QI-Core Implementation Guide
4.1.1 - STU 4.1.1
US
This page is part of the Quality Improvement Core Framework (v4.1.1: STU 4) based on FHIR R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions
Draft as of 2018-08-22 |
Definitions for the qicore-diagnosticreport-lab resource profile.
1. DiagnosticReport | |
Definition | The US Core Diagnostic Report Profile is based upon the core FHIR DiagnosticReport Resource and created to meet the 2015 Edition Common Clinical Data Set 'Laboratory test(s) and Laboratory value(s)/result(s)' requirements. |
Control | 0..* |
Alternate Names | Report, Test, Result, Results, Labs, Laboratory, Lab Result, Lab Report |
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. |
Invariants | Defined on this element dom-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. |
Control | 0..1 |
Type | string |
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. |
3. 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. |
Control | 0..1 |
Type | Meta |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
4. 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. |
Control | 0..1 |
Type | uri |
Is Modifier | true |
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. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
5. DiagnosticReport.language | |
Definition | The base language in which the resource is written. |
Control | 0..1 |
Binding | The codes SHOULD be taken from CommonLanguages Max Binding: AllLanguages A human language. |
Type | code |
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). |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
6. 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. |
Control | 0..1 |
Type | Narrative |
Alternate Names | narrative, html, xhtml, display |
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. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
7. 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. |
Control | 0..* |
Type | Resource |
Alternate Names | inline resources, anonymous resources, contained resources |
Comments | This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels. |
8. DiagnosticReport.extension | |
Definition | An Extension |
Control | 0..* |
Type | Extension |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) |
Slicing | This element introduces a set of slices on DiagnosticReport.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
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9. DiagnosticReport.extension:locationPerformed | |
SliceName | locationPerformed |
Definition | Facility location where this report was prepared. |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | Extension(locationPerformed) (Extension Type: Reference(Location)) |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) |
10. DiagnosticReport.extension:locationPerformed.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Control | 0..1 |
Type | string |
11. DiagnosticReport.extension:locationPerformed.extension | |
Definition | An Extension |
Control | 0..0 |
Type | Extension |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) |
Slicing | This element introduces a set of slices on DiagnosticReport.extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
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12. DiagnosticReport.extension:locationPerformed.url | |
Definition | Source of the definition for the extension code - a logical name or a URL. |
Control | 1..1 |
Type | uri |
Comments | 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. |
Fixed Value | http://hl7.org/fhir/StructureDefinition/diagnosticReport-locationPerformed |
13. DiagnosticReport.extension:locationPerformed.value[x]:valueReference | |
SliceName | valueReference |
Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
Control | 1..1 |
Type | Reference(QICoreLocation) |
[x] Note | See Choice of Data Types for further information about how to use [x] |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
14. 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). |
Control | 0..* |
Type | Extension |
Is Modifier | true |
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 Names | extensions, user content |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) |
15. DiagnosticReport.identifier | |
Definition | Identifiers assigned to this report by the performer or other systems. |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..* |
Type | Identifier |
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 Names | ReportID, Filler ID, Placer ID |
Comments | Usually assigned by the Information System of the diagnostic service provider (filler id). |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
16. DiagnosticReport.basedOn | |
Definition | Details concerning a service requested. |
Control | 0..* |
Type | Reference(CarePlan | QICoreImmunizationRecommendation | QICoreMedicationRequest | NutritionOrder | QICoreServiceRequest) |
Requirements | This allows tracing of authorization for the report and tracking whether proposals/recommendations were acted upon. |
Alternate Names | Request |
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. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
17. DiagnosticReport.status | |
Definition | The status of the diagnostic report. |
Control | 1..1 |
Binding | The codes SHALL be taken from DiagnosticReportStatus |
Type | code |
Is Modifier | true |
Must Support | true |
Requirements | Diagnostic services routinely issue provisional/incomplete reports, and sometimes withdraw previously released reports. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
18. DiagnosticReport.category | |
Definition | 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. |
Control | 1..* |
Binding | For example codes, see DiagnosticServiceSectionCodes Codes for diagnostic service sections. |
Type | CodeableConcept |
Must Support | true |
Alternate Names | Department, Sub-department, Service, Discipline |
Comments | 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. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
Slicing | This element introduces a set of slices on DiagnosticReport.category. The slices are unordered and Open, and can be differentiated using the following discriminators:
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19. DiagnosticReport.category:LaboratorySlice | |
SliceName | LaboratorySlice |
Definition | 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. |
Control | 1..1 |
Binding | For example codes, see DiagnosticServiceSectionCodes Codes for diagnostic service sections. |
Type | CodeableConcept |
Must Support | true |
Alternate Names | Department, Sub-department, Service, Discipline |
Comments | 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. |
Pattern Value | <valueCodeableConcept xmlns="http://hl7.org/fhir"> <coding> <system value="http://terminology.hl7.org/CodeSystem/v2-0074"/> <code value="LAB"/> </coding> </valueCodeableConcept> |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
20. DiagnosticReport.code | |
Definition | The test, panel or battery that was ordered. |
Control | 1..1 |
Binding | The codes SHALL be taken from US Core Diagnostic Report Laboratory Codes; other codes may be used where these codes are not suitable LOINC codes |
Type | CodeableConcept |
Must Support | true |
Alternate Names | Type |
Comments | UsageNote= The typical patterns for codes are: 1) a LOINC code either as a translation from a "local" code or as a primary code, or 2) a local code only if no suitable LOINC exists, or 3) both the local and the LOINC translation. Systems SHALL be capable of sending the local code if one exists. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
21. 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. |
Control | 1..1 |
Type | Reference(QICorePatient) |
Must Support | true |
Requirements | SHALL know the subject context. |
Alternate Names | Patient |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
22. DiagnosticReport.encounter | |
Definition | The healthcare event (e.g. a patient and healthcare provider interaction) which this DiagnosticReport is about. |
Control | 0..1 |
Type | Reference(QICoreEncounter) |
Requirements | Links the request to the Encounter context. |
Alternate Names | Context |
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). |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
23. DiagnosticReport.effective[x] | |
Definition | This is the Specimen Collection Datetime or Period which is the physically relevent dateTime for laboratory tests. |
Control | 1..1 |
Type | Choice of: dateTime, Period |
[x] Note | See Choice of Data Types for further information about how to use [x] |
Must Support | true |
Must Support Types | No must-support rules about the choice of types/profiles |
Requirements | Need to know where in the patient history to file/present this report. |
Alternate Names | Observation time, Effective Time, Occurrence |
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. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
24. 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. |
Control | 1..1 |
Type | instant |
Must Support | true |
Requirements | Clinicians need to be able to check the date that the report was released. |
Alternate Names | Date published, Date Issued, Date Verified |
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. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
25. DiagnosticReport.performer | |
Definition | The diagnostic service that is responsible for issuing the report. |
Control | 0..* |
Type | Reference(QICorePractitioner | QICoreOrganization) |
Must Support | true |
Must Support Types | No must-support rules about the choice of types/profiles |
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 Names | Laboratory, Service, Practitioner, Department, Company, Authorized by, Director |
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. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
26. DiagnosticReport.resultsInterpreter | |
Definition | The practitioner or organization that is responsible for the report's conclusions and interpretations. |
Control | 0..* |
Type | Reference(Practitioner | PractitionerRole | Organization | CareTeam) |
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 Names | Analyzed by, Reported by |
Comments | Might not be the same entity that takes responsibility for the clinical report. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
27. DiagnosticReport.specimen | |
Definition | Details about the specimens on which this diagnostic report is based. |
Control | 0..* |
Type | Reference(QICoreSpecimen) |
Requirements | Need to be able to report information about the collected specimens on which the report is based. |
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. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
28. DiagnosticReport.result | |
Definition | Observations that are part of this diagnostic report. |
Control | 0..* |
Type | Reference(USCoreLaboratoryResultObservationProfile) |
Must Support | true |
Requirements | Need to support individual results, or groups of results, where the result grouping is arbitrary, but meaningful. |
Alternate Names | Data, Atomic Value, Result, Atomic result, Data, Test, Analyte, Battery, Organizer |
Comments | Observations can contain observations. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
29. 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. |
Control | 0..* |
Type | Reference(QICoreImagingStudy) |
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. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
30. 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). |
Control | 0..* |
Type | BackboneElement |
Requirements | Many diagnostic services include images in the report as part of their service. |
Alternate Names | DICOM, Slides, Scans |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
31. 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. |
Control | 0..1 |
Type | string |
32. 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. |
Control | 0..* |
Type | Extension |
Alternate Names | extensions, user content |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) |
33. 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). |
Control | 0..* |
Type | Extension |
Is Modifier | true |
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 Names | extensions, user content, modifiers |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) |
34. 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. |
Control | 0..1 |
Type | string |
Requirements | The provider of the report should make a comment about each image included in the report. |
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. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
35. DiagnosticReport.media.link | |
Definition | Reference to the image source. |
Control | 1..1 |
Type | Reference(Media) |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
36. DiagnosticReport.conclusion | |
Definition | Concise and clinically contextualized summary conclusion (interpretation/impression) of the diagnostic report. |
Control | 0..1 |
Type | string |
Must Support | true |
Requirements | Need to be able to provide a conclusion that is not lost among the basic result data. |
Alternate Names | Report |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
37. DiagnosticReport.conclusionCode | |
Definition | One or more codes that represent the summary conclusion (interpretation/impression) of the diagnostic report. |
Control | 0..* |
Binding | The codes SHOULD be taken from SNOMEDCTClinicalFindings This value set includes all the "Clinical finding" SNOMED CT codes - concepts where concept is-a 404684003 (Clinical finding (finding)). |
Type | CodeableConcept |
Must Support | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
38. 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. |
Control | 0..* |
Type | Attachment |
Requirements | Gives laboratory the ability to provide its own fully formatted report for clinical fidelity. |
Comments | "application/pdf" is recommended as the most reliable and interoperable in this context. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |