Beobachtungen, Messungen (Observation)
VitalParameter
Innerhalb der Deutschen Basisprofile werden Profile für den Ressourcen-Typ 'Observation' spezifiziert welche genutzt werden können um Vitalparameter und Körpermaße zu kodieren.
Diese Profile sind angelehnt an die Internationlen VitalSign Profile enthalten jedoch technische Korrekturen (Verbessertes Slicing und korrigierte FHIRPath-Expressions) oder Einschränkungen auf in Deutschland gebräuchliche Maßeinheiten.
Folgende Observation-Profile wurden in diesem Zusammenhang abgestimmt:
Weitere Details sind der jeweiligen verlinkten Unterseite zu entnehmen.
Kompatibilität zu den internationalen Vitalparameter Profilen
Im folgenden wird die Kompatibilität zu den internationalen VitalSign Profilen fein granuliert erläutert.
Bedeutung der Kompatibilität
Abwärtskompatibel: International VitalSigns -> Vitalparameter Basisprofil
Aufwärtskompatibel: Vitalparameter Basisprofil -> International Vitalsigns
Kopfumfang
- Unterschied: Binding von
valueQuantity.code
auf 'http://fhir.de/ValueSet/VitalSignDE_Body_Length_UCUM' anstatt 'http://hl7.org/fhir/ValueSet/ucum-bodylength'- Erklärung: Dieses Binding beschränkt den Code auf die in Deutschland üblicherweise verwendete Maßeinheit 'cm'
- Abwärtskompatibel: Nicht abwärtskompatibel bei Verwendung der Maßeinheit '[in_i]'
- Aufwärtskompatibel: Ja
Körpergewicht
- Unterschied: Binding von
Observation.code
auf 'http://fhir.de/ValueSet/VitalSignDE_Body_Weight_Loinc' anstatt fixed value 'http://loinc.org|29463-7'- Erklärung: Dieses geänderte Binding und das Eliminieren des fixed values ermöglicht es, auch das Gewicht bei der Geburt spezifisch zu erfassen
- Abwärtskompatibel: Nur bei Verwendung des LOINC Codes '29463-7'
- Aufwärtskompatibel: Ja
- Unterschied: Binding von
Observation.valueQuantity.code
auf 'http://fhir.de/ValueSet/VitalSignDE_Body_Weigth_UCUM'- Erklärung: Dieses Binding beschränkt die Codes auf die in Deutschland üblicherweise verwendeten Maßeinheiten 'kg' und 'g'
- Abwärtskompatibel: Nur bei Verwendung der Codes 'kg' oder 'g'
- Aufwärtskompatibel: Ja
Körperlänge/Körpergröße
- Unterschied: Binding von
Observation.code.coding:loinc
auf 'http://fhir.de/ValueSet/VitalSignDE_Body_Height_Loinc' anstatt fixed value 'http://loinc.org|8302-2'- Erklärung: Dieses geänderte Binding und das Eliminieren des fixed values ermöglicht es, auch die Größe bei der Geburt spezifisch zu erfassen
- Abwärtskompatibel: Ja
- Aufwärtskompatibel: Nur bei Verwendung des Codes '8302-2'
- Unterschied: Binding von
Observation.valueQuantity.code
auf 'http://fhir.de/ValueSet/VitalSignDE_Body_Length_UCUM'- Erklärung: Dieses Binding beschränkt die Codes auf die in Deutschland üblicherweise verwendeten Maßeinheiten 'cm' und 'm'
- Abwärtskompatibel: Nur bei Verwendung der Codes 'cm' oder 'm'
- Aufwärtskompatibel: Ja
Körpertemperatur
- Unterschied: Pattern anstatt fixed value auf
Observation.code.coding:loinc
- Erklärung: Dies erlaubt Extensions auf dem Element
- Abwärtskompatibel: Ja
- Aufwärtskompatibel: Ja, falls keine Extension verwendet wurde
- Unterschied: Pattern 'cel' auf
Observation.valueQuantity.code
- Erklärung: Dies lässt nur die in Deutschland üblicherweise verwendete Einheit Celsius zu
- Abwärtskompatibel: Nur bei Verwendung des Codes 'cel'
- Aufwärtskompatibel: Ja
Blutdruck
- Unterschied: Pattern anstatt fixed values auf alle fixed values des Diffs
- Erklärung: Dies erlaubt Extensions auf den Elementen
- Abwärtskompatibel: Ja
- Aufwärtskompatibel: Ja, falls keine Extension verwendet wurde
- Unterschied: Zusätzlicher Slice
component:meanB
für den durchschnittlichen Blutdruck- Erklärung: Erlaubt das Erfassen des durchschnittlichen Blutdrucks, stellt aber keine Inkompatibilität zum internationalen Profil dar da der Slice nicht verpflichtend ist
- Abwärtskompatibel: Ja
- Aufwärtskompatibel: Ja
Periphere Arterielle Sauerstoffsättigung
- Unterschied: Pattern anstatt fixed values auf
Observation.code.coding
sowieObservation.valueQuantity
- Erklärung: Dies erlaubt Extensions auf den Elementen
- Abwärtskompatibel: Ja
- Aufwärtskompatibel: Ja, falls keine Extension verwendet wurde
Atemfrequenz
- Unterschied: Pattern anstatt fixed values auf
Observation.code.coding
sowieObservation.valueQuantity
- Erklärung: Dies erlaubt Extensions auf den Elementen
- Abwärtskompatibel: Ja
- Aufwärtskompatibel: Ja, falls keine Extension verwendet wurde
Herzfrequenz
- Unterschied: Pattern anstatt fixed values auf
Observation.code.coding
sowieObservation.valueQuantity
- Erklärung: Dies erlaubt Extensions auf den Elementen
- Abwärtskompatibel: Ja
- Aufwärtskompatibel: Ja, falls keine Extension verwendet wurde
Pflegegrad
Deutsches Profil zur Abbildung des Pflegegrads eines Patienten incl. Abbildung des erfolgten Antrags auf Einstufung in einen Pflegegrad.
Profil
Name: ObservationDePflegegrad (Simplifier Projekt Link)
Canonical: http://fhir.de/StructureDefinition/observation-de-pflegegrad
ObservationDePflegegrad (Observation) | I | Observation | 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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identifier | Σ | 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 I | 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. 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. Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Constraints
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partOf | Σ I | 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 registered | preliminary | final | amended + DefinitionThe status of the result value. 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 | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element idObservation.category Classification of type of observation DefinitionA code that classifies the general type of observation being made. 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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code | Σ | 1..1 | CodeableConcept | There are no (further) constraints on this element Element idObservation.code Type of observation (code / type) Alternate namesName DefinitionDescribes what was observed. Sometimes this is called the observation "name". 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 | 1..* | Coding | 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. Unordered, Open, by $this(Pattern) Constraints
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loinc | Σ | 1..1 | CodingPattern | Element idObservation.code.coding:loinc 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.
{ "system": "http://loinc.org", "code": "80391-6" }
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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 I | 1..1 | Reference(Patient) | Element idObservation.subject Who and/or what the observation is about DefinitionThe patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the 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.
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focus | Σ I | 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 I | 0..1 | 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 | 1..1 | 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. Unordered, Open, by $this(Type) Constraints
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(All Slices) | There are no (further) constraints on this element | |||
effectiveDateTime | dateTime | Data type | ||
effectivePeriod | Σ | 0..1 | Period | Element idObservation.effective[x]:effectivePeriod 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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id | 0..1 | string | There are no (further) constraints on this element Element idObservation.effective[x]:effectivePeriod.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.effective[x]:effectivePeriod.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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start | Σ I | 1..1 | dateTime | There are no (further) constraints on this element Element idObservation.effective[x]:effectivePeriod.start Starting time with inclusive boundary DefinitionThe start of the period. The boundary is inclusive. If the low element is missing, the meaning is that the low boundary is not known.
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end | Σ I | 0..1 | dateTime | There are no (further) constraints on this element Element idObservation.effective[x]:effectivePeriod.end End time with inclusive boundary, if not ongoing DefinitionThe end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time. The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03. If the end of the period is missing, it means that the period is ongoing
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issued | Σ | 0..1 | 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 I | 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. 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. 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] Actual result DefinitionThe information determined as a result of making the observation, if the information has a simple value. An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations. 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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valueCodeableConcept | CodeableConcept | Data type | ||
id | 0..1 | string | There are no (further) constraints on this element Element idObservation.value[x].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.value[x].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..* | CodingBinding | Element idObservation.value[x].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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text | Σ | 0..1 | string | There are no (further) constraints on this element Element idObservation.value[x].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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dataAbsentReason | I | 0..1 | 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 High, low, normal, etc. Alternate namesAbnormal Flag DefinitionA categorical assessment of an observation value. For example, high, low, normal. 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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note | 0..* | Annotation | There are no (further) constraints on this element Element idObservation.note Comments about the observation DefinitionComments about the observation or the results. 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 | 0..1 | CodeableConcept | There are no (further) constraints on this element Element idObservation.method How it was done DefinitionIndicates the mechanism used to perform the observation. 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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specimen | I | 0..1 | Reference(Specimen) | There are no (further) constraints on this element Element idObservation.specimen Specimen used for this observation DefinitionThe specimen that was used when this observation was made. Should only be used if not implicit in code found in
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device | I | 0..1 | 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..* | 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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id | 0..1 | string | There are no (further) constraints on this element Element idObservation.referenceRange.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.referenceRange.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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modifierExtension | Σ ?! I | 0..* | Extension | There are no (further) constraints on this element Element idObservation.referenceRange.modifierExtension Extensions that cannot be ignored even if unrecognized Alternate namesextensions, user content, modifiers DefinitionMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). 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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low | I | 0..1 | SimpleQuantity | There are no (further) constraints on this element Element idObservation.referenceRange.low Low Range, if relevant DefinitionThe value of the low bound of the reference range. The low bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the low bound is omitted, it is assumed to be meaningless (e.g. reference range is <=2.3). The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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high | I | 0..1 | SimpleQuantity | There are no (further) constraints on this element Element idObservation.referenceRange.high High Range, if relevant DefinitionThe value of the high bound of the reference range. The high bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the high bound is omitted, it is assumed to be meaningless (e.g. reference range is >= 2.3). The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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type | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idObservation.referenceRange.type Reference range qualifier DefinitionCodes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range. Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation. This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed. Code for the meaning of a reference range.
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appliesTo | 0..* | CodeableConcept | There are no (further) constraints on this element Element idObservation.referenceRange.appliesTo Reference range population DefinitionCodes to indicate the target population this reference range applies to. For example, a reference range may be based on the normal population or a particular sex or race. Multiple Need to be able to identify the target population for proper interpretation. This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed. Codes identifying the population the reference range applies to.
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age | I | 0..1 | Range | There are no (further) constraints on this element Element idObservation.referenceRange.age Applicable age range, if relevant DefinitionThe age at which this reference range is applicable. This is a neonatal age (e.g. number of weeks at term) if the meaning says so. Some analytes vary greatly over age. The stated low and high value are assumed to have arbitrarily high precision when it comes to determining which values are in the range. I.e. 1.99 is not in the range 2 -> 3.
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text | 0..1 | string | There are no (further) constraints on this element Element idObservation.referenceRange.text Text based reference range in an observation DefinitionText based reference range in an observation which may be used when a quantitative range is not appropriate for an observation. An example would be a reference value of "Negative" or a list or table of "normals". Note that FHIR strings SHALL NOT exceed 1MB in size
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hasMember | Σ I | 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 I | 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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Beispiel:
<Observation xmlns="http://hl7.org/fhir"> <id value="Example-observation-pflegegrad" /> <meta> <profile value="http://fhir.de/StructureDefinition/observation-de-pflegegrad" /> </meta> <status value="final" /> <code> <coding> <system value="http://loinc.org" /> <code value="80391-6" /> <display value="Pflegegrad" /> </coding> </code> <subject> <reference value="Patient/example" /> </subject> <effectivePeriod> <start value="2019-01-09" /> </effectivePeriod> <valueCodeableConcept> <coding> <system value="http://fhir.de/CodeSystem/bfarm/ops" /> <version value="2019" /> <code value="9-984.6" /> <display value="Pflegebedürftig nach Pflegegrad 1" /> </coding> </valueCodeableConcept> </Observation>
Diskussion siehe hier: https://chat.fhir.org/#narrow/stream/179183-german-(d-a-ch)/topic/Observation.20(Pflegestufe)
Grad der Behinderung
Profil
Name: GradDerBehinderung (Simplifier Projekt Link)
Canonical: http://fhir.de/StructureDefinition/GradDerBehinderung
GradDerBehinderung (Observation) | I | Observation | 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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identifier | Σ | 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 I | 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. 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. Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Constraints
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partOf | Σ I | 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 registered | preliminary | final | amended + DefinitionThe status of the result value. 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 | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element idObservation.category Classification of type of observation DefinitionA code that classifies the general type of observation being made. 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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code | Σ | 1..1 | CodeableConcept | There are no (further) constraints on this element Element idObservation.code Type of observation (code / type) Alternate namesName DefinitionDescribes what was observed. Sometimes this is called the observation "name". 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 | 1..* | Coding | 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. Unordered, Open, by $this(Pattern) Constraints
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snomedct | Σ | 1..1 | CodingPattern | Element idObservation.code.coding:snomedct 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.
{ "system": "http://snomed.info/sct", "code": "116149007" }
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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 I | 0..1 | Reference(Patient | Group | Device | Location) | There are no (further) constraints on this element Element idObservation.subject Who and/or what the observation is about DefinitionThe patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the 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. Reference(Patient | Group | Device | Location) Constraints
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focus | Σ I | 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 I | 0..1 | 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..1 | 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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effectiveDateTime | dateTime | There are no (further) constraints on this element Data type | ||
effectivePeriod | Period | There are no (further) constraints on this element Data type | ||
effectiveTiming | Timing | There are no (further) constraints on this element Data type | ||
effectiveInstant | instant | There are no (further) constraints on this element Data type | ||
issued | Σ | 0..1 | 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 I | 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. 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. Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Constraints
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value[x] | Σ I | 0..1 | Element idObservation.value[x] Actual result DefinitionThe information determined as a result of making the observation, if the information has a simple value. An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations. 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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valueInteger | integer | Data type | ||
dataAbsentReason | I | 0..1 | 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 High, low, normal, etc. Alternate namesAbnormal Flag DefinitionA categorical assessment of an observation value. For example, high, low, normal. 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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note | 0..* | Annotation | There are no (further) constraints on this element Element idObservation.note Comments about the observation DefinitionComments about the observation or the results. 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..1 | 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 | 0..1 | CodeableConcept | There are no (further) constraints on this element Element idObservation.method How it was done DefinitionIndicates the mechanism used to perform the observation. 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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specimen | I | 0..1 | Reference(Specimen) | There are no (further) constraints on this element Element idObservation.specimen Specimen used for this observation DefinitionThe specimen that was used when this observation was made. Should only be used if not implicit in code found in
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device | I | 0..1 | 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..* | 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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id | 0..1 | string | There are no (further) constraints on this element Element idObservation.referenceRange.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.referenceRange.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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modifierExtension | Σ ?! I | 0..* | Extension | There are no (further) constraints on this element Element idObservation.referenceRange.modifierExtension Extensions that cannot be ignored even if unrecognized Alternate namesextensions, user content, modifiers DefinitionMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). 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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low | I | 0..1 | SimpleQuantity | There are no (further) constraints on this element Element idObservation.referenceRange.low Low Range, if relevant DefinitionThe value of the low bound of the reference range. The low bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the low bound is omitted, it is assumed to be meaningless (e.g. reference range is <=2.3). The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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high | I | 0..1 | SimpleQuantity | There are no (further) constraints on this element Element idObservation.referenceRange.high High Range, if relevant DefinitionThe value of the high bound of the reference range. The high bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the high bound is omitted, it is assumed to be meaningless (e.g. reference range is >= 2.3). The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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type | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idObservation.referenceRange.type Reference range qualifier DefinitionCodes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range. Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation. This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed. Code for the meaning of a reference range.
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appliesTo | 0..* | CodeableConcept | There are no (further) constraints on this element Element idObservation.referenceRange.appliesTo Reference range population DefinitionCodes to indicate the target population this reference range applies to. For example, a reference range may be based on the normal population or a particular sex or race. Multiple Need to be able to identify the target population for proper interpretation. This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed. Codes identifying the population the reference range applies to.
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age | I | 0..1 | Range | There are no (further) constraints on this element Element idObservation.referenceRange.age Applicable age range, if relevant DefinitionThe age at which this reference range is applicable. This is a neonatal age (e.g. number of weeks at term) if the meaning says so. Some analytes vary greatly over age. The stated low and high value are assumed to have arbitrarily high precision when it comes to determining which values are in the range. I.e. 1.99 is not in the range 2 -> 3.
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text | 0..1 | string | There are no (further) constraints on this element Element idObservation.referenceRange.text Text based reference range in an observation DefinitionText based reference range in an observation which may be used when a quantitative range is not appropriate for an observation. An example would be a reference value of "Negative" or a list or table of "normals". Note that FHIR strings SHALL NOT exceed 1MB in size
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hasMember | Σ I | 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 I | 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..* | BackboneElement | 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. Unordered, Open, by code(Value) Constraints
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(All Slices) | There are no (further) constraints on this element | |||
id | 0..1 | string | There are no (further) constraints on this element Element idObservation.component.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.component.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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modifierExtension | Σ ?! I | 0..* | Extension | There are no (further) constraints on this element Element idObservation.component.modifierExtension Extensions that cannot be ignored even if unrecognized Alternate namesextensions, user content, modifiers DefinitionMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). 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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code | Σ | 1..1 | CodeableConcept | There are no (further) constraints on this element Element idObservation.component.code Type of component observation (code / type) DefinitionDescribes what was observed. Sometimes this is called the observation "code". Knowing what kind of observation is being made is essential to understanding the observation. All code-value and 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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value[x] | Σ | 0..1 | There are no (further) constraints on this element Element idObservation.component.value[x] Actual component result DefinitionThe information determined as a result of making the observation, if the information has a simple value. An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations. Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section 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 | ||
valueBoolean | boolean | There are no (further) constraints on this element Data type | ||
valueInteger | integer | There are no (further) constraints on this element Data type | ||
valueRange | Range | There are no (further) constraints on this element Data type | ||
valueRatio | Ratio | There are no (further) constraints on this element Data type | ||
valueSampledData | SampledData | There are no (further) constraints on this element Data type | ||
valueTime | time | There are no (further) constraints on this element Data type | ||
valueDateTime | dateTime | There are no (further) constraints on this element Data type | ||
valuePeriod | Period | There are no (further) constraints on this element Data type | ||
dataAbsentReason | I | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idObservation.component.dataAbsentReason Why the component result is missing DefinitionProvides a reason why the expected value in the element Observation.component.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 "test not done". The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values. Codes specifying why the result (
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interpretation | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element idObservation.component.interpretation High, low, normal, etc. Alternate namesAbnormal Flag DefinitionA categorical assessment of an observation value. For example, high, low, normal. 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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referenceRange | 0..* | see (referenceRange) | There are no (further) constraints on this element Element idObservation.component.referenceRange Provides guide for interpretation of component result DefinitionGuidance on how to interpret the value by comparison to a normal or recommended range. 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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merkzeichen | Σ | 0..* | BackboneElement | There are no (further) constraints on this element Element idObservation.component:merkzeichen 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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id | 0..1 | string | There are no (further) constraints on this element Element idObservation.component:merkzeichen.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.component:merkzeichen.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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modifierExtension | Σ ?! I | 0..* | Extension | There are no (further) constraints on this element Element idObservation.component:merkzeichen.modifierExtension Extensions that cannot be ignored even if unrecognized Alternate namesextensions, user content, modifiers DefinitionMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). 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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code | Σ | 1..1 | CodeableConceptBinding | Element idObservation.component:merkzeichen.code Type of component observation (code / type) DefinitionDescribes what was observed. Sometimes this is called the observation "code". Knowing what kind of observation is being made is essential to understanding the observation. All code-value and 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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value[x] | Σ | 0..1 | Pattern | Element idObservation.component:merkzeichen.value[x] Actual component result DefinitionThe information determined as a result of making the observation, if the information has a simple value. An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations. Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.
true
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valueBoolean | boolean | Data type | ||
dataAbsentReason | I | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idObservation.component:merkzeichen.dataAbsentReason Why the component result is missing DefinitionProvides a reason why the expected value in the element Observation.component.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 "test not done". The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values. Codes specifying why the result (
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interpretation | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element idObservation.component:merkzeichen.interpretation High, low, normal, etc. Alternate namesAbnormal Flag DefinitionA categorical assessment of an observation value. For example, high, low, normal. 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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referenceRange | 0..* | see (referenceRange) | There are no (further) constraints on this element Element idObservation.component:merkzeichen.referenceRange Provides guide for interpretation of component result DefinitionGuidance on how to interpret the value by comparison to a normal or recommended range. 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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Beispiel:
<Observation xmlns="http://hl7.org/fhir"> <id value="Example-grad-der-behinderung" /> <meta> <profile value="http://fhir.de/StructureDefinition/GradDerBehinderung" /> </meta> <status value="final" /> <code> <coding> <system value="http://snomed.info/sct" /> <code value="116149007" /> </coding> </code> <subject> <reference value="Patient/example" /> </subject> <valueInteger value="100" /> <component> <code> <coding> <system value="http://fhir.de/CodeSystem/merkzeichen-de" /> <code value="G" /> </coding> </code> <valueBoolean value="true" /> </component> <component> <code> <coding> <system value="http://fhir.de/CodeSystem/merkzeichen-de" /> <code value="H" /> </coding> </code> <valueBoolean value="true" /> </component> </Observation>
EKG
Deutsches Profil zur Abbildung eines Elektrokardiogramms. Dieses Profil erfasst die gängigsten EKG Ableitungen in den Komponenten der Observation und definiert ein entsprechendes, auf LOINC basierendes, ValueSet.
Profil
Name: EkgDE (Simplifier Projekt Link)
Canonical: http://fhir.de/StructureDefinition/observation-de-ekg
EkgDE (Observation) | I | Observation | 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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identifier | Σ | 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 I | 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. 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. Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Constraints
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partOf | Σ I | 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 registered | preliminary | final | amended + DefinitionThe status of the result value. 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..* | CodeableConceptBinding | There are no (further) constraints on this element Element idObservation.category Classification of type of observation DefinitionA code that classifies the general type of observation being made. 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 | 0..* | CodingPattern | 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.
{ "system": "http://terminology.hl7.org/CodeSystem/observation-category", "code": "procedure" }
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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 | 1..1 | CodeableConcept | There are no (further) constraints on this element Element idObservation.code Type of observation (code / type) Alternate namesName DefinitionDescribes what was observed. Sometimes this is called the observation "name". 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 | 1..* | Coding | 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. Unordered, Open, by $this(Pattern) Constraints
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loinc | Σ | 1..* | CodingPattern | Element idObservation.code.coding:loinc 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.
{ "system": "http://loinc.org", "code": "11524-6" }
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snomed | Σ | 0..* | CodingPattern | Element idObservation.code.coding:snomed 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.
{ "system": "http://snomed.info/sct", "code": "106073009" }
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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 I | 1..1 | Reference(Patient | Group | Device | Location) | There are no (further) constraints on this element Element idObservation.subject Who and/or what the observation is about DefinitionThe patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the 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. Reference(Patient | Group | Device | Location) Constraints
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focus | Σ I | 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 I | 0..1 | 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] | S Σ I | 1..1 | 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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effectiveDateTime | dateTime | Data type | ||
issued | Σ | 0..1 | 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 I | 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. 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. Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Constraints
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value[x] | Σ I | 0..0 | There are no (further) constraints on this element Element idObservation.value[x] Actual result DefinitionThe information determined as a result of making the observation, if the information has a simple value. An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations. 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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dataAbsentReason | I | 0..1 | 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 High, low, normal, etc. Alternate namesAbnormal Flag DefinitionA categorical assessment of an observation value. For example, high, low, normal. 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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note | 0..* | Annotation | There are no (further) constraints on this element Element idObservation.note Comments about the observation DefinitionComments about the observation or the results. 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..1 | 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 | 0..1 | CodeableConcept | There are no (further) constraints on this element Element idObservation.method How it was done DefinitionIndicates the mechanism used to perform the observation. 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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specimen | I | 0..1 | Reference(Specimen) | There are no (further) constraints on this element Element idObservation.specimen Specimen used for this observation DefinitionThe specimen that was used when this observation was made. Should only be used if not implicit in code found in
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device | I | 0..1 | 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..* | 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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id | 0..1 | string | There are no (further) constraints on this element Element idObservation.referenceRange.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.referenceRange.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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modifierExtension | Σ ?! I | 0..* | Extension | There are no (further) constraints on this element Element idObservation.referenceRange.modifierExtension Extensions that cannot be ignored even if unrecognized Alternate namesextensions, user content, modifiers DefinitionMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). 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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low | I | 0..1 | SimpleQuantity | There are no (further) constraints on this element Element idObservation.referenceRange.low Low Range, if relevant DefinitionThe value of the low bound of the reference range. The low bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the low bound is omitted, it is assumed to be meaningless (e.g. reference range is <=2.3). The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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high | I | 0..1 | SimpleQuantity | There are no (further) constraints on this element Element idObservation.referenceRange.high High Range, if relevant DefinitionThe value of the high bound of the reference range. The high bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the high bound is omitted, it is assumed to be meaningless (e.g. reference range is >= 2.3). The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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type | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idObservation.referenceRange.type Reference range qualifier DefinitionCodes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range. Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation. This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed. Code for the meaning of a reference range.
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appliesTo | 0..* | CodeableConcept | There are no (further) constraints on this element Element idObservation.referenceRange.appliesTo Reference range population DefinitionCodes to indicate the target population this reference range applies to. For example, a reference range may be based on the normal population or a particular sex or race. Multiple Need to be able to identify the target population for proper interpretation. This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed. Codes identifying the population the reference range applies to.
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age | I | 0..1 | Range | There are no (further) constraints on this element Element idObservation.referenceRange.age Applicable age range, if relevant DefinitionThe age at which this reference range is applicable. This is a neonatal age (e.g. number of weeks at term) if the meaning says so. Some analytes vary greatly over age. The stated low and high value are assumed to have arbitrarily high precision when it comes to determining which values are in the range. I.e. 1.99 is not in the range 2 -> 3.
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text | 0..1 | string | There are no (further) constraints on this element Element idObservation.referenceRange.text Text based reference range in an observation DefinitionText based reference range in an observation which may be used when a quantitative range is not appropriate for an observation. An example would be a reference value of "Negative" or a list or table of "normals". Note that FHIR strings SHALL NOT exceed 1MB in size
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hasMember | Σ I | 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 I | 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 | 1..* | 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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id | 0..1 | string | There are no (further) constraints on this element Element idObservation.component.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.component.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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modifierExtension | Σ ?! I | 0..* | Extension | There are no (further) constraints on this element Element idObservation.component.modifierExtension Extensions that cannot be ignored even if unrecognized Alternate namesextensions, user content, modifiers DefinitionMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). 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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code | Σ | 1..1 | CodeableConceptBinding | Element idObservation.component.code Type of component observation (code / type) DefinitionDescribes what was observed. Sometimes this is called the observation "code". Knowing what kind of observation is being made is essential to understanding the observation. All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation. Codes identifying the EKG lead
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id | 0..1 | string | There are no (further) constraints on this element Element idObservation.component.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.component.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 | 1..* | Coding | There are no (further) constraints on this element Element idObservation.component.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.
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text | Σ | 0..1 | string | There are no (further) constraints on this element Element idObservation.component.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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value[x] | Σ | 1..1 | There are no (further) constraints on this element Element idObservation.component.value[x] Actual component result DefinitionThe information determined as a result of making the observation, if the information has a simple value. An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations. Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.
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valueSampledData | SampledData | Data type | ||
id | 0..1 | string | There are no (further) constraints on this element Element idObservation.component.value[x].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.component.value[x].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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origin | Σ I | 1..1 | SimpleQuantity | There are no (further) constraints on this element Element idObservation.component.value[x].origin Zero value and units DefinitionThe base quantity that a measured value of zero represents. In addition, this provides the units of the entire measurement series. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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period | Σ | 1..1 | decimal | There are no (further) constraints on this element Element idObservation.component.value[x].period Number of milliseconds between samples DefinitionThe length of time between sampling times, measured in milliseconds. This is usually a whole number.
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factor | Σ | 0..1 | decimal | There are no (further) constraints on this element Element idObservation.component.value[x].factor Multiply data by this before adding to origin DefinitionA correction factor that is applied to the sampled data points before they are added to the origin. Do not use an IEEE type floating point type, instead use something that works like a true decimal, with inbuilt precision (e.g. Java BigInteger) If no factor is assigned, the data is not adjusted before adding to the origin
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lowerLimit | Σ | 0..1 | decimal | There are no (further) constraints on this element Element idObservation.component.value[x].lowerLimit Lower limit of detection DefinitionThe lower limit of detection of the measured points. This is needed if any of the data points have the value "L" (lower than detection limit). Do not use an IEEE type floating point type, instead use something that works like a true decimal, with inbuilt precision (e.g. Java BigInteger)
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upperLimit | Σ | 0..1 | decimal | There are no (further) constraints on this element Element idObservation.component.value[x].upperLimit Upper limit of detection DefinitionThe upper limit of detection of the measured points. This is needed if any of the data points have the value "U" (higher than detection limit). Do not use an IEEE type floating point type, instead use something that works like a true decimal, with inbuilt precision (e.g. Java BigInteger)
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dimensions | Σ | 1..1 | positiveInt | There are no (further) constraints on this element Element idObservation.component.value[x].dimensions Number of sample points at each time point DefinitionThe number of sample points at each time point. If this value is greater than one, then the dimensions will be interlaced - all the sample points for a point in time will be recorded at once. If there is more than one dimension, the code for the type of data will define the meaning of the dimensions (typically ECG data).
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data | 1..1 | string | There are no (further) constraints on this element Element idObservation.component.value[x].data Decimal values with spaces, or "E" | "U" | "L" DefinitionA series of data points which are decimal values separated by a single space (character u20). The special values "E" (error), "L" (below detection limit) and "U" (above detection limit) can also be used in place of a decimal value. Data may be missing if it is omitted for summarization purposes. In general, data is required for any actual use of a SampledData.
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dataAbsentReason | I | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idObservation.component.dataAbsentReason Why the component result is missing DefinitionProvides a reason why the expected value in the element Observation.component.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 "test not done". The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values. Codes specifying why the result (
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interpretation | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element idObservation.component.interpretation High, low, normal, etc. Alternate namesAbnormal Flag DefinitionA categorical assessment of an observation value. For example, high, low, normal. 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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referenceRange | 0..* | see (referenceRange) | There are no (further) constraints on this element Element idObservation.component.referenceRange Provides guide for interpretation of component result DefinitionGuidance on how to interpret the value by comparison to a normal or recommended range. 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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Beispiel:
{ "resourceType": "Observation", "id": "Example-observation-ekg", "meta": { "profile": [ "http://fhir.de/StructureDefinition/observation-de-ekg" ] }, "code": { "coding": [ { "code": "11524-6", "system": "http://loinc.org", "display": "EKG study" }, { "code": "106073009", "system": "http://snomed.info/sct", "display": "EKG wave, interval AND/OR segment" } ] }, "subject": { "reference": "Patient/example" }, "status": "final", "category": [ { "coding": [ { "code": "procedure", "system": "http://terminology.hl7.org/CodeSystem/observation-category" } ] } ], "device": { "reference": "Device/example" }, "effectiveDateTime": "2019-07-02", "component": [ { "code": { "coding": [ { "code": "LP7386-8", "system": "http://loinc.org", "display": "Lead I" } ] }, "valueSampledData": { "origin": { "value": 2048 }, "period": 10, "dimensions": 1, "data": "2041 2043 2037 2047 2060 2062 2051 2023 2014 2027 2034 2033 2040 2047 2047 2053 2058 2064 2059 2063 2061 2052 2053 2038 1966 1885 1884 2009 2129 2166 2137 2102 2086 2077 2067 2067 2060 2059 2062 2062 2060 2057 2045 2047 2057 2054 2042 2029 2027 2018 2007 1995 2001 2012 2024 2039 2068 2092 2111 2125 2131 2148 2137 2138 2128 2128 2115 2099 2097 2096 2101 2101 2091 2073 2076 2077 2084 2081 2088 2092 2070 2069 2074 2077 2075 2068 2064 2060 2062 2074 2075 2074 2075 2063 2058 2058 2064 2064 2070 2074 2067 2060 2062 2063 2061 2059 2048 2052 2049 2048 2051 2059 2059 2066 2077 2073" } }, { "code": { "coding": [ { "code": "LP7386-6", "system": "http://loinc.org", "display": "Lead II" } ] }, "valueSampledData": { "origin": { "value": 2048 }, "period": 10, "dimensions": 1, "data": "2041 2043 2037 2047 2060 2062 2051 2023 2014 2027 2034 2033 2040 2047 2047 2053 2058 2064 2059 2063 2061 2052 2053 2038 1966 1885 1884 2009 2129 2166 2137 2102 2086 2077 2067 2067 2060 2059 2062 2062 2060 2057 2045 2047 2057 2054 2042 2029 2027 2018 2007 1995 2001 2012 2024 2039 2068 2092 2111 2125 2131 2148 2137 2138 2128 2128 2115 2099 2097 2096 2101 2101 2091 2073 2076 2077 2084 2081 2088 2092 2070 2069 2074 2077 2075 2068 2064 2060 2062 2074 2075 2074 2075 2063 2058 2058 2064 2064 2070 2074 2067 2060 2062 2063 2061 2059 2048 2052 2049 2048 2051 2059 2059 2066 2077 2073" } }, { "code": { "coding": [ { "code": "LP7386-4", "system": "http://loinc.org", "display": "Lead III" } ] }, "valueSampledData": { "origin": { "value": 2048 }, "period": 10, "dimensions": 1, "data": "2041 2043 2037 2047 2060 2062 2051 2023 2014 2027 2034 2033 2040 2047 2047 2053 2058 2064 2059 2063 2061 2052 2053 2038 1966 1885 1884 2009 2129 2166 2137 2102 2086 2077 2067 2067 2060 2059 2062 2062 2060 2057 2045 2047 2057 2054 2042 2029 2027 2018 2007 1995 2001 2012 2024 2039 2068 2092 2111 2125 2131 2148 2137 2138 2128 2128 2115 2099 2097 2096 2101 2101 2091 2073 2076 2077 2084 2081 2088 2092 2070 2069 2074 2077 2075 2068 2064 2060 2062 2074 2075 2074 2075 2063 2058 2058 2064 2064 2070 2074 2067 2060 2062 2063 2061 2059 2048 2052 2049 2048 2051 2059 2059 2066 2077 2073" } } ] }
Skalen und Scores
Hinweis | Standard Level: Proposal! |
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Der nachfolgende Abschnitt des Implementierungsleitfadens ist vollständig, wurde jedoch noch nicht ausführlich getestet und umfassend implementiert. Der Abschnitt kann noch überarbeitet werden, falls sich die Vorschläge in der Praxis nicht bewähren sollten. Feedback, Fragen und Verbesserungsvorschläge bitte im deutschsprachigen Bereich des internationalen FHIR-Chats diskutieren. | |
Nicht-kompatible Änderungen sind nach wie vor möglich! |
Motivation
Die Repräsentation von Skalen und Scores in der Medizin stellt häufig eine Herausforderung dar. Viele Implementierer sind sich der unterschiedlichen Qualitäten verschiedener Skalen-Systeme nicht bewusst. FHIR lässt viele Freiheitsgrade, Skalare Werte z.B. in Observation-Ressourcen abzubilden (Als Integer, Decimal, CodeableConcept…) und damit auch viel Potential für inkompatible Implementierungen oder semantisch falsche oder unzureichende Repräsentationen.
Diese Seite soll einen Best Practice Leitfaden und eine Entscheidungshilfe für die korrekte Repräsentation von Scores und Skalen bieten, ohne jedes bekannte Assessment-Tool einzeln zu betrachten und zu profilieren. Stattdessen werden die Skalen und Scores anhand ihrer Eigenschaften unterschieden und kategorisiert.
Skalen
Quelle für Definitionen: Wikipedia - Skalenniveau
Nominalskala
Definition: Für verschiedene Objekte oder Erscheinungen wird mithilfe eines Vergleichs lediglich eine Entscheidung über Gleichheit oder Ungleichheit der Merkmalsausprägung getroffen (z. B. x ≠ y ≠ z). Es handelt sich also nur um qualitative Merkmale (z. B. Blutgruppen oder Geschlecht). Es gilt die Gleichheitsrelation, also kann man entscheiden, ob zwei Ausprägungen gleich oder ungleich sind. Die Werte können aber nicht der Größe nach sortiert werden, im Sinne von „ist größer als“ oder „besser als“.
Messbare Eigenschaft: Häufigkeit
Beispiele: Blutgruppe
Empfehlungen für Abbildung als Observation:
'Observation.code': Wahl eines (LOINC-/SNOMED-)Codes für die Beschreibung der verwendeten Skala
'Observation.value[x]': Datentyp CodeableConcept mit einem Binding an ein (SNOMED-/LOINC-)ValueSet, das die Skalenwerte repräsentiert und deren Bedeutung definiert.
Beispiele in FHIR:
Ordinalskala
Definition: Für ein ordinal skalierbares Merkmal bestehen Rangordnungen der Art „größer“, „kleiner“, „mehr“, „weniger“, „stärker“, „schwächer“ zwischen je zwei unterschiedlichen Merkmalswerten (z. B. x > y > z). Über die Abstände zwischen diesen benachbarten Urteilsklassen ist jedoch nichts ausgesagt. Meist handelt es sich um qualitative Merkmale, wie z. B. der in der Frage gesuchte „höchste erreichbare Bildungsabschluss“. Ein weiteres Beispiel sind die Schulnoten: Note 1 ist besser als Note 2, es ist aber ausgesprochen zweifelhaft, ob der Unterschied zwischen Note 1 und 2 gleich groß ist wie der zwischen Note 3 und Note 4.
Messbare Eigenschaft: Häufigkeit, Rangfolge
Beispiele: Bristol Stool Scale
Empfehlungen für Abbildung als Observation:
'Observation.code': Wahl eines (LOINC-/SNOMED-)Codes für die Beschreibung der verwendeten Skala
'Observation.value[x]': Datentyp CodeableConcept mit einem Binding an ein ValueSet, das die Skalenwerte repräsentiert und deren Bedeutung definiert. Verwendung der ordinal-Value-Extension bei der Definition des CodeSystems (bzw. des CodeSystem-Supplements) oder des ValueSets, wenn die Rangfolge für die Auswertung relevant ist.
Beispiele in FHIR:
- Beispiel für ein ValueSet mit ordinal-value-Extension: Exsudatmenge
Kardinalskala
Definition:
- Intervallskala: Die Reihenfolge der Merkmalswerte ist festgelegt, und die Größe des Abstandes zwischen zwei Werten lässt sich sachlich begründen. Als metrische Skala macht sie Aussagen über den Betrag der Unterschiede zwischen zwei Klassen. Die Ungleichheit der Merkmalswerte lässt sich durch Differenzbildung quantifizieren (z. B. beim Datum könnte das Ergebnis lauten „drei Jahre früher“). Der Nullpunkt („nach Christi Geburt“) und der Abstand der Klassen (Jahre oder Monde) sind jedoch willkürlich festgelegt. Hinweis: Bei den metrischen Skalen unterscheidet man diskrete und kontinuierliche Merkmale.
- Verhältnisskala: Die Verhältnisskala besitzt das höchste Skalenniveau. Bei ihr handelt es sich ebenfalls um eine metrische Skala, im Unterschied zur Intervallskala existiert jedoch ein absoluter Nullpunkt (z. B. Blutdruck, absolute Temperatur, Lebensalter, Längenmaße). Einzig bei diesem Skalenniveau sind Multiplikation und Division sinnvoll und erlaubt. Verhältnisse von Merkmalswerten dürfen also gebildet werden (z. B. x = y · z).
Messbare Eigenschaft:: Häufigkeit, Rangfolge, Abstand, (Nullpunkt)
Beispiele: Körpertemperatur, Körpergewicht, BMI
Empfehlungen für Abbildung als Observation:
'Observation.code': Wahl eines (LOINC-/SNOMED-)Codes für die Art der Beobachtung, unabhängig von der Maßeinheit
'Observation.value[x]': Datentyp Quantity mit Angabe der UCUM-codierten Maßeinheit
Beispiele in FHIR:
Scores
Unter einem Score versteht man in der Medizin einen Punktwert, der im Rahmen eines klinischen Assessments für einen Patienten anhand von vielen verschiedenen diagnostischen Parametern (z.B. Alter, Vorerkrankungen, Nierenfunktion, Lungenfunktion, Laborwerte, usw.) bestimmt wird.
Quelle: https://flexikon.doccheck.com/de/Score
Beispiele:
Empfehlungen für Abbildung als Observation:
'Observation.code': Wahl eines (LOINC-/SNOMED-)Codes für die Art des verwendeten Assessment-Tools
'Observation.value[x]': Datentyp Quantity mit der UCUM-Default Maßeinheit “1”
'Observation.valueQuantity.system': =http://unitsofmeasure.org
'Observation.valueQuantity.code': =1
'Observation.valueQuantity.unit': Hier wird der gewünschte Display-Wert (“Punktwert” oder “Punkte”) gesetzt.
'Observation.referenceRange': da die Interpretation eines Scores nicht selbsterklärend ist, sollten die Referenzbereiche und deren Interpretation in den Instanzen stets mit angegeben werden.
Beispiele in FHIR:
- Glasgow Coma Scale
- APGAR-Score (Anm: bei den Einzelkomponenten handelt es sich offenbar um Ordinalskalen, lediglich der Gesamtwert ist ein Score! Entgegen der in diesem Abschnitt beschriebenen Empfehlung, die Einheit des Scores in
valueQuantity
aufhttp://unitsofmeasure.org#1
zu setzen, wird im Beispiel bei HL7 International die Einheit aufhttp://unitsofmeasure.org#{score}
gesetzt.) - Beispiel für die Angabe der Referenzbereiche des IBS-SSS (Irritable Bowel Syndrome Severity Scoring System):
<referenceRange> <low> <value value="0" /> </low> <high> <value value="74" /> </high> <text value="Sehr milde Symptome" /> </referenceRange> <referenceRange> <low> <value value="75" /> </low> <high> <value value="174" /> </high> <text value="Milde Symptome" /> </referenceRange> <referenceRange> <low> <value value="175" /> </low> <high> <value value="299" /> </high> <text value="Moderate Symptome" /> </referenceRange> <referenceRange> <low> <value value="300" /> </low> <high> <value value="500" /> </high> <text value="Schwere Symptome" /> </referenceRange>