Cancer Pathology Data Sharing
2.0.0 - STU 2

Cancer Pathology Data Sharing, published by HL7 International / Orders and Observations. This guide is not an authorized publication; it is the continuous build for version 2.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/cancer-reporting/ and changes regularly. See the Directory of published versions

## Resource Profile: US Pathology Observation

Official URL: http://hl7.org/fhir/us/cancer-reporting/StructureDefinition/us-pathology-observation | Version: 2.0.0
Standards status: Trial-use | Maturity Level: 2 | Computable Name: USPathologyObservation

This Observation profile is inspired by both US Core Simple Observation and the IHE SDC/eCP on FHIR Observation Profile. It adds category to differentiate Section and Question Observations. Section(s) contain one or more hasMember relationships to Questions, will not have a value element, and have no derivedFrom relationships. Questions have a derivedFrom relationship with Section AND contain EITHER a value element OR one or more hasMember relationships.

## Introduction

This US Pathology Observation profile is inspired by the IHE SDC/eCP on FHIR Observation Profile which maps the CAP protocol’s structured elements into FHIR Observations. The profile defines how to capture pathology data from structured cancer protocols in a standardized FHIR format.

## Background

The IHE Structured Data Capture (SDC) standard, IHE SDC eCP on FHIR, uses a form-driven workflow to capture and encode data and then create FHIR Observations from the captured data. The College of American Pathologists (CAP) has developed and tested the IHE SDC IG for collection of data from electronic Cancer Protocols (eCPs) by means of Structured Data Capture templates with XML-based schema which enforces ordering, optionality and standardization.

## CAP Protocol Structure

- The CAP electronic Cancer Protocols (eCPs) templates utilize a structured format with several key components:

- Sections: Represent major divisions within the protocol (e.g., “SPECIMEN,” “TUMOR”) that organize related content.
- Child Items: Encapsulates questions, list fields, and sub-sections within a section.
- Questions: Individual data elements which store captured responses which are derived from sections
- Ordering: Indicated for each element through an order attribute (order = “27”) which explicitly defines the sequence of sections, questions, and responses.

## Data Structure Rules

### Category Slicing

The Observation resource is sliced based on the category element to distinguish between sections and questions:

- category:section: When this slice is used (indicating the Observation represents a section), the `code` element must use a value from the “CAP eCP Section Codes” ValueSet (binding: required).

- category:question: When this slice is used (indicating the Observation represents a question), the `code` element must use a value from the “CAP eCP Question Codes” ValueSet (binding: required).

This slicing approach enforces the appropriate terminology bindings based on whether the Observation represents a structural section or a specific question.

### Hierarchical Structure

- Sections: CAP protocol sections (e.g., “SPECIMEN,” “TUMOR”) are stored as Observations that act as a grouping container using hasMember, which references child Observations (i.e., questions within the section).
- Parent-Child Relationships: If a question belongs to a section, the section Observation references its child Observations using hasMember whereas the child references the parent through derivedFrom.

### Key Elements

- category: Specifies whether this is a Section (has no value) or a Question (has a value)
  - Must use the appropriate slice (section or question) from ObservationCategoryCodes
- code: Represents the CAP protocol section or question ID
  - For category:section, must come from the CAP eCP Section Codes ValueSet
  - For category:question, must come from the CAP eCP Question Codes ValueSet
- value[x]: Stores responses for the question
- derivedFrom: References parent Observations, allowing hierarchical relationships between related responses
- hasMember: References child Observations, supporting nested data
- component: Stores additional data fields related to a question such as “Other (Specify)”

### Special Cases

- Multiselect Questions: If the question is Multiselect, multiple Observations with the same Question Code should be created.
- Follow-up Fields: If the question has a follow-up text or number entry field (e.g., “Other (Specify)”), the information from the textbox should be stored in the Observation.component.value, and the Observation.component.code should repeat the Observation.value as the sub-question.

Usages:

- Use this Profile: US Pathology Bundle
- Refer to this Profile: US Pathology Composition Laboratory Report, US Pathology Diagnostic Report and US Pathology Observation
- Examples for this Profile: Observation/observation-additional-dimension, Observation/observation-additional-findings-specify, Observation/observation-clock-position-8, Observation/observation-clock-position... Show 38 more, Observation/observation-distant-metastasis-distant-sites, Observation/observation-distant-metastasis, Observation/observation-ductal-carcinoma, Observation/observation-glandular-differentiation, Observation/observation-histologic-grade, Observation/observation-histologic-type, Observation/observation-margins-closest-margin-to-invasive-carcinoma, Observation/observation-margins-distance-to-closest-margin, Observation/observation-margins-margin-status-for-invasive-carcinoma, Observation/observation-mitotic-rate, Observation/observation-nuclear-pleomorphism, Observation/observation-overall-grade, Observation/observation-procedure-breast-excision, Observation/observation-ptnm-classification-pN-Category, Observation/observation-ptnm-classification-pT-Category, Observation/observation-regional-lymph-node-status, Observation/observation-regional-lymph-nodes-number-examined, Observation/observation-regional-lymph-nodes-number-sentinel, Observation/observation-section-additional-findings, Observation/observation-section-comments, Observation/observation-section-distant-metastasis, Observation/observation-section-lymph-nodes, Observation/observation-section-margins, Observation/observation-section-ptnm-classification, Observation/observation-section-regional-lymph-nodes, Observation/observation-section-special-studies, Observation/observation-section-specimen, Observation/observation-section-tumor-extent, Observation/observation-section-tumor, Observation/observation-special-studies-breast-biomarker, Observation/observation-special-studies-estrogen-receptor-status, Observation/observation-special-studies-estrogen-receptor, Observation/observation-special-studies-her2, Observation/observation-special-studies-negative, Observation/observation-specimen-laterality, Observation/observation-tumor-focality, Observation/observation-tumor-site and Observation/observation-tumor-size

You can also check for usages in the FHIR IG Statistics

### Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

- Differential Table
- Key Elements Table
- Snapshot Table
- Statistics/References
- All

This structure is derived from USCoreSimpleObservationProfile

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation |  |  | USCoreSimpleObservationProfile |
identifier | S | 1..* | Identifier | The SDC instanceGUID
Slices for category |  |  |  | Content/Rules for all slices
category:cap-form-category | S | 1..1 | CodeableConcept | (USCDI) Classification of type of observation Binding: US Pathology Form Category Codes (required)
code |  | 1..1 | CodeableConcept | SDC question ID
Slices for value[x] |  | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | (USCDI) Actual result Slice: Unordered, Open by type:$this
value[x]:valueQuantity |  | 0..1 | Quantity | (USCDI) Actual result Binding: UnitsOfMeasureCaseSensitive (3.0.0) (required): This is the entire UCUM code set.
value[x]:valueCodeableConcept |  | 0..1 | CodeableConcept | (USCDI) Actual result Binding: CAP eCP Answer Codes (extensible)
hasMember | S | 0..* | Reference(US Pathology Observation) | Child observation reference
derivedFrom | S | 0..* | Reference(US Pathology Observation) | Parent observation reference
component | S | 0..* | BackboneElement | Additional entry
Documentation for this format

#### Terminology Bindings (Differential)

Path | Status | Usage | ValueSet | Version | Source
Observation.category:cap-form-category | Base | required | US Pathology Form Category Codes | 📦2.0.0 | This IG
Observation.value[x]:valueQuantity | Base | required | UnitsOfMeasureCaseSensitive | 📍3.0.0 | THO v6.5
Observation.value[x]:valueCodeableConcept | Base | extensible | CAP eCP Answer Codes | 📦2.0.0 | This IG

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | USCoreSimpleObservationProfile | assessment observation Constraints: obs-6, obs-7
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
identifier | S Σ | 1..* | Identifier | The SDC instanceGUID
status | ?!S Σ | 1..1 | code | (USCDI) registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category | S | 1..* | CodeableConcept | (USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:us-core | S | 0..* | CodeableConcept | (USCDI) Classification of type of observation Binding: US Core Simple Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets
category:cap-form-category | S | 1..1 | CodeableConcept | (USCDI) Classification of type of observation Binding: US Pathology Form Category Codes (required)
code | S Σ | 1..1 | CodeableConcept | SDC question ID Binding: LOINCCodes (preferred)
subject | S Σ | 1..1 | Reference(US Core Patient Profile) | (USCDI) Who and/or what the observation is about
effective[x] | S Σ | 0..1 |  | (USCDI) Clinically relevant time/time-period for observation
effectiveDateTime |  |  | dateTime S |
effectivePeriod |  |  | Period |
effectiveTiming |  |  | Timing |
effectiveInstant |  |  | instant |
performer | S Σ | 0..* | Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) | (USCDI) Who is responsible for the observation
Slices for value[x] | S Σ C | 0..1 |  | (USCDI) Actual result Slice: Unordered, Open by type:$this
valueQuantity |  |  | Quantity S |
valueCodeableConcept |  |  | CodeableConcept S |
valueString |  |  | string S |
valueBoolean |  |  | boolean S |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueSampledData |  |  | SampledData |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
value[x]:valueQuantity | S Σ C | 0..1 | Quantity S | (USCDI) Actual result Binding: UnitsOfMeasureCaseSensitive (3.0.0) (required): This is the entire UCUM code set.
value[x]:valueCodeableConcept | S Σ C | 0..1 | CodeableConcept S | (USCDI) Actual result Binding: CAP eCP Answer Codes (extensible)
hasMember | S Σ | 0..* | Reference(US Pathology Observation) | Child observation reference
derivedFrom | S Σ | 0..* | Reference(US Pathology Observation) | Parent observation reference
component | S Σ | 0..* | BackboneElement | Additional entry
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.
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
Observation.status | Base | required | ObservationStatus | 📍4.0.1 | FHIR Std.
Observation.category | Base | preferred | Observation Category Codes | 📦4.0.1 | FHIR Std.
Observation.category:us-core | Base | required | US Core Simple Observation Category | 📦6.1.0 | US Core v6.1
Observation.category:cap-form-category | Base | required | US Pathology Form Category Codes | 📦2.0.0 | This IG
Observation.code | Base | preferred | LOINC Codes | 📦4.0.1 | FHIR Std.
Observation.value[x]:valueQuantity | Base | required | UnitsOfMeasureCaseSensitive | 📍3.0.0 | THO v6.5
Observation.value[x]:valueCodeableConcept | Base | extensible | CAP eCP Answer Codes | 📦2.0.0 | This IG
Observation.component.​code | Base | example | LOINC Codes | 📦4.0.1 | FHIR Std.

#### Constraints

Id | Grade | Path(s) | Description | Expression
dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | Observation | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource | `contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()`
dom-4 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated | `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()`
dom-5 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | Observation | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`
obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present | `dataAbsentReason.empty() or value.empty()`
obs-7 | error | Observation | If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present | `value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()`

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | USCoreSimpleObservationProfile | assessment observation Constraints: obs-6, obs-7
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.
Additional Bindings | Purpose
AllLanguages | Max Binding
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
identifier | S Σ | 1..* | Identifier | The SDC instanceGUID
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 | ?!S Σ | 1..1 | code | (USCDI) registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category | S | 1..* | CodeableConcept | (USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:us-core | S | 0..* | CodeableConcept | (USCDI) Classification of type of observation Binding: US Core Simple Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets
category:cap-form-category | S | 1..1 | CodeableConcept | (USCDI) Classification of type of observation Binding: US Pathology Form Category Codes (required)
code | S Σ | 1..1 | CodeableConcept | SDC question ID Binding: LOINCCodes (preferred)
subject | S Σ | 1..1 | Reference(US Core Patient Profile) | (USCDI) Who and/or what the observation is about
focus | Σ | 0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record
encounter | Σ | 0..1 | Reference(Encounter) | Healthcare event during which this observation is made
effective[x] | S Σ | 0..1 |  | (USCDI) Clinically relevant time/time-period for observation
effectiveDateTime |  |  | dateTime S |
effectivePeriod |  |  | Period |
effectiveTiming |  |  | Timing |
effectiveInstant |  |  | instant |
issued | Σ | 0..1 | instant | Date/Time this version was made available
performer | S Σ | 0..* | Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) | (USCDI) Who is responsible for the observation
Slices for value[x] | S Σ C | 0..1 |  | (USCDI) Actual result Slice: Unordered, Open by type:$this
valueQuantity |  |  | Quantity S |
valueCodeableConcept |  |  | CodeableConcept S |
valueString |  |  | string S |
valueBoolean |  |  | boolean S |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueSampledData |  |  | SampledData |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
value[x]:valueQuantity | S Σ C | 0..1 | Quantity S | (USCDI) Actual result Binding: UnitsOfMeasureCaseSensitive (3.0.0) (required): This is the entire UCUM code set.
value[x]:valueCodeableConcept | S Σ C | 0..1 | CodeableConcept S | (USCDI) Actual result Binding: CAP eCP Answer Codes (extensible)
dataAbsentReason | C | 0..1 | CodeableConcept | Why the 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.
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 |  | 0..1 | Reference(Specimen) | Specimen used for this observation
device |  | 0..1 | Reference(Device | DeviceMetric) | (Measurement) Device
referenceRange | C | 0..* | BackboneElement | Provides guide for interpretation Constraints: obs-3
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 | S Σ | 0..* | Reference(US Pathology Observation) | Child observation reference
derivedFrom | S Σ | 0..* | Reference(US Pathology Observation) | Parent observation reference
component | S Σ | 0..* | BackboneElement | Additional entry
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

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
Observation.language | Base | preferred | Common Languages | 📦4.0.1 | FHIR Std.
Observation.status | Base | required | ObservationStatus | 📍4.0.1 | FHIR Std.
Observation.category | Base | preferred | Observation Category Codes | 📦4.0.1 | FHIR Std.
Observation.category:us-core | Base | required | US Core Simple Observation Category | 📦6.1.0 | US Core v6.1
Observation.category:cap-form-category | Base | required | US Pathology Form Category Codes | 📦2.0.0 | This IG
Observation.code | Base | preferred | LOINC Codes | 📦4.0.1 | FHIR Std.
Observation.value[x]:valueQuantity | Base | required | UnitsOfMeasureCaseSensitive | 📍3.0.0 | THO v6.5
Observation.value[x]:valueCodeableConcept | Base | extensible | CAP eCP Answer Codes | 📦2.0.0 | This IG
Observation.dataAbsentReason | Base | extensible | DataAbsentReason | 📦4.0.1 | FHIR Std.
Observation.interpretation | Base | extensible | Observation Interpretation Codes | 📦4.0.1 | FHIR Std.
Observation.bodySite | Base | example | SNOMED CT Body Structures | 📦4.0.1 | FHIR Std.
Observation.method | Base | example | Observation Methods | 📦4.0.1 | FHIR Std.
Observation.referenceRange.​type | Base | preferred | Observation Reference Range Meaning Codes | 📦4.0.1 | FHIR Std.
Observation.referenceRange.​appliesTo | Base | example | Observation Reference Range Applies To Codes | 📦4.0.1 | FHIR Std.
Observation.component.​code | Base | example | LOINC Codes | 📦4.0.1 | FHIR Std.
Observation.component.​dataAbsentReason | Base | extensible | DataAbsentReason | 📦4.0.1 | FHIR Std.
Observation.component.​interpretation | Base | extensible | Observation Interpretation Codes | 📦4.0.1 | FHIR Std.

#### Constraints

Id | Grade | Path(s) | Description | Expression
dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | Observation | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource | `contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()`
dom-4 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated | `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()`
dom-5 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | Observation | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`
obs-3 | error | Observation.referenceRange | Must have at least a low or a high or text | `low.exists() or high.exists() or text.exists()`
obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present | `dataAbsentReason.empty() or value.empty()`
obs-7 | error | Observation | If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present | `value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()`

This structure is derived from USCoreSimpleObservationProfile

Summary

Mandatory: 2 elements
Must-Support: 5 elements

Structures

This structure refers to these other structures:

- US Pathology Observation (http://hl7.org/fhir/us/cancer-reporting/StructureDefinition/us-pathology-observation)

Slices

This structure defines the following Slices:

- The element 1 is sliced based on the value of Observation.value[x]

Maturity: 2

Differential View

This structure is derived from USCoreSimpleObservationProfile

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation |  |  | USCoreSimpleObservationProfile |
identifier | S | 1..* | Identifier | The SDC instanceGUID
Slices for category |  |  |  | Content/Rules for all slices
category:cap-form-category | S | 1..1 | CodeableConcept | (USCDI) Classification of type of observation Binding: US Pathology Form Category Codes (required)
code |  | 1..1 | CodeableConcept | SDC question ID
Slices for value[x] |  | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | (USCDI) Actual result Slice: Unordered, Open by type:$this
value[x]:valueQuantity |  | 0..1 | Quantity | (USCDI) Actual result Binding: UnitsOfMeasureCaseSensitive (3.0.0) (required): This is the entire UCUM code set.
value[x]:valueCodeableConcept |  | 0..1 | CodeableConcept | (USCDI) Actual result Binding: CAP eCP Answer Codes (extensible)
hasMember | S | 0..* | Reference(US Pathology Observation) | Child observation reference
derivedFrom | S | 0..* | Reference(US Pathology Observation) | Parent observation reference
component | S | 0..* | BackboneElement | Additional entry
Documentation for this format

#### Terminology Bindings (Differential)

Path | Status | Usage | ValueSet | Version | Source
Observation.category:cap-form-category | Base | required | US Pathology Form Category Codes | 📦2.0.0 | This IG
Observation.value[x]:valueQuantity | Base | required | UnitsOfMeasureCaseSensitive | 📍3.0.0 | THO v6.5
Observation.value[x]:valueCodeableConcept | Base | extensible | CAP eCP Answer Codes | 📦2.0.0 | This IG

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | USCoreSimpleObservationProfile | assessment observation Constraints: obs-6, obs-7
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
identifier | S Σ | 1..* | Identifier | The SDC instanceGUID
status | ?!S Σ | 1..1 | code | (USCDI) registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category | S | 1..* | CodeableConcept | (USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:us-core | S | 0..* | CodeableConcept | (USCDI) Classification of type of observation Binding: US Core Simple Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets
category:cap-form-category | S | 1..1 | CodeableConcept | (USCDI) Classification of type of observation Binding: US Pathology Form Category Codes (required)
code | S Σ | 1..1 | CodeableConcept | SDC question ID Binding: LOINCCodes (preferred)
subject | S Σ | 1..1 | Reference(US Core Patient Profile) | (USCDI) Who and/or what the observation is about
effective[x] | S Σ | 0..1 |  | (USCDI) Clinically relevant time/time-period for observation
effectiveDateTime |  |  | dateTime S |
effectivePeriod |  |  | Period |
effectiveTiming |  |  | Timing |
effectiveInstant |  |  | instant |
performer | S Σ | 0..* | Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) | (USCDI) Who is responsible for the observation
Slices for value[x] | S Σ C | 0..1 |  | (USCDI) Actual result Slice: Unordered, Open by type:$this
valueQuantity |  |  | Quantity S |
valueCodeableConcept |  |  | CodeableConcept S |
valueString |  |  | string S |
valueBoolean |  |  | boolean S |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueSampledData |  |  | SampledData |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
value[x]:valueQuantity | S Σ C | 0..1 | Quantity S | (USCDI) Actual result Binding: UnitsOfMeasureCaseSensitive (3.0.0) (required): This is the entire UCUM code set.
value[x]:valueCodeableConcept | S Σ C | 0..1 | CodeableConcept S | (USCDI) Actual result Binding: CAP eCP Answer Codes (extensible)
hasMember | S Σ | 0..* | Reference(US Pathology Observation) | Child observation reference
derivedFrom | S Σ | 0..* | Reference(US Pathology Observation) | Parent observation reference
component | S Σ | 0..* | BackboneElement | Additional entry
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.
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
Observation.status | Base | required | ObservationStatus | 📍4.0.1 | FHIR Std.
Observation.category | Base | preferred | Observation Category Codes | 📦4.0.1 | FHIR Std.
Observation.category:us-core | Base | required | US Core Simple Observation Category | 📦6.1.0 | US Core v6.1
Observation.category:cap-form-category | Base | required | US Pathology Form Category Codes | 📦2.0.0 | This IG
Observation.code | Base | preferred | LOINC Codes | 📦4.0.1 | FHIR Std.
Observation.value[x]:valueQuantity | Base | required | UnitsOfMeasureCaseSensitive | 📍3.0.0 | THO v6.5
Observation.value[x]:valueCodeableConcept | Base | extensible | CAP eCP Answer Codes | 📦2.0.0 | This IG
Observation.component.​code | Base | example | LOINC Codes | 📦4.0.1 | FHIR Std.

#### Constraints

Id | Grade | Path(s) | Description | Expression
dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | Observation | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource | `contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()`
dom-4 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated | `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()`
dom-5 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | Observation | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`
obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present | `dataAbsentReason.empty() or value.empty()`
obs-7 | error | Observation | If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present | `value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()`

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Observation | C | 0..* | USCoreSimpleObservationProfile | assessment observation Constraints: obs-6, obs-7
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.
Additional Bindings | Purpose
AllLanguages | Max Binding
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
identifier | S Σ | 1..* | Identifier | The SDC instanceGUID
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 | ?!S Σ | 1..1 | code | (USCDI) registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category | S | 1..* | CodeableConcept | (USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:us-core | S | 0..* | CodeableConcept | (USCDI) Classification of type of observation Binding: US Core Simple Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets
category:cap-form-category | S | 1..1 | CodeableConcept | (USCDI) Classification of type of observation Binding: US Pathology Form Category Codes (required)
code | S Σ | 1..1 | CodeableConcept | SDC question ID Binding: LOINCCodes (preferred)
subject | S Σ | 1..1 | Reference(US Core Patient Profile) | (USCDI) Who and/or what the observation is about
focus | Σ | 0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record
encounter | Σ | 0..1 | Reference(Encounter) | Healthcare event during which this observation is made
effective[x] | S Σ | 0..1 |  | (USCDI) Clinically relevant time/time-period for observation
effectiveDateTime |  |  | dateTime S |
effectivePeriod |  |  | Period |
effectiveTiming |  |  | Timing |
effectiveInstant |  |  | instant |
issued | Σ | 0..1 | instant | Date/Time this version was made available
performer | S Σ | 0..* | Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) | (USCDI) Who is responsible for the observation
Slices for value[x] | S Σ C | 0..1 |  | (USCDI) Actual result Slice: Unordered, Open by type:$this
valueQuantity |  |  | Quantity S |
valueCodeableConcept |  |  | CodeableConcept S |
valueString |  |  | string S |
valueBoolean |  |  | boolean S |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueSampledData |  |  | SampledData |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
value[x]:valueQuantity | S Σ C | 0..1 | Quantity S | (USCDI) Actual result Binding: UnitsOfMeasureCaseSensitive (3.0.0) (required): This is the entire UCUM code set.
value[x]:valueCodeableConcept | S Σ C | 0..1 | CodeableConcept S | (USCDI) Actual result Binding: CAP eCP Answer Codes (extensible)
dataAbsentReason | C | 0..1 | CodeableConcept | Why the 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.
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 |  | 0..1 | Reference(Specimen) | Specimen used for this observation
device |  | 0..1 | Reference(Device | DeviceMetric) | (Measurement) Device
referenceRange | C | 0..* | BackboneElement | Provides guide for interpretation Constraints: obs-3
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 | S Σ | 0..* | Reference(US Pathology Observation) | Child observation reference
derivedFrom | S Σ | 0..* | Reference(US Pathology Observation) | Parent observation reference
component | S Σ | 0..* | BackboneElement | Additional entry
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

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
Observation.language | Base | preferred | Common Languages | 📦4.0.1 | FHIR Std.
Observation.status | Base | required | ObservationStatus | 📍4.0.1 | FHIR Std.
Observation.category | Base | preferred | Observation Category Codes | 📦4.0.1 | FHIR Std.
Observation.category:us-core | Base | required | US Core Simple Observation Category | 📦6.1.0 | US Core v6.1
Observation.category:cap-form-category | Base | required | US Pathology Form Category Codes | 📦2.0.0 | This IG
Observation.code | Base | preferred | LOINC Codes | 📦4.0.1 | FHIR Std.
Observation.value[x]:valueQuantity | Base | required | UnitsOfMeasureCaseSensitive | 📍3.0.0 | THO v6.5
Observation.value[x]:valueCodeableConcept | Base | extensible | CAP eCP Answer Codes | 📦2.0.0 | This IG
Observation.dataAbsentReason | Base | extensible | DataAbsentReason | 📦4.0.1 | FHIR Std.
Observation.interpretation | Base | extensible | Observation Interpretation Codes | 📦4.0.1 | FHIR Std.
Observation.bodySite | Base | example | SNOMED CT Body Structures | 📦4.0.1 | FHIR Std.
Observation.method | Base | example | Observation Methods | 📦4.0.1 | FHIR Std.
Observation.referenceRange.​type | Base | preferred | Observation Reference Range Meaning Codes | 📦4.0.1 | FHIR Std.
Observation.referenceRange.​appliesTo | Base | example | Observation Reference Range Applies To Codes | 📦4.0.1 | FHIR Std.
Observation.component.​code | Base | example | LOINC Codes | 📦4.0.1 | FHIR Std.
Observation.component.​dataAbsentReason | Base | extensible | DataAbsentReason | 📦4.0.1 | FHIR Std.
Observation.component.​interpretation | Base | extensible | Observation Interpretation Codes | 📦4.0.1 | FHIR Std.

#### Constraints

Id | Grade | Path(s) | Description | Expression
dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | Observation | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource | `contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()`
dom-4 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated | `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()`
dom-5 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | Observation | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`
obs-3 | error | Observation.referenceRange | Must have at least a low or a high or text | `low.exists() or high.exists() or text.exists()`
obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present | `dataAbsentReason.empty() or value.empty()`
obs-7 | error | Observation | If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present | `value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()`

This structure is derived from USCoreSimpleObservationProfile

Summary

Mandatory: 2 elements
Must-Support: 5 elements

Structures

This structure refers to these other structures:

- US Pathology Observation (http://hl7.org/fhir/us/cancer-reporting/StructureDefinition/us-pathology-observation)

Slices

This structure defines the following Slices:

- The element 1 is sliced based on the value of Observation.value[x]

Maturity: 2

Other representations of profile: CSV, Excel, Schematron