Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
0.1.20 - Build CI
Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
0.1.20 - Build CI
Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 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/ and changes regularly. See the Directory of published versions
| Draft as of 2024-03-04 |
XML representation of the mfg-test-site-organization resource profile.
<StructureDefinition xmlns="http://hl7.org/fhir">
<id value="mfg-test-site-organization"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><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 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-mfg-test-site-organization-definitions.html#Organization">Organization</a><a name="Organization"> </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/organization.html">Organization</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is an abstract profile. </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-mfg-test-site-organization-definitions.html#Organization.meta">meta</a><a name="Organization.meta"> </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"/><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_bck100.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-mfg-test-site-organization-definitions.html#Organization.meta.profile">profile</a><a name="Organization.meta.profile"> </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/references.html">canonical</a>(<a style="opacity: 0.5" href="http://hl7.org/fhir/R5/structuredefinition.html">StructureDefinition</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">Profiles this resource claims to conform to</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_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_slice.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Definition" class="hierarchy"/> <a style="font-style: italic" href="StructureDefinition-mfg-test-site-organization-definitions.html#Organization.identifier" title="Manufacturing Site Unique Identifier: A unique identifier assigned to the establishment (facility) which manufactures, prepares, propagates, compounds or processes drugs. [Source: Adapted from FDA Drug Establishment Current Registration Site]
Testing Site Unique Identifier: A unique identifier assigned to the establishment (facility) which performs the testing. [Source: SME Defined]">Slices for identifier</a><a name="Organization.identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic"/><span style="font-style: italic">1</span><span style="font-style: italic">..</span><span style="opacity: 0.5; font-style: italic">*</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; font-style: italic" href="http://hl7.org/fhir/R5/datatypes.html#Identifier">Identifier</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Manufacturing Site Unique Identifier | Testing Site Unique Identifier</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Open by value:system</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_bck133.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_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> identifier:All Slices<a name="Organization.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"/><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_bck1330.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_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-mfg-test-site-organization-definitions.html#Organization.identifier.type" title="A value that identifies the source of the unique identifier. [Source: SME Defined]
Examples: Data Universal Number System (DUNS), Facility Establishment Identifiers (FEI), etc.">type</a><a name="Organization.identifier.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"><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#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">Manufacturing Site Unique Identifier Type | Testing Site Unique Identifier Type<br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-org-identifier-type-terminology.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-org-identifier-type-terminology">Testing Site and Organization Identifier 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: 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_bck1330.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_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-mfg-test-site-organization-definitions.html#Organization.identifier.system">system</a><a name="Organization.identifier.system"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><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#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The namespace for the identifier 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_bck1320.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_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-mfg-test-site-organization-definitions.html#Organization.identifier.value">value</a><a name="Organization.identifier.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#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">The value that is unique</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_bck135.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-mfg-test-site-organization-definitions.html#Organization.identifier:DUNSNumber" title="Slice DUNSNumber">identifier:DUNSNumber</a><a name="Organization.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><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 (org-length9)">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">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 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">Identifies this organization across multiple systems</span><br/><span style="font-weight:bold">org-length9: </span>Identifier number is 9 digits</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_bck1340.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_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: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-mfg-test-site-organization-definitions.html#Organization.identifier:DUNSNumber.system">system</a><a name="Organization.identifier.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"><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#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"><span style="opacity: 0.5">The namespace for the identifier value</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">urn:oid:1.3.6.1.4.1.519.1</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_bck125.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: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-mfg-test-site-organization-definitions.html#Organization.identifier:FEINumber" title="Slice FEINumber">identifier:FEINumber</a><a name="Organization.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><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 (org-length7)">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">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 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">Identifies this organization across multiple systems</span><br/><span style="font-weight:bold">org-length7: </span>Identifier number is 7 or 10 digits</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_bck1240.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_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-mfg-test-site-organization-definitions.html#Organization.identifier:FEINumber.system">system</a><a name="Organization.identifier.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"><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#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"><span style="opacity: 0.5">The namespace for the identifier value</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">urn:oid:2.16.840.1.113883.4.82</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-mfg-test-site-organization-definitions.html#Organization.name" title="Manufacturing Site Name: The name of the establishment (facilities) which manufacture, prepare, propagate, compound, process or package drugs that are commercially distributed in the U.S. or offered for import to the U.S[Source: Adapted from FDA Drug Establishment Current Registration Site]
Testing Site Name: The name of the establishment (facility) which tests the raw materials, intermediates, drug substance, drug product, packaging components. [Source: SME Defined]">name</a><a name="Organization.name"> </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">Manufacturing Site Name | Testing Site 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_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: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-mfg-test-site-organization-definitions.html#Organization.contact">contact</a><a name="Organization.contact"> </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 style="opacity: 0.5" href="http://hl7.org/fhir/R5/metadatatypes.html#ExtendedContactDetail">ExtendedContactDetail</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">Official contact details for the Organization</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_bck000.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: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-mfg-test-site-organization-definitions.html#Organization.contact.address" title="Manufacturing Site Physical Address: The complete address for the supplier [Source: SME Defined]
Testing Site Address: The complete address for the testing site. [Source: SME defined]">address</a><a name="Organization.contact.address"> </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-pq-cmc-address.html" title="Address">PqAddress</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Manufacturing Site Physical Address | Testing Site Address</td></tr>
<tr><td colspan="5" class="hierarchy"><br/><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAABmJLR0QA/wD/AP+gvaeTAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3goXBCwdPqAP0wAAAldJREFUOMuNk0tIlFEYhp9z/vE2jHkhxXA0zJCMitrUQlq4lnSltEqCFhFG2MJFhIvIFpkEWaTQqjaWZRkp0g26URZkTpbaaOJkDqk10szoODP//7XIMUe0elcfnPd9zsfLOYplGrpRwZaqTtw3K7PtGem7Q6FoidbGgqHVy/HRb669R+56zx7eRV1L31JGxYbBtjKK93cxeqfyQHbehkZbUkK20goELEuIzEd+dHS+qz/Y8PTSif0FnGkbiwcAjHaU1+QWOptFiyCLp/LnKptpqIuXHx6rbR26kJcBX3yLgBfnd7CxwJmflpP2wUg0HIAoUUpZBmKzELGWcN8nAr6Gpu7tLU/CkwAaoKTWRSQyt89Q8w6J+oVQkKnBoblH7V0PPvUOvDYXfopE/SJmALsxnVm6LbkotrUtNowMeIrVrBcBpaMmdS0j9df7abpSuy7HWehwJdt1lhVwi/J58U5beXGAF6c3UXLycw1wdFklArBn87xdh0ZsZtArghBdAA3+OEDVubG4UEzP6x1FOWneHh2VDAHBAt80IbdXDcesNoCvs3E5AFyNSU5nbrDPZpcUEQQTFZiEVx+51fxMhhyJEAgvlriadIJZZksRuwBYMOPBbO3hePVVqgEJhFeUuFLhIPkRP6BQLIBrmMenujm/3g4zc398awIe90Zb5A1vREALqneMcYgP/xVQWlG+Ncu5vgwwlaUNx+3799rfe96u9K0JSDXcOzOTJg4B6IgmXfsygc7/Bvg9g9E58/cDVmGIBOP/zT8Bz1zqWqpbXIsd0O9hajXfL6u4BaOS6SeWAAAAAElFTkSuQmCC" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
<valueCode value="brr"/>
</extension>
<url
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization"/>
<version value="0.1.20"/>
<name value="MfgTestSiteOrganization"/>
<title value="Manufacturing and/or Test Site Organization"/>
<status value="draft"/>
<date value="2024-03-04T02:24:01+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 profile for the data elements required to identify an organization that manufactures, processes or tests drug products or substances."/>
<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="w5"/>
<uri value="http://hl7.org/fhir/fivews"/>
<name value="FiveWs Pattern Mapping"/>
</mapping>
<mapping>
<identity value="v2"/>
<uri value="http://hl7.org/v2"/>
<name value="HL7 V2 Mapping"/>
</mapping>
<mapping>
<identity value="rim"/>
<uri value="http://hl7.org/v3"/>
<name value="RIM Mapping"/>
</mapping>
<mapping>
<identity value="interface"/>
<uri value="http://hl7.org/fhir/interface"/>
<name value="Interface Pattern"/>
</mapping>
<mapping>
<identity value="servd"/>
<uri value="http://www.omg.org/spec/ServD/1.0/"/>
<name value="ServD"/>
</mapping>
<kind value="resource"/>
<abstract value="true"/>
<type value="Organization"/>
<baseDefinition
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
<derivation value="constraint"/>
<snapshot>
<element id="Organization">
<path value="Organization"/>
<short
value="A grouping of people or organizations with a common purpose"/>
<definition
value="A formally or informally recognized grouping of people or organizations formed for the purpose of achieving some form of collective action. Includes companies, institutions, corporations, departments, community groups, healthcare practice groups, payer/insurer, etc."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Organization"/>
<min value="0"/>
<max value="*"/>
</base>
<constraint>
<key value="dom-2"/>
<severity value="error"/>
<human
value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/>
<expression value="contained.contained.empty()"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-3"/>
<severity value="error"/>
<human
value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource"/>
<expression
value="contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-4"/>
<severity value="error"/>
<human
value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/>
<expression
value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-5"/>
<severity value="error"/>
<human
value="If a resource is contained in another resource, it SHALL NOT have a security label"/>
<expression value="contained.meta.security.empty()"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">
<valueMarkdown
value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."/>
</extension>
<key value="dom-6"/>
<severity value="warning"/>
<human
value="A resource should have narrative for robust management"/>
<expression value="text.`div`.exists()"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="org-1"/>
<severity value="error"/>
<human
value="The organization SHALL at least have a name or an identifier, and possibly more than one"/>
<expression value="(identifier.count() + name.count()) > 0"/>
<source value="http://hl7.org/fhir/StructureDefinition/Organization"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map
value="Entity, Role, or Act,Organization(classCode=ORG, determinerCode=INST)"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="administrative.group"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="(also see master files messages)"/>
</mapping>
<mapping>
<identity value="interface"/>
<map value="ParticipantContactable"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="Organization"/>
</mapping>
</element>
<element id="Organization.id">
<path value="Organization.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="Organization.meta">
<path value="Organization.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="Organization.meta.id">
<path value="Organization.meta.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="Organization.meta.extension">
<path value="Organization.meta.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="Organization.meta.versionId">
<path value="Organization.meta.versionId"/>
<short value="Version specific identifier"/>
<definition
value="The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted."/>
<comment
value="The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Meta.versionId"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="id"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR 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="Organization.meta.lastUpdated">
<path value="Organization.meta.lastUpdated"/>
<short value="When the resource version last changed"/>
<definition
value="When the resource last changed - e.g. when the version changed."/>
<comment
value="This element is generally omitted in instances submitted in a PUT or POST. Instead, it is populated in the response instance and when retrieving information using a GET. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a [read](http://hl7.org/fhir/R5/http.html#read) interaction."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Meta.lastUpdated"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="instant"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR 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="Organization.meta.source">
<path value="Organization.meta.source"/>
<short value="Identifies where the resource comes from"/>
<definition
value="A uri that identifies the source system of the resource. This provides a minimal amount of [Provenance](provenance.html#) information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc."/>
<comment
value="The exact use of the source (and the possible implied Provenance.entity.role and agent.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. The source may correspond to Provenance.entity.what[x] or Provenance.agent.who[x], though it may be a more general or abstract reference.
This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Meta.source"/>
<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>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="Organization.meta.profile">
<path value="Organization.meta.profile"/>
<short value="Profiles this resource claims to conform to"/>
<definition
value="A list of profiles (references to [StructureDefinition](structuredefinition.html#) resources) that this resource claims to conform to. The URL is a reference to [StructureDefinition.url](structuredefinition-definitions.html#StructureDefinition.url)."/>
<comment
value="It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Meta.profile"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="canonical"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/StructureDefinition"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must 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="Organization.meta.security">
<path value="Organization.meta.security"/>
<short value="Security Labels applied to this resource"/>
<definition
value="Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure."/>
<comment
value="The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Meta.security"/>
<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"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="SecurityLabels"/>
</extension>
<strength value="extensible"/>
<description
value="Security Labels from the Healthcare Privacy and Security Classification System."/>
<valueSet value="http://hl7.org/fhir/ValueSet/security-labels"/>
</binding>
</element>
<element id="Organization.meta.tag">
<path value="Organization.meta.tag"/>
<short value="Tags applied to this resource"/>
<definition
value="Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource."/>
<comment
value="The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Meta.tag"/>
<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"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="Tags"/>
</extension>
<strength value="example"/>
<description
value="Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones"."/>
<valueSet value="http://hl7.org/fhir/ValueSet/common-tags"/>
</binding>
</element>
<element id="Organization.implicitRules">
<path value="Organization.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="Organization.language">
<path value="Organization.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="Organization.text">
<path value="Organization.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="Organization.contained">
<path value="Organization.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="Organization.extension">
<path value="Organization.extension"/>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Organization.modifierExtension">
<path value="Organization.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="Organization.identifier">
<path value="Organization.identifier"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="system"/>
</discriminator>
<description value="Require specific types of identifiers."/>
<rules value="open"/>
</slicing>
<short
value="Manufacturing Site Unique Identifier | Testing Site Unique Identifier"/>
<definition
value="Manufacturing Site Unique Identifier: A unique identifier assigned to the establishment (facility) which manufactures, prepares, propagates, compounds or processes drugs. [Source: Adapted from FDA Drug Establishment Current Registration Site]
Testing Site Unique Identifier: A unique identifier assigned to the establishment (facility) which performs the testing. [Source: SME Defined]"/>
<requirements
value="Organizations are known by a variety of ids. Some institutions maintain several, and most collect identifiers for exchange with other organizations concerning the organization."/>
<min value="1"/>
<max value="*"/>
<base>
<path value="Organization.identifier"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Identifier"/>
</type>
<condition value="org-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"/>
<mapping>
<identity value="w5"/>
<map value="FiveWs.identifier"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="XON.10 / XON.3"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".scopes[Role](classCode=IDENT)"/>
</mapping>
<mapping>
<identity value="interface"/>
<map value="Participant.identifier"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./Identifiers"/>
</mapping>
</element>
<element id="Organization.identifier.id">
<path value="Organization.identifier.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="Organization.identifier.extension">
<path value="Organization.identifier.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="Organization.identifier.use">
<path value="Organization.identifier.use"/>
<short value="usual | official | temp | secondary | old (If known)"/>
<definition value="The purpose of this identifier."/>
<comment
value="Applications can assume that an identifier is permanent unless it explicitly says that it is temporary."/>
<requirements
value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.use"/>
<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="true"/>
<isModifierReason
value="This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one."/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="IdentifierUse"/>
</extension>
<strength value="required"/>
<description
value="Identifies the purpose for this identifier, if known ."/>
<valueSet value="http://hl7.org/fhir/ValueSet/identifier-use|5.0.0"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Role.code or implied by context"/>
</mapping>
</element>
<element id="Organization.identifier.type">
<path value="Organization.identifier.type"/>
<short
value="Manufacturing Site Unique Identifier Type | Testing Site Unique Identifier Type"/>
<definition
value="A value that identifies the source of the unique identifier. [Source: SME Defined]
Examples: Data Universal Number System (DUNS), Facility Establishment Identifiers (FEI), etc."/>
<comment
value="This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type."/>
<requirements
value="Allows users to make use of identifiers when the identifier system is not known."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.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>
<strength value="required"/>
<valueSet
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-org-identifier-type-terminology"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="CX.5"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Role.code or implied by context"/>
</mapping>
</element>
<element id="Organization.identifier.system">
<path value="Organization.identifier.system"/>
<short value="The namespace for the identifier value"/>
<definition
value="Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique."/>
<comment value="Identifier.system is always case sensitive."/>
<requirements
value="There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Identifier.system"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="uri"/>
</type>
<example>
<label value="General"/>
<valueUri value="http://www.acme.com/identifiers/patient"/>
</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="v2"/>
<map value="CX.4 / EI-2-4"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="II.root or Role.id.root"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./IdentifierType"/>
</mapping>
</element>
<element id="Organization.identifier.value">
<path value="Organization.identifier.value"/>
<short value="The value that is unique"/>
<definition
value="The portion of the identifier typically relevant to the user and which is unique within the context of the system."/>
<comment
value="If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Identifier.value"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<example>
<label value="General"/>
<valueString value="123456"/>
</example>
<condition value="ident-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"/>
<mapping>
<identity value="v2"/>
<map value="CX.1 / EI.1"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./Value"/>
</mapping>
</element>
<element id="Organization.identifier.period">
<path value="Organization.identifier.period"/>
<short value="Time period when id is/was valid for use"/>
<definition
value="Time period during which identifier is/was valid for use."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.period"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Period"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="CX.7 + CX.8"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Role.effectiveTime or implied by context"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./StartDate and ./EndDate"/>
</mapping>
</element>
<element id="Organization.identifier.assigner">
<path value="Organization.identifier.assigner"/>
<short value="Organization that issued id (may be just text)"/>
<definition value="Organization that issued/manages the identifier."/>
<comment
value="The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.assigner"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="CX.4 / (CX.4,CX.9,CX.10)"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./IdentifierIssuingAuthority"/>
</mapping>
</element>
<element id="Organization.identifier:DUNSNumber">
<path value="Organization.identifier"/>
<sliceName value="DUNSNumber"/>
<short value="Identifies this organization across multiple systems"/>
<definition
value="Identifier for the organization that is used to identify the organization across multiple disparate systems."/>
<requirements
value="Organizations are known by a variety of ids. Some institutions maintain several, and most collect identifiers for exchange with other organizations concerning the organization."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Organization.identifier"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Identifier"/>
</type>
<condition value="org-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>
<constraint>
<key value="org-length9"/>
<severity value="error"/>
<human value="Identifier number is 9 digits"/>
<expression
value="system = 'urn:oid:1.3.6.1.4.1.519.1' implies value.length() = 9"/>
<source
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="w5"/>
<map value="FiveWs.identifier"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="XON.10 / XON.3"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".scopes[Role](classCode=IDENT)"/>
</mapping>
<mapping>
<identity value="interface"/>
<map value="Participant.identifier"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./Identifiers"/>
</mapping>
</element>
<element id="Organization.identifier:DUNSNumber.id">
<path value="Organization.identifier.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="Organization.identifier:DUNSNumber.extension">
<path value="Organization.identifier.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="Organization.identifier:DUNSNumber.use">
<path value="Organization.identifier.use"/>
<short value="usual | official | temp | secondary | old (If known)"/>
<definition value="The purpose of this identifier."/>
<comment
value="Applications can assume that an identifier is permanent unless it explicitly says that it is temporary."/>
<requirements
value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.use"/>
<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="true"/>
<isModifierReason
value="This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one."/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="IdentifierUse"/>
</extension>
<strength value="required"/>
<description
value="Identifies the purpose for this identifier, if known ."/>
<valueSet value="http://hl7.org/fhir/ValueSet/identifier-use|5.0.0"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Role.code or implied by context"/>
</mapping>
</element>
<element id="Organization.identifier:DUNSNumber.type">
<path value="Organization.identifier.type"/>
<short value="Description of identifier"/>
<definition
value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose."/>
<comment
value="This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type."/>
<requirements
value="Allows users to make use of identifiers when the identifier system is not known."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.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>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="IdentifierType"/>
</extension>
<strength value="extensible"/>
<description
value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose."/>
<valueSet value="http://hl7.org/fhir/ValueSet/identifier-type"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="CX.5"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Role.code or implied by context"/>
</mapping>
</element>
<element id="Organization.identifier:DUNSNumber.system">
<path value="Organization.identifier.system"/>
<short value="The namespace for the identifier value"/>
<definition
value="Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique."/>
<comment value="Identifier.system is always case sensitive."/>
<requirements
value="There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.system"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="uri"/>
</type>
<patternUri value="urn:oid:1.3.6.1.4.1.519.1"/>
<example>
<label value="General"/>
<valueUri value="http://www.acme.com/identifiers/patient"/>
</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="CX.4 / EI-2-4"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="II.root or Role.id.root"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./IdentifierType"/>
</mapping>
</element>
<element id="Organization.identifier:DUNSNumber.value">
<path value="Organization.identifier.value"/>
<short value="The value that is unique"/>
<definition
value="The portion of the identifier typically relevant to the user and which is unique within the context of the system."/>
<comment
value="If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.value"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<example>
<label value="General"/>
<valueString value="123456"/>
</example>
<condition value="ident-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>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="CX.1 / EI.1"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./Value"/>
</mapping>
</element>
<element id="Organization.identifier:DUNSNumber.period">
<path value="Organization.identifier.period"/>
<short value="Time period when id is/was valid for use"/>
<definition
value="Time period during which identifier is/was valid for use."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.period"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Period"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="CX.7 + CX.8"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Role.effectiveTime or implied by context"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./StartDate and ./EndDate"/>
</mapping>
</element>
<element id="Organization.identifier:DUNSNumber.assigner">
<path value="Organization.identifier.assigner"/>
<short value="Organization that issued id (may be just text)"/>
<definition value="Organization that issued/manages the identifier."/>
<comment
value="The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.assigner"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="CX.4 / (CX.4,CX.9,CX.10)"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./IdentifierIssuingAuthority"/>
</mapping>
</element>
<element id="Organization.identifier:FEINumber">
<path value="Organization.identifier"/>
<sliceName value="FEINumber"/>
<short value="Identifies this organization across multiple systems"/>
<definition
value="Identifier for the organization that is used to identify the organization across multiple disparate systems."/>
<requirements
value="Organizations are known by a variety of ids. Some institutions maintain several, and most collect identifiers for exchange with other organizations concerning the organization."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Organization.identifier"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Identifier"/>
</type>
<condition value="org-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>
<constraint>
<key value="org-length7"/>
<severity value="error"/>
<human value="Identifier number is 7 or 10 digits"/>
<expression
value="system = 'urn:oid:2.16.840.1.113883.4.82' implies value.length() = 7 or value.length() = 10"/>
<source
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="w5"/>
<map value="FiveWs.identifier"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="XON.10 / XON.3"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".scopes[Role](classCode=IDENT)"/>
</mapping>
<mapping>
<identity value="interface"/>
<map value="Participant.identifier"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./Identifiers"/>
</mapping>
</element>
<element id="Organization.identifier:FEINumber.id">
<path value="Organization.identifier.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="Organization.identifier:FEINumber.extension">
<path value="Organization.identifier.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="Organization.identifier:FEINumber.use">
<path value="Organization.identifier.use"/>
<short value="usual | official | temp | secondary | old (If known)"/>
<definition value="The purpose of this identifier."/>
<comment
value="Applications can assume that an identifier is permanent unless it explicitly says that it is temporary."/>
<requirements
value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.use"/>
<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="true"/>
<isModifierReason
value="This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one."/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="IdentifierUse"/>
</extension>
<strength value="required"/>
<description
value="Identifies the purpose for this identifier, if known ."/>
<valueSet value="http://hl7.org/fhir/ValueSet/identifier-use|5.0.0"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Role.code or implied by context"/>
</mapping>
</element>
<element id="Organization.identifier:FEINumber.type">
<path value="Organization.identifier.type"/>
<short value="Description of identifier"/>
<definition
value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose."/>
<comment
value="This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type."/>
<requirements
value="Allows users to make use of identifiers when the identifier system is not known."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.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>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="IdentifierType"/>
</extension>
<strength value="extensible"/>
<description
value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose."/>
<valueSet value="http://hl7.org/fhir/ValueSet/identifier-type"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="CX.5"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Role.code or implied by context"/>
</mapping>
</element>
<element id="Organization.identifier:FEINumber.system">
<path value="Organization.identifier.system"/>
<short value="The namespace for the identifier value"/>
<definition
value="Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique."/>
<comment value="Identifier.system is always case sensitive."/>
<requirements
value="There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.system"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="uri"/>
</type>
<patternUri value="urn:oid:2.16.840.1.113883.4.82"/>
<example>
<label value="General"/>
<valueUri value="http://www.acme.com/identifiers/patient"/>
</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="CX.4 / EI-2-4"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="II.root or Role.id.root"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./IdentifierType"/>
</mapping>
</element>
<element id="Organization.identifier:FEINumber.value">
<path value="Organization.identifier.value"/>
<short value="The value that is unique"/>
<definition
value="The portion of the identifier typically relevant to the user and which is unique within the context of the system."/>
<comment
value="If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.value"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<example>
<label value="General"/>
<valueString value="123456"/>
</example>
<condition value="ident-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>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="CX.1 / EI.1"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./Value"/>
</mapping>
</element>
<element id="Organization.identifier:FEINumber.period">
<path value="Organization.identifier.period"/>
<short value="Time period when id is/was valid for use"/>
<definition
value="Time period during which identifier is/was valid for use."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.period"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Period"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="CX.7 + CX.8"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Role.effectiveTime or implied by context"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./StartDate and ./EndDate"/>
</mapping>
</element>
<element id="Organization.identifier:FEINumber.assigner">
<path value="Organization.identifier.assigner"/>
<short value="Organization that issued id (may be just text)"/>
<definition value="Organization that issued/manages the identifier."/>
<comment
value="The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.assigner"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="CX.4 / (CX.4,CX.9,CX.10)"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./IdentifierIssuingAuthority"/>
</mapping>
</element>
<element id="Organization.active">
<path value="Organization.active"/>
<short
value="Whether the organization's record is still in active use"/>
<definition
value="Whether the organization's record is still in active use."/>
<comment
value="This active flag is not intended to be used to mark an organization as temporarily closed or under construction. Instead the Location(s) within the Organization should have the suspended status. If further details of the reason for the suspension are required, then an extension on this element should be used.
This element is labeled as a modifier because it may be used to mark that the resource was created in error."/>
<requirements
value="Need a flag to indicate a record is no longer to be used and should generally be hidden for the user in the UI."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Organization.active"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="boolean"/>
</type>
<meaningWhenMissing
value="This resource is generally assumed to be active if no value is provided for the active element"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="true"/>
<isModifierReason
value="This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid"/>
<isSummary value="true"/>
<mapping>
<identity value="w5"/>
<map value="FiveWs.status"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="No equivalent in HL7 V2"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".status"/>
</mapping>
<mapping>
<identity value="interface"/>
<map value="Participant.active"/>
</mapping>
<mapping>
<identity value="servd"/>
<map
value="./Status (however this concept in ServD more covers why the organization is active or not, could be delisted, deregistered, not operational yet) this could alternatively be derived from ./StartDate and ./EndDate and given a context date."/>
</mapping>
</element>
<element id="Organization.type">
<path value="Organization.type"/>
<short value="Kind of organization"/>
<definition value="The kind(s) of organization that this is."/>
<comment
value="Organizations can be corporations, wards, sections, clinical teams, government departments, etc. Note that code is generally a classifier of the type of organization; in many applications, codes are used to identity a particular organization (say, ward) as opposed to another of the same type - these are identifiers, not codes
When considering if multiple types are appropriate, you should evaluate if child organizations would be a more appropriate use of the concept, as different types likely are in different sub-areas of the organization. This is most likely to be used where type values have orthogonal values, such as a religious, academic and medical center.
We expect that some jurisdictions will profile this optionality to be a single cardinality."/>
<requirements
value="Need to be able to track the kind of organization that this is - different organization types have different uses."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Organization.type"/>
<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="OrganizationType"/>
</extension>
<strength value="example"/>
<description value="Used to categorize the organization."/>
<valueSet value="http://hl7.org/fhir/ValueSet/organization-type"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.class"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="No equivalent in v2"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".code"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Organization.name">
<path value="Organization.name"/>
<short value="Manufacturing Site Name | Testing Site Name"/>
<definition
value="Manufacturing Site Name: The name of the establishment (facilities) which manufacture, prepare, propagate, compound, process or package drugs that are commercially distributed in the U.S. or offered for import to the U.S[Source: Adapted from FDA Drug Establishment Current Registration Site]
Testing Site Name: The name of the establishment (facility) which tests the raw materials, intermediates, drug substance, drug product, packaging components. [Source: SME Defined]"/>
<comment
value="If the name of an organization changes, consider putting the old name in the alias column so that it can still be located through searches."/>
<requirements
value="Need to use the name as the label of the organization."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Organization.name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<condition value="org-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"/>
<mapping>
<identity value="v2"/>
<map value="XON.1"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".name"/>
</mapping>
<mapping>
<identity value="interface"/>
<map value="Participant.name"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value=".PreferredName/Name"/>
</mapping>
</element>
<element id="Organization.alias">
<path value="Organization.alias"/>
<short
value="A list of alternate names that the organization is known as, or was known as in the past"/>
<definition
value="A list of alternate names that the organization is known as, or was known as in the past."/>
<comment
value="There are no dates associated with the alias/historic names, as this is not intended to track when names were used, but to assist in searching so that older names can still result in identifying the organization."/>
<requirements
value="Over time locations and organizations go through many changes and can be known by different names.
For searching knowing previous names that the organization was known by can be very useful."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Organization.alias"/>
<min value="0"/>
<max value="*"/>
</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=".name"/>
</mapping>
</element>
<element id="Organization.description">
<path value="Organization.description"/>
<short
value="Additional details about the Organization that could be displayed as further information to identify the Organization beyond its name"/>
<definition
value="Description of the organization, which helps provide additional general context on the organization to ensure that the correct organization is selected."/>
<requirements
value="Humans need additional information to verify a correct Organization has been selected."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Organization.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="rim"/>
<map
value=".playingEntity[classCode=PLC determinerCode=INSTANCE].desc"/>
</mapping>
</element>
<element id="Organization.contact">
<path value="Organization.contact"/>
<short value="Official contact details for the Organization"/>
<definition
value="The contact details of communication devices available relevant to the specific Organization. This can include addresses, phone numbers, fax numbers, mobile numbers, email addresses and web sites."/>
<comment
value="The address/telecom use code 'home' are not to be used. Note that these contacts are not the contact details of people who provide the service (that would be through PractitionerRole), these are official contacts for the Organization itself for specific purposes. E.g. Mailing Addresses, Billing Addresses, Contact numbers for Booking or Billing Enquiries, general web address, web address for online bookings etc."/>
<requirements
value="Need to keep track of assigned contact points within bigger organization."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Organization.contact"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="ExtendedContactDetail"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR 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="org-3"/>
<severity value="error"/>
<human
value="The telecom of an organization can never be of use 'home'"/>
<expression value="telecom.where(use = 'home').empty()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Organization"/>
</constraint>
<constraint>
<key value="org-4"/>
<severity value="error"/>
<human
value="The address of an organization can never be of use 'home'"/>
<expression value="address.where(use = 'home').empty()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Organization"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value=".contactParty"/>
</mapping>
</element>
<element id="Organization.contact.id">
<path value="Organization.contact.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="Organization.contact.extension">
<path value="Organization.contact.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="Organization.contact.purpose">
<path value="Organization.contact.purpose"/>
<short value="The type of contact"/>
<definition value="The purpose/type of contact."/>
<comment
value="If no purpose is defined, then these contact details may be used for any purpose."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ExtendedContactDetail.purpose"/>
<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>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="Purpose"/>
</extension>
<strength value="preferred"/>
<description
value="The purpose for which an extended contact detail should be used."/>
<valueSet
value="http://terminology.hl7.org/ValueSet/contactentity-type"/>
</binding>
</element>
<element id="Organization.contact.name">
<path value="Organization.contact.name"/>
<short value="Name of an individual to contact"/>
<definition
value="The name of an individual to contact, some types of contact detail are usually blank."/>
<comment
value="If there is no named individual, the telecom/address information is not generally monitored by a specific individual."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ExtendedContactDetail.name"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="HumanName"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR 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="Organization.contact.telecom">
<path value="Organization.contact.telecom"/>
<short value="Contact details (e.g.phone/fax/url)"/>
<definition
value="The contact details application for the purpose defined."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ExtendedContactDetail.telecom"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="ContactPoint"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR 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="Organization.contact.address">
<path value="Organization.contact.address"/>
<short
value="Manufacturing Site Physical Address | Testing Site Address"/>
<definition
value="Manufacturing Site Physical Address: The complete address for the supplier [Source: SME Defined]
Testing Site Address: The complete address for the testing site. [Source: SME defined]"/>
<comment
value="Note: address is intended to describe postal addresses for administrative purposes, not to describe absolute geographical coordinates. Postal addresses are often used as proxies for physical locations (also see the [Location](location.html#) resource)."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ExtendedContactDetail.address"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Address"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-cmc-address"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR 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="addr-state"/>
<severity value="error"/>
<human
value="If the country is USA, then the state and postal code exist"/>
<expression
value="country = 'USA' implies (state.exists() and state.length() = 2 and postalCode.exists())"/>
<source
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-cmc-address"/>
</constraint>
<constraint>
<key value="addr-zip"/>
<severity value="error"/>
<human
value="If the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers"/>
<expression
value="country = 'USA' implies postalCode.matches('^[0-9]{5}(-[0-9]{4})?$')"/>
<source
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-cmc-address"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a,AD"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="XAD"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="Address"/>
</mapping>
</element>
<element id="Organization.contact.organization">
<path value="Organization.contact.organization"/>
<short
value="This contact detail is handled/monitored by a specific organization"/>
<definition
value="This contact detail is handled/monitored by a specific organization. If the name is provided in the contact, then it is referring to the named individual within this organization."/>
<requirements
value="Some specific types of contact information can be an handled by an organization (eg legal council is via a specific firm)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ExtendedContactDetail.organization"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="Organization.contact.period">
<path value="Organization.contact.period"/>
<short value="Period that this contact was valid for usage"/>
<definition value="Period that this contact was valid for usage."/>
<comment
value="If the details have multiple periods, then enter in a new ExtendedContact with the new period."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ExtendedContactDetail.period"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Period"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="Organization.partOf">
<path value="Organization.partOf"/>
<short
value="The organization of which this organization forms a part"/>
<definition
value="The organization of which this organization forms a part."/>
<requirements
value="Need to be able to track the hierarchy of organizations within an organization."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Organization.partOf"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-hierarchy">
<valueBoolean value="true"/>
</extension>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="No equivalent in HL7 V2"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".playedBy[classCode=Part].scoper"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Organization.endpoint">
<path value="Organization.endpoint"/>
<short
value="Technical endpoints providing access to services operated for the organization"/>
<definition
value="Technical endpoints providing access to services operated for the organization."/>
<requirements
value="Organizations have multiple systems that provide various services and need to be able to define the technical connection details for how to connect to them, and for what purpose."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Organization.endpoint"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Endpoint"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must 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="Organization.qualification">
<path value="Organization.qualification"/>
<short
value="Qualifications, certifications, accreditations, licenses, training, etc. pertaining to the provision of care"/>
<definition
value="The official certifications, accreditations, training, designations and licenses that authorize and/or otherwise endorse the provision of care by the organization.
For example, an approval to provide a type of services issued by a certifying body (such as the US Joint Commission) to an organization."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Organization.qualification"/>
<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="v2"/>
<map value="CER?"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Organization.qualification.id">
<path value="Organization.qualification.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="Organization.qualification.extension">
<path value="Organization.qualification.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="Organization.qualification.modifierExtension">
<path value="Organization.qualification.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="Organization.qualification.identifier">
<path value="Organization.qualification.identifier"/>
<short
value="An identifier for this qualification for the organization"/>
<definition
value="An identifier allocated to this qualification for this organization."/>
<requirements
value="Often, specific identities are assigned for the qualification by the assigning organization."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Organization.qualification.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="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Organization.qualification.code">
<path value="Organization.qualification.code"/>
<short value="Coded representation of the qualification"/>
<definition value="Coded representation of the qualification."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Organization.qualification.code"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="Qualification"/>
</extension>
<strength value="example"/>
<description
value="Specific qualification the organization has to provide a service."/>
</binding>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Organization.qualification.period">
<path value="Organization.qualification.period"/>
<short value="Period during which the qualification is valid"/>
<definition value="Period during which the qualification is valid."/>
<requirements
value="Qualifications are often for a limited period of time, and can be revoked."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Organization.qualification.period"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Period"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Organization.qualification.issuer">
<path value="Organization.qualification.issuer"/>
<short
value="Organization that regulates and issues the qualification"/>
<definition
value="Organization that regulates and issues the qualification."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Organization.qualification.issuer"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
</snapshot>
<differential>
<element id="Organization.meta.profile">
<path value="Organization.meta.profile"/>
<min value="1"/>
<max value="1"/>
<mustSupport value="true"/>
</element>
<element id="Organization.identifier">
<path value="Organization.identifier"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="system"/>
</discriminator>
<description value="Require specific types of identifiers."/>
<rules value="open"/>
</slicing>
<short
value="Manufacturing Site Unique Identifier | Testing Site Unique Identifier"/>
<definition
value="Manufacturing Site Unique Identifier: A unique identifier assigned to the establishment (facility) which manufactures, prepares, propagates, compounds or processes drugs. [Source: Adapted from FDA Drug Establishment Current Registration Site]
Testing Site Unique Identifier: A unique identifier assigned to the establishment (facility) which performs the testing. [Source: SME Defined]"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="Organization.identifier.type">
<path value="Organization.identifier.type"/>
<short
value="Manufacturing Site Unique Identifier Type | Testing Site Unique Identifier Type"/>
<definition
value="A value that identifies the source of the unique identifier. [Source: SME Defined]
Examples: Data Universal Number System (DUNS), Facility Establishment Identifiers (FEI), etc."/>
<mustSupport value="true"/>
<binding>
<strength value="required"/>
<valueSet
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-org-identifier-type-terminology"/>
</binding>
</element>
<element id="Organization.identifier.system">
<path value="Organization.identifier.system"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="Organization.identifier.value">
<path value="Organization.identifier.value"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="Organization.identifier:DUNSNumber">
<path value="Organization.identifier"/>
<sliceName value="DUNSNumber"/>
<min value="0"/>
<max value="1"/>
<constraint>
<key value="org-length9"/>
<severity value="error"/>
<human value="Identifier number is 9 digits"/>
<expression
value="system = 'urn:oid:1.3.6.1.4.1.519.1' implies value.length() = 9"/>
<source
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization"/>
</constraint>
<mustSupport value="true"/>
</element>
<element id="Organization.identifier:DUNSNumber.system">
<path value="Organization.identifier.system"/>
<patternUri value="urn:oid:1.3.6.1.4.1.519.1"/>
</element>
<element id="Organization.identifier:FEINumber">
<path value="Organization.identifier"/>
<sliceName value="FEINumber"/>
<min value="0"/>
<max value="1"/>
<constraint>
<key value="org-length7"/>
<severity value="error"/>
<human value="Identifier number is 7 or 10 digits"/>
<expression
value="system = 'urn:oid:2.16.840.1.113883.4.82' implies value.length() = 7 or value.length() = 10"/>
<source
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization"/>
</constraint>
<mustSupport value="true"/>
</element>
<element id="Organization.identifier:FEINumber.system">
<path value="Organization.identifier.system"/>
<patternUri value="urn:oid:2.16.840.1.113883.4.82"/>
</element>
<element id="Organization.name">
<path value="Organization.name"/>
<short value="Manufacturing Site Name | Testing Site Name"/>
<definition
value="Manufacturing Site Name: The name of the establishment (facilities) which manufacture, prepare, propagate, compound, process or package drugs that are commercially distributed in the U.S. or offered for import to the U.S[Source: Adapted from FDA Drug Establishment Current Registration Site]
Testing Site Name: The name of the establishment (facility) which tests the raw materials, intermediates, drug substance, drug product, packaging components. [Source: SME Defined]"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="Organization.contact">
<path value="Organization.contact"/>
<min value="1"/>
<max value="1"/>
</element>
<element id="Organization.contact.address">
<path value="Organization.contact.address"/>
<short
value="Manufacturing Site Physical Address | Testing Site Address"/>
<definition
value="Manufacturing Site Physical Address: The complete address for the supplier [Source: SME Defined]
Testing Site Address: The complete address for the testing site. [Source: SME defined]"/>
<min value="1"/>
<type>
<code value="Address"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-cmc-address"/>
</type>
<mustSupport value="true"/>
</element>
</differential>
</StructureDefinition>
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#0.1.20 based on FHIR 5.0.0. Generated 2024-03-04
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