Study Conduct Sub-Domain::ReferenceResult

: Public Class

Created:	7/8/2009 10:42:49 AM
Modified:	8/14/2018 1:58:54 PM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{4916F6DF-641C-49a3-832B-3A171C1D70CD}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View SC: Study Conduct, Performer, SDTM 3.1.3 View, Lab-Related Classes, CDISC Lab Data Model v1.0.1, Anatomic Pathology Structured Report (APSR)

DEFINITION: The possible or expected results that can be obtained by observing, monitoring, measuring or otherwise qualitatively or quantitatively recording one or more aspects of physiologic or psychologic processes. EXAMPLE(S): The normal range for a systolic blood pressure reading is 110-130 for adult males: ReferenceResult.referenceTypeCode = normal range ReferenceResult.valueTypeCode = systolic blood pressure ReferenceResult.value(ANY=#gt;IVL#lt;PQ#gt;) = 110-130 mm[Hg] ReferenceResult.populationScopeCode = adult males The limit of quantitation for a PK assay, concentration of drug XYZ is 2-60 nanograms/ml for adult women as processed by Acme Labs: ReferenceResult.referenceTypeCode = limit of quantitation ReferenceResult.valueTypeCode = PK assay, concentration of drug XYZ ReferenceResult.value(ANY=#gt;IVL#lt;PQ#gt;) = 2-60 nanograms/ml ReferenceResult #gt; PerformingLaboratory #gt; Laboratory #gt; Organization.name = Acme Labs The normal range for a hemoglobin concentration measurement on an adult female performed by Acme Labs is 12.1 to 15.1 g/dL: ReferenceResult.referenceTypeCode = normal range ReferenceResult.valueTypeCode = hemoglobin concentration measurement ReferenceResult.value(ANY=#gt;IVL#lt;PQ#gt;) = 12.1 to 15.1 g/dL ReferenceResult.populationScopeCode = adult females ReferenceResult #gt; PerformingLaboratory #gt; Laboratory #gt; Organization.name = Acme Labs The normal range for a fasting blood glucose measurement on an adult performed by Acme Labs is 3.6 to 5.8 mmol/L: ReferenceResult.referenceTypeCode = normal range ReferenceResult.valueTypeCode = blood glucose measurement ReferenceResult.value(ANY=#gt;IVL#lt;PQ#gt;)= 3.6 to 5.8 mmol/L ReferenceResult.populationScopeCode = adult ReferenceResult.fastingStatusIndicator = true ReferenceResult #gt; PerformingLaboratory #gt; Laboratory #gt; Organization.name = Acme Labs OTHER NAME(S): Normal range, reference range, limit of quantitation, clinical concern range, data checking range, alert range NOTE(S): The context of a reference result may include any combination of the following: the performing lab, the performing device, and the population to which the reference value pertains. The context may also omit any of those aspects as well.

Attributes
Associations To
Associations From
Tagged Values
Constraints

Attribute

Public ANY
value

Details:

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

Map:APSRv2.1=[Problem] hl7:organizer - [Problem] hl7:organizer > hl7:component [Lab Obs] > hl7:observation > hl7:referenceRange > hl7:observationRange > hl7:value
Map:CDASHv1.1=LB.LBORNRHI
Map:CDASHv1.1=LB.LBORNRLO
Map:CDISCLabv1.0.1=Base Result.SI Reference Range High
Map:CDISCLabv1.0.1=Base Result.SI Reference Range Low
Map:CDISCLabv1.0.1=Base Result.Reported Reference Range Low
Map:CDISCLabv1.0.1=Base Result.Reported Reference Range High
Map:CDISCLabv1.0.1=Base Result.Conventional Reference Range High
Map:CDISCLabv1.0.1=Base Result.Conventional Reference Range Low
Map:CDMHv1.0=ReferenceResult.value
Map:CTOM=ClinicalResult.labReferenceRangeCode
Map:CTRv1.0=ReferenceResult.value
Map:HCTv1.0=CDE 2953113:Lab Results.What is the upper limit of normal value of total serum bilirubin?
Map:HCTv1.0=CDE 2953268:Lab Results.Upper limit of normal for lambda free light chain:
Map:HCTv1.0=CDE 2953266:Lab Results.upper limit of normal for kappa free light chain:
Map:HCTv1.0=CDE 2963544:Lab Results.What is the upper limit of normal value of beta-2-microglobulin protein?
Map:HCTv1.0=CDE 2953270:Lab Results.Unit of measure: kappa
Map:HCTv1.0=CDE 2954096:Lab Results.Specify the serum immunoglobin lower limit of normal value:
Map:HCTv1.0=CDE 2953111:Lab Results.What is the upper limit of normal value of AST (SGOT)?
Map:HCTv1.0=CDE 2953277:Lab Results.Unit of measure: lambda
Map:HCTv1.0=CDE 2597015:Lab Results.Lactate Dehydrogenase ULN
Map:HCTv1.0=CDE 2954133:Lab Results.Serum Immunoglobin Upper Limit of Normal
Map:HCTv1.0=CDE 2953866:Lab Results.LDH Upper Limit of Normal Unit of Measure
Map:HCTv1.0=CDE 2953117:Lab Results.What is the upper limit of normal value of serum creatinine?
Map:HCTv1.0=CDE 2953862:Lab Results.Serum Creatinine Upper Limit of Normal
Map:Lab=LabResult.referenceRangeHigh
Map:Lab=LabResult.referenceRangeLow
Map:Lab=LaboratoryResult.referenceTextList
Map:Lab=LabResult.referenceTextList
Map:LabViewer2.2=LaboratoryResult.referenceRangeHigh
Map:LabViewer2.2=LaboratoryResult.referenceRangeLow
Map:NCI CRF Standard=CDE 2841221v1.0: Test Result Low Test Reference Range Number
Map:NCI CRF Standard=CDE 2841212v1.0: Test Result High Test Reference Range Number
Map:SDTM IGv3.1.1=LB.LBORNRHI
Map:SDTM IGv3.1.1=LB.LBSTNRHI
Map:SDTM IGv3.1.1=LB.LBORNRLO
Map:SDTM IGv3.1.1=LB.LBSTNRC
Map:SDTM IGv3.1.1=LB.LBSTNRLO
Map:SDTM IGv3.1.2=LB.LBSTNRC
Map:SDTM IGv3.1.2=LB.LBORNRHI
Map:SDTM IGv3.1.2=PC.PCLLOQ
Map:SDTM IGv3.1.2=LB.LBORNRLO
Map:SDTM IGv3.1.2=LB.LBSTNRLO
Map:SDTM IGv3.1.2=LB.LBSTNRHI
Map:SDTM IGv3.1.3=LB.LBORNRHI
Map:SDTM IGv3.1.3=LB.LBORNRLO
Map:SDTM IGv3.1.3=LB.LBSTNRC
Map:SDTM IGv3.1.3=LB.LBSTNRHI
Map:SDTM IGv3.1.3=LB.LBSTNRLO
Map:SDTM IGv3.1.3=PC.PCLLOQ

Notes:

DEFINITION: A reference for some measurement that a physician or other health professional can use to interpret a set of results for a particular experimental unit. EXAMPLE(S): For systolic blood pressure, ReferenceResult.value(ANY) would be constrained to IVL#lt;PQ#gt; and would = 110-130 mm[Hg] OTHER NAME(S): NOTE(S):

Public CD
valueTypeCode

Details:

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

Map:CTOM=ClinicalResult.value
Map:CTRv1.0=ReferenceResult.valueTypeCode

Notes:

DEFINITION: A coded value specifying the kind of clinical result to which this reference result must be associated. EXAMPLE(S): For a blood pressure measurement, the valueTypeCode may be systolic or diastolic. OTHER NAME(S): NOTE(S):

Public CD
referenceTypeCode

Details:

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

Map:APSRv2.1=[Problem] hl7:organizer - [Problem] hl7:organizer > hl7:component [Lab Obs] > hl7:observation > hl7:referenceRange > @typeCode
Map:CTRv1.0=ReferenceResult.referenceTypeCode
Map:SDTM IGv3.1.2=LB.LBSTNRHI
Map:SDTM IGv3.1.2=LB.LBSTNRLO
Map:SDTM IGv3.1.2=LB.LBSTNRC
Map:SDTM IGv3.1.2=PC.PCLLOQ
Map:SDTM IGv3.1.2=LB.LBORNLO
Map:SDTM IGv3.1.2=LB.LBORNHI

Notes:

DEFINITION: A coded value specifying the kind of reference, i.e. how it is to be used or what its purpose is. EXAMPLE(S): normal range limit of quantitation clinical concern range data checking range alert range 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:CTOM=LesionDescription.contactAnatomicSiteCode
Map:CTOM=LesionDescription.contactAnatomicSiteCodeSystem
Map:CTRv1.0=ReferenceResult.targetAnatomicSiteCode
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

Notes:

DEFINITION: A coded value specifying the anatomic location that is the focus of a reference result. EXAMPLE(S): Arm for skin rash 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
targetAnatomicSiteLateralityCode

Details:

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

Map:CTRv1.0=ReferenceResult.targetAnatomicSiteLateralityCode
Map:SDTM IGv3.1.1=VS.VSLOC
Map:SDTM IGv3.1.1=PE.PELOC
Map:SDTM IGv3.1.1=AE.AELOC
Map:SDTM IGv3.1.1=EX.EXLOC

Notes:

DEFINITION: A coded value specifying the side of the body (or a paired organ) that is a target site for a result. EXAMPLE(S): bilateral, left, right OTHER NAME(S): NOTE(S): This attribute is deprecated in BRIDG 3.1 since the only source use case for splitting out laterality from anatomic site comes from CTOM. All other source models had these concepts combined in one attribute. Therefore it was determined to combine these attributes to match the majority of use cases.

Public CD
populationScopeCode

Details:

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

Map:APSRv2.1=[Problem] hl7:organizer - [Problem] hl7:organizer > hl7:component [Lab Obs] > hl7:observation > hl7:referenceRange > hl7:observationRange > hl7:precondition > lab:criterion > lab:value
Map:APSRv2.1=[Problem] hl7:organizer - [Problem] hl7:organizer > hl7:component [Lab Obs] > hl7:observation > hl7:referenceRange > hl7:observationRange > hl7:precondition > lab:criterion > lab:code
Map:BRIDGSCC=Model Integrity
Map:CTRv1.0=ReferenceResult.populationScopeCode

Notes:

DEFINITION: A coded value specifying the type of subjects to which this reference result applies. EXAMPLE(S): adult males adult females minor males minor females OTHER NAME(S): NOTE(S):

Public BL
fastingStatusIndicator

Details:

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

Map:BRIDGSCC=Model Integrity
Map:CTRv1.0=ReferenceResult.fastingStatusIndicator

Notes:

DEFINITION: Specifies whether the result applies to when the subject had been abstaining from eating when the specimen was obtained. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public ST
comment

Details:

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

Map:CTOM=DiseaseResponse.commentText
Map:CTRv1.0=ReferenceResult.comment
Map:Lab=LabResult.referenceRangeComments
Map:LabViewer2.2=LaboratoryResult.referenceRangeComment
Map:SDTM IGv3.1.1=CO.COVAL

Notes:

DEFINITION: Additional description of the reference result. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Element	Source Role	Target Role
Device Class	Name: performedReferenceResult	Name: performingDevice
Details: DESCRIPTION:<br/>Each ReferenceResult might apply to results produced by one Device. Each Device might produce one or more ReferenceResult.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Laboratory Class	Name: performedReferenceResult	Name: performingLaboratory
Details: DESCRIPTION:<br/>Each ReferenceResult might apply to results produced by one Laboratory. Each Laboratory might produce one or more ReferenceResult.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>

Element	Source Role	Target Role
PerformedClinicalResult Class	Name: referencingPerformedClinicalResult	Name: referencedReferenceResult
Details: DESCRIPTION:<br/>Each PerformedClinicalResult might reference one or more ReferenceResult. Each ReferenceResult might be referenced by one or more PerformedClinicalResult.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Tag	Value
Map:APSRv2.1	[Problem] hl7:organizer - [Problem] hl7:organizer > hl7:component [Lab Obs] > hl7:observation > hl7:referenceRange
Details:
Map:BRIDGSCC	Model Integrity
Details:
Map:CDMHv1.0	ReferenceResult
Details:
Map:CTRv1.0	ReferenceResult
Details:

Constraint	Type	Status
apply to results produced by actualIndicator Qualifier	Invariant	Approved
Details: Only Device or Organization (via PerformingLaboratory) with actualIndicator = "true" is valid. <br/>