Background information: https://docs.google.com/document/d/1sXh4PS7cGO1xx1EqmxAblQm-S1HlKLBmRCo94JGMHWI/edit
Background InfoGraphics (Dutch): https://www.nictiz.nl/wp-content/uploads/2018/09/NIC_infographic_LIR_def.pdf
When: 9 nov 2018 Q1-Q4
“Tracing of implants from manufacturer to patient and registry”
Submitting WG/Project/Implementer Group
IHE Pharmacy, GS1 Netherlands, HL7
We describe this use case for the Dutch situation, but the flow is generic so should also work for other countries and regions. The focus will be on the FHIR interactions (with the EMR as focus) for the Dutch HL7 Connectathon and FHIR devdays.
There is a need for traceability of implants from manufacturer through the supply chain up and until the patient. One of the crucial elements to be able to realise this is the prevalence of standardised information in a standardised barcode. Regulation and national agreements are driving the use of such information and barcodes which is referred to as the ‘Unique Device Identifier’ (UDI): EU MDR, ADC, LIR. The standards to be used as a UDI are GS1 and HIBC.
To be able to process the standardised information within the healthcare providers systems a IHE profile for Uniform Barcode Processing (UBP) is created.
This use case is scalable to other registries like the Dutch Arthoplastry Implant Registry (LROI), the Dutch Breast Implant registry (DBIR) and has a strong relationship with the Dutch MedMij, VIPP and Registratie aan de bron/Eenheid van taal programs.
Proposed Track Lead
- Esther Peelen
- Michael Tan
- Michael van der Zel
- See Connectathon_Track_Lead_Responsibilities for more details
Hospital Integrator (ICT) or Hospital Integration Team Member (UMCG Arnoud Homan & Mathijs Koning)
MediCore (epd en integrator) roles
Ruud Koreman (LIR)
Chris van der Togt (LROI)
Hinne Rakhorst NVPC (DBIR)
Someone from GS1 (GS1)?? Expand barcode, lookup details in GDSN?
Please include information here regarding how much advance preparation will be required if creating a client and/or server.
Make sure you have client and server software accessible. For creating demo data it is a good idea to have some FHIR JSON/XML example editor like Eclipse, Forge, or VSCode and a tool to upload the examples to a test FHIR service, like Postman.
Role 1 IHE UBP Barcode processor
Demo Implementation Sourecode: https://github.com/mvdzel/ihe-ubp-fhir
Demo reader/consumer app: https://vdzel.home.xs4all.nl/ihe-barcode-demo/
Role 2 EMR (Mock) - Barcode reader/consumer
The server https://vonk.test-nictiz.nl/ acts as a MedMij Test server. It is loaded with all the conformance resources from this Simplifier project: https://simplifier.net/nictizstu3-zib2017 and should have a lot of examples that conform to those resources
Role 3 Integrator / Broker - Cloverleaf / Mirth / Ensemble with FHIR support
Role 4 Implant Registry (LIR, LROI, DBIR)
Specs and examples: https://github.com/mvdzel/lir-fhir
Role 5 Test Lab Platform
Scenario 1 Step 1 Name, Action:, Precondition:, Success Criteria:, Bonus point:
Scenario 1 register a procedure in the EMR
EMR has received implant details from logistics department to OR supply (which in turn looked them up in GDSN)
associated FHIR resources are present in EMR
Do the procedure and register used implant in the EMR
Scan the barcodes (Patient, Implant)
Create/update the associated FHIR resources
- Send implant message to Implant Registry
- Implant Registry
- Check and store the Implant message
Scenario 2 register an explant in the EMR
Same as scenario 1, but then an explant message
Scenario 3 alternative for 1 / 2 (& 5)
Same as scenario 1 and 2 (& 5), but now as a batch,
Get new procedures and used implants and submit to Implant Registry
Get new explant procedures and submit to Implant Registry
Scenario 4 perform a recall
- Receive a request from the implant manufacturer
Get list of implants based on lot/batch for a recall and split per care provider
- ??? Send the list to each provider
Get list of patients based on list of implants
Scenario 5 DELETE a faulty registration
Currently the LIR specifications do not specify how.
FHIR DELETE? - Epic proposes to send a decease message and then a new implant message.
Bonus points (for all scenarios):
Lookup barcode details in GDSN using IHE UBP
Test data (for all scenarios)
Patient = 12345678
Procedure = 234234234
Implant UDI = (01)234234xxxx
Security and Privacy Considerations
Resource must be anonymized/masked when submitted to the Implant Registry.
Identification of hospital through AGB or URA or Client Certificate?