minimal Common Oncology Data Elements (mCODE) Implementation Guide
4.0.0-ballot - STU4 Ballot
minimal Common Oncology Data Elements (mCODE) Implementation Guide
4.0.0-ballot - STU4 Ballot
minimal Common Oncology Data Elements (mCODE) Implementation Guide, published by HL7 International / Clinical Interoperability Council. This guide is not an authorized publication; it is the continuous build for version 4.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-mCODE-ig/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-tumor-marker-test | Version: 4.0.0-ballot | |||
| Active as of 2024-04-03 | Maturity Level: 4 | Computable Name: TumorMarkerTest | ||
| Other Identifiers: OID:2.16.840.1.113883.4.642.40.15.42.61 | ||||
The result of a tumor marker test. Tumor marker tests are generally used to guide cancer treatment decisions and monitor treatment, as well as to predict the chance of recovery and cancer recurrence.
A tumor marker is a substance found in tissue or blood or other body fluids that may be a sign of cancer or certain benign (non-cancer) conditions. Most tumor markers are made by both normal cells and cancer cells, but they are made in larger amounts by cancer cells. A tumor marker may help to diagnose cancer, plan treatment, or find out how well treatment is working or if cancer has come back. Examples of tumor markers include CA-125 (in ovarian cancer), CA 15-3 (in breast cancer), CEA (in colon cancer), and PSA (in prostate cancer). Tumor markers differ from genomic markers in that they are measured at the levels of the protein and substance post-RNA protein synthesis. (Definition adapted from: NCI Dictionary of Cancer Terms and Cancer.Net).
Observation resources associated with an [in-scope patient] with an Observation.code in the value set TumorMarkerTestVS SHALL conform to this profile. Beyond this requirement, a producer of resources SHOULD ensure that any resource instance associated with an in-scope patient that would reasonably be expected to conform to this profile SHOULD be published in this form, for example, when employing a code that extends the TumorMarkerTestVS value set. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.
Usage:
Changes since version true:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from USCoreLaboratoryResultObservationProfile
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Observation | 0..* | USCoreLaboratoryResultObservationProfile | Measurements and simple assertions | |
  Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
 relatedCondition | S | 0..* | CodeableConcept, Reference(Condition) | Condition associated with this test. URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition |
 code | 1..1 | CodeableConcept | Laboratory Test Name Binding: Tumor Marker Test Value Set (extensible) | |
 subject | 1..1 | Reference(Cancer Patient Profile) | Who and/or what the observation is about | |
  effective[x] | 0..1 | Clinically relevant time/time-period for observation | ||
  effectiveDateTime | dateTime | |||
  effectivePeriod | Period | |||
| value[x] | 1..1 | Result Value | ||
| valueQuantity | Quantity | |||
| valueCodeableConcept | CodeableConcept | |||
| valueString | string | |||
| valueRatio | Ratio | |||
| specimen | S | 0..1 | Reference(Human Specimen Profile) | Specimen used for this observation |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Observation.code | extensible | TumorMarkerTestVShttp://hl7.org/fhir/us/mcode/ValueSet/mcode-tumor-marker-test-vsfrom this IG |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Observation | C | 0..* | USCoreLaboratoryResultObservationProfile | 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 |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| relatedCondition | S | 0..* | CodeableConcept, Reference(Condition) | Condition associated with this test. URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition |
 modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| status | ?!SΣ | 1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required) |
 Slices for category | S | 1..* | CodeableConcept | Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. |
 category:Laboratory | S | 1..1 | CodeableConcept | Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following |
   coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: laboratory | |
| code | SΣ | 1..1 | CodeableConcept | Laboratory Test Name Binding: Tumor Marker Test Value Set (extensible) |
| subject | SΣ | 1..1 | Reference(Cancer Patient Profile) | Who and/or what the observation is about |
| effective[x] | SΣC | 0..1 | Clinically relevant time/time-period for observation us-core-1: Datetime must be at least to day. | |
| effectiveDateTime | dateTime | |||
| value[x] | SΣC | 1..1 | Result Value us-core-4: SHOULD use Snomed CT for coded Results us-core-3: SHALL use UCUM for coded quantity units. | |
| valueQuantity | Quantity | |||
| valueCodeableConcept | CodeableConcept | |||
| valueString | string | |||
| dataAbsentReason | SC | 0..1 | CodeableConcept | Why the result is missing Binding: DataAbsentReason (extensible) |
| specimen | S | 0..1 | Reference(Human Specimen Profile) | Specimen used for this observation |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| Observation.status | required | ObservationStatushttp://hl7.org/fhir/ValueSet/observation-statusfrom the FHIR Standard | |
| Observation.category | preferred | ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-categoryfrom the FHIR Standard | |
| Observation.category:Laboratory | preferred | Pattern: laboratoryhttp://hl7.org/fhir/ValueSet/observation-categoryfrom the FHIR Standard | |
| Observation.code | extensible | TumorMarkerTestVShttp://hl7.org/fhir/us/mcode/ValueSet/mcode-tumor-marker-test-vsfrom this IG | |
| Observation.dataAbsentReason | extensible | DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reasonfrom the FHIR Standard |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| Observation | C | 0..* | USCoreLaboratoryResultObservationProfile | 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 | ||||
| id | Σ | 0..1 | id | Logical id of this artifact | ||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| relatedCondition | S | 0..* | CodeableConcept, Reference(Condition) | Condition associated with this test. URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition | ||||
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | Σ | 0..* | Identifier | Business Identifier for observation | ||||
| basedOn | 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 | ||||
| status | ?!SΣ | 1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required) | ||||
| Slices for category | S | 1..* | CodeableConcept | Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. | ||||
| category:Laboratory | S | 1..1 | CodeableConcept | Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following | ||||
 id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
 coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
 id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: laboratory | |||||
| display | 0..1 | string | Representation defined by the system | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
 text | 0..1 | string | Plain text representation of the concept | |||||
| code | SΣ | 1..1 | CodeableConcept | Laboratory Test Name Binding: Tumor Marker Test Value Set (extensible) | ||||
| subject | SΣ | 1..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 | ||||
| encounter | Σ | 0..1 | Reference(Encounter) | Healthcare event during which this observation is made | ||||
| effective[x] | SΣC | 0..1 | Clinically relevant time/time-period for observation us-core-1: Datetime must be at least to day. | |||||
| effectiveDateTime | dateTime S | |||||||
| effectivePeriod | Period | |||||||
| issued | 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 | ||||
| value[x] | SΣC | 1..1 | Result Value us-core-4: SHOULD use Snomed CT for coded Results us-core-3: SHALL use UCUM for coded quantity units. | |||||
| valueQuantity | Quantity S | |||||||
| valueCodeableConcept | CodeableConcept S | |||||||
| valueString | string S | |||||||
| valueRatio | Ratio | |||||||
| dataAbsentReason | SC | 0..1 | CodeableConcept | Why the result is missing Binding: DataAbsentReason (extensible) | ||||
| interpretation | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. | |||||
| note | 0..* | Annotation | Comments about the observation | |||||
| bodySite | 0..1 | CodeableConcept | Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality. | |||||
| method | 0..1 | CodeableConcept | How it was done Binding: ObservationMethods (example): Methods for simple observations. | |||||
| specimen | S | 0..1 | Reference(Human Specimen Profile) | Specimen used for this observation | ||||
| device | 0..1 | Reference(Device | DeviceMetric) | (Measurement) Device | |||||
| referenceRange | C | 0..* | BackboneElement | Provides guide for interpretation obs-3: Must have at least a low or a high or text | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| low | C | 0..1 | SimpleQuantity | Low Range, if relevant | ||||
| high | C | 0..1 | SimpleQuantity | High Range, if relevant | ||||
| type | 0..1 | CodeableConcept | Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range. | |||||
| appliesTo | 0..* | CodeableConcept | Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to. | |||||
| age | 0..1 | Range | Applicable age range, if relevant | |||||
| text | 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 | ||||
| derivedFrom | Σ | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | Related measurements the observation is made from | ||||
 component | Σ | 0..* | BackboneElement | Component results | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| code | Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. | ||||
| value[x] | Σ | 0..1 | Actual component result | |||||
| valueQuantity | Quantity | |||||||
| valueCodeableConcept | CodeableConcept | |||||||
| valueString | string | |||||||
| valueBoolean | boolean | |||||||
| valueInteger | integer | |||||||
| valueRange | Range | |||||||
| valueRatio | Ratio | |||||||
| valueSampledData | SampledData | |||||||
| valueTime | time | |||||||
| valueDateTime | dateTime | |||||||
| valuePeriod | Period | |||||||
| dataAbsentReason | C | 0..1 | CodeableConcept | Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. | ||||
| interpretation | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. | |||||
| referenceRange | 0..* | See referenceRange (Observation) | Provides guide for interpretation of component result | |||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | URI | |||
| Observation.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| Observation.status | required | ObservationStatushttp://hl7.org/fhir/ValueSet/observation-statusfrom the FHIR Standard | ||||
| Observation.category | preferred | ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-categoryfrom the FHIR Standard | ||||
| Observation.category:Laboratory | preferred | Pattern: laboratoryhttp://hl7.org/fhir/ValueSet/observation-categoryfrom the FHIR Standard | ||||
| Observation.code | extensible | TumorMarkerTestVShttp://hl7.org/fhir/us/mcode/ValueSet/mcode-tumor-marker-test-vsfrom this IG | ||||
| Observation.dataAbsentReason | extensible | DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reasonfrom the FHIR Standard | ||||
| Observation.interpretation | extensible | ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretationfrom the FHIR Standard | ||||
| Observation.bodySite | example | SNOMEDCTBodyStructureshttp://hl7.org/fhir/ValueSet/body-sitefrom the FHIR Standard | ||||
| Observation.method | example | ObservationMethodshttp://hl7.org/fhir/ValueSet/observation-methodsfrom the FHIR Standard | ||||
| Observation.referenceRange.type | preferred | ObservationReferenceRangeMeaningCodeshttp://hl7.org/fhir/ValueSet/referencerange-meaningfrom the FHIR Standard | ||||
| Observation.referenceRange.appliesTo | example | ObservationReferenceRangeAppliesToCodeshttp://hl7.org/fhir/ValueSet/referencerange-appliestofrom the FHIR Standard | ||||
| Observation.component.code | example | LOINCCodes (a valid code from LOINC)http://hl7.org/fhir/ValueSet/observation-codesfrom the FHIR Standard | ||||
| Observation.component.dataAbsentReason | extensible | DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reasonfrom the FHIR Standard | ||||
| Observation.component.interpretation | extensible | ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretationfrom the FHIR Standard |
This structure is derived from USCoreLaboratoryResultObservationProfile
Summary
Mandatory: 1 element
Must-Support: 2 elements
Structures
This structure refers to these other structures:
Extensions
This structure refers to these extensions:
Maturity: 4
Differential View
This structure is derived from USCoreLaboratoryResultObservationProfile
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Observation | 0..* | USCoreLaboratoryResultObservationProfile | Measurements and simple assertions | |
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| relatedCondition | S | 0..* | CodeableConcept, Reference(Condition) | Condition associated with this test. URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition |
| code | 1..1 | CodeableConcept | Laboratory Test Name Binding: Tumor Marker Test Value Set (extensible) | |
| subject | 1..1 | Reference(Cancer Patient Profile) | Who and/or what the observation is about | |
| effective[x] | 0..1 | Clinically relevant time/time-period for observation | ||
| effectiveDateTime | dateTime | |||
| effectivePeriod | Period | |||
| value[x] | 1..1 | Result Value | ||
| valueQuantity | Quantity | |||
| valueCodeableConcept | CodeableConcept | |||
| valueString | string | |||
| valueRatio | Ratio | |||
| specimen | S | 0..1 | Reference(Human Specimen Profile) | Specimen used for this observation |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Observation.code | extensible | TumorMarkerTestVShttp://hl7.org/fhir/us/mcode/ValueSet/mcode-tumor-marker-test-vsfrom this IG |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Observation | C | 0..* | USCoreLaboratoryResultObservationProfile | 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 |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| relatedCondition | S | 0..* | CodeableConcept, Reference(Condition) | Condition associated with this test. URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition |
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| status | ?!SΣ | 1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required) |
| Slices for category | S | 1..* | CodeableConcept | Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. |
| category:Laboratory | S | 1..1 | CodeableConcept | Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following |
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: laboratory | |
| code | SΣ | 1..1 | CodeableConcept | Laboratory Test Name Binding: Tumor Marker Test Value Set (extensible) |
| subject | SΣ | 1..1 | Reference(Cancer Patient Profile) | Who and/or what the observation is about |
| effective[x] | SΣC | 0..1 | Clinically relevant time/time-period for observation us-core-1: Datetime must be at least to day. | |
| effectiveDateTime | dateTime | |||
| value[x] | SΣC | 1..1 | Result Value us-core-4: SHOULD use Snomed CT for coded Results us-core-3: SHALL use UCUM for coded quantity units. | |
| valueQuantity | Quantity | |||
| valueCodeableConcept | CodeableConcept | |||
| valueString | string | |||
| dataAbsentReason | SC | 0..1 | CodeableConcept | Why the result is missing Binding: DataAbsentReason (extensible) |
| specimen | S | 0..1 | Reference(Human Specimen Profile) | Specimen used for this observation |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| Observation.status | required | ObservationStatushttp://hl7.org/fhir/ValueSet/observation-statusfrom the FHIR Standard | |
| Observation.category | preferred | ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-categoryfrom the FHIR Standard | |
| Observation.category:Laboratory | preferred | Pattern: laboratoryhttp://hl7.org/fhir/ValueSet/observation-categoryfrom the FHIR Standard | |
| Observation.code | extensible | TumorMarkerTestVShttp://hl7.org/fhir/us/mcode/ValueSet/mcode-tumor-marker-test-vsfrom this IG | |
| Observation.dataAbsentReason | extensible | DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reasonfrom the FHIR Standard |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| Observation | C | 0..* | USCoreLaboratoryResultObservationProfile | 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 | ||||
| id | Σ | 0..1 | id | Logical id of this artifact | ||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| relatedCondition | S | 0..* | CodeableConcept, Reference(Condition) | Condition associated with this test. URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition | ||||
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | Σ | 0..* | Identifier | Business Identifier for observation | ||||
| basedOn | 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 | ||||
| status | ?!SΣ | 1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required) | ||||
| Slices for category | S | 1..* | CodeableConcept | Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. | ||||
| category:Laboratory | S | 1..1 | CodeableConcept | Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: laboratory | |||||
| display | 0..1 | string | Representation defined by the system | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | 0..1 | string | Plain text representation of the concept | |||||
| code | SΣ | 1..1 | CodeableConcept | Laboratory Test Name Binding: Tumor Marker Test Value Set (extensible) | ||||
| subject | SΣ | 1..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 | ||||
| encounter | Σ | 0..1 | Reference(Encounter) | Healthcare event during which this observation is made | ||||
| effective[x] | SΣC | 0..1 | Clinically relevant time/time-period for observation us-core-1: Datetime must be at least to day. | |||||
| effectiveDateTime | dateTime S | |||||||
| effectivePeriod | Period | |||||||
| issued | 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 | ||||
| value[x] | SΣC | 1..1 | Result Value us-core-4: SHOULD use Snomed CT for coded Results us-core-3: SHALL use UCUM for coded quantity units. | |||||
| valueQuantity | Quantity S | |||||||
| valueCodeableConcept | CodeableConcept S | |||||||
| valueString | string S | |||||||
| valueRatio | Ratio | |||||||
| dataAbsentReason | SC | 0..1 | CodeableConcept | Why the result is missing Binding: DataAbsentReason (extensible) | ||||
| interpretation | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. | |||||
| note | 0..* | Annotation | Comments about the observation | |||||
| bodySite | 0..1 | CodeableConcept | Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality. | |||||
| method | 0..1 | CodeableConcept | How it was done Binding: ObservationMethods (example): Methods for simple observations. | |||||
| specimen | S | 0..1 | Reference(Human Specimen Profile) | Specimen used for this observation | ||||
| device | 0..1 | Reference(Device | DeviceMetric) | (Measurement) Device | |||||
| referenceRange | C | 0..* | BackboneElement | Provides guide for interpretation obs-3: Must have at least a low or a high or text | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| low | C | 0..1 | SimpleQuantity | Low Range, if relevant | ||||
| high | C | 0..1 | SimpleQuantity | High Range, if relevant | ||||
| type | 0..1 | CodeableConcept | Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range. | |||||
| appliesTo | 0..* | CodeableConcept | Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to. | |||||
| age | 0..1 | Range | Applicable age range, if relevant | |||||
| text | 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 | ||||
| derivedFrom | Σ | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | Related measurements the observation is made from | ||||
| component | Σ | 0..* | BackboneElement | Component results | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| code | Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. | ||||
| value[x] | Σ | 0..1 | Actual component result | |||||
| valueQuantity | Quantity | |||||||
| valueCodeableConcept | CodeableConcept | |||||||
| valueString | string | |||||||
| valueBoolean | boolean | |||||||
| valueInteger | integer | |||||||
| valueRange | Range | |||||||
| valueRatio | Ratio | |||||||
| valueSampledData | SampledData | |||||||
| valueTime | time | |||||||
| valueDateTime | dateTime | |||||||
| valuePeriod | Period | |||||||
| dataAbsentReason | C | 0..1 | CodeableConcept | Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. | ||||
| interpretation | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. | |||||
| referenceRange | 0..* | See referenceRange (Observation) | Provides guide for interpretation of component result | |||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | URI | |||
| Observation.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| Observation.status | required | ObservationStatushttp://hl7.org/fhir/ValueSet/observation-statusfrom the FHIR Standard | ||||
| Observation.category | preferred | ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-categoryfrom the FHIR Standard | ||||
| Observation.category:Laboratory | preferred | Pattern: laboratoryhttp://hl7.org/fhir/ValueSet/observation-categoryfrom the FHIR Standard | ||||
| Observation.code | extensible | TumorMarkerTestVShttp://hl7.org/fhir/us/mcode/ValueSet/mcode-tumor-marker-test-vsfrom this IG | ||||
| Observation.dataAbsentReason | extensible | DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reasonfrom the FHIR Standard | ||||
| Observation.interpretation | extensible | ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretationfrom the FHIR Standard | ||||
| Observation.bodySite | example | SNOMEDCTBodyStructureshttp://hl7.org/fhir/ValueSet/body-sitefrom the FHIR Standard | ||||
| Observation.method | example | ObservationMethodshttp://hl7.org/fhir/ValueSet/observation-methodsfrom the FHIR Standard | ||||
| Observation.referenceRange.type | preferred | ObservationReferenceRangeMeaningCodeshttp://hl7.org/fhir/ValueSet/referencerange-meaningfrom the FHIR Standard | ||||
| Observation.referenceRange.appliesTo | example | ObservationReferenceRangeAppliesToCodeshttp://hl7.org/fhir/ValueSet/referencerange-appliestofrom the FHIR Standard | ||||
| Observation.component.code | example | LOINCCodes (a valid code from LOINC)http://hl7.org/fhir/ValueSet/observation-codesfrom the FHIR Standard | ||||
| Observation.component.dataAbsentReason | extensible | DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reasonfrom the FHIR Standard | ||||
| Observation.component.interpretation | extensible | ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretationfrom the FHIR Standard |
This structure is derived from USCoreLaboratoryResultObservationProfile
Summary
Mandatory: 1 element
Must-Support: 2 elements
Structures
This structure refers to these other structures:
Extensions
This structure refers to these extensions:
Maturity: 4
Other representations of profile: CSV, Excel, Schematron
IG © 2019+ HL7 International / Clinical Interoperability Council. Package hl7.fhir.us.mcode#4.0.0-ballot based on FHIR 4.0.1. Generated 2024-04-03
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