Phenomics Exchange for Research and Diagnostics
0.1.0 - ci-build
Phenomics Exchange for Research and Diagnostics
0.1.0 - ci-build
Phenomics Exchange for Research and Diagnostics, published by HL7 International / Clinical Interoperability Council. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/phenomics-exchange-ig/ and changes regularly. See the Directory of published versions
| Draft as of 2021-10-18 |
XML representation of the phenopackets-variant resource profile.
<StructureDefinition xmlns="http://hl7.org/fhir">
<id value="phenopackets-variant"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><table border="0" cellpadding="0" cellspacing="0" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top"><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="The logical name of the element">Name</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Information about the use of the element">Flags</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Minimum and Maximum # of times the the element can appear in the instance">Card.</a></th><th style="width: 100px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Reference to the type of the element">Type</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Additional information about the element">Description & Constraints</a><span style="float: right"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_resource.png" alt="." style="background-color: white; background-color: inherit" title="Resource" class="hierarchy"/> <a href="StructureDefinition-phenopackets-variant-definitions.html#Observation">Observation</a><a name="Observation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/uv/genomics-reporting/STU2/StructureDefinition-variant.html">Variant</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Variant</span></td></tr>
<tr><td colspan="5" class="hierarchy"><br/><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
<valueCode value="cic"/>
</extension>
<url
value="http://hl7.org/fhir/uv/phenomics-exchange/StructureDefinition/phenopackets-variant"/>
<version value="0.1.0"/>
<name value="PhenopacketsVariant"/>
<title value="Phenopackets Variant"/>
<status value="draft"/>
<date value="2021-10-18T06:00:00-04:00"/>
<publisher value="HL7 International / Clinical Interoperability Council"/>
<contact>
<name value="HL7 International / Clinical Interoperability Council"/>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/cic"/>
</telecom>
<telecom>
<system value="email"/>
<value value="cic@lists.HL7.org"/>
</telecom>
</contact>
<description
value="A profile of Genomics Reporting Variant profile that represents relevant phenopackets building blocks."/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
</jurisdiction>
<copyright
value="[Global Alliance for Genomics and Health](https://www.ga4gh.org)"/>
<fhirVersion value="4.0.1"/>
<mapping>
<identity value="workflow"/>
<uri value="http://hl7.org/fhir/workflow"/>
<name value="Workflow Pattern"/>
</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/fivews"/>
<name value="FiveWs Pattern Mapping"/>
</mapping>
<mapping>
<identity value="sct-attr"/>
<uri value="http://snomed.org/attributebinding"/>
<name value="SNOMED CT Attribute Binding"/>
</mapping>
<kind value="resource"/>
<abstract value="false"/>
<type value="Observation"/>
<baseDefinition
value="http://hl7.org/fhir/uv/genomics-reporting/StructureDefinition/variant"/>
<derivation value="constraint"/>
<snapshot>
<element id="Observation">
<path value="Observation"/>
<short value="Variant"/>
<definition
value="Measurements and simple assertions made about a patient, device or other subject."/>
<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 laboratory reports, etc."/>
<alias value="Vital Signs"/>
<alias value="Measurement"/>
<alias value="Results"/>
<alias value="Tests"/>
<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="http://hl7.org/fhir/StructureDefinition/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 or SHALL refer to the containing resource"/>
<expression
value="contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()"/>
<xpath
value="not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))"/>
<source
value="http://hl7.org/fhir/StructureDefinition/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="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-5"/>
<severity value="error"/>
<human
value="If a resource is contained in another resource, it SHALL NOT have a security label"/>
<expression value="contained.meta.security.empty()"/>
<xpath value="not(exists(f:contained/*/f:meta/f:security))"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">
<valueMarkdown
value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."/>
</extension>
<key value="dom-6"/>
<severity value="warning"/>
<human
value="A resource should have narrative for robust management"/>
<expression value="text.`div`.exists()"/>
<xpath value="exists(f:text/h:div)"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</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="http://hl7.org/fhir/StructureDefinition/Observation"/>
</constraint>
<constraint>
<key value="obs-7"/>
<severity value="error"/>
<human
value="If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present"/>
<expression
value="value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()"/>
<xpath
value="not(f:*[starts-with(local-name(.), 'value')] and (for $coding in f:code/f:coding return f:component/f:code/f:coding[f:code/@value=$coding/f:code/@value] [f:system/@value=$coding/f:system/@value]))"/>
<source value="http://hl7.org/fhir/StructureDefinition/Observation"/>
</constraint>
<isModifier value="false"/>
<isSummary 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>
</element>
<element id="Observation.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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="id"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="Observation.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 might 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="Observation.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. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc."/>
<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. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.implicitRules"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="uri"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation"/>
<isSummary value="true"/>
</element>
<element id="Observation.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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet">
<valueCanonical value="http://hl7.org/fhir/ValueSet/all-languages"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="Language"/>
</extension>
<strength value="preferred"/>
<description value="A human language."/>
<valueSet value="http://hl7.org/fhir/ValueSet/languages"/>
</binding>
</element>
<element id="Observation.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 can 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 information 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="Act.text?"/>
</mapping>
</element>
<element id="Observation.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. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels."/>
<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>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.extension">
<path value="Observation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<ordered value="false"/>
<rules value="open"/>
</slicing>
<short value="Extension"/>
<definition value="An Extension"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="Observation.extension:secondary-finding">
<path value="Observation.extension"/>
<sliceName value="secondary-finding"/>
<short
value="Secondary findings are genetic test results that provide information about variants in a gene unrelated to the primary purpose for the testing, most often discovered when [Whole Exome Sequencing (WES)](https://en.wikipedia.org/wiki/Exome_sequencing) or [Whole Genome Sequencing (WGS)](https://en.wikipedia.org/wiki/Whole_genome_sequencing) is performed. This extension should be used to denote when a genetic finding is being shared as a secondary finding, and ideally refer to a corresponding guideline or policy statement.
For more detail, please see:
https://ghr.nlm.nih.gov/primer/testing/secondaryfindings"/>
<definition
value="Secondary findings are genetic test results that provide information about variants in a gene unrelated to the primary purpose for the testing, most often discovered when [Whole Exome Sequencing (WES)](https://en.wikipedia.org/wiki/Exome_sequencing) or [Whole Genome Sequencing (WGS)](https://en.wikipedia.org/wiki/Whole_genome_sequencing) is performed. This extension should be used to denote when a genetic finding is being shared as a secondary finding, and ideally refer to a corresponding guideline or policy statement.
For more detail, please see:
https://ghr.nlm.nih.gov/primer/testing/secondaryfindings."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/StructureDefinition/observation-secondaryFinding"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
</element>
<element id="Observation.extension:body-structure">
<path value="Observation.extension"/>
<sliceName value="body-structure"/>
<short value="Target anatomic location or structure"/>
<definition
value="Record details about the anatomical location of a specimen or body part. This resource may be used when a coded concept does not provide the necessary detail needed for the use case."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile value="http://hl7.org/fhir/StructureDefinition/bodySite"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
</element>
<element id="Observation.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 and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="workflow"/>
<map value="Event.identifier"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.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>
</element>
<element id="Observation.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. For example, a MedicationRequest may require a patient to have laboratory test performed before it is dispensed."/>
<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"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/DeviceRequest"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/ImmunizationRecommendation"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/MedicationRequest"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/NutritionOrder"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/ServiceRequest"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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=".inboundRelationship[typeCode=COMP].source[moodCode=EVN]"/>
</mapping>
</element>
<element id="Observation.partOf">
<path value="Observation.partOf"/>
<short value="Part of referenced event"/>
<definition
value="A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure."/>
<comment
value="To link an Observation to an Encounter use `encounter`. See the [Notes](http://hl7.org/fhir/R4/observation.html#obsgrouping) below for guidance on referencing another Observation."/>
<alias value="Container"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Observation.partOf"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/MedicationAdministration"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/MedicationDispense"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/MedicationStatement"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Procedure"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Immunization"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/ImagingStudy"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="workflow"/>
<map value="Event.partOf"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="Varies by domain"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".outboundRelationship[typeCode=FLFS].target"/>
</mapping>
</element>
<element id="Observation.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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationStatus"/>
</extension>
<strength value="required"/>
<description value="Codes providing the status of an observation."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-status|4.0.1"/>
</binding>
<mapping>
<identity value="workflow"/>
<map value="Event.status"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.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>
</element>
<element id="Observation.category">
<path value="Observation.category"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="coding"/>
</discriminator>
<description value="Slice based on the category.code pattern"/>
<ordered value="false"/>
<rules value="open"/>
</slicing>
<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="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-category"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.class"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value=".outboundRelationship[typeCode="COMP].target[classCode="LIST", moodCode="EVN"].code"/>
</mapping>
</element>
<element id="Observation.category:labCategory">
<path value="Observation.category"/>
<sliceName value="labCategory"/>
<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="1"/>
<base>
<path value="Observation.category"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-category"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.class"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value=".outboundRelationship[typeCode="COMP].target[classCode="LIST", moodCode="EVN"].code"/>
</mapping>
</element>
<element id="Observation.category:labCategory.id">
<path value="Observation.category.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.category:labCategory.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.category:labCategory.coding">
<path value="Observation.category.coding"/>
<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 alternative encodings within a code system, and translations to other code systems."/>
<min value="1"/>
<max value="*"/>
<base>
<path value="CodeableConcept.coding"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Coding"/>
</type>
<patternCoding>
<system
value="http://terminology.hl7.org/CodeSystem/observation-category"/>
<code value="laboratory"/>
</patternCoding>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.category:labCategory.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"/>
<base>
<path value="CodeableConcept.text"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.code">
<path value="Observation.code"/>
<short value="69548-6"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "name"."/>
<comment
value="*All* code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<requirements
value="Knowing what kind of observation is being made is essential to understanding the observation."/>
<alias value="Name"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Observation.code"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="69548-6"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="workflow"/>
<map value="Event.code"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.subject">
<path value="Observation.subject"/>
<short value="Who and/or what the observation is about"/>
<definition
value="The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the `focus` element or the `code` itself specifies the actual focus of the observation."/>
<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."/>
<requirements
value="Observations have no value if you don't know who or what they're about."/>
<min value="0"/>
<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/StructureDefinition/Patient"/>
<targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Device"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Location"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="workflow"/>
<map value="Event.subject"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.subject[x]"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="PID-3"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="participation[typeCode=RTGT]"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.subject"/>
</mapping>
</element>
<element id="Observation.focus">
<path value="Observation.focus"/>
<short
value="What the observation is about, when it is not about the subject of record"/>
<definition
value="The actual focus of an observation when it is not the patient of record representing something or someone associated with the patient such as a spouse, parent, fetus, or donor. For example, fetus observations in a mother's record. The focus of an observation could also be an existing condition, an intervention, the subject's diet, another observation of the subject, or a body structure such as tumor or implanted device. An example use case would be using the Observation resource to capture whether the mother is trained to change her child's tracheostomy tube. In this example, the child is the patient of record and the mother is the focus."/>
<comment
value="Typically, an observation is made about the subject - a patient, or group of patients, location, or device - and the distinction between the subject and what is directly measured for an observation is specified in the observation code itself ( e.g., "Blood Glucose") and does not need to be represented separately using this element. Use `specimen` if a reference to a specimen is required. If a code is required instead of a resource use either `bodysite` for bodysites or the standard extension [focusCode](http://hl7.org/fhir/R4/extension-observation-focuscode.html)."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Observation.focus"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Resource"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="w5"/>
<map value="FiveWs.subject[x]"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="OBX-3"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="participation[typeCode=SBJ]"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.subject"/>
</mapping>
</element>
<element id="Observation.encounter">
<path value="Observation.encounter"/>
<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 but still be tied to the context of the encounter (e.g. pre-admission laboratory tests)."/>
<requirements
value="For some observations it may be important to know the link between an observation and a particular encounter."/>
<alias value="Context"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Observation.encounter"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Encounter"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="workflow"/>
<map value="Event.context"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.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>
</element>
<element id="Observation.effective[x]">
<path value="Observation.effective[x]"/>
<short value="Clinically relevant time/time-period for observation"/>
<definition
value="The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself."/>
<comment
value="At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the [Timing](http://hl7.org/fhir/R4/datatypes.html#timing) datatype which allow the measurement to be tied to regular life events."/>
<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>
<type>
<code value="Timing"/>
</type>
<type>
<code value="instant"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="workflow"/>
<map value="Event.occurrence[x]"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.done[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>
</element>
<element id="Observation.issued">
<path value="Observation.issued"/>
<short value="Date/Time this version was made available"/>
<definition
value="The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified."/>
<comment
value="For Observations that don’t require review and verification, it may be the same as the [`lastUpdated` ](http://hl7.org/fhir/R4/resource-definitions.html#Meta.lastUpdated) time of the resource itself. For Observations that do require review and verification for certain updates, it might not be the same as the `lastUpdated` time of the resource itself due to a non-clinically significant update that doesn’t require the new version to be reviewed and verified again."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Observation.issued"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="instant"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="w5"/>
<map value="FiveWs.recorded"/>
</mapping>
<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>
</element>
<element id="Observation.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"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/CareTeam"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Patient"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/RelatedPerson"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="workflow"/>
<map value="Event.performer.actor"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.actor"/>
</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>
</element>
<element id="Observation.value[x]">
<path value="Observation.value[x]"/>
<slicing>
<discriminator>
<type value="type"/>
<path value="$this"/>
</discriminator>
<ordered value="false"/>
<rules value="closed"/>
</slicing>
<short value="Actual result"/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might 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="CodeableConcept"/>
</type>
<condition value="obs-7"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<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>
</element>
<element id="Observation.value[x]:valueCodeableConcept">
<path value="Observation.value[x]"/>
<sliceName value="valueCodeableConcept"/>
<short value="Indeterminate | No call | Present | Absent."/>
<definition
value="The presence or absence of the variant described in the components. If not searching for specific variations and merely reporting what's found, the profile's value should be set to 'Present'."/>
<comment
value="An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might 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="CodeableConcept"/>
</type>
<condition value="obs-7"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<strength value="required"/>
<valueSet value="http://loinc.org/vs/LL1971-2"/>
</binding>
<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>
</element>
<element id="Observation.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.interpretation">
<path value="Observation.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.note">
<path value="Observation.note"/>
<short
value="Comments about the Observation that also contain a coded type"/>
<definition
value="A text note which also contains information about who made the statement and when."/>
<comment
value="May include general statements about the observation, or statements about significant, unexpected or unreliable results values, or information about its source when relevant to its interpretation.
The CodedAnnotation data type, while not allowing for or intending to make the content computable, does allow the author to indicate the type of note. This does not replace the use of interpretation, value, or component values.
One important note is that Annotation is a FHIR data type, this is **NOT** about annotations in the genomic context."/>
<requirements
value="Need to be able to provide free text additional information. Notes SHALL NOT contain information which can be captured in a structured way."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Observation.note"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Annotation"/>
<profile
value="http://hl7.org/fhir/uv/genomics-reporting/StructureDefinition/coded-annotation"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Act"/>
</mapping>
</element>
<element id="Observation.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[ bodySite](http://hl7.org/fhir/R4/extension-bodysite.html)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Observation.bodySite"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="BodySite"/>
</extension>
<strength value="example"/>
<description
value="Codes describing anatomical locations. May include laterality."/>
<valueSet value="http://hl7.org/fhir/ValueSet/body-site"/>
</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.method">
<path value="Observation.method"/>
<short
value="Sequencing | SNP array | PCR | Computational analysis | ..."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<strength value="extensible"/>
<valueSet value="http://loinc.org/vs/LL4048-6"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="OBX-17"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="methodCode"/>
</mapping>
</element>
<element id="Observation.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="0"/>
<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/StructureDefinition/Specimen"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.device">
<path value="Observation.device"/>
<short value="(Measurement) Device"/>
<definition value="The device used to generate the observation data."/>
<comment
value="Note that this is not meant to represent a device involved in the transmission of the result, e.g., a gateway. Such devices may be documented using the Provenance resource where relevant."/>
<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/StructureDefinition/Device"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/DeviceMetric"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.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. Multiple reference ranges are interpreted as an "OR". In other words, to represent two distinct target populations, two `referenceRange` elements would be used."/>
<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 might 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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/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))"/>
<source value="http://hl7.org/fhir/StructureDefinition/Observation"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.referenceRange.id">
<path value="Observation.referenceRange.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.referenceRange.modifierExtension">
<path value="Observation.referenceRange.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="v2"/>
<map value="OBX-7"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value:IVL_PQ.low"/>
</mapping>
</element>
<element id="Observation.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="v2"/>
<map value="OBX-7"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value:IVL_PQ.high"/>
</mapping>
</element>
<element id="Observation.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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationRangeMeaning"/>
</extension>
<strength value="preferred"/>
<description value="Code for the meaning of a reference range."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/referencerange-meaning"/>
</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.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. Multiple `appliesTo` are interpreted as an "AND" of the target populations. For example, to represent a target population of African American females, both a code of female and a code for African American would be used."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/referencerange-appliesto"/>
</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.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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map
value="outboundRelationship[typeCode=PRCN].targetObservationCriterion[code="age"].value"/>
</mapping>
</element>
<element id="Observation.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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="v2"/>
<map value="OBX-7"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value:ST"/>
</mapping>
</element>
<element id="Observation.hasMember">
<path value="Observation.hasMember"/>
<short value="Related resource that belongs to the Observation group"/>
<definition
value="This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group."/>
<comment
value="When using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see [Notes](http://hl7.org/fhir/R4/observation.html#obsgrouping) below. Note that a system may calculate results from [QuestionnaireResponse](http://hl7.org/fhir/R4/questionnaireresponse.html) into a final score and represent the score as an Observation."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Observation.hasMember"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Observation"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/QuestionnaireResponse"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/MolecularSequence"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.derivedFrom">
<path value="Observation.derivedFrom"/>
<short value="Related measurements the observation is made from"/>
<definition
value="The target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image."/>
<comment
value="All the reference choices that are listed in this element can represent clinical observations and other measurements that may be the source for a derived value. The most common reference will be another Observation. For a discussion on the ways Observations can assembled in groups together, see [Notes](http://hl7.org/fhir/R4/observation.html#obsgrouping) below."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Observation.derivedFrom"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/ImagingStudy"/>
<targetProfile value="http://hl7.org/fhir/StructureDefinition/Media"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/QuestionnaireResponse"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Observation"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/MolecularSequence"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="Relationships established by OBX-4 usage"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".targetObservation"/>
</mapping>
</element>
<element id="Observation.component">
<path value="Observation.component"/>
<slicing>
<discriminator>
<type value="pattern"/>
<path value="code"/>
</discriminator>
<description value="Slice based on the component.code pattern"/>
<rules value="open"/>
</slicing>
<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](http://hl7.org/fhir/R4/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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.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"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.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="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might 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="boolean"/>
</type>
<type>
<code value="integer"/>
</type>
<type>
<code value="Range"/>
</type>
<type>
<code value="Ratio"/>
</type>
<type>
<code value="SampledData"/>
</type>
<type>
<code value="time"/>
</type>
<type>
<code value="dateTime"/>
</type>
<type>
<code value="Period"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.component.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:conclusion-string">
<path value="Observation.component"/>
<sliceName value="conclusion-string"/>
<short value="Clinical Conclusion"/>
<definition
value="Concise and clinically contextualized summary conclusion (interpretation/impression) of the observation"/>
<comment
value="An example would be the interpretative information, typically canned, about a variant identified in the patient."/>
<requirements
value="Need to be able to provide a conclusion that is not lost among the basic result data."/>
<min value="0"/>
<max value="1"/>
<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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:conclusion-string.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:conclusion-string.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:conclusion-string.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:conclusion-string.code">
<path value="Observation.component.code"/>
<short value="conclusion-string"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs"/>
<code value="conclusion-string"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:conclusion-string.value[x]">
<path value="Observation.component.value[x]"/>
<short value="Summary conclusion (interpretation/impression)"/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might 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="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:conclusion-string.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.component:conclusion-string.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:conclusion-string.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:gene-studied">
<path value="Observation.component"/>
<sliceName value="gene-studied"/>
<short value="Gene Studied"/>
<definition value="The gene(s) on which the variant is located."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:gene-studied.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:gene-studied.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:gene-studied.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:gene-studied.code">
<path value="Observation.component.code"/>
<short value="48018-6"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="48018-6"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:gene-studied.value[x]">
<path value="Observation.component.value[x]"/>
<short
value="The HGNC gene symbol is to be used as display text and the HGNC gene ID used as the code. If no HGNC code issued for this gene yet, NCBI gene IDs SHALL be used."/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Observation.component.value[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<strength value="extensible"/>
<valueSet
value="http://hl7.org/fhir/uv/genomics-reporting/ValueSet/hgnc-vs"/>
</binding>
<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.component:gene-studied.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.component:gene-studied.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:gene-studied.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:cytogenetic-location">
<path value="Observation.component"/>
<sliceName value="cytogenetic-location"/>
<short value="Cytogenetic (Chromosome) Location"/>
<definition
value="The relevant chromosomal region. The combination of numbers and letters provide a genetic 'address'."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:cytogenetic-location.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:cytogenetic-location.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="Observation.component:cytogenetic-location.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:cytogenetic-location.code">
<path value="Observation.component.code"/>
<short value="48001-2"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="48001-2"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:cytogenetic-location.value[x]">
<path value="Observation.component.value[x]"/>
<short value="Example: 1q21.1"/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Observation.component.value[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:cytogenetic-location.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.component:cytogenetic-location.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:cytogenetic-location.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:reference-sequence-assembly">
<path value="Observation.component"/>
<sliceName value="reference-sequence-assembly"/>
<short value="Human Reference Sequence Assembly"/>
<definition
value="The reference genome/assembly used in this analysis."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:reference-sequence-assembly.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="Observation.component:reference-sequence-assembly.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="Observation.component:reference-sequence-assembly.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:reference-sequence-assembly.code">
<path value="Observation.component.code"/>
<short value="62374-4"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="62374-4"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:reference-sequence-assembly.value[x]">
<path value="Observation.component.value[x]"/>
<short value="GRCh37 | GRCh38 | ..."/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Observation.component.value[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<strength value="extensible"/>
<valueSet value="http://loinc.org/vs/LL1040-6"/>
</binding>
<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.component:reference-sequence-assembly.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element
id="Observation.component:reference-sequence-assembly.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:reference-sequence-assembly.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:coding-hgvs">
<path value="Observation.component"/>
<sliceName value="coding-hgvs"/>
<short value="Coding (cDNA) Change - cHGVS"/>
<definition
value="Description of the coding (cDNA) sequence change using a valid HGVS-formatted string."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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="1"/>
<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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:coding-hgvs.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:coding-hgvs.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:coding-hgvs.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:coding-hgvs.code">
<path value="Observation.component.code"/>
<short value="48004-6"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="48004-6"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:coding-hgvs.value[x]">
<path value="Observation.component.value[x]"/>
<short
value="A valid HGVS-formatted 'c.' string, e.g. NM_005228.5:c.2369C>T."/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Observation.component.value[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<strength value="required"/>
<valueSet
value="http://hl7.org/fhir/uv/genomics-reporting/ValueSet/hgvs-vs"/>
</binding>
<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.component:coding-hgvs.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.component:coding-hgvs.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:coding-hgvs.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:genomic-hgvs">
<path value="Observation.component"/>
<sliceName value="genomic-hgvs"/>
<short value="Genomic (gDNA) Change - gHGVS"/>
<definition
value="Description of the genomic (gDNA) sequence change using a valid HGVS-formatted string."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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="1"/>
<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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:genomic-hgvs.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:genomic-hgvs.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:genomic-hgvs.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:genomic-hgvs.code">
<path value="Observation.component.code"/>
<short value="81290-9"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="81290-9"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:genomic-hgvs.value[x]">
<path value="Observation.component.value[x]"/>
<short
value="A valid HGVS-formatted 'g.' string, e.g. NC_000016.9:g.2124200_2138612dup"/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Observation.component.value[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<strength value="required"/>
<valueSet
value="http://hl7.org/fhir/uv/genomics-reporting/ValueSet/hgvs-vs"/>
</binding>
<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.component:genomic-hgvs.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.component:genomic-hgvs.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:genomic-hgvs.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:cytogenomic-nomenclature">
<path value="Observation.component"/>
<sliceName value="cytogenomic-nomenclature"/>
<short value="Cytogenomic Nomenclature (ISCN)"/>
<definition
value="Fully describes a variant with a single code. Typically a large variant such as a mosaic, abnormal chromosome numbers, etc."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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="1"/>
<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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:cytogenomic-nomenclature.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:cytogenomic-nomenclature.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="Observation.component:cytogenomic-nomenclature.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:cytogenomic-nomenclature.code">
<path value="Observation.component.code"/>
<short value="81291-7"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="81291-7"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:cytogenomic-nomenclature.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="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Observation.component.value[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<strength value="example"/>
<description value="Binding not yet defined"/>
</binding>
<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.component:cytogenomic-nomenclature.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element
id="Observation.component:cytogenomic-nomenclature.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:cytogenomic-nomenclature.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:genomic-ref-seq">
<path value="Observation.component"/>
<sliceName value="genomic-ref-seq"/>
<short value="Genomic Reference Sequence"/>
<definition
value="ID of the genomic reference sequence, which includes transcribed and non transcribed stretches"/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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="1"/>
<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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:genomic-ref-seq.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:genomic-ref-seq.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:genomic-ref-seq.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:genomic-ref-seq.code">
<path value="Observation.component.code"/>
<short value="48013-7"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="48013-7"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:genomic-ref-seq.value[x]">
<path value="Observation.component.value[x]"/>
<short value="Versioned genomic reference sequence identifier"/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Observation.component.value[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<strength value="example"/>
<description value="Multiple bindings acceptable (NCBI or LRG)"/>
</binding>
<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.component:genomic-ref-seq.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.component:genomic-ref-seq.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:genomic-ref-seq.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:transcript-ref-seq">
<path value="Observation.component"/>
<sliceName value="transcript-ref-seq"/>
<short value="Reference Transcript"/>
<definition
value="NCBI's RefSeq ('NM_...'), Ensembl ('ENST...'), and LRG ('LRG...' plus 't1' to indicate transcript)"/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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="1"/>
<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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:transcript-ref-seq.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:transcript-ref-seq.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:transcript-ref-seq.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:transcript-ref-seq.code">
<path value="Observation.component.code"/>
<short value="51958-7"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="51958-7"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:transcript-ref-seq.value[x]">
<path value="Observation.component.value[x]"/>
<short value="Versioned transcript reference sequence identifier"/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Observation.component.value[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<strength value="example"/>
<description value="Multiple bindings acceptable (NCBI or LRG)"/>
</binding>
<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.component:transcript-ref-seq.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.component:transcript-ref-seq.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:transcript-ref-seq.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:exact-start-end">
<path value="Observation.component"/>
<sliceName value="exact-start-end"/>
<short value="Exact Start-End"/>
<definition
value="The exact integer-based genomic coordinates of the start and end of the variant region."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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="1"/>
<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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:exact-start-end.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:exact-start-end.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:exact-start-end.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:exact-start-end.code">
<path value="Observation.component.code"/>
<short value="81254-5"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="81254-5"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:exact-start-end.value[x]">
<path value="Observation.component.value[x]"/>
<short
value="Range in question. 'High' can be omitted for single nucleotide variants."/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might 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="Range"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:exact-start-end.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.component:exact-start-end.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:exact-start-end.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:inner-start-end">
<path value="Observation.component"/>
<sliceName value="inner-start-end"/>
<short value="Inner Start-End"/>
<definition
value="The genomic coordinates of the narrowest genomic range in which the variant might reside. Used when the exact boundaries of the variant are not clear."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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="1"/>
<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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:inner-start-end.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:inner-start-end.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:inner-start-end.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:inner-start-end.code">
<path value="Observation.component.code"/>
<short value="81302-2"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="81302-2"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:inner-start-end.value[x]">
<path value="Observation.component.value[x]"/>
<short value="Imprecise variant inner-bounding range"/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might 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="Range"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:inner-start-end.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.component:inner-start-end.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:inner-start-end.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:outer-start-end">
<path value="Observation.component"/>
<sliceName value="outer-start-end"/>
<short value="Outer Start-End"/>
<definition
value="The genomic coordinates of the widest genomic range in which the variant might reside. Used when the exact boundaries of the variant are not clear."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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="1"/>
<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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:outer-start-end.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:outer-start-end.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:outer-start-end.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:outer-start-end.code">
<path value="Observation.component.code"/>
<short value="81301-4"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="81301-4"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:outer-start-end.value[x]">
<path value="Observation.component.value[x]"/>
<short value="Imprecise variant outer-bounding range"/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might 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="Range"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:outer-start-end.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.component:outer-start-end.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:outer-start-end.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:coordinate-system">
<path value="Observation.component"/>
<sliceName value="coordinate-system"/>
<short value="Coordinate System"/>
<definition
value="These are different ways of identifying nucleotides or amino acids within a sequence. In the 1-based system, the first unit of the polymer (e.g. the first nucleotide) is counted as number 1. In the 0-based system, the number 0 designates the location before the first nucleotide. Different databases and file types may use different systems."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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="1"/>
<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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:coordinate-system.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:coordinate-system.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:coordinate-system.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:coordinate-system.code">
<path value="Observation.component.code"/>
<short value="92822-6"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="92822-6"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:coordinate-system.value[x]">
<path value="Observation.component.value[x]"/>
<short
value="0-based interval counting | 0-based character counting | 1-based character counting"/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Observation.component.value[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<strength value="extensible"/>
<valueSet value="http://loinc.org/vs/LL5323-2"/>
</binding>
<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.component:coordinate-system.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.component:coordinate-system.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:coordinate-system.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:ref-allele">
<path value="Observation.component"/>
<sliceName value="ref-allele"/>
<short value="Genomic Ref Allele"/>
<definition
value="Reference values ('normal') examined within the Reference Sequence."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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="1"/>
<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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:ref-allele.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:ref-allele.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:ref-allele.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:ref-allele.code">
<path value="Observation.component.code"/>
<short value="69547-8"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="69547-8"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:ref-allele.value[x]">
<path value="Observation.component.value[x]"/>
<short value="Normalized string per the VCF format."/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might 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="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:ref-allele.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.component:ref-allele.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:ref-allele.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:alt-allele">
<path value="Observation.component"/>
<sliceName value="alt-allele"/>
<short value="Genomic Alt Allele"/>
<definition
value="The genomic alternate allele is the contiguous segment of DNA in the test sample that differs from the reference allele at the same location and thus defines a variant."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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="1"/>
<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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:alt-allele.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:alt-allele.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:alt-allele.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:alt-allele.code">
<path value="Observation.component.code"/>
<short value="69551-0"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="69551-0"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:alt-allele.value[x]">
<path value="Observation.component.value[x]"/>
<short value="Normalized string per the VCF format."/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might 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="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:alt-allele.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.component:alt-allele.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:alt-allele.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:coding-change-type">
<path value="Observation.component"/>
<sliceName value="coding-change-type"/>
<short value="Coding DNA Change Type"/>
<definition
value="Type of DNA change observed. Convenience property for variants with exact breakpoints, required otherwise."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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="1"/>
<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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:coding-change-type.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:coding-change-type.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:coding-change-type.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:coding-change-type.code">
<path value="Observation.component.code"/>
<short value="48019-4"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="48019-4"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:coding-change-type.value[x]">
<path value="Observation.component.value[x]"/>
<short
value="deletion | insertion | delins | SNV | copy_number_gain | copy_number_loss | ... (many)"/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Observation.component.value[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<strength value="extensible"/>
<description value="Concepts in sequence ontology under SO:0002072"/>
<valueSet
value="http://hl7.org/fhir/uv/genomics-reporting/ValueSet/dna-change-type-vs"/>
</binding>
<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.component:coding-change-type.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.component:coding-change-type.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:coding-change-type.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:genomic-source-class">
<path value="Observation.component"/>
<sliceName value="genomic-source-class"/>
<short value="Genomic Source Class"/>
<definition
value="The genomic class of the specimen being analyzed: Germline for inherited genome, somatic for cancer genome, and prenatal for fetal genome."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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="1"/>
<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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:genomic-source-class.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:genomic-source-class.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="Observation.component:genomic-source-class.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:genomic-source-class.code">
<path value="Observation.component.code"/>
<short value="48002-0"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="48002-0"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:genomic-source-class.value[x]">
<path value="Observation.component.value[x]"/>
<short
value="Germline | Somatic | Fetal | Likely germline | Likely somatic | Likely fetal | Unknown genomic origin | De novo"/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Observation.component.value[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<strength value="extensible"/>
<valueSet value="http://loinc.org/vs/LL378-1"/>
</binding>
<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.component:genomic-source-class.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.component:genomic-source-class.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:genomic-source-class.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:sample-allelic-frequency">
<path value="Observation.component"/>
<sliceName value="sample-allelic-frequency"/>
<short value="Sample Allelic Frequency"/>
<definition
value="The relative frequency of the allele at a given locus in the sample."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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="1"/>
<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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:sample-allelic-frequency.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:sample-allelic-frequency.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="Observation.component:sample-allelic-frequency.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:sample-allelic-frequency.code">
<path value="Observation.component.code"/>
<short value="81258-6"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="81258-6"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:sample-allelic-frequency.value[x]">
<path value="Observation.component.value[x]"/>
<short value="Relative frequency in the sample"/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:sample-allelic-frequency.value[x].id">
<path value="Observation.component.value[x].id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="Observation.component:sample-allelic-frequency.value[x].extension">
<path value="Observation.component.value[x].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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="Observation.component:sample-allelic-frequency.value[x].value">
<path value="Observation.component.value[x].value"/>
<short value="Numerical value (with implicit precision)"/>
<definition
value="The value of the measured amount. The value includes an implicit precision in the presentation of the value."/>
<comment
value="The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books)."/>
<requirements
value="Precision is handled implicitly in almost all cases of measurement."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Quantity.value"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="decimal"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="SN.2 / CQ - N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value"/>
</mapping>
</element>
<element
id="Observation.component:sample-allelic-frequency.value[x].comparator">
<path value="Observation.component.value[x].comparator"/>
<short
value="< | <= | >= | > - how to understand the value"/>
<definition
value="How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value."/>
<requirements
value="Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Quantity.comparator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<meaningWhenMissing
value="If there is no comparator, then there is no modification of the value"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="QuantityComparator"/>
</extension>
<strength value="required"/>
<description
value="How the Quantity should be understood and represented."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="SN.1 / CQ.1"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="IVL properties"/>
</mapping>
</element>
<element
id="Observation.component:sample-allelic-frequency.value[x].unit">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="Observation.component.value[x].unit"/>
<short value="Unit representation"/>
<definition value="A human-readable form of the unit."/>
<requirements
value="There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Quantity.unit"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="(see OBX.6 etc.) / CQ.2"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="PQ.unit"/>
</mapping>
</element>
<element
id="Observation.component:sample-allelic-frequency.value[x].system">
<path value="Observation.component.value[x].system"/>
<short value="System that defines coded unit form"/>
<definition
value="The identification of the system that provides the coded form of the unit."/>
<requirements
value="Need to know the system that defines the coded form of the unit."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Quantity.system"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="uri"/>
</type>
<patternUri value="http://unitsofmeasure.org"/>
<condition value="qty-3"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="(see OBX.6 etc.) / CQ.2"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="CO.codeSystem, PQ.translation.codeSystem"/>
</mapping>
</element>
<element
id="Observation.component:sample-allelic-frequency.value[x].code">
<path value="Observation.component.value[x].code"/>
<short value="Coded form of the unit"/>
<definition
value="A computer processable form of the unit in some unit representation system."/>
<comment
value="The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system."/>
<requirements
value="Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Quantity.code"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="(see OBX.6 etc.) / CQ.2"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="PQ.code, MO.currency, PQ.translation.code"/>
</mapping>
</element>
<element
id="Observation.component:sample-allelic-frequency.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element
id="Observation.component:sample-allelic-frequency.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:sample-allelic-frequency.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:allelic-read-depth">
<path value="Observation.component"/>
<sliceName value="allelic-read-depth"/>
<short value="Allelic Read Depth"/>
<definition
value="Specifies the number of reads that identified the allele in question whether it consists of one or a small sequence of contiguous nucleotides. Different methods and purposes require different numbers of reads to be acceptable. Often >400, sometimes as few as 2-4."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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="1"/>
<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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:allelic-read-depth.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:allelic-read-depth.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:allelic-read-depth.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:allelic-read-depth.code">
<path value="Observation.component.code"/>
<short value="82121-5"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="82121-5"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:allelic-read-depth.value[x]">
<path value="Observation.component.value[x]"/>
<short value="Unfiltered count of supporting reads"/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:allelic-read-depth.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.component:allelic-read-depth.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:allelic-read-depth.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:allelic-state">
<path value="Observation.component"/>
<sliceName value="allelic-state"/>
<short value="Allelic State"/>
<definition
value="The observed level of occurrence of the variant in the set of chromosomes."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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="1"/>
<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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:allelic-state.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:allelic-state.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:allelic-state.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:allelic-state.code">
<path value="Observation.component.code"/>
<short value="53034-5"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="53034-5"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:allelic-state.value[x]">
<path value="Observation.component.value[x]"/>
<short
value="Heteroplasmic | Homoplasmic | Homozygous | Heterozygous | Hemizygous"/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Observation.component.value[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<strength value="extensible"/>
<valueSet value="http://loinc.org/vs/LL381-5"/>
</binding>
<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.component:allelic-state.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.component:allelic-state.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:allelic-state.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:variant-inheritance">
<path value="Observation.component"/>
<sliceName value="variant-inheritance"/>
<short value="Variant Inheritance"/>
<definition
value="By which parent the variant was inherited in the patient, if known."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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="1"/>
<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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:variant-inheritance.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:variant-inheritance.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="Observation.component:variant-inheritance.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:variant-inheritance.code">
<path value="Observation.component.code"/>
<short value="variant-inheritance"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs"/>
<code value="variant-inheritance"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:variant-inheritance.value[x]">
<path value="Observation.component.value[x]"/>
<short value="Maternal | Paternal | Unknown"/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Observation.component.value[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<strength value="extensible"/>
<valueSet
value="http://hl7.org/fhir/uv/genomics-reporting/ValueSet/variant-inheritance-vs"/>
</binding>
<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.component:variant-inheritance.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.component:variant-inheritance.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:variant-inheritance.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:variation-code">
<path value="Observation.component"/>
<sliceName value="variation-code"/>
<short value="Variation Code"/>
<definition
value="Accession number in a variant database such as ClinVar, given for cross-reference."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:variation-code.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:variation-code.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:variation-code.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:variation-code.code">
<path value="Observation.component.code"/>
<short value="81252-9"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="81252-9"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:variation-code.value[x]">
<path value="Observation.component.value[x]"/>
<short value="ClinVar ID or similar"/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Observation.component.value[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<strength value="example"/>
<description value="Multiple bindings acceptable"/>
</binding>
<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.component:variation-code.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.component:variation-code.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:variation-code.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:chromosome-identifier">
<path value="Observation.component"/>
<sliceName value="chromosome-identifier"/>
<short value="Chromosome Identifier"/>
<definition
value="An indicator, enumerated in humans by numbers 1-22, X, and Y, representing the chromosome on which the variant is located."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:chromosome-identifier.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:chromosome-identifier.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="Observation.component:chromosome-identifier.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:chromosome-identifier.code">
<path value="Observation.component.code"/>
<short value="48000-4"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="48000-4"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:chromosome-identifier.value[x]">
<path value="Observation.component.value[x]"/>
<short
value="Chromosome 1 | Chromosome 2 | ... | Chromosome 22 | Chromosome X | Chromosome Y"/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Observation.component.value[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<strength value="required"/>
<valueSet value="http://loinc.org/vs/LL2938-0"/>
</binding>
<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.component:chromosome-identifier.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.component:chromosome-identifier.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:chromosome-identifier.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:protein-hgvs">
<path value="Observation.component"/>
<sliceName value="protein-hgvs"/>
<short value="Protein (Amino Acid) Change - pHGVS"/>
<definition
value="Description of the protein (amino acid) sequence change using a valid HGVS-formatted string. The description of the variant is surrounded in parentheses if it is calculated rather than directly observed."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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="1"/>
<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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:protein-hgvs.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:protein-hgvs.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:protein-hgvs.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:protein-hgvs.code">
<path value="Observation.component.code"/>
<short value="48005-3"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="48005-3"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:protein-hgvs.value[x]">
<path value="Observation.component.value[x]"/>
<short
value="A valid HGVS-formatted 'p.' string, e.g. NP_000050.2:p.(Asn1836Lys)"/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Observation.component.value[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<strength value="required"/>
<valueSet
value="http://hl7.org/fhir/uv/genomics-reporting/ValueSet/hgvs-vs"/>
</binding>
<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.component:protein-hgvs.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.component:protein-hgvs.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:protein-hgvs.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:amino-acid-change-type">
<path value="Observation.component"/>
<sliceName value="amino-acid-change-type"/>
<short value="Amino Acid Change Type"/>
<definition
value="Codified type for associated Amino Acid Marker, for convenience."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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="1"/>
<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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:amino-acid-change-type.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:amino-acid-change-type.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="Observation.component:amino-acid-change-type.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:amino-acid-change-type.code">
<path value="Observation.component.code"/>
<short value="48006-1"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="48006-1"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:amino-acid-change-type.value[x]">
<path value="Observation.component.value[x]"/>
<short
value="Wild type | Deletion | Duplication | Frameshift | Initiating Methionine | Insertion | Insertion and Deletion | Missense | Nonsense | Silent"/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Observation.component.value[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<strength value="extensible"/>
<valueSet value="http://loinc.org/vs/LL380-7"/>
</binding>
<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.component:amino-acid-change-type.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element
id="Observation.component:amino-acid-change-type.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:amino-acid-change-type.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:molecular-consequence">
<path value="Observation.component"/>
<sliceName value="molecular-consequence"/>
<short value="Molecular Consequence"/>
<definition
value="The calculated or observed effect of a variant on its downstream transcript and, if applicable, ensuing protein sequence."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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="1"/>
<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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:molecular-consequence.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:molecular-consequence.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="Observation.component:molecular-consequence.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:molecular-consequence.code">
<path value="Observation.component.code"/>
<short value="molecular-consequence"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs"/>
<code value="molecular-consequence"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:molecular-consequence.value[x]">
<path value="Observation.component.value[x]"/>
<short
value="stop_lost | stop_gained | inframe_insertion | frameshift_variant | ... (many)"/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Observation.component.value[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<strength value="extensible"/>
<description value="Concepts in sequence ontology under SO:0001537."/>
<valueSet
value="http://hl7.org/fhir/uv/genomics-reporting/ValueSet/molecular-consequence-vs"/>
</binding>
<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.component:molecular-consequence.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.component:molecular-consequence.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:molecular-consequence.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:copy-number">
<path value="Observation.component"/>
<sliceName value="copy-number"/>
<short value="Genomic Structural Variant Copy Number"/>
<definition
value="The copy number of the large variant. In HGVS, this is the numeric value following the “X”. It is a unit-less value. Note that a copy number of 1 can imply a deletion."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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="1"/>
<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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:copy-number.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:copy-number.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:copy-number.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:copy-number.code">
<path value="Observation.component.code"/>
<short value="82155-3"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system value="http://loinc.org"/>
<code value="82155-3"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:copy-number.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="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="cnt-3"/>
<severity value="error"/>
<human
value="There SHALL be a code with a value of '1' if there is a value. If system is present, it SHALL be UCUM. If present, the value SHALL be a whole number."/>
<expression
value="(code.exists() or value.empty()) and (system.empty() or system = %ucum) and (code.empty() or code = '1') and (value.empty() or value.hasValue().not() or value.toString().contains('.').not())"/>
<source
value="http://hl7.org/fhir/uv/genomics-reporting/StructureDefinition/variant"/>
</constraint>
<isModifier value="false"/>
<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.component:copy-number.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element id="Observation.component:copy-number.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:copy-number.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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.component:variant-confidence-status">
<path value="Observation.component"/>
<sliceName value="variant-confidence-status"/>
<short value="Variant Confidence Status"/>
<definition
value="A code that represents the confidence of a true positive variant call."/>
<comment
value="For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/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="1"/>
<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() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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.component:variant-confidence-status.id">
<path value="Observation.component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Observation.component:variant-confidence-status.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. 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 can 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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="Observation.component:variant-confidence-status.modifierExtension">
<path value="Observation.component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<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."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<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>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Observation.component:variant-confidence-status.code">
<path value="Observation.component.code"/>
<short value="variant-confidence-status"/>
<definition
value="Describes what was observed. Sometimes this is called the observation "code"."/>
<comment
value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation."/>
<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>
<patternCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs"/>
<code value="variant-confidence-status"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<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."/>
<valueSet value="http://hl7.org/fhir/ValueSet/observation-codes"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</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>
</element>
<element id="Observation.component:variant-confidence-status.value[x]">
<path value="Observation.component.value[x]"/>
<short value="High | Intermediate | Low"/>
<definition
value="The information determined as a result of making the observation, if the information has a simple value."/>
<comment
value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below."/>
<requirements
value="An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Observation.component.value[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<strength value="required"/>
<valueSet
value="http://hl7.org/fhir/uv/genomics-reporting/ValueSet/variant-confidence-status-vs"/>
</binding>
<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.component:variant-confidence-status.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.component.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"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationValueAbsentReason"/>
</extension>
<strength value="extensible"/>
<description
value="Codes specifying why the result (`Observation.value[x]`) is missing."/>
<valueSet value="http://hl7.org/fhir/ValueSet/data-absent-reason"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="value.nullFlavor"/>
</mapping>
</element>
<element
id="Observation.component:variant-confidence-status.interpretation">
<path value="Observation.component.interpretation"/>
<short value="High, low, normal, etc."/>
<definition
value="A categorical assessment of an observation value. For example, high, low, normal."/>
<comment
value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result."/>
<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="*"/>
<base>
<path value="Observation.component.interpretation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ObservationInterpretation"/>
</extension>
<strength value="extensible"/>
<description
value="Codes identifying interpretations of observations."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/observation-interpretation"/>
</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.component:variant-confidence-status.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 might 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>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<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>
</snapshot>
<differential>
<element id="Observation">
<path value="Observation"/>
</element>
</differential>
</StructureDefinition>
IG © 2021+ HL7 International / Clinical Interoperability Council. Package hl7.fhir.uv.phenomics-exchange#0.1.0 based on FHIR 4.0.1. Generated 2024-06-18
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change