North West Genomic Medicine Service Alliance - Local Development build (v0.0.7) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
It transmits the observation results from the Order Filler to the Order Result Tracker, when a result is acquired, clinically validated, modified, or deleted at the Order Filler level.
Regional Order Results management [LAB-3] Component Diagram
Options
IHE LTW LAB-3 Modernisation Options
Traditional Workflow
Traditional Workflow
This is the most widely used method for exchanging laboratory reports and is based on the HL7 v2 ORU_R01 message. Currently, many NHS trusts and laboratories use custom implementations of this standard, which are adapted via Trust Integration Engines (TIE). To reduce integration costs and enhance regional interoperability, we propose developing a regional standard for ORU_R01. This will build upon the Digital Health and Care Wales - HL7 ORU_R01 2.5.1 Implementation Guide (as NHS England has not issued equivalent guidance) and incorporate elements from:
Reports will be shared in PDF format, potentially limited to regionally placed orders (supported by complementary integration methods).
The regional ORU_R01 design is not specific to genomics and can be reused across the six regional diagnostic networks (including imaging and pathology).
IHE LTW Traditional Workflow Option
Workflow Steps
Order Placement
The Order Placer sends a Laboratory Order O21 (IHE LTW LAB-1) to the Order Filler.
Test Execution
The Order Filler performs the laboratory test (internal step).
Optional Preliminary Report
The Order Filler may send a Laboratory Report (preliminary) R01 (IHE LTW LAB-3) back to the Order Placer.
This is marked as optional (opt) in the diagram.
Final Report
The Order Filler sends the Laboratory Report (final) R01 (IHE LTW LAB-3) to the Order Placer.
Regional Order Results management [LAB-3] Sequence Diagram
Regional Genomic Data Sharing
Regional Genomic Data Sharing
One major limitation of the traditional workflow is that reports are only accessible within systems that received them via HL7 v2 ORU_R01. This phase introduces a regional Clinical Data Repository (CDR) for genomics, accessible to all care providers in the region.
The CDR will be built using the InterSystems FHIR Repository and follow FHIR RESTful/IHE QEDm (PCC-44) standards. In future phases, it will connect to the national Genomics CDR through a Health Information Exchange (HIE) integration pattern.
Initially, the CDR will be populated by converting HL7 v2 ORU_R01 (and OML_O21) messages into HL7 FHIR, with additional data sources providing structured genomic reports based on the Genomics Reporting Implementation Guide. This will also serve as a useful resource for HL7 v2 developers, offering insights into converting v2 messages into FHIR.
Shared Patient Genomic Record Option
Flow Description
Methods of populating the Clinical Data Repository
Laboratory Order Submission
The Order Placer sends a copy of the laboratory order (O21) to the Clinical Data Repository.
This follows the IHE LTW LAB-1 profile.
Laboratory Test Execution
The Order Filler performs the test (internal action).
Preliminary Laboratory Report (Optional)
A preliminary lab report (R01) may be sent to the Clinical Data Repository.
This uses IHE LTW LAB-3.
Final Laboratory Report
A final lab report (R01) is sent to the Clinical Data Repository.
This also uses IHE LTW LAB-3.
Using the Clinical Data Repository
Querying Genomic Data
The Practitioner queries the Shared Patient Genomic Repository using IHE QEDm PCC-44.
Results Returned
The Clinical Data Repository sends back the results to the Practitioner.
Order Fulfillment Tasking
This introduces an alternative way of requesting a laboratory order which is based on FHIR Workflow
Order Fulfillment Tasking
In this workflow, both the order and report are shared instead of being sent. The communication between the Order Placer and Filler changes to a conversation rather than messaging pattern around the Fulfillment Task.
Flow Description:
Order Creation
The Order Placer creates an order (e.g., a laboratory test order).
Order Fulfillment Task (requested)
The Order Placer sends an Order Fulfillment Task request to the Order Filler.
Query Repository for Order Details (IHE QEDm PCC-44)
The Order Filler queries a repository to retrieve the detailed order information, using the IHE QEDm PCC-44 profile.
Order Fulfillment Task (accepted)
The Order Filler accepts the order and confirms receipt.
At this stage, the laboratory or service acknowledges that it will perform the requested task.
Order Fulfillment Task (in-progress)
The Order Filler begins processing the order.
Internally, this corresponds to starting testing.
Testing Completion & Report Generation
Once the testing is finished, the Order Filler writes the report.
The Order Fulfillment Task is marked as completed.
Query Repository for Laboratory Report (IHE QEDm PCC-44)
The Order Placer queries the repository to retrieve the laboratory report produced by the Order Filler.
The NHS Trust system creates a laboratory order (Order O21, IHE LTW LAB-1).
This order is sent to the Regional Integration Engine.
Order Fulfillment Request
The RIE sends an Order Fulfillment Task (requested) to the Order Filler.
Order Details Query
The Order Filler queries the repository for laboratory order details (IHE QEDm PCC-44).
Order Acceptance
The Order Filler accepts the order fulfillment task and sends acknowledgment back to the RIE.
Order Processing (Testing Phase)
The Order Filler begins testing (internally marked as “Start testing”).
It updates the RIE with Order Fulfillment Task (in-progress).
Order Completion
After completing tests and writing the report (internally marked “Finish testing and Write Report”),
The Order Filler sends Order Fulfillment Task (completed) back to the RIE.
Report Query and Distribution
The RIE queries the repository for the laboratory report (IHE QEDm PCC-44).
The final Laboratory Report (R01, IHE LTW LAB-3) is sent to the NHS Trust system.
Key Notes
Traditional HL7 v2/IHE LTW messages (O21, R01, LAB-1, LAB-3) are used alongside FHIR task-based workflow messages (requested, accepted, in-progress, completed).
The RIE acts as a bridge, integrating traditional order management with modern FHIR-based fulfillment.
The Order Filler (GOMS) is also a bridge linking to other Order Fillers which perform the actual testing and provides results back through this combined workflow.
Communication Task, Subscription, and Event Notifications
This phase introduces real-time notification support, similar to online order tracking where updates are sent via email or SMS.
The Practitioner sends a subscription request (e.g., to an Order, Report, or other clinical resource) to the Regional Integration Engine.
This is based on the FHIR Subscription standard.
Communication Request
Alternatively, the Practitioner may send a CommunicationRequest Task to the Integration Engine.
The Integration Engine converts this task into a Subscription, ensuring the Practitioner will receive updates when relevant events occur.
Event Notification (when event occurs)
Once the subscribed event occurs (e.g., new lab report, status update, or order completion), the Regional Integration Engine sends an Event Notification back to the Practitioner.
This closes the loop, ensuring the Practitioner is informed in real time.
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