DiagnosticReport
Rationale behind the usage of contained resources
In the context of providing support to management of documents in general, and AGP Report specifically, Data Architecture has proposed a model based on FHIR’s Diagnostic Report.
The particular scope of this use case, in which the CGM Values from the report are not stored in RDC's internal storage, implies that these Observations do not have an associated ID to refer to. In other words, they do not exist outside of the scope of the DiagnosticReport profile.
To cover this gap, it was agreed to use FHIR's contained-resources approach. This property enables a structure within the DiagnosticReport profile that allows to directly store Observations within it, with no internal ID required. With respect to implementation and reading of the final object, the contained
property contains an array of CGM Observations.
Overview
Profile (Observation) is for providing additional context information in diagnostic domain such as Carbs, EWM etc.,
Below is the
code
that are currently used under this Observation: [Code to be updated]System Code Display http://roche.com/fhir/iop/cs AGP-Report AGP-Report
Canonical url - http://roche.com/fhir/iop/StructureDefinition/DiagnosticReport
The below overview shows the elements of the resource, data type and the cardinality of each. Further details like "Binding"/"Fixed values"/"contraints" etc can be found on clicking on each element.
Structure definition :
DiagnosticReport | I | DiagnosticReport | There are no (further) constraints on this element Element idDiagnosticReport A Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports Alternate namesReport, Test, Result, Results, Labs, Laboratory DefinitionThe findings and interpretation of diagnostic tests performed on patients, groups of patients, products, substances, devices, and locations, and/or specimens derived from these. The report includes clinical context such as requesting provider information, and some mix of atomic results, images, textual and coded interpretations, and formatted representation of diagnostic reports. The report also includes non-clinical context such as batch analysis and stability reporting of products and substances. 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.
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id | Σ | 0..1 | id | There are no (further) constraints on this element Element idDiagnosticReport.id Logical id of this artifact DefinitionThe logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case. |
meta | Σ | 0..1 | Meta | There are no (further) constraints on this element Element idDiagnosticReport.meta Metadata about the resource DefinitionThe 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.
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implicitRules | Σ ?! | 0..1 | uri | There are no (further) constraints on this element Element idDiagnosticReport.implicitRules A set of rules under which this content was created DefinitionA 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 its narrative along with other profiles, value sets, etc.
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language | 0..1 | codeBinding | There are no (further) constraints on this element Element idDiagnosticReport.language Language of the resource content DefinitionThe 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). IETF language tag for a human language
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text | I | 0..1 | Narrative | There are no (further) constraints on this element Element idDiagnosticReport.text Text summary of the resource, for human interpretation Alternate namesnarrative, html, xhtml, display DefinitionA 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 a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
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contained | I | 0..* | Resource | Element idDiagnosticReport.contained Contained, inline Resources Alternate namesinline resources, anonymous resources, contained resources DefinitionThese resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning. 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. Unordered, Open, by $this(Type) Mappings
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CGM_Observation | I | 0..* | CGM_Observation | Element idDiagnosticReport.contained:CGM_Observation Measurements and simple assertions Alternate namesinline resources, anonymous resources, contained resources, Vital Signs, Measurement, Results, Tests DefinitionMeasurements and simple assertions made about a patient, device or other subject. Used for simple observations such as device measurements, laboratory atomic results, vital signs, height, weight, smoking status, comments, etc. Other resources are used to provide context for observations such as laboratory reports, etc.
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extension | I | 0..* | Extension | There are no (further) constraints on this element Element idDiagnosticReport.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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modifierExtension | Σ ?! I | 0..* | Extension | There are no (further) constraints on this element Element idDiagnosticReport.modifierExtension Extensions that cannot be ignored Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). 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. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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identifier | Σ I | 0..0 | Identifier | There are no (further) constraints on this element Element idDiagnosticReport.identifier Business identifier for report Alternate namesReportID, Filler ID, Placer ID DefinitionIdentifiers assigned to this report by the performer or other systems. 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. Usually assigned by the Information System of the diagnostic service provider (filler id).
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basedOn | I | 0..0 | Reference(CarePlan | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | There are no (further) constraints on this element Element idDiagnosticReport.basedOn What was requested Alternate namesRequest DefinitionDetails concerning a service requested. This allows tracing of authorization for the report and tracking whether proposals/recommendations were acted upon. 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. Reference(CarePlan | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Constraints
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status | Σ ?! | 1..1 | codeBinding | There are no (further) constraints on this element Element idDiagnosticReport.status registered | partial | preliminary | modified | final | amended | corrected | appended | cancelled | entered-in-error | unknown DefinitionThe status of the diagnostic report. Diagnostic services routinely issue provisional/incomplete reports, and sometimes withdraw previously released reports. Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size The status of the diagnostic report.
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category | Σ | 0..0 | CodeableConcept | There are no (further) constraints on this element Element idDiagnosticReport.category Service category Alternate namesDepartment, Sub-department, Service, Discipline DefinitionA 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. 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. HL7 V2 table 0074
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code | Σ | 1..1 | CodeableConceptBinding | Element idDiagnosticReport.code Name/Code for this diagnostic report Alternate namesType DefinitionA code or name that describes this diagnostic report. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. LOINC Codes for Diagnostic Reports
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subject | Σ I | 0..1 | Reference(Patient | Group | Device | Location | Organization | Practitioner | Medication | Substance | BiologicallyDerivedProduct) | There are no (further) constraints on this element Element idDiagnosticReport.subject The subject of the report - usually, but not always, the patient Alternate namesPatient DefinitionThe 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. SHALL know the subject context. References SHALL be a reference to an actual FHIR resource, and SHALL be resolvable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(Patient | Group | Device | Location | Organization | Practitioner | Medication | Substance | BiologicallyDerivedProduct) Constraints
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encounter | Σ I | 0..0 | Reference(Encounter) | There are no (further) constraints on this element Element idDiagnosticReport.encounter Health care event when test ordered Alternate namesContext DefinitionThe healthcare event (e.g. a patient and healthcare provider interaction) which this DiagnosticReport is about. Links the request to the Encounter context. 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).
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effective[x] | Σ | 0..1 | There are no (further) constraints on this element Element idDiagnosticReport.effective[x] Clinically relevant time/time-period for report Alternate namesObservation time, Effective Time, Occurrence DefinitionThe 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. Need to know where in the patient history to file/present this report. 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.
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effectivePeriod | Period | Data type | ||
issued | Σ | 0..0 | instant | There are no (further) constraints on this element Element idDiagnosticReport.issued DateTime this version was made Alternate namesDate published, Date Issued, Date Verified DefinitionThe date and time that this version of the report was made available to providers, typically after the report was reviewed and verified. Clinicians need to be able to check the date that the report was released. 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.
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performer | Σ I | 0..* | Reference(Practitioner | PractitionerRole | Organization) | Element idDiagnosticReport.performer Responsible Diagnostic Service Alternate namesLaboratory, Service, Practitioner, Department, Company, Authorized by, Director DefinitionThe diagnostic service that is responsible for issuing the report. 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. 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. Reference(Practitioner | PractitionerRole | Organization) Constraints
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resultsInterpreter | Σ I | 0..0 | Reference(Practitioner | PractitionerRole | Organization) | Element idDiagnosticReport.resultsInterpreter Primary result interpreter Alternate namesAnalyzed by, Reported by DefinitionThe practitioner or organization that is responsible for the report's conclusions and interpretations. 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. Might not be the same entity that takes responsibility for the clinical report. Reference(Practitioner | PractitionerRole | Organization) Constraints
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specimen | I | 0..0 | Reference(Specimen) | There are no (further) constraints on this element Element idDiagnosticReport.specimen Specimens this report is based on DefinitionDetails about the specimens on which this diagnostic report is based. Need to be able to report information about the collected specimens on which the 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.
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result | I | 0..* | Reference(Observation) | There are no (further) constraints on this element Element idDiagnosticReport.result Observations Alternate namesData, Atomic Value, Result, Atomic result, Data, Test, Analyte, Battery, Organizer DefinitionObservations that are part of this diagnostic report. Need to support individual results, or groups of results, where the result grouping is arbitrary, but meaningful. Observations can contain observations.
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note | 0..0 | Annotation | There are no (further) constraints on this element Element idDiagnosticReport.note Comments about the diagnostic report DefinitionComments about the diagnostic report. Need to be able to provide free text additional information. May include general statements about the diagnostic report, or statements about significant, unexpected or unreliable results values contained within the diagnostic report, or information about its source when relevant to its interpretation.
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study | I | 0..0 | Reference(GenomicStudy | ImagingStudy) | There are no (further) constraints on this element Element idDiagnosticReport.study Reference to full details of an analysis associated with the diagnostic report DefinitionOne or more links to full details of any study performed during the diagnostic investigation. An ImagingStudy might comprise a set of radiologic images obtained via a procedure that are analyzed as a group. 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. A GenomicStudy might comprise one or more analyses, each serving a specific purpose. These analyses may vary in method (e.g., karyotyping, CNV, or SNV detection), performer, software, devices used, or regions targeted. For laboratory-type studies like GenomeStudy, type resources will be used for tracking additional metadata and workflow aspects of complex studies. ImagingStudy and the media element are somewhat overlapping - typically, the list of image references in the media 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. Reference(GenomicStudy | ImagingStudy) Constraints
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supportingInfo | 0..0 | BackboneElement | There are no (further) constraints on this element Element idDiagnosticReport.supportingInfo Additional information supporting the diagnostic report DefinitionThis backbone element contains supporting information that was used in the creation of the report not included in the results already included in the report.
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media | Σ | 0..0 | BackboneElement | There are no (further) constraints on this element Element idDiagnosticReport.media Key images or data associated with this report Alternate namesDICOM, Slides, Scans DefinitionA list of key images or data associated with this report. The images or data are generally created during the diagnostic process, and may be directly of the patient, or of treated specimens (i.e. slides of interest). Many diagnostic services include images or data in the report as part of their service.
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composition | I | 0..0 | Reference(Composition) | There are no (further) constraints on this element Element idDiagnosticReport.composition Reference to a Composition resource for the DiagnosticReport structure DefinitionReference to a Composition resource instance that provides structure for organizing the contents of the DiagnosticReport. The Composition provides structure to the content of the DiagnosticReport (and only contains contents referenced in the DiagnosticReport) - e.g., to order the sections of an anatomic pathology structured report.
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conclusion | 0..0 | markdown | There are no (further) constraints on this element Element idDiagnosticReport.conclusion Clinical conclusion (interpretation) of test results Alternate namesReport DefinitionConcise 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. Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/
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conclusionCode | 0..0 | CodeableConcept | There are no (further) constraints on this element Element idDiagnosticReport.conclusionCode Codes for the clinical conclusion of test results DefinitionOne or more codes that represent the summary conclusion (interpretation/impression) of the diagnostic report. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. SNOMED CT Clinical Findings
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presentedForm | I | 0..* | Attachment | There are no (further) constraints on this element Element idDiagnosticReport.presentedForm Entire report as issued DefinitionRich text representation of the entire result as issued by the diagnostic service. Multiple formats are allowed but they SHALL be semantically equivalent. Gives laboratory the ability to provide its own fully formatted report for clinical fidelity. "application/pdf" is recommended as the most reliable and interoperable in this context.
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id | 0..1 | string | There are no (further) constraints on this element Element idDiagnosticReport.presentedForm.id Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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extension | I | 0..* | Extension | There are no (further) constraints on this element Element idDiagnosticReport.presentedForm.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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contentType | Σ I | 0..1 | codeBinding | There are no (further) constraints on this element Element idDiagnosticReport.presentedForm.contentType Mime type of the content, with charset etc. DefinitionIdentifies the type of the data in the attachment and allows a method to be chosen to interpret or render the data. Includes mime type parameters such as charset where appropriate. Processors of the data need to be able to know how to interpret the data. Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049)
General text/plain; charset=UTF-8, image/png Mappings
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language | Σ | 0..1 | codeBinding | There are no (further) constraints on this element Element idDiagnosticReport.presentedForm.language Human language of the content (BCP-47) DefinitionThe human language of the content. The value can be any valid value according to BCP 47. Users need to be able to choose between the languages in a set of attachments. Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size IETF language tag for a human language.
General en-AU Mappings
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data | I | 0..1 | base64Binary | There are no (further) constraints on this element Element idDiagnosticReport.presentedForm.data Data inline, base64ed DefinitionThe actual data of the attachment - a sequence of bytes, base64 encoded. The data needs to able to be transmitted inline. The base64-encoded data SHALL be expressed in the same character set as the base resource XML or JSON.
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url | Σ | 0..1 | url | There are no (further) constraints on this element Element idDiagnosticReport.presentedForm.url Uri where the data can be found DefinitionA location where the data can be accessed. The data needs to be transmitted by reference. If both data and url are provided, the url SHALL point to the same content as the data contains. Urls may be relative references or may reference transient locations such as a wrapping envelope using cid: though this has ramifications for using signatures. Relative URLs are interpreted relative to the service url, like a resource reference, rather than relative to the resource itself. If a URL is provided, it SHALL resolve to actual data.
General http://www.acme.com/logo-small.png Mappings
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size | Σ | 0..1 | integer64 | There are no (further) constraints on this element Element idDiagnosticReport.presentedForm.size Number of bytes of content (if url provided) DefinitionThe number of bytes of data that make up this attachment (before base64 encoding, if that is done). Representing the size allows applications to determine whether they should fetch the content automatically in advance, or refuse to fetch it at all. The number of bytes is redundant if the data is provided as a base64binary, but is useful if the data is provided as a url reference.
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hash | Σ | 0..1 | base64Binary | There are no (further) constraints on this element Element idDiagnosticReport.presentedForm.hash Hash of the data (sha-1, base64ed) DefinitionThe calculated hash of the data using SHA-1. Represented using base64. Included so that applications can verify that the contents of a location have not changed due to technical failures (e.g., storage rot, transport glitch, incorrect version). The hash is calculated on the data prior to base64 encoding, if the data is based64 encoded. The hash is not intended to support digital signatures. Where protection against malicious threats a digital signature should be considered, see Provenance.signature for mechanism to protect a resource with a digital signature.
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title | Σ | 0..1 | string | There are no (further) constraints on this element Element idDiagnosticReport.presentedForm.title Label to display in place of the data DefinitionA label or set of text to display in place of the data. Applications need a label to display to a human user in place of the actual data if the data cannot be rendered or perceived by the viewer. May sometimes be derived from the source filename.
General Official Corporate Logo Mappings
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creation | Σ | 0..1 | dateTime | There are no (further) constraints on this element Element idDiagnosticReport.presentedForm.creation Date attachment was first created DefinitionThe date that the attachment was first created. This is often tracked as an integrity issue for use of the attachment. UTC offset is allowed for dates and partial dates
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height | 0..1 | positiveInt | There are no (further) constraints on this element Element idDiagnosticReport.presentedForm.height Height of the image in pixels (photo/video) DefinitionHeight of the image in pixels (photo/video). 32 bit number; for values larger than this, use decimal
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width | 0..1 | positiveInt | There are no (further) constraints on this element Element idDiagnosticReport.presentedForm.width Width of the image in pixels (photo/video) DefinitionWidth of the image in pixels (photo/video). 32 bit number; for values larger than this, use decimal
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frames | 0..0 | positiveInt | There are no (further) constraints on this element Element idDiagnosticReport.presentedForm.frames Number of frames if > 1 (photo) DefinitionThe number of frames in a photo. This is used with a multi-page fax, or an imaging acquisition context that takes multiple slices in a single image, or an animated gif. If there is more than one frame, this SHALL have a value in order to alert interface software that a multi-frame capable rendering widget is required. if the number of frames is not supplied, the value may be unknown. Applications should not assume that there is only one frame unless it is explicitly stated.
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duration | 0..1 | decimal | There are no (further) constraints on this element Element idDiagnosticReport.presentedForm.duration Length in seconds (audio / video) DefinitionThe duration of the recording in seconds - for audio and video. The duration might differ from occurrencePeriod if recording was paused.
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pages | 0..1 | positiveInt | There are no (further) constraints on this element Element idDiagnosticReport.presentedForm.pages Number of printed pages DefinitionThe number of pages when printed. 32 bit number; for values larger than this, use decimal
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Attribute description :
Attribute | Description | Terminology reference |
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status | status of diagnostic report | status |
code | Standard code defines the report type is a ARG report. | To be updated report-codes |
Subject | Subject on which the report was derived. i.e patient | |
effectiveDateTime | The date time observed value is asserted as being true. | |
performer | Organization or HCP responsible for issuing the report. | |
result | Reference to the observations that are part of this report. | |
presentedForm | representation of the entire result in the report. |