Release 5 Draft Ballot

This page is part of the FHIR Specification (v4.6.0: R5 Draft Ballot - see ballot notes). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4

Orders and Observations Work GroupMaturity Level: 1 Trial UseSecurity Category: Business Compartments: Not linked to any defined compartments

Detailed Descriptions for the elements in the ObservationDefinition resource.

ObservationDefinition
Element IdObservationDefinition
Definition

Set of definitional characteristics for a kind of observation or measurement produced or consumed by an orderable health care service.

Cardinality0..*
TypeDomainResource
Requirements

In a catalog of health-related services that use or produce observations and measurements, this resource describes the expected characteristics of these observation / measurements.

Summaryfalse
Comments

An instance of this resource informs the consumer of a health-related service (such as a lab diagnostic test or panel) about how the observations used or produced by this service will look like.

Invariants
Defined on this element
cnl-0Warning Name should be usable as an identifier for the module by machine processing applications such as code generationname.matches('[A-Z]([A-Za-z0-9_]){0,254}')
ObservationDefinition.url
Element IdObservationDefinition.url
Definition

An absolute URL that is used to identify this ObservationDefinition when it is referenced in a specification, model, design or an instance. This SHALL be a URL, SHOULD be globally unique, and SHOULD be an address at which this ObservationDefinition is (or will be) published. The URL SHOULD include the major version of the ObservationDefinition. For more information see Technical and Business Versions.

Cardinality0..1
Typeuri
Requirements

Allows the ObservationDefinition to be referenced by a single globally unique identifier.

Summarytrue
Comments

Can be a urn:uuid: or a urn:oid:, but real http: addresses are preferred. This is the URI that will be used when making canonical references to this resource.

ObservationDefinition.identifier
Element IdObservationDefinition.identifier
Definition

Business identifiers assigned to this ObservationDefinition. by the performer and/or other systems. These identifiers remain constant as the resource is updated and propagates from server to server.

NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..1
TypeIdentifier
Requirements

Allows identification of the ObservationDefinition as it is known by various participating systems and in a way that remains consistent across servers.

Summarytrue
Comments

This is a business identifier, not a resource identifier. It is best practice for the identifier to only appear on a single resource instance, however business practices may occasionally dictate that multiple resource instances with the same identifier can exist - possibly even with different resource types.

ObservationDefinition.version
Element IdObservationDefinition.version
Definition

The identifier that is used to identify this version of the ObservationDefinition when it is referenced in a specification, model, design or instance. This is an arbitrary value managed by the ObservationDefinition author and is not expected to be globally unique. For example, it might be a timestamp (e.g. yyyymmdd) if a managed version is not available. There is also no expectation that versions are orderable.

NoteThis is a business versionId, not a resource version id (see discussion)
Cardinality0..1
Typestring
Summarytrue
Comments

There may be multiple different instances of a ObservationDefinition that have the same identifier but different versions.

ObservationDefinition.name
Element IdObservationDefinition.name
Definition

A natural language name identifying the ObservationDefinition. This name should be usable as an identifier for the module by machine processing applications such as code generation.

Cardinality0..1
Typestring
Requirements

Support human navigation and code generation.

Summarytrue
Comments

The name is not expected to be globally unique. The name should be a simple alphanumeric type name to ensure that it is machine-processing friendly.

Invariants
Affect this element
cnl-0Warning Name should be usable as an identifier for the module by machine processing applications such as code generationname.matches('[A-Z]([A-Za-z0-9_]){0,254}')
ObservationDefinition.title
Element IdObservationDefinition.title
Definition

A short, descriptive, user-friendly title for the ObservationDefinition.

Cardinality0..1
Typestring
Summarytrue
ObservationDefinition.status
Element IdObservationDefinition.status
Definition

The current state of the ObservationDefinition.

Cardinality1..1
Terminology BindingPublicationStatus (Required)
Typecode
Is Modifiertrue (Reason: Not known why this is labelled a modifier)
Summarytrue
Comments

A nominal state-transition diagram can be found in the [[definition.html#statemachine | Definition pattern]] documentation Unknown does not represent "other" - one of the defined statuses must apply. Unknown is used when the authoring system is not sure what the current status is.

ObservationDefinition.experimental
Element IdObservationDefinition.experimental
Definition

A flag to indicate that this ObservationDefinition is authored for testing purposes (or education/evaluation/marketing), and is not intended to be used for genuine usage.

Cardinality0..1
Typeboolean
Is Modifiertrue (Reason: Not known why this is labelled a modifier)
Summarytrue
Comments

Allows filtering of ObservationDefinition that are appropriate for use vs. not.

ObservationDefinition.date
Element IdObservationDefinition.date
Definition

The date (and optionally time) when the ObservationDefinition was published. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the ObservationDefinition changes.

Cardinality0..1
TypedateTime
Alternate Namesrevision date
Summarytrue
Comments

Note that this is not the same as the resource last-modified-date, since the resource may be a secondary representation of the ObservationDefinition. Additional specific dates may be added as extensions or be found by consulting Provenances associated with past versions of the resource.

ObservationDefinition.publisher
Element IdObservationDefinition.publisher
Definition

Helps establish the "authority/credibility" of the ObservationDefinition. May also allow for contact.

Cardinality0..1
TypeReference(Practitioner | PractitionerRole | Organization)
PatternsReference(Practitioner,PractitionerRole,Organization): Common patterns = Participant
Requirements

Usually an organization, but may be an individual. The publisher (or steward) of the ObservationDefinition is the organization or individual primarily responsible for the maintenance and upkeep of the ObservationDefinition. This is not necessarily the same individual or organization that developed and initially authored the content. The publisher is the primary point of contact for questions or issues with the ObservationDefinition. This item SHOULD be populated unless the information is available from context.

Summarytrue
ObservationDefinition.contact
Element IdObservationDefinition.contact
Definition

Contact details to assist a user in finding and communicating with the publisher.

Cardinality0..*
TypeContactDetail
Summarytrue
Comments

May be a web site, an email address, a telephone number, etc.

ObservationDefinition.description
Element IdObservationDefinition.description
Definition

A free text natural language description of the ObservationDefinition from the consumer's perspective.

Cardinality0..1
Typemarkdown
Summaryfalse
Comments

This description can be used to capture details such as why the ObservationDefinition was built, comments about misuse, instructions for clinical use and interpretation, literature references, examples from the paper world, etc. It is not a rendering of the module as conveyed in the text field of the resource itself. This item SHOULD be populated unless the information is available from context.

ObservationDefinition.useContext
Element IdObservationDefinition.useContext
Definition

The content was developed with a focus and intent of supporting the contexts that are listed. These contexts may be general categories (gender, age, ...) or may be references to specific programs (insurance plans, studies, ...) and may be used to assist with indexing and searching for appropriate ObservationDefinition instances.

Cardinality0..*
TypeUsageContext
Requirements

Assist in searching for appropriate content.

Summarytrue
Comments

When multiple usageContexts are specified, there is no expectation for whether all or any of the contexts apply.

ObservationDefinition.jurisdiction
Element IdObservationDefinition.jurisdiction
Definition

A jurisdiction in which the ObservationDefinition is intended to be used.

Cardinality0..*
Terminology BindingJurisdiction (Extensible)
TypeCodeableConcept
Summarytrue
Comments

It may be possible for the ObservationDefinition to be used in jurisdictions other than those for which it was originally designed or intended.

ObservationDefinition.purpose
Element IdObservationDefinition.purpose
Definition

Explains why this ObservationDefinition is needed and why it has been designed as it has.

Cardinality0..1
Typemarkdown
Summaryfalse
Comments

This element does not describe the usage of the ObservationDefinition. Rather it is for traceability of ''why'' the resource is either needed or ''why'' it is defined as it is. This may be used to point to source materials or specifications that drove the structure of this ObservationDefinition.

ObservationDefinition.copyright
Element IdObservationDefinition.copyright
Definition

Copyright statement relating to the ObservationDefinition and/or its contents. Copyright statements are generally legal restrictions on the use and publishing of the ObservationDefinition.

Cardinality0..1
Typemarkdown
Requirements

Consumers of the ObservationDefinition must be able to determine any legal restrictions on the use of the artifact and/or its content.

Alternate NamesLicense; Restrictions
Summaryfalse
ObservationDefinition.approvalDate
Element IdObservationDefinition.approvalDate
Definition

The date on which the asset content was approved by the publisher. Approval happens once when the content is officially approved for usage.

Cardinality0..1
Typedate
Summaryfalse
Comments

The date may be more recent than the approval date because of minor changes / editorial corrections.

ObservationDefinition.lastReviewDate
Element IdObservationDefinition.lastReviewDate
Definition

The date on which the asset content was last reviewed. Review happens periodically after that, but doesn't change the original approval date.

Cardinality0..1
Typedate
Summaryfalse
Comments

If specified, this is usually after the approval date.

ObservationDefinition.effectivePeriod
Element IdObservationDefinition.effectivePeriod
Definition

The period during which the ObservationDefinition content was or is planned to be effective.

Cardinality0..1
TypePeriod
Summarytrue
Comments

The effective period for an ObservationDefinition determines when the content is applicable for usage and is independent of publication and review dates. For example, an observation intended to be used for the year 2021 might be published in 2020.

ObservationDefinition.derivedFromCanonical
Element IdObservationDefinition.derivedFromCanonical
Definition

The canonical URL pointing to another FHIR-defined ObservationDefinition that is adhered to in whole or in part by this definition.

Cardinality0..*
Typecanonical(ObservationDefinition)
Summarytrue
ObservationDefinition.derivedFromUri
Element IdObservationDefinition.derivedFromUri
Definition

The URL pointing to an externally-defined observation definition, guideline or other definition that is adhered to in whole or in part by this definition.

Cardinality0..*
Typeuri
Requirements

Observation definitions may be refinements of other definitions.

Summarytrue
ObservationDefinition.subject
Element IdObservationDefinition.subject
Definition

A code that describes the intended kind of subject of Observation instances conforming to this ObservationDefinition.

Cardinality0..1
TypeCodeableConcept
Summarytrue
Comments

Examples: person, animal, device, air, surface ….

ObservationDefinition.performerType
Element IdObservationDefinition.performerType
Definition

The type of individual/organization/device that is expected to act upon instances of this definition.

Cardinality0..1
TypeCodeableConcept
Summarytrue
ObservationDefinition.category
Element IdObservationDefinition.category
Definition

A code that classifies the general type of observation.

Cardinality0..*
Terminology BindingObservation Category Codes (Example)
TypeCodeableConcept
Requirements

Used for filtering what kinds of observations are retrieved and displayed.

Alternate NamesClass of observation
Summarytrue
Comments

This element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used for one instance of ObservationDefinition. The level of granularity is defined by the category concepts in the value set.

ObservationDefinition.code
Element IdObservationDefinition.code
Definition

Describes what will be observed. Sometimes this is called the observation "name".

Cardinality1..1
Terminology BindingLOINC Codes (Example)
TypeCodeableConcept
Summarytrue
ObservationDefinition.permittedDataType
Element IdObservationDefinition.permittedDataType
Definition

The data types allowed for the value element of the instance observations conforming to this ObservationDefinition.

Cardinality0..*
Terminology BindingObservationDataType (Required)
Typecode
Summaryfalse
ObservationDefinition.multipleResultsAllowed
Element IdObservationDefinition.multipleResultsAllowed
Definition

Multiple results allowed for observations conforming to this ObservationDefinition.

Cardinality0..1
Typeboolean
Summaryfalse
Comments

An example of observation allowing multiple results is "bacteria identified by culture". Conversely, the measurement of a potassium level allows a single result.

ObservationDefinition.bodySite
Element IdObservationDefinition.bodySite
Definition

The site on the subject's body where the observation is to be made.

Cardinality0..1
Terminology BindingSNOMED CT Body Structures (Example)
TypeCodeableConcept
Summaryfalse
Comments

Only used if the defined observation is to be made directly on a body part and if this body part is not implied by code found in ObservationDefinition.code. Not used for in vitro diagnostic observations. Example: 14975008 |Forearm structure|.

ObservationDefinition.method
Element IdObservationDefinition.method
Definition

The method or technique used to perform the observation.

Cardinality0..1
Terminology BindingObservation Methods (Example)
TypeCodeableConcept
Requirements

In some cases, method can impact results.

Summaryfalse
Comments

Only used if not implicit in observation code Example: 702659008 |Automated count technique|.

ObservationDefinition.specimen
Element IdObservationDefinition.specimen
Definition

The kind of specimen that this type of observation is produced on.

Cardinality0..*
TypeReference(SpecimenDefinition)
Summaryfalse
Comments

Only used for in vitro observations. When multiple occurrences of specimen are present, they are to be combined with a logical AND: all specified specimens are needed for the observation.

ObservationDefinition.device
Element IdObservationDefinition.device
Definition

The measurement model of device or actual device used to produce observations of this type.

Cardinality0..*
TypeReference(DeviceDefinition | Device)
PatternsReference(DeviceDefinition,Device): No common pattern
Summaryfalse
Comments

When multiple occurrences of device are present, they are to be combined with a logical OR: at least one of the specified devices is used to produce the observation.

ObservationDefinition.preferredReportName
Element IdObservationDefinition.preferredReportName
Definition

The preferred name to be used when reporting the results of observations conforming to this ObservationDefinition.

Cardinality0..1
Typestring
Summaryfalse
ObservationDefinition.quantitativeDetails
Element IdObservationDefinition.quantitativeDetails
Definition

Characteristics for quantitative results of observations conforming to this ObservationDefinition.

Cardinality0..1
Summaryfalse
ObservationDefinition.quantitativeDetails.unit
Element IdObservationDefinition.quantitativeDetails.unit
Definition

Primary unit used to report quantitative results of observations conforming to this ObservationDefinition.

Cardinality0..1
Terminology BindingUCUM Codes (Extensible)
TypeCodeableConcept
Summaryfalse
ObservationDefinition.quantitativeDetails.customaryUnit
Element IdObservationDefinition.quantitativeDetails.customaryUnit
Definition

Secondary unit used to report quantitative results of observations conforming to this ObservationDefinition.

Cardinality0..1
Terminology BindingUCUM Codes (Extensible)
TypeCodeableConcept
Summaryfalse
ObservationDefinition.quantitativeDetails.conversionFactor
Element IdObservationDefinition.quantitativeDetails.conversionFactor
Definition

Factor for converting value expressed with primary unit to value expressed with secondary unit.

Cardinality0..1
Typedecimal
Summaryfalse
ObservationDefinition.quantitativeDetails.decimalPrecision
Element IdObservationDefinition.quantitativeDetails.decimalPrecision
Definition

Number of digits after decimal separator when the results of such observations are of type Quantity.

Cardinality0..1
Typeinteger
Summaryfalse
ObservationDefinition.qualifiedValue
Element IdObservationDefinition.qualifiedValue
Definition

A set of qualified values associated with a context and a set of conditions - provides a range for quantitative and ordinal observations and a collection of value sets for qualitative observations.

Cardinality0..*
Summaryfalse
ObservationDefinition.qualifiedValue.context
Element IdObservationDefinition.qualifiedValue.context
Definition

A concept defining the context for this set of qualified values.

Cardinality0..1
Terminology BindingObservation Reference Range Meaning Codes (Extensible)
TypeCodeableConcept
Summaryfalse
ObservationDefinition.qualifiedValue.appliesTo
Element IdObservationDefinition.qualifiedValue.appliesTo
Definition

The target population this set of qualified values applies to.

Cardinality0..*
Terminology BindingObservation Reference Range Applies To Codes (Example)
TypeCodeableConcept
Summaryfalse
Comments

If this element is not present then the global population is assumed.

ObservationDefinition.qualifiedValue.gender
Element IdObservationDefinition.qualifiedValue.gender
Definition

The gender this set of qualified values applies to.

Cardinality0..1
Terminology BindingAdministrativeGender (Required)
Typecode
Summaryfalse
ObservationDefinition.qualifiedValue.age
Element IdObservationDefinition.qualifiedValue.age
Definition

The age range this set of qualified values applies to.

Cardinality0..1
TypeRange
Summaryfalse
Comments

Some analytes vary greatly over age.

ObservationDefinition.qualifiedValue.gestationalAge
Element IdObservationDefinition.qualifiedValue.gestationalAge
Definition

The gestational age this set of qualified values applies to.

Cardinality0..1
TypeRange
Summaryfalse
ObservationDefinition.qualifiedValue.condition
Element IdObservationDefinition.qualifiedValue.condition
Definition

Text based condition for which the the set of qualified values is valid.

Cardinality0..1
Typestring
Summaryfalse
ObservationDefinition.qualifiedValue.rangeCategory
Element IdObservationDefinition.qualifiedValue.rangeCategory
Definition

The category of range of values for continuous or ordinal observations that match the criteria of this set of qualified values.

Cardinality0..1
Terminology BindingObservationRangeCategory (Required)
Typecode
Summaryfalse
ObservationDefinition.qualifiedValue.range
Element IdObservationDefinition.qualifiedValue.range
Definition

The range of values defined for continuous or ordinal observations that match the criteria of this set of qualified values.

Cardinality0..1
TypeRange
Requirements

The unit may be not relevant for ordinal values. In case it is there, it is the same as quantitativeDetails.unit.

Summaryfalse
ObservationDefinition.qualifiedValue.validCodedValueSet
Element IdObservationDefinition.qualifiedValue.validCodedValueSet
Definition

The set of valid coded results for qualitative observations that match the criteria of this set of qualified values.

Cardinality0..1
Typecanonical(ValueSet)
Summaryfalse
ObservationDefinition.qualifiedValue.normalCodedValueSet
Element IdObservationDefinition.qualifiedValue.normalCodedValueSet
Definition

The set of normal coded results for qualitative observations that match the criteria of this set of qualified values.

Cardinality0..1
Typecanonical(ValueSet)
Summaryfalse
ObservationDefinition.qualifiedValue.abnormalCodedValueSet
Element IdObservationDefinition.qualifiedValue.abnormalCodedValueSet
Definition

The set of abnormal coded results for qualitative observations that match the criteria of this set of qualified values.

Cardinality0..1
Typecanonical(ValueSet)
Summaryfalse
ObservationDefinition.qualifiedValue.criticalCodedValueSet
Element IdObservationDefinition.qualifiedValue.criticalCodedValueSet
Definition

The set of critical coded results for qualitative observations that match the criteria of this set of qualified values.

Cardinality0..1
Typecanonical(ValueSet)
Summaryfalse
ObservationDefinition.hasMember
Element IdObservationDefinition.hasMember
Definition

This ObservationDefinition defines a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group.

Cardinality0..*
TypeReference(ObservationDefinition | Questionnaire)
PatternsReference(ObservationDefinition,Questionnaire): No common pattern
Summaryfalse
ObservationDefinition.component
Element IdObservationDefinition.component
Definition

Some observations have multiple component observations, expressed as separate code value pairs.

Cardinality0..*
Requirements

Component observations share the same attributes as the primary observation and are always treated as a part of it (they are not separable).

Summaryfalse
ObservationDefinition.component.code
Element IdObservationDefinition.component.code
Definition

Describes what will be observed.

Cardinality1..1
Terminology BindingLOINC Codes (Example)
TypeCodeableConcept
Summaryfalse
ObservationDefinition.component.permittedDataType
Element IdObservationDefinition.component.permittedDataType
Definition

The data types allowed for the value element of the instance of this component observations.

Cardinality0..*
Terminology BindingObservationDataType (Required)
Typecode
Summaryfalse
ObservationDefinition.component.quantitativeDetails
Element IdObservationDefinition.component.quantitativeDetails
Definition

Characteristics for quantitative results of this observation.

Cardinality0..1
TypeSee ObservationDefinition.quantitativeDetails
Summaryfalse
ObservationDefinition.component.qualifiedValue
Element IdObservationDefinition.component.qualifiedValue
Definition

A set of qualified values associated with a context and a set of conditions - provides a range for quantitative and ordinal observations and a collection of value sets for qualitative observations.

Cardinality0..*
TypeSee ObservationDefinition.qualifiedValue
Summaryfalse