Laboratory Report composition.

A composition is a set of healthcare-related information that is assembled together into a single logical document that provides a single coherent statement of meaning, establishes its own context and that has clinical attestation with regard to who is making the statement. While a Composition defines the structure, it does not actually contain the content: rather the full content of a document is contained in a Bundle, of which the Composition is the first resource contained.

While the focus of this specification is on patient-specific clinical statements, this resource can also apply to other healthcare-related statements such as study protocol designs, healthcare invoices and other activities that are not necessarily patient-specific or clinical.

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.

Version specific identifier for the composition, assigned when each version is created/updated.

While each resource, including the composition itself, has its own version identifier, this is a formal identifier for the logical version of the composition as a whole. It would remain constant if the resources were moved to a new server, and all got new individual resource versions, for example.

This extension provides a link to the order [(Reference(ServiceRequest)] or requisition [ServiceRequest.requisition (i.e., 'Request.groupIdentifier')] that this report document is based on and fulfills.

An Extension

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.

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

This extension applies to the Composition resource and is used to represent an intended recipient of the composition.

An Extension

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.

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

This extension provides a reference to the DiagnosticReport instance that is associated with this Composition.

An Extension

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.

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

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.

Added to the FHIR R4 guide to strictly conform with the R4 rules for document bundle resources inclusion. Using this extension implies to accept a circular reference Composition to/from 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

The workflow/clinical status of this composition. The status is a marker for the clinical standing of the document.

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

The workflow/clinical status of the composition.

Need to be able to mark interim, amended, or withdrawn compositions or documents.

Specifies that it refers to a Laboratory Report

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

Key metadata element describing the composition, used in searching/filtering.

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

High-level kind of a clinical document at a macro level.

Helps humans to assess whether the composition is of interest when viewing an index of compositions or documents.

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.

Helps humans to assess whether the composition is of interest when viewing an index of compositions or documents.

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.

Helps humans to assess whether the composition is of interest when viewing an index of compositions or documents.

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

Essential metadata for searching for the composition. Identifies who and/or what the composition/document is about.

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.

Provides context for the composition and supports searching.

The composition editing time, when the composition was last logically changed by the author.

The Last Modified Date on the composition may be after the date of the document was attested without being changed.

dateTime is used for tracking, organizing versions and searching. Note that this is the time of authoring. When packaged in a document, Bundle.timestamp is the date of packaging.

Identifies who is responsible for the information in the Laboratory Report, not necessarily who typed it in.

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

Identifies who is responsible for the content.

Official human-readable label for the composition.

For this document should be "Laboratory Report" or any equivalent translation

For many compositions, the title is the same as the text or a display name of Composition.type (e.g. a "consultation" or "progress note"). Note that CDA does not make title mandatory, but there are no known cases where it is useful for title to be omitted, so it is mandatory here. Feedback on this requirement is welcome during the trial use period.

A participant who has attested to the accuracy of the composition/document.

Only list each attester once.

Identifies responsibility for the accuracy of the composition content.

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.

The type of attestation the authenticator offers.

The way in which a person authenticated a composition.

Indicates the level of authority of the attestation.

When the composition was attested by the party.

Identifies when the information in the composition was deemed accurate. (Things may have changed since then.).

Who attested the composition in the specified way.

For a Laboratory Report it is usually non expected that the attester would be a Patient or a RealtedPerson

Identifies who has taken on the responsibility for accuracy of the composition content.

The clinical service, such as a colonoscopy or an appendectomy, being documented.

The event needs to be consistent with the type element, though can provide further information if desired.

Provides context for the composition and creates a linkage between a resource describing an event and the composition created describing the event.

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.

This list of codes represents the main clinical acts, such as a colonoscopy or an appendectomy, being documented. In some cases, the event is inherent in the typeCode, such as a "History and Physical Report" in which the procedure being documented is necessarily a "History and Physical" act.

An event can further specialize the act inherent in the typeCode, such as where it is simply "Procedure Report" and the procedure was a "colonoscopy". If one or more eventCodes are included, they SHALL NOT conflict with the values inherent in the classCode, practiceSettingCode or typeCode, as such a conflict would create an ambiguous situation. This short list of codes is provided to be used as key words for certain types of queries.

This list of codes represents the main clinical acts being documented.

The period of time covered by the documentation. There is no assertion that the documentation is a complete representation for this period, only that it documents events during this time.

The description and/or reference of the event(s) being documented. For example, this could be used to document such a colonoscopy or an appendectomy.

The "body" of the report is organized as a tree of up to two levels of sections: top level sections represent laboratory specialties. A top level section SHALL contain either one text block carrying all the text results produced for this specialty along with Laboratory Data Entries or a set of Laboratory Report Item Sections. In the first case the specialty section happens to also be a leaf section. In the latter case, each (second level) leaf section contained in the (top level) specialty section represents a Report Item: i.e., a battery, a specimen study (especially in microbiology), or an individual test. In addition, any leaf section SHALL contain a Laboratory Data Entries containing the observations of that section in a machine-readable format.

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.

The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.

The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.

Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.

A code identifying the kind of content contained within the section. This must be consistent with the section title.

The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document.

If the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.

Classification of a section of a composition/document.

Provides computable standardized labels to topics within the document.

Variant 1: With this option, all laboratory report data entries are provided in the top level sections and no sub-sections are allowed.

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.

The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.

The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.

Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.

A code identifying the kind of content contained within the section. This must be consistent with the section title.

The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document.

If the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.

Provides computable standardized labels to topics within the document.

A human-readable narrative that contains the attested content of the section, 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.

Document profiles may define what content should be represented in the narrative to ensure clinical safety.

A reference to the actual resource from which the narrative in the section is derived.

If there are no entries in the list, an emptyReason SHOULD be provided.

A nested sub-section within this section.

Nested sections are primarily used to help human readers navigate to particular portions of the document.

Variant 2: With this option, this top level section doesn't include NEITHER a top level text NOR entry elements. Each Report Item is contained in a corresponding sub-sections which contains the Lab Report Data Entry.

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.

The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.

The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.

Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.

A code identifying the kind of content contained within the section. This must be consistent with the section title.

The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document.

If the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.

Provides computable standardized labels to topics within the document.

A human-readable narrative that contains the attested content of the section, 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.

Document profiles may define what content should be represented in the narrative to ensure clinical safety.

A reference to the actual resource from which the narrative in the section is derived.

If there are no entries in the list, an emptyReason SHOULD be provided.

A nested sub-section within this section.

Nested sections are primarily used to help human readers navigate to particular portions of the document.

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.

The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.

The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.

Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.

A code identifying the kind of content contained within the section. This must be consistent with the section title.

The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document.

If the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.

Provides computable standardized labels to topics within the document.

A human-readable narrative that contains the attested content of the section, 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.

Document profiles may define what content should be represented in the narrative to ensure clinical safety.

A reference to the actual resource from which the narrative in the section is derived.

If there are no entries in the list, an emptyReason SHOULD be provided.

A nested sub-section within this section.

Nested sections are primarily used to help human readers navigate to particular portions of the document.

Narrative expression of comments accompanying the report, such as suggestions for evaluation, technical notes from the laboratory, etc.

Examples: Suggestion: This result should be evaluated in relation to the patient's medical history and clinical condition. Technical note: A list of accredited examination(s) is available at www.laboratory.com.

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.

The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.

The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.

Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.

A code identifying the kind of content contained within the section. This must be consistent with the section title.

The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document.

If the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.

Classification of a section of a composition/document.

Provides computable standardized labels to topics within the document.

A human-readable narrative that contains the attested content of the section, 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.

Document profiles may define what content should be represented in the narrative to ensure clinical safety.

A reference to the actual resource from which the narrative in the section is derived.

If there are no entries in the list, an emptyReason SHOULD be provided.

A nested sub-section within this section.

Nested sections are primarily used to help human readers navigate to particular portions of the document.

Laboratory Report composition.

A composition is a set of healthcare-related information that is assembled together into a single logical document that provides a single coherent statement of meaning, establishes its own context and that has clinical attestation with regard to who is making the statement. While a Composition defines the structure, it does not actually contain the content: rather the full content of a document is contained in a Bundle, of which the Composition is the first resource contained.

Added to the FHIR R4 guide to strictly conform with the R4 rules for document bundle resources inclusion. Using this extension implies to accept a circular reference Composition to/from DiagnosticReport

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

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

Specifies that it refers to a Laboratory Report

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

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

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.

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

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.

Identifies who is responsible for the information in the Laboratory Report, not necessarily who typed it in.

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

Official human-readable label for the composition.

For this document should be "Laboratory Report" or any equivalent translation

For a Laboratory Report it is usually non expected that the attester would be a Patient or a RealtedPerson

The "body" of the report is organized as a tree of up to two levels of sections: top level sections represent laboratory specialties. A top level section SHALL contain either one text block carrying all the text results produced for this specialty along with Laboratory Data Entries or a set of Laboratory Report Item Sections. In the first case the specialty section happens to also be a leaf section. In the latter case, each (second level) leaf section contained in the (top level) specialty section represents a Report Item: i.e., a battery, a specimen study (especially in microbiology), or an individual test. In addition, any leaf section SHALL contain a Laboratory Data Entries containing the observations of that section in a machine-readable format.

Variant 1: With this option, all laboratory report data entries are provided in the top level sections and no sub-sections are allowed.

Variant 2: With this option, this top level section doesn't include NEITHER a top level text NOR entry elements. Each Report Item is contained in a corresponding sub-sections which contains the Lab Report Data Entry.

Narrative expression of comments accompanying the report, such as suggestions for evaluation, technical notes from the laboratory, etc.

Examples: Suggestion: This result should be evaluated in relation to the patient's medical history and clinical condition. Technical note: A list of accredited examination(s) is available at www.laboratory.com.

Laboratory Report composition.

A composition is a set of healthcare-related information that is assembled together into a single logical document that provides a single coherent statement of meaning, establishes its own context and that has clinical attestation with regard to who is making the statement. While a Composition defines the structure, it does not actually contain the content: rather the full content of a document is contained in a Bundle, of which the Composition is the first resource contained.

While the focus of this specification is on patient-specific clinical statements, this resource can also apply to other healthcare-related statements such as study protocol designs, healthcare invoices and other activities that are not necessarily patient-specific or clinical.

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

Version specific identifier for the composition, assigned when each version is created/updated.

While each resource, including the composition itself, has its own version identifier, this is a formal identifier for the logical version of the composition as a whole. It would remain constant if the resources were moved to a new server, and all got new individual resource versions, for example.

This extension provides a link to the order [(Reference(ServiceRequest)] or requisition [ServiceRequest.requisition (i.e., 'Request.groupIdentifier')] that this report document is based on and fulfills.

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

An Extension

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.

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

This extension applies to the Composition resource and is used to represent an intended recipient of the composition.

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

An Extension

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.

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

This extension provides a reference to the DiagnosticReport instance that is associated with this Composition.

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

An Extension

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.

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

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.

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.

Added to the FHIR R4 guide to strictly conform with the R4 rules for document bundle resources inclusion. Using this extension implies to accept a circular reference Composition to/from DiagnosticReport

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).

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.

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

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.

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).

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

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.

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

The workflow/clinical status of this composition. The status is a marker for the clinical standing of the document.

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

The workflow/clinical status of the composition.

Need to be able to mark interim, amended, or withdrawn compositions or documents.

Specifies that it refers to a Laboratory Report

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

Key metadata element describing the composition, used in searching/filtering.

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

High-level kind of a clinical document at a macro level.

Helps humans to assess whether the composition is of interest when viewing an index of compositions or documents.

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.

Helps humans to assess whether the composition is of interest when viewing an index of compositions or documents.

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.

Helps humans to assess whether the composition is of interest when viewing an index of compositions or documents.

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

Essential metadata for searching for the composition. Identifies who and/or what the composition/document is about.

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.

Provides context for the composition and supports searching.

The composition editing time, when the composition was last logically changed by the author.

The Last Modified Date on the composition may be after the date of the document was attested without being changed.

dateTime is used for tracking, organizing versions and searching. Note that this is the time of authoring. When packaged in a document, Bundle.timestamp is the date of packaging.

Identifies who is responsible for the information in the Laboratory Report, not necessarily who typed it in.

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

Identifies who is responsible for the content.

Official human-readable label for the composition.

For this document should be "Laboratory Report" or any equivalent translation

For many compositions, the title is the same as the text or a display name of Composition.type (e.g. a "consultation" or "progress note"). Note that CDA does not make title mandatory, but there are no known cases where it is useful for title to be omitted, so it is mandatory here. Feedback on this requirement is welcome during the trial use period.

The code specifying the level of confidentiality of the Composition.

The exact use of this element, and enforcement and issues related to highly sensitive documents are out of scope for the base specification, and delegated to implementation profiles (see security section). This element is labeled as a modifier because highly confidential documents must not be treated as if they are not.

Codes specifying the level of confidentiality of the composition.

A participant who has attested to the accuracy of the composition/document.

Only list each attester once.

Identifies responsibility for the accuracy of the composition content.

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