Study Conduct Sub-Domain::PerformedProcedure

: Public Class

Created:	1/20/2005 9:36:16 AM
Modified:	8/14/2018 1:58:55 PM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{38B180D1-CE88-4443-B857-534D0CD57C90}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View BSP: Biospecimen, View EX: Experiment, View AE: Adverse Event, View CM: Common, View SC: Study Conduct, Oncology & Imaging View, Oncology View, SDTM 3.1.3 View, SDTM Exposure (EX) Domain View, Participant Registration, SEER View, Lab-Related Classes, Anatomic Pathology Structured Report (APSR)

DEFINITION: The completed action whose immediate and primary intention is the alteration of the physical or mental condition of the subject, study subject or experimental unit. EXAMPLE(S): Procedures may involve the disruption of some body surface (e.g. an incision in a surgical procedure) conservative procedures such as reduction of a luxated joint, including physiotherapy such as chiropractic treatment, massage, balneotherapy, acupuncture, shiatsu, counseling, etc. OTHER NAME(S): NOTE(S): The documented use cases from life sciences are limited to procedure and observations. Use cases for other kinds of activities in life sciences are needed to support this relationship at the Activity level. In the next release, this relationship will have to be re-assessed.

Attributes
Associations To
Associations From
Tagged Values
Constraints
Other Links

Attribute

Public CD
methodCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:APSRv2.1=SB: Procedure Steps Section - hl7:ClinicalDocument > hl7:component > hl7:structuredBody > hl7:component [Proc Steps] > hl7:section > hl7:entry > hl7:procedure > hl7:methodCode
Map:APSRv2.1=SB: Procedure Steps Section - hl7:ClinicalDocument > hl7:component > hl7:structuredBody > hl7:component [Proc Steps] > hl7:section > hl7:entry > hl7:procedure > hl7:methodCode > @codeSystem
Map:caAERSv2.2=RadiationIntervention.administration
Map:CDMHv1.0=PerformedProcedure.methodCode
Map:CTOM=SpecimenAcquisition.methodCode
Map:CTRv1.0=PerformedProcedure.methodCode
Map:HCTv1.0=CDE 2748813:Therapies.Specify the other malignant cell removal method:
Map:HCTv1.0=CDE 2789998:Tissue Banking.What method was used to thaw the product?
Map:HCTv1.0=CDE 2790003:Tissue Banking.Specify other thaw method:
Map:Lab=SpecimenCollection.method
Map:LabViewer2.2=SpecimenCollection.method
Map:LabViewer2.2=SpecimenCollection.type
Map:LSDAMv2.2.3Plus=PerformedSpecimenFixed.fixationType
Map:LSDAMv2.2.3Plus=PerformedProcedure.methodCode
Map:LSDAMv2.2.3Plus=InvitroCharacterization.assayType
Map:SDTM IGv3.1.1=LB.LBMETHOD
Map:SDTM IGv3.1.1=EG.EGMETHOD

Notes:

DEFINITION: A coded value specifying the technique that is used to perform the procedure. EXAMPLE(S): Finger stick, veni puncture, Abdominal/ ascites effusion, Biopsy, Bronchial alveolar lavage (BAL) (for specimen collection) Capillary electrophoresis and HPLC (for In Vitro Characterization) Cell counting, flow cytometry (for In Vivo Characterization) Open, laparoscopic (for cholecystectomy) OTHER NAME(S): NOTE(S):

Public CD
targetAnatomicSiteCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:AE=Intervention.targetSite
Map:APSRv2.1=SB: Procedure Steps Section - hl7:ClinicalDocument > hl7:component > hl7:structuredBody > hl7:component [Proc Steps] > hl7:section > hl7:entry > hl7:procedure > hl7:targetSiteCode > hl7:qualifier > hl7:name > @displayName
Map:APSRv2.1=[Problem] hl7:organizer - [Problem] hl7:organizer > hl7:component [Lab Obs] > hl7:observation > hl7:entryRelationship [Specimen Collection] > hl7:procedure > hl7:targetSiteCode > @codeSystem
Map:APSRv2.1=SB: Procedure Steps Section - hl7:ClinicalDocument > hl7:component > hl7:structuredBody > hl7:component [Proc Steps] > hl7:section > hl7:entry > hl7:procedure > hl7:targetSiteCode
Map:APSRv2.1=SB: Procedure Steps Section - hl7:ClinicalDocument > hl7:component > hl7:structuredBody > hl7:component [Proc Steps] > hl7:section > hl7:entry > hl7:procedure > hl7:targetSiteCode > hl7:qualifier > hl7:name
Map:APSRv2.1=SB: Procedure Steps Section - hl7:ClinicalDocument > hl7:component > hl7:structuredBody > hl7:component [Proc Steps] > hl7:section > hl7:entry > hl7:procedure > hl7:targetSiteCode > hl7:qualifier > hl7:name > @codeSystem
Map:APSRv2.1=SB: Procedure Steps Section - hl7:ClinicalDocument > hl7:component > hl7:structuredBody > hl7:component [Proc Steps] > hl7:section > hl7:entry > hl7:procedure > hl7:targetSiteCode > hl7:qualifier > hl7:name > @code
Map:APSRv2.1=SB: Procedure Steps Section - hl7:ClinicalDocument > hl7:component > hl7:structuredBody > hl7:component [Proc Steps] > hl7:section > hl7:entry > hl7:procedure > hl7:targetSiteCode > hl7:qualifier > hl7:value
Map:APSRv2.1=SB: Procedure Steps Section - hl7:ClinicalDocument > hl7:component > hl7:structuredBody > hl7:component [Proc Steps] > hl7:section > hl7:entry > hl7:procedure > hl7:targetSiteCode > hl7:qualifier > hl7:value > @displayName
Map:APSRv2.1=SB: Procedure Steps Section - hl7:ClinicalDocument > hl7:component > hl7:structuredBody > hl7:component [Proc Steps] > hl7:section > hl7:entry > hl7:procedure > hl7:targetSiteCode > hl7:qualifier > hl7:value > @code
Map:APSRv2.1=SB: Procedure Steps Section - hl7:ClinicalDocument > hl7:component > hl7:structuredBody > hl7:component [Proc Steps] > hl7:section > hl7:entry > hl7:procedure > hl7:targetSiteCode > hl7:qualifier > hl7:value > @codeSystem
Map:APSRv2.1=SB: Procedure Steps Section - hl7:ClinicalDocument > hl7:component > hl7:structuredBody > hl7:component [Proc Steps] > hl7:section > hl7:entry > hl7:procedure > hl7:targetSiteCode > hl7:qualifier > hl7:value > @codeSystemName
Map:APSRv2.1=SB: Procedure Steps Section - hl7:ClinicalDocument > hl7:component > hl7:structuredBody > hl7:component [Proc Steps] > hl7:section > hl7:entry > hl7:procedure > hl7:targetSiteCode > hl7:qualifier
Map:APSRv2.1=SB: Procedure Steps Section - hl7:ClinicalDocument > hl7:component > hl7:structuredBody > hl7:component [Proc Steps] > hl7:section > hl7:entry > hl7:procedure > hl7:targetSiteCode > hl7:qualifier > hl7:value > @displayName
Map:caAERSv2.2=Lab.site
Map:CTOM=Procedure.anatomicSiteCode
Map:CTOM=SpecimenAcquisition.anatomicSiteCode
Map:CTOM=Radiation.anatomicSiteCodeSystem
Map:CTOM=Surgery.anatomicSiteCodeSystem
Map:CTOM=Surgery.anatomicSiteCode
Map:CTOM=Procedure.anatomicSiteCodeSystem
Map:CTOM=SpecimenAcquisition.anatomicSiteCodeSystem
Map:CTOM=Radiation.anatomicSiteCode
Map:CTRv1.0=PerformedProcedure.targetAnatomicSiteCode
Map:HCTv1.0=CDE 2957282:Therapies.What is the site of radiation therapy?
Map:HCTv1.0=CDE 2980936:Anatomic Sites.Specify the other site of orthopedic surgery
Map:HCTv1.0=CDE 2954787:Therapies.Specify other surgery site(s)
Map:HCTv1.0=CDE 2952974:Therapies.What was the radiation field?
Map:HCTv1.0=CDE 64160//:Anatomic Sites.Site of Biopsy
Map:HCTv1.0=CDE 2980893:Anatomic Sites.Site of orthopedic surgery
Map:LSDAMv2.2.3Plus=PerformedProcedure.targetAnatomicSiteCode
Map:PGx v1.0=BE.BELOC
Map:PGx v1.0=BS.BSANTREG
Map:SDTM IGv3.1.1=PE.PELOC
Map:SDTM IGv3.1.1=AE.AELOC
Map:SDTM IGv3.1.1=EX.EXLOC
Map:SDTM IGv3.1.1=VS.VSLOC
Map:SDTM IGv3.1.2=MB.MBLOC
Map:SDTM IGv3.1.3=MB.MBLOC

Notes:

DEFINITION: A coded value specifying the anatomic location that is the focus of a procedure. EXAMPLE(S): Kidney (or a nephrectomy) OTHER NAME(S): NOTE(S): Multiple contiguous sites within the same organ system may be referenced. Sources that capture anatomic site and laterality separately should map both to this attribute. For implementation models based on BRIDG where site and laterality are captured separately, you may wish to capture both concepts as a post-coordinated code structure or as multiple code repetitions.

Public CD
targetAnatomicSiteConditionCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTOM=SpecimenAcquisition.siteConditionCode
Map:CTRv1.0=PerformedProcedure.targetAnatomicSiteConditionCode
Map:LSDAMv2.2.3Plus=PerformedProcedure.targetAnatomicSiteConditionCode

Notes:

DEFINITION: A coded value specifying the state of the target anatomic site. EXAMPLE(S): The subject's left arm was bruised where the IV was inserted. OTHER NAME(S): NOTE(S):

Public CD
targetAnatomicSiteLateralityCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTRv1.0=PerformedProcedure.targetAnatomicSiteLateralityCode
Map:LSDAMv2.2.3Plus=PerformedProcedure.targetAnatomicSiteLateralityCode
Map:PGx v1.0=BE.BELOC
Map:SDTM IGv3.1.1=PE.PELOC
Map:SDTM IGv3.1.1=VS.VSLOC
Map:SDTM IGv3.1.1=EX.EXLOC
Map:SDTM IGv3.1.1=AE.AELOC
Map:SDTM IGv3.1.2=MB.MBLOC
Map:SDTM IGv3.1.3=TU.TULAT

Notes:

DEFINITION: A coded value specifying the side of the body (or a paired organ) that is a target site for a procedure. EXAMPLE(S): bilateral, left, right OTHER NAME(S): NOTE(S): This attribute was deprecated in BRIDG 3.1 but undeprecated in 4.0 since source use cases for separate laterality include SDTM and CTOM. This change ensures that users of the BRIDG model are not bound to a particular kind of vocabulary, such as pre- or post-coordinated vocabularies. Collapsing laterality into the target site code is an implementation option.

Public CD
targetAnatomicSiteDirectionalityCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:SDTM IGv3.1.3=TU.TUDIR

Notes:

DEFINITION: A coded value specifying the directional portion of the anatomic site that is a target site for a procedure. EXAMPLE(S): upper, interior OTHER NAME(S): NOTE(S): This attribute complements the target anatomic site code and target anatomic site laterality code.

Public CD
approachAnatomicSiteCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:AE=Intervention.approachSite
Map:APSRv2.1=SB: Procedure Steps Section - hl7:ClinicalDocument > hl7:component > hl7:structuredBody > hl7:component [Proc Steps] > hl7:section > hl7:entry > hl7:procedure > hl7:approachSiteCode
Map:APSRv2.1=SB: Procedure Steps Section - hl7:ClinicalDocument > hl7:component > hl7:structuredBody > hl7:component [Proc Steps] > hl7:section > hl7:entry > hl7:procedure > hl7:approachSiteCode > @code
Map:APSRv2.1=SB: Procedure Steps Section - hl7:ClinicalDocument > hl7:component > hl7:structuredBody > hl7:component [Proc Steps] > hl7:section > hl7:entry > hl7:procedure > hl7:approachSiteCode > @codeSystemName
Map:APSRv2.1=SB: Procedure Steps Section - hl7:ClinicalDocument > hl7:component > hl7:structuredBody > hl7:component [Proc Steps] > hl7:section > hl7:entry > hl7:procedure > hl7:approachSiteCode > @displayName
Map:APSRv2.1=SB: Procedure Steps Section - hl7:ClinicalDocument > hl7:component > hl7:structuredBody > hl7:component [Proc Steps] > hl7:section > hl7:entry > hl7:procedure > hl7:approachSiteCode > @codeSystem
Map:CDASHv1.1=EX.EXLOC
Map:CTRv1.0=PerformedProcedure.approachAnatomicSiteCode
Map:HCTv1.0=CDE 2416537:Therapy Doses.Radiation Field
Map:HCTv1.0=CDE 2769666:Anatomic Sites.What is the anatomic site of the central venous access catheter?
Map:HCTv1.0=CDE 2769668:Anatomic Sites.Specify the other site of the central line placement:
Map:LSDAMv2.2.3Plus=PerformedProcedure.approachAnatomicSiteCode
Map:SDTM IGv3.1.1=AE.AELOC
Map:SDTM IGv3.1.1=EX.EXLOC
Map:SDTM IGv3.1.1=VS.VSLOC
Map:SDTM IGv3.1.1=PE.PELOC
Map:SDTM IGv3.1.2=EX.EXLOC
Map:SDTM IGv3.1.3=EX.EXLOC

Notes:

DEFINITION: A coded value specifying the anatomic location or access point for a procedure. EXAMPLE(S): Arm for an injection, trans-abdominal for a nephrectomy. OTHER NAME(S): NOTE(S): Sources that capture anatomic site and laterality separately should map both to this attribute. For implementation models based on BRIDG where site and laterality are captured separately, you may wish to capture both concepts as a post-coordinated code structure or as multiple code repetitions.

Public CD
approachAnatomicSiteLateralityCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CDASHv1.1=EX.EXLOC
Map:CTRv1.0=PerformedProcedure.approachAnatomicSiteLateralityCode
Map:LSDAMv2.2.3Plus=PerformedProcedure.approachAnatomicSiteLateralityCode
Map:PGx v1.0=BE.BELOC
Map:SDTM IGv3.1.1=AE.AELOC
Map:SDTM IGv3.1.1=VS.VSLOC
Map:SDTM IGv3.1.1=PE.PELOC
Map:SDTM IGv3.1.1=EX.EXLOC
Map:SDTM IGv3.1.2=EX.EXLOC

Notes:

DEFINITION: A coded value specifying the side of the body (or a paired organ) that is an access point for a procedure. EXAMPLE(S): bilateral, left, right OTHER NAME(S): NOTE(S): This attribute was deprecated in BRIDG 3.1 but undeprecated in 4.0 since source use cases for separate laterality include SDTM and CTOM. This change ensures that users of the BRIDG model are not bound to a particular kind of vocabulary, such as pre- or post-coordinated vocabularies. Collapsing laterality into the target site code is an implementation option.

Public BL
principalIndicator

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CDMHv1.0=PerformedProcedure.priorityCode

Notes:

DEFINITION: Specifies whether this procedure was the primary procedure performed during the encounter. EXAMPLE(S): OTHER NAME(S): Principal Procedure Flag NOTE(S):

Public DSET<CD>
nonReasonCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to *
Transient:	False
Derived:	False
IsID:	False

Map:HCTv1.0=CDE 2750712:Therapies.Did a particular reason for the non-myeloablative / reduced intensity preparative regimen occur?

Notes:

DEFINITION: A coded value specifying the motivation, cause or rationale that is explicitly NOT why an activity occurred. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public INT.NONNEG
quantity

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:
Transient:	False
Derived:	True
IsID:	False

Map:CDMHv1.0=CDMH_PerformedProcedure.quantity

Notes:

DEFINITION: An integer representing the number of times this procedure was performed. EXAMPLE(S): OTHER NAME(S): NOTE(S): Theoretically the quantity may be derived by counting the individual occurrences of the procedure being performed, each with its own distinct date & time.

Element	Source Role	Target Role
PerformedObservationResult Class	Name: recordedPerformedProcedure	Name: triggeringPerformedObservationResult
Details: DESCRIPTION:<br/>Each PerformedProcedure might be recorded as a result of one PerformedObservationResult. Each PerformedObservationResult might result in recording one or more PerformedProcedure.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Product Class	Name: usingPerformedProcedure	Name: usedProduct
Details: DESCRIPTION:<br/>Each PerformedProcedure might use one or more Product. Each Product might be used during one or more PerformedProcedure.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Element	Source Role	Target Role
PerformedDiagnosisProcedureRelationship Class	Name: addressedPerformedDiagnosisProcedureRelationship	Name: addressingPerformedProcedure
Details: DESCRIPTION:<br/>Each PerformedDiagnosisProcedureRelationship always is addressed by one PerformedProcedure. Each PerformedProcedure might address one or more PerformedDiagnosisProcedureRelationship.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
SafetyReportVersion Class	Name: reportingSafetyReportVersion	Name: reportedPerformedProcedure
Details: DESCRIPTION:<br/>Each SafetyReportVersion might report as prior therapies one or more PerformedProcedure. Each PerformedProcedure might be reported as a prior therapy in one or more SafetyReportVersion.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Tag	Value
Map:AE	Intervention
Details:
Map:APSRv2.1	[Problem] hl7:organizer - [Problem] hl7:organizer > hl7:component [Any kind of AP observation] > hl7:observation > hl7:reference > [CHOICE OF EXTERNAL ACT/OBS/PROC/DOC] > hl7:externalProcedure
Details:
Map:APSRv2.1	SB: Procedure Steps Section - hl7:ClinicalDocument > hl7:component > hl7:structuredBody > hl7:component [Proc Steps] > hl7:section > hl7:entry > hl7:procedure > hl7:reference > [CHOICE OF EXTERNAL ACT/OBS/PROC/DOC] > hl7:externalProcedure
Details:
Map:APSRv2.1	SB: Procedure Steps Section - hl7:ClinicalDocument > hl7:component > hl7:structuredBody > hl7:component [Proc Steps] > hl7:section > hl7:entry > hl7:procedure
Details:
Map:caAERSv2.2	TreatmentAssignment
Details:
Map:caAERSv2.2	SurgeryIntervention
Details:
Map:caAERSv2.2	RadiationIntervention
Details:
Map:caAERSv2.2	StudyParticipantPriorTherapy
Details:
Map:CDMHv1.0	PerformedProcedure
Details:
Map:CTRv1.0	PerformedProcedure
Details:
Map:ICSRr2	Procedure (in A_ProductReportingRelevantInformation)
Details:
Map:ICSRr2	ProductUseReference (in IndividualCaseSafetyReport)
Details:
Map:LSDAMv2.2.3Plus	PerformedProcedure
Details:

Constraint	Type	Status
uses actualIndicator Qualifier	Invariant	Approved
Details: Only Product with actualIndicator = "true" is valid.<br/>
use Association Set Qualifier	Invariant	Approved
Details: The association from ExperimentalActivityItem is only valid if the PerformedProcedure is occurring in the context of an Experiment or a SpecimenProcessing project, and in such case the association to Product is not valid.<br/>

Object	Type	Connection	Direction	Notes
PerformedSubstanceAdministration	Class	Generalization	From	DESCRIPTION: Each PerformedSubstanceAdministration always specializes one PerformedProcedure. Each PerformedProcedure might be specialized by one PerformedSubstanceAdministration. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
PerformedActivity	Class	Generalization	To	DESCRIPTION: Each PerformedProcedure always specializes one PerformedActivity. Each PerformedActivity might be specialized by one PerformedProcedure. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
PerformedSupply	Class	Generalization	From	DESCRIPTION: Each PerformedSupply always specializes one PerformedProcedure. Each PerformedProcedure might be specialized by one PerformedSupply. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
PerformedSpecimenCollection	Class	Generalization	From	DESCRIPTION: Each PerformedSpecimenCollection always specializes one PerformedProcedure. Each PerformedProcedure might be specialized by one PerformedSpecimenCollection. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
PerformedSubstanceExtraction	Class	Generalization	From	DESCRIPTION: Each PerformedSubstanceExtraction always specializes one PerformedProcedure. Each PerformedProcedure might be specialized by one PerformedSubstanceExtraction. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
PerformedMaterialProcessStep	Class	Generalization	From	DESCRIPTION: Each PerformedMaterialProcessStep always specializes one PerformedProcedure. Each PerformedProcedure might be specialized by one PerformedMaterialProcessStep. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):