| 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 | 2.0.0-ballot |
| Status | active |
| Date | 2024-12-12T01:58:44+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 | |
| codeable-concept-text-only | Text Only Codeable Concept |
| literal-reference | Literal Reference |
| 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 | |||
  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:$this |
 coding:DefinitionType | S | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following |
   system | 1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/plan-definition-type | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: workflow-definition | |
 display | 1..1 | string | Representation defined by the system Fixed Value: Workflow Definition | |
| coding:SpecType | S | 1..1 | Coding | Specification Type Binding: Specification Type Terminology (required) |
| status | S | 1..1 | code | draft | active | retired | unknown |
 subject[x] | S | 1..1 | LiteralReference(Drug Product Handle | Drug Substance Handle | Excipient Drug Substance) {b} | Type of individual the plan definition is focused on |
| date | S | 1..1 | dateTime | Specification Version Date |
| approvalDate | S | 0..1 | date | Specification Status Date |
| goal | S | 0..* | BackboneElement | Acceptance Criteria |
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| ac-additional-info | 0..1 | markdown | Acceptance Criteria Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension | |
| description | S | 1..1 | CodeableConcept | Original Text |
| addresses | S | 1..* | CodeableConcept | Acceptance Criteria Usage Binding: Test Usage Terminology (required) |
| target | SC | 1..* | BackboneElement | Acceptance Criteron cmc-target-range: When the Range extension is present, detail cannot be present. |
 Slices for modifierExtension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| modifierExtension:targetRange | S | 0..1 | TargetRange | Target Range |
 measure | S | 0..1 | CodeableConceptTextOnly | Detailed parameter being measured if more granular than Sub-Test |
| Slices for detail[x] | S | 0..1 | The target value to be achieved Slice: Unordered, Open by type:$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 | S | 1..1 | Coding | Code defined by a terminology system Binding: Test Method Origin Terminology (required) |
| text | S | 1..1 | string | Analytical Procedure |
| reason | S | 1..2 | CodeableConcept | Test Category | Test Subcategory Binding: Test Category Terminology (required) |
| extension | 1..* | Extension | Extension | |
| Slices for extension | Content/Rules for all slices | |||
| categoryLevel | S | 1..1 | positiveInt | Hierarchical Level URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension |
| 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,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\" alt=\"doco\" style=\"background-color: inherit\"/></a></span></th></tr><tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_resource.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Resource\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition\">PlanDefinition</a><a name=\"PlanDefinition\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/plandefinition.html\">PlanDefinition</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\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=\"StructureDefinition-literal-reference.html\" title=\"Literal Reference\">LiteralReference</a>(<a href=\"StructureDefinition-pqcmc-drug-product-handle.html\">Drug Product Handle</a> | <a href=\"StructureDefinition-pqcmc-routine-drug-substance.html\">Drug Substance Handle</a> | <a href=\"StructureDefinition-pqcmc-excipient.html\">Excipient Drug Substance</a>)<a href=\"http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html\"> {</a><a href=\"http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html\" title=\"When the resource is in a Bundle, the resource the reference points to will be found in the same bundle as the resource that includes the reference.\">b</a><a href=\"http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html\">}</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Type of individual the plan definition is focused on</span></td></tr>\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_bck110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.addresses\" title=\"A coded value specifying when a particular analytical procedure or measurement is being performed on a substance or a product. [Source: SME Defined] Examples: Release, Stability.\nNote: The concept of 'In-Process' is subsumed by the Release code.\">addresses</a><a name=\"PlanDefinition.goal.addresses\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Acceptance Criteria Usage<br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-test-usage-terminology.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-usage-terminology\">Test Usage Terminology</a> (<a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\">required</a>)</td></tr>\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_bck101.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target\">target</a><a name=\"PlanDefinition.goal.target\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span><a style=\"padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;\" href=\"http://hl7.org/fhir/R5/conformance-rules.html#constraints\" title=\"This element has or is affected by constraints ( cmc-target-range )\">C</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Acceptance Criteron<br/><span style=\"font-weight:bold\">cmc-target-range: </span>When the Range extension is present, detail cannot be present.</td></tr>\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_bck1013.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_modifier_extension_simple.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Simple Extension\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.modifierExtension\">Slices for modifierExtension</a><a name=\"PlanDefinition.goal.target.modifierExtension\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/extensibility.html#Extension\">Extension</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Extension</span><br/><span style=\"font-weight:bold\">Slice: </span>Unordered, Open by value:url</td></tr>\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.modifierExtension:targetRange\" title=\"Slice targetRange\">modifierExtension:targetRange</a><a name=\"PlanDefinition.goal.target.modifierExtension.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"StructureDefinition-pq-target-range.html\" title=\"Extension\">TargetRange</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Target Range</span></td></tr>\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_bck1010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_datatype.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.goal.target.measure\">measure</a><a name=\"PlanDefinition.goal.target.measure\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"StructureDefinition-codeable-concept-text-only.html\" title=\"CodeableConcept\">CodeableConceptTextOnly</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Detailed parameter being measured if more granular than Sub-Test</td></tr>\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_bck0110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.code.coding\">coding</a><a name=\"PlanDefinition.action.code.coding\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Code defined by a terminology system</span><br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-test-method-origin-terminology.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-method-origin-terminology\">Test Method Origin Terminology</a> (<a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\">required</a>)</td></tr>\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_bck0100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.code.text\" title=\"The name of the technique used to determine the nature of a characteristic. [Source: SME Defined].\">text</a><a name=\"PlanDefinition.action.code.text\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Analytical Procedure</td></tr>\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.reason\" title=\"A high level grouping of quality attributes for products, substances, raw materials, excipients, intermediates and reagents. [Source: SME Defined] Examples: Assay, Biological Properties.\">reason</a><a name=\"PlanDefinition.action.reason\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..2</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Test Category | Test Subcategory<br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-test-category-terminology.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology\">Test Category Terminology</a> (<a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\">required</a>)</td></tr>\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_extension_simple.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Simple Extension\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.reason.extension\">extension</a><a name=\"PlanDefinition.action.reason.extension\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/extensibility.html#Extension\">Extension</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Extension</span></td></tr>\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_bck0103.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Definition\" class=\"hierarchy\"/> Slices for extension<a name=\"PlanDefinition.action.reason.extension.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Content/Rules for all slices</td></tr>\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_bck01024.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-quality-specification-definitions.html#PlanDefinition.action.reason.extension:categoryLevel\" title=\"Extension URL = http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension\">categoryLevel</a><a name=\"PlanDefinition.action.reason.extension.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#positiveInt\">positiveInt</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Hierarchical Level</span><br/><span style=\"font-weight:bold\">URL: </span><a href=\"StructureDefinition-pq-hierarchical-level-extension.html\">http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension</a></td></tr>\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" : "2.0.0-ballot",
"name" : "QualitySpecification",
"title" : "Quality Specification",
"status" : "active",
"date" : "2024-12-12T01:58:44+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.implicitRules",
"path" : "PlanDefinition.implicitRules",
"short" : "A set of rules under which this content was created",
"definition" : "A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.",
"comment" : "Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.",
"min" : 0,
"max" : "1",
"base" : {
&quo ty" : "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.type.text",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PlanDefinition.type.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.status",
"path" : "PlanDefinition.status",
"short" : "draft | active | retired | unknown",
"definition" : "The status of this plan definition. Enables tracking the life-cycle of the content.",
"comment" : "Allows filtering of plan definitions that are appropriate for use versus not.\n\nSee guidance around (not) making local changes to elements [here](http://hl7.org/fhir/R5/canonicalresource.html#localization).",
"min" : 1,
"max" : "1",
"base" : {
"path" : "PlanDefinition.status",
"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" : true,
"isModifier" : true,
"isModifierReason" : "This is labeled as \"Is Modifier\" because applications should not use a retired {{title}} without due consideration",
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "PublicationStatus"
}
],
"strength" : "required",
"description" : "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 to indicate that this plan definition is authored for testing purposes (or education/evaluation/marketing) and is not intended to be used for genuine usage.",
"comment" : "Allows filtering of plan definitions that are appropriate for use versus not.",
"requirements" : "Enables experimental content to be developed following the same lifecycle that would be used for a production-level plan definition.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.experimental",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "boolean"
}
],
"meaningWhenMissing" : "If absent, this resource is treated as though it is not experimental.",
"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,
"mapping" : [
{
"identity" : "workflow",
"map" : "Definition.experimental"
},
{
"identity" : "w5",
"map" : "FiveWs.class"
},
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.subject[x]",
"path" : "PlanDefinition.subject[x]",
"short" : "Type of individual the plan definition is focused on",
"definition" : "A code, group definition, or canonical reference that describes or identifies the intended subject of the plan definition. Canonical references are allowed to support the definition of protocols for drug and substance quality specifications, and is allowed to reference a MedicinalProductDefinition, SubstanceDefinition, AdministrableProductDefinition, ManufacturedItemDefinition, or PackagedProductDefinition resource.",
"comment" : "Note that the choice of canonical for the subject element was introduced in R4B to support pharmaceutical quality use cases. To ensure as much backwards-compatibility as possible, it is recommended to only use the new canonical type with these use cases.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "PlanDefinition.subject[x]",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Reference",
"profile" : [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-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"
],
"aggregation" : [
"bundled"
]
}
],
"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" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "workflow",
"map" : "Definition.subject"
},
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"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.",
"comment" : "The date is often not tracked until the resource is published, but may be present on draft content. Note that this is not the same as the resource last-modified-date, since the resource may be a secondary representation of the plan definition. Additional specific dates may be added as extensions or be found by consulting Provenances associated with past versions of the resource.\n\nSee guidance around (not) making local changes to elements [here](http://hl7.org/fhir/R5/canonicalresource.html#localization).",
"alias" : [
"Revision Date"
],
"min" : 1,
"max" : "1",
"base" : {
"path" : "PlanDefinition.date",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "dateTime"
}
],
"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" : "workflow",
"map" : "Definition.date"
},
{
"identity" : "w5",
"map" : "FiveWs.recorded"
},
{
"identity" : "rim",
"map" : ".participation[typeCode=AUT].time"
}
]
},
{
"id" : "PlanDefinition.publisher",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PlanDefinition.publisher",
"short" : "Name of the publisher/steward (organization or individual)",
"definition" : "The name of the organization or individual responsible for the release and ongoing maintenance of the plan definition.",
"comment" : "Usually an organization but may be an individual. The publisher (or steward) of the plan definition is the organization or individual primarily responsible for the maintenance and upkeep of the plan definition. This is not necessarily the same individual or organization that developed and initially authored the content. The publisher is the primary point of contact for questions or issues with the plan definition. This item SHOULD be populated unless the information is available from context.",
"requirements" : "Helps establish the \"authority/credibility\" of the plan definition. May also allow for contact.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.publisher",
"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" : true,
"mapping" : [
{
"identity" : "workflow",
"map" : "Definition.publisher"
},
{
"identity" : "w5",
"map" : "FiveWs.witness"
},
{
"identity" : "rim",
"map" : ".participation[typeCode=AUT].role"
}
]
},
{
"id" : "PlanDefinition.contact",
"path" : "PlanDefinition.contact",
"short" : "Contact details for the publisher",
"definition" : "Contact details to assist a user in finding and communicating with the publisher.",
"comment" : "May be a web site, an email address, a telephone number, etc.\n\nSee guidance around (not) making local changes to elements [here](http://hl7.org/fhir/R5/canonicalresource.html#localization).",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.contact",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "ContactDetail"
}
],
"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,
"mapping" : [
{
"identity" : "workflow",
"map" : "Definition.contact"
},
{
"identity" : "rim",
"map" : ".participation[typeCode=CALLBCK].role"
}
]
},
{
"id" : "PlanDefinition.description",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PlanDefinition.description",
"short" : "Natural language description of the plan definition",
"definition" : "A free text natural language description of the plan definition from a consumer's perspective.",
"comment" : "This description can be used to capture details such as comments about misuse, instructions for clinical use and interpretation, literature references, examples from the paper world, etc. It is not a rendering of the plan definition as conveyed in the 'text' field of the resource itself. This item SHOULD be populated unless the information is available from context (e.g. the language of the plan definition is presumed to be the predominant language in the place the plan definition was created).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.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" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "workflow",
"map" : "Definition.description"
},
{
"identity" : "rim",
"map" : ".text"
}
]
},
{
"id" : "PlanDefinition.useContext",
"path" : "PlanDefinition.useContext",
"short" : "The context that the content is intended to support",
"definition" : "The content was developed with a focus and intent of supporting the contexts that are listed. These contexts may be general categories (gender, age, ...) or may be references to specific programs (insurance plans, studies, ...) and may be used to assist with indexing and searching for appropriate plan definition instances.",
"comment" : "When multiple useContexts are specified, there is no expectation that all or any of the contexts apply.",
"requirements" : "Assist in searching for appropriate content.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.useContext",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "UsageContext"
}
],
"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,
"mapping" : [
{
"identity" : "workflow",
"map" : "Definition.useContext"
},
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.jurisdiction",
"path" : "PlanDefinition.jurisdiction",
"short" : "Intended jurisdiction for plan definition (if applicable)",
"definition" : "A legal or geographic region in which the plan definition is intended to be used.",
"comment" : "It may be possible for the plan definition to be used in jurisdictions other than those for which it was originally designed or intended.\n\nDEPRECATION NOTE: For consistency, implementations are encouraged to migrate to using the new 'jurisdiction' code in the useContext element. (I.e. useContext.code indicating http://terminology.hl7.org/CodeSystem/usage-context-type#jurisdiction and useContext.valueCodeableConcept indicating the jurisdiction.)",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.jurisdiction",
"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" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "Jurisdiction"
}
],
"strength" : "extensible",
"description" : "Countries and regions within which this artifact is targeted for use.",
"valueSet" : "http://hl7.org/fhir/ValueSet/jurisdiction"
},
"mapping" : [
{
"identity" : "workflow",
"map" : "Definition.jurisdiction"
},
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.purpose",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PlanDefinition.purpose",
"short" : "Why this plan definition is defined",
"definition" : "Explanation of why this plan definition is needed and why it has been designed as it has.",
"comment" : "This element does not describe the usage of the plan definition. Instead, it provides traceability of ''why'' the resource is either needed or ''why'' it is defined as it is. This may be used to point to source materials or specifications that drove the structure of this plan definition.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.purpose",
"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.purpose"
},
{
"identity" : "w5",
"map" : "FiveWs.why[x]"
},
{
"identity" : "rim",
"map" : ".reasonCode.text"
},
{
"identity" : "objimpl",
"map" : "no-gen-base"
}
]
},
{
"id" : "PlanDefinition.usage",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PlanDefinition.usage",
"short" : "Describes the clinical usage of the plan",
"definition" : "A detailed description of how the plan definition is used from a clinical perspective.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.usage",
"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" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.copyright",
"path" : "PlanDefinition.copyright",
"short" : "Use and/or publishing restrictions",
"definition" : "A copyright statement relating to the plan definition and/or its contents. Copyright statements are generally legal restrictions on the use and publishing of the plan definition.",
"comment" : "The short copyright declaration (e.g. (c) '2015+ xyz organization' should be sent in the copyrightLabel element.",
"requirements" : "Consumers must be able to determine any legal restrictions on the use of the plan definition and/or its content.",
"alias" : [
"License",
"Restrictions"
],
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.copyright",
"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.copyright"
},
{
"identity" : "rim",
"map" : "N/A (to add?)"
},
{
"identity" : "objimpl",
"map" : "no-gen-base"
}
]
},
{
"id" : "PlanDefinition.copyrightLabel",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PlanDefinition.copyrightLabel",
"short" : "Copyright holder and year(s)",
"definition" : "A short string (<50 characters), suitable for inclusion in a page footer that identifies the copyright holder, effective period, and optionally whether rights are resctricted. (e.g. 'All rights reserved', 'Some rights reserved').",
"comment" : "The (c) symbol should NOT be included in this string. It will be added by software when rendering the notation. Full details about licensing, restrictions, warrantees, etc. goes in the more general 'copyright' element.",
"requirements" : "Defines the content expected to be rendered in all representations of the artifact.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.copyrightLabel",
"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" : "workflow",
"map" : "Definition.copyrightLabel"
},
{
"identity" : "rim",
"map" : "N/A (to add?)"
},
{
"identity" : "objimpl",
"map" : "no-gen-base"
}
]
},
{
"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.",
"comment" : "The 'date' element may be more recent than the approval date because of minor changes or editorial corrections.\n\nSee guidance around (not) making local changes to elements [here](http://hl7.org/fhir/R5/canonicalresource.html#localization).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.approvalDate",
"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"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "workflow",
"map" : "Definition.approvalDate"
},
{
"identity" : "rim",
"map" : ".outboundRelationship[typeCode=\"SUBJ\"].act[classCode=CACT;moodCode=EVN;code=\"approval\"].effectiveTime"
},
{
"identity" : "objimpl",
"map" : "no-gen-base"
}
]
},
{
"id" : "PlanDefinition.lastReviewDate",
"path" : "PlanDefinition.lastReviewDate",
"short" : "When the plan definition was last reviewed by the publisher",
"definition" : "The date on which the resource content was last reviewed. Review happens periodically after approval but does not change the original approval date.",
"comment" : "If specified, this date follows the original approval date.\n\nSee guidance around (not) making local changes to elements [here](http://hl7.org/fhir/R5/canonicalresource.html#localization).",
"requirements" : "Gives a sense of how \"current\" the content is. Resources that have not been reviewed in a long time may have a risk of being less appropriate/relevant.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.lastReviewDate",
"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"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "workflow",
"map" : "Definition.lastReviewDate"
},
{
"identity" : "rim",
"map" : ".outboundRelationship[typeCode=\"SUBJ\"; subsetCode=\"RECENT\"].act[classCode=CACT;moodCode=EVN;code=\"review\"].effectiveTime"
},
{
"identity" : "objimpl",
"map" : "no-gen-base"
}
]
},
{
"id" : "PlanDefinition.effectivePeriod",
"path" : "PlanDefinition.effectivePeriod",
"short" : "When the plan definition is expected to be used",
"definition" : "The period during which the plan definition content was or is planned to be in active use.",
"comment" : "The effective period for a plan definition determines when the content is applicable for usage and is independent of publication and review dates. For example, a plan definition intended to be used for the year 2016 might be published in 2015.\n\nSee guidance around (not) making local changes to elements [here](http://hl7.org/fhir/R5/canonicalresource.html#localization).",
"requirements" : "Allows establishing a transition before a resource comes into effect and also allows for a sunsetting process when new versions of the plan definition are or are expected to be used instead.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.effectivePeriod",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Period"
}
],
"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,
"mapping" : [
{
"identity" : "workflow",
"map" : "Definition.effectivePeriod"
},
{
"identity" : "rim",
"map" : "N/A (to add?)"
},
{
"identity" : "objimpl",
"map" : "no-gen-base"
}
]
},
{
"id" : "PlanDefinition.topic",
"path" : "PlanDefinition.topic",
"short" : "E.g. Education, Treatment, Assessment",
"definition" : "Descriptive topics related to the content of the plan definition. Topics provide a high-level categorization of the definition that can be useful for filtering and searching.",
"comment" : "DEPRECATION NOTE: For consistency, implementations are encouraged to migrate to using the new 'topic' code in the useContext element. (I.e. useContext.code indicating http://terminology.hl7.org/CodeSystem/usage-context-type#topic and useContext.valueCodeableConcept indicating the topic)",
"requirements" : "Repositories must be able to determine how to categorize the plan definition so that it can be found by topical searches.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.topic",
"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" : "DefinitionTopic"
}
],
"strength" : "example",
"description" : "High-level categorization of the definition, used for searching, sorting, and filtering.",
"valueSet" : "http://hl7.org/fhir/ValueSet/definition-topic"
},
"mapping" : [
{
"identity" : "workflow",
"map" : "Definition.subject[x]"
},
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.author",
"path" : "PlanDefinition.author",
"short" : "Who authored the content",
"definition" : "An individiual or organization primarily involved in the creation and maintenance of the content.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.author",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "ContactDetail"
}
],
"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=AUT]"
}
]
},
{
"id" : "PlanDefinition.editor",
"path" : "PlanDefinition.editor",
"short" : "Who edited the content",
"definition" : "An individual or organization primarily responsible for internal coherence of the content.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.editor",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "ContactDetail"
}
],
"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=AUT]"
}
]
},
{
"id" : "PlanDefinition.reviewer",
"path" : "PlanDefinition.reviewer",
"short" : "Who reviewed the content",
"definition" : "An individual or organization asserted by the publisher to be primarily responsible for review of some aspect of the content.",
"comment" : "See guidance around (not) making local changes to elements [here](http://hl7.org/fhir/R5/canonicalresource.html#localization).",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.reviewer",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "ContactDetail"
}
],
"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=VRF] {not clear whether VRF best corresponds to reviewer or endorser}"
}
]
},
{
"id" : "PlanDefinition.endorser",
"path" : "PlanDefinition.endorser",
"short" : "Who endorsed the content",
"definition" : "An individual or organization asserted by the publisher to be responsible for officially endorsing the content for use in some setting.",
"comment" : "See guidance around (not) making local changes to elements [here](http://hl7.org/fhir/R5/canonicalresource.html#localization).",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.endorser",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "ContactDetail"
}
],
"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=VRF] {not clear whether VRF best corresponds to reviewer or endorser}"
}
]
},
{
"id" : "PlanDefinition.relatedArtifact",
"path" : "PlanDefinition.relatedArtifact",
"short" : "Additional documentation, citations",
"definition" : "Related artifacts such as additional documentation, justification, or bibliographic references.",
"comment" : "Each related artifact is either an attachment, or a reference to another resource, but not both.",
"requirements" : "Plan definitions must be able to provide enough information for consumers of the content (and/or interventions or results produced by the content) to be able to determine and understand the justification for and evidence in support of the content.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.relatedArtifact",
"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,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : ".outboundRelationship[typeCode=DOC,RSON,PREV, DRIV, USE, COMP] {successor would be PREV w/ inversionInd=true; No support for citation}"
}
]
},
{
"id" : "PlanDefinition.library",
"path" : "PlanDefinition.library",
"short" : "Logic used by the plan definition",
"definition" : "A reference to a Library resource containing any formal logic used by the plan definition.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.library",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "canonical",
"targetProfile" : [
"http://hl7.org/fhir/StructureDefinition/Library"
]
}
],
"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.goal",
"path" : "PlanDefinition.goal",
"short" : "Acceptance Criteria",
"definition" : "A goal describes an expected outcome that activities within the plan are intended to achieve. For example, weight loss, restoring an activity of daily living, obtaining herd immunity via immunization, meeting a process improvement objective, meeting the acceptance criteria for a test as specified by a quality specification, etc.",
"requirements" : "Goal information needs to be captured for order sets, protocols, and care plan definitions to better describe the objectives of the protocol activities and to guide the creation of specific goals within the derived care plans and orders.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.goal",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"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.goal.id",
"path" : "PlanDefinition.goal.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.goal.extension",
"path" : "PlanDefinition.goal.extension",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "url"
}
],
"ordered" : false,
"rules" : "open"
},
"short" : "Extension",
"definition" : "An Extension",
"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
},
{
"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",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension",
"profile" : [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-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
},
{
"id" : "PlanDefinition.goal.modifierExtension",
"path" : "PlanDefinition.goal.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.goal.category",
"path" : "PlanDefinition.goal.category",
"short" : "E.g. Treatment, dietary, behavioral",
"definition" : "Indicates a category the goal falls within.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.goal.category",
"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" : "GoalCategory"
}
],
"strength" : "example",
"description" : "Example codes for grouping goals for filtering or presentation.",
"valueSet" : "http://hl7.org/fhir/ValueSet/goal-category"
},
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"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.",
"comment" : "If no code is available, use CodeableConcept.text.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "PlanDefinition.goal.description",
"min" : 1,
"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" : true,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "GoalDescription"
}
],
"strength" : "example",
"description" : "Describes goals that can be achieved.",
"valueSet" : "http://hl7.org/fhir/ValueSet/clinical-findings"
},
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.goal.priority",
"path" : "PlanDefinition.goal.priority",
"short" : "high-priority | medium-priority | low-priority",
"definition" : "Identifies the expected level of importance associated with reaching/sustaining the defined goal.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.goal.priority",
"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" : "GoalPriority"
}
],
"strength" : "preferred",
"description" : "Indicates the level of importance associated with reaching or sustaining a goal.",
"valueSet" : "http://hl7.org/fhir/ValueSet/goal-priority"
},
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.goal.start",
"path" : "PlanDefinition.goal.start",
"short" : "When goal pursuit begins",
"definition" : "The event after which the goal should begin being pursued.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.goal.start",
"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" : "GoalStartEvent"
}
],
"strength" : "example",
"description" : "Identifies the types of events that might trigger the start of a goal.",
"valueSet" : "http://hl7.org/fhir/ValueSet/goal-start-event"
},
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.goal.addresses",
"path" : "PlanDefinition.goal.addresses",
"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,
"max" : "*",
"base" : {
"path" : "PlanDefinition.goal.addresses",
"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" : {
"strength" : "required",
"valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-usage-terminology"
},
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.goal.documentation",
"path" : "PlanDefinition.goal.documentation",
"short" : "Supporting documentation for the goal",
"definition" : "Didactic or other informational resources associated with the goal that provide further supporting information about the goal. Information resources can include inline text commentary and links to web resources.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.goal.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,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.goal.target",
"path" : "PlanDefinition.goal.target",
"short" : "Acceptance Criteron",
"definition" : "Indicates what should be done and within what timeframe.",
"min" : 1,
"max" : "*",
"base" : {
"path" : "PlanDefinition.goal.target",
"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-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,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.goal.target.id",
"path" : "PlanDefinition.goal.target.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.goal.target.extension",
"path" : "PlanDefinition.goal.target.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.goal.target.modifierExtension",
"path" : "PlanDefinition.goal.target.modifierExtension",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "url"
}
],
"ordered" : false,
"rules" : "open"
},
"short" : "Extension",
"definition" : "An Extension",
"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
},
{
"id" : "PlanDefinition.goal.target.modifierExtension:targetRange",
"path" : "PlanDefinition.goal.target.modifierExtension",
"sliceName" : "targetRange",
"short" : "Target Range",
"definition" : "The FHIR Range datatype uses Simple Quantities to represent the high and low bounds, which do not allow a comparator to be set. This extension allows the high and low bounds to have a comparator",
"min" : 0,
"max" : "1",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension",
"profile" : [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-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"
},
{
"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" : true,
"isModifierReason" : "When present, the target cannot have a detail; instead this extension acts as its detail"
},
{
"id" : "PlanDefinition.goal.target.measure",
"path" : "PlanDefinition.goal.target.measure",
"short" : "Detailed parameter being measured if more granular than Sub-Test",
"definition" : "A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text.",
"comment" : "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.goal.target.measure",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept",
"profile" : [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"
]
}
],
"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,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "GoalTargetMeasure"
}
],
"strength" : "example",
"description" : "Identifies types of parameters that can be tracked to determine goal achievement.",
"valueSet" : "http://hl7.org/fhir/ValueSet/observation-codes"
},
"mapping" : [
{
"identity" : "rim",
"map" : "n/a,CD"
},
{
"identity" : "v2",
"map" : "CE/CNE/CWE"
},
{
"identity" : "orim",
"map" : "fhir:CodeableConcept rdfs:subClassOf dt:CD"
}
]
},
{
"id" : "PlanDefinition.goal.target.detail[x]",
"path" : "PlanDefinition.goal.target.detail[x]",
"slicing" : {
"discriminator" : [
{
"type" : "type",
"path" : "$this"
}
],
"ordered" : false,
"rules" : "closed"
},
"short" : "The target value to be achieved",
"definition" : "The target value of the measure to be achieved to signify fulfillment of the goal, e.g. 150 pounds or 7.0%, or in the case of pharmaceutical quality - NMT 0.6%, Clear solution, etc. Either the high or low or both values of the range can be specified. When a low value is missing, it indicates that the goal is achieved at any value at or below the high value. Similarly, if the high value is missing, it indicates that the goal is achieved at any value at or above the low value.",
"comment" : "A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the goal.target.measure defines a coded value.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.goal.target.detail[x]",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Quantity"
},
{
"code" : "string"
},
{
"code" : "integer"
}
],
"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.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]",
"comment" : "A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the goal.target.measure defines a coded value.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.goal.target.detail[x]",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Quantity"
}
],
"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" : {
"strength" : "required",
"valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure"
},
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"id" : "PlanDefinition.goal.target.detail[x]:detailQuantity.id",
"path" : "PlanDefinition.goal.target.detail[x].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.goal.target.detail[x]:detailQuantity.extension",
"path" : "PlanDefinition.goal.target.detail[x].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.goal.target.detail[x]:detailQuantity.value",
"path" : "PlanDefinition.goal.target.detail[x].value",
"short" : "Numerical value (with implicit precision)",
"definition" : "The value of the measured amount. The value includes an implicit precision in the presentation of the value.",
"comment" : "The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).",
"requirements" : "Precision is handled implicitly in almost all cases of measurement.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Quantity.value",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "decimal"
}
],
"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" : "SN.2 / CQ - N/A"
},
{
"identity" : "rim",
"map" : "PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value"
}
]
},
{
"id" : "PlanDefinition.goal.target.detail[x]:detailQuantity.comparator",
"path" : "PlanDefinition.goal.target.detail[x].comparator",
"short" : "< | <= | >= | > | ad - how to understand the value",
"definition" : "How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is \"<\" , then the real value is < stated value.",
"requirements" : "Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Quantity.comparator",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"meaningWhenMissing" : "If there is no comparator, then there is no modification of the value",
"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" : true,
"isModifierReason" : "This is labeled as \"Is Modifier\" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value",
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "QuantityComparator"
}
],
"strength" : "required",
"description" : "How the Quantity should be understood and represented.",
"valueSet" : "http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0"
},
"mapping" : [
{
"identity" : "v2",
"map" : "SN.1 / CQ.1"
},
{
"identity" : "rim",
"map" : "IVL properties"
}
]
},
{
"id" : "PlanDefinition.goal.target.detail[x]:detailQuantity.unit",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PlanDefinition.goal.target.detail[x].unit",
"short" : "Unit representation",
"definition" : "A human-readable form of the unit.",
"requirements" : "There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Quantity.unit",
"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" : "(see OBX.6 etc.) / CQ.2"
},
{
"identity" : "rim",
"map" : "PQ.unit"
}
]
},
{
"id" : "PlanDefinition.goal.target.detail[x]:detailQuantity.system",
"path" : "PlanDefinition.goal.target.detail[x].system",
"short" : "System that defines coded unit form",
"definition" : "The identification of the system that provides the coded form of the unit.",
"requirements" : "Need to know the system that defines the coded form of the unit.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Quantity.system",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "uri"
}
],
"condition" : [
"qty-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"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "v2",
"map" : "(see OBX.6 etc.) / CQ.2"
},
{
"identity" : "rim",
"map" : "CO.codeSystem, PQ.translation.codeSystem"
}
]
},
{
"id" : "PlanDefinition.goal.target.detail[x]:detailQuantity.code",
"path" : "PlanDefinition.goal.target.detail[x].code",
"short" : "Coded form of the unit",
"definition" : "A computer processable form of the unit in some unit representation system.",
"comment" : "The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.",
"requirements" : "Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Quantity.code",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"condition" : [
"qty-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" : true,
"mapping" : [
{
"identity" : "v2",
"map" : "(see OBX.6 etc.) / CQ.2"
},
{
"identity" : "rim",
"map" : "PQ.code, MO.currency, PQ.translation.code"
}
]
},
{
"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)",
"comment" : "A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the goal.target.measure defines a coded value.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.goal.target.detail[x]",
"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.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.",
"comment" : "A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the goal.target.measure defines a coded value.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.goal.target.detail[x]",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "integer"
}
],
"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.goal.target.due",
"path" : "PlanDefinition.goal.target.due",
"short" : "Reach goal within",
"definition" : "Indicates the timeframe after the start of the goal in which the goal should be met.",
"min" : 0,
"max" : "0",
"base" : {
"path" : "PlanDefinition.goal.target.due",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Duration"
}
],
"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.actor",
"path" : "PlanDefinition.actor",
"short" : "Actors within the plan",
"definition" : "Actors represent the individuals or groups involved in the execution of the defined set of activities.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.actor",
"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.actor.id",
"path" : "PlanDefinition.actor.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.actor.extension",
"path" : "PlanDefinition.actor.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.actor.modifierExtension",
"path" : "PlanDefinition.actor.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.actor.title",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PlanDefinition.actor.title",
"short" : "User-visible title",
"definition" : "A descriptive label for the actor.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PlanDefinition.actor.title",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elem ],
"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.",
"comment" : "The hash is calculated on the data prior to base64 encoding, if the data is based64 encoded. The hash is not intended to support digital signatures. Where protection against malicious threats a digital signature should be considered, see [Provenance.signature](http://hl7.org/fhir/R5/provenance-definitions.html#Provenance.signature) for mechanism to protect a resource with a digital signature.",
"requirements" : "Included so that applications can verify that the contents of a location have not changed due to technical failures (e.g., storage rot, transport glitch, incorrect version).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Attachment.hash",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "base64Binary"
}
],
"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" : ".integrityCheck[parent::ED/integrityCheckAlgorithm=\"SHA-1\"]"
}
]
},
{
"id" : "PlanDefinition.action.action.documentation.document.title",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"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.",
"comment" : "May sometimes be derived from the source filename.",
"requirements" : "Applications need a label to display to a human user in place of the actual data if the data cannot be rendered or perceived by the viewer.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Attachment.title",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"example" : [
{
"label" : "General",
"valueString" : "Official Corporate Logo"
}
],
"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" : "rim",
"map" : "./title/data"
}
]
},
{
"id" : "PlanDefinition.action.action.documentation.document.creation",
"path" : "PlanDefinition.action.action.documentation.document.creation",
"short" : "Date attachment was first created",
"definition" : "The date that the attachment was first created.",
"requirements" : "This is often tracked as an integrity issue for use of the attachment.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Attachment.creation",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "dateTime"
}
],
"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.height",
"path" : "PlanDefinition.action.action.documentation.document.height",
"short" : "Height of the image in pixels (photo/video)",
"definition" : "Height of the image in pixels (photo/video).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Attachment.height",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "positiveInt"
}
],
"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" : false,
"mapping" : [
{
"identity" : "rim",
"map" : ".outboundRelationship[typeCode=\"COMP].target[classCode=\"OBS\", moodCode=\"EVN\",code=\"<CODE>\"].value"
}
]
},
{
"id" : "PlanDefinition.action.action.documentation.document.width",
"path" : "PlanDefinition.action.action.documentation.document.width",
"short" : "Width of the image in pixels (photo/video)",
"definition" : "Width of the image in pixels (photo/video).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Attachment.width",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "positiveInt"
}
],
"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" : false,
"mapping" : [
{
"identity" : "rim",
"map" : ".outboundRelationship[typeCode=\"COMP].target[classCode=\"OBS\", moodCode=\"EVN\",code=\"<CODE>\"].value"
}
]
},
{
"id" : "PlanDefinition.action.action.documentation.document.frames",
"path" : "PlanDefinition.action.action.documentation.document.frames",
"short" : "Number of frames if > 1 (photo)",
"definition" : "The number of frames in a photo. This is used with a multi-page fax, or an imaging acquisition context that takes multiple slices in a single image, or an animated gif. If there is more than one frame, this SHALL have a value in order to alert interface software that a multi-frame capable rendering widget is required.",
"comment" : "if the number of frames is not supplied, the value may be unknown. Applications should not assume that there is only one frame unless it is explicitly stated.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Attachment.frames",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "positiveInt"
}
],
"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" : false,
"mapping" : [
{
"identity" : "rim",
"map" : ".outboundRelationship[typeCode=\"COMP].target[classCode=\"OBS\", moodCode=\"EVN\",code=\"<CODE>\"].value"
}
]
},
{
"id" : "PlanDefinition.action.action.documentation.document.duration",
"path" : "PlanDefinition.action.action.documentation.document.duration",
"short" : "Length in seconds (audio / video)",
"definition" : "The duration of the recording in seconds - for audio and video.",
"comment" : "The duration might differ from occurrencePeriod if recording was paused.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Attachment.duration",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "decimal"
}
],
"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" : false,
"mapping" : [
{
"identity" : "rim",
"map" : ".outboundRelationship[typeCode=\"COMP].target[classCode=\"OBS\", moodCode=\"EVN\",code=\"<CODE>\"].value"
}
]
},
{
"id" : "PlanDefinition.action.action.documentation.document.pages",
"path" : "PlanDefinition.action.action.documentation.document.pages",
"short" : "Number of printed pages",
"definition" : "The number of pages when printed.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Attachment.pages",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "positiveInt"
}
],
"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" : false
},
{
"id" : "PlanDefinition.action.action.documentation.resource",
"path" : "PlanDefinition.action.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.action.documentation.resourceReference",
"path" : "PlanDefinition.action.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.action.documentation.publicationStatus",
"path" : "PlanDefinition.action.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.action.documentation.publicationDate",
"path" : "PlanDefinition.action.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.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" : {
"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.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.",
"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.trigger",
"path" : "PlanDefinition.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.condition",
"path" : "PlanDefinition.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"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A (to add?)"
}
]
},
{
"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" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "PlanDefinition.action.action.condition.extension",
"path" : "PlanDefinition.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.condition.modifierExtension",
"path" : "PlanDefinition.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.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,
"isModifier" : false,
"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,
"isModifier" : false,
"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"
}
],
"mustSupport" : false,
"isModifier" : false,
"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"
}
],
& e chosen as part of realizing the action definition.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PlanDefinition.action.action",
"min" : 0,
"max" : "*"
},
"contentReference" : "http://hl7.org/fhir/StructureDefinition/PlanDefinition#PlanDefinition.action",
"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" : "{InverseRelationship of Definition.partOf}"
},
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"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.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",
"profile" : [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-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"
],
"aggregation" : [
"bundled"
]
}
],
"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",
"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.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",
"path" : "PlanDefinition.goal.target.measure",
"short" : "Detailed parameter being measured if more granular than Sub-Test",
"type" : [
{
"code" : "CodeableConcept",
"profile" : [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"
]
}
],
"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",
"path" : "PlanDefinition.action.code.coding",
"min" : 1,
"max" : "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,
"binding" : {
"strength" : "required",
"valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology"
}
},
{
"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.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.