<status value="draft" /> <experimental value="false" /> <date value="2023-12-06T00:00:00-08:00" /> <description value="This profile represents the constraints applied to the Observation resource by the PS-CA project to represent results produced by laboratory (including pathology) tests or panels/studies in a patient summary. This observation may represent the result of a simple laboratory test such as hematocrit or it may group the set of results produced by a multi-test study or panel such as a complete blood count, a dynamic function test, or a urine specimen study. In the latter case, the observation carries the overall conclusion of the study and or a global interpretation by the producer of the study, in the comment element; and references the atomic results of the study as "has-member" child observations. It allows for cross-border and cross-jurisdiction sharing of laboratory result information" /> <purpose value="This profile constrains the Observation resource to represent a laboratory or pathology in vitro diagnostic test or panel/study. In case of a panel/study, the results of the panel appear as sub-observations. In this case this top-level Observation acts as a grouper of all the observations belonging to the panel or study. The top-level observation may carry a conclusion in the value element and or a global interpretation by the producer of the study, in the comment element." /> <copyright value="Copyright © 2024+ Canada Health Infoway. All rights reserved. [Terms of Use and License Agreements](https://ic.infoway-inforoute.ca/en/about/tou). [Privacy Policy](https://www.infoway-inforoute.ca/en/legal/privacy-policy)." /> <fhirVersion value="4.0.1" /> <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" /> <short value="Laboratory (including Pathology) result for a simple test or for a panel/study" /> <definition value="This observation may represent the result of a simple laboratory or pathology test such as hematocrit or it may group the set of results produced by a multi-test study or panel such as a complete blood count, a dynamic function test, or a urine specimen study. In the latter case, the observation carries the overall conclusion of the study and references the atomic results of the study as "has-member" child observations" /> <comment value="Represents either a lab simple observation or the group of observations produced by a laboratory study." /> <constraint> <key value="psca-lab-pat-1" /> <severity value="error" /> <human value="At least one of these Observation elements shall be provided: "value", "dataAbsentReason", "hasMember" or "component"" /> <expression value="value.exists() or hasMember.exists() or component.exists() or dataAbsentReason.exists()" /> <source value="http://fhir.infoway-inforoute.ca/io/psca/StructureDefinition/observation-results-laboratory-pathology-ca-ps" /> </constraint> <constraint> <key value="psca-lab-pat-2" /> <severity value="error" /> <human value="If observation has components, at least one of these Observation.component elements shall be provided: "value" or "dataAbsentReason"" /> <expression value="component.exists() implies (component.value.exists() or component.dataAbsentReason.exists())" /> <source value="http://fhir.infoway-inforoute.ca/io/psca/StructureDefinition/observation-results-laboratory-pathology-ca-ps" /> </constraint> </element> <element id="Observation.status"> <path value="Observation.status" /> <label value="Observation 'complete' status codes" /> <binding> <strength value="required" /> <valueSet value="http://hl7.org/fhir/uv/ips/ValueSet/results-status-uv-ips" /> </binding> </element> <element id="Observation.category"> <path value="Observation.category" /> <slicing> <discriminator> <type value="pattern" /> <path value="$this" /> </discriminator> <rules value="open" /> </slicing> <definition value="A code that classifies the general type of observation being made. In this profile, fixed to "laboratory"." /> <comment value=""laboratory" includes laboratory medicine and pathology" /> <min value="1" /> <type> <code value="CodeableConcept" /> <profile value="http://fhir.infoway-inforoute.ca/io/psca/StructureDefinition/CodeableConcept-ca-ps" /> </type> </element> <element id="Observation.category:laboratory"> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:populate" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/producer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:no-error" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:handle" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHOULD:display" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <path value="Observation.category" /> <sliceName value="laboratory" /> <min value="1" /> <max value="1" /> <patternCodeableConcept> <coding> <system value="http://terminology.hl7.org/CodeSystem/observation-category" /> <code value="laboratory" /> </coding> </patternCodeableConcept> <mustSupport value="true" /> </element> <element id="Observation.code"> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:populate" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/producer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:no-error" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:handle" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHOULD:display" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <path value="Observation.code" /> <definition value="Describes what was observed. Sometimes this is called the observation "name". In this profile this code represents either a simple laboratory test or a single pathology examination or a laboratory or pathology study with multiple child observations." /> <comment value="In the context of this profile, when the observation plays the role of a grouper of member sub-observations, the code represent the group (for instance a panel code). In case no code is available, at least a text shall be provided. Work is underway to define the pan-Canadian terminology that will be preferred and/or socialized for this element" /> <type> <code value="CodeableConcept" /> <profile value="http://fhir.infoway-inforoute.ca/io/psca/StructureDefinition/CodeableConcept-ca-ps" /> </type> <mustSupport value="true" /> <binding> <extension url="http://hl7.org/fhir/tools/StructureDefinition/additional-binding"> <extension url="purpose"> <valueCode value="candidate" /> </extension> <extension url="valueSet"> <valueCanonical value="http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-pathology-observations-uv-ips" /> </extension> <extension url="documentation"> <valueMarkdown value="LOINC Observation codes utilized in IPS. This additional binding is surfaced to socialize the value sets that are proposed for international exchange in IPS. Where multiple codings can be supplied, it is encouraged to supply the original coding alongside the pan-Canadian preferred terminology." /> </extension> </extension> <strength value="example" /> <description value="Work is underway to define the pan-Canadian terminology that will be preferred and/or socialized for this element. A stub value set pointing to pCLOCD code system is put forth in the meantime to encourage implementers to utilize the Canadian localization of LOINC" /> <valueSet value="http://fhir.infoway-inforoute.ca/io/psca/ValueSet/pCLOCD" /> </binding> </element> <element id="Observation.subject"> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:populate" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/producer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:no-error" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:handle" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHOULD:display" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <path value="Observation.subject" /> <definition value="The patient, or group of patients, location, or device whose characteristics (direct or indirect) are described by the observation and into whose record the observation is placed. Comments: Indirect characteristics may be those of a specimen, fetus, donor, other observer (for example a relative or EMT), or any observation made about the subject. In this profile is constrained to the patient" /> <min value="1" /> <type> <code value="Reference" /> <targetProfile value="http://fhir.infoway-inforoute.ca/io/psca/StructureDefinition/patient-ca-ps" /> <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.subject.reference"> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:populate" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/producer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:no-error" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:handle" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHOULD:display" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <path value="Observation.subject.reference" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="Observation.effective[x]"> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:populate" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/producer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:no-error" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:handle" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHOULD:display" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <path value="Observation.effective[x]" /> <min value="1" /> <type> <code value="dateTime" /> </type> <type> <code value="Period" /> </type> <mustSupport value="true" /> </element> <element id="Observation.performer"> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:populate" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/producer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:no-error" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:handle" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHOULD:display" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <path value="Observation.performer" /> <comment value="IPS considers this a Must Support element with a minimum cardinality of 1. While all jurisdictions supporting laboratory in patient summary have indicated they can populate performer, some jurisdictions indicated this may be populated with provincial health authority information that may not be clinically meaningful. This constraint may be evaluated in IPS and PS-CA in the next release as updates are made to the underlying data models that underpin the FHIR profiles." /> <min value="1" /> <type> <code value="Reference" /> <targetProfile value="http://fhir.infoway-inforoute.ca/io/psca/StructureDefinition/practitioner-lab-ca-ps" /> <targetProfile value="http://fhir.infoway-inforoute.ca/io/psca/StructureDefinition/practitionerrole-lab-ca-ps" /> <targetProfile value="http://fhir.infoway-inforoute.ca/io/psca/StructureDefinition/organization-lab-ca-ps" /> <targetProfile value="http://fhir.infoway-inforoute.ca/io/psca/StructureDefinition/patient-ca-ps" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/CareTeam" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/RelatedPerson" /> </type> <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> </element> <element id="Observation.value[x]:valueString"> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:able-to-populate" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/producer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:no-error" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHOULD:handle" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <path value="Observation.value[x]" /> <sliceName value="valueString" /> <min value="0" /> <max value="1" /> <type> <code value="string" /> </type> <mustSupport value="true" /> </element> <element id="Observation.value[x]:valueQuantity"> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:able-to-populate" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/producer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:no-error" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHOULD:handle" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <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]:valueCodeableConcept"> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:able-to-populate" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/producer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:no-error" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHOULD:handle" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <path value="Observation.value[x]" /> <sliceName value="valueCodeableConcept" /> <comment value="Work is underway to define the pan-Canadian terminology that will be preferred and/or socialized for this element. IPS-UV flags this as a Must Support element. It is not currently flagged as Must Support in PS-CA, as stakeholders have indicated the element may not be supported by the majority of systems today. Systems that do support the element are encouraged to include it in generated Patient Summary documents, and support it when received. Vendors should expect that some jurisdictions may add a Must Support requirement within the context of their own jurisdictional content." /> <min value="0" /> <max value="1" /> <type> <code value="CodeableConcept" /> <profile value="http://fhir.infoway-inforoute.ca/io/psca/StructureDefinition/CodeableConcept-ca-ps" /> </type> <mustSupport value="true" /> <binding> <extension url="http://hl7.org/fhir/tools/StructureDefinition/additional-binding"> <extension url="purpose"> <valueCode value="candidate" /> </extension> <extension url="valueSet"> <valueCanonical value="http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-pathology-uv-ips" /> </extension> <extension url="documentation"> <valueMarkdown value="SNOMED CT laboratory result codes utilized in IPS. This additional binding is surfaced to socialize the value sets that are proposed for international exchange in IPS. Where multiple codings can be supplied, it is encouraged to supply the original coding alongside the pan-Canadian preferred terminology." /> </extension> </extension> <strength value="example" /> <description value="Work is underway to define the pan-Canadian terminology that will be preferred and/or socialized for this element" /> </binding> </element> <element id="Observation.interpretation"> <path value="Observation.interpretation" /> <type> <code value="CodeableConcept" /> <profile value="http://fhir.infoway-inforoute.ca/io/psca/StructureDefinition/CodeableConcept-ca-ps" /> </type> </element> <element id="Observation.specimen"> <path value="Observation.specimen" /> <type> <code value="Reference" /> <targetProfile value="http://hl7.org/fhir/uv/ips/StructureDefinition/Specimen-uv-ips" /> </type> </element> <element id="Observation.hasMember"> <path value="Observation.hasMember" /> <definition value="A reference to another Observation profiled by Observation-results-laboratory-pathology-ca-ps. The target observation (for instance an individual test member of a panel) is considered as a sub-observation of the current one, which plays the role of a grouper." /> <comment value="This element is used in the context of the patient summary when there is a need to group a collection of observations, because they belong to the same panel, or because they share a common interpretation comment, or a common media attachment (illustrative image or graph). In these cases, the current observation is the grouper, and its set of sub-observations are related observations using the type "has-member". For a discussion on the ways Observations can be assembled in groups together see [Observation Grouping](http://hl7.org/fhir/observation.html#obsgrouping)." /> <type> <code value="Reference" /> <targetProfile value="http://fhir.infoway-inforoute.ca/io/psca/StructureDefinition/observation-results-laboratory-pathology-ca-ps" /> </type> </element> <element id="Observation.component"> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:able-to-populate" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/producer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHALL:no-error" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/obligation"> <extension url="code"> <valueCode value="SHOULD:handle" /> </extension> <extension url="actor"> <valueCanonical value="http://fhir.infoway-inforoute.ca/io/psca/ActorDefinition/consumer" /> </extension> </extension> <path value="Observation.component" /> <mustSupport value="true" /> </element> </differential> </StructureDefinition>