NHS North West Genomics
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NHS North West Genomics - Local Development build (v2.2.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Use Case: Cheshire and Merseyside Pathology

References

  1. Inter Laboratory Workflow (ILW) - the generic sub-order/reflex pattern this follows (LAB-35/LAB-36)
  2. Haemato-Oncology Diagnostic Pathway - the related HODS-orchestrated scenario
  3. Cancer Background Information for Use Cases - Colorectal Cancer Diagnostic Pathways - this use case can often occur around cancer
  4. LAB-40 HL7 v2.9 SET IHE Specimen Event Tracking (SET) and Hl7 v2.7 OSM_R26 Unsolicited Specimen Shipment Manifest Message

Clinical Pathway Overview

What is being tested

A genomic/molecular test that follows on from a pathology result - typically a tumour biopsy where the histology findings indicate that genomic testing is now needed (e.g. to identify a targetable mutation). Rather than the referring clinician placing a separate genomics order, the pathology laboratory reflexes the sample onward for genomic testing.

The end-to-end clinical journey

  1. Patient presents - a clinician orders a pathology test (e.g. on a biopsy) for a suspected condition, often cancer.
  2. Sample taken - the tissue/blood sample is collected and sent for pathology.
  3. Pathology testing performed - the pathology laboratory examines the sample. (LAB-1/LAB-3.)
  4. Genomic reflex, if indicated - based on the pathology finding, the sample is reflexed on for genomic testing, either by the pathology lab or (less commonly) ordered directly by the clinician. (LAB-35/LAB-36, or a separate LAB-1.)
  5. Genomic testing performed.
  6. Report reaches the clinician - either via the pathology laboratory or directly from genomics. (LAB-3.)
  7. Clinical decision - diagnosis and treatment planning is informed by the combined pathology and genomic result.
flowchart LR
    A[Pathology test ordered<br/>e.g. biopsy] --> B[Sample taken]
    B --> C[Pathology<br/>testing]
    C -->|Reflexed if indicated| D[Genomic<br/>testing]
    C --> E[Report reaches<br/>clinician]
    D --> E
    E --> F[Diagnosis and<br/>treatment planning]

Why this matters for developers

  • The genomic order can arrive two ways: reflexed from pathology (LAB-35/LAB-36) or placed directly by the clinician (LAB-1) - both must be supported, see the Transactions table below.
  • The reflex path reuses the ILW sub-order pattern even though pathology and genomics sit within the same NW region, rather than different Genomic Laboratory Hubs - this is a reflex-within-region use of the sub-order pattern, not a genuine external sub-contract.

Actors

IHE Actor Role System (example)
Order Placer Referring clinician MFT EPIC
Order Filler (receiving LAB-1) / Requestor (ILW, if sending LAB-35) Pathology laboratory MFT EPIC Beaker or CFT Shire
Order Filler / Subcontractor (ILW, if reflexed) Genomics laboratory iGene

Transactions

Transaction Description Direction
LAB-1 Laboratory Order (Pathology) Order Placer → Order Filler (Pathology)
LAB-3 Laboratory Report (Pathology) Order Filler (Pathology) → Order Placer
LAB-1 Laboratory Order (Genomics, if placed directly by Order Placer) Order Placer → Order Filler (Genomics)
LAB-35 Genomic Reflex Order (if placed by Pathology) Order Filler (Pathology) → Order Filler (Genomics)
LAB-36 Genomic Report (reflex) Order Filler (Genomics) → Order Filler (Pathology)
LAB-3 Laboratory Report (Genomics, either path) Order Filler (Genomics or Pathology) → Order Placer

Current Process

Use Case: Genomic Test Order following on from Pathology Test Order


graph TD;
    subgraph Pathology["Pathology - Greater Manchester ICS"]
        OrderPlacer[Order Placer<br/>e.g. MFT EPIC] --> |"1. Sends Laboratory Order (Pathology)<br/>ORM_O01 or OML_O21"| OrderFiller["Order Filler (Pathology)<br/>e.g. MFT EPIC Beaker or CFT Shire"]
        OrderPlacer --> |"2. Asks for (Orders)"| SpecimenCollection
        SpecimenCollection[Specimen Collection] --> |3. Sends Specimen| OrderFiller
        OrderFiller --> |4. Send Laboratory Report<br/>ORU_R01| OrderPlacer
    end 
    subgraph Genomics["Genomics - North West Region"]
      OrderPlacerG["Order Placer (Pathology)"] --> |5. Send Laboratory Order<br/>OML_O21| OrderFillerG["Order Filler (Genomics)<br/>e.g. iGene"]
      OrderPlacerG --> |6. Sends Specimen| OrderFillerG
      OrderFillerG --> |7. Sends Laboratory Report<br/>ORU_R01| OrderPlacerG
    end

    OrderFiller --> OrderPlacerG
    OrderFiller --> |8. Sends Laboratory Report<br/>ORU_R01| OrderPlacer

Genomic LTW Business Process - Use Case 3

Genomic LTW Business Process - Use Case 3


In this use case the original order is raised by the Order Placer and sent to a Pathology LIMS (Pathology Order Filler). The Pathology LIMS follows the processes outlined in Process Flow: Genomic Test Order and Process Flow: Genomic Test Report for pathology testing.
As part of this testing, the clinical process requires a genomics test to be performed. This genomics process is largely the same except for:

  • The order is sent as one interaction as the sample does not need to be collected.
  • The order should contain the pathology report detailing the results of the pathology tests.
sequenceDiagram


participant EPR as Order Placer
participant LIMSP as Order Filler (Pathology)
participant LIMSG as Order Filler (Genomics)


EPR ->> LIMSP: Submit Laboratory Order O21 (LAB-1)

LIMSP -->> LIMSP : Performs Test

opt Order Filler (Pathology) creates Genomic Order

    note over LIMSP,LIMSG: Same specimen can be reused for multiple tests

    LIMSP ->> LIMSG: Submit Genomic Reflex Order O21 (LAB-35)
    LIMSP -->> LIMSG: Send Specimen (not a technical interaction)
    LIMSG ->> LIMSP: Send Genomic Report R01 (LAB-36)
end

LIMSP ->> EPR: Send Laboratory Report R01 (LAB-3)

Main Process Flow

  • Initial Laboratory Order
    • Step 1: The Order Placer submits a Laboratory Order O21 (LAB-1) to Order Filler (Pathology).
    • Step 2: Order Filler (Pathology) sends back a Laboratory Report R01 (LAB-3).
    • Note: As required by local clinical guidelines, this step can also include imaging orders.
  • Optional Path 1 – Genomic Order created by original order placer
    • Condition: [Genomic Order created by original order placer].
    • Note: The same specimen can be reused for multiple tests.
    • Step 3: Order Placer submits a Genomic Order O21 (LAB-1) to Order Filler (Genomics).
    • Step 4: Specimen is sent from Order Placer to Genomics.
    • Step 5: Order Filler (Genomics) sends a Genomic Report R01 (LAB-3) back to the Order Placer.
  • Optional Path 2 – Genomic Order created by Pathology
    • Condition: [Order Filler (Pathology) creates Genomic Order].
    • Note: The same specimen can be reused for multiple tests.
    • Step 6: Order Filler (Pathology) submits a Genomic Order O21 (LAB-35) to Order Filler (Genomics).
    • Step 7: Specimen is sent from Pathology to Genomics.
    • Step 8: Order Filler (Genomics) sends a Genomic Report R01 (LAB-36) to Order Filler (Pathology).
    • Step 9: Pathology sends the Genomic Report R01 (LAB-3) to the Order Placer.

This use case can often occur around cancer - see Cancer Background Information for Use Cases for the Colorectal Cancer diagnostic pathway example.

Future Process

Use Case: Pathology Reflex Order Supplemented by Resource Exchange (PCC-44)

Rather than always duplicating pathology content in full into the genomic reflex order/message, the LAB-35 reflex order from Pathology could carry just enough to identify the pathology data it relates to - e.g. a Pathology Order Filler Number, Pathology Patient Identifier and/or Pathology Specimen Identifier, the same reference-based direction proposed on Cancer Test Additional Ask At Order Entry Questions's own Pathologist / Pathology hospital fields. If the Order Filler (Genomics) then finds it needs more pathology detail than the reflex order itself carries, it can use Resource Exchange (PCC-44) to query the Resource Access Provider on demand, rather than requiring Pathology to push everything up front - the same pattern NHS England Genomic Order Management Service (GOMS) already uses.

sequenceDiagram
    participant LIMSP as Order Filler (Pathology)
    participant LIMSG as Order Filler (Genomics)
    participant Provider as Resource Access Provider

    LIMSP ->> LIMSG: Submit Genomic Reflex Order O21 (LAB-35)
    opt Pathology detail in the reflex order is insufficient
        LIMSG ->> Provider: Resource Exchange (PCC-44) query - e.g. by<br/>Pathology Order Filler Number/Patient/Specimen identifier
        Provider -->> LIMSG: Respond with pathology resources<br/>(e.g. DiagnosticReport, Observation)
    end
    LIMSG -->> LIMSG: Performs genomic test
    LIMSG ->> LIMSP: Send Genomic Report R01 (LAB-36)

This keeps the reflex order itself lightweight while still letting genomics pull whatever additional pathology detail it needs, on demand, rather than the pathology LIMS/genomics order needing to anticipate and carry every field a downstream test might require.

Data Models

Examples

No example resources are published yet for this scenario.

Security Considerations

Includes:

Developer Guides

No Developer Guides notebook covers this use case yet.