: Public Class
Created: 12/15/2005 10:35:53 AM
Modified: 3/28/2018 5:35:56 PM
Project:
Advanced:
DEFINITION:<br/>A result of a clinical observation, i.e. from an examination, test or direct observation performed on the experimental unit.  <br/><br/>EXAMPLE(S):<br/>The performed observation of "WBC count" would be associated to a clinical result called "WBC result" in which the results of the observation (7500 WBCs) would be stored.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>There is an association between the observation that has the original data (and the original units) and the observation in which the data elements have been converted into standardized units.  <br/><br/>If further use case are discovered it may be necessary to move the recursive relationship up to PerformedObservationResult.<br/>
Attribute
Public CD
  normalRangeComparisonCode
Details:
Map:CDASHv1.1=LB.LBNRIND
Map:CDISCLabv1.0.1=Base Result.Alert Flag
Map:CTRv1.0=PerformedClinicalResult.normalRangeComparisonCode
Map:LSDAMv2.2.3Plus=PerformedClinicalResult.normalRangeComparisonCode
Map:SDTM IGv3.1.1=LB.LBNRIND
Map:SDTM IGv3.1.1=EG.EGNRIND
Map:SDTM IGv3.1.1=VS.VSNRIND
Map:SDTM IGv3.1.2=LB.LBNRIND
Map:SDTM IGv3.1.3=LB.LBNRIND
Notes: DEFINITION:<br/>A coded value specifying the relationship of a value to a normal range or reference range of values.<br/><br/>EXAMPLE(S):<br/>high, low, within normal range, outside normal range<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Derived from comparing PerformedObservationResult.value to the ReferenceResult.value.<br/>
Public ST
  infectiousAgent
Details:
Map:caAERSv2.2=Lab.infectiousAgent
Map:CTRv1.0=PerformedClinicalResult.infectiousAgent
Map:LSDAMv2.2.3Plus=PerformedClinicalResult.infectiousAgent
Notes: DEFINITION:<br/>The name of the specific microbe that the test is intended to identify.<br/><br/>EXAMPLE(S):<br/>streptococcus pneumoniae, staphylococcus aureus<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S): <br/>Derived from PerformedObservation directly or indirectly linked to DefinedActivity.nameCode(CD).originaltext.<br/>
Public CD
  targetBiomarkerCode
Details:
Map:HCTv1.0=CDE 2695256:Lab Results.1st A antigen specificity:
Notes: DEFINITION:<br/>A coded value specifying a variation in cellular or biochemical components or processes, structures, or functions that is objectively measurable in a biological system and that characterizes normal biologic processes, pathogenic processes, an organism's state of health or disease, likelihood of developing a disease, prognosis, or response to a particular therapeutic intervention.  This is the focus of an observation. <br/><br/>EXAMPLE(S):<br/>Biomarkers include but are not limited to such phenotypic parameters as specific enzyme or hormone concentration, specific gene phenotype, presence or absence of biological substance. <br/>For an observation with a nameCode of "Determine the Allele for the HLA-A Locus on Chromosome 6", the observation result might have a targetBiomarkerCode of "HLA-A" and a value of "HLA-A*01:01:01" (the specific allele)<br/>For an observation with a nameCode of "Determine the variant nucleotide for Single Nucleotide Polymorphism RS110789", the observation result might have a targetBiomarkerCode of "Rs110789" and a value of "C" (cytosine, the specific nucleotide that is variant)<br/><br/>OTHER NAME(S): <br/>Genetic Marker  <br/><br/>NOTE(S):<br/>There is no associated 'approach' for a Biomarker, as there is for an anatomic site.  In the context of Bone Marrow Transplantation, the bodily substance that is collected to determine the Biomarker (the HLA Alleles) is typically blood or saliva.  Thus, the thing that is collected is the typeCode of the Material that is collected via a PerformedSpecimenCollection.<br/><br/>The attribute 'targetBiomarkerCode' was chosen as inclusive of 'targetGeneticMarkerCode', which is more specific to the Bone Marrow Transplantation domain.  However,  the Life Sciences Domain Analysis Model is using Biomarker as the focus of their Genomic Analysis, and thus this broader definition was chosen to facilitate that alignment. <br/>
Public BL
  biomarkerIndicator
Details:
Map:CTOM=ClinicalResult.biomarkerIndicator
Map:CTRv1.0=PerformedClinicalResult.biomarkerIndicator
Map:LSDAMv2.2.3Plus=PerformedClinicalResult.biomarkerIndicator
Notes: DEFINITION:<br/>Specifies whether a result is considered a biomarker. <br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>This attribute is based on a result as stated in the NCI Thesaurus for Biomarker: A variation in cellular or biochemical components or processes, structures, or functions that is objectively measurable in a biological system and that characterizes normal biologic processes, pathogenic processes, an organism's state of health or disease, likelihood of developing a disease, prognosis, or response to a particular therapeutic intervention. Biomarkers include but not limited to such phenotypic parameters as specific enzyme or hormone concentration, specific gene phenotype, presence or absence of biological substances.<br/>
Public BL
  asCollectedIndicator
Details:
Map:CTRv1.0=PerformedClinicalResult.asCollectedIndicator
Map:LSDAMv2.2.3Plus=PerformedClinicalResult.asCollectedIndicator
Map:SDTM IGv3.1.1=LB.LBORRES
Notes: DEFINITION:<br/>Specifies whether the observation is represented in the units or values as originally collected.<br/><br/>EXAMPLE(S):<br/>A performing lab may have completed the observation or lab test using conventional units, but the sponsor may wish to have the test reported in SI units. This flag will be set to "true" on the lab test that has the original units, and "false" on the lab test in which the units that are different than the lab test's original units.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public CD
  statusCode
Details:
Map:CDISCLabv1.0.1=Base Result.Reported Result Status
Map:CTRv1.0=PerformedClinicalResult.statusCode
Map:HCTv1.0=CDE 3061547:Lab Results.What was the status of the serum alpha-fetoprotein finding?
Map:HCTv1.0=CDE 2963402:Lab Results.What was the status of the lymphocytes present in bone marrow finding?
Map:HCTv1.0=CDE 2986015:Lab Results.What was the low stroma histology type?
Map:HCTv1.0=CDE 2861065:Lab Results.What was the status of the serum albumin finding?
Map:HCTv1.0=CDE 2861054:Lab Results.What was the status of the serum beta 2 microglobulin finding?
Map:HCTv1.0=CDE 2970736:Lab Results.What was the status of the expression of proto-oncogenes finding?
Map:HCTv1.0=CDE 2934447:Lab Results.What was the status of the blasts in bone marrow finding?
Map:HCTv1.0=CDE 2866061:Lab Results.What was the status of the cerebrospinal fluid total protein finding?
Map:HCTv1.0=CDE 2863877:Lab Results.What was the status of the serum ferritin finding?
Map:HCTv1.0=CDE 2952889:Lab Results.What was the status of the serum free light chains (kappa) finding?
Map:HCTv1.0=CDE 2952919:Lab Results.What was the status of the serum free light chains lambda finding?
Map:HCTv1.0=CDE 2863186:Lab Results.What was the status of the hematocrit finding?
Map:HCTv1.0=CDE 2940075:Lab Results.What was the status of the neutrophil finding?
Map:HCTv1.0=CDE 2884436:Lab Results.What was the status of the lymphocytes finding?
Map:HCTv1.0=CDE 2952875:Lab Results.What was the status of the urinary monoclonal light chain finding?
Map:HCTv1.0=CDE 2861133:Lab Results.What was the status of the plasma cells in bone marrow from an unknown source finding?
Map:HCTv1.0=CDE 2953864:Lab Results.What was the status of the lactate dehydrogenase finding?
Map:HCTv1.0=CDE 2982913:Lab Results.What was the status of the uncorrected reticulocyte finding?
Map:HCTv1.0=CDE 2970537:Lab Results.What was the status of the N-myc amplification finding?
Map:HCTv1.0=CDE 2970731:Lab Results.What was the status of the TRK expression finding?
Map:HCTv1.0=CDE 2860841:Lab Results.What was the status of the platelet finding?
Map:HCTv1.0=CDE 2895879:Lab Results.What was the status of the eosinophil finding?
Map:HCTv1.0=CDE 3019776:Lab Results.What was the status of the modal chromosome number finding?
Map:HCTv1.0=CDE 2954073:Lab Results.What was the status of the serum immunologic finding?
Map:HCTv1.0=CDE 2963488:Lab Results.What was the status of the prolymphocytes finding?
Map:HCTv1.0=CDE 2969525:Lab Results.What was the status of the vanillyl mandelic acid finding?
Map:HCTv1.0=CDE 2967117:Lab Results.What was the status of the homovanillic acid finding?
Map:HCTv1.0=CDE 2953017:Lab Results.What was the status of the serum monoclonal M protein finding?
Map:HCTv1.0=CDE 2974094:Lab Results.What was the status of the gamma-enolase finding?
Map:HCTv1.0=CDE 2897741:Lab Results.What was the status of the basophil finding?
Map:HCTv1.0=CDE 2957563:Lab Results.HER2 IHC Status
Map:HCTv1.0=CDE 3061552:Lab Results.What was the status of the serum beta-human chorionic gonadotropin finding?
Map:HCTv1.0=CDE 2860929:Lab Results.What was the status of the blood blast count finding?
Map:Lab=LabResult.reportedResultStatus
Map:LabViewer2.2=LaboratoryResult.reportedResultStatus
Map:LSDAMv2.2.3Plus=PerformedClinicalResult.reportedResultStatusCode
Notes: DEFINITION:<br/>A coded value specifying the phase in the lifecycle of the reported result.<br/><br/>EXAMPLE(S):<br/>preliminary, final, corrected<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Element Source Role Target Role
PerformedClinicalResult
Class   		Name: originalPerformedClinicalResult
  		Name: convertedPerformedClinicalResult
 
Details:
DESCRIPTION:<br/>Each [original] PerformedClinicalResult might be converted into one or more [converted] PerformedClinicalResult. Each [converted] PerformedClinicalResult might be converted from one [original] PerformedClinicalResult.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
ReferenceResult
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/>
Element Source Role Target Role
PerformedClinicalResult
Class   		Name: originalPerformedClinicalResult
  		Name: convertedPerformedClinicalResult
 
Details:
DESCRIPTION:<br/>Each [original] PerformedClinicalResult might be converted into one or more [converted] PerformedClinicalResult. Each [converted] PerformedClinicalResult might be converted from one [original] PerformedClinicalResult.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Tag Value
Map:caAERSv2.2 LabValue
Details:
 
Map:CDISCLabv1.0.1 Base Result
Details:
 
Map:CDMHv1.0 PerformedClinicalResult
Details:
 
Map:CTRv1.0 PerformedClinicalResult
Details:
 
Map:LabViewer2.2 LaboratoryResult
Details:
 
Map:LSDAMv2.2.3Plus PerformedClinicalResult
Details:
 
Constraint Type Status
reference Qualifier Invariant Approved
Details:
If a PerformedClinicalResult references a ReferenceResult, it is required that PerformedClinicalResult.typeCode = ReferenceResult.valueTypeCode. It is further required that the fastingStatusIndicator on the PerformedSpecimenCollection that produced the specimen upon which the clinical test was performed = ReferenceResult.fastingStatusIndicator if specified. <br/>
Object Type Connection Direction Notes
PerformedObservationResult Class Generalization To DESCRIPTION: Each PerformedClinicalResult always specializes one PerformedObservationResult. Each PerformedObservationResult might be specialized by one PerformedClinicalResult. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):