Example Usage Scenarios:

The following are example usage scenarios for this profile:

• Query for clinical observations or assessments about a patient's health status.
• Record or update clinical observations or assessments about a patient's health status.

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.

Each Observation Must Have:

1. a status
2. a category code*
3. a code
4. a patient

Each Observation Must Support:

1. a time indicating when the observation was made
2. who answered the questions (in other words, a performer)*
3. a value

Additional USCDI Requirements:

This Additional USCDI Requirements element is not Mandatory or Must Support but is required for ONC Health IT certification testing and is included in the formal definition of the profile and the Observation examples.

1. a screening and assessments category code*
2. references to an associated survey, assessment, or screening tool*

*see guidance below

Profile Specific Implementation Guidance:

• The codes can be from LOINC or SNOMED CT.
• The value for these types of observations may be:
  • a string
  • a code
  • a "qualifier" confirming or refuting a statement about findings in code. For example: code: Transport too expensive (SNOMED CT: 160695008)
    value: true

• *At a minimum, Certifying Systems SHALL support, the US Core Screening Assessment Observation Category codes, SHOULD support the other US Core Simple Observation 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 sdoh, functional-status, or social history 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.
• See the Screening and Assessments guidance page for how this profile can represent "clinical judgments".
  • *Observations formally part of an assessment tool or survey SHOULD use the US Core Observation Screening Assessment Profile. However, an assertion or determination derived from screening and assessment tools SHOULD reference them using Observation.derivedFrom.
• *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 none of the Observation.derivedFrom referenced target profiles are flagged as Must Support, Certifying System SHALL support at least one of them. Client Applications SHALL support all.
  • As documented here, when using Observation.derivedFrom to reference an Observation, the referenced Observation SHOULD be a US Core Observation.

Changes since version 7.0.0:

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://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&category=social-history

   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&code=http://loinc.org|

   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=social-history&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=social-history&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&social-history&_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|&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)