WHO Digital Documentation of COVID-19 Certificates (DDCC)
1.0.1 - release International flag

This page is part of the WHO Digital Documentation of COVID-19 Certificates (DDCC) (v1.0.1: releases Draft) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, see the Directory of published versions

Resource Profile: DDCCDiagnosticReport - Detailed Descriptions

Active as of 2024-12-18

Definitions for the DDCCDiagnosticReport resource profile.

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

0. DiagnosticReport
2. DiagnosticReport.code
BindingThe codes SHALL be taken from WHO Type of Covid-19 Test
(required to http://smart.who.int/ddcc/ValueSet/WHODDCCTypeofTestCOVID19)
4. DiagnosticReport.effective[x]
TypedateTime, Period
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
6. DiagnosticReport.specimen
Control1..1
TypeReference(DDCC Specimen)
Must Supporttrue
8. DiagnosticReport.result
Control1..1
TypeReference(DDCC Observation)
10. DiagnosticReport.result:observation-results
Slice Nameobservation-results
Control0..1
TypeReference(DDCC Observation)

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

0. DiagnosticReport
Definition

The findings and interpretation of diagnostic tests performed on patients, groups of patients, devices, and locations, and/or specimens derived from these. The report includes clinical context such as requesting and provider information, and some mix of atomic results, images, textual and coded interpretations, and formatted representation of diagnostic reports.

ShortA Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
Comments

This is intended to capture a single report and is not suitable for use in displaying summary information that covers multiple reports. For example, this resource has not been designed for laboratory cumulative reporting formats nor detailed structured reports for sequencing.

Control0..*
Is Modifierfalse
Summaryfalse
Alternate NamesReport, Test, Result, Results, Labs, Laboratory
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. DiagnosticReport.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.

ShortA set of rules under which this content was created
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 it's narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. DiagnosticReport.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 manageable, 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).

ShortExtensions that cannot be ignored
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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summaryfalse
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
Invariantsele-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())
6. DiagnosticReport.status
Definition

The status of the diagnostic report.

Shortregistered | partial | preliminary | final +
Control1..1
BindingThe codes SHALL be taken from DiagnosticReportStatushttp://hl7.org/fhir/ValueSet/diagnostic-report-status|4.0.1
(required to http://hl7.org/fhir/ValueSet/diagnostic-report-status|4.0.1)

The status of the diagnostic report.

Typecode
Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Diagnostic services routinely issue provisional/incomplete reports, and sometimes withdraw previously released reports.

Fixed Valuefinal
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. DiagnosticReport.category
Definition

A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text.


A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.

ShortConcept - reference to a terminology or just textService category
Comments

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.


Multiple categories are allowed using various categorization schemes. The level of granularity is defined by the category concepts in the value set. More fine-grained filtering can be performed using the metadata and/or terminology hierarchy in DiagnosticReport.code.

Control10..1*
This element is affected by the following invariants: ele-1
BindingFor example codes, see DiagnosticServiceSectionCodeshttp://hl7.org/fhir/ValueSet/diagnostic-service-sections
(example to http://hl7.org/fhir/ValueSet/diagnostic-service-sections)

Codes for diagnostic service sections.

TypeCodeableConcept(Codeable Concept (IPS))
Is Modifierfalse
Must Supporttrue
Alternate NamesDepartment, Sub-department, Service, Discipline
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. DiagnosticReport.code
Definition

A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text.


A code or name that describes this diagnostic report.

ShortConcept - reference to a terminology or just textName/Code for this diagnostic report
Comments

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Control1..1
This element is affected by the following invariants: ele-1
BindingThe codes SHALL be taken from The codes SHOULD be taken from WHO Type of Covid-19 Testhttp://hl7.org/fhir/ValueSet/report-codes
(required to http://smart.who.int/ddcc/ValueSet/WHODDCCTypeofTestCOVID19)
TypeCodeableConcept(Codeable Concept (IPS))
Is Modifierfalse
Must Supporttrue
Alternate NamesType
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. DiagnosticReport.subject
Definition

The subject of the report. Usually, but not always, this is a patient. However, diagnostic services also perform analyses on specimens collected from a variety of other sources.

ShortThe subject of the report - usually, but not always, the patient
Control10..1
TypeReference(Patient (IPS), Group, Patient, Device, Location)
Is Modifierfalse
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
Summarytrue
Requirements

SHALL know the subject context.

Alternate NamesPatient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. DiagnosticReport.subject.reference
Definition

A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

ShortLiteral reference, Relative, internal or absolute URL
Comments

Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

Control10..1
This element is affected by the following invariants: ref-1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. DiagnosticReport.effective[x]
Definition

The time or time-period the observed values are related to. When the subject of the report is a patient, this is usually either the time of the procedure or of specimen collection(s), but very often the source of the date/time is not known, only the date/time itself.

ShortClinically relevant time/time-period for report
Comments

If the diagnostic procedure was performed on the patient, this is the time it was performed. If there are specimens, the diagnostically relevant time can be derived from the specimen collection times, but the specimen information is not always available, and the exact relationship between the specimens and the diagnostically relevant time is not always automatic.

Control10..1
TypedateTime, Period
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

Need to know where in the patient history to file/present this report.

Alternate NamesObservation time, Effective Time, Occurrence
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. DiagnosticReport.effective[x].extension:data-absent-reason
Slice Namedata-absent-reason
Definition

Provides a reason why the effectiveTime is missing.

Shorteffective[x] absence reason
Control0..1
TypeExtension(Data Absent Reason) (Extension Type: code)
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-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())
20. DiagnosticReport.performer
Definition

The diagnostic service that is responsible for issuing the report.

ShortResponsible Diagnostic Service
Comments

This is not necessarily the source of the atomic data items or the entity that interpreted the results. It is the entity that takes responsibility for the clinical report.

Control0..*
TypeReference(Practitioner (IPS), PractitionerRole (IPS), Organization (IPS), CareTeam, Practitioner, PractitionerRole, Organization)
Is Modifierfalse
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
Summarytrue
Requirements

Need to know whom to contact if there are queries about the results. Also may need to track the source of reports for secondary data analysis.

Alternate NamesLaboratory, Service, Practitioner, Department, Company, Authorized by, Director
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. DiagnosticReport.specimen
Definition

Details about the specimens on which this diagnostic report is based.

ShortSpecimens this report is based on
Comments

If the specimen is sufficiently specified with a code in the test result name, then this additional data may be redundant. If there are multiple specimens, these may be represented per observation or group.

Control10..1*
TypeReference(DDCC Specimen, Specimen)
Is Modifierfalse
Must Supporttrue
Summaryfalse
Requirements

Need to be able to report information about the collected specimens on which the report is based.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. DiagnosticReport.result
Definition

Observation results included in the diagnostic report.


Observations that are part of this diagnostic report.

ShortObservation results included in the diagnostic report.Observations
Comments

Observations can contain observations.

Control10..1*
TypeReference(DDCC Observation, Observation)
Is Modifierfalse
Must Supporttrue
Summaryfalse
Requirements

Need to support individual results, or groups of results, where the result grouping is arbitrary, but meaningful.

Alternate NamesData, Atomic Value, Result, Atomic result, Data, Test, Analyte, Battery, Organizer
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on DiagnosticReport.result. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • profile @ resolve()
  • 26. DiagnosticReport.result:observation-results
    Slice Nameobservation-results
    Definition

    Observations that are part of this diagnostic report.

    ShortObservations
    Comments

    Observations can contain observations.

    Control0..1*
    TypeReference(DDCC Observation, Observation)
    Is Modifierfalse
    Must Supporttrue
    Summaryfalse
    Requirements

    Need to support individual results, or groups of results, where the result grouping is arbitrary, but meaningful.

    Alternate NamesData, Atomic Value, Result, Atomic result, Data, Test, Analyte, Battery, Organizer
    Invariantsele-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

    0. DiagnosticReport
    Definition

    The findings and interpretation of diagnostic tests performed on patients, groups of patients, devices, and locations, and/or specimens derived from these. The report includes clinical context such as requesting and provider information, and some mix of atomic results, images, textual and coded interpretations, and formatted representation of diagnostic reports.

    ShortA Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
    Comments

    This is intended to capture a single report and is not suitable for use in displaying summary information that covers multiple reports. For example, this resource has not been designed for laboratory cumulative reporting formats nor detailed structured reports for sequencing.

    Control0..*
    Is Modifierfalse
    Summaryfalse
    Alternate NamesReport, Test, Result, Results, Labs, Laboratory
    Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
    dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
    dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
    dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
    dom-6: A resource should have narrative for robust management (text.`div`.exists())
    2. DiagnosticReport.id
    Definition

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

    ShortLogical id of this artifact
    Comments

    The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

    Control0..1
    Typeid
    Is Modifierfalse
    Summarytrue
    4. DiagnosticReport.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.

    ShortMetadata about the resource
    Control0..1
    TypeMeta
    Is Modifierfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    6. DiagnosticReport.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.

    ShortA set of rules under which this content was created
    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 it's narrative along with other profiles, value sets, etc.

    Control0..1
    Typeuri
    Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    8. DiagnosticReport.language
    Definition

    The base language in which the resource is written.

    ShortLanguage of the resource content
    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).

    Control0..1
    BindingThe codes SHOULD be taken from CommonLanguages
    (preferred to http://hl7.org/fhir/ValueSet/languages)

    A human language.

    Additional BindingsPurpose
    AllLanguagesMax Binding
    Typecode
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    10. DiagnosticReport.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.

    ShortText summary of the resource, for human interpretation
    Comments

    Contained resources do not have 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.

    Control0..1
    TypeNarrative
    Is Modifierfalse
    Summaryfalse
    Alternate Namesnarrative, html, xhtml, display
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    12. DiagnosticReport.contained
    Definition

    These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

    ShortContained, inline 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.

    Control0..*
    TypeResource
    Is Modifierfalse
    Summaryfalse
    Alternate Namesinline resources, anonymous resources, contained resources
    14. DiagnosticReport.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 manageable, 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.

    ShortAdditional content defined by implementations
    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.

    Control0..*
    TypeExtension
    Is Modifierfalse
    Summaryfalse
    Alternate Namesextensions, user content
    Invariantsele-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())
    16. DiagnosticReport.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 manageable, 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).

    ShortExtensions that cannot be ignored
    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.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
    Summaryfalse
    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
    Invariantsele-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())
    18. DiagnosticReport.identifier
    Definition

    Identifiers assigned to this report by the performer or other systems.

    ShortBusiness identifier for report
    Comments

    Usually assigned by the Information System of the diagnostic service provider (filler id).

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

    Need to know what identifier to use when making queries about this report from the source laboratory, and for linking to the report outside FHIR context.

    Alternate NamesReportID, Filler ID, Placer ID
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    20. DiagnosticReport.basedOn
    Definition

    Details concerning a service requested.

    ShortWhat was requested
    Comments

    Note: Usually there is one test request for each result, however in some circumstances multiple test requests may be represented using a single test result resource. Note that there are also cases where one request leads to multiple reports.

    Control0..*
    TypeReference(CarePlan, ImmunizationRecommendation, MedicationRequest, NutritionOrder, ServiceRequest)
    Is Modifierfalse
    Summaryfalse
    Requirements

    This allows tracing of authorization for the report and tracking whether proposals/recommendations were acted upon.

    Alternate NamesRequest
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    22. DiagnosticReport.status
    Definition

    The status of the diagnostic report.

    Shortregistered | partial | preliminary | final +
    Control1..1
    BindingThe codes SHALL be taken from DiagnosticReportStatus
    (required to http://hl7.org/fhir/ValueSet/diagnostic-report-status|4.0.1)

    The status of the diagnostic report.

    Typecode
    Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Requirements

    Diagnostic services routinely issue provisional/incomplete reports, and sometimes withdraw previously released reports.

    Fixed Valuefinal
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    24. DiagnosticReport.category
    Definition

    A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text.

    ShortConcept - reference to a terminology or just text
    Comments

    Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

    Control1..1
    This element is affected by the following invariants: ele-1
    BindingFor example codes, see DiagnosticServiceSectionCodes
    (example to http://hl7.org/fhir/ValueSet/diagnostic-service-sections)

    Codes for diagnostic service sections.

    TypeCodeableConcept(Codeable Concept (IPS))
    Is Modifierfalse
    Must Supporttrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    26. DiagnosticReport.code
    Definition

    A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text.

    ShortConcept - reference to a terminology or just text
    Comments

    Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

    Control1..1
    This element is affected by the following invariants: ele-1
    BindingThe codes SHALL be taken from WHO Type of Covid-19 Test
    (required to http://smart.who.int/ddcc/ValueSet/WHODDCCTypeofTestCOVID19)
    TypeCodeableConcept(Codeable Concept (IPS))
    Is Modifierfalse
    Must Supporttrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    28. DiagnosticReport.subject
    Definition

    The subject of the report. Usually, but not always, this is a patient. However, diagnostic services also perform analyses on specimens collected from a variety of other sources.

    ShortThe subject of the report - usually, but not always, the patient
    Control1..1
    TypeReference(Patient (IPS), Group)
    Is Modifierfalse
    Must Supporttrue
    Must Support TypesNo must-support rules about the choice of types/profiles
    Summarytrue
    Requirements

    SHALL know the subject context.

    Alternate NamesPatient
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    30. DiagnosticReport.subject.id
    Definition

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

    ShortUnique id for inter-element referencing
    Control0..1
    Typestring
    Is Modifierfalse
    XML FormatIn the XML format, this property is represented as an attribute.
    Summaryfalse
    32. DiagnosticReport.subject.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 manageable, 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.

    ShortAdditional content defined by implementations
    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.

    Control0..*
    TypeExtension
    Is Modifierfalse
    Summaryfalse
    Alternate Namesextensions, user content
    Invariantsele-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())
    SlicingThis element introduces a set of slices on DiagnosticReport.subject.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 34. DiagnosticReport.subject.reference
      Definition

      A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

      ShortLiteral reference, Relative, internal or absolute URL
      Comments

      Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

      Control1..1
      This element is affected by the following invariants: ref-1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      36. DiagnosticReport.subject.type
      Definition

      The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

      The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

      ShortType the reference refers to (e.g. "Patient")
      Comments

      This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

      Control0..1
      BindingUnless not suitable, these codes SHALL be taken from ResourceType
      (extensible to http://hl7.org/fhir/ValueSet/resource-types)

      Aa resource (or, for logical models, the URI of the logical model).

      Typeuri
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      38. DiagnosticReport.subject.identifier
      Definition

      An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

      ShortLogical reference, when literal reference is not known
      Comments

      When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

      When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

      Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

      Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control0..1
      TypeIdentifier
      Is Modifierfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      40. DiagnosticReport.subject.display
      Definition

      Plain text narrative that identifies the resource in addition to the resource reference.

      ShortText alternative for the resource
      Comments

      This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

      Control0..1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      42. DiagnosticReport.encounter
      Definition

      The healthcare event (e.g. a patient and healthcare provider interaction) which this DiagnosticReport is about.

      ShortHealth care event when test ordered
      Comments

      This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).

      Control0..1
      TypeReference(Encounter)
      Is Modifierfalse
      Summarytrue
      Requirements

      Links the request to the Encounter context.

      Alternate NamesContext
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      44. DiagnosticReport.effective[x]
      Definition

      The time or time-period the observed values are related to. When the subject of the report is a patient, this is usually either the time of the procedure or of specimen collection(s), but very often the source of the date/time is not known, only the date/time itself.

      ShortClinically relevant time/time-period for report
      Comments

      If the diagnostic procedure was performed on the patient, this is the time it was performed. If there are specimens, the diagnostically relevant time can be derived from the specimen collection times, but the specimen information is not always available, and the exact relationship between the specimens and the diagnostically relevant time is not always automatic.

      Control1..1
      TypedateTime
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summarytrue
      Requirements

      Need to know where in the patient history to file/present this report.

      Alternate NamesObservation time, Effective Time, Occurrence
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      46. DiagnosticReport.effective[x].id
      Definition

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

      ShortUnique id for inter-element referencing
      Control0..1
      Typestring
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      48. DiagnosticReport.effective[x].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 manageable, 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.

      ShortAdditional content defined by implementations
      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.

      Control0..*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-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())
      SlicingThis element introduces a set of slices on DiagnosticReport.effective[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 50. DiagnosticReport.effective[x].extension:data-absent-reason
        Slice Namedata-absent-reason
        Definition

        Provides a reason why the effectiveTime is missing.

        Shorteffective[x] absence reason
        Control0..1
        TypeExtension(Data Absent Reason) (Extension Type: code)
        Is Modifierfalse
        Must Supporttrue
        Summaryfalse
        Invariantsele-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())
        52. DiagnosticReport.issued
        Definition

        The date and time that this version of the report was made available to providers, typically after the report was reviewed and verified.

        ShortDateTime this version was made
        Comments

        May be different from the update time of the resource itself, because that is the status of the record (potentially a secondary copy), not the actual release time of the report.

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

        Clinicians need to be able to check the date that the report was released.

        Alternate NamesDate published, Date Issued, Date Verified
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        54. DiagnosticReport.performer
        Definition

        The diagnostic service that is responsible for issuing the report.

        ShortResponsible Diagnostic Service
        Comments

        This is not necessarily the source of the atomic data items or the entity that interpreted the results. It is the entity that takes responsibility for the clinical report.

        Control0..*
        TypeReference(Practitioner (IPS), PractitionerRole (IPS), Organization (IPS), CareTeam)
        Is Modifierfalse
        Must Supporttrue
        Must Support TypesNo must-support rules about the choice of types/profiles
        Summarytrue
        Requirements

        Need to know whom to contact if there are queries about the results. Also may need to track the source of reports for secondary data analysis.

        Alternate NamesLaboratory, Service, Practitioner, Department, Company, Authorized by, Director
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        56. DiagnosticReport.resultsInterpreter
        Definition

        The practitioner or organization that is responsible for the report's conclusions and interpretations.

        ShortPrimary result interpreter
        Comments

        Might not be the same entity that takes responsibility for the clinical report.

        Control0..*
        TypeReference(Practitioner, PractitionerRole, Organization, CareTeam)
        Is Modifierfalse
        Summarytrue
        Requirements

        Need to know whom to contact if there are queries about the results. Also may need to track the source of reports for secondary data analysis.

        Alternate NamesAnalyzed by, Reported by
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        58. DiagnosticReport.specimen
        Definition

        Details about the specimens on which this diagnostic report is based.

        ShortSpecimens this report is based on
        Comments

        If the specimen is sufficiently specified with a code in the test result name, then this additional data may be redundant. If there are multiple specimens, these may be represented per observation or group.

        Control1..1
        TypeReference(DDCC Specimen)
        Is Modifierfalse
        Must Supporttrue
        Summaryfalse
        Requirements

        Need to be able to report information about the collected specimens on which the report is based.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        60. DiagnosticReport.result
        Definition

        Observation results included in the diagnostic report.

        ShortObservation results included in the diagnostic report.
        Comments

        Observations can contain observations.

        Control1..1
        TypeReference(DDCC Observation)
        Is Modifierfalse
        Must Supporttrue
        Summaryfalse
        Requirements

        Need to support individual results, or groups of results, where the result grouping is arbitrary, but meaningful.

        Alternate NamesData, Atomic Value, Result, Atomic result, Data, Test, Analyte, Battery, Organizer
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        SlicingThis element introduces a set of slices on DiagnosticReport.result. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • profile @ resolve()
        • 62. DiagnosticReport.result:observation-results
          Slice Nameobservation-results
          Definition

          Observations that are part of this diagnostic report.

          ShortObservations
          Comments

          Observations can contain observations.

          Control0..1
          TypeReference(DDCC Observation)
          Is Modifierfalse
          Must Supporttrue
          Summaryfalse
          Requirements

          Need to support individual results, or groups of results, where the result grouping is arbitrary, but meaningful.

          Alternate NamesData, Atomic Value, Result, Atomic result, Data, Test, Analyte, Battery, Organizer
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          64. DiagnosticReport.imagingStudy
          Definition

          One or more links to full details of any imaging performed during the diagnostic investigation. Typically, this is imaging performed by DICOM enabled modalities, but this is not required. A fully enabled PACS viewer can use this information to provide views of the source images.

          ShortReference to full details of imaging associated with the diagnostic report
          Comments

          ImagingStudy and the image element are somewhat overlapping - typically, the list of image references in the image element will also be found in one of the imaging study resources. However, each caters to different types of displays for different types of purposes. Neither, either, or both may be provided.

          Control0..*
          TypeReference(ImagingStudy)
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          66. DiagnosticReport.media
          Definition

          A list of key images associated with this report. The images are generally created during the diagnostic process, and may be directly of the patient, or of treated specimens (i.e. slides of interest).

          ShortKey images associated with this report
          Control0..*
          TypeBackboneElement
          Is Modifierfalse
          Summarytrue
          Requirements

          Many diagnostic services include images in the report as part of their service.

          Alternate NamesDICOM, Slides, Scans
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          68. DiagnosticReport.media.id
          Definition

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

          ShortUnique id for inter-element referencing
          Control0..1
          Typestring
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          70. DiagnosticReport.media.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 manageable, 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.

          ShortAdditional content defined by implementations
          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.

          Control0..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-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())
          72. DiagnosticReport.media.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 manageable, 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).

          ShortExtensions that cannot be ignored even if unrecognized
          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.

          Control0..*
          TypeExtension
          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
          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
          Invariantsele-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())
          74. DiagnosticReport.media.comment
          Definition

          A comment about the image. Typically, this is used to provide an explanation for why the image is included, or to draw the viewer's attention to important features.

          ShortComment about the image (e.g. explanation)
          Comments

          The comment should be displayed with the image. It would be common for the report to include additional discussion of the image contents in other sections such as the conclusion.

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

          The provider of the report should make a comment about each image included in the report.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          76. DiagnosticReport.media.link
          Definition

          Reference to the image source.

          ShortReference to the image source
          Control1..1
          TypeReference(Media)
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          78. DiagnosticReport.conclusion
          Definition

          Concise and clinically contextualized summary conclusion (interpretation/impression) of the diagnostic report.

          ShortClinical conclusion (interpretation) of test results
          Control0..1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summaryfalse
          Requirements

          Need to be able to provide a conclusion that is not lost among the basic result data.

          Alternate NamesReport
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          80. DiagnosticReport.conclusionCode
          Definition

          One or more codes that represent the summary conclusion (interpretation/impression) of the diagnostic report.

          ShortCodes for the clinical conclusion of test results
          Control0..*
          BindingFor example codes, see SNOMEDCTClinicalFindings
          (example to http://hl7.org/fhir/ValueSet/clinical-findings)

          Diagnosis codes provided as adjuncts to the report.

          TypeCodeableConcept
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          82. DiagnosticReport.presentedForm
          Definition

          Rich text representation of the entire result as issued by the diagnostic service. Multiple formats are allowed but they SHALL be semantically equivalent.

          ShortEntire report as issued
          Comments

          "application/pdf" is recommended as the most reliable and interoperable in this context.

          Control0..*
          TypeAttachment
          Is Modifierfalse
          Summaryfalse
          Requirements

          Gives laboratory the ability to provide its own fully formatted report for clinical fidelity.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))