SARS-CoV-2-Erregernachweis
https://demis.rki.de/fhir/StructureDefinition/PathogenDetectionSARSCoV2
| PathogenDetectionSARSCoV2 (Observation) | I | Erregernachweis | There are no (further) constraints on this element Element idObservation Measurements and simple assertions Alternate namesVital Signs, Measurement, Results, Tests DefinitionMeasurements and simple assertions made about a patient, device or other subject. 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.
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| id | Σ | 0..1 | string | There are no (further) constraints on this element Element idObservation.id Logical id of this artifact DefinitionThe logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. The only time that a resource does not have an id is when it is being submitted to the server using a create operation. |
| meta | Σ | 0..1 | Meta | There are no (further) constraints on this element Element idObservation.meta Metadata about the resource DefinitionThe 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.
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| implicitRules | Σ ?! | 0..1 | uri | There are no (further) constraints on this element Element idObservation.implicitRules A set of rules under which this content was created DefinitionA 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. 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.
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| language | 0..1 | codeBinding | There are no (further) constraints on this element Element idObservation.language Language of the resource content DefinitionThe base language in which the resource is written. 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). A human language.
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| text | 0..1 | Narrative | There are no (further) constraints on this element Element idObservation.text Text summary of the resource, for human interpretation Alternate namesnarrative, html, xhtml, display DefinitionA 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. 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.
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| contained | 0..* | Resource | There are no (further) constraints on this element Element idObservation.contained Contained, inline Resources Alternate namesinline resources, anonymous resources, contained resources DefinitionThese 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. 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.
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| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idObservation.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay 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. 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.
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| modifierExtension | ?! I | 0..* | Extension | There are no (further) constraints on this element Element idObservation.modifierExtension Extensions that cannot be ignored Alternate namesextensions, user content DefinitionMay 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). 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. 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.
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| identifier | Σ | 0..0 | Identifier | There are no (further) constraints on this element Element idObservation.identifier Business Identifier for observation DefinitionA unique identifier assigned to this observation. Allows observations to be distinguished and referenced.
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| basedOn | Σ | 0..0 | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | There are no (further) constraints on this element Element idObservation.basedOn Fulfills plan, proposal or order Alternate namesFulfills DefinitionA 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. Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon. Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Constraints
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| partOf | Σ | 0..0 | Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) | There are no (further) constraints on this element Element idObservation.partOf Part of referenced event Alternate namesContainer DefinitionA larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure. To link an Observation to an Encounter use Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) Constraints
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| status | Σ ?! | 1..1 | codeBinding | There are no (further) constraints on this element Element idObservation.status Status des Erregernachweis-Ergebnisses. DefinitionStatus des Erregernachweis-Ergenisses. Für DEMIS ist der Status grundsätzlich mit dem Wert „final“ aus dem entsprechend hinterlegten ValueSet zu belegen. Need to track the status of individual results. Some results are finalized before the whole report is finalized. This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid. Codes providing the status of an observation.
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| category | 1..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idObservation.category Klassifikation des Nachweises DefinitionKlassifikation der durchgeführten Untersuchung. Für DEMIS ist die entsprechende Klassifikation grundsätzlich mit dem Wert „laboratory“ aus dem entsprechend hinterlegten ValueSet zu belegen. Used for filtering what observations are retrieved and displayed. 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. Codes for high level observation categories.
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| id | 0..1 | string | There are no (further) constraints on this element Element idObservation.category.id Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idObservation.category.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay 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. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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| coding | Σ | 1..1 | Coding | There are no (further) constraints on this element Element idObservation.category.coding Code defined by a terminology system DefinitionA reference to a code defined by a terminology system. Allows for alternative encodings within a code system, and translations to other code systems. 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.
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| id | 0..1 | string | There are no (further) constraints on this element Element idObservation.category.coding.id Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idObservation.category.coding.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay 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. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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| system | Σ | 1..1 | uriFixed Value | There are no (further) constraints on this element Element idObservation.category.coding.system Identity of the terminology system DefinitionThe identification of the code system that defines the meaning of the symbol in the code. Need to be unambiguous about the source of the definition of the symbol. 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.
http://terminology.hl7.org/CodeSystem/observation-category
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| version | Σ | 0..1 | string | There are no (further) constraints on this element Element idObservation.category.coding.version Version of the system - if relevant DefinitionThe 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. 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.
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| code | Σ | 1..1 | codeFixed Value | There are no (further) constraints on this element Element idObservation.category.coding.code Symbol in syntax defined by the system DefinitionA 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). Need to refer to a particular code in the system.
laboratory
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| display | Σ | 0..1 | string | There are no (further) constraints on this element Element idObservation.category.coding.display Representation defined by the system DefinitionA representation of the meaning of the code in the system, following the rules of the system. Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
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| userSelected | Σ | 0..1 | boolean | There are no (further) constraints on this element Element idObservation.category.coding.userSelected If this coding was chosen directly by the user DefinitionIndicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). 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. 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.
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| text | Σ | 0..1 | string | There are no (further) constraints on this element Element idObservation.category.text Plain text representation of the concept DefinitionA 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. 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. Very often the text is the same as a displayName of one of the codings.
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| code | Σ I | 1..1 | CodeableConcept | There are no (further) constraints on this element Element idObservation.code Typ des durchgeführten Labortests. Alternate namesName DefinitionTyp 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. Knowing what kind of observation is being made is essential to understanding the observation. 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. Codes identifying names of simple observations.
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| id | 0..1 | string | There are no (further) constraints on this element Element idObservation.code.id Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idObservation.code.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay 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. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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| coding | Σ | 0..1 | CodingBinding | Element idObservation.code.coding Code defined by a terminology system DefinitionA reference to a code defined by a terminology system. Allows for alternative encodings within a code system, and translations to other code systems. 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. LaboratoryTestSARSCoV2 (extensible) Constraints
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| id | 0..1 | string | There are no (further) constraints on this element Element idObservation.code.coding.id Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idObservation.code.coding.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay 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. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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| system | Σ | 1..1 | uri | There are no (further) constraints on this element Element idObservation.code.coding.system Identity of the terminology system DefinitionThe identification of the code system that defines the meaning of the symbol in the code. Need to be unambiguous about the source of the definition of the symbol. 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.
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| version | Σ | 0..1 | string | There are no (further) constraints on this element Element idObservation.code.coding.version Version of the system - if relevant DefinitionThe 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. 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.
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| code | Σ | 1..1 | code | There are no (further) constraints on this element Element idObservation.code.coding.code Symbol in syntax defined by the system DefinitionA 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). Need to refer to a particular code in the system.
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| display | Σ | 0..1 | string | There are no (further) constraints on this element Element idObservation.code.coding.display Representation defined by the system DefinitionA representation of the meaning of the code in the system, following the rules of the system. Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
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| userSelected | Σ | 0..1 | boolean | There are no (further) constraints on this element Element idObservation.code.coding.userSelected If this coding was chosen directly by the user DefinitionIndicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). 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. 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.
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| text | Σ | 0..1 | string | There are no (further) constraints on this element Element idObservation.code.text Plain text representation of the concept DefinitionA 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. 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. Very often the text is the same as a displayName of one of the codings.
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| subject | Σ | 1..1 | Reference(Betroffene Person) | There are no (further) constraints on this element Element idObservation.subject Verweis auf die in der Meldung benannte betroffene Person. DefinitionVerweis 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. Observations have no value if you don't know who or what they're about. 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. Allowed aggregation: bundled Constraints
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| id | 0..1 | string | There are no (further) constraints on this element Element idObservation.subject.id Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idObservation.subject.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay 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. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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| reference | Σ I | 1..1 | string | There are no (further) constraints on this element Element idObservation.subject.reference Literal reference, Relative, internal or absolute URL DefinitionA 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. 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.
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| type | Σ | 0..1 | uriBinding | There are no (further) constraints on this element Element idObservation.subject.type Type the reference refers to (e.g. "Patient") DefinitionThe 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). 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. Aa resource (or, for logical models, the URI of the logical model).
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| identifier | Σ | 0..1 | Identifier | There are no (further) constraints on this element Element idObservation.subject.identifier Logical reference, when literal reference is not known DefinitionAn 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. 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).
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| display | Σ | 0..1 | string | There are no (further) constraints on this element Element idObservation.subject.display Text alternative for the resource DefinitionPlain text narrative that identifies the resource in addition to the resource reference. 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.
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| focus | Σ | 0..0 | Reference(Resource) | There are no (further) constraints on this element Element idObservation.focus What the observation is about, when it is not about the subject of record DefinitionThe 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. 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
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| encounter | Σ | 0..0 | Reference(Encounter) | There are no (further) constraints on this element Element idObservation.encounter Healthcare event during which this observation is made Alternate namesContext DefinitionThe healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made. For some observations it may be important to know the link between an observation and a particular encounter. 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).
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| effective[x] | Σ | 0..0 | There are no (further) constraints on this element Element idObservation.effective[x] Clinically relevant time/time-period for observation Alternate namesOccurrence DefinitionThe 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. Knowing when an observation was deemed true is important to its relevance as well as determining trends. 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.
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| issued | Σ | 0..0 | instant | There are no (further) constraints on this element Element idObservation.issued Date/Time this version was made available DefinitionThe date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified. For Observations that don’t require review and verification, it may be the same as the
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| performer | Σ | 0..0 | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | There are no (further) constraints on this element Element idObservation.performer Who is responsible for the observation DefinitionWho was responsible for asserting the observed value as "true". May give a degree of confidence in the observation and also indicates where follow-up questions should be directed. Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Constraints
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| value[x] | Σ I | 1..1 | There are no (further) constraints on this element Element idObservation.value[x] Ergebnis des durchgeführten Labortests. DefinitionErgebnis des durchgeführten Labortests. Für qualitative Tests muss valueCodableConcept mit einem Code aus der AnswerList genutzt werden, welche für den jeweiligen Test (vgl. Observation.code) im LOINC hinterlegt ist. Für quantitative Tests muss valueQuantity genutzt werden. 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. An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations. 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.
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| valueQuantity | Quantity | There are no (further) constraints on this element Data type | ||
| valueCodeableConcept | CodeableConcept | There are no (further) constraints on this element Data type | ||
| valueString | string | There are no (further) constraints on this element Data type | ||
| dataAbsentReason | I | 0..0 | CodeableConceptBinding | There are no (further) constraints on this element Element idObservation.dataAbsentReason Why the result is missing DefinitionProvides a reason why the expected value in the element Observation.value[x] is missing. For many results it is necessary to handle exceptional values in measurements. 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. Codes specifying why the result (
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| interpretation | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element idObservation.interpretation Interpretation des Testergebnisses Alternate namesAbnormal Flag DefinitionInterpretation 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. For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result. 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. Codes identifying interpretations of observations.
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| id | 0..1 | string | There are no (further) constraints on this element Element idObservation.interpretation.id Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idObservation.interpretation.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay 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. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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| coding | Σ | 0..* | Coding | There are no (further) constraints on this element Element idObservation.interpretation.coding Code defined by a terminology system DefinitionA reference to a code defined by a terminology system. Allows for alternative encodings within a code system, and translations to other code systems. 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.
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| id | 0..1 | string | There are no (further) constraints on this element Element idObservation.interpretation.coding.id Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idObservation.interpretation.coding.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay 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. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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| system | Σ | 1..1 | uri | There are no (further) constraints on this element Element idObservation.interpretation.coding.system Identity of the terminology system DefinitionThe identification of the code system that defines the meaning of the symbol in the code. Need to be unambiguous about the source of the definition of the symbol. 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.
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| version | Σ | 0..1 | string | There are no (further) constraints on this element Element idObservation.interpretation.coding.version Version of the system - if relevant DefinitionThe 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. 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.
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| code | Σ | 1..1 | code | There are no (further) constraints on this element Element idObservation.interpretation.coding.code Symbol in syntax defined by the system DefinitionA 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). Need to refer to a particular code in the system.
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| display | Σ | 0..1 | string | There are no (further) constraints on this element Element idObservation.interpretation.coding.display Representation defined by the system DefinitionA representation of the meaning of the code in the system, following the rules of the system. Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
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| userSelected | Σ | 0..1 | boolean | There are no (further) constraints on this element Element idObservation.interpretation.coding.userSelected If this coding was chosen directly by the user DefinitionIndicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). 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. 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.
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| text | Σ | 0..1 | string | There are no (further) constraints on this element Element idObservation.interpretation.text Plain text representation of the concept DefinitionA 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. 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. Very often the text is the same as a displayName of one of the codings.
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| note | 0..* | Annotation | There are no (further) constraints on this element Element idObservation.note Textuelle Hinweise zum Untersuchungsergebnis. DefinitionTextuelle Hinweise zum Untersuchungsergebnis, die dem Gesundheitsamt eine bessere Bewertung der Ergebnisse ermöglichen. Need to be able to provide free text additional information. 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.
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| bodySite | 0..0 | CodeableConcept | There are no (further) constraints on this element Element idObservation.bodySite Observed body part DefinitionIndicates the site on the subject's body where the observation was made (i.e. the target site). 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. Codes describing anatomical locations. May include laterality.
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| method | I | 0..1 | CodeableConcept | There are no (further) constraints on this element Element idObservation.method Angaben zur genutzten Nachweismethode. DefinitionAngaben 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. In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results. Only used if not implicit in code for Observation.code. Methods for simple observations.
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| id | 0..1 | string | There are no (further) constraints on this element Element idObservation.method.id Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idObservation.method.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay 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. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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| coding | Σ | 0..1 | CodingBinding | Element idObservation.method.coding Code defined by a terminology system DefinitionA reference to a code defined by a terminology system. Allows for alternative encodings within a code system, and translations to other code systems. 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.
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| id | 0..1 | string | There are no (further) constraints on this element Element idObservation.method.coding.id Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idObservation.method.coding.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay 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. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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| system | Σ | 1..1 | uri | There are no (further) constraints on this element Element idObservation.method.coding.system Identity of the terminology system DefinitionThe identification of the code system that defines the meaning of the symbol in the code. Need to be unambiguous about the source of the definition of the symbol. 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.
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| version | Σ | 0..1 | string | There are no (further) constraints on this element Element idObservation.method.coding.version Version of the system - if relevant DefinitionThe 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. 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.
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| code | Σ | 1..1 | code | There are no (further) constraints on this element Element idObservation.method.coding.code Symbol in syntax defined by the system DefinitionA 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). Need to refer to a particular code in the system.
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| display | Σ | 0..1 | string | There are no (further) constraints on this element Element idObservation.method.coding.display Representation defined by the system DefinitionA representation of the meaning of the code in the system, following the rules of the system. Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
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| userSelected | Σ | 0..1 | boolean | There are no (further) constraints on this element Element idObservation.method.coding.userSelected If this coding was chosen directly by the user DefinitionIndicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). 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. 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.
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| text | Σ | 0..1 | string | There are no (further) constraints on this element Element idObservation.method.text Plain text representation of the concept DefinitionA 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. 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. Very often the text is the same as a displayName of one of the codings.
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| specimen | 1..1 | Reference(SARS-CoV-2-Probe) | Element idObservation.specimen Verweis auf die dem Labortest zugrundeliegende Probe. DefinitionVerweis auf die dem Labortest zugrundeliegende Probe. Über die Probe können Angaben zum verwendeten Material und deren Einsender gemacht werden. Should only be used if not implicit in code found in
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| device | 0..0 | Reference(Device | DeviceMetric) | There are no (further) constraints on this element Element idObservation.device (Measurement) Device DefinitionThe device used to generate the observation data. 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. Reference(Device | DeviceMetric) Constraints
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| referenceRange | I | 0..0 | BackboneElement | There are no (further) constraints on this element Element idObservation.referenceRange Provides guide for interpretation DefinitionGuidance 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 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. 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.
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| hasMember | Σ | 0..0 | Reference(Observation | QuestionnaireResponse | MolecularSequence) | There are no (further) constraints on this element Element idObservation.hasMember Related resource that belongs to the Observation group DefinitionThis 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. 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. Reference(Observation | QuestionnaireResponse | MolecularSequence) Constraints
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| derivedFrom | Σ | 0..0 | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | There are no (further) constraints on this element Element idObservation.derivedFrom Related measurements the observation is made from DefinitionThe 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. 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. Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Constraints
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| component | Σ | 0..0 | BackboneElement | There are no (further) constraints on this element Element idObservation.component Component results DefinitionSome 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. 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. For a discussion on the ways Observations can be assembled in groups together see Notes below.
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<StructureDefinition xmlns="http://hl7.org/fhir"> <id value="demis-rki-de-sd-pathogenDetectionSARSCoV2" /> <url value="https://demis.rki.de/fhir/StructureDefinition/PathogenDetectionSARSCoV2" /> <version value="1.0" /> <name value="PathogenDetectionSARSCoV2" /> <title value="SARS-CoV-2-Erregernachweis" /> <status value="draft" /> <date value="2020-04-07" /> <description value="Der SARS-CoV-2-Erregernachweis spezifiziert den Erregernachweis hinsichtlich des Labortestes, der Nachweismethode und der Probe für SARS-CoV-2." /> <fhirVersion value="4.0.0" /> <mapping> <identity value="workflow" /> <uri value="http://hl7.org/fhir/workflow" /> <name value="Workflow Pattern" /> </mapping> <mapping> <identity value="sct-concept" /> <uri value="http://snomed.info/conceptdomain" /> <name value="SNOMED CT Concept Domain Binding" /> </mapping> <mapping> <identity value="v2" /> <uri value="http://hl7.org/v2" /> <name value="HL7 v2 Mapping" /> </mapping> <mapping> <identity value="rim" /> <uri value="http://hl7.org/v3" /> <name value="RIM Mapping" /> </mapping> <mapping> <identity value="w5" /> <uri value="http://hl7.org/fhir/fivews" /> <name value="FiveWs Pattern Mapping" /> </mapping> <mapping> <identity value="sct-attr" /> <uri value="http://snomed.org/attributebinding" /> <name value="SNOMED CT Attribute Binding" /> </mapping> <kind value="resource" /> <abstract value="false" /> <type value="Observation" /> <baseDefinition value="https://demis.rki.de/fhir/StructureDefinition/PathogenDetection" /> <derivation value="constraint" /> <differential> <element id="Observation.code.coding"> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="normative" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version"> <valueCode value="4.0.0" /> </extension> <path value="Observation.code.coding" /> <binding> <strength value="extensible" /> <valueSet value="https://demis.rki.de/fhir/ValueSet/laboratoryTestSARSCoV2" /> </binding> </element> <element id="Observation.method.coding"> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="normative" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version"> <valueCode value="4.0.0" /> </extension> <path value="Observation.method.coding" /> <binding> <strength value="required" /> <valueSet value="https://demis.rki.de/fhir/ValueSet/methodSARSCoV2" /> </binding> </element> <element id="Observation.specimen"> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="normative" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version"> <valueCode value="4.0.0" /> </extension> <path value="Observation.specimen" /> <type> <code value="Reference" /> <targetProfile value="https://demis.rki.de/fhir/StructureDefinition/SpecimenSARSCoV2" /> </type> </element> </differential> </StructureDefinition>
Beispiel:
<Observation xmlns="http://hl7.org/fhir"> <meta> <profile value="https://demis.rki.de/fhir/StructureDefinition/Outbreak" /> </meta> <status value="final" /> <code> <coding> <system value="http://loinc.org" /> <code value="77980-1" /> <display value="Case is associated with a known outbreak" /> </coding> </code> <hasMember> <reference value="urn:uuid:61ebe359-bfdc-4613-8bf2-c5e300945f0n25" /> </hasMember> </Observation>