Medizininformatik Initiative - ImplementationGuide - Onkologie v2026
PSA-Wert
Inhalt
Dieses Profil beschreibt den PSA-Wert (Prostataspezifisches Antigen) bei Patienten mit Prostatakarzinom in der Onkologie. Der PSA-Wert ist ein zentraler Tumormarker für die Diagnostik, Verlaufskontrolle und Therapieüberwachung bei Prostatakarzinom.
Das Profil basiert auf einer FHIR Observation-Ressource und verwendet LOINC zur Kodierung des beobachteten Parameters. PSA-Werte können sowohl als Gesamt-PSA als auch als freies PSA dokumentiert werden.
Verknüpfungen zu anderen Ressourcen
Der PSA-Wert ist eine wichtige tumorspezifische Beobachtung:
- verweist über
Observation.focusauf die Primärdiagnose (MII_PR_Onko_Diagnose_Primaertumor) - verweist über
Observation.subjectauf den Patienten (Patient-Ressource) - kann über
Observation.encountermit einem spezifischen Behandlungsfall verknüpft werden
oBDS-Kontext
Gemäß oBDS P1 wird der PSA-Wert als Tumormarker für Diagnostik und Verlaufskontrolle dokumentiert. Es können sowohl Diagnose- als auch Verlaufs-PSA-Werte erfasst werden.
Terminologie-Binding
Das ValueSet für PSA-Codes ist required gebunden, da LOINC-Codes für PSA-Bestimmungen standardisiert und eindeutig definiert sind.
PSA-Codes
- Freies PSA: LOINC 10886-0 "Prostate specific antigen Free [Mass/volume] in Serum or Plasma"
| Name | Status | Version | Canonical | Basis |
|---|---|---|---|---|
| MII_PR_Onko_Prostata_PSA | active | 2026.0.0 | https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-prostate-psa | http://hl7.org/fhir/StructureDefinition/Observation |
Inhalt
| MII_PR_Onko_Prostata_PSA (Observation) | C | Observation | |
| id | Σ | 0..1 | id |
| meta | Σ | 0..1 | Meta |
| id | 0..1 | string | |
| extension | C | 0..* | Extension |
| versionId | Σ | 0..1 | id |
| lastUpdated | Σ | 0..1 | instant |
| source | Σ | 0..1 | uri |
| profile | S Σ | 0..* | canonical(StructureDefinition) |
| security | Σ | 0..* | CodingBinding |
| tag | Σ | 0..* | Coding |
| implicitRules | Σ ?! | 0..1 | uri |
| language | 0..1 | codeBinding | |
| text | 0..1 | Narrative | |
| contained | 0..* | Resource | |
| extension | C | 0..* | Extension |
| modifierExtension | ?! C | 0..* | Extension |
| identifier | Σ | 0..* | Identifier |
| basedOn | Σ C | 0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) |
| partOf | Σ C | 0..* | Reference(ImagingStudy | Immunization | MedicationAdministration | MedicationDispense | MedicationStatement | Procedure) |
| status | Σ ?! | 1..1 | codeBinding |
| category | 0..* | CodeableConceptBinding | |
| code | S Σ | 1..1 | CodeableConcept |
| id | 0..1 | string | |
| extension | C | 0..* | Extension |
| coding | Σ | 0..* | CodingBinding |
| text | Σ | 0..1 | string |
| subject | S Σ C | 1..1 | Reference(Patient) |
| focus | S Σ C | 0..* | Reference(MII_PR_Onko_Diagnose_Primaertumor) |
| encounter | S Σ C | 0..1 | Reference(Encounter) |
| effective[x] | Σ | 0..1 | |
| effectiveInstant | instant | ||
| effectivePeriod | Period | ||
| effectiveTiming | Timing | ||
| effectiveDateTime | Σ | 0..1 | dateTime |
| issued | Σ | 0..1 | instant |
| performer | Σ C | 0..* | Reference(CareTeam | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson) |
| value[x] | S Σ C | 1..1 | Quantity |
| id | 0..1 | string | |
| extension | C | 0..* | Extension |
| value | Σ | 1..1 | decimal |
| comparator | Σ ?! | 0..1 | codeBinding |
| unit | Σ | 0..1 | stringPattern |
| system | Σ C | 0..1 | uriPattern |
| code | Σ | 0..1 | codePattern |
| dataAbsentReason | C | 0..1 | CodeableConceptBinding |
| interpretation | 0..* | CodeableConceptBinding | |
| note | 0..* | Annotation | |
| bodySite | 0..1 | CodeableConcept | |
| method | 0..1 | CodeableConcept | |
| specimen | C | 0..1 | Reference(Specimen) |
| device | C | 0..1 | Reference(Device | DeviceMetric) |
| referenceRange | C | 0..* | BackboneElement |
| id | 0..1 | string | |
| extension | C | 0..* | Extension |
| modifierExtension | Σ ?! C | 0..* | Extension |
| low | C | 0..1 | SimpleQuantity |
| high | C | 0..1 | SimpleQuantity |
| type | 0..1 | CodeableConceptBinding | |
| appliesTo | 0..* | CodeableConcept | |
| age | C | 0..1 | Range |
| text | 0..1 | string | |
| hasMember | Σ C | 0..* | Reference(MolecularSequence | Observation | QuestionnaireResponse) |
| derivedFrom | Σ C | 0..* | Reference(DocumentReference | ImagingStudy | Media | MolecularSequence | Observation | QuestionnaireResponse) |
| component | Σ | 0..* | BackboneElement |
| id | 0..1 | string | |
| extension | C | 0..* | Extension |
| modifierExtension | Σ ?! C | 0..* | Extension |
| code | Σ | 1..1 | CodeableConcept |
| value[x] | Σ | 0..1 | |
| valueBoolean | boolean | ||
| valueCodeableConcept | CodeableConcept | ||
| valueDateTime | dateTime | ||
| valueInteger | integer | ||
| valuePeriod | Period | ||
| valueQuantity | Quantity | ||
| valueRange | Range | ||
| valueRatio | Ratio | ||
| valueSampledData | SampledData | ||
| valueString | string | ||
| valueTime | time | ||
| dataAbsentReason | C | 0..1 | CodeableConceptBinding |
| interpretation | 0..* | CodeableConceptBinding | |
| referenceRange | 0..* | see (referenceRange) |
Dieses Profil beschreibt den PSA-Wert sowohl beim Monitoring als auch in der Verlaufskontrolle in der Onkologie |
| Feldname | Kurzbeschreibung |
|---|---|
| Observation.meta.profile | |
| Observation.code | PSA-Wert |
| Observation.subject | |
| Observation.focus | |
| Observation.encounter | |
| Observation.value[x] | PSA-Wert |
<url value="https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-prostate-psa" />
</telecom>
</contact>
<description value="Dieses Profil beschreibt den PSA-Wert sowohl beim Monitoring als auch in der Verlaufskontrolle in der Onkologie" />
</mapping>
<definition value="Measurements and simple assertions made about a patient, device or other subject." />
<comment value="Used for simple observations such as device measurements, laboratory atomic results, vital signs, height, weight, smoking status, comments, etc. Other resources are used to provide context for observations such as laboratory reports, etc." />
</base>
<human value="If the resource is contained in another resource, it SHALL NOT contain nested Resources" />
</constraint>
<human value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated" />
<xpath value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))" />
</constraint>
<human value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource" />
<expression value="contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()" />
<xpath value="not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))" />
</constraint>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">
<valueMarkdown value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time." />
</extension>
</constraint>
<human value="If a resource is contained in another resource, it SHALL NOT have a security label" />
</constraint>
<human value="If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present" />
<expression value="value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()" />
<xpath value="not(f:*[starts-with(local-name(.), 'value')] and (for $coding in f:code/f:coding return f:component/f:code/f:coding[f:code/@value=$coding/f:code/@value] [f:system/@value=$coding/f:system/@value]))" />
</constraint>
<xpath value="not(exists(f:dataAbsentReason)) or (not(exists(*[starts-with(local-name(.), 'value')])))" />
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes." />
<comment value="The only time that a resource does not have an id is when it is being submitted to the server using a create operation." />
</base>
</extension>
</type>
</element>
<definition value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
</discriminator>
</slicing>
<definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
<comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</mapping>
</element>
<definition value="The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted." />
<comment value="The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes." />
</base>
</type>
</constraint>
</mapping>
</element>
<comment value="This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a [read](http.html#read) interaction." />
</base>
</type>
</constraint>
</mapping>
</element>
<definition value="A uri that identifies the source system of the resource. This provides a minimal amount of [Provenance](provenance.html#) information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc." />
<comment value="In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. \n\nThis element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL." />
</base>
</type>
</constraint>
</mapping>
</element>
<definition value="A list of profiles (references to [StructureDefinition](structuredefinition.html#) resources) that this resource claims to conform to. The URL is a reference to [StructureDefinition.url](structuredefinition-definitions.html#StructureDefinition.url)." />
<comment value="It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set." />
</base>
</type>
</constraint>
</mapping>
</element>
<definition value="Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure." />
<comment value="The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored." />
</base>
</type>
</constraint>
</extension>
<description value="Security Labels from the Healthcare Privacy and Security Classification System." />
</binding>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource." />
<comment value="The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored." />
</base>
</type>
</constraint>
</extension>
<description value="Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones"." />
</binding>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc." />
<comment value="Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc." />
</base>
</type>
</constraint>
<isModifierReason value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation" />
</mapping>
</element>
<comment value="Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)." />
</base>
</type>
</constraint>
</extension>
</extension>
</binding>
</mapping>
</element>
<definition value="A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety." />
<comment value="Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
<definition value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope." />
<comment value="This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels." />
</base>
</type>
</mapping>
</mapping>
</element>
</discriminator>
</slicing>
<definition value="May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
<comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</mapping>
</element>
</discriminator>
</slicing>
<definition value="May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
<comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
<requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension)." />
</base>
</type>
</constraint>
</constraint>
<isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them" />
</mapping>
</mapping>
</element>
</base>
</type>
</constraint>
</mapping>
</mapping>
<map value="II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]" />
</mapping>
</mapping>
</mapping>
</mapping>
<map value="OBX.21 For OBX segments from systems without OBX-21 support a combination of ORC/OBR and OBX must be negotiated between trading partners to uniquely identify the OBX segment. Depending on how V2 has been implemented each of these may be an option: 1) OBR-3 + OBX-3 + OBX-4 or 2) OBR-3 + OBR-4 + OBX-3 + OBX-4 or 2) some other way to uniquely ID the OBR/ORC + OBX-3 + OBX-4." />
</mapping>
</mapping>
</element>
<definition value="A plan, proposal or order that is fulfilled in whole or in part by this event. For example, a MedicationRequest may require a patient to have laboratory test performed before it is dispensed." />
<comment value="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." />
<requirements value="Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon." />
</base>
</type>
</constraint>
<expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))" />
<xpath value="not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])" />
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure." />
<comment value="To link an Observation to an Encounter use `encounter`. See the [Notes](observation.html#obsgrouping) below for guidance on referencing another Observation." />
</base>
</type>
</constraint>
<expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))" />
<xpath value="not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])" />
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
</extension>
<comment value="This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid." />
<requirements value="Need to track the status of individual results. Some results are finalized before the whole report is finalized." />
</base>
</type>
</constraint>
<isModifierReason value="This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid" />
</extension>
</binding>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
<map value="status Amended & Final are differentiated by whether it is the subject of a ControlAct event with a type of "revise"" />
</mapping>
</element>
<comment value="In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set." />
</base>
</type>
</constraint>
</extension>
</binding>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="PSA-Wert wie im oBDS definiert. Der PSA-Wert ist ein Tumormarker, der bei der Diagnostik und Verlaufskontrolle von Prostatakrebs verwendet wird. Er wird in ng/ml gemessen. Bei Vorliegen kann dieser Datenpunkt auch durch eine Observation aus dem Labormodul abgebildet werden." />
<comment value="*All* code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation." />
<requirements value="Knowing what kind of observation is being made is essential to understanding the observation." />
</base>
</type>
</constraint>
</extension>
</binding>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
</discriminator>
</slicing>
<definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
<comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</mapping>
</element>
<comment value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true." />
<requirements value="Allows for alternative encodings within a code system, and translations to other code systems." />
</base>
</type>
</constraint>
<valueSet value="https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-prostata-psa-loinc" />
</binding>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
</extension>
<definition value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user." />
<requirements value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the `focus` element or the `code` itself specifies the actual focus of the observation." />
<comment value="One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated." />
</base>
</type>
</constraint>
<expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))" />
<xpath value="not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])" />
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="The actual focus of an observation when it is not the patient of record representing something or someone associated with the patient such as a spouse, parent, fetus, or donor. For example, fetus observations in a mother's record. The focus of an observation could also be an existing condition, an intervention, the subject's diet, another observation of the subject, or a body structure such as tumor or implanted device. An example use case would be using the Observation resource to capture whether the mother is trained to change her child's tracheostomy tube. In this example, the child is the patient of record and the mother is the focus." />
<comment value="Typically, an observation is made about the subject - a patient, or group of patients, location, or device - and the distinction between the subject and what is directly measured for an observation is specified in the observation code itself ( e.g., "Blood Glucose") and does not need to be represented separately using this element. Use `specimen` if a reference to a specimen is required. If a code is required instead of a resource use either `bodysite` for bodysites or the standard extension [focusCode](extension-observation-focuscode.html)." />
</base>
<targetProfile value="https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-diagnose-primaertumor" />
</type>
</constraint>
<expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))" />
<xpath value="not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])" />
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made." />
<comment value="This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests)." />
<requirements value="For some observations it may be important to know the link between an observation and a particular encounter." />
</base>
</type>
</constraint>
<expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))" />
<xpath value="not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])" />
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
</discriminator>
</slicing>
<definition value="The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself." />
<comment value="At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the [Timing](datatypes.html#timing) datatype which allow the measurement to be tied to regular life events." />
<requirements value="Knowing when an observation was deemed true is important to its relevance as well as determining trends." />
</base>
</type>
</type>
</type>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself." />
<comment value="At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the [Timing](datatypes.html#timing) datatype which allow the measurement to be tied to regular life events." />
<requirements value="Knowing when an observation was deemed true is important to its relevance as well as determining trends." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified." />
<comment value="For Observations that don’t require review and verification, it may be the same as the [`lastUpdated` ](resource-definitions.html#Meta.lastUpdated) time of the resource itself. For Observations that do require review and verification for certain updates, it might not be the same as the `lastUpdated` time of the resource itself due to a non-clinically significant update that doesn’t require the new version to be reviewed and verified again." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<comment value="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." />
<requirements value="May give a degree of confidence in the observation and also indicates where follow-up questions should be directed." />
</base>
</type>
</constraint>
<expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))" />
<xpath value="not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])" />
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
<map value="OBX.15 / (Practitioner) OBX-16, PRT-5:PRT-4='RO' / (Device) OBX-18 , PRT-10:PRT-4='EQUIP' / (Organization) OBX-23, PRT-8:PRT-4='PO'" />
</mapping>
</mapping>
</element>
</extension>
</extension>
</extension>
</short>
</extension>
</extension>
</extension>
</definition>
<comment value="An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the [Notes section](observation.html#notes) below." />
<requirements value="An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
</discriminator>
</slicing>
<definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
<comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</mapping>
</element>
<definition value="The value of the measured amount. The value includes an implicit precision in the presentation of the value." />
<comment value="The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books)." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value." />
<requirements value="Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology." />
</base>
</type>
<meaningWhenMissing value="If there is no comparator, then there is no modification of the value" />
</constraint>
<isModifierReason value="This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value" />
</extension>
</binding>
</mapping>
</mapping>
</mapping>
</element>
</extension>
<requirements value="There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
<comment value="The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system." />
<requirements value="Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
<definition value="Provides a reason why the expected value in the element Observation.value[x] is missing." />
<comment value="Null or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "specimen unsatisfactory". \n\nThe alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Note that an observation may only be reported if there are values to report. For example differential cell counts values may be reported only when > 0. Because of these options, use-case agreements are required to interpret general observations for null or exceptional values." />
<requirements value="For many results it is necessary to handle exceptional values in measurements." />
</base>
</type>
</constraint>
</extension>
</binding>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="A categorical assessment of an observation value. For example, high, low, normal." />
<comment value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result." />
<requirements value="For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result." />
</base>
</type>
</constraint>
</extension>
</binding>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<comment value="May include general statements about the observation, or statements about significant, unexpected or unreliable results values, or information about its source when relevant to its interpretation." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="Indicates the site on the subject's body where the observation was made (i.e. the target site)." />
<comment value="Only used if not implicit in code found in Observation.code. In many systems, this may be represented as a related observation instead of an inline component. \n\nIf 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](extension-bodysite.html)." />
</base>
</type>
</constraint>
</extension>
</binding>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<requirements value="In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results." />
</base>
</type>
</constraint>
</extension>
</binding>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<comment value="Should only be used if not implicit in code found in `Observation.code`. Observations are not made on specimens themselves; they are made on a subject, but in many cases by the means of a specimen. Note that although specimens are often involved, they are not always tracked and reported explicitly. Also note that observation resources may be used in contexts that track the specimen explicitly (e.g. Diagnostic Report)." />
</base>
</type>
</constraint>
<expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))" />
<xpath value="not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])" />
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<comment value="Note that this is not meant to represent a device involved in the transmission of the result, e.g., a gateway. Such devices may be documented using the Provenance resource where relevant." />
</base>
</type>
</constraint>
<expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))" />
<xpath value="not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])" />
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="Guidance on how to interpret the value by comparison to a normal or recommended range. Multiple reference ranges are interpreted as an "OR". In other words, to represent two distinct target populations, two `referenceRange` elements would be used." />
<comment value="Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties." />
<requirements value="Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
</discriminator>
</slicing>
<definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
<comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</mapping>
</element>
<definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
<comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
<requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension)." />
</base>
</type>
</constraint>
</constraint>
<isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
</mapping>
</mapping>
</element>
<definition value="The value of the low bound of the reference range. The low bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the low bound is omitted, it is assumed to be meaningless (e.g. reference range is <=2.3)." />
<comment value="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." />
</base>
</type>
</constraint>
</constraint>
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="The value of the high bound of the reference range. The high bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the high bound is omitted, it is assumed to be meaningless (e.g. reference range is >= 2.3)." />
<comment value="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." />
</base>
</type>
</constraint>
</constraint>
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="Codes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range." />
<comment value="This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed." />
<requirements value="Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation." />
</base>
</type>
</constraint>
</extension>
</binding>
</mapping>
</mapping>
</mapping>
</mapping>
<map value="< 260245000 |Findings values| OR \n< 365860008 |General clinical state finding| \nOR \n< 250171008 |Clinical history or observation findings| OR \n< 415229000 |Racial group| OR \n< 365400002 |Finding of puberty stage| OR\n< 443938003 |Procedure carried out on subject|" />
</mapping>
</mapping>
</mapping>
</element>
<definition value="Codes to indicate the target population this reference range applies to. For example, a reference range may be based on the normal population or a particular sex or race. Multiple `appliesTo` are interpreted as an "AND" of the target populations. For example, to represent a target population of African American females, both a code of female and a code for African American would be used." />
<comment value="This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed." />
<requirements value="Need to be able to identify the target population for proper interpretation." />
</base>
</type>
</constraint>
</extension>
</binding>
</mapping>
</mapping>
</mapping>
</mapping>
<map value="< 260245000 |Findings values| OR \n< 365860008 |General clinical state finding| \nOR \n< 250171008 |Clinical history or observation findings| OR \n< 415229000 |Racial group| OR \n< 365400002 |Finding of puberty stage| OR\n< 443938003 |Procedure carried out on subject|" />
</mapping>
</mapping>
</mapping>
</element>
<definition value="The age at which this reference range is applicable. This is a neonatal age (e.g. number of weeks at term) if the meaning says so." />
<comment value="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." />
</base>
</type>
</constraint>
<xpath value="not(exists(f:low/f:value/@value)) or not(exists(f:high/f:value/@value)) or (number(f:low/f:value/@value) <= number(f:high/f:value/@value))" />
</constraint>
</mapping>
</mapping>
<map value="IVL<QTY[not(type="TS")]> [lowClosed="true" and highClosed="true"]or URG<QTY[not(type="TS")]>" />
</mapping>
</mapping>
</element>
<definition value="Text based reference range in an observation which may be used when a quantitative range is not appropriate for an observation. An example would be a reference value of "Negative" or a list or table of "normals"." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
<definition value="This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group." />
<comment value="When using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see [Notes](observation.html#obsgrouping) below. Note that a system may calculate results from [QuestionnaireResponse](questionnaireresponse.html) into a final score and represent the score as an Observation." />
</base>
</type>
</constraint>
<expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))" />
<xpath value="not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])" />
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="The target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image." />
<comment value="All the reference choices that are listed in this element can represent clinical observations and other measurements that may be the source for a derived value. The most common reference will be another Observation. For a discussion on the ways Observations can assembled in groups together, see [Notes](observation.html#obsgrouping) below." />
</base>
</type>
</constraint>
<expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))" />
<xpath value="not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])" />
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations." />
<comment value="For a discussion on the ways Observations can be assembled in groups together see [Notes](observation.html#notes) below." />
<requirements value="Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
</discriminator>
</slicing>
<definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." />
<comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</mapping>
</element>
<definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." />
<comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." />
<requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension)." />
</base>
</type>
</constraint>
</constraint>
<isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
</mapping>
</mapping>
</element>
<definition value="Describes what was observed. Sometimes this is called the observation "code"." />
<comment value="*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation." />
<requirements value="Knowing what kind of observation is being made is essential to understanding the observation." />
</base>
</type>
</constraint>
</extension>
</binding>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="The information determined as a result of making the observation, if the information has a simple value." />
<comment value="Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the [Notes section](observation.html#notes) below." />
<requirements value="An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations." />
</base>
</type>
</type>
</type>
</type>
</type>
</type>
</type>
</type>
</type>
</type>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="Provides a reason why the expected value in the element Observation.component.value[x] is missing." />
<comment value=""Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done". \n\nThe alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values." />
<requirements value="For many results it is necessary to handle exceptional values in measurements." />
</base>
</type>
</constraint>
</extension>
</binding>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="A categorical assessment of an observation value. For example, high, low, normal." />
<comment value="Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result." />
<requirements value="For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result." />
</base>
</type>
</constraint>
</extension>
</binding>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
<definition value="Guidance on how to interpret the value by comparison to a normal or recommended range." />
<comment value="Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties." />
<requirements value="Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts." />
</base>
</mapping>
</mapping>
</element>
</snapshot>
</mapping>
</element>
</element>
<definition value="PSA-Wert wie im oBDS definiert. Der PSA-Wert ist ein Tumormarker, der bei der Diagnostik und Verlaufskontrolle von Prostatakrebs verwendet wird. Er wird in ng/ml gemessen. Bei Vorliegen kann dieser Datenpunkt auch durch eine Observation aus dem Labormodul abgebildet werden." />
</element>
<valueSet value="https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-prostata-psa-loinc" />
</binding>
</element>
</type>
</element>
<targetProfile value="https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-diagnose-primaertumor" />
</type>
</element>
</element>
</discriminator>
</slicing>
</element>
</type>
</mapping>
</element>
</extension>
</extension>
</extension>
</short>
</extension>
</extension>
</extension>
</definition>
</type>
</element>
</mapping>
</element>
</element>
</element>
</element>
</differential>
</StructureDefinition>
{
"url": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-prostate-psa",
],
"description": "Dieses Profil beschreibt den PSA-Wert sowohl beim Monitoring als auch in der Verlaufskontrolle in der Onkologie",
],
{
"comment": "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.",
"Vital Signs",
"Measurement",
"Results",
"Tests"
],
},
{
},
{
"human": "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"xpath": "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))",
},
{
"human": "If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource",
"expression": "contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()",
"xpath": "not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))",
},
{
{
},
{
"valueMarkdown": "When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."
}
],
},
{
},
{
"human": "If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present",
"expression": "value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()",
"xpath": "not(f:*[starts-with(local-name(.), 'value')] and (for $coding in f:code/f:coding return f:component/f:code/f:coding[f:code/@value=$coding/f:code/@value] [f:system/@value=$coding/f:system/@value]))",
},
{
"xpath": "not(exists(f:dataAbsentReason)) or (not(exists(*[starts-with(local-name(.), 'value')])))",
}
],
{
},
{
},
{
},
{
},
{
},
{
}
]
},
{
"definition": "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"comment": "The only time that a resource does not have an id is when it is being submitted to the server using a create operation.",
},
{
{
}
],
}
],
},
{
"definition": "The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.",
},
],
"ele-1"
],
{
}
],
]
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
],
},
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment": "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.",
"extensions",
"user content"
],
},
],
"ele-1"
],
{
},
{
}
],
]
},
{
"definition": "The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.",
"comment": "The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.",
},
],
"ele-1"
],
{
}
],
]
},
{
"comment": "This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a [read](http.html#read) interaction.",
},
],
"ele-1"
],
{
}
],
]
},
{
"definition": "A uri that identifies the source system of the resource. This provides a minimal amount of [Provenance](provenance.html#) information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.",
"comment": "In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. \n\nThis element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.",
},
],
"ele-1"
],
{
}
],
]
},
{
"definition": "A list of profiles (references to [StructureDefinition](structuredefinition.html#) resources) that this resource claims to conform to. The URL is a reference to [StructureDefinition.url](structuredefinition-definitions.html#StructureDefinition.url).",
"comment": "It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.",
},
{
"http://hl7.org/fhir/StructureDefinition/StructureDefinition"
]
}
],
"ele-1"
],
{
}
],
]
},
{
"definition": "Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.",
"comment": "The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.",
},
],
"ele-1"
],
{
}
],
{
}
],
},
{
},
{
},
{
},
{
}
]
},
{
"definition": "Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.",
"comment": "The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.",
},
],
"ele-1"
],
{
}
],
{
}
],
"description": "Codes that represent various types of tags, commonly workflow-related; e.g. \"Needs review by Dr. Jones\".",
},
{
},
{
},
{
},
{
}
]
},
{
"definition": "A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.",
"comment": "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.",
},
],
"ele-1"
],
{
}
],
"isModifierReason": "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation",
]
},
{
"comment": "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).",
},
],
"ele-1"
],
{
}
],
{
},
{
}
],
},
]
},
{
"definition": "A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.",
"comment": "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.",
"narrative",
"html",
"xhtml",
"display"
],
},
],
"ele-1"
],
{
}
],
{
},
{
},
{
}
]
},
{
"definition": "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.",
"comment": "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.",
"inline resources",
"anonymous resources",
"contained resources"
],
},
],
]
},
{
],
},
"definition": "May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment": "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.",
"extensions",
"user content"
],
},
],
"ele-1"
],
{
},
{
}
],
]
},
{
],
},
"definition": "May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements": "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](extensibility.html#modifierExtension).",
"extensions",
"user content"
],
},
],
"ele-1"
],
{
},
{
}
],
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
]
},
{
},
],
"ele-1"
],
{
}
],
{
},
{
},
{
"map": "II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]"
},
{
},
{
},
{
},
{
"map": "OBX.21 For OBX segments from systems without OBX-21 support a combination of ORC/OBR and OBX must be negotiated between trading partners to uniquely identify the OBX segment. Depending on how V2 has been implemented each of these may be an option: 1) OBR-3 + OBX-3 + OBX-4 or 2) OBR-3 + OBR-4 + OBX-3 + OBX-4 or 2) some other way to uniquely ID the OBR/ORC + OBX-3 + OBX-4."
},
{
}
]
},
{
"definition": "A plan, proposal or order that is fulfilled in whole or in part by this event. For example, a MedicationRequest may require a patient to have laboratory test performed before it is dispensed.",
"comment": "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.",
"requirements": "Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon.",
"Fulfills"
],
},
{
"http://hl7.org/fhir/StructureDefinition/CarePlan",
"http://hl7.org/fhir/StructureDefinition/DeviceRequest",
"http://hl7.org/fhir/StructureDefinition/ImmunizationRecommendation",
"http://hl7.org/fhir/StructureDefinition/MedicationRequest",
"http://hl7.org/fhir/StructureDefinition/NutritionOrder",
"http://hl7.org/fhir/StructureDefinition/ServiceRequest"
]
}
],
"ele-1"
],
{
},
{
"expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))",
"xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
}
],
{
},
{
},
{
},
{
},
{
}
]
},
{
"definition": "A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure.",
"comment": "To link an Observation to an Encounter use `encounter`. See the [Notes](observation.html#obsgrouping) below for guidance on referencing another Observation.",
"Container"
],
},
{
"http://hl7.org/fhir/StructureDefinition/MedicationAdministration",
"http://hl7.org/fhir/StructureDefinition/MedicationDispense",
"http://hl7.org/fhir/StructureDefinition/MedicationStatement",
"http://hl7.org/fhir/StructureDefinition/Procedure",
"http://hl7.org/fhir/StructureDefinition/Immunization",
"http://hl7.org/fhir/StructureDefinition/ImagingStudy"
]
}
],
"ele-1"
],
{
},
{
"expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))",
"xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
}
],
{
},
{
},
{
},
{
},
{
}
]
},
{
{
}
],
"comment": "This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.",
"requirements": "Need to track the status of individual results. Some results are finalized before the whole report is finalized.",
},
],
"ele-1"
],
{
}
],
"isModifierReason": "This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid",
{
}
],
},
{
},
{
},
{
},
{
},
{
},
{
"map": "status Amended & Final are differentiated by whether it is the subject of a ControlAct event with a type of \"revise\""
}
]
},
{
"comment": "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.",
},
],
"ele-1"
],
{
}
],
{
}
],
},
{
},
{
},
{
},
{
},
{
},
{
}
]
},
{
"definition": "PSA-Wert wie im oBDS definiert. Der PSA-Wert ist ein Tumormarker, der bei der Diagnostik und Verlaufskontrolle von Prostatakrebs verwendet wird. Er wird in ng/ml gemessen. Bei Vorliegen kann dieser Datenpunkt auch durch eine Observation aus dem Labormodul abgebildet werden.",
"comment": "*All* code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.",
"requirements": "Knowing what kind of observation is being made is essential to understanding the observation.",
"Name"
],
},
],
"ele-1"
],
{
}
],
{
}
],
},
{
},
{
},
{
},
{
},
{
},
{
},
{
},
{
},
{
},
{
}
]
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
],
},
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment": "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.",
"extensions",
"user content"
],
},
],
"ele-1"
],
{
},
{
}
],
]
},
{
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
},
],
"ele-1"
],
{
}
],
"valueSet": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-prostata-psa-loinc"
},
{
},
{
},
{
},
{
},
{
},
{
},
{
}
]
},
{
{
}
],
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
},
],
"ele-1"
],
{
}
],
{
},
{
},
{
},
{
}
]
},
{
"definition": "The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the `focus` element or the `code` itself specifies the actual focus of the observation.",
"comment": "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.",
},
],
"ele-1"
],
{
},
{
"expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))",
"xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
}
],
{
},
{
},
{
},
{
},
{
},
{
},
{
}
]
},
{
"definition": "The actual focus of an observation when it is not the patient of record representing something or someone associated with the patient such as a spouse, parent, fetus, or donor. For example, fetus observations in a mother's record. The focus of an observation could also be an existing condition, an intervention, the subject's diet, another observation of the subject, or a body structure such as tumor or implanted device. An example use case would be using the Observation resource to capture whether the mother is trained to change her child's tracheostomy tube. In this example, the child is the patient of record and the mother is the focus.",
"comment": "Typically, an observation is made about the subject - a patient, or group of patients, location, or device - and the distinction between the subject and what is directly measured for an observation is specified in the observation code itself ( e.g., \"Blood Glucose\") and does not need to be represented separately using this element. Use `specimen` if a reference to a specimen is required. If a code is required instead of a resource use either `bodysite` for bodysites or the standard extension [focusCode](extension-observation-focuscode.html).",
},
{
"https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-diagnose-primaertumor"
]
}
],
"ele-1"
],
{
},
{
"expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))",
"xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
}
],
{
},
{
},
{
},
{
},
{
},
{
}
]
},
{
"definition": "The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made.",
"comment": "This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).",
"requirements": "For some observations it may be important to know the link between an observation and a particular encounter.",
"Context"
],
},
],
"ele-1"
],
{
},
{
"expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))",
"xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
}
],
{
},
{
},
{
},
{
},
{
},
{
}
]
},
{
},
"definition": "The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the \"physiologically relevant time\". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.",
"comment": "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](datatypes.html#timing) datatype which allow the measurement to be tied to regular life events.",
"requirements": "Knowing when an observation was deemed true is important to its relevance as well as determining trends.",
"Occurrence"
],
},
],
"ele-1"
],
{
}
],
{
},
{
},
{
},
{
},
{
}
]
},
{
"definition": "The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the \"physiologically relevant time\". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.",
"comment": "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](datatypes.html#timing) datatype which allow the measurement to be tied to regular life events.",
"requirements": "Knowing when an observation was deemed true is important to its relevance as well as determining trends.",
"Occurrence"
],
},
],
"ele-1"
],
{
}
],
{
},
{
},
{
},
{
},
{
},
{
}
]
},
{
"definition": "The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified.",
"comment": "For Observations that don’t require review and verification, it may be the same as the [`lastUpdated` ](resource-definitions.html#Meta.lastUpdated) time of the resource itself. For Observations that do require review and verification for certain updates, it might not be the same as the `lastUpdated` time of the resource itself due to a non-clinically significant update that doesn’t require the new version to be reviewed and verified again.",
},
],
"ele-1"
],
{
}
],
{
},
{
},
{
},
{
}
]
},
{
"comment": "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.",
"requirements": "May give a degree of confidence in the observation and also indicates where follow-up questions should be directed.",
},
{
"http://hl7.org/fhir/StructureDefinition/Practitioner",
"http://hl7.org/fhir/StructureDefinition/PractitionerRole",
"http://hl7.org/fhir/StructureDefinition/Organization",
"http://hl7.org/fhir/StructureDefinition/CareTeam",
"http://hl7.org/fhir/StructureDefinition/Patient",
"http://hl7.org/fhir/StructureDefinition/RelatedPerson"
]
}
],
"ele-1"
],
{
},
{
"expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))",
"xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
}
],
{
},
{
},
{
},
{
},
{
"map": "OBX.15 / (Practitioner) OBX-16, PRT-5:PRT-4='RO' / (Device) OBX-18 , PRT-10:PRT-4='EQUIP' / (Organization) OBX-23, PRT-8:PRT-4='PO'"
},
{
}
]
},
{
{
],
}
]
},
{
{
},
{
}
],
}
]
},
"comment": "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](observation.html#notes) below.",
"requirements": "An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.",
},
],
"ele-1",
"obs-7"
],
{
}
],
{
},
{
},
{
},
{
},
{
}
]
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
],
},
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment": "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.",
"extensions",
"user content"
],
},
],
"ele-1"
],
{
},
{
}
],
]
},
{
"definition": "The value of the measured amount. The value includes an implicit precision in the presentation of the value.",
"comment": "The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).",
},
],
"ele-1"
],
{
}
],
{
},
{
},
{
},
{
}
]
},
{
"definition": "How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is \"<\" , then the real value is < stated value.",
"requirements": "Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.",
},
],
"ele-1"
],
{
}
],
"isModifierReason": "This is labeled as \"Is Modifier\" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value",
{
}
],
},
{
},
{
},
{
}
]
},
{
{
}
],
"requirements": "There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.",
},
],
"ele-1"
],
{
}
],
{
},
{
},
{
}
]
},
{
},
],
"ele-1",
"qty-3"
],
{
}
],
{
},
{
},
{
}
]
},
{
"comment": "The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.",
"requirements": "Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.",
},
],
"ele-1"
],
{
}
],
{
},
{
},
{
}
]
},
{
"definition": "Provides a reason why the expected value in the element Observation.value[x] is missing.",
"comment": "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\". \n\nThe 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.",
},
],
"ele-1",
"obs-6"
],
{
}
],
{
}
],
},
{
},
{
},
{
},
{
},
{
},
{
}
]
},
{
"comment": "Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.",
"requirements": "For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.",
"Abnormal Flag"
],
},
],
"ele-1"
],
{
}
],
{
}
],
},
{
},
{
},
{
},
{
},
{
},
{
},
{
},
{
}
]
},
{
"comment": "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.",
},
],
"ele-1"
],
{
}
],
{
},
{
},
{
},
{
},
{
}
]
},
{
"definition": "Indicates the site on the subject's body where the observation was made (i.e. the target site).",
"comment": "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. \n\nIf 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](extension-bodysite.html).",
},
],
"ele-1"
],
{
}
],
{
}
],
},
{
},
{
},
{
},
{
},
{
},
{
},
{
},
{
}
]
},
{
"requirements": "In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results.",
},
],
"ele-1"
],
{
}
],
{
}
],
},
{
},
{
},
{
},
{
},
{
},
{
}
]
},
{
"comment": "Should only be used if not implicit in code found in `Observation.code`. Observations are not made on specimens themselves; they are made on a subject, but in many cases by the means of a specimen. Note that although specimens are often involved, they are not always tracked and reported explicitly. Also note that observation resources may be used in contexts that track the specimen explicitly (e.g. Diagnostic Report).",
},
],
"ele-1"
],
{
},
{
"expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))",
"xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
}
],
{
},
{
},
{
},
{
},
{
},
{
}
]
},
{
"comment": "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.",
},
{
"http://hl7.org/fhir/StructureDefinition/Device",
"http://hl7.org/fhir/StructureDefinition/DeviceMetric"
]
}
],
"ele-1"
],
{
},
{
"expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))",
"xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
}
],
{
},
{
},
{
},
{
},
{
},
{
}
]
},
{
"definition": "Guidance on how to interpret the value by comparison to a normal or recommended range. Multiple reference ranges are interpreted as an \"OR\". In other words, to represent two distinct target populations, two `referenceRange` elements would be used.",
"comment": "Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.",
"requirements": "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.",
},
],
"ele-1"
],
{
},
{
}
],
{
},
{
},
{
}
]
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
],
},
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment": "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.",
"extensions",
"user content"
],
},
],
"ele-1"
],
{
},
{
}
],
]
},
{
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements": "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](extensibility.html#modifierExtension).",
"extensions",
"user content",
"modifiers"
],
},
],
"ele-1"
],
{
},
{
}
],
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
]
},
{
"definition": "The value of the low bound of the reference range. The low bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the low bound is omitted, it is assumed to be meaningless (e.g. reference range is <=2.3).",
"comment": "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.",
},
],
"ele-1",
"obs-3"
],
{
},
{
},
{
}
],
{
},
{
},
{
},
{
},
{
}
]
},
{
"definition": "The value of the high bound of the reference range. The high bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the high bound is omitted, it is assumed to be meaningless (e.g. reference range is >= 2.3).",
"comment": "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.",
},
],
"ele-1",
"obs-3"
],
{
},
{
},
{
}
],
{
},
{
},
{
},
{
},
{
}
]
},
{
"definition": "Codes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range.",
"comment": "This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed.",
"requirements": "Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation.",
},
],
"ele-1"
],
{
}
],
{
}
],
},
{
},
{
},
{
},
{
},
{
"map": "< 260245000 |Findings values| OR \n< 365860008 |General clinical state finding| \nOR \n< 250171008 |Clinical history or observation findings| OR \n< 415229000 |Racial group| OR \n< 365400002 |Finding of puberty stage| OR\n< 443938003 |Procedure carried out on subject|"
},
{
},
{
}
]
},
{
"definition": "Codes to indicate the target population this reference range applies to. For example, a reference range may be based on the normal population or a particular sex or race. Multiple `appliesTo` are interpreted as an \"AND\" of the target populations. For example, to represent a target population of African American females, both a code of female and a code for African American would be used.",
"comment": "This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed.",
},
],
"ele-1"
],
{
}
],
{
}
],
},
{
},
{
},
{
},
{
},
{
"map": "< 260245000 |Findings values| OR \n< 365860008 |General clinical state finding| \nOR \n< 250171008 |Clinical history or observation findings| OR \n< 415229000 |Racial group| OR \n< 365400002 |Finding of puberty stage| OR\n< 443938003 |Procedure carried out on subject|"
},
{
},
{
}
]
},
{
"definition": "The age at which this reference range is applicable. This is a neonatal age (e.g. number of weeks at term) if the meaning says so.",
"comment": "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.",
},
],
"ele-1"
],
{
},
{
"xpath": "not(exists(f:low/f:value/@value)) or not(exists(f:high/f:value/@value)) or (number(f:low/f:value/@value) <= number(f:high/f:value/@value))",
}
],
{
},
{
},
{
"map": "IVL<QTY[not(type=\"TS\")]> [lowClosed=\"true\" and highClosed=\"true\"]or URG<QTY[not(type=\"TS\")]>"
},
{
}
]
},
{
"definition": "Text based reference range in an observation which may be used when a quantitative range is not appropriate for an observation. An example would be a reference value of \"Negative\" or a list or table of \"normals\".",
},
],
"ele-1"
],
{
}
],
{
},
{
},
{
}
]
},
{
"definition": "This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group.",
"comment": "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](observation.html#obsgrouping) below. Note that a system may calculate results from [QuestionnaireResponse](questionnaireresponse.html) into a final score and represent the score as an Observation.",
},
{
"http://hl7.org/fhir/StructureDefinition/Observation",
"http://hl7.org/fhir/StructureDefinition/QuestionnaireResponse",
"http://hl7.org/fhir/StructureDefinition/MolecularSequence"
]
}
],
"ele-1"
],
{
},
{
"expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))",
"xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
}
],
{
},
{
},
{
},
{
}
]
},
{
"definition": "The target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image.",
"comment": "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](observation.html#obsgrouping) below.",
},
{
"http://hl7.org/fhir/StructureDefinition/DocumentReference",
"http://hl7.org/fhir/StructureDefinition/ImagingStudy",
"http://hl7.org/fhir/StructureDefinition/Media",
"http://hl7.org/fhir/StructureDefinition/QuestionnaireResponse",
"http://hl7.org/fhir/StructureDefinition/Observation",
"http://hl7.org/fhir/StructureDefinition/MolecularSequence"
]
}
],
"ele-1"
],
{
},
{
"expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))",
"xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
}
],
{
},
{
},
{
},
{
}
]
},
{
"definition": "Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.",
"comment": "For a discussion on the ways Observations can be assembled in groups together see [Notes](observation.html#notes) below.",
"requirements": "Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.",
},
],
"ele-1"
],
{
}
],
{
},
{
},
{
}
]
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
],
},
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment": "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.",
"extensions",
"user content"
],
},
],
"ele-1"
],
{
},
{
}
],
]
},
{
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements": "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](extensibility.html#modifierExtension).",
"extensions",
"user content",
"modifiers"
],
},
],
"ele-1"
],
{
},
{
}
],
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
]
},
{
"comment": "*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.",
"requirements": "Knowing what kind of observation is being made is essential to understanding the observation.",
},
],
"ele-1"
],
{
}
],
{
}
],
},
{
},
{
},
{
},
{
},
{
},
{
},
{
},
{
}
]
},
{
"definition": "The information determined as a result of making the observation, if the information has a simple value.",
"comment": "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](observation.html#notes) below.",
"requirements": "An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.",
},
{
},
{
},
{
},
{
},
{
},
{
},
{
},
{
},
{
},
{
},
{
}
],
"ele-1"
],
{
}
],
{
},
{
},
{
},
{
},
{
}
]
},
{
"definition": "Provides a reason why the expected value in the element Observation.component.value[x] is missing.",
"comment": "\"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\". \n\nThe 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.",
},
],
"ele-1",
"obs-6"
],
{
}
],
{
}
],
},
{
},
{
},
{
},
{
},
{
},
{
}
]
},
{
"comment": "Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.",
"requirements": "For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.",
"Abnormal Flag"
],
},
],
"ele-1"
],
{
}
],
{
}
],
},
{
},
{
},
{
},
{
},
{
},
{
},
{
},
{
}
]
},
{
"definition": "Guidance on how to interpret the value by comparison to a normal or recommended range.",
"comment": "Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.",
"requirements": "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.",
},
{
},
{
}
]
}
]
},
{
]
},
{
},
{
"definition": "PSA-Wert wie im oBDS definiert. Der PSA-Wert ist ein Tumormarker, der bei der Diagnostik und Verlaufskontrolle von Prostatakrebs verwendet wird. Er wird in ng/ml gemessen. Bei Vorliegen kann dieser Datenpunkt auch durch eine Observation aus dem Labormodul abgebildet werden.",
},
{
"valueSet": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-prostata-psa-loinc"
}
},
{
],
},
{
{
"https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-diagnose-primaertumor"
]
}
],
},
{
},
{
}
},
{
],
]
},
{
{
],
}
]
},
{
{
},
{
}
],
}
]
},
],
},
{
]
},
{
},
{
},
{
}
]
}
}
Mapping Datensatz zu FHIR
| Datensatz | Erklaerung | FHIR |
|---|---|---|
| PSA-Wert | Prostataspezifisches Antigen in ng/ml für Diagnostik und Verlaufskontrolle. | Observation.where(code.coding.system='http://loinc.org' and code.coding.code='2857-1').valueQuantity |
Mapping Einheitlicher onkologischer Basisdatensatz (oBDS) zu FHIR
| oBDS | Definition | FHIR |
|---|---|---|
| P7 | PSA-Wert | Observation |
| P8 | Datum PSA-Wert (oBDS 238) | Observation.effective[x] |
| P7 | PSA-Wert (oBDS 237) | Observation.value[x].value |
Suchparameter
Folgende Suchparameter sind für das Prostata-PSA Profil relevant, auch in Kombination:
Der Suchparameter "_id" MUSS unterstützt werden:
Beispiele:
GET [base]/Observation?_id=12345Anwendungshinweise: Weitere Informationen zur Suche nach "_id" finden sich in der FHIR-Basisspezifikation - Abschnitt "Parameters for all resources".
Der Suchparameter "_profile" MUSS unterstützt werden:
Beispiele:
GET [base]/Observation?_profile=https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-prostate-psaAnwendungshinweise: Weitere Informationen zur Suche nach "_profile" finden sich in der FHIR-Basisspezifikation - Abschnitt "Parameters for all resources".
Der Suchparameter "code" MUSS unterstützt werden:
Beispiele:
GET [base]/Observation?code=http://loinc.org|2857-1Anwendungshinweise: Weitere Informationen zur Suche nach "Observation.code" finden sich in der FHIR-Basisspezifikation - Abschnitt "Token Search".
Der Suchparameter "subject" MUSS unterstützt werden:
Beispiele:
GET [base]/Observation?subject=Patient/testAnwendungshinweise: Weitere Informationen zur Suche nach "Observation.subject" finden sich in der FHIR-Basisspezifikation - Abschnitt "reference".
Der Suchparameter "focus" MUSS unterstützt werden:
Beispiele:
GET [base]/Observation?focus=Condition/primaertumorAnwendungshinweise: Weitere Informationen zur Suche nach "Observation.focus" finden sich in der FHIR-Basisspezifikation - Abschnitt "reference".
Der Suchparameter "value-quantity" MUSS unterstützt werden:
Beispiele:
GET [base]/Observation?value-quantity=gt5.0Anwendungshinweise: Weitere Informationen zur Suche nach "Observation.value" finden sich in der FHIR-Basisspezifikation - Abschnitt "Quantity Search".
Beispiele
{
"resourceType": "Observation",
"id": "mii-exa-onko-prostata-psa-diagnose-1",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-prostate-psa|2027.0.0-ballot.1"
]
},
"status": "final",
"code": {
"coding": [
{
"system": "http://loinc.org",
"code": "2857-1",
"display": "Prostate specific Ag [Mass/volume] in Serum or Plasma"
}
]
},
"subject": {
"reference": "Patient/mii-exa-onko-prostata-bundle-patient"
},
"focus": [
{
"reference": "Condition/mii-exa-onko-prostata-diagnose"
}
],
"effectiveDateTime": "2024-01-02",
"valueQuantity": {
"value": 12,
"unit": "ng/ml"
}
}
{
"resourceType": "Observation",
"id": "mii-exa-onko-prostata-psa-verlauf-1",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-prostate-psa|2027.0.0-ballot.1"
]
},
"status": "final",
"code": {
"coding": [
{
"system": "http://loinc.org",
"code": "2857-1",
"display": "Prostate specific Ag [Mass/volume] in Serum or Plasma"
}
]
},
"subject": {
"reference": "Patient/mii-exa-onko-prostata-bundle-patient"
},
"focus": [
{
"reference": "Condition/mii-exa-onko-prostata-diagnose"
}
],
"effectiveDateTime": "2024-06-24",
"valueQuantity": {
"value": 3.4,
"unit": "ng/ml"
}
}