| Package | hl7.fhir.us.pq-cmc-fda |
| Type | StructureDefinition |
| Id | Id |
| FHIR Version | R5 |
| Source | http://hl7.org/fhir/us/pq-cmc-fda/https://build.fhir.org/ig/HL7/FHIR-us-pq-cmc-fda/StructureDefinition-pqcmc-quality-specification.html |
| Url | http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification |
| Version | 1.1.6 |
| Status | active |
| Date | 2024-09-17T03:56:09+00:00 |
| Name | QualitySpecification |
| Title | Quality Specification |
| Experimental | False |
| Realm | us |
| Authority | hl7 |
| Description | A quality specification is for a drug product or drug substance (excipient, API or raw material). |
| Type | PlanDefinition |
| Kind | resource |
| StructureDefinition | |
cmc-ectd-document-32s23  | CMC eCTD 32S23 Document |
| cmc-ectd-document-sp4151 | CMC eCTD SP4151 Document |
| ectd-composition-32s23 | eCTD Substance Control of Materials Composition |
| ectd-composition-sp4151 | eCTD Specification Composition |
| StructureDefinition | |
| pq-additional-info-extension | Additional Information |
| pq-hierarchical-level-extension | Hierarchical Level |
| pq-specification-status-extension | Specification Status |
| pq-target-range | Target Range |
| pqcmc-drug-product-handle | Drug Product Handle |
| pqcmc-excipient | Excipient Drug Substance |
| pqcmc-routine-drug-substance | Drug Substance Handle |
| http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-type-terminology | Specification Type Terminology |
| http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology | Test Category Terminology |
| http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-method-origin-terminology | Test Method Origin Terminology |
| http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-usage-terminology | Test Usage Terminology |
| http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure | Units Of Measure |
Note: links and images are rebased to the (stated) source
Generated Narrative: StructureDefinition pqcmc-quality-specification
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  PlanDefinition | PlanDefinition | |||
  meta | ||||
  profile | S | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to |
 Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |
  ApprovalStatus | S | 1..1 | CodeableConcept | Specification Status URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension Binding: Specification Status Terminology (required) |
 spec-additional-info | 0..1 | markdown | Specification Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension | |
| identifier | S | 0..* | Identifier | Additional identifier for the plan definition |
| version | S | 1..1 | string | Specification Version |
| title | S | 1..1 | string | Specification Title |
| subtitle | S | 0..1 | string | Specification Subtitle |
| type | S | 1..1 | CodeableConcept | Specification Type |
 Slices for coding | S | 2..2 | Coding | Code defined by a terminology system Slice: Unordered, Closed by value:$this |
 coding:DefinitionType | S | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following |
   system | 1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/plan-definition-type | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: workflow-definition | |
 display | 1..1 | string | Representation defined by the system Fixed Value: Workflow Definition | |
| coding:SpecType | S | 1..1 | Coding | Specification Type Binding: Specification Type Terminology (required) |
| status | S | 1..1 | code | draft | active | retired | unknown |
 subject[x] | S | 1..1 | Reference(Drug Product Handle | Drug Substance Handle | Excipient Drug Substance) | Type of individual the plan definition is focused on |
| date | S | 1..1 | dateTime | Specification Version Date |
| approvalDate | S | 0..1 | date | Specification Status Date |
| goal | S | 0..* | BackboneElement | Acceptance Criteria |
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| ac-additional-info | 0..1 | markdown | Acceptance Criteria Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension | |
| description | S | 1..1 | CodeableConcept | Original Text |
| addresses | S | 1..* | CodeableConcept | What does the goal address |
| coding | ||||
| code | S | 1..1 | code | Acceptance Criteria Usage Binding: Test Usage Terminology (required) |
| text | 0..1 | string | Accpetance Criteria Usage | |
| target | SC | 1..* | BackboneElement | Acceptance Criteron cmc-target-range: When the Range extension is present, detail cannot be present. |
 Slices for modifierExtension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| modifierExtension:targetRange | S | 0..1 | TargetRange | Target Range |
| measure | ||||
| text | S | 0..1 | string | Detailed parameter being measured if more granular than Sub-Test |
| Slices for detail[x] | S | 0..1 | The target value to be achieved Slice: Unordered, Open by type:$this | |
 detailQuantity | Quantity | |||
 detailString | string | |||
| detailInteger | integer | |||
| detail[x]:detailQuantity | S | 0..1 | Quantity | ValueNumeric Binding: Units Of Measure (required) |
| value | S | 1..1 | decimal | Numerical value (with implicit precision) |
| comparator | S | 0..1 | code | < | <= | >= | > | ad - how to understand the value |
| unit | S | 1..1 | string | Unit representation |
| code | S | 1..1 | code | Coded form of the unit |
| detail[x]:detailString | S | 0..1 | string | Value |
| detail[x]:detailInteger | S | 0..1 | integer | Number of Replicates |
| due | 0..0 | |||
| action | SC | 1..* | BackboneElement | Method cmc-link-required: Action linkId is required for alternate tests cmc-single-or-multistage: if a test is multi-stage, the test can't have a prefix and its stages must have a name and can't be named 'Single Stage' and must be unique. If it's single stage its prefix is 'Single Stage' and its groups can't have prefixes |
| linkId | S | 0..1 | string | only required for alternate tests |
| prefix | S | 0..1 | string | Stage Name |
| title | S | 1..1 | string | Test Name |
| description | S | 0..1 | markdown | Test Additional Information |
| code | S | 1..1 | CodeableConcept | Test Method Origin |
| coding | ||||
| code | S | 1..1 | code | Symbol in syntax defined by the system Binding: Test Method Origin Terminology (required) |
| text | S | 1..1 | string | Analytical Procedure |
| reason | S | 1..2 | CodeableConcept | Test Category | Test Subcategory |
| extension | 1..* | Extension | Extension | |
| Slices for extension | Content/Rules for all slices | |||
| categoryLevel | S | 1..1 | integer | Hierarchical Level URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension |
| coding | S | 0..* | Coding | Code defined by a terminology system Binding: Test Category Terminology (required) |
| code | S | 1..1 | code | Symbol in syntax defined by the system |
| display | 1..1 | string | Representation defined by the system | |
| documentation | S | 0..1 | RelatedArtifact | Supporting documentation for the intended performer of the action |
| type | 1..1 | code | documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as Required Pattern: documentation | |
| label | S | 1..1 | string | Reference to Procedure |
| goalId | S | 0..* | id | Reference to Acceptance Criteria |
| relatedAction | S | 0..* | BackboneElement | Alternate Test |
| targetId | S | 1..1 | id | What action is this related to |
| relationship | S | 1..1 | code | Code is concurrent Required Pattern: concurrent |
| action | S | 0..* | BackboneElement | Groups or Stages |
| prefix | S | 0..1 | string | Stage Name |
| title | S | 0..1 | string | Test Name (only reqired if different than above) |
| description | S | 0..1 | markdown | Test Additional Information | Stage Additional Information |
| documentation | S | 0..* | RelatedArtifact | Supporting documentation for the intended performer of the action |
| type | 1..1 | code | documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as Required Pattern: documentation | |
| document | S | 1..1 | Attachment | Test or Stage Additional Information Visual Attachments |
| contentType | S | 1..1 | code | Mime type of the content, with charset etc. |
| data | S | 1..1 | base64Binary | Data inline, base64ed |
| title | S | 1..1 | string | Document file name including the file extension |
| goalId | S | 0..* | id | Reference to Acceptance Criteria |
| action | SC | 0..* | BackboneElement | Sub-Test cmc-subtest-rrt: a subtest's prefix represents relative retention time, should it exist |
| prefix | S | 0..1 | string | RRT |
| title | S | 1..1 | string | Test Name | RRT (complex testing) |
| description | S | 0..1 | markdown | Test Additional Information | Stage Additional Information |
| goalId | S | 1..* | id | Reference to Acceptance Criteria |
| Documentation for this format | ||||
FHIR{
"resourceType" : "StructureDefinition",
"id" : "pqcmc-quality-specification",
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: StructureDefinition pqcmc-quality-specification</b></p><a name=\"pqcmc-quality-specification\"> </a><a name=\"hcpqcmc-quality-specification\"> </a><a name=\"pqcmc-quality-specification-en-US\"> </a><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;\"><tr style=\"border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top\"><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"The logical name of the element\">Name</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Information about the use of the element\">Flags</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Minimum and Maximum # of times the element can appear in the instance\">Card.</a></th><th style=\"width: 100px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Reference to the type of the element\">Type</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Additional information about the element\">Description & Constraints</a><span style=\"float: right\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\"/></a></span></th></tr><tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_resource.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Resource\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition\">PlanDefinition</a><a name=\"PlanDefinition\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/plandefinition.html\">PlanDefinition</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.meta\">meta</a><a name=\"PlanDefinition.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>\r\n<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-pqcmc-quality-specification-definitions.html#PlanDefinition.meta.profile\">profile</a><a name=\"PlanDefinition.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\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/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>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_extension_simple.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Simple Extension\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.extension\">Slices for extension</a><a name=\"PlanDefinition.extension\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/extensibility.html#Extension\">Extension</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Extension</span><br/><span style=\"font-weight:bold\">Slice: </span>Unordered, Open by value:url</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.extension:ApprovalStatus\" title=\"Extension URL = http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension\">ApprovalStatus</a><a name=\"PlanDefinition.extension.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Specification Status</span><br/><span style=\"font-weight:bold\">URL: </span><a href=\"StructureDefinition-pq-specification-status-extension.html\">http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension</a><br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-specification-status-terminology.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-status-terminology\">Specification Status Terminology</a> (<a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\">required</a>)</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck124.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.extension:spec-additional-info\" title=\"Extension URL = http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension\">spec-additional-info</a><a name=\"PlanDefinition.extension.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#markdown\">markdown</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Specification Additional Information<br/><span style=\"font-weight:bold\">URL: </span><a href=\"StructureDefinition-pq-additional-info-extension.html\">http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension</a></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.identifier\">identifier</a><a name=\"PlanDefinition.identifier\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Identifier\">Identifier</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Additional identifier for the plan definition</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.version\" title=\"The alphanumeric text assigned by the sponsor to a particular edition of a specification. [Source: SME Defined] Examples: 2.1, 13.2, ST1, 00001, 00002, companyname-001.\nNote: This value should be unique across all specifications for a given material, not just those with the same name\">version</a><a name=\"PlanDefinition.version\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Specification Version</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.title\" title=\"The textual identification for the specification. [Source: SME Defined]\nExample: &lt;drug name> 75 mg chewable tablets\nNote: This may include the name of the drug substance, product or the raw material/excipients\">title</a><a name=\"PlanDefinition.title\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Specification Title</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.subtitle\" title=\"An additional textual identification for the specification [Source: SME Defined].\">subtitle</a><a name=\"PlanDefinition.subtitle\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Specification Subtitle</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.type\" title=\"A classification of specification related to the kind of entity it is referencing. [Source: SME Defined]\nExamples: Drug product, Drug substance. \">type</a><a name=\"PlanDefinition.type\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Specification Type</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck103.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Definition\" class=\"hierarchy\"/> <a style=\"font-style: italic\" href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.type.coding\">Slices for coding</a><a name=\"PlanDefinition.type.coding\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"font-style: italic\"/><span style=\"font-style: italic\">2</span><span style=\"font-style: italic\">..</span><span style=\"font-style: italic\">2</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; font-style: italic\" href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5; font-style: italic\">Code defined by a terminology system</span><br style=\"font-style: italic\"/><span style=\"font-weight:bold; font-style: italic\">Slice: </span><span style=\"font-style: italic\">Unordered, Closed by value:$this</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1035.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.type.coding:DefinitionType\" title=\"Slice DefinitionType\">coding:DefinitionType</a><a name=\"PlanDefinition.type.coding.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Code defined by a terminology system</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">At least the following</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10350.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system\">system</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#uri\">uri</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Identity of the terminology system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">http://terminology.hl7.org/CodeSystem/plan-definition-type</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10350.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Symbol in syntax defined by the system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">workflow-definition</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10340.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Representation defined by the system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">Workflow Definition</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1024.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.type.coding:SpecType\" title=\"Slice SpecType: A classification of specification related to the kind of the entity it is referencing.\">coding:SpecType</a><a name=\"PlanDefinition.type.coding.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Specification Type<br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-specification-type-terminology.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-type-terminology\">Specification Type Terminology</a> (<a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\">required</a>)</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.status\">status</a><a name=\"PlanDefinition.status\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">1</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">draft | active | retired | unknown</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_reference.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Reference to another Resource\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.subject[x]\">subject[x]</a><a name=\"PlanDefinition.subject_x_\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/references.html\">Reference</a>(<a href=\"StructureDefinition-pqcmc-drug-product-handle.html\">Drug Product Handle</a> | <a href=\"StructureDefinition-pqcmc-routine-drug-substance.html\">Drug Substance Handle</a> | <a href=\"StructureDefinition-pqcmc-excipient.html\">Excipient Drug Substance</a>)</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Type of individual the plan definition is focused on</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.date\" title=\"The date when the sponsor assigned a date to a specific version. [Source: SME Defined]\nNote: This is the date a particular version of the specification was internally accepted by the submitter.\">date</a><a name=\"PlanDefinition.date\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#dateTime\">dateTime</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Specification Version Date</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.approvalDate\" title=\"The date on which the FDA approval status for a specification became effective. [Source: SME Defined]\nNote: If the application is not yet approved, then this is the date of the current submission OR the date of the complete response (CR).\nNote: This is not the application approval status date.\">approvalDate</a><a name=\"PlanDefinition.approvalDate\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#date\">date</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Specification Status Date</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal\">goal</a><a name=\"PlanDefinition.goal\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Acceptance Criteria</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck113.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_extension_simple.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Simple Extension\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.extension\">Slices for extension</a><a name=\"PlanDefinition.goal.extension\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/extensibility.html#Extension\">Extension</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Extension</span><br/><span style=\"font-weight:bold\">Slice: </span>Unordered, Open by value:url</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1124.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.extension:ac-additional-info\" title=\"Extension URL = http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension\">ac-additional-info</a><a name=\"PlanDefinition.goal.extension.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#markdown\">markdown</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Acceptance Criteria Additional Information<br/><span style=\"font-weight:bold\">URL: </span><a href=\"StructureDefinition-pq-additional-info-extension.html\">http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension</a></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.description\" title=\"The text of the acceptance criteria as provided in the specification. [Source: SME Defined]\nExamples: White to off-white cake; 22.5 - 27.5 mg/ml Note: This is the text as it appears in the Specification.\">description</a><a name=\"PlanDefinition.goal.description\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">1</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Original Text</td></tr>\r\n<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_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.addresses\">addresses</a><a name=\"PlanDefinition.goal.addresses\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">What does the goal address</span></td></tr>\r\n<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_bck1111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.addresses.coding\">coding</a><a name=\"PlanDefinition.goal.addresses.coding\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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\"/></tr>\r\n<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_bck11100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.addresses.coding.code\" title=\"A coded value specifying when a particular analytical procedure or measurement is being performed on a substance or a product. [Source: SME Defined] Examples: Release, Stability.\nNote: The concept of 'In-Process' is subsumed by the Release code.\">code</a><a name=\"PlanDefinition.goal.addresses.coding.code\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Acceptance Criteria Usage<br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-test-usage-terminology.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-usage-terminology\">Test Usage Terminology</a> (<a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\">required</a>)</td></tr>\r\n<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_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.addresses.text\">text</a><a name=\"PlanDefinition.goal.addresses.text\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#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\">Accpetance Criteria Usage</td></tr>\r\n<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_bck101.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target\">target</a><a name=\"PlanDefinition.goal.target\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #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><a style=\"padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;\" href=\"http://hl7.org/fhir/R5/conformance-rules.html#constraints\" title=\"This element has or is affected by constraints ( cmc-target-range )\">C</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Acceptance Criteron<br/><span style=\"font-weight:bold\">cmc-target-range: </span>When the Range extension is present, detail cannot be present.</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1013.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_modifier_extension_simple.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Simple Extension\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.modifierExtension\">Slices for modifierExtension</a><a name=\"PlanDefinition.goal.target.modifierExtension\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/extensibility.html#Extension\">Extension</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Extension</span><br/><span style=\"font-weight:bold\">Slice: </span>Unordered, Open by value:url</td></tr>\r\n<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_bck10124.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.modifierExtension:targetRange\" title=\"Slice targetRange\">modifierExtension:targetRange</a><a name=\"PlanDefinition.goal.target.modifierExtension.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"StructureDefinition-pq-target-range.html\" title=\"Extension\">TargetRange</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\">Target Range</span></td></tr>\r\n<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_bck1011.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.measure\">measure</a><a name=\"PlanDefinition.goal.target.measure\"> </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\"/></tr>\r\n<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_bck10100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.measure.text\">text</a><a name=\"PlanDefinition.goal.target.measure.text\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Detailed parameter being measured if more granular than Sub-Test</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1013.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Definition\" class=\"hierarchy\"/> <a style=\"font-style: italic\" href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.detail[x]\">Slices for detail[x]</a><a name=\"PlanDefinition.goal.target.detail_x_\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"font-style: italic\"/><span style=\"opacity: 0.5; font-style: italic\">0</span><span style=\"opacity: 0.5; font-style: italic\">..</span><span style=\"opacity: 0.5; font-style: italic\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5; font-style: italic\">The target value to be achieved</span><br style=\"font-style: italic\"/><span style=\"font-weight:bold; font-style: italic\">Slice: </span><span style=\"font-style: italic\">Unordered, Open by type:$this</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10130.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_datatype.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <span title=\"Quantity Type: A measured amount (or an amount that can potentially be measured). Note that measured amounts include amounts that are not precisely quantified, including amounts involving arbitrary units and floating currencies.\">detailQuantity</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#Quantity\">Quantity</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10130.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_primitive.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <span title=\"string Type: A sequence of Unicode characters\">detailString</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10130.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_primitive.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <span title=\"integer Type: A whole number\">detailInteger</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#integer\">integer</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10135.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.detail[x]:detailQuantity\" title=\"Slice detailQuantity: The acceptable quantitative or numeric value for the result of the test. [Source: SME Defined]\">detail[x]:detailQuantity</a><a name=\"PlanDefinition.goal.target.detail_x_.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#Quantity\">Quantity</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">ValueNumeric<br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-units-of-measure.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure\">Units Of Measure</a> (<a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\">required</a>)</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101350.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.detail[x]:detailQuantity.value\">value</a><a name=\"PlanDefinition.goal.target.detail_x_.value\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#decimal\">decimal</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Numerical value (with implicit precision)</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101350.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.detail[x]:detailQuantity.comparator\">comparator</a><a name=\"PlanDefinition.goal.target.detail_x_.comparator\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">< | <= | >= | > | ad - how to understand the value</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101350.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.detail[x]:detailQuantity.unit\">unit</a><a name=\"PlanDefinition.goal.target.detail_x_.unit\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Unit representation</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101340.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.detail[x]:detailQuantity.code\">code</a><a name=\"PlanDefinition.goal.target.detail_x_.code\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Coded form of the unit</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10134.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.detail[x]:detailString\" title=\"Slice detailString: A textual description and/or a number that identifies a level within a sequential test. [Source: SME Defined] Examples – Single Stage, Stage 1, Stage 2 (sometimes referred to as L1, L2 L3 or A1, A2 as in USP &lt;711>)\nNote: A Stage may or may not provide a conditional sequence with associated acceptance criteria. [Source: SME Defined] (e.g., dissolution test, pyrogen test - USP &lt;151>; 21 CFR 610.13 (b) Test for pyrogenic substances)\">detail[x]:detailString</a><a name=\"PlanDefinition.goal.target.detail_x_.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Value</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10124.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.detail[x]:detailInteger\" title=\"Slice detailInteger: An identification number for a member of the set of results for a test, usually the sequence order in which the test was executed. Individual tests are executed on multiple samples to give greater validity to the findings. [Source SME Defined] \nExamples: Prepare six aliquots from the sample. Test 8 samples. If any fall above 110%, test an additional 7 samples. Record all replicate values as stated in the method.\">detail[x]:detailInteger</a><a name=\"PlanDefinition.goal.target.detail_x_.4\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#integer\">integer</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Number of Replicates</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <span style=\"text-decoration:line-through\">due</span><a name=\"PlanDefinition.goal.target.due\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"text-decoration:line-through\"/><span style=\"text-decoration:line-through\">0</span><span style=\"text-decoration:line-through\">..</span><span style=\"text-decoration:line-through\">0</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action\">action</a><a name=\"PlanDefinition.action\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span><a style=\"padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;\" href=\"http://hl7.org/fhir/R5/conformance-rules.html#constraints\" title=\"This element has or is affected by constraints ( cmc-link-required, cmc-single-or-multistage )\">C</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Method<br/><span style=\"font-weight:bold\">cmc-link-required: </span>Action linkId is required for alternate tests<br/><span style=\"font-weight:bold\">cmc-single-or-multistage: </span>if a test is multi-stage, the test can't have a prefix and its stages must have a name and can't be named 'Single Stage' and must be unique. If it's single stage its prefix is 'Single Stage' and its groups can't have prefixes</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.linkId\">linkId</a><a name=\"PlanDefinition.action.linkId\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">only required for alternate tests</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.prefix\" title=\"A textual description and/or a number that identifies a level within a sequential test. [Source: SME Defined] Examples – Single Stage, Stage 1, Stage 2 (sometimes referred to as L1, L2 L3 or A1, A2 as in USP &lt;711&gt;)\nNote: A Stage may or may not provide a conditional sequence with associated acceptance criteria. [Source: SME Defined] (e.g., dissolution test, pyrogen test - &lt;151&gt;; 21 CFR 610.13 (b) Test for pyrogenic substances)\n\nImplememtation Note: Value at this level is 'Single Stage'\">prefix</a><a name=\"PlanDefinition.action.prefix\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Stage Name</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.title\" title=\"The textual description of a procedure or analytical method. [Source: SME Defined]\nExamples: Assay by HPLC, moisture by Karl Fischer, analysis for impurities.\nNote: as defined by the sponsor\">title</a><a name=\"PlanDefinition.action.title\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Test Name</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.description\" title=\"Test Additional Information: Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined].\nIf there is more than one comment, include in this element. Markdown allows formating for clarity.\">description</a><a name=\"PlanDefinition.action.description\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#markdown\">markdown</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Test Additional Information</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck011.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.code\" title=\"A coded value specifying the source of the method. [Source: SME Defined] Example: Compendial\">code</a><a name=\"PlanDefinition.action.code\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Test Method Origin</td></tr>\r\n<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_bck0111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.code.coding\">coding</a><a name=\"PlanDefinition.action.code.coding\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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\"/></tr>\r\n<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_bck01100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.code.coding.code\">code</a><a name=\"PlanDefinition.action.code.coding.code\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Symbol in syntax defined by the system</span><br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-test-method-origin-terminology.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-method-origin-terminology\">Test Method Origin Terminology</a> (<a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\">required</a>)</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.code.text\" title=\"The name of the technique used to determine the nature of a characteristic. [Source: SME Defined].\">text</a><a name=\"PlanDefinition.action.code.text\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: 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\">Analytical Procedure</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck011.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.reason\" title=\"A high level grouping of quality attributes for products, substances, raw materials, excipients, intermediates and reagents. [Source: SME Defined] Examples: Assay, Biological Properties.\">reason</a><a name=\"PlanDefinition.action.reason\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #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..2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Test Category | Test Subcategory</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_extension_simple.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Simple Extension\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.reason.extension\">extension</a><a name=\"PlanDefinition.action.reason.extension\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/extensibility.html#Extension\">Extension</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Extension</span></td></tr>\r\n<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_bck0113.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Definition\" class=\"hierarchy\"/> Slices for extension<a name=\"PlanDefinition.action.reason.extension.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #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\">Content/Rules for all slices</td></tr>\r\n<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_bck01124.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.reason.extension:categoryLevel\" title=\"Extension URL = http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension\">categoryLevel</a><a name=\"PlanDefinition.action.reason.extension.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#integer\">integer</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Hierarchical Level</span><br/><span style=\"font-weight:bold\">URL: </span><a href=\"StructureDefinition-pq-hierarchical-level-extension.html\">http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension</a></td></tr>\r\n<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_bck0101.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.reason.coding\">coding</a><a name=\"PlanDefinition.action.reason.coding\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Code defined by a terminology system</span><br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-test-category-terminology.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology\">Test Category Terminology</a> (<a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\">required</a>)</td></tr>\r\n<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_bck01010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.reason.coding.code\">code</a><a name=\"PlanDefinition.action.reason.coding.code\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Symbol in syntax defined by the system</span></td></tr>\r\n<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_bck01000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.reason.coding.display\">display</a><a name=\"PlanDefinition.action.reason.coding.display\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<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\">Representation defined by the system</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck011.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.documentation\">documentation</a><a name=\"PlanDefinition.action.documentation\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span>..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/metadatatypes.html#RelatedArtifact\">RelatedArtifact</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Supporting documentation for the intended performer of the action</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.documentation.type\">type</a><a name=\"PlanDefinition.action.documentation.type\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">1</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">documentation</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.documentation.label\" title=\"A sponsor/applicant provided alphanumeric code that identifies the procedure. [Source: SME Defined]. Example: HP1234-2008\nNote: This could also be a transferred lab method.\">label</a><a name=\"PlanDefinition.action.documentation.label\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Reference to Procedure</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.goalId\">goalId</a><a name=\"PlanDefinition.action.goalId\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#id\">id</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Reference to Acceptance Criteria</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck011.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.relatedAction\" title=\"Alternate Tests are one or more test that are equivalent often using differnt method or equipment. The tests are used interchangeably and only one is used to satisfy the drug product specificaion.\">relatedAction</a><a name=\"PlanDefinition.action.relatedAction\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Alternate Test</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.relatedAction.targetId\">targetId</a><a name=\"PlanDefinition.action.relatedAction.targetId\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">1</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#id\">id</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">What action is this related to</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.relatedAction.relationship\">relationship</a><a name=\"PlanDefinition.action.relatedAction.relationship\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">1</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Code is concurrent<br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">concurrent</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck001.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_datatype.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action\">action</a><a name=\"PlanDefinition.action.action\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Groups or Stages</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.prefix\" title=\"A textual description and/or a number that identifies a level within a sequential test. [Source: SME Defined] Examples – Single Stage, Stage 1, Stage 2 (sometimes referred to as L1, L2 L3 or A1, A2 as in USP &lt;711&gt;)\nNote: A Stage may or may not provide a conditional sequence with associated acceptance criteria. [Source: SME Defined] (e.g., dissolution test, pyrogen test - &lt;151&gt;; 21 CFR 610.13 (b) Test for pyrogenic substances)\n\nImplememtation Note: not requried if action.prefix is 'Single Stage'\">prefix</a><a name=\"PlanDefinition.action.action.prefix\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Stage Name</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.title\" title=\"Test Name: The textual description of a procedure or analytical method. [Source: SME Defined]\nExamples: Assay by HPLC, moisture by Karl Fischer, analysis for impurities.\nNote: as defined by the sponsor\nNote: The test name of the action.action can be different than the action. Example, the action test is Microbial Limits and the action.action test is Staphylococcus aureus.\">title</a><a name=\"PlanDefinition.action.action.title\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Test Name (only reqired if different than above)</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.description\" title=\"Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined].\n\nImplementation Note: If there is more than one comment, include in this element. Markdown allows formating for clarity.\">description</a><a name=\"PlanDefinition.action.action.description\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#markdown\">markdown</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Test Additional Information | Stage Additional Information</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0011.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.documentation\">documentation</a><a name=\"PlanDefinition.action.action.documentation\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/metadatatypes.html#RelatedArtifact\">RelatedArtifact</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Supporting documentation for the intended performer of the action</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.documentation.type\">type</a><a name=\"PlanDefinition.action.action.documentation.type\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">1</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">documentation</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00101.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.documentation.document\" title=\"Any visual data described andor referenced in additional informatation\">document</a><a name=\"PlanDefinition.action.action.documentation.document\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Attachment\">Attachment</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Test or Stage Additional Information Visual Attachments</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck001010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.documentation.document.contentType\">contentType</a><a name=\"PlanDefinition.action.action.documentation.document.contentType\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Mime type of the content, with charset etc.</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck001010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.documentation.document.data\">data</a><a name=\"PlanDefinition.action.action.documentation.document.data\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#base64Binary\">base64Binary</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Data inline, base64ed</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck001000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.documentation.document.title\" title=\"A format or abbreviation name that identifies a file structure. [Source: SME Defined]\nUsed for the following: Analytical Instrument Data File Type, Impurity Analysis Graphic, Impurity Analytical Instrument Data File, Impurity Chemical Structure Data File, and Substance Structure Graphic.\">title</a><a name=\"PlanDefinition.action.action.documentation.document.title\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Document file name including the file extension</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.goalId\">goalId</a><a name=\"PlanDefinition.action.action.goalId\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#id\">id</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Reference to Acceptance Criteria</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0001.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_datatype.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.action\">action</a><a name=\"PlanDefinition.action.action.action\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span><a style=\"padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;\" href=\"http://hl7.org/fhir/R5/conformance-rules.html#constraints\" title=\"This element has or is affected by constraints ( cmc-subtest-rrt )\">C</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Sub-Test<br/><span style=\"font-weight:bold\">cmc-subtest-rrt: </span>a subtest's prefix represents relative retention time, should it exist</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.action.prefix\" title=\"RRT: The ratio of the retention time of a component relative to that of another used as a reference obtained under identical conditions as an alias for the name of the unidentified impurities. [Source: Adapted from USP] \nExample: 1:23 (a ratio)\nNote: This is the title or name of the impurity (sometimes expressed as a ratio) and not the value.\n\nImplementation Note: This value can only be 'RRT'. It is used to desinate that RRT value(s) expressed in action.action.action.title are relative retention times.\">prefix</a><a name=\"PlanDefinition.action.action.action.prefix\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">RRT</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.action.title\" title=\"Test Name: The textual description of a procedure or analytical method. [Source: SME Defined]\nExamples: Assay by HPLC, moisture by Karl Fischer, analysis for impurities.\nNote: as defined by the sponsor\nNote: The test name of the action.action can be different than the action. Example, the action test is Microbial Limits and the action.action test is Staphylococcus aureus.\n\nRRT: The ratio of the retention time of a component relative to that of another used as a reference obtained under identical conditions as an alias for the name of the unidentified impurities. [Source: Adapted from USP] \nExample: 1:23 (a ratio)\nNote: This is the title or name of the impurity (sometimes expressed as a ratio) and not the value. \n\nImplementation Note: For RRT, if there is a range associated with the unidentified peak then the range can be entered instead of indivual values. E.g.: 0.4 – 0.8.\">title</a><a name=\"PlanDefinition.action.action.action.title\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Test Name | RRT (complex testing)</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.action.description\" title=\"Test Additional Information: Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined].\nStage Additional Information: Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined]\nIf there is more than one comment, include in this element. Markdown allows formating for clarity. If both types are present, indicate type.\">description</a><a name=\"PlanDefinition.action.action.action.description\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#markdown\">markdown</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Test Additional Information | Stage Additional Information</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.action.action.goalId\">goalId</a><a name=\"PlanDefinition.action.action.action.goalId\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#id\">id</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Reference to Acceptance Criteria</td></tr>\r\n<tr><td colspan=\"5\" class=\"hierarchy\"><br/><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" alt=\"doco\" style=\"background-color: inherit\"/> Documentation for this format</a></td></tr></table></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-implements",
"valueUri" : "http://hl7.org/fhir/StructureDefinition/MetadataResource"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "brr"
}
],
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification",
"identifier" : [
{
"system" : "urn:ietf:rfc:3986",
"value" : "urn:oid:2.16.840.1.113883.4.642.40.36.42.30"
}
],
"version" : "1.1.6",
"name" : "QualitySpecification",
"title" : "Quality Specification",
"status" : "active",
"date" : "2024-09-17T03:56:09+00:00",
"publisher" : "HL7 International / Biomedical Research and Regulation",
"contact" : [
{
"name" : "HL7 International / Biomedical Research and Regulation",
"telecom" : [
{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/rcrim"
},
{
"system" : "email",
"value" : "brr@lists.HL7.org"
}
]
}
],
"description" : "A quality specification is for a drug product or drug substance (excipient, API or raw material).",
"jurisdiction" : [
{
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "US",
"display" : "United States of America"
}
]
}
],
"fhirVersion" : "5.0.0",
"mapping" : [
{
"identity" : "workflow",
"uri" : "http://hl7.org/fhir/workflow",
"name" : "Workflow Pattern"
},
{
"identity" : "w5",
"uri" : "http://hl7.org/fhir/fivews",
"name" : "FiveWs Pattern Mapping"
},
{
"identity" : "rim",
"uri" : "http://hl7.org/v3",
"name" : "RIM Mapping"
},
{
"identity" : "objimpl",
"uri" : "http://hl7.org/fhir/object-implementation",
"name" : "Object Implementation Information"
}
],
"kind" : "resource",
"abstract" : false,
"type" : "PlanDefinition",
"baseDefinition" : "http://hl7.org/fhir/StructureDefinition/PlanDefinition",
"derivation" : "constraint",
"snapshot" : {
"element" : [
{
"id" : "PlanDefinition",
"path" : "PlanDefinition",
"short" : "The definition of a plan for a series of actions, independent of any specific patient or context",
"definition" : "This resource allows for the definition of various types of plans as a sharable, consumable, and executable artifact. The resource is general enough to support the description of a broad range of clinical and non-clinical artifacts such as clinical decision support rules, order sets, protocols, and drug quality specifications.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition",
"min" : 0,
"max" : "*"
},
"constraint" : [
{
"key" : "cnl-0",
"severity" : "warning",
"human" : "Name should be usable as an identifier for the module by machine processing applications such as code generation",
"expression" : "name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')",
"source" : "http://hl7.org/fhir/StructureDefinition/PlanDefinition"
},
{
"key" : "pld-3",
"severity" : "warning",
"human" : "goalid should reference the id of a goal definition",
"expression" : "%context.repeat(action).where((goalId in %context.goal.id).not()).exists().not()",
"source" : "http://hl7.org/fhir/StructureDefinition/PlanDefinition"
},
{
"key" : "pld-4",
"severity" : "warning",
"human" : "targetId should reference the id of an action",
"expression" : "%context.repeat(action).relatedAction.where((targetId in %context.repeat(action).id).not()).exists().not()",
"source" : "http://hl7.org/fhir/StructureDefinition/PlanDefinition"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "w5",
"map" : "conformance.behavior,clinical.general"
},
{
"identity" : "workflow",
"map" : "Definition"
},
{
"identity" : "rim",
"map" : "Act[classCode=GROUPER;moodCode=DEFN]"
}
]
},
{
"id" : "PlanDefinition.id",
"path" : "PlanDefinition.id",
"short" : "Logical id of this artifact",
"definition" : "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"comment" : "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" : 0,
"max" : "1",
"base" : {
"path" : "Resource.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "id"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PlanDefinition.meta",
"path" : "PlanDefinition.meta",
"short" : "Metadata about the resource",
"definition" : "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" : 0,
"max" : "1",
"base" : {
"path" : "Resource.meta",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Meta"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PlanDefinition.meta.id",
"path" : "PlanDefinition.meta.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "id"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.meta.extension",
"path" : "PlanDefinition.meta.extension",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "url"
}
],
"description" : "Extensions are always sliced by (at least) url",
"rules" : "open"
},
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.meta.versionId",
"path" : "PlanDefinition.meta.versionId",
"short" : "Version specific identifier",
"definition" : "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" : "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" : 0,
"max" : "1",
"base" : {
"path" : "Meta.versionId",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "id"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PlanDefinition.meta.lastUpdated",
"path" : "PlanDefinition.meta.lastUpdated",
"short" : "When the resource version last changed",
"definition" : "When the resource last changed - e.g. when the version changed.",
"comment" : "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" : 0,
"max" : "1",
"base" : {
"path" : "Meta.lastUpdated",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "instant"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PlanDefinition.meta.source",
"path" : "PlanDefinition.meta.source",
"short" : "Identifies where the resource comes from",
"definition" : "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" : "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. \n\nThis 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" : 0,
"max" : "1",
"base" : {
"path" : "Meta.source",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "uri"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PlanDefinition.meta.profile",
"path" : "PlanDefinition.meta.profile",
"short" : "Profiles this resource claims to conform to",
"definition" : "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" : "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" : 0,
"max" : "*",
"base" : {
"path" : "Meta.profile",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "canonical",
"targetProfile" : [
"http://hl7.org/fhir/StructureDefinition/StructureDefinition"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PlanDefinition.meta.security",
"path" : "PlanDefinition.meta.security",
"short" : "Security Labels applied to this resource",
"definition" : "Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.",
"comment" : "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" : 0,
"max" : "*",
"base" : {
"path" : "Meta.security",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Coding"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "SecurityLabels"
}
],
"strength" : "extensible",
"description" : "Security Labels from the Healthcare Privacy and Security Classification System.",
"valueSet" : "http://hl7.org/fhir/ValueSet/security-labels"
}
},
{
"id" : "PlanDefinition.meta.tag",
"path" : "PlanDefinition.meta.tag",
"short" : "Tags applied to this resource",
"definition" : "Tags applied to this resource. Tags are intended to be used to : "The lifecycle status of an artifact.",
"valueSet" : "http://hl7.org/fhir/ValueSet/publication-status|5.0.0"
},
"mapping" : [
{
"identity" : "workflow",
"map" : "Definition.status {different ValueSet}"
},
{
"identity" : "w5",
"map" : "FiveWs.status"
},
{
"identity" : "rim",
"map" : ".status"
}
]
},
{
"id" : "PlanDefinition.experimental",
"path" : "PlanDefinition.experimental",
"short" : "For testing purposes, not real usage",
"definition" : "A Boolean value t },
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bind "code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.goal.target.detail[x]:detailQuantity.extension",
"path" : "PlanDefinition.goal.target.detail[x].extension",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "url"
}
&n "source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "v2",
"map" : "C*E.2 - but note this is not well followed"
},
{
"identity" : "rim",
"map" : "CV.displayName"
},
{
"identity" : "orim",
"map" : "fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName"
}
]
},
{
"id" : "PlanDefinition.action.code.coding.userSelected",
"path" : "PlanDefinition.action.code.coding.userSelected",
"short" : "If this coding was chosen directly by the user",
"definition" : "Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).",
"comment" : "Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.",
"requirements" : "This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Coding.userSelected",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "boolean"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "v2",
"map" : "Sometimes implied by being first"
},
{
"identity" : "rim",
"map" : "CD.codingRationale"
},
{
"identity" : "orim",
"map" : "fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\\#true a [ fhir:source \"true\"; fhir:target dt:CDCoding.codingRationale\\#O ]"
}
]
},
{
"id" : "PlanDefinition.action.code.text",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PlanDefinition.action.code.text",
"short" : "Analytical Procedure",
"definition" : "The name of the technique used to determine the nature of a characteristic. [Source: SME Defined].",
"comment" : "Very often the text is the same as a displayName of one of the codings.",
"requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "CodeableConcept.text",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "v2",
"map" : "C*E.9. But note many systems use C*E.2 for this"
},
{
"identity" : "rim",
"map" : "./originalText[mediaType/code=\"text/plain\"]/data"
},
{
"identity" : "orim",
"map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
}
]
},
{
"id" : "PlanDefinition.action.reason",
"path" : "PlanDefinition.action.reason",
"short" : "Test Category | Test Subcategory",
"definition" : "A high level grouping of quality attributes for products, substances, raw materials, excipients, intermediates and reagents. [Source: SME Defined] Examples: Assay, Biological Properties.",
"comment" : "This is different than the clinical evidence documentation, it's an actual business description of the reason for performing the action.",
"min" : 1,
"max" : "2",
"base" : {
"path" : "PlanDefinition.action.reason",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionReasonCode"
}
],
"strength" : "example",
"description" : "Provides examples of reasons for actions to be performed.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-reason-code"
},
"mapping" : [
{
"identity" : "rim",
"map" : ".reasonCode"
}
]
},
{
"id" : "PlanDefinition.action.reason.id",
"path" : "PlanDefinition.action.reason.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "id"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.reason.extension",
"path" : "PlanDefinition.action.reason.extension",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "url"
}
],
"description" : "Extensions are always sliced by (at least) url",
"rules" : "open"
},
"short" : "Extension",
"definition" : "An Extension",
"min" : 1,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "PlanDefinition.action.reason.extension:categoryLevel",
"path" : "PlanDefinition.action.reason.extension",
"sliceName" : "categoryLevel",
"short" : "Hierarchical Level",
"definition" : "Numeric level in the hierarchical value-set. As an example, this extension is used to distinguished between Test Category | Test Subcategory in Quality Specifications. Test Category is level 1 and Test Subcategory is level two. A constraint enforces values greater than zero.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension",
"profile" : [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "PlanDefinition.action.reason.coding",
"path" : "PlanDefinition.action.reason.coding",
"short" : "Code defined by a terminology system",
"definition" : "A reference to a code defined by a terminology system.",
"comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "CodeableConcept.coding",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Coding"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"strength" : "required",
"valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology"
},
"mapping" : [
{
"identity" : "v2",
"map" : "C*E.1-8, C*E.10-22"
},
{
"identity" : "rim",
"map" : "union(., ./translation)"
},
{
"identity" : "orim",
"map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
}
]
},
{
"id" : "PlanDefinition.action.reason.coding.id",
"path" : "PlanDefinition.action.reason.coding.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "id"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.reason.coding.extension",
"path" : "PlanDefinition.action.reason.coding.extension",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "url"
}
],
"description" : "Extensions are always sliced by (at least) url",
"rules" : "open"
},
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.reason.coding.system",
"path" : "PlanDefinition.action.reason.coding.system",
"short" : "Identity of the terminology system",
"definition" : "The identification of the code system that defines the meaning of the symbol in the code.",
"comment" : "The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.",
"requirements" : "Need to be unambiguous about the source of the definition of the symbol.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Coding.system",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "uri"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "v2",
"map" : "C*E.3"
},
{
"identity" : "rim",
"map" : "./codeSystem"
},
{
"identity" : "orim",
"map" : "fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem"
}
]
},
{
"id" : "PlanDefinition.action.reason.coding.version",
"path" : "PlanDefinition.action.reason.coding.version",
"short" : "Version of the system - if relevant",
"definition" : "The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.",
"comment" : "Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Coding.version",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "v2",
"map" : "C*E.7"
},
{
"identity" : "rim",
"map" : "./codeSystemVersion"
},
{
"identity" : "orim",
"map" : "fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion"
}
]
},
{
"id" : "PlanDefinition.action.reason.coding.code",
"path" : "PlanDefinition.action.reason.coding.code",
"short" : "Symbol in syntax defined by the system",
"definition" : "A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).",
"requirements" : "Need to refer to a particular code in the system.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Coding.code",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"condition" : [
"cod-1"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "v2",
"map" : "C*E.1"
},
{
"identity" : "rim",
"map" : "./code"
},
{
"identity" : "orim",
"map" : "fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code"
}
]
},
{
"id" : "PlanDefinition.action.reason.coding.display",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PlanDefinition.action.reason.coding.display",
"short" : "Representation defined by the system",
"definition" : "A representation of the meaning of the code in the system, following the rules of the system.",
"requirements" : "Need to be able to carry a human-readable meaning of the code for readers that do not know the system.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Coding.display",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"condition" : [
"cod-1"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "v2",
"map" : "C*E.2 - but note this is not well followed"
},
{
"identity" : "rim",
"map" : "CV.displayName"
},
{
"identity" : "orim",
"map" : "fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName"
}
]
},
{
"id" : "PlanDefinition.action.reason.coding.userSelected",
"path" : "PlanDefinition.action.reason.coding.userSelected",
"short" : "If this coding was chosen directly by the user",
"definition" : "Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).",
"comment" : "Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.",
"requirements" : "This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Coding.userSelected",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "boolean"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "v2",
"map" : "Sometimes implied by being first"
},
{
"identity" : "rim",
"map" : "CD.codingRationale"
},
{
"identity" : "orim",
"map" : "fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\\#true a [ fhir:source \"true\"; fhir:target dt:CDCoding.codingRationale\\#O ]"
}
]
},
{
"id" : "PlanDefinition.action.reason.text",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PlanDefinition.action.reason.text",
"short" : "Plain text representation of the concept",
"definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"comment" : "Very often the text is the same as a displayName of one of the codings.",
"requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "CodeableConcept.text",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "v2",
"map" : "C*E.9. But note many systems use C*E.2 for this"
},
{
"identity" : "rim",
"map" : "./originalText[mediaType/code=\"text/plain\"]/data"
},
{
"identity" : "orim",
"map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
}
]
},
{
"id" : "PlanDefinition.action.documentation",
"path" : "PlanDefinition.action.documentation",
"short" : "Supporting documentation for the intended performer of the action",
"definition" : "Didactic or other informational resources associated with the action that can be provided to the CDS recipient. Information resources can include inline text commentary and links to web resources.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.documentation",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "RelatedArtifact"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.documentation.id",
"path" : "PlanDefinition.action.documentation.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "id"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.documentation.extension",
"path" : "PlanDefinition.action.documentation.extension",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "url"
}
],
"description" : "Extensions are always sliced by (at least) url",
"rules" : "open"
},
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.documentation.type",
"path" : "PlanDefinition.action.documentation.type",
"short" : "documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as",
"definition" : "The type of relationship to the related artifact.",
"comment" : "The presence of both sides of a relationship type (e.g. successor and predecessor) is required to support use cases where one side of a relationship is not represented in FHIR. However, this feature SHALL NOT be used to create bi-directional resource links in FHIR instances. Specifically, following the methodology of \"new points to old\" and \"many points to one\", when using related artifact elements to describe and reference FHIR resources, the type element SHALL be drawn from the fhir-related-artifact-type ValueSet.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "RelatedArtifact.type",
"min" : 1,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"patternCode" : "documentation",
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "RelatedArtifactType"
}
],
"strength" : "required",
"description" : "The type of relationship to the related artifact.",
"valueSet" : "http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0"
}
},
{
"id" : "PlanDefinition.action.documentation.classifier",
"path" : "PlanDefinition.action.documentation.classifier",
"short" : "Additional classifiers",
"definition" : "Provides additional classifiers of the related artifact.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "RelatedArtifact.classifier",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "RelatedArtifactClassifier"
}
],
"strength" : "example",
"description" : "Additional classifiers for the related artifact.",
"valueSet" : "http://hl7.org/fhir/ValueSet/citation-artifact-classifier"
}
},
{
"id" : "PlanDefinition.action.documentation.label",
"path" : "PlanDefinition.action.documentation.label",
"short" : "Reference to Procedure",
"definition" : "A sponsor/applicant provided alphanumeric code that identifies the procedure. [Source: SME Defined]. Example: HP1234-2008\nNote: This could also be a transferred lab method.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "RelatedArtifact.label",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PlanDefinition.action.documentation.display",
"path" : "PlanDefinition.action.documentation.display",
"short" : "Brief description of the related artifact",
"definition" : "A brief description of the document or knowledge resource being referenced, suitable for display to a consumer.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "RelatedArtifact.display",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PlanDefinition.action.documentation.citation",
"path" : "PlanDefinition.action.documentation.citation",
"short" : "Bibliographic citation for the artifact",
"definition" : "A bibliographic citation for the related artifact. This text SHOULD be formatted according to an accepted citation format.",
"comment" : "Additional structured information about citations should be captured as extensions.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "RelatedArtifact.citation",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "markdown"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PlanDefinition.action.documentation.document",
"path" : "PlanDefinition.action.documentation.document",
"short" : "What document is being referenced",
"definition" : "The document being referenced, represented as an attachment. This is exclusive with the resource element.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "RelatedArtifact.document",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Attachment"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PlanDefinition.action.documentation.resource",
"path" : "PlanDefinition.action.documentation.resource",
"short" : "What artifact is being referenced",
"definition" : "The related artifact, such as a library, value set, profile, or other knowledge resource.",
"comment" : "If the type is predecessor, this is a reference to the succeeding knowledge resource. If the type is successor, this is a reference to the prior knowledge resource.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "RelatedArtifact.resource",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "canonical",
"targetProfile" : [
"http://hl7.org/fhir/StructureDefinition/Resource"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PlanDefinition.action.documentation.resourceReference",
"path" : "PlanDefinition.action.documentation.resourceReference",
"short" : "What artifact, if not a conformance resource",
"definition" : "The related artifact, if the artifact is not a canonical resource, or a resource reference to a canonical resource.",
"comment" : "If both resource and resourceReference are present, they SHOULD be consistent and reference the same resource. Although relatedArtifact is intended to support references to definitional resources, there are cases where non-definitional resources can be definitional (such as Location where the kind is mode). Related artifacts SHOULD be used to reference definitional resources, and profiles SHOULD be used to make that explicit for particular use cases.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "RelatedArtifact.resourceReference",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : [
"http://hl7.org/fhir/StructureDefinition/Resource"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PlanDefinition.action.documentation.publicationStatus",
"path" : "PlanDefinition.action.documentation.publicationStatus",
"short" : "draft | active | retired | unknown",
"definition" : "The publication status of the artifact being referred to.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "RelatedArtifact.publicationStatus",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "RelatedArtifactPublicationStatus"
}
],
"strength" : "required",
"description" : "Publication status of an artifact being referred to.",
"valueSet" : "http://hl7.org/fhir/ValueSet/publication-status|5.0.0"
}
},
{
"id" : "PlanDefinition.action.documentation.publicationDate",
"path" : "PlanDefinition.action.documentation.publicationDate",
"short" : "Date of publication of the artifact being referred to",
"definition" : "The date of publication of the artifact being referred to.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "RelatedArtifact.publicationDate",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "date"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PlanDefinition.action.goalId",
"path" : "PlanDefinition.action.goalId",
"short" : "Reference to Acceptance Criteria",
"definition" : "Identifies goals that this action supports. The reference must be to a goal element defined within this plan definition. In pharmaceutical quality, a goal represents acceptance criteria (Goal) for a given action (Test), so the goalId would be the unique id of a defined goal element establishing the acceptance criteria for the action.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.goalId",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "id"
}
],
"condition" : [
"pld-3"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.subject[x]",
"path" : "PlanDefinition.action.subject[x]",
"short" : "Type of individual the action is focused on",
"definition" : "A code, group definition, or canonical reference that describes the intended subject of the action and its children, if any. Canonical references are allowed to support the definition of protocols for drug and substance quality specifications, and is allowed to reference a MedicinalProductDefinition, SubstanceDefinition, AdministrableProductDefinition, ManufacturedItemDefinition, or PackagedProductDefinition resource.",
"comment" : "The subject of an action overrides the subject at a parent action or on the root of the PlanDefinition if specified.\n\nIn addition, because the subject needs to be resolved during realization, use of subjects in actions (or in the ActivityDefinition referenced by the action) resolves based on the set of subjects supplied in context and by type (i.e. the patient subject would resolve to a resource of type Patient).",
"requirements" : "Multiple steps in a protocol often have different groups of steps that are focused on testing different things. The subject of an action specifies the focus of the action and any child actions.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.subject[x]",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
},
{
"code" : "Reference",
"targetProfile" : [
"http://hl7.org/fhir/StructureDefinition/Group"
]
},
{
"code" : "canonical"
}
],
"meaningWhenMissing" : "Patient",
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "SubjectType"
}
],
"strength" : "extensible",
"description" : "The possible types of subjects for a plan definition (E.g. Patient, Practitioner, Organization, Location, etc.).",
"valueSet" : "http://hl7.org/fhir/ValueSet/participant-resource-types"
},
"mapping" : [
{
"identity" : "workflow",
"map" : "Definition.subject"
},
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.trigger",
"path" : "PlanDefinition.action.trigger",
"short" : "When the action should be triggered",
"definition" : "A description of when the action should be triggered. When multiple triggers are specified on an action, any triggering event invokes the action.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.trigger",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "TriggerDefinition"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.condition",
"path" : "PlanDefinition.action.condition",
"short" : "Whether or not the action is applicable",
"definition" : "An expression that describes applicability criteria or start/stop conditions for the action.",
"comment" : "When multiple conditions of the same kind are present, the effects are combined using AND semantics, so the overall condition is true only if all the conditions are true.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.condition",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.condition.id",
"path" : "PlanDefinition.action.condition.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.condition.extension",
"path" : "PlanDefinition.action.condition.extension",
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.condition.modifierExtension",
"path" : "PlanDefinition.action.condition.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.condition.kind",
"path" : "PlanDefinition.action.condition.kind",
"short" : "applicability | start | stop",
"definition" : "The kind of condition.",
"comment" : "Applicability criteria are used to determine immediate applicability when a plan definition is applied to a given context. Start and stop criteria are carried through application and used to describe enter/exit criteria for an action.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.condition.kind",
"min" : 1,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionConditionKind"
}
],
"strength" : "required",
"description" : "Defines the kinds of conditions that can appear on actions.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-condition-kind|5.0.0"
},
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.condition.expression",
"path" : "PlanDefinition.action.condition.expression",
"short" : "Boolean-valued expression",
"definition" : "An expression that returns true or false, indicating whether the condition is satisfied.",
"comment" : "The expression may be inlined or may be a reference to a named expression within a logic library referenced by the library element.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.condition.expression",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Expression"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.input",
"path" : "PlanDefinition.action.input",
"short" : "Input data requirements",
"definition" : "Defines input data requirements for the action.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.input",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "pld-0",
"severity" : "error",
"human" : "Input data elements must have a requirement or a relatedData, but not both",
"expression" : "requirement.exists() xor relatedData.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/PlanDefinition"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.input.id",
"path" : "PlanDefinition.action.input.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.input.extension",
"path" : "PlanDefinition.action.input.extension",
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.input.modifierExtension",
"path" : "PlanDefinition.action.input.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.input.title",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PlanDefinition.action.input.title",
"short" : "User-visible title",
"definition" : "A human-readable label for the data requirement used to label data flows in BPMN or similar diagrams. Also provides a human readable label when rendering the data requirement that conveys its purpose to human readers.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.input.title",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.input.requirement",
"path" : "PlanDefinition.action.input.requirement",
"short" : "What data is provided",
"definition" : "Defines the data that is to be provided as input to the action.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.input.requirement",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "DataRequirement"
}
],
"condition" : [
"pld-0"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.input.relatedData",
"path" : "PlanDefinition.action.input.relatedData",
"short" : "What data is provided",
"definition" : "Points to an existing input or output element that provides data to this input.",
"comment" : "The relatedData element allows indicating that an input to a parent action is an input to specific child actions. It also allows the output of one action to be identified as the input to a different action",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.input.relatedData",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "id"
}
],
"condition" : [
"pld-0"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.output",
"path" : "PlanDefinition.action.output",
"short" : "Output data definition",
"definition" : "Defines the outputs of the action, if any.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.output",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "pld-1",
"severity" : "error",
"human" : "Output data element must have a requirement or a relatedData, but not both",
"expression" : "requirement.exists() xor relatedData.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/PlanDefinition"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.output.id",
"path" : "PlanDefinition.action.output.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.output.extension",
"path" : "PlanDefinition.action.output.extension",
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.output.modifierExtension",
"path" : "PlanDefinition.action.output.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.output.title",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PlanDefinition.action.output.title",
"short" : "User-visible title",
"definition" : "A human-readable label for the data requirement used to label data flows in BPMN or similar diagrams. Also provides a human readable label when rendering the data requirement that conveys its purpose to human readers.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.output.title",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.output.requirement",
"path" : "PlanDefinition.action.output.requirement",
"short" : "What data is provided",
"definition" : "Defines the data that results as output from the action.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.output.requirement",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "DataRequirement"
}
],
"condition" : [
"pld-1"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.output.relatedData",
"path" : "PlanDefinition.action.output.relatedData",
"short" : "What data is provided",
"definition" : "Points to an existing input or output element that is results as output from the action.",
"comment" : "The relatedData element allows indicating that the output of child action is also the output of a parent action. It also allows the input of one action to be identified as the output of a different action",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.output.relatedData",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"condition" : [
"pld-1"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.relatedAction",
"path" : "PlanDefinition.action.relatedAction",
"short" : "Alternate Test",
"definition" : "Alternate Tests are one or more test that are equivalent often using differnt method or equipment. The tests are used interchangeably and only one is used to satisfy the drug product specificaion.",
"comment" : "When an action depends on multiple actions, the meaning is that all actions are dependencies, rather than that any of the actions are a dependency.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.relatedAction",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"condition" : [
"pld-4"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.relatedAction.id",
"path" : "PlanDefinition.action.relatedAction.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.relatedAction.extension",
"path" : "PlanDefinition.action.relatedAction.extension",
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.relatedAction.modifierExtension",
"path" : "PlanDefinition.action.relatedAction.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.relatedAction.targetId",
"path" : "PlanDefinition.action.relatedAction.targetId",
"short" : "What action is this related to",
"definition" : "The element id of the target related action.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.relatedAction.targetId",
"min" : 1,
"max" : "1"
},
"type" : [
{
"code" : "id"
}
],
"condition" : [
"pld-4"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.relatedAction.relationship",
"path" : "PlanDefinition.action.relatedAction.relationship",
"short" : "Code is concurrent",
"definition" : "The relationship of the start of this action to the related action.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.relatedAction.relationship",
"min" : 1,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"patternCode" : "concurrent",
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionRelationshipType"
}
],
"strength" : "required",
"description" : "Defines the types of relationships between actions.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0"
},
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.relatedAction.endRelationship",
"path" : "PlanDefinition.action.relatedAction.endRelationship",
"short" : "before | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end",
"definition" : "The relationship of the end of this action to the related action.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.relatedAction.endRelationship",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionRelationshipType"
}
],
"strength" : "required",
"description" : "Defines the types of relationships between actions.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0"
},
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.relatedAction.offset[x]",
"path" : "PlanDefinition.action.relatedAction.offset[x]",
"short" : "Time offset for the relationship",
"definition" : "A duration or range of durations to apply to the relationship. For example, 30-60 minutes before.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.relatedAction.offset[x]",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Duration"
},
{
"code" : "Range"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.timing[x]",
"path" : "PlanDefinition.action.timing[x]",
"short" : "When the action should take place",
"definition" : "An optional value describing when the action should be performed.",
"comment" : "The intent of the timing element is to provide timing when the action should be performed. As a definitional resource, this timing is interpreted as part of an apply operation so that the timing of the result actions in a CarePlan or RequestOrchestration, for example, would be specified by evaluating the timing definition in the context of the apply and setting the resulting timing on the appropriate elements of the target resource. If the timing is an Age, the activity is expected to be performed when the subject is the given Age. When the timing is a Duration, the activity is expected to be performed within the specified duration from the apply. When the timing is a Range, it may be a range of Ages or Durations, providing a range for the expected timing of the resulting activity. When the timing is a Timing, it is establishing a schedule for the timing of the resulting activity.",
"requirements" : "Allows prompting for activities and detection of missed planned activities.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.timing[x]",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Age"
},
{
"code" : "Duration"
},
{
"code" : "Range"
},
{
"code" : "Timing"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : ".effectiveTime"
}
]
},
{
"id" : "PlanDefinition.action.location",
"path" : "PlanDefinition.action.location",
"short" : "Where it should happen",
"definition" : "Identifies the facility where the action will occur; e.g. home, hospital, specific clinic, etc.",
"comment" : "May reference a specific clinical location or may just identify a type of location.",
"requirements" : "Helps in planning of activity.",
"alias" : [
"facility"
],
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.location",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableReference",
"targetProfile" : [
"http://hl7.org/fhir/StructureDefinition/Location"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : ".participation[typeCode=LOC].role"
}
]
},
{
"id" : "PlanDefinition.action.participant",
"path" : "PlanDefinition.action.participant",
"short" : "Who should participate in the action",
"definition" : "Indicates who should participate in performing the action described.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.participant",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : ".participation[typeCode=PFM]"
}
]
},
{
"id" : "PlanDefinition.action.participant.id",
"path" : "PlanDefinition.action.participant.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.participant.extension",
"path" : "PlanDefinition.action.participant.extension",
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.participant.modifierExtension",
"path" : "PlanDefinition.action.participant.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.participant.actorId",
"path" : "PlanDefinition.action.participant.actorId",
"short" : "What actor",
"definition" : "A reference to the id element of the actor who will participate in this action.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.participant.actorId",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.participant.type",
"path" : "PlanDefinition.action.participant.type",
"short" : "careteam | device | group | healthcareservice | location | organization | patient | practitioner | practitionerrole | relatedperson",
"definition" : "The type of participant in the action.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.participant.type",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActivityParticipantType"
}
],
"strength" : "required",
"description" : "The type of participant in the activity.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0"
},
"mapping" : [
{
"identity" : "rim",
"map" : ".role.classCode"
}
]
},
{
"id" : "PlanDefinition.action.participant.typeCanonical",
"path" : "PlanDefinition.action.participant.typeCanonical",
"short" : "Who or what can participate",
"definition" : "The type of participant in the action.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.participant.typeCanonical",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "canonical",
"targetProfile" : [
"http://hl7.org/fhir/StructureDefinition/CapabilityStatement"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : ".role.classCode"
}
]
},
{
"id" : "PlanDefinition.action.participant.typeReference",
"path" : "PlanDefinition.action.participant.typeReference",
"short" : "Who or what can participate",
"definition" : "The type of participant in the action.",
"comment" : "When this element is a reference, it SHOULD be a reference to a definitional resource (for example, a location type, rather than a specific location).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.participant.typeReference",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : [
"http://hl7.org/fhir/StructureDefinition/CareTeam",
"http://hl7.org/fhir/StructureDefinition/Device",
"http://hl7.org/fhir/StructureDefinition/DeviceDefinition",
"http://hl7.org/fhir/StructureDefinition/Endpoint",
"http://hl7.org/fhir/StructureDefinition/Group",
"http://hl7.org/fhir/StructureDefinition/HealthcareService",
"http://hl7.org/fhir/StructureDefinition/Location",
"http://hl7.org/fhir/StructureDefinition/Organization",
"http://hl7.org/fhir/StructureDefinition/Patient",
"http://hl7.org/fhir/StructureDefinition/Practitioner",
"http://hl7.org/fhir/StructureDefinition/PractitionerRole",
"http://hl7.org/fhir/StructureDefinition/RelatedPerson"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : ".role.classCode"
}
]
},
{
"id" : "PlanDefinition.action.participant.role",
"path" : "PlanDefinition.action.participant.role",
"short" : "E.g. Nurse, Surgeon, Parent",
"definition" : "The role the participant should play in performing the described action.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.participant.role",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionParticipantRole"
}
],
"strength" : "example",
"description" : "Defines roles played by participants for the action.",
"valueSet" : "http://terminology.hl7.org/ValueSet/action-participant-role"
},
"mapping" : [
{
"identity" : "rim",
"map" : ".role.code"
}
]
},
{
"id" : "PlanDefinition.action.participant.function",
"path" : "PlanDefinition.action.participant.function",
"short" : "E.g. Author, Reviewer, Witness, etc",
"definition" : "Indicates how the actor will be involved in the action - author, reviewer, witness, etc.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.participant.function",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionParticipantFunction"
}
],
"strength" : "example",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-participant-function"
},
"mapping" : [
{
"identity" : "rim",
"map" : ".role.code"
}
]
},
{
"id" : "PlanDefinition.action.type",
"path" : "PlanDefinition.action.type",
"short" : "create | update | remove | fire-event",
"definition" : "The type of action to perform (create, update, remove).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.type",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionType"
}
],
"strength" : "extensible",
"description" : "The type of action to be performed.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-type"
},
"mapping" : [
{
"identity" : "rim",
"map" : ".moodCode { Maybe? this is effectively Create, Update, or Delete }"
}
]
},
{
"id" : "PlanDefinition.action.groupingBehavior",
"path" : "PlanDefinition.action.groupingBehavior",
"short" : "visual-group | logical-group | sentence-group",
"definition" : "Defines the grouping behavior for the action and its children.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.groupingBehavior",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"meaningWhenMissing" : "If no grouping behavior is specified but the action has children (i.e. is a group), the grouping behavior is assumed to be `logical-group`.",
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionGroupingBehavior"
}
],
"strength" : "required",
"description" : "Defines organization behavior of a group.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-grouping-behavior|5.0.0"
},
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.selectionBehavior",
"path" : "PlanDefinition.action.selectionBehavior",
"short" : "any | all | all-or-none | exactly-one | at-most-one | one-or-more",
"definition" : "Defines the selection behavior for the action and its children.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.selectionBehavior",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"meaningWhenMissing" : "If no selection behavior is specified but the action has children (i.e. is a group), the selection behavior is assumed to be `all`.",
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionSelectionBehavior"
}
],
"strength" : "required",
"description" : "Defines selection behavior of a group.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-selection-behavior|5.0.0"
},
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.requiredBehavior",
"path" : "PlanDefinition.action.requiredBehavior",
"short" : "must | could | must-unless-documented",
"definition" : "Defines the required behavior for the action.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.requiredBehavior",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"meaningWhenMissing" : "If no required behavior is specified but the action has children (i.e. is a group), the required behavior is assumed to be `could`.",
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionRequiredBehavior"
}
],
"strength" : "required",
"description" : "Defines expectations around whether an action or action group is required.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-required-behavior|5.0.0"
},
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.precheckBehavior",
"path" : "PlanDefinition.action.precheckBehavior",
"short" : "yes | no",
"definition" : "Defines whether the action should usually be preselected.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.precheckBehavior",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"meaningWhenMissing" : "If no precheck behavior is specified but the action has children (i.e. is a group), the precheck behavior is assumed to be `no`.",
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionPrecheckBehavior"
}
],
"strength" : "required",
"description" : "Defines selection frequency behavior for an action or group.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-precheck-behavior|5.0.0"
},
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.cardinalityBehavior",
"path" : "PlanDefinition.action.cardinalityBehavior",
"short" : "single | multiple",
"definition" : "Defines whether the action can be selected multiple times.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.cardinalityBehavior",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"meaningWhenMissing" : "If no cardinality behavior is specified but the action has children (i.e. is a group), the cardinality behavior is assumed to be `single`.",
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionCardinalityBehavior"
}
],
"strength" : "required",
"description" : "Defines behavior for an action or a group for how many times that item may be repeated.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-cardinality-behavior|5.0.0"
},
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.definition[x]",
"path" : "PlanDefinition.action.definition[x]",
"short" : "Description of the activity to be performed",
"definition" : "A reference to an ActivityDefinition that describes the action to be taken in detail, a MessageDefinition describing a message to be snet, a PlanDefinition that describes a series of actions to be taken, a Questionnaire that should be filled out, a SpecimenDefinition describing a specimen to be collected, or an ObservationDefinition that specifies what observation should be captured.",
"comment" : "Note that the definition is optional, and if no definition is specified, a dynamicValue with a root ($this) path can be used to define the entire resource dynamically.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.definition[x]",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "canonical",
"targetProfile" : [
"http://hl7.org/fhir/StructureDefinition/ActivityDefinition",
"http://hl7.org/fhir/StructureDefinition/MessageDefinition",
"http://hl7.org/fhir/StructureDefinition/ObservationDefinition",
"http://hl7.org/fhir/StructureDefinition/PlanDefinition",
"http://hl7.org/fhir/StructureDefinition/Questionnaire",
"http://hl7.org/fhir/StructureDefinition/SpecimenDefinition"
]
},
{
"code" : "uri"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "Act[classCode=ACT; moodCode=DEFN]"
}
]
},
{
"id" : "PlanDefinition.action.transform",
"path" : "PlanDefinition.action.transform",
"short" : "Transform to apply the template",
"definition" : "A reference to a StructureMap resource that defines a transform that can be executed to produce the intent resource using the ActivityDefinition instance as the input.",
"comment" : "Note that when a referenced ActivityDefinition also defines a transform, the transform specified here generally takes precedence. In addition, if both a transform and dynamic values are specific, the dynamic values are applied to the result of the transform.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.transform",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "canonical",
"targetProfile" : [
"http://hl7.org/fhir/StructureDefinition/StructureMap"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.dynamicValue",
"path" : "PlanDefinition.action.dynamicValue",
"short" : "Dynamic aspects of the definition",
"definition" : "Customizations that should be applied to the statically defined resource. For example, if the dosage of a medication must be computed based on the patient's weight, a customization would be used to specify an expression that calculated the weight, and the path on the resource that would contain the result.",
"comment" : "Dynamic values are applied in the order in which they are defined in the PlanDefinition resource. Note that when dynamic values are also specified by a referenced ActivityDefinition, the dynamicValues from the ActivityDefinition are applied first, followed by the dynamicValues specified here. In addition, if both a transform and dynamic values are specific, the dynamic values are applied to the result of the transform.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.dynamicValue",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.dynamicValue.id",
"path" : "PlanDefinition.action.dynamicValue.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.dynamicValue.extension",
"path" : "PlanDefinition.action.dynamicValue.extension",
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.dynamicValue.modifierExtension",
"path" : "PlanDefinition.action.dynamicValue.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.dynamicValue.path",
"path" : "PlanDefinition.action.dynamicValue.path",
"short" : "The path to the element to be set dynamically",
"definition" : "The path to the element to be customized. This is the path on the resource that will hold the result of the calculation defined by the expression. The specified path SHALL be a FHIRPath resolvable on the specified target type of the ActivityDefinition, and SHALL consist only of identifiers, constant indexers, and a restricted subset of functions. The path is allowed to contain qualifiers (.) to traverse sub-elements, as well as indexers ([x]) to traverse multiple-cardinality sub-elements (see the [Simple FHIRPath Profile](http://hl7.org/fhir/R5/fhirpath.html#simple) for full details).",
"comment" : "To specify the path to the current action being realized, the %action environment variable is available in this path. For example, to specify the description element of the target action, the path would be %action.description. The path attribute contains a [Simple FHIRPath Subset](http://hl7.org/fhir/R5/fhirpath.html#simple) that allows path traversal, but not calculation.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.dynamicValue.path",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.dynamicValue.expression",
"path" : "PlanDefinition.action.dynamicValue.expression",
"short" : "An expression that provides the dynamic value for the customization",
"definition" : "An expression specifying the value of the customized element.",
"comment" : "The expression may be inlined or may be a reference to a named expression within a logic library referenced by the library element.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.dynamicValue.expression",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Expression"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.action",
"path" : "PlanDefinition.action.action",
"short" : "Groups or Stages",
"definition" : "Sub actions that are contained within the action. The behavior of this action determines the functionality of the sub-actions. For example, a selection behavior of at-most-one indicates that of the sub-actions, at most one may be chosen as part of realizing the action definition.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.action",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "workflow",
"map" : "{InverseRelationship of Definition.partOf}"
},
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.action.id",
"path" : "PlanDefinition.action.action.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.extension",
"path" : "PlanDefinition.action.action.extension",
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.modifierExtension",
"path" : "PlanDefinition.action.action.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.action.linkId",
"path" : "PlanDefinition.action.action.linkId",
"short" : "Unique id for the action in the PlanDefinition",
"definition" : "An identifier that is unique within the PlanDefinition to allow linkage within the realized CarePlan and/or RequestOrchestration.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.linkId",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.prefix",
"path" : "PlanDefinition.action.action.prefix",
"short" : "Stage Name",
"definition" : "A textual description and/or a number that identifies a level within a sequential test. [Source: SME Defined] Examples – Single Stage, Stage 1, Stage 2 (sometimes referred to as L1, L2 L3 or A1, A2 as in USP <711>)\nNote: A Stage may or may not provide a conditional sequence with associated acceptance criteria. [Source: SME Defined] (e.g., dissolution test, pyrogen test - <151>; 21 CFR 610.13 (b) Test for pyrogenic substances)\n\nImplememtation Note: not requried if action.prefix is 'Single Stage'",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.prefix",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.title",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PlanDefinition.action.action.title",
"short" : "Test Name (only reqired if different than above)",
"definition" : "Test Name: The textual description of a procedure or analytical method. [Source: SME Defined]\nExamples: Assay by HPLC, moisture by Karl Fischer, analysis for impurities.\nNote: as defined by the sponsor\nNote: The test name of the action.action can be different than the action. Example, the action test is Microbial Limits and the action.action test is Staphylococcus aureus.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.title",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "workflow",
"map" : "Definition.title"
},
{
"identity" : "rim",
"map" : ".title"
}
]
},
{
"id" : "PlanDefinition.action.action.description",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PlanDefinition.action.action.description",
"short" : "Test Additional Information | Stage Additional Information",
"definition" : "Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined].\n\nImplementation Note: If there is more than one comment, include in this element. Markdown allows formating for clarity.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.description",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "markdown"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "workflow",
"map" : "Definition.description"
},
{
"identity" : "rim",
"map" : ".text"
}
]
},
{
"id" : "PlanDefinition.action.action.textEquivalent",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PlanDefinition.action.action.textEquivalent",
"short" : "Static text equivalent of the action, used if the dynamic aspects cannot be interpreted by the receiving system",
"definition" : "A text equivalent of the action to be performed. This provides a human-interpretable description of the action when the definition is consumed by a system that might not be capable of interpreting it dynamically.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.textEquivalent",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "markdown"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "workflow",
"map" : "Definition.description"
},
{
"identity" : "rim",
"map" : ".text"
}
]
},
{
"id" : "PlanDefinition.action.action.priority",
"path" : "PlanDefinition.action.action.priority",
"short" : "routine | urgent | asap | stat",
"definition" : "Indicates how quickly the action should be addressed with respect to other actions.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.priority",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "RequestPriority"
}
],
"strength" : "required",
"description" : "Identifies the level of importance to be assigned to actioning the request.",
"valueSet" : "http://hl7.org/fhir/ValueSet/request-priority|5.0.0"
},
"mapping" : [
{
"identity" : "rim",
"map" : ".priority"
}
]
},
{
"id" : "PlanDefinition.action.action.code",
"path" : "PlanDefinition.action.action.code",
"short" : "Code representing the meaning of the action or sub-actions",
"definition" : "A code that provides a meaning, grouping, or classification for the action or action group. For example, a section may have a LOINC code for the section of a documentation template. In pharmaceutical quality, an action (Test) such as pH could be classified as a physical property.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.code",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionCode"
}
],
"strength" : "example",
"description" : "Provides examples of actions to be performed.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-code"
},
"mapping" : [
{
"identity" : "rim",
"map" : ".classCode"
}
]
},
{
"id" : "PlanDefinition.action.action.reason",
"path" : "PlanDefinition.action.action.reason",
"short" : "Why the action should be performed",
"definition" : "A description of why this action is necessary or appropriate.",
"comment" : "This is different than the clinical evidence documentation, it's an actual business description of the reason for performing the action.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.reason",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionReasonCode"
}
],
"strength" : "example",
"description" : "Provides examples of reasons for actions to be performed.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-reason-code"
},
"mapping" : [
{
"identity" : "rim",
"map" : ".reasonCode"
}
]
},
{
"id" : "PlanDefinition.action.action.documentation",
"path" : "PlanDefinition.action.action.documentation",
"short" : "Supporting documentation for the intended performer of the action",
"definition" : "Didactic or other informational resources associated with the action that can be provided to the CDS recipient. Information resources can include inline text commentary and links to web resources.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.documentation",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "RelatedArtifact"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.documentation.id",
"path" : "PlanDefinition.action.action.documentation.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "id"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.documentation.extension",
"path" : "PlanDefinition.action.action.documentation.extension",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "url"
}
],
"description" : "Extensions are always sliced by (at least) url",
"rules" : "open"
},
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.documentation.type",
"path" : "PlanDefinition.action.action.documentation.type",
"short" : "documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as",
"definition" : "The type of relationship to the related artifact.",
"comment" : "The presence of both sides of a relationship type (e.g. successor and predecessor) is required to support use cases where one side of a relationship is not represented in FHIR. However, this feature SHALL NOT be used to create bi-directional resource links in FHIR instances. Specifically, following the methodology of \"new points to old\" and \"many points to one\", when using related artifact elements to describe and reference FHIR resources, the type element SHALL be drawn from the fhir-related-artifact-type ValueSet.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "RelatedArtifact.type",
"min" : 1,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"patternCode" : "documentation",
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "RelatedArtifactType"
}
],
"strength" : "required",
"description" : "The type of relationship to the related artifact.",
"valueSet" : "http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0"
}
},
{
"id" : "PlanDefinition.action.action.documentation.classifier",
"path" : "PlanDefinition.action.action.documentation.classifier",
"short" : "Additional classifiers",
"definition" : "Provides additional classifiers of the related artifact.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "RelatedArtifact.classifier",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "RelatedArtifactClassifier"
}
],
"strength" : "example",
"description" : "Additional classifiers for the related artifact.",
"valueSet" : "http://hl7.org/fhir/ValueSet/citation-artifact-classifier"
}
},
{
"id" : "PlanDefinition.action.action.documentation.label",
"path" : "PlanDefinition.action.action.documentation.label",
"short" : "Short label",
"definition" : "A short label that can be used to reference the citation from elsewhere in the containing artifact, such as a footnote index.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "RelatedArtifact.label",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PlanDefinition.action.action.documentation.display",
"path" : "PlanDefinition.action.action.documentation.display",
"short" : "Brief description of the related artifact",
"definition" : "A brief description of the document or knowledge resource being referenced, suitable for display to a consumer.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "RelatedArtifact.display",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PlanDefinition.action.action.documentation.citation",
"path" : "PlanDefinition.action.action.documentation.citation",
"short" : "Bibliographic citation for the artifact",
"definition" : "A bibliographic citation for the related artifact. This text SHOULD be formatted according to an accepted citation format.",
"comment" : "Additional structured information about citations should be captured as extensions.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "RelatedArtifact.citation",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "markdown"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PlanDefinition.action.action.documentation.document",
"path" : "PlanDefinition.action.action.documentation.document",
"short" : "Test or Stage Additional Information Visual Attachments",
"definition" : "Any visual data described andor referenced in additional informatation",
"min" : 1,
"max" : "1",
"base" : {
"path" : "RelatedArtifact.document",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Attachment"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PlanDefinition.action.action.documentation.document.id",
"path" : "PlanDefinition.action.action.documentation.document.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "id"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.documentation.document.extension",
"path" : "PlanDefinition.action.action.documentation.document.extension",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "url"
}
],
"description" : "Extensions are always sliced by (at least) url",
"rules" : "open"
},
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.documentation.document.contentType",
"path" : "PlanDefinition.action.action.documentation.document.contentType",
"short" : "Mime type of the content, with charset etc.",
"definition" : "Identifies the type of the data in the attachment and allows a method to be chosen to interpret or render the data. Includes mime type parameters such as charset where appropriate.",
"requirements" : "Processors of the data need to be able to know how to interpret the data.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Attachment.contentType",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"example" : [
{
"label" : "General",
"valueCode" : "text/plain; charset=UTF-8, image/png"
}
],
"condition" : [
"att-1"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "MimeType"
}
],
"strength" : "required",
"description" : "BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049)",
"valueSet" : "http://hl7.org/fhir/ValueSet/mimetypes|5.0.0"
},
"mapping" : [
{
"identity" : "v2",
"map" : "ED.2+ED.3/RP.2+RP.3. Note conversion may be needed if old style values are being used"
},
{
"identity" : "rim",
"map" : "./mediaType, ./charset"
}
]
},
{
"id" : "PlanDefinition.action.action.documentation.document.language",
"path" : "PlanDefinition.action.action.documentation.document.language",
"short" : "Human language of the content (BCP-47)",
"definition" : "The human language of the content. The value can be any valid value according to BCP 47.",
"requirements" : "Users need to be able to choose between the languages in a set of attachments.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Attachment.language",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"example" : [
{
"label" : "General",
"valueCode" : "en-AU"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "Language"
}
],
"strength" : "required",
"description" : "IETF language tag for a human language.",
"valueSet" : "http://hl7.org/fhir/ValueSet/all-languages|5.0.0",
"additional" : [
{
"purpose" : "starter",
"valueSet" : "http://hl7.org/fhir/ValueSet/languages"
}
]
},
"mapping" : [
{
"identity" : "rim",
"map" : "./language"
}
]
},
{
"id" : "PlanDefinition.action.action.documentation.document.data",
"path" : "PlanDefinition.action.action.documentation.document.data",
"short" : "Data inline, base64ed",
"definition" : "The actual data of the attachment - a sequence of bytes, base64 encoded.",
"comment" : "The base64-encoded data SHALL be expressed in the same character set as the base resource XML or JSON.",
"requirements" : "The data needs to able to be transmitted inline.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Attachment.data",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "base64Binary"
}
],
"condition" : [
"att-1"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "v2",
"map" : "ED.5"
},
{
"identity" : "rim",
"map" : "./data"
}
]
},
{
"id" : "PlanDefinition.action.action.documentation.document.url",
"path" : "PlanDefinition.action.action.documentation.document.url",
"short" : "Uri where the data can be found",
"definition" : "A location where the data can be accessed.",
"comment" : "If both data and url are provided, the url SHALL point to the same content as the data contains. Urls may be relative references or may reference transient locations such as a wrapping envelope using cid: though this has ramifications for using signatures. Relative URLs are interpreted relative to the service url, like a resource reference, rather than relative to the resource itself. If a URL is provided, it SHALL resolve to actual data.",
"requirements" : "The data needs to be transmitted by reference.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Attachment.url",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "url"
}
],
"example" : [
{
"label" : "General",
"valueUrl" : "http://www.acme.com/logo-small.png"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "v2",
"map" : "RP.1+RP.2 - if they refer to a URL (see v2.6)"
},
{
"identity" : "rim",
"map" : "./reference/literal"
}
]
},
{
"id" : "PlanDefinition.action.action.documentation.document.size",
"path" : "PlanDefinition.action.action.documentation.document.size",
"short" : "Number of bytes of content (if url provided)",
"definition" : "The number of bytes of data that make up this attachment (before base64 encoding, if that is done).",
"comment" : "The number of bytes is redundant if the data is provided as a base64binary, but is useful if the data is provided as a url reference.",
"requirements" : "Representing the size allows applications to determine whether they should fetch the content automatically in advance, or refuse to fetch it at all.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Attachment.size",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "integer64"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (needs data type R3 proposal)"
}
]
},
{
"id" : "PlanDefinition.action.action.documentation.document.hash",
"path" : "PlanDefinition.action.action.documentation.document.hash",
"short" : "Hash of the data (sha-1, base64ed)",
"definition" : "The calculated hash of the data using SHA-1. Represented using base64.",
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"requirements" : "Included so that applications can verify that the contents of a location have not changed due to technical failures (e.g., storage rot, transport glitch, incorrect version).",
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"key" : "ele-1",
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{
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{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
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}
],
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],
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{
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}
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"min" : 0,
"max" : "1",
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{
"key" : "ele-1",
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{
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}
]
},
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"id" : "PlanDefinition.action.action.documentation.document.width",
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"id" : "PlanDefinition.action.action.documentation.document.frames",
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"min" : 0,
"max" : "1",
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}
],
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"key" : "ele-1",
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],
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"identity" : "rim",
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]
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"id" : "PlanDefinition.action.action.documentation.document.duration",
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"comment" : "The duration might differ from occurrencePeriod if recording was paused.",
"min" : 0,
"max" : "1",
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"type" : [
{
"code" : "decimal"
}
],
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{
"key" : "ele-1",
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],
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]
},
{
"id" : "PlanDefinition.action.action.documentation.document.pages",
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"max" : "1",
"base" : {
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},
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}
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"key" : "ele-1",
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],
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},
{
"id" : "PlanDefinition.action.action.documentation.resource",
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"comment" : "If the type is predecessor, this is a reference to the succeeding knowledge resource. If the type is successor, this is a reference to the prior knowledge resource.",
"min" : 0,
"max" : "1",
"base" : {
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"max" : "1"
},
"type" : [
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"code" : "canonical",
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}
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"key" : "ele-1",
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}
],
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},
{
"id" : "PlanDefinition.action.action.documentation.resourceReference",
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"comment" : "If both resource and resourceReference are present, they SHOULD be consistent and reference the same resource. Although relatedArtifact is intended to support references to definitional resources, there are cases where non-definitional resources can be definitional (such as Location where the kind is mode). Related artifacts SHOULD be used to reference definitional resources, and profiles SHOULD be used to make that explicit for particular use cases.",
"min" : 0,
"max" : "1",
"base" : {
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"min" : 0,
"max" : "1"
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]
}
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{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
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"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
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"isSummary" : true
},
{
"id" : "PlanDefinition.action.action.documentation.publicationStatus",
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"definition" : "The publication status of the artifact being referred to.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "RelatedArtifact.publicationStatus",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
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{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
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"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
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}
],
"strength" : "required",
"description" : "Publication status of an artifact being referred to.",
"valueSet" : "http://hl7.org/fhir/ValueSet/publication-status|5.0.0"
}
},
{
"id" : "PlanDefinition.action.action.documentation.publicationDate",
"path" : "PlanDefinition.action.action.documentation.publicationDate",
"short" : "Date of publication of the artifact being referred to",
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"min" : 0,
"max" : "1",
"base" : {
"path" : "RelatedArtifact.publicationDate",
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"max" : "1"
},
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}
],
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"key" : "ele-1",
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}
],
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},
{
"id" : "PlanDefinition.action.action.goalId",
"path" : "PlanDefinition.action.action.goalId",
"short" : "Reference to Acceptance Criteria",
"definition" : "Identifies goals that this action supports. The reference must be to a goal element defined within this plan definition. In pharmaceutical quality, a goal represents acceptance criteria (Goal) for a given action (Test), so the goalId would be the unique id of a defined goal element establishing the acceptance criteria for the action.",
"min" : 0,
"max" : "*",
"base" : {
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"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "id"
}
],
"condition" : [
"pld-3"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
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"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.subject[x]",
"path" : "PlanDefinition.action.action.subject[x]",
"short" : "Type of individual the action is focused on",
"definition" : "A code, group definition, or canonical reference that describes the intended subject of the action and its children, if any. Canonical references are allowed to support the definition of protocols for drug and substance quality specifications, and is allowed to reference a MedicinalProductDefinition, SubstanceDefinition, AdministrableProductDefinition, ManufacturedItemDefinition, or PackagedProductDefinition resource.",
"comment" : "The subject of an action overrides the subject at a parent action or on the root of the PlanDefinition if specified.\n\nIn addition, because the subject needs to be resolved during realization, use of subjects in actions (or in the ActivityDefinition referenced by the action) resolves based on the set of subjects supplied in context and by type (i.e. the patient subject would resolve to a resource of type Patient).",
"requirements" : "Multiple steps in a protocol often have different groups of steps that are focused on testing different things. The subject of an action specifies the focus of the action and any child actions.",
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"max" : "1",
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},
"type" : [
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},
{
"code" : "Reference",
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]
},
{
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}
],
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"key" : "ele-1",
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}
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"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "SubjectType"
}
],
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"valueSet" : "http://hl7.org/fhir/ValueSet/participant-resource-types"
},
"mapping" : [
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"identity" : "workflow",
"map" : "Definition.subject"
},
{
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}
]
},
{
"id" : "PlanDefinition.action.action.trigger",
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"min" : 0,
"max" : "*",
"base" : {
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"min" : 0,
"max" : "*"
},
"type" : [
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"code" : "TriggerDefinition"
}
],
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{
"key" : "ele-1",
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}
],
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"mapping" : [
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"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.condition",
"path" : "PlanDefinition.action.action.condition",
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"comment" : "When multiple conditions of the same kind are present, the effects are combined using AND semantics, so the overall condition is true only if all the conditions are true.",
"min" : 0,
"max" : "*",
"base" : {
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"max" : "*"
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}
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"key" : "ele-1",
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"mapping" : [
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}
]
},
{
"id" : "PlanDefinition.action.action.condition.id",
"path" : "PlanDefinition.action.action.condition.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
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],
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"identity" : "rim",
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}
]
},
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"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
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"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
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{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
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"mapping" : [
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"identity" : "rim",
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}
]
},
{
"id" : "PlanDefinition.action.action.condition.modifierExtension",
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"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
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"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.action.condition.kind",
"path" : "PlanDefinition.action.action.condition.kind",
"short" : "applicability | start | stop",
"definition" : "The kind of condition.",
"comment" : "Applicability criteria are used to determine immediate applicability when a plan definition is applied to a given context. Start and stop criteria are carried through application and used to describe enter/exit criteria for an action.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.condition.kind",
"min" : 1,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionConditionKind"
}
],
"strength" : "required",
"description" : "Defines the kinds of conditions that can appear on actions.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-condition-kind|5.0.0"
},
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.condition.expression",
"path" : "PlanDefinition.action.action.condition.expression",
"short" : "Boolean-valued expression",
"definition" : "An expression that returns true or false, indicating whether the condition is satisfied.",
"comment" : "The expression may be inlined or may be a reference to a named expression within a logic library referenced by the library element.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.condition.expression",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Expression"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.input",
"path" : "PlanDefinition.action.action.input",
"short" : "Input data requirements",
"definition" : "Defines input data requirements for the action.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.input",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "pld-0",
"severity" : "error",
"human" : "Input data elements must have a requirement or a relatedData, but not both",
"expression" : "requirement.exists() xor relatedData.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/PlanDefinition"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.input.id",
"path" : "PlanDefinition.action.action.input.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.input.extension",
"path" : "PlanDefinition.action.action.input.extension",
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.input.modifierExtension",
"path" : "PlanDefinition.action.action.input.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.action.input.title",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PlanDefinition.action.action.input.title",
"short" : "User-visible title",
"definition" : "A human-readable label for the data requirement used to label data flows in BPMN or similar diagrams. Also provides a human readable label when rendering the data requirement that conveys its purpose to human readers.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.input.title",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.input.requirement",
"path" : "PlanDefinition.action.action.input.requirement",
"short" : "What data is provided",
"definition" : "Defines the data that is to be provided as input to the action.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.input.requirement",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "DataRequirement"
}
],
"condition" : [
"pld-0"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.input.relatedData",
"path" : "PlanDefinition.action.action.input.relatedData",
"short" : "What data is provided",
"definition" : "Points to an existing input or output element that provides data to this input.",
"comment" : "The relatedData element allows indicating that an input to a parent action is an input to specific child actions. It also allows the output of one action to be identified as the input to a different action",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.input.relatedData",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "id"
}
],
"condition" : [
"pld-0"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.output",
"path" : "PlanDefinition.action.action.output",
"short" : "Output data definition",
"definition" : "Defines the outputs of the action, if any.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.output",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "pld-1",
"severity" : "error",
"human" : "Output data element must have a requirement or a relatedData, but not both",
"expression" : "requirement.exists() xor relatedData.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/PlanDefinition"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.output.id",
"path" : "PlanDefinition.action.action.output.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.output.extension",
"path" : "PlanDefinition.action.action.output.extension",
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.output.modifierExtension",
"path" : "PlanDefinition.action.action.output.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.action.output.title",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PlanDefinition.action.action.output.title",
"short" : "User-visible title",
"definition" : "A human-readable label for the data requirement used to label data flows in BPMN or similar diagrams. Also provides a human readable label when rendering the data requirement that conveys its purpose to human readers.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.output.title",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.output.requirement",
"path" : "PlanDefinition.action.action.output.requirement",
"short" : "What data is provided",
"definition" : "Defines the data that results as output from the action.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.output.requirement",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "DataRequirement"
}
],
"condition" : [
"pld-1"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.output.relatedData",
"path" : "PlanDefinition.action.action.output.relatedData",
"short" : "What data is provided",
"definition" : "Points to an existing input or output element that is results as output from the action.",
"comment" : "The relatedData element allows indicating that the output of child action is also the output of a parent action. It also allows the input of one action to be identified as the output of a different action",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.output.relatedData",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"condition" : [
"pld-1"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.relatedAction",
"path" : "PlanDefinition.action.action.relatedAction",
"short" : "Relationship to another action",
"definition" : "A relationship to another action such as \"before\" or \"30-60 minutes after start of\".",
"comment" : "When an action depends on multiple actions, the meaning is that all actions are dependencies, rather than that any of the actions are a dependency.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.relatedAction",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"condition" : [
"pld-4"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.relatedAction.id",
"path" : "PlanDefinition.action.action.relatedAction.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.relatedAction.extension",
"path" : "PlanDefinition.action.action.relatedAction.extension",
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.relatedAction.modifierExtension",
"path" : "PlanDefinition.action.action.relatedAction.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.action.relatedAction.targetId",
"path" : "PlanDefinition.action.action.relatedAction.targetId",
"short" : "What action is this related to",
"definition" : "The element id of the target related action.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.relatedAction.targetId",
"min" : 1,
"max" : "1"
},
"type" : [
{
"code" : "id"
}
],
"condition" : [
"pld-4"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.relatedAction.relationship",
"path" : "PlanDefinition.action.action.relatedAction.relationship",
"short" : "before | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end",
"definition" : "The relationship of the start of this action to the related action.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.relatedAction.relationship",
"min" : 1,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionRelationshipType"
}
],
"strength" : "required",
"description" : "Defines the types of relationships between actions.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0"
},
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.relatedAction.endRelationship",
"path" : "PlanDefinition.action.action.relatedAction.endRelationship",
"short" : "before | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end",
"definition" : "The relationship of the end of this action to the related action.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.relatedAction.endRelationship",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionRelationshipType"
}
],
"strength" : "required",
"description" : "Defines the types of relationships between actions.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0"
},
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.relatedAction.offset[x]",
"path" : "PlanDefinition.action.action.relatedAction.offset[x]",
"short" : "Time offset for the relationship",
"definition" : "A duration or range of durations to apply to the relationship. For example, 30-60 minutes before.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.relatedAction.offset[x]",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Duration"
},
{
"code" : "Range"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.timing[x]",
"path" : "PlanDefinition.action.action.timing[x]",
"short" : "When the action should take place",
"definition" : "An optional value describing when the action should be performed.",
"comment" : "The intent of the timing element is to provide timing when the action should be performed. As a definitional resource, this timing is interpreted as part of an apply operation so that the timing of the result actions in a CarePlan or RequestOrchestration, for example, would be specified by evaluating the timing definition in the context of the apply and setting the resulting timing on the appropriate elements of the target resource. If the timing is an Age, the activity is expected to be performed when the subject is the given Age. When the timing is a Duration, the activity is expected to be performed within the specified duration from the apply. When the timing is a Range, it may be a range of Ages or Durations, providing a range for the expected timing of the resulting activity. When the timing is a Timing, it is establishing a schedule for the timing of the resulting activity.",
"requirements" : "Allows prompting for activities and detection of missed planned activities.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.timing[x]",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Age"
},
{
"code" : "Duration"
},
{
"code" : "Range"
},
{
"code" : "Timing"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : ".effectiveTime"
}
]
},
{
"id" : "PlanDefinition.action.action.location",
"path" : "PlanDefinition.action.action.location",
"short" : "Where it should happen",
"definition" : "Identifies the facility where the action will occur; e.g. home, hospital, specific clinic, etc.",
"comment" : "May reference a specific clinical location or may just identify a type of location.",
"requirements" : "Helps in planning of activity.",
"alias" : [
"facility"
],
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.location",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableReference",
"targetProfile" : [
"http://hl7.org/fhir/StructureDefinition/Location"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : ".participation[typeCode=LOC].role"
}
]
},
{
"id" : "PlanDefinition.action.action.participant",
"path" : "PlanDefinition.action.action.participant",
"short" : "Who should participate in the action",
"definition" : "Indicates who should participate in performing the action described.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.participant",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : ".participation[typeCode=PFM]"
}
]
},
{
"id" : "PlanDefinition.action.action.participant.id",
"path" : "PlanDefinition.action.action.participant.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.participant.extension",
"path" : "PlanDefinition.action.action.participant.extension",
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.participant.modifierExtension",
"path" : "PlanDefinition.action.action.participant.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.action.participant.actorId",
"path" : "PlanDefinition.action.action.participant.actorId",
"short" : "What actor",
"definition" : "A reference to the id element of the actor who will participate in this action.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.participant.actorId",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.participant.type",
"path" : "PlanDefinition.action.action.participant.type",
"short" : "careteam | device | group | healthcareservice | location | organization | patient | practitioner | practitionerrole | relatedperson",
"definition" : "The type of participant in the action.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.participant.type",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActivityParticipantType"
}
],
"strength" : "required",
"description" : "The type of participant in the activity.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0"
},
"mapping" : [
{
"identity" : "rim",
"map" : ".role.classCode"
}
]
},
{
"id" : "PlanDefinition.action.action.participant.typeCanonical",
"path" : "PlanDefinition.action.action.participant.typeCanonical",
"short" : "Who or what can participate",
"definition" : "The type of participant in the action.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.participant.typeCanonical",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "canonical",
"targetProfile" : [
"http://hl7.org/fhir/StructureDefinition/CapabilityStatement"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : ".role.classCode"
}
]
},
{
"id" : "PlanDefinition.action.action.participant.typeReference",
"path" : "PlanDefinition.action.action.participant.typeReference",
"short" : "Who or what can participate",
"definition" : "The type of participant in the action.",
"comment" : "When this element is a reference, it SHOULD be a reference to a definitional resource (for example, a location type, rather than a specific location).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.participant.typeReference",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : [
"http://hl7.org/fhir/StructureDefinition/CareTeam",
"http://hl7.org/fhir/StructureDefinition/Device",
"http://hl7.org/fhir/StructureDefinition/DeviceDefinition",
"http://hl7.org/fhir/StructureDefinition/Endpoint",
"http://hl7.org/fhir/StructureDefinition/Group",
"http://hl7.org/fhir/StructureDefinition/HealthcareService",
"http://hl7.org/fhir/StructureDefinition/Location",
"http://hl7.org/fhir/StructureDefinition/Organization",
"http://hl7.org/fhir/StructureDefinition/Patient",
"http://hl7.org/fhir/StructureDefinition/Practitioner",
"http://hl7.org/fhir/StructureDefinition/PractitionerRole",
"http://hl7.org/fhir/StructureDefinition/RelatedPerson"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : ".role.classCode"
}
]
},
{
"id" : "PlanDefinition.action.action.participant.role",
"path" : "PlanDefinition.action.action.participant.role",
"short" : "E.g. Nurse, Surgeon, Parent",
"definition" : "The role the participant should play in performing the described action.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.participant.role",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionParticipantRole"
}
],
"strength" : "example",
"description" : "Defines roles played by participants for the action.",
"valueSet" : "http://terminology.hl7.org/ValueSet/action-participant-role"
},
"mapping" : [
{
"identity" : "rim",
"map" : ".role.code"
}
]
},
{
"id" : "PlanDefinition.action.action.participant.function",
"path" : "PlanDefinition.action.action.participant.function",
"short" : "E.g. Author, Reviewer, Witness, etc",
"definition" : "Indicates how the actor will be involved in the action - author, reviewer, witness, etc.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.participant.function",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionParticipantFunction"
}
],
"strength" : "example",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-participant-function"
},
"mapping" : [
{
"identity" : "rim",
"map" : ".role.code"
}
]
},
{
"id" : "PlanDefinition.action.action.type",
"path" : "PlanDefinition.action.action.type",
"short" : "create | update | remove | fire-event",
"definition" : "The type of action to perform (create, update, remove).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.type",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionType"
}
],
"strength" : "extensible",
"description" : "The type of action to be performed.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-type"
},
"mapping" : [
{
"identity" : "rim",
"map" : ".moodCode { Maybe? this is effectively Create, Update, or Delete }"
}
]
},
{
"id" : "PlanDefinition.action.action.groupingBehavior",
"path" : "PlanDefinition.action.action.groupingBehavior",
"short" : "visual-group | logical-group | sentence-group",
"definition" : "Defines the grouping behavior for the action and its children.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.groupingBehavior",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"meaningWhenMissing" : "If no grouping behavior is specified but the action has children (i.e. is a group), the grouping behavior is assumed to be `logical-group`.",
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionGroupingBehavior"
}
],
"strength" : "required",
"description" : "Defines organization behavior of a group.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-grouping-behavior|5.0.0"
},
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.action.selectionBehavior",
"path" : "PlanDefinition.action.action.selectionBehavior",
"short" : "any | all | all-or-none | exactly-one | at-most-one | one-or-more",
"definition" : "Defines the selection behavior for the action and its children.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.selectionBehavior",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"meaningWhenMissing" : "If no selection behavior is specified but the action has children (i.e. is a group), the selection behavior is assumed to be `all`.",
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionSelectionBehavior"
}
],
"strength" : "required",
"description" : "Defines selection behavior of a group.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-selection-behavior|5.0.0"
},
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.action.requiredBehavior",
"path" : "PlanDefinition.action.action.requiredBehavior",
"short" : "must | could | must-unless-documented",
"definition" : "Defines the required behavior for the action.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.requiredBehavior",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"meaningWhenMissing" : "If no required behavior is specified but the action has children (i.e. is a group), the required behavior is assumed to be `could`.",
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionRequiredBehavior"
}
],
"strength" : "required",
"description" : "Defines expectations around whether an action or action group is required.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-required-behavior|5.0.0"
},
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.action.precheckBehavior",
"path" : "PlanDefinition.action.action.precheckBehavior",
"short" : "yes | no",
"definition" : "Defines whether the action should usually be preselected.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.precheckBehavior",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"meaningWhenMissing" : "If no precheck behavior is specified but the action has children (i.e. is a group), the precheck behavior is assumed to be `no`.",
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionPrecheckBehavior"
}
],
"strength" : "required",
"description" : "Defines selection frequency behavior for an action or group.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-precheck-behavior|5.0.0"
},
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.action.cardinalityBehavior",
"path" : "PlanDefinition.action.action.cardinalityBehavior",
"short" : "single | multiple",
"definition" : "Defines whether the action can be selected multiple times.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.cardinalityBehavior",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"meaningWhenMissing" : "If no cardinality behavior is specified but the action has children (i.e. is a group), the cardinality behavior is assumed to be `single`.",
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionCardinalityBehavior"
}
],
"strength" : "required",
"description" : "Defines behavior for an action or a group for how many times that item may be repeated.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-cardinality-behavior|5.0.0"
},
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.action.definition[x]",
"path" : "PlanDefinition.action.action.definition[x]",
"short" : "Description of the activity to be performed",
"definition" : "A reference to an ActivityDefinition that describes the action to be taken in detail, a MessageDefinition describing a message to be snet, a PlanDefinition that describes a series of actions to be taken, a Questionnaire that should be filled out, a SpecimenDefinition describing a specimen to be collected, or an ObservationDefinition that specifies what observation should be captured.",
"comment" : "Note that the definition is optional, and if no definition is specified, a dynamicValue with a root ($this) path can be used to define the entire resource dynamically.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.definition[x]",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "canonical",
"targetProfile" : [
"http://hl7.org/fhir/StructureDefinition/ActivityDefinition",
"http://hl7.org/fhir/StructureDefinition/MessageDefinition",
"http://hl7.org/fhir/StructureDefinition/ObservationDefinition",
"http://hl7.org/fhir/StructureDefinition/PlanDefinition",
"http://hl7.org/fhir/StructureDefinition/Questionnaire",
"http://hl7.org/fhir/StructureDefinition/SpecimenDefinition"
]
},
{
"code" : "uri"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "Act[classCode=ACT; moodCode=DEFN]"
}
]
},
{
"id" : "PlanDefinition.action.action.transform",
"path" : "PlanDefinition.action.action.transform",
"short" : "Transform to apply the template",
"definition" : "A reference to a StructureMap resource that defines a transform that can be executed to produce the intent resource using the ActivityDefinition instance as the input.",
"comment" : "Note that when a referenced ActivityDefinition also defines a transform, the transform specified here generally takes precedence. In addition, if both a transform and dynamic values are specific, the dynamic values are applied to the result of the transform.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.transform",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "canonical",
"targetProfile" : [
"http://hl7.org/fhir/StructureDefinition/StructureMap"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.action.dynamicValue",
"path" : "PlanDefinition.action.action.dynamicValue",
"short" : "Dynamic aspects of the definition",
"definition" : "Customizations that should be applied to the statically defined resource. For example, if the dosage of a medication must be computed based on the patient's weight, a customization would be used to specify an expression that calculated the weight, and the path on the resource that would contain the result.",
"comment" : "Dynamic values are applied in the order in which they are defined in the PlanDefinition resource. Note that when dynamic values are also specified by a referenced ActivityDefinition, the dynamicValues from the ActivityDefinition are applied first, followed by the dynamicValues specified here. In addition, if both a transform and dynamic values are specific, the dynamic values are applied to the result of the transform.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.dynamicValue",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.action.dynamicValue.id",
"path" : "PlanDefinition.action.action.dynamicValue.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.dynamicValue.extension",
"path" : "PlanDefinition.action.action.dynamicValue.extension",
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.dynamicValue.modifierExtension",
"path" : "PlanDefinition.action.action.dynamicValue.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.action.dynamicValue.path",
"path" : "PlanDefinition.action.action.dynamicValue.path",
"short" : "The path to the element to be set dynamically",
"definition" : "The path to the element to be customized. This is the path on the resource that will hold the result of the calculation defined by the expression. The specified path SHALL be a FHIRPath resolvable on the specified target type of the ActivityDefinition, and SHALL consist only of identifiers, constant indexers, and a restricted subset of functions. The path is allowed to contain qualifiers (.) to traverse sub-elements, as well as indexers ([x]) to traverse multiple-cardinality sub-elements (see the [Simple FHIRPath Profile](http://hl7.org/fhir/R5/fhirpath.html#simple) for full details).",
"comment" : "To specify the path to the current action being realized, the %action environment variable is available in this path. For example, to specify the description element of the target action, the path would be %action.description. The path attribute contains a [Simple FHIRPath Subset](http://hl7.org/fhir/R5/fhirpath.html#simple) that allows path traversal, but not calculation.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.dynamicValue.path",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.action.dynamicValue.expression",
"path" : "PlanDefinition.action.action.dynamicValue.expression",
"short" : "An expression that provides the dynamic value for the customization",
"definition" : "An expression specifying the value of the customized element.",
"comment" : "The expression may be inlined or may be a reference to a named expression within a logic library referenced by the library element.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.dynamicValue.expression",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Expression"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.action.action",
"path" : "PlanDefinition.action.action.action",
"short" : "Sub-Test",
"definition" : "Sub actions that are contained within the action. The behavior of this action determines the functionality of the sub-actions. For example, a selection behavior of at-most-one indicates that of the sub-actions, at most one may be chosen as part of realizing the action definition.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.action",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "cmc-subtest-rrt",
"severity" : "error",
"human" : "a subtest's prefix represents relative retention time, should it exist",
"expression" : "prefix.exists() implies prefix.single() = 'RRT'",
"source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "workflow",
"map" : "{InverseRelationship of Definition.partOf}"
},
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.action.action.id",
"path" : "PlanDefinition.action.action.action.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.action.extension",
"path" : "PlanDefinition.action.action.action.extension",
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.action.modifierExtension",
"path" : "PlanDefinition.action.action.action.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.action.action.linkId",
"path" : "PlanDefinition.action.action.action.linkId",
"short" : "Unique id for the action in the PlanDefinition",
"definition" : "An identifier that is unique within the PlanDefinition to allow linkage within the realized CarePlan and/or RequestOrchestration.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.linkId",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.action.prefix",
"path" : "PlanDefinition.action.action.action.prefix",
"short" : "RRT",
"definition" : "RRT: The ratio of the retention time of a component relative to that of another used as a reference obtained under identical conditions as an alias for the name of the unidentified impurities. [Source: Adapted from USP] \nExample: 1:23 (a ratio)\nNote: This is the title or name of the impurity (sometimes expressed as a ratio) and not the value.\n\nImplementation Note: This value can only be 'RRT'. It is used to desinate that RRT value(s) expressed in action.action.action.title are relative retention times.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.prefix",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
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"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.action.title",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PlanDefinition.action.action.action.title",
"short" : "Test Name | RRT (complex testing)",
"definition" : "Test Name: The textual description of a procedure or analytical method. [Source: SME Defined]\nExamples: Assay by HPLC, moisture by Karl Fischer, analysis for impurities.\nNote: as defined by the sponsor\nNote: The test name of the action.action can be different than the action. Example, the action test is Microbial Limits and the action.action test is Staphylococcus aureus.\n\nRRT: The ratio of the retention time of a component relative to that of another used as a reference obtained under identical conditions as an alias for the name of the unidentified impurities. [Source: Adapted from USP] \nExample: 1:23 (a ratio)\nNote: This is the title or name of the impurity (sometimes expressed as a ratio) and not the value. \n\nImplementation Note: For RRT, if there is a range associated with the unidentified peak then the range can be entered instead of indivual values. E.g.: 0.4 – 0.8.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.title",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "workflow",
"map" : "Definition.title"
},
{
"identity" : "rim",
"map" : ".title"
}
]
},
{
"id" : "PlanDefinition.action.action.action.description",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PlanDefinition.action.action.action.description",
"short" : "Test Additional Information | Stage Additional Information",
"definition" : "Test Additional Information: Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined].\nStage Additional Information: Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined]\nIf there is more than one comment, include in this element. Markdown allows formating for clarity. If both types are present, indicate type.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.description",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "markdown"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "workflow",
"map" : "Definition.description"
},
{
"identity" : "rim",
"map" : ".text"
}
]
},
{
"id" : "PlanDefinition.action.action.action.textEquivalent",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PlanDefinition.action.action.action.textEquivalent",
"short" : "Static text equivalent of the action, used if the dynamic aspects cannot be interpreted by the receiving system",
"definition" : "A text equivalent of the action to be performed. This provides a human-interpretable description of the action when the definition is consumed by a system that might not be capable of interpreting it dynamically.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.textEquivalent",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "markdown"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "workflow",
"map" : "Definition.description"
},
{
"identity" : "rim",
"map" : ".text"
}
]
},
{
"id" : "PlanDefinition.action.action.action.priority",
"path" : "PlanDefinition.action.action.action.priority",
"short" : "routine | urgent | asap | stat",
"definition" : "Indicates how quickly the action should be addressed with respect to other actions.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.priority",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "RequestPriority"
}
],
"strength" : "required",
"description" : "Identifies the level of importance to be assigned to actioning the request.",
"valueSet" : "http://hl7.org/fhir/ValueSet/request-priority|5.0.0"
},
"mapping" : [
{
"identity" : "rim",
"map" : ".priority"
}
]
},
{
"id" : "PlanDefinition.action.action.action.code",
"path" : "PlanDefinition.action.action.action.code",
"short" : "Code representing the meaning of the action or sub-actions",
"definition" : "A code that provides a meaning, grouping, or classification for the action or action group. For example, a section may have a LOINC code for the section of a documentation template. In pharmaceutical quality, an action (Test) such as pH could be classified as a physical property.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.code",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionCode"
}
],
"strength" : "example",
"description" : "Provides examples of actions to be performed.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-code"
},
"mapping" : [
{
"identity" : "rim",
"map" : ".classCode"
}
]
},
{
"id" : "PlanDefinition.action.action.action.reason",
"path" : "PlanDefinition.action.action.action.reason",
"short" : "Why the action should be performed",
"definition" : "A description of why this action is necessary or appropriate.",
"comment" : "This is different than the clinical evidence documentation, it's an actual business description of the reason for performing the action.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.reason",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionReasonCode"
}
],
"strength" : "example",
"description" : "Provides examples of reasons for actions to be performed.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-reason-code"
},
"mapping" : [
{
"identity" : "rim",
"map" : ".reasonCode"
}
]
},
{
"id" : "PlanDefinition.action.action.action.documentation",
"path" : "PlanDefinition.action.action.action.documentation",
"short" : "Supporting documentation for the intended performer of the action",
"definition" : "Didactic or other informational resources associated with the action that can be provided to the CDS recipient. Information resources can include inline text commentary and links to web resources.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.documentation",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "RelatedArtifact"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
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"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.action.goalId",
"path" : "PlanDefinition.action.action.action.goalId",
"short" : "Reference to Acceptance Criteria",
"definition" : "Identifies goals that this action supports. The reference must be to a goal element defined within this plan definition. In pharmaceutical quality, a goal represents acceptance criteria (Goal) for a given action (Test), so the goalId would be the unique id of a defined goal element establishing the acceptance criteria for the action.",
"min" : 1,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.goalId",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "id"
}
],
"condition" : [
"pld-3"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.action.subject[x]",
"path" : "PlanDefinition.action.action.action.subject[x]",
"short" : "Type of individual the action is focused on",
"definition" : "A code, group definition, or canonical reference that describes the intended subject of the action and its children, if any. Canonical references are allowed to support the definition of protocols for drug and substance quality specifications, and is allowed to reference a MedicinalProductDefinition, SubstanceDefinition, AdministrableProductDefinition, ManufacturedItemDefinition, or PackagedProductDefinition resource.",
"comment" : "The subject of an action overrides the subject at a parent action or on the root of the PlanDefinition if specified.\n\nIn addition, because the subject needs to be resolved during realization, use of subjects in actions (or in the ActivityDefinition referenced by the action) resolves based on the set of subjects supplied in context and by type (i.e. the patient subject would resolve to a resource of type Patient).",
"requirements" : "Multiple steps in a protocol often have different groups of steps that are focused on testing different things. The subject of an action specifies the focus of the action and any child actions.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.subject[x]",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
},
{
"code" : "Reference",
"targetProfile" : [
"http://hl7.org/fhir/StructureDefinition/Group"
]
},
{
"code" : "canonical"
}
],
"meaningWhenMissing" : "Patient",
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "SubjectType"
}
],
"strength" : "extensible",
"description" : "The possible types of subjects for a plan definition (E.g. Patient, Practitioner, Organization, Location, etc.).",
"valueSet" : "http://hl7.org/fhir/ValueSet/participant-resource-types"
},
"mapping" : [
{
"identity" : "workflow",
"map" : "Definition.subject"
},
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.action.trigger",
"path" : "PlanDefinition.action.action.action.trigger",
"short" : "When the action should be triggered",
"definition" : "A description of when the action should be triggered. When multiple triggers are specified on an action, any triggering event invokes the action.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.trigger",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "TriggerDefinition"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.action.condition",
"path" : "PlanDefinition.action.action.action.condition",
"short" : "Whether or not the action is applicable",
"definition" : "An expression that describes applicability criteria or start/stop conditions for the action.",
"comment" : "When multiple conditions of the same kind are present, the effects are combined using AND semantics, so the overall condition is true only if all the conditions are true.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.condition",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
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"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.action.condition.id",
"path" : "PlanDefinition.action.action.action.condition.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.action.condition.extension",
"path" : "PlanDefinition.action.action.action.condition.extension",
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.action.condition.modifierExtension",
"path" : "PlanDefinition.action.action.action.condition.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.action.action.condition.kind",
"path" : "PlanDefinition.action.action.action.condition.kind",
"short" : "applicability | start | stop",
"definition" : "The kind of condition.",
"comment" : "Applicability criteria are used to determine immediate applicability when a plan definition is applied to a given context. Start and stop criteria are carried through application and used to describe enter/exit criteria for an action.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.condition.kind",
"min" : 1,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionConditionKind"
}
],
"strength" : "required",
"description" : "Defines the kinds of conditions that can appear on actions.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-condition-kind|5.0.0"
},
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.action.condition.expression",
"path" : "PlanDefinition.action.action.action.condition.expression",
"short" : "Boolean-valued expression",
"definition" : "An expression that returns true or false, indicating whether the condition is satisfied.",
"comment" : "The expression may be inlined or may be a reference to a named expression within a logic library referenced by the library element.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.condition.expression",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Expression"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.action.input",
"path" : "PlanDefinition.action.action.action.input",
"short" : "Input data requirements",
"definition" : "Defines input data requirements for the action.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.input",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "pld-0",
"severity" : "error",
"human" : "Input data elements must have a requirement or a relatedData, but not both",
"expression" : "requirement.exists() xor relatedData.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/PlanDefinition"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.action.input.id",
"path" : "PlanDefinition.action.action.action.input.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.action.input.extension",
"path" : "PlanDefinition.action.action.action.input.extension",
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.action.input.modifierExtension",
"path" : "PlanDefinition.action.action.action.input.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.action.action.input.title",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PlanDefinition.action.action.action.input.title",
"short" : "User-visible title",
"definition" : "A human-readable label for the data requirement used to label data flows in BPMN or similar diagrams. Also provides a human readable label when rendering the data requirement that conveys its purpose to human readers.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.input.title",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.action.input.requirement",
"path" : "PlanDefinition.action.action.action.input.requirement",
"short" : "What data is provided",
"definition" : "Defines the data that is to be provided as input to the action.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.input.requirement",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "DataRequirement"
}
],
"condition" : [
"pld-0"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.action.input.relatedData",
"path" : "PlanDefinition.action.action.action.input.relatedData",
"short" : "What data is provided",
"definition" : "Points to an existing input or output element that provides data to this input.",
"comment" : "The relatedData element allows indicating that an input to a parent action is an input to specific child actions. It also allows the output of one action to be identified as the input to a different action",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.input.relatedData",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "id"
}
],
"condition" : [
"pld-0"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.action.output",
"path" : "PlanDefinition.action.action.action.output",
"short" : "Output data definition",
"definition" : "Defines the outputs of the action, if any.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.output",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "pld-1",
"severity" : "error",
"human" : "Output data element must have a requirement or a relatedData, but not both",
"expression" : "requirement.exists() xor relatedData.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/PlanDefinition"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.action.output.id",
"path" : "PlanDefinition.action.action.action.output.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.action.output.extension",
"path" : "PlanDefinition.action.action.action.output.extension",
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.action.output.modifierExtension",
"path" : "PlanDefinition.action.action.action.output.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.action.action.output.title",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PlanDefinition.action.action.action.output.title",
"short" : "User-visible title",
"definition" : "A human-readable label for the data requirement used to label data flows in BPMN or similar diagrams. Also provides a human readable label when rendering the data requirement that conveys its purpose to human readers.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.output.title",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.action.output.requirement",
"path" : "PlanDefinition.action.action.action.output.requirement",
"short" : "What data is provided",
"definition" : "Defines the data that results as output from the action.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.output.requirement",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "DataRequirement"
}
],
"condition" : [
"pld-1"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.action.output.relatedData",
"path" : "PlanDefinition.action.action.action.output.relatedData",
"short" : "What data is provided",
"definition" : "Points to an existing input or output element that is results as output from the action.",
"comment" : "The relatedData element allows indicating that the output of child action is also the output of a parent action. It also allows the input of one action to be identified as the output of a different action",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.output.relatedData",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"condition" : [
"pld-1"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.action.relatedAction",
"path" : "PlanDefinition.action.action.action.relatedAction",
"short" : "Relationship to another action",
"definition" : "A relationship to another action such as \"before\" or \"30-60 minutes after start of\".",
"comment" : "When an action depends on multiple actions, the meaning is that all actions are dependencies, rather than that any of the actions are a dependency.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.relatedAction",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"condition" : [
"pld-4"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.action.relatedAction.id",
"path" : "PlanDefinition.action.action.action.relatedAction.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.action.relatedAction.extension",
"path" : "PlanDefinition.action.action.action.relatedAction.extension",
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.action.relatedAction.modifierExtension",
"path" : "PlanDefinition.action.action.action.relatedAction.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PlanDefinition.action.action.action.relatedAction.targetId",
"path" : "PlanDefinition.action.action.action.relatedAction.targetId",
"short" : "What action is this related to",
"definition" : "The element id of the target related action.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.relatedAction.targetId",
"min" : 1,
"max" : "1"
},
"type" : [
{
"code" : "id"
}
],
"condition" : [
"pld-4"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.action.relatedAction.relationship",
"path" : "PlanDefinition.action.action.action.relatedAction.relationship",
"short" : "before | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end",
"definition" : "The relationship of the start of this action to the related action.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.relatedAction.relationship",
"min" : 1,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ActionRelationshipType"
}
],
"strength" : "required",
"description" : "Defines the types of relationships between actions.",
"valueSet" : "http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0"
},
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.action.action.action.relatedAction.endRelationship",
"path" : "PlanDefinition.action.action.action.relatedAction.endRelationship",
"short" : "before | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end",
"definition" : "The relationship of the end of this action to the related action.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.action.relatedAction.endRelationship",
"min" : 0,
"max" : "1"
},
&n }
]
},
{
"id" : "PlanDefinition.asNeeded[x]",
"path" : "PlanDefinition.asNeeded[x]",
"short" : "Preconditions for service",
"definition" : "If a CodeableConcept is present, it indicates the pre-condition for performing the service. For example \"pain\", \"on flare-up\", etc.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.asNeeded[x]",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "boolean"
},
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ProcedureAsNeededReason"
}
],
"strength" : "example",
"description" : "A coded concept identifying the pre-condition that should hold prior to performing a procedure. For example \"pain\", \"on flare-up\", etc.",
"valueSet" : "http://hl7.org/fhir/ValueSet/medication-as-needed-reason"
},
"mapping" : [
{
"identity" : "rim",
"map" : "boolean: precondition.negationInd (inversed - so negationInd = true means asNeeded=false CodeableConcept: precondition.observationEventCriterion[code=\"Assertion\"].value"
}
]
}
]
},
"differential" : {
"element" : [
{
"id" : "PlanDefinition.meta.profile",
"path" : "PlanDefinition.meta.profile",
"mustSupport" : true
},
{
"id" : "PlanDefinition.extension",
"path" : "PlanDefinition.extension",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "url"
}
],
"ordered" : false,
"rules" : "open"
},
"min" : 1
},
{
"id" : "PlanDefinition.extension:ApprovalStatus",
"path" : "PlanDefinition.extension",
"sliceName" : "ApprovalStatus",
"min" : 1,
"max" : "1",
"type" : [
{
"code" : "Extension",
"profile" : [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension"
]
}
],
"mustSupport" : true
},
{
"id" : "PlanDefinition.extension:spec-additional-info",
"path" : "PlanDefinition.extension",
"sliceName" : "spec-additional-info",
"short" : "Specification Additional Information",
"definition" : "Placeholder for providing any comments that are relevant to the specification. [Source: SME Defined]\nExamples: replaces method ABC, using the XYZ facility.",
"min" : 0,
"max" : "1",
"type" : [
{
"code" : "Extension",
"profile" : [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension"
]
}
]
},
{
"id" : "PlanDefinition.identifier",
"path" : "PlanDefinition.identifier",
"mustSupport" : true
},
{
"id" : "PlanDefinition.version",
"path" : "PlanDefinition.version",
"short" : "Specification Version",
"definition" : "The alphanumeric text assigned by the sponsor to a particular edition of a specification. [Source: SME Defined] Examples: 2.1, 13.2, ST1, 00001, 00002, companyname-001.\nNote: This value should be unique across all specifications for a given material, not just those with the same name",
"min" : 1,
"mustSupport" : true
},
{
"id" : "PlanDefinition.title",
"path" : "PlanDefinition.title",
"short" : "Specification Title",
"definition" : "The textual identification for the specification. [Source: SME Defined]\nExample: <drug name> 75 mg chewable tablets\nNote: This may include the name of the drug substance, product or the raw material/excipients",
"min" : 1,
"mustSupport" : true
},
{
"id" : "PlanDefinition.subtitle",
"path" : "PlanDefinition.subtitle",
"short" : "Specification Subtitle",
"definition" : "An additional textual identification for the specification [Source: SME Defined].",
"mustSupport" : true
},
{
"id" : "PlanDefinition.type",
"path" : "PlanDefinition.type",
"short" : "Specification Type",
"definition" : "A classification of specification related to the kind of entity it is referencing. [Source: SME Defined]\nExamples: Drug product, Drug substance. ",
"min" : 1,
"mustSupport" : true
},
{
"id" : "PlanDefinition.type.coding",
"path" : "PlanDefinition.type.coding",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "$this"
}
],
"description" : "Slice on the coding itself",
"ordered" : false,
"rules" : "closed"
},
"min" : 2,
"max" : "2",
"mustSupport" : true
},
{
"id" : "PlanDefinition.type.coding:DefinitionType",
"path" : "PlanDefinition.type.coding",
"sliceName" : "DefinitionType",
"min" : 1,
"max" : "1",
"patternCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/plan-definition-type",
"code" : "workflow-definition",
"display" : "Workflow Definition"
},
"mustSupport" : true
},
{
"id" : "PlanDefinition.type.coding:SpecType",
"path" : "PlanDefinition.type.coding",
"sliceName" : "SpecType",
"short" : "Specification Type",
"definition" : "A classification of specification related to the kind of the entity it is referencing.",
"min" : 1,
"max" : "1",
"mustSupport" : true,
"binding" : {
"strength" : "required",
"valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-type-terminology"
}
},
{
"id" : "PlanDefinition.status",
"path" : "PlanDefinition.status",
"mustSupport" : true
},
{
"id" : "PlanDefinition.subject[x]",
"path" : "PlanDefinition.subject[x]",
"min" : 1,
"type" : [
{
"code" : "Reference",
"targetProfile" : [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-handle",
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance",
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
]
}
],
"mustSupport" : true
},
{
"id" : "PlanDefinition.date",
"path" : "PlanDefinition.date",
"short" : "Specification Version Date",
"definition" : "The date when the sponsor assigned a date to a specific version. [Source: SME Defined]\nNote: This is the date a particular version of the specification was internally accepted by the submitter.",
"min" : 1,
"mustSupport" : true
},
{
"id" : "PlanDefinition.approvalDate",
"path" : "PlanDefinition.approvalDate",
"short" : "Specification Status Date",
"definition" : "The date on which the FDA approval status for a specification became effective. [Source: SME Defined]\nNote: If the application is not yet approved, then this is the date of the current submission OR the date of the complete response (CR).\nNote: This is not the application approval status date.",
"mustSupport" : true
},
{
"id" : "PlanDefinition.goal",
"path" : "PlanDefinition.goal",
"short" : "Acceptance Criteria",
"mustSupport" : true
},
{
"id" : "PlanDefinition.goal.extension",
"path" : "PlanDefinition.goal.extension",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "url"
}
],
"ordered" : false,
"rules" : "open"
}
},
{
"id" : "PlanDefinition.goal.extension:ac-additional-info",
"path" : "PlanDefinition.goal.extension",
"sliceName" : "ac-additional-info",
"short" : "Acceptance Criteria Additional Information",
"definition" : "A coded value specifying when a particular analytical procedure or measurement is being performed on a substance or a product. [Source: SME Defined] Examples: Release, Stability.\nNote: The concept of 'In-Process' is subsumed by the Release code.\nExample: value changed from 4% to 5% on 01/01/2010) ",
"min" : 0,
"max" : "1",
"type" : [
{
"code" : "Extension",
"profile" : [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension"
]
}
]
},
{
"id" : "PlanDefinition.goal.description",
"path" : "PlanDefinition.goal.description",
"short" : "Original Text",
"definition" : "The text of the acceptance criteria as provided in the specification. [Source: SME Defined]\nExamples: White to off-white cake; 22.5 - 27.5 mg/ml Note: This is the text as it appears in the Specification.",
"mustSupport" : true
},
{
"id" : "PlanDefinition.goal.addresses",
"path" : "PlanDefinition.goal.addresses",
"min" : 1,
"mustSupport" : true
},
{
"id" : "PlanDefinition.goal.addresses.coding.code",
"path" : "PlanDefinition.goal.addresses.coding.code",
"short" : "Acceptance Criteria Usage",
"definition" : "A coded value specifying when a particular analytical procedure or measurement is being performed on a substance or a product. [Source: SME Defined] Examples: Release, Stability.\nNote: The concept of 'In-Process' is subsumed by the Release code.",
"min" : 1,
"mustSupport" : true,
"binding" : {
"strength" : "required",
"valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-usage-terminology"
}
},
{
"id" : "PlanDefinition.goal.addresses.text",
"path" : "PlanDefinition.goal.addresses.text",
"short" : "Accpetance Criteria Usage"
},
{
"id" : "PlanDefinition.goal.target",
"path" : "PlanDefinition.goal.target",
"short" : "Acceptance Criteron",
"min" : 1,
"constraint" : [
{
"key" : "cmc-target-range",
"severity" : "error",
"human" : "When the Range extension is present, detail cannot be present.",
"expression" : "modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range').exists() implies detail.exists().not()",
"source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"
}
],
"mustSupport" : true
},
{
"id" : "PlanDefinition.goal.target.modifierExtension",
"path" : "PlanDefinition.goal.target.modifierExtension",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "url"
}
],
"ordered" : false,
"rules" : "open"
}
},
{
"id" : "PlanDefinition.goal.target.modifierExtension:targetRange",
"path" : "PlanDefinition.goal.target.modifierExtension",
"sliceName" : "targetRange",
"min" : 0,
"max" : "1",
"type" : [
{
"code" : "Extension",
"profile" : [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range"
]
}
],
"mustSupport" : true
},
{
"id" : "PlanDefinition.goal.target.measure.text",
"path" : "PlanDefinition.goal.target.measure.text",
"short" : "Detailed parameter being measured if more granular than Sub-Test",
"mustSupport" : true
},
{
"id" : "PlanDefinition.goal.target.detail[x]",
"path" : "PlanDefinition.goal.target.detail[x]",
"slicing" : {
"discriminator" : [
{
"type" : "type",
"path" : "$this"
}
],
"ordered" : false,
"rules" : "open"
},
"type" : [
{
"code" : "Quantity"
},
{
"code" : "string"
},
{
"code" : "integer"
}
],
"mustSupport" : true
},
{
"id" : "PlanDefinition.goal.target.detail[x]:detailQuantity",
"path" : "PlanDefinition.goal.target.detail[x]",
"sliceName" : "detailQuantity",
"short" : "ValueNumeric",
"definition" : "The acceptable quantitative or numeric value for the result of the test. [Source: SME Defined]",
"min" : 0,
"max" : "1",
"type" : [
{
"code" : "Quantity"
}
],
"mustSupport" : true,
"binding" : {
"strength" : "required",
"valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure"
}
},
{
"id" : "PlanDefinition.goal.target.detail[x]:detailQuantity.value",
"path" : "PlanDefinition.goal.target.detail[x].value",
"min" : 1,
"mustSupport" : true
},
{
"id" : "PlanDefinition.goal.target.detail[x]:detailQuantity.comparator",
"path" : "PlanDefinition.goal.target.detail[x].comparator",
"mustSupport" : true
},
{
"id" : "PlanDefinition.goal.target.detail[x]:detailQuantity.unit",
"path" : "PlanDefinition.goal.target.detail[x].unit",
"min" : 1,
"mustSupport" : true
},
{
"id" : "PlanDefinition.goal.target.detail[x]:detailQuantity.code",
"path" : "PlanDefinition.goal.target.detail[x].code",
"min" : 1,
"mustSupport" : true
},
{
"id" : "PlanDefinition.goal.target.detail[x]:detailString",
"path" : "PlanDefinition.goal.target.detail[x]",
"sliceName" : "detailString",
"short" : "Value",
"definition" : "A textual description and/or a number that identifies a level within a sequential test. [Source: SME Defined] Examples – Single Stage, Stage 1, Stage 2 (sometimes referred to as L1, L2 L3 or A1, A2 as in USP <711>)\nNote: A Stage may or may not provide a conditional sequence with associated acceptance criteria. [Source: SME Defined] (e.g., dissolution test, pyrogen test - USP <151>; 21 CFR 610.13 (b) Test for pyrogenic substances)",
"min" : 0,
"max" : "1",
"type" : [
{
"code" : "string"
}
],
"mustSupport" : true
},
{
"id" : "PlanDefinition.goal.target.detail[x]:detailInteger",
"path" : "PlanDefinition.goal.target.detail[x]",
"sliceName" : "detailInteger",
"short" : "Number of Replicates",
"definition" : "An identification number for a member of the set of results for a test, usually the sequence order in which the test was executed. Individual tests are executed on multiple samples to give greater validity to the findings. [Source SME Defined] \nExamples: Prepare six aliquots from the sample. Test 8 samples. If any fall above 110%, test an additional 7 samples. Record all replicate values as stated in the method.",
"min" : 0,
"max" : "1",
"type" : [
{
"code" : "integer"
}
],
"mustSupport" : true
},
{
"id" : "PlanDefinition.goal.target.due",
"path" : "PlanDefinition.goal.target.due",
"max" : "0"
},
{
"id" : "PlanDefinition.action",
"path" : "PlanDefinition.action",
"short" : "Method",
"min" : 1,
"constraint" : [
{
"key" : "cmc-link-required",
"severity" : "error",
"human" : "Action linkId is required for alternate tests",
"expression" : "(action.relatedAction.count() > 0) implies action.linkId.exists()",
"source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"
},
{
"key" : "cmc-single-or-multistage",
"severity" : "error",
"human" : "if a test is multi-stage, the test can't have a prefix and its stages must have a name and can't be named 'Single Stage' and must be unique. If it's single stage its prefix is 'Single Stage' and its groups can't have prefixes",
"expression" : "((\n prefix.exists() implies \n action.prefix.empty() and prefix = 'Single Stage' \n) and (\n prefix.empty() implies (\n (action.where(\n prefix.exists() and \n prefix != 'Single Stage'\n ).count() = action.count()) and \n action.prefix.isDistinct()\n )\n)) = true",
"source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"
}
],
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.linkId",
"path" : "PlanDefinition.action.linkId",
"short" : "only required for alternate tests",
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.prefix",
"path" : "PlanDefinition.action.prefix",
"short" : "Stage Name",
"definition" : "A textual description and/or a number that identifies a level within a sequential test. [Source: SME Defined] Examples – Single Stage, Stage 1, Stage 2 (sometimes referred to as L1, L2 L3 or A1, A2 as in USP <711>)\nNote: A Stage may or may not provide a conditional sequence with associated acceptance criteria. [Source: SME Defined] (e.g., dissolution test, pyrogen test - <151>; 21 CFR 610.13 (b) Test for pyrogenic substances)\n\nImplememtation Note: Value at this level is 'Single Stage'",
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.title",
"path" : "PlanDefinition.action.title",
"short" : "Test Name",
"definition" : "The textual description of a procedure or analytical method. [Source: SME Defined]\nExamples: Assay by HPLC, moisture by Karl Fischer, analysis for impurities.\nNote: as defined by the sponsor",
"min" : 1,
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.description",
"path" : "PlanDefinition.action.description",
"short" : "Test Additional Information",
"definition" : "Test Additional Information: Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined].\nIf there is more than one comment, include in this element. Markdown allows formating for clarity.",
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.code",
"path" : "PlanDefinition.action.code",
"short" : "Test Method Origin",
"definition" : "A coded value specifying the source of the method. [Source: SME Defined] Example: Compendial",
"min" : 1,
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.code.coding.code",
"path" : "PlanDefinition.action.code.coding.code",
"min" : 1,
"mustSupport" : true,
"binding" : {
"strength" : "required",
"valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-method-origin-terminology"
}
},
{
"id" : "PlanDefinition.action.code.text",
"path" : "PlanDefinition.action.code.text",
"short" : "Analytical Procedure",
"definition" : "The name of the technique used to determine the nature of a characteristic. [Source: SME Defined].",
"min" : 1,
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.reason",
"path" : "PlanDefinition.action.reason",
"short" : "Test Category | Test Subcategory",
"definition" : "A high level grouping of quality attributes for products, substances, raw materials, excipients, intermediates and reagents. [Source: SME Defined] Examples: Assay, Biological Properties.",
"min" : 1,
"max" : "2",
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.reason.extension",
"path" : "PlanDefinition.action.reason.extension",
"min" : 1
},
{
"id" : "PlanDefinition.action.reason.extension:categoryLevel",
"path" : "PlanDefinition.action.reason.extension",
"sliceName" : "categoryLevel",
"min" : 1,
"max" : "1",
"type" : [
{
"code" : "Extension",
"profile" : [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"
]
}
],
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.reason.coding",
"path" : "PlanDefinition.action.reason.coding",
"mustSupport" : true,
"binding" : {
"strength" : "required",
"valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology"
}
},
{
"id" : "PlanDefinition.action.reason.coding.code",
"path" : "PlanDefinition.action.reason.coding.code",
"min" : 1,
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.reason.coding.display",
"path" : "PlanDefinition.action.reason.coding.display",
"min" : 1
},
{
"id" : "PlanDefinition.action.documentation",
"path" : "PlanDefinition.action.documentation",
"max" : "1",
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.documentation.type",
"path" : "PlanDefinition.action.documentation.type",
"patternCode" : "documentation"
},
{
"id" : "PlanDefinition.action.documentation.label",
"path" : "PlanDefinition.action.documentation.label",
"short" : "Reference to Procedure",
"definition" : "A sponsor/applicant provided alphanumeric code that identifies the procedure. [Source: SME Defined]. Example: HP1234-2008\nNote: This could also be a transferred lab method.",
"min" : 1,
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.goalId",
"path" : "PlanDefinition.action.goalId",
"short" : "Reference to Acceptance Criteria",
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.relatedAction",
"path" : "PlanDefinition.action.relatedAction",
"short" : "Alternate Test",
"definition" : "Alternate Tests are one or more test that are equivalent often using differnt method or equipment. The tests are used interchangeably and only one is used to satisfy the drug product specificaion.",
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.relatedAction.targetId",
"path" : "PlanDefinition.action.relatedAction.targetId",
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.relatedAction.relationship",
"path" : "PlanDefinition.action.relatedAction.relationship",
"short" : "Code is concurrent",
"patternCode" : "concurrent",
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.action",
"path" : "PlanDefinition.action.action",
"short" : "Groups or Stages",
"type" : [
{
"code" : "BackboneElement"
}
],
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.action.prefix",
"path" : "PlanDefinition.action.action.prefix",
"short" : "Stage Name",
"definition" : "A textual description and/or a number that identifies a level within a sequential test. [Source: SME Defined] Examples – Single Stage, Stage 1, Stage 2 (sometimes referred to as L1, L2 L3 or A1, A2 as in USP <711>)\nNote: A Stage may or may not provide a conditional sequence with associated acceptance criteria. [Source: SME Defined] (e.g., dissolution test, pyrogen test - <151>; 21 CFR 610.13 (b) Test for pyrogenic substances)\n\nImplememtation Note: not requried if action.prefix is 'Single Stage'",
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.action.title",
"path" : "PlanDefinition.action.action.title",
"short" : "Test Name (only reqired if different than above)",
"definition" : "Test Name: The textual description of a procedure or analytical method. [Source: SME Defined]\nExamples: Assay by HPLC, moisture by Karl Fischer, analysis for impurities.\nNote: as defined by the sponsor\nNote: The test name of the action.action can be different than the action. Example, the action test is Microbial Limits and the action.action test is Staphylococcus aureus.",
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.action.description",
"path" : "PlanDefinition.action.action.description",
"short" : "Test Additional Information | Stage Additional Information",
"definition" : "Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined].\n\nImplementation Note: If there is more than one comment, include in this element. Markdown allows formating for clarity.",
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.action.documentation",
"path" : "PlanDefinition.action.action.documentation",
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.action.documentation.type",
"path" : "PlanDefinition.action.action.documentation.type",
"patternCode" : "documentation"
},
{
"id" : "PlanDefinition.action.action.documentation.document",
"path" : "PlanDefinition.action.action.documentation.document",
"short" : "Test or Stage Additional Information Visual Attachments",
"definition" : "Any visual data described andor referenced in additional informatation",
"min" : 1,
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.action.documentation.document.contentType",
"path" : "PlanDefinition.action.action.documentation.document.contentType",
"min" : 1,
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.action.documentation.document.data",
"path" : "PlanDefinition.action.action.documentation.document.data",
"min" : 1,
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.action.documentation.document.title",
"path" : "PlanDefinition.action.action.documentation.document.title",
"short" : "Document file name including the file extension",
"definition" : "A format or abbreviation name that identifies a file structure. [Source: SME Defined]\nUsed for the following: Analytical Instrument Data File Type, Impurity Analysis Graphic, Impurity Analytical Instrument Data File, Impurity Chemical Structure Data File, and Substance Structure Graphic.",
"min" : 1,
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.action.goalId",
"path" : "PlanDefinition.action.action.goalId",
"short" : "Reference to Acceptance Criteria",
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.action.action",
"path" : "PlanDefinition.action.action.action",
"short" : "Sub-Test",
"type" : [
{
"code" : "BackboneElement"
}
],
"constraint" : [
{
"key" : "cmc-subtest-rrt",
"severity" : "error",
"human" : "a subtest's prefix represents relative retention time, should it exist",
"expression" : "prefix.exists() implies prefix.single() = 'RRT'",
"source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"
}
],
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.action.action.prefix",
"path" : "PlanDefinition.action.action.action.prefix",
"short" : "RRT",
"definition" : "RRT: The ratio of the retention time of a component relative to that of another used as a reference obtained under identical conditions as an alias for the name of the unidentified impurities. [Source: Adapted from USP] \nExample: 1:23 (a ratio)\nNote: This is the title or name of the impurity (sometimes expressed as a ratio) and not the value.\n\nImplementation Note: This value can only be 'RRT'. It is used to desinate that RRT value(s) expressed in action.action.action.title are relative retention times.",
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.action.action.title",
"path" : "PlanDefinition.action.action.action.title",
"short" : "Test Name | RRT (complex testing)",
"definition" : "Test Name: The textual description of a procedure or analytical method. [Source: SME Defined]\nExamples: Assay by HPLC, moisture by Karl Fischer, analysis for impurities.\nNote: as defined by the sponsor\nNote: The test name of the action.action can be different than the action. Example, the action test is Microbial Limits and the action.action test is Staphylococcus aureus.\n\nRRT: The ratio of the retention time of a component relative to that of another used as a reference obtained under identical conditions as an alias for the name of the unidentified impurities. [Source: Adapted from USP] \nExample: 1:23 (a ratio)\nNote: This is the title or name of the impurity (sometimes expressed as a ratio) and not the value. \n\nImplementation Note: For RRT, if there is a range associated with the unidentified peak then the range can be entered instead of indivual values. E.g.: 0.4 – 0.8.",
"min" : 1,
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.action.action.description",
"path" : "PlanDefinition.action.action.action.description",
"short" : "Test Additional Information | Stage Additional Information",
"definition" : "Test Additional Information: Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined].\nStage Additional Information: Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined]\nIf there is more than one comment, include in this element. Markdown allows formating for clarity. If both types are present, indicate type.",
"mustSupport" : true
},
{
"id" : "PlanDefinition.action.action.action.goalId",
"path" : "PlanDefinition.action.action.action.goalId",
"short" : "Reference to Acceptance Criteria",
"min" : 1,
"mustSupport" : true
}
]
}
}
XIG built as of ??metadata-date??. Found ??metadata-resources?? resources in ??metadata-packages?? packages.