Order Catalog Implementation Guide
current - CI Build International flag

Order Catalog Implementation Guide, published by HL7 International - Orders and Observations Work Group. This is not an authorized publication; it is the continuous build for version current). This version is based on the current content of https://github.com/HL7/fhir-order-catalog/ and changes regularly. See the Directory of published versions

Resource Profile: LabObservationDefinition - Detailed Descriptions

Draft as of 2023-07-08

Definitions for the LabObservationDefinition resource profile.

Guidance on how to interpret the contents of this table can be found here.

1. ObservationDefinition
2. ObservationDefinition.quantitativeDetails
Control0..?
Must Supporttrue
3. ObservationDefinition.quantitativeDetails.unit
Control0..?
Must Supporttrue
4. ObservationDefinition.quantitativeDetails.unit.coding
Control0..?
5. ObservationDefinition.quantitativeDetails.unit.coding.system
Control0..?
Fixed Valuehttp://unitsofmeasure.org
6. ObservationDefinition.code
Control0..?
7. ObservationDefinition.code.coding
Control0..?
SlicingThis element introduces a set of slices on ObservationDefinition.code.coding. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ system
8. ObservationDefinition.code.coding:LOINC
SliceNameLOINC
Control0..1
9. ObservationDefinition.code.coding:LOINC.system
Control0..?
Fixed Valuehttp://loinc.org
10. ObservationDefinition.permittedDataType
Must Supporttrue
11. ObservationDefinition.multipleResultsAllowed
Must Supporttrue

Guidance on how to interpret the contents of this table can be found here.

1. ObservationDefinition
Definition

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

Control0..*
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.

InvariantsDefined on this element
cnl-0: Name should be usable as an identifier for the module by machine processing applications such as code generation (: name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$'))
obd-0: If permittedUnit exists, then permittedDataType=Quantity must exist. (: permittedUnit.exists() implies (permittedDataType = 'Quantity').exists())
2. ObservationDefinition.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Control0..1
Typeuri
Is Modifiertrue
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
3. ObservationDefinition.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

Control0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

4. ObservationDefinition.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
5. ObservationDefinition.status
Definition

The current state of the ObservationDefinition.

Control1..1
BindingThe codes SHALL be taken from PublicationStatus

Codes identifying the state of an ObservationDefinition.

Typecode
Is Modifiertrue
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
6. ObservationDefinition.code
Definition

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

Control1..1
BindingFor example codes, see LOINCCodes

Codes identifying names of simple observations.

TypeCodeableConcept
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
7. ObservationDefinition.permittedDataType
Definition

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

Control0..* This element is affected by the following invariants: obd-0
BindingThe codes SHALL be taken from ObservationDataType

Permitted data type for observation value.

Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summaryfalse
Example
General:CodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
8. ObservationDefinition.multipleResultsAllowed
Definition

Multiple results allowed for observations conforming to this ObservationDefinition.

Control0..1
Typeboolean
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
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.

Example
General:true
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))

Guidance on how to interpret the contents of this table can be found here.

1. ObservationDefinition
Definition

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

Control0..*
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.

2. ObservationDefinition.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

Control0..1
Typeid
Summarytrue
Comments

Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.

3. ObservationDefinition.meta
Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

Control0..1
TypeMeta
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
4. ObservationDefinition.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Control0..1
Typeuri
Is Modifiertrue
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
5. ObservationDefinition.language
Definition

The base language in which the resource is written.

Control0..1
BindingThe codes SHALL be taken from AllLanguages IETF language tag for a human languag
Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Comments

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
6. ObservationDefinition.text
Definition

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

Control0..1 This element is affected by the following invariants: dom-6
TypeNarrative
Summaryfalse
Alternate Namesnarrative, html, xhtml, display
Comments

Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
7. ObservationDefinition.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

Control0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

8. ObservationDefinition.extension
Definition

May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
9. ObservationDefinition.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
10. 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.

Control0..1
Typeuri
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

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

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
11. 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.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
TypeIdentifier
Summarytrue
Requirements

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

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
12. 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.

NoteThis is a business versionId, not a resource version id (see discussion)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Comments

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
13. ObservationDefinition.versionAlgorithm[x]
Definition

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

Control0..1
BindingThe codes SHALL be taken from VersionAlgorithm; other codes may be used where these codes are not suitable
TypeChoice of: string, Coding
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
14. 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.

Control0..1 This element is affected by the following invariants: cnl-0
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Support human navigation and code generation.

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
15. ObservationDefinition.title
Definition

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

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Obligations
Obligations
??
??
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
16. ObservationDefinition.status
Definition

The current state of the ObservationDefinition.

Control1..1
BindingThe codes SHALL be taken from PublicationStatus Codes identifying the state of an ObservationDefinition
Typecode
Is Modifiertrue
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
17. 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.

Control0..1
Typeboolean
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Comments

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

Meaning if MissingIf absent, this resource is treated as though it is not experimental.
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
18. 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.

Control0..1
TypedateTime
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Alternate Namesrevision date
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
19. ObservationDefinition.publisher
Definition

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

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Obligations
Obligations
??
??
Summarytrue
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
20. ObservationDefinition.contact
Definition

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

Control0..*
TypeContactDetail
Summarytrue
Comments

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

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
21. ObservationDefinition.description
Definition

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

Control0..1
Typemarkdown
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Obligations
Obligations
??
??
Summaryfalse
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
22. 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.

Control0..*
TypeUsageContext
Summarytrue
Requirements

Assist in searching for appropriate content.

Comments

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
23. ObservationDefinition.jurisdiction
Definition

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

Control0..*
BindingThe codes SHALL be taken from JurisdictionValueSet; other codes may be used where these codes are not suitable Codes for country, country subdivision and region for indicating where a resource is intended to be used
TypeCodeableConcept
Obligations
Obligations
??
Standards StatusDeprecated (from Trial Use)
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.

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.)

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
24. ObservationDefinition.purpose
Definition

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

Control0..1
Typemarkdown
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Obligations
Obligations
??
??
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
25. 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.

Control0..1
Typemarkdown
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Obligations
Obligations
??
??
Summaryfalse
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
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
26. 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').

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Obligations
Obligations
??
??
Summaryfalse
Requirements

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

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
27. 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.

Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
28. 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.

Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Comments

If specified, this is usually after the approval date.

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
29. ObservationDefinition.effectivePeriod
Definition

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

Control0..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 definition intended to be used for the year 2021 might be published in 2020.

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
30. ObservationDefinition.derivedFromCanonical
Definition

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

Control0..*
Typecanonical(ObservationDefinition)
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
31. 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.

Control0..*
Typeuri
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Observation definitions may be refinements of other definitions.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
32. ObservationDefinition.subject
Definition

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

Control0..*
TypeCodeableConcept
Summarytrue
Comments

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
33. ObservationDefinition.performerType
Definition

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

Control0..1
TypeCodeableConcept
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
34. ObservationDefinition.category
Definition

A code that classifies the general type of observation.

Control0..*
BindingFor example codes, see ObservationCategoryCodes Codes for high level observation categories
TypeCodeableConcept
Summarytrue
Requirements

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

Alternate NamesClass of observation
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
35. ObservationDefinition.code
Definition

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

Control1..1
BindingFor example codes, see LOINCCodes Codes identifying names of simple observations
TypeCodeableConcept
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
36. ObservationDefinition.permittedDataType
Definition

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

Control0..* This element is affected by the following invariants: obd-0
BindingThe codes SHALL be taken from ObservationDataType Permitted data type for observation value
Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summaryfalse
Example
General:CodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
37. ObservationDefinition.multipleResultsAllowed
Definition

Multiple results allowed for observations conforming to this ObservationDefinition.

Control0..1
Typeboolean
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
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.

Example
General:true
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
38. ObservationDefinition.bodySite
Definition

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

Control0..1
BindingFor example codes, see SNOMEDCTBodyStructures SNOMED CT body structures
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|.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
39. ObservationDefinition.method
Definition

The method or technique used to perform the observation.

Control0..1
BindingFor example codes, see ObservationMethods Methods for simple observations
TypeCodeableConcept
Summaryfalse
Requirements

In some cases, method can impact results.

Comments

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
40. ObservationDefinition.specimen
Definition

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

Control0..*
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
41. ObservationDefinition.device
Definition

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

Control0..*
TypeReference(DeviceDefinition|Device)
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
42. ObservationDefinition.preferredReportName
Definition

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

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
43. ObservationDefinition.permittedUnit
Definition

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

Control0..* This element is affected by the following invariants: obd-0
BindingThe codes SHOULD be taken from UCUMCodes Codes identifying units of measure
TypeCoding
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
44. 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.

Control0..*
TypeBackboneElement
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
45. ObservationDefinition.qualifiedValue.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1 This element is affected by the following invariants: ele-1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
46. ObservationDefinition.qualifiedValue.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
47. ObservationDefinition.qualifiedValue.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
48. ObservationDefinition.qualifiedValue.context
Definition

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

Control0..1
BindingThe codes SHALL be taken from ObservationReferenceRangeMeaningCodes; other codes may be used where these codes are not suitable
TypeCodeableConcept
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
49. ObservationDefinition.qualifiedValue.appliesTo
Definition

The target population this set of qualified values applies to.

Control0..*
BindingFor example codes, see ObservationReferenceRangeAppliesToCodes
TypeCodeableConcept
Summaryfalse
Comments

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
50. ObservationDefinition.qualifiedValue.gender
Definition

The gender this set of qualified values applies to.

Control0..1
BindingThe codes SHALL be taken from AdministrativeGender
Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Example
General:female
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
51. ObservationDefinition.qualifiedValue.age
Definition

The age range this set of qualified values applies to.

Control0..1
TypeRange
Summaryfalse
Comments

Some analytes vary greatly over age.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
52. ObservationDefinition.qualifiedValue.gestationalAge
Definition

The gestational age this set of qualified values applies to.

Control0..1
TypeRange
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
53. ObservationDefinition.qualifiedValue.condition
Definition

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

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
54. 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.

Control0..1
BindingThe codes SHALL be taken from ObservationRangeCategory
Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Example
General:critical
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
55. ObservationDefinition.qualifiedValue.range
Definition

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

Control0..1
TypeRange
Summaryfalse
Requirements

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
56. ObservationDefinition.qualifiedValue.validCodedValueSet
Definition

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

Control0..1
Typecanonical(ValueSet)
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
57. ObservationDefinition.qualifiedValue.normalCodedValueSet
Definition

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

Control0..1
Typecanonical(ValueSet)
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
58. ObservationDefinition.qualifiedValue.abnormalCodedValueSet
Definition

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

Control0..1
Typecanonical(ValueSet)
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
59. ObservationDefinition.qualifiedValue.criticalCodedValueSet
Definition

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

Control0..1
Typecanonical(ValueSet)
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
60. 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.

Control0..*
TypeReference(ObservationDefinition|Questionnaire)
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
61. ObservationDefinition.component
Definition

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

Control0..*
TypeBackboneElement
Summaryfalse
Requirements

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
obd-1: If permittedUnit exists, then permittedDataType=Quantity must exist. (: permittedUnit.exists() implies (permittedDataType = 'Quantity').exists())
62. ObservationDefinition.component.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1 This element is affected by the following invariants: ele-1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
63. ObservationDefinition.component.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
64. ObservationDefinition.component.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
65. ObservationDefinition.component.code
Definition

Describes what will be observed.

Control1..1
BindingFor example codes, see LOINCCodes Codes identifying names of simple observations
TypeCodeableConcept
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
66. ObservationDefinition.component.permittedDataType
Definition

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

Control0..* This element is affected by the following invariants: obd-1
BindingThe codes SHALL be taken from ObservationDataType Permitted data type for observation value
Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Example
General:CodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
67. ObservationDefinition.component.permittedUnit
Definition

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

Control0..* This element is affected by the following invariants: obd-1
BindingThe codes SHOULD be taken from UCUMCodes Codes identifying units of measure
TypeCoding
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
68. 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.

Control0..*
TypeSee ttp://hl7.org/fhir/StructureDefinition/ObservationDefinition#ObservationDefinition.qualifiedValue
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))