SARS-CoV-2-Erregernachweis

https://demis.rki.de/fhir/StructureDefinition/PathogenDetectionCVDP

Observation	I		Observation	There are no (further) constraints on this element Element id Observation Short description Measurements and simple assertions Alternate names Vital Signs, Measurement, Results, Tests Definition Measurements and simple assertions made about a patient, device or other subject. Comments 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. Data type Observation Constraints dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.empty()` dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()` dom-3: 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 `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()` dom-6: A resource should have narrative for robust management text.`div`.exists() dom-5: If a resource is contained in another resource, it SHALL NOT have a security label `contained.meta.security.empty()` obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present `value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()` obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present `dataAbsentReason.empty() or value.empty()` Mappings rim: Entity. Role, or Act workflow: Event sct-concept: < 363787002 \|Observable entity\| v2: OBX rim: Observation[classCode=OBS, moodCode=EVN]
id	Σ	0..1	string	There are no (further) constraints on this element Element id Observation.id Short description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. Comments The only time that a resource does not have an id is when it is being submitted to the server using a create operation. Data type string
meta	S Σ	1..1	Meta	There are no (further) constraints on this element Element id Observation.meta Short description Metadata about the resource Definition 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. Data type Meta Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
id		0..1	string	There are no (further) constraints on this element Element id Observation.meta.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.meta.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
versionId	Σ	0..1	id	There are no (further) constraints on this element Element id Observation.meta.versionId Short description Version specific identifier Definition The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted. Comments The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes. Data type id Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
lastUpdated	Σ	0..1	instant	There are no (further) constraints on this element Element id Observation.meta.lastUpdated Short description When the resource version last changed Definition When the resource last changed - e.g. when the version changed. Comments This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction. Data type instant Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
source	Σ	0..1	uri	There are no (further) constraints on this element Element id Observation.meta.source Short description Identifies where the resource comes from Definition A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc. Comments In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
profile	S Σ	1..1	canonical(StructureDefinition)Fixed Value	Element id Observation.meta.profile Short description Profiles this resource claims to conform to Definition A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url. Comments It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set. Data type canonical(StructureDefinition) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Fixed value https://demis.rki.de/fhir/StructureDefinition/PathogenDetectionCVDP Mappings rim: n/a
security	Σ	0..*	CodingBinding	There are no (further) constraints on this element Element id Observation.meta.security Short description Security Labels applied to this resource Definition Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure. Comments The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored. Data type Coding Binding Security Labels from the Healthcare Privacy and Security Classification System. All Security Labels (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
tag	Σ	0..*	Coding	There are no (further) constraints on this element Element id Observation.meta.tag Short description Tags applied to this resource Definition Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource. Comments The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored. Data type Coding Binding Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones". CommonTags (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
implicitRules	Σ ?!	0..1	uri	There are no (further) constraints on this element Element id Observation.implicitRules Short description A set of rules under which this content was created Definition 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. Comments 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. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
language		0..1	codeBinding	There are no (further) constraints on this element Element id Observation.language Short description Language of the resource content Definition The base language in which the resource is written. Comments 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). Data type code Binding A human language. CommonLanguages (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
text		0..1	Narrative	There are no (further) constraints on this element Element id Observation.text Short description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display Definition 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. Comments 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. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A rim: Act.text?
contained		0..*	Resource	There are no (further) constraints on this element Element id Observation.contained Short description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources Definition 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. Comments 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. Data type Resource Mappings rim: Entity. Role, or Act rim: N/A
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	?! I	0..*	Extension	There are no (further) constraints on this element Element id Observation.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content Definition 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). Requirements 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
identifier	Σ	0..*	Identifier	There are no (further) constraints on this element Element id Observation.identifier Short description Business Identifier for observation Definition A unique identifier assigned to this observation. Requirements Allows observations to be distinguished and referenced. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier workflow: Event.identifier w5: FiveWs.identifier v2: 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. rim: id
basedOn	Σ I	0..0	Reference(CarePlan \| DeviceRequest \| ImmunizationRecommendation \| MedicationRequest \| NutritionOrder \| ServiceRequest)	There are no (further) constraints on this element Element id Observation.basedOn Short description Fulfills plan, proposal or order Alternate names Fulfills Definition 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 Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(CarePlan \| DeviceRequest \| ImmunizationRecommendation \| MedicationRequest \| NutritionOrder \| ServiceRequest) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.basedOn v2: ORC rim: .inboundRelationship[typeCode=COMP].source[moodCode=EVN]
partOf	Σ I	0..0	Reference(MedicationAdministration \| MedicationDispense \| MedicationStatement \| Procedure \| Immunization \| ImagingStudy)	There are no (further) constraints on this element Element id Observation.partOf Short description Part of referenced event Alternate names Container Definition A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure. Comments To link an Observation to an Encounter use `encounter`. See the Notes below for guidance on referencing another Observation. Data type Reference(MedicationAdministration \| MedicationDispense \| MedicationStatement \| Procedure \| Immunization \| ImagingStudy) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.partOf v2: Varies by domain rim: .outboundRelationship[typeCode=FLFS].target
status	S Σ ?!	1..1	codeBinding	There are no (further) constraints on this element Element id Observation.status Short description Status des Erregernachweis-Ergebnisses Definition Status des Erregernachweis-Ergenisses Requirements Need to track the status of individual results. Some results are finalized before the whole report is finalized. Comments Der Status ist szenarienspezifisch folgendermaßen zu belegen: amended - bei einer Korrekturmeldung; final - in allen anderen Fällen Data type code Binding Status des Erregernachweis PathogenDetectionStatus (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a workflow: Event.status w5: FiveWs.status sct-concept: < 445584004 \|Report by finality status\| v2: OBX-11 rim: status Amended & Final are differentiated by whether it is the subject of a ControlAct event with a type of "revise"
category	S	1..1	CodeableConceptBinding	There are no (further) constraints on this element Element id Observation.category Short description Klassifikation des Nachweises Definition Klassifikation der durchgeführten Untersuchung. Für DEMIS ist die entsprechende Klassifikation grundsätzlich mit dem Wert „laboratory“ aus dem entsprechend hinterlegten ValueSet zu belegen. Requirements Used for filtering what observations are retrieved and displayed. Comments 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. Data type CodeableConcept Binding Codes for high level observation categories. ObservationCategoryCodes (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD w5: FiveWs.class rim: .outboundRelationship[typeCode="COMP].target[classCode="LIST", moodCode="EVN"].code
id		0..1	string	There are no (further) constraints on this element Element id Observation.category.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.category.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
coding	S Σ	1..1	CodingPattern	There are no (further) constraints on this element Element id Observation.category.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments 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. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Pattern { "system": "http://terminology.hl7.org/CodeSystem/observation-category", "code": "laboratory" } Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
text	Σ	0..1	string	There are no (further) constraints on this element Element id Observation.category.text Short description Plain text representation of the concept Definition 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. Requirements 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. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
code	S Σ I	1..1	CodeableConcept	Element id Observation.code Short description Typ des durchgeführten Labortests. Alternate names Name Definition Typ des durchgeführten Labortests. Der Wert muss als LOINC-Code - entsprechend des vom RKI definierten und in regelmäßigen Abständen aktualisierten ValueSets (https://demis.rki.de/fhir/ValueSet/laboratoryTest) – im coding Element dargestellt werden. Für eine begrenzte Übergangszeit ist die Verwendung des text Elementes in Ausnahmefällen zulässig. Folgende Ausbaustufen des Systems werden hier jedoch deutlich restriktiver sein, um einen automatisierte Weiterverarbeitung der Inhalte im Gesundheitsamt zu ermöglichen. Um SARS-CoV-2-Mutationen und -Varianten zu melden sind folgende LOINC Codes zu verwenden: Für den Nachweis einer Variante mittels Sequenzierung ist der LOINC code 96741-4 (https://loinc.org/96741-4/) zu verwenden. Die Variante soll als valueString in der PANGOLIN Notation angegeben werden. Für den Nachweis einzelner Mutationen im Spike protein (S Gen) ist der LOINC-Code 96751-3 (https://loinc.org/96751-3/) zu verwenden. Mutationen sollen in der Notation entsprechend der Empfehlungen der Human Genome Variation Society (HGVS) als valueString angegeben werden. Requirements Knowing what kind of observation is being made is essential to understanding the observation. Comments 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. Data type CodeableConcept Binding Codes identifying names of simple observations. LOINCCodes (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` codingOrText: Entweder coding oder text muss angegeben sein. `coding.empty() or text.empty()` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD workflow: Event.code w5: FiveWs.what[x] sct-concept: < 363787002 \|Observable entity\| OR < 386053000 \|Evaluation procedure\| v2: OBX-3 rim: code sct-attr: 116680003 \|Is a\|
id		0..1	string	There are no (further) constraints on this element Element id Observation.code.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.code.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
coding	Σ	0..1	CodingBinding	Element id Observation.code.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments 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. Data type Coding Binding LaboratoryTestCVDP (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id Observation.code.coding.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.code.coding.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
system	S Σ	1..1	uriFixed Value	There are no (further) constraints on this element Element id Observation.code.coding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Fixed value http://loinc.org Mappings rim: n/a v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id Observation.code.coding.version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	S Σ	1..1	code	There are no (further) constraints on this element Element id Observation.code.coding.code Short description Symbol in syntax defined by the system Definition A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Requirements Need to refer to a particular code in the system. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
display	Σ	0..1	string	There are no (further) constraints on this element Element id Observation.code.coding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id Observation.code.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	Σ	0..1	string	There are no (further) constraints on this element Element id Observation.code.text Short description Plain text representation of the concept Definition 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. Requirements 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. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
subject	S Σ I	1..1	Reference(package/StructureDefinition-NotifiedPerson.json \| package/StructureDefinition-NotifiedPersonNotByName.json)	There are no (further) constraints on this element Element id Observation.subject Short description Verweis auf die in der Meldung benannte betroffene Person. Definition Verweis auf die in der Meldung benannte betroffene Person. Hierbei handelt es sich grundsätzlich um den Verweis auf die in der Erregernachweismeldung als „subject“ referenzierte Patient Ressource. Requirements Observations have no value if you don't know who or what they're about. Comments 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. Data type Reference(package/StructureDefinition-NotifiedPerson.json \| package/StructureDefinition-NotifiedPersonNotByName.json) Allowed aggregation: bundled Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.subject w5: FiveWs.subject[x] v2: PID-3 rim: participation[typeCode=RTGT] w5: FiveWs.subject
id		0..1	string	There are no (further) constraints on this element Element id Observation.subject.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.subject.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
reference	S Σ I	1..1	string	There are no (further) constraints on this element Element id Observation.subject.reference Short description Literal reference, Relative, internal or absolute URL Definition A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources. Comments Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
type	Σ	0..1	uriBinding	There are no (further) constraints on this element Element id Observation.subject.type Short description Type the reference refers to (e.g. "Patient") Definition The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent. The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources). Comments This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified. Data type uri Binding Aa resource (or, for logical models, the URI of the logical model). ResourceType (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
identifier	Σ	0..1	Identifier	There are no (further) constraints on this element Element id Observation.subject.identifier Short description Logical reference, when literal reference is not known Definition An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference. Comments When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it. Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation\|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any). Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier rim: .identifier
display	Σ	0..1	string	There are no (further) constraints on this element Element id Observation.subject.display Short description Text alternative for the resource Definition Plain text narrative that identifies the resource in addition to the resource reference. Comments This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
focus	Σ I	0..0	Reference(Resource)	There are no (further) constraints on this element Element id Observation.focus Short description What the observation is about, when it is not about the subject of record Definition 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. Comments 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. Data type Reference(Resource) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5: FiveWs.subject[x] v2: OBX-3 rim: participation[typeCode=SBJ] w5: FiveWs.subject
encounter	Σ I	0..0	Reference(Encounter)	There are no (further) constraints on this element Element id Observation.encounter Short description Healthcare event during which this observation is made Alternate names Context Definition The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made. Requirements For some observations it may be important to know the link between an observation and a particular encounter. Comments 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). Data type Reference(Encounter) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.context w5: FiveWs.context v2: PV1 rim: inboundRelationship[typeCode=COMP].source[classCode=ENC, moodCode=EVN]
effective[x]	Σ	0..0		There are no (further) constraints on this element Element id Observation.effective[x] Short description Clinically relevant time/time-period for observation Alternate names Occurrence Definition 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. Requirements Knowing when an observation was deemed true is important to its relevance as well as determining trends. Comments 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 datatype which allow the measurement to be tied to regular life events. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a workflow: Event.occurrence[x] w5: FiveWs.done[x] v2: OBX-14, and/or OBX-19 after v2.4 (depends on who observation made) rim: effectiveTime
issued	Σ	0..0	instant	There are no (further) constraints on this element Element id Observation.issued Short description Date/Time this version was made available Definition The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified. Comments For Observations that don’t require review and verification, it may be the same as the `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. Data type instant Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.recorded v2: OBR.22 (or MSH.7), or perhaps OBX-19 (depends on who observation made) rim: participation[typeCode=AUT].time
performer	Σ I	0..0	Reference(Practitioner \| PractitionerRole \| Organization \| CareTeam \| Patient \| RelatedPerson)	There are no (further) constraints on this element Element id Observation.performer Short description Who is responsible for the observation Definition Who was responsible for asserting the observed value as "true". Requirements May give a degree of confidence in the observation and also indicates where follow-up questions should be directed. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Practitioner \| PractitionerRole \| Organization \| CareTeam \| Patient \| RelatedPerson) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.performer.actor w5: FiveWs.actor v2: 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' rim: participation[typeCode=PRF]
value[x]	S Σ I	1..1		There are no (further) constraints on this element Element id Observation.value[x] Short description Ergebnis des durchgeführten Labortests. Definition Ergebnis des durchgeführten Labortests. Für qualitative Tests muss valueCodableConcept mit einem Code aus der AnswerList genutzt werden. Wir verweisen dazu in erster Linie auf die hinterlegte Answercodeliste im Implementierungsleitfaden (https://simplifier.net/guide/rki.demis.laboratory/Home/resources/terminologies/valuesets/answerSet?version=current) oder auf die für den jeweiligen Labortestest auf loinc.org hinterlegten Answer-Codes. Für quantitative Tests muss valueQuantity genutzt werden. Siehe auch https://wiki.gematik.de/display/DSKB/Implementierungshinweise+zur+Labormeldung. Für eine begrenzte Übergangszeit ist die Verwendung von valueString in Ausnahmefällen zulässig. Folgende Ausbaustufen des Systems werden hier jedoch deutlich restriktiver sein, um einen automatisierte Weiterverarbeitung der Inhalte im Gesundheitsamt zu ermöglichen. Requirements An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations. Comments 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 below. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a sct-concept: < 441742003 \|Evaluation finding\| v2: OBX.2, OBX.5, OBX.6 rim: value sct-attr: 363714003 \|Interprets\|
valueQuantity			Quantity	There are no (further) constraints on this element Data type Quantity
valueCodeableConcept			CodeableConcept	There are no (further) constraints on this element Data type CodeableConcept
valueString			string	There are no (further) constraints on this element Data type string
dataAbsentReason	I	0..0	CodeableConceptBinding	There are no (further) constraints on this element Element id Observation.dataAbsentReason Short description Why the result is missing Definition Provides a reason why the expected value in the element Observation.value[x] is missing. Requirements For many results it is necessary to handle exceptional values in measurements. Comments 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. Data type CodeableConcept Binding Codes specifying why the result (`Observation.value[x]`) is missing. DataAbsentReason (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD v2: N/A rim: value.nullFlavor
interpretation	S	1..*	CodeableConceptBinding	There are no (further) constraints on this element Element id Observation.interpretation Short description Interpretation des Testergebnisses Alternate names Abnormal Flag Definition Interpretation des Testergebnisses. Mindestens eine vollständig kodierte Interpretation des Testergebnisses, die Auskunft über die Bewertung in Bezug auf die Festlegung der Meldetatbestände gemäß IfSG gibt, muss angegeben werden. Relevante Codes sind POS für positive direkte oder indirekte Erregernachweise, NEG für negative und IND für unbestimmte Ergebnisse. Requirements For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result. Comments 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. Data type CodeableConcept Binding Codes identifying interpretations of observations. ObservationInterpretationCodes (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD sct-concept: < 260245000 \|Findings values\| v2: OBX-8 rim: interpretationCode sct-attr: 363713009 \|Has interpretation\|
id		0..1	string	There are no (further) constraints on this element Element id Observation.interpretation.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.interpretation.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
coding	Σ	0..*	Coding	There are no (further) constraints on this element Element id Observation.interpretation.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments 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. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id Observation.interpretation.coding.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.interpretation.coding.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
system	S Σ	1..1	uri	There are no (further) constraints on this element Element id Observation.interpretation.coding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id Observation.interpretation.coding.version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	S Σ	1..1	code	There are no (further) constraints on this element Element id Observation.interpretation.coding.code Short description Symbol in syntax defined by the system Definition A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Requirements Need to refer to a particular code in the system. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
display	Σ	0..1	string	There are no (further) constraints on this element Element id Observation.interpretation.coding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id Observation.interpretation.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	Σ	0..1	string	There are no (further) constraints on this element Element id Observation.interpretation.text Short description Plain text representation of the concept Definition 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. Requirements 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. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
note	S	0..*	Annotation	There are no (further) constraints on this element Element id Observation.note Short description Textuelle Hinweise zum Untersuchungsergebnis. Definition Textuelle Hinweise zum Untersuchungsergebnis, die dem Gesundheitsamt eine bessere Bewertung der Ergebnisse ermöglichen. Requirements Need to be able to provide free text additional information. Comments 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. Data type Annotation Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act v2: NTE.3 (partner NTE to OBX, or sometimes another (child?) OBX) rim: subjectOf.observationEvent[code="annotation"].value
id		0..1	string	There are no (further) constraints on this element Element id Observation.note.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.note.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
author[x]	Σ	0..1		There are no (further) constraints on this element Element id Observation.note.author[x] Short description Individual responsible for the annotation Definition The individual responsible for making the annotation. Comments Organization is used when there's no need for specific attribution as to who made the comment. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.participant[typeCode=AUT].role
authorString			string	There are no (further) constraints on this element Data type string
authorReference			Reference(Practitioner \| Patient \| RelatedPerson \| Organization)	There are no (further) constraints on this element Data type Reference(Practitioner \| Patient \| RelatedPerson \| Organization)
time	Σ	0..1	dateTime	There are no (further) constraints on this element Element id Observation.note.time Short description When the annotation was made Definition Indicates when this particular annotation was made. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.effectiveTime
text	S Σ	1..1	markdown	There are no (further) constraints on this element Element id Observation.note.text Short description The annotation - text content (as markdown) Definition The text of the annotation in markdown format. Comments Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/ Data type markdown Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act.text
bodySite		0..0	CodeableConcept	There are no (further) constraints on this element Element id Observation.bodySite Short description Observed body part Definition Indicates the site on the subject's body where the observation was made (i.e. the target site). Comments 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. Data type CodeableConcept Binding Codes describing anatomical locations. May include laterality. SNOMEDCTBodyStructures (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD sct-concept: < 123037004 \|Body structure\| v2: OBX-20 rim: targetSiteCode sct-attr: 718497002 \|Inherent location\|
method	S I	0..1	CodeableConcept	There are no (further) constraints on this element Element id Observation.method Short description Angaben zur genutzten Nachweismethode. Definition Angaben zur genutzten Nachweismethode. Über die im Observation.code verschlüsselte Nachweismethode hinaus, sollen dem öffentlichen Gesundheitsdienst detaillierte Angaben zur jeweils genutzten Nachweismethode bereitgestellt werden. Sofern verfügbar, ist einer der durch das RKI definierten Codes aus dem referenzierten ValueSet zu verwenden. Requirements In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results. Comments Die Angabe der Nachweismethode unter Verwendung von method.text ist in folgenden zwei Ausnahmefällen zulässig: Die Nachweismethode ist in dem ValueSet https://demis.rki.de/fhir/ValueSet/method nicht enthalten. Bitte geben Sie Feedback an DEMIS (demis-support@rki.de), damit das ValueSet ergänzt werden kann. Das Primärsystem kann die internen Codes zur Zeit noch nicht korrekt auf die SNOMED-Codes des ValueSets https://demis.rki.de/fhir/ValueSet/method mappen. Data type CodeableConcept Binding Methods for simple observations. ObservationMethods (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` codingOrText: Entweder coding oder text muss angegeben sein. `coding.empty() or text.empty()` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD v2: OBX-17 rim: methodCode
id		0..1	string	There are no (further) constraints on this element Element id Observation.method.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.method.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
coding	Σ	0..1	CodingBinding	There are no (further) constraints on this element Element id Observation.method.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments 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. Data type Coding Binding Method (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id Observation.method.coding.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.method.coding.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
system	S Σ	1..1	uri	There are no (further) constraints on this element Element id Observation.method.coding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id Observation.method.coding.version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	S Σ	1..1	code	There are no (further) constraints on this element Element id Observation.method.coding.code Short description Symbol in syntax defined by the system Definition A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Requirements Need to refer to a particular code in the system. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
display	Σ	0..1	string	There are no (further) constraints on this element Element id Observation.method.coding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id Observation.method.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	Σ	0..1	string	There are no (further) constraints on this element Element id Observation.method.text Short description Plain text representation of the concept Definition 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. Requirements 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. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
specimen	S I	1..1	Reference(Probe für Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2))	Element id Observation.specimen Short description Verweis auf die dem Labortest zugrundeliegende Probe. Definition Verweis auf die dem Labortest zugrundeliegende Probe. Über die Probe können Angaben zum verwendeten Material und deren Einsender gemacht werden. Comments 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). Data type Reference(Probe für Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2)) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) sct-concept: < 123038009 \|Specimen\| v2: SPM segment rim: participation[typeCode=SPC].specimen sct-attr: 704319004 \|Inherent in\|
device	I	0..1	Reference(Device \| DeviceMetric)	There are no (further) constraints on this element Element id Observation.device Short description (Measurement) Device Definition The device used to generate the observation data. Comments 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. Data type Reference(Device \| DeviceMetric) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) sct-concept: < 49062001 \|Device\| v2: OBX-17 / PRT -10 rim: participation[typeCode=DEV] sct-attr: 424226004 \|Using device\|
referenceRange	I	0..0	BackboneElement	There are no (further) constraints on this element Element id Observation.referenceRange Short description Provides guide for interpretation Definition 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. Requirements 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. Comments 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. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` obs-3: Must have at least a low or a high or text `low.exists() or high.exists() or text.exists()` Mappings rim: n/a v2: OBX.7 rim: outboundRelationship[typeCode=REFV]/target[classCode=OBS, moodCode=EVN]
hasMember	Σ I	0..0	Reference(Observation \| QuestionnaireResponse \| MolecularSequence)	There are no (further) constraints on this element Element id Observation.hasMember Short description Related resource that belongs to the Observation group Definition 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. Comments 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 below. Note that a system may calculate results from QuestionnaireResponse into a final score and represent the score as an Observation. Data type Reference(Observation \| QuestionnaireResponse \| MolecularSequence) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) v2: Relationships established by OBX-4 usage rim: outBoundRelationship
derivedFrom	Σ I	0..*	Reference(DocumentReference \| ImagingStudy \| Media \| QuestionnaireResponse \| Observation \| MolecularSequence)	There are no (further) constraints on this element Element id Observation.derivedFrom Short description Related measurements the observation is made from Definition 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. Comments 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 below. Data type Reference(DocumentReference \| ImagingStudy \| Media \| QuestionnaireResponse \| Observation \| MolecularSequence) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) v2: Relationships established by OBX-4 usage rim: .targetObservation
component	Σ	0..0	BackboneElement	There are no (further) constraints on this element Element id Observation.component Short description Component results Definition 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. Requirements 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. Comments For a discussion on the ways Observations can be assembled in groups together see Notes below. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: containment by OBX-4? rim: outBoundRelationship[typeCode=COMP]

Beispiele:

Nachweis der britischen Variante B.1.1.7 mittels Ganzgenomsequenzierung

Für den Nachweis einer Variante mittels Sequenzierung ist der LOINC code 96741-4 zu verwenden. Varianten sollen als valueString in der PANGOLIN Notation angegeben werden. Die PANGOLIN Notation setzt sich aus einem Buchstaben, gefolgt von maximal drei Zahlen – getrennt durch einen Punkt – zusammen.

<Observation xmlns="http://hl7.org/fhir">
    <id value="PathogenDetection-B.1.1.7-example" />
    <meta>
        <profile value="https://demis.rki.de/fhir/StructureDefinition/PathogenDetectionCVDP" />
    </meta>
    <status value="final" />
    <category>
        <coding>
            <system value="http://terminology.hl7.org/CodeSystem/observation-category" />
            <code value="laboratory" />
        </coding>
    </category>
    <code>
        <coding>
            <system value="http://loinc.org" />
            <code value="96741-4" />
            <display value="SARS-CoV-2 (COVID-19) variant Sequencing Nom (Specimen)" />
        </coding>
    </code>
    <subject>
        <reference value="Patient/113de363-be19-46b4-8364-71416c7e662b" />
    </subject>
    <valueString value="#B.1.1.7" />
    <interpretation>
        <coding>
            <system value="http://terminology.hl7.org/CodeSystem/v3-ObservationInterpretation" />
            <code value="POS" />
        </coding>
    </interpretation>
    <note>
        <text value="Ich bin ein optionaler beschreibender Text ..." />
    </note>
    <method>
        <coding>
            <system value="http://snomed.info/sct" />
            <code value="115418004" />
            <display value="Viral Sequencing (procedure)" />
        </coding>
    </method>
    <specimen>
        <reference value="Specimen/47d61bca-9c53-4422-bb33-3621da084bf4" />
    </specimen>
</Observation>

Nachweis der N501Y Mutation

Für den Nachweis einzelner Mutationen im Spike protein (S Gen) z.B. mittels einer Target-PCR ist der LOINC-Code 96751-3 zu verwenden. Mutationen sollen in der Notation entsprechend der Empfehlungen der Human Genome Variation Society (HGVS) in einem valueString angegeben werden.

<Observation xmlns="http://hl7.org/fhir">
    <id value="PathogenDetection-N501Y-example" />
    <meta>
        <profile value="https://demis.rki.de/fhir/StructureDefinition/PathogenDetectionCVDP" />
    </meta>
    <status value="final" />
    <category>
        <coding>
            <system value="http://terminology.hl7.org/CodeSystem/observation-category" />
            <code value="laboratory" />
        </coding>
    </category>
    <code>
        <coding>
            <system value="http://loinc.org" />
            <code value="96751-3" />
            <display value="SARS-CoV-2 (COVID-19) S gene mutation detected Molgen Nom (Specimen)" />
        </coding>
    </code>
    <subject>
        <reference value="Patient/113de363-be19-46b4-8364-71416c7e662b" />
    </subject>
    <valueString value="N501Y" />
    <interpretation>
        <coding>
            <system value="http://terminology.hl7.org/CodeSystem/v3-ObservationInterpretation" />
            <code value="POS" />
        </coding>
    </interpretation>
    <note>
        <text value="Ich bin ein optionaler beschreibender Text ..." />
    </note>
    <specimen>
        <reference value="Specimen/47d61bca-9c53-4422-bb33-3621da084bf4" />
    </specimen>
</Observation>

Nachweis der britischen Variante B.1.1.7 mittels Target-PCR

Um eine Variante mit einer gewissen Wahrscheinlichkeit mittels einzelner Mutationen zu bestimmen, werden eine oder mehrere Target-PCRs durchgeführt. Im valueString werden die ermittelten Mutationen - getrennt durch ein Semikolon - aufgelistet und die wahrscheinliche Variante in PANGOLIN Notation - beginnend mit einem Doppelkreuz - angehängt.

<Observation xmlns="http://hl7.org/fhir">
    <id value="PathogenDetection-B.1.1.7-example-2" />
    <meta>
        <profile value="https://demis.rki.de/fhir/StructureDefinition/PathogenDetectionCVDP" />
    </meta>
    <status value="final" />
    <category>
        <coding>
            <system value="http://terminology.hl7.org/CodeSystem/observation-category" />
            <code value="laboratory" />
        </coding>
    </category>
    <code>
        <coding>
            <system value="http://loinc.org" />
            <code value="96751-3" />
            <display value="SARS-CoV-2 (COVID-19) S gene mutation detected Molgen Nom (Specimen)" />
        </coding>
    </code>
    <subject>
        <reference value="Patient/113de363-be19-46b4-8364-71416c7e662b" />
    </subject>
    <valueString value="N501Y;H69_V70del#B.1.1.7" />
    <interpretation>
        <coding>
            <system value="http://terminology.hl7.org/CodeSystem/v3-ObservationInterpretation" />
            <code value="POS" />
        </coding>
    </interpretation>
    <note>
        <text value="Ich bin ein optionaler beschreibender Text ..." />
    </note>
    <specimen>
        <reference value="Specimen/47d61bca-9c53-4422-bb33-3621da084bf4" />
    </specimen>
</Observation>

Angabe des CT-Wertes

Hinweis: valueString wie hier angegeben, KANN NOCH, ABER SOLL ZUKÜNFTIG NICH MEHR VERWENDET WERDEN. Stattdessen soll valueQuantity wie in folgendem Beispiel genutz werden:

<Observation xmlns="http://hl7.org/fhir">
    <id value="PathogenDetection-CT-example" />
    <meta>
        <profile value="https://demis.rki.de/fhir/StructureDefinition/PathogenDetectionCVDP" />
    </meta>
    <status value="final" />
    <category>
        <coding>
            <system value="http://terminology.hl7.org/CodeSystem/observation-category" />
            <code value="laboratory" />
        </coding>
    </category>
    <code>
        <coding>
            <system value="http://loinc.org" />
            <code value="96764-6" />
            <display value="SARS-CoV-2 (COVID-19) E gene [Cycle Threshold #] in Respiratory specimen by NAA with probe detection" />
        </coding>
    </code>
    <subject>
        <reference value="Patient/113de363-be19-46b4-8364-71416c7e662b" />
    </subject>
    <valueQuantity>
        <value value="30" />
        <comparator value="&lt;" />
        <unit value="Cycles" />
        <system value="http://unitsofmeasure.org" />
        <code value="{Ct_value}" />
    </valueQuantity>
    <interpretation>
        <coding>
            <system value="http://terminology.hl7.org/CodeSystem/v3-ObservationInterpretation" />
            <code value="POS" />
        </coding>
    </interpretation>
    <specimen>
        <reference value="Specimen/47d61bca-9c53-4422-bb33-3621da084bf4" />
    </specimen>
</Observation>

Angabe der SARS-CoV-2-Virusmenge (Kopien/ml)

<Observation xmlns="http://hl7.org/fhir">
    <id value="PathogenDetection-viralLoad-example" />
    <meta>
        <profile value="https://demis.rki.de/fhir/StructureDefinition/PathogenDetectionCVDP" />
    </meta>
    <status value="final" />
    <category>
        <coding>
            <system value="http://terminology.hl7.org/CodeSystem/observation-category" />
            <code value="laboratory" />
        </coding>
    </category>
    <code>
        <coding>
            <system value="http://loinc.org" />
            <code value="95522-9" />
            <display value="SARS-CoV-2 (COVID-19) N gene [Log #/volume] (viral load) in Respiratory specimen by NAA with probe detection" />
        </coding>
    </code>
    <subject>
        <reference value="Patient/113de363-be19-46b4-8364-71416c7e662b" />
    </subject>
    <valueString value="&gt;106/ml" />
    <interpretation>
        <coding>
            <system value="http://terminology.hl7.org/CodeSystem/v3-ObservationInterpretation" />
            <code value="POS" />
        </coding>
    </interpretation>
    <specimen>
        <reference value="Specimen/47d61bca-9c53-4422-bb33-3621da084bf4" />
    </specimen>
</Observation>