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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

Track Name

“Tracing of implants from manufacturer to patient and registry”

Submitting WG/Project/Implementer Group

IHE Pharmacy, GS1 Netherlands, HL7

Justification

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.

Related tracks

Safe administration of medication in Cure and Care (MMA UBP)

Proposed Track Lead

Expected participants

  • 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?

Roles

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

Specs: http://www.ihe.net/uploadedFiles/Documents/Pharmacy/IHE_Pharm_Suppl_UBP.pdf

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

E.g. Touchstone.

Scenarios

Scenario 1 Step 1 Name, Action:, Precondition:, Success Criteria:, Bonus point:

Scenario 1 register a procedure in the EMR

Precondition:

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

Actions:

  1. EMR

    1. Do the procedure and register used implant in the EMR
      Scan the barcodes (Patient, Implant)
      Create/update the associated FHIR resources

  2. Integrator

    1. Send implant message to Implant Registry
  3. Implant Registry
    1. 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,

Actions:

  1. ...

  2. Integrator

    1. Get new procedures and used implants and submit to Implant Registry

    2. Get new explant procedures and submit to Implant Registry

Scenario 4 perform a recall

Actions:

  1. Inspectorate

    1. Receive a request from the implant manufacturer
  2. Implant Registry

    1. Get list of implants based on lot/batch for a recall and split per care provider

    2. ??? Send the list to each provider
  3. EMR
    1. 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

TestScript(s)


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?


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