NHS North West Genomics
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Questionnaire: North West Genomics Test Report

Official URL: https://fhir.nwgenomics.nhs.uk/Questionnaire/GenomicTestReport Version: 2.2.0
Active as of 2026-09-20 Computable Name:

The aim of this is to support conversion of Genomic Report (HL7 v2 ORU) for use by several NHS Trusts (as HL7 v2 or FHIR).

This Questionnaire describes the common requirement for a Genomic Test Report, extended by Report Panel Questionnaires for each kind of individual test finding - see Report Panels below for the full list.

Although this Questionnaire is genomics-specific in name, the model it describes - Patient, Hospital Spell, Diagnostic Workflow and Results - is a core model for diagnostic reports generally, not something unique to genomics. The same shape applies equally to pathology, radiology and clinical referral reports; genomics is simply the domain this IG documents it against first. See Diagnostic Model Overview for the basic model this Questionnaire adds detail to, and how it relates to Genomic Test Order on the order side.

References

Domain Archetype

This is a level 2 (field-level) view of the basic model introduced in Diagnostic Model Overview, showing the entities and key attributes a Genomic Test Report actually carries:

erDiagram
    Patient ||--|{ DiagnosticReport : subject
    HospitalSpell ||--o{ DiagnosticReport : encounter
    ServiceRequest |o--o{ DiagnosticReport : "basedOn (optional)"
    DiagnosticReport }o--o{ PractitionerRole : "performer / resultsInterpreter"
    PractitionerRole }o--|| Organization : organization
    DiagnosticReport ||--o{ Specimen : specimen
    DiagnosticReport ||--o{ Observation : "result (Report Panels)"
    DiagnosticReport ||--o| Binary : "presentedForm (Attachment.url)"
    DocumentReference ||--o| Binary : "content (Attachment.url)"

    Patient {
        Identifier nhsNumber
        Identifier medicalRecordNumber
    }

    HospitalSpell {
        Identifier hospitalProviderSpellIdentifier
    }

    ServiceRequest {
        Identifier orderIdentifier "Placer/Filler Order Number"
    }

    DiagnosticReport {
        Identifier reportIdentifier
        code code "Procedure/Test Code"
        dateTime effectiveDateTime "Report Date"
        code status "Report Status"
        string conclusion
        CodeableConcept conclusionCode "Outcome"
    }

    PractitionerRole {
        Identifier practitionerIdentifier
    }

    Organization {
        Identifier organisationCode
    }

    Specimen {
        Identifier specimenId
        Identifier accessionIdentifier
    }

    Observation {
        code code "Panel-specific finding"
    }

    DocumentReference {
        code type "Narrative Report"
    }

    Binary {
        code contentType
        base64Binary data
    }

ServiceRequest is shown as optional (basedOn) because it is only present for a closed-loop report - one answering a specific prior order the reporting system already knows about. An unsolicited report, produced without a matching order ever having been received, has no order to reference - see Order Reference below.

Narrative Report. The full report, as a PDF, is HL7 v2's OBX (type = ED) - see OBX (type = ED), whose own v2-to-FHIR conversion mapping is to DocumentReference. DiagnosticReport.presentedForm and DocumentReference.content are both just an Attachment with a url - in this IG, both point at the same Binary resource holding the actual PDF bytes, rather than each carrying its own separate copy. DocumentReference is the resource this content would be shared via (e.g. IHE XDS.b/MHD, or the NHS England National Record Locator), while DiagnosticReport.presentedForm is the more direct route for a system that already holds the DiagnosticReport and just wants the PDF alongside it.

Diagnostic Report

Unstructured and Structured Laboratory Reports

A laboratory report contains both structured and unstructured information, and they complement each other rather than replace one another.

  • Structured data consists of discrete, machine-readable elements such as the patient, specimen, request, observations (test results), identifiers, and reporting clinician. In HL7 FHIR these are represented by resources such as Patient, Specimen, ServiceRequest, Observation, Practitioner, and DiagnosticReport. In HL7 v2 these correspond to segments such as PID, SPM, ORC, OBR, and OBX.
  • Unstructured data is the human-readable laboratory report (typically a PDF) that includes the full clinical interpretation, comments, formatting, signatures, and contextual information that may not be represented as discrete data. In FHIR this is attached to the DiagnosticReport.presentedForm (or referenced via DocumentReference), while in HL7 v2 it is commonly carried in OBX segments using encapsulated data (ED).

The Laboratory Report acts as the bridge between these two worlds. It references the structured observations for computer processing, clinical decision support, analytics, and interoperability, while also linking to the complete unstructured report that clinicians view as the authoritative laboratory document. This approach ensures that systems can exchange computable data without losing the rich narrative and legal record contained in the original laboratory report.

Laboratory Report with FHIR and V2 Mappings

Genomic Report Page 1

Genomic Report Page 1

Laboratory Report with detailed FHIR Mappings

Genomic Report Page 1

FHIR Document / Clinical Document Architecture

The FHIR DiagnosticReport illustrated above is well suited to workflow-based information exchange, where structured clinical data is exchanged between systems and individual observations can be processed, queried, and acted upon. However, it may be less suitable for document sharing use cases, such as IHE XDS/MHD or the NHS England National Record Locator (NRL), where the laboratory report is exchanged as a complete clinical document. In these scenarios, the preferred approach is a FHIR Document (the FHIR equivalent of a Clinical Document Architecture (CDA) document), which packages the report into a self-contained, attested document with a Composition resource as its root. This preserves the report as a legal and clinical record while still allowing structured data to be included.

Further details are available in the Document Perspective section of the HL7 Europe Laboratory Implementation Guide: HL7 Europe Laboratory Report

NW Genomics example FHIR Document - Genomic Report

Laboratory Report with FHIR Composition Mappings

Genomic Report Page 1

Detailed Model

Metadata is data that applies to the patient's entire clinical pathway and so it extends beyond diagnostic tests. Test detail tends to be common across all diagnostic tests in a patient's pathway, not just genomics.

Patient Demographics

Name LOINC Value Set / Data Type Cardinality HL7 v2 OML_O21 Message HL7 FHIR ServiceRequest HL7 FHIR Resource (Message + RESTful)
NHS Number   NHS Number 0..1 PID ServiceRequest.subject.identifier Patient
Medical Record Number   Medical Record Number 0..1 PID ServiceRequest.subject.identifier Patient

Hospital Spell

Treat as mandatory for reflex or subcontracted orders.

Name LOINC Value Set / Data Type Cardinality HL7 v2 OML_O21 Message HL7 FHIR ServiceRequest HL7 FHIR Resource (Message + RESTful)
Hospital Service   Service 0..1 PV1-10   Encounter.serviceType
Case Identification or Account Number 56797-4 HospitalProviderSpellIdentifier 0..1 PV1-19 ServiceRequest.encounter.identifier Encounter.identifier HospitalSpell

Diagnostic Workflow

Order Reference

DiagnosticReport.basedOn references the ServiceRequest (order, per Genomic Test Order) that this report answers, carried in HL7 v2 as ORC-2/ORC-3 (see the Order Number row below).

  • Closed-loop referral: where the reporting system already holds the original order (e.g. it filled that order itself, or was told about it via a prior LAB-1), basedOn is populated and this section is present.
  • Unsolicited report: ORU_R01 (and its FHIR Message equivalent) is explicitly designed to also support reporting a result for an order the receiving system never saw in the first place. In that case there is no ServiceRequest to reference, basedOn is absent, and this section - and the Order Number row below - simply doesn't apply.

See ctDNA Management Information - How the Two Event Messages Link Together for a fuller worked explanation of solicited vs unsolicited reports in this IG.

Name Description Value Set / Data Type Cardinality HL7 v2 ORU_RO1 Message HL7 FHIR DiagnosticReport HL7 FHIR Resource (RESTful)
Order Number The Unique order number assigned by the Order Placer (order comms or EHR), that requested the report - absent for an unsolicited report, see Order Reference above. Order Identifier 0..1 ORC-2 DiagnosticReport.basedOn ServiceRequest
Report Number Identifies the report, assigned by Order Filler (LIMS) Report Identifier 1..1 OBR-3 DiagnosticReport.identifier[ReportNumber]  
(Order) Procedure Code For Genomics this is Test Directory Code. (For Radiology this is NICIP code) See below 1..1 OBR-4 DiagnosticReport.code  
Account(/Visit) Number Assigned by the Order Placer where it is known as spell or episode id. It is used by all diagnostics to link tests to a spell/episode Hospital Provider Spell Identifier   PV1-19 DiagnosticReport.encounter  
Report date Date/time the report was issued   1..1 OBR-7 DiagnosticReport.effectiveDateTime  
Report Status     1..1 OBR-22 DiagnosticReport.status  
Conclusion Conclusion       DiagnosticReport.conclusion  
Outcome Conclusion Code Genomic Test Outcome Codes 0..1 OBX LOINC 51968-6 DiagnosticReport.conclusionCode  
Results Interpreter Who created the report England Practitioner Identifier 0..* OBR-32 and OBR-33 DiagnosticReport.resultsInterpreter Practitioner
Performer (operator)   England Practitioner Identifier 1..* OBR-34 DiagnosticReport.performer[operator] Practitioner
Performer (organisation) The organisation who created the report Organisation Code 1..*   DiagnosticReport.performer[organization] Organizaton
Specimen The sample(s) that were used for testing See Genomic Test Order - Specimen 0..1 SPM DiagnosticReport.specimen.identifier Specimen
Results Detailed (strucutured) results Domain specific - see below 0..* OBX DiagnosticReport.results Varies
Narrative Report Results and entire Report in PDF representation Domain specific - see below 0..* OBX (type=ED) DiagnosticReport.presentedForm  

Results

DiagnosticReport.result (see Detailed Model above) is where the individual findings of a test live. This is specific to genomics and focused on the requirements of general clinicians, not genomic specialists, so this section will tend to be an extract of the wider Genomics Reporting Implementation Guide rather than a complete restatement of it. It divides into two parts:

  • Report Panels - the computable data models (FHIR Questionnaires) this IG has built for specific kinds of result, each derivedFrom/extended from Genomic Test Report the same way Ask At Order Entry Questionnaires extend Genomic Test Order.
  • Genomic Results - the underlying HL7 FHIR Genomics Reporting profiles and resources those panels (and this IG's other genomic content) are built from. Some of these are also modelled as a Report Panel Questionnaire above - where that's the case, the table below says so rather than repeating the same content twice.
flowchart LR
    CORE["Common Core<br/>Genomic Test Report"]
    PANEL["+ Report Panel Questionnaire<br/>(varies by result type - e.g. Reportable<br/>Variant, BCR-ABL Monitoring, Chimerism Testing)"]
    RESULTS["+ Genomic Results<br/>(e.g. Reportable Variant, Laboratory Analyte<br/>Result, Diagnostic Implication)"]
    QNAIRE["Report as recorded in LIMS<br/>(NW Genomics)"]
    MSG["HL7 v2 ORU_R01<br/>or FHIR Message R01"]
    EPR["EPR<br/>(NHS Trust)"]

    CORE --> QNAIRE
    PANEL --> QNAIRE
    RESULTS --> QNAIRE
    QNAIRE -->|"report issued"| MSG
    MSG --> EPR

The common core, whichever Report Panel Questionnaire applies, and the actual Genomic Results it carries together are what a Questionnaire/QuestionnaireResponse represents - the report as recorded inside the LIMS. HL7 v2 ORU_R01/FHIR Message R01 is a different thing: the wire format that same report is sent onward to an EPR in, once it's issued - not the record the LIMS itself holds. Report Panels and Genomic Results are what vary between result types; the message shape they end up populating downstream does not - the mirror image of Genomic Test Order's Ask At Order Entry Questions/OML_O21/FHIR Message O21 pattern on the order side.

Genomic Test Report only models the report-level metadata common to every report (patient, order/report identifiers, dates, status, conclusion, performers) - its /Results group deliberately doesn't model individual test findings inline. Instead, each individual result is carried under DiagnosticReport.result as a separate, panel-specific Questionnaire, one per kind of test - each documenting the discrete fields a particular result type needs, in the same Questionnaire-as-computable-data-model style as Genomic Test Report and Genomic Test Order themselves (see How To Engineer (scale and deliver) Interoperability).

Report Panels

Report Panel Questionnaire Code Used In Status
Reportable Variant Result Panel LOINC 81250-3 "Discrete genetic variant panel" OMICS DSS Result Integration Grounded in real Variant examples
BCR-ABL Monitoring Result Panel LOINC 69380-4 "BCR-ABL1 fusion transcript … [# Ratio] … (International Scale)" BCR-ABL Monitoring Grounded in real Observation examples
Chimerism Testing Result Panel Local code (STR-based chimerism testing) Histocompatibility and Immunogenetics Candidate mapping, not yet confirmed against a real example - see the Questionnaire's own description

New result types should follow this pattern - add a new panel Questionnaire (rather than extending Genomic Test Report itself), and list it in the table above.

Genomic Results

classDiagram
    class GenomicReport["Genomic Laboratory Report (result)"]
    class Variant
    class GenomicStudy["Genomic Study"]
    class DiagnosticImplication["Diagnostic Implication"]
    class TherapeuticImplication["Therapeutic Implication"]
    class GenomicStudyAnalysis["Genomic Study Analysis"]

    Variant --|> GenomicReport 
    GenomicStudy --|> GenomicReport
    GenomicStudyAnalysis --|> GenomicReport
    DiagnosticImplication --|> GenomicReport
    TherapeuticImplication ..|> GenomicReport
    Variant <|--|> DiagnosticImplication
    Variant <|..|> TherapeuticImplication

The underlying HL7 FHIR profiles/resources this IG's genomic results are built from - either directly, or (where noted) via one of the Report Panels above:

Genomic Result Code Used In Report Panel
​Genomic Study (Procedure) - description - Examples below (Lynch syndrome, cystic fibrosis carrier) (none yet)
Genomic Study Analysis (extension on Genomic Study) LOINC 48002-0 "Genomic source class [Type]" Not yet confirmed against a real example (none yet)
Laboratory Analyte Result (Observation) - BCR-ABL Monitoring BCR-ABL Monitoring Result Panel
Reportable Variant (Observation) LOINC 48018-6 "Gene studied [ID]" (component) OMICS DSS Result Integration Reportable Variant Result Panel
Molecular Consequence (Observation) Sequence Ontology (functional-effect), e.g. SO_0001786 loss_of_heterozygosity OMICS DSS Result Integration - see Outstanding Issues for why Loss of Heterozygosity is modelled this way Reportable Variant Result Panel
Diagnostic Implication (Observation) - description - Examples below (Lynch syndrome, cystic fibrosis carrier) (none yet)
Histocompatibility and Immunogenetic Reporting - Histocompatibility and Immunogenetics Chimerism Testing Result Panel (candidate mapping by analogy, not confirmed - see the Questionnaire's own description)
Cytogenetic Genomic Report (this IG's own future/proposed model - no balloted HL7 profile exists yet) LOINC cytogenetics panels, e.g. 62389-2 (master panel), 62356-1 (ISCN), 62367-8 (FISH) Haemato-Oncology Diagnostic Pathway - Future genomic data model (proposed) (none yet - proposed direction only)

Examples

Inherited MMR deficiency (Lynch syndrome) - R210

HL7 LRI (Ref A) Example 2 (5.9.1.2) - FOUND DISCRETE – TARGETED MUTATIONS ANALYSIS THAT STUDIES MANY MUTATIONS (106)

Primary or Secondary Care Examples

Genetic Counseling Examples

Cystic fibrosis Carrier R184

HL7 LRI (Ref A) Example 3 (5.9.1.3) - SIMPLE VARIANT – MUTATION ANALYSIS WITH SEQUENCE PLUS DELETION-DUPLICATION STUDY

Profile: Questionnaire

LinkIDTextCardinalityTypeDescription & Constraintsdoco
.. The aim of this is to support conversion of Genomic Report (HL7 v2 ORU) for use by several NHS Trusts (as HL7 v2 or FHIR). Questionnaire https://fhir.nwgenomics.nhs.uk/Questionnaire/GenomicTestReport#2.2.0
... /Metadata Metadata 0..1 group Value Set:
.... LN/89061-6 NHS Number 0..1 string Definition: Patient.identifier:nhsNumber
Value Set:
.... LN/76435-7 Hospital Number (Medical Record Number) 1..1 string Definition: Patient.identifier:MedicalRecordNumber
Value Set:
.... LN/56797-4 Account Number (Episode or Stay Number) 0..1 string Definition: DiagnosticReport.encounter.identifier.value
Value Set:
..... LN/56797-4-designNote PV1-19 (also known as stay number) 0..1 display Value Set:
.... HL7/PV1-10 Hospital Service 0..1 choice Definition: Encounter.serviceType
Value Set: Service
... /81306-3 Overall study variables type (Test Details) 0..1 group Value Set:
.... LN/106194-4 Test request ID/Order ID/Order Placer Number 0..1 string Definition: ServiceRequest.identifier:OrderIdentifier
Value Set:
.... LN/106183-7 Order Filler Number 0..1 string Definition: ServiceRequest.identifier:OrderFillerNumber
Value Set:
.... HL7/OBR-3 Report Number 1..1 string Definition: DiagnosticReport.identifier:ReportNumber
Value Set:
.... HL7/ORC-21 Referring Organisation ODS Code / Ordering Facility 0..1 string Definition: PractitionerRole.organization.identifier.value
Value Set:
.... HL7/OBR-7 Report Date 1..1 dateTime Definition: DiagnosticReport.effectiveDateTime
Value Set:
.... HL7/OBR-25 Report Status 1..1 choice Definition: DiagnosticReport.status
Value Set: DiagnosticReportStatus
.... HL7/OBR-32 Results Interpreter 0..1 string Definition: DiagnosticReport.resultsInterpreter
Value Set:
..... HL7/OBR-32-designNote OBR-32 (Principal) and OBR-33 (Assistant) - see Practitioner Identifier. 0..1 display Value Set:
.... HL7/OBR-34 Performer (Operator/Technician) 0..1 string Definition: DiagnosticReport.performer:operator
Value Set:
.... DiagnosticReport/performer-organization Performer (Organisation) 0..1 string Definition: DiagnosticReport.performer:organization
Value Set:
..... DiagnosticReport/performer-organization-designNote The organisation that produced the report - see Organisation Code. No dedicated HL7 v2 field identified for this element. 0..1 display Value Set:
.... Specimen Specimen/Biopsy 0..1 group Definition: Specimen
Value Set:
..... LN/80398-1 Specimen ID Number 0..1 string Definition: Specimen.identifier
Value Set:
..... Specimen/accessionIdentifier Lab DNA Number (If Known) 0..1 string Definition: Specimen.accessionIdentifier
Value Set:
.... /81306-3/51967-8 Gene dis assessed 0..1 choice Definition: Observation.valueCodeableConcept
Value Set: Genomic Clinical Indication Codes
.... HL7/OBR-4-r Test Code 0..1 choice Definition: DiagnosticReport.code
Value Set:
..... HL7/OBR-4-r-designNote OBR-4, carried on the report. The same code is carried on the order as ServiceRequest.code - see Genomic Test Order. 0..1 display Value Set:
... /Results Results 0..1 group Definition: DiagnosticReport.result
Value Set:
.... /81306-3/51969-4 Gene analysis narr rpt Doc 0..1 string Definition: DiagnosticReport.presentedForm
Value Set:
.... DiagnosticReport/conclusion Conclusion 0..1 string Definition: DiagnosticReport.conclusion
Value Set:
..... DiagnosticReport/conclusion-designNote Free-text interpretive summary. No dedicated LOINC/OBX code identified for this element - see the Outcome item below for the coded equivalent. 0..1 display Value Set:
.... /81306-3/TESTOUTCOME Outcome (NHS England Genomics Test Outcome) 0..1 choice Definition: DiagnosticReport.conclusionCode.coding:GenomicTestOutcomeCode
Value Set: Genomic Test Outcome Codes
.... /Results/ReportPanels Individual test results are carried as separate, panel-specific Questionnaires nested under DiagnosticReport.result - see Report Panels below for the full list (e.g. Reportable Variant Result Panel, BCR-ABL Monitoring Result Panel, Chimerism Testing Result Panel). 0..1 display Value Set:

doco Documentation for this format

Profile: Questionnaire

Metadata

  • linkId: /Metadata
  • Answers:

NHS Number

Hospital Number (Medical Record Number)*

Account Number (Episode or Stay Number)

PV1-19 (also known as stay number)

  • linkId: LN/56797-4-designNote
  • Answers:

Hospital Service

Overall study variables type (Test Details)

  • linkId: /81306-3
  • Answers:

Test request ID/Order ID/Order Placer Number

Order Filler Number

Report Number*

Referring Organisation ODS Code / Ordering Facility

Report Date*

Report Status*

Results Interpreter

OBR-32 (Principal) and OBR-33 (Assistant) - see Practitioner Identifier.

  • linkId: HL7/OBR-32-designNote
  • Answers:

Performer (Operator/Technician)

Performer (Organisation)

The organisation that produced the report - see Organisation Code. No dedicated HL7 v2 field identified for this element.

  • linkId: DiagnosticReport/performer-organization-designNote
  • Answers:

Specimen/Biopsy

  • linkId: Specimen
  • Definition:: Specimen
  • Answers:

Specimen ID Number

Lab DNA Number (If Known)

Gene dis assessed

Test Code

OBR-4, carried on the report. The same code is carried on the order as ServiceRequest.code - see Genomic Test Order.

  • linkId: HL7/OBR-4-r-designNote
  • Answers:

Results

Gene analysis narr rpt Doc

Conclusion

Free-text interpretive summary. No dedicated LOINC/OBX code identified for this element - see the Outcome item below for the coded equivalent.

  • linkId: DiagnosticReport/conclusion-designNote
  • Answers:

Outcome (NHS England Genomics Test Outcome)

Individual test results are carried as separate, panel-specific Questionnaires nested under DiagnosticReport.result - see Report Panels below for the full list (e.g. Reportable Variant Result Panel, BCR-ABL Monitoring Result Panel, Chimerism Testing Result Panel).

  • linkId: /Results/ReportPanels
  • Answers:

Profile: Questionnaire

LinkIDDescription & Constraintsdoco
.. /Metadata Value Set:
... LN/89061-6 Definition: Patient.identifier:nhsNumber
Value Set:
... LN/76435-7 Definition: Patient.identifier:MedicalRecordNumber
Value Set:
... LN/56797-4 Definition: DiagnosticReport.encounter.identifier.value
Value Set:
.... LN/56797-4-designNote Value Set:
... HL7/PV1-10 Definition: Encounter.serviceType
Value Set: Service
.. /81306-3 Value Set:
... LN/106194-4 Definition: ServiceRequest.identifier:OrderIdentifier
Value Set:
... LN/106183-7 Definition: ServiceRequest.identifier:OrderFillerNumber
Value Set:
... HL7/OBR-3 Definition: DiagnosticReport.identifier:ReportNumber
Value Set:
... HL7/ORC-21 Definition: PractitionerRole.organization.identifier.value
Value Set:
... HL7/OBR-7 Definition: DiagnosticReport.effectiveDateTime
Value Set:
... HL7/OBR-25 Definition: DiagnosticReport.status
Value Set: DiagnosticReportStatus
... HL7/OBR-32 Definition: DiagnosticReport.resultsInterpreter
Value Set:
.... HL7/OBR-32-designNote Value Set:
... HL7/OBR-34 Definition: DiagnosticReport.performer:operator
Value Set:
... DiagnosticReport/performer-organization Definition: DiagnosticReport.performer:organization
Value Set:
.... DiagnosticReport/performer-organization-designNote Value Set:
... Specimen Definition: Specimen
Value Set:
.... LN/80398-1 Definition: Specimen.identifier
Value Set:
.... Specimen/accessionIdentifier Definition: Specimen.accessionIdentifier
Value Set:
... /81306-3/51967-8 Definition: Observation.valueCodeableConcept
Value Set: Genomic Clinical Indication Codes
... HL7/OBR-4-r Definition: DiagnosticReport.code
Value Set:
.... HL7/OBR-4-r-designNote Value Set:
.. /Results Definition: DiagnosticReport.result
Value Set:
... /81306-3/51969-4 Definition: DiagnosticReport.presentedForm
Value Set:
... DiagnosticReport/conclusion Definition: DiagnosticReport.conclusion
Value Set:
.... DiagnosticReport/conclusion-designNote Value Set:
... /81306-3/TESTOUTCOME Definition: DiagnosticReport.conclusionCode.coding:GenomicTestOutcomeCode
Value Set: Genomic Test Outcome Codes
... /Results/ReportPanels Value Set:

doco Documentation for this format

Test this Questionnaire

Try this questionnaire out:

Responses for this Questionnaire

There are currently no QuestionnaireResponse instances for this Questionnaire defined in this IG.