Laboratory Report DiagnosticReport

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.

• DiagnosticReport: Laboratory Report

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.

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.

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.

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.

An Extension

This extension implements the R5 composition element. It allow to link this DiagnosticReport with the Composition documenting this Laboratory Report.

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Reference to a Composition resource instance that provides structure for organizing the contents of the DiagnosticReport.

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).

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.

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.

The status of the diagnostic report.

DiagnosticReport.status and Composition.status shall be aligned, based on the http://hl7.eu/fhir/laboratory/ConceptMap/ConceptMap-eu-diagRptStatus2CompStatus mapping

The status of the diagnostic report.

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

A code that classifies this laboratory report. Two basic categories has been selected in this guide: laboratory specialty and Study type. Laboratory specialty is characteristic of the laboratory that produced the test result while Study type is an arbitrary classificion of the test type.

DiagnosticReport.category and Composition.category shall be aligned

Codes for diagnostic service sections.

Laboratory services, i.e., results of tests performed, could be characterized using typology of services, commonly called study types. Study type could be seen as an attribute or grouping mechanism that assigns a common clinical sense to certain types of laboratory test results., e.g., Hemoglobin, Platelet count, etc. belongs to 'Hematology study'.

In comparison to the laboratory specialty which is an attribute of laboratory, study type is a categorization of laboratory service. It needs to be mentioned that classification of test to study types in not standardized.

Laboratory specialty is an attribute of any laboratory setting representing professional qualification of the laboratory to execute certain kind of laboratory tests.

Specialty could be used as parameter for searching/querying of laboratory test results.

Specifies that it refers to a Laboratory Report

At least one DiagnosticReport.code.coding and Composition.type.coding SHALL be equal

Who or what this report is about. The report can be about a human patient, a living subject, a device (e.g. a machine), a location or even a group of subjects (such as a document about a herd of livestock, or a set of patients that share a common exposure).

DiagnosticReport and Composition SHALL have the same subject

SHALL know the subject context.

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.

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.

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

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.

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.

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

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

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.

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

The diagnostic service that is responsible for issuing the report.

If a DiagnosticReport.resultsInterpreter exists this is expected to be a Composition.author; otherwise a DiagnosticReport.performer should be an author.

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.

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

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.

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

Observations that are part of this diagnostic report.

Observations can contain observations.

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

A list of additional data, other then presented form of the report, associated with this report. This data is generally created during the diagnostic process, and may be directly of the patient, or of treated specimens (i.e. slides of interest).

Some diagnostic reports may include additional data such as images, diagrams or documents that are relevant to the report. This additional information can provide further context and support for the findings presented in the report.

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).

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.

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.

A reference to the image or data associated with this report.

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

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

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

Diagnosis codes provided as adjuncts to the report.

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

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

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

• DiagnosticReport: Laboratory Report

Laboratory Report DiagnosticReport

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.

• DiagnosticReport: Laboratory Report

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

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

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.

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.

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.

The base language in which the resource is written.

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).

A human language.

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.

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.

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.

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.

An Extension

This extension implements the R5 composition element. It allow to link this DiagnosticReport with the Composition documenting this Laboratory Report.

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

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.

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.

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Reference to a Composition resource instance that provides structure for organizing the contents of the DiagnosticReport.

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).

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.

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.

Identifiers assigned to this Laboratory Report by the performer or other systems. It shall be common to several report versions

Composition.identifier SHALL be equal to one of the DiagnosticReport.identifier, if at least one exists

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.

Details concerning a service requested.

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.

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

The status of the diagnostic report.

DiagnosticReport.status and Composition.status shall be aligned, based on the http://hl7.eu/fhir/laboratory/ConceptMap/ConceptMap-eu-diagRptStatus2CompStatus mapping

The status of the diagnostic report.

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

A code that classifies this laboratory report. Two basic categories has been selected in this guide: laboratory specialty and Study type. Laboratory specialty is characteristic of the laboratory that produced the test result while Study type is an arbitrary classificion of the test type.

DiagnosticReport.category and Composition.category shall be aligned

Codes for diagnostic service sections.

Laboratory services, i.e., results of tests performed, could be characterized using typology of services, commonly called study types. Study type could be seen as an attribute or grouping mechanism that assigns a common clinical sense to certain types of laboratory test results., e.g., Hemoglobin, Platelet count, etc. belongs to 'Hematology study'.

In comparison to the laboratory specialty which is an attribute of laboratory, study type is a categorization of laboratory service. It needs to be mentioned that classification of test to study types in not standardized.

Laboratory specialty is an attribute of any laboratory setting representing professional qualification of the laboratory to execute certain kind of laboratory tests.

Specialty could be used as parameter for searching/querying of laboratory test results.

Specifies that it refers to a Laboratory Report

At least one DiagnosticReport.code.coding and Composition.type.coding SHALL be equal

Who or what this report is about. The report can be about a human patient, a living subject, a device (e.g. a machine), a location or even a group of subjects (such as a document about a herd of livestock, or a set of patients that share a common exposure).

DiagnosticReport and Composition SHALL have the same subject

SHALL know the subject context.

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

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).

DiagnosticReport and Composition SHALL have the same encounter.

Links the request to the Encounter context.

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.

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.

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

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.

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.

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

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

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.

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

The diagnostic service that is responsible for issuing the report.

If a DiagnosticReport.resultsInterpreter exists this is expected to be a Composition.author; otherwise a DiagnosticReport.performer should be an author.

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.

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

If a DiagnosticReport.resultsInterpreter exists this is expected to be a Composition.author; otherwise a DiagnosticReport.performer should be an author.

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.

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

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.

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

Observations that are part of this diagnostic report.

Observations can contain observations.

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

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.

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.

A list of additional data, other then presented form of the report, associated with this report. This data is generally created during the diagnostic process, and may be directly of the patient, or of treated specimens (i.e. slides of interest).

Some diagnostic reports may include additional data such as images, diagrams or documents that are relevant to the report. This additional information can provide further context and support for the findings presented in the report.

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

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.

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.

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).

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.

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.

Allows for a comment about the image or data, such as an explanation of its significance or context within the diagnostic report.

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.

The provider of the report should make a comment about each image or data included in the report. This comment can provide valuable context and help the reader understand the significance of the image or data in relation to the overall findings of the report.

A reference to the image or data associated with this report.

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

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

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

Diagnosis codes provided as adjuncts to the report.

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

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

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