" title="The text of the acceptance criteria as provided in the specification. [Source: SME Defined]
Examples: White to off-white cake; 22.5 - 27.5 mg/ml Note: This is the text as it appears in the Specification.">description</a><a name="PlanDefinition.goal.description"> </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><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">Original Text</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_bck110.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.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-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.addresses" title="A coded value specifying when a particular analytical procedure or measurement is being performed on a substance or a product. [Source: SME Defined] Examples: Release, Stability.
Note: The concept of 'In-Process' is subsumed by the Release code.">addresses</a><a name="PlanDefinition.goal.addresses"> </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">*</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">Acceptance Criteria Usage<br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-test-usage-terminology.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-usage-terminology">Test Usage Terminology</a> (<a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</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_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target">target</a><a name="PlanDefinition.goal.target"> </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><a style="padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;" href="http://hl7.org/fhir/R5/conformance-rules.html#constraints" title="This element has or is affected by constraints ( cmc-target-range )">C</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">*</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/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">Acceptance Criteron<br/><span style="font-weight:bold">cmc-target-range: </span>When the Range extension is present, detail cannot be present.</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_bck1013.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_modifier_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a href="StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.modifierExtension">Slices for modifierExtension</a><a name="PlanDefinition.goal.target.modifierExtension"> </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">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</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/extensibility.html#Extension">Extension</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">Extension</span><br/><span style="font-weight:bold">Slice: </span>Unordered, Open by value:url</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_bck10124.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_vline.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-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.modifierExtension:targetRange" title="Slice targetRange">modifierExtension:targetRange</a><a name="PlanDefinition.goal.target.modifierExtension.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"><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">0..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-pq-target-range.html" title="Extension">TargetRange</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">Target Range</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_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.measure">measure</a><a name="PlanDefinition.goal.target.measure"> </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><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 href="StructureDefinition-codeable-concept-text-only.html" title="CodeableConcept">CodeableConceptTextOnly</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Detailed parameter being measured if more granular than Sub-Test</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_bck1013.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_slice.png" alt="." style="background-color: white; background-color: inherit" title="Slice Definition" class="hierarchy"/> <a style="font-style: italic" href="StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.detail[x]">Slices for detail[x]</a><a name="PlanDefinition.goal.target.detail_x_"> </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; font-style: italic" 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="font-style: italic"/><span style="opacity: 0.5; font-style: italic">0</span><span style="opacity: 0.5; font-style: italic">..</span><span style="opacity: 0.5; font-style: italic">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"/><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; font-style: italic">The target value to be achieved</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Open by type:$this</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_bck10130.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_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <span title="Quantity Type: A measured amount (or an amount that can potentially be measured). Note that measured amounts include amounts that are not precisely quantified, including amounts involving arbitrary units and floating currencies.">detailQuantity</span></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"></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#Quantity">Quantity</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; 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: 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_bck10130.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_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <span title="string Type: A sequence of Unicode characters">detailString</span></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><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"/></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_bck10130.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_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <span title="integer Type: A whole number">detailInteger</span></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"></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#integer">integer</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; 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: 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_bck10135.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_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_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-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.detail[x]:detailQuantity" title="Slice detailQuantity: The acceptable quantitative or numeric value for the result of the test. [Source: SME Defined]">detail[x]:detailQuantity</a><a name="PlanDefinition.goal.target.detail_x_.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"><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">0..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#Quantity">Quantity</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">ValueNumeric<br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-units-of-measure.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure">Units Of Measure</a> (<a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</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_bck101350.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_vline.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_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-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.detail[x]:detailQuantity.value">value</a><a name="PlanDefinition.goal.target.detail_x_.value"> </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#decimal">decimal</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">Numerical value (with implicit precision)</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_bck101350.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_vline.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_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-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.detail[x]:detailQuantity.comparator">comparator</a><a name="PlanDefinition.goal.target.detail_x_.comparator"> </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">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#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">< | <= | >= | > | ad - how to understand the value</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_bck101350.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_vline.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_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-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.detail[x]:detailQuantity.unit">unit</a><a name="PlanDefinition.goal.target.detail_x_.unit"> </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">Unit representation</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_bck101340.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_vline.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_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-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.detail[x]:detailQuantity.code">code</a><a name="PlanDefinition.goal.target.detail_x_.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="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..<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">Coded form of the unit</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_bck10134.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_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.detail[x]:detailString" title="Slice detailString: A textual description and/or a number that identifies a level within a sequential test. [Source: SME Defined] Examples – Single Stage, Stage 1, Stage 2 (sometimes referred to as L1, L2 L3 or A1, A2 as in USP &lt;711>)
Note: A Stage may or may not provide a conditional sequence with associated acceptance criteria. [Source: SME Defined] (e.g., dissolution test, pyrogen test - USP &lt;151>; 21 CFR 610.13 (b) Test for pyrogenic substances)">detail[x]:detailString</a><a name="PlanDefinition.goal.target.detail_x_.3"> </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">0..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">Value</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_bck10124.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_vline.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-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.detail[x]:detailInteger" title="Slice detailInteger: An identification number for a member of the set of results for a test, usually the sequence order in which the test was executed. Individual tests are executed on multiple samples to give greater validity to the findings. [Source SME Defined]
Examples: Prepare six aliquots from the sample. Test 8 samples. If any fall above 110%, test an additional 7 samples. Record all replicate values as stated in the method.">detail[x]:detailInteger</a><a name="PlanDefinition.goal.target.detail_x_.4"> </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">0..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#integer">integer</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Number of Replicates</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_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <span style="text-decoration:line-through">due</span><a name="PlanDefinition.goal.target.due"> </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="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></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"/></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_bck01.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_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action">action</a><a name="PlanDefinition.action"> </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><a style="padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;" href="http://hl7.org/fhir/R5/conformance-rules.html#constraints" title="This element has or is affected by constraints ( cmc-link-required, cmc-single-or-multistage )">C</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">*</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/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">Method<br/><span style="font-weight:bold">cmc-link-required: </span>Action linkId is required for alternate tests<br/><span style="font-weight:bold">cmc-single-or-multistage: </span>if a test is multi-stage, the test can't have a prefix and its stages must have a name and can't be named 'Single Stage' and must be unique. If it's single stage its prefix is 'Single Stage' and its groups can't have prefixes</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_bck010.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.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.linkId">linkId</a><a name="PlanDefinition.action.linkId"> </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><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#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">only required for alternate tests</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_bck010.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.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.prefix" title="A textual description and/or a number that identifies a level within a sequential test. [Source: SME Defined] Examples – Single Stage, Stage 1, Stage 2 (sometimes referred to as L1, L2 L3 or A1, A2 as in USP &lt;711&gt;)
Note: A Stage may or may not provide a conditional sequence with associated acceptance criteria. [Source: SME Defined] (e.g., dissolution test, pyrogen test - &lt;151&gt;; 21 CFR 610.13 (b) Test for pyrogenic substances)
Implememtation Note: Value at this level is 'Single Stage'">prefix</a><a name="PlanDefinition.action.prefix"> </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">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#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">Stage Name</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_bck010.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.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.title" title="The textual description of a procedure or analytical method. [Source: SME Defined]
Examples: Assay by HPLC, moisture by Karl Fischer, analysis for impurities.
Note: as defined by the sponsor">title</a><a name="PlanDefinition.action.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">Test Name</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_bck010.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.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.description" title="Test Additional Information: Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined].
If there is more than one comment, include in this element. Markdown allows formating for clarity.">description</a><a name="PlanDefinition.action.description"> </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">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#markdown">markdown</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Test Additional Information</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_bck011.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.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.code" title="A coded value specifying the source of the method. [Source: SME Defined] Example: Compendial">code</a><a name="PlanDefinition.action.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">Test Method Origin</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_bck0110.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.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.code.coding">coding</a><a name="PlanDefinition.action.code.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"><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/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"><span style="opacity: 0.5">Code defined by a terminology system</span><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-test-method-origin-terminology.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-method-origin-terminology">Test Method Origin Terminology</a> (<a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</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_bck0100.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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.code.text" title="The name of the technique used to determine the nature of a characteristic. [Source: SME Defined].">text</a><a name="PlanDefinition.action.code.text"> </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">Analytical Procedure</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_bck011.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.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.reason" title="A high level grouping of quality attributes for products, substances, raw materials, excipients, intermediates and reagents. [Source: SME Defined] Examples: Assay, Biological Properties.">reason</a><a name="PlanDefinition.action.reason"> </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..2</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">Test Category | Test Subcategory<br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-test-category-terminology.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology">Test Category Terminology</a> (<a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</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_bck0110.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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a href="StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.reason.extension">extension</a><a name="PlanDefinition.action.reason.extension"> </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..<span style="opacity: 0.5">*</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/extensibility.html#Extension">Extension</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">Extension</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_bck0103.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.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: white; background-color: inherit" title="Slice Definition" class="hierarchy"/> Slices for extension<a name="PlanDefinition.action.reason.extension.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_bck01024.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.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: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.reason.extension:categoryLevel" title="Extension URL = http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">categoryLevel</a><a name="PlanDefinition.action.reason.extension.3"> </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="http://hl7.org/fhir/R5/datatypes.html#positiveInt">positiveInt</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">Hierarchical Level</span><br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-pq-hierarchical-level-extension.html">http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension</a></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_bck011.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.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.documentation">documentation</a><a name="PlanDefinition.action.documentation"> </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">0</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 style="opacity: 0.5" href="http://hl7.org/fhir/R5/metadatatypes.html#RelatedArtifact">RelatedArtifact</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">Supporting documentation for the intended performer of the action</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_bck0110.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.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.documentation.type">type</a><a name="PlanDefinition.action.documentation.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#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"><span style="opacity: 0.5">documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">documentation</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_bck0100.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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.documentation.label" title="A sponsor/applicant provided alphanumeric code that identifies the procedure. [Source: SME Defined]. Example: HP1234-2008
Note: This could also be a transferred lab method.">label</a><a name="PlanDefinition.action.documentation.label"> </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..<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#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">Reference to Procedure</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_bck010.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.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.goalId">goalId</a><a name="PlanDefinition.action.goalId"> </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><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</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#id">id</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Reference to Acceptance Criteria</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_bck011.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.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.relatedAction" title="Alternate Tests are one or more test that are equivalent often using differnt method or equipment. The tests are used interchangeably and only one is used to satisfy the drug product specificaion.">relatedAction</a><a name="PlanDefinition.action.relatedAction"> </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">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</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/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">Alternate Test</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_bck0110.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.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.relatedAction.targetId">targetId</a><a name="PlanDefinition.action.relatedAction.targetId"> </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">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#id">id</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">What action is this related to</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_bck0100.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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.relatedAction.relationship">relationship</a><a name="PlanDefinition.action.relatedAction.relationship"> </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><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">Code is concurrent<br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">concurrent</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_bck001.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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action">action</a><a name="PlanDefinition.action.action"> </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><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</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 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">Groups or Stages</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_bck0010.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.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.prefix" title="A textual description and/or a number that identifies a level within a sequential test. [Source: SME Defined] Examples – Single Stage, Stage 1, Stage 2 (sometimes referred to as L1, L2 L3 or A1, A2 as in USP &lt;711&gt;)
Note: A Stage may or may not provide a conditional sequence with associated acceptance criteria. [Source: SME Defined] (e.g., dissolution test, pyrogen test - &lt;151&gt;; 21 CFR 610.13 (b) Test for pyrogenic substances)
Implememtation Note: not requried if action.prefix is 'Single Stage'">prefix</a><a name="PlanDefinition.action.action.prefix"> </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">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#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">Stage Name</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_bck0010.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.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.title" title="Test Name: The textual description of a procedure or analytical method. [Source: SME Defined]
Examples: Assay by HPLC, moisture by Karl Fischer, analysis for impurities.
Note: as defined by the sponsor
Note: The test name of the action.action can be different than the action. Example, the action test is Microbial Limits and the action.action test is Staphylococcus aureus.">title</a><a name="PlanDefinition.action.action.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"><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: #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">Test Name (only reqired if different than above)</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_bck0010.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.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.description" title="Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined].
Implementation Note: If there is more than one comment, include in this element. Markdown allows formating for clarity.">description</a><a name="PlanDefinition.action.action.description"> </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">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#markdown">markdown</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Test Additional Information | Stage Additional Information</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_bck0011.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.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.documentation">documentation</a><a name="PlanDefinition.action.action.documentation"> </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><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</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/metadatatypes.html#RelatedArtifact">RelatedArtifact</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">Supporting documentation for the intended performer of the action</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_bck00110.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.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.documentation.type">type</a><a name="PlanDefinition.action.action.documentation.type"> </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">documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">documentation</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_bck00101.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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.documentation.document" title="Any visual data described andor referenced in additional informatation">document</a><a name="PlanDefinition.action.action.documentation.document"> </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#Attachment">Attachment</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Test or Stage Additional Information Visual Attachments</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_bck001010.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.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_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.documentation.document.contentType">contentType</a><a name="PlanDefinition.action.action.documentation.document.contentType"> </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..<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">Mime type of the content, with charset etc.</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_bck001010.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.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_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.documentation.document.data">data</a><a name="PlanDefinition.action.action.documentation.document.data"> </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#base64Binary">base64Binary</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">Data inline, base64ed</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_bck001000.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.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_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.documentation.document.title" title="A format or abbreviation name that identifies a file structure. [Source: SME Defined]
Used for the following: Analytical Instrument Data File Type, Impurity Analysis Graphic, Impurity Analytical Instrument Data File, Impurity Chemical Structure Data File, and Substance Structure Graphic.">title</a><a name="PlanDefinition.action.action.documentation.document.title"> </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..<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#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">Document file name including the file extension</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_bck0010.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.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.goalId">goalId</a><a name="PlanDefinition.action.action.goalId"> </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><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</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#id">id</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Reference to Acceptance Criteria</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_bck0001.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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.action">action</a><a name="PlanDefinition.action.action.action"> </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><a style="padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;" href="http://hl7.org/fhir/R5/conformance-rules.html#constraints" title="This element has or is affected by constraints ( cmc-subtest-rrt )">C</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">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</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 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">Sub-Test<br/><span style="font-weight:bold">cmc-subtest-rrt: </span>a subtest's prefix represents relative retention time, should it exist</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_bck00010.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_blank.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.action.prefix" title="RRT: The ratio of the retention time of a component relative to that of another used as a reference obtained under identical conditions as an alias for the name of the unidentified impurities. [Source: Adapted from USP]
Example: 1:23 (a ratio)
Note: This is the title or name of the impurity (sometimes expressed as a ratio) and not the value.
Implementation Note: This value can only be 'RRT'. It is used to desinate that RRT value(s) expressed in action.action.action.title are relative retention times.">prefix</a><a name="PlanDefinition.action.action.action.prefix"> </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><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#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">RRT</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_bck00010.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_blank.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.action.title" title="Test Name: The textual description of a procedure or analytical method. [Source: SME Defined]
Examples: Assay by HPLC, moisture by Karl Fischer, analysis for impurities.
Note: as defined by the sponsor
Note: The test name of the action.action can be different than the action. Example, the action test is Microbial Limits and the action.action test is Staphylococcus aureus.
RRT: The ratio of the retention time of a component relative to that of another used as a reference obtained under identical conditions as an alias for the name of the unidentified impurities. [Source: Adapted from USP]
Example: 1:23 (a ratio)
Note: This is the title or name of the impurity (sometimes expressed as a ratio) and not the value.
Implementation Note: For RRT, if there is a range associated with the unidentified peak then the range can be entered instead of indivual values. E.g.: 0.4 – 0.8.">title</a><a name="PlanDefinition.action.action.action.title"> </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..<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#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">Test Name | RRT (complex testing)</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_bck00010.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_blank.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-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.action.description" title="Test Additional Information: Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined].
Stage Additional Information: Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined]
If there is more than one comment, include in this element. Markdown allows formating for clarity. If both types are present, indicate type.">description</a><a name="PlanDefinition.action.action.action.description"> </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><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#markdown">markdown</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Test Additional Information | Stage Additional Information</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_bck00000.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_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_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.action.goalId">goalId</a><a name="PlanDefinition.action.action.action.goalId"> </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..<span style="opacity: 0.5">*</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#id">id</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Reference to Acceptance Criteria</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,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" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-implements">
<valueUri
value="http://hl7.org/fhir/StructureDefinition/MetadataResource"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
<valueCode value="brr"/>
</extension>
<url
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"/>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:oid:2.16.840.1.113883.4.642.40.36.42.30"/>
</identifier>
<version value="2.0.0-ballot"/>
<name value="QualitySpecification"/>
<title value="Quality Specification"/>
<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="A quality specification is for a drug product or drug substance (excipient, API or raw material)."/>
<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="objimpl"/>
<uri value="http://hl7.org/fhir/object-implementation"/>
<name value="Object Implementation Information"/>
</mapping>
<kind value="resource"/>
<abstract value="false"/>
<type value="PlanDefinition"/>
<baseDefinition
value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/>
<derivation value="constraint"/>
<snapshot>
<element id="PlanDefinition">
<path value="PlanDefinition"/>
<short
value="The definition of a plan for a series of actions, independent of any specific patient or context"/>
<definition
value="This resource allows for the definition of various types of plans as a sharable, consumable, and executable artifact. The resource is general enough to support the description of a broad range of clinical and non-clinical artifacts such as clinical decision support rules, order sets, protocols, and drug quality specifications."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition"/>
<min value="0"/>
<max value="*"/>
</base>
<constraint>
<key value="cnl-0"/>
<severity value="warning"/>
<human
value="Name should be usable as an identifier for the module by machine processing applications such as code generation"/>
<expression
value="name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')"/>
<source
value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/>
</constraint>
<constraint>
<key value="pld-3"/>
<severity value="warning"/>
<human value="goalid should reference the id of a goal definition"/>
<expression
value="%context.repeat(action).where((goalId in %context.goal.id).not()).exists().not()"/>
<source
value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/>
</constraint>
<constraint>
<key value="pld-4"/>
<severity value="warning"/>
<human value="targetId should reference the id of an action"/>
<expression
value="%context.repeat(action).relatedAction.where((targetId in %context.repeat(action).id).not()).exists().not()"/>
<source
value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="w5"/>
<map value="conformance.behavior,clinical.general"/>
</mapping>
<mapping>
<identity value="workflow"/>
<map value="Definition"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Act[classCode=GROUPER;moodCode=DEFN]"/>
</mapping>
</element>
<element id="PlanDefinition.id">
<path value="PlanDefinition.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="PlanDefinition.meta">
<path value="PlanDefinition.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="PlanDefinition.implicitRules">
<path value="PlanDefinition.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="PlanDefinition.language">
<path value="PlanDefinition.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="PlanDefinition.text">
<path value="PlanDefinition.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="PlanDefinition.contained">
<path value="PlanDefinition.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="PlanDefinition.extension">
<path value="PlanDefinition.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<ordered value="false"/>
<rules value="open"/>
</slicing>
<short value="Extension"/>
<definition value="An Extension"/>
<min value="1"/>
<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"/>
</element>
<element id="PlanDefinition.extension:ApprovalStatus">
<path value="PlanDefinition.extension"/>
<sliceName value="ApprovalStatus"/>
<short value="Specification Status"/>
<definition
value="A classification of the regulatory status of the specification."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-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="true"/>
<isModifier value="false"/>
</element>
<element id="PlanDefinition.extension:spec-additional-info">
<path value="PlanDefinition.extension"/>
<sliceName value="spec-additional-info"/>
<short value="Specification Additional Information"/>
<definition
value="Placeholder for providing any comments that are relevant to the specification. [Source: SME Defined]
Examples: replaces method ABC, using the XYZ facility."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-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"/>
</element>
<element id="PlanDefinition.modifierExtension">
<path value="PlanDefinition.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="PlanDefinition.url">
<path value="PlanDefinition.url"/>
<short
value="Canonical identifier for this plan definition, represented as a URI (globally unique)"/>
<definition
value="An absolute URI that is used to identify this plan definition 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 plan definition is (or will be) published. This URL can be the target of a canonical reference. It SHALL remain the same when the plan definition 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.
The determination of when to create a new version of a resource (same url, new version) vs. defining a new artifact is up to the author. Considerations for making this decision are found in [Technical and Business Versions](http://hl7.org/fhir/R5/resource.html#versions).
In some cases, the resource can no longer be found at the stated url, but the url itself cannot change. Implementations can use the [meta.source](http://hl7.org/fhir/R5/resource.html#meta) element to indicate where the current master source of the resource can be found."/>
<requirements
value="Allows the plan definition to be referenced by a single globally unique identifier."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.url"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="uri"/>
</type>
<constraint>
<key value="cnl-1"/>
<severity value="warning"/>
<human
value="URL should not contain | or # - these characters make processing canonical references problematic"/>
<expression value="exists() implies matches('^[^|# ]+$')"/>
<source
value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/>
</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="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="workflow"/>
<map value="Definition.url"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.identifier"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".identifier[scope=BUSN;reliability=ISS]"/>
</mapping>
</element>
<element id="PlanDefinition.identifier">
<path value="PlanDefinition.identifier"/>
<short value="Additional identifier for the plan definition"/>
<definition
value="A formal identifier that is used to identify this plan definition when it is represented in other formats, or referenced in a specification, model, design or an instance."/>
<comment
value="Typically, this is used for identifiers that can go in an HL7 V3 II (instance identifier) data type, and can then identify this plan definition outside of FHIR, where it is not possible to use the logical URI."/>
<requirements
value="Allows externally provided and/or usable business identifiers to be easily associated with the module."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.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="Definition.identifier"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.identifier"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".identifier"/>
</mapping>
<mapping>
<identity value="objimpl"/>
<map value="no-gen-base"/>
</mapping>
</element>
<element id="PlanDefinition.version">
<path value="PlanDefinition.version"/>
<short value="Specification Version"/>
<definition
value="The alphanumeric text assigned by the sponsor to a particular edition of a specification. [Source: SME Defined] Examples: 2.1, 13.2, ST1, 00001, 00002, companyname-001.
Note: This value should be unique across all specifications for a given material, not just those with the same name"/>
<comment
value="There may be different plan definition instances that have the same identifier but different versions. The version can be appended to the url in a reference to allow a reference to a particular business version of the plan definition with the format [url]|[version]. The version SHOULD NOT contain a '#' - see [Business Version](http://hl7.org/fhir/R5/resource.html#bv-format)."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="PlanDefinition.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="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="workflow"/>
<map value="Definition.version"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.version"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
<mapping>
<identity value="objimpl"/>
<map value="no-gen-base"/>
</mapping>
</element>
<element id="PlanDefinition.versionAlgorithm[x]">
<path value="PlanDefinition.versionAlgorithm[x]"/>
<short value="How to compare versions"/>
<definition
value="Indicates the mechanism used to compare versions to determine which is more current."/>
<comment
value="If set as a string, this is a FHIRPath expression that has two additional context variables passed in - %version1 and %version2 and will return a negative number if version1 is newer, a positive number if version2 and a 0 if the version ordering can't be successfully be determined."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.versionAlgorithm[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<type>
<code value="Coding"/>
</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>
<strength value="extensible"/>
<valueSet value="http://hl7.org/fhir/ValueSet/version-algorithm"/>
</binding>
<mapping>
<identity value="workflow"/>
<map value="Definition.versionAlgorithm"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.version"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
<mapping>
<identity value="objimpl"/>
<map value="no-gen-base"/>
</mapping>
</element>
<element id="PlanDefinition.name">
<path value="PlanDefinition.name"/>
<short value="Name for this plan definition (computer friendly)"/>
<definition
value="A natural language name identifying the plan definition. 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="PlanDefinition.name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<condition value="cnl-0"/>
<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="Definition.name"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.title">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.title"/>
<short value="Specification Title"/>
<definition
value="The textual identification for the specification. [Source: SME Defined]
Example: &lt;drug name> 75 mg chewable tablets
Note: This may include the name of the drug substance, product or the raw material/excipients"/>
<comment
value="This name does not need to be machine-processing friendly and may contain punctuation, white-space, etc."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="PlanDefinition.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="true"/>
<mapping>
<identity value="workflow"/>
<map value="Definition.title"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".title"/>
</mapping>
</element>
<element id="PlanDefinition.subtitle">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.subtitle"/>
<short value="Specification Subtitle"/>
<definition
value="An additional textual identification for the specification [Source: SME Defined]."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.subtitle"/>
<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="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.type">
<path value="PlanDefinition.type"/>
<short value="Specification Type"/>
<definition
value="A classification of specification related to the kind of entity it is referencing. [Source: SME Defined]
Examples: Drug product, Drug substance. "/>
<min value="1"/>
<max value="1"/>
<base>
<path value="PlanDefinition.type"/>
<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="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="PlanDefinitionType"/>
</extension>
<strength value="extensible"/>
<description value="The type of PlanDefinition."/>
<valueSet value="http://hl7.org/fhir/ValueSet/plan-definition-type"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.type.id">
<path value="PlanDefinition.type.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="id"/>
</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="PlanDefinition.type.extension">
<path value="PlanDefinition.type.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<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="PlanDefinition.type.coding">
<path value="PlanDefinition.type.coding"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="$this"/>
</discriminator>
<description value="Slice on the coding itself"/>
<ordered value="false"/>
<rules value="closed"/>
</slicing>
<short value="Code defined by a terminology system"/>
<definition
value="A reference to a code defined by a terminology system."/>
<comment
value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true."/>
<requirements
value="Allows for alternative encodings within a code system, and translations to other code systems."/>
<min value="2"/>
<max value="2"/>
<base>
<path value="CodeableConcept.coding"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Coding"/>
</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="v2"/>
<map value="C*E.1-8, C*E.10-22"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="union(., ./translation)"/>
</mapping>
<mapping>
<identity value="orim"/>
<map
value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/>
</mapping>
</element>
<element id="PlanDefinition.type.coding:DefinitionType">
<path value="PlanDefinition.type.coding"/>
<sliceName value="DefinitionType"/>
<short value="Code defined by a terminology system"/>
<definition
value="A reference to a code defined by a terminology system."/>
<comment
value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true."/>
<requirements
value="Allows for alternative encodings within a code system, and translations to other code systems."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="CodeableConcept.coding"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Coding"/>
</type>
<patternCoding>
<system
value="http://terminology.hl7.org/CodeSystem/plan-definition-type"/>
<code value="workflow-definition"/>
<display value="Workflow Definition"/>
</patternCoding>
<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="v2"/>
<map value="C*E.1-8, C*E.10-22"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="union(., ./translation)"/>
</mapping>
<mapping>
<identity value="orim"/>
<map
value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/>
</mapping>
</element>
<element id="PlanDefinition.type.coding:SpecType">
<path value="PlanDefinition.type.coding"/>
<sliceName value="SpecType"/>
<short value="Specification Type"/>
<definition
value="A classification of specification related to the kind of the entity it is referencing."/>
<comment
value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true."/>
<requirements
value="Allows for alternative encodings within a code system, and translations to other code systems."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="CodeableConcept.coding"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Coding"/>
</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"/>
<binding>
<strength value="required"/>
<valueSet
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-type-terminology"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="C*E.1-8, C*E.10-22"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="union(., ./translation)"/>
</mapping>
<mapping>
<identity value="orim"/>
<map
value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/>
</mapping>
</element>
<element id="PlanDefinition.type.text">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.type.text"/>
<short value="Plain text representation of the concept"/>
<definition
value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user."/>
<comment
value="Very often the text is the same as a displayName of one of the codings."/>
<requirements
value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="CodeableConcept.text"/>
<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>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="C*E.9. But note many systems use C*E.2 for this"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="./originalText[mediaType/code="text/plain"]/data"/>
</mapping>
<mapping>
<identity value="orim"/>
<map
value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/>
</mapping>
</element>
<element id="PlanDefinition.status">
<path value="PlanDefinition.status"/>
<short value="draft | active | retired | unknown"/>
<definition
value="The status of this plan definition. Enables tracking the life-cycle of the content."/>
<comment
value="Allows filtering of plan definitions that are appropriate for use versus not.
See guidance around (not) making local changes to elements [here](http://hl7.org/fhir/R5/canonicalresource.html#localization)."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="PlanDefinition.status"/>
<min value="1"/>
<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="true"/>
<isModifier value="true"/>
<isModifierReason
value="This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="PublicationStatus"/>
</extension>
<strength value="required"/>
<description value="The lifecycle status of an artifact."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/publication-status|5.0.0"/>
</binding>
<mapping>
<identity value="workflow"/>
<map value="Definition.status {different ValueSet}"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.status"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".status"/>
</mapping>
</element>
<element id="PlanDefinition.experimental">
<path value="PlanDefinition.experimental"/>
<short value="For testing purposes, not real usage"/>
<definition
value="A Boolean value to indicate that this plan definition is authored for testing purposes (or education/evaluation/marketing) and is not intended to be used for genuine usage."/>
<comment
value="Allows filtering of plan definitions that are appropriate for use versus not."/>
<requirements
value="Enables experimental content to be developed following the same lifecycle that would be used for a production-level plan definition."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.experimental"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="boolean"/>
</type>
<meaningWhenMissing
value="If absent, this resource is treated as though it is not experimental."/>
<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="Definition.experimental"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.class"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.subject[x]">
<path value="PlanDefinition.subject[x]"/>
<short value="Type of individual the plan definition is focused on"/>
<definition
value="A code, group definition, or canonical reference that describes or identifies the intended subject of the plan definition. Canonical references are allowed to support the definition of protocols for drug and substance quality specifications, and is allowed to reference a MedicinalProductDefinition, SubstanceDefinition, AdministrableProductDefinition, ManufacturedItemDefinition, or PackagedProductDefinition resource."/>
<comment
value="Note that the choice of canonical for the subject element was introduced in R4B to support pharmaceutical quality use cases. To ensure as much backwards-compatibility as possible, it is recommended to only use the new canonical type with these use cases."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="PlanDefinition.subject[x]"/>
<min value="0"/>
<max value="1"/>
</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-drug-product-handle"/>
<targetProfile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance"/>
<targetProfile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"/>
<aggregation value="bundled"/>
</type>
<meaningWhenMissing value="Patient"/>
<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="workflow"/>
<map value="Definition.subject"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.date">
<path value="PlanDefinition.date"/>
<short value="Specification Version Date"/>
<definition
value="The date when the sponsor assigned a date to a specific version. [Source: SME Defined]
Note: This is the date a particular version of the specification was internally accepted by the submitter."/>
<comment
value="The date is often not tracked until the resource is published, but may be present on draft content. Note that this is not the same as the resource last-modified-date, since the resource may be a secondary representation of the plan definition. Additional specific dates may be added as extensions or be found by consulting Provenances associated with past versions of the resource.
See guidance around (not) making local changes to elements [here](http://hl7.org/fhir/R5/canonicalresource.html#localization)."/>
<alias value="Revision Date"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="PlanDefinition.date"/>
<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="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="workflow"/>
<map value="Definition.date"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.recorded"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".participation[typeCode=AUT].time"/>
</mapping>
</element>
<element id="PlanDefinition.publisher">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.publisher"/>
<short
value="Name of the publisher/steward (organization or individual)"/>
<definition
value="The name of the organization or individual responsible for the release and ongoing maintenance of the plan definition."/>
<comment
value="Usually an organization but may be an individual. The publisher (or steward) of the plan definition is the organization or individual primarily responsible for the maintenance and upkeep of the plan definition. This is not necessarily the same individual or organization that developed and initially authored the content. The publisher is the primary point of contact for questions or issues with the plan definition. This item SHOULD be populated unless the information is available from context."/>
<requirements
value="Helps establish the "authority/credibility" of the plan definition. May also allow for contact."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.publisher"/>
<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="workflow"/>
<map value="Definition.publisher"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.witness"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".participation[typeCode=AUT].role"/>
</mapping>
</element>
<element id="PlanDefinition.contact">
<path value="PlanDefinition.contact"/>
<short value="Contact details for the publisher"/>
<definition
value="Contact details to assist a user in finding and communicating with the publisher."/>
<comment
value="May be a web site, an email address, a telephone number, etc.
See guidance around (not) making local changes to elements [here](http://hl7.org/fhir/R5/canonicalresource.html#localization)."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.contact"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="ContactDetail"/>
</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="Definition.contact"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".participation[typeCode=CALLBCK].role"/>
</mapping>
</element>
<element id="PlanDefinition.description">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.description"/>
<short value="Natural language description of the plan definition"/>
<definition
value="A free text natural language description of the plan definition from a consumer's perspective."/>
<comment
value="This description can be used to capture details such as comments about misuse, instructions for clinical use and interpretation, literature references, examples from the paper world, etc. It is not a rendering of the plan definition as conveyed in the 'text' field of the resource itself. This item SHOULD be populated unless the information is available from context (e.g. the language of the plan definition is presumed to be the predominant language in the place the plan definition was created)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.description"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="markdown"/>
</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="Definition.description"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".text"/>
</mapping>
</element>
<element id="PlanDefinition.useContext">
<path value="PlanDefinition.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 plan definition 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="PlanDefinition.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"/>
<mapping>
<identity value="workflow"/>
<map value="Definition.useContext"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.jurisdiction">
<path value="PlanDefinition.jurisdiction"/>
<short
value="Intended jurisdiction for plan definition (if applicable)"/>
<definition
value="A legal or geographic region in which the plan definition is intended to be used."/>
<comment
value="It may be possible for the plan definition to be used in jurisdictions other than those for which it was originally designed or intended.
DEPRECATION NOTE: For consistency, implementations are encouraged to migrate to using the new 'jurisdiction' code in the useContext element. (I.e. useContext.code indicating http://terminology.hl7.org/CodeSystem/usage-context-type#jurisdiction and useContext.valueCodeableConcept indicating the jurisdiction.)"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.jurisdiction"/>
<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="Jurisdiction"/>
</extension>
<strength value="extensible"/>
<description
value="Countries and regions within which this artifact is targeted for use."/>
<valueSet value="http://hl7.org/fhir/ValueSet/jurisdiction"/>
</binding>
<mapping>
<identity value="workflow"/>
<map value="Definition.jurisdiction"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.purpose">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.purpose"/>
<short value="Why this plan definition is defined"/>
<definition
value="Explanation of why this plan definition is needed and why it has been designed as it has."/>
<comment
value="This element does not describe the usage of the plan definition. Instead, it provides traceability of ''why'' the resource is either needed or ''why'' it is defined as it is. This may be used to point to source materials or specifications that drove the structure of this plan definition."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.purpose"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="markdown"/>
</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="workflow"/>
<map value="Definition.purpose"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.why[x]"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".reasonCode.text"/>
</mapping>
<mapping>
<identity value="objimpl"/>
<map value="no-gen-base"/>
</mapping>
</element>
<element id="PlanDefinition.usage">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.usage"/>
<short value="Describes the clinical usage of the plan"/>
<definition
value="A detailed description of how the plan definition is used from a clinical perspective."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.usage"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="markdown"/>
</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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.copyright">
<path value="PlanDefinition.copyright"/>
<short value="Use and/or publishing restrictions"/>
<definition
value="A copyright statement relating to the plan definition and/or its contents. Copyright statements are generally legal restrictions on the use and publishing of the plan definition."/>
<comment
value="The short copyright declaration (e.g. (c) '2015+ xyz organization' should be sent in the copyrightLabel element."/>
<requirements
value="Consumers must be able to determine any legal restrictions on the use of the plan definition and/or its content."/>
<alias value="License"/>
<alias value="Restrictions"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.copyright"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="markdown"/>
</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="workflow"/>
<map value="Definition.copyright"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
<mapping>
<identity value="objimpl"/>
<map value="no-gen-base"/>
</mapping>
</element>
<element id="PlanDefinition.copyrightLabel">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.copyrightLabel"/>
<short value="Copyright holder and year(s)"/>
<definition
value="A short string (<50 characters), suitable for inclusion in a page footer that identifies the copyright holder, effective period, and optionally whether rights are resctricted. (e.g. 'All rights reserved', 'Some rights reserved')."/>
<comment
value="The (c) symbol should NOT be included in this string. It will be added by software when rendering the notation. Full details about licensing, restrictions, warrantees, etc. goes in the more general 'copyright' element."/>
<requirements
value="Defines the content expected to be rendered in all representations of the artifact."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.copyrightLabel"/>
<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="workflow"/>
<map value="Definition.copyrightLabel"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
<mapping>
<identity value="objimpl"/>
<map value="no-gen-base"/>
</mapping>
</element>
<element id="PlanDefinition.approvalDate">
<path value="PlanDefinition.approvalDate"/>
<short value="Specification Status Date"/>
<definition
value="The date on which the FDA approval status for a specification became effective. [Source: SME Defined]
Note: If the application is not yet approved, then this is the date of the current submission OR the date of the complete response (CR).
Note: This is not the application approval status date."/>
<comment
value="The 'date' element may be more recent than the approval date because of minor changes or editorial corrections.
See guidance around (not) making local changes to elements [here](http://hl7.org/fhir/R5/canonicalresource.html#localization)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.approvalDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="date"/>
</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="workflow"/>
<map value="Definition.approvalDate"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value=".outboundRelationship[typeCode="SUBJ"].act[classCode=CACT;moodCode=EVN;code="approval"].effectiveTime"/>
</mapping>
<mapping>
<identity value="objimpl"/>
<map value="no-gen-base"/>
</mapping>
</element>
<element id="PlanDefinition.lastReviewDate">
<path value="PlanDefinition.lastReviewDate"/>
<short
value="When the plan definition was last reviewed by the publisher"/>
<definition
value="The date on which the resource content was last reviewed. Review happens periodically after approval but does not change the original approval date."/>
<comment
value="If specified, this date follows the original approval date.
See guidance around (not) making local changes to elements [here](http://hl7.org/fhir/R5/canonicalresource.html#localization)."/>
<requirements
value="Gives a sense of how "current" the content is. Resources that have not been reviewed in a long time may have a risk of being less appropriate/relevant."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.lastReviewDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="date"/>
</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="workflow"/>
<map value="Definition.lastReviewDate"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value=".outboundRelationship[typeCode="SUBJ"; subsetCode="RECENT"].act[classCode=CACT;moodCode=EVN;code="review"].effectiveTime"/>
</mapping>
<mapping>
<identity value="objimpl"/>
<map value="no-gen-base"/>
</mapping>
</element>
<element id="PlanDefinition.effectivePeriod">
<path value="PlanDefinition.effectivePeriod"/>
<short value="When the plan definition is expected to be used"/>
<definition
value="The period during which the plan definition content was or is planned to be in active use."/>
<comment
value="The effective period for a plan definition determines when the content is applicable for usage and is independent of publication and review dates. For example, a plan definition intended to be used for the year 2016 might be published in 2015.
See guidance around (not) making local changes to elements [here](http://hl7.org/fhir/R5/canonicalresource.html#localization)."/>
<requirements
value="Allows establishing a transition before a resource comes into effect and also allows for a sunsetting process when new versions of the plan definition are or are expected to be used instead."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.effectivePeriod"/>
<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="workflow"/>
<map value="Definition.effectivePeriod"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
<mapping>
<identity value="objimpl"/>
<map value="no-gen-base"/>
</mapping>
</element>
<element id="PlanDefinition.topic">
<path value="PlanDefinition.topic"/>
<short value="E.g. Education, Treatment, Assessment"/>
<definition
value="Descriptive topics related to the content of the plan definition. Topics provide a high-level categorization of the definition that can be useful for filtering and searching."/>
<comment
value="DEPRECATION NOTE: For consistency, implementations are encouraged to migrate to using the new 'topic' code in the useContext element. (I.e. useContext.code indicating http://terminology.hl7.org/CodeSystem/usage-context-type#topic and useContext.valueCodeableConcept indicating the topic)"/>
<requirements
value="Repositories must be able to determine how to categorize the plan definition so that it can be found by topical searches."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.topic"/>
<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="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="DefinitionTopic"/>
</extension>
<strength value="example"/>
<description
value="High-level categorization of the definition, used for searching, sorting, and filtering."/>
<valueSet value="http://hl7.org/fhir/ValueSet/definition-topic"/>
</binding>
<mapping>
<identity value="workflow"/>
<map value="Definition.subject[x]"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.author">
<path value="PlanDefinition.author"/>
<short value="Who authored the content"/>
<definition
value="An individiual or organization primarily involved in the creation and maintenance of the content."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.author"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="ContactDetail"/>
</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=AUT]"/>
</mapping>
</element>
<element id="PlanDefinition.editor">
<path value="PlanDefinition.editor"/>
<short value="Who edited the content"/>
<definition
value="An individual or organization primarily responsible for internal coherence of the content."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.editor"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="ContactDetail"/>
</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=AUT]"/>
</mapping>
</element>
<element id="PlanDefinition.reviewer">
<path value="PlanDefinition.reviewer"/>
<short value="Who reviewed the content"/>
<definition
value="An individual or organization asserted by the publisher to be primarily responsible for review of some aspect of the content."/>
<comment
value="See guidance around (not) making local changes to elements [here](http://hl7.org/fhir/R5/canonicalresource.html#localization)."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.reviewer"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="ContactDetail"/>
</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=VRF] {not clear whether VRF best corresponds to reviewer or endorser}"/>
</mapping>
</element>
<element id="PlanDefinition.endorser">
<path value="PlanDefinition.endorser"/>
<short value="Who endorsed the content"/>
<definition
value="An individual or organization asserted by the publisher to be responsible for officially endorsing the content for use in some setting."/>
<comment
value="See guidance around (not) making local changes to elements [here](http://hl7.org/fhir/R5/canonicalresource.html#localization)."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.endorser"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="ContactDetail"/>
</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=VRF] {not clear whether VRF best corresponds to reviewer or endorser}"/>
</mapping>
</element>
<element id="PlanDefinition.relatedArtifact">
<path value="PlanDefinition.relatedArtifact"/>
<short value="Additional documentation, citations"/>
<definition
value="Related artifacts such as additional documentation, justification, or bibliographic references."/>
<comment
value="Each related artifact is either an attachment, or a reference to another resource, but not both."/>
<requirements
value="Plan definitions must be able to provide enough information for consumers of the content (and/or interventions or results produced by the content) to be able to determine and understand the justification for and evidence in support of the content."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.relatedArtifact"/>
<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[typeCode=DOC,RSON,PREV, DRIV, USE, COMP] {successor would be PREV w/ inversionInd=true; No support for citation}"/>
</mapping>
</element>
<element id="PlanDefinition.library">
<path value="PlanDefinition.library"/>
<short value="Logic used by the plan definition"/>
<definition
value="A reference to a Library resource containing any formal logic used by the plan definition."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.library"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="canonical"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Library"/>
</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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.goal">
<path value="PlanDefinition.goal"/>
<short value="Acceptance Criteria"/>
<definition
value="A goal describes an expected outcome that activities within the plan are intended to achieve. For example, weight loss, restoring an activity of daily living, obtaining herd immunity via immunization, meeting a process improvement objective, meeting the acceptance criteria for a test as specified by a quality specification, etc."/>
<requirements
value="Goal information needs to be captured for order sets, protocols, and care plan definitions to better describe the objectives of the protocol activities and to guide the creation of specific goals within the derived care plans and orders."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.goal"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<condition value="pld-3"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.goal.id">
<path value="PlanDefinition.goal.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="PlanDefinition.goal.extension">
<path value="PlanDefinition.goal.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<ordered value="false"/>
<rules value="open"/>
</slicing>
<short value="Extension"/>
<definition value="An Extension"/>
<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"/>
</element>
<element id="PlanDefinition.goal.extension:ac-additional-info">
<path value="PlanDefinition.goal.extension"/>
<sliceName value="ac-additional-info"/>
<short value="Acceptance Criteria Additional Information"/>
<definition
value="A coded value specifying when a particular analytical procedure or measurement is being performed on a substance or a product. [Source: SME Defined] Examples: Release, Stability.
Note: The concept of 'In-Process' is subsumed by the Release code.
Example: value changed from 4% to 5% on 01/01/2010) "/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-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"/>
</element>
<element id="PlanDefinition.goal.modifierExtension">
<path value="PlanDefinition.goal.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="PlanDefinition.goal.category">
<path value="PlanDefinition.goal.category"/>
<short value="E.g. Treatment, dietary, behavioral"/>
<definition value="Indicates a category the goal falls within."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.goal.category"/>
<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="GoalCategory"/>
</extension>
<strength value="example"/>
<description
value="Example codes for grouping goals for filtering or presentation."/>
<valueSet value="http://hl7.org/fhir/ValueSet/goal-category"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.goal.description">
<path value="PlanDefinition.goal.description"/>
<short value="Original Text"/>
<definition
value="The text of the acceptance criteria as provided in the specification. [Source: SME Defined]
Examples: White to off-white cake; 22.5 - 27.5 mg/ml Note: This is the text as it appears in the Specification."/>
<comment value="If no code is available, use CodeableConcept.text."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="PlanDefinition.goal.description"/>
<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="true"/>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="GoalDescription"/>
</extension>
<strength value="example"/>
<description value="Describes goals that can be achieved."/>
<valueSet value="http://hl7.org/fhir/ValueSet/clinical-findings"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.goal.priority">
<path value="PlanDefinition.goal.priority"/>
<short value="high-priority | medium-priority | low-priority"/>
<definition
value="Identifies the expected level of importance associated with reaching/sustaining the defined goal."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.goal.priority"/>
<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="GoalPriority"/>
</extension>
<strength value="preferred"/>
<description
value="Indicates the level of importance associated with reaching or sustaining a goal."/>
<valueSet value="http://hl7.org/fhir/ValueSet/goal-priority"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.goal.start">
<path value="PlanDefinition.goal.start"/>
<short value="When goal pursuit begins"/>
<definition
value="The event after which the goal should begin being pursued."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.goal.start"/>
<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="GoalStartEvent"/>
</extension>
<strength value="example"/>
<description
value="Identifies the types of events that might trigger the start of a goal."/>
<valueSet value="http://hl7.org/fhir/ValueSet/goal-start-event"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.goal.addresses">
<path value="PlanDefinition.goal.addresses"/>
<short value="Acceptance Criteria Usage"/>
<definition
value="A coded value specifying when a particular analytical procedure or measurement is being performed on a substance or a product. [Source: SME Defined] Examples: Release, Stability.
Note: The concept of 'In-Process' is subsumed by the Release code."/>
<min value="1"/>
<max value="*"/>
<base>
<path value="PlanDefinition.goal.addresses"/>
<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="true"/>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<strength value="required"/>
<valueSet
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-usage-terminology"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.goal.documentation">
<path value="PlanDefinition.goal.documentation"/>
<short value="Supporting documentation for the goal"/>
<definition
value="Didactic or other informational resources associated with the goal that provide further supporting information about the goal. Information resources can include inline text commentary and links to web resources."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.goal.documentation"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.goal.target">
<path value="PlanDefinition.goal.target"/>
<short value="Acceptance Criteron"/>
<definition
value="Indicates what should be done and within what timeframe."/>
<min value="1"/>
<max value="*"/>
<base>
<path value="PlanDefinition.goal.target"/>
<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>
<constraint>
<key value="cmc-target-range"/>
<severity value="error"/>
<human
value="When the Range extension is present, detail cannot be present."/>
<expression
value="modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range').exists() implies detail.exists().not()"/>
<source
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.goal.target.id">
<path value="PlanDefinition.goal.target.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="PlanDefinition.goal.target.extension">
<path value="PlanDefinition.goal.target.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="PlanDefinition.goal.target.modifierExtension">
<path value="PlanDefinition.goal.target.modifierExtension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<ordered value="false"/>
<rules value="open"/>
</slicing>
<short value="Extension"/>
<definition value="An Extension"/>
<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"/>
</element>
<element id="PlanDefinition.goal.target.modifierExtension:targetRange">
<path value="PlanDefinition.goal.target.modifierExtension"/>
<sliceName value="targetRange"/>
<short value="Target Range"/>
<definition
value="The FHIR Range datatype uses Simple Quantities to represent the high and low bounds, which do not allow a comparator to be set. This extension allows the high and low bounds to have a comparator"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range"/>
</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="true"/>
<isModifier value="true"/>
<isModifierReason
value="When present, the target cannot have a detail; instead this extension acts as its detail"/>
</element>
<element id="PlanDefinition.goal.target.measure">
<path value="PlanDefinition.goal.target.measure"/>
<short
value="Detailed parameter being measured if more granular than Sub-Test"/>
<definition
value="A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text."/>
<comment
value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.goal.target.measure"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"/>
</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"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="GoalTargetMeasure"/>
</extension>
<strength value="example"/>
<description
value="Identifies types of parameters that can be tracked to determine goal achievement."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="n/a,CD"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CE/CNE/CWE"/>
</mapping>
<mapping>
<identity value="orim"/>
<map value="fhir:CodeableConcept rdfs:subClassOf dt:CD"/>
</mapping>
</element>
<element id="PlanDefinition.goal.target.detail[x]">
<path value="PlanDefinition.goal.target.detail[x]"/>
<slicing>
<discriminator>
<type value="type"/>
<path value="$this"/>
</discriminator>
<ordered value="false"/>
<rules value="closed"/>
</slicing>
<short value="The target value to be achieved"/>
<definition
value="The target value of the measure to be achieved to signify fulfillment of the goal, e.g. 150 pounds or 7.0%, or in the case of pharmaceutical quality - NMT 0.6%, Clear solution, etc. Either the high or low or both values of the range can be specified. When a low value is missing, it indicates that the goal is achieved at any value at or below the high value. Similarly, if the high value is missing, it indicates that the goal is achieved at any value at or above the low value."/>
<comment
value="A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the goal.target.measure defines a coded value."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.goal.target.detail[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Quantity"/>
</type>
<type>
<code value="string"/>
</type>
<type>
<code value="integer"/>
</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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.goal.target.detail[x]:detailQuantity">
<path value="PlanDefinition.goal.target.detail[x]"/>
<sliceName value="detailQuantity"/>
<short value="ValueNumeric"/>
<definition
value="The acceptable quantitative or numeric value for the result of the test. [Source: SME Defined]"/>
<comment
value="A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the goal.target.measure defines a coded value."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.goal.target.detail[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Quantity"/>
</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>
<strength value="required"/>
<valueSet
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.goal.target.detail[x]:detailQuantity.id">
<path value="PlanDefinition.goal.target.detail[x].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="id"/>
</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="PlanDefinition.goal.target.detail[x]:detailQuantity.extension">
<path value="PlanDefinition.goal.target.detail[x].extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<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="PlanDefinition.goal.target.detail[x]:detailQuantity.value">
<path value="PlanDefinition.goal.target.detail[x].value"/>
<short value="Numerical value (with implicit precision)"/>
<definition
value="The value of the measured amount. The value includes an implicit precision in the presentation of the value."/>
<comment
value="The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books)."/>
<requirements
value="Precision is handled implicitly in almost all cases of measurement."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Quantity.value"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="decimal"/>
</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="v2"/>
<map value="SN.2 / CQ - N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value"/>
</mapping>
</element>
<element
id="PlanDefinition.goal.target.detail[x]:detailQuantity.comparator">
<path value="PlanDefinition.goal.target.detail[x].comparator"/>
<short
value="< | <= | >= | > | ad - how to understand the value"/>
<definition
value="How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value."/>
<requirements
value="Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Quantity.comparator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<meaningWhenMissing
value="If there is no comparator, then there is no modification of the value"/>
<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="true"/>
<isModifierReason
value="This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="QuantityComparator"/>
</extension>
<strength value="required"/>
<description
value="How the Quantity should be understood and represented."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="SN.1 / CQ.1"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="IVL properties"/>
</mapping>
</element>
<element id="PlanDefinition.goal.target.detail[x]:detailQuantity.unit">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.goal.target.detail[x].unit"/>
<short value="Unit representation"/>
<definition value="A human-readable form of the unit."/>
<requirements
value="There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Quantity.unit"/>
<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="true"/>
<mapping>
<identity value="v2"/>
<map value="(see OBX.6 etc.) / CQ.2"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="PQ.unit"/>
</mapping>
</element>
<element id="PlanDefinition.goal.target.detail[x]:detailQuantity.system">
<path value="PlanDefinition.goal.target.detail[x].system"/>
<short value="System that defines coded unit form"/>
<definition
value="The identification of the system that provides the coded form of the unit."/>
<requirements
value="Need to know the system that defines the coded form of the unit."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Quantity.system"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="uri"/>
</type>
<condition value="qty-3"/>
<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>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="(see OBX.6 etc.) / CQ.2"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="CO.codeSystem, PQ.translation.codeSystem"/>
</mapping>
</element>
<element id="PlanDefinition.goal.target.detail[x]:detailQuantity.code">
<path value="PlanDefinition.goal.target.detail[x].code"/>
<short value="Coded form of the unit"/>
<definition
value="A computer processable form of the unit in some unit representation system."/>
<comment
value="The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system."/>
<requirements
value="Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Quantity.code"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<condition value="qty-3"/>
<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="v2"/>
<map value="(see OBX.6 etc.) / CQ.2"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="PQ.code, MO.currency, PQ.translation.code"/>
</mapping>
</element>
<element id="PlanDefinition.goal.target.detail[x]:detailString">
<path value="PlanDefinition.goal.target.detail[x]"/>
<sliceName value="detailString"/>
<short value="Value"/>
<definition
value="A textual description and/or a number that identifies a level within a sequential test. [Source: SME Defined] Examples – Single Stage, Stage 1, Stage 2 (sometimes referred to as L1, L2 L3 or A1, A2 as in USP &lt;711>)
Note: A Stage may or may not provide a conditional sequence with associated acceptance criteria. [Source: SME Defined] (e.g., dissolution test, pyrogen test - USP &lt;151>; 21 CFR 610.13 (b) Test for pyrogenic substances)"/>
<comment
value="A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the goal.target.measure defines a coded value."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.goal.target.detail[x]"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.goal.target.detail[x]:detailInteger">
<path value="PlanDefinition.goal.target.detail[x]"/>
<sliceName value="detailInteger"/>
<short value="Number of Replicates"/>
<definition
value="An identification number for a member of the set of results for a test, usually the sequence order in which the test was executed. Individual tests are executed on multiple samples to give greater validity to the findings. [Source SME Defined]
Examples: Prepare six aliquots from the sample. Test 8 samples. If any fall above 110%, test an additional 7 samples. Record all replicate values as stated in the method."/>
<comment
value="A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the goal.target.measure defines a coded value."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.goal.target.detail[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="integer"/>
</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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.goal.target.due">
<path value="PlanDefinition.goal.target.due"/>
<short value="Reach goal within"/>
<definition
value="Indicates the timeframe after the start of the goal in which the goal should be met."/>
<min value="0"/>
<max value="0"/>
<base>
<path value="PlanDefinition.goal.target.due"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Duration"/>
</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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.actor">
<path value="PlanDefinition.actor"/>
<short value="Actors within the plan"/>
<definition
value="Actors represent the individuals or groups involved in the execution of the defined set of activities."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.actor"/>
<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=PFM]"/>
</mapping>
</element>
<element id="PlanDefinition.actor.id">
<path value="PlanDefinition.actor.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="PlanDefinition.actor.extension">
<path value="PlanDefinition.actor.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="PlanDefinition.actor.modifierExtension">
<path value="PlanDefinition.actor.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="PlanDefinition.actor.title">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.actor.title"/>
<short value="User-visible title"/>
<definition value="A descriptive label for the actor."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.actor.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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.actor.description">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.actor.description"/>
<short value="Describes the actor"/>
<definition
value="A description of how the actor fits into the overall actions of the plan definition."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.actor.description"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="markdown"/>
</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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.actor.option">
<path value="PlanDefinition.actor.option"/>
<short value="Who or what can be this actor"/>
<definition
value="The characteristics of the candidates that could serve as the actor."/>
<min value="1"/>
<max value="*"/>
<base>
<path value="PlanDefinition.actor.option"/>
<min value="1"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.actor.option.id">
<path value="PlanDefinition.actor.option.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="PlanDefinition.actor.option.extension">
<path value="PlanDefinition.actor.option.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="PlanDefinition.actor.option.modifierExtension">
<path value="PlanDefinition.actor.option.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="PlanDefinition.actor.option.type">
<path value="PlanDefinition.actor.option.type"/>
<short
value="careteam | device | group | healthcareservice | location | organization | patient | practitioner | practitionerrole | relatedperson"/>
<definition value="The type of participant in the action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.actor.option.type"/>
<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="ActivityParticipantType"/>
</extension>
<strength value="required"/>
<description value="The type of participant in the activity."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value=".role.classCode"/>
</mapping>
</element>
<element id="PlanDefinition.actor.option.typeCanonical">
<path value="PlanDefinition.actor.option.typeCanonical"/>
<short value="Who or what can participate"/>
<definition value="The type of participant in the action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.actor.option.typeCanonical"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="canonical"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/CapabilityStatement"/>
</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=".role.classCode"/>
</mapping>
</element>
<element id="PlanDefinition.actor.option.typeReference">
<path value="PlanDefinition.actor.option.typeReference"/>
<short value="Who or what can participate"/>
<definition value="The type of participant in the action."/>
<comment
value="When this element is a reference, it SHOULD be a reference to a definitional resource (for example, a location type, rather than a specific location)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.actor.option.typeReference"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/CareTeam"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Device"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/DeviceDefinition"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Endpoint"/>
<targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/HealthcareService"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Location"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Patient"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Practitioner"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/RelatedPerson"/>
</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=".role.classCode"/>
</mapping>
</element>
<element id="PlanDefinition.actor.option.role">
<path value="PlanDefinition.actor.option.role"/>
<short value="E.g. Nurse, Surgeon, Parent"/>
<definition
value="The role the participant should play in performing the described action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.actor.option.role"/>
<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="ActionParticipantRole"/>
</extension>
<strength value="example"/>
<valueSet
value="http://terminology.hl7.org/ValueSet/action-participant-role"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action">
<path value="PlanDefinition.action"/>
<short value="Method"/>
<definition
value="An action or group of actions to be taken as part of the plan. For example, in clinical care, an action would be to prescribe a particular indicated medication, or perform a particular test as appropriate. In pharmaceutical quality, an action would be the test that needs to be performed on a drug product as defined in the quality specification."/>
<comment
value="Note that there is overlap between many of the elements defined here and the ActivityDefinition resource. When an ActivityDefinition is referenced (using the definition element), the overlapping elements in the plan override the content of the referenced ActivityDefinition unless otherwise documented in the specific elements. See the PlanDefinition resource for more detailed information."/>
<min value="1"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<condition value="pld-3"/>
<condition value="pld-4"/>
<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="cmc-link-required"/>
<severity value="error"/>
<human value="Action linkId is required for alternate tests"/>
<expression
value="(action.relatedAction.count() > 0) implies action.linkId.exists()"/>
<source
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"/>
</constraint>
<constraint>
<key value="cmc-single-or-multistage"/>
<severity value="error"/>
<human
value="if a test is multi-stage, the test can't have a prefix and its stages must have a name and can't be named 'Single Stage' and must be unique. If it's single stage its prefix is 'Single Stage' and its groups can't have prefixes"/>
<expression
value="((
prefix.exists() implies
action.prefix.empty() and prefix = 'Single Stage'
) and (
prefix.empty() implies (
(action.where(
prefix.exists() and
prefix != 'Single Stage'
).count() = action.count()) and
action.prefix.isDistinct()
)
)) = true"/>
<source
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="workflow"/>
<map value="{Is a contained Definition}"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Act[classCode=ACT; moodCode=DEFN]"/>
</mapping>
</element>
<element id="PlanDefinition.action.id">
<path value="PlanDefinition.action.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="PlanDefinition.action.extension">
<path value="PlanDefinition.action.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="PlanDefinition.action.modifierExtension">
<path value="PlanDefinition.action.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="PlanDefinition.action.linkId">
<path value="PlanDefinition.action.linkId"/>
<short value="only required for alternate tests"/>
<definition
value="An identifier that is unique within the PlanDefinition to allow linkage within the realized CarePlan and/or RequestOrchestration."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.linkId"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.prefix">
<path value="PlanDefinition.action.prefix"/>
<short value="Stage Name"/>
<definition
value="A textual description and/or a number that identifies a level within a sequential test. [Source: SME Defined] Examples – Single Stage, Stage 1, Stage 2 (sometimes referred to as L1, L2 L3 or A1, A2 as in USP &lt;711&gt;)
Note: A Stage may or may not provide a conditional sequence with associated acceptance criteria. [Source: SME Defined] (e.g., dissolution test, pyrogen test - &lt;151&gt;; 21 CFR 610.13 (b) Test for pyrogenic substances)
Implememtation Note: Value at this level is 'Single Stage'"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.prefix"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.title">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.action.title"/>
<short value="Test Name"/>
<definition
value="The textual description of a procedure or analytical method. [Source: SME Defined]
Examples: Assay by HPLC, moisture by Karl Fischer, analysis for impurities.
Note: as defined by the sponsor"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.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="workflow"/>
<map value="Definition.title"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".title"/>
</mapping>
</element>
<element id="PlanDefinition.action.description">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.action.description"/>
<short value="Test Additional Information"/>
<definition
value="Test Additional Information: Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined].
If there is more than one comment, include in this element. Markdown allows formating for clarity."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.description"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="markdown"/>
</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="workflow"/>
<map value="Definition.description"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".text"/>
</mapping>
</element>
<element id="PlanDefinition.action.textEquivalent">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.action.textEquivalent"/>
<short
value="Static text equivalent of the action, used if the dynamic aspects cannot be interpreted by the receiving system"/>
<definition
value="A text equivalent of the action to be performed. This provides a human-interpretable description of the action when the definition is consumed by a system that might not be capable of interpreting it dynamically."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.textEquivalent"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="markdown"/>
</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="workflow"/>
<map value="Definition.description"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".text"/>
</mapping>
</element>
<element id="PlanDefinition.action.priority">
<path value="PlanDefinition.action.priority"/>
<short value="routine | urgent | asap | stat"/>
<definition
value="Indicates how quickly the action should be addressed with respect to other actions."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.priority"/>
<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="RequestPriority"/>
</extension>
<strength value="required"/>
<description
value="Identifies the level of importance to be assigned to actioning the request."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/request-priority|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value=".priority"/>
</mapping>
</element>
<element id="PlanDefinition.action.code">
<path value="PlanDefinition.action.code"/>
<short value="Test Method Origin"/>
<definition
value="A coded value specifying the source of the method. [Source: SME Defined] Example: Compendial"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.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="ActionCode"/>
</extension>
<strength value="example"/>
<description value="Provides examples of actions to be performed."/>
<valueSet value="http://hl7.org/fhir/ValueSet/action-code"/>
</binding>
<mapping>
<identity value="rim"/>
<map value=".classCode"/>
</mapping>
</element>
<element id="PlanDefinition.action.code.id">
<path value="PlanDefinition.action.code.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="id"/>
</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="PlanDefinition.action.code.extension">
<path value="PlanDefinition.action.code.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<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="PlanDefinition.action.code.coding">
<path value="PlanDefinition.action.code.coding"/>
<short value="Code defined by a terminology system"/>
<definition
value="A reference to a code defined by a terminology system."/>
<comment
value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true."/>
<requirements
value="Allows for alternative encodings within a code system, and translations to other code systems."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="CodeableConcept.coding"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Coding"/>
</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"/>
<binding>
<strength value="required"/>
<valueSet
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-method-origin-terminology"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="C*E.1-8, C*E.10-22"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="union(., ./translation)"/>
</mapping>
<mapping>
<identity value="orim"/>
<map
value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/>
</mapping>
</element>
<element id="PlanDefinition.action.code.text">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.action.code.text"/>
<short value="Analytical Procedure"/>
<definition
value="The name of the technique used to determine the nature of a characteristic. [Source: SME Defined]."/>
<comment
value="Very often the text is the same as a displayName of one of the codings."/>
<requirements
value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="CodeableConcept.text"/>
<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="true"/>
<mapping>
<identity value="v2"/>
<map value="C*E.9. But note many systems use C*E.2 for this"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="./originalText[mediaType/code="text/plain"]/data"/>
</mapping>
<mapping>
<identity value="orim"/>
<map
value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/>
</mapping>
</element>
<element id="PlanDefinition.action.reason">
<path value="PlanDefinition.action.reason"/>
<short value="Test Category | Test Subcategory"/>
<definition
value="A high level grouping of quality attributes for products, substances, raw materials, excipients, intermediates and reagents. [Source: SME Defined] Examples: Assay, Biological Properties."/>
<comment
value="This is different than the clinical evidence documentation, it's an actual business description of the reason for performing the action."/>
<min value="1"/>
<max value="2"/>
<base>
<path value="PlanDefinition.action.reason"/>
<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="true"/>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<strength value="required"/>
<valueSet
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology"/>
</binding>
<mapping>
<identity value="rim"/>
<map value=".reasonCode"/>
</mapping>
</element>
<element id="PlanDefinition.action.reason.id">
<path value="PlanDefinition.action.reason.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="id"/>
</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="PlanDefinition.action.reason.extension">
<path value="PlanDefinition.action.reason.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Extension"/>
<definition value="An Extension"/>
<min value="1"/>
<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"/>
</element>
<element id="PlanDefinition.action.reason.extension:categoryLevel">
<path value="PlanDefinition.action.reason.extension"/>
<sliceName value="categoryLevel"/>
<short value="Hierarchical Level"/>
<definition
value="Numeric level in the hierarchical value-set. As an example, this extension is used to distinguished between Test Category | Test Subcategory in Quality Specifications. Test Category is level 1 and Test Subcategory is level two. A constraint enforces values greater than zero."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-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="true"/>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="PlanDefinition.action.reason.coding">
<path value="PlanDefinition.action.reason.coding"/>
<short value="Code defined by a terminology system"/>
<definition
value="A reference to a code defined by a terminology system."/>
<comment
value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true."/>
<requirements
value="Allows for alternative encodings within a code system, and translations to other code systems."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="CodeableConcept.coding"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Coding"/>
</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>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="C*E.1-8, C*E.10-22"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="union(., ./translation)"/>
</mapping>
<mapping>
<identity value="orim"/>
<map
value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/>
</mapping>
</element>
<element id="PlanDefinition.action.reason.text">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.action.reason.text"/>
<short value="Plain text representation of the concept"/>
<definition
value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user."/>
<comment
value="Very often the text is the same as a displayName of one of the codings."/>
<requirements
value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="CodeableConcept.text"/>
<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>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="C*E.9. But note many systems use C*E.2 for this"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="./originalText[mediaType/code="text/plain"]/data"/>
</mapping>
<mapping>
<identity value="orim"/>
<map
value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/>
</mapping>
</element>
<element id="PlanDefinition.action.documentation">
<path value="PlanDefinition.action.documentation"/>
<short
value="Supporting documentation for the intended performer of the action"/>
<definition
value="Didactic or other informational resources associated with the action that can be provided to the CDS recipient. Information resources can include inline text commentary and links to web resources."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.documentation"/>
<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="true"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.documentation.id">
<path value="PlanDefinition.action.documentation.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="id"/>
</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="PlanDefinition.action.documentation.extension">
<path value="PlanDefinition.action.documentation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<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="PlanDefinition.action.documentation.type">
<path value="PlanDefinition.action.documentation.type"/>
<short
value="documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as"/>
<definition value="The type of relationship to the related artifact."/>
<comment
value="The presence of both sides of a relationship type (e.g. successor and predecessor) is required to support use cases where one side of a relationship is not represented in FHIR. However, this feature SHALL NOT be used to create bi-directional resource links in FHIR instances. Specifically, following the methodology of "new points to old" and "many points to one", when using related artifact elements to describe and reference FHIR resources, the type element SHALL be drawn from the fhir-related-artifact-type ValueSet."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="RelatedArtifact.type"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<patternCode value="documentation"/>
<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>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="RelatedArtifactType"/>
</extension>
<strength value="required"/>
<description
value="The type of relationship to the related artifact."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0"/>
</binding>
</element>
<element id="PlanDefinition.action.documentation.classifier">
<path value="PlanDefinition.action.documentation.classifier"/>
<short value="Additional classifiers"/>
<definition
value="Provides additional classifiers of the related artifact."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="RelatedArtifact.classifier"/>
<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>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="RelatedArtifactClassifier"/>
</extension>
<strength value="example"/>
<description
value="Additional classifiers for the related artifact."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/citation-artifact-classifier"/>
</binding>
</element>
<element id="PlanDefinition.action.documentation.label">
<path value="PlanDefinition.action.documentation.label"/>
<short value="Reference to Procedure"/>
<definition
value="A sponsor/applicant provided alphanumeric code that identifies the procedure. [Source: SME Defined]. Example: HP1234-2008
Note: This could also be a transferred lab method."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="RelatedArtifact.label"/>
<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="true"/>
</element>
<element id="PlanDefinition.action.documentation.display">
<path value="PlanDefinition.action.documentation.display"/>
<short value="Brief description of the related artifact"/>
<definition
value="A brief description of the document or knowledge resource being referenced, suitable for display to a consumer."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="RelatedArtifact.display"/>
<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>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="PlanDefinition.action.documentation.citation">
<path value="PlanDefinition.action.documentation.citation"/>
<short value="Bibliographic citation for the artifact"/>
<definition
value="A bibliographic citation for the related artifact. This text SHOULD be formatted according to an accepted citation format."/>
<comment
value="Additional structured information about citations should be captured as extensions."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="RelatedArtifact.citation"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="markdown"/>
</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>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="PlanDefinition.action.documentation.document">
<path value="PlanDefinition.action.documentation.document"/>
<short value="What document is being referenced"/>
<definition
value="The document being referenced, represented as an attachment. This is exclusive with the resource element."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="RelatedArtifact.document"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Attachment"/>
</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>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="PlanDefinition.action.documentation.resource">
<path value="PlanDefinition.action.documentation.resource"/>
<short value="What artifact is being referenced"/>
<definition
value="The related artifact, such as a library, value set, profile, or other knowledge resource."/>
<comment
value="If the type is predecessor, this is a reference to the succeeding knowledge resource. If the type is successor, this is a reference to the prior knowledge resource."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="RelatedArtifact.resource"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="canonical"/>
<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>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="PlanDefinition.action.documentation.resourceReference">
<path value="PlanDefinition.action.documentation.resourceReference"/>
<short value="What artifact, if not a conformance resource"/>
<definition
value="The related artifact, if the artifact is not a canonical resource, or a resource reference to a canonical resource."/>
<comment
value="If both resource and resourceReference are present, they SHOULD be consistent and reference the same resource. Although relatedArtifact is intended to support references to definitional resources, there are cases where non-definitional resources can be definitional (such as Location where the kind is mode). Related artifacts SHOULD be used to reference definitional resources, and profiles SHOULD be used to make that explicit for particular use cases."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="RelatedArtifact.resourceReference"/>
<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>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="PlanDefinition.action.documentation.publicationStatus">
<path value="PlanDefinition.action.documentation.publicationStatus"/>
<short value="draft | active | retired | unknown"/>
<definition
value="The publication status of the artifact being referred to."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="RelatedArtifact.publicationStatus"/>
<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>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="RelatedArtifactPublicationStatus"/>
</extension>
<strength value="required"/>
<description
value="Publication status of an artifact being referred to."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/publication-status|5.0.0"/>
</binding>
</element>
<element id="PlanDefinition.action.documentation.publicationDate">
<path value="PlanDefinition.action.documentation.publicationDate"/>
<short value="Date of publication of the artifact being referred to"/>
<definition
value="The date of publication of the artifact being referred to."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="RelatedArtifact.publicationDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="date"/>
</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>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="PlanDefinition.action.goalId">
<path value="PlanDefinition.action.goalId"/>
<short value="Reference to Acceptance Criteria"/>
<definition
value="Identifies goals that this action supports. The reference must be to a goal element defined within this plan definition. In pharmaceutical quality, a goal represents acceptance criteria (Goal) for a given action (Test), so the goalId would be the unique id of a defined goal element establishing the acceptance criteria for the action."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.goalId"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="id"/>
</type>
<condition value="pld-3"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.subject[x]">
<path value="PlanDefinition.action.subject[x]"/>
<short value="Type of individual the action is focused on"/>
<definition
value="A code, group definition, or canonical reference that describes the intended subject of the action and its children, if any. Canonical references are allowed to support the definition of protocols for drug and substance quality specifications, and is allowed to reference a MedicinalProductDefinition, SubstanceDefinition, AdministrableProductDefinition, ManufacturedItemDefinition, or PackagedProductDefinition resource."/>
<comment
value="The subject of an action overrides the subject at a parent action or on the root of the PlanDefinition if specified.
In addition, because the subject needs to be resolved during realization, use of subjects in actions (or in the ActivityDefinition referenced by the action) resolves based on the set of subjects supplied in context and by type (i.e. the patient subject would resolve to a resource of type Patient)."/>
<requirements
value="Multiple steps in a protocol often have different groups of steps that are focused on testing different things. The subject of an action specifies the focus of the action and any child actions."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.subject[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<type>
<code value="Reference"/>
<targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/>
</type>
<type>
<code value="canonical"/>
</type>
<meaningWhenMissing value="Patient"/>
<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="SubjectType"/>
</extension>
<strength value="extensible"/>
<description
value="The possible types of subjects for a plan definition (E.g. Patient, Practitioner, Organization, Location, etc.)."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/participant-resource-types"/>
</binding>
<mapping>
<identity value="workflow"/>
<map value="Definition.subject"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.trigger">
<path value="PlanDefinition.action.trigger"/>
<short value="When the action should be triggered"/>
<definition
value="A description of when the action should be triggered. When multiple triggers are specified on an action, any triggering event invokes the action."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.trigger"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="TriggerDefinition"/>
</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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.condition">
<path value="PlanDefinition.action.condition"/>
<short value="Whether or not the action is applicable"/>
<definition
value="An expression that describes applicability criteria or start/stop conditions for the action."/>
<comment
value="When multiple conditions of the same kind are present, the effects are combined using AND semantics, so the overall condition is true only if all the conditions are true."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.condition"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.condition.id">
<path value="PlanDefinition.action.condition.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="PlanDefinition.action.condition.extension">
<path value="PlanDefinition.action.condition.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="PlanDefinition.action.condition.modifierExtension">
<path value="PlanDefinition.action.condition.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="PlanDefinition.action.condition.kind">
<path value="PlanDefinition.action.condition.kind"/>
<short value="applicability | start | stop"/>
<definition value="The kind of condition."/>
<comment
value="Applicability criteria are used to determine immediate applicability when a plan definition is applied to a given context. Start and stop criteria are carried through application and used to describe enter/exit criteria for an action."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.condition.kind"/>
<min value="1"/>
<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="ActionConditionKind"/>
</extension>
<strength value="required"/>
<description
value="Defines the kinds of conditions that can appear on actions."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-condition-kind|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.condition.expression">
<path value="PlanDefinition.action.condition.expression"/>
<short value="Boolean-valued expression"/>
<definition
value="An expression that returns true or false, indicating whether the condition is satisfied."/>
<comment
value="The expression may be inlined or may be a reference to a named expression within a logic library referenced by the library element."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.condition.expression"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Expression"/>
</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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.input">
<path value="PlanDefinition.action.input"/>
<short value="Input data requirements"/>
<definition value="Defines input data requirements for the action."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.input"/>
<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>
<constraint>
<key value="pld-0"/>
<severity value="error"/>
<human
value="Input data elements must have a requirement or a relatedData, but not both"/>
<expression value="requirement.exists() xor relatedData.exists()"/>
<source
value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.input.id">
<path value="PlanDefinition.action.input.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="PlanDefinition.action.input.extension">
<path value="PlanDefinition.action.input.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="PlanDefinition.action.input.modifierExtension">
<path value="PlanDefinition.action.input.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="PlanDefinition.action.input.title">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.action.input.title"/>
<short value="User-visible title"/>
<definition
value="A human-readable label for the data requirement used to label data flows in BPMN or similar diagrams. Also provides a human readable label when rendering the data requirement that conveys its purpose to human readers."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.input.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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.input.requirement">
<path value="PlanDefinition.action.input.requirement"/>
<short value="What data is provided"/>
<definition
value="Defines the data that is to be provided as input to the action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.input.requirement"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="DataRequirement"/>
</type>
<condition value="pld-0"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.input.relatedData">
<path value="PlanDefinition.action.input.relatedData"/>
<short value="What data is provided"/>
<definition
value="Points to an existing input or output element that provides data to this input."/>
<comment
value="The relatedData element allows indicating that an input to a parent action is an input to specific child actions. It also allows the output of one action to be identified as the input to a different action"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.input.relatedData"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="id"/>
</type>
<condition value="pld-0"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.output">
<path value="PlanDefinition.action.output"/>
<short value="Output data definition"/>
<definition value="Defines the outputs of the action, if any."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.output"/>
<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>
<constraint>
<key value="pld-1"/>
<severity value="error"/>
<human
value="Output data element must have a requirement or a relatedData, but not both"/>
<expression value="requirement.exists() xor relatedData.exists()"/>
<source
value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.output.id">
<path value="PlanDefinition.action.output.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="PlanDefinition.action.output.extension">
<path value="PlanDefinition.action.output.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="PlanDefinition.action.output.modifierExtension">
<path value="PlanDefinition.action.output.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="PlanDefinition.action.output.title">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.action.output.title"/>
<short value="User-visible title"/>
<definition
value="A human-readable label for the data requirement used to label data flows in BPMN or similar diagrams. Also provides a human readable label when rendering the data requirement that conveys its purpose to human readers."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.output.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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.output.requirement">
<path value="PlanDefinition.action.output.requirement"/>
<short value="What data is provided"/>
<definition
value="Defines the data that results as output from the action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.output.requirement"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="DataRequirement"/>
</type>
<condition value="pld-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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.output.relatedData">
<path value="PlanDefinition.action.output.relatedData"/>
<short value="What data is provided"/>
<definition
value="Points to an existing input or output element that is results as output from the action."/>
<comment
value="The relatedData element allows indicating that the output of child action is also the output of a parent action. It also allows the input of one action to be identified as the output of a different action"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.output.relatedData"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<condition value="pld-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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.relatedAction">
<path value="PlanDefinition.action.relatedAction"/>
<short value="Alternate Test"/>
<definition
value="Alternate Tests are one or more test that are equivalent often using differnt method or equipment. The tests are used interchangeably and only one is used to satisfy the drug product specificaion."/>
<comment
value="When an action depends on multiple actions, the meaning is that all actions are dependencies, rather than that any of the actions are a dependency."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.relatedAction"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<condition value="pld-4"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.relatedAction.id">
<path value="PlanDefinition.action.relatedAction.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="PlanDefinition.action.relatedAction.extension">
<path value="PlanDefinition.action.relatedAction.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="PlanDefinition.action.relatedAction.modifierExtension">
<path value="PlanDefinition.action.relatedAction.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="PlanDefinition.action.relatedAction.targetId">
<path value="PlanDefinition.action.relatedAction.targetId"/>
<short value="What action is this related to"/>
<definition value="The element id of the target related action."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.relatedAction.targetId"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="id"/>
</type>
<condition value="pld-4"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.relatedAction.relationship">
<path value="PlanDefinition.action.relatedAction.relationship"/>
<short value="Code is concurrent"/>
<definition
value="The relationship of the start of this action to the related action."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.relatedAction.relationship"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<patternCode value="concurrent"/>
<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="ActionRelationshipType"/>
</extension>
<strength value="required"/>
<description
value="Defines the types of relationships between actions."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.relatedAction.endRelationship">
<path value="PlanDefinition.action.relatedAction.endRelationship"/>
<short
value="before | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end"/>
<definition
value="The relationship of the end of this action to the related action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.relatedAction.endRelationship"/>
<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="ActionRelationshipType"/>
</extension>
<strength value="required"/>
<description
value="Defines the types of relationships between actions."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.relatedAction.offset[x]">
<path value="PlanDefinition.action.relatedAction.offset[x]"/>
<short value="Time offset for the relationship"/>
<definition
value="A duration or range of durations to apply to the relationship. For example, 30-60 minutes before."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.relatedAction.offset[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Duration"/>
</type>
<type>
<code value="Range"/>
</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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.timing[x]">
<path value="PlanDefinition.action.timing[x]"/>
<short value="When the action should take place"/>
<definition
value="An optional value describing when the action should be performed."/>
<comment
value="The intent of the timing element is to provide timing when the action should be performed. As a definitional resource, this timing is interpreted as part of an apply operation so that the timing of the result actions in a CarePlan or RequestOrchestration, for example, would be specified by evaluating the timing definition in the context of the apply and setting the resulting timing on the appropriate elements of the target resource. If the timing is an Age, the activity is expected to be performed when the subject is the given Age. When the timing is a Duration, the activity is expected to be performed within the specified duration from the apply. When the timing is a Range, it may be a range of Ages or Durations, providing a range for the expected timing of the resulting activity. When the timing is a Timing, it is establishing a schedule for the timing of the resulting activity."/>
<requirements
value="Allows prompting for activities and detection of missed planned activities."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.timing[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Age"/>
</type>
<type>
<code value="Duration"/>
</type>
<type>
<code value="Range"/>
</type>
<type>
<code value="Timing"/>
</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=".effectiveTime"/>
</mapping>
</element>
<element id="PlanDefinition.action.location">
<path value="PlanDefinition.action.location"/>
<short value="Where it should happen"/>
<definition
value="Identifies the facility where the action will occur; e.g. home, hospital, specific clinic, etc."/>
<comment
value="May reference a specific clinical location or may just identify a type of location."/>
<requirements value="Helps in planning of activity."/>
<alias value="facility"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.location"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableReference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Location"/>
</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=LOC].role"/>
</mapping>
</element>
<element id="PlanDefinition.action.participant">
<path value="PlanDefinition.action.participant"/>
<short value="Who should participate in the action"/>
<definition
value="Indicates who should participate in performing the action described."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.participant"/>
<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=PFM]"/>
</mapping>
</element>
<element id="PlanDefinition.action.participant.id">
<path value="PlanDefinition.action.participant.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="PlanDefinition.action.participant.extension">
<path value="PlanDefinition.action.participant.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="PlanDefinition.action.participant.modifierExtension">
<path value="PlanDefinition.action.participant.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="PlanDefinition.action.participant.actorId">
<path value="PlanDefinition.action.participant.actorId"/>
<short value="What actor"/>
<definition
value="A reference to the id element of the actor who will participate in this action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.participant.actorId"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.participant.type">
<path value="PlanDefinition.action.participant.type"/>
<short
value="careteam | device | group | healthcareservice | location | organization | patient | practitioner | practitionerrole | relatedperson"/>
<definition value="The type of participant in the action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.participant.type"/>
<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="ActivityParticipantType"/>
</extension>
<strength value="required"/>
<description value="The type of participant in the activity."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value=".role.classCode"/>
</mapping>
</element>
<element id="PlanDefinition.action.participant.typeCanonical">
<path value="PlanDefinition.action.participant.typeCanonical"/>
<short value="Who or what can participate"/>
<definition value="The type of participant in the action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.participant.typeCanonical"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="canonical"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/CapabilityStatement"/>
</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=".role.classCode"/>
</mapping>
</element>
<element id="PlanDefinition.action.participant.typeReference">
<path value="PlanDefinition.action.participant.typeReference"/>
<short value="Who or what can participate"/>
<definition value="The type of participant in the action."/>
<comment
value="When this element is a reference, it SHOULD be a reference to a definitional resource (for example, a location type, rather than a specific location)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.participant.typeReference"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/CareTeam"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Device"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/DeviceDefinition"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Endpoint"/>
<targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/HealthcareService"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Location"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Patient"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Practitioner"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/RelatedPerson"/>
</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=".role.classCode"/>
</mapping>
</element>
<element id="PlanDefinition.action.participant.role">
<path value="PlanDefinition.action.participant.role"/>
<short value="E.g. Nurse, Surgeon, Parent"/>
<definition
value="The role the participant should play in performing the described action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.participant.role"/>
<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="ActionParticipantRole"/>
</extension>
<strength value="example"/>
<description
value="Defines roles played by participants for the action."/>
<valueSet
value="http://terminology.hl7.org/ValueSet/action-participant-role"/>
</binding>
<mapping>
<identity value="rim"/>
<map value=".role.code"/>
</mapping>
</element>
<element id="PlanDefinition.action.participant.function">
<path value="PlanDefinition.action.participant.function"/>
<short value="E.g. Author, Reviewer, Witness, etc"/>
<definition
value="Indicates how the actor will be involved in the action - author, reviewer, witness, etc."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.participant.function"/>
<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="ActionParticipantFunction"/>
</extension>
<strength value="example"/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-participant-function"/>
</binding>
<mapping>
<identity value="rim"/>
<map value=".role.code"/>
</mapping>
</element>
<element id="PlanDefinition.action.type">
<path value="PlanDefinition.action.type"/>
<short value="create | update | remove | fire-event"/>
<definition
value="The type of action to perform (create, update, remove)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.type"/>
<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="ActionType"/>
</extension>
<strength value="extensible"/>
<description value="The type of action to be performed."/>
<valueSet value="http://hl7.org/fhir/ValueSet/action-type"/>
</binding>
<mapping>
<identity value="rim"/>
<map
value=".moodCode { Maybe? this is effectively Create, Update, or Delete }"/>
</mapping>
</element>
<element id="PlanDefinition.action.groupingBehavior">
<path value="PlanDefinition.action.groupingBehavior"/>
<short value="visual-group | logical-group | sentence-group"/>
<definition
value="Defines the grouping behavior for the action and its children."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.groupingBehavior"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<meaningWhenMissing
value="If no grouping behavior is specified but the action has children (i.e. is a group), the grouping behavior is assumed to be `logical-group`."/>
<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="ActionGroupingBehavior"/>
</extension>
<strength value="required"/>
<description value="Defines organization behavior of a group."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-grouping-behavior|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.selectionBehavior">
<path value="PlanDefinition.action.selectionBehavior"/>
<short
value="any | all | all-or-none | exactly-one | at-most-one | one-or-more"/>
<definition
value="Defines the selection behavior for the action and its children."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.selectionBehavior"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<meaningWhenMissing
value="If no selection behavior is specified but the action has children (i.e. is a group), the selection behavior is assumed to be `all`."/>
<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="ActionSelectionBehavior"/>
</extension>
<strength value="required"/>
<description value="Defines selection behavior of a group."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-selection-behavior|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.requiredBehavior">
<path value="PlanDefinition.action.requiredBehavior"/>
<short value="must | could | must-unless-documented"/>
<definition value="Defines the required behavior for the action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.requiredBehavior"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<meaningWhenMissing
value="If no required behavior is specified but the action has children (i.e. is a group), the required behavior is assumed to be `could`."/>
<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="ActionRequiredBehavior"/>
</extension>
<strength value="required"/>
<description
value="Defines expectations around whether an action or action group is required."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-required-behavior|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.precheckBehavior">
<path value="PlanDefinition.action.precheckBehavior"/>
<short value="yes | no"/>
<definition
value="Defines whether the action should usually be preselected."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.precheckBehavior"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<meaningWhenMissing
value="If no precheck behavior is specified but the action has children (i.e. is a group), the precheck behavior is assumed to be `no`."/>
<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="ActionPrecheckBehavior"/>
</extension>
<strength value="required"/>
<description
value="Defines selection frequency behavior for an action or group."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-precheck-behavior|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.cardinalityBehavior">
<path value="PlanDefinition.action.cardinalityBehavior"/>
<short value="single | multiple"/>
<definition
value="Defines whether the action can be selected multiple times."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.cardinalityBehavior"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<meaningWhenMissing
value="If no cardinality behavior is specified but the action has children (i.e. is a group), the cardinality behavior is assumed to be `single`."/>
<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="ActionCardinalityBehavior"/>
</extension>
<strength value="required"/>
<description
value="Defines behavior for an action or a group for how many times that item may be repeated."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-cardinality-behavior|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.definition[x]">
<path value="PlanDefinition.action.definition[x]"/>
<short value="Description of the activity to be performed"/>
<definition
value="A reference to an ActivityDefinition that describes the action to be taken in detail, a MessageDefinition describing a message to be snet, a PlanDefinition that describes a series of actions to be taken, a Questionnaire that should be filled out, a SpecimenDefinition describing a specimen to be collected, or an ObservationDefinition that specifies what observation should be captured."/>
<comment
value="Note that the definition is optional, and if no definition is specified, a dynamicValue with a root ($this) path can be used to define the entire resource dynamically."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.definition[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="canonical"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/ActivityDefinition"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/MessageDefinition"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/ObservationDefinition"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Questionnaire"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/SpecimenDefinition"/>
</type>
<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="false"/>
<mapping>
<identity value="rim"/>
<map value="Act[classCode=ACT; moodCode=DEFN]"/>
</mapping>
</element>
<element id="PlanDefinition.action.transform">
<path value="PlanDefinition.action.transform"/>
<short value="Transform to apply the template"/>
<definition
value="A reference to a StructureMap resource that defines a transform that can be executed to produce the intent resource using the ActivityDefinition instance as the input."/>
<comment
value="Note that when a referenced ActivityDefinition also defines a transform, the transform specified here generally takes precedence. In addition, if both a transform and dynamic values are specific, the dynamic values are applied to the result of the transform."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.transform"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="canonical"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/StructureMap"/>
</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="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.dynamicValue">
<path value="PlanDefinition.action.dynamicValue"/>
<short value="Dynamic aspects of the definition"/>
<definition
value="Customizations that should be applied to the statically defined resource. For example, if the dosage of a medication must be computed based on the patient's weight, a customization would be used to specify an expression that calculated the weight, and the path on the resource that would contain the result."/>
<comment
value="Dynamic values are applied in the order in which they are defined in the PlanDefinition resource. Note that when dynamic values are also specified by a referenced ActivityDefinition, the dynamicValues from the ActivityDefinition are applied first, followed by the dynamicValues specified here. In addition, if both a transform and dynamic values are specific, the dynamic values are applied to the result of the transform."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.dynamicValue"/>
<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="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.dynamicValue.id">
<path value="PlanDefinition.action.dynamicValue.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="PlanDefinition.action.dynamicValue.extension">
<path value="PlanDefinition.action.dynamicValue.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="PlanDefinition.action.dynamicValue.modifierExtension">
<path value="PlanDefinition.action.dynamicValue.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="PlanDefinition.action.dynamicValue.path">
<path value="PlanDefinition.action.dynamicValue.path"/>
<short value="The path to the element to be set dynamically"/>
<definition
value="The path to the element to be customized. This is the path on the resource that will hold the result of the calculation defined by the expression. The specified path SHALL be a FHIRPath resolvable on the specified target type of the ActivityDefinition, and SHALL consist only of identifiers, constant indexers, and a restricted subset of functions. The path is allowed to contain qualifiers (.) to traverse sub-elements, as well as indexers ([x]) to traverse multiple-cardinality sub-elements (see the [Simple FHIRPath Profile](http://hl7.org/fhir/R5/fhirpath.html#simple) for full details)."/>
<comment
value="To specify the path to the current action being realized, the %action environment variable is available in this path. For example, to specify the description element of the target action, the path would be %action.description. The path attribute contains a [Simple FHIRPath Subset](http://hl7.org/fhir/R5/fhirpath.html#simple) that allows path traversal, but not calculation."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.dynamicValue.path"/>
<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="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.dynamicValue.expression">
<path value="PlanDefinition.action.dynamicValue.expression"/>
<short
value="An expression that provides the dynamic value for the customization"/>
<definition
value="An expression specifying the value of the customized element."/>
<comment
value="The expression may be inlined or may be a reference to a named expression within a logic library referenced by the library element."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.dynamicValue.expression"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Expression"/>
</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="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.action">
<path value="PlanDefinition.action.action"/>
<short value="Groups or Stages"/>
<definition
value="Sub actions that are contained within the action. The behavior of this action determines the functionality of the sub-actions. For example, a selection behavior of at-most-one indicates that of the sub-actions, at most one may be chosen as part of realizing the action definition."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.action"/>
<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="true"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="workflow"/>
<map value="{InverseRelationship of Definition.partOf}"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.id">
<path value="PlanDefinition.action.action.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="PlanDefinition.action.action.extension">
<path value="PlanDefinition.action.action.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="PlanDefinition.action.action.modifierExtension">
<path value="PlanDefinition.action.action.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="PlanDefinition.action.action.linkId">
<path value="PlanDefinition.action.action.linkId"/>
<short value="Unique id for the action in the PlanDefinition"/>
<definition
value="An identifier that is unique within the PlanDefinition to allow linkage within the realized CarePlan and/or RequestOrchestration."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.linkId"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.prefix">
<path value="PlanDefinition.action.action.prefix"/>
<short value="Stage Name"/>
<definition
value="A textual description and/or a number that identifies a level within a sequential test. [Source: SME Defined] Examples – Single Stage, Stage 1, Stage 2 (sometimes referred to as L1, L2 L3 or A1, A2 as in USP &lt;711&gt;)
Note: A Stage may or may not provide a conditional sequence with associated acceptance criteria. [Source: SME Defined] (e.g., dissolution test, pyrogen test - &lt;151&gt;; 21 CFR 610.13 (b) Test for pyrogenic substances)
Implememtation Note: not requried if action.prefix is 'Single Stage'"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.prefix"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.title">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.action.action.title"/>
<short value="Test Name (only reqired if different than above)"/>
<definition
value="Test Name: The textual description of a procedure or analytical method. [Source: SME Defined]
Examples: Assay by HPLC, moisture by Karl Fischer, analysis for impurities.
Note: as defined by the sponsor
Note: The test name of the action.action can be different than the action. Example, the action test is Microbial Limits and the action.action test is Staphylococcus aureus."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.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="workflow"/>
<map value="Definition.title"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".title"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.description">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.action.action.description"/>
<short
value="Test Additional Information | Stage Additional Information"/>
<definition
value="Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined].
Implementation Note: If there is more than one comment, include in this element. Markdown allows formating for clarity."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.description"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="markdown"/>
</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="workflow"/>
<map value="Definition.description"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".text"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.textEquivalent">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.action.action.textEquivalent"/>
<short
value="Static text equivalent of the action, used if the dynamic aspects cannot be interpreted by the receiving system"/>
<definition
value="A text equivalent of the action to be performed. This provides a human-interpretable description of the action when the definition is consumed by a system that might not be capable of interpreting it dynamically."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.textEquivalent"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="markdown"/>
</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="workflow"/>
<map value="Definition.description"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".text"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.priority">
<path value="PlanDefinition.action.action.priority"/>
<short value="routine | urgent | asap | stat"/>
<definition
value="Indicates how quickly the action should be addressed with respect to other actions."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.priority"/>
<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="RequestPriority"/>
</extension>
<strength value="required"/>
<description
value="Identifies the level of importance to be assigned to actioning the request."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/request-priority|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value=".priority"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.code">
<path value="PlanDefinition.action.action.code"/>
<short
value="Code representing the meaning of the action or sub-actions"/>
<definition
value="A code that provides a meaning, grouping, or classification for the action or action group. For example, a section may have a LOINC code for the section of a documentation template. In pharmaceutical quality, an action (Test) such as pH could be classified as a physical property."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.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="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ActionCode"/>
</extension>
<strength value="example"/>
<description value="Provides examples of actions to be performed."/>
<valueSet value="http://hl7.org/fhir/ValueSet/action-code"/>
</binding>
<mapping>
<identity value="rim"/>
<map value=".classCode"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.reason">
<path value="PlanDefinition.action.action.reason"/>
<short value="Why the action should be performed"/>
<definition
value="A description of why this action is necessary or appropriate."/>
<comment
value="This is different than the clinical evidence documentation, it's an actual business description of the reason for performing the action."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.reason"/>
<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="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ActionReasonCode"/>
</extension>
<strength value="example"/>
<description
value="Provides examples of reasons for actions to be performed."/>
<valueSet value="http://hl7.org/fhir/ValueSet/action-reason-code"/>
</binding>
<mapping>
<identity value="rim"/>
<map value=".reasonCode"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.documentation">
<path value="PlanDefinition.action.action.documentation"/>
<short
value="Supporting documentation for the intended performer of the action"/>
<definition
value="Didactic or other informational resources associated with the action that can be provided to the CDS recipient. Information resources can include inline text commentary and links to web resources."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.documentation"/>
<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="true"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.documentation.id">
<path value="PlanDefinition.action.action.documentation.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="id"/>
</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="PlanDefinition.action.action.documentation.extension">
<path value="PlanDefinition.action.action.documentation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<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="PlanDefinition.action.action.documentation.type">
<path value="PlanDefinition.action.action.documentation.type"/>
<short
value="documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as"/>
<definition value="The type of relationship to the related artifact."/>
<comment
value="The presence of both sides of a relationship type (e.g. successor and predecessor) is required to support use cases where one side of a relationship is not represented in FHIR. However, this feature SHALL NOT be used to create bi-directional resource links in FHIR instances. Specifically, following the methodology of "new points to old" and "many points to one", when using related artifact elements to describe and reference FHIR resources, the type element SHALL be drawn from the fhir-related-artifact-type ValueSet."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="RelatedArtifact.type"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<patternCode value="documentation"/>
<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>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="RelatedArtifactType"/>
</extension>
<strength value="required"/>
<description
value="The type of relationship to the related artifact."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0"/>
</binding>
</element>
<element id="PlanDefinition.action.action.documentation.classifier">
<path value="PlanDefinition.action.action.documentation.classifier"/>
<short value="Additional classifiers"/>
<definition
value="Provides additional classifiers of the related artifact."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="RelatedArtifact.classifier"/>
<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>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="RelatedArtifactClassifier"/>
</extension>
<strength value="example"/>
<description
value="Additional classifiers for the related artifact."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/citation-artifact-classifier"/>
</binding>
</element>
<element id="PlanDefinition.action.action.documentation.label">
<path value="PlanDefinition.action.action.documentation.label"/>
<short value="Short label"/>
<definition
value="A short label that can be used to reference the citation from elsewhere in the containing artifact, such as a footnote index."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="RelatedArtifact.label"/>
<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>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="PlanDefinition.action.action.documentation.display">
<path value="PlanDefinition.action.action.documentation.display"/>
<short value="Brief description of the related artifact"/>
<definition
value="A brief description of the document or knowledge resource being referenced, suitable for display to a consumer."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="RelatedArtifact.display"/>
<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>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="PlanDefinition.action.action.documentation.citation">
<path value="PlanDefinition.action.action.documentation.citation"/>
<short value="Bibliographic citation for the artifact"/>
<definition
value="A bibliographic citation for the related artifact. This text SHOULD be formatted according to an accepted citation format."/>
<comment
value="Additional structured information about citations should be captured as extensions."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="RelatedArtifact.citation"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="markdown"/>
</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>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="PlanDefinition.action.action.documentation.document">
<path value="PlanDefinition.action.action.documentation.document"/>
<short value="Test or Stage Additional Information Visual Attachments"/>
<definition
value="Any visual data described andor referenced in additional informatation"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="RelatedArtifact.document"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Attachment"/>
</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"/>
</element>
<element id="PlanDefinition.action.action.documentation.document.id">
<path value="PlanDefinition.action.action.documentation.document.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="id"/>
</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="PlanDefinition.action.action.documentation.document.extension">
<path
value="PlanDefinition.action.action.documentation.document.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<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="PlanDefinition.action.action.documentation.document.contentType">
<path
value="PlanDefinition.action.action.documentation.document.contentType"/>
<short value="Mime type of the content, with charset etc."/>
<definition
value="Identifies the type of the data in the attachment and allows a method to be chosen to interpret or render the data. Includes mime type parameters such as charset where appropriate."/>
<requirements
value="Processors of the data need to be able to know how to interpret the data."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Attachment.contentType"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<example>
<label value="General"/>
<valueCode value="text/plain; charset=UTF-8, image/png"/>
</example>
<condition value="att-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="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="MimeType"/>
</extension>
<strength value="required"/>
<description
value="BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049)"/>
<valueSet value="http://hl7.org/fhir/ValueSet/mimetypes|5.0.0"/>
</binding>
<mapping>
<identity value="v2"/>
<map
value="ED.2+ED.3/RP.2+RP.3. Note conversion may be needed if old style values are being used"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="./mediaType, ./charset"/>
</mapping>
</element>
<element
id="PlanDefinition.action.action.documentation.document.language">
<path
value="PlanDefinition.action.action.documentation.document.language"/>
<short value="Human language of the content (BCP-47)"/>
<definition
value="The human language of the content. The value can be any valid value according to BCP 47."/>
<requirements
value="Users need to be able to choose between the languages in a set of attachments."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Attachment.language"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<example>
<label value="General"/>
<valueCode value="en-AU"/>
</example>
<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>
<isModifier value="false"/>
<isSummary value="true"/>
<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>
<mapping>
<identity value="rim"/>
<map value="./language"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.documentation.document.data">
<path value="PlanDefinition.action.action.documentation.document.data"/>
<short value="Data inline, base64ed"/>
<definition
value="The actual data of the attachment - a sequence of bytes, base64 encoded."/>
<comment
value="The base64-encoded data SHALL be expressed in the same character set as the base resource XML or JSON."/>
<requirements value="The data needs to able to be transmitted inline."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Attachment.data"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="base64Binary"/>
</type>
<condition value="att-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="true"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="v2"/>
<map value="ED.5"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="./data"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.documentation.document.url">
<path value="PlanDefinition.action.action.documentation.document.url"/>
<short value="Uri where the data can be found"/>
<definition value="A location where the data can be accessed."/>
<comment
value="If both data and url are provided, the url SHALL point to the same content as the data contains. Urls may be relative references or may reference transient locations such as a wrapping envelope using cid: though this has ramifications for using signatures. Relative URLs are interpreted relative to the service url, like a resource reference, rather than relative to the resource itself. If a URL is provided, it SHALL resolve to actual data."/>
<requirements value="The data needs to be transmitted by reference."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Attachment.url"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="url"/>
</type>
<example>
<label value="General"/>
<valueUrl value="http://www.acme.com/logo-small.png"/>
</example>
<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>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="RP.1+RP.2 - if they refer to a URL (see v2.6)"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="./reference/literal"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.documentation.document.size">
<path value="PlanDefinition.action.action.documentation.document.size"/>
<short value="Number of bytes of content (if url provided)"/>
<definition
value="The number of bytes of data that make up this attachment (before base64 encoding, if that is done)."/>
<comment
value="The number of bytes is redundant if the data is provided as a base64binary, but is useful if the data is provided as a url reference."/>
<requirements
value="Representing the size allows applications to determine whether they should fetch the content automatically in advance, or refuse to fetch it at all."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Attachment.size"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="integer64"/>
</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>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A (needs data type R3 proposal)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.documentation.document.hash">
<path value="PlanDefinition.action.action.documentation.document.hash"/>
<short value="Hash of the data (sha-1, base64ed)"/>
<definition
value="The calculated hash of the data using SHA-1. Represented using base64."/>
<comment
value="The hash is calculated on the data prior to base64 encoding, if the data is based64 encoded. The hash is not intended to support digital signatures. Where protection against malicious threats a digital signature should be considered, see [Provenance.signature](http://hl7.org/fhir/R5/provenance-definitions.html#Provenance.signature) for mechanism to protect a resource with a digital signature."/>
<requirements
value="Included so that applications can verify that the contents of a location have not changed due to technical failures (e.g., storage rot, transport glitch, incorrect version)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Attachment.hash"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="base64Binary"/>
</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>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map
value=".integrityCheck[parent::ED/integrityCheckAlgorithm="SHA-1"]"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.documentation.document.title">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path
value="PlanDefinition.action.action.documentation.document.title"/>
<short value="Document file name including the file extension"/>
<definition
value="A format or abbreviation name that identifies a file structure. [Source: SME Defined]
Used for the following: Analytical Instrument Data File Type, Impurity Analysis Graphic, Impurity Analytical Instrument Data File, Impurity Chemical Structure Data File, and Substance Structure Graphic."/>
<comment value="May sometimes be derived from the source filename."/>
<requirements
value="Applications need a label to display to a human user in place of the actual data if the data cannot be rendered or perceived by the viewer."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Attachment.title"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<example>
<label value="General"/>
<valueString value="Official Corporate Logo"/>
</example>
<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="rim"/>
<map value="./title/data"/>
</mapping>
</element>
<element
id="PlanDefinition.action.action.documentation.document.creation">
<path
value="PlanDefinition.action.action.documentation.document.creation"/>
<short value="Date attachment was first created"/>
<definition value="The date that the attachment was first created."/>
<requirements
value="This is often tracked as an integrity issue for use of the attachment."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Attachment.creation"/>
<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>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A (needs data type R3 proposal)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.documentation.document.height">
<path
value="PlanDefinition.action.action.documentation.document.height"/>
<short value="Height of the image in pixels (photo/video)"/>
<definition value="Height of the image in pixels (photo/video)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Attachment.height"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="positiveInt"/>
</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>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map
value=".outboundRelationship[typeCode="COMP].target[classCode="OBS", moodCode="EVN",code="<CODE>"].value"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.documentation.document.width">
<path
value="PlanDefinition.action.action.documentation.document.width"/>
<short value="Width of the image in pixels (photo/video)"/>
<definition value="Width of the image in pixels (photo/video)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Attachment.width"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="positiveInt"/>
</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>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map
value=".outboundRelationship[typeCode="COMP].target[classCode="OBS", moodCode="EVN",code="<CODE>"].value"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.documentation.document.frames">
<path
value="PlanDefinition.action.action.documentation.document.frames"/>
<short value="Number of frames if > 1 (photo)"/>
<definition
value="The number of frames in a photo. This is used with a multi-page fax, or an imaging acquisition context that takes multiple slices in a single image, or an animated gif. If there is more than one frame, this SHALL have a value in order to alert interface software that a multi-frame capable rendering widget is required."/>
<comment
value="if the number of frames is not supplied, the value may be unknown. Applications should not assume that there is only one frame unless it is explicitly stated."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Attachment.frames"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="positiveInt"/>
</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>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map
value=".outboundRelationship[typeCode="COMP].target[classCode="OBS", moodCode="EVN",code="<CODE>"].value"/>
</mapping>
</element>
<element
id="PlanDefinition.action.action.documentation.document.duration">
<path
value="PlanDefinition.action.action.documentation.document.duration"/>
<short value="Length in seconds (audio / video)"/>
<definition
value="The duration of the recording in seconds - for audio and video."/>
<comment
value="The duration might differ from occurrencePeriod if recording was paused."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Attachment.duration"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="decimal"/>
</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>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map
value=".outboundRelationship[typeCode="COMP].target[classCode="OBS", moodCode="EVN",code="<CODE>"].value"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.documentation.document.pages">
<path
value="PlanDefinition.action.action.documentation.document.pages"/>
<short value="Number of printed pages"/>
<definition value="The number of pages when printed."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Attachment.pages"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="positiveInt"/>
</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>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="PlanDefinition.action.action.documentation.resource">
<path value="PlanDefinition.action.action.documentation.resource"/>
<short value="What artifact is being referenced"/>
<definition
value="The related artifact, such as a library, value set, profile, or other knowledge resource."/>
<comment
value="If the type is predecessor, this is a reference to the succeeding knowledge resource. If the type is successor, this is a reference to the prior knowledge resource."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="RelatedArtifact.resource"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="canonical"/>
<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>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element
id="PlanDefinition.action.action.documentation.resourceReference">
<path
value="PlanDefinition.action.action.documentation.resourceReference"/>
<short value="What artifact, if not a conformance resource"/>
<definition
value="The related artifact, if the artifact is not a canonical resource, or a resource reference to a canonical resource."/>
<comment
value="If both resource and resourceReference are present, they SHOULD be consistent and reference the same resource. Although relatedArtifact is intended to support references to definitional resources, there are cases where non-definitional resources can be definitional (such as Location where the kind is mode). Related artifacts SHOULD be used to reference definitional resources, and profiles SHOULD be used to make that explicit for particular use cases."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="RelatedArtifact.resourceReference"/>
<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>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element
id="PlanDefinition.action.action.documentation.publicationStatus">
<path
value="PlanDefinition.action.action.documentation.publicationStatus"/>
<short value="draft | active | retired | unknown"/>
<definition
value="The publication status of the artifact being referred to."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="RelatedArtifact.publicationStatus"/>
<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>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="RelatedArtifactPublicationStatus"/>
</extension>
<strength value="required"/>
<description
value="Publication status of an artifact being referred to."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/publication-status|5.0.0"/>
</binding>
</element>
<element id="PlanDefinition.action.action.documentation.publicationDate">
<path
value="PlanDefinition.action.action.documentation.publicationDate"/>
<short value="Date of publication of the artifact being referred to"/>
<definition
value="The date of publication of the artifact being referred to."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="RelatedArtifact.publicationDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="date"/>
</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>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="PlanDefinition.action.action.goalId">
<path value="PlanDefinition.action.action.goalId"/>
<short value="Reference to Acceptance Criteria"/>
<definition
value="Identifies goals that this action supports. The reference must be to a goal element defined within this plan definition. In pharmaceutical quality, a goal represents acceptance criteria (Goal) for a given action (Test), so the goalId would be the unique id of a defined goal element establishing the acceptance criteria for the action."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.goalId"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="id"/>
</type>
<condition value="pld-3"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.subject[x]">
<path value="PlanDefinition.action.action.subject[x]"/>
<short value="Type of individual the action is focused on"/>
<definition
value="A code, group definition, or canonical reference that describes the intended subject of the action and its children, if any. Canonical references are allowed to support the definition of protocols for drug and substance quality specifications, and is allowed to reference a MedicinalProductDefinition, SubstanceDefinition, AdministrableProductDefinition, ManufacturedItemDefinition, or PackagedProductDefinition resource."/>
<comment
value="The subject of an action overrides the subject at a parent action or on the root of the PlanDefinition if specified.
In addition, because the subject needs to be resolved during realization, use of subjects in actions (or in the ActivityDefinition referenced by the action) resolves based on the set of subjects supplied in context and by type (i.e. the patient subject would resolve to a resource of type Patient)."/>
<requirements
value="Multiple steps in a protocol often have different groups of steps that are focused on testing different things. The subject of an action specifies the focus of the action and any child actions."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.subject[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<type>
<code value="Reference"/>
<targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/>
</type>
<type>
<code value="canonical"/>
</type>
<meaningWhenMissing value="Patient"/>
<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="SubjectType"/>
</extension>
<strength value="extensible"/>
<description
value="The possible types of subjects for a plan definition (E.g. Patient, Practitioner, Organization, Location, etc.)."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/participant-resource-types"/>
</binding>
<mapping>
<identity value="workflow"/>
<map value="Definition.subject"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.trigger">
<path value="PlanDefinition.action.action.trigger"/>
<short value="When the action should be triggered"/>
<definition
value="A description of when the action should be triggered. When multiple triggers are specified on an action, any triggering event invokes the action."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.trigger"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="TriggerDefinition"/>
</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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.condition">
<path value="PlanDefinition.action.action.condition"/>
<short value="Whether or not the action is applicable"/>
<definition
value="An expression that describes applicability criteria or start/stop conditions for the action."/>
<comment
value="When multiple conditions of the same kind are present, the effects are combined using AND semantics, so the overall condition is true only if all the conditions are true."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.condition"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.condition.id">
<path value="PlanDefinition.action.action.condition.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="PlanDefinition.action.action.condition.extension">
<path value="PlanDefinition.action.action.condition.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="PlanDefinition.action.action.condition.modifierExtension">
<path value="PlanDefinition.action.action.condition.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="PlanDefinition.action.action.condition.kind">
<path value="PlanDefinition.action.action.condition.kind"/>
<short value="applicability | start | stop"/>
<definition value="The kind of condition."/>
<comment
value="Applicability criteria are used to determine immediate applicability when a plan definition is applied to a given context. Start and stop criteria are carried through application and used to describe enter/exit criteria for an action."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.condition.kind"/>
<min value="1"/>
<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="ActionConditionKind"/>
</extension>
<strength value="required"/>
<description
value="Defines the kinds of conditions that can appear on actions."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-condition-kind|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.condition.expression">
<path value="PlanDefinition.action.action.condition.expression"/>
<short value="Boolean-valued expression"/>
<definition
value="An expression that returns true or false, indicating whether the condition is satisfied."/>
<comment
value="The expression may be inlined or may be a reference to a named expression within a logic library referenced by the library element."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.condition.expression"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Expression"/>
</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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.input">
<path value="PlanDefinition.action.action.input"/>
<short value="Input data requirements"/>
<definition value="Defines input data requirements for the action."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.input"/>
<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>
<constraint>
<key value="pld-0"/>
<severity value="error"/>
<human
value="Input data elements must have a requirement or a relatedData, but not both"/>
<expression value="requirement.exists() xor relatedData.exists()"/>
<source
value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.input.id">
<path value="PlanDefinition.action.action.input.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="PlanDefinition.action.action.input.extension">
<path value="PlanDefinition.action.action.input.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="PlanDefinition.action.action.input.modifierExtension">
<path value="PlanDefinition.action.action.input.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="PlanDefinition.action.action.input.title">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.action.action.input.title"/>
<short value="User-visible title"/>
<definition
value="A human-readable label for the data requirement used to label data flows in BPMN or similar diagrams. Also provides a human readable label when rendering the data requirement that conveys its purpose to human readers."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.input.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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.input.requirement">
<path value="PlanDefinition.action.action.input.requirement"/>
<short value="What data is provided"/>
<definition
value="Defines the data that is to be provided as input to the action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.input.requirement"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="DataRequirement"/>
</type>
<condition value="pld-0"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.input.relatedData">
<path value="PlanDefinition.action.action.input.relatedData"/>
<short value="What data is provided"/>
<definition
value="Points to an existing input or output element that provides data to this input."/>
<comment
value="The relatedData element allows indicating that an input to a parent action is an input to specific child actions. It also allows the output of one action to be identified as the input to a different action"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.input.relatedData"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="id"/>
</type>
<condition value="pld-0"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.output">
<path value="PlanDefinition.action.action.output"/>
<short value="Output data definition"/>
<definition value="Defines the outputs of the action, if any."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.output"/>
<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>
<constraint>
<key value="pld-1"/>
<severity value="error"/>
<human
value="Output data element must have a requirement or a relatedData, but not both"/>
<expression value="requirement.exists() xor relatedData.exists()"/>
<source
value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.output.id">
<path value="PlanDefinition.action.action.output.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="PlanDefinition.action.action.output.extension">
<path value="PlanDefinition.action.action.output.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="PlanDefinition.action.action.output.modifierExtension">
<path value="PlanDefinition.action.action.output.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="PlanDefinition.action.action.output.title">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.action.action.output.title"/>
<short value="User-visible title"/>
<definition
value="A human-readable label for the data requirement used to label data flows in BPMN or similar diagrams. Also provides a human readable label when rendering the data requirement that conveys its purpose to human readers."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.output.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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.output.requirement">
<path value="PlanDefinition.action.action.output.requirement"/>
<short value="What data is provided"/>
<definition
value="Defines the data that results as output from the action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.output.requirement"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="DataRequirement"/>
</type>
<condition value="pld-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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.output.relatedData">
<path value="PlanDefinition.action.action.output.relatedData"/>
<short value="What data is provided"/>
<definition
value="Points to an existing input or output element that is results as output from the action."/>
<comment
value="The relatedData element allows indicating that the output of child action is also the output of a parent action. It also allows the input of one action to be identified as the output of a different action"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.output.relatedData"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<condition value="pld-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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.relatedAction">
<path value="PlanDefinition.action.action.relatedAction"/>
<short value="Relationship to another action"/>
<definition
value="A relationship to another action such as "before" or "30-60 minutes after start of"."/>
<comment
value="When an action depends on multiple actions, the meaning is that all actions are dependencies, rather than that any of the actions are a dependency."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.relatedAction"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<condition value="pld-4"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.relatedAction.id">
<path value="PlanDefinition.action.action.relatedAction.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="PlanDefinition.action.action.relatedAction.extension">
<path value="PlanDefinition.action.action.relatedAction.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="PlanDefinition.action.action.relatedAction.modifierExtension">
<path
value="PlanDefinition.action.action.relatedAction.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="PlanDefinition.action.action.relatedAction.targetId">
<path value="PlanDefinition.action.action.relatedAction.targetId"/>
<short value="What action is this related to"/>
<definition value="The element id of the target related action."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.relatedAction.targetId"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="id"/>
</type>
<condition value="pld-4"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.relatedAction.relationship">
<path value="PlanDefinition.action.action.relatedAction.relationship"/>
<short
value="before | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end"/>
<definition
value="The relationship of the start of this action to the related action."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.relatedAction.relationship"/>
<min value="1"/>
<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="ActionRelationshipType"/>
</extension>
<strength value="required"/>
<description
value="Defines the types of relationships between actions."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.relatedAction.endRelationship">
<path
value="PlanDefinition.action.action.relatedAction.endRelationship"/>
<short
value="before | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end"/>
<definition
value="The relationship of the end of this action to the related action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.relatedAction.endRelationship"/>
<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="ActionRelationshipType"/>
</extension>
<strength value="required"/>
<description
value="Defines the types of relationships between actions."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.relatedAction.offset[x]">
<path value="PlanDefinition.action.action.relatedAction.offset[x]"/>
<short value="Time offset for the relationship"/>
<definition
value="A duration or range of durations to apply to the relationship. For example, 30-60 minutes before."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.relatedAction.offset[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Duration"/>
</type>
<type>
<code value="Range"/>
</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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.timing[x]">
<path value="PlanDefinition.action.action.timing[x]"/>
<short value="When the action should take place"/>
<definition
value="An optional value describing when the action should be performed."/>
<comment
value="The intent of the timing element is to provide timing when the action should be performed. As a definitional resource, this timing is interpreted as part of an apply operation so that the timing of the result actions in a CarePlan or RequestOrchestration, for example, would be specified by evaluating the timing definition in the context of the apply and setting the resulting timing on the appropriate elements of the target resource. If the timing is an Age, the activity is expected to be performed when the subject is the given Age. When the timing is a Duration, the activity is expected to be performed within the specified duration from the apply. When the timing is a Range, it may be a range of Ages or Durations, providing a range for the expected timing of the resulting activity. When the timing is a Timing, it is establishing a schedule for the timing of the resulting activity."/>
<requirements
value="Allows prompting for activities and detection of missed planned activities."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.timing[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Age"/>
</type>
<type>
<code value="Duration"/>
</type>
<type>
<code value="Range"/>
</type>
<type>
<code value="Timing"/>
</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=".effectiveTime"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.location">
<path value="PlanDefinition.action.action.location"/>
<short value="Where it should happen"/>
<definition
value="Identifies the facility where the action will occur; e.g. home, hospital, specific clinic, etc."/>
<comment
value="May reference a specific clinical location or may just identify a type of location."/>
<requirements value="Helps in planning of activity."/>
<alias value="facility"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.location"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableReference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Location"/>
</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=LOC].role"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.participant">
<path value="PlanDefinition.action.action.participant"/>
<short value="Who should participate in the action"/>
<definition
value="Indicates who should participate in performing the action described."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.participant"/>
<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=PFM]"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.participant.id">
<path value="PlanDefinition.action.action.participant.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="PlanDefinition.action.action.participant.extension">
<path value="PlanDefinition.action.action.participant.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="PlanDefinition.action.action.participant.modifierExtension">
<path
value="PlanDefinition.action.action.participant.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="PlanDefinition.action.action.participant.actorId">
<path value="PlanDefinition.action.action.participant.actorId"/>
<short value="What actor"/>
<definition
value="A reference to the id element of the actor who will participate in this action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.participant.actorId"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.participant.type">
<path value="PlanDefinition.action.action.participant.type"/>
<short
value="careteam | device | group | healthcareservice | location | organization | patient | practitioner | practitionerrole | relatedperson"/>
<definition value="The type of participant in the action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.participant.type"/>
<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="ActivityParticipantType"/>
</extension>
<strength value="required"/>
<description value="The type of participant in the activity."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value=".role.classCode"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.participant.typeCanonical">
<path value="PlanDefinition.action.action.participant.typeCanonical"/>
<short value="Who or what can participate"/>
<definition value="The type of participant in the action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.participant.typeCanonical"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="canonical"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/CapabilityStatement"/>
</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=".role.classCode"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.participant.typeReference">
<path value="PlanDefinition.action.action.participant.typeReference"/>
<short value="Who or what can participate"/>
<definition value="The type of participant in the action."/>
<comment
value="When this element is a reference, it SHOULD be a reference to a definitional resource (for example, a location type, rather than a specific location)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.participant.typeReference"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/CareTeam"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Device"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/DeviceDefinition"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Endpoint"/>
<targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/HealthcareService"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Location"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Patient"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Practitioner"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/RelatedPerson"/>
</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=".role.classCode"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.participant.role">
<path value="PlanDefinition.action.action.participant.role"/>
<short value="E.g. Nurse, Surgeon, Parent"/>
<definition
value="The role the participant should play in performing the described action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.participant.role"/>
<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="ActionParticipantRole"/>
</extension>
<strength value="example"/>
<description
value="Defines roles played by participants for the action."/>
<valueSet
value="http://terminology.hl7.org/ValueSet/action-participant-role"/>
</binding>
<mapping>
<identity value="rim"/>
<map value=".role.code"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.participant.function">
<path value="PlanDefinition.action.action.participant.function"/>
<short value="E.g. Author, Reviewer, Witness, etc"/>
<definition
value="Indicates how the actor will be involved in the action - author, reviewer, witness, etc."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.participant.function"/>
<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="ActionParticipantFunction"/>
</extension>
<strength value="example"/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-participant-function"/>
</binding>
<mapping>
<identity value="rim"/>
<map value=".role.code"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.type">
<path value="PlanDefinition.action.action.type"/>
<short value="create | update | remove | fire-event"/>
<definition
value="The type of action to perform (create, update, remove)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.type"/>
<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="ActionType"/>
</extension>
<strength value="extensible"/>
<description value="The type of action to be performed."/>
<valueSet value="http://hl7.org/fhir/ValueSet/action-type"/>
</binding>
<mapping>
<identity value="rim"/>
<map
value=".moodCode { Maybe? this is effectively Create, Update, or Delete }"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.groupingBehavior">
<path value="PlanDefinition.action.action.groupingBehavior"/>
<short value="visual-group | logical-group | sentence-group"/>
<definition
value="Defines the grouping behavior for the action and its children."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.groupingBehavior"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<meaningWhenMissing
value="If no grouping behavior is specified but the action has children (i.e. is a group), the grouping behavior is assumed to be `logical-group`."/>
<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="ActionGroupingBehavior"/>
</extension>
<strength value="required"/>
<description value="Defines organization behavior of a group."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-grouping-behavior|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.selectionBehavior">
<path value="PlanDefinition.action.action.selectionBehavior"/>
<short
value="any | all | all-or-none | exactly-one | at-most-one | one-or-more"/>
<definition
value="Defines the selection behavior for the action and its children."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.selectionBehavior"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<meaningWhenMissing
value="If no selection behavior is specified but the action has children (i.e. is a group), the selection behavior is assumed to be `all`."/>
<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="ActionSelectionBehavior"/>
</extension>
<strength value="required"/>
<description value="Defines selection behavior of a group."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-selection-behavior|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.requiredBehavior">
<path value="PlanDefinition.action.action.requiredBehavior"/>
<short value="must | could | must-unless-documented"/>
<definition value="Defines the required behavior for the action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.requiredBehavior"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<meaningWhenMissing
value="If no required behavior is specified but the action has children (i.e. is a group), the required behavior is assumed to be `could`."/>
<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="ActionRequiredBehavior"/>
</extension>
<strength value="required"/>
<description
value="Defines expectations around whether an action or action group is required."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-required-behavior|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.precheckBehavior">
<path value="PlanDefinition.action.action.precheckBehavior"/>
<short value="yes | no"/>
<definition
value="Defines whether the action should usually be preselected."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.precheckBehavior"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<meaningWhenMissing
value="If no precheck behavior is specified but the action has children (i.e. is a group), the precheck behavior is assumed to be `no`."/>
<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="ActionPrecheckBehavior"/>
</extension>
<strength value="required"/>
<description
value="Defines selection frequency behavior for an action or group."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-precheck-behavior|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.cardinalityBehavior">
<path value="PlanDefinition.action.action.cardinalityBehavior"/>
<short value="single | multiple"/>
<definition
value="Defines whether the action can be selected multiple times."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.cardinalityBehavior"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<meaningWhenMissing
value="If no cardinality behavior is specified but the action has children (i.e. is a group), the cardinality behavior is assumed to be `single`."/>
<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="ActionCardinalityBehavior"/>
</extension>
<strength value="required"/>
<description
value="Defines behavior for an action or a group for how many times that item may be repeated."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-cardinality-behavior|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.definition[x]">
<path value="PlanDefinition.action.action.definition[x]"/>
<short value="Description of the activity to be performed"/>
<definition
value="A reference to an ActivityDefinition that describes the action to be taken in detail, a MessageDefinition describing a message to be snet, a PlanDefinition that describes a series of actions to be taken, a Questionnaire that should be filled out, a SpecimenDefinition describing a specimen to be collected, or an ObservationDefinition that specifies what observation should be captured."/>
<comment
value="Note that the definition is optional, and if no definition is specified, a dynamicValue with a root ($this) path can be used to define the entire resource dynamically."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.definition[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="canonical"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/ActivityDefinition"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/MessageDefinition"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/ObservationDefinition"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Questionnaire"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/SpecimenDefinition"/>
</type>
<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="false"/>
<mapping>
<identity value="rim"/>
<map value="Act[classCode=ACT; moodCode=DEFN]"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.transform">
<path value="PlanDefinition.action.action.transform"/>
<short value="Transform to apply the template"/>
<definition
value="A reference to a StructureMap resource that defines a transform that can be executed to produce the intent resource using the ActivityDefinition instance as the input."/>
<comment
value="Note that when a referenced ActivityDefinition also defines a transform, the transform specified here generally takes precedence. In addition, if both a transform and dynamic values are specific, the dynamic values are applied to the result of the transform."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.transform"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="canonical"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/StructureMap"/>
</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="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.dynamicValue">
<path value="PlanDefinition.action.action.dynamicValue"/>
<short value="Dynamic aspects of the definition"/>
<definition
value="Customizations that should be applied to the statically defined resource. For example, if the dosage of a medication must be computed based on the patient's weight, a customization would be used to specify an expression that calculated the weight, and the path on the resource that would contain the result."/>
<comment
value="Dynamic values are applied in the order in which they are defined in the PlanDefinition resource. Note that when dynamic values are also specified by a referenced ActivityDefinition, the dynamicValues from the ActivityDefinition are applied first, followed by the dynamicValues specified here. In addition, if both a transform and dynamic values are specific, the dynamic values are applied to the result of the transform."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.dynamicValue"/>
<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="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.dynamicValue.id">
<path value="PlanDefinition.action.action.dynamicValue.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="PlanDefinition.action.action.dynamicValue.extension">
<path value="PlanDefinition.action.action.dynamicValue.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="PlanDefinition.action.action.dynamicValue.modifierExtension">
<path
value="PlanDefinition.action.action.dynamicValue.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="PlanDefinition.action.action.dynamicValue.path">
<path value="PlanDefinition.action.action.dynamicValue.path"/>
<short value="The path to the element to be set dynamically"/>
<definition
value="The path to the element to be customized. This is the path on the resource that will hold the result of the calculation defined by the expression. The specified path SHALL be a FHIRPath resolvable on the specified target type of the ActivityDefinition, and SHALL consist only of identifiers, constant indexers, and a restricted subset of functions. The path is allowed to contain qualifiers (.) to traverse sub-elements, as well as indexers ([x]) to traverse multiple-cardinality sub-elements (see the [Simple FHIRPath Profile](http://hl7.org/fhir/R5/fhirpath.html#simple) for full details)."/>
<comment
value="To specify the path to the current action being realized, the %action environment variable is available in this path. For example, to specify the description element of the target action, the path would be %action.description. The path attribute contains a [Simple FHIRPath Subset](http://hl7.org/fhir/R5/fhirpath.html#simple) that allows path traversal, but not calculation."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.dynamicValue.path"/>
<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="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.dynamicValue.expression">
<path value="PlanDefinition.action.action.dynamicValue.expression"/>
<short
value="An expression that provides the dynamic value for the customization"/>
<definition
value="An expression specifying the value of the customized element."/>
<comment
value="The expression may be inlined or may be a reference to a named expression within a logic library referenced by the library element."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.dynamicValue.expression"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Expression"/>
</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="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action">
<path value="PlanDefinition.action.action.action"/>
<short value="Sub-Test"/>
<definition
value="Sub actions that are contained within the action. The behavior of this action determines the functionality of the sub-actions. For example, a selection behavior of at-most-one indicates that of the sub-actions, at most one may be chosen as part of realizing the action definition."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.action"/>
<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>
<constraint>
<key value="cmc-subtest-rrt"/>
<severity value="error"/>
<human
value="a subtest's prefix represents relative retention time, should it exist"/>
<expression value="prefix.exists() implies prefix.single() = 'RRT'"/>
<source
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="workflow"/>
<map value="{InverseRelationship of Definition.partOf}"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.id">
<path value="PlanDefinition.action.action.action.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="PlanDefinition.action.action.action.extension">
<path value="PlanDefinition.action.action.action.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="PlanDefinition.action.action.action.modifierExtension">
<path value="PlanDefinition.action.action.action.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="PlanDefinition.action.action.action.linkId">
<path value="PlanDefinition.action.action.action.linkId"/>
<short value="Unique id for the action in the PlanDefinition"/>
<definition
value="An identifier that is unique within the PlanDefinition to allow linkage within the realized CarePlan and/or RequestOrchestration."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.linkId"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.prefix">
<path value="PlanDefinition.action.action.action.prefix"/>
<short value="RRT"/>
<definition
value="RRT: The ratio of the retention time of a component relative to that of another used as a reference obtained under identical conditions as an alias for the name of the unidentified impurities. [Source: Adapted from USP]
Example: 1:23 (a ratio)
Note: This is the title or name of the impurity (sometimes expressed as a ratio) and not the value.
Implementation Note: This value can only be 'RRT'. It is used to desinate that RRT value(s) expressed in action.action.action.title are relative retention times."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.prefix"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.title">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.action.action.action.title"/>
<short value="Test Name | RRT (complex testing)"/>
<definition
value="Test Name: The textual description of a procedure or analytical method. [Source: SME Defined]
Examples: Assay by HPLC, moisture by Karl Fischer, analysis for impurities.
Note: as defined by the sponsor
Note: The test name of the action.action can be different than the action. Example, the action test is Microbial Limits and the action.action test is Staphylococcus aureus.
RRT: The ratio of the retention time of a component relative to that of another used as a reference obtained under identical conditions as an alias for the name of the unidentified impurities. [Source: Adapted from USP]
Example: 1:23 (a ratio)
Note: This is the title or name of the impurity (sometimes expressed as a ratio) and not the value.
Implementation Note: For RRT, if there is a range associated with the unidentified peak then the range can be entered instead of indivual values. E.g.: 0.4 – 0.8."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.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="workflow"/>
<map value="Definition.title"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".title"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.description">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.action.action.action.description"/>
<short
value="Test Additional Information | Stage Additional Information"/>
<definition
value="Test Additional Information: Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined].
Stage Additional Information: Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined]
If there is more than one comment, include in this element. Markdown allows formating for clarity. If both types are present, indicate type."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.description"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="markdown"/>
</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="workflow"/>
<map value="Definition.description"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".text"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.textEquivalent">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.action.action.action.textEquivalent"/>
<short
value="Static text equivalent of the action, used if the dynamic aspects cannot be interpreted by the receiving system"/>
<definition
value="A text equivalent of the action to be performed. This provides a human-interpretable description of the action when the definition is consumed by a system that might not be capable of interpreting it dynamically."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.textEquivalent"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="markdown"/>
</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="workflow"/>
<map value="Definition.description"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".text"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.priority">
<path value="PlanDefinition.action.action.action.priority"/>
<short value="routine | urgent | asap | stat"/>
<definition
value="Indicates how quickly the action should be addressed with respect to other actions."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.priority"/>
<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="RequestPriority"/>
</extension>
<strength value="required"/>
<description
value="Identifies the level of importance to be assigned to actioning the request."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/request-priority|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value=".priority"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.code">
<path value="PlanDefinition.action.action.action.code"/>
<short
value="Code representing the meaning of the action or sub-actions"/>
<definition
value="A code that provides a meaning, grouping, or classification for the action or action group. For example, a section may have a LOINC code for the section of a documentation template. In pharmaceutical quality, an action (Test) such as pH could be classified as a physical property."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.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="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ActionCode"/>
</extension>
<strength value="example"/>
<description value="Provides examples of actions to be performed."/>
<valueSet value="http://hl7.org/fhir/ValueSet/action-code"/>
</binding>
<mapping>
<identity value="rim"/>
<map value=".classCode"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.reason">
<path value="PlanDefinition.action.action.action.reason"/>
<short value="Why the action should be performed"/>
<definition
value="A description of why this action is necessary or appropriate."/>
<comment
value="This is different than the clinical evidence documentation, it's an actual business description of the reason for performing the action."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.reason"/>
<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="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ActionReasonCode"/>
</extension>
<strength value="example"/>
<description
value="Provides examples of reasons for actions to be performed."/>
<valueSet value="http://hl7.org/fhir/ValueSet/action-reason-code"/>
</binding>
<mapping>
<identity value="rim"/>
<map value=".reasonCode"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.documentation">
<path value="PlanDefinition.action.action.action.documentation"/>
<short
value="Supporting documentation for the intended performer of the action"/>
<definition
value="Didactic or other informational resources associated with the action that can be provided to the CDS recipient. Information resources can include inline text commentary and links to web resources."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.documentation"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.goalId">
<path value="PlanDefinition.action.action.action.goalId"/>
<short value="Reference to Acceptance Criteria"/>
<definition
value="Identifies goals that this action supports. The reference must be to a goal element defined within this plan definition. In pharmaceutical quality, a goal represents acceptance criteria (Goal) for a given action (Test), so the goalId would be the unique id of a defined goal element establishing the acceptance criteria for the action."/>
<min value="1"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.goalId"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="id"/>
</type>
<condition value="pld-3"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.subject[x]">
<path value="PlanDefinition.action.action.action.subject[x]"/>
<short value="Type of individual the action is focused on"/>
<definition
value="A code, group definition, or canonical reference that describes the intended subject of the action and its children, if any. Canonical references are allowed to support the definition of protocols for drug and substance quality specifications, and is allowed to reference a MedicinalProductDefinition, SubstanceDefinition, AdministrableProductDefinition, ManufacturedItemDefinition, or PackagedProductDefinition resource."/>
<comment
value="The subject of an action overrides the subject at a parent action or on the root of the PlanDefinition if specified.
In addition, because the subject needs to be resolved during realization, use of subjects in actions (or in the ActivityDefinition referenced by the action) resolves based on the set of subjects supplied in context and by type (i.e. the patient subject would resolve to a resource of type Patient)."/>
<requirements
value="Multiple steps in a protocol often have different groups of steps that are focused on testing different things. The subject of an action specifies the focus of the action and any child actions."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.subject[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<type>
<code value="Reference"/>
<targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/>
</type>
<type>
<code value="canonical"/>
</type>
<meaningWhenMissing value="Patient"/>
<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="SubjectType"/>
</extension>
<strength value="extensible"/>
<description
value="The possible types of subjects for a plan definition (E.g. Patient, Practitioner, Organization, Location, etc.)."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/participant-resource-types"/>
</binding>
<mapping>
<identity value="workflow"/>
<map value="Definition.subject"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.trigger">
<path value="PlanDefinition.action.action.action.trigger"/>
<short value="When the action should be triggered"/>
<definition
value="A description of when the action should be triggered. When multiple triggers are specified on an action, any triggering event invokes the action."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.trigger"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="TriggerDefinition"/>
</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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.condition">
<path value="PlanDefinition.action.action.action.condition"/>
<short value="Whether or not the action is applicable"/>
<definition
value="An expression that describes applicability criteria or start/stop conditions for the action."/>
<comment
value="When multiple conditions of the same kind are present, the effects are combined using AND semantics, so the overall condition is true only if all the conditions are true."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.condition"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.condition.id">
<path value="PlanDefinition.action.action.action.condition.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="PlanDefinition.action.action.action.condition.extension">
<path value="PlanDefinition.action.action.action.condition.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="PlanDefinition.action.action.action.condition.modifierExtension">
<path
value="PlanDefinition.action.action.action.condition.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="PlanDefinition.action.action.action.condition.kind">
<path value="PlanDefinition.action.action.action.condition.kind"/>
<short value="applicability | start | stop"/>
<definition value="The kind of condition."/>
<comment
value="Applicability criteria are used to determine immediate applicability when a plan definition is applied to a given context. Start and stop criteria are carried through application and used to describe enter/exit criteria for an action."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.condition.kind"/>
<min value="1"/>
<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="ActionConditionKind"/>
</extension>
<strength value="required"/>
<description
value="Defines the kinds of conditions that can appear on actions."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-condition-kind|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.condition.expression">
<path value="PlanDefinition.action.action.action.condition.expression"/>
<short value="Boolean-valued expression"/>
<definition
value="An expression that returns true or false, indicating whether the condition is satisfied."/>
<comment
value="The expression may be inlined or may be a reference to a named expression within a logic library referenced by the library element."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.condition.expression"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Expression"/>
</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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.input">
<path value="PlanDefinition.action.action.action.input"/>
<short value="Input data requirements"/>
<definition value="Defines input data requirements for the action."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.input"/>
<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>
<constraint>
<key value="pld-0"/>
<severity value="error"/>
<human
value="Input data elements must have a requirement or a relatedData, but not both"/>
<expression value="requirement.exists() xor relatedData.exists()"/>
<source
value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.input.id">
<path value="PlanDefinition.action.action.action.input.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="PlanDefinition.action.action.action.input.extension">
<path value="PlanDefinition.action.action.action.input.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="PlanDefinition.action.action.action.input.modifierExtension">
<path
value="PlanDefinition.action.action.action.input.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="PlanDefinition.action.action.action.input.title">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.action.action.action.input.title"/>
<short value="User-visible title"/>
<definition
value="A human-readable label for the data requirement used to label data flows in BPMN or similar diagrams. Also provides a human readable label when rendering the data requirement that conveys its purpose to human readers."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.input.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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.input.requirement">
<path value="PlanDefinition.action.action.action.input.requirement"/>
<short value="What data is provided"/>
<definition
value="Defines the data that is to be provided as input to the action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.input.requirement"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="DataRequirement"/>
</type>
<condition value="pld-0"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.input.relatedData">
<path value="PlanDefinition.action.action.action.input.relatedData"/>
<short value="What data is provided"/>
<definition
value="Points to an existing input or output element that provides data to this input."/>
<comment
value="The relatedData element allows indicating that an input to a parent action is an input to specific child actions. It also allows the output of one action to be identified as the input to a different action"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.input.relatedData"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="id"/>
</type>
<condition value="pld-0"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.output">
<path value="PlanDefinition.action.action.action.output"/>
<short value="Output data definition"/>
<definition value="Defines the outputs of the action, if any."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.output"/>
<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>
<constraint>
<key value="pld-1"/>
<severity value="error"/>
<human
value="Output data element must have a requirement or a relatedData, but not both"/>
<expression value="requirement.exists() xor relatedData.exists()"/>
<source
value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.output.id">
<path value="PlanDefinition.action.action.action.output.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="PlanDefinition.action.action.action.output.extension">
<path value="PlanDefinition.action.action.action.output.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="PlanDefinition.action.action.action.output.modifierExtension">
<path
value="PlanDefinition.action.action.action.output.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="PlanDefinition.action.action.action.output.title">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="PlanDefinition.action.action.action.output.title"/>
<short value="User-visible title"/>
<definition
value="A human-readable label for the data requirement used to label data flows in BPMN or similar diagrams. Also provides a human readable label when rendering the data requirement that conveys its purpose to human readers."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.output.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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.output.requirement">
<path value="PlanDefinition.action.action.action.output.requirement"/>
<short value="What data is provided"/>
<definition
value="Defines the data that results as output from the action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.output.requirement"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="DataRequirement"/>
</type>
<condition value="pld-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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.output.relatedData">
<path value="PlanDefinition.action.action.action.output.relatedData"/>
<short value="What data is provided"/>
<definition
value="Points to an existing input or output element that is results as output from the action."/>
<comment
value="The relatedData element allows indicating that the output of child action is also the output of a parent action. It also allows the input of one action to be identified as the output of a different action"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.output.relatedData"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<condition value="pld-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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.relatedAction">
<path value="PlanDefinition.action.action.action.relatedAction"/>
<short value="Relationship to another action"/>
<definition
value="A relationship to another action such as "before" or "30-60 minutes after start of"."/>
<comment
value="When an action depends on multiple actions, the meaning is that all actions are dependencies, rather than that any of the actions are a dependency."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.relatedAction"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<condition value="pld-4"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.relatedAction.id">
<path value="PlanDefinition.action.action.action.relatedAction.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="PlanDefinition.action.action.action.relatedAction.extension">
<path
value="PlanDefinition.action.action.action.relatedAction.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="PlanDefinition.action.action.action.relatedAction.modifierExtension">
<path
value="PlanDefinition.action.action.action.relatedAction.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="PlanDefinition.action.action.action.relatedAction.targetId">
<path
value="PlanDefinition.action.action.action.relatedAction.targetId"/>
<short value="What action is this related to"/>
<definition value="The element id of the target related action."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.relatedAction.targetId"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="id"/>
</type>
<condition value="pld-4"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element
id="PlanDefinition.action.action.action.relatedAction.relationship">
<path
value="PlanDefinition.action.action.action.relatedAction.relationship"/>
<short
value="before | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end"/>
<definition
value="The relationship of the start of this action to the related action."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.relatedAction.relationship"/>
<min value="1"/>
<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="ActionRelationshipType"/>
</extension>
<strength value="required"/>
<description
value="Defines the types of relationships between actions."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element
id="PlanDefinition.action.action.action.relatedAction.endRelationship">
<path
value="PlanDefinition.action.action.action.relatedAction.endRelationship"/>
<short
value="before | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end"/>
<definition
value="The relationship of the end of this action to the related action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.relatedAction.endRelationship"/>
<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="ActionRelationshipType"/>
</extension>
<strength value="required"/>
<description
value="Defines the types of relationships between actions."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A (to add?)"/>
</mapping>
</element>
<element
id="PlanDefinition.action.action.action.relatedAction.offset[x]">
<path
value="PlanDefinition.action.action.action.relatedAction.offset[x]"/>
<short value="Time offset for the relationship"/>
<definition
value="A duration or range of durations to apply to the relationship. For example, 30-60 minutes before."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.relatedAction.offset[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Duration"/>
</type>
<type>
<code value="Range"/>
</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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.timing[x]">
<path value="PlanDefinition.action.action.action.timing[x]"/>
<short value="When the action should take place"/>
<definition
value="An optional value describing when the action should be performed."/>
<comment
value="The intent of the timing element is to provide timing when the action should be performed. As a definitional resource, this timing is interpreted as part of an apply operation so that the timing of the result actions in a CarePlan or RequestOrchestration, for example, would be specified by evaluating the timing definition in the context of the apply and setting the resulting timing on the appropriate elements of the target resource. If the timing is an Age, the activity is expected to be performed when the subject is the given Age. When the timing is a Duration, the activity is expected to be performed within the specified duration from the apply. When the timing is a Range, it may be a range of Ages or Durations, providing a range for the expected timing of the resulting activity. When the timing is a Timing, it is establishing a schedule for the timing of the resulting activity."/>
<requirements
value="Allows prompting for activities and detection of missed planned activities."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.timing[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Age"/>
</type>
<type>
<code value="Duration"/>
</type>
<type>
<code value="Range"/>
</type>
<type>
<code value="Timing"/>
</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=".effectiveTime"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.location">
<path value="PlanDefinition.action.action.action.location"/>
<short value="Where it should happen"/>
<definition
value="Identifies the facility where the action will occur; e.g. home, hospital, specific clinic, etc."/>
<comment
value="May reference a specific clinical location or may just identify a type of location."/>
<requirements value="Helps in planning of activity."/>
<alias value="facility"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.location"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableReference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Location"/>
</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=LOC].role"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.participant">
<path value="PlanDefinition.action.action.action.participant"/>
<short value="Who should participate in the action"/>
<definition
value="Indicates who should participate in performing the action described."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.participant"/>
<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=PFM]"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.participant.id">
<path value="PlanDefinition.action.action.action.participant.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="PlanDefinition.action.action.action.participant.extension">
<path
value="PlanDefinition.action.action.action.participant.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="PlanDefinition.action.action.action.participant.modifierExtension">
<path
value="PlanDefinition.action.action.action.participant.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="PlanDefinition.action.action.action.participant.actorId">
<path value="PlanDefinition.action.action.action.participant.actorId"/>
<short value="What actor"/>
<definition
value="A reference to the id element of the actor who will participate in this action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.participant.actorId"/>
<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="N/A (to add?)"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.participant.type">
<path value="PlanDefinition.action.action.action.participant.type"/>
<short
value="careteam | device | group | healthcareservice | location | organization | patient | practitioner | practitionerrole | relatedperson"/>
<definition value="The type of participant in the action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.participant.type"/>
<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="ActivityParticipantType"/>
</extension>
<strength value="required"/>
<description value="The type of participant in the activity."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value=".role.classCode"/>
</mapping>
</element>
<element
id="PlanDefinition.action.action.action.participant.typeCanonical">
<path
value="PlanDefinition.action.action.action.participant.typeCanonical"/>
<short value="Who or what can participate"/>
<definition value="The type of participant in the action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.participant.typeCanonical"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="canonical"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/CapabilityStatement"/>
</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=".role.classCode"/>
</mapping>
</element>
<element
id="PlanDefinition.action.action.action.participant.typeReference">
<path
value="PlanDefinition.action.action.action.participant.typeReference"/>
<short value="Who or what can participate"/>
<definition value="The type of participant in the action."/>
<comment
value="When this element is a reference, it SHOULD be a reference to a definitional resource (for example, a location type, rather than a specific location)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.participant.typeReference"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/CareTeam"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Device"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/DeviceDefinition"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Endpoint"/>
<targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/HealthcareService"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Location"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Patient"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Practitioner"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/RelatedPerson"/>
</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=".role.classCode"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.participant.role">
<path value="PlanDefinition.action.action.action.participant.role"/>
<short value="E.g. Nurse, Surgeon, Parent"/>
<definition
value="The role the participant should play in performing the described action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.participant.role"/>
<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="ActionParticipantRole"/>
</extension>
<strength value="example"/>
<description
value="Defines roles played by participants for the action."/>
<valueSet
value="http://terminology.hl7.org/ValueSet/action-participant-role"/>
</binding>
<mapping>
<identity value="rim"/>
<map value=".role.code"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.participant.function">
<path value="PlanDefinition.action.action.action.participant.function"/>
<short value="E.g. Author, Reviewer, Witness, etc"/>
<definition
value="Indicates how the actor will be involved in the action - author, reviewer, witness, etc."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.participant.function"/>
<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="ActionParticipantFunction"/>
</extension>
<strength value="example"/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-participant-function"/>
</binding>
<mapping>
<identity value="rim"/>
<map value=".role.code"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.type">
<path value="PlanDefinition.action.action.action.type"/>
<short value="create | update | remove | fire-event"/>
<definition
value="The type of action to perform (create, update, remove)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.type"/>
<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="ActionType"/>
</extension>
<strength value="extensible"/>
<description value="The type of action to be performed."/>
<valueSet value="http://hl7.org/fhir/ValueSet/action-type"/>
</binding>
<mapping>
<identity value="rim"/>
<map
value=".moodCode { Maybe? this is effectively Create, Update, or Delete }"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.groupingBehavior">
<path value="PlanDefinition.action.action.action.groupingBehavior"/>
<short value="visual-group | logical-group | sentence-group"/>
<definition
value="Defines the grouping behavior for the action and its children."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.groupingBehavior"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<meaningWhenMissing
value="If no grouping behavior is specified but the action has children (i.e. is a group), the grouping behavior is assumed to be `logical-group`."/>
<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="ActionGroupingBehavior"/>
</extension>
<strength value="required"/>
<description value="Defines organization behavior of a group."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-grouping-behavior|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.selectionBehavior">
<path value="PlanDefinition.action.action.action.selectionBehavior"/>
<short
value="any | all | all-or-none | exactly-one | at-most-one | one-or-more"/>
<definition
value="Defines the selection behavior for the action and its children."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.selectionBehavior"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<meaningWhenMissing
value="If no selection behavior is specified but the action has children (i.e. is a group), the selection behavior is assumed to be `all`."/>
<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="ActionSelectionBehavior"/>
</extension>
<strength value="required"/>
<description value="Defines selection behavior of a group."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-selection-behavior|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.requiredBehavior">
<path value="PlanDefinition.action.action.action.requiredBehavior"/>
<short value="must | could | must-unless-documented"/>
<definition value="Defines the required behavior for the action."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.requiredBehavior"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<meaningWhenMissing
value="If no required behavior is specified but the action has children (i.e. is a group), the required behavior is assumed to be `could`."/>
<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="ActionRequiredBehavior"/>
</extension>
<strength value="required"/>
<description
value="Defines expectations around whether an action or action group is required."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-required-behavior|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.precheckBehavior">
<path value="PlanDefinition.action.action.action.precheckBehavior"/>
<short value="yes | no"/>
<definition
value="Defines whether the action should usually be preselected."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.precheckBehavior"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<meaningWhenMissing
value="If no precheck behavior is specified but the action has children (i.e. is a group), the precheck behavior is assumed to be `no`."/>
<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="ActionPrecheckBehavior"/>
</extension>
<strength value="required"/>
<description
value="Defines selection frequency behavior for an action or group."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-precheck-behavior|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.cardinalityBehavior">
<path value="PlanDefinition.action.action.action.cardinalityBehavior"/>
<short value="single | multiple"/>
<definition
value="Defines whether the action can be selected multiple times."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.cardinalityBehavior"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<meaningWhenMissing
value="If no cardinality behavior is specified but the action has children (i.e. is a group), the cardinality behavior is assumed to be `single`."/>
<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="ActionCardinalityBehavior"/>
</extension>
<strength value="required"/>
<description
value="Defines behavior for an action or a group for how many times that item may be repeated."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/action-cardinality-behavior|5.0.0"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.definition[x]">
<path value="PlanDefinition.action.action.action.definition[x]"/>
<short value="Description of the activity to be performed"/>
<definition
value="A reference to an ActivityDefinition that describes the action to be taken in detail, a MessageDefinition describing a message to be snet, a PlanDefinition that describes a series of actions to be taken, a Questionnaire that should be filled out, a SpecimenDefinition describing a specimen to be collected, or an ObservationDefinition that specifies what observation should be captured."/>
<comment
value="Note that the definition is optional, and if no definition is specified, a dynamicValue with a root ($this) path can be used to define the entire resource dynamically."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.definition[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="canonical"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/ActivityDefinition"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/MessageDefinition"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/ObservationDefinition"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Questionnaire"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/SpecimenDefinition"/>
</type>
<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="false"/>
<mapping>
<identity value="rim"/>
<map value="Act[classCode=ACT; moodCode=DEFN]"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.transform">
<path value="PlanDefinition.action.action.action.transform"/>
<short value="Transform to apply the template"/>
<definition
value="A reference to a StructureMap resource that defines a transform that can be executed to produce the intent resource using the ActivityDefinition instance as the input."/>
<comment
value="Note that when a referenced ActivityDefinition also defines a transform, the transform specified here generally takes precedence. In addition, if both a transform and dynamic values are specific, the dynamic values are applied to the result of the transform."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.transform"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="canonical"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/StructureMap"/>
</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="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.dynamicValue">
<path value="PlanDefinition.action.action.action.dynamicValue"/>
<short value="Dynamic aspects of the definition"/>
<definition
value="Customizations that should be applied to the statically defined resource. For example, if the dosage of a medication must be computed based on the patient's weight, a customization would be used to specify an expression that calculated the weight, and the path on the resource that would contain the result."/>
<comment
value="Dynamic values are applied in the order in which they are defined in the PlanDefinition resource. Note that when dynamic values are also specified by a referenced ActivityDefinition, the dynamicValues from the ActivityDefinition are applied first, followed by the dynamicValues specified here. In addition, if both a transform and dynamic values are specific, the dynamic values are applied to the result of the transform."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.dynamicValue"/>
<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="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.dynamicValue.id">
<path value="PlanDefinition.action.action.action.dynamicValue.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="PlanDefinition.action.action.action.dynamicValue.extension">
<path
value="PlanDefinition.action.action.action.dynamicValue.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="PlanDefinition.action.action.action.dynamicValue.modifierExtension">
<path
value="PlanDefinition.action.action.action.dynamicValue.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="PlanDefinition.action.action.action.dynamicValue.path">
<path value="PlanDefinition.action.action.action.dynamicValue.path"/>
<short value="The path to the element to be set dynamically"/>
<definition
value="The path to the element to be customized. This is the path on the resource that will hold the result of the calculation defined by the expression. The specified path SHALL be a FHIRPath resolvable on the specified target type of the ActivityDefinition, and SHALL consist only of identifiers, constant indexers, and a restricted subset of functions. The path is allowed to contain qualifiers (.) to traverse sub-elements, as well as indexers ([x]) to traverse multiple-cardinality sub-elements (see the [Simple FHIRPath Profile](http://hl7.org/fhir/R5/fhirpath.html#simple) for full details)."/>
<comment
value="To specify the path to the current action being realized, the %action environment variable is available in this path. For example, to specify the description element of the target action, the path would be %action.description. The path attribute contains a [Simple FHIRPath Subset](http://hl7.org/fhir/R5/fhirpath.html#simple) that allows path traversal, but not calculation."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.dynamicValue.path"/>
<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="N/A"/>
</mapping>
</element>
<element
id="PlanDefinition.action.action.action.dynamicValue.expression">
<path
value="PlanDefinition.action.action.action.dynamicValue.expression"/>
<short
value="An expression that provides the dynamic value for the customization"/>
<definition
value="An expression specifying the value of the customized element."/>
<comment
value="The expression may be inlined or may be a reference to a named expression within a logic library referenced by the library element."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.action.dynamicValue.expression"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Expression"/>
</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="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.action.action.action.action">
<path value="PlanDefinition.action.action.action.action"/>
<short value="A sub-action"/>
<definition
value="Sub actions that are contained within the action. The behavior of this action determines the functionality of the sub-actions. For example, a selection behavior of at-most-one indicates that of the sub-actions, at most one may be chosen as part of realizing the action definition."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="PlanDefinition.action.action"/>
<min value="0"/>
<max value="*"/>
</base>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/PlanDefinition#PlanDefinition.action"/>
<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="workflow"/>
<map value="{InverseRelationship of Definition.partOf}"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="PlanDefinition.asNeeded[x]">
<path value="PlanDefinition.asNeeded[x]"/>
<short value="Preconditions for service"/>
<definition
value="If a CodeableConcept is present, it indicates the pre-condition for performing the service. For example "pain", "on flare-up", etc."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="PlanDefinition.asNeeded[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="boolean"/>
</type>
<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="ProcedureAsNeededReason"/>
</extension>
<strength value="example"/>
<description
value="A coded concept identifying the pre-condition that should hold prior to performing a procedure. For example "pain", "on flare-up", etc."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/medication-as-needed-reason"/>
</binding>
<mapping>
<identity value="rim"/>
<map
value="boolean: precondition.negationInd (inversed - so negationInd = true means asNeeded=false CodeableConcept: precondition.observationEventCriterion[code="Assertion"].value"/>
</mapping>
</element>
</snapshot>
<differential>
<element id="PlanDefinition.extension">
<path value="PlanDefinition.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<ordered value="false"/>
<rules value="open"/>
</slicing>
<min value="1"/>
</element>
<element id="PlanDefinition.extension:ApprovalStatus">
<path value="PlanDefinition.extension"/>
<sliceName value="ApprovalStatus"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension"/>
</type>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.extension:spec-additional-info">
<path value="PlanDefinition.extension"/>
<sliceName value="spec-additional-info"/>
<short value="Specification Additional Information"/>
<definition
value="Placeholder for providing any comments that are relevant to the specification. [Source: SME Defined]
Examples: replaces method ABC, using the XYZ facility."/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension"/>
</type>
</element>
<element id="PlanDefinition.identifier">
<path value="PlanDefinition.identifier"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.version">
<path value="PlanDefinition.version"/>
<short value="Specification Version"/>
<definition
value="The alphanumeric text assigned by the sponsor to a particular edition of a specification. [Source: SME Defined] Examples: 2.1, 13.2, ST1, 00001, 00002, companyname-001.
Note: This value should be unique across all specifications for a given material, not just those with the same name"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.title">
<path value="PlanDefinition.title"/>
<short value="Specification Title"/>
<definition
value="The textual identification for the specification. [Source: SME Defined]
Example: &lt;drug name> 75 mg chewable tablets
Note: This may include the name of the drug substance, product or the raw material/excipients"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.subtitle">
<path value="PlanDefinition.subtitle"/>
<short value="Specification Subtitle"/>
<definition
value="An additional textual identification for the specification [Source: SME Defined]."/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.type">
<path value="PlanDefinition.type"/>
<short value="Specification Type"/>
<definition
value="A classification of specification related to the kind of entity it is referencing. [Source: SME Defined]
Examples: Drug product, Drug substance. "/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.type.coding">
<path value="PlanDefinition.type.coding"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="$this"/>
</discriminator>
<description value="Slice on the coding itself"/>
<ordered value="false"/>
<rules value="closed"/>
</slicing>
<min value="2"/>
<max value="2"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.type.coding:DefinitionType">
<path value="PlanDefinition.type.coding"/>
<sliceName value="DefinitionType"/>
<min value="1"/>
<max value="1"/>
<patternCoding>
<system
value="http://terminology.hl7.org/CodeSystem/plan-definition-type"/>
<code value="workflow-definition"/>
<display value="Workflow Definition"/>
</patternCoding>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.type.coding:SpecType">
<path value="PlanDefinition.type.coding"/>
<sliceName value="SpecType"/>
<short value="Specification Type"/>
<definition
value="A classification of specification related to the kind of the entity it is referencing."/>
<min value="1"/>
<max value="1"/>
<mustSupport value="true"/>
<binding>
<strength value="required"/>
<valueSet
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-type-terminology"/>
</binding>
</element>
<element id="PlanDefinition.status">
<path value="PlanDefinition.status"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.subject[x]">
<path value="PlanDefinition.subject[x]"/>
<min 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-drug-product-handle"/>
<targetProfile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance"/>
<targetProfile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"/>
<aggregation value="bundled"/>
</type>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.date">
<path value="PlanDefinition.date"/>
<short value="Specification Version Date"/>
<definition
value="The date when the sponsor assigned a date to a specific version. [Source: SME Defined]
Note: This is the date a particular version of the specification was internally accepted by the submitter."/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.approvalDate">
<path value="PlanDefinition.approvalDate"/>
<short value="Specification Status Date"/>
<definition
value="The date on which the FDA approval status for a specification became effective. [Source: SME Defined]
Note: If the application is not yet approved, then this is the date of the current submission OR the date of the complete response (CR).
Note: This is not the application approval status date."/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.goal">
<path value="PlanDefinition.goal"/>
<short value="Acceptance Criteria"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.goal.extension">
<path value="PlanDefinition.goal.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<ordered value="false"/>
<rules value="open"/>
</slicing>
</element>
<element id="PlanDefinition.goal.extension:ac-additional-info">
<path value="PlanDefinition.goal.extension"/>
<sliceName value="ac-additional-info"/>
<short value="Acceptance Criteria Additional Information"/>
<definition
value="A coded value specifying when a particular analytical procedure or measurement is being performed on a substance or a product. [Source: SME Defined] Examples: Release, Stability.
Note: The concept of 'In-Process' is subsumed by the Release code.
Example: value changed from 4% to 5% on 01/01/2010) "/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension"/>
</type>
</element>
<element id="PlanDefinition.goal.description">
<path value="PlanDefinition.goal.description"/>
<short value="Original Text"/>
<definition
value="The text of the acceptance criteria as provided in the specification. [Source: SME Defined]
Examples: White to off-white cake; 22.5 - 27.5 mg/ml Note: This is the text as it appears in the Specification."/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.goal.addresses">
<path value="PlanDefinition.goal.addresses"/>
<short value="Acceptance Criteria Usage"/>
<definition
value="A coded value specifying when a particular analytical procedure or measurement is being performed on a substance or a product. [Source: SME Defined] Examples: Release, Stability.
Note: The concept of 'In-Process' is subsumed by the Release code."/>
<min value="1"/>
<mustSupport value="true"/>
<binding>
<strength value="required"/>
<valueSet
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-usage-terminology"/>
</binding>
</element>
<element id="PlanDefinition.goal.target">
<path value="PlanDefinition.goal.target"/>
<short value="Acceptance Criteron"/>
<min value="1"/>
<constraint>
<key value="cmc-target-range"/>
<severity value="error"/>
<human
value="When the Range extension is present, detail cannot be present."/>
<expression
value="modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range').exists() implies detail.exists().not()"/>
<source
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"/>
</constraint>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.goal.target.modifierExtension">
<path value="PlanDefinition.goal.target.modifierExtension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<ordered value="false"/>
<rules value="open"/>
</slicing>
</element>
<element id="PlanDefinition.goal.target.modifierExtension:targetRange">
<path value="PlanDefinition.goal.target.modifierExtension"/>
<sliceName value="targetRange"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range"/>
</type>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.goal.target.measure">
<path value="PlanDefinition.goal.target.measure"/>
<short
value="Detailed parameter being measured if more granular than Sub-Test"/>
<type>
<code value="CodeableConcept"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"/>
</type>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.goal.target.detail[x]">
<path value="PlanDefinition.goal.target.detail[x]"/>
<slicing>
<discriminator>
<type value="type"/>
<path value="$this"/>
</discriminator>
<ordered value="false"/>
<rules value="open"/>
</slicing>
<type>
<code value="Quantity"/>
</type>
<type>
<code value="string"/>
</type>
<type>
<code value="integer"/>
</type>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.goal.target.detail[x]:detailQuantity">
<path value="PlanDefinition.goal.target.detail[x]"/>
<sliceName value="detailQuantity"/>
<short value="ValueNumeric"/>
<definition
value="The acceptable quantitative or numeric value for the result of the test. [Source: SME Defined]"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Quantity"/>
</type>
<mustSupport value="true"/>
<binding>
<strength value="required"/>
<valueSet
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure"/>
</binding>
</element>
<element id="PlanDefinition.goal.target.detail[x]:detailQuantity.value">
<path value="PlanDefinition.goal.target.detail[x].value"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element
id="PlanDefinition.goal.target.detail[x]:detailQuantity.comparator">
<path value="PlanDefinition.goal.target.detail[x].comparator"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.goal.target.detail[x]:detailQuantity.unit">
<path value="PlanDefinition.goal.target.detail[x].unit"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.goal.target.detail[x]:detailQuantity.code">
<path value="PlanDefinition.goal.target.detail[x].code"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.goal.target.detail[x]:detailString">
<path value="PlanDefinition.goal.target.detail[x]"/>
<sliceName value="detailString"/>
<short value="Value"/>
<definition
value="A textual description and/or a number that identifies a level within a sequential test. [Source: SME Defined] Examples – Single Stage, Stage 1, Stage 2 (sometimes referred to as L1, L2 L3 or A1, A2 as in USP &lt;711>)
Note: A Stage may or may not provide a conditional sequence with associated acceptance criteria. [Source: SME Defined] (e.g., dissolution test, pyrogen test - USP &lt;151>; 21 CFR 610.13 (b) Test for pyrogenic substances)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="string"/>
</type>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.goal.target.detail[x]:detailInteger">
<path value="PlanDefinition.goal.target.detail[x]"/>
<sliceName value="detailInteger"/>
<short value="Number of Replicates"/>
<definition
value="An identification number for a member of the set of results for a test, usually the sequence order in which the test was executed. Individual tests are executed on multiple samples to give greater validity to the findings. [Source SME Defined]
Examples: Prepare six aliquots from the sample. Test 8 samples. If any fall above 110%, test an additional 7 samples. Record all replicate values as stated in the method."/>
<min value="0"/>
<max value="1"/>
<type>
<code value="integer"/>
</type>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.goal.target.due">
<path value="PlanDefinition.goal.target.due"/>
<max value="0"/>
</element>
<element id="PlanDefinition.action">
<path value="PlanDefinition.action"/>
<short value="Method"/>
<min value="1"/>
<constraint>
<key value="cmc-link-required"/>
<severity value="error"/>
<human value="Action linkId is required for alternate tests"/>
<expression
value="(action.relatedAction.count() > 0) implies action.linkId.exists()"/>
<source
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"/>
</constraint>
<constraint>
<key value="cmc-single-or-multistage"/>
<severity value="error"/>
<human
value="if a test is multi-stage, the test can't have a prefix and its stages must have a name and can't be named 'Single Stage' and must be unique. If it's single stage its prefix is 'Single Stage' and its groups can't have prefixes"/>
<expression
value="((
prefix.exists() implies
action.prefix.empty() and prefix = 'Single Stage'
) and (
prefix.empty() implies (
(action.where(
prefix.exists() and
prefix != 'Single Stage'
).count() = action.count()) and
action.prefix.isDistinct()
)
)) = true"/>
<source
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"/>
</constraint>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.linkId">
<path value="PlanDefinition.action.linkId"/>
<short value="only required for alternate tests"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.prefix">
<path value="PlanDefinition.action.prefix"/>
<short value="Stage Name"/>
<definition
value="A textual description and/or a number that identifies a level within a sequential test. [Source: SME Defined] Examples – Single Stage, Stage 1, Stage 2 (sometimes referred to as L1, L2 L3 or A1, A2 as in USP &lt;711&gt;)
Note: A Stage may or may not provide a conditional sequence with associated acceptance criteria. [Source: SME Defined] (e.g., dissolution test, pyrogen test - &lt;151&gt;; 21 CFR 610.13 (b) Test for pyrogenic substances)
Implememtation Note: Value at this level is 'Single Stage'"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.title">
<path value="PlanDefinition.action.title"/>
<short value="Test Name"/>
<definition
value="The textual description of a procedure or analytical method. [Source: SME Defined]
Examples: Assay by HPLC, moisture by Karl Fischer, analysis for impurities.
Note: as defined by the sponsor"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.description">
<path value="PlanDefinition.action.description"/>
<short value="Test Additional Information"/>
<definition
value="Test Additional Information: Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined].
If there is more than one comment, include in this element. Markdown allows formating for clarity."/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.code">
<path value="PlanDefinition.action.code"/>
<short value="Test Method Origin"/>
<definition
value="A coded value specifying the source of the method. [Source: SME Defined] Example: Compendial"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.code.coding">
<path value="PlanDefinition.action.code.coding"/>
<min value="1"/>
<max value="1"/>
<mustSupport value="true"/>
<binding>
<strength value="required"/>
<valueSet
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-method-origin-terminology"/>
</binding>
</element>
<element id="PlanDefinition.action.code.text">
<path value="PlanDefinition.action.code.text"/>
<short value="Analytical Procedure"/>
<definition
value="The name of the technique used to determine the nature of a characteristic. [Source: SME Defined]."/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.reason">
<path value="PlanDefinition.action.reason"/>
<short value="Test Category | Test Subcategory"/>
<definition
value="A high level grouping of quality attributes for products, substances, raw materials, excipients, intermediates and reagents. [Source: SME Defined] Examples: Assay, Biological Properties."/>
<min value="1"/>
<max value="2"/>
<mustSupport value="true"/>
<binding>
<strength value="required"/>
<valueSet
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology"/>
</binding>
</element>
<element id="PlanDefinition.action.reason.extension">
<path value="PlanDefinition.action.reason.extension"/>
<min value="1"/>
</element>
<element id="PlanDefinition.action.reason.extension:categoryLevel">
<path value="PlanDefinition.action.reason.extension"/>
<sliceName value="categoryLevel"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"/>
</type>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.documentation">
<path value="PlanDefinition.action.documentation"/>
<max value="1"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.documentation.type">
<path value="PlanDefinition.action.documentation.type"/>
<patternCode value="documentation"/>
</element>
<element id="PlanDefinition.action.documentation.label">
<path value="PlanDefinition.action.documentation.label"/>
<short value="Reference to Procedure"/>
<definition
value="A sponsor/applicant provided alphanumeric code that identifies the procedure. [Source: SME Defined]. Example: HP1234-2008
Note: This could also be a transferred lab method."/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.goalId">
<path value="PlanDefinition.action.goalId"/>
<short value="Reference to Acceptance Criteria"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.relatedAction">
<path value="PlanDefinition.action.relatedAction"/>
<short value="Alternate Test"/>
<definition
value="Alternate Tests are one or more test that are equivalent often using differnt method or equipment. The tests are used interchangeably and only one is used to satisfy the drug product specificaion."/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.relatedAction.targetId">
<path value="PlanDefinition.action.relatedAction.targetId"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.relatedAction.relationship">
<path value="PlanDefinition.action.relatedAction.relationship"/>
<short value="Code is concurrent"/>
<patternCode value="concurrent"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.action">
<path value="PlanDefinition.action.action"/>
<short value="Groups or Stages"/>
<type>
<code value="BackboneElement"/>
</type>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.action.prefix">
<path value="PlanDefinition.action.action.prefix"/>
<short value="Stage Name"/>
<definition
value="A textual description and/or a number that identifies a level within a sequential test. [Source: SME Defined] Examples – Single Stage, Stage 1, Stage 2 (sometimes referred to as L1, L2 L3 or A1, A2 as in USP &lt;711&gt;)
Note: A Stage may or may not provide a conditional sequence with associated acceptance criteria. [Source: SME Defined] (e.g., dissolution test, pyrogen test - &lt;151&gt;; 21 CFR 610.13 (b) Test for pyrogenic substances)
Implememtation Note: not requried if action.prefix is 'Single Stage'"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.action.title">
<path value="PlanDefinition.action.action.title"/>
<short value="Test Name (only reqired if different than above)"/>
<definition
value="Test Name: The textual description of a procedure or analytical method. [Source: SME Defined]
Examples: Assay by HPLC, moisture by Karl Fischer, analysis for impurities.
Note: as defined by the sponsor
Note: The test name of the action.action can be different than the action. Example, the action test is Microbial Limits and the action.action test is Staphylococcus aureus."/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.action.description">
<path value="PlanDefinition.action.action.description"/>
<short
value="Test Additional Information | Stage Additional Information"/>
<definition
value="Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined].
Implementation Note: If there is more than one comment, include in this element. Markdown allows formating for clarity."/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.action.documentation">
<path value="PlanDefinition.action.action.documentation"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.action.documentation.type">
<path value="PlanDefinition.action.action.documentation.type"/>
<patternCode value="documentation"/>
</element>
<element id="PlanDefinition.action.action.documentation.document">
<path value="PlanDefinition.action.action.documentation.document"/>
<short value="Test or Stage Additional Information Visual Attachments"/>
<definition
value="Any visual data described andor referenced in additional informatation"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element
id="PlanDefinition.action.action.documentation.document.contentType">
<path
value="PlanDefinition.action.action.documentation.document.contentType"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.action.documentation.document.data">
<path value="PlanDefinition.action.action.documentation.document.data"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.action.documentation.document.title">
<path
value="PlanDefinition.action.action.documentation.document.title"/>
<short value="Document file name including the file extension"/>
<definition
value="A format or abbreviation name that identifies a file structure. [Source: SME Defined]
Used for the following: Analytical Instrument Data File Type, Impurity Analysis Graphic, Impurity Analytical Instrument Data File, Impurity Chemical Structure Data File, and Substance Structure Graphic."/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.action.goalId">
<path value="PlanDefinition.action.action.goalId"/>
<short value="Reference to Acceptance Criteria"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.action.action">
<path value="PlanDefinition.action.action.action"/>
<short value="Sub-Test"/>
<type>
<code value="BackboneElement"/>
</type>
<constraint>
<key value="cmc-subtest-rrt"/>
<severity value="error"/>
<human
value="a subtest's prefix represents relative retention time, should it exist"/>
<expression value="prefix.exists() implies prefix.single() = 'RRT'"/>
<source
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"/>
</constraint>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.action.action.prefix">
<path value="PlanDefinition.action.action.action.prefix"/>
<short value="RRT"/>
<definition
value="RRT: The ratio of the retention time of a component relative to that of another used as a reference obtained under identical conditions as an alias for the name of the unidentified impurities. [Source: Adapted from USP]
Example: 1:23 (a ratio)
Note: This is the title or name of the impurity (sometimes expressed as a ratio) and not the value.
Implementation Note: This value can only be 'RRT'. It is used to desinate that RRT value(s) expressed in action.action.action.title are relative retention times."/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.action.action.title">
<path value="PlanDefinition.action.action.action.title"/>
<short value="Test Name | RRT (complex testing)"/>
<definition
value="Test Name: The textual description of a procedure or analytical method. [Source: SME Defined]
Examples: Assay by HPLC, moisture by Karl Fischer, analysis for impurities.
Note: as defined by the sponsor
Note: The test name of the action.action can be different than the action. Example, the action test is Microbial Limits and the action.action test is Staphylococcus aureus.
RRT: The ratio of the retention time of a component relative to that of another used as a reference obtained under identical conditions as an alias for the name of the unidentified impurities. [Source: Adapted from USP]
Example: 1:23 (a ratio)
Note: This is the title or name of the impurity (sometimes expressed as a ratio) and not the value.
Implementation Note: For RRT, if there is a range associated with the unidentified peak then the range can be entered instead of indivual values. E.g.: 0.4 – 0.8."/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.action.action.description">
<path value="PlanDefinition.action.action.action.description"/>
<short
value="Test Additional Information | Stage Additional Information"/>
<definition
value="Test Additional Information: Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined].
Stage Additional Information: Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined]
If there is more than one comment, include in this element. Markdown allows formating for clarity. If both types are present, indicate type."/>
<mustSupport value="true"/>
</element>
<element id="PlanDefinition.action.action.action.goalId">
<path value="PlanDefinition.action.action.action.goalId"/>
<short value="Reference to Acceptance Criteria"/>
<min value="1"/>
<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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