minimal Common Oncology Data Elements (mCODE) Implementation Guide
1.16.0 - STU Release 2 (Ballot Version)
minimal Common Oncology Data Elements (mCODE) Implementation Guide
1.16.0 - STU Release 2 (Ballot Version)
This page is part of the HL7 FHIR Implementation Guide: minimal Common Oncology Data Elements (mCODE) Release 1 - US Realm | STU1 (v1.16.0: STU 2 Ballot 1) based on FHIR R4. The current version which supercedes this version is 2.0.0. For a full list of available versions, see the Directory of published versions 
| Defining URL: | http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-tumor-marker-test |
| Version: | 1.16.0 |
| Name: | TumorMarkerTest |
| Title: | Tumor Marker Test |
| Status: | Active as of 2021-04-15T12:44:45+00:00 |
| Definition: | 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. |
| Publisher: | HL7 International Clinical Interoperability Council |
| Source Resource: | XML / JSON / Turtle |
The official URL for this profile is:
http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-tumor-marker-test
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 genetic 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 mCODE patient with an Observation.code in the value set TumorMarkerTestVS MUST conform to this profile. Beyond this requirement, a producer of resources SHOULD ensure that any resource instance associated with an mCODE 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.
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from USCoreLaboratoryResultObservationProfile
This structure is derived from USCoreLaboratoryResultObservationProfile
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Observation | 0..* | USCoreLaboratoryResultObservationProfile | Measurements and simple assertions | |
  code | I | 1..1 | CodeableConcept | Laboratory Test Name Binding: Tumor Marker Test Value Set (required) tumor-marker-test-code-invariant: If the code representing 'Other tumor marker test, specify' is used, a second code from outside the original value set must be present. The second code MUST NOT represent a concept in or subsumed by any concept in the original value set. |
 subject | 1..1 | Reference(Cancer Patient) | Who and/or what the observation is about | |
  value[x] | 0..1 | Result Value | ||
  valueQuantity | Quantity | |||
| valueCodeableConcept | CodeableConcept | |||
 valueString | string | |||
 valueRatio | Ratio | |||
| specimen | S | 0..1 | Reference(Specimen) | Specimen used for this observation |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Observation | I | 0..* | USCoreLaboratoryResultObservationProfile | Measurements and simple assertions |
| id | Σ | 0..1 | string | 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) Max Binding: AllLanguages: A human language. | |
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |
| contained | 0..* | Resource | Contained, inline Resources | |
 extension | 0..* | Extension | Additional content defined by implementations | |
 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) |
 category | S | 1..* | (Slice Definition) | 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 | SΣI | 1..1 | CodeableConcept | Laboratory Test Name Binding: Tumor Marker Test Value Set (required) tumor-marker-test-code-invariant: If the code representing 'Other tumor marker test, specify' is used, a second code from outside the original value set must be present. The second code MUST NOT represent a concept in or subsumed by any concept in the original value set. |
| subject | SΣ | 1..1 | Reference(Cancer Patient) | 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] | SΣI | 0..1 | Clinically relevant time/time-period for observation us-core-1: Datetime must be at least to day. | |
| effectiveDateTime | dateTime | |||
| 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] | SΣI | 0..1 | Result Value | |
| valueQuantity | Quantity | |||
| valueCodeableConcept | CodeableConcept | |||
| valueString | string | |||
| valueRatio | Ratio | |||
| dataAbsentReason | SI | 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(Specimen) | Specimen used for this observation |
| device | 0..1 | Reference(Device | DeviceMetric) | (Measurement) Device | |
| referenceRange | I | 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 | I | 0..1 | SimpleQuantity | Low Range, if relevant |
| high | I | 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 | I | 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 | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Observation | I | 0..* | USCoreLaboratoryResultObservationProfile | Measurements and simple assertions |
| status | ?!Σ | 1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required) |
| category | 1..* | (Slice Definition) | Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. | |
| category:Laboratory | 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 | ΣI | 1..1 | CodeableConcept | Laboratory Test Name Binding: Tumor Marker Test Value Set (required) tumor-marker-test-code-invariant: If the code representing 'Other tumor marker test, specify' is used, a second code from outside the original value set must be present. The second code MUST NOT represent a concept in or subsumed by any concept in the original value set. |
| subject | Σ | 1..1 | Reference(Cancer Patient) | Who and/or what the observation is about |
| effective[x] | ΣI | 0..1 | Clinically relevant time/time-period for observation us-core-1: Datetime must be at least to day. | |
| effectiveDateTime | dateTime | |||
| effectivePeriod | Period | |||
| value[x] | ΣI | 0..1 | Result Value | |
| valueQuantity | Quantity | |||
| valueCodeableConcept | CodeableConcept | |||
| valueString | string | |||
| valueRatio | Ratio | |||
| dataAbsentReason | I | 0..1 | CodeableConcept | Why the result is missing Binding: DataAbsentReason (extensible) |
| specimen | 0..1 | Reference(Specimen) | Specimen used for this observation | |
| Documentation for this format | ||||
This structure is derived from USCoreLaboratoryResultObservationProfile
Differential View
This structure is derived from USCoreLaboratoryResultObservationProfile
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Observation | 0..* | USCoreLaboratoryResultObservationProfile | Measurements and simple assertions | |
| code | I | 1..1 | CodeableConcept | Laboratory Test Name Binding: Tumor Marker Test Value Set (required) tumor-marker-test-code-invariant: If the code representing 'Other tumor marker test, specify' is used, a second code from outside the original value set must be present. The second code MUST NOT represent a concept in or subsumed by any concept in the original value set. |
| subject | 1..1 | Reference(Cancer Patient) | Who and/or what the observation is about | |
| value[x] | 0..1 | Result Value | ||
| valueQuantity | Quantity | |||
| valueCodeableConcept | CodeableConcept | |||
| valueString | string | |||
| valueRatio | Ratio | |||
| specimen | S | 0..1 | Reference(Specimen) | Specimen used for this observation |
| Documentation for this format | ||||
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Observation | I | 0..* | USCoreLaboratoryResultObservationProfile | Measurements and simple assertions |
| id | Σ | 0..1 | string | 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) Max Binding: AllLanguages: A human language. | |
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |
| contained | 0..* | Resource | Contained, inline Resources | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| 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) |
| category | S | 1..* | (Slice Definition) | 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 | SΣI | 1..1 | CodeableConcept | Laboratory Test Name Binding: Tumor Marker Test Value Set (required) tumor-marker-test-code-invariant: If the code representing 'Other tumor marker test, specify' is used, a second code from outside the original value set must be present. The second code MUST NOT represent a concept in or subsumed by any concept in the original value set. |
| subject | SΣ | 1..1 | Reference(Cancer Patient) | 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] | SΣI | 0..1 | Clinically relevant time/time-period for observation us-core-1: Datetime must be at least to day. | |
| effectiveDateTime | dateTime | |||
| 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] | SΣI | 0..1 | Result Value | |
| valueQuantity | Quantity | |||
| valueCodeableConcept | CodeableConcept | |||
| valueString | string | |||
| valueRatio | Ratio | |||
| dataAbsentReason | SI | 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(Specimen) | Specimen used for this observation |
| device | 0..1 | Reference(Device | DeviceMetric) | (Measurement) Device | |
| referenceRange | I | 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 | I | 0..1 | SimpleQuantity | Low Range, if relevant |
| high | I | 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 | I | 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 | ||||
Other representations of profile: Schematron
| Path | Conformance | ValueSet / Code |
| Observation.language | preferred | CommonLanguages Max Binding: AllLanguages |
| Observation.status | required | ObservationStatus |
| Observation.category | preferred | ObservationCategoryCodes |
| Observation.category:Laboratory | preferred | Pattern: laboratory |
| Observation.code | required | TumorMarkerTestVS |
| Observation.dataAbsentReason | extensible | DataAbsentReason |
| Observation.interpretation | extensible | ObservationInterpretationCodes |
| Observation.bodySite | example | SNOMEDCTBodyStructures |
| Observation.method | example | ObservationMethods |
| Observation.referenceRange.type | preferred | ObservationReferenceRangeMeaningCodes |
| Observation.referenceRange.appliesTo | example | ObservationReferenceRangeAppliesToCodes |
| Observation.component.code | example | LOINCCodes |
| Observation.component.dataAbsentReason | extensible | DataAbsentReason |
| Observation.component.interpretation | extensible | ObservationInterpretationCodes |
| Id | Path | Details | Requirements |
| tumor-marker-test-code-invariant | Observation.code | If the code representing 'Other tumor marker test, specify' is used, a second code from outside the original value set must be present. The second code MUST NOT represent a concept in or subsumed by any concept in the original value set. : coding.where(code = 'TMT-OTHER').exists() implies coding.where(code != 'TMT-OTHER' and $this.memberOf('http://hl7.org/fhir/us/mcode/ValueSet/mcode-tumor-marker-test-vs').not()).exists() | |
| us-core-1 | Observation.effective[x] | Datetime must be at least to day. : ($this as dateTime).toString().length() >= 8 | |
| obs-3 | Observation.referenceRange | Must have at least a low or a high or text : low.exists() or high.exists() or text.exists() |
IG © 2019+ HL7 International Clinical Interoperability Council. Package hl7.fhir.us.mcode#1.16.0 based on FHIR 4.0.1. Generated 2021-04-15
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