R6 Ballot (2nd Draft)

Publish-box (todo)

Orders and Observations icon Work GroupMaturity Level: 1 Trial UseSecurity Category: Business Compartments: No defined compartments

Detailed Descriptions for the elements in the ObservationDefinition resource.

ObservationDefinition
Element Id ObservationDefinition
Definition

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

Short Display Definition of an observation
Cardinality 0..*
Type MetadataResource
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.

Summary false
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.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
obd-0Rule If permittedUnit exists, then permittedDataType=Quantity must exist.permittedUnit.exists() implies permittedDataType.exists(value = 'Quantity')
ObservationDefinition.url
Element Id ObservationDefinition.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.

Short Display Logical canonical URL to reference this ObservationDefinition (globally unique)
Cardinality 0..1
Type uri
Requirements

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

Summary true
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 Id ObservationDefinition.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.

Short Display Business identifier of the ObservationDefinition
Note This is a business identifier, not a resource identifier (see discussion)
Cardinality 0..1
Type Identifier
Requirements

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

Summary true
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 Id ObservationDefinition.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.

Short Display Business version of the ObservationDefinition
Note This is a business versionId, not a resource version id (see discussion)
Cardinality 0..1
Type string
Summary true
Comments

There may be multiple different instances of an observationDefinition that have the same identifier but different versions.

ObservationDefinition.versionAlgorithm[x]
Element Id ObservationDefinition.versionAlgorithm[x]
Definition

Indicates the mechanism used to compare versions to determine which is more current.

Short Display How to compare versions
Cardinality 0..1
Terminology Binding Version Algorithm (Extensible)
Type string|Coding
[x] Note See Choice of Datatypes for further information about how to use [x]
Summary true
Comments

If set as a string, this is a FHIRPath expression that has two additional context variables passed in - %version1 and %version2 and will return a negative number if version1 is newer, a positive number if version2 and a 0 if the version ordering can't be successfully be determined.

ObservationDefinition.name
Element Id ObservationDefinition.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.

Short Display Name for this ObservationDefinition (computer friendly)
Cardinality 0..1
Type string
Requirements

Support human navigation and code generation.

Summary true
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.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
ObservationDefinition.title
Element Id ObservationDefinition.title
Definition

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

Short Display Name for this ObservationDefinition (human friendly)
Cardinality 0..1
Type string
Summary true
ObservationDefinition.status
Element Id ObservationDefinition.status
Definition

The current state of the ObservationDefinition.

Short Display draft | active | retired | unknown
Cardinality 1..1
Terminology Binding PublicationStatus (Required)
Type code
Is Modifier true (Reason: Not known why this is labelled a modifier)
Summary true
Comments

A nominal state-transition diagram can be found in the 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.

See guidance around (not) making local changes to elements here.

ObservationDefinition.experimental
Element Id ObservationDefinition.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.

Short Display If for testing purposes, not real usage
Cardinality 0..1
Type boolean
Meaning if Missing If absent, this resource is treated as though it is not experimental.
Summary true
Comments

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

ObservationDefinition.date
Element Id ObservationDefinition.date
Definition

The date (and optionally time) when the ObservationDefinition was last significantly changed. 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.

Short Display Date last changed
Cardinality 0..1
Type dateTime
Alternate Names revision date
Summary true
Comments

The date is often not tracked until the resource is published, but may be present on draft content. 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.

See guidance around (not) making local changes to elements here.

ObservationDefinition.publisher
Element Id ObservationDefinition.publisher
Definition

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

Short Display The name of the individual or organization that published the ObservationDefinition
Cardinality 0..1
Type string
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.

Summary true
ObservationDefinition.contact
Element Id ObservationDefinition.contact
Definition

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

Short Display Contact details for the publisher
Cardinality 0..*
Type ContactDetail
Summary true
Comments

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

See guidance around (not) making local changes to elements here.

ObservationDefinition.description
Element Id ObservationDefinition.description
Definition

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

Short Display Natural language description of the ObservationDefinition
Cardinality 0..1
Type markdown
Summary false
Comments

This description can be used to capture details such as 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 Id ObservationDefinition.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.

Short Display Content intends to support these contexts
Cardinality 0..*
Type UsageContext
Requirements

Assist in searching for appropriate content.

Summary true
Comments

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

ObservationDefinition.jurisdiction
Standards Status This element has a standards status of "Deprecated" which is different from the status of the whole resource
Element Id ObservationDefinition.jurisdiction
Definition

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

Short Display Intended jurisdiction for this ObservationDefinition (if applicable)
Cardinality 0..*
Terminology Binding Jurisdiction ValueSet (Extensible)
Type CodeableConcept
Summary true
Comments

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

DEPRECATION NOTE: For consistency, implementations are encouraged to migrate to using the new 'jurisdiction' code in the useContext element. (I.e. useContext.code indicating http://terminology.hl7.org/CodeSystem/usage-context-type#jurisdiction and useContext.valueCodeableConcept indicating the jurisdiction.)

ObservationDefinition.purpose
Element Id ObservationDefinition.purpose
Definition

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

Short Display Why this ObservationDefinition is defined
Cardinality 0..1
Type markdown
Summary false
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 Id ObservationDefinition.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.

Short Display Use and/or publishing restrictions
Cardinality 0..1
Type markdown
Requirements

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

Alternate Names License; Restrictions
Summary false
ObservationDefinition.copyrightLabel
Element Id ObservationDefinition.copyrightLabel
Definition

A short string (<50 characters), suitable for inclusion in a page footer that identifies the copyright holder, effective period, and optionally whether rights are resctricted. (e.g. 'All rights reserved', 'Some rights reserved').

Short Display Copyright holder and year(s)
Cardinality 0..1
Type string
Requirements

Defines the content expected to be rendered in all representations of the artifact.

Summary false
Comments

The (c) symbol should NOT be included in this string. It will be added by software when rendering the notation. Full details about licensing, restrictions, warrantees, etc. goes in the more general 'copyright' element.

ObservationDefinition.approvalDate
Element Id ObservationDefinition.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.

Short Display When ObservationDefinition was approved by publisher
Cardinality 0..1
Type date
Summary false
Comments

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

See guidance around (not) making local changes to elements here.

ObservationDefinition.lastReviewDate
Element Id ObservationDefinition.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.

Short Display Date on which the asset content was last reviewed by the publisher
Cardinality 0..1
Type date
Summary false
Comments

If specified, this is usually after the approval date.

See guidance around (not) making local changes to elements here.

ObservationDefinition.effectivePeriod
Element Id ObservationDefinition.effectivePeriod
Definition

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

Short Display The effective date range for the ObservationDefinition
Cardinality 0..1
Type Period
Summary true
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 definition intended to be used for the year 2021 might be published in 2020.

See guidance around (not) making local changes to elements here.

ObservationDefinition.derivedFromCanonical
Element Id ObservationDefinition.derivedFromCanonical
Definition

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

Short Display Based on FHIR definition of another observation
Cardinality 0..*
Type canonical(ObservationDefinition)
Summary true
ObservationDefinition.derivedFromUri
Element Id ObservationDefinition.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.

Short Display Based on external definition
Cardinality 0..*
Type uri
Requirements

Observation definitions may be refinements of other definitions.

Summary true
ObservationDefinition.subject
Element Id ObservationDefinition.subject
Definition

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

Short Display Type of subject for the defined observation
Cardinality 0..*
Type CodeableConcept
Summary true
Comments

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

ObservationDefinition.performerType
Element Id ObservationDefinition.performerType
Definition

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

Short Display Desired kind of performer for such kind of observation
Cardinality 0..1
Type CodeableConcept
Summary true
ObservationDefinition.category
Element Id ObservationDefinition.category
Definition

A code that classifies the general type of observation.

Short Display General type of observation
Cardinality 0..*
Terminology Binding Observation Category Codes (Example)
Type CodeableConcept
Requirements

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

Alternate Names Class of observation
Summary true
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 Id ObservationDefinition.code
Definition

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

Short Display Type of observation
Cardinality 1..1
Terminology Binding LOINC Codes (Example)
Type CodeableConcept
Summary true
ObservationDefinition.permittedDataType
Element Id ObservationDefinition.permittedDataType
Definition

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

Short Display Quantity | CodeableConcept | string | boolean | integer | Range | Ratio | SampledData | time | dateTime | Period
Cardinality 0..*
Terminology Binding Observation Data Type (Required)
Type code
Summary false
Invariants
Affect this element
obd-0Rule If permittedUnit exists, then permittedDataType=Quantity must exist.permittedUnit.exists() implies permittedDataType.exists(value = 'Quantity')
ObservationDefinition.multipleResultsAllowed
Element Id ObservationDefinition.multipleResultsAllowed
Definition

Multiple results allowed for observations conforming to this ObservationDefinition.

Short Display Multiple results allowed for conforming observations
Cardinality 0..1
Type boolean
Summary false
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 Id ObservationDefinition.bodySite
Definition

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

Short Display Body part to be observed
Cardinality 0..1
Terminology Binding SNOMED CT Body Structures (Example)
Type CodeableConcept
Summary false
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 Id ObservationDefinition.method
Definition

The method or technique used to perform the observation.

Short Display Method used to produce the observation
Cardinality 0..1
Terminology Binding Observation Methods (Example)
Type CodeableConcept
Requirements

In some cases, method can impact results.

Summary false
Comments

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

ObservationDefinition.specimen
Element Id ObservationDefinition.specimen
Definition

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

Short Display Kind of specimen used by this type of observation
Cardinality 0..*
Type Reference(SpecimenDefinition)
Summary false
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 Id ObservationDefinition.device
Definition

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

Short Display Measurement device or model of device
Cardinality 0..*
Type Reference(DeviceDefinition | Device)
Summary false
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 Id ObservationDefinition.preferredReportName
Definition

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

Short Display The preferred name to be used when reporting the observation results
Cardinality 0..1
Type string
Summary false
ObservationDefinition.permittedUnit
Element Id ObservationDefinition.permittedUnit
Definition

Units allowed for the valueQuantity element in the instance observations conforming to this ObservationDefinition.

Short Display Unit for quantitative results
Cardinality 0..*
Terminology Binding UCUM Codes (Preferred)
Type Coding
Summary false
Invariants
Affect this element
obd-0Rule If permittedUnit exists, then permittedDataType=Quantity must exist.permittedUnit.exists() implies permittedDataType.exists(value = 'Quantity')
ObservationDefinition.qualifiedValue
Element Id ObservationDefinition.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.

Short Display Set of qualified values for observation results
Cardinality 0..*
Summary false
ObservationDefinition.qualifiedValue.context
Element Id ObservationDefinition.qualifiedValue.context
Definition

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

Short Display Context qualifier for the set of qualified values
Cardinality 0..1
Terminology Binding Observation Reference Range Meaning Codes (Extensible)
Type CodeableConcept
Summary false
ObservationDefinition.qualifiedValue.appliesTo
Element Id ObservationDefinition.qualifiedValue.appliesTo
Definition

The target population this set of qualified values applies to.

Short Display Targetted population for the set of qualified values
Cardinality 0..*
Terminology Binding Observation Reference Range Applies To Codes (Example)
Type CodeableConcept
Summary false
Comments

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

ObservationDefinition.qualifiedValue.gender
Element Id ObservationDefinition.qualifiedValue.gender
Definition

The gender this set of qualified values applies to.

Short Display male | female | other | unknown
Cardinality 0..1
Terminology Binding AdministrativeGender (Required)
Type code
Summary false
ObservationDefinition.qualifiedValue.age
Element Id ObservationDefinition.qualifiedValue.age
Definition

The age range this set of qualified values applies to.

Short Display Applicable age range for the set of qualified values
Cardinality 0..1
Type Range
Summary false
Comments

Some analytes vary greatly over age.

ObservationDefinition.qualifiedValue.gestationalAge
Element Id ObservationDefinition.qualifiedValue.gestationalAge
Definition

The gestational age this set of qualified values applies to.

Short Display Applicable gestational age range for the set of qualified values
Cardinality 0..1
Type Range
Summary false
ObservationDefinition.qualifiedValue.condition
Element Id ObservationDefinition.qualifiedValue.condition
Definition

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

Short Display Condition associated with the set of qualified values
Cardinality 0..1
Type string
Summary false
ObservationDefinition.qualifiedValue.rangeCategory
Element Id ObservationDefinition.qualifiedValue.rangeCategory
Definition

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

Short Display reference | critical | absolute
Cardinality 0..1
Terminology Binding Observation Range Category (Required)
Type code
Summary false
ObservationDefinition.qualifiedValue.range
Element Id ObservationDefinition.qualifiedValue.range
Definition

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

Short Display The range for continuous or ordinal observations
Cardinality 0..1
Type Range
Requirements

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

Summary false
ObservationDefinition.qualifiedValue.validCodedValueSet
Element Id ObservationDefinition.qualifiedValue.validCodedValueSet
Definition

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

Short Display Value set of valid coded values as part of this set of qualified values
Cardinality 0..1
Type canonical(ValueSet)
Summary false
ObservationDefinition.qualifiedValue.normalCodedValueSet
Element Id ObservationDefinition.qualifiedValue.normalCodedValueSet
Definition

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

Short Display Value set of normal coded values as part of this set of qualified values
Cardinality 0..1
Type canonical(ValueSet)
Summary false
ObservationDefinition.qualifiedValue.abnormalCodedValueSet
Element Id ObservationDefinition.qualifiedValue.abnormalCodedValueSet
Definition

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

Short Display Value set of abnormal coded values as part of this set of qualified values
Cardinality 0..1
Type canonical(ValueSet)
Summary false
ObservationDefinition.qualifiedValue.criticalCodedValueSet
Element Id ObservationDefinition.qualifiedValue.criticalCodedValueSet
Definition

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

Short Display Value set of critical coded values as part of this set of qualified values
Cardinality 0..1
Type canonical(ValueSet)
Summary false
ObservationDefinition.qualifiedValue.interpretation
Element Id ObservationDefinition.qualifiedValue.interpretation
Definition

The expected coded interpretation values of an observation that matches this qualified interval. For example, high, low, normal.

Short Display Expected coded interpretation values
Cardinality 0..*
Terminology Binding Observation Interpretation Codes (Extensible)
Type CodeableConcept
Summary false
ObservationDefinition.hasMember
Element Id ObservationDefinition.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.

Short Display Definitions of related resources belonging to this kind of observation group
Cardinality 0..*
Type Reference(ObservationDefinition | Questionnaire)
Summary false
ObservationDefinition.component
Element Id ObservationDefinition.component
Definition

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

Short Display Component results
Cardinality 0..*
Requirements

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

Summary false
Invariants
Defined on this element
obd-1Rule If permittedUnit exists, then permittedDataType=Quantity must exist.permittedUnit.exists() implies permittedDataType.exists(value = 'Quantity')
ObservationDefinition.component.code
Element Id ObservationDefinition.component.code
Definition

Describes what will be observed.

Short Display Type of observation
Cardinality 1..1
Terminology Binding LOINC Codes (Example)
Type CodeableConcept
Summary false
ObservationDefinition.component.permittedDataType
Element Id ObservationDefinition.component.permittedDataType
Definition

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

Short Display Quantity | CodeableConcept | string | boolean | integer | Range | Ratio | SampledData | time | dateTime | Period
Cardinality 0..*
Terminology Binding Observation Data Type (Required)
Type code
Summary false
Invariants
Affect this element
obd-1Rule If permittedUnit exists, then permittedDataType=Quantity must exist.permittedUnit.exists() implies permittedDataType.exists(value = 'Quantity')
ObservationDefinition.component.permittedUnit
Element Id ObservationDefinition.component.permittedUnit
Definition

Units allowed for the valueQuantity element in the instance observations conforming to this ObservationDefinition.

Short Display Unit for quantitative results
Cardinality 0..*
Terminology Binding UCUM Codes (Preferred)
Type Coding
Summary false
Invariants
Affect this element
obd-1Rule If permittedUnit exists, then permittedDataType=Quantity must exist.permittedUnit.exists() implies permittedDataType.exists(value = 'Quantity')
ObservationDefinition.component.qualifiedValue
Element Id ObservationDefinition.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.

Short Display Set of qualified values for observation results
Cardinality 0..*
Type See ObservationDefinition.qualifiedValue
Summary false