{
"description": "This profile constrains the Observation resource to represent results produced by pathology studies in a patient summary. It is informed by the constraints of the [Observation Results (Pathology) IPS-UV profile](http://hl7.org/fhir/uv/ips/StructureDefinition-Observation-results-pathology-uv-ips.html) to allow for cross-border and cross-jurisdiction sharing of Diagnostic Result information. Notably there is no equivalent Canadian Baseline Profile at the time of this draft.",
"_filename": "structuredefinition-profile-observation-results-pathology-ca-ps.json",
"package_name": "ca.infoway.io.psca",
"date": "2023-12-06T00:00:00-08:00",
"derivation": "constraint",
"publisher": null,
"fhirVersion": "4.0.1",
"purpose": "This profile constrains the Observation resource to represent a pathology in vitro study. In case of a multiple-observation study, the results of the study appear as sub-observations. In this case this top-level Observation acts as a grouper of all the observations belonging to the 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.",
"name": "ObservationResultsPathologyPSCA",
"abstract": false,
"copyright": "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).",
"type": "Observation",
"experimental": "false",
"resourceType": "StructureDefinition",
"title": "Observation Results: pathology (PS-CA)",
"package_version": "2.0.0-DFT-Ballot-alpha2",
"status": "draft",
"id": "ea2eb602-e7fb-46f7-b894-a6b4f43ae760",
"kind": "resource",
"url": "http://fhir.infoway-inforoute.ca/io/psca/StructureDefinition/observation-results-pathology-ca-ps",
"version": null,
"differential": {
"element": [ {
"id": "Observation",
"path": "Observation",
"short": "Pathology result for a simple test or for a panel/study",
"comment": "Represents either a simple pathology observation or the group of observations produced by a pathology study. Preliminary analysis has identified that pathology observations may not be differentiated or supported by jurisdictions including the diagnostic results section in their initial patient summaries, further feedback and investigation is required with participating jurisdictions to confirm the support of any of the pathology observation elements - until then, initial constraints put forth in the IPS-UV specification have been maintained with minimal relaxation.",
"constraint": [ {
"key": "psca-path-1",
"human": "if no \"hasMember\" element is present then Observation must have a \"value\"",
"severity": "error",
"expression": "value.exists() or hasMember.exists()"
} ],
"definition": "This observation may represent the result of a simple pathology study or it may group the set of results produced by a multi-test study or panel. 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"
}, {
"id": "Observation.status",
"path": "Observation.status",
"comment": "This profile derives from the PS-CA Observation Results profile which constrains results in the PS-CA to only use a status of \"final\". \n\n**Feedback is requested on whether this is too restrictive, and, e.g. \"amended\" or \"corrected\" should also be allowed.**"
}, {
"id": "Observation.category",
"min": 1,
"path": "Observation.category",
"comment": "At least one category code should be fixed to \"laboratory\", which includes laboratory medicine and pathology. This supports filtering for the types of observations that are retrieved and displayed",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "$this",
"type": "pattern"
} ]
},
"definition": "A code that classifies the general type of observation being made. In this profile, fixed to \"\".",
"mustSupport": true
}, {
"id": "Observation.category:laboratory",
"max": "1",
"min": 1,
"path": "Observation.category",
"sliceName": "laboratory",
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "laboratory",
"system": "http://terminology.hl7.org/CodeSystem/observation-category"
} ]
}
}, {
"id": "Observation.code",
"path": "Observation.code",
"binding": {
"strength": "example",
"valueSet": "http://fhir.infoway-inforoute.ca/io/psca/ValueSet/pCLOCD",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/additional-binding",
"extension": [ {
"url": "purpose",
"valueCode": "candidate"
}, {
"url": "valueSet",
"valueCanonical": "http://hl7.org/fhir/uv/ips/ValueSet/results-pathology-observations-uv-ips"
}, {
"url": "documentation",
"valueMarkdown": "LOINC Pathology 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."
} ]
} ],
"description": "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"
},
"comment": "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. \n\nWork is underway to define the pan-Canadian terminology that will be preferred and/or socialized for this element",
"definition": "Describes what was observed. Sometimes this is called the observation \"name\". In this profile this code represents either a simple pathology test or a pathology study with multiple child observations",
"mustSupport": true
}, {
"id": "Observation.subject",
"path": "Observation.subject",
"type": [ {
"code": "Reference",
"targetProfile": [ "http://fhir.infoway-inforoute.ca/io/psca/StructureDefinition/patient-ca-ps" ]
} ],
"definition": "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.\n\nIn this profile is constrained to the patient.",
"mustSupport": true
}, {
"id": "Observation.performer",
"min": 1,
"path": "Observation.performer",
"type": [ {
"code": "Reference",
"targetProfile": [ "http://fhir.infoway-inforoute.ca/io/psca/StructureDefinition/practitioner-lab-ca-ps", "http://fhir.infoway-inforoute.ca/io/psca/StructureDefinition/practitionerrole-lab-ca-ps", "http://fhir.infoway-inforoute.ca/io/psca/StructureDefinition/organization-lab-ca-ps", "http://fhir.infoway-inforoute.ca/io/psca/StructureDefinition/patient-ca-ps", "http://hl7.org/fhir/StructureDefinition/CareTeam", "http://hl7.org/fhir/StructureDefinition/RelatedPerson" ]
} ],
"comment": "IPS considers this a Must Support element with a minimum cardinality of 1. While all jurisdictions supporting pathology 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.",
"mustSupport": true
}, {
"id": "Observation.value[x]",
"path": "Observation.value[x]",
"slicing": {
"rules": "closed",
"discriminator": [ {
"path": "$this",
"type": "type"
} ]
},
"mustSupport": true
}, {
"id": "Observation.value[x]:valueString",
"path": "Observation.value[x]",
"type": [ {
"code": "string"
} ],
"sliceName": "valueString",
"mustSupport": true
}, {
"id": "Observation.value[x]:valueRange",
"path": "Observation.value[x]",
"type": [ {
"code": "Range",
"profile": [ "http://fhir.infoway-inforoute.ca/io/psca/StructureDefinition/Range-ca-ps" ]
} ],
"sliceName": "valueRange"
}, {
"id": "Observation.value[x]:valueRatio",
"path": "Observation.value[x]",
"type": [ {
"code": "Ratio",
"profile": [ "http://fhir.infoway-inforoute.ca/io/psca/StructureDefinition/Ratio-ca-ps" ]
} ],
"sliceName": "valueRatio"
}, {
"id": "Observation.value[x]:valueTime",
"path": "Observation.value[x]",
"type": [ {
"code": "time"
} ],
"sliceName": "valueTime"
}, {
"id": "Observation.value[x]:valueDateTime",
"path": "Observation.value[x]",
"type": [ {
"code": "dateTime"
} ],
"sliceName": "valueDateTime"
}, {
"id": "Observation.value[x]:valuePeriod",
"path": "Observation.value[x]",
"type": [ {
"code": "Period"
} ],
"sliceName": "valuePeriod"
}, {
"id": "Observation.value[x]:valueQuantity",
"path": "Observation.value[x]",
"type": [ {
"code": "Quantity",
"profile": [ "http://fhir.infoway-inforoute.ca/io/psca/StructureDefinition/Quantity-ca-ps" ]
} ],
"comment": "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.",
"sliceName": "valueQuantity"
}, {
"id": "Observation.value[x]:valueCodeableConcept",
"path": "Observation.value[x]",
"type": [ {
"code": "CodeableConcept",
"profile": [ "http://fhir.infoway-inforoute.ca/io/psca/StructureDefinition/CodeableConcept-ca-ps" ]
} ],
"binding": {
"strength": "example",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/additional-binding",
"extension": [ {
"url": "purpose",
"valueCode": "candidate"
}, {
"url": "valueSet",
"valueCanonical": "http://hl7.org/fhir/uv/ips/ValueSet/result-coded-value-pathology-uv-ips"
}, {
"url": "documentation",
"valueMarkdown": "SNOMED CT pathology 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."
} ]
} ],
"description": "Work is underway to define the pan-Canadian terminology that will be preferred and/or socialized for this element"
},
"comment": "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.",
"sliceName": "valueCodeableConcept"
} ]
},
"baseDefinition": "http://fhir.infoway-inforoute.ca/io/psca/StructureDefinition/observation-results-ca-ps"
}