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
Where the Order Placer sends the Laboratory Order to the Order Filler, the lab performs the test and then sends the Laboratory Report back to the Order Placer. However, variations can exist such as the order is updated or the order is entered directly on the Order Fillersystem (these are currently out of scope).
Use Case: Genomic Test Order
An order is created by the clinical practice and placed to the laboratory.
Genomics Test Order Activity
Select Genomic Test Order Form
Within the system creating the genomics order, the practitioner will select a form for the test required. Below are several examples from North West Genomic Laboratory Hub - Test Request Forms.
How this is implemented will vary between different NHS organisations and systems they use.
NW GLH Genomic Testing Request Form – Rare Disease
Request for Genetic Testing for Haemoglobinopathies
Complete Genomic Test Order Form
These forms may (/will?) will have a computable definition called an template (FHIR Questionnaire) which will list the technical content requirements for the form. At present only one archetype has been defined:
For submission, this form will be converted by the Order Placer to a communication format called HL7 FHIR (and for compatability reasons HL7 v2.
If the Order Placer has a FHIR enabled Electronic Patient Record (e.g. EPIC, Cerner, Meditech, etc), they may use HL7 SDC - Form Data Extraction to assist with this process.
The FHIR exchange style used FHIR Message following laboratory-order message definition. This definition is based on HL7 v2 OML_O21 Laboratory Order which simplifies conversion to/from pipe+hat (v2) and json (FHIR) formats.
At present the NW GLH Laboratory Information Management System (LIMS) will not support HL7 FHIR. The Regional Integration Exchange (RIE) will perform conversion between v2 and FHIR formats.
It is not expected the NW GLH Laboratory Information Management System (LIMS) will support UK SNOMED CT, and the RIE will handle the conversion either internally using FHIR ConceptMap or a terminology service with the following capabilities IHE Sharing Valuesets, Codes, and Maps (SVCM)
Collect Sample and Update Genomic Test Order
After submitting the original order, the sample will be collected and sent to the Order Filler. The Order Filler will update the Test Order to include details such as a specimen collection date, order filler number, etc.
Use Case: Genomic Test Report
A report is created by the clinical practice and sent to the order result tracker.
Perform Diagnostic Test → Write Preliminary Report (Order Filler).
Send (Preliminary) Genomic Test Report IHE LAB-3 from the Order Filler to the Intermediary (RIE).
RIE sends HL7 v2 message Laboratory Report ORU_R01 to the Order Placer.
The same HL7 v2 message is also sent from the Intermediary to the Order Placer.
Final Report Stage
Complete Report (Order Filler).
Send (Final) Genomic Test Report IHE LAB-3 from the Order Filler to the Intermediary (RIE).
RIE sends HL7 v2 message Laboratory Report ORU_R01 to the Order Placer.
Completion Notification
When all tests in the order are complete, a Task Complete Notification is sent to the Order Placer.
This notification can be sent via email or another messaging system.
Use Case: Genomic Test Order following on from Pathology Test Order
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 Use Case 1: Genomic Test Order and Use Case 2: 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.
Multiple Diagnostic Tests - LAB-1 and 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-2) 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
Message translation and code conversion: The Regional Integration Engine (RIE) handles translations and code mappings to and from the Genomic Order Management Service FHIR API.
Routing of orders and reports: The RIE routes orders and reports for other GMSAs through the Genomic Order Management Service FHIR API.
Regional workflow consistency: Existing regional workflows remain largely unchanged, with both HL7 v2 and FHIR standardised across the region.
Report compatibility: Reports are aligned with neighbouring Welsh NHS systems, using DHCW HL7 v2 ORU as the core model for both HL7 v2 and FHIR in the North West.
Relationship to NHS England Genomic Order Management Service
Relationship to NHS England Pathology
This guide builds on the use cases described in the NHS England Pathology FHIR Implementation Guide, extending them to support a wider range of stakeholders and introducing standards for the Laboratory Order LAB-1.
Order Placer role: The GP Electronic Patient Record (EPR) System and the Order Communications System together form the Order Placer role, which may also be fulfilled by other EPR systems.
Intermediary between Order Placer and Order Filler: This intermediary performs message translation and code conversion.
Order Result Tracker role: For results, the GP EPR System acts as the Order Result Tracker, though other systems (e.g. Secondary Care EPR) can provide this function.
Intermediary between Order Filler and Order Result Tracker: This intermediary also handles message translation and code conversion.
Canonical model: A standardised model (Canonical model), expressed in HL7 FHIR, that can be implemented using HL7 v2, FHIR, and IHE XDS. It aligns with the latest HL7 UK Core and NHS England Data Model and Dictionary. While primarily focused on genomics, it incorporates elements from pathology and radiology for compatibility, and mandates the use of NHS England National Procedure Codes.
Relationship to NHS England Pathology
Security Considerations
TODO - is OAuth2 based using client credentials flow.
including use of JWT access tokens and including future support for SMART-on-FHIR Scopes)
FHIR AuditEvent for Logging Access
TLS for Transport Security
Cross-Profile Considerations
It is recommended that the actors receive patient demographic and encounter updates only within the
context of a work order. Whenever patient data changes, due to: