Für die Abbildung von Labordaten in FHIR verweist das TC auf das entsprechende Kerndatensatz-Modul der MI-Initiative https://simplifier.net/medizininformatikinitiative-laborprofile
Diskussion im Chat: https://chat.fhir.org/#narrow/stream/179307-german.2Fmi-initiative
Observation | 0..* | Observation | 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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identifier | Σ | 0..* | Identifier | Element IdObservation.identifier Business Identifier for observation DefinitionA unique identifier assigned to this observation. Allows observations to be distinguished and referenced.
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basedOn | Σ | 0..* | Reference(CarePlan| DeviceRequest| ImmunizationRecommendation| MedicationRequest| NutritionOrder| ServiceRequest) | 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 | 0..* | Reference(MedicationAdministration| MedicationDispense| MedicationStatement| Procedure| Immunization| ImagingStudy) | 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 | 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.
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category | 0..* | CodeableConceptBinding | 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. observation-category (preferred) Constraints
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code | Σ | 1..1 | CodeableConcept | 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.
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coding | Σ | 0..* | 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 system(Value) Constraints
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loinc | Σ | 1..* | Coding | 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.
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system | Σ | 1..1 | uriFixed Value | Element IdObservation.code.coding:loinc.system Identity of the terminology system DefinitionThe identification of the code system that defines the meaning of the symbol in the code. Need to be unambiguous about the source of the definition of the symbol. The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.
http://loinc.org
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version | Σ | 0..1 | string | Element IdObservation.code.coding:loinc.version Version of the system - if relevant DefinitionThe version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
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code | Σ | 1..1 | codeFixed Value | Element IdObservation.code.coding:loinc.code Symbol in syntax defined by the system DefinitionA symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Need to refer to a particular code in the system. Note that FHIR strings SHALL NOT exceed 1MB in size
80391-6
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display | Σ | 0..1 | string | Element IdObservation.code.coding:loinc.display Representation defined by the system DefinitionA representation of the meaning of the code in the system, following the rules of the system. Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Note that FHIR strings SHALL NOT exceed 1MB in size
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userSelected | Σ | 0..1 | boolean | Element IdObservation.code.coding:loinc.userSelected If this coding was chosen directly by the user DefinitionIndicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
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text | Σ | 0..1 | string | Element IdObservation.code.text Plain text representation of the concept DefinitionA human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Very often the text is the same as a displayName of one of the codings.
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subject | Σ | 1..1 | Reference(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 | 0..* | Reference(Resource) | Element IdObservation.focus What the observation is about, when it is not about the subject of record DefinitionThe actual focus of an observation when it is not the patient of record representing something or someone associated with the patient such as a spouse, parent, fetus, or donor. For example, fetus observations in a mother's record. The focus of an observation could also be an existing condition, an intervention, the subject's diet, another observation of the subject, or a body structure such as tumor or implanted device. An example use case would be using the Observation resource to capture whether the mother is trained to change her child's tracheostomy tube. In this example, the child is the patient of record and the mother is the focus. Typically, an observation is made about the subject - a patient, or group of patients, location, or device - and the distinction between the subject and what is directly measured for an observation is specified in the observation code itself ( e.g., "Blood Glucose") and does not need to be represented separately using this element. Use
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encounter | Σ | 0..1 | Reference(Encounter) | 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, Closed, by $this(Type) Constraints
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start | Σ | 1..1 | dateTime | Element IdObservation.effective[x].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 | 0..1 | dateTime | Element IdObservation.effective[x].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.
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effectivePeriod | Period | Data Type | ||
issued | Σ | 0..1 | instant | Element IdObservation.issued Date/Time this version was made available DefinitionThe date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified. For Observations that don’t require review and verification, it may be the same as the
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performer | Σ | 0..* | Reference(Practitioner| PractitionerRole| Organization| CareTeam| Patient| RelatedPerson) | 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 | 1..1 | Binding | 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. Unordered, Closed, by $this(Type) Binding Constraints
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coding | Σ | 1..* | Coding-Profil für OPS | Element IdObservation.value[x].coding A reference to a 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.
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text | Σ | 0..1 | string | 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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valueCodeableConcept | CodeableConcept | Data Type | ||
dataAbsentReason | 0..1 | CodeableConceptBinding | 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. data-absent-reason (extensible) Constraints
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interpretation | 0..* | CodeableConceptBinding | 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. observation-interpretation (extensible) Constraints
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note | 0..* | Annotation | 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 | 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.
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method | 0..1 | CodeableConcept | 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.
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specimen | 0..1 | Reference(Specimen) | 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 | 0..1 | Reference(Device| DeviceMetric) | 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 | 0..* | BackboneElement | 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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low | 0..1 | SimpleQuantity | 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 | 0..1 | SimpleQuantity | 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 | 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. referencerange-meaning (preferred) Constraints
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appliesTo | 0..* | CodeableConcept | 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. referencerange-appliesto (example) Constraints
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age | 0..1 | Range | 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 | 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 | 0..* | Reference(Observation| QuestionnaireResponse| MolecularSequence) | Element IdObservation.hasMember Related resource that belongs to the Observation group DefinitionThis observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group. When using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see Notes below. Note that a system may calculate results from QuestionnaireResponse into a final score and represent the score as an Observation. Reference(Observation| QuestionnaireResponse| MolecularSequence) Constraints
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derivedFrom | Σ | 0..* | Reference(DocumentReference| ImagingStudy| Media| QuestionnaireResponse| Observation| MolecularSequence) | 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 | 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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<Observation xmlns="http://hl7.org/fhir"> <meta> <profile value="http://fhir.de/StructureDefinition/observation-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/dimdi/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)