HL7 FHIR® Implementation Guide: Breast Cancer Data, Release 1 - US Realm (Draft for Comment)
This page is part of the Breast Cancer Data Logical Models and FHIR Profiles (v0.1.0: STU 1 Draft) based on FHIR R3. . For a full list of available versions, see the Directory of published versions 
| Name | Definition |
| AverageCEP17SignalsPerCell | Average number CEP17 signals per cell (dual probe only) |
| AverageHER2SignalsPerCell | Average number of HER2 signals per cell |
| AverageStainingIntensity | The degree or magnitude of staining (nuclear positivity) across cells in the specimen. |
| BreastCancerDistantMetastasesClassification | The presence of distant metastases, based on criteria defined by the staging system being used. |
| BreastCancerHistologicGrade | 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. |
| BreastCancerPresenceStatement | 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. CIMI Alignment (and question for reviewers): The Topic of this statement is 'Neoplasm of the breast', not 'Assertion', with the logic that the topic of the statement is more specific than 'Assertion'. The result (the value) gives the particular type (histologic type) of the condition. Does this make sense? |
| BreastCancerPrimaryTumorClassification | The size and extent of the primary tumor, based on criteria defined by the staging system being used. |
| BreastCancerRegionalNodesClassification | The presence of metastases in regional lymph nodes, based on criteria defined by the staging system being used. |
| BreastCancerStage | The stage of a breast cancer. Different staging systems use different staging groups, so there are currently no terminology bindings associated with this class. |
| BreastSite | A body site specific to the breast structure. |
| BreastSpecimen | Specimen resulting from biopsy or excision of breast and surrounding tissue. |
| 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. |
| CompleteMembraneStainingPercent | Percentage of cells with uniform intense complete membrane staining. |
| DCISNuclearGrade | 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. |
| DistanceToNipple | The body site location in relation to the nipple. |
| EstrogenReceptorStatus | 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). |
| HER2ReceptorStatus | 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,10 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. |
| HER2byIHC | HER2 receptor status as determined by Immunohistochemistry (IHC). |
| HER2byISH | HER2 receptor status as determined by In Situ Hybridization (ISH). |
| HER2toCEP17Ratio | HER2 to CEP17 Ratio (dual probe only) |
| MammaprintRecurrenceScore | 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. |
| 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. |
| MorphologyBehavior | A description of the morphology and behavioral characteristics of the cancer. |
| NuclearPleomorphismScore | How large and varied the nuclei of the tumor cells are. Scored 1 to 3, with 3 being the most pleomorphism. |
| 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. |
| OncotypeDxDCISRecurrenceScore | 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? |
| OncotypeDxInvasiveRecurrenceScore | 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? |
| ProgesteroneReceptorStatus | 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). |
| ProsignaRecurrenceScore | 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. |
| StageSuffix | A suffix used in conjuction with certain breast cancer stages, based on criteria defined by the staging system being used. |
| StageTimingPrefix | Indicates when the staging was done, in terms of treatment landmarks. |
| 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. |
| Name | Definition |
| Abatement | The end of the condition, either remission or resolution. This attribute corresponds to dateAbated and hasAbated in CIMI V0.0.4, but includes additional datatypes corresponding to FHIR |
| Age | How long something has existed in time. |
| AgeRange | A quantitative range of ages. One of the two ages must be specified. |
| AnatomicalDirection | Anatomical location or specimen further detailing directionality. |
| AnatomicalLocation | A location or structure in the body, including tissues, regions, cavities, and spaces; for example, right elbow, or left ventricle of the heart. CIMI Alignment: In CIMI V0.0.4, AnatomicalLocation has no parent class. This appears to have been an oversight, and the parent should have been Entity, as modeled here. |
| ApplicableAgeRange | The age at which this reference range is applicable. This is a neonatal age (e.g. number of weeks at term) if the meaning says so. |
| ApplicableSubpopulation | Codes to indicate the target population this reference range applies to. For example, a reference range may be based on the normal population or a particular sex or race. |
| AssertionContext | The parent class of contexts that can associate with AssertionTopic and its subclasses. CIMI Alignment: This class was recently added to CIMI (after V0.0.4). |
| AssertionTopic | The base topic for conditions, allergies, adverse events, etc. These are things that are asserted to exist or not. The Value is interpreted in the context of the class; for an AdverseSensitivityToSubstance, the value is the substance; for a ConditionPresenceStatement, the Value represents the type of condition found. CIMI Alignment: In CIMI V0.0.4, this class was called Assertion, but CIMI recently decided to change the name to AssertionTopic, as anticipated here. In CIMI V0.0.4, Assertion defines three attributes: dateAsserted, verificationStatus, and findingMethod. VerificationStatus more properly only applies in the PresenceContext context, and can be found there. FindingMethod more properly belongs in FindingTopic, and can be found there. |
| Category | A class or division of people or things having particular shared characteristics |
| Certainty | The degree of confidence in a conclusion or assertion. CIMI Alignment: This attribute aligns with KnownOrSuspectedPresent.certainty in CIMI V0.0.4, but with the recent realignment of CIMI classes, this attribute is attached to the correct class, PresenceContext. |
| ClinicalStatement | A special type of information entry consisting of a topic and a context. The ClinicalStatement class provides the core pattern for more specific clinical statement classes, such as a statement that a finding has been found in a patient or that a procedure has been proposed by a clinical decision support system. The ClinicalStatement pattern defines the core attributes common to most clinical statements and specifies a composition pattern that encourage model component reuse and better alignment with the SNOMED CT Concept Model. A clinical statement is composed of the StatementTopic class (grouping of attributes for capturing information about a procedure or a clinical finding) and the StatementContext class (grouping of attributes providing the context for the statement topic such as whether a procedure was performed, requested, not performed or whether a finding is suspected present or absent in the patient). At the archetype level, the topic and context components are coordinated to form the clinical statement. For instance, the composition of the ProcedureTopic with the NotPerformed context indicates that the given procedure was not performed. |
| ClinicalStatus | A flag indicating whether the condition is active or inactive, recurring, in remission, or resolved (as of the last update of the Condition). CIMI Alignment: This attribute corresponds to FindingContext.status, but has been changed to better align with FHIR. |
| ClockDirection | A direction indicated by an angle relative to 12 o'clock. |
| CodeSystem | A formal terminology system. |
| CodeSystemVersion | The version of the vocabulary being used, if applicable. |
| CollectionMethod | How the specimen was obtained. |
| CollectionSite | The body site where specimen was collected |
| CollectionTime | When the sample was obtained, as a specific time or time period. CIMI Alignment: Specimen collection time seems to be missing in CIMI V0.0.4. The time may be in the CollectionProcedure, but if the specimen collection time is recorded in Performance.Attribution (a list of actions), it would be nearly impossible to create a mapping. |
| Comparator | |
| CompoundClinicalStatement | A CompoundClinicalStatement is a clinical statement representing a collection of independent clinical statements. Each statement within a compound clinical statement may exist outside of the context of the compound clinical statement without any alteration to its meaning. An example is a Panel. Note that complex medications are indivisible clinical statements even though their structure may be a composite data structure. They are generally treated as an independent entry in a record and their parts do not constitute independent entries in a record. |
| ConditionPresenceContext | The context for a condition that is known, suspected, or possibly present. CIMI Alignment: In CIMI V0.0.4, this class was called AssertionKnownOrSuspectedPresent. The corresponding CIMI class is ungoing a name change to include the word 'StatementContext' and remove the word 'Assertion'. The presence of terminology bindings (necessary to align with FHIR clinicalStatus, severity, and criticality) means that this class cannot be defined entirely within the CIMI reference model. The constraints could only exist in an archetype derived from the reference model class. The logical model here represents both the class structure and the terminology bindings. |
| ConditionPresenceStatement | A condition that is or may be present in a subject. 'Condition' is interpreted broadly and could be a disorder, abnormality, problem, injury, complaint, functionality, illness, disease, ailment, sickness, affliction, upset, difficulty, disorder, symptom, worry, or trouble. In CIMI terms, it is an archetype of ClinicalStatement that combines a ConditionTopic with the ConditionPresenceContext context. The core attributes of ClinicalStatement are not included here because of mapping difficulties to FHIR DomainResource. |
| ConditionTopic | Representation of a condition, independent of context of being present, absent, risk, expectation etc. 'Condition' is interpreted broadly to include disorder, abnormality, problem, injury, complaint, functionality, concern, illness, disease, ailment, sickness, affliction, upset, difficulty, disorder, symptom, etc. The value set binding of Value is required to map to US-Core. The value set binding of Category is preferred in US-Core. CIMI Alignment: In CIMI V0.0.4, this class was called ConditionAssertion, but CIMI has recently changed it to ConditionTopic. ConditionAssertion had properties associated with the presence of the condition, including severity, dueTo, diseasePhase, and more. In the current logical model, properties associated with condition occurrence have been moved to ConditionPresenceContext. |
| Content | Abstract ancestor of all concrete content types. A unit of content that makes up a composition - e.g., a clinical statement in a patient record, a simple or composite action is a knowledge document, a catalog entry in a catalog. |
| ContextCode | A code representing the ontological status of the statement, e.g., whether it exists, does not exist, is planned, etc. Attribute aligns with the SNOMED CT Situation with Explicit Context (SWEC) Concept Model context attributes: 'Finding context (attribute)' (SCTID: 408729009) and 'Procedure context (attribute)' (SCTID: 408730004). The range allowed for this attribute shall be consistent with the SNOMED CT concept model specification for SWEC. CIMI Alignment: ContextCode is the new CIMI name for the attribute formerly called 'type' in CIMI V0.0.4. |
| Criticality | The potential clinical harm associated with a condition. When the worst case result is assessed to have a life-threatening or organ system threatening potential, it is considered to be of high criticality. |
| DeltaFlag | Indicator of significant change (delta) from the last or previous measurement. |
| Denominator | The divisor of a fraction. |
| DiagnosticService | 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. |
| DisplayText | A string meant for reading by a person, for example, accompanying a code. |
| Encounter | An abstract class that represents an encounter class. This class has been stubbed out to limit the scope of this implementation guide to classes relevant to this ballot concerning breast cancer. |
| Entity | Root class for entities such as people, organizations, and devices that have a separately identifiable existence. CIMI Alignment: In CIMI V0.0.4, Entity was a subclass of Party. Party is part of CIMI's participation model, which is undergoing review and revision. Rather than introducing the complexity of the CIMI participation model, which has little relevance to breast cancer profiles and is undergoing revision anyway, the Party class has been omitted. |
| Entry | Entry contains attributes that apply to all such items. An Entry may represent an item in a single person's health record, or could represent an entity that surfaces in multiple patient records, such as organizations or practitioners. For the purposes of the breast cancer ballot, this class has been stubbed out, to delving into the differences between the standard attributes of CIMI entries versus FHIR resources. |
| EvaluationComponent | A simplified, non-separable evaluation consisting of a finding code (represented by the Concept), value (or exception value), reference range, and interpretation. The subject of the evaluation component is the same as in the parent evaluation. |
| EvaluationResultContext | The parent class of contexts that can associate with EvaluationResultTopic and its subclasses. CIMI Alignment: This class was recently added to CIMI (after V0.0.4) |
| EvaluationResultRecorded | Represents the result of evaluations (measurements, tests, or questions) that have been performed. EvaluationResultRecorded has a value representing the result (answer), or an ExceptionValue indicating why the value is not present. The subject of a finding can be the entire patient, or an entity such as a location body structure, intervention, or condition. Things observed about the subject can include social and behavioral factors, subjective and objective observations, and assessments. |
| EvaluationResultTopic | The base class, independent of context, for evaluations (measurements, tests, or questions) and a value containing the result (answer). The subject of a finding can be the entire patient, or an entity such as a location body structure, intervention, or condition. Things observed about the subject can include social and behavioral factors, subjective and objective observations, and assessments. CIMI Alignment: 1) In CIMI V0.0.4, LaboratoryTestResult.specimen is 0..* but that cardinality makes it impossible to map to FHIR Observation, where specimen is 0..1. The cardinality of Specimen has been changed to 0..1 to enable FHIR mapping. 2) In CIMI V0.0.4, Findings (including EvaluationResult and LaboratoryTestResult) do not have related ('has-member') observations, nor components (sub-observations). These features of FHIR Observations were found to be very useful in modeling breast cancer pathology, and are included here. This represents a significant departure from the CIMI model. CompoundClinicalStatement has not been used to represent panel-like findings, because of the complexity of mapping this class to FHIR. 3) In CIMI V0.0.4, allowable datatypes for result (aka Value) include EmbeddedContent, GpsLocation, Multimedia, ParsableContent, and other types not allowed in a FHIR Observation. To make mapping feasible, the types of Value were restricted to only the allowable FHIR datatypes. 4) ExceptionValue has been moved to the RecordedContext, because it is only relevant when a value is supposed to be recorded, but is not. 5) The cardinality of FindingMethod has been changed from 0..* to 0..1 to make it possible to map to FHIR, where Observation.method is 0..1. 6) The class PhysicalEvaluationResult has been united with this class, and the body location (AnatomicalLocation) has been added to this class. This is because bodySite is part of Observation, and it cannot be profiled out of EvaluationResult and then re-included in PhysicalEvaluationResult. 7) The cardinality of AnatomicalLocation has been changed from 0..* to 0..1 to make it possible to map to FHIR, where Observation.bodySite is 0..1. 8) The attribute evaluationDate has been moved to RecordedContext, because it only applies to evaluations that have been done. 9) The attributes device and evaluationProcedure have been removed for brevity, since they are not used in the current IG. |
| ExceptionValue | Reason that a value associated with a test or other finding is missing. CIMI Alignment: This attribute corresponds to EvaluationResultTopic.exceptionValue, but has been moved from topic to context because missing values are only relevant when they should be recorded, but are not. The value set binding extends the set of FHIR's required data absent values, with additional concepts from CIMI. |
| FindingContext | The FindingContext class provides the context for the EvaluationResultTopic and AssertionTopic in a clinical statement. For instance, a statement about findings may state that the finding was observed to be present or absent. This class aligns with the SNOMED Situation with Explicit Context.The base class for representing the ontological status of a finding, e.g., present, absent, goal, risk, expectation, etc. CIMI Alignment: In CIMI V0.0.4, FindingContext included a 'status' attribute. However, there are several problems with this. (1) To align with FHIR, the datatype of status should be Concept, not Attribution. (2) In FHIR, different types of status with different shades of meaning are found in different subclasses, for example, clinicalStatus and verificationStatus in Condition, and status in Observation. (3) Status will not be uniform in meaning across all CIMI finding contexts. For example, in GoalContext, the relevant status might be the progress toward the goal, which does not have the same meaning as the status of an EvaluationResult. |
| FindingMethod | The technique used to create the finding; for example, the specific imaging technique, lab test code, or assessment vehicle. CIMI Alignment: In CIMI V0.0.4, this attribute was called 'method'. The value set binding reflects CIMI's preference for LOINC codes. |
| FindingStatus | Indicates whether the finding is preliminary, amended, final, etc.. CIMI Alignment: This class corresponds to FindingContext.status, but has been aligned to FHIR. The value set binding is required by FHIR. |
| FindingTopic | Base class - independent of context - for all kinds of determinations: questions/answers, conditions, observations, allergies, and other findings. The subject of a finding can be the entire patient, or an entity such as a location body structure, intervention, or condition. Things observed about the subject can include social and behavioral factors, subjective and objective observations, and assessments. CIMI Alignment: In CIMI V0.0.4, FindingTopic has four attributes: result, description, multimedia, and intepretation. Here, result is represented by EvaluationResultTopic.Value and AssertionTopic.Value. Description and Multimedia have been omitted for brevity. |
| IndivisibleClinicalStatement | Represents clinical statements that cannot be further decomposed into multiple independent clinical statements, i.e., all clinical statements that are not CompoundClinicalStatements. An indivisible clinical statement must be able to stand alone, such as a systolic blood pressure measurement, which can be interpreted both inside a blood pressure panel or on its own. If the statement cannot stand alone, e.g., the size of a wound, which cannot exist outside the context of the wound itself, then the Component class should be used instead. |
| InformationEntry | An entry in a patient record or in a report, generally used for the documentation of clinical information about a subject of information such as a patient or a relative of the patient, asserted by a particular source, recorded, and potentially verified. CIMI Alignment: The CIMI-defined attributes from InformationEntry (identifier, subjectOfInformation, attribution, additionalText, and recordStatus) have been omitted from the current model because of problems mapping between InformationEntry and FHIR DomainResource. Attributes in DomainResource (id, versionId, lastUpdated, profile, security, tag, implicitRules, language, text, contained, extension, modifierExtension) are quite different than those in InformationEntry. Reconciling these differences is outside the scope of the current ballot on breast cancer. |
| Interpretation | A clinical interpretation of a finding. CIMI Alignment: The value set binding has been chosen to align with FHIR. (Note: it is not clear if Interpretation belongs in FindingTopic, rather than a context class, but that is how CIMI has modeled it.) |
| LaboratoryTestResultRecorded | Measurement resulting from a laboratory analysis. The category is fixed to 'laboratory' to align with US-Core. |
| Laterality | Anatomical location or specimen further detailing the side(s) of interest. |
| Locatable | Abstract top level class in the hierarchy. Locatable defines the idea of 'locatability in an archetyped structure'. CIMI Alignment: The Locatable class reflects CIMI's current implementation using Archetype Description Language (ADL). Its attributes (archetype_node_id, name, and archetype_details) are necessary to serialize CIMI definitions in ADL. By all rights, these attributes should be invisible in clinical models. To avoid complicating the breast cancer profiles with extensions irrelevant to the clinical content, the attributes of Locatable have been omitted. |
| LowerBound | The lower limit on a range |
| Members | Members 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. Although the proper place to define Members this might be in EvaluationResultTopic, it cannot be defined there because the value references EvaluationResultRecorded, which is a clinical statement class. CIMI Alignment: CIMI V0.0.4 does not have this attribute and uses CompoundClinicalStatement to create panels. Compared to having a separate class, the current representation closer alignment with FHIR and greater flexibility (related observations can be added to any observation). |
| Numerator | The dividend of a fraction. |
| Onset | The beginning or first appearance of a mental or physical disorder. CIMI Alignment: This attribute aligns with FHIR Condition.onset and with dateOfOnset and ageAtOnset in CIMI V0.0.4, but includes additional datatypes corresponding to FHIR |
| Percentage | A percentage value where 100.0 represents 100%. |
| PercentageRange | A range of percentage values. |
| Precondition | A description of the conditions or context of an observation; for example, under sedation, fasting or post-exercise. Body position and body site are also qualifiers, but handled separately. A qualifier cannot modify the measurement type; for example, a fasting blood sugar is still a blood sugar. |
| PresenceContext | PresenceContext indicates that the finding in question exists or is present to some level of certainty. For example, if the finding involves a myocardial infarction, the presence context implies that cardiac arrest has (or may have) taken place. Note that the name Presence is used rather than Present to prevent confusion with the temporal meaning of present. CIMI Alignment: In CIMI V0.0.4, there were two classes, KnownOrSuspectedPresent and AssertionKnownOrSuspectedPresent. CIMI has recently decided to combine these classes and rename it PresenceContext, as represented here. |
| PresentOnAdmission | If the problem or condition existed before the current episode of care. |
| Quantity | A quantity with units, whose value may be bounded from above or below, as defined in FHIR. This definition is not fully consistent with CIMI V0.0.4 (whose definition of Quantity lacks a comparator, but includes numerical precision). Complex data types that appear frequently in FHIR have not been profiled, even if CIMI defines them differently. This choice means that the breast cancer profiles use the native FHIR datatype, rather than having to substitute a CIMI profile everywhere the native type is used. |
| Range | An interval defined by a quantitative upper and/or lower bound. One of the two bounds must be specified, and the lower bound must be less than the upper bound. When Quantities are specified, the units of measure must be the same. |
| Ratio | A unit of measurement for the quotient of the amount of one entity to another. |
| ReceivedTime | Time received by accepting facility or unit. |
| RecordedContext | Context for an evaluation result, used to indicate an evaluation has been made. For example, measurement of blood pressure that has been made simply exists (although the value can be present or absent, accurate or inaccurate). The RecordedContext indicates the information presented stands on its own as presented. It can also apply to clinical notes. CIMI Alignment: The RecordedContext class did not exist in CIMI V0.0.4, but CIMI has recently added it. |
| ReferenceRange | The usual or acceptable range for a test result. |
| RelevantTime | The time or time period that the finding addresses. The clinically relevant time is not necessarily when the information is gathered or when a test is carried out, but for example, when a specimen was collected, or the time period referred to by the question. Use a TimePeriod for a measurement or specimen collection continued over a significant period of time (e.g. 24 hour Urine Sodium). CIMI Alignment: This attribute has been added, since recorded values must have an associated time. The datatype has been chosen to align with FHIR. |
| Severity | Degree of harshness or extent of a symptom, disorder, or condition. |
| SimpleQuantity | A quantity where the comparator is not used, as defined in FHIR. This class is not defined in CIMI V0.0.4 reference model. It could potentially be an archetype of Quantity. Complex data types that appear frequently in FHIR have not been profiled, even if CIMI defines them differently. This choice means that the breast cancer profiles use the native FHIR datatype, rather than having to substitute a CIMI profile everywhere the native type is used. |
| SimplifiedLaboratoryTestResultRecorded | The usual case for a test result from a pathology lab, based on a specimen taken from a patient. Note that the body site is not explicit here; it is part of the specimen resource associated with the lab result. |
| SourceSpecimen | Identifier for the source specimen from which this specimen was derived. CIMI Alignment: In CIMI V0.0.4, this attribute is called parentSpecimenIdentifier (datatype Identifier). The corresponding element in FHIR (Specimen.parent) is type ref(Specimen). It is impossible to map Idenfier to Specimen, so the datatype of this element has been changed to make the mapping feasible. |
| Specimen | A specimen is a substance, physical object, or collection of objects, that the laboratory considers a single discrete, uniquely identified unit that is the subject of one or more steps in the laboratory workflow. A specimen may include multiple physical pieces as long as they are considered a single unit within the laboratory workflow. A specimen results from one to many specimen collection procedures, and may be contained in multiple specimen containers. Specimen may have one or more processing activities. CIMI Alignment: This class has been cut down to parts relevant to the current oncology ballot. The attribute parentSpecimenIdentifier has been changed from an Identifier to a reference to a Specimen, to make it possible to map to FHIR. |
| StageDetail | The full staging information |
| Stage | The relative advancement in the course of a disease. The value is the summary stage or stage group. StageDetail optionally contains the full staging information. This attribute does not have a direct analogy in CIMI V0.0.4 (the closest being ConditionAssertion.diseasePhase), but is included here for consistency with FHIR and because staging is important in the context of breast cancer and cancer in general. |
| StatementContext | 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. CIMI Alignment: ContextCode is the new CIMI name for the attribute formerly called 'type' in CIMI V0.0.4. The attribute 'temporalContext' that appeared in CIMI V0.0.4 is no longer part of CIMI. |
| StatementTopic | 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). CIMI Alignment: StatementTopic had an attribute called 'key' in CIMI V0.0.4, but CIMI is renaming it 'TopicCode', as represented here. |
| TimePeriodEnd | The time at which something is to end or did end. Boundary is considered inclusive. |
| 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. |
| TimePeriodStart | The time at which something is to take effect, start, or did start. Boundary is considered inclusive. |
| TopicCode | The concept representing the finding or action that is the topic of the statement. For action topics, the TopicCode represents the action being described. For findings, the TopicCode represents the 'question' or property being investigated. For evaluation result findings, the TopicCode contains a concept for an observable entity, such as systolic blood pressure. For assertion findings, the TopicCode contains a code representing the condition, allergy, or other item being asserted. In all cases, the TopicCode describes the topic independent of the context of the action or the finding. CIMI Alignment: TopicCode is the new CIMI name for the attribute formerly called 'key' in CIMI V0.0.4. |
| Type | The most specific code (lowest level term) describing the kind or sort of thing being represented. |
| Units | Code for the unit of measure of the quantity. |
| UpperBound | The upper limit on a quantitative value. |
| VerificationStatus | Whether an assessment has been confirmed by testing or observation. CIMI Alignment: This attribute corresponds to FindingContext.status, but has been defined to align with FHIR. |