US Core Implementation Guide
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US Core Implementation Guide, published by HL7 International / Cross-Group Projects. This guide is not an authorized publication; it is the continuous build for version 8.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/US-Core/ and changes regularly. See the Directory of published versions

Resource Profile: US Core Observation Screening Assessment Profile

Official URL: http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-screening-assessment Version: 8.0.0
Standards status: Trial-use Computable Name: USCoreObservationScreeningAssessmentProfile
Other Identifiers: OID:2.16.840.1.113883.4.642.40.2.42.46

Copyright/Legal: Used by permission of HL7 International, all rights reserved Creative Commons License

The US Core Observation Screening Assessment Profile inherits from the FHIR Observation resource; refer to it for scope and usage definitions. This profile meets the requirements of the U.S. Core Data for Interoperability (USCDI) Health Status Assessments Data Class. It sets the minimum expectations for the Observation Resource to record, search, and fetch observations representing the questions and responses to surveys and screening and assessment tools. For example, a social history status such as education or food insecurity or an assessment of cognitive, functional, or disability status. It can represent a single response, multiple responses, and multi-select "check all that apply" type questions. This profile specifies which core elements, extensions, vocabularies, and value sets SHALL be present in the resource and constrains how the elements are used. Providing the floor for standards development for specific use cases promotes interoperability and adoption. Before reviewing this profile, implementers are encouraged to read the Screening and Assessments guidance page, which documents the process of recording responses and capturing assertions/determinations resulting from surveys and questionnaires.

Example Usage Scenarios:

The following are example usage scenarios for this profile:

  • Query for screening or assessment results for a patient.
  • Record or update screening and assessment results belonging to a Patient

Mandatory and Must Support Data Elements

The following data elements must always be present (Mandatory definition) or must be supported if the data is present in the sending system (Must Support definition). They are presented below in a simple human-readable explanation. Profile-specific guidance and examples are provided as well. The Formal Views below provides the formal summary, definitions, and terminology requirements.

  1. a status
  2. a category code of "survey"
  3. a LOINC code, if available, which tells you the survey question
  4. a patient

Each Observation Must Support:

  1. additional categories that further specify the assessment or screening*
  2. a time indicating when the survey was taken
  3. the answer or a reason why the data is absent*
    • if the result value is a numeric quantity and coded quantity units are used, UCUM is required.
  4. who answered the questions (in other words, a performer)*
  5. related questionnaire responses or observations that this observation is made from
  6. reference to observations that make up this observation*

* see guidance below

Profile Specific Implementation Guidance:

  • *See the Screening and Assessments guidance page for how this profile represents surveys, screenings, and assessments.
    • Each response to individual questions and each answer to a multi-select or "check all that apply" question is a separate US Core Screening and Assessments Observation. The question is communicated in Observation.code, and the answer is in Observation.value.
    • Multi-question screenings and assessments use the US Core Screening and Assessments Observation to represent a "panel" or grouping. The multi-question surveys or assessments Observation.code is an overarching assessment or screening code, and the Observation.value element SHOULD be empty. Observation.hasMember references US Core Screening and Assessments Observations that represent the responses to each question in the screening or assessment.

  • A practitioner's clinical observation or assertion about a patient's health status, which is not a response to a screening or assessment question, SHOULD use the US Core Simple Observation Profile instead.

  • *The category type "survey" is required, and, at a minimum, Servers SHALL support, the US Core Screening Assessment Observation Category codes, SHOULD support the other US Core Screening Assessment Observation Maximum Category codes, and MAY support other categories.

    • The Observation.category element provides an efficient way of restricting search on observations to a given context such as survey observations. Example searches are shown in the Quick Start section below. However, Clients need to understand that data categorization is somewhat subjective. The categorization applied by the source may not align with the Client's expectations. Clients may find it more useful to use queries based on a specific code or set of codes or to perform additional Client-side filtering of query results.
  • *An Observation without a value, SHALL include a reason why the data is absent unless there are 1) component observations, or 2) reporting panel observations using Observation.hasMember.
    • For further guidance, see the Observation Grouping section in FHIR Specification.
    • Systems that never provide an observation without a value are not required to support Observation.dataAbsentReason.
  • *An Observation.component without a value, SHALL include a reason why the data is absent.
    • Systems that never provide a component observation without a component value are not required to support Observation.component.dataAbsentReason.
  • *Although 'Observation.performer' target profiles US Core Practitioner Profile and US Core Patient Profile are labeled Must Support. Servers are not required to support both, but SHALL support at least one. Clients SHALL support both.
  • *Although 'Observation.derivedFrom' target profiles Observation and US Core QuestionnaireResponse Profile are labeled Must Support. The certifying Server system is not required to support both, but SHALL support at least one. The Client application SHALL support both.

Usage:

Changes since version 7.0.0:

  • The data elements list has changed
  • One or more text definitions, invariants or bindings have changed

    • Formal Views of Profile Content

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

    NameFlagsCard.TypeDescription & Constraintsdoco
    .. Observation C 0..* Observation Survey Observation
    dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
    dom-3: 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
    dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
    dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
    dom-6: A resource should have narrative for robust management
    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
    ele-1: All FHIR elements must have a @value or children
    ... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
    ele-1: All FHIR elements must have a @value or children
    ext-1: Must have either extensions or value[x], not both
    ... status ?!SΣ 1..1 code registered | preliminary | final | amended +
    Binding: ObservationStatus (required): Codes providing the status of an observation.


    ele-1: All FHIR elements must have a @value or children
    ... Slices for category S 1..* CodeableConcept Classification of type of observation
    Slice: Unordered, Open by value:$this
    Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


    ele-1: All FHIR elements must have a @value or children
    .... category:survey S 1..1 CodeableConcept Classification of type of observation
    Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


    ele-1: All FHIR elements must have a @value or children

    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: survey
    .... category:screening-assessment S 0..* CodeableConcept Classification of type of observation
    Binding: US Core Screening Assessment Observation Maximum Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets

    Additional BindingsPurpose
    US Core Screening Assessment Observation Category Min Binding

    ele-1: All FHIR elements must have a @value or children
    ... code SΣ 1..1 CodeableConcept Type of observation (code / type)
    Binding: Screening and Assesment Survey Codes . (preferred)
    ele-1: All FHIR elements must have a @value or children
    ... subject SΣ 1..1 Reference(US Core Patient Profile) Who and/or what the observation is about
    ele-1: All FHIR elements must have a @value or children
    ... effective[x] SΣC 0..1 Clinically relevant time/time-period for observation
    ele-1: All FHIR elements must have a @value or children
    us-core-1: Datetime must be at least to day.
    .... effectiveDateTime dateTime
    ... performer SΣ 0..* Reference(US Core Practitioner Profile | US Core Patient Profile) Who is responsible for the observation
    ele-1: All FHIR elements must have a @value or children
    ... value[x] SΣC 0..1 Actual result
    ele-1: All FHIR elements must have a @value or children
    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): Codes specifying why the result (Observation.value[x]) is missing.


    ele-1: All FHIR elements must have a @value or children
    ... hasMember SΣ 0..* Reference(US Core Observation Screening Assessment Profile) Reference to panel members or multi-select responses or multi-select responses
    ele-1: All FHIR elements must have a @value or children
    ... derivedFrom SΣ 0..* Reference(US Core Observation Screening Assessment Profile | US Core QuestionnaireResponse Profile) Related measurements the observation is made from
    ele-1: All FHIR elements must have a @value or children

    doco Documentation for this format

    Terminology Bindings

    PathConformanceValueSet / CodeURI
    Observation.statusrequiredObservationStatus
    http://hl7.org/fhir/ValueSet/observation-status|4.0.1
    from the FHIR Standard
    Observation.categorypreferredObservationCategoryCodes
    http://hl7.org/fhir/ValueSet/observation-category
    from the FHIR Standard
    Observation.category:surveypreferredPattern: survey
    http://hl7.org/fhir/ValueSet/observation-category
    from the FHIR Standard
    Observation.category:screening-assessmentrequiredUSCoreScreeningAssessmentObservationMaximumCategory
    http://hl7.org/fhir/us/core/ValueSet/us-core-screening-assessment-observation-maximum-category
    from this IG
    Additional Bindings Purpose
    US Core Screening Assessment Observation Category Min Binding
    Observation.codepreferredScreeningAndAssesmentSurveyCodes .
    http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1267.13
    Observation.dataAbsentReasonextensibleDataAbsentReason
    http://hl7.org/fhir/ValueSet/data-absent-reason
    from the FHIR Standard

    Constraints

    IdGradePath(s)DetailsRequirements
    us-core-1errorObservation.effective[x]Datetime must be at least to day.
    : $this is dateTime implies $this.toString().length() >= 10
    us-core-2errorObservationIf there is no component or hasMember element then either a value[x] or a data absent reason must be present
    : (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists())
    us-core-3errorObservation.value[x]SHALL use UCUM for coded quantity units.
    : ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org'

     

    Other representations of profile: CSV, Excel, Schematron

    Notes:

    Quick Start

    Below is an overview of the required Server RESTful FHIR interactions for this profile - for example, search and read operations - when supporting the US Core interactions to access this profile's information (Profile Support + Interaction Support). Note that systems that support only US Core Profiles (Profile Only Support) are not required to support these interactions. See the US Core Server CapabilityStatement for a complete list of supported RESTful interactions for this IG.

    • See the Scopes Format section for a description of the SMART scopes syntax.
    • See the Search Syntax section for a description of the US Core search syntax.
    • See the General Requirements section for additional rules and expectations when a Server requires status parameters.
    • See the General Guidance section for additional guidance on searching for multiple patients.

    US Core Scopes

    Servers providing access to assessment data SHALL support these US Core SMART Scopes:

    • resource level scopes: <patient|user|system>/Observation.rs

    • granular scopes: <patient|user|system>/Observation.rs?category=http://terminology.hl7.org/CodeSystem/observation-category|survey

    • granular scopes: <patient|user|system>/Observation.rs?category=http://hl7.org/fhir/us/core/CodeSystem/us-core-category|sdoh

    Mandatory Search Parameters:

    The following search parameters and search parameter combinations SHALL be supported:

    1. SHALL support searching using the combination of the patient and category search parameters:

      GET [base]/Observation?patient={Type/}[id]&category=http://terminology.hl7.org/CodeSystem/observation-category|laboratory

      Example:

      1. GET [base]/Observation?patient=1134281&amp;category=survey

      Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and a category code = laboratory (how to search by reference and how to search by token)

    2. SHALL support searching using the combination of the patient and code search parameters:
      • including optional support for OR search on code (e.g.code={system|}[code],{system|}[code],...)

      GET [base]/Observation?patient={Type/}[id]&code={system|}[code]{,{system|}[code],...}

      Example:

      1. GET [base]/Observation?patient=1134281&amp;code=http://loinc.org|9271-8
      2. GET [base]/Observation?patient=1134281&amp;code=http://loinc.org|9271-8,http://loinc.org|32405-3,http://loinc.org|32403-8

      Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and observation code(s). SHOULD support search by multiple report codes. The Observation code parameter searches `Observation.code only. (how to search by reference and how to search by token)

    3. SHALL support searching using the combination of the patient and category and date search parameters:
      • including support for these date comparators: gt,lt,ge,le
      • including optional support for AND search on date (e.g.date=[date]&date=[date]]&...)

      GET [base]/Observation?patient={Type/}[id]&category=http://terminology.hl7.org/CodeSystem/observation-category|laboratory&date={gt|lt|ge|le}[date]{&date={gt|lt|ge|le}[date]&...}

      Example:

      1. GET [base]Observation?patient=555580&category=survey&date=ge2018-03-14T00:00:00Z

      Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and date and a category code = laboratory (how to search by reference and how to search by token and how to search by date)

    Optional Search Parameters:

    The following search parameter combinations SHOULD be supported:

    1. SHOULD support searching using the combination of the patient and category and status search parameters:
      • including support for OR search on status (e.g.status={system|}[code],{system|}[code],...)

      GET [base]/Observation?patient={Type/}[id]&category=http://terminology.hl7.org/CodeSystem/observation-category|laboratory&status={system|}[code]{,{system|}[code],...}

      Example:

      1. GET [base]/Observation?patient=1134281&category=survey&status=final

      Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and category = laboratory and status (how to search by reference and how to search by token)

    2. SHOULD support searching using the combination of the patient and category and _lastUpdated search parameters:
      • including support for these _lastUpdated comparators: gt,lt,ge,le
      • including optional support for AND search on _lastUpdated (e.g._lastUpdated=[date]&_lastUpdated=[date]]&...)

      GET [base]/Observation?patient={Type/}[id]&category={system|}[code]&_lastUpdated={gt|lt|ge|le}[date]{&_lastUpdated={gt|lt|ge|le}[date]&...}

      Example:

      1. GET [base]Observation?patient=555580&survey&_lastUpdated=ge2024-01-01T00:00:00Z

      Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and category and _lastUpdated. See the US Core General Guidance page for Searching Using lastUpdated. (how to search by reference and how to search by token and how to search by date)

    3. SHOULD support searching using the combination of the patient and code and date search parameters:
      • including optional support for OR search on code (e.g.code={system|}[code],{system|}[code],...)
      • including support for these date comparators: gt,lt,ge,le
      • including optional support for AND search on date (e.g.date=[date]&date=[date]]&...)

      GET [base]/Observation?patient={Type/}[id]&code={system|}[code]{,{system|}[code],...}&date={gt|lt|ge|le}[date]{&date={gt|lt|ge|le}[date]&...}

      Example:

      1. GET [base]Observation?patient=555580&code=http://loinc.org|9271-8&date=ge2019-01-01T00:00:00Z

      Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and date and report code(s). SHOULD support search by multiple report codes. (how to search by reference and how to search by token and how to search by date)