| Left: | US Core Laboratory Result Observation Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-lab) |
| Right: | Cancer Risk Assessment Profile (http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-risk-assessment) |
| Error | StructureDefinition.url | Values for url differ: 'http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-lab' vs 'http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-risk-assessment' |
| Error | StructureDefinition.version | Values for version differ: '7.0.0-ballot' vs '4.0.0-ballot' |
| Information | StructureDefinition.name | Values for name differ: 'USCoreLaboratoryResultObservationProfile' vs 'CancerRiskAssessment' |
| Information | StructureDefinition.title | Values for title differ: 'US Core Laboratory Result Observation Profile' vs 'Cancer Risk Assessment Profile' |
| Information | StructureDefinition.date | Values for date differ: '2023-10-17' vs '2024-04-10T14:01:17+00:00' |
| Information | StructureDefinition.publisher | Values for publisher differ: 'HL7 International / Cross-Group Projects' vs 'HL7 International / Clinical Interoperability Council' |
| Warning | StructureDefinition.abstract | Values for abstract differ: 'false' vs 'true' |
| Error | StructureDefinition.baseDefinition | Values for baseDefinition differ: 'http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-clinical-result' vs 'http://hl7.org/fhir/StructureDefinition/Observation' |
| Information | StructureDefinition.definition | Values for definition differ: '\-' vs 'Measurements and simple assertions made about a patient, device or other subject.' |
| Information | StructureDefinition.comment | Values for comment differ: '\-' vs '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.' |
| Warning | Observation.category | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | Observation.category | Element minimum cardinalities differ: '1' vs '0' |
| Information | StructureDefinition.short | Values for short differ: 'Laboratory Test Name' vs 'The type of risk assessment information reported.' |
| Information | StructureDefinition.definition | Values for definition differ: 'The name of the clinical test or procedure performed on a patient. A LOINC **SHALL** be used if the concept is present in LOINC.' vs 'The kind of risk assessment reported. This element identifies the type of value that is reported in Observation.value and is necessary for the correct interpretation of that value. The distinction between Observation.code and Observation.method is important. Observation.code identifies the kind of risk assessment being reported while Observation.method represents the risk assessment system used to determine the code. Observation.code may imply the risk assessment system. When the risk assessment system is implied by Observation.code, Observation.method is not required. However, when Observation.code does not imply a risk assessment system, then the risk assessment system must be specified in Observation.method. The value (Observation.valueCodeableConcept) may also imply certain things about the kind of risk assessment being reported. However, even if the value is partly or wholly self-identifying, it is not a reliable indicator of the type of risk assessment being reported or the method of assessment. Therefore, Observation.code must in all cases be reported.' |
| Information | StructureDefinition.comment | Values for comment differ: 'The typical patterns for codes are: 1) a LOINC code either as a translation from a 'local' code or as a primary code, or 2) a local code only if no suitable LOINC exists, or 3) both the local and the LOINC translation. Systems SHALL be capable of sending the local code if one exists. When using LOINC , Use either the SHORTNAME or LONG_COMMON_NAME field for the display.' vs '*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.' |
| Information | StructureDefinition.definition | Values for definition differ: '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.' vs 'The patient associated with risk assessment.' |
| Information | Observation.subject | Element minimum cardinalities differ: '1' vs '0' |
| Information | StructureDefinition.short | Values for short differ: 'What the observation is about, when it is not about the subject of record' vs 'The cancer condition associated with risk assessment.' |
| Information | StructureDefinition.definition | Values for definition differ: '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.' vs 'Risk assessments are associated with a particular primary cancer condition. Observation.focus is used to point back to that condition.' |
| Warning | Observation.focus | Elements differ in definition for mustSupport: 'false' vs 'true' |
| Information | StructureDefinition.short | Values for short differ: 'Encounter associated with Observation' vs 'Healthcare event during which this observation is made' |
| Warning | Observation.encounter | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'Result Value' vs 'The value of the risk assessment' |
| Information | StructureDefinition.definition | Values for definition differ: 'The Laboratory result value. If a coded value, the valueCodeableConcept.code **SHOULD** be selected from [SNOMED CT](http://hl7.org/fhir/ValueSet/uslab-obs-codedresults) if the concept exists. If a numeric value, valueQuantity.code **SHALL** be selected from [UCUM](http://unitsofmeasure.org). A FHIR [UCUM Codes value set](http://hl7.org/fhir/STU3/valueset-ucum-units.html) that defines all UCUM codes is in the FHIR specification.' vs 'The classification resulting from the risk evaluation.' |
| Warning | Observation.dataAbsentReason | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'Result interpretation' vs 'High, low, normal, etc.' |
| Information | StructureDefinition.comment | Values for comment differ: 'Categorical assessment of a laboratory value, often in relation to a test's reference range. Examples include but are not limited to high, low, critical, and normal.' vs '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.' |
| Warning | Observation.interpretation | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Warning | Observation.specimen | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: '(Measurement) Device' vs 'Not used in this profile' |
| Information | StructureDefinition.definition | Values for definition differ: 'The device used to generate the observation data.' vs 'Not used in this profile' |
| Information | StructureDefinition.short | Values for short differ: 'Result reference range' vs 'Not used in this profile' |
| Information | StructureDefinition.definition | Values for definition differ: '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.' vs 'Not used in this profile' |
| Information | StructureDefinition.comment | Values for comment differ: 'Upper and lower limit of test values expected for a designated population of individuals. Reference range values may differ by patient characteristics, laboratory test manufacturer and laboratory test performer.' vs '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.' |
| Warning | Observation.referenceRange | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'Related resource that belongs to the Observation group' vs 'Prognostic factors contributing to risk assessment.' |
| Information | StructureDefinition.definition | Values for definition differ: '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.' vs 'References to the prognostic factors affecting the risk assessment.' |
| Name | Value | Comments | |
|---|---|---|---|
 abstract | false | true |
|
| baseDefinition | http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-clinical-result | http://hl7.org/fhir/StructureDefinition/Observation |
|
| copyright | Used by permission of HL7 International, all rights reserved Creative Commons License |
| |
| date | 2023-10-17 | 2024-04-10T14:01:17+00:00 |
|
| description | The US Core Laboratory Result Observation Profile is based upon the US Core Observation Clinical Result Profile and, along with the US Core DiagnosticReport Profile for Laboratory Results Reporting, meets the U.S. Core Data for Interoperability (USCDI) Laboratory requirements. Laboratory results are grouped and summarized using the DiagnosticReport resource, which references Observation resources. Each Observation resource represents an individual laboratory test and result value, a “nested” panel (such as a microbial susceptibility panel) that references other observations, or rarely a laboratory test with component result values. The US Core Laboratory Result Observation Profile sets minimum expectations for the Observation resource to record, search, and fetch laboratory test results associated with a patient to promote interoperability and adoption through common implementation. It identifies which core elements, extensions, vocabularies, and value sets SHALL be present in the resource and constrains the way the elements are used when using this profile. It provides the floor for standards development for specific use cases. | Parent profile for observations regarding cancer risk assessment. Risk assessment is a process used to estimate the risk that a certain event will happen. In medicine, this may include a person’s risk of having a child with a certain condition or disease, such as cancer. It may also be used to estimate the risk of carrying a certain gene mutation (change), or of having an adverse event (unexpected medical problem) in response to certain types of drugs or other substances. A risk assessment may be done by collecting information about a person’s age, sex, personal and family medical history, ethnic background, lifestyle, and other factors and using statistics tools to calculate risk (Definition from: [NCI Dictionary of Cancer Terms](https://www.cancer.gov/publications/dictionaries/cancer-terms/def/risk-assessment)). The key elements are the code, method, value, and optionally, prognostic factors referenced in the hasMember element. |
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| experimental | false |
| |
| fhirVersion | 4.0.1 | ||
| jurisdiction | |||
 jurisdiction[0] | urn:iso:std:iso:3166#US | ||
| kind | resource | ||
| name | USCoreLaboratoryResultObservationProfile | CancerRiskAssessment |
|
| publisher | HL7 International / Cross-Group Projects | HL7 International / Clinical Interoperability Council |
|
| purpose | |||
| status | active | ||
| title | US Core Laboratory Result Observation Profile | Cancer Risk Assessment Profile |
|
| type | Observation | ||
| url | http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-lab | http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-risk-assessment |
|
| version | 7.0.0-ballot | 4.0.0-ballot |
|
| Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | R Type | R Description & Constraints | Comments | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 Observation | C | 0..* | USCoreObservationClinicalResultProfile | Measurements and simple assertions obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present | C | 0..* | Observation | This is an abstract profile. Child profiles: ALLRiskAssessment, RhabdomyosarcomaRiskAssessment Measurements and simple assertions obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present | |||||||||
 id | Σ | 0..1 | id | Logical id of this artifact | Σ | 0..1 | id | Logical id of this artifact | |||||||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | Σ | 0..1 | Meta | Metadata about the resource | |||||||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ?!Σ | 0..1 | uri | A set of rules under which this content was created | |||||||||
| language | 0..1 | code | Language of the resource content Binding: ?? (preferred): A human language.
| 0..1 | code | Language of the resource content Binding: ?? (preferred): A human language.
| |||||||||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||||||||
| contained | 0..* | Resource | Contained, inline Resources | 0..* | Resource | Contained, inline Resources | |||||||||||
 extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
 modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ?! | 0..* | Extension | Extensions that cannot be ignored | |||||||||
| identifier | Σ | 0..* | Identifier | Business Identifier for observation | Σ | 0..* | Identifier | Business Identifier for observation | |||||||||
| basedOn | Σ | 0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | Fulfills plan, proposal or order | Σ | 0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | Fulfills plan, proposal or order | |||||||||
| partOf | Σ | 0..* | Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) | Part of referenced event | Σ | 0..* | Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) | Part of referenced event | |||||||||
| status | ?!SΣ | 1..1 | code | registered | preliminary | final | amended + Binding: ?? (required): Codes providing the status of an observation. | ?!SΣ | 1..1 | code | registered | preliminary | final | amended + Binding: ?? (required): Codes providing the status of an observation. | |||||||||
| Slices for category | S | 1..* | CodeableConcept | Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ?? (preferred): Codes for high level observation categories. | 0..* | CodeableConcept | Classification of type of observation Binding: ?? (preferred): Codes for high level observation categories. |
| |||||||||
| code | SΣ | 1..1 | CodeableConcept | Laboratory Test Name Binding: ?? (extensible): Laboratory LOINC Codes | SΣ | 1..1 | CodeableConcept | The type of risk assessment information reported. Binding: ?? (preferred) | |||||||||
| subject | SΣ | 1..1 | Reference(US Core Patient Profile S | Group | Device | US Core Location Profile) | Who and/or what the observation is about | SΣ | 0..1 | Reference(Cancer Patient Profile) | Who and/or what the observation is about |
| ||||||||
| focus | Σ | 0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record | SΣ | 0..* | Reference(Primary Cancer Condition Profile) | The cancer condition associated with risk assessment. |
| ||||||||
| encounter | SΣ | 0..1 | Reference(US Core Encounter Profile) | Encounter associated with Observation | Σ | 0..1 | Reference(Encounter) | Healthcare event during which this observation is made |
| ||||||||
| effective[x] | SΣC | 0..1 | dateTime S, Period, Timing, instant | Clinically relevant time/time-period for observation us-core-1: Datetime must be at least to day. | SΣ | 0..1 | dateTime, Period, Timing, instant | Clinically relevant time/time-period for observation | |||||||||
| issued | Σ | 0..1 | instant | Date/Time this version was made available | Σ | 0..1 | instant | Date/Time this version was made available | |||||||||
| performer | Σ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | Who is responsible for the observation | Σ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | Who is responsible for the observation | |||||||||
| value[x] | SΣC | 0..1 | Quantity S, CodeableConcept S, string S, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Result Value us-core-3: SHALL use UCUM for coded quantity units. us-core-4: SHOULD use Snomed CT for coded Results | SΣC | 0..1 | CodeableConcept | The value of the risk assessment Binding: ?? (example) | |||||||||
| dataAbsentReason | SC | 0..1 | CodeableConcept | Why the result is missing Binding: ?? (extensible): Codes specifying why the result (Observation.value[x]) is missing. | C | 0..1 | CodeableConcept | Why the result is missing Binding: ?? (extensible): Codes specifying why the result (Observation.value[x]) is missing. |
| ||||||||
| interpretation | S | 0..* | CodeableConcept | Result interpretation Binding: ?? (extensible): Observation Interpretation Codes | 0..* | CodeableConcept | High, low, normal, etc. Binding: ?? (extensible): Codes identifying interpretations of observations. |
| |||||||||
| note | 0..* | Annotation | Comments about the observation | 0..* | Annotation | Comments about the observation | |||||||||||
| bodySite | 0..1 | CodeableConcept | Observed body part Binding: ?? (example): Codes describing anatomical locations. May include laterality. | 0..1 | CodeableConcept | Observed body part Binding: ?? (example): Codes describing anatomical locations. May include laterality. | |||||||||||
| method | 0..1 | CodeableConcept | How it was done Binding: ?? (example): Methods for simple observations. | 0..1 | CodeableConcept | How it was done Binding: ?? (example): Methods for simple observations. | |||||||||||
| specimen | S | 0..1 | Reference(US Core Specimen Profile) | Specimen used for this observation | 0..1 | Reference(Specimen) | Specimen used for this observation |
| |||||||||
| device | 0..1 | Reference(Device | DeviceMetric) | (Measurement) Device | 0..1 | Reference(Device | DeviceMetric) | Not used in this profile | |||||||||||
 referenceRange | SC | 0..* | BackboneElement | Result reference range obs-3: Must have at least a low or a high or text | C | 0..* | BackboneElement | Not used in this profile obs-3: Must have at least a low or a high or text |
| ||||||||
 id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| low | C | 0..1 | ?? | Low Range, if relevant | C | 0..1 | ?? | Low Range, if relevant | |||||||||
| high | C | 0..1 | ?? | High Range, if relevant | C | 0..1 | ?? | High Range, if relevant | |||||||||
| type | 0..1 | CodeableConcept | Reference range qualifier Binding: ?? (preferred): Code for the meaning of a reference range. | 0..1 | CodeableConcept | Reference range qualifier Binding: ?? (preferred): Code for the meaning of a reference range. | |||||||||||
| appliesTo | 0..* | CodeableConcept | Reference range population Binding: ?? (example): Codes identifying the population the reference range applies to. | 0..* | CodeableConcept | Reference range population Binding: ?? (example): Codes identifying the population the reference range applies to. | |||||||||||
| age | 0..1 | Range | Applicable age range, if relevant | 0..1 | Range | Applicable age range, if relevant | |||||||||||
| text | 0..1 | string | Text based reference range in an observation | 0..1 | string | Text based reference range in an observation | |||||||||||
| hasMember | Σ | 0..* | Reference(Observation | QuestionnaireResponse | MolecularSequence) | Related resource that belongs to the Observation group | Σ | 0..* | Reference(Observation | QuestionnaireResponse | MolecularSequence) | Prognostic factors contributing to risk assessment. | |||||||||
| derivedFrom | Σ | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | Related measurements the observation is made from | Σ | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | Related measurements the observation is made from | |||||||||
 component | Σ | 0..* | BackboneElement | Component results | Σ | 0..* | BackboneElement | Component results | |||||||||
 id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| code | Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: ?? (example): Codes identifying names of simple observations. | Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: ?? (example): Codes identifying names of simple observations. | |||||||||
| value[x] | Σ | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Actual component result | Σ | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Actual component result | |||||||||
| dataAbsentReason | C | 0..1 | CodeableConcept | Why the component result is missing Binding: ?? (extensible): Codes specifying why the result (Observation.value[x]) is missing. | C | 0..1 | CodeableConcept | Why the component result is missing Binding: ?? (extensible): Codes specifying why the result (Observation.value[x]) is missing. | |||||||||
| interpretation | 0..* | CodeableConcept | High, low, normal, etc. Binding: ?? (extensible): Codes identifying interpretations of observations. | 0..* | CodeableConcept | High, low, normal, etc. Binding: ?? (extensible): Codes identifying interpretations of observations. | |||||||||||
 referenceRange | 0..* | See referenceRange (Observation) | Provides guide for interpretation of component result | 0..* | See referenceRange (Observation) | Provides guide for interpretation of component result | |||||||||||
| Documentation for this format | |||||||||||||||||