This page is part of the Pharmaceutical Quality (Industry) (v1.0.0: STU1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

• Content
• Detailed Descriptions
• Mappings
• Examples

Resource Profile: PlanDefinition - Drug

This PlanDefinition profile represents a protocol, analytical procedure, manufacturing process, or other workflow definition used in pharmaceutical quality (PQ) data gathering.

Usage:

• Use this Resource Profile: Bundle – Analytical Procedure PQ, Bundle – Batch Analysis PQ, Bundle – Container Closure System PQ, Bundle - Drug Product Compatibility PQ... Show 7 more, Bundle – Drug Product Specification PQ, Bundle – Drug Reference Standards PQ, Bundle – Drug Stability PQ, Bundle – Drug Substance Characterization PQ, Bundle – Drug Substance Specification PQ, Bundle - Product Manufacturing PQ and Bundle - Product Process Validation PQ
• Refer to this Resource Profile: Extension - Manufacturing Process PQ
• Examples for this Resource Profile: PlanDefinition/plandefinition-drug-pq-ex1-validation-protocol, PlanDefinition/plandefinition-drug-pq-ex2-manufacturing-plan, PlanDefinition/plandefinition-drug-pq-ex3-drug-specification, PlanDefinition/plandefinition-drug-pq-ex4-mnf-process and PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol

Formal Views of Profile Content

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

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from PlanDefinition

Name	Flags	Card.	Type	Description & Constraints
PlanDefinition		0..*	PlanDefinition	The definition of a plan for a series of actions, independent of any specific patient or context
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
plan-document-reference	S	0..*	Reference(DocumentReference - Drug PQ)	plan-document-reference URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-plan-document-reference-pq
history-of-process	S	0..*	markdown, string	history-of-process URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-history-of-process-pq
identifier	S	0..*	Identifier	Additional identifier for the plan definition
version	S	0..1	string	Business version of the plan definition
title	S	0..1	string	Name for this plan definition (human friendly)
type	S	0..1	CodeableConcept	order-set | clinical-protocol | eca-rule | workflow-definition Binding: Plan Type (example)
status	S	1..1	code	draft | active | retired | unknown
subject[x]	S	0..1	CodeableConcept, Reference(Group | MedicinalProductDefinition | SubstanceDefinition | AdministrableProductDefinition | ManufacturedItemDefinition | PackagedProductDefinition), canonical(EvidenceVariable)	Type of individual the plan definition is focused on
jurisdiction	S	0..*	CodeableConcept	Intended jurisdiction for plan definition (if applicable)
effectivePeriod	S	0..1	Period	When the plan definition is expected to be used
goal	S	0..*	BackboneElement	What the plan is trying to accomplish
category	S	0..1	CodeableConcept	E.g. Treatment, dietary, behavioral Binding: Equipment Classes (example)
priority	S	0..1	CodeableConcept	high-priority | medium-priority | low-priority Binding: Goal Priority (example)
actor
option
role		0..1	CodeableConcept	E.g. Nurse, Surgeon, Parent Binding: Test Category (example)
action	S	0..*	BackboneElement	Action defined by the plan
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
process-parameters	S	0..*	(Complex)	process-parameters URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq
process-step-scale	S	0..*	Coding	process-step-scale URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-step-scale-pq Binding: Manufacturing Step Scale (example)
code	S	0..1	CodeableConcept	Code representing the meaning of the action or sub-actions Binding: ActionCode (example) Additional Bindings Purpose Manufacturing Step Extensible Binding Characterization Steps Extensible Binding Specification Type Extensible Binding
participant
typeReference
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
manufacturing-participant	S	0..*	Reference(SubstanceDefinition - Component Substance Drug PQ)	manufacturing-participant URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq
role	S	0..1	CodeableConcept	E.g. Nurse, Surgeon, Parent Binding: Manufacturing Participant Role (example)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
PlanDefinition.type	example	VsPlanTypePQ (a valid code from Pharmaceutical Plan Type Codes) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-planType-pq from this IG
PlanDefinition.goal.category	example	VsEquipmentClassPQ (a valid code from Pharmaceutical Manufacturing Equipment Class Codes) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-equipmentClass-pq from this IG
PlanDefinition.goal.priority	example	VsGoalPriorityPQ (a valid code from Goal Priority - example) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-goalPriority-pq from this IG
PlanDefinition.actor.option.role	example	VsTestCategoryPQ (a valid code from Pharmaceutical Test Category Codes) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-testCategory-pq from this IG
PlanDefinition.action.code	example	ActionCode Additional Bindings Purpose Manufacturing Step Extensible Binding Characterization Steps Extensible Binding Specification Type Extensible Binding http://hl7.org/fhir/ValueSet/action-code from the FHIR Standard
PlanDefinition.action.participant.role	example	VsManufacturingParticipantRolePQ (a valid code from Manufacturing Participant Role Codes) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-manufacturingParticipantRole-pq from this IG

Name	Flags	Card.	Type	Description & Constraints
PlanDefinition	C	0..*	PlanDefinition	The 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
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
plan-document-reference	S	0..*	Reference(DocumentReference - Drug PQ)	plan-document-reference URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-plan-document-reference-pq
history-of-process	S	0..*	markdown, string	history-of-process URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-history-of-process-pq
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..*	Identifier	Additional identifier for the plan definition
version	SΣ	0..1	string	Business version of the plan definition
title	SΣ	0..1	string	Name for this plan definition (human friendly)
type	SΣ	0..1	CodeableConcept	order-set | clinical-protocol | eca-rule | workflow-definition Binding: Plan Type (example)
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
subject[x]	S	0..1		Type of individual the plan definition is focused on Binding: ParticipantResourceTypes (extensible): The possible types of subjects for a plan definition (E.g. Patient, Practitioner, Organization, Location, etc.).
subjectCodeableConcept			CodeableConcept
subjectReference			Reference(Group | MedicinalProductDefinition | SubstanceDefinition | AdministrableProductDefinition | ManufacturedItemDefinition | PackagedProductDefinition)
subjectCanonical			canonical(EvidenceVariable)
jurisdiction	SΣ	0..*	CodeableConcept	Intended jurisdiction for plan definition (if applicable) Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
effectivePeriod	SΣ	0..1	Period	When the plan definition is expected to be used
goal	SC	0..*	BackboneElement	What the plan is trying to accomplish
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
category	S	0..1	CodeableConcept	E.g. Treatment, dietary, behavioral Binding: Equipment Classes (example)
description		1..1	CodeableConcept	Code or text describing the goal Binding: SNOMEDCTClinicalFindings (example): Describes goals that can be achieved.
priority	S	0..1	CodeableConcept	high-priority | medium-priority | low-priority Binding: Goal Priority (example)
action	SC	0..*	BackboneElement	Action defined by the plan
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
process-parameters	S	0..*	(Complex)	process-parameters URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq
process-step-scale	S	0..*	Coding	process-step-scale URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-step-scale-pq Binding: Manufacturing Step Scale (example)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	S	0..1	CodeableConcept	Code representing the meaning of the action or sub-actions Binding: ActionCode (example) Additional Bindings Purpose Manufacturing Step Extensible Binding Characterization Steps Extensible Binding Specification Type Extensible Binding
participant		0..*	BackboneElement	Who should participate in the action
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
typeReference		0..1	Reference(CareTeam | Device | DeviceDefinition | Endpoint | Group | HealthcareService | Location | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson)	Who or what can participate
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
manufacturing-participant	S	0..*	Reference(SubstanceDefinition - Component Substance Drug PQ)	manufacturing-participant URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
role	S	0..1	CodeableConcept	E.g. Nurse, Surgeon, Parent Binding: Manufacturing Participant Role (example)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
PlanDefinition.type	example	VsPlanTypePQ (a valid code from Pharmaceutical Plan Type Codes) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-planType-pq from this IG
PlanDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
PlanDefinition.subject[x]	extensible	ParticipantResourceTypes http://hl7.org/fhir/ValueSet/participant-resource-types from the FHIR Standard
PlanDefinition.jurisdiction	extensible	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
PlanDefinition.goal.category	example	VsEquipmentClassPQ (a valid code from Pharmaceutical Manufacturing Equipment Class Codes) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-equipmentClass-pq from this IG
PlanDefinition.goal.description	example	SNOMEDCTClinicalFindings http://hl7.org/fhir/ValueSet/clinical-findings from the FHIR Standard
PlanDefinition.goal.priority	example	VsGoalPriorityPQ (a valid code from Goal Priority - example) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-goalPriority-pq from this IG
PlanDefinition.action.code	example	ActionCode Additional Bindings Purpose Manufacturing Step Extensible Binding Characterization Steps Extensible Binding Specification Type Extensible Binding http://hl7.org/fhir/ValueSet/action-code from the FHIR Standard
PlanDefinition.action.participant.role	example	VsManufacturingParticipantRolePQ (a valid code from Manufacturing Participant Role Codes) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-manufacturingParticipantRole-pq from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
cnl-0	warning	PlanDefinition	Name 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-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
pld-3	warning	PlanDefinition	goalid should reference the id of a goal definition : %context.repeat(action).where((goalId in %context.goal.id).not()).exists().not()
pld-4	warning	PlanDefinition	targetId should reference the id of an action : %context.repeat(action).relatedAction.where((targetId in %context.repeat(action).id).not()).exists().not()

Name	Flags	Card.	Type	Description & Constraints
PlanDefinition	C	0..*	PlanDefinition	The 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	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
plan-document-reference	S	0..*	Reference(DocumentReference - Drug PQ)	plan-document-reference URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-plan-document-reference-pq
history-of-process	S	0..*	markdown, string	history-of-process URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-history-of-process-pq
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
url	ΣC	0..1	uri	Canonical 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	SΣ	0..*	Identifier	Additional identifier for the plan definition
version	SΣ	0..1	string	Business version of the plan definition
versionAlgorithm[x]	Σ	0..1		How to compare versions Binding: VersionAlgorithm (extensible)
versionAlgorithmString			string
versionAlgorithmCoding			Coding
name	ΣC	0..1	string	Name for this plan definition (computer friendly)
title	SΣ	0..1	string	Name for this plan definition (human friendly)
subtitle		0..1	string	Subordinate title of the plan definition
type	SΣ	0..1	CodeableConcept	order-set | clinical-protocol | eca-rule | workflow-definition Binding: Plan Type (example)
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
experimental	Σ	0..1	boolean	For testing purposes, not real usage
subject[x]	S	0..1		Type of individual the plan definition is focused on Binding: ParticipantResourceTypes (extensible): The possible types of subjects for a plan definition (E.g. Patient, Practitioner, Organization, Location, etc.).
subjectCodeableConcept			CodeableConcept
subjectReference			Reference(Group | MedicinalProductDefinition | SubstanceDefinition | AdministrableProductDefinition | ManufacturedItemDefinition | PackagedProductDefinition)
subjectCanonical			canonical(EvidenceVariable)
date	Σ	0..1	dateTime	Date last changed
publisher	Σ	0..1	string	Name of the publisher/steward (organization or individual)
contact	Σ	0..*	ContactDetail	Contact details for the publisher
description	Σ	0..1	markdown	Natural language description of the plan definition
useContext	Σ	0..*	UsageContext	The context that the content is intended to support
jurisdiction	SΣ	0..*	CodeableConcept	Intended jurisdiction for plan definition (if applicable) Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
purpose		0..1	markdown	Why this plan definition is defined
usage		0..1	markdown	Describes the clinical usage of the plan
copyright		0..1	markdown	Use and/or publishing restrictions
copyrightLabel		0..1	string	Copyright holder and year(s)
approvalDate		0..1	date	When the plan definition was approved by publisher
lastReviewDate		0..1	date	When the plan definition was last reviewed by the publisher
effectivePeriod	SΣ	0..1	Period	When the plan definition is expected to be used
topic		0..*	CodeableConcept	E.g. Education, Treatment, Assessment Binding: DefinitionTopic (example): High-level categorization of the definition, used for searching, sorting, and filtering.
author		0..*	ContactDetail	Who authored the content
editor		0..*	ContactDetail	Who edited the content
reviewer		0..*	ContactDetail	Who reviewed the content
endorser		0..*	ContactDetail	Who endorsed the content
relatedArtifact		0..*	RelatedArtifact	Additional documentation, citations
library		0..*	canonical(Library)	Logic used by the plan definition
goal	SC	0..*	BackboneElement	What the plan is trying to accomplish
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
category	S	0..1	CodeableConcept	E.g. Treatment, dietary, behavioral Binding: Equipment Classes (example)
description		1..1	CodeableConcept	Code or text describing the goal Binding: SNOMEDCTClinicalFindings (example): Describes goals that can be achieved.
priority	S	0..1	CodeableConcept	high-priority | medium-priority | low-priority Binding: Goal Priority (example)
start		0..1	CodeableConcept	When goal pursuit begins Binding: GoalStartEvent (example): Identifies the types of events that might trigger the start of a goal.
addresses		0..*	CodeableConcept	What does the goal address Binding: ConditionProblemDiagnosisCodes (example): Identifies problems, conditions, issues, or concerns that goals may address.
documentation		0..*	RelatedArtifact	Supporting documentation for the goal
target		0..*	BackboneElement	Target outcome for the goal
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
measure		0..1	CodeableConcept	The parameter whose value is to be tracked Binding: LOINCCodes (example): Identifies types of parameters that can be tracked to determine goal achievement.
detail[x]		0..1		The target value to be achieved
detailQuantity			Quantity
detailRange			Range
detailCodeableConcept			CodeableConcept
detailString			string
detailBoolean			boolean
detailInteger			integer
detailRatio			Ratio
due		0..1	Duration	Reach goal within
actor		0..*	BackboneElement	Actors within the plan
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	User-visible title
description		0..1	markdown	Describes the actor
option		1..*	BackboneElement	Who or what can be this actor
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type		0..1	code	careteam | device | group | healthcareservice | location | organization | patient | practitioner | practitionerrole | relatedperson Binding: ActionParticipantType (required): The type of participant in the activity.
typeCanonical		0..1	canonical(CapabilityStatement)	Who or what can participate
typeReference		0..1	Reference(CareTeam | Device | DeviceDefinition | Endpoint | Group | HealthcareService | Location | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson)	Who or what can participate
role		0..1	CodeableConcept	E.g. Nurse, Surgeon, Parent Binding: Test Category (example)
action	SC	0..*	BackboneElement	Action defined by the plan
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
process-parameters	S	0..*	(Complex)	process-parameters URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq
process-step-scale	S	0..*	Coding	process-step-scale URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-step-scale-pq Binding: Manufacturing Step Scale (example)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
linkId		0..1	string	Unique id for the action in the PlanDefinition
prefix		0..1	string	User-visible prefix for the action (e.g. 1. or A.)
title		0..1	string	User-visible title
description		0..1	markdown	Brief description of the action
textEquivalent		0..1	markdown	Static text equivalent of the action, used if the dynamic aspects cannot be interpreted by the receiving system
priority		0..1	code	routine | urgent | asap | stat Binding: RequestPriority (required): Identifies the level of importance to be assigned to actioning the request.
code	S	0..1	CodeableConcept	Code representing the meaning of the action or sub-actions Binding: ActionCode (example) Additional Bindings Purpose Manufacturing Step Extensible Binding Characterization Steps Extensible Binding Specification Type Extensible Binding
reason		0..*	CodeableConcept	Why the action should be performed Binding: ActionReasonCode (example): Provides examples of reasons for actions to be performed.
documentation		0..*	RelatedArtifact	Supporting documentation for the intended performer of the action
goalId	C	0..*	id	What goals this action supports
subject[x]		0..1		Type 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.).
subjectCodeableConcept			CodeableConcept
subjectReference			Reference(Group)
subjectCanonical			canonical(Any)
trigger		0..*	TriggerDefinition	When the action should be triggered
condition		0..*	BackboneElement	Whether or not the action is applicable
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
kind		1..1	code	applicability | start | stop Binding: ActionConditionKind (required): Defines the kinds of conditions that can appear on actions.
expression		0..1	Expression	Boolean-valued expression
input	C	0..*	BackboneElement	Input data requirements pld-0: Input data elements must have a requirement or a relatedData, but not both
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	User-visible title
requirement	C	0..1	DataRequirement	What data is provided
relatedData	C	0..1	id	What data is provided
output	C	0..*	BackboneElement	Output data definition pld-1: Output data element must have a requirement or a relatedData, but not both
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	User-visible title
requirement	C	0..1	DataRequirement	What data is provided
relatedData	C	0..1	string	What data is provided
relatedAction	C	0..*	BackboneElement	Relationship to another action
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
targetId	C	1..1	id	What action is this related to
relationship		1..1	code	before | 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..1	code	before | 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..1		Time offset for the relationship
offsetDuration			Duration
offsetRange			Range
timing[x]		0..1		When the action should take place
timingAge			Age
timingDuration			Duration
timingRange			Range
timingTiming			Timing
location		0..1	CodeableReference(Location)	Where it should happen
participant		0..*	BackboneElement	Who should participate in the action
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
actorId		0..1	string	What actor
type		0..1	code	careteam | device | group | healthcareservice | location | organization | patient | practitioner | practitionerrole | relatedperson Binding: ActionParticipantType (required): The type of participant in the activity.
typeCanonical		0..1	canonical(CapabilityStatement)	Who or what can participate
typeReference		0..1	Reference(CareTeam | Device | DeviceDefinition | Endpoint | Group | HealthcareService | Location | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson)	Who or what can participate
id		0..1	id	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
manufacturing-participant	S	0..*	Reference(SubstanceDefinition - Component Substance Drug PQ)	manufacturing-participant URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	ΣC	0..1	Identifier	Logical reference, when literal reference is not known
display	ΣC	0..1	string	Text alternative for the resource
role	S	0..1	CodeableConcept	E.g. Nurse, Surgeon, Parent Binding: Manufacturing Participant Role (example)
function		0..1	CodeableConcept	E.g. Author, Reviewer, Witness, etc Binding: ActionParticipantFunction (example)
type		0..1	CodeableConcept	create | update | remove | fire-event Binding: ActionType (extensible): The type of action to be performed.
groupingBehavior		0..1	code	visual-group | logical-group | sentence-group Binding: ActionGroupingBehavior (required): Defines organization behavior of a group.
selectionBehavior		0..1	code	any | all | all-or-none | exactly-one | at-most-one | one-or-more Binding: ActionSelectionBehavior (required): Defines selection behavior of a group.
requiredBehavior		0..1	code	must | could | must-unless-documented Binding: ActionRequiredBehavior (required): Defines expectations around whether an action or action group is required.
precheckBehavior		0..1	code	yes | no Binding: ActionPrecheckBehavior (required): Defines selection frequency behavior for an action or group.
cardinalityBehavior		0..1	code	single | multiple Binding: ActionCardinalityBehavior (required): Defines behavior for an action or a group for how many times that item may be repeated.
definition[x]		0..1		Description of the activity to be performed
definitionCanonical			canonical(ActivityDefinition | MessageDefinition | ObservationDefinition | PlanDefinition | Questionnaire | SpecimenDefinition)
definitionUri			uri
transform		0..1	canonical(StructureMap)	Transform to apply the template
dynamicValue		0..*	BackboneElement	Dynamic aspects of the definition
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
path		0..1	string	The path to the element to be set dynamically
expression		0..1	Expression	An expression that provides the dynamic value for the customization
action		0..*	See action (PlanDefinition)	A sub-action
asNeeded[x]	Σ	0..1		Preconditions 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.
asNeededBoolean			boolean
asNeededCodeableConcept			CodeableConcept
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
PlanDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
PlanDefinition.versionAlgorithm[x]	extensible	VersionAlgorithm http://hl7.org/fhir/ValueSet/version-algorithm from the FHIR Standard
PlanDefinition.type	example	VsPlanTypePQ (a valid code from Pharmaceutical Plan Type Codes) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-planType-pq from this IG
PlanDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
PlanDefinition.subject[x]	extensible	ParticipantResourceTypes http://hl7.org/fhir/ValueSet/participant-resource-types from the FHIR Standard
PlanDefinition.jurisdiction	extensible	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
PlanDefinition.topic	example	DefinitionTopic http://hl7.org/fhir/ValueSet/definition-topic from the FHIR Standard
PlanDefinition.goal.category	example	VsEquipmentClassPQ (a valid code from Pharmaceutical Manufacturing Equipment Class Codes) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-equipmentClass-pq from this IG
PlanDefinition.goal.description	example	SNOMEDCTClinicalFindings http://hl7.org/fhir/ValueSet/clinical-findings from the FHIR Standard
PlanDefinition.goal.priority	example	VsGoalPriorityPQ (a valid code from Goal Priority - example) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-goalPriority-pq from this IG
PlanDefinition.goal.start	example	GoalStartEvent http://hl7.org/fhir/ValueSet/goal-start-event from the FHIR Standard
PlanDefinition.goal.addresses	example	ConditionProblemDiagnosisCodes http://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard
PlanDefinition.goal.target.measure	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
PlanDefinition.actor.option.type	required	ActionParticipantType http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0 from the FHIR Standard
PlanDefinition.actor.option.role	example	VsTestCategoryPQ (a valid code from Pharmaceutical Test Category Codes) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-testCategory-pq from this IG
PlanDefinition.action.priority	required	RequestPriority http://hl7.org/fhir/ValueSet/request-priority|5.0.0 from the FHIR Standard
PlanDefinition.action.code	example	ActionCode Additional Bindings Purpose Manufacturing Step Extensible Binding Characterization Steps Extensible Binding Specification Type Extensible Binding http://hl7.org/fhir/ValueSet/action-code from the FHIR Standard
PlanDefinition.action.reason	example	ActionReasonCode http://hl7.org/fhir/ValueSet/action-reason-code from the FHIR Standard
PlanDefinition.action.subject[x]	extensible	ParticipantResourceTypes http://hl7.org/fhir/ValueSet/participant-resource-types from the FHIR Standard
PlanDefinition.action.condition.kind	required	ActionConditionKind http://hl7.org/fhir/ValueSet/action-condition-kind|5.0.0 from the FHIR Standard
PlanDefinition.action.relatedAction.relationship	required	ActionRelationshipType http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0 from the FHIR Standard
PlanDefinition.action.relatedAction.endRelationship	required	ActionRelationshipType http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0 from the FHIR Standard
PlanDefinition.action.participant.type	required	ActionParticipantType http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0 from the FHIR Standard
PlanDefinition.action.participant.typeReference.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard
PlanDefinition.action.participant.role	example	VsManufacturingParticipantRolePQ (a valid code from Manufacturing Participant Role Codes) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-manufacturingParticipantRole-pq from this IG
PlanDefinition.action.participant.function	example	ActionParticipantFunction http://hl7.org/fhir/ValueSet/action-participant-function from the FHIR Standard
PlanDefinition.action.type	extensible	ActionType http://hl7.org/fhir/ValueSet/action-type from the FHIR Standard
PlanDefinition.action.groupingBehavior	required	ActionGroupingBehavior http://hl7.org/fhir/ValueSet/action-grouping-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.selectionBehavior	required	ActionSelectionBehavior http://hl7.org/fhir/ValueSet/action-selection-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.requiredBehavior	required	ActionRequiredBehavior http://hl7.org/fhir/ValueSet/action-required-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.precheckBehavior	required	ActionPrecheckBehavior http://hl7.org/fhir/ValueSet/action-precheck-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.cardinalityBehavior	required	ActionCardinalityBehavior http://hl7.org/fhir/ValueSet/action-cardinality-behavior|5.0.0 from the FHIR Standard
PlanDefinition.asNeeded[x]	example	SNOMEDCTMedicationAsNeededReasonCodes http://hl7.org/fhir/ValueSet/medication-as-needed-reason from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cnl-0	warning	PlanDefinition	Name 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}$')
cnl-1	warning	PlanDefinition.url	URL should not contain | or # - these characters make processing canonical references problematic : exists() implies matches('^[^|# ]+$')
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
pld-0	error	PlanDefinition.action.input	Input data elements must have a requirement or a relatedData, but not both : requirement.exists() xor relatedData.exists()
pld-1	error	PlanDefinition.action.output	Output data element must have a requirement or a relatedData, but not both : requirement.exists() xor relatedData.exists()
pld-3	warning	PlanDefinition	goalid should reference the id of a goal definition : %context.repeat(action).where((goalId in %context.goal.id).not()).exists().not()
pld-4	warning	PlanDefinition	targetId should reference the id of an action : %context.repeat(action).relatedAction.where((targetId in %context.repeat(action).id).not()).exists().not()

This structure is derived from PlanDefinition

Summary

Must-Support: 19 elements

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-plan-document-reference-pq
• http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-history-of-process-pq
• http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq
• http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-step-scale-pq
• http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq

Differential View

This structure is derived from PlanDefinition

Name	Flags	Card.	Type	Description & Constraints
PlanDefinition		0..*	PlanDefinition	The definition of a plan for a series of actions, independent of any specific patient or context
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
plan-document-reference	S	0..*	Reference(DocumentReference - Drug PQ)	plan-document-reference URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-plan-document-reference-pq
history-of-process	S	0..*	markdown, string	history-of-process URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-history-of-process-pq
identifier	S	0..*	Identifier	Additional identifier for the plan definition
version	S	0..1	string	Business version of the plan definition
title	S	0..1	string	Name for this plan definition (human friendly)
type	S	0..1	CodeableConcept	order-set | clinical-protocol | eca-rule | workflow-definition Binding: Plan Type (example)
status	S	1..1	code	draft | active | retired | unknown
subject[x]	S	0..1	CodeableConcept, Reference(Group | MedicinalProductDefinition | SubstanceDefinition | AdministrableProductDefinition | ManufacturedItemDefinition | PackagedProductDefinition), canonical(EvidenceVariable)	Type of individual the plan definition is focused on
jurisdiction	S	0..*	CodeableConcept	Intended jurisdiction for plan definition (if applicable)
effectivePeriod	S	0..1	Period	When the plan definition is expected to be used
goal	S	0..*	BackboneElement	What the plan is trying to accomplish
category	S	0..1	CodeableConcept	E.g. Treatment, dietary, behavioral Binding: Equipment Classes (example)
priority	S	0..1	CodeableConcept	high-priority | medium-priority | low-priority Binding: Goal Priority (example)
actor
option
role		0..1	CodeableConcept	E.g. Nurse, Surgeon, Parent Binding: Test Category (example)
action	S	0..*	BackboneElement	Action defined by the plan
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
process-parameters	S	0..*	(Complex)	process-parameters URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq
process-step-scale	S	0..*	Coding	process-step-scale URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-step-scale-pq Binding: Manufacturing Step Scale (example)
code	S	0..1	CodeableConcept	Code representing the meaning of the action or sub-actions Binding: ActionCode (example) Additional Bindings Purpose Manufacturing Step Extensible Binding Characterization Steps Extensible Binding Specification Type Extensible Binding
participant
typeReference
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
manufacturing-participant	S	0..*	Reference(SubstanceDefinition - Component Substance Drug PQ)	manufacturing-participant URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq
role	S	0..1	CodeableConcept	E.g. Nurse, Surgeon, Parent Binding: Manufacturing Participant Role (example)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
PlanDefinition.type	example	VsPlanTypePQ (a valid code from Pharmaceutical Plan Type Codes) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-planType-pq from this IG
PlanDefinition.goal.category	example	VsEquipmentClassPQ (a valid code from Pharmaceutical Manufacturing Equipment Class Codes) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-equipmentClass-pq from this IG
PlanDefinition.goal.priority	example	VsGoalPriorityPQ (a valid code from Goal Priority - example) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-goalPriority-pq from this IG
PlanDefinition.actor.option.role	example	VsTestCategoryPQ (a valid code from Pharmaceutical Test Category Codes) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-testCategory-pq from this IG
PlanDefinition.action.code	example	ActionCode Additional Bindings Purpose Manufacturing Step Extensible Binding Characterization Steps Extensible Binding Specification Type Extensible Binding http://hl7.org/fhir/ValueSet/action-code from the FHIR Standard
PlanDefinition.action.participant.role	example	VsManufacturingParticipantRolePQ (a valid code from Manufacturing Participant Role Codes) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-manufacturingParticipantRole-pq from this IG

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
PlanDefinition	C	0..*	PlanDefinition	The 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
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
plan-document-reference	S	0..*	Reference(DocumentReference - Drug PQ)	plan-document-reference URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-plan-document-reference-pq
history-of-process	S	0..*	markdown, string	history-of-process URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-history-of-process-pq
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..*	Identifier	Additional identifier for the plan definition
version	SΣ	0..1	string	Business version of the plan definition
title	SΣ	0..1	string	Name for this plan definition (human friendly)
type	SΣ	0..1	CodeableConcept	order-set | clinical-protocol | eca-rule | workflow-definition Binding: Plan Type (example)
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
subject[x]	S	0..1		Type of individual the plan definition is focused on Binding: ParticipantResourceTypes (extensible): The possible types of subjects for a plan definition (E.g. Patient, Practitioner, Organization, Location, etc.).
subjectCodeableConcept			CodeableConcept
subjectReference			Reference(Group | MedicinalProductDefinition | SubstanceDefinition | AdministrableProductDefinition | ManufacturedItemDefinition | PackagedProductDefinition)
subjectCanonical			canonical(EvidenceVariable)
jurisdiction	SΣ	0..*	CodeableConcept	Intended jurisdiction for plan definition (if applicable) Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
effectivePeriod	SΣ	0..1	Period	When the plan definition is expected to be used
goal	SC	0..*	BackboneElement	What the plan is trying to accomplish
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
category	S	0..1	CodeableConcept	E.g. Treatment, dietary, behavioral Binding: Equipment Classes (example)
description		1..1	CodeableConcept	Code or text describing the goal Binding: SNOMEDCTClinicalFindings (example): Describes goals that can be achieved.
priority	S	0..1	CodeableConcept	high-priority | medium-priority | low-priority Binding: Goal Priority (example)
action	SC	0..*	BackboneElement	Action defined by the plan
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
process-parameters	S	0..*	(Complex)	process-parameters URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq
process-step-scale	S	0..*	Coding	process-step-scale URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-step-scale-pq Binding: Manufacturing Step Scale (example)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	S	0..1	CodeableConcept	Code representing the meaning of the action or sub-actions Binding: ActionCode (example) Additional Bindings Purpose Manufacturing Step Extensible Binding Characterization Steps Extensible Binding Specification Type Extensible Binding
participant		0..*	BackboneElement	Who should participate in the action
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
typeReference		0..1	Reference(CareTeam | Device | DeviceDefinition | Endpoint | Group | HealthcareService | Location | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson)	Who or what can participate
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
manufacturing-participant	S	0..*	Reference(SubstanceDefinition - Component Substance Drug PQ)	manufacturing-participant URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
role	S	0..1	CodeableConcept	E.g. Nurse, Surgeon, Parent Binding: Manufacturing Participant Role (example)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
PlanDefinition.type	example	VsPlanTypePQ (a valid code from Pharmaceutical Plan Type Codes) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-planType-pq from this IG
PlanDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
PlanDefinition.subject[x]	extensible	ParticipantResourceTypes http://hl7.org/fhir/ValueSet/participant-resource-types from the FHIR Standard
PlanDefinition.jurisdiction	extensible	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
PlanDefinition.goal.category	example	VsEquipmentClassPQ (a valid code from Pharmaceutical Manufacturing Equipment Class Codes) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-equipmentClass-pq from this IG
PlanDefinition.goal.description	example	SNOMEDCTClinicalFindings http://hl7.org/fhir/ValueSet/clinical-findings from the FHIR Standard
PlanDefinition.goal.priority	example	VsGoalPriorityPQ (a valid code from Goal Priority - example) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-goalPriority-pq from this IG
PlanDefinition.action.code	example	ActionCode Additional Bindings Purpose Manufacturing Step Extensible Binding Characterization Steps Extensible Binding Specification Type Extensible Binding http://hl7.org/fhir/ValueSet/action-code from the FHIR Standard
PlanDefinition.action.participant.role	example	VsManufacturingParticipantRolePQ (a valid code from Manufacturing Participant Role Codes) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-manufacturingParticipantRole-pq from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
cnl-0	warning	PlanDefinition	Name 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-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
pld-3	warning	PlanDefinition	goalid should reference the id of a goal definition : %context.repeat(action).where((goalId in %context.goal.id).not()).exists().not()
pld-4	warning	PlanDefinition	targetId should reference the id of an action : %context.repeat(action).relatedAction.where((targetId in %context.repeat(action).id).not()).exists().not()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
PlanDefinition	C	0..*	PlanDefinition	The 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	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
plan-document-reference	S	0..*	Reference(DocumentReference - Drug PQ)	plan-document-reference URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-plan-document-reference-pq
history-of-process	S	0..*	markdown, string	history-of-process URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-history-of-process-pq
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
url	ΣC	0..1	uri	Canonical 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	SΣ	0..*	Identifier	Additional identifier for the plan definition
version	SΣ	0..1	string	Business version of the plan definition
versionAlgorithm[x]	Σ	0..1		How to compare versions Binding: VersionAlgorithm (extensible)
versionAlgorithmString			string
versionAlgorithmCoding			Coding
name	ΣC	0..1	string	Name for this plan definition (computer friendly)
title	SΣ	0..1	string	Name for this plan definition (human friendly)
subtitle		0..1	string	Subordinate title of the plan definition
type	SΣ	0..1	CodeableConcept	order-set | clinical-protocol | eca-rule | workflow-definition Binding: Plan Type (example)
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
experimental	Σ	0..1	boolean	For testing purposes, not real usage
subject[x]	S	0..1		Type of individual the plan definition is focused on Binding: ParticipantResourceTypes (extensible): The possible types of subjects for a plan definition (E.g. Patient, Practitioner, Organization, Location, etc.).
subjectCodeableConcept			CodeableConcept
subjectReference			Reference(Group | MedicinalProductDefinition | SubstanceDefinition | AdministrableProductDefinition | ManufacturedItemDefinition | PackagedProductDefinition)
subjectCanonical			canonical(EvidenceVariable)
date	Σ	0..1	dateTime	Date last changed
publisher	Σ	0..1	string	Name of the publisher/steward (organization or individual)
contact	Σ	0..*	ContactDetail	Contact details for the publisher
description	Σ	0..1	markdown	Natural language description of the plan definition
useContext	Σ	0..*	UsageContext	The context that the content is intended to support
jurisdiction	SΣ	0..*	CodeableConcept	Intended jurisdiction for plan definition (if applicable) Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
purpose		0..1	markdown	Why this plan definition is defined
usage		0..1	markdown	Describes the clinical usage of the plan
copyright		0..1	markdown	Use and/or publishing restrictions
copyrightLabel		0..1	string	Copyright holder and year(s)
approvalDate		0..1	date	When the plan definition was approved by publisher
lastReviewDate		0..1	date	When the plan definition was last reviewed by the publisher
effectivePeriod	SΣ	0..1	Period	When the plan definition is expected to be used
topic		0..*	CodeableConcept	E.g. Education, Treatment, Assessment Binding: DefinitionTopic (example): High-level categorization of the definition, used for searching, sorting, and filtering.
author		0..*	ContactDetail	Who authored the content
editor		0..*	ContactDetail	Who edited the content
reviewer		0..*	ContactDetail	Who reviewed the content
endorser		0..*	ContactDetail	Who endorsed the content
relatedArtifact		0..*	RelatedArtifact	Additional documentation, citations
library		0..*	canonical(Library)	Logic used by the plan definition
goal	SC	0..*	BackboneElement	What the plan is trying to accomplish
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
category	S	0..1	CodeableConcept	E.g. Treatment, dietary, behavioral Binding: Equipment Classes (example)
description		1..1	CodeableConcept	Code or text describing the goal Binding: SNOMEDCTClinicalFindings (example): Describes goals that can be achieved.
priority	S	0..1	CodeableConcept	high-priority | medium-priority | low-priority Binding: Goal Priority (example)
start		0..1	CodeableConcept	When goal pursuit begins Binding: GoalStartEvent (example): Identifies the types of events that might trigger the start of a goal.
addresses		0..*	CodeableConcept	What does the goal address Binding: ConditionProblemDiagnosisCodes (example): Identifies problems, conditions, issues, or concerns that goals may address.
documentation		0..*	RelatedArtifact	Supporting documentation for the goal
target		0..*	BackboneElement	Target outcome for the goal
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
measure		0..1	CodeableConcept	The parameter whose value is to be tracked Binding: LOINCCodes (example): Identifies types of parameters that can be tracked to determine goal achievement.
detail[x]		0..1		The target value to be achieved
detailQuantity			Quantity
detailRange			Range
detailCodeableConcept			CodeableConcept
detailString			string
detailBoolean			boolean
detailInteger			integer
detailRatio			Ratio
due		0..1	Duration	Reach goal within
actor		0..*	BackboneElement	Actors within the plan
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	User-visible title
description		0..1	markdown	Describes the actor
option		1..*	BackboneElement	Who or what can be this actor
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type		0..1	code	careteam | device | group | healthcareservice | location | organization | patient | practitioner | practitionerrole | relatedperson Binding: ActionParticipantType (required): The type of participant in the activity.
typeCanonical		0..1	canonical(CapabilityStatement)	Who or what can participate
typeReference		0..1	Reference(CareTeam | Device | DeviceDefinition | Endpoint | Group | HealthcareService | Location | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson)	Who or what can participate
role		0..1	CodeableConcept	E.g. Nurse, Surgeon, Parent Binding: Test Category (example)
action	SC	0..*	BackboneElement	Action defined by the plan
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
process-parameters	S	0..*	(Complex)	process-parameters URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq
process-step-scale	S	0..*	Coding	process-step-scale URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-step-scale-pq Binding: Manufacturing Step Scale (example)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
linkId		0..1	string	Unique id for the action in the PlanDefinition
prefix		0..1	string	User-visible prefix for the action (e.g. 1. or A.)
title		0..1	string	User-visible title
description		0..1	markdown	Brief description of the action
textEquivalent		0..1	markdown	Static text equivalent of the action, used if the dynamic aspects cannot be interpreted by the receiving system
priority		0..1	code	routine | urgent | asap | stat Binding: RequestPriority (required): Identifies the level of importance to be assigned to actioning the request.
code	S	0..1	CodeableConcept	Code representing the meaning of the action or sub-actions Binding: ActionCode (example) Additional Bindings Purpose Manufacturing Step Extensible Binding Characterization Steps Extensible Binding Specification Type Extensible Binding
reason		0..*	CodeableConcept	Why the action should be performed Binding: ActionReasonCode (example): Provides examples of reasons for actions to be performed.
documentation		0..*	RelatedArtifact	Supporting documentation for the intended performer of the action
goalId	C	0..*	id	What goals this action supports
subject[x]		0..1		Type 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.).
subjectCodeableConcept			CodeableConcept
subjectReference			Reference(Group)
subjectCanonical			canonical(Any)
trigger		0..*	TriggerDefinition	When the action should be triggered
condition		0..*	BackboneElement	Whether or not the action is applicable
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
kind		1..1	code	applicability | start | stop Binding: ActionConditionKind (required): Defines the kinds of conditions that can appear on actions.
expression		0..1	Expression	Boolean-valued expression
input	C	0..*	BackboneElement	Input data requirements pld-0: Input data elements must have a requirement or a relatedData, but not both
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	User-visible title
requirement	C	0..1	DataRequirement	What data is provided
relatedData	C	0..1	id	What data is provided
output	C	0..*	BackboneElement	Output data definition pld-1: Output data element must have a requirement or a relatedData, but not both
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	User-visible title
requirement	C	0..1	DataRequirement	What data is provided
relatedData	C	0..1	string	What data is provided
relatedAction	C	0..*	BackboneElement	Relationship to another action
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
targetId	C	1..1	id	What action is this related to
relationship		1..1	code	before | 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..1	code	before | 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..1		Time offset for the relationship
offsetDuration			Duration
offsetRange			Range
timing[x]		0..1		When the action should take place
timingAge			Age
timingDuration			Duration
timingRange			Range
timingTiming			Timing
location		0..1	CodeableReference(Location)	Where it should happen
participant		0..*	BackboneElement	Who should participate in the action
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
actorId		0..1	string	What actor
type		0..1	code	careteam | device | group | healthcareservice | location | organization | patient | practitioner | practitionerrole | relatedperson Binding: ActionParticipantType (required): The type of participant in the activity.
typeCanonical		0..1	canonical(CapabilityStatement)	Who or what can participate
typeReference		0..1	Reference(CareTeam | Device | DeviceDefinition | Endpoint | Group | HealthcareService | Location | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson)	Who or what can participate
id		0..1	id	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
manufacturing-participant	S	0..*	Reference(SubstanceDefinition - Component Substance Drug PQ)	manufacturing-participant URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	ΣC	0..1	Identifier	Logical reference, when literal reference is not known
display	ΣC	0..1	string	Text alternative for the resource
role	S	0..1	CodeableConcept	E.g. Nurse, Surgeon, Parent Binding: Manufacturing Participant Role (example)
function		0..1	CodeableConcept	E.g. Author, Reviewer, Witness, etc Binding: ActionParticipantFunction (example)
type		0..1	CodeableConcept	create | update | remove | fire-event Binding: ActionType (extensible): The type of action to be performed.
groupingBehavior		0..1	code	visual-group | logical-group | sentence-group Binding: ActionGroupingBehavior (required): Defines organization behavior of a group.
selectionBehavior		0..1	code	any | all | all-or-none | exactly-one | at-most-one | one-or-more Binding: ActionSelectionBehavior (required): Defines selection behavior of a group.
requiredBehavior		0..1	code	must | could | must-unless-documented Binding: ActionRequiredBehavior (required): Defines expectations around whether an action or action group is required.
precheckBehavior		0..1	code	yes | no Binding: ActionPrecheckBehavior (required): Defines selection frequency behavior for an action or group.
cardinalityBehavior		0..1	code	single | multiple Binding: ActionCardinalityBehavior (required): Defines behavior for an action or a group for how many times that item may be repeated.
definition[x]		0..1		Description of the activity to be performed
definitionCanonical			canonical(ActivityDefinition | MessageDefinition | ObservationDefinition | PlanDefinition | Questionnaire | SpecimenDefinition)
definitionUri			uri
transform		0..1	canonical(StructureMap)	Transform to apply the template
dynamicValue		0..*	BackboneElement	Dynamic aspects of the definition
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
path		0..1	string	The path to the element to be set dynamically
expression		0..1	Expression	An expression that provides the dynamic value for the customization
action		0..*	See action (PlanDefinition)	A sub-action
asNeeded[x]	Σ	0..1		Preconditions 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.
asNeededBoolean			boolean
asNeededCodeableConcept			CodeableConcept
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
PlanDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
PlanDefinition.versionAlgorithm[x]	extensible	VersionAlgorithm http://hl7.org/fhir/ValueSet/version-algorithm from the FHIR Standard
PlanDefinition.type	example	VsPlanTypePQ (a valid code from Pharmaceutical Plan Type Codes) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-planType-pq from this IG
PlanDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
PlanDefinition.subject[x]	extensible	ParticipantResourceTypes http://hl7.org/fhir/ValueSet/participant-resource-types from the FHIR Standard
PlanDefinition.jurisdiction	extensible	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
PlanDefinition.topic	example	DefinitionTopic http://hl7.org/fhir/ValueSet/definition-topic from the FHIR Standard
PlanDefinition.goal.category	example	VsEquipmentClassPQ (a valid code from Pharmaceutical Manufacturing Equipment Class Codes) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-equipmentClass-pq from this IG
PlanDefinition.goal.description	example	SNOMEDCTClinicalFindings http://hl7.org/fhir/ValueSet/clinical-findings from the FHIR Standard
PlanDefinition.goal.priority	example	VsGoalPriorityPQ (a valid code from Goal Priority - example) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-goalPriority-pq from this IG
PlanDefinition.goal.start	example	GoalStartEvent http://hl7.org/fhir/ValueSet/goal-start-event from the FHIR Standard
PlanDefinition.goal.addresses	example	ConditionProblemDiagnosisCodes http://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard
PlanDefinition.goal.target.measure	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
PlanDefinition.actor.option.type	required	ActionParticipantType http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0 from the FHIR Standard
PlanDefinition.actor.option.role	example	VsTestCategoryPQ (a valid code from Pharmaceutical Test Category Codes) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-testCategory-pq from this IG
PlanDefinition.action.priority	required	RequestPriority http://hl7.org/fhir/ValueSet/request-priority|5.0.0 from the FHIR Standard
PlanDefinition.action.code	example	ActionCode Additional Bindings Purpose Manufacturing Step Extensible Binding Characterization Steps Extensible Binding Specification Type Extensible Binding http://hl7.org/fhir/ValueSet/action-code from the FHIR Standard
PlanDefinition.action.reason	example	ActionReasonCode http://hl7.org/fhir/ValueSet/action-reason-code from the FHIR Standard
PlanDefinition.action.subject[x]	extensible	ParticipantResourceTypes http://hl7.org/fhir/ValueSet/participant-resource-types from the FHIR Standard
PlanDefinition.action.condition.kind	required	ActionConditionKind http://hl7.org/fhir/ValueSet/action-condition-kind|5.0.0 from the FHIR Standard
PlanDefinition.action.relatedAction.relationship	required	ActionRelationshipType http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0 from the FHIR Standard
PlanDefinition.action.relatedAction.endRelationship	required	ActionRelationshipType http://hl7.org/fhir/ValueSet/action-relationship-type|5.0.0 from the FHIR Standard
PlanDefinition.action.participant.type	required	ActionParticipantType http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0 from the FHIR Standard
PlanDefinition.action.participant.typeReference.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard
PlanDefinition.action.participant.role	example	VsManufacturingParticipantRolePQ (a valid code from Manufacturing Participant Role Codes) http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-manufacturingParticipantRole-pq from this IG
PlanDefinition.action.participant.function	example	ActionParticipantFunction http://hl7.org/fhir/ValueSet/action-participant-function from the FHIR Standard
PlanDefinition.action.type	extensible	ActionType http://hl7.org/fhir/ValueSet/action-type from the FHIR Standard
PlanDefinition.action.groupingBehavior	required	ActionGroupingBehavior http://hl7.org/fhir/ValueSet/action-grouping-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.selectionBehavior	required	ActionSelectionBehavior http://hl7.org/fhir/ValueSet/action-selection-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.requiredBehavior	required	ActionRequiredBehavior http://hl7.org/fhir/ValueSet/action-required-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.precheckBehavior	required	ActionPrecheckBehavior http://hl7.org/fhir/ValueSet/action-precheck-behavior|5.0.0 from the FHIR Standard
PlanDefinition.action.cardinalityBehavior	required	ActionCardinalityBehavior http://hl7.org/fhir/ValueSet/action-cardinality-behavior|5.0.0 from the FHIR Standard
PlanDefinition.asNeeded[x]	example	SNOMEDCTMedicationAsNeededReasonCodes http://hl7.org/fhir/ValueSet/medication-as-needed-reason from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cnl-0	warning	PlanDefinition	Name 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}$')
cnl-1	warning	PlanDefinition.url	URL should not contain | or # - these characters make processing canonical references problematic : exists() implies matches('^[^|# ]+$')
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
pld-0	error	PlanDefinition.action.input	Input data elements must have a requirement or a relatedData, but not both : requirement.exists() xor relatedData.exists()
pld-1	error	PlanDefinition.action.output	Output data element must have a requirement or a relatedData, but not both : requirement.exists() xor relatedData.exists()
pld-3	warning	PlanDefinition	goalid should reference the id of a goal definition : %context.repeat(action).where((goalId in %context.goal.id).not()).exists().not()
pld-4	warning	PlanDefinition	targetId should reference the id of an action : %context.repeat(action).relatedAction.where((targetId in %context.repeat(action).id).not()).exists().not()

This structure is derived from PlanDefinition

Summary

Must-Support: 19 elements

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-plan-document-reference-pq
• http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-history-of-process-pq
• http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq
• http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-step-scale-pq
• http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq