Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
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Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc/ and changes regularly. See the Directory of published versions

Resource Profile: Quality Specification

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification Version: 0.1.20
Draft as of 2024-03-04 Computable Name: QualitySpecification

A quality specification is for a drug product or drug substance (excipient, API or raw material).

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from PlanDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. PlanDefinition PlanDefinition
... meta
.... profile S0..1canonical(StructureDefinition)Profiles this resource claims to conform to
... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
... specificationType S1..1CodeableConceptSpecification Type
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-type-extension
Binding: Specification Type Terminology (required)
... identifier S0..1IdentifierAdditional identifier for the plan definition
... version S1..1stringSpecification Version
... title S1..1stringSpecification Title
... subtitle S0..1stringSpecification Subtitle
... status S1..1codedraft | active | retired | unknown
... subject[x] S1..1Reference(Routine Drug Product | Routine Drug Substance | Excipient Drug Substance)Type of individual the plan definition is focused on
... date S1..1dateTimeSpecification Version Date
... useContext S1..1UsageContextSpecification Status
.... code 1..1CodingType of context being specified
Required Pattern: At least the following
..... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/usage-context-type
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: workflow
..... display1..1stringRepresentation defined by the system
Fixed Value: Workflow Setting
.... Slices for value[x] 1..1CodeableConceptValue that defines the context
Slice: Unordered, Open by type:$this
..... value[x]:valueCodeableConcept S1..1CodeableConceptValue that defines the context
...... coding 0..*CodingCode defined by a terminology system
Binding: Specification Status Terminology (required)
... approvalDate S0..1dateSpecification Status Date
... goal S0..*BackboneElementAcceptance Criteria
.... description S1..1CodeableConceptOriginal Text
.... addresses S1..*CodeableConceptWhat does the goal address
..... coding
...... code S1..1codeAcceptance Criteria Usage
Binding: Test Usage Terminology (required)
..... text 0..1stringAccpetance Criteria Usage
.... documentation S0..*RelatedArtifactSupporting documentation for the goal
..... type 1..1codedocumentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as
Required Pattern: comments-on
..... display S1..1stringAcceptance Criteria Additional Information
.... target S1..*BackboneElementAcceptance Criteron
..... measure
...... text S0..1stringDetailed parameter being measured if more granular than Sub-Test
..... Slices for detail[x] S0..1The target value to be achieved
Slice: Unordered, Open by type:$this
...... detailQuantityQuantity
...... detailRangeRange
...... detailCodeableConceptCodeableConcept
...... detailIntegerinteger
...... detail[x]:detailQuantity S0..1QuantityValueNumeric
....... extension 1..*ExtensionExtension
....... interpretationCode S1..1CodeableConceptInterpretation Code
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension
Binding: Interpretation Code Terminology (required)
........ value[x] 0..1CodeableConceptInterpretation Code
....... value S1..1decimalNumerical value (with implicit precision)
....... unit S1..1stringUnit representation
....... code S1..1codeCoded form of the unit
Binding: Units Of Measure Terminology (required)
...... detail[x]:detailRange S0..1RangeValueNumeric (range)
....... low 1..1SimpleQuantityLow limit
........ extension 1..*ExtensionExtension
........ interpretationCodeLow S1..1CodeableConceptInterpretation Code
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension
Binding: Interpretation Code Terminology (required)
......... value[x] 0..1CodeableConceptInterpretation Code
........ value S1..1decimalNumerical value (with implicit precision)
........ unit S1..1stringUnit representation
........ code S1..1codeCoded form of the unit
Binding: Units Of Measure Terminology (required)
....... high 1..1SimpleQuantityHigh limit
........ extension 1..*ExtensionExtension
........ interpretationCodeHigh S1..1CodeableConceptInterpretation Code
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension
Binding: Interpretation Code Terminology (required)
......... value[x] 0..1CodeableConceptInterpretation Code
........ value S1..1decimalNumerical value (with implicit precision)
........ unit S1..1stringUnit representation
........ code S1..1codeCoded form of the unit
Binding: Units Of Measure Terminology (required)
...... detail[x]:detailCodeableConcept S0..1CodeableConceptThe target value to be achieved
....... coding S1..1CodingInterpretation Code
Binding: Interpretation Code Terminology (required)
Required Pattern: At least the following
........ system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
........ code1..1codeSymbol in syntax defined by the system
Fixed Value: C48793
........ display1..1stringRepresentation defined by the system
Fixed Value: EQ
....... text S1..1stringValue
...... detail[x]:detailInteger S0..1integerNumber of Replicates
..... due 0..0
... action SC1..*BackboneElementMethod
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
.... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
.... testOrder S1..1decimalTest Order
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension
..... value[x] S1..1decimalValue of extension
.... linkId S0..1stringonly required for alternate tests
.... prefix S0..1stringStage Name
.... title S1..1stringTest Name
.... description S0..1markdownTest Additional Information
.... code S1..1CodeableConceptTest Method Origin
..... coding
...... code S1..1codeSymbol in syntax defined by the system
Binding: Test Method Origin Terminology (required)
..... text S1..1stringAnalytical Procedure
.... reason S1..2CodeableConceptTest Category | Test Subcategory
..... extension 1..*ExtensionExtension
..... categoryLevel S1..1integerHierarchical Level
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
..... coding S0..*CodingCode defined by a terminology system
Binding: Test Category Terminology (required)
...... code S1..1codeSymbol in syntax defined by the system
...... display 1..1stringRepresentation defined by the system
.... documentation S0..1RelatedArtifactSupporting documentation for the intended performer of the action
..... type 1..1codedocumentation | 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 S1..1stringReference to Procedure
.... goalId S0..*idReference to Acceptance Criteria
.... relatedAction S0..*BackboneElementAlternate Test
..... targetId S1..1idWhat action is this related to
..... relationship S1..1codeCode is concurrent
Required Pattern: concurrent
.... selectionBehavior S0..1codeCode is exactly-one
Required Pattern: exactly-one
.... action S0..*BackboneElementGroups or Stages
..... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
..... stageOrder S1..1decimalStage Sequence Order
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension
...... value[x] S1..1decimalValue of extension
..... prefix S0..1stringStage Name
..... title S0..1stringTest Name (only reqired if different than above)
..... description S0..1markdownTest Additional Information | Stage Additional Information
..... documentation S0..*RelatedArtifactSupporting documentation for the intended performer of the action
...... type 1..1codedocumentation | 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 S1..1AttachmentTest or Stage Additional Information Visual Attachments
....... contentType S1..1codeMime type of the content, with charset etc.
....... data S1..1base64BinaryData inline, base64ed
....... title S1..1stringDocument file name including the file extension
..... goalId S0..*idReference to Acceptance Criteria
..... action SC0..*BackboneElementSub-Test
cmc-subtest-rrt: a subtest's prefix represents relative retention time, should it exist
...... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
...... testOrder S1..1decimalTest Order
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension
....... value[x] S1..1decimalValue of extension
...... prefix S0..1stringRRT
...... title S1..1stringTest Name | RRT (complex testing)
...... description S0..1markdownTest Additional Information | Stage Additional Information
...... goalId S1..*idReference to Acceptance Criteria

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet / CodeURI
PlanDefinition.useContext.value[x]:valueCodeableConcept.codingrequiredPqcmcSpecificationStatusTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-status-terminology
from this IG
PlanDefinition.goal.addresses.coding.coderequiredPqcmcTestUsageTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-usage-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailQuantity.coderequiredPqcmcUnitsMeasureTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailRange.low.coderequiredPqcmcUnitsMeasureTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailRange.high.coderequiredPqcmcUnitsMeasureTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailCodeableConcept.codingrequiredPattern: C48793("EQ")
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-interpretation-code-terminology
from this IG
PlanDefinition.action.code.coding.coderequiredPqcmcTestMethodOriginTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-method-origin-terminology
from this IG
PlanDefinition.action.reason.codingrequiredPqcmcTestCategoryTerminology (a valid code from Hierarchical Test Category Codes)
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology
from this IG

Constraints

IdGradePath(s)DetailsRequirements
cmc-link-requirederrorPlanDefinition.actionAction linkId is required for alternate tests
: (action.relatedAction.count() > 0) implies action.linkId.exists()
cmc-single-or-multistageerrorPlanDefinition.actionif 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
: (( prefix.exists() implies action.prefix.empty() and prefix = 'Single Stage' ) and ( prefix.empty() implies ( (action.where( prefix.exists() and prefix != 'Single Stage' ).count() = action.count()) and action.prefix.isDistinct() ) )) = true
cmc-subtest-rrterrorPlanDefinition.action.action.actiona subtest's prefix represents relative retention time, should it exist
: prefix.exists() implies prefix.single() = 'RRT'
NameFlagsCard.TypeDescription & Constraintsdoco
.. PlanDefinition C0..*PlanDefinitionThe definition of a plan for a series of actions, independent of any specific patient or context
cnl-0: Name should be usable as an identifier for the module by machine processing applications such as code generation
pld-3: goalid should reference the id of a goal definition
pld-4: targetId should reference the id of an action
... meta Σ0..1MetaMetadata about the resource
.... profile SΣ0..1canonical(StructureDefinition)Profiles this resource claims to conform to
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... contained 0..*ResourceContained, inline Resources
... specificationType S1..1CodeableConceptSpecification Type
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-type-extension
Binding: Specification Type Terminology (required)
... spec-additional-info S0..1markdownSpecification Additional Information
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
... identifier SΣ0..1IdentifierAdditional identifier for the plan definition
... version SΣ1..1stringSpecification Version
... title SΣ1..1stringSpecification Title
... subtitle S0..1stringSpecification Subtitle
... status ?!SΣ1..1codedraft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... subject[x] S1..1Reference(Routine Drug Product | Routine Drug Substance | Excipient Drug Substance)Type of individual the plan definition is focused on
... date SΣ1..1dateTimeSpecification Version Date
... useContext SΣ1..1UsageContextSpecification Status
.... code Σ1..1CodingType of context being specified
Binding: UsageContextType (extensible): A code that specifies a type of context being specified by a usage context.


Required Pattern: At least the following
..... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/usage-context-type
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: workflow
..... display1..1stringRepresentation defined by the system
Fixed Value: Workflow Setting
.... Slices for value[x] Σ1..1CodeableConceptValue that defines the context
Slice: Unordered, Closed by type:$this
Binding: ContextOfUseValueSet (example): A code that defines the specific value for the context being specified.

..... value[x]:valueCodeableConcept SΣ1..1CodeableConceptValue that defines the context
Binding: ContextOfUseValueSet (example): A code that defines the specific value for the context being specified.

...... coding Σ0..*CodingCode defined by a terminology system
Binding: Specification Status Terminology (required)
... approvalDate S0..1dateSpecification Status Date
... goal SC0..*BackboneElementAcceptance Criteria
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... description S1..1CodeableConceptOriginal Text
Binding: SNOMEDCTClinicalFindings (example): Describes goals that can be achieved.

.... addresses S1..*CodeableConceptWhat does the goal address
Binding: ConditionProblemDiagnosisCodes (example): Identifies problems, conditions, issues, or concerns that goals may address.


..... coding Σ0..*CodingCode defined by a terminology system
...... code SΣC1..1codeAcceptance Criteria Usage
Binding: Test Usage Terminology (required)
..... text Σ0..1stringAccpetance Criteria Usage
.... documentation S0..*RelatedArtifactSupporting documentation for the goal
..... type Σ1..1codedocumentation | 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
Binding: RelatedArtifactType (required): The type of relationship to the related artifact.


Required Pattern: comments-on
..... display SΣ1..1stringAcceptance Criteria Additional Information
.... target S1..*BackboneElementAcceptance Criteron
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... measure 0..1CodeableConceptThe parameter whose value is to be tracked
Binding: LOINCCodes (example): Identifies types of parameters that can be tracked to determine goal achievement.

...... text SΣ0..1stringDetailed parameter being measured if more granular than Sub-Test
..... Slices for detail[x] S0..1The target value to be achieved
Slice: Unordered, Closed by type:$this
...... detailQuantityQuantity
...... detailRangeRange
...... detailCodeableConceptCodeableConcept
...... detailIntegerinteger
...... detail[x]:detailQuantity S0..1QuantityValueNumeric
....... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
....... interpretationCode S1..1CodeableConceptInterpretation Code
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension
Binding: Interpretation Code Terminology (required)
........ extension 0..0
........ url 1..1uri"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"
........ value[x] 0..1CodeableConceptInterpretation Code
Binding: Interpretation Code Terminology (required)
....... value SΣ1..1decimalNumerical value (with implicit precision)
....... comparator ?!Σ0..1code< | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

....... unit SΣ1..1stringUnit representation
....... code SΣC1..1codeCoded form of the unit
Binding: Units Of Measure Terminology (required)
...... detail[x]:detailRange S0..1RangeValueNumeric (range)
....... low ΣC1..1SimpleQuantityLow limit
........ Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
........ interpretationCodeLow S1..1CodeableConceptInterpretation Code
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension
Binding: Interpretation Code Terminology (required)
......... extension 0..0
......... url 1..1uri"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"
......... value[x] 0..1CodeableConceptInterpretation Code
Binding: Interpretation Code Terminology (required)
........ value SΣ1..1decimalNumerical value (with implicit precision)
........ unit SΣ1..1stringUnit representation
........ code SΣC1..1codeCoded form of the unit
Binding: Units Of Measure Terminology (required)
....... high ΣC1..1SimpleQuantityHigh limit
........ Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
........ interpretationCodeHigh S1..1CodeableConceptInterpretation Code
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension
Binding: Interpretation Code Terminology (required)
......... extension 0..0
......... url 1..1uri"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"
......... value[x] 0..1CodeableConceptInterpretation Code
Binding: Interpretation Code Terminology (required)
........ value SΣ1..1decimalNumerical value (with implicit precision)
........ unit SΣ1..1stringUnit representation
........ code SΣC1..1codeCoded form of the unit
Binding: Units Of Measure Terminology (required)
...... detail[x]:detailCodeableConcept S0..1CodeableConceptThe target value to be achieved
....... coding SΣ1..1CodingInterpretation Code
Binding: Interpretation Code Terminology (required)

Required Pattern: At least the following
........ system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
........ code1..1codeSymbol in syntax defined by the system
Fixed Value: C48793
........ display1..1stringRepresentation defined by the system
Fixed Value: EQ
....... text SΣ1..1stringValue
...... detail[x]:detailInteger S0..1integerNumber of Replicates
... action SC1..*BackboneElementMethod
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
.... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
.... testOrder S1..1decimalTest Order
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension
..... extension 0..0
..... url 1..1uri"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"
..... value[x] SC1..1decimalValue of extension
cmc-greater-than-zero: Hierachial levels are greater than 0
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... linkId S0..1stringonly required for alternate tests
.... prefix S0..1stringStage Name
.... title S1..1stringTest Name
.... description S0..1markdownTest Additional Information
.... code S1..1CodeableConceptTest Method Origin
Binding: ActionCode (example): Provides examples of actions to be performed.

..... coding Σ0..*CodingCode defined by a terminology system
...... code SΣC1..1codeSymbol in syntax defined by the system
Binding: Test Method Origin Terminology (required)
..... text SΣ1..1stringAnalytical Procedure
.... reason S1..2CodeableConceptTest Category | Test Subcategory
Binding: ActionReasonCode (example): Provides examples of reasons for actions to be performed.


..... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
..... categoryLevel S1..1integerHierarchical Level
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
..... coding SΣ0..*CodingCode defined by a terminology system
Binding: Test Category Terminology (required)
...... code SΣC1..1codeSymbol in syntax defined by the system
...... display ΣC1..1stringRepresentation defined by the system
.... documentation S0..1RelatedArtifactSupporting documentation for the intended performer of the action
..... type Σ1..1codedocumentation | 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
Binding: RelatedArtifactType (required): The type of relationship to the related artifact.


Required Pattern: documentation
..... label SΣ1..1stringReference to Procedure
.... goalId SC0..*idReference to Acceptance Criteria
.... relatedAction SC0..*BackboneElementAlternate Test
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... targetId SC1..1idWhat action is this related to
..... relationship S1..1codeCode is concurrent
Binding: ActionRelationshipType (required): Defines the types of relationships between actions.


Required Pattern: concurrent
.... selectionBehavior S0..1codeCode is exactly-one
Binding: ActionSelectionBehavior (required): Defines selection behavior of a group.


Required Pattern: exactly-one
.... action S0..*BackboneElementGroups or Stages
..... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
..... stageOrder S1..1decimalStage Sequence Order
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension
...... extension 0..0
...... url 1..1uri"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"
...... value[x] SC1..1decimalValue of extension
cmc-greater-than-zero: Hierachial levels are greater than 0
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... prefix S0..1stringStage Name
..... title S0..1stringTest Name (only reqired if different than above)
..... description S0..1markdownTest Additional Information | Stage Additional Information
..... documentation S0..*RelatedArtifactSupporting documentation for the intended performer of the action
...... type Σ1..1codedocumentation | 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
Binding: RelatedArtifactType (required): The type of relationship to the related artifact.


Required Pattern: documentation
...... document SΣ1..1AttachmentTest or Stage Additional Information Visual Attachments
....... contentType SΣC1..1codeMime type of the content, with charset etc.
Binding: MimeTypes (required): BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049)


Example General: text/plain; charset=UTF-8, image/png
....... data SC1..1base64BinaryData inline, base64ed
....... title SΣ1..1stringDocument file name including the file extension
Example General: Official Corporate Logo
..... goalId SC0..*idReference to Acceptance Criteria
..... action SC0..*BackboneElementSub-Test
cmc-subtest-rrt: a subtest's prefix represents relative retention time, should it exist
...... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
...... testOrder S1..1decimalTest Order
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension
....... extension 0..0
....... url 1..1uri"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"
....... value[x] SC1..1decimalValue of extension
cmc-greater-than-zero: Hierachial levels are greater than 0
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... prefix S0..1stringRRT
...... title S1..1stringTest Name | RRT (complex testing)
...... description S0..1markdownTest Additional Information | Stage Additional Information
...... goalId SC1..*idReference to Acceptance Criteria

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
PlanDefinition.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
PlanDefinition.useContext.codeextensiblePattern: workflow("Workflow Setting")
http://terminology.hl7.org/ValueSet/usage-context-type
PlanDefinition.useContext.value[x]exampleContextOfUseValueSet
http://hl7.org/fhir/ValueSet/use-context
from the FHIR Standard
PlanDefinition.useContext.value[x]:valueCodeableConceptexampleContextOfUseValueSet
http://hl7.org/fhir/ValueSet/use-context
from the FHIR Standard
PlanDefinition.useContext.value[x]:valueCodeableConcept.codingrequiredPqcmcSpecificationStatusTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-status-terminology
from this IG
PlanDefinition.goal.descriptionexampleSNOMEDCTClinicalFindings
http://hl7.org/fhir/ValueSet/clinical-findings
from the FHIR Standard
PlanDefinition.goal.addressesexampleConditionProblemDiagnosisCodes
http://hl7.org/fhir/ValueSet/condition-code
from the FHIR Standard
PlanDefinition.goal.addresses.coding.coderequiredPqcmcTestUsageTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-usage-terminology
from this IG
PlanDefinition.goal.documentation.typerequiredPattern: comments-on
http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0
from the FHIR Standard
PlanDefinition.goal.target.measureexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
PlanDefinition.goal.target.detail[x]:detailQuantity.extension:interpretationCode.value[x]requiredPqcmcInterpretationCodeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-interpretation-code-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
PlanDefinition.goal.target.detail[x]:detailQuantity.coderequiredPqcmcUnitsMeasureTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailRange.low.extension:interpretationCodeLow.value[x]requiredPqcmcInterpretationCodeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-interpretation-code-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailRange.low.coderequiredPqcmcUnitsMeasureTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailRange.high.extension:interpretationCodeHigh.value[x]requiredPqcmcInterpretationCodeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-interpretation-code-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailRange.high.coderequiredPqcmcUnitsMeasureTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailCodeableConcept.codingrequiredPattern: C48793("EQ")
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-interpretation-code-terminology
from this IG
PlanDefinition.action.codeexampleActionCode
http://hl7.org/fhir/ValueSet/action-code
from the FHIR Standard
PlanDefinition.action.code.coding.coderequiredPqcmcTestMethodOriginTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-method-origin-terminology
from this IG
PlanDefinition.action.reasonexampleActionReasonCode
http://hl7.org/fhir/ValueSet/action-reason-code
from the FHIR Standard
PlanDefinition.action.reason.codingrequiredPqcmcTestCategoryTerminology (a valid code from Hierarchical Test Category Codes)
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology
from this IG
PlanDefinition.action.documentation.typerequiredPattern: documentation
http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0
from the FHIR Standard
PlanDefinition.action.relatedAction.relationshiprequiredPattern: concurrent
http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0
from the FHIR Standard
PlanDefinition.action.selectionBehaviorrequiredPattern: exactly-one
http://hl7.org/fhir/ValueSet/action-selection-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.action.documentation.typerequiredPattern: documentation
http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0
from the FHIR Standard
PlanDefinition.action.action.documentation.document.contentTyperequiredMimeTypes (a valid code from urn:ietf:bcp:13)
http://hl7.org/fhir/ValueSet/mimetypes|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmc-greater-than-zeroerrorPlanDefinition.action.extension:testOrder.value[x], PlanDefinition.action.action.extension:stageOrder.value[x], PlanDefinition.action.action.action.extension:testOrder.value[x]Hierachial levels are greater than 0
: ($this > 0) = true
cmc-link-requirederrorPlanDefinition.actionAction linkId is required for alternate tests
: (action.relatedAction.count() > 0) implies action.linkId.exists()
cmc-single-or-multistageerrorPlanDefinition.actionif a test is multi-stage, the test can't have a prefix and its stages must have a name and can't be named 'Single Stage' and must be unique. If it's single stage its prefix is 'Single Stage' and its groups can't have prefixes
: (( prefix.exists() implies action.prefix.empty() and prefix = 'Single Stage' ) and ( prefix.empty() implies ( (action.where( prefix.exists() and prefix != 'Single Stage' ).count() = action.count()) and action.prefix.isDistinct() ) )) = true
cmc-subtest-rrterrorPlanDefinition.action.action.actiona subtest's prefix represents relative retention time, should it exist
: prefix.exists() implies prefix.single() = 'RRT'
cnl-0warningPlanDefinitionName should be usable as an identifier for the module by machine processing applications such as code generation
: name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
pld-3warningPlanDefinitiongoalid should reference the id of a goal definition
: %context.repeat(action).where((goalId in %context.goal.id).not()).exists().not()
pld-4warningPlanDefinitiontargetId should reference the id of an action
: %context.repeat(action).relatedAction.where((targetId in %context.repeat(action).id).not()).exists().not()
NameFlagsCard.TypeDescription & Constraintsdoco
.. PlanDefinition C0..*PlanDefinitionThe definition of a plan for a series of actions, independent of any specific patient or context
cnl-0: Name should be usable as an identifier for the module by machine processing applications such as code generation
pld-3: goalid should reference the id of a goal definition
pld-4: targetId should reference the id of an action
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ0..1idVersion specific identifier
.... lastUpdated Σ0..1instantWhen the resource version last changed
.... source Σ0..1uriIdentifies where the resource comes from
.... profile SΣ0..1canonical(StructureDefinition)Profiles this resource claims to conform to
.... security Σ0..*CodingSecurity Labels applied to this resource
Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.


.... tag Σ0..*CodingTags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".


... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguagesStarter Set
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
... specificationType S1..1CodeableConceptSpecification Type
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-type-extension
Binding: Specification Type Terminology (required)
... spec-additional-info S0..1markdownSpecification Additional Information
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
... url ΣC0..1uriCanonical identifier for this plan definition, represented as a URI (globally unique)
cnl-1: URL should not contain | or # - these characters make processing canonical references problematic
... identifier SΣ0..1IdentifierAdditional identifier for the plan definition
... version SΣ1..1stringSpecification Version
... versionAlgorithm[x] Σ0..1How to compare versions
Binding: VersionAlgorithm (extensible)
.... versionAlgorithmStringstring
.... versionAlgorithmCodingCoding
... name ΣC0..1stringName for this plan definition (computer friendly)
... title SΣ1..1stringSpecification Title
... subtitle S0..1stringSpecification Subtitle
... type Σ0..1CodeableConceptorder-set | clinical-protocol | eca-rule | workflow-definition
Binding: PlanDefinitionType (extensible): The type of PlanDefinition.

... status ?!SΣ1..1codedraft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... experimental Σ0..1booleanFor testing purposes, not real usage
... subject[x] S1..1Reference(Routine Drug Product | Routine Drug Substance | Excipient Drug Substance)Type of individual the plan definition is focused on
... date SΣ1..1dateTimeSpecification Version Date
... publisher Σ0..1stringName of the publisher/steward (organization or individual)
... contact Σ0..*ContactDetailContact details for the publisher
... description Σ0..1markdownNatural language description of the plan definition
... useContext SΣ1..1UsageContextSpecification Status
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... code Σ1..1CodingType of context being specified
Binding: UsageContextType (extensible): A code that specifies a type of context being specified by a usage context.


Required Pattern: At least the following
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/usage-context-type
..... version0..1stringVersion of the system - if relevant
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: workflow
..... display1..1stringRepresentation defined by the system
Fixed Value: Workflow Setting
..... userSelected0..1booleanIf this coding was chosen directly by the user
.... Slices for value[x] Σ1..1CodeableConceptValue that defines the context
Slice: Unordered, Closed by type:$this
Binding: ContextOfUseValueSet (example): A code that defines the specific value for the context being specified.

..... value[x]:valueCodeableConcept SΣ1..1CodeableConceptValue that defines the context
Binding: ContextOfUseValueSet (example): A code that defines the specific value for the context being specified.

...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ0..*CodingCode defined by a terminology system
Binding: Specification Status Terminology (required)
...... text Σ0..1stringPlain text representation of the concept
... jurisdiction Σ0..*CodeableConceptIntended jurisdiction for plan definition (if applicable)
Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.


... purpose 0..1markdownWhy this plan definition is defined
... usage 0..1markdownDescribes the clinical usage of the plan
... copyright 0..1markdownUse and/or publishing restrictions
... copyrightLabel 0..1stringCopyright holder and year(s)
... approvalDate S0..1dateSpecification Status Date
... lastReviewDate 0..1dateWhen the plan definition was last reviewed by the publisher
... effectivePeriod Σ0..1PeriodWhen the plan definition is expected to be used
... topic 0..*CodeableConceptE.g. Education, Treatment, Assessment
Binding: DefinitionTopic (example): High-level categorization of the definition, used for searching, sorting, and filtering.


... author 0..*ContactDetailWho authored the content
... editor 0..*ContactDetailWho edited the content
... reviewer 0..*ContactDetailWho reviewed the content
... endorser 0..*ContactDetailWho endorsed the content
... relatedArtifact 0..*RelatedArtifactAdditional documentation, citations
... library 0..*canonical(Library)Logic used by the plan definition
... goal SC0..*BackboneElementAcceptance Criteria
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... category 0..1CodeableConceptE.g. Treatment, dietary, behavioral
Binding: GoalCategory (example): Example codes for grouping goals for filtering or presentation.

.... description S1..1CodeableConceptOriginal Text
Binding: SNOMEDCTClinicalFindings (example): Describes goals that can be achieved.

.... priority 0..1CodeableConcepthigh-priority | medium-priority | low-priority
Binding: GoalPriority (preferred): Indicates the level of importance associated with reaching or sustaining a goal.

.... start 0..1CodeableConceptWhen goal pursuit begins
Binding: GoalStartEvent (example): Identifies the types of events that might trigger the start of a goal.

.... addresses S1..*CodeableConceptWhat does the goal address
Binding: ConditionProblemDiagnosisCodes (example): Identifies problems, conditions, issues, or concerns that goals may address.


..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ0..*CodingCode defined by a terminology system
...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ0..1uriIdentity of the terminology system
...... version Σ0..1stringVersion of the system - if relevant
...... code SΣC1..1codeAcceptance Criteria Usage
Binding: Test Usage Terminology (required)
...... display ΣC0..1stringRepresentation defined by the system
...... userSelected Σ0..1booleanIf this coding was chosen directly by the user
..... text Σ0..1stringAccpetance Criteria Usage
.... documentation S0..*RelatedArtifactSupporting documentation for the goal
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... type Σ1..1codedocumentation | 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
Binding: RelatedArtifactType (required): The type of relationship to the related artifact.


Required Pattern: comments-on
..... classifier Σ0..*CodeableConceptAdditional classifiers
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.


..... label Σ0..1stringShort label
..... display SΣ1..1stringAcceptance Criteria Additional Information
..... citation Σ0..1markdownBibliographic citation for the artifact
..... document Σ0..1AttachmentWhat document is being referenced
..... resource Σ0..1canonical(Resource)What artifact is being referenced
..... resourceReference Σ0..1Reference(Resource)What artifact, if not a conformance resource
..... publicationStatus Σ0..1codedraft | active | retired | unknown
Binding: PublicationStatus (required): Publication status of an artifact being referred to.

..... publicationDate Σ0..1dateDate of publication of the artifact being referred to
.... target S1..*BackboneElementAcceptance Criteron
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... measure 0..1CodeableConceptThe parameter whose value is to be tracked
Binding: LOINCCodes (example): Identifies types of parameters that can be tracked to determine goal achievement.

...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ0..*CodingCode defined by a terminology system
...... text SΣ0..1stringDetailed parameter being measured if more granular than Sub-Test
..... Slices for detail[x] S0..1The target value to be achieved
Slice: Unordered, Closed by type:$this
...... detailQuantityQuantity
...... detailRangeRange
...... detailCodeableConceptCodeableConcept
...... detailIntegerinteger
...... detail[x]:detailQuantity S0..1QuantityValueNumeric
....... id 0..1idUnique id for inter-element referencing
....... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
....... interpretationCode S1..1CodeableConceptInterpretation Code
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension
Binding: Interpretation Code Terminology (required)
........ id 0..1idUnique id for inter-element referencing
........ extension 0..0
........ url 1..1uri"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"
........ value[x] 0..1CodeableConceptInterpretation Code
Binding: Interpretation Code Terminology (required)
....... value SΣ1..1decimalNumerical value (with implicit precision)
....... comparator ?!Σ0..1code< | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

....... unit SΣ1..1stringUnit representation
....... system ΣC0..1uriSystem that defines coded unit form
....... code SΣC1..1codeCoded form of the unit
Binding: Units Of Measure Terminology (required)
...... detail[x]:detailRange S0..1RangeValueNumeric (range)
....... id 0..1idUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
....... low ΣC1..1SimpleQuantityLow limit
........ id 0..1idUnique id for inter-element referencing
........ Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
........ interpretationCodeLow S1..1CodeableConceptInterpretation Code
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension
Binding: Interpretation Code Terminology (required)
......... id 0..1idUnique id for inter-element referencing
......... extension 0..0
......... url 1..1uri"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"
......... value[x] 0..1CodeableConceptInterpretation Code
Binding: Interpretation Code Terminology (required)
........ value SΣ1..1decimalNumerical value (with implicit precision)
........ unit SΣ1..1stringUnit representation
........ system ΣC0..1uriSystem that defines coded unit form
........ code SΣC1..1codeCoded form of the unit
Binding: Units Of Measure Terminology (required)
....... high ΣC1..1SimpleQuantityHigh limit
........ id 0..1idUnique id for inter-element referencing
........ Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
........ interpretationCodeHigh S1..1CodeableConceptInterpretation Code
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension
Binding: Interpretation Code Terminology (required)
......... id 0..1idUnique id for inter-element referencing
......... extension 0..0
......... url 1..1uri"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"
......... value[x] 0..1CodeableConceptInterpretation Code
Binding: Interpretation Code Terminology (required)
........ value SΣ1..1decimalNumerical value (with implicit precision)
........ unit SΣ1..1stringUnit representation
........ system ΣC0..1uriSystem that defines coded unit form
........ code SΣC1..1codeCoded form of the unit
Binding: Units Of Measure Terminology (required)
...... detail[x]:detailCodeableConcept S0..1CodeableConceptThe target value to be achieved
....... id 0..1idUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
....... coding SΣ1..1CodingInterpretation Code
Binding: Interpretation Code Terminology (required)

Required Pattern: At least the following
........ id0..1stringUnique id for inter-element referencing
........ extension0..*ExtensionAdditional content defined by implementations
........ system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
........ version0..1stringVersion of the system - if relevant
........ code1..1codeSymbol in syntax defined by the system
Fixed Value: C48793
........ display1..1stringRepresentation defined by the system
Fixed Value: EQ
........ userSelected0..1booleanIf this coding was chosen directly by the user
....... text SΣ1..1stringValue
...... detail[x]:detailInteger S0..1integerNumber of Replicates
... actor 0..*BackboneElementActors within the plan
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... title 0..1stringUser-visible title
.... description 0..1markdownDescribes the actor
.... option 1..*BackboneElementWho or what can be this actor
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type 0..1codecareteam | device | group | healthcareservice | location | organization | patient | practitioner | practitionerrole | relatedperson
Binding: ActionParticipantType (required): The type of participant in the activity.

..... typeCanonical 0..1canonical(CapabilityStatement)Who or what can participate
..... typeReference 0..1Reference(CareTeam | Device | DeviceDefinition | Endpoint | Group | HealthcareService | Location | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson)Who or what can participate
..... role 0..1CodeableConceptE.g. Nurse, Surgeon, Parent
Binding: Action Participant Role (example)
... action SC1..*BackboneElementMethod
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
.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
.... testOrder S1..1decimalTest Order
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension
..... id 0..1idUnique id for inter-element referencing
..... extension 0..0
..... url 1..1uri"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"
..... value[x] SC1..1decimalValue of extension
cmc-greater-than-zero: Hierachial levels are greater than 0
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... linkId S0..1stringonly required for alternate tests
.... prefix S0..1stringStage Name
.... title S1..1stringTest Name
.... description S0..1markdownTest Additional Information
.... textEquivalent 0..1markdownStatic text equivalent of the action, used if the dynamic aspects cannot be interpreted by the receiving system
.... priority 0..1coderoutine | urgent | asap | stat
Binding: RequestPriority (required): Identifies the level of importance to be assigned to actioning the request.

.... code S1..1CodeableConceptTest Method Origin
Binding: ActionCode (example): Provides examples of actions to be performed.

..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ0..*CodingCode defined by a terminology system
...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ0..1uriIdentity of the terminology system
...... version Σ0..1stringVersion of the system - if relevant
...... code SΣC1..1codeSymbol in syntax defined by the system
Binding: Test Method Origin Terminology (required)
...... display ΣC0..1stringRepresentation defined by the system
...... userSelected Σ0..1booleanIf this coding was chosen directly by the user
..... text SΣ1..1stringAnalytical Procedure
.... reason S1..2CodeableConceptTest Category | Test Subcategory
Binding: ActionReasonCode (example): Provides examples of reasons for actions to be performed.


..... id 0..1idUnique id for inter-element referencing
..... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
..... categoryLevel S1..1integerHierarchical Level
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
..... coding SΣ0..*CodingCode defined by a terminology system
Binding: Test Category Terminology (required)
...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ0..1uriIdentity of the terminology system
...... version Σ0..1stringVersion of the system - if relevant
...... code SΣC1..1codeSymbol in syntax defined by the system
...... display ΣC1..1stringRepresentation defined by the system
...... userSelected Σ0..1booleanIf this coding was chosen directly by the user
..... text Σ0..1stringPlain text representation of the concept
.... documentation S0..1RelatedArtifactSupporting documentation for the intended performer of the action
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... type Σ1..1codedocumentation | 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
Binding: RelatedArtifactType (required): The type of relationship to the related artifact.


Required Pattern: documentation
..... classifier Σ0..*CodeableConceptAdditional classifiers
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.


..... label SΣ1..1stringReference to Procedure
..... display Σ0..1stringBrief description of the related artifact
..... citation Σ0..1markdownBibliographic citation for the artifact
..... document Σ0..1AttachmentWhat document is being referenced
..... resource Σ0..1canonical(Resource)What artifact is being referenced
..... resourceReference Σ0..1Reference(Resource)What artifact, if not a conformance resource
..... publicationStatus Σ0..1codedraft | active | retired | unknown
Binding: PublicationStatus (required): Publication status of an artifact being referred to.

..... publicationDate Σ0..1dateDate of publication of the artifact being referred to
.... goalId SC0..*idReference to Acceptance Criteria
.... subject[x] 0..1Type of individual the action is focused on
Binding: ParticipantResourceTypes (extensible): The possible types of subjects for a plan definition (E.g. Patient, Practitioner, Organization, Location, etc.).

..... subjectCodeableConceptCodeableConcept
..... subjectReferenceReference(Group)
..... subjectCanonicalcanonical(Any)
.... trigger 0..*TriggerDefinitionWhen the action should be triggered
.... condition 0..*BackboneElementWhether or not the action is applicable
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... kind 1..1codeapplicability | start | stop
Binding: ActionConditionKind (required): Defines the kinds of conditions that can appear on actions.

..... expression 0..1ExpressionBoolean-valued expression
.... input C0..*BackboneElementInput data requirements
pld-0: Input data elements must have a requirement or a relatedData, but not both
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringUser-visible title
..... requirement C0..1DataRequirementWhat data is provided
..... relatedData C0..1idWhat data is provided
.... output C0..*BackboneElementOutput data definition
pld-1: Output data element must have a requirement or a relatedData, but not both
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringUser-visible title
..... requirement C0..1DataRequirementWhat data is provided
..... relatedData C0..1stringWhat data is provided
.... relatedAction SC0..*BackboneElementAlternate Test
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... targetId SC1..1idWhat action is this related to
..... relationship S1..1codeCode is concurrent
Binding: ActionRelationshipType (required): Defines the types of relationships between actions.


Required Pattern: concurrent
..... endRelationship 0..1codebefore | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end
Binding: ActionRelationshipType (required): Defines the types of relationships between actions.

..... offset[x] 0..1Time offset for the relationship
...... offsetDurationDuration
...... offsetRangeRange
.... timing[x] 0..1When the action should take place
..... timingAgeAge
..... timingDurationDuration
..... timingRangeRange
..... timingTimingTiming
.... location 0..1CodeableReference(Location)Where it should happen
.... participant 0..*BackboneElementWho should participate in the action
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... actorId 0..1stringWhat actor
..... type 0..1codecareteam | device | group | healthcareservice | location | organization | patient | practitioner | practitionerrole | relatedperson
Binding: ActionParticipantType (required): The type of participant in the activity.

..... typeCanonical 0..1canonical(CapabilityStatement)Who or what can participate
..... typeReference 0..1Reference(CareTeam | Device | DeviceDefinition | Endpoint | Group | HealthcareService | Location | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson)Who or what can participate
..... role 0..1CodeableConceptE.g. Nurse, Surgeon, Parent
Binding: Action Participant Role (example): Defines roles played by participants for the action.

..... function 0..1CodeableConceptE.g. Author, Reviewer, Witness, etc
Binding: ActionParticipantFunction (example)
.... type 0..1CodeableConceptcreate | update | remove | fire-event
Binding: ActionType (extensible): The type of action to be performed.

.... groupingBehavior 0..1codevisual-group | logical-group | sentence-group
Binding: ActionGroupingBehavior (required): Defines organization behavior of a group.

.... selectionBehavior S0..1codeCode is exactly-one
Binding: ActionSelectionBehavior (required): Defines selection behavior of a group.


Required Pattern: exactly-one
.... requiredBehavior 0..1codemust | could | must-unless-documented
Binding: ActionRequiredBehavior (required): Defines expectations around whether an action or action group is required.

.... precheckBehavior 0..1codeyes | no
Binding: ActionPrecheckBehavior (required): Defines selection frequency behavior for an action or group.

.... cardinalityBehavior 0..1codesingle | multiple
Binding: ActionCardinalityBehavior (required): Defines behavior for an action or a group for how many times that item may be repeated.

.... definition[x] 0..1Description of the activity to be performed
..... definitionCanonicalcanonical(ActivityDefinition | MessageDefinition | ObservationDefinition | PlanDefinition | Questionnaire | SpecimenDefinition)
..... definitionUriuri
.... transform 0..1canonical(StructureMap)Transform to apply the template
.... dynamicValue 0..*BackboneElementDynamic aspects of the definition
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... path 0..1stringThe path to the element to be set dynamically
..... expression 0..1ExpressionAn expression that provides the dynamic value for the customization
.... action S0..*BackboneElementGroups or Stages
..... id 0..1stringUnique id for inter-element referencing
..... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
..... stageOrder S1..1decimalStage Sequence Order
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension
...... id 0..1idUnique id for inter-element referencing
...... extension 0..0
...... url 1..1uri"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"
...... value[x] SC1..1decimalValue of extension
cmc-greater-than-zero: Hierachial levels are greater than 0
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... linkId 0..1stringUnique id for the action in the PlanDefinition
..... prefix S0..1stringStage Name
..... title S0..1stringTest Name (only reqired if different than above)
..... description S0..1markdownTest Additional Information | Stage Additional Information
..... textEquivalent 0..1markdownStatic text equivalent of the action, used if the dynamic aspects cannot be interpreted by the receiving system
..... priority 0..1coderoutine | urgent | asap | stat
Binding: RequestPriority (required): Identifies the level of importance to be assigned to actioning the request.

..... code 0..1CodeableConceptCode representing the meaning of the action or sub-actions
Binding: ActionCode (example): Provides examples of actions to be performed.

..... reason 0..*CodeableConceptWhy the action should be performed
Binding: ActionReasonCode (example): Provides examples of reasons for actions to be performed.


..... documentation S0..*RelatedArtifactSupporting documentation for the intended performer of the action
...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... type Σ1..1codedocumentation | 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
Binding: RelatedArtifactType (required): The type of relationship to the related artifact.


Required Pattern: documentation
...... classifier Σ0..*CodeableConceptAdditional classifiers
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.


...... label Σ0..1stringShort label
...... display Σ0..1stringBrief description of the related artifact
...... citation Σ0..1markdownBibliographic citation for the artifact
...... document SΣ1..1AttachmentTest or Stage Additional Information Visual Attachments
....... id 0..1idUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
....... contentType SΣC1..1codeMime type of the content, with charset etc.
Binding: MimeTypes (required): BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049)


Example General: text/plain; charset=UTF-8, image/png
....... language Σ0..1codeHuman language of the content (BCP-47)
Binding: AllLanguages (required): IETF language tag for a human language.

Additional BindingsPurpose
CommonLanguagesStarter Set

Example General: en-AU
....... data SC1..1base64BinaryData inline, base64ed
....... url Σ0..1urlUri where the data can be found
Example General: http://www.acme.com/logo-small.png
....... size Σ0..1integer64Number of bytes of content (if url provided)
....... hash Σ0..1base64BinaryHash of the data (sha-1, base64ed)
....... title SΣ1..1stringDocument file name including the file extension
Example General: Official Corporate Logo
....... creation Σ0..1dateTimeDate attachment was first created
....... height 0..1positiveIntHeight of the image in pixels (photo/video)
....... width 0..1positiveIntWidth of the image in pixels (photo/video)
....... frames 0..1positiveIntNumber of frames if > 1 (photo)
....... duration 0..1decimalLength in seconds (audio / video)
....... pages 0..1positiveIntNumber of printed pages
...... resource Σ0..1canonical(Resource)What artifact is being referenced
...... resourceReference Σ0..1Reference(Resource)What artifact, if not a conformance resource
...... publicationStatus Σ0..1codedraft | active | retired | unknown
Binding: PublicationStatus (required): Publication status of an artifact being referred to.

...... publicationDate Σ0..1dateDate of publication of the artifact being referred to
..... goalId SC0..*idReference to Acceptance Criteria
..... subject[x] 0..1Type of individual the action is focused on
Binding: ParticipantResourceTypes (extensible): The possible types of subjects for a plan definition (E.g. Patient, Practitioner, Organization, Location, etc.).

...... subjectCodeableConceptCodeableConcept
...... subjectReferenceReference(Group)
...... subjectCanonicalcanonical(Any)
..... trigger 0..*TriggerDefinitionWhen the action should be triggered
..... condition 0..*BackboneElementWhether or not the action is applicable
...... id 0..1stringUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... kind 1..1codeapplicability | start | stop
Binding: ActionConditionKind (required): Defines the kinds of conditions that can appear on actions.

...... expression 0..1ExpressionBoolean-valued expression
..... input C0..*BackboneElementInput data requirements
pld-0: Input data elements must have a requirement or a relatedData, but not both
...... id 0..1stringUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... title 0..1stringUser-visible title
...... requirement C0..1DataRequirementWhat data is provided
...... relatedData C0..1idWhat data is provided
..... output C0..*BackboneElementOutput data definition
pld-1: Output data element must have a requirement or a relatedData, but not both
...... id 0..1stringUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... title 0..1stringUser-visible title
...... requirement C0..1DataRequirementWhat data is provided
...... relatedData C0..1stringWhat data is provided
..... relatedAction C0..*BackboneElementRelationship to another action
...... id 0..1stringUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... targetId C1..1idWhat action is this related to
...... relationship 1..1codebefore | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end
Binding: ActionRelationshipType (required): Defines the types of relationships between actions.

...... endRelationship 0..1codebefore | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end
Binding: ActionRelationshipType (required): Defines the types of relationships between actions.

...... offset[x] 0..1Time offset for the relationship
....... offsetDurationDuration
....... offsetRangeRange
..... timing[x] 0..1When the action should take place
...... timingAgeAge
...... timingDurationDuration
...... timingRangeRange
...... timingTimingTiming
..... location 0..1CodeableReference(Location)Where it should happen
..... participant 0..*BackboneElementWho should participate in the action
...... id 0..1stringUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... actorId 0..1stringWhat actor
...... type 0..1codecareteam | device | group | healthcareservice | location | organization | patient | practitioner | practitionerrole | relatedperson
Binding: ActionParticipantType (required): The type of participant in the activity.

...... typeCanonical 0..1canonical(CapabilityStatement)Who or what can participate
...... typeReference 0..1Reference(CareTeam | Device | DeviceDefinition | Endpoint | Group | HealthcareService | Location | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson)Who or what can participate
...... role 0..1CodeableConceptE.g. Nurse, Surgeon, Parent
Binding: Action Participant Role (example): Defines roles played by participants for the action.

...... function 0..1CodeableConceptE.g. Author, Reviewer, Witness, etc
Binding: ActionParticipantFunction (example)
..... type 0..1CodeableConceptcreate | update | remove | fire-event
Binding: ActionType (extensible): The type of action to be performed.

..... groupingBehavior 0..1codevisual-group | logical-group | sentence-group
Binding: ActionGroupingBehavior (required): Defines organization behavior of a group.

..... selectionBehavior 0..1codeany | all | all-or-none | exactly-one | at-most-one | one-or-more
Binding: ActionSelectionBehavior (required): Defines selection behavior of a group.

..... requiredBehavior 0..1codemust | could | must-unless-documented
Binding: ActionRequiredBehavior (required): Defines expectations around whether an action or action group is required.

..... precheckBehavior 0..1codeyes | no
Binding: ActionPrecheckBehavior (required): Defines selection frequency behavior for an action or group.

..... cardinalityBehavior 0..1codesingle | multiple
Binding: ActionCardinalityBehavior (required): Defines behavior for an action or a group for how many times that item may be repeated.

..... definition[x] 0..1Description of the activity to be performed
...... definitionCanonicalcanonical(ActivityDefinition | MessageDefinition | ObservationDefinition | PlanDefinition | Questionnaire | SpecimenDefinition)
...... definitionUriuri
..... transform 0..1canonical(StructureMap)Transform to apply the template
..... dynamicValue 0..*BackboneElementDynamic aspects of the definition
...... id 0..1stringUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... path 0..1stringThe path to the element to be set dynamically
...... expression 0..1ExpressionAn expression that provides the dynamic value for the customization
..... action SC0..*BackboneElementSub-Test
cmc-subtest-rrt: a subtest's prefix represents relative retention time, should it exist
...... id 0..1stringUnique id for inter-element referencing
...... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
...... testOrder S1..1decimalTest Order
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension
....... id 0..1idUnique id for inter-element referencing
....... extension 0..0
....... url 1..1uri"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"
....... value[x] SC1..1decimalValue of extension
cmc-greater-than-zero: Hierachial levels are greater than 0
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... linkId 0..1stringUnique id for the action in the PlanDefinition
...... prefix S0..1stringRRT
...... title S1..1stringTest Name | RRT (complex testing)
...... description S0..1markdownTest Additional Information | Stage Additional Information
...... textEquivalent 0..1markdownStatic text equivalent of the action, used if the dynamic aspects cannot be interpreted by the receiving system
...... priority 0..1coderoutine | urgent | asap | stat
Binding: RequestPriority (required): Identifies the level of importance to be assigned to actioning the request.

...... code 0..1CodeableConceptCode representing the meaning of the action or sub-actions
Binding: ActionCode (example): Provides examples of actions to be performed.

...... reason 0..*CodeableConceptWhy the action should be performed
Binding: ActionReasonCode (example): Provides examples of reasons for actions to be performed.


...... documentation 0..*RelatedArtifactSupporting documentation for the intended performer of the action
...... goalId SC1..*idReference to Acceptance Criteria
...... subject[x] 0..1Type of individual the action is focused on
Binding: ParticipantResourceTypes (extensible): The possible types of subjects for a plan definition (E.g. Patient, Practitioner, Organization, Location, etc.).

....... subjectCodeableConceptCodeableConcept
....... subjectReferenceReference(Group)
....... subjectCanonicalcanonical(Any)
...... trigger 0..*TriggerDefinitionWhen the action should be triggered
...... condition 0..*BackboneElementWhether or not the action is applicable
....... id 0..1stringUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
....... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
....... kind 1..1codeapplicability | start | stop
Binding: ActionConditionKind (required): Defines the kinds of conditions that can appear on actions.

....... expression 0..1ExpressionBoolean-valued expression
...... input C0..*BackboneElementInput data requirements
pld-0: Input data elements must have a requirement or a relatedData, but not both
....... id 0..1stringUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
....... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
....... title 0..1stringUser-visible title
....... requirement C0..1DataRequirementWhat data is provided
....... relatedData C0..1idWhat data is provided
...... output C0..*BackboneElementOutput data definition
pld-1: Output data element must have a requirement or a relatedData, but not both
....... id 0..1stringUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
....... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
....... title 0..1stringUser-visible title
....... requirement C0..1DataRequirementWhat data is provided
....... relatedData C0..1stringWhat data is provided
...... relatedAction C0..*BackboneElementRelationship to another action
....... id 0..1stringUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
....... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
....... targetId C1..1idWhat action is this related to
....... relationship 1..1codebefore | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end
Binding: ActionRelationshipType (required): Defines the types of relationships between actions.

....... endRelationship 0..1codebefore | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end
Binding: ActionRelationshipType (required): Defines the types of relationships between actions.

....... offset[x] 0..1Time offset for the relationship
........ offsetDurationDuration
........ offsetRangeRange
...... timing[x] 0..1When the action should take place
....... timingAgeAge
....... timingDurationDuration
....... timingRangeRange
....... timingTimingTiming
...... location 0..1CodeableReference(Location)Where it should happen
...... participant 0..*BackboneElementWho should participate in the action
....... id 0..1stringUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
....... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
....... actorId 0..1stringWhat actor
....... type 0..1codecareteam | device | group | healthcareservice | location | organization | patient | practitioner | practitionerrole | relatedperson
Binding: ActionParticipantType (required): The type of participant in the activity.

....... typeCanonical 0..1canonical(CapabilityStatement)Who or what can participate
....... typeReference 0..1Reference(CareTeam | Device | DeviceDefinition | Endpoint | Group | HealthcareService | Location | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson)Who or what can participate
....... role 0..1CodeableConceptE.g. Nurse, Surgeon, Parent
Binding: Action Participant Role (example): Defines roles played by participants for the action.

....... function 0..1CodeableConceptE.g. Author, Reviewer, Witness, etc
Binding: ActionParticipantFunction (example)
...... type 0..1CodeableConceptcreate | update | remove | fire-event
Binding: ActionType (extensible): The type of action to be performed.

...... groupingBehavior 0..1codevisual-group | logical-group | sentence-group
Binding: ActionGroupingBehavior (required): Defines organization behavior of a group.

...... selectionBehavior 0..1codeany | all | all-or-none | exactly-one | at-most-one | one-or-more
Binding: ActionSelectionBehavior (required): Defines selection behavior of a group.

...... requiredBehavior 0..1codemust | could | must-unless-documented
Binding: ActionRequiredBehavior (required): Defines expectations around whether an action or action group is required.

...... precheckBehavior 0..1codeyes | no
Binding: ActionPrecheckBehavior (required): Defines selection frequency behavior for an action or group.

...... cardinalityBehavior 0..1codesingle | multiple
Binding: ActionCardinalityBehavior (required): Defines behavior for an action or a group for how many times that item may be repeated.

...... definition[x] 0..1Description of the activity to be performed
....... definitionCanonicalcanonical(ActivityDefinition | MessageDefinition | ObservationDefinition | PlanDefinition | Questionnaire | SpecimenDefinition)
....... definitionUriuri
...... transform 0..1canonical(StructureMap)Transform to apply the template
...... dynamicValue 0..*BackboneElementDynamic aspects of the definition
....... id 0..1stringUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
....... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
....... path 0..1stringThe path to the element to be set dynamically
....... expression 0..1ExpressionAn expression that provides the dynamic value for the customization
...... action 0..*See action (PlanDefinition)A sub-action
... asNeeded[x] Σ0..1Preconditions for service
Binding: SNOMEDCTMedicationAsNeededReasonCodes (example): A coded concept identifying the pre-condition that should hold prior to performing a procedure. For example "pain", "on flare-up", etc.

.... asNeededBooleanboolean
.... asNeededCodeableConceptCodeableConcept

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
PlanDefinition.meta.securityextensibleAllSecurityLabels
http://hl7.org/fhir/ValueSet/security-labels
from the FHIR Standard
PlanDefinition.meta.tagexampleCommonTags
http://hl7.org/fhir/ValueSet/common-tags
from the FHIR Standard
PlanDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
PlanDefinition.versionAlgorithm[x]extensibleVersionAlgorithm
http://hl7.org/fhir/ValueSet/version-algorithm
from the FHIR Standard
PlanDefinition.typeextensiblePlanDefinitionType
http://hl7.org/fhir/ValueSet/plan-definition-type
from the FHIR Standard
PlanDefinition.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
PlanDefinition.useContext.codeextensiblePattern: workflow("Workflow Setting")
http://terminology.hl7.org/ValueSet/usage-context-type
PlanDefinition.useContext.value[x]exampleContextOfUseValueSet
http://hl7.org/fhir/ValueSet/use-context
from the FHIR Standard
PlanDefinition.useContext.value[x]:valueCodeableConceptexampleContextOfUseValueSet
http://hl7.org/fhir/ValueSet/use-context
from the FHIR Standard
PlanDefinition.useContext.value[x]:valueCodeableConcept.codingrequiredPqcmcSpecificationStatusTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-status-terminology
from this IG
PlanDefinition.jurisdictionextensibleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
PlanDefinition.topicexampleDefinitionTopic
http://hl7.org/fhir/ValueSet/definition-topic
from the FHIR Standard
PlanDefinition.goal.categoryexampleGoalCategory
http://hl7.org/fhir/ValueSet/goal-category
from the FHIR Standard
PlanDefinition.goal.descriptionexampleSNOMEDCTClinicalFindings
http://hl7.org/fhir/ValueSet/clinical-findings
from the FHIR Standard
PlanDefinition.goal.prioritypreferredGoalPriority
http://hl7.org/fhir/ValueSet/goal-priority
from the FHIR Standard
PlanDefinition.goal.startexampleGoalStartEvent
http://hl7.org/fhir/ValueSet/goal-start-event
from the FHIR Standard
PlanDefinition.goal.addressesexampleConditionProblemDiagnosisCodes
http://hl7.org/fhir/ValueSet/condition-code
from the FHIR Standard
PlanDefinition.goal.addresses.coding.coderequiredPqcmcTestUsageTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-usage-terminology
from this IG
PlanDefinition.goal.documentation.typerequiredPattern: comments-on
http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0
from the FHIR Standard
PlanDefinition.goal.documentation.classifierexampleCitationArtifactClassifier
http://hl7.org/fhir/ValueSet/citation-artifact-classifier
from the FHIR Standard
PlanDefinition.goal.documentation.publicationStatusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
PlanDefinition.goal.target.measureexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
PlanDefinition.goal.target.detail[x]:detailQuantity.extension:interpretationCode.value[x]requiredPqcmcInterpretationCodeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-interpretation-code-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
PlanDefinition.goal.target.detail[x]:detailQuantity.coderequiredPqcmcUnitsMeasureTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailRange.low.extension:interpretationCodeLow.value[x]requiredPqcmcInterpretationCodeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-interpretation-code-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailRange.low.coderequiredPqcmcUnitsMeasureTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailRange.high.extension:interpretationCodeHigh.value[x]requiredPqcmcInterpretationCodeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-interpretation-code-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailRange.high.coderequiredPqcmcUnitsMeasureTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailCodeableConcept.codingrequiredPattern: C48793("EQ")
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-interpretation-code-terminology
from this IG
PlanDefinition.actor.option.typerequiredActionParticipantType
http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0
from the FHIR Standard
PlanDefinition.actor.option.roleexampleActionParticipantRole
http://terminology.hl7.org/ValueSet/action-participant-role
PlanDefinition.action.priorityrequiredRequestPriority
http://hl7.org/fhir/ValueSet/request-priority|5.0.0
from the FHIR Standard
PlanDefinition.action.codeexampleActionCode
http://hl7.org/fhir/ValueSet/action-code
from the FHIR Standard
PlanDefinition.action.code.coding.coderequiredPqcmcTestMethodOriginTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-method-origin-terminology
from this IG
PlanDefinition.action.reasonexampleActionReasonCode
http://hl7.org/fhir/ValueSet/action-reason-code
from the FHIR Standard
PlanDefinition.action.reason.codingrequiredPqcmcTestCategoryTerminology (a valid code from Hierarchical Test Category Codes)
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology
from this IG
PlanDefinition.action.documentation.typerequiredPattern: documentation
http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0
from the FHIR Standard
PlanDefinition.action.documentation.classifierexampleCitationArtifactClassifier
http://hl7.org/fhir/ValueSet/citation-artifact-classifier
from the FHIR Standard
PlanDefinition.action.documentation.publicationStatusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
PlanDefinition.action.subject[x]extensibleParticipantResourceTypes
http://hl7.org/fhir/ValueSet/participant-resource-types
from the FHIR Standard
PlanDefinition.action.condition.kindrequiredActionConditionKind
http://hl7.org/fhir/ValueSet/action-condition-kind|5.0.0
from the FHIR Standard
PlanDefinition.action.relatedAction.relationshiprequiredPattern: concurrent
http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0
from the FHIR Standard
PlanDefinition.action.relatedAction.endRelationshiprequiredActionRelationshipType
http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0
from the FHIR Standard
PlanDefinition.action.participant.typerequiredActionParticipantType
http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0
from the FHIR Standard
PlanDefinition.action.participant.roleexampleActionParticipantRole
http://terminology.hl7.org/ValueSet/action-participant-role
PlanDefinition.action.participant.functionexampleActionParticipantFunction
http://hl7.org/fhir/ValueSet/action-participant-function
from the FHIR Standard
PlanDefinition.action.typeextensibleActionType
http://hl7.org/fhir/ValueSet/action-type
from the FHIR Standard
PlanDefinition.action.groupingBehaviorrequiredActionGroupingBehavior
http://hl7.org/fhir/ValueSet/action-grouping-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.selectionBehaviorrequiredPattern: exactly-one
http://hl7.org/fhir/ValueSet/action-selection-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.requiredBehaviorrequiredActionRequiredBehavior
http://hl7.org/fhir/ValueSet/action-required-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.precheckBehaviorrequiredActionPrecheckBehavior
http://hl7.org/fhir/ValueSet/action-precheck-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.cardinalityBehaviorrequiredActionCardinalityBehavior
http://hl7.org/fhir/ValueSet/action-cardinality-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.action.priorityrequiredRequestPriority
http://hl7.org/fhir/ValueSet/request-priority|5.0.0
from the FHIR Standard
PlanDefinition.action.action.codeexampleActionCode
http://hl7.org/fhir/ValueSet/action-code
from the FHIR Standard
PlanDefinition.action.action.reasonexampleActionReasonCode
http://hl7.org/fhir/ValueSet/action-reason-code
from the FHIR Standard
PlanDefinition.action.action.documentation.typerequiredPattern: documentation
http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0
from the FHIR Standard
PlanDefinition.action.action.documentation.classifierexampleCitationArtifactClassifier
http://hl7.org/fhir/ValueSet/citation-artifact-classifier
from the FHIR Standard
PlanDefinition.action.action.documentation.document.contentTyperequiredMimeTypes (a valid code from urn:ietf:bcp:13)
http://hl7.org/fhir/ValueSet/mimetypes|5.0.0
from the FHIR Standard
PlanDefinition.action.action.documentation.document.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
PlanDefinition.action.action.documentation.publicationStatusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
PlanDefinition.action.action.subject[x]extensibleParticipantResourceTypes
http://hl7.org/fhir/ValueSet/participant-resource-types
from the FHIR Standard
PlanDefinition.action.action.condition.kindrequiredActionConditionKind
http://hl7.org/fhir/ValueSet/action-condition-kind|5.0.0
from the FHIR Standard
PlanDefinition.action.action.relatedAction.relationshiprequiredActionRelationshipType
http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0
from the FHIR Standard
PlanDefinition.action.action.relatedAction.endRelationshiprequiredActionRelationshipType
http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0
from the FHIR Standard
PlanDefinition.action.action.participant.typerequiredActionParticipantType
http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0
from the FHIR Standard
PlanDefinition.action.action.participant.roleexampleActionParticipantRole
http://terminology.hl7.org/ValueSet/action-participant-role
PlanDefinition.action.action.participant.functionexampleActionParticipantFunction
http://hl7.org/fhir/ValueSet/action-participant-function
from the FHIR Standard
PlanDefinition.action.action.typeextensibleActionType
http://hl7.org/fhir/ValueSet/action-type
from the FHIR Standard
PlanDefinition.action.action.groupingBehaviorrequiredActionGroupingBehavior
http://hl7.org/fhir/ValueSet/action-grouping-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.action.selectionBehaviorrequiredActionSelectionBehavior
http://hl7.org/fhir/ValueSet/action-selection-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.action.requiredBehaviorrequiredActionRequiredBehavior
http://hl7.org/fhir/ValueSet/action-required-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.action.precheckBehaviorrequiredActionPrecheckBehavior
http://hl7.org/fhir/ValueSet/action-precheck-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.action.cardinalityBehaviorrequiredActionCardinalityBehavior
http://hl7.org/fhir/ValueSet/action-cardinality-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.action.action.priorityrequiredRequestPriority
http://hl7.org/fhir/ValueSet/request-priority|5.0.0
from the FHIR Standard
PlanDefinition.action.action.action.codeexampleActionCode
http://hl7.org/fhir/ValueSet/action-code
from the FHIR Standard
PlanDefinition.action.action.action.reasonexampleActionReasonCode
http://hl7.org/fhir/ValueSet/action-reason-code
from the FHIR Standard
PlanDefinition.action.action.action.subject[x]extensibleParticipantResourceTypes
http://hl7.org/fhir/ValueSet/participant-resource-types
from the FHIR Standard
PlanDefinition.action.action.action.condition.kindrequiredActionConditionKind
http://hl7.org/fhir/ValueSet/action-condition-kind|5.0.0
from the FHIR Standard
PlanDefinition.action.action.action.relatedAction.relationshiprequiredActionRelationshipType
http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0
from the FHIR Standard
PlanDefinition.action.action.action.relatedAction.endRelationshiprequiredActionRelationshipType
http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0
from the FHIR Standard
PlanDefinition.action.action.action.participant.typerequiredActionParticipantType
http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0
from the FHIR Standard
PlanDefinition.action.action.action.participant.roleexampleActionParticipantRole
http://terminology.hl7.org/ValueSet/action-participant-role
PlanDefinition.action.action.action.participant.functionexampleActionParticipantFunction
http://hl7.org/fhir/ValueSet/action-participant-function
from the FHIR Standard
PlanDefinition.action.action.action.typeextensibleActionType
http://hl7.org/fhir/ValueSet/action-type
from the FHIR Standard
PlanDefinition.action.action.action.groupingBehaviorrequiredActionGroupingBehavior
http://hl7.org/fhir/ValueSet/action-grouping-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.action.action.selectionBehaviorrequiredActionSelectionBehavior
http://hl7.org/fhir/ValueSet/action-selection-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.action.action.requiredBehaviorrequiredActionRequiredBehavior
http://hl7.org/fhir/ValueSet/action-required-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.action.action.precheckBehaviorrequiredActionPrecheckBehavior
http://hl7.org/fhir/ValueSet/action-precheck-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.action.action.cardinalityBehaviorrequiredActionCardinalityBehavior
http://hl7.org/fhir/ValueSet/action-cardinality-behavior|5.0.0
from the FHIR Standard
PlanDefinition.asNeeded[x]exampleSNOMEDCTMedicationAsNeededReasonCodes
http://hl7.org/fhir/ValueSet/medication-as-needed-reason
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmc-greater-than-zeroerrorPlanDefinition.action.extension:testOrder.value[x], PlanDefinition.action.action.extension:stageOrder.value[x], PlanDefinition.action.action.action.extension:testOrder.value[x]Hierachial levels are greater than 0
: ($this > 0) = true
cmc-link-requirederrorPlanDefinition.actionAction linkId is required for alternate tests
: (action.relatedAction.count() > 0) implies action.linkId.exists()
cmc-single-or-multistageerrorPlanDefinition.actionif a test is multi-stage, the test can't have a prefix and its stages must have a name and can't be named 'Single Stage' and must be unique. If it's single stage its prefix is 'Single Stage' and its groups can't have prefixes
: (( prefix.exists() implies action.prefix.empty() and prefix = 'Single Stage' ) and ( prefix.empty() implies ( (action.where( prefix.exists() and prefix != 'Single Stage' ).count() = action.count()) and action.prefix.isDistinct() ) )) = true
cmc-subtest-rrterrorPlanDefinition.action.action.actiona subtest's prefix represents relative retention time, should it exist
: prefix.exists() implies prefix.single() = 'RRT'
cnl-0warningPlanDefinitionName should be usable as an identifier for the module by machine processing applications such as code generation
: name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
cnl-1warningPlanDefinition.urlURL should not contain | or # - these characters make processing canonical references problematic
: exists() implies matches('^[^|# ]+$')
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
pld-0errorPlanDefinition.action.input, PlanDefinition.action.action.input, PlanDefinition.action.action.action.inputInput data elements must have a requirement or a relatedData, but not both
: requirement.exists() xor relatedData.exists()
pld-1errorPlanDefinition.action.output, PlanDefinition.action.action.output, PlanDefinition.action.action.action.outputOutput data element must have a requirement or a relatedData, but not both
: requirement.exists() xor relatedData.exists()
pld-3warningPlanDefinitiongoalid should reference the id of a goal definition
: %context.repeat(action).where((goalId in %context.goal.id).not()).exists().not()
pld-4warningPlanDefinitiontargetId should reference the id of an action
: %context.repeat(action).relatedAction.where((targetId in %context.repeat(action).id).not()).exists().not()

Differential View

This structure is derived from PlanDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. PlanDefinition PlanDefinition
... meta
.... profile S0..1canonical(StructureDefinition)Profiles this resource claims to conform to
... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
... specificationType S1..1CodeableConceptSpecification Type
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-type-extension
Binding: Specification Type Terminology (required)
... identifier S0..1IdentifierAdditional identifier for the plan definition
... version S1..1stringSpecification Version
... title S1..1stringSpecification Title
... subtitle S0..1stringSpecification Subtitle
... status S1..1codedraft | active | retired | unknown
... subject[x] S1..1Reference(Routine Drug Product | Routine Drug Substance | Excipient Drug Substance)Type of individual the plan definition is focused on
... date S1..1dateTimeSpecification Version Date
... useContext S1..1UsageContextSpecification Status
.... code 1..1CodingType of context being specified
Required Pattern: At least the following
..... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/usage-context-type
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: workflow
..... display1..1stringRepresentation defined by the system
Fixed Value: Workflow Setting
.... Slices for value[x] 1..1CodeableConceptValue that defines the context
Slice: Unordered, Open by type:$this
..... value[x]:valueCodeableConcept S1..1CodeableConceptValue that defines the context
...... coding 0..*CodingCode defined by a terminology system
Binding: Specification Status Terminology (required)
... approvalDate S0..1dateSpecification Status Date
... goal S0..*BackboneElementAcceptance Criteria
.... description S1..1CodeableConceptOriginal Text
.... addresses S1..*CodeableConceptWhat does the goal address
..... coding
...... code S1..1codeAcceptance Criteria Usage
Binding: Test Usage Terminology (required)
..... text 0..1stringAccpetance Criteria Usage
.... documentation S0..*RelatedArtifactSupporting documentation for the goal
..... type 1..1codedocumentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as
Required Pattern: comments-on
..... display S1..1stringAcceptance Criteria Additional Information
.... target S1..*BackboneElementAcceptance Criteron
..... measure
...... text S0..1stringDetailed parameter being measured if more granular than Sub-Test
..... Slices for detail[x] S0..1The target value to be achieved
Slice: Unordered, Open by type:$this
...... detailQuantityQuantity
...... detailRangeRange
...... detailCodeableConceptCodeableConcept
...... detailIntegerinteger
...... detail[x]:detailQuantity S0..1QuantityValueNumeric
....... extension 1..*ExtensionExtension
....... interpretationCode S1..1CodeableConceptInterpretation Code
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension
Binding: Interpretation Code Terminology (required)
........ value[x] 0..1CodeableConceptInterpretation Code
....... value S1..1decimalNumerical value (with implicit precision)
....... unit S1..1stringUnit representation
....... code S1..1codeCoded form of the unit
Binding: Units Of Measure Terminology (required)
...... detail[x]:detailRange S0..1RangeValueNumeric (range)
....... low 1..1SimpleQuantityLow limit
........ extension 1..*ExtensionExtension
........ interpretationCodeLow S1..1CodeableConceptInterpretation Code
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension
Binding: Interpretation Code Terminology (required)
......... value[x] 0..1CodeableConceptInterpretation Code
........ value S1..1decimalNumerical value (with implicit precision)
........ unit S1..1stringUnit representation
........ code S1..1codeCoded form of the unit
Binding: Units Of Measure Terminology (required)
....... high 1..1SimpleQuantityHigh limit
........ extension 1..*ExtensionExtension
........ interpretationCodeHigh S1..1CodeableConceptInterpretation Code
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension
Binding: Interpretation Code Terminology (required)
......... value[x] 0..1CodeableConceptInterpretation Code
........ value S1..1decimalNumerical value (with implicit precision)
........ unit S1..1stringUnit representation
........ code S1..1codeCoded form of the unit
Binding: Units Of Measure Terminology (required)
...... detail[x]:detailCodeableConcept S0..1CodeableConceptThe target value to be achieved
....... coding S1..1CodingInterpretation Code
Binding: Interpretation Code Terminology (required)
Required Pattern: At least the following
........ system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
........ code1..1codeSymbol in syntax defined by the system
Fixed Value: C48793
........ display1..1stringRepresentation defined by the system
Fixed Value: EQ
....... text S1..1stringValue
...... detail[x]:detailInteger S0..1integerNumber of Replicates
..... due 0..0
... action SC1..*BackboneElementMethod
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
.... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
.... testOrder S1..1decimalTest Order
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension
..... value[x] S1..1decimalValue of extension
.... linkId S0..1stringonly required for alternate tests
.... prefix S0..1stringStage Name
.... title S1..1stringTest Name
.... description S0..1markdownTest Additional Information
.... code S1..1CodeableConceptTest Method Origin
..... coding
...... code S1..1codeSymbol in syntax defined by the system
Binding: Test Method Origin Terminology (required)
..... text S1..1stringAnalytical Procedure
.... reason S1..2CodeableConceptTest Category | Test Subcategory
..... extension 1..*ExtensionExtension
..... categoryLevel S1..1integerHierarchical Level
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
..... coding S0..*CodingCode defined by a terminology system
Binding: Test Category Terminology (required)
...... code S1..1codeSymbol in syntax defined by the system
...... display 1..1stringRepresentation defined by the system
.... documentation S0..1RelatedArtifactSupporting documentation for the intended performer of the action
..... type 1..1codedocumentation | 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 S1..1stringReference to Procedure
.... goalId S0..*idReference to Acceptance Criteria
.... relatedAction S0..*BackboneElementAlternate Test
..... targetId S1..1idWhat action is this related to
..... relationship S1..1codeCode is concurrent
Required Pattern: concurrent
.... selectionBehavior S0..1codeCode is exactly-one
Required Pattern: exactly-one
.... action S0..*BackboneElementGroups or Stages
..... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
..... stageOrder S1..1decimalStage Sequence Order
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension
...... value[x] S1..1decimalValue of extension
..... prefix S0..1stringStage Name
..... title S0..1stringTest Name (only reqired if different than above)
..... description S0..1markdownTest Additional Information | Stage Additional Information
..... documentation S0..*RelatedArtifactSupporting documentation for the intended performer of the action
...... type 1..1codedocumentation | 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 S1..1AttachmentTest or Stage Additional Information Visual Attachments
....... contentType S1..1codeMime type of the content, with charset etc.
....... data S1..1base64BinaryData inline, base64ed
....... title S1..1stringDocument file name including the file extension
..... goalId S0..*idReference to Acceptance Criteria
..... action SC0..*BackboneElementSub-Test
cmc-subtest-rrt: a subtest's prefix represents relative retention time, should it exist
...... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
...... testOrder S1..1decimalTest Order
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension
....... value[x] S1..1decimalValue of extension
...... prefix S0..1stringRRT
...... title S1..1stringTest Name | RRT (complex testing)
...... description S0..1markdownTest Additional Information | Stage Additional Information
...... goalId S1..*idReference to Acceptance Criteria

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet / CodeURI
PlanDefinition.useContext.value[x]:valueCodeableConcept.codingrequiredPqcmcSpecificationStatusTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-status-terminology
from this IG
PlanDefinition.goal.addresses.coding.coderequiredPqcmcTestUsageTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-usage-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailQuantity.coderequiredPqcmcUnitsMeasureTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailRange.low.coderequiredPqcmcUnitsMeasureTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailRange.high.coderequiredPqcmcUnitsMeasureTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailCodeableConcept.codingrequiredPattern: C48793("EQ")
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-interpretation-code-terminology
from this IG
PlanDefinition.action.code.coding.coderequiredPqcmcTestMethodOriginTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-method-origin-terminology
from this IG
PlanDefinition.action.reason.codingrequiredPqcmcTestCategoryTerminology (a valid code from Hierarchical Test Category Codes)
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology
from this IG

Constraints

IdGradePath(s)DetailsRequirements
cmc-link-requirederrorPlanDefinition.actionAction linkId is required for alternate tests
: (action.relatedAction.count() > 0) implies action.linkId.exists()
cmc-single-or-multistageerrorPlanDefinition.actionif 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
: (( prefix.exists() implies action.prefix.empty() and prefix = 'Single Stage' ) and ( prefix.empty() implies ( (action.where( prefix.exists() and prefix != 'Single Stage' ).count() = action.count()) and action.prefix.isDistinct() ) )) = true
cmc-subtest-rrterrorPlanDefinition.action.action.actiona subtest's prefix represents relative retention time, should it exist
: prefix.exists() implies prefix.single() = 'RRT'

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. PlanDefinition C0..*PlanDefinitionThe definition of a plan for a series of actions, independent of any specific patient or context
cnl-0: Name should be usable as an identifier for the module by machine processing applications such as code generation
pld-3: goalid should reference the id of a goal definition
pld-4: targetId should reference the id of an action
... meta Σ0..1MetaMetadata about the resource
.... profile SΣ0..1canonical(StructureDefinition)Profiles this resource claims to conform to
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... contained 0..*ResourceContained, inline Resources
... specificationType S1..1CodeableConceptSpecification Type
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-type-extension
Binding: Specification Type Terminology (required)
... spec-additional-info S0..1markdownSpecification Additional Information
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
... identifier SΣ0..1IdentifierAdditional identifier for the plan definition
... version SΣ1..1stringSpecification Version
... title SΣ1..1stringSpecification Title
... subtitle S0..1stringSpecification Subtitle
... status ?!SΣ1..1codedraft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... subject[x] S1..1Reference(Routine Drug Product | Routine Drug Substance | Excipient Drug Substance)Type of individual the plan definition is focused on
... date SΣ1..1dateTimeSpecification Version Date
... useContext SΣ1..1UsageContextSpecification Status
.... code Σ1..1CodingType of context being specified
Binding: UsageContextType (extensible): A code that specifies a type of context being specified by a usage context.


Required Pattern: At least the following
..... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/usage-context-type
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: workflow
..... display1..1stringRepresentation defined by the system
Fixed Value: Workflow Setting
.... Slices for value[x] Σ1..1CodeableConceptValue that defines the context
Slice: Unordered, Closed by type:$this
Binding: ContextOfUseValueSet (example): A code that defines the specific value for the context being specified.

..... value[x]:valueCodeableConcept SΣ1..1CodeableConceptValue that defines the context
Binding: ContextOfUseValueSet (example): A code that defines the specific value for the context being specified.

...... coding Σ0..*CodingCode defined by a terminology system
Binding: Specification Status Terminology (required)
... approvalDate S0..1dateSpecification Status Date
... goal SC0..*BackboneElementAcceptance Criteria
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... description S1..1CodeableConceptOriginal Text
Binding: SNOMEDCTClinicalFindings (example): Describes goals that can be achieved.

.... addresses S1..*CodeableConceptWhat does the goal address
Binding: ConditionProblemDiagnosisCodes (example): Identifies problems, conditions, issues, or concerns that goals may address.


..... coding Σ0..*CodingCode defined by a terminology system
...... code SΣC1..1codeAcceptance Criteria Usage
Binding: Test Usage Terminology (required)
..... text Σ0..1stringAccpetance Criteria Usage
.... documentation S0..*RelatedArtifactSupporting documentation for the goal
..... type Σ1..1codedocumentation | 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
Binding: RelatedArtifactType (required): The type of relationship to the related artifact.


Required Pattern: comments-on
..... display SΣ1..1stringAcceptance Criteria Additional Information
.... target S1..*BackboneElementAcceptance Criteron
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... measure 0..1CodeableConceptThe parameter whose value is to be tracked
Binding: LOINCCodes (example): Identifies types of parameters that can be tracked to determine goal achievement.

...... text SΣ0..1stringDetailed parameter being measured if more granular than Sub-Test
..... Slices for detail[x] S0..1The target value to be achieved
Slice: Unordered, Closed by type:$this
...... detailQuantityQuantity
...... detailRangeRange
...... detailCodeableConceptCodeableConcept
...... detailIntegerinteger
...... detail[x]:detailQuantity S0..1QuantityValueNumeric
....... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
....... interpretationCode S1..1CodeableConceptInterpretation Code
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension
Binding: Interpretation Code Terminology (required)
........ extension 0..0
........ url 1..1uri"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"
........ value[x] 0..1CodeableConceptInterpretation Code
Binding: Interpretation Code Terminology (required)
....... value SΣ1..1decimalNumerical value (with implicit precision)
....... comparator ?!Σ0..1code< | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

....... unit SΣ1..1stringUnit representation
....... code SΣC1..1codeCoded form of the unit
Binding: Units Of Measure Terminology (required)
...... detail[x]:detailRange S0..1RangeValueNumeric (range)
....... low ΣC1..1SimpleQuantityLow limit
........ Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
........ interpretationCodeLow S1..1CodeableConceptInterpretation Code
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension
Binding: Interpretation Code Terminology (required)
......... extension 0..0
......... url 1..1uri"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"
......... value[x] 0..1CodeableConceptInterpretation Code
Binding: Interpretation Code Terminology (required)
........ value SΣ1..1decimalNumerical value (with implicit precision)
........ unit SΣ1..1stringUnit representation
........ code SΣC1..1codeCoded form of the unit
Binding: Units Of Measure Terminology (required)
....... high ΣC1..1SimpleQuantityHigh limit
........ Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
........ interpretationCodeHigh S1..1CodeableConceptInterpretation Code
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension
Binding: Interpretation Code Terminology (required)
......... extension 0..0
......... url 1..1uri"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"
......... value[x] 0..1CodeableConceptInterpretation Code
Binding: Interpretation Code Terminology (required)
........ value SΣ1..1decimalNumerical value (with implicit precision)
........ unit SΣ1..1stringUnit representation
........ code SΣC1..1codeCoded form of the unit
Binding: Units Of Measure Terminology (required)
...... detail[x]:detailCodeableConcept S0..1CodeableConceptThe target value to be achieved
....... coding SΣ1..1CodingInterpretation Code
Binding: Interpretation Code Terminology (required)

Required Pattern: At least the following
........ system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
........ code1..1codeSymbol in syntax defined by the system
Fixed Value: C48793
........ display1..1stringRepresentation defined by the system
Fixed Value: EQ
....... text SΣ1..1stringValue
...... detail[x]:detailInteger S0..1integerNumber of Replicates
... action SC1..*BackboneElementMethod
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
.... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
.... testOrder S1..1decimalTest Order
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension
..... extension 0..0
..... url 1..1uri"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"
..... value[x] SC1..1decimalValue of extension
cmc-greater-than-zero: Hierachial levels are greater than 0
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... linkId S0..1stringonly required for alternate tests
.... prefix S0..1stringStage Name
.... title S1..1stringTest Name
.... description S0..1markdownTest Additional Information
.... code S1..1CodeableConceptTest Method Origin
Binding: ActionCode (example): Provides examples of actions to be performed.

..... coding Σ0..*CodingCode defined by a terminology system
...... code SΣC1..1codeSymbol in syntax defined by the system
Binding: Test Method Origin Terminology (required)
..... text SΣ1..1stringAnalytical Procedure
.... reason S1..2CodeableConceptTest Category | Test Subcategory
Binding: ActionReasonCode (example): Provides examples of reasons for actions to be performed.


..... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
..... categoryLevel S1..1integerHierarchical Level
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
..... coding SΣ0..*CodingCode defined by a terminology system
Binding: Test Category Terminology (required)
...... code SΣC1..1codeSymbol in syntax defined by the system
...... display ΣC1..1stringRepresentation defined by the system
.... documentation S0..1RelatedArtifactSupporting documentation for the intended performer of the action
..... type Σ1..1codedocumentation | 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
Binding: RelatedArtifactType (required): The type of relationship to the related artifact.


Required Pattern: documentation
..... label SΣ1..1stringReference to Procedure
.... goalId SC0..*idReference to Acceptance Criteria
.... relatedAction SC0..*BackboneElementAlternate Test
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... targetId SC1..1idWhat action is this related to
..... relationship S1..1codeCode is concurrent
Binding: ActionRelationshipType (required): Defines the types of relationships between actions.


Required Pattern: concurrent
.... selectionBehavior S0..1codeCode is exactly-one
Binding: ActionSelectionBehavior (required): Defines selection behavior of a group.


Required Pattern: exactly-one
.... action S0..*BackboneElementGroups or Stages
..... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
..... stageOrder S1..1decimalStage Sequence Order
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension
...... extension 0..0
...... url 1..1uri"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"
...... value[x] SC1..1decimalValue of extension
cmc-greater-than-zero: Hierachial levels are greater than 0
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... prefix S0..1stringStage Name
..... title S0..1stringTest Name (only reqired if different than above)
..... description S0..1markdownTest Additional Information | Stage Additional Information
..... documentation S0..*RelatedArtifactSupporting documentation for the intended performer of the action
...... type Σ1..1codedocumentation | 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
Binding: RelatedArtifactType (required): The type of relationship to the related artifact.


Required Pattern: documentation
...... document SΣ1..1AttachmentTest or Stage Additional Information Visual Attachments
....... contentType SΣC1..1codeMime type of the content, with charset etc.
Binding: MimeTypes (required): BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049)


Example General: text/plain; charset=UTF-8, image/png
....... data SC1..1base64BinaryData inline, base64ed
....... title SΣ1..1stringDocument file name including the file extension
Example General: Official Corporate Logo
..... goalId SC0..*idReference to Acceptance Criteria
..... action SC0..*BackboneElementSub-Test
cmc-subtest-rrt: a subtest's prefix represents relative retention time, should it exist
...... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
...... testOrder S1..1decimalTest Order
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension
....... extension 0..0
....... url 1..1uri"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"
....... value[x] SC1..1decimalValue of extension
cmc-greater-than-zero: Hierachial levels are greater than 0
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... prefix S0..1stringRRT
...... title S1..1stringTest Name | RRT (complex testing)
...... description S0..1markdownTest Additional Information | Stage Additional Information
...... goalId SC1..*idReference to Acceptance Criteria

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
PlanDefinition.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
PlanDefinition.useContext.codeextensiblePattern: workflow("Workflow Setting")
http://terminology.hl7.org/ValueSet/usage-context-type
PlanDefinition.useContext.value[x]exampleContextOfUseValueSet
http://hl7.org/fhir/ValueSet/use-context
from the FHIR Standard
PlanDefinition.useContext.value[x]:valueCodeableConceptexampleContextOfUseValueSet
http://hl7.org/fhir/ValueSet/use-context
from the FHIR Standard
PlanDefinition.useContext.value[x]:valueCodeableConcept.codingrequiredPqcmcSpecificationStatusTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-status-terminology
from this IG
PlanDefinition.goal.descriptionexampleSNOMEDCTClinicalFindings
http://hl7.org/fhir/ValueSet/clinical-findings
from the FHIR Standard
PlanDefinition.goal.addressesexampleConditionProblemDiagnosisCodes
http://hl7.org/fhir/ValueSet/condition-code
from the FHIR Standard
PlanDefinition.goal.addresses.coding.coderequiredPqcmcTestUsageTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-usage-terminology
from this IG
PlanDefinition.goal.documentation.typerequiredPattern: comments-on
http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0
from the FHIR Standard
PlanDefinition.goal.target.measureexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
PlanDefinition.goal.target.detail[x]:detailQuantity.extension:interpretationCode.value[x]requiredPqcmcInterpretationCodeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-interpretation-code-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
PlanDefinition.goal.target.detail[x]:detailQuantity.coderequiredPqcmcUnitsMeasureTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailRange.low.extension:interpretationCodeLow.value[x]requiredPqcmcInterpretationCodeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-interpretation-code-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailRange.low.coderequiredPqcmcUnitsMeasureTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailRange.high.extension:interpretationCodeHigh.value[x]requiredPqcmcInterpretationCodeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-interpretation-code-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailRange.high.coderequiredPqcmcUnitsMeasureTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailCodeableConcept.codingrequiredPattern: C48793("EQ")
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-interpretation-code-terminology
from this IG
PlanDefinition.action.codeexampleActionCode
http://hl7.org/fhir/ValueSet/action-code
from the FHIR Standard
PlanDefinition.action.code.coding.coderequiredPqcmcTestMethodOriginTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-method-origin-terminology
from this IG
PlanDefinition.action.reasonexampleActionReasonCode
http://hl7.org/fhir/ValueSet/action-reason-code
from the FHIR Standard
PlanDefinition.action.reason.codingrequiredPqcmcTestCategoryTerminology (a valid code from Hierarchical Test Category Codes)
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology
from this IG
PlanDefinition.action.documentation.typerequiredPattern: documentation
http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0
from the FHIR Standard
PlanDefinition.action.relatedAction.relationshiprequiredPattern: concurrent
http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0
from the FHIR Standard
PlanDefinition.action.selectionBehaviorrequiredPattern: exactly-one
http://hl7.org/fhir/ValueSet/action-selection-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.action.documentation.typerequiredPattern: documentation
http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0
from the FHIR Standard
PlanDefinition.action.action.documentation.document.contentTyperequiredMimeTypes (a valid code from urn:ietf:bcp:13)
http://hl7.org/fhir/ValueSet/mimetypes|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmc-greater-than-zeroerrorPlanDefinition.action.extension:testOrder.value[x], PlanDefinition.action.action.extension:stageOrder.value[x], PlanDefinition.action.action.action.extension:testOrder.value[x]Hierachial levels are greater than 0
: ($this > 0) = true
cmc-link-requirederrorPlanDefinition.actionAction linkId is required for alternate tests
: (action.relatedAction.count() > 0) implies action.linkId.exists()
cmc-single-or-multistageerrorPlanDefinition.actionif a test is multi-stage, the test can't have a prefix and its stages must have a name and can't be named 'Single Stage' and must be unique. If it's single stage its prefix is 'Single Stage' and its groups can't have prefixes
: (( prefix.exists() implies action.prefix.empty() and prefix = 'Single Stage' ) and ( prefix.empty() implies ( (action.where( prefix.exists() and prefix != 'Single Stage' ).count() = action.count()) and action.prefix.isDistinct() ) )) = true
cmc-subtest-rrterrorPlanDefinition.action.action.actiona subtest's prefix represents relative retention time, should it exist
: prefix.exists() implies prefix.single() = 'RRT'
cnl-0warningPlanDefinitionName should be usable as an identifier for the module by machine processing applications such as code generation
: name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
pld-3warningPlanDefinitiongoalid should reference the id of a goal definition
: %context.repeat(action).where((goalId in %context.goal.id).not()).exists().not()
pld-4warningPlanDefinitiontargetId should reference the id of an action
: %context.repeat(action).relatedAction.where((targetId in %context.repeat(action).id).not()).exists().not()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. PlanDefinition C0..*PlanDefinitionThe definition of a plan for a series of actions, independent of any specific patient or context
cnl-0: Name should be usable as an identifier for the module by machine processing applications such as code generation
pld-3: goalid should reference the id of a goal definition
pld-4: targetId should reference the id of an action
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ0..1idVersion specific identifier
.... lastUpdated Σ0..1instantWhen the resource version last changed
.... source Σ0..1uriIdentifies where the resource comes from
.... profile SΣ0..1canonical(StructureDefinition)Profiles this resource claims to conform to
.... security Σ0..*CodingSecurity Labels applied to this resource
Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.


.... tag Σ0..*CodingTags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".


... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguagesStarter Set
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
... specificationType S1..1CodeableConceptSpecification Type
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-type-extension
Binding: Specification Type Terminology (required)
... spec-additional-info S0..1markdownSpecification Additional Information
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
... url ΣC0..1uriCanonical identifier for this plan definition, represented as a URI (globally unique)
cnl-1: URL should not contain | or # - these characters make processing canonical references problematic
... identifier SΣ0..1IdentifierAdditional identifier for the plan definition
... version SΣ1..1stringSpecification Version
... versionAlgorithm[x] Σ0..1How to compare versions
Binding: VersionAlgorithm (extensible)
.... versionAlgorithmStringstring
.... versionAlgorithmCodingCoding
... name ΣC0..1stringName for this plan definition (computer friendly)
... title SΣ1..1stringSpecification Title
... subtitle S0..1stringSpecification Subtitle
... type Σ0..1CodeableConceptorder-set | clinical-protocol | eca-rule | workflow-definition
Binding: PlanDefinitionType (extensible): The type of PlanDefinition.

... status ?!SΣ1..1codedraft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... experimental Σ0..1booleanFor testing purposes, not real usage
... subject[x] S1..1Reference(Routine Drug Product | Routine Drug Substance | Excipient Drug Substance)Type of individual the plan definition is focused on
... date SΣ1..1dateTimeSpecification Version Date
... publisher Σ0..1stringName of the publisher/steward (organization or individual)
... contact Σ0..*ContactDetailContact details for the publisher
... description Σ0..1markdownNatural language description of the plan definition
... useContext SΣ1..1UsageContextSpecification Status
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... code Σ1..1CodingType of context being specified
Binding: UsageContextType (extensible): A code that specifies a type of context being specified by a usage context.


Required Pattern: At least the following
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/usage-context-type
..... version0..1stringVersion of the system - if relevant
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: workflow
..... display1..1stringRepresentation defined by the system
Fixed Value: Workflow Setting
..... userSelected0..1booleanIf this coding was chosen directly by the user
.... Slices for value[x] Σ1..1CodeableConceptValue that defines the context
Slice: Unordered, Closed by type:$this
Binding: ContextOfUseValueSet (example): A code that defines the specific value for the context being specified.

..... value[x]:valueCodeableConcept SΣ1..1CodeableConceptValue that defines the context
Binding: ContextOfUseValueSet (example): A code that defines the specific value for the context being specified.

...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ0..*CodingCode defined by a terminology system
Binding: Specification Status Terminology (required)
...... text Σ0..1stringPlain text representation of the concept
... jurisdiction Σ0..*CodeableConceptIntended jurisdiction for plan definition (if applicable)
Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.


... purpose 0..1markdownWhy this plan definition is defined
... usage 0..1markdownDescribes the clinical usage of the plan
... copyright 0..1markdownUse and/or publishing restrictions
... copyrightLabel 0..1stringCopyright holder and year(s)
... approvalDate S0..1dateSpecification Status Date
... lastReviewDate 0..1dateWhen the plan definition was last reviewed by the publisher
... effectivePeriod Σ0..1PeriodWhen the plan definition is expected to be used
... topic 0..*CodeableConceptE.g. Education, Treatment, Assessment
Binding: DefinitionTopic (example): High-level categorization of the definition, used for searching, sorting, and filtering.


... author 0..*ContactDetailWho authored the content
... editor 0..*ContactDetailWho edited the content
... reviewer 0..*ContactDetailWho reviewed the content
... endorser 0..*ContactDetailWho endorsed the content
... relatedArtifact 0..*RelatedArtifactAdditional documentation, citations
... library 0..*canonical(Library)Logic used by the plan definition
... goal SC0..*BackboneElementAcceptance Criteria
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... category 0..1CodeableConceptE.g. Treatment, dietary, behavioral
Binding: GoalCategory (example): Example codes for grouping goals for filtering or presentation.

.... description S1..1CodeableConceptOriginal Text
Binding: SNOMEDCTClinicalFindings (example): Describes goals that can be achieved.

.... priority 0..1CodeableConcepthigh-priority | medium-priority | low-priority
Binding: GoalPriority (preferred): Indicates the level of importance associated with reaching or sustaining a goal.

.... start 0..1CodeableConceptWhen goal pursuit begins
Binding: GoalStartEvent (example): Identifies the types of events that might trigger the start of a goal.

.... addresses S1..*CodeableConceptWhat does the goal address
Binding: ConditionProblemDiagnosisCodes (example): Identifies problems, conditions, issues, or concerns that goals may address.


..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ0..*CodingCode defined by a terminology system
...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ0..1uriIdentity of the terminology system
...... version Σ0..1stringVersion of the system - if relevant
...... code SΣC1..1codeAcceptance Criteria Usage
Binding: Test Usage Terminology (required)
...... display ΣC0..1stringRepresentation defined by the system
...... userSelected Σ0..1booleanIf this coding was chosen directly by the user
..... text Σ0..1stringAccpetance Criteria Usage
.... documentation S0..*RelatedArtifactSupporting documentation for the goal
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... type Σ1..1codedocumentation | 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
Binding: RelatedArtifactType (required): The type of relationship to the related artifact.


Required Pattern: comments-on
..... classifier Σ0..*CodeableConceptAdditional classifiers
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.


..... label Σ0..1stringShort label
..... display SΣ1..1stringAcceptance Criteria Additional Information
..... citation Σ0..1markdownBibliographic citation for the artifact
..... document Σ0..1AttachmentWhat document is being referenced
..... resource Σ0..1canonical(Resource)What artifact is being referenced
..... resourceReference Σ0..1Reference(Resource)What artifact, if not a conformance resource
..... publicationStatus Σ0..1codedraft | active | retired | unknown
Binding: PublicationStatus (required): Publication status of an artifact being referred to.

..... publicationDate Σ0..1dateDate of publication of the artifact being referred to
.... target S1..*BackboneElementAcceptance Criteron
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... measure 0..1CodeableConceptThe parameter whose value is to be tracked
Binding: LOINCCodes (example): Identifies types of parameters that can be tracked to determine goal achievement.

...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ0..*CodingCode defined by a terminology system
...... text SΣ0..1stringDetailed parameter being measured if more granular than Sub-Test
..... Slices for detail[x] S0..1The target value to be achieved
Slice: Unordered, Closed by type:$this
...... detailQuantityQuantity
...... detailRangeRange
...... detailCodeableConceptCodeableConcept
...... detailIntegerinteger
...... detail[x]:detailQuantity S0..1QuantityValueNumeric
....... id 0..1idUnique id for inter-element referencing
....... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
....... interpretationCode S1..1CodeableConceptInterpretation Code
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension
Binding: Interpretation Code Terminology (required)
........ id 0..1idUnique id for inter-element referencing
........ extension 0..0
........ url 1..1uri"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"
........ value[x] 0..1CodeableConceptInterpretation Code
Binding: Interpretation Code Terminology (required)
....... value SΣ1..1decimalNumerical value (with implicit precision)
....... comparator ?!Σ0..1code< | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

....... unit SΣ1..1stringUnit representation
....... system ΣC0..1uriSystem that defines coded unit form
....... code SΣC1..1codeCoded form of the unit
Binding: Units Of Measure Terminology (required)
...... detail[x]:detailRange S0..1RangeValueNumeric (range)
....... id 0..1idUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
....... low ΣC1..1SimpleQuantityLow limit
........ id 0..1idUnique id for inter-element referencing
........ Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
........ interpretationCodeLow S1..1CodeableConceptInterpretation Code
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension
Binding: Interpretation Code Terminology (required)
......... id 0..1idUnique id for inter-element referencing
......... extension 0..0
......... url 1..1uri"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"
......... value[x] 0..1CodeableConceptInterpretation Code
Binding: Interpretation Code Terminology (required)
........ value SΣ1..1decimalNumerical value (with implicit precision)
........ unit SΣ1..1stringUnit representation
........ system ΣC0..1uriSystem that defines coded unit form
........ code SΣC1..1codeCoded form of the unit
Binding: Units Of Measure Terminology (required)
....... high ΣC1..1SimpleQuantityHigh limit
........ id 0..1idUnique id for inter-element referencing
........ Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
........ interpretationCodeHigh S1..1CodeableConceptInterpretation Code
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension
Binding: Interpretation Code Terminology (required)
......... id 0..1idUnique id for inter-element referencing
......... extension 0..0
......... url 1..1uri"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"
......... value[x] 0..1CodeableConceptInterpretation Code
Binding: Interpretation Code Terminology (required)
........ value SΣ1..1decimalNumerical value (with implicit precision)
........ unit SΣ1..1stringUnit representation
........ system ΣC0..1uriSystem that defines coded unit form
........ code SΣC1..1codeCoded form of the unit
Binding: Units Of Measure Terminology (required)
...... detail[x]:detailCodeableConcept S0..1CodeableConceptThe target value to be achieved
....... id 0..1idUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
....... coding SΣ1..1CodingInterpretation Code
Binding: Interpretation Code Terminology (required)

Required Pattern: At least the following
........ id0..1stringUnique id for inter-element referencing
........ extension0..*ExtensionAdditional content defined by implementations
........ system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
........ version0..1stringVersion of the system - if relevant
........ code1..1codeSymbol in syntax defined by the system
Fixed Value: C48793
........ display1..1stringRepresentation defined by the system
Fixed Value: EQ
........ userSelected0..1booleanIf this coding was chosen directly by the user
....... text SΣ1..1stringValue
...... detail[x]:detailInteger S0..1integerNumber of Replicates
... actor 0..*BackboneElementActors within the plan
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... title 0..1stringUser-visible title
.... description 0..1markdownDescribes the actor
.... option 1..*BackboneElementWho or what can be this actor
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type 0..1codecareteam | device | group | healthcareservice | location | organization | patient | practitioner | practitionerrole | relatedperson
Binding: ActionParticipantType (required): The type of participant in the activity.

..... typeCanonical 0..1canonical(CapabilityStatement)Who or what can participate
..... typeReference 0..1Reference(CareTeam | Device | DeviceDefinition | Endpoint | Group | HealthcareService | Location | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson)Who or what can participate
..... role 0..1CodeableConceptE.g. Nurse, Surgeon, Parent
Binding: Action Participant Role (example)
... action SC1..*BackboneElementMethod
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
.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
.... testOrder S1..1decimalTest Order
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension
..... id 0..1idUnique id for inter-element referencing
..... extension 0..0
..... url 1..1uri"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"
..... value[x] SC1..1decimalValue of extension
cmc-greater-than-zero: Hierachial levels are greater than 0
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... linkId S0..1stringonly required for alternate tests
.... prefix S0..1stringStage Name
.... title S1..1stringTest Name
.... description S0..1markdownTest Additional Information
.... textEquivalent 0..1markdownStatic text equivalent of the action, used if the dynamic aspects cannot be interpreted by the receiving system
.... priority 0..1coderoutine | urgent | asap | stat
Binding: RequestPriority (required): Identifies the level of importance to be assigned to actioning the request.

.... code S1..1CodeableConceptTest Method Origin
Binding: ActionCode (example): Provides examples of actions to be performed.

..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ0..*CodingCode defined by a terminology system
...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ0..1uriIdentity of the terminology system
...... version Σ0..1stringVersion of the system - if relevant
...... code SΣC1..1codeSymbol in syntax defined by the system
Binding: Test Method Origin Terminology (required)
...... display ΣC0..1stringRepresentation defined by the system
...... userSelected Σ0..1booleanIf this coding was chosen directly by the user
..... text SΣ1..1stringAnalytical Procedure
.... reason S1..2CodeableConceptTest Category | Test Subcategory
Binding: ActionReasonCode (example): Provides examples of reasons for actions to be performed.


..... id 0..1idUnique id for inter-element referencing
..... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
..... categoryLevel S1..1integerHierarchical Level
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
..... coding SΣ0..*CodingCode defined by a terminology system
Binding: Test Category Terminology (required)
...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ0..1uriIdentity of the terminology system
...... version Σ0..1stringVersion of the system - if relevant
...... code SΣC1..1codeSymbol in syntax defined by the system
...... display ΣC1..1stringRepresentation defined by the system
...... userSelected Σ0..1booleanIf this coding was chosen directly by the user
..... text Σ0..1stringPlain text representation of the concept
.... documentation S0..1RelatedArtifactSupporting documentation for the intended performer of the action
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... type Σ1..1codedocumentation | 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
Binding: RelatedArtifactType (required): The type of relationship to the related artifact.


Required Pattern: documentation
..... classifier Σ0..*CodeableConceptAdditional classifiers
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.


..... label SΣ1..1stringReference to Procedure
..... display Σ0..1stringBrief description of the related artifact
..... citation Σ0..1markdownBibliographic citation for the artifact
..... document Σ0..1AttachmentWhat document is being referenced
..... resource Σ0..1canonical(Resource)What artifact is being referenced
..... resourceReference Σ0..1Reference(Resource)What artifact, if not a conformance resource
..... publicationStatus Σ0..1codedraft | active | retired | unknown
Binding: PublicationStatus (required): Publication status of an artifact being referred to.

..... publicationDate Σ0..1dateDate of publication of the artifact being referred to
.... goalId SC0..*idReference to Acceptance Criteria
.... subject[x] 0..1Type of individual the action is focused on
Binding: ParticipantResourceTypes (extensible): The possible types of subjects for a plan definition (E.g. Patient, Practitioner, Organization, Location, etc.).

..... subjectCodeableConceptCodeableConcept
..... subjectReferenceReference(Group)
..... subjectCanonicalcanonical(Any)
.... trigger 0..*TriggerDefinitionWhen the action should be triggered
.... condition 0..*BackboneElementWhether or not the action is applicable
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... kind 1..1codeapplicability | start | stop
Binding: ActionConditionKind (required): Defines the kinds of conditions that can appear on actions.

..... expression 0..1ExpressionBoolean-valued expression
.... input C0..*BackboneElementInput data requirements
pld-0: Input data elements must have a requirement or a relatedData, but not both
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringUser-visible title
..... requirement C0..1DataRequirementWhat data is provided
..... relatedData C0..1idWhat data is provided
.... output C0..*BackboneElementOutput data definition
pld-1: Output data element must have a requirement or a relatedData, but not both
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... title 0..1stringUser-visible title
..... requirement C0..1DataRequirementWhat data is provided
..... relatedData C0..1stringWhat data is provided
.... relatedAction SC0..*BackboneElementAlternate Test
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... targetId SC1..1idWhat action is this related to
..... relationship S1..1codeCode is concurrent
Binding: ActionRelationshipType (required): Defines the types of relationships between actions.


Required Pattern: concurrent
..... endRelationship 0..1codebefore | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end
Binding: ActionRelationshipType (required): Defines the types of relationships between actions.

..... offset[x] 0..1Time offset for the relationship
...... offsetDurationDuration
...... offsetRangeRange
.... timing[x] 0..1When the action should take place
..... timingAgeAge
..... timingDurationDuration
..... timingRangeRange
..... timingTimingTiming
.... location 0..1CodeableReference(Location)Where it should happen
.... participant 0..*BackboneElementWho should participate in the action
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... actorId 0..1stringWhat actor
..... type 0..1codecareteam | device | group | healthcareservice | location | organization | patient | practitioner | practitionerrole | relatedperson
Binding: ActionParticipantType (required): The type of participant in the activity.

..... typeCanonical 0..1canonical(CapabilityStatement)Who or what can participate
..... typeReference 0..1Reference(CareTeam | Device | DeviceDefinition | Endpoint | Group | HealthcareService | Location | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson)Who or what can participate
..... role 0..1CodeableConceptE.g. Nurse, Surgeon, Parent
Binding: Action Participant Role (example): Defines roles played by participants for the action.

..... function 0..1CodeableConceptE.g. Author, Reviewer, Witness, etc
Binding: ActionParticipantFunction (example)
.... type 0..1CodeableConceptcreate | update | remove | fire-event
Binding: ActionType (extensible): The type of action to be performed.

.... groupingBehavior 0..1codevisual-group | logical-group | sentence-group
Binding: ActionGroupingBehavior (required): Defines organization behavior of a group.

.... selectionBehavior S0..1codeCode is exactly-one
Binding: ActionSelectionBehavior (required): Defines selection behavior of a group.


Required Pattern: exactly-one
.... requiredBehavior 0..1codemust | could | must-unless-documented
Binding: ActionRequiredBehavior (required): Defines expectations around whether an action or action group is required.

.... precheckBehavior 0..1codeyes | no
Binding: ActionPrecheckBehavior (required): Defines selection frequency behavior for an action or group.

.... cardinalityBehavior 0..1codesingle | multiple
Binding: ActionCardinalityBehavior (required): Defines behavior for an action or a group for how many times that item may be repeated.

.... definition[x] 0..1Description of the activity to be performed
..... definitionCanonicalcanonical(ActivityDefinition | MessageDefinition | ObservationDefinition | PlanDefinition | Questionnaire | SpecimenDefinition)
..... definitionUriuri
.... transform 0..1canonical(StructureMap)Transform to apply the template
.... dynamicValue 0..*BackboneElementDynamic aspects of the definition
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... path 0..1stringThe path to the element to be set dynamically
..... expression 0..1ExpressionAn expression that provides the dynamic value for the customization
.... action S0..*BackboneElementGroups or Stages
..... id 0..1stringUnique id for inter-element referencing
..... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
..... stageOrder S1..1decimalStage Sequence Order
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension
...... id 0..1idUnique id for inter-element referencing
...... extension 0..0
...... url 1..1uri"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"
...... value[x] SC1..1decimalValue of extension
cmc-greater-than-zero: Hierachial levels are greater than 0
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... linkId 0..1stringUnique id for the action in the PlanDefinition
..... prefix S0..1stringStage Name
..... title S0..1stringTest Name (only reqired if different than above)
..... description S0..1markdownTest Additional Information | Stage Additional Information
..... textEquivalent 0..1markdownStatic text equivalent of the action, used if the dynamic aspects cannot be interpreted by the receiving system
..... priority 0..1coderoutine | urgent | asap | stat
Binding: RequestPriority (required): Identifies the level of importance to be assigned to actioning the request.

..... code 0..1CodeableConceptCode representing the meaning of the action or sub-actions
Binding: ActionCode (example): Provides examples of actions to be performed.

..... reason 0..*CodeableConceptWhy the action should be performed
Binding: ActionReasonCode (example): Provides examples of reasons for actions to be performed.


..... documentation S0..*RelatedArtifactSupporting documentation for the intended performer of the action
...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... type Σ1..1codedocumentation | 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
Binding: RelatedArtifactType (required): The type of relationship to the related artifact.


Required Pattern: documentation
...... classifier Σ0..*CodeableConceptAdditional classifiers
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.


...... label Σ0..1stringShort label
...... display Σ0..1stringBrief description of the related artifact
...... citation Σ0..1markdownBibliographic citation for the artifact
...... document SΣ1..1AttachmentTest or Stage Additional Information Visual Attachments
....... id 0..1idUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
....... contentType SΣC1..1codeMime type of the content, with charset etc.
Binding: MimeTypes (required): BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049)


Example General: text/plain; charset=UTF-8, image/png
....... language Σ0..1codeHuman language of the content (BCP-47)
Binding: AllLanguages (required): IETF language tag for a human language.

Additional BindingsPurpose
CommonLanguagesStarter Set

Example General: en-AU
....... data SC1..1base64BinaryData inline, base64ed
....... url Σ0..1urlUri where the data can be found
Example General: http://www.acme.com/logo-small.png
....... size Σ0..1integer64Number of bytes of content (if url provided)
....... hash Σ0..1base64BinaryHash of the data (sha-1, base64ed)
....... title SΣ1..1stringDocument file name including the file extension
Example General: Official Corporate Logo
....... creation Σ0..1dateTimeDate attachment was first created
....... height 0..1positiveIntHeight of the image in pixels (photo/video)
....... width 0..1positiveIntWidth of the image in pixels (photo/video)
....... frames 0..1positiveIntNumber of frames if > 1 (photo)
....... duration 0..1decimalLength in seconds (audio / video)
....... pages 0..1positiveIntNumber of printed pages
...... resource Σ0..1canonical(Resource)What artifact is being referenced
...... resourceReference Σ0..1Reference(Resource)What artifact, if not a conformance resource
...... publicationStatus Σ0..1codedraft | active | retired | unknown
Binding: PublicationStatus (required): Publication status of an artifact being referred to.

...... publicationDate Σ0..1dateDate of publication of the artifact being referred to
..... goalId SC0..*idReference to Acceptance Criteria
..... subject[x] 0..1Type of individual the action is focused on
Binding: ParticipantResourceTypes (extensible): The possible types of subjects for a plan definition (E.g. Patient, Practitioner, Organization, Location, etc.).

...... subjectCodeableConceptCodeableConcept
...... subjectReferenceReference(Group)
...... subjectCanonicalcanonical(Any)
..... trigger 0..*TriggerDefinitionWhen the action should be triggered
..... condition 0..*BackboneElementWhether or not the action is applicable
...... id 0..1stringUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... kind 1..1codeapplicability | start | stop
Binding: ActionConditionKind (required): Defines the kinds of conditions that can appear on actions.

...... expression 0..1ExpressionBoolean-valued expression
..... input C0..*BackboneElementInput data requirements
pld-0: Input data elements must have a requirement or a relatedData, but not both
...... id 0..1stringUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... title 0..1stringUser-visible title
...... requirement C0..1DataRequirementWhat data is provided
...... relatedData C0..1idWhat data is provided
..... output C0..*BackboneElementOutput data definition
pld-1: Output data element must have a requirement or a relatedData, but not both
...... id 0..1stringUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... title 0..1stringUser-visible title
...... requirement C0..1DataRequirementWhat data is provided
...... relatedData C0..1stringWhat data is provided
..... relatedAction C0..*BackboneElementRelationship to another action
...... id 0..1stringUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... targetId C1..1idWhat action is this related to
...... relationship 1..1codebefore | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end
Binding: ActionRelationshipType (required): Defines the types of relationships between actions.

...... endRelationship 0..1codebefore | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end
Binding: ActionRelationshipType (required): Defines the types of relationships between actions.

...... offset[x] 0..1Time offset for the relationship
....... offsetDurationDuration
....... offsetRangeRange
..... timing[x] 0..1When the action should take place
...... timingAgeAge
...... timingDurationDuration
...... timingRangeRange
...... timingTimingTiming
..... location 0..1CodeableReference(Location)Where it should happen
..... participant 0..*BackboneElementWho should participate in the action
...... id 0..1stringUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... actorId 0..1stringWhat actor
...... type 0..1codecareteam | device | group | healthcareservice | location | organization | patient | practitioner | practitionerrole | relatedperson
Binding: ActionParticipantType (required): The type of participant in the activity.

...... typeCanonical 0..1canonical(CapabilityStatement)Who or what can participate
...... typeReference 0..1Reference(CareTeam | Device | DeviceDefinition | Endpoint | Group | HealthcareService | Location | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson)Who or what can participate
...... role 0..1CodeableConceptE.g. Nurse, Surgeon, Parent
Binding: Action Participant Role (example): Defines roles played by participants for the action.

...... function 0..1CodeableConceptE.g. Author, Reviewer, Witness, etc
Binding: ActionParticipantFunction (example)
..... type 0..1CodeableConceptcreate | update | remove | fire-event
Binding: ActionType (extensible): The type of action to be performed.

..... groupingBehavior 0..1codevisual-group | logical-group | sentence-group
Binding: ActionGroupingBehavior (required): Defines organization behavior of a group.

..... selectionBehavior 0..1codeany | all | all-or-none | exactly-one | at-most-one | one-or-more
Binding: ActionSelectionBehavior (required): Defines selection behavior of a group.

..... requiredBehavior 0..1codemust | could | must-unless-documented
Binding: ActionRequiredBehavior (required): Defines expectations around whether an action or action group is required.

..... precheckBehavior 0..1codeyes | no
Binding: ActionPrecheckBehavior (required): Defines selection frequency behavior for an action or group.

..... cardinalityBehavior 0..1codesingle | multiple
Binding: ActionCardinalityBehavior (required): Defines behavior for an action or a group for how many times that item may be repeated.

..... definition[x] 0..1Description of the activity to be performed
...... definitionCanonicalcanonical(ActivityDefinition | MessageDefinition | ObservationDefinition | PlanDefinition | Questionnaire | SpecimenDefinition)
...... definitionUriuri
..... transform 0..1canonical(StructureMap)Transform to apply the template
..... dynamicValue 0..*BackboneElementDynamic aspects of the definition
...... id 0..1stringUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... path 0..1stringThe path to the element to be set dynamically
...... expression 0..1ExpressionAn expression that provides the dynamic value for the customization
..... action SC0..*BackboneElementSub-Test
cmc-subtest-rrt: a subtest's prefix represents relative retention time, should it exist
...... id 0..1stringUnique id for inter-element referencing
...... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
...... testOrder S1..1decimalTest Order
URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension
....... id 0..1idUnique id for inter-element referencing
....... extension 0..0
....... url 1..1uri"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"
....... value[x] SC1..1decimalValue of extension
cmc-greater-than-zero: Hierachial levels are greater than 0
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... linkId 0..1stringUnique id for the action in the PlanDefinition
...... prefix S0..1stringRRT
...... title S1..1stringTest Name | RRT (complex testing)
...... description S0..1markdownTest Additional Information | Stage Additional Information
...... textEquivalent 0..1markdownStatic text equivalent of the action, used if the dynamic aspects cannot be interpreted by the receiving system
...... priority 0..1coderoutine | urgent | asap | stat
Binding: RequestPriority (required): Identifies the level of importance to be assigned to actioning the request.

...... code 0..1CodeableConceptCode representing the meaning of the action or sub-actions
Binding: ActionCode (example): Provides examples of actions to be performed.

...... reason 0..*CodeableConceptWhy the action should be performed
Binding: ActionReasonCode (example): Provides examples of reasons for actions to be performed.


...... documentation 0..*RelatedArtifactSupporting documentation for the intended performer of the action
...... goalId SC1..*idReference to Acceptance Criteria
...... subject[x] 0..1Type of individual the action is focused on
Binding: ParticipantResourceTypes (extensible): The possible types of subjects for a plan definition (E.g. Patient, Practitioner, Organization, Location, etc.).

....... subjectCodeableConceptCodeableConcept
....... subjectReferenceReference(Group)
....... subjectCanonicalcanonical(Any)
...... trigger 0..*TriggerDefinitionWhen the action should be triggered
...... condition 0..*BackboneElementWhether or not the action is applicable
....... id 0..1stringUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
....... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
....... kind 1..1codeapplicability | start | stop
Binding: ActionConditionKind (required): Defines the kinds of conditions that can appear on actions.

....... expression 0..1ExpressionBoolean-valued expression
...... input C0..*BackboneElementInput data requirements
pld-0: Input data elements must have a requirement or a relatedData, but not both
....... id 0..1stringUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
....... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
....... title 0..1stringUser-visible title
....... requirement C0..1DataRequirementWhat data is provided
....... relatedData C0..1idWhat data is provided
...... output C0..*BackboneElementOutput data definition
pld-1: Output data element must have a requirement or a relatedData, but not both
....... id 0..1stringUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
....... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
....... title 0..1stringUser-visible title
....... requirement C0..1DataRequirementWhat data is provided
....... relatedData C0..1stringWhat data is provided
...... relatedAction C0..*BackboneElementRelationship to another action
....... id 0..1stringUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
....... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
....... targetId C1..1idWhat action is this related to
....... relationship 1..1codebefore | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end
Binding: ActionRelationshipType (required): Defines the types of relationships between actions.

....... endRelationship 0..1codebefore | before-start | before-end | concurrent | concurrent-with-start | concurrent-with-end | after | after-start | after-end
Binding: ActionRelationshipType (required): Defines the types of relationships between actions.

....... offset[x] 0..1Time offset for the relationship
........ offsetDurationDuration
........ offsetRangeRange
...... timing[x] 0..1When the action should take place
....... timingAgeAge
....... timingDurationDuration
....... timingRangeRange
....... timingTimingTiming
...... location 0..1CodeableReference(Location)Where it should happen
...... participant 0..*BackboneElementWho should participate in the action
....... id 0..1stringUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
....... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
....... actorId 0..1stringWhat actor
....... type 0..1codecareteam | device | group | healthcareservice | location | organization | patient | practitioner | practitionerrole | relatedperson
Binding: ActionParticipantType (required): The type of participant in the activity.

....... typeCanonical 0..1canonical(CapabilityStatement)Who or what can participate
....... typeReference 0..1Reference(CareTeam | Device | DeviceDefinition | Endpoint | Group | HealthcareService | Location | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson)Who or what can participate
....... role 0..1CodeableConceptE.g. Nurse, Surgeon, Parent
Binding: Action Participant Role (example): Defines roles played by participants for the action.

....... function 0..1CodeableConceptE.g. Author, Reviewer, Witness, etc
Binding: ActionParticipantFunction (example)
...... type 0..1CodeableConceptcreate | update | remove | fire-event
Binding: ActionType (extensible): The type of action to be performed.

...... groupingBehavior 0..1codevisual-group | logical-group | sentence-group
Binding: ActionGroupingBehavior (required): Defines organization behavior of a group.

...... selectionBehavior 0..1codeany | all | all-or-none | exactly-one | at-most-one | one-or-more
Binding: ActionSelectionBehavior (required): Defines selection behavior of a group.

...... requiredBehavior 0..1codemust | could | must-unless-documented
Binding: ActionRequiredBehavior (required): Defines expectations around whether an action or action group is required.

...... precheckBehavior 0..1codeyes | no
Binding: ActionPrecheckBehavior (required): Defines selection frequency behavior for an action or group.

...... cardinalityBehavior 0..1codesingle | multiple
Binding: ActionCardinalityBehavior (required): Defines behavior for an action or a group for how many times that item may be repeated.

...... definition[x] 0..1Description of the activity to be performed
....... definitionCanonicalcanonical(ActivityDefinition | MessageDefinition | ObservationDefinition | PlanDefinition | Questionnaire | SpecimenDefinition)
....... definitionUriuri
...... transform 0..1canonical(StructureMap)Transform to apply the template
...... dynamicValue 0..*BackboneElementDynamic aspects of the definition
....... id 0..1stringUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
....... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
....... path 0..1stringThe path to the element to be set dynamically
....... expression 0..1ExpressionAn expression that provides the dynamic value for the customization
...... action 0..*See action (PlanDefinition)A sub-action
... asNeeded[x] Σ0..1Preconditions for service
Binding: SNOMEDCTMedicationAsNeededReasonCodes (example): A coded concept identifying the pre-condition that should hold prior to performing a procedure. For example "pain", "on flare-up", etc.

.... asNeededBooleanboolean
.... asNeededCodeableConceptCodeableConcept

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
PlanDefinition.meta.securityextensibleAllSecurityLabels
http://hl7.org/fhir/ValueSet/security-labels
from the FHIR Standard
PlanDefinition.meta.tagexampleCommonTags
http://hl7.org/fhir/ValueSet/common-tags
from the FHIR Standard
PlanDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
PlanDefinition.versionAlgorithm[x]extensibleVersionAlgorithm
http://hl7.org/fhir/ValueSet/version-algorithm
from the FHIR Standard
PlanDefinition.typeextensiblePlanDefinitionType
http://hl7.org/fhir/ValueSet/plan-definition-type
from the FHIR Standard
PlanDefinition.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
PlanDefinition.useContext.codeextensiblePattern: workflow("Workflow Setting")
http://terminology.hl7.org/ValueSet/usage-context-type
PlanDefinition.useContext.value[x]exampleContextOfUseValueSet
http://hl7.org/fhir/ValueSet/use-context
from the FHIR Standard
PlanDefinition.useContext.value[x]:valueCodeableConceptexampleContextOfUseValueSet
http://hl7.org/fhir/ValueSet/use-context
from the FHIR Standard
PlanDefinition.useContext.value[x]:valueCodeableConcept.codingrequiredPqcmcSpecificationStatusTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-status-terminology
from this IG
PlanDefinition.jurisdictionextensibleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
PlanDefinition.topicexampleDefinitionTopic
http://hl7.org/fhir/ValueSet/definition-topic
from the FHIR Standard
PlanDefinition.goal.categoryexampleGoalCategory
http://hl7.org/fhir/ValueSet/goal-category
from the FHIR Standard
PlanDefinition.goal.descriptionexampleSNOMEDCTClinicalFindings
http://hl7.org/fhir/ValueSet/clinical-findings
from the FHIR Standard
PlanDefinition.goal.prioritypreferredGoalPriority
http://hl7.org/fhir/ValueSet/goal-priority
from the FHIR Standard
PlanDefinition.goal.startexampleGoalStartEvent
http://hl7.org/fhir/ValueSet/goal-start-event
from the FHIR Standard
PlanDefinition.goal.addressesexampleConditionProblemDiagnosisCodes
http://hl7.org/fhir/ValueSet/condition-code
from the FHIR Standard
PlanDefinition.goal.addresses.coding.coderequiredPqcmcTestUsageTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-usage-terminology
from this IG
PlanDefinition.goal.documentation.typerequiredPattern: comments-on
http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0
from the FHIR Standard
PlanDefinition.goal.documentation.classifierexampleCitationArtifactClassifier
http://hl7.org/fhir/ValueSet/citation-artifact-classifier
from the FHIR Standard
PlanDefinition.goal.documentation.publicationStatusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
PlanDefinition.goal.target.measureexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
PlanDefinition.goal.target.detail[x]:detailQuantity.extension:interpretationCode.value[x]requiredPqcmcInterpretationCodeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-interpretation-code-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
PlanDefinition.goal.target.detail[x]:detailQuantity.coderequiredPqcmcUnitsMeasureTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailRange.low.extension:interpretationCodeLow.value[x]requiredPqcmcInterpretationCodeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-interpretation-code-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailRange.low.coderequiredPqcmcUnitsMeasureTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailRange.high.extension:interpretationCodeHigh.value[x]requiredPqcmcInterpretationCodeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-interpretation-code-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailRange.high.coderequiredPqcmcUnitsMeasureTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
from this IG
PlanDefinition.goal.target.detail[x]:detailCodeableConcept.codingrequiredPattern: C48793("EQ")
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-interpretation-code-terminology
from this IG
PlanDefinition.actor.option.typerequiredActionParticipantType
http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0
from the FHIR Standard
PlanDefinition.actor.option.roleexampleActionParticipantRole
http://terminology.hl7.org/ValueSet/action-participant-role
PlanDefinition.action.priorityrequiredRequestPriority
http://hl7.org/fhir/ValueSet/request-priority|5.0.0
from the FHIR Standard
PlanDefinition.action.codeexampleActionCode
http://hl7.org/fhir/ValueSet/action-code
from the FHIR Standard
PlanDefinition.action.code.coding.coderequiredPqcmcTestMethodOriginTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-method-origin-terminology
from this IG
PlanDefinition.action.reasonexampleActionReasonCode
http://hl7.org/fhir/ValueSet/action-reason-code
from the FHIR Standard
PlanDefinition.action.reason.codingrequiredPqcmcTestCategoryTerminology (a valid code from Hierarchical Test Category Codes)
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology
from this IG
PlanDefinition.action.documentation.typerequiredPattern: documentation
http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0
from the FHIR Standard
PlanDefinition.action.documentation.classifierexampleCitationArtifactClassifier
http://hl7.org/fhir/ValueSet/citation-artifact-classifier
from the FHIR Standard
PlanDefinition.action.documentation.publicationStatusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
PlanDefinition.action.subject[x]extensibleParticipantResourceTypes
http://hl7.org/fhir/ValueSet/participant-resource-types
from the FHIR Standard
PlanDefinition.action.condition.kindrequiredActionConditionKind
http://hl7.org/fhir/ValueSet/action-condition-kind|5.0.0
from the FHIR Standard
PlanDefinition.action.relatedAction.relationshiprequiredPattern: concurrent
http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0
from the FHIR Standard
PlanDefinition.action.relatedAction.endRelationshiprequiredActionRelationshipType
http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0
from the FHIR Standard
PlanDefinition.action.participant.typerequiredActionParticipantType
http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0
from the FHIR Standard
PlanDefinition.action.participant.roleexampleActionParticipantRole
http://terminology.hl7.org/ValueSet/action-participant-role
PlanDefinition.action.participant.functionexampleActionParticipantFunction
http://hl7.org/fhir/ValueSet/action-participant-function
from the FHIR Standard
PlanDefinition.action.typeextensibleActionType
http://hl7.org/fhir/ValueSet/action-type
from the FHIR Standard
PlanDefinition.action.groupingBehaviorrequiredActionGroupingBehavior
http://hl7.org/fhir/ValueSet/action-grouping-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.selectionBehaviorrequiredPattern: exactly-one
http://hl7.org/fhir/ValueSet/action-selection-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.requiredBehaviorrequiredActionRequiredBehavior
http://hl7.org/fhir/ValueSet/action-required-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.precheckBehaviorrequiredActionPrecheckBehavior
http://hl7.org/fhir/ValueSet/action-precheck-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.cardinalityBehaviorrequiredActionCardinalityBehavior
http://hl7.org/fhir/ValueSet/action-cardinality-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.action.priorityrequiredRequestPriority
http://hl7.org/fhir/ValueSet/request-priority|5.0.0
from the FHIR Standard
PlanDefinition.action.action.codeexampleActionCode
http://hl7.org/fhir/ValueSet/action-code
from the FHIR Standard
PlanDefinition.action.action.reasonexampleActionReasonCode
http://hl7.org/fhir/ValueSet/action-reason-code
from the FHIR Standard
PlanDefinition.action.action.documentation.typerequiredPattern: documentation
http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0
from the FHIR Standard
PlanDefinition.action.action.documentation.classifierexampleCitationArtifactClassifier
http://hl7.org/fhir/ValueSet/citation-artifact-classifier
from the FHIR Standard
PlanDefinition.action.action.documentation.document.contentTyperequiredMimeTypes (a valid code from urn:ietf:bcp:13)
http://hl7.org/fhir/ValueSet/mimetypes|5.0.0
from the FHIR Standard
PlanDefinition.action.action.documentation.document.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
PlanDefinition.action.action.documentation.publicationStatusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
PlanDefinition.action.action.subject[x]extensibleParticipantResourceTypes
http://hl7.org/fhir/ValueSet/participant-resource-types
from the FHIR Standard
PlanDefinition.action.action.condition.kindrequiredActionConditionKind
http://hl7.org/fhir/ValueSet/action-condition-kind|5.0.0
from the FHIR Standard
PlanDefinition.action.action.relatedAction.relationshiprequiredActionRelationshipType
http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0
from the FHIR Standard
PlanDefinition.action.action.relatedAction.endRelationshiprequiredActionRelationshipType
http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0
from the FHIR Standard
PlanDefinition.action.action.participant.typerequiredActionParticipantType
http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0
from the FHIR Standard
PlanDefinition.action.action.participant.roleexampleActionParticipantRole
http://terminology.hl7.org/ValueSet/action-participant-role
PlanDefinition.action.action.participant.functionexampleActionParticipantFunction
http://hl7.org/fhir/ValueSet/action-participant-function
from the FHIR Standard
PlanDefinition.action.action.typeextensibleActionType
http://hl7.org/fhir/ValueSet/action-type
from the FHIR Standard
PlanDefinition.action.action.groupingBehaviorrequiredActionGroupingBehavior
http://hl7.org/fhir/ValueSet/action-grouping-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.action.selectionBehaviorrequiredActionSelectionBehavior
http://hl7.org/fhir/ValueSet/action-selection-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.action.requiredBehaviorrequiredActionRequiredBehavior
http://hl7.org/fhir/ValueSet/action-required-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.action.precheckBehaviorrequiredActionPrecheckBehavior
http://hl7.org/fhir/ValueSet/action-precheck-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.action.cardinalityBehaviorrequiredActionCardinalityBehavior
http://hl7.org/fhir/ValueSet/action-cardinality-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.action.action.priorityrequiredRequestPriority
http://hl7.org/fhir/ValueSet/request-priority|5.0.0
from the FHIR Standard
PlanDefinition.action.action.action.codeexampleActionCode
http://hl7.org/fhir/ValueSet/action-code
from the FHIR Standard
PlanDefinition.action.action.action.reasonexampleActionReasonCode
http://hl7.org/fhir/ValueSet/action-reason-code
from the FHIR Standard
PlanDefinition.action.action.action.subject[x]extensibleParticipantResourceTypes
http://hl7.org/fhir/ValueSet/participant-resource-types
from the FHIR Standard
PlanDefinition.action.action.action.condition.kindrequiredActionConditionKind
http://hl7.org/fhir/ValueSet/action-condition-kind|5.0.0
from the FHIR Standard
PlanDefinition.action.action.action.relatedAction.relationshiprequiredActionRelationshipType
http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0
from the FHIR Standard
PlanDefinition.action.action.action.relatedAction.endRelationshiprequiredActionRelationshipType
http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0
from the FHIR Standard
PlanDefinition.action.action.action.participant.typerequiredActionParticipantType
http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0
from the FHIR Standard
PlanDefinition.action.action.action.participant.roleexampleActionParticipantRole
http://terminology.hl7.org/ValueSet/action-participant-role
PlanDefinition.action.action.action.participant.functionexampleActionParticipantFunction
http://hl7.org/fhir/ValueSet/action-participant-function
from the FHIR Standard
PlanDefinition.action.action.action.typeextensibleActionType
http://hl7.org/fhir/ValueSet/action-type
from the FHIR Standard
PlanDefinition.action.action.action.groupingBehaviorrequiredActionGroupingBehavior
http://hl7.org/fhir/ValueSet/action-grouping-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.action.action.selectionBehaviorrequiredActionSelectionBehavior
http://hl7.org/fhir/ValueSet/action-selection-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.action.action.requiredBehaviorrequiredActionRequiredBehavior
http://hl7.org/fhir/ValueSet/action-required-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.action.action.precheckBehaviorrequiredActionPrecheckBehavior
http://hl7.org/fhir/ValueSet/action-precheck-behavior|5.0.0
from the FHIR Standard
PlanDefinition.action.action.action.cardinalityBehaviorrequiredActionCardinalityBehavior
http://hl7.org/fhir/ValueSet/action-cardinality-behavior|5.0.0
from the FHIR Standard
PlanDefinition.asNeeded[x]exampleSNOMEDCTMedicationAsNeededReasonCodes
http://hl7.org/fhir/ValueSet/medication-as-needed-reason
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmc-greater-than-zeroerrorPlanDefinition.action.extension:testOrder.value[x], PlanDefinition.action.action.extension:stageOrder.value[x], PlanDefinition.action.action.action.extension:testOrder.value[x]Hierachial levels are greater than 0
: ($this > 0) = true
cmc-link-requirederrorPlanDefinition.actionAction linkId is required for alternate tests
: (action.relatedAction.count() > 0) implies action.linkId.exists()
cmc-single-or-multistageerrorPlanDefinition.actionif a test is multi-stage, the test can't have a prefix and its stages must have a name and can't be named 'Single Stage' and must be unique. If it's single stage its prefix is 'Single Stage' and its groups can't have prefixes
: (( prefix.exists() implies action.prefix.empty() and prefix = 'Single Stage' ) and ( prefix.empty() implies ( (action.where( prefix.exists() and prefix != 'Single Stage' ).count() = action.count()) and action.prefix.isDistinct() ) )) = true
cmc-subtest-rrterrorPlanDefinition.action.action.actiona subtest's prefix represents relative retention time, should it exist
: prefix.exists() implies prefix.single() = 'RRT'
cnl-0warningPlanDefinitionName should be usable as an identifier for the module by machine processing applications such as code generation
: name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
cnl-1warningPlanDefinition.urlURL should not contain | or # - these characters make processing canonical references problematic
: exists() implies matches('^[^|# ]+$')
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
pld-0errorPlanDefinition.action.input, PlanDefinition.action.action.input, PlanDefinition.action.action.action.inputInput data elements must have a requirement or a relatedData, but not both
: requirement.exists() xor relatedData.exists()
pld-1errorPlanDefinition.action.output, PlanDefinition.action.action.output, PlanDefinition.action.action.action.outputOutput data element must have a requirement or a relatedData, but not both
: requirement.exists() xor relatedData.exists()
pld-3warningPlanDefinitiongoalid should reference the id of a goal definition
: %context.repeat(action).where((goalId in %context.goal.id).not()).exists().not()
pld-4warningPlanDefinitiontargetId should reference the id of an action
: %context.repeat(action).relatedAction.where((targetId in %context.repeat(action).id).not()).exists().not()

 

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