MII-Initiative

MII IG Labor DE v2024

ObservationLab bildet das Ergebnis einer einzelnen Laboruntersuchung ab.

Metadaten

CanonicalStatusVersionBasis
https://www.medizininformatik-initiative.de/fhir/core/modul-labor/StructureDefinition/ObservationLabactive2024.0.0-ballothttp://hl7.org/fhir/StructureDefinition/Observation

Inhalt

idS Σ0..1string
id0..1string
extensionI0..*Extension
versionIdΣ0..1id
lastUpdatedΣ0..1instant
sourceS Σ0..1uri
profileS Σ0..*canonical(StructureDefinition)
securityΣ0..*CodingBinding
tagΣ0..*Coding
implicitRulesΣ ?!0..1uri
language0..1codeBinding
text0..1Narrative
contained0..*Resource
extensionI0..*Extension
modifierExtension?! I0..*Extension
id0..1string
extensionI0..*Extension
useΣ ?!0..1codeBinding
id0..1string
extensionI0..*Extension
id0..1string
extensionI0..*Extension
systemS Σ1..1uriFixed Value
versionΣ0..1string
codeS Σ1..1codeFixed Value
displayΣ0..1string
userSelectedΣ0..1boolean
textΣ0..1string
systemS Σ1..1uri
valueS Σ1..1string
periodΣ I0..1Period
assignerS Σ I1..1MII-Reference(Organization)
basedOnΣ I0..*Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)
partOfΣ I0..*Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)
statusS Σ ?!1..1codeBinding
id0..1string
extensionI0..*Extension
loinc-observationS Σ1..1CodingPattern
observation-categoryS Σ1..1CodingPattern
textΣ0..1string
codeS Σ1..1CodeableConceptBinding
subjectS Σ I1..1MII-Reference(Patient | Group | Device | Location)
focusΣ I0..*Reference(Resource)
encounterS Σ I0..1Reference(Encounter)
id0..1string
QuelleKlinischesBezugsdatumS I0..1Extension(Coding)
value0..1System.DateTime
issuedS Σ0..1instant
performerΣ I0..*Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)
valueRangeRange
valueRatioRatio
id0..1string
pqTranslationI0..*Extension(Quantity)
id0..1string
quantityPrecisionS I0..1Extension(integer)
value0..1System.Decimal
comparatorΣ ?!0..1codeBinding
unitS Σ1..1string
systemS Σ I1..1uriFixed Value
codeS Σ1..1code
id0..1string
extensionI0..*Extension
id0..1string
extensionI0..*Extension
systemS Σ1..1uri
versionΣ0..1string
codeS Σ1..1code
displayΣ0..1string
userSelectedΣ0..1boolean
textΣ0..1string
dataAbsentReasonS I0..1CodeableConceptBinding
interpretationS0..*CodeableConceptBinding
noteS0..*Annotation
bodySite0..0CodeableConcept
methodS0..1CodeableConcept
id0..1string
extensionI0..*Extension
referenceS Σ I0..1string
typeΣ0..1uriBinding
identifierS Σ0..1Identifier
displayΣ0..1string
deviceS I0..1Reference(Device | DeviceMetric)
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
lowI0..1SimpleQuantity
highI0..1SimpleQuantity
type0..1CodeableConceptBinding
appliesTo0..*CodeableConcept
ageI0..1Range
text0..1string
hasMemberΣ I0..*Reference(Observation | QuestionnaireResponse | MolecularSequence)
derivedFromΣ I0..*Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
codeΣ1..1CodeableConcept
valueQuantityQuantity
valueCodeableConceptCodeableConcept
valueStringstring
valueBooleanboolean
valueIntegerinteger
valueRangeRange
valueRatioRatio
valueSampledDataSampledData
valueTimetime
valueDateTimedateTime
valuePeriodPeriod
dataAbsentReasonI0..1CodeableConceptBinding
interpretation0..*CodeableConceptBinding
referenceRange0..*see (referenceRange)
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<StructureDefinition xmlns="http://hl7.org/fhir">
    <id value="mii-pr-labor-laboruntersuchung" />
    <url value="https://www.medizininformatik-initiative.de/fhir/core/modul-labor/StructureDefinition/ObservationLab" />
    <version value="2024.0.0-ballot" />
    <name value="MII_PR_Labor_Laboruntersuchung" />
    <title value="MII PR Labor Laboruntersuchung" />
    <status value="active" />
    <publisher value="Medizininformatik Initiative" />
    <contact>
        <telecom>
            <system value="url" />
            <value value="https://www.medizininformatik-initiative.de" />
        </telecom>
    </contact>
    <description value="Dieses Profil beschreibt eine Laborergebnis in der Medizininformatik-Initiative." />
    <purpose value="Dieses Profil beschreibt eine Laborergebnis in der Medizininformatik-Initiative." />
    <fhirVersion value="4.0.1" />
    <mapping>
        <identity value="workflow" />
        <uri value="http://hl7.org/fhir/workflow" />
        <name value="Workflow Pattern" />
    </mapping>
    <mapping>
        <identity value="sct-concept" />
        <uri value="http://snomed.info/conceptdomain" />
        <name value="SNOMED CT Concept Domain Binding" />
    </mapping>
    <mapping>
        <identity value="v2" />
        <uri value="http://hl7.org/v2" />
        <name value="HL7 v2 Mapping" />
    </mapping>
    <mapping>
        <identity value="rim" />
        <uri value="http://hl7.org/v3" />
        <name value="RIM Mapping" />
    </mapping>
    <mapping>
        <identity value="w5" />
        <uri value="http://hl7.org/fhir/fivews" />
        <name value="FiveWs Pattern Mapping" />
    </mapping>
    <mapping>
        <identity value="sct-attr" />
        <uri value="http://snomed.org/attributebinding" />
        <name value="SNOMED CT Attribute Binding" />
    </mapping>
    <kind value="resource" />
    <abstract value="false" />
    <type value="Observation" />
    <baseDefinition value="http://hl7.org/fhir/StructureDefinition/Observation" />
    <derivation value="constraint" />
    <differential>
        <element id="Observation">
            <path value="Observation" />
            <constraint>
                <key value="mii-lab-2" />
                <severity value="error" />
                <human value="Falls kein Laborwert verf&#252;gbar ist, muss eine dataAbsentReason angegeben werden" />
                <expression value="hasMember.exists() xor value.exists().not() implies dataAbsentReason.exists()" />
                <source value="https://www.medizininformatik-initiative.de/fhir/core/modul-labor/StructureDefinition/ObservationLab" />
            </constraint>
        </element>
        <element id="Observation.id">
            <path value="Observation.id" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.meta">
            <path value="Observation.meta" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.meta.source">
            <path value="Observation.meta.source" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.meta.profile">
            <path value="Observation.meta.profile" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.identifier">
            <path value="Observation.identifier" />
            <slicing>
                <discriminator>
                    <type value="pattern" />
                    <path value="type" />
                </discriminator>
                <rules value="open" />
            </slicing>
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.identifier:analyseBefundCode">
            <path value="Observation.identifier" />
            <sliceName value="analyseBefundCode" />
            <min value="1" />
            <max value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.identifier:analyseBefundCode.type">
            <path value="Observation.identifier.type" />
            <min value="1" />
            <patternCodeableConcept>
                <coding>
                    <system value="http://terminology.hl7.org/CodeSystem/v2-0203" />
                    <code value="OBI" />
                </coding>
            </patternCodeableConcept>
            <mustSupport value="true" />
            <binding>
                <strength value="extensible" />
                <valueSet value="https://www.medizininformatik-initiative.de/fhir/core/modul-labor/ValueSet/mii-vs-labor-identifier-type-codes" />
            </binding>
        </element>
        <element id="Observation.identifier:analyseBefundCode.type.coding">
            <path value="Observation.identifier.type.coding" />
            <slicing>
                <discriminator>
                    <type value="value" />
                    <path value="system" />
                </discriminator>
                <rules value="open" />
            </slicing>
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.identifier:analyseBefundCode.type.coding:observationInstanceV2">
            <path value="Observation.identifier.type.coding" />
            <sliceName value="observationInstanceV2" />
            <min value="1" />
            <max value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.identifier:analyseBefundCode.type.coding:observationInstanceV2.system">
            <path value="Observation.identifier.type.coding.system" />
            <min value="1" />
            <fixedUri value="http://terminology.hl7.org/CodeSystem/v2-0203" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.identifier:analyseBefundCode.type.coding:observationInstanceV2.code">
            <path value="Observation.identifier.type.coding.code" />
            <min value="1" />
            <fixedCode value="OBI" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.identifier:analyseBefundCode.system">
            <path value="Observation.identifier.system" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.identifier:analyseBefundCode.value">
            <path value="Observation.identifier.value" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.identifier:analyseBefundCode.assigner">
            <path value="Observation.identifier.assigner" />
            <min value="1" />
            <type>
                <code value="Reference" />
                <profile value="https://www.medizininformatik-initiative.de/fhir/core/StructureDefinition/MII-Reference" />
                <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization" />
            </type>
            <mustSupport value="true" />
        </element>
        <element id="Observation.status">
            <path value="Observation.status" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.category">
            <path value="Observation.category" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.category.coding">
            <path value="Observation.category.coding" />
            <slicing>
                <discriminator>
                    <type value="pattern" />
                    <path value="$this" />
                </discriminator>
                <rules value="open" />
            </slicing>
            <min value="2" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.category.coding:loinc-observation">
            <path value="Observation.category.coding" />
            <sliceName value="loinc-observation" />
            <min value="1" />
            <max value="1" />
            <patternCoding>
                <system value="http://loinc.org" />
                <code value="26436-6" />
            </patternCoding>
            <mustSupport value="true" />
        </element>
        <element id="Observation.category.coding:observation-category">
            <path value="Observation.category.coding" />
            <sliceName value="observation-category" />
            <min value="1" />
            <max value="1" />
            <patternCoding>
                <system value="http://terminology.hl7.org/CodeSystem/observation-category" />
                <code value="laboratory" />
            </patternCoding>
            <mustSupport value="true" />
        </element>
        <element id="Observation.code">
            <path value="Observation.code" />
            <mustSupport value="true" />
            <binding>
                <strength value="preferred" />
                <description value="Intensional Value Set Definition: LOINC {  {    STATUS in {ACTIVE}    CLASSTYPE in {1}    CLASS exclude {CHALSKIN, H&amp;P.HX.LAB, H&amp;P.HX, NR STATS, PATH.PROTOCOLS.*}  } }" />
                <valueSet value="http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-ips" />
            </binding>
        </element>
        <element id="Observation.subject">
            <path value="Observation.subject" />
            <min value="1" />
            <type>
                <code value="Reference" />
                <profile value="https://www.medizininformatik-initiative.de/fhir/core/StructureDefinition/MII-Reference" />
                <targetProfile value="http://hl7.org/fhir/StructureDefinition/Patient" />
                <targetProfile value="http://hl7.org/fhir/StructureDefinition/Group" />
                <targetProfile value="http://hl7.org/fhir/StructureDefinition/Device" />
                <targetProfile value="http://hl7.org/fhir/StructureDefinition/Location" />
            </type>
            <mustSupport value="true" />
        </element>
        <element id="Observation.encounter">
            <path value="Observation.encounter" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.effective[x]">
            <path value="Observation.effective[x]" />
            <min value="1" />
            <type>
                <code value="dateTime" />
            </type>
            <constraint>
                <key value="mii-lab-1" />
                <severity value="error" />
                <human value="Datetime must be at least to day" />
                <expression value="($this as dateTime).hasValue() implies ($this as dateTime).toString().length() &gt;= 8" />
                <source value="https://www.medizininformatik-initiative.de/fhir/core/modul-labor/StructureDefinition/ObservationLab" />
            </constraint>
            <mustSupport value="true" />
        </element>
        <element id="Observation.effective[x].extension:QuelleKlinischesBezugsdatum">
            <path value="Observation.effective[x].extension" />
            <sliceName value="QuelleKlinischesBezugsdatum" />
            <min value="0" />
            <max value="1" />
            <type>
                <code value="Extension" />
                <profile value="https://www.medizininformatik-initiative.de/fhir/core/modul-labor/StructureDefinition/QuelleKlinischesBezugsdatum" />
            </type>
            <mustSupport value="true" />
        </element>
        <element id="Observation.issued">
            <path value="Observation.issued" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.value[x]">
            <path value="Observation.value[x]" />
            <slicing>
                <discriminator>
                    <type value="type" />
                    <path value="$this" />
                </discriminator>
                <ordered value="false" />
                <rules value="open" />
            </slicing>
            <type>
                <code value="Quantity" />
            </type>
            <type>
                <code value="CodeableConcept" />
            </type>
            <type>
                <code value="Range" />
            </type>
            <type>
                <code value="Ratio" />
            </type>
            <mustSupport value="true" />
        </element>
        <element id="Observation.value[x]:valueQuantity">
            <path value="Observation.value[x]" />
            <sliceName value="valueQuantity" />
            <min value="0" />
            <max value="1" />
            <type>
                <code value="Quantity" />
            </type>
            <mustSupport value="true" />
        </element>
        <element id="Observation.value[x]:valueQuantity.extension:pqTranslation">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="draft" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="Observation.value[x].extension" />
            <sliceName value="pqTranslation" />
            <min value="0" />
            <max value="*" />
            <type>
                <code value="Extension" />
                <profile value="http://hl7.org/fhir/StructureDefinition/iso21090-PQ-translation" />
            </type>
        </element>
        <element id="Observation.value[x]:valueQuantity.value">
            <path value="Observation.value[x].value" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.value[x]:valueQuantity.value.extension:quantityPrecision">
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
                <valueCode value="draft" />
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
                <valueCode value="4.0.0" />
            </extension>
            <path value="Observation.value[x].value.extension" />
            <sliceName value="quantityPrecision" />
            <min value="0" />
            <max value="1" />
            <type>
                <code value="Extension" />
                <profile value="http://hl7.org/fhir/StructureDefinition/quantity-precision" />
            </type>
            <mustSupport value="true" />
        </element>
        <element id="Observation.value[x]:valueQuantity.unit">
            <path value="Observation.value[x].unit" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.value[x]:valueQuantity.system">
            <path value="Observation.value[x].system" />
            <min value="1" />
            <fixedUri value="http://unitsofmeasure.org" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.value[x]:valueQuantity.code">
            <path value="Observation.value[x].code" />
            <comment value="The mandatory system is UCUM." />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.value[x]:valueCodeableConcept">
            <path value="Observation.value[x]" />
            <sliceName value="valueCodeableConcept" />
            <min value="0" />
            <max value="1" />
            <type>
                <code value="CodeableConcept" />
            </type>
            <mustSupport value="true" />
        </element>
        <element id="Observation.value[x]:valueCodeableConcept.coding">
            <path value="Observation.value[x].coding" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.value[x]:valueCodeableConcept.coding.system">
            <path value="Observation.value[x].coding.system" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.value[x]:valueCodeableConcept.coding.code">
            <path value="Observation.value[x].coding.code" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.dataAbsentReason">
            <path value="Observation.dataAbsentReason" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.interpretation">
            <path value="Observation.interpretation" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.note">
            <path value="Observation.note" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.bodySite">
            <path value="Observation.bodySite" />
            <max value="0" />
        </element>
        <element id="Observation.method">
            <path value="Observation.method" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.specimen">
            <path value="Observation.specimen" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.specimen.reference">
            <path value="Observation.specimen.reference" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.specimen.identifier">
            <path value="Observation.specimen.identifier" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.device">
            <path value="Observation.device" />
            <mustSupport value="true" />
        </element>
        <element id="Observation.referenceRange">
            <path value="Observation.referenceRange" />
            <mustSupport value="true" />
        </element>
    </differential>
</StructureDefinition>
{
    "resourceType": "StructureDefinition",
    "id": "mii-pr-labor-laboruntersuchung",
    "url": "https://www.medizininformatik-initiative.de/fhir/core/modul-labor/StructureDefinition/ObservationLab",
    "version": "2024.0.0-ballot",
    "name": "MII_PR_Labor_Laboruntersuchung",
    "title": "MII PR Labor Laboruntersuchung",
    "status": "active",
    "publisher": "Medizininformatik Initiative",
    "contact":  [
        {
            "telecom":  [
                {
                    "system": "url",
                    "value": "https://www.medizininformatik-initiative.de"
                }
            ]
        }
    ],
    "description": "Dieses Profil beschreibt eine Laborergebnis in der Medizininformatik-Initiative.",
    "purpose": "Dieses Profil beschreibt eine Laborergebnis in der Medizininformatik-Initiative.",
    "fhirVersion": "4.0.1",
    "mapping":  [
        {
            "identity": "workflow",
            "uri": "http://hl7.org/fhir/workflow",
            "name": "Workflow Pattern"
        },
        {
            "identity": "sct-concept",
            "uri": "http://snomed.info/conceptdomain",
            "name": "SNOMED CT Concept Domain Binding"
        },
        {
            "identity": "v2",
            "uri": "http://hl7.org/v2",
            "name": "HL7 v2 Mapping"
        },
        {
            "identity": "rim",
            "uri": "http://hl7.org/v3",
            "name": "RIM Mapping"
        },
        {
            "identity": "w5",
            "uri": "http://hl7.org/fhir/fivews",
            "name": "FiveWs Pattern Mapping"
        },
        {
            "identity": "sct-attr",
            "uri": "http://snomed.org/attributebinding",
            "name": "SNOMED CT Attribute Binding"
        }
    ],
    "kind": "resource",
    "abstract": false,
    "type": "Observation",
    "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Observation",
    "derivation": "constraint",
    "differential": {
        "element":  [
            {
                "id": "Observation",
                "path": "Observation",
                "constraint":  [
                    {
                        "key": "mii-lab-2",
                        "severity": "error",
                        "human": "Falls kein Laborwert verfügbar ist, muss eine dataAbsentReason angegeben werden",
                        "expression": "hasMember.exists() xor value.exists().not() implies dataAbsentReason.exists()",
                        "source": "https://www.medizininformatik-initiative.de/fhir/core/modul-labor/StructureDefinition/ObservationLab"
                    }
                ]
            },
            {
                "id": "Observation.id",
                "path": "Observation.id",
                "mustSupport": true
            },
            {
                "id": "Observation.meta",
                "path": "Observation.meta",
                "mustSupport": true
            },
            {
                "id": "Observation.meta.source",
                "path": "Observation.meta.source",
                "mustSupport": true
            },
            {
                "id": "Observation.meta.profile",
                "path": "Observation.meta.profile",
                "mustSupport": true
            },
            {
                "id": "Observation.identifier",
                "path": "Observation.identifier",
                "slicing": {
                    "discriminator":  [
                        {
                            "type": "pattern",
                            "path": "type"
                        }
                    ],
                    "rules": "open"
                },
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.identifier:analyseBefundCode",
                "path": "Observation.identifier",
                "sliceName": "analyseBefundCode",
                "min": 1,
                "max": "1",
                "mustSupport": true
            },
            {
                "id": "Observation.identifier:analyseBefundCode.type",
                "path": "Observation.identifier.type",
                "min": 1,
                "patternCodeableConcept": {
                    "coding":  [
                        {
                            "code": "OBI",
                            "system": "http://terminology.hl7.org/CodeSystem/v2-0203"
                        }
                    ]
                },
                "mustSupport": true,
                "binding": {
                    "strength": "extensible",
                    "valueSet": "https://www.medizininformatik-initiative.de/fhir/core/modul-labor/ValueSet/mii-vs-labor-identifier-type-codes"
                }
            },
            {
                "id": "Observation.identifier:analyseBefundCode.type.coding",
                "path": "Observation.identifier.type.coding",
                "slicing": {
                    "discriminator":  [
                        {
                            "type": "value",
                            "path": "system"
                        }
                    ],
                    "rules": "open"
                },
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.identifier:analyseBefundCode.type.coding:observationInstanceV2",
                "path": "Observation.identifier.type.coding",
                "sliceName": "observationInstanceV2",
                "min": 1,
                "max": "1",
                "mustSupport": true
            },
            {
                "id": "Observation.identifier:analyseBefundCode.type.coding:observationInstanceV2.system",
                "path": "Observation.identifier.type.coding.system",
                "min": 1,
                "fixedUri": "http://terminology.hl7.org/CodeSystem/v2-0203",
                "mustSupport": true
            },
            {
                "id": "Observation.identifier:analyseBefundCode.type.coding:observationInstanceV2.code",
                "path": "Observation.identifier.type.coding.code",
                "min": 1,
                "fixedCode": "OBI",
                "mustSupport": true
            },
            {
                "id": "Observation.identifier:analyseBefundCode.system",
                "path": "Observation.identifier.system",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.identifier:analyseBefundCode.value",
                "path": "Observation.identifier.value",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.identifier:analyseBefundCode.assigner",
                "path": "Observation.identifier.assigner",
                "min": 1,
                "type":  [
                    {
                        "code": "Reference",
                        "profile":  [
                            "https://www.medizininformatik-initiative.de/fhir/core/StructureDefinition/MII-Reference"
                        ],
                        "targetProfile":  [
                            "http://hl7.org/fhir/StructureDefinition/Organization"
                        ]
                    }
                ],
                "mustSupport": true
            },
            {
                "id": "Observation.status",
                "path": "Observation.status",
                "mustSupport": true
            },
            {
                "id": "Observation.category",
                "path": "Observation.category",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.category.coding",
                "path": "Observation.category.coding",
                "slicing": {
                    "discriminator":  [
                        {
                            "type": "pattern",
                            "path": "$this"
                        }
                    ],
                    "rules": "open"
                },
                "min": 2,
                "mustSupport": true
            },
            {
                "id": "Observation.category.coding:loinc-observation",
                "path": "Observation.category.coding",
                "sliceName": "loinc-observation",
                "min": 1,
                "max": "1",
                "patternCoding": {
                    "code": "26436-6",
                    "system": "http://loinc.org"
                },
                "mustSupport": true
            },
            {
                "id": "Observation.category.coding:observation-category",
                "path": "Observation.category.coding",
                "sliceName": "observation-category",
                "min": 1,
                "max": "1",
                "patternCoding": {
                    "code": "laboratory",
                    "system": "http://terminology.hl7.org/CodeSystem/observation-category"
                },
                "mustSupport": true
            },
            {
                "id": "Observation.code",
                "path": "Observation.code",
                "mustSupport": true,
                "binding": {
                    "strength": "preferred",
                    "valueSet": "http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-ips",
                    "description": "Intensional Value Set Definition: LOINC {  {    STATUS in {ACTIVE}    CLASSTYPE in {1}    CLASS exclude {CHALSKIN, H&P.HX.LAB, H&P.HX, NR STATS, PATH.PROTOCOLS.*}  } }"
                }
            },
            {
                "id": "Observation.subject",
                "path": "Observation.subject",
                "min": 1,
                "type":  [
                    {
                        "code": "Reference",
                        "profile":  [
                            "https://www.medizininformatik-initiative.de/fhir/core/StructureDefinition/MII-Reference"
                        ],
                        "targetProfile":  [
                            "http://hl7.org/fhir/StructureDefinition/Patient",
                            "http://hl7.org/fhir/StructureDefinition/Group",
                            "http://hl7.org/fhir/StructureDefinition/Device",
                            "http://hl7.org/fhir/StructureDefinition/Location"
                        ]
                    }
                ],
                "mustSupport": true
            },
            {
                "id": "Observation.encounter",
                "path": "Observation.encounter",
                "mustSupport": true
            },
            {
                "id": "Observation.effective[x]",
                "path": "Observation.effective[x]",
                "min": 1,
                "type":  [
                    {
                        "code": "dateTime"
                    }
                ],
                "constraint":  [
                    {
                        "key": "mii-lab-1",
                        "severity": "error",
                        "human": "Datetime must be at least to day",
                        "expression": "($this as dateTime).hasValue() implies ($this as dateTime).toString().length() >= 8",
                        "source": "https://www.medizininformatik-initiative.de/fhir/core/modul-labor/StructureDefinition/ObservationLab"
                    }
                ],
                "mustSupport": true
            },
            {
                "id": "Observation.effective[x].extension:QuelleKlinischesBezugsdatum",
                "path": "Observation.effective[x].extension",
                "sliceName": "QuelleKlinischesBezugsdatum",
                "min": 0,
                "max": "1",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "https://www.medizininformatik-initiative.de/fhir/core/modul-labor/StructureDefinition/QuelleKlinischesBezugsdatum"
                        ]
                    }
                ],
                "mustSupport": true
            },
            {
                "id": "Observation.issued",
                "path": "Observation.issued",
                "mustSupport": true
            },
            {
                "id": "Observation.value[x]",
                "path": "Observation.value[x]",
                "slicing": {
                    "discriminator":  [
                        {
                            "type": "type",
                            "path": "$this"
                        }
                    ],
                    "ordered": false,
                    "rules": "open"
                },
                "type":  [
                    {
                        "code": "Quantity"
                    },
                    {
                        "code": "CodeableConcept"
                    },
                    {
                        "code": "Range"
                    },
                    {
                        "code": "Ratio"
                    }
                ],
                "mustSupport": true
            },
            {
                "id": "Observation.value[x]:valueQuantity",
                "path": "Observation.value[x]",
                "sliceName": "valueQuantity",
                "min": 0,
                "max": "1",
                "type":  [
                    {
                        "code": "Quantity"
                    }
                ],
                "mustSupport": true
            },
            {
                "id": "Observation.value[x]:valueQuantity.extension:pqTranslation",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "draft"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "Observation.value[x].extension",
                "sliceName": "pqTranslation",
                "min": 0,
                "max": "*",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "http://hl7.org/fhir/StructureDefinition/iso21090-PQ-translation"
                        ]
                    }
                ]
            },
            {
                "id": "Observation.value[x]:valueQuantity.value",
                "path": "Observation.value[x].value",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.value[x]:valueQuantity.value.extension:quantityPrecision",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
                        "valueCode": "draft"
                    },
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
                        "valueCode": "4.0.0"
                    }
                ],
                "path": "Observation.value[x].value.extension",
                "sliceName": "quantityPrecision",
                "min": 0,
                "max": "1",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "http://hl7.org/fhir/StructureDefinition/quantity-precision"
                        ]
                    }
                ],
                "mustSupport": true
            },
            {
                "id": "Observation.value[x]:valueQuantity.unit",
                "path": "Observation.value[x].unit",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.value[x]:valueQuantity.system",
                "path": "Observation.value[x].system",
                "min": 1,
                "fixedUri": "http://unitsofmeasure.org",
                "mustSupport": true
            },
            {
                "id": "Observation.value[x]:valueQuantity.code",
                "path": "Observation.value[x].code",
                "comment": "The mandatory system is UCUM.",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.value[x]:valueCodeableConcept",
                "path": "Observation.value[x]",
                "sliceName": "valueCodeableConcept",
                "min": 0,
                "max": "1",
                "type":  [
                    {
                        "code": "CodeableConcept"
                    }
                ],
                "mustSupport": true
            },
            {
                "id": "Observation.value[x]:valueCodeableConcept.coding",
                "path": "Observation.value[x].coding",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.value[x]:valueCodeableConcept.coding.system",
                "path": "Observation.value[x].coding.system",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.value[x]:valueCodeableConcept.coding.code",
                "path": "Observation.value[x].coding.code",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Observation.dataAbsentReason",
                "path": "Observation.dataAbsentReason",
                "mustSupport": true
            },
            {
                "id": "Observation.interpretation",
                "path": "Observation.interpretation",
                "mustSupport": true
            },
            {
                "id": "Observation.note",
                "path": "Observation.note",
                "mustSupport": true
            },
            {
                "id": "Observation.bodySite",
                "path": "Observation.bodySite",
                "max": "0"
            },
            {
                "id": "Observation.method",
                "path": "Observation.method",
                "mustSupport": true
            },
            {
                "id": "Observation.specimen",
                "path": "Observation.specimen",
                "mustSupport": true
            },
            {
                "id": "Observation.specimen.reference",
                "path": "Observation.specimen.reference",
                "mustSupport": true
            },
            {
                "id": "Observation.specimen.identifier",
                "path": "Observation.specimen.identifier",
                "mustSupport": true
            },
            {
                "id": "Observation.device",
                "path": "Observation.device",
                "mustSupport": true
            },
            {
                "id": "Observation.referenceRange",
                "path": "Observation.referenceRange",
                "mustSupport": true
            }
        ]
    }
}

Constraints/Invarianten

NameSchweregradBeschreibungAusdruck
mii-lab-2errorFalls kein Laborwert verfügbar ist, muss eine dataAbsentReason angegeben werdenhasMember.exists() xor value.exists().not() implies dataAbsentReason.exists()
mii-lab-1errorDatetime must be at least to day($this as dateTime).hasValue() implies ($this as dateTime).toString().length() >= 8

RestFul API

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Mappings

FHIR Element Erklärung
Patient.id Must-support, jedoch optional
Patient.meta Must-support, jedoch optional
Observation.identifier Observation muss eindeutig identifizierbar sein, keine Vorgaben zur Kodierung, Präferenz: 'LOINC CODE_Befundnummer'
Observation.status Finale & vorläufige Ergebnisse sind zulässig.
Observation.category LOINC & HL7 Code, weitere Codings erlaubt.
Keine Vorgabe für Laborgruppen/-bereiche, da hier keine standortübergreifende Abstimmung erfolgt.
Für Laborgruppen wird auf das ValueSet Laborgruppe verwiesen. Dieses kann optional verwendet werden.
Observation.code IPS LOINC ValueSet
Observation.subject Patientenbezug muss stets gegeben sein.
Observation.effective[x] Zeitpunkt des Beginns der Untersuchung/Messung. Zeitpunkt sollte als dateTime kodiert werden, siehe mii-lab-1 Constraint. Der klinische Bezugszeitpunkt sollte jedoch entweder auf Basis von Specimen.collection.collected[x] oder DiagnosticReport.effective[x] ermittelt werden. Nur diese Werte entsprechen dem Zeitpunkt zumde die gemessene Eigenschaft im Probenmaterial (e.g. Analytkonzentration) mutmaßlich der Eigenschaft im Patienten entsprach.
Observation.valueQuantity UCUM Quantity - verpflichtend, keine abweichende Kodierung zugelassen.
Observation.valueCodeableConcept Für die Kodierung von semi-quantitativen (0 - +++) Ergebnissen, siehe ValueSet 'Semi_quantitative_Laborergebnisse'
Observation.note Optionaler Text
Observation.method Kodierte Methode zur welche verwendet wurde zur Messung von Observation.value. Nur zu befüllen falls Methode nicht implizit in Observation.code enthalten ist (z.B. im LOINC Code). Es wird keine Codierungsempfehlung angegeben, da diese Information meist nicht strukturiert vorliegt in den Quellsystemen.
Observation.specimen Optionale Referenz, zukünftige Spezifikationen weiterer Kerndatensatzmodule können diesbezüglich Vorgaben ausgestalten.
Observation.referenceRange Sollte - falls vorhanden - als high, low (SimpleQuantity) kodiert werden. Abweichend ansonsten per referenceRange.text.
Observation.component Observation.hasMember ist im Bereich der klinischen Chemie zu bevorzugen (passendere Semantik). Element ist für die Harmonisierung mit Genetischen Befunden erlaubt.

FHIR Element Logischer Datensatz
Observation.identifier Laborbefund.Laboruntersuchung.Identifikation
Observation.status Laborbefund.Laboruntersuchung.Status
Observation.category Laborbefund.Laboruntersuchung.Bereich
Observation.category Laborbefund.Laboruntersuchung.Gruppe
Observation.code Laborbefund.Laboruntersuchung.Laborparameter
Observation.code Laborbefund.Laboruntersuchung.Laborparameter
Observation.effective[x] Laborbefund.Laboruntersuchung.Untersuchungszeitpunkt
Observation.issued Laborbefund.Laboruntersuchung.Dokumentationsdatum
Observation.valueQuantity Laborbefund.Laboruntersuchung.Messwert
Observation.interpretation Laborbefund.Laboruntersuchung.Interpretation
Observation.note Laborbefund.Laboruntersuchung.Kommentar
Observation.method Laborbefund.Laboruntersuchung.Untersuchungsmethode
Observation.referenceRange Laborbefund.Laboruntersuchung.Referenzbereich

Beispiele

Beispiel (vollständig):

{
    "resourceType": "Observation",
    "id": "mii-exa-labor-laborwert",
    "meta": {
        "profile":  [
            "https://www.medizininformatik-initiative.de/fhir/core/modul-labor/StructureDefinition/ObservationLab"
        ]
    },
    "identifier":  [
        {
            "type": {
                "coding":  [
                    {
                        "system": "http://terminology.hl7.org/CodeSystem/v2-0203",
                        "code": "OBI"
                    }
                ]
            },
            "system": "https://exmaple.org/fhir/sid/test-lab-results",
            "value": "59826-8_1234567890",
            "assigner": {
                "identifier": {
                    "system": "https://www.medizininformatik-initiative.de/fhir/core/CodeSystem/core-location-identifier",
                    "value": "DIZ-ID"
                }
            }
        }
    ],
    "category":  [
        {
            "coding":  [
                {
                    "code": "26436-6",
                    "system": "http://loinc.org",
                    "display": "Laboratory studies (set)"
                },
                {
                    "code": "laboratory",
                    "system": "http://terminology.hl7.org/CodeSystem/observation-category",
                    "display": "Laboratory"
                },
                {
                    "code": "Niere/Elektrolyte",
                    "system": "http://exmple.org/fhir/sid/Laborgruppe"
                }
            ]
        }
    ],
    "valueQuantity": {
        "system": "http://unitsofmeasure.org",
        "extension":  [
            {
                "url": "http://hl7.org/fhir/StructureDefinition/iso21090-PQ-translation",
                "valueQuantity": {
                    "value": 0.81,
                    "code": "mg/dL",
                    "system": "http://unitsofmeasure.org",
                    "unit": "mg/dL"
                }
            }
        ],
        "value": 72,
        "_value": {
            "extension":  [
                {
                    "url": "http://hl7.org/fhir/StructureDefinition/quantity-precision",
                    "valueInteger": 1
                }
            ]
        },
        "code": "umol/L",
        "unit": "µmol/l"
    },
    "status": "final",
    "code": {
        "coding":  [
            {
                "code": "59826-8",
                "system": "http://loinc.org",
                "display": "Creatinine [Moles/volume] in Blood"
            }
        ],
        "text": "Kreatinin"
    },
    "subject": {
        "reference": "Patient/111"
    },
    "encounter": {
        "reference": "Encounter/555"
    },
    "effectiveDateTime": "2018-11-20T12:05:00+01:00",
    "_effectiveDateTime": {
        "extension":  [
            {
                "url": "https://www.medizininformatik-initiative.de/fhir/core/modul-labor/StructureDefinition/QuelleKlinischesBezugsdatum",
                "valueCoding": {
                    "code": "399445004",
                    "system": "http://snomed.info/sct",
                    "version": "http://snomed.info/sct/900000000000207008/version/20230731",
                    "display": "Specimen collection date (observable entity)"
                }
            }
        ]
    },
    "issued": "2018-03-11T10:28:00+01:00",
    "performer":  [
        {
            "reference": "Organization/7772",
            "display": "Zentrallabor des IKCL"
        }
    ],
    "interpretation":  [
        {
            "coding":  [
                {
                    "code": "N",
                    "system": "http://terminology.hl7.org/CodeSystem/v3-ObservationInterpretation"
                }
            ]
        }
    ],
    "referenceRange":  [
        {
            "low": {
                "value": 72
            },
            "high": {
                "value": 127
            },
            "type": {
                "coding":  [
                    {
                        "code": "normal",
                        "system": "http://terminology.hl7.org/CodeSystem/referencerange-meaning",
                        "display": "Normal Range"
                    }
                ]
            }
        }
    ]
}