HL7 FHIR Implementation Guide: Breast Cancer Data, Release 1 - US Realm (Draft for Comment 2)
This page is part of the Breast Cancer Data Logical Models and FHIR Profiles (v0.2.0: STU 1 Draft) based on FHIR R3. . For a full list of available versions, see the Directory of published versions 
<StructureDefinition xmlns="http://hl7.org/fhir"> <id value="cimi-statement-LaboratoryObservation"/> <text> <status value="generated"/> <div xmlns="http://www.w3.org/1999/xhtml"> <p><b>BC LaboratoryObservation Profile</b></p> <p>A coded finding based on a specimen collected from a patient.</p> <p><b>BC Mapping Summary</b></p> <p><pre>cimi.statement.LaboratoryObservation maps to http://hl7.org/fhir/us/core/StructureDefinition/us-core-observationresults: PersonOfRecord maps to subject LaboratoryObservationTopic.TopicCode maps to code LaboratoryObservationTopic.FindingMethod maps to method LaboratoryObservationTopic.Details maps to comment LaboratoryObservationTopic.Category maps to category LaboratoryObservationTopic.AnatomicalLocation maps to bodySite LaboratoryObservationTopic.Device maps to device LaboratoryObservationTopic.Specimen maps to specimen LaboratoryObservationTopic.ReferenceRange maps to referenceRange LaboratoryObservationTopic.ReferenceRange.Range.LowerBound maps to referenceRange.low LaboratoryObservationTopic.ReferenceRange.Range.UpperBound maps to referenceRange.high LaboratoryObservationTopic.ReferenceRange.Type maps to referenceRange.type LaboratoryObservationTopic.ReferenceRange.ApplicableSubpopulation maps to referenceRange.appliesTo LaboratoryObservationTopic.ReferenceRange.ApplicableAgeRange maps to referenceRange.age LaboratoryObservationTopic.EvaluationComponent maps to component (slice on = coding.code; slice strategy = includes) LaboratoryObservationTopic.EvaluationComponent._Concept maps to component.code LaboratoryObservationTopic.EvaluationComponent.Quantity maps to component.value[x] LaboratoryObservationTopic.EvaluationComponent.CodeableConcept maps to component.value[x] LaboratoryObservationTopic.EvaluationComponent.string maps to component.value[x] LaboratoryObservationTopic.EvaluationComponent.Range maps to component.value[x] LaboratoryObservationTopic.EvaluationComponent.Ratio maps to component.value[x] LaboratoryObservationTopic.EvaluationComponent.Media maps to component.value[x] LaboratoryObservationTopic.EvaluationComponent.time maps to component.value[x] LaboratoryObservationTopic.EvaluationComponent.dateTime maps to component.value[x] LaboratoryObservationTopic.EvaluationComponent.TimePeriod maps to component.value[x] LaboratoryObservationTopic.EvaluationComponent.IntegerQuantity maps to component.value[x] LaboratoryObservationTopic.EvaluationComponent.ExceptionValue maps to component.dataAbsentReason LaboratoryObservationTopic.EvaluationComponent.Interpretation maps to component.interpretation LaboratoryObservationTopic.EvaluationComponent.ReferenceRange maps to component.referenceRange fix related.type to #has-member LaboratoryObservationTopic.PanelMembers maps to related LaboratoryObservationTopic.PanelMembers.Observation maps to related.target (slice at = related; slice on = target.reference.resolve(); slice on type = profile; slice strategy = includes) ObservationContext.ResultValue maps to value[x] ObservationContext.ExceptionValue maps to dataAbsentReason ObservationContext.Interpretation maps to interpretation ObservationContext.Issued maps to issued ObservationContext.FindingStatus maps to status ObservationContext.RelevantTime maps to effective[x] ObservationContext.DeltaFlag maps to http://hl7.org/fhir/StructureDefinition/observation-delta </pre></p> </div> </text> <url value="http://hl7.org/fhir/us/breastcancer/StructureDefinition/cimi-statement-LaboratoryObservation"/> <identifier> <system value="http://hl7.org/fhir/us/breastcancer"/> <value value="cimi.statement.LaboratoryObservation"/> </identifier> <version value="0.2.0"/> <name value="LaboratoryObservationProfile"/> <title value="BC LaboratoryObservation Profile"/> <status value="draft"/> <date value="2018-08-17T00:00:00+10:00"/> <publisher value="The HL7 Cancer Interoperability Group sponsored by Clinical Interoperability Council Work Group (CIC)"/> <contact> <telecom> <system value="url"/> <value value="http://www.hl7.org/Special/committees/cic/index.cfm"/> </telecom> </contact> <description value="A coded finding based on a specimen collected from a patient."/> <jurisdiction> <coding> <system value="urn:iso:std:iso:3166"/> <code value="US"/> <display value="United States of America"/> </coding> </jurisdiction> <fhirVersion value="3.0.1"/> <mapping> <identity value="argonaut-dq-dstu2"/> <uri value="http://unknown.org/Argonaut%20DQ%20DSTU2"/> <name value="Argonaut DQ DSTU2"/> </mapping> <mapping> <identity value="workflow"/> <uri value="http://hl7.org/fhir/workflow"/> <name value="Workflow Mapping"/> </mapping> <mapping> <identity value="sct-concept"/> <uri value="http://snomed.info/conceptdomain"/> <name value="SNOMED CT Concept Domain Binding"/> </mapping> <mapping> <identity value="v2"/> <uri value="http://hl7.org/v2"/> <name value="HL7 v2 Mapping"/> </mapping> <mapping> <identity value="rim"/> <uri value="http://hl7.org/v3"/> <name value="RIM Mapping"/> </mapping> <mapping> <identity value="w5"/> <uri value="http://hl7.org/fhir/w5"/> <name value="W5 Mapping"/> </mapping> <mapping> <identity value="sct-attr"/> <uri value="http://snomed.info/sct"/> <name value="SNOMED CT Attribute Binding"/> </mapping> <kind value="resource"/> <abstract value="false"/> <type value="Observation"/> <baseDefinition value="http://hl7.org/fhir/us/core/StructureDefinition/us-core-observationresults"/> <derivation value="constraint"/> <snapshot> <element id="Observation:cimi-statement-LaboratoryObservation"> <path value="Observation"/> <short value="BC LaboratoryObservation Profile"/> <definition value="A coded finding based on a specimen collected from a patient."/> <comment value="Used for simple observations such as device measurements, laboratory atomic results, vital signs, height, weight, smoking status, comments, etc. Other resources are used to provide context for observations such as lab reports, etc."/> <alias value="Vital Signs"/> <alias value="Measurement"/> <alias value="Results"/> <alias value="Tests"/> <alias value="Obs"/> <min value="0"/> <max value="*"/> <base> <path value="Observation"/> <min value="0"/> <max value="*"/> </base> <constraint> <key value="dom-2"/> <severity value="error"/> <human value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/> <expression value="contained.contained.empty()"/> <xpath value="not(parent::f:contained and f:contained)"/> <source value="DomainResource"/> </constraint> <constraint> <key value="dom-1"/> <severity value="error"/> <human value="If the resource is contained in another resource, it SHALL NOT contain any narrative"/> <expression value="contained.text.empty()"/> <xpath value="not(parent::f:contained and f:text)"/> <source value="DomainResource"/> </constraint> <constraint> <key value="dom-4"/> <severity value="error"/> <human value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/> <expression value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/> <xpath value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))"/> <source value="DomainResource"/> </constraint> <constraint> <key value="dom-3"/> <severity value="error"/> <human value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource"/> <expression value="contained.where(('#'+id in %resource.descendants().reference).not()).empty()"/> <xpath value="not(exists(for $id in f:contained/*/@id return $id[not(ancestor::f:contained/parent::*/descendant::f:reference/@value=concat('#', $id))]))"/> <source value="DomainResource"/> </constraint> <constraint> <key value="obs-7"/> <severity value="error"/> <human value="If code is the same as a component code then the value element associated with the code SHALL NOT be present"/> <expression value="value.empty() or code!=component.code"/> <xpath value="not(exists(f:*[starts-with(local-name(.), 'value')])) or not(count(for $coding in f:code/f:coding return parent::*/f:component/f:code/f:coding[f:code/@value=$coding/f:code/@value and f:system/@value=$coding/f:system/@value])=0)"/> <source value="Observation"/> </constraint> <constraint> <key value="obs-6"/> <severity value="error"/> <human value="dataAbsentReason SHALL only be present if Observation.value[x] is not present"/> <expression value="dataAbsentReason.empty() or value.empty()"/> <xpath value="not(exists(f:dataAbsentReason)) or (not(exists(*[starts-with(local-name(.), 'value')])))"/> <source value="Observation"/> </constraint> <constraint> <key value="us-core-2"/> <severity value="error"/> <human value="If there is no component or related element then either a value[x] or a data absent reason must be present"/> <expression value="(component.empty() and related.empty()) implies (dataAbsentReason or value)"/> <xpath value="exists(f:component) or exists(f:related) or exists(f:*[starts-with(local-name(.), 'value)]) or exists(f:dataAbsentReason)"/> </constraint> <mustSupport value="false"/> <mapping> <identity value="rim"/> <map value="Entity. Role, or Act"/> </mapping> <mapping> <identity value="workflow"/> <map value="Event"/> </mapping> <mapping> <identity value="sct-concept"/> <map value="< 363787002 |Observable entity|"/> </mapping> <mapping> <identity value="v2"/> <map value="OBX"/> </mapping> <mapping> <identity value="rim"/> <map value="Observation[classCode=OBS, moodCode=EVN]"/> </mapping> <mapping> <identity value="w5"/> <map value="clinical.diagnostics"/> </mapping> <mapping> <identity value="argonaut-dq-dstu2"/> <map value="Observation"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.id"> <path value="Observation.id"/> <short value="Logical id of this artifact"/> <definition value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes."/> <comment value="The only time that a resource does not have an id is when it is being submitted to the server using a create operation."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.id"/> <min value="0"/> <max value="1"/> </base> <type> <code value="id"/> </type> <isSummary value="true"/> </element> <element id="Observation:cimi-statement-LaboratoryObservation.meta"> <path value="Observation.meta"/> <short value="Metadata about the resource"/> <definition value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content may not always be associated with version changes to the resource."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.meta"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Meta"/> </type> <isSummary value="true"/> </element> <element id="Observation:cimi-statement-LaboratoryObservation.implicitRules"> <path value="Observation.implicitRules"/> <short value="A set of rules under which this content was created"/> <definition value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content."/> <comment value="Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.implicitRules"/> <min value="0"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <isModifier value="true"/> <isSummary value="true"/> </element> <element id="Observation:cimi-statement-LaboratoryObservation.language"> <path value="Observation.language"/> <short value="Language of the resource content"/> <definition value="The base language in which the resource is written."/> <comment value="Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.language"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet"> <valueReference> <reference value="http://hl7.org/fhir/ValueSet/all-languages"/> </valueReference> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="Language"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true"/> </extension> <strength value="extensible"/> <description value="A human language."/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/languages"/> </valueSetReference> </binding> </element> <element id="Observation:cimi-statement-LaboratoryObservation.text"> <path value="Observation.text"/> <short value="Text summary of the resource, for human interpretation"/> <definition value="A human-readable narrative that contains a summary of the resource, and may be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety."/> <comment value="Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded in formation is added later."/> <alias value="narrative"/> <alias value="html"/> <alias value="xhtml"/> <alias value="display"/> <min value="0"/> <max value="1"/> <base> <path value="DomainResource.text"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Narrative"/> </type> <condition value="dom-1"/> <mapping> <identity value="rim"/> <map value="Act.text?"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.contained"> <path value="Observation.contained"/> <short value="Contained, inline Resources"/> <definition value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope."/> <comment value="This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again."/> <alias value="inline resources"/> <alias value="anonymous resources"/> <alias value="contained resources"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.contained"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Resource"/> </type> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.extension"> <path value="Observation.extension"/> <slicing id="2"> <discriminator> <type value="value"/> <path value="url"/> </discriminator> <ordered value="false"/> <rules value="open"/> </slicing> <short value="Additional Content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the resource. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.extension:deltaflag"> <path value="Observation.extension"/> <sliceName value="deltaflag"/> <definition value="Indicator of significant change (delta) from the last or previous measurement."/> <min value="0"/> <max value="1"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/observation-delta"/> </type> </element> <element id="Observation:cimi-statement-LaboratoryObservation.modifierExtension"> <path value="Observation.modifierExtension"/> <short value="Extensions that cannot be ignored"/> <definition value="May be used to represent additional information that is not part of the basic definition of the resource, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <isModifier value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.identifier"> <path value="Observation.identifier"/> <short value="Business Identifier for observation"/> <definition value="A unique identifier assigned to this observation."/> <requirements value="Allows observations to be distinguished and referenced."/> <min value="0"/> <max value="*"/> <base> <path value="Observation.identifier"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Identifier"/> </type> <isSummary value="true"/> <mapping> <identity value="workflow"/> <map value="Event.identifier"/> </mapping> <mapping> <identity value="v2"/> <map value="OBX.21 For OBX segments from systems without OBX-21 support a combination of ORC/OBR and OBX must be negotiated between trading partners to uniquely identify the OBX segment. Depending on how V2 has been implemented each of these may be an option: 1) OBR-3 + OBX-3 + OBX-4 or 2) OBR-3 + OBR-4 + OBX-3 + OBX-4 or 2) some other way to uniquely ID the OBR/ORC + OBX-3 + OBX-4."/> </mapping> <mapping> <identity value="rim"/> <map value="id"/> </mapping> <mapping> <identity value="w5"/> <map value="id"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.basedOn"> <path value="Observation.basedOn"/> <short value="Fulfills plan, proposal or order"/> <definition value="A plan, proposal or order that is fulfilled in whole or in part by this event."/> <requirements value="Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon."/> <alias value="Fulfills"/> <min value="0"/> <max value="*"/> <base> <path value="Observation.basedOn"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/CarePlan"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/DeviceRequest"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ImmunizationRecommendation"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationRequest"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/NutritionOrder"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ProcedureRequest"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ReferralRequest"/> </type> <isSummary value="true"/> <mapping> <identity value="workflow"/> <map value="Event.basedOn"/> </mapping> <mapping> <identity value="v2"/> <map value="ORC"/> </mapping> <mapping> <identity value="rim"/> <map value=".outboundRelationship[typeCode=FLFS].target"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.status"> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint"> <valueString value="default: final"/> </extension> <path value="Observation.status"/> <short value="registered | preliminary | final | amended +"/> <definition value="The status of the result value."/> <comment value="This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid."/> <requirements value="Need to track the status of individual results. Some results are finalized before the whole report is finalized."/> <min value="1"/> <max value="1"/> <base> <path value="Observation.status"/> <min value="1"/> <max value="1"/> </base> <type> <code value="code"/> </type> <mustSupport value="true"/> <isModifier value="true"/> <isSummary value="true"/> <binding> <strength value="required"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/observation-status"/> </valueSetReference> </binding> <mapping> <identity value="workflow"/> <map value="Event.status"/> </mapping> <mapping> <identity value="sct-concept"/> <map value="< 445584004 |Report by finality status|"/> </mapping> <mapping> <identity value="v2"/> <map value="OBX-11"/> </mapping> <mapping> <identity value="rim"/> <map value="status Amended & Final are differentiated by whether it is the subject of a ControlAct event with a type of "revise""/> </mapping> <mapping> <identity value="w5"/> <map value="status"/> </mapping> <mapping> <identity value="argonaut-dq-dstu2"/> <map value="Observation.status"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.category"> <path value="Observation.category"/> <short value="Classification of type of observation"/> <definition value="A code that classifies the general type of observation being made."/> <comment value="In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set."/> <requirements value="Used for filtering what observations are retrieved and displayed."/> <min value="1"/> <max value="*"/> <base> <path value="Observation.category"/> <min value="0"/> <max value="*"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="us-core-5"/> <severity value="error"/> <human value="Must have a category of 'laboratory' and a code system 'http://hl7.org/fhir/observation-category'"/> <expression value="where(coding.system='http://hl7.org/fhir/observation-category' and coding.code='laboratory').exists()"/> <xpath value="exists(f:coding/code[@value='laboratory']) and exists(f:coding/system[@value='http://hl7.org/fhir/observation-category'])"/> </constraint> <mustSupport value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ObservationCategory"/> </extension> <strength value="preferred"/> <description value="Codes for high level observation categories."/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/observation-category"/> </valueSetReference> </binding> <mapping> <identity value="rim"/> <map value=".outboundRelationship[typeCode="COMP].target[classCode="LIST", moodCode="EVN"].code"/> </mapping> <mapping> <identity value="w5"/> <map value="class"/> </mapping> <mapping> <identity value="argonaut-dq-dstu2"/> <map value="Observation.category"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.category.id"> <path value="Observation.category.id"/> <representation value="xmlAttr"/> <short value="xml:id (or equivalent in JSON)"/> <definition value="unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.category.extension"> <path value="Observation.category.extension"/> <slicing> <discriminator> <type value="value"/> <path value="url"/> </discriminator> <description value="Extensions are always sliced by (at least) url"/> <rules value="open"/> </slicing> <short value="Additional Content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.category.coding"> <path value="Observation.category.coding"/> <slicing id="1"> <discriminator> <type value="value"/> <path value="code"/> </discriminator> <ordered value="false"/> <rules value="open"/> </slicing> <short value="Code defined by a terminology system"/> <definition value="A reference to a code defined by a terminology system."/> <comment value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true."/> <requirements value="Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings."/> <min value="1"/> <max value="*"/> <type> <code value="Coding"/> </type> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="C*E.1-8, C*E.10-22"/> </mapping> <mapping> <identity value="rim"/> <map value="union(., ./translation)"/> </mapping> <mapping> <identity value="orim"/> <map value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.category.coding:Fixed_laboratory"> <path value="Observation.category.coding"/> <sliceName value="Fixed_laboratory"/> <definition value="A reference to a code defined by a terminology system."/> <min value="1"/> <max value="1"/> <type> <code value="Coding"/> </type> <isSummary value="true"/> </element> <element id="Observation:cimi-statement-LaboratoryObservation.category.coding:Fixed_laboratory.id"> <path value="Observation.category.coding.id"/> <representation value="xmlAttr"/> <short value="xml:id (or equivalent in JSON)"/> <definition value="unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.category.coding:Fixed_laboratory.extension"> <path value="Observation.category.coding.extension"/> <slicing> <discriminator> <type value="value"/> <path value="url"/> </discriminator> <description value="Extensions are always sliced by (at least) url"/> <rules value="open"/> </slicing> <short value="Additional Content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.category.coding:Fixed_laboratory.system"> <path value="Observation.category.coding.system"/> <short value="Identity of the terminology system"/> <definition value="The identification of the code system that defines the meaning of the symbol in the code."/> <comment value="The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously."/> <requirements value="Need to be unambiguous about the source of the definition of the symbol."/> <min value="0"/> <max value="1"/> <type> <code value="uri"/> </type> <fixedUri value="http://hl7.org/fhir/observation-category"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="C*E.3"/> </mapping> <mapping> <identity value="rim"/> <map value="./codeSystem"/> </mapping> <mapping> <identity value="orim"/> <map value="fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.category.coding:Fixed_laboratory.version"> <path value="Observation.category.coding.version"/> <short value="Version of the system - if relevant"/> <definition value="The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured. and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged."/> <comment value="Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date."/> <min value="0"/> <max value="1"/> <type> <code value="string"/> </type> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="C*E.7"/> </mapping> <mapping> <identity value="rim"/> <map value="./codeSystemVersion"/> </mapping> <mapping> <identity value="orim"/> <map value="fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.category.coding:Fixed_laboratory.code"> <path value="Observation.category.coding.code"/> <short value="Symbol in syntax defined by the system"/> <definition value="A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination)."/> <requirements value="Need to refer to a particular code in the system."/> <min value="0"/> <max value="1"/> <type> <code value="code"/> </type> <fixedCode value="laboratory"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="C*E.1"/> </mapping> <mapping> <identity value="rim"/> <map value="./code"/> </mapping> <mapping> <identity value="orim"/> <map value="fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.category.coding:Fixed_laboratory.display"> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable"> <valueBoolean value="true"/> </extension> <path value="Observation.category.coding.display"/> <short value="Representation defined by the system"/> <definition value="A representation of the meaning of the code in the system, following the rules of the system."/> <requirements value="Need to be able to carry a human-readable meaning of the code for readers that do not know the system."/> <min value="0"/> <max value="1"/> <type> <code value="string"/> </type> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="C*E.2 - but note this is not well followed"/> </mapping> <mapping> <identity value="rim"/> <map value="CV.displayName"/> </mapping> <mapping> <identity value="orim"/> <map value="fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.category.coding:Fixed_laboratory.userSelected"> <path value="Observation.category.coding.userSelected"/> <short value="If this coding was chosen directly by the user"/> <definition value="Indicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays)."/> <comment value="Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely."/> <requirements value="This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing."/> <min value="0"/> <max value="1"/> <type> <code value="boolean"/> </type> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="Sometimes implied by being first"/> </mapping> <mapping> <identity value="rim"/> <map value="CD.codingRationale"/> </mapping> <mapping> <identity value="orim"/> <map value="fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.category.text"> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable"> <valueBoolean value="true"/> </extension> <path value="Observation.category.text"/> <short value="Plain text representation of the concept"/> <definition value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user."/> <comment value="Very often the text is the same as a displayName of one of the codings."/> <requirements value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source."/> <min value="0"/> <max value="1"/> <type> <code value="string"/> </type> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="C*E.9. But note many systems use C*E.2 for this"/> </mapping> <mapping> <identity value="rim"/> <map value="./originalText[mediaType/code="text/plain"]/data"/> </mapping> <mapping> <identity value="orim"/> <map value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.code"> <path value="Observation.code"/> <short value="Laboratory Test Name"/> <definition value="The test that was performed. A LOINC **SHALL** be used if the concept is present in LOINC."/> <comment value="The typical patterns for codes are: 1) a LOINC code either as a translation from a "local" code or as a primary code, or 2) a local code only if no suitable LOINC exists, or 3) both the local and the LOINC translation. Systems SHALL be capable of sending the local code if one exists. When using LOINC , Use either the SHORTNAME or LONG_COMMON_NAME field for the display."/> <requirements value="Knowing what kind of observation is being made is essential to understanding the observation."/> <alias value="Name"/> <alias value="Test Name"/> <alias value="Observation Identifer"/> <min value="1"/> <max value="1"/> <base> <path value="Observation.code"/> <min value="1"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <mustSupport value="true"/> <isSummary value="true"/> <binding> <strength value="extensible"/> <description value="LOINC codes"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/observation-codes"/> </valueSetReference> </binding> <mapping> <identity value="workflow"/> <map value="Event.code"/> </mapping> <mapping> <identity value="sct-concept"/> <map value="< 363787002 |Observable entity| OR < 386053000 |Evaluation procedure|"/> </mapping> <mapping> <identity value="v2"/> <map value="OBX-3"/> </mapping> <mapping> <identity value="rim"/> <map value="code"/> </mapping> <mapping> <identity value="sct-attr"/> <map value="116680003 |Is a|"/> </mapping> <mapping> <identity value="w5"/> <map value="what"/> </mapping> <mapping> <identity value="argonaut-dq-dstu2"/> <map value="Observation.code"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.subject"> <path value="Observation.subject"/> <short value="Who and/or what this is about"/> <definition value="The patient, or group of patients, location, or device whose characteristics (direct or indirect) are described by the observation and into whose record the observation is placed. Comments: Indirect characteristics may be those of a specimen, fetus, donor, other observer (for example a relative or EMT), or any observation made about the subject."/> <comment value="One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated. If the target of the observation is different than the subject, the general extension [observation-focal-subject](extension-observation-focal-subject.html). may be used. However, the distinction between the patient's own value for an observation versus that of the fetus, or the donor or blood product unit, etc., are often specified in the observation code."/> <requirements value="Observations have no value if you don't know who or what they're about."/> <min value="1"/> <max value="1"/> <base> <path value="Observation.subject"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/core/StructureDefinition/us-core-patient"/> </type> <mustSupport value="true"/> <isSummary value="true"/> <mapping> <identity value="workflow"/> <map value="Event.subject"/> </mapping> <mapping> <identity value="v2"/> <map value="PID-3"/> </mapping> <mapping> <identity value="rim"/> <map value="participation[typeCode=SBJ]"/> </mapping> <mapping> <identity value="w5"/> <map value="who.focus"/> </mapping> <mapping> <identity value="argonaut-dq-dstu2"/> <map value="Observation.subject"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.context"> <path value="Observation.context"/> <short value="Healthcare event during which this observation is made"/> <definition value="The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made."/> <comment value="This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter or episode but still be tied to the context of the encounter or episode (e.g. pre-admission lab tests)."/> <requirements value="For some observations it may be important to know the link between an observation and a particular encounter."/> <alias value="Encounter"/> <min value="0"/> <max value="1"/> <base> <path value="Observation.context"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Encounter"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/EpisodeOfCare"/> </type> <mapping> <identity value="workflow"/> <map value="Event.context"/> </mapping> <mapping> <identity value="v2"/> <map value="PV1"/> </mapping> <mapping> <identity value="rim"/> <map value="inboundRelationship[typeCode=COMP].source[classCode=ENC, moodCode=EVN]"/> </mapping> <mapping> <identity value="w5"/> <map value="context"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.effective[x]"> <path value="Observation.effective[x]"/> <short value="Clinically relevant time/time-period for observation"/> <definition value="For lab tests this is the specimen collection date. For Ask at Order Entry Questions (AOE)'s this is the date the question was asked."/> <comment value="At least a date should be present unless this observation is a historical report."/> <requirements value="Knowing when an observation was deemed true is important to its relevance as well as determining trends."/> <alias value="Occurrence"/> <min value="0"/> <max value="1"/> <base> <path value="Observation.effective[x]"/> <min value="0"/> <max value="1"/> </base> <type> <code value="dateTime"/> </type> <type> <code value="Period"/> </type> <constraint> <key value="us-core-1"/> <severity value="error"/> <human value="Datetime must be at least to day."/> <expression value="($this as dateTime).toString().length() >= 8"/> <xpath value="f:matches(effectiveDateTime,/\d{4}-[01]\d-[0-3]\dT[0-2]\d:[0-5]\d([+-][0-2]\d:[0-5]\d|Z)/)"/> </constraint> <mustSupport value="true"/> <isSummary value="true"/> <mapping> <identity value="workflow"/> <map value="Event.occurrence[x]"/> </mapping> <mapping> <identity value="v2"/> <map value="OBX-14, and/or OBX-19 after v2.4 (depends on who observation made)"/> </mapping> <mapping> <identity value="rim"/> <map value="effectiveTime"/> </mapping> <mapping> <identity value="w5"/> <map value="when.done"/> </mapping> <mapping> <identity value="argonaut-dq-dstu2"/> <map value="Observation.effective[x]"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.issued"> <path value="Observation.issued"/> <short value="Date/Time this was made available"/> <definition value="The date and time this observation was made available to providers, typically after the results have been reviewed and verified."/> <comment value="Updated when the result is updated."/> <min value="0"/> <max value="1"/> <base> <path value="Observation.issued"/> <min value="0"/> <max value="1"/> </base> <type> <code value="instant"/> </type> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="OBR.22 (or MSH.7), or perhaps OBX-19 (depends on who observation made)"/> </mapping> <mapping> <identity value="rim"/> <map value="participation[typeCode=AUT].time"/> </mapping> <mapping> <identity value="w5"/> <map value="when.recorded"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.performer"> <path value="Observation.performer"/> <short value="Who is responsible for the observation"/> <definition value="Who was responsible for asserting the observed value as "true"."/> <requirements value="May give a degree of confidence in the observation and also indicates where follow-up questions should be directed."/> <min value="0"/> <max value="*"/> <base> <path value="Observation.performer"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Patient"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/RelatedPerson"/> </type> <isSummary value="true"/> <mapping> <identity value="workflow"/> <map value="Event.performer"/> </mapping> <mapping> <identity value="v2"/> <map value="OBX.15 / (Practitioner) OBX-16, PRT-5:PRT-4='RO' / (Device) OBX-18 , PRT-10:PRT-4='EQUIP' / (Organization) OBX-23, PRT-8:PRT-4='PO'"/> </mapping> <mapping> <identity value="rim"/> <map value="participation[typeCode=PRF]"/> </mapping> <mapping> <identity value="w5"/> <map value="who.actor"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.value[x]"> <path value="Observation.value[x]"/> <short value="Result Value"/> <definition value="The Laboratory result value. If a coded value, the valueCodeableConcept.code **SHOULD** be selected from [SNOMED CT](http://hl7.org/fhir/ValueSet/uslab-obs-codedresults). If a numeric value, valueQuantity.code **SHALL** be selected from [UCUM](http://unitsofmeasure.org). A FHIR [UCUM Codes value set](http://hl7.org/fhir/STU3/valueset-ucum-units.html) that defines all UCUM codes is in the FHIR specification."/> <comment value="Normally, an observation will have either a single value or a set of related observations. A few observations (e.g. Apgar score) may have both a value and related observations (for an Apgar score, the observations from which the measure is derived). If a value is present, the datatype for this element should be determined by Observation.code. This element has a variable name depending on the type as follows: valueQuantity, valueCodeableConcept, valueString, valueBoolean, valueRange, valueRatio, valueSampledData, valueAttachment, valueTime, valueDateTime, or valuePeriod. (The name format is "'value' + the type name" with a capital on the first letter of the type). If the data element is usually coded or if the type associated with the Observation.value defines a coded value, use CodeableConcept instead of string datatype even if the value is uncoded text. A value set is bound to the ValueCodeableConcept element. For further discussion and examples see the [notes section](observation.html#notes) below."/> <requirements value="An observation exists to have a value, though it may not if it is in error, or if it represents a group of observations."/> <min value="0"/> <max value="1"/> <base> <path value="Observation.value[x]"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Quantity"/> </type> <type> <code value="CodeableConcept"/> </type> <type> <code value="string"/> </type> <type> <code value="boolean"/> </type> <type> <code value="Range"/> </type> <type> <code value="Ratio"/> <profile value="http://hl7.org/fhir/us/breastcancer/StructureDefinition/shr-core-Ratio"/> </type> <type> <code value="time"/> </type> <type> <code value="dateTime"/> </type> <type> <code value="Period"/> </type> <condition value="obs-7"/> <constraint> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice"> <valueBoolean value="true"/> </extension> <key value="us-core-4"/> <severity value="warning"/> <human value="SHOULD use Snomed CT for coded Results"/> <expression value="valueCodeableConcept.coding.system.empty() or valueCodeableConcept.coding.system = 'http://snomed.info/sct'"/> <xpath value="not(exists(f:valueCodeableConcept/f:coding/f:system) ) or f:valueCodeableConcept/f:coding/f:system[@value='http://snomed.info/sct']"/> </constraint> <constraint> <key value="us-core-3"/> <severity value="error"/> <human value="SHALL use UCUM for coded quantity units."/> <expression value="valueQuantity.system.empty() or valueQuantity.system = 'http://unitsofmeasure.org'"/> <xpath value="not(exists(f:valueQuantity/f:system) ) or f:valueQuantity/f:system[@value='http://unitsofmeasure.org']"/> </constraint> <mustSupport value="true"/> <isSummary value="true"/> <mapping> <identity value="workflow"/> <map value="Event.notDone, Event.notDoneReason (maps to valeu[x] or dataAbsentReason)"/> </mapping> <mapping> <identity value="sct-concept"/> <map value="< 441742003 |Evaluation finding|"/> </mapping> <mapping> <identity value="v2"/> <map value="OBX.2, OBX.5, OBX.6"/> </mapping> <mapping> <identity value="rim"/> <map value="value"/> </mapping> <mapping> <identity value="sct-attr"/> <map value="363714003 |Interprets|"/> </mapping> <mapping> <identity value="argonaut-dq-dstu2"/> <map value="Observation.value[x]"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.dataAbsentReason"> <path value="Observation.dataAbsentReason"/> <short value="Why the result is missing"/> <definition value="Provides a reason why the expected value in the element Observation.value[x] is missing."/> <comment value="Null or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "specimen unsatisfactory". The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Note that an observation may only be reported if there are values to report. For example differential cell counts values may be reported only when > 0. Because of these options, use-case agreements are required to interpret general observations for null or exceptional values."/> <requirements value="For many results it is necessary to handle exceptional values in measurements."/> <min value="0"/> <max value="1"/> <base> <path value="Observation.dataAbsentReason"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <condition value="obs-6"/> <mustSupport value="true"/> <binding> <strength value="extensible"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/data-absent-reason"/> </valueSetReference> </binding> <mapping> <identity value="workflow"/> <map value="Event.notDone, Event.notDoneReason (maps to valeu[x] or dataAbsentReason)"/> </mapping> <mapping> <identity value="v2"/> <map value="N/A"/> </mapping> <mapping> <identity value="rim"/> <map value="value.nullFlavor"/> </mapping> <mapping> <identity value="argonaut-dq-dstu2"/> <map value="Observation.dataAbsentReason"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.interpretation"> <path value="Observation.interpretation"/> <short value="High, low, normal, etc."/> <definition value="The assessment made based on the result of the observation. Intended as a simple compact code often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result. Otherwise known as abnormal flag."/> <requirements value="For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result."/> <alias value="Abnormal Flag"/> <min value="0"/> <max value="1"/> <base> <path value="Observation.interpretation"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ObservationInterpretation"/> </extension> <strength value="extensible"/> <description value="Codes identifying interpretations of observations."/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/observation-interpretation"/> </valueSetReference> </binding> <mapping> <identity value="sct-concept"/> <map value="< 260245000 |Findings values|"/> </mapping> <mapping> <identity value="v2"/> <map value="OBX-8"/> </mapping> <mapping> <identity value="rim"/> <map value="interpretationCode"/> </mapping> <mapping> <identity value="sct-attr"/> <map value="363713009 |Has interpretation|"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.comment"> <path value="Observation.comment"/> <short value="Comments about result"/> <definition value="May include statements about significant, unexpected or unreliable values, or information about the source of the value where this may be relevant to the interpretation of the result."/> <requirements value="Need to be able to provide free text additional information."/> <min value="0"/> <max value="1"/> <base> <path value="Observation.comment"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <mapping> <identity value="workflow"/> <map value="Event.note"/> </mapping> <mapping> <identity value="v2"/> <map value="NTE.3 (partner NTE to OBX, or sometimes another (child?) OBX)"/> </mapping> <mapping> <identity value="rim"/> <map value="subjectOf.observationEvent[code="annotation"].value"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.bodySite"> <path value="Observation.bodySite"/> <short value="Observed body part"/> <definition value="Indicates the site on the subject's body where the observation was made (i.e. the target site)."/> <comment value="Only used if not implicit in code found in Observation.code. In many systems, this may be represented as a related observation instead of an inline component. If the use case requires BodySite to be handled as a separate resource (e.g. to identify and track separately) then use the standard extension[ body-site-instance](extension-body-site-instance.html)."/> <min value="0"/> <max value="0"/> <base> <path value="Observation.bodySite"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <binding> <strength value="required"/> <valueSetReference> <reference value="http://hl7.org/fhir/us/breastcancer/ValueSet/cimi-element-AnatomicalLocationVS"/> </valueSetReference> </binding> <mapping> <identity value="sct-concept"/> <map value="< 123037004 |Body structure|"/> </mapping> <mapping> <identity value="v2"/> <map value="OBX-20"/> </mapping> <mapping> <identity value="rim"/> <map value="targetSiteCode"/> </mapping> <mapping> <identity value="sct-attr"/> <map value="718497002 |Inherent location|"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.method"> <path value="Observation.method"/> <short value="How it was done"/> <definition value="Indicates the mechanism used to perform the observation."/> <comment value="Only used if not implicit in code for Observation.code."/> <requirements value="In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results."/> <min value="0"/> <max value="1"/> <base> <path value="Observation.method"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <binding> <strength value="preferred"/> <valueSetReference> <reference value="http://loinc.org/vs"/> </valueSetReference> </binding> <mapping> <identity value="v2"/> <map value="OBX-17"/> </mapping> <mapping> <identity value="rim"/> <map value="methodCode"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.specimen"> <path value="Observation.specimen"/> <short value="Specimen used for this observation"/> <definition value="The specimen that was used when this observation was made."/> <comment value="Should only be used if not implicit in code found in `Observation.code`. Observations are not made on specimens themselves; they are made on a subject, but in many cases by the means of a specimen. Note that although specimens are often involved, they are not always tracked and reported explicitly. Also note that observation resources may be used in contexts that track the specimen explicitly (e.g. Diagnostic Report)."/> <min value="1"/> <max value="1"/> <base> <path value="Observation.specimen"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/breastcancer/StructureDefinition/cimi-entity-Specimen"/> </type> <mapping> <identity value="sct-concept"/> <map value="< 123038009 |Specimen|"/> </mapping> <mapping> <identity value="v2"/> <map value="SPM segment"/> </mapping> <mapping> <identity value="rim"/> <map value="participation[typeCode=SPC].specimen"/> </mapping> <mapping> <identity value="sct-attr"/> <map value="704319004 |Inherent in|"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.device"> <path value="Observation.device"/> <short value="(Measurement) Device"/> <definition value="The device used to generate the observation data."/> <comment value="An extension should be used if further typing of the device is needed. Devices used to support obtaining an observation can be represented using either an extension or through the Observation.related element."/> <min value="0"/> <max value="1"/> <base> <path value="Observation.device"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/core/StructureDefinition/us-core-device"/> </type> <mapping> <identity value="sct-concept"/> <map value="< 49062001 |Device|"/> </mapping> <mapping> <identity value="v2"/> <map value="OBX-17 / PRT -10"/> </mapping> <mapping> <identity value="rim"/> <map value="participation[typeCode=DEV]"/> </mapping> <mapping> <identity value="sct-attr"/> <map value="424226004 |Using device|"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.referenceRange"> <path value="Observation.referenceRange"/> <short value="Provides guide for interpretation"/> <definition value="Guidance on how to interpret the value by comparison to a normal or recommended range."/> <comment value="Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this may not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties."/> <requirements value="Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts."/> <min value="0"/> <max value="*"/> <base> <path value="Observation.referenceRange"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() | (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="Element"/> </constraint> <constraint> <key value="obs-3"/> <severity value="error"/> <human value="Must have at least a low or a high or text"/> <expression value="low.exists() or high.exists() or text.exists()"/> <xpath value="(exists(f:low) or exists(f:high)or exists(f:text))"/> </constraint> <mapping> <identity value="v2"/> <map value="OBX.7"/> </mapping> <mapping> <identity value="rim"/> <map value="outboundRelationship[typeCode=REFV]/target[classCode=OBS, moodCode=EVN]"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.referenceRange.id"> <path value="Observation.referenceRange.id"/> <representation value="xmlAttr"/> <short value="xml:id (or equivalent in JSON)"/> <definition value="unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.referenceRange.extension"> <path value="Observation.referenceRange.extension"/> <short value="Additional Content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.referenceRange.modifierExtension"> <path value="Observation.referenceRange.modifierExtension"/> <short value="Extensions that cannot be ignored"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <isModifier value="true"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.referenceRange.low"> <path value="Observation.referenceRange.low"/> <short value="Low Range, if relevant"/> <definition value="The value of the low bound of the reference range. The low bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the low bound is omitted, it is assumed to be meaningless (e.g. reference range is <=2.3)."/> <min value="0"/> <max value="1"/> <base> <path value="Observation.referenceRange.low"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Quantity"/> <profile value="http://hl7.org/fhir/StructureDefinition/SimpleQuantity"/> </type> <condition value="obs-3"/> <mapping> <identity value="v2"/> <map value="OBX-7"/> </mapping> <mapping> <identity value="rim"/> <map value="value:IVL_PQ.low"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.referenceRange.high"> <path value="Observation.referenceRange.high"/> <short value="High Range, if relevant"/> <definition value="The value of the high bound of the reference range. The high bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the high bound is omitted, it is assumed to be meaningless (e.g. reference range is >= 2.3)."/> <min value="0"/> <max value="1"/> <base> <path value="Observation.referenceRange.high"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Quantity"/> <profile value="http://hl7.org/fhir/StructureDefinition/SimpleQuantity"/> </type> <condition value="obs-3"/> <mapping> <identity value="v2"/> <map value="OBX-7"/> </mapping> <mapping> <identity value="rim"/> <map value="value:IVL_PQ.high"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.referenceRange.type"> <path value="Observation.referenceRange.type"/> <short value="Reference range qualifier"/> <definition value="Codes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range."/> <comment value="This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed."/> <requirements value="Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc, - for proper interpretation."/> <min value="0"/> <max value="1"/> <base> <path value="Observation.referenceRange.type"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ObservationRangeMeaning"/> </extension> <strength value="extensible"/> <description value="Code for the meaning of a reference range."/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/referencerange-meaning"/> </valueSetReference> </binding> <mapping> <identity value="sct-concept"/> <map value="< 260245000 |Findings values| OR < 365860008 |General clinical state finding| OR < 250171008 |Clinical history or observation findings| OR < 415229000 |Racial group| OR < 365400002 |Finding of puberty stage| OR < 443938003 |Procedure carried out on subject|"/> </mapping> <mapping> <identity value="v2"/> <map value="OBX-10"/> </mapping> <mapping> <identity value="rim"/> <map value="interpretationCode"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.referenceRange.appliesTo"> <path value="Observation.referenceRange.appliesTo"/> <short value="Reference range population"/> <definition value="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."/> <comment value="This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed."/> <requirements value="Need to be able to identify the target population for proper interpretation."/> <min value="0"/> <max value="*"/> <base> <path value="Observation.referenceRange.appliesTo"/> <min value="0"/> <max value="*"/> </base> <type> <code value="CodeableConcept"/> </type> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ObservationRangeType"/> </extension> <strength value="extensible"/> <description value="Codes identifying the population the reference range applies to."/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/referencerange-appliesto"/> </valueSetReference> </binding> <mapping> <identity value="sct-concept"/> <map value="< 260245000 |Findings values| OR < 365860008 |General clinical state finding| OR < 250171008 |Clinical history or observation findings| OR < 415229000 |Racial group| OR < 365400002 |Finding of puberty stage| OR < 443938003 |Procedure carried out on subject|"/> </mapping> <mapping> <identity value="v2"/> <map value="OBX-10"/> </mapping> <mapping> <identity value="rim"/> <map value="interpretationCode"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.referenceRange.age"> <path value="Observation.referenceRange.age"/> <short value="Applicable age range, if relevant"/> <definition value="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."/> <requirements value="Some analytes vary greatly over age."/> <min value="0"/> <max value="1"/> <base> <path value="Observation.referenceRange.age"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Range"/> </type> <mapping> <identity value="rim"/> <map value="outboundRelationship[typeCode=PRCN].targetObservationCriterion[code="age"].value"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.referenceRange.text"> <path value="Observation.referenceRange.text"/> <short value="Text based reference range in an observation"/> <definition value="Text based reference range in an observation which may be used when a quantitative range is not appropriate for an observation. An example would be a reference value of "Negative" or a list or table of 'normals'."/> <min value="0"/> <max value="1"/> <base> <path value="Observation.referenceRange.text"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <mapping> <identity value="v2"/> <map value="OBX-7"/> </mapping> <mapping> <identity value="rim"/> <map value="value:ST"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.related"> <path value="Observation.related"/> <short value="Resource related to this observation"/> <definition value="A reference to another resource (usually another Observation) whose relationship is defined by the relationship type code."/> <comment value="For a discussion on the ways Observations can assembled in groups together see [Notes below](observation.html#4.20.4)."/> <requirements value="Normally, an observation will have either a value or a set of related observations. A few observations (e.g. Apgar score) may have both a value and a set of related observations or sometimes a QuestionnaireResponse from which the measure is derived."/> <min value="0"/> <max value="1"/> <base> <path value="Observation.related"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() | (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="Element"/> </constraint> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="Relationships established by OBX-4 usage"/> </mapping> <mapping> <identity value="rim"/> <map value="outBoundRelationship"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.related.id"> <path value="Observation.related.id"/> <representation value="xmlAttr"/> <short value="xml:id (or equivalent in JSON)"/> <definition value="unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.related.extension"> <path value="Observation.related.extension"/> <short value="Additional Content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.related.modifierExtension"> <path value="Observation.related.modifierExtension"/> <short value="Extensions that cannot be ignored"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <isModifier value="true"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.related.type"> <path value="Observation.related.type"/> <short value="has-member | derived-from | sequel-to | replaces | qualified-by | interfered-by"/> <definition value="A code specifying the kind of relationship that exists with the target resource."/> <comment value="The "derived-from" type is the only logical choice when referencing the QuestionnaireAnswer resource."/> <requirements value="A relationship type SHOULD be provided."/> <min value="0"/> <max value="1"/> <base> <path value="Observation.related.type"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <fixedCode value="has-member"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ObservationRelationshipType"/> </extension> <strength value="required"/> <description value="Codes specifying how two observations are related."/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/observation-relationshiptypes"/> </valueSetReference> </binding> <mapping> <identity value="v2"/> <map value="N/A"/> </mapping> <mapping> <identity value="rim"/> <map value=".typeCode"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.related.target"> <path value="Observation.related.target"/> <short value="Resource that is related to this one"/> <definition value="A reference to the observation or [QuestionnaireResponse](questionnaireresponse.html#) resource that is related to this observation."/> <min value="1"/> <max value="1"/> <base> <path value="Observation.related.target"/> <min value="1"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/breastcancer/StructureDefinition/cimi-statement-Observation"/> </type> <mapping> <identity value="rim"/> <map value=".targetObservation"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.component"> <path value="Observation.component"/> <short value="Component results"/> <definition value="Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations."/> <comment value="For a discussion on the ways Observations can be assembled in groups together see [Notes](observation.html#notes) below."/> <requirements value="Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation."/> <min value="0"/> <max value="*"/> <base> <path value="Observation.component"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() | (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="Element"/> </constraint> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="containment by OBX-4?"/> </mapping> <mapping> <identity value="rim"/> <map value="outBoundRelationship[typeCode=COMP]"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.component.id"> <path value="Observation.component.id"/> <representation value="xmlAttr"/> <short value="xml:id (or equivalent in JSON)"/> <definition value="unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.component.extension"> <path value="Observation.component.extension"/> <short value="Additional Content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.component.modifierExtension"> <path value="Observation.component.modifierExtension"/> <short value="Extensions that cannot be ignored"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <isModifier value="true"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.component.code"> <path value="Observation.component.code"/> <short value="Type of component observation (code / type)"/> <definition value="Describes what was observed. Sometimes this is called the observation "code"."/> <requirements value="Knowing what kind of observation is being made is essential to understanding the observation."/> <min value="1"/> <max value="1"/> <base> <path value="Observation.component.code"/> <min value="1"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ObservationCode"/> </extension> <strength value="example"/> <description value="Codes identifying names of simple observations."/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/observation-codes"/> </valueSetReference> </binding> <mapping> <identity value="sct-concept"/> <map value="< 363787002 |Observable entity| OR < 386053000 |Evaluation procedure|"/> </mapping> <mapping> <identity value="v2"/> <map value="OBX-3"/> </mapping> <mapping> <identity value="rim"/> <map value="code"/> </mapping> <mapping> <identity value="w5"/> <map value="what"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.component.value[x]"> <path value="Observation.component.value[x]"/> <short value="Actual component result"/> <definition value="The information determined as a result of making the observation, if the information has a simple value."/> <comment value="Normally, an observation will have either a single value or a set of related observations. A few observations (e.g. Apgar score) may have both a value and related observations (for an Apgar score, the observations from which the measure is derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For boolean values use valueCodeableConcept and select codes from <http://hl7.org/fhir/ValueSet/v2-0136> (these "yes/no" concepts can be mapped to the display name "true/false" or other mutually exclusive terms that may be needed"). The element, Observation.value[x], has a variable name depending on the type as follows: valueQuantity, valueCodeableConcept, valueRatio, valueChoice, valuePeriod, valueSampleData, or valueString (the name format is "'value' + the type name" with a capital on the first letter of the type)."/> <requirements value="An observation exists to have a value, though it may not if it is in error, or if it represents a group of observations."/> <min value="0"/> <max value="1"/> <base> <path value="Observation.component.value[x]"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Quantity"/> </type> <type> <code value="CodeableConcept"/> </type> <type> <code value="string"/> </type> <type> <code value="Range"/> </type> <type> <code value="Ratio"/> <profile value="http://hl7.org/fhir/us/breastcancer/StructureDefinition/shr-core-Ratio"/> </type> <type> <code value="Attachment"/> </type> <type> <code value="time"/> </type> <type> <code value="dateTime"/> </type> <type> <code value="Period"/> </type> <isSummary value="true"/> <mapping> <identity value="sct-concept"/> <map value="363714003 |Interprets| < 441742003 |Evaluation finding|"/> </mapping> <mapping> <identity value="v2"/> <map value="OBX.2, OBX.5, OBX.6"/> </mapping> <mapping> <identity value="rim"/> <map value="value"/> </mapping> <mapping> <identity value="sct-attr"/> <map value="363714003 |Interprets|"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.component.dataAbsentReason"> <path value="Observation.component.dataAbsentReason"/> <short value="Why the component result is missing"/> <definition value="Provides a reason why the expected value in the element Observation.value[x] is missing."/> <comment value=""Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done". The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values."/> <requirements value="For many results it is necessary to handle exceptional values in measurements."/> <min value="0"/> <max value="1"/> <base> <path value="Observation.component.dataAbsentReason"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <condition value="obs-6"/> <binding> <strength value="extensible"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/data-absent-reason"/> </valueSetReference> </binding> <mapping> <identity value="v2"/> <map value="N/A"/> </mapping> <mapping> <identity value="rim"/> <map value="value.nullFlavor"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.component.interpretation"> <path value="Observation.component.interpretation"/> <short value="High, low, normal, etc."/> <definition value="The assessment made based on the result of the observation. Intended as a simple compact code often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result. Otherwise known as abnormal flag."/> <comment value="The component interpretation applies only to the individual component value. For an overall interpretation all components together use thes Observation.interpretation element."/> <requirements value="For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result."/> <alias value="Abnormal Flag"/> <min value="0"/> <max value="1"/> <base> <path value="Observation.component.interpretation"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ObservationInterpretation"/> </extension> <strength value="extensible"/> <description value="Codes identifying interpretations of observations."/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/observation-interpretation"/> </valueSetReference> </binding> <mapping> <identity value="sct-concept"/> <map value="< 260245000 |Findings values|"/> </mapping> <mapping> <identity value="v2"/> <map value="OBX-8"/> </mapping> <mapping> <identity value="rim"/> <map value="interpretationCode"/> </mapping> <mapping> <identity value="sct-attr"/> <map value="363713009 |Has interpretation|"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.component.referenceRange"> <path value="Observation.component.referenceRange"/> <short value="Provides guide for interpretation of component result"/> <definition value="Guidance on how to interpret the value by comparison to a normal or recommended range."/> <comment value="Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this may not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties."/> <requirements value="Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts."/> <min value="0"/> <max value="*"/> <base> <path value="Observation.component.referenceRange"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <mapping> <identity value="v2"/> <map value="OBX.7"/> </mapping> <mapping> <identity value="rim"/> <map value="outboundRelationship[typeCode=REFV]/target[classCode=OBS, moodCode=EVN]"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.component.referenceRange.id"> <path value="Observation.component.referenceRange.id"/> <representation value="xmlAttr"/> <short value="xml:id (or equivalent in JSON)"/> <definition value="unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.component.referenceRange.extension"> <path value="Observation.component.referenceRange.extension"/> <short value="Additional Content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.component.referenceRange.modifierExtension"> <path value="Observation.component.referenceRange.modifierExtension"/> <short value="Extensions that cannot be ignored"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <isModifier value="true"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.component.referenceRange.low"> <path value="Observation.component.referenceRange.low"/> <short value="Low Range, if relevant"/> <definition value="The value of the low bound of the reference range. The low bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the low bound is omitted, it is assumed to be meaningless (e.g. reference range is <=2.3)."/> <min value="0"/> <max value="1"/> <type> <code value="Quantity"/> <profile value="http://hl7.org/fhir/StructureDefinition/SimpleQuantity"/> </type> <condition value="obs-3"/> <mapping> <identity value="v2"/> <map value="OBX-7"/> </mapping> <mapping> <identity value="rim"/> <map value="value:IVL_PQ.low"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.component.referenceRange.high"> <path value="Observation.component.referenceRange.high"/> <short value="High Range, if relevant"/> <definition value="The value of the high bound of the reference range. The high bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the high bound is omitted, it is assumed to be meaningless (e.g. reference range is >= 2.3)."/> <min value="0"/> <max value="1"/> <type> <code value="Quantity"/> <profile value="http://hl7.org/fhir/StructureDefinition/SimpleQuantity"/> </type> <condition value="obs-3"/> <mapping> <identity value="v2"/> <map value="OBX-7"/> </mapping> <mapping> <identity value="rim"/> <map value="value:IVL_PQ.high"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.component.referenceRange.type"> <path value="Observation.component.referenceRange.type"/> <short value="Reference range qualifier"/> <definition value="Codes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range."/> <comment value="This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed."/> <requirements value="Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc, - for proper interpretation."/> <min value="0"/> <max value="1"/> <type> <code value="CodeableConcept"/> </type> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ObservationRangeMeaning"/> </extension> <strength value="extensible"/> <description value="Code for the meaning of a reference range."/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/referencerange-meaning"/> </valueSetReference> </binding> <mapping> <identity value="sct-concept"/> <map value="< 260245000 |Findings values| OR < 365860008 |General clinical state finding| OR < 250171008 |Clinical history or observation findings| OR < 415229000 |Racial group| OR < 365400002 |Finding of puberty stage| OR < 443938003 |Procedure carried out on subject|"/> </mapping> <mapping> <identity value="v2"/> <map value="OBX-10"/> </mapping> <mapping> <identity value="rim"/> <map value="interpretationCode"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.component.referenceRange.appliesTo"> <path value="Observation.component.referenceRange.appliesTo"/> <short value="Reference range population"/> <definition value="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."/> <comment value="This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed."/> <requirements value="Need to be able to identify the target population for proper interpretation."/> <min value="0"/> <max value="*"/> <type> <code value="CodeableConcept"/> </type> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ObservationRangeType"/> </extension> <strength value="example"/> <description value="Codes identifying the population the reference range applies to."/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/referencerange-appliesto"/> </valueSetReference> </binding> <mapping> <identity value="sct-concept"/> <map value="< 260245000 |Findings values| OR < 365860008 |General clinical state finding| OR < 250171008 |Clinical history or observation findings| OR < 415229000 |Racial group| OR < 365400002 |Finding of puberty stage| OR < 443938003 |Procedure carried out on subject|"/> </mapping> <mapping> <identity value="v2"/> <map value="OBX-10"/> </mapping> <mapping> <identity value="rim"/> <map value="interpretationCode"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.component.referenceRange.age"> <path value="Observation.component.referenceRange.age"/> <short value="Applicable age range, if relevant"/> <definition value="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."/> <requirements value="Some analytes vary greatly over age."/> <min value="0"/> <max value="1"/> <type> <code value="Range"/> </type> <mapping> <identity value="rim"/> <map value="outboundRelationship[typeCode=PRCN].targetObservationCriterion[code="age"].value"/> </mapping> </element> <element id="Observation:cimi-statement-LaboratoryObservation.component.referenceRange.text"> <path value="Observation.component.referenceRange.text"/> <short value="Text based reference range in an observation"/> <definition value="Text based reference range in an observation which may be used when a quantitative range is not appropriate for an observation. An example would be a reference value of "Negative" or a list or table of 'normals'."/> <min value="0"/> <max value="1"/> <type> <code value="string"/> </type> <mapping> <identity value="v2"/> <map value="OBX-7"/> </mapping> <mapping> <identity value="rim"/> <map value="value:ST"/> </mapping> </element> </snapshot> <differential> <element id="Observation:cimi-statement-LaboratoryObservation"> <path value="Observation"/> <short value="BC LaboratoryObservation Profile"/> <definition value="A coded finding based on a specimen collected from a patient."/> <mustSupport value="false"/> </element> <element id="Observation:cimi-statement-LaboratoryObservation.extension:deltaflag"> <path value="Observation.extension"/> <sliceName value="deltaflag"/> <definition value="Indicator of significant change (delta) from the last or previous measurement."/> <min value="0"/> <max value="1"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/observation-delta"/> </type> </element> <element id="Observation:cimi-statement-LaboratoryObservation.category"> <path value="Observation.category"/> </element> <element id="Observation:cimi-statement-LaboratoryObservation.category.coding"> <path value="Observation.category.coding"/> <slicing id="1"> <discriminator> <type value="value"/> <path value="code"/> </discriminator> <ordered value="false"/> <rules value="open"/> </slicing> <min value="1"/> <max value="*"/> </element> <element id="Observation:cimi-statement-LaboratoryObservation.category.coding:Fixed_laboratory"> <path value="Observation.category.coding"/> <sliceName value="Fixed_laboratory"/> <definition value="A reference to a code defined by a terminology system."/> <min value="1"/> <max value="1"/> <type> <code value="Coding"/> </type> <isSummary value="true"/> </element> <element id="Observation:cimi-statement-LaboratoryObservation.category.coding:Fixed_laboratory.system"> <path value="Observation.category.coding.system"/> <fixedUri value="http://hl7.org/fhir/observation-category"/> </element> <element id="Observation:cimi-statement-LaboratoryObservation.category.coding:Fixed_laboratory.code"> <path value="Observation.category.coding.code"/> <fixedCode value="laboratory"/> </element> <element id="Observation:cimi-statement-LaboratoryObservation.value[x]"> <path value="Observation.value[x]"/> <type> <code value="Quantity"/> </type> <type> <code value="CodeableConcept"/> </type> <type> <code value="string"/> </type> <type> <code value="boolean"/> </type> <type> <code value="Range"/> </type> <type> <code value="Ratio"/> <profile value="http://hl7.org/fhir/us/breastcancer/StructureDefinition/shr-core-Ratio"/> </type> <type> <code value="time"/> </type> <type> <code value="dateTime"/> </type> <type> <code value="Period"/> </type> </element> <element id="Observation:cimi-statement-LaboratoryObservation.dataAbsentReason"> <path value="Observation.dataAbsentReason"/> <binding> <strength value="extensible"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/data-absent-reason"/> </valueSetReference> </binding> </element> <element id="Observation:cimi-statement-LaboratoryObservation.bodySite"> <path value="Observation.bodySite"/> <min value="0"/> <max value="0"/> <binding> <strength value="required"/> <valueSetReference> <reference value="http://hl7.org/fhir/us/breastcancer/ValueSet/cimi-element-AnatomicalLocationVS"/> </valueSetReference> </binding> </element> <element id="Observation:cimi-statement-LaboratoryObservation.method"> <path value="Observation.method"/> <binding> <strength value="preferred"/> <valueSetReference> <reference value="http://loinc.org/vs"/> </valueSetReference> </binding> </element> <element id="Observation:cimi-statement-LaboratoryObservation.specimen"> <path value="Observation.specimen"/> <min value="1"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/breastcancer/StructureDefinition/cimi-entity-Specimen"/> </type> </element> <element id="Observation:cimi-statement-LaboratoryObservation.device"> <path value="Observation.device"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/core/StructureDefinition/us-core-device"/> </type> </element> <element id="Observation:cimi-statement-LaboratoryObservation.referenceRange"> <path value="Observation.referenceRange"/> </element> <element id="Observation:cimi-statement-LaboratoryObservation.referenceRange.appliesTo"> <path value="Observation.referenceRange.appliesTo"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ObservationRangeType"/> </extension> <strength value="extensible"/> <description value="Codes identifying the population the reference range applies to."/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/referencerange-appliesto"/> </valueSetReference> </binding> </element> <element id="Observation:cimi-statement-LaboratoryObservation.related"> <path value="Observation.related"/> <min value="0"/> <max value="1"/> </element> <element id="Observation:cimi-statement-LaboratoryObservation.related.type"> <path value="Observation.related.type"/> <fixedCode value="has-member"/> </element> <element id="Observation:cimi-statement-LaboratoryObservation.related.target"> <path value="Observation.related.target"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/breastcancer/StructureDefinition/cimi-statement-Observation"/> </type> </element> <element id="Observation:cimi-statement-LaboratoryObservation.component"> <path value="Observation.component"/> </element> <element id="Observation:cimi-statement-LaboratoryObservation.component.value[x]"> <path value="Observation.component.value[x]"/> <type> <code value="Quantity"/> </type> <type> <code value="CodeableConcept"/> </type> <type> <code value="string"/> </type> <type> <code value="Range"/> </type> <type> <code value="Ratio"/> <profile value="http://hl7.org/fhir/us/breastcancer/StructureDefinition/shr-core-Ratio"/> </type> <type> <code value="Attachment"/> </type> <type> <code value="time"/> </type> <type> <code value="dateTime"/> </type> <type> <code value="Period"/> </type> </element> <element id="Observation:cimi-statement-LaboratoryObservation.component.dataAbsentReason"> <path value="Observation.component.dataAbsentReason"/> <binding> <strength value="extensible"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/data-absent-reason"/> </valueSetReference> </binding> </element> </differential> </StructureDefinition>