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shr.oncology

SHR implementation of ASCO requirements.

AverageCEP17SignalsPerCell

Average number CEP17 signals per cell (dual probe only) 74861-6

Based On EvaluationComponent

Value:  Quantity A quantity with units, whose value may be bounded from above or below, as defined in FHIR
ReferenceRange not used The usual or acceptable range for a test result.
ComponentResultValue optional The actual value of the component finding.
ExceptionValue optional Reason that a value associated with a test or other finding is missing.
Interpretation optional A clinical interpretation of a finding.

AverageHER2SignalsPerCell

Average number of HER2 signals per cell 74860-8

Based On EvaluationComponent

Value:  Quantity A quantity with units, whose value may be bounded from above or below, as defined in FHIR
ReferenceRange not used The usual or acceptable range for a test result.
ComponentResultValue optional The actual value of the component finding.
ExceptionValue optional Reason that a value associated with a test or other finding is missing.
Interpretation optional A clinical interpretation of a finding.

AverageStainingIntensity

The degree or magnitude of staining (nuclear positivity) across cells in the specimen. Average intensity of positive staining neoplastic cells (observable entity) (444775005)

Based On CodedEvaluationComponent

Value:  CodeableConcept must be from StainingIntensityVS
A set of codes drawn from different coding systems, representing the same concept.
ComponentResultValue must be a CodeableConcept
optional The actual value of the component finding.
ReferenceRange not used The usual or acceptable range for a test result.
ExceptionValue optional Reason that a value associated with a test or other finding is missing.
Interpretation optional A clinical interpretation of a finding.

BreastCancerDistantMetastasesClassification

The presence of distant metastases, based on criteria defined by the staging system being used. M category (observable entity) (277208005)

Based On CodedEvaluationComponent

Value:  CodeableConcept A set of codes drawn from different coding systems, representing the same concept.
ComponentResultValue must be a CodeableConcept
optional The actual value of the component finding.
ReferenceRange not used The usual or acceptable range for a test result.
ExceptionValue optional Reason that a value associated with a test or other finding is missing.
Interpretation optional A clinical interpretation of a finding.

BreastCancerHistologicGrade [Entry]

The Elston Grade/Nottingham Score, representative of the aggressive potential of the tumor. Well differentiated cells (Grade 1) look similar to normal cells and are usually slow growing, while poorly differentiated cells (Grade 3) look very different than normal and are fast-growing. 44648-4

Based On SimplifiedLaboratoryTestResultRecorded

DiagnosticService is pathology
0 or more A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.
PanelMembers not used PanelMember represent the elements of a group of a related but independent evaluations. Examples are the measurements that compose a complete blood count (CBC), or the elements of a pathology report. Each member is an independent evaluation, but the grouping reflects a composite lab order, shared specimen, or a single report author. Typically the Category and Reason are not given for individual findings that are part of the panel, but rather given at the level of the panel itself.
StatementTopic must be a EvaluationResultTopic
required Compositional and reusable grouping of clinical statement attributes that make up the clinical focus of a statement. StatementTopic class attributes are aligned with SNOMED CT Concept Model attributes when such an overlap exists. Note that this class does not include contextual attributes such as the nature of the action (ordered, proposed, planned, etc...), the nature of the patient state being described (e.g., present, suspected present, absent), and the attribution of this information (the who, when, where, how, why of the information recorded).
         where  EvaluationResultTopic
StatementContext must be a EvaluationResultRecordedContext
required Compositional and reusable grouping of clinical statement attributes that provides the context for the topic of a clinical statement. The StatementContext class aligns with the SNOMED CT Situations with Explicit Context (SWEC) Concept Model. The StatementContext provides the expressivity required to specify that an act was performed or not performed or that a finding was asserted to be present or absent for the given subject of information. It also often holds provenance information relevant to the context of the clinical statement. It is important to note that by default the context applies to the conjunction of the attribute specified in the statement. For instance, if a clinical statement has a topic describing a rash on left arm and a context of 'absent', then the statement states that the subject of interest did not have a rash on the left arm but might have had one on the right arm.
         where  EvaluationResultRecordedContext
SubjectOfInformation required The person or thing that this entry relates to, usually the Person of Record (see Entry). However, not all entries have health information specifically about the patient, but in different contexts, could refer to a fetus, family member (living or dead), device, location, organization, behavior, finding, condition, wound, or intervention. CIMI alignment: SubjectOfInformation is not a Participation -- unlike CIMI. There's no action to participate in. Participant has extra unnecessary attributes, such as 'onBehalfOf'.
SourceOfInformation optional The person or entity that provided the information in the entry, e.g. the subject (patient), medical professional, family member, device or software program, as distinct from who recorded the entry.
Annotation 0 or more An added or follow-up note, often after the fact, that contains metadata about who made the statement and when.
RecordStatus optional Concept indicating the state of this record, e.g., 'entered in error'.
Recorded optional The person who entered the order on behalf of another individual for example in the case of a verbal or a telephone order.
Signed optional Provenance information specific to the signing of the clinical statement.
Cosigned 0 or more Provenance information specific to the cosigning of the clinical statement.
Verified 0 or more Provenance information specific to the verification process associated with this statement (e.g., verifier, when verified, etc.)

BreastCancerPresenceStatement [Entry]

Diagnosis of cancer originating in the tissues of the breast, and potentially spread to other organs of the body. The BreastCancerPresenceStatement is a subclass of ConditionPresenceStatement, which is a departure from CIMI. In CIMI, this would be a archetype of ClinicalStatement combining a BreastCancerConditionTopic with the ConditionPresenceContext. This would require definition of BreastCancerConditionTopic in the reference model, follwed by introduction of constraints on Value, Category, Stage, and MorphologyBehavior in the corresponding archetype. Neoplasm of breast (disorder) (126926005)

Based On ConditionPresenceStatement

MorphologyBehavior must be from MorphologyBehaviorVS
optional A description of the morphology and behavioral characteristics of the cancer.
SourceOfInformation must be a PatientOrPractitionerOrRelatedPerson
optional The person or entity that provided the information in the entry, e.g. the subject (patient), medical professional, family member, device or software program, as distinct from who recorded the entry.
StatementTopic must be a ConditionTopic
required Compositional and reusable grouping of clinical statement attributes that make up the clinical focus of a statement. StatementTopic class attributes are aligned with SNOMED CT Concept Model attributes when such an overlap exists. Note that this class does not include contextual attributes such as the nature of the action (ordered, proposed, planned, etc...), the nature of the patient state being described (e.g., present, suspected present, absent), and the attribution of this information (the who, when, where, how, why of the information recorded).
         where  ConditionTopic
StatementContext must be a ConditionPresenceContext
required Compositional and reusable grouping of clinical statement attributes that provides the context for the topic of a clinical statement. The StatementContext class aligns with the SNOMED CT Situations with Explicit Context (SWEC) Concept Model. The StatementContext provides the expressivity required to specify that an act was performed or not performed or that a finding was asserted to be present or absent for the given subject of information. It also often holds provenance information relevant to the context of the clinical statement. It is important to note that by default the context applies to the conjunction of the attribute specified in the statement. For instance, if a clinical statement has a topic describing a rash on left arm and a context of 'absent', then the statement states that the subject of interest did not have a rash on the left arm but might have had one on the right arm.
         where  ConditionPresenceContext
SubjectOfInformation must be a Patient
required The person or thing that this entry relates to, usually the Person of Record (see Entry). However, not all entries have health information specifically about the patient, but in different contexts, could refer to a fetus, family member (living or dead), device, location, organization, behavior, finding, condition, wound, or intervention. CIMI alignment: SubjectOfInformation is not a Participation -- unlike CIMI. There's no action to participate in. Participant has extra unnecessary attributes, such as 'onBehalfOf'.
Annotation 0 or more An added or follow-up note, often after the fact, that contains metadata about who made the statement and when.
RecordStatus optional Concept indicating the state of this record, e.g., 'entered in error'.
Recorded optional The person who entered the order on behalf of another individual for example in the case of a verbal or a telephone order.
Signed optional Provenance information specific to the signing of the clinical statement.
Cosigned 0 or more Provenance information specific to the cosigning of the clinical statement.
Verified 0 or more Provenance information specific to the verification process associated with this statement (e.g., verifier, when verified, etc.)

BreastCancerPrimaryTumorClassification

The size and extent of the primary tumor, based on criteria defined by the staging system being used. T category (78873005)

Based On CodedEvaluationComponent

Value:  CodeableConcept A set of codes drawn from different coding systems, representing the same concept.
StageSuffix optional A suffix used in conjuction with certain breast cancer stages, based on criteria defined by the staging system being used.
ComponentResultValue must be a CodeableConcept
optional The actual value of the component finding.
ReferenceRange not used The usual or acceptable range for a test result.
ExceptionValue optional Reason that a value associated with a test or other finding is missing.
Interpretation optional A clinical interpretation of a finding.

BreastCancerRegionalNodesClassification

The presence of metastases in regional lymph nodes, based on criteria defined by the staging system being used. N category (277206009)

Based On CodedEvaluationComponent

Value:  CodeableConcept A set of codes drawn from different coding systems, representing the same concept.
StageSuffix optional A suffix used in conjuction with certain breast cancer stages, based on criteria defined by the staging system being used.
ComponentResultValue must be a CodeableConcept
optional The actual value of the component finding.
ReferenceRange not used The usual or acceptable range for a test result.
ExceptionValue optional Reason that a value associated with a test or other finding is missing.
Interpretation optional A clinical interpretation of a finding.

BreastCancerStage [Entry]

The stage of a breast cancer. Different staging systems use different staging groups, so there are currently no terminology bindings associated with this class. Malignant Neoplasm of Breast Staging (C2216702)

Based On PanelRecorded

StageTimingPrefix optional Indicates when the staging was done, in terms of treatment landmarks.
StatementTopic must be a PanelTopic
required Compositional and reusable grouping of clinical statement attributes that make up the clinical focus of a statement. StatementTopic class attributes are aligned with SNOMED CT Concept Model attributes when such an overlap exists. Note that this class does not include contextual attributes such as the nature of the action (ordered, proposed, planned, etc...), the nature of the patient state being described (e.g., present, suspected present, absent), and the attribution of this information (the who, when, where, how, why of the information recorded).
         where  PanelTopic
         where  EvaluationResultTopic
DiagnosticService 0 or more A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.
StatementContext must be a EvaluationResultRecordedContext
required Compositional and reusable grouping of clinical statement attributes that provides the context for the topic of a clinical statement. The StatementContext class aligns with the SNOMED CT Situations with Explicit Context (SWEC) Concept Model. The StatementContext provides the expressivity required to specify that an act was performed or not performed or that a finding was asserted to be present or absent for the given subject of information. It also often holds provenance information relevant to the context of the clinical statement. It is important to note that by default the context applies to the conjunction of the attribute specified in the statement. For instance, if a clinical statement has a topic describing a rash on left arm and a context of 'absent', then the statement states that the subject of interest did not have a rash on the left arm but might have had one on the right arm.
         where  EvaluationResultRecordedContext
SubjectOfInformation required The person or thing that this entry relates to, usually the Person of Record (see Entry). However, not all entries have health information specifically about the patient, but in different contexts, could refer to a fetus, family member (living or dead), device, location, organization, behavior, finding, condition, wound, or intervention. CIMI alignment: SubjectOfInformation is not a Participation -- unlike CIMI. There's no action to participate in. Participant has extra unnecessary attributes, such as 'onBehalfOf'.
SourceOfInformation optional The person or entity that provided the information in the entry, e.g. the subject (patient), medical professional, family member, device or software program, as distinct from who recorded the entry.
Annotation 0 or more An added or follow-up note, often after the fact, that contains metadata about who made the statement and when.
RecordStatus optional Concept indicating the state of this record, e.g., 'entered in error'.
Recorded optional The person who entered the order on behalf of another individual for example in the case of a verbal or a telephone order.
Signed optional Provenance information specific to the signing of the clinical statement.
Cosigned 0 or more Provenance information specific to the cosigning of the clinical statement.
Verified 0 or more Provenance information specific to the verification process associated with this statement (e.g., verifier, when verified, etc.)

BreastSite [Entry]

A body site specific to the breast structure.

Based On AnatomicalLocation

Value:  CodeableConcept must be from BreastSiteVS
A set of codes drawn from different coding systems, representing the same concept.
ClockDirection optional A direction indicated by an angle relative to 12 o'clock.
DistanceFromBreastSiteToNipple optional Distance between the feature of interest (e.g., the tumor) and the nipple.
AnatomicalDirection not used Anatomical location or specimen further detailing directionality.
Laterality optional Anatomical location or specimen further detailing the side(s) of interest.

BreastSpecimen [Entry]

Specimen resulting from biopsy or excision of breast and surrounding tissue.

Based On Specimen

Type must be from BreastSpecimenTypeVS
required The most specific code (lowest level term) describing the kind or sort of thing being represented.
CollectionSite must be a BreastSite
optional The body site where specimen was collected
CollectionMethod must be from BreastSpecimenCollectionMethodVS
optional How the specimen was obtained.
SourceSpecimen must be a BreastSpecimen
optional Identifier for the source specimen from which this specimen was derived.
ColdIschemiaTime optional The time period between the chilling of a tissue or tissue sample and the time it is warmed. CIMI Alignment: In CIMI Version 0.0.4, specimen processing is represented as a 'SpecimenProcessingPerformed' clinical statement, mapped to FHIR Procedure. However, specimen processing should actually map to Specimen.processing, part of the Specimen resource. It would be a difficult mapping exercise (beyond the scope of this IG) to express the mapping rule that any CIMI SpecimenProcessingPerformed clinical statement needs to mapped to FHIR by (1) finding the corresponding Specimen entity, and (2) mapping the content of (possibly multiple) SpecimenProcessingPerformed into the FHIR Specimen resource. To avoid this complexity, the breast cancer model expresses the cold ischemia time as an attribute of the BreastSpecimen rather than a separate procedure.
AccessionIdentifier optional Identifier assigned by the lab
SpecimenStatus must be from http://hl7.org/fhir/ValueSet/specimen-status
optional State of the specimen, such as obtained, processed, used.
SubjectOfInformation must be a Patient
required The person or thing that this entry relates to, usually the Person of Record (see Entry). However, not all entries have health information specifically about the patient, but in different contexts, could refer to a fetus, family member (living or dead), device, location, organization, behavior, finding, condition, wound, or intervention. CIMI alignment: SubjectOfInformation is not a Participation -- unlike CIMI. There's no action to participate in. Participant has extra unnecessary attributes, such as 'onBehalfOf'.
ReceivedTime optional Time the item was delivered to, or accepted by, the receiving facility or unit.
CollectionTime optional When the sample was obtained, as a specific time or time period.
SpecimenContainer 0 or more Direct container of specimen (tube/slide, etc.)
SpecimenTreatment 0 or more Treatment performed on the specimen.
HandlingRisk 0 or more Cautions on the handling of this specimen.
SpecialHandling 0 or more Information about the proper handling of the specimen.

ColdIschemiaTime

The time period between the chilling of a tissue or tissue sample and the time it is warmed. CIMI Alignment: In CIMI Version 0.0.4, specimen processing is represented as a 'SpecimenProcessingPerformed' clinical statement, mapped to FHIR Procedure. However, specimen processing should actually map to Specimen.processing, part of the Specimen resource. It would be a difficult mapping exercise (beyond the scope of this IG) to express the mapping rule that any CIMI SpecimenProcessingPerformed clinical statement needs to mapped to FHIR by (1) finding the corresponding Specimen entity, and (2) mapping the content of (possibly multiple) SpecimenProcessingPerformed into the FHIR Specimen resource. To avoid this complexity, the breast cancer model expresses the cold ischemia time as an attribute of the BreastSpecimen rather than a separate procedure. 44778-9

Value:  TimePeriod A period of time defined by a start and end time, date, or year. If the start element is missing, the start of the period is not known. If the end element is missing, it means that the period is ongoing, or the start may be in the past, and the end date in the future, which means that period is expected/planned to end at the specified time. The end value includes any matching date/time. For example, the period 2011-05-23 to 2011-05-27 includes all the times from the start of the 23rd May through to the end of the 27th of May.

CompleteMembraneStainingPercent

Percentage of cells with uniform intense complete membrane staining. Cells.HER2 uniform intense membrane staining/100 cells (85328-3)

Based On EvaluationComponent

Value:  Quantity Units is %
A quantity with units, whose value may be bounded from above or below, as defined in FHIR
ReferenceRange not used The usual or acceptable range for a test result.
ComponentResultValue optional The actual value of the component finding.
ExceptionValue optional Reason that a value associated with a test or other finding is missing.
Interpretation optional A clinical interpretation of a finding.

DCISNuclearGrade [Entry]

An evaluation of the size and shape of the nucleus in tumor cells and the percentage of tumor cells that are in the process of dividing or growing. Cancers with low nuclear grade grow and spread less quickly than cancers with high nuclear grade. C18513

Based On SimplifiedLaboratoryTestResultRecorded

PanelMembers not used PanelMember represent the elements of a group of a related but independent evaluations. Examples are the measurements that compose a complete blood count (CBC), or the elements of a pathology report. Each member is an independent evaluation, but the grouping reflects a composite lab order, shared specimen, or a single report author. Typically the Category and Reason are not given for individual findings that are part of the panel, but rather given at the level of the panel itself.
DiagnosticService 0 or more A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.
StatementTopic must be a EvaluationResultTopic
required Compositional and reusable grouping of clinical statement attributes that make up the clinical focus of a statement. StatementTopic class attributes are aligned with SNOMED CT Concept Model attributes when such an overlap exists. Note that this class does not include contextual attributes such as the nature of the action (ordered, proposed, planned, etc...), the nature of the patient state being described (e.g., present, suspected present, absent), and the attribution of this information (the who, when, where, how, why of the information recorded).
         where  EvaluationResultTopic
StatementContext must be a EvaluationResultRecordedContext
required Compositional and reusable grouping of clinical statement attributes that provides the context for the topic of a clinical statement. The StatementContext class aligns with the SNOMED CT Situations with Explicit Context (SWEC) Concept Model. The StatementContext provides the expressivity required to specify that an act was performed or not performed or that a finding was asserted to be present or absent for the given subject of information. It also often holds provenance information relevant to the context of the clinical statement. It is important to note that by default the context applies to the conjunction of the attribute specified in the statement. For instance, if a clinical statement has a topic describing a rash on left arm and a context of 'absent', then the statement states that the subject of interest did not have a rash on the left arm but might have had one on the right arm.
         where  EvaluationResultRecordedContext
SubjectOfInformation required The person or thing that this entry relates to, usually the Person of Record (see Entry). However, not all entries have health information specifically about the patient, but in different contexts, could refer to a fetus, family member (living or dead), device, location, organization, behavior, finding, condition, wound, or intervention. CIMI alignment: SubjectOfInformation is not a Participation -- unlike CIMI. There's no action to participate in. Participant has extra unnecessary attributes, such as 'onBehalfOf'.
SourceOfInformation optional The person or entity that provided the information in the entry, e.g. the subject (patient), medical professional, family member, device or software program, as distinct from who recorded the entry.
Annotation 0 or more An added or follow-up note, often after the fact, that contains metadata about who made the statement and when.
RecordStatus optional Concept indicating the state of this record, e.g., 'entered in error'.
Recorded optional The person who entered the order on behalf of another individual for example in the case of a verbal or a telephone order.
Signed optional Provenance information specific to the signing of the clinical statement.
Cosigned 0 or more Provenance information specific to the cosigning of the clinical statement.
Verified 0 or more Provenance information specific to the verification process associated with this statement (e.g., verifier, when verified, etc.)

DistanceFromBreastSiteToNipple

Distance between the feature of interest (e.g., the tumor) and the nipple.

Value:  Quantity Units is cm
A quantity with units, whose value may be bounded from above or below, as defined in FHIR

EstrogenReceptorStatus [Entry]

Estrogen receptor alpha is the predominant estrogen receptor expressed in breast tissue and is overexpressed in around 50% of breast carcinomas. ER status (positive=present or overexpressed; negative=absent) is a factor in determining prognosis and treatment options. We are seeking feedback if it is better to put the positive/negative status in Value or Interpretation. The current approach is that positive/negative designation is a value, even though that value is (in fact) an interpretation of evidence (NuclearPositivity and AverageStainingIntensity). Estrogen receptor [Interpretation] in Tissue (16112-5)

Based On SimplifiedLaboratoryTestResultRecorded

DiagnosticService is pathology
0 or more A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.
PanelMembers not used PanelMember represent the elements of a group of a related but independent evaluations. Examples are the measurements that compose a complete blood count (CBC), or the elements of a pathology report. Each member is an independent evaluation, but the grouping reflects a composite lab order, shared specimen, or a single report author. Typically the Category and Reason are not given for individual findings that are part of the panel, but rather given at the level of the panel itself.
StatementTopic must be a EvaluationResultTopic
required Compositional and reusable grouping of clinical statement attributes that make up the clinical focus of a statement. StatementTopic class attributes are aligned with SNOMED CT Concept Model attributes when such an overlap exists. Note that this class does not include contextual attributes such as the nature of the action (ordered, proposed, planned, etc...), the nature of the patient state being described (e.g., present, suspected present, absent), and the attribution of this information (the who, when, where, how, why of the information recorded).
         where  EvaluationResultTopic
StatementContext must be a EvaluationResultRecordedContext
required Compositional and reusable grouping of clinical statement attributes that provides the context for the topic of a clinical statement. The StatementContext class aligns with the SNOMED CT Situations with Explicit Context (SWEC) Concept Model. The StatementContext provides the expressivity required to specify that an act was performed or not performed or that a finding was asserted to be present or absent for the given subject of information. It also often holds provenance information relevant to the context of the clinical statement. It is important to note that by default the context applies to the conjunction of the attribute specified in the statement. For instance, if a clinical statement has a topic describing a rash on left arm and a context of 'absent', then the statement states that the subject of interest did not have a rash on the left arm but might have had one on the right arm.
         where  EvaluationResultRecordedContext
SubjectOfInformation required The person or thing that this entry relates to, usually the Person of Record (see Entry). However, not all entries have health information specifically about the patient, but in different contexts, could refer to a fetus, family member (living or dead), device, location, organization, behavior, finding, condition, wound, or intervention. CIMI alignment: SubjectOfInformation is not a Participation -- unlike CIMI. There's no action to participate in. Participant has extra unnecessary attributes, such as 'onBehalfOf'.
SourceOfInformation optional The person or entity that provided the information in the entry, e.g. the subject (patient), medical professional, family member, device or software program, as distinct from who recorded the entry.
Annotation 0 or more An added or follow-up note, often after the fact, that contains metadata about who made the statement and when.
RecordStatus optional Concept indicating the state of this record, e.g., 'entered in error'.
Recorded optional The person who entered the order on behalf of another individual for example in the case of a verbal or a telephone order.
Signed optional Provenance information specific to the signing of the clinical statement.
Cosigned 0 or more Provenance information specific to the cosigning of the clinical statement.
Verified 0 or more Provenance information specific to the verification process associated with this statement (e.g., verifier, when verified, etc.)

HER2byIHC [Entry]

HER2 receptor status as determined by Immunohistochemistry (IHC). 72383-3

Based On LaboratoryTestResultRecorded

DiagnosticService is pathology
0 or more A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.
StatementTopic must be a EvaluationResultTopic
required Compositional and reusable grouping of clinical statement attributes that make up the clinical focus of a statement. StatementTopic class attributes are aligned with SNOMED CT Concept Model attributes when such an overlap exists. Note that this class does not include contextual attributes such as the nature of the action (ordered, proposed, planned, etc...), the nature of the patient state being described (e.g., present, suspected present, absent), and the attribution of this information (the who, when, where, how, why of the information recorded).
         where  EvaluationResultTopic
StatementContext must be a EvaluationResultRecordedContext
required Compositional and reusable grouping of clinical statement attributes that provides the context for the topic of a clinical statement. The StatementContext class aligns with the SNOMED CT Situations with Explicit Context (SWEC) Concept Model. The StatementContext provides the expressivity required to specify that an act was performed or not performed or that a finding was asserted to be present or absent for the given subject of information. It also often holds provenance information relevant to the context of the clinical statement. It is important to note that by default the context applies to the conjunction of the attribute specified in the statement. For instance, if a clinical statement has a topic describing a rash on left arm and a context of 'absent', then the statement states that the subject of interest did not have a rash on the left arm but might have had one on the right arm.
         where  EvaluationResultRecordedContext
SubjectOfInformation required The person or thing that this entry relates to, usually the Person of Record (see Entry). However, not all entries have health information specifically about the patient, but in different contexts, could refer to a fetus, family member (living or dead), device, location, organization, behavior, finding, condition, wound, or intervention. CIMI alignment: SubjectOfInformation is not a Participation -- unlike CIMI. There's no action to participate in. Participant has extra unnecessary attributes, such as 'onBehalfOf'.
SourceOfInformation optional The person or entity that provided the information in the entry, e.g. the subject (patient), medical professional, family member, device or software program, as distinct from who recorded the entry.
Annotation 0 or more An added or follow-up note, often after the fact, that contains metadata about who made the statement and when.
RecordStatus optional Concept indicating the state of this record, e.g., 'entered in error'.
Recorded optional The person who entered the order on behalf of another individual for example in the case of a verbal or a telephone order.
Signed optional Provenance information specific to the signing of the clinical statement.
Cosigned 0 or more Provenance information specific to the cosigning of the clinical statement.
Verified 0 or more Provenance information specific to the verification process associated with this statement (e.g., verifier, when verified, etc.)

HER2byISH [Entry]

HER2 receptor status as determined by In Situ Hybridization (ISH). 85318-4

Based On LaboratoryTestResultRecorded

DiagnosticService is pathology
0 or more A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.
StatementTopic must be a EvaluationResultTopic
required Compositional and reusable grouping of clinical statement attributes that make up the clinical focus of a statement. StatementTopic class attributes are aligned with SNOMED CT Concept Model attributes when such an overlap exists. Note that this class does not include contextual attributes such as the nature of the action (ordered, proposed, planned, etc...), the nature of the patient state being described (e.g., present, suspected present, absent), and the attribution of this information (the who, when, where, how, why of the information recorded).
         where  EvaluationResultTopic
StatementContext must be a EvaluationResultRecordedContext
required Compositional and reusable grouping of clinical statement attributes that provides the context for the topic of a clinical statement. The StatementContext class aligns with the SNOMED CT Situations with Explicit Context (SWEC) Concept Model. The StatementContext provides the expressivity required to specify that an act was performed or not performed or that a finding was asserted to be present or absent for the given subject of information. It also often holds provenance information relevant to the context of the clinical statement. It is important to note that by default the context applies to the conjunction of the attribute specified in the statement. For instance, if a clinical statement has a topic describing a rash on left arm and a context of 'absent', then the statement states that the subject of interest did not have a rash on the left arm but might have had one on the right arm.
         where  EvaluationResultRecordedContext
SubjectOfInformation required The person or thing that this entry relates to, usually the Person of Record (see Entry). However, not all entries have health information specifically about the patient, but in different contexts, could refer to a fetus, family member (living or dead), device, location, organization, behavior, finding, condition, wound, or intervention. CIMI alignment: SubjectOfInformation is not a Participation -- unlike CIMI. There's no action to participate in. Participant has extra unnecessary attributes, such as 'onBehalfOf'.
SourceOfInformation optional The person or entity that provided the information in the entry, e.g. the subject (patient), medical professional, family member, device or software program, as distinct from who recorded the entry.
Annotation 0 or more An added or follow-up note, often after the fact, that contains metadata about who made the statement and when.
RecordStatus optional Concept indicating the state of this record, e.g., 'entered in error'.
Recorded optional The person who entered the order on behalf of another individual for example in the case of a verbal or a telephone order.
Signed optional Provenance information specific to the signing of the clinical statement.
Cosigned 0 or more Provenance information specific to the cosigning of the clinical statement.
Verified 0 or more Provenance information specific to the verification process associated with this statement (e.g., verifier, when verified, etc.)

HER2ReceptorStatus [Entry]

HER2 receptor status. HER2 is a member of the human epidermal growth factor receptor family of proteins and is encoded by the ERBB2 oncogene. HER2 is overexpressed in 20-30% of breast tumors, and is associated with an aggressive clinical course and poor prognosis. HER2 status (positive=present or overexpressed; negative=absent) is a factor in determining prognosis and treatment options. We are seeking feedback if it is better to put the positive/negative status in Value or Interpretation. The current approach is that positive/negative designation is a value, even though that value is (in fact) an interpretation of evidence from HER2 by IHC and/or HER2 by ISH tests, not a direct observation. HER2 [Interpretation] in Tissue (48676-1)

Based On PanelRecorded

DiagnosticService is pathology
0 or more A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.
StatementTopic must be a PanelTopic
required Compositional and reusable grouping of clinical statement attributes that make up the clinical focus of a statement. StatementTopic class attributes are aligned with SNOMED CT Concept Model attributes when such an overlap exists. Note that this class does not include contextual attributes such as the nature of the action (ordered, proposed, planned, etc...), the nature of the patient state being described (e.g., present, suspected present, absent), and the attribution of this information (the who, when, where, how, why of the information recorded).
         where  PanelTopic
         where  EvaluationResultTopic
StatementContext must be a EvaluationResultRecordedContext
required Compositional and reusable grouping of clinical statement attributes that provides the context for the topic of a clinical statement. The StatementContext class aligns with the SNOMED CT Situations with Explicit Context (SWEC) Concept Model. The StatementContext provides the expressivity required to specify that an act was performed or not performed or that a finding was asserted to be present or absent for the given subject of information. It also often holds provenance information relevant to the context of the clinical statement. It is important to note that by default the context applies to the conjunction of the attribute specified in the statement. For instance, if a clinical statement has a topic describing a rash on left arm and a context of 'absent', then the statement states that the subject of interest did not have a rash on the left arm but might have had one on the right arm.
         where  EvaluationResultRecordedContext
SubjectOfInformation required The person or thing that this entry relates to, usually the Person of Record (see Entry). However, not all entries have health information specifically about the patient, but in different contexts, could refer to a fetus, family member (living or dead), device, location, organization, behavior, finding, condition, wound, or intervention. CIMI alignment: SubjectOfInformation is not a Participation -- unlike CIMI. There's no action to participate in. Participant has extra unnecessary attributes, such as 'onBehalfOf'.
SourceOfInformation optional The person or entity that provided the information in the entry, e.g. the subject (patient), medical professional, family member, device or software program, as distinct from who recorded the entry.
Annotation 0 or more An added or follow-up note, often after the fact, that contains metadata about who made the statement and when.
RecordStatus optional Concept indicating the state of this record, e.g., 'entered in error'.
Recorded optional The person who entered the order on behalf of another individual for example in the case of a verbal or a telephone order.
Signed optional Provenance information specific to the signing of the clinical statement.
Cosigned 0 or more Provenance information specific to the cosigning of the clinical statement.
Verified 0 or more Provenance information specific to the verification process associated with this statement (e.g., verifier, when verified, etc.)

HER2toCEP17Ratio

HER2 to CEP17 Ratio (dual probe only) 49683-6

Based On EvaluationComponent

Value:  Quantity A quantity with units, whose value may be bounded from above or below, as defined in FHIR
ReferenceRange not used The usual or acceptable range for a test result.
ComponentResultValue optional The actual value of the component finding.
ExceptionValue optional Reason that a value associated with a test or other finding is missing.
Interpretation optional A clinical interpretation of a finding.

MammaprintRecurrenceScore [Entry]

Breast cancer genomic signature assay for 10-year risk of distant recurrence score calculated by Mammaprint. In the United States, MammaPrint can only be used on cancers that are stage I or stage II, invasive, smaller than 5 centimeters, and estrogen-receptor-positive or -negative. Scores range from -1.0 to +1.0, with scores less than 0 indicating high risk, and scores greater than 0 indicating low risk. The is currently no LOINC code for Mammaprint test. C2827401

Based On SimplifiedLaboratoryTestResultRecorded

DiagnosticService is pathology
0 or more A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.
PanelMembers not used PanelMember represent the elements of a group of a related but independent evaluations. Examples are the measurements that compose a complete blood count (CBC), or the elements of a pathology report. Each member is an independent evaluation, but the grouping reflects a composite lab order, shared specimen, or a single report author. Typically the Category and Reason are not given for individual findings that are part of the panel, but rather given at the level of the panel itself.
StatementTopic must be a EvaluationResultTopic
required Compositional and reusable grouping of clinical statement attributes that make up the clinical focus of a statement. StatementTopic class attributes are aligned with SNOMED CT Concept Model attributes when such an overlap exists. Note that this class does not include contextual attributes such as the nature of the action (ordered, proposed, planned, etc...), the nature of the patient state being described (e.g., present, suspected present, absent), and the attribution of this information (the who, when, where, how, why of the information recorded).
         where  EvaluationResultTopic
StatementContext must be a EvaluationResultRecordedContext
required Compositional and reusable grouping of clinical statement attributes that provides the context for the topic of a clinical statement. The StatementContext class aligns with the SNOMED CT Situations with Explicit Context (SWEC) Concept Model. The StatementContext provides the expressivity required to specify that an act was performed or not performed or that a finding was asserted to be present or absent for the given subject of information. It also often holds provenance information relevant to the context of the clinical statement. It is important to note that by default the context applies to the conjunction of the attribute specified in the statement. For instance, if a clinical statement has a topic describing a rash on left arm and a context of 'absent', then the statement states that the subject of interest did not have a rash on the left arm but might have had one on the right arm.
         where  EvaluationResultRecordedContext
SubjectOfInformation required The person or thing that this entry relates to, usually the Person of Record (see Entry). However, not all entries have health information specifically about the patient, but in different contexts, could refer to a fetus, family member (living or dead), device, location, organization, behavior, finding, condition, wound, or intervention. CIMI alignment: SubjectOfInformation is not a Participation -- unlike CIMI. There's no action to participate in. Participant has extra unnecessary attributes, such as 'onBehalfOf'.
SourceOfInformation optional The person or entity that provided the information in the entry, e.g. the subject (patient), medical professional, family member, device or software program, as distinct from who recorded the entry.
Annotation 0 or more An added or follow-up note, often after the fact, that contains metadata about who made the statement and when.
RecordStatus optional Concept indicating the state of this record, e.g., 'entered in error'.
Recorded optional The person who entered the order on behalf of another individual for example in the case of a verbal or a telephone order.
Signed optional Provenance information specific to the signing of the clinical statement.
Cosigned 0 or more Provenance information specific to the cosigning of the clinical statement.
Verified 0 or more Provenance information specific to the verification process associated with this statement (e.g., verifier, when verified, etc.)

MitoticCountScore

How fast the tumor cells are growing and dividing, determined from the number of mitotic cells present. Scored 1 to 3, with 3 being the most mitotic cells. We are seeking feedback on the value of representing the mitotic rate as a value rather than coded ranges. 85300-2

Based On CodedEvaluationComponent

Value:  CodeableConcept must be from MitoticCountScoreVS
A set of codes drawn from different coding systems, representing the same concept.
ExceptionValue must be from NottinghamNullVS
optional Reason that a value associated with a test or other finding is missing.
ComponentResultValue must be a CodeableConcept
optional The actual value of the component finding.
ReferenceRange not used The usual or acceptable range for a test result.
Interpretation optional A clinical interpretation of a finding.

MorphologyBehavior

A description of the morphology and behavioral characteristics of the cancer.

Value:  CodeableConcept A set of codes drawn from different coding systems, representing the same concept.

NuclearPleomorphismScore

How large and varied the nuclei of the tumor cells are. Scored 1 to 3, with 3 being the most pleomorphism. 44645-0

Based On CodedEvaluationComponent

Value:  CodeableConcept must be from NuclearPleomorphismScoreVS
A set of codes drawn from different coding systems, representing the same concept.
ExceptionValue must be from NottinghamNullVS
optional Reason that a value associated with a test or other finding is missing.
ComponentResultValue must be a CodeableConcept
optional The actual value of the component finding.
ReferenceRange not used The usual or acceptable range for a test result.
Interpretation optional A clinical interpretation of a finding.

NuclearPositivity

The percentage of cells that test (stain) positive for the presence of a receptor. We are seeking feedback on whether nuclear positivity should be an exact percentage or a range of percentages. As currently defined, an exact nuclear positivity could be represented by a zero-width range, where the lower and upper bounds would be the same number.

Based On EvaluationComponent

Value:  PercentageRange A range of percentage values.
ReferenceRange not used The usual or acceptable range for a test result.
ComponentResultValue optional The actual value of the component finding.
ExceptionValue optional Reason that a value associated with a test or other finding is missing.
Interpretation optional A clinical interpretation of a finding.

OncotypeDxDCISRecurrenceScore [Entry]

The Oncotype DX test for DCIS (Ductal Carcinoma in Situ) breast cancer. Risk scores range from 0 to 100 with the following interpretations: 0-38: Low-Risk, 39-54: Intermediate-Risk, 55+: High-Risk. No LOINC code currently exists for this test. We are seeking feedback on the value of separating OncotypeDx scores for DCIS and invasive breast carcinomas. Does it make more sense to report the OncotypeDx as a single score, regardless of the type of cancer? C3898101

Based On SimplifiedLaboratoryTestResultRecorded

DiagnosticService is pathology
0 or more A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.
PanelMembers not used PanelMember represent the elements of a group of a related but independent evaluations. Examples are the measurements that compose a complete blood count (CBC), or the elements of a pathology report. Each member is an independent evaluation, but the grouping reflects a composite lab order, shared specimen, or a single report author. Typically the Category and Reason are not given for individual findings that are part of the panel, but rather given at the level of the panel itself.
StatementTopic must be a EvaluationResultTopic
required Compositional and reusable grouping of clinical statement attributes that make up the clinical focus of a statement. StatementTopic class attributes are aligned with SNOMED CT Concept Model attributes when such an overlap exists. Note that this class does not include contextual attributes such as the nature of the action (ordered, proposed, planned, etc...), the nature of the patient state being described (e.g., present, suspected present, absent), and the attribution of this information (the who, when, where, how, why of the information recorded).
         where  EvaluationResultTopic
StatementContext must be a EvaluationResultRecordedContext
required Compositional and reusable grouping of clinical statement attributes that provides the context for the topic of a clinical statement. The StatementContext class aligns with the SNOMED CT Situations with Explicit Context (SWEC) Concept Model. The StatementContext provides the expressivity required to specify that an act was performed or not performed or that a finding was asserted to be present or absent for the given subject of information. It also often holds provenance information relevant to the context of the clinical statement. It is important to note that by default the context applies to the conjunction of the attribute specified in the statement. For instance, if a clinical statement has a topic describing a rash on left arm and a context of 'absent', then the statement states that the subject of interest did not have a rash on the left arm but might have had one on the right arm.
         where  EvaluationResultRecordedContext
SubjectOfInformation required The person or thing that this entry relates to, usually the Person of Record (see Entry). However, not all entries have health information specifically about the patient, but in different contexts, could refer to a fetus, family member (living or dead), device, location, organization, behavior, finding, condition, wound, or intervention. CIMI alignment: SubjectOfInformation is not a Participation -- unlike CIMI. There's no action to participate in. Participant has extra unnecessary attributes, such as 'onBehalfOf'.
SourceOfInformation optional The person or entity that provided the information in the entry, e.g. the subject (patient), medical professional, family member, device or software program, as distinct from who recorded the entry.
Annotation 0 or more An added or follow-up note, often after the fact, that contains metadata about who made the statement and when.
RecordStatus optional Concept indicating the state of this record, e.g., 'entered in error'.
Recorded optional The person who entered the order on behalf of another individual for example in the case of a verbal or a telephone order.
Signed optional Provenance information specific to the signing of the clinical statement.
Cosigned 0 or more Provenance information specific to the cosigning of the clinical statement.
Verified 0 or more Provenance information specific to the verification process associated with this statement (e.g., verifier, when verified, etc.)

OncotypeDxInvasiveRecurrenceScore [Entry]

The Oncotype DX test for invasive breast cancer examines the activity of 21 genes in a patient’s breast tumor tissue to provide personalized information for tailoring treatment based on the biology of their individual disease. The value from 0 to 100 indicates the estimated risk of recurrence, with the highest risk indicated by a score greater than 31. No LOINC code currently exists for this test. We are seeking feedback on the value of separating OncotypeDx scores for DCIS and invasive breast carcinomas. Does it make more sense to report the OncotypeDx as a single score, regardless of the type of cancer? C1709318

Based On SimplifiedLaboratoryTestResultRecorded

DiagnosticService is pathology
0 or more A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.
PanelMembers not used PanelMember represent the elements of a group of a related but independent evaluations. Examples are the measurements that compose a complete blood count (CBC), or the elements of a pathology report. Each member is an independent evaluation, but the grouping reflects a composite lab order, shared specimen, or a single report author. Typically the Category and Reason are not given for individual findings that are part of the panel, but rather given at the level of the panel itself.
StatementTopic must be a EvaluationResultTopic
required Compositional and reusable grouping of clinical statement attributes that make up the clinical focus of a statement. StatementTopic class attributes are aligned with SNOMED CT Concept Model attributes when such an overlap exists. Note that this class does not include contextual attributes such as the nature of the action (ordered, proposed, planned, etc...), the nature of the patient state being described (e.g., present, suspected present, absent), and the attribution of this information (the who, when, where, how, why of the information recorded).
         where  EvaluationResultTopic
StatementContext must be a EvaluationResultRecordedContext
required Compositional and reusable grouping of clinical statement attributes that provides the context for the topic of a clinical statement. The StatementContext class aligns with the SNOMED CT Situations with Explicit Context (SWEC) Concept Model. The StatementContext provides the expressivity required to specify that an act was performed or not performed or that a finding was asserted to be present or absent for the given subject of information. It also often holds provenance information relevant to the context of the clinical statement. It is important to note that by default the context applies to the conjunction of the attribute specified in the statement. For instance, if a clinical statement has a topic describing a rash on left arm and a context of 'absent', then the statement states that the subject of interest did not have a rash on the left arm but might have had one on the right arm.
         where  EvaluationResultRecordedContext
SubjectOfInformation required The person or thing that this entry relates to, usually the Person of Record (see Entry). However, not all entries have health information specifically about the patient, but in different contexts, could refer to a fetus, family member (living or dead), device, location, organization, behavior, finding, condition, wound, or intervention. CIMI alignment: SubjectOfInformation is not a Participation -- unlike CIMI. There's no action to participate in. Participant has extra unnecessary attributes, such as 'onBehalfOf'.
SourceOfInformation optional The person or entity that provided the information in the entry, e.g. the subject (patient), medical professional, family member, device or software program, as distinct from who recorded the entry.
Annotation 0 or more An added or follow-up note, often after the fact, that contains metadata about who made the statement and when.
RecordStatus optional Concept indicating the state of this record, e.g., 'entered in error'.
Recorded optional The person who entered the order on behalf of another individual for example in the case of a verbal or a telephone order.
Signed optional Provenance information specific to the signing of the clinical statement.
Cosigned 0 or more Provenance information specific to the cosigning of the clinical statement.
Verified 0 or more Provenance information specific to the verification process associated with this statement (e.g., verifier, when verified, etc.)

ProgesteroneReceptorStatus [Entry]

Progesterone receptor status is a factor in determining prognosis and treatment options. The value is the percentage of cells that test (stain) positive for the presence of a receptor. The interpretation of positive or negative (found in the interpretation property) is based on the staining percentage, and may take into account the staining intensity. Based on discussion with Cancer Interoperability Group subject matter experts, there was insufficient rationale to include the following components in the data model: StainingControl, PrimaryAntibody, Allred Score (both total and component scores). We are seeking feedback on whether or not those components should be included in this model. We are seeking feedback if it is better to put the positive/negative status in Value or Interpretation. The current approach is that positive/negative designation is a value, even though that value is (in fact) an interpretation of evidence (NuclearPositivity and AverageStainingIntensity). 16113-3

Based On SimplifiedLaboratoryTestResultRecorded

DiagnosticService is pathology
0 or more A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.
PanelMembers not used PanelMember represent the elements of a group of a related but independent evaluations. Examples are the measurements that compose a complete blood count (CBC), or the elements of a pathology report. Each member is an independent evaluation, but the grouping reflects a composite lab order, shared specimen, or a single report author. Typically the Category and Reason are not given for individual findings that are part of the panel, but rather given at the level of the panel itself.
StatementTopic must be a EvaluationResultTopic
required Compositional and reusable grouping of clinical statement attributes that make up the clinical focus of a statement. StatementTopic class attributes are aligned with SNOMED CT Concept Model attributes when such an overlap exists. Note that this class does not include contextual attributes such as the nature of the action (ordered, proposed, planned, etc...), the nature of the patient state being described (e.g., present, suspected present, absent), and the attribution of this information (the who, when, where, how, why of the information recorded).
         where  EvaluationResultTopic
StatementContext must be a EvaluationResultRecordedContext
required Compositional and reusable grouping of clinical statement attributes that provides the context for the topic of a clinical statement. The StatementContext class aligns with the SNOMED CT Situations with Explicit Context (SWEC) Concept Model. The StatementContext provides the expressivity required to specify that an act was performed or not performed or that a finding was asserted to be present or absent for the given subject of information. It also often holds provenance information relevant to the context of the clinical statement. It is important to note that by default the context applies to the conjunction of the attribute specified in the statement. For instance, if a clinical statement has a topic describing a rash on left arm and a context of 'absent', then the statement states that the subject of interest did not have a rash on the left arm but might have had one on the right arm.
         where  EvaluationResultRecordedContext
SubjectOfInformation required The person or thing that this entry relates to, usually the Person of Record (see Entry). However, not all entries have health information specifically about the patient, but in different contexts, could refer to a fetus, family member (living or dead), device, location, organization, behavior, finding, condition, wound, or intervention. CIMI alignment: SubjectOfInformation is not a Participation -- unlike CIMI. There's no action to participate in. Participant has extra unnecessary attributes, such as 'onBehalfOf'.
SourceOfInformation optional The person or entity that provided the information in the entry, e.g. the subject (patient), medical professional, family member, device or software program, as distinct from who recorded the entry.
Annotation 0 or more An added or follow-up note, often after the fact, that contains metadata about who made the statement and when.
RecordStatus optional Concept indicating the state of this record, e.g., 'entered in error'.
Recorded optional The person who entered the order on behalf of another individual for example in the case of a verbal or a telephone order.
Signed optional Provenance information specific to the signing of the clinical statement.
Cosigned 0 or more Provenance information specific to the cosigning of the clinical statement.
Verified 0 or more Provenance information specific to the verification process associated with this statement (e.g., verifier, when verified, etc.)

ProsignaRecurrenceScore [Entry]

Breast cancer genomic signature assay for 10-year risk of distant recurrence score calculated by Prosigna. The Prosigna Score is reported on a 0 -100 scale (referred to as ROR Score or Risk of Recurrence Score in the literature), which is correlated with the probability of distant recurrence at ten years for post-menopausal women with hormone receptor positive, early stage breast cancer. 76544-6

Based On SimplifiedLaboratoryTestResultRecorded

DiagnosticService is pathology
0 or more A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.
PanelMembers not used PanelMember represent the elements of a group of a related but independent evaluations. Examples are the measurements that compose a complete blood count (CBC), or the elements of a pathology report. Each member is an independent evaluation, but the grouping reflects a composite lab order, shared specimen, or a single report author. Typically the Category and Reason are not given for individual findings that are part of the panel, but rather given at the level of the panel itself.
StatementTopic must be a EvaluationResultTopic
required Compositional and reusable grouping of clinical statement attributes that make up the clinical focus of a statement. StatementTopic class attributes are aligned with SNOMED CT Concept Model attributes when such an overlap exists. Note that this class does not include contextual attributes such as the nature of the action (ordered, proposed, planned, etc...), the nature of the patient state being described (e.g., present, suspected present, absent), and the attribution of this information (the who, when, where, how, why of the information recorded).
         where  EvaluationResultTopic
StatementContext must be a EvaluationResultRecordedContext
required Compositional and reusable grouping of clinical statement attributes that provides the context for the topic of a clinical statement. The StatementContext class aligns with the SNOMED CT Situations with Explicit Context (SWEC) Concept Model. The StatementContext provides the expressivity required to specify that an act was performed or not performed or that a finding was asserted to be present or absent for the given subject of information. It also often holds provenance information relevant to the context of the clinical statement. It is important to note that by default the context applies to the conjunction of the attribute specified in the statement. For instance, if a clinical statement has a topic describing a rash on left arm and a context of 'absent', then the statement states that the subject of interest did not have a rash on the left arm but might have had one on the right arm.
         where  EvaluationResultRecordedContext
SubjectOfInformation required The person or thing that this entry relates to, usually the Person of Record (see Entry). However, not all entries have health information specifically about the patient, but in different contexts, could refer to a fetus, family member (living or dead), device, location, organization, behavior, finding, condition, wound, or intervention. CIMI alignment: SubjectOfInformation is not a Participation -- unlike CIMI. There's no action to participate in. Participant has extra unnecessary attributes, such as 'onBehalfOf'.
SourceOfInformation optional The person or entity that provided the information in the entry, e.g. the subject (patient), medical professional, family member, device or software program, as distinct from who recorded the entry.
Annotation 0 or more An added or follow-up note, often after the fact, that contains metadata about who made the statement and when.
RecordStatus optional Concept indicating the state of this record, e.g., 'entered in error'.
Recorded optional The person who entered the order on behalf of another individual for example in the case of a verbal or a telephone order.
Signed optional Provenance information specific to the signing of the clinical statement.
Cosigned 0 or more Provenance information specific to the cosigning of the clinical statement.
Verified 0 or more Provenance information specific to the verification process associated with this statement (e.g., verifier, when verified, etc.)

StageSuffix

A suffix used in conjuction with certain breast cancer stages, based on criteria defined by the staging system being used.

Value:  CodeableConcept A set of codes drawn from different coding systems, representing the same concept.

StageTimingPrefix

Indicates when the staging was done, in terms of treatment landmarks. Timing of stage (260869008)

Value:  CodeableConcept must be from StageTimingPrefixVS
A set of codes drawn from different coding systems, representing the same concept.

TubuleFormationScore

A comparison between structures formed by the tumor cells and those formed by normal cells. Scored 1 to 3 with 3 being the most abnormal. Granular differentiation (85321-8)

Based On CodedEvaluationComponent

Value:  CodeableConcept must be from TubuleFormationScoreVS
A set of codes drawn from different coding systems, representing the same concept.
ExceptionValue must be from NottinghamNullVS
optional Reason that a value associated with a test or other finding is missing.
ComponentResultValue must be a CodeableConcept
optional The actual value of the component finding.
ReferenceRange not used The usual or acceptable range for a test result.
Interpretation optional A clinical interpretation of a finding.