1. Healthcare Product Supply Interoperability
Challenges and first steps
Presented by Jose Costa Teixeira August 2014

2. Summary
Scope
Ongoing work
Challenges
Process and Deliverables

3. Scope Support the current clinical flows with the “Supply” dimension.
Devices following the same rules as medication
Devices: “consumable” devices, implanted devices..
Should also support ancilliary devices like consumables, diagnostic and therapeutic devices..
Flexibility of procedures and flows
Software and Devices Vendors
Material flows
Business and Billing models
Operational preferences
Legal variations
Support emerging operational aspects:
Inventory maintenance and optimization
Traceability
Automatic product identification / authentication
Flexible billing

4. Preliminary/Ongoing work
Capture use cases
Pharmacy
Supply and Catalog
Other domains
Review literature and existing international guidance
Review in IHE DCC for establishing cross-domain work + new domain
Preparation HL7 alignment / Change proposals
Preparation DICOM supplement (Contrast administration)
Submit Work Item proposals
Prepare generic architecture
Some references (non standards):

5. Challenge 1: Clinical + Logistics
Clinical and Logistics processes have different perspectives. And they must coexist. There is no clear cut between Logistics and Clinical
Flow of information is continuous
Several activities may be done on either side
Convert internal or Clinical codes into Trade item codes
Aggregate several patient orders into one replenishment orders
Aggregate / split orders across shipments
Most organizations are expected to have mixed flows
Consignment + in-house inventory
Internal + external product codes
Patient-specific + bulk Ordering
Different billing models for different item types / suppliers
...
These vary per region, per product type...
Making an isolated “Logistics” process would not address real issues

6. Challenge 1: Solution Define pivotal processes, support variations
Support activities like “dispense” “prepare” whether they happen at bedside, or in pharmacy.
Define a unified international Profile
+ regional implementation guides

7. Challenge 2: Several Standards involved
Types of standards
Interoperability
Catalog of medicinal products
Logistic data exchange
Inventory Control
Supply Management
Ordering
Consumptions
Operational support (e.g. Billing)
AIDC
With semantics, international
Barcodes (e.g. GTIN)
RFIDs...
Without semantics
Barcodes (proprietary / internal numbering)
AIDC: Automatic Identification and Data Capture
AIDC = Automatic Identification and data capture

8. Challenge 2: Solution Profile standards (one of the key goals of IHE)
Align where needed (e.g. Harmonizations, CPs)
Define IHE model, detached from any specifics of the standards
Validate with key standards

9. Profiling example – Hospital Supply
HL7 v2
Wide adoption in Hospital systems
Message-based
GS1
Growing adoption in Healthcare logistics
Identification and message based
Broad scope
GS1-HL7 collaboration in place (MoU,...)
Different standards have different scopes and architectures, so an alignment is needed
MoU – Memo of Understanding between HL7 and GS1

10. Usage report & tracking
Predominant standards (typical)
Logistics (GS1)
Clinical (HL7)
Profiling summary example – WIP
Dispensing
Systems
Manufacturer
Distributor
Hospital
Point of care
Catalog maintenance
Selection of vendors | Pricing & Contracts | Update product data
Internal data (Clinical data, internal prices, usage rules, usage instructions)
Consult product data
Inventory management
Availability and recall
Permissions, availability, recall
Orders and returns
Stock orders and bulk orders
Point of care ordering & order processing
Consignment items
Usage report & tracking
Consignment items
Patient usage
Stock status, consumption
Billing
Patient charges / intra-hospital charges
Hospital billing

11. Continuity of Interoperability
Given the overlap of scope, the transition across standards must be continuous.
i.e. The profiles must ensure that the transition from e.g. HL7 to GS1 can happen in different points in the same process chain
Solution is to have one single interoperability architecture that can be implemented with different standards

12. Preliminary results1 (WIP)
Transaction
Name
GS1 XML v3.1
HL7 v2 .8 2
CAT-1
Catalog update request 3
CAT-2
Catalog update
Item Data Notification
MFN (WIP*)
SUP-1
Supply Order
Order
RDE / OMS
SUP-2
Order response
Order Response
WIP
SUP-3
Dispense notice
Dispatch Advice
RDS
SUP-4
Reception notice
Receiving Advice
SUP-5
Consumption report
Consumption Report
RDS (WIP)
INV-1
Refill request
Replenishment request
OMS
INV-2
Stock refill proposal
Replenishment proposal
N/A
INV-3
Inventory query
MFN? (WIP)
INV-4
Inventory update
INVRPT
*Work In Progress
1 Based on current work, these transactions should consist the basic building blocks for a working profile
2 Only as of v2.6 does HL7 have some of the mandatory mechanisms. V2.9 can be expected to incorporate present work
2 Profiling work in progress

13. Challenge 3: Traceability & Privacy
Full traceability is great but...
Is an additional constraint in order handling
e.g. Aggregating orders for several patients may break traceability
Is a special constrain in the delivery process
Keep item identification from source to use
May collide with privacy concerns
Use of specific (individualized) device or medication may expose private information. This information must therefore be protected.

14. Challenge 3: Traceability & Privacy
Answer:
Traceability and Privacy must be built-in, not “extra” transactions.
Reusing ATNA and other IHE (ITI) recommendations
Providing guidance for use

15. Challenge 4: Very big scope
Solution: iterative design (IHE way)
Start with well established models and needs.
Define an architecture which
Covers current needs
Is expandable to foreseeable cases
The results consists in using IHE as a methodology

16. Process and deliverables
Collect known needs from use cases
Delivery: White papers (IHE Pharmacy)
Supply
Catalog
Define and publish Architecture
Delivery: Technical Framework(s) (IHE Pharmacy, other domains)
Define national extensions (Deployment committees)
Delivery: National extentions (TF Vol. 4)
Validate (Connectathon) and iterate

17. Cross-profile and Cross-domain
PHARM HMW: Supply Mechanisms are foreseen
PHARM CMPD: No overlap (supply is from Pharmacy to Vendor)
RAD SWF: Integrated with SWF – New whitepaper proposed August 2014, deferred to 2015
Others TBD (part of the work)
No comment

18. Conclusion / next steps
IHE Whitepapers
Proposal (Done)
Acceptance (Done)
Writing (WIP)
Publication
Technical framework
Acceptance
Alignment with other domains
Writing (started in parallel with HMW)
Next: As described for Challenge 4:
Delimit the scope for a first deliverable, and advance on supply frameworks
Work cycle of IHE international

19. Healthcare Product Supply
Diagnosis or therapy usually requires products:
Medication, devices, consumables, nutrition products…
These products are explicitly requested or implicitly expected.
But a lot has to happen in the background for this to happen
Clinical workflows are not isolated from the management of these products and their supply and lifecycle (availability, traceability…)
We propose to handle the interoperability concerns of supply of health products

20. Example Use Cases Management of inventory, expired products…
Traceability
What items/batches have been given to patient X?
Which patients have been given batch ABC?
When ordering a product, physician considers availability …

21. Opportunity
Increasing awareness – traceability for patient safety, counterfeit drugs, operational efficiency
There are norms and guidance (e.g. GS1, HL7…)
Supply seems a side concern for most profiles
Pharmacy has an intrinsic concern – Usually pharmacies handle most materials, not only medication.
Other domains have their workflow – This diversity should be respected
IHE Pharmacy is outlining a vision, and does not want to go alone
Only by bridging to other domains can improvement be optimal:
For the patient
For the institutions

22. Goal Define an interoperability framework for supply, enabling:
Better patient safety by better information
Better management of operations
Close the gap between supplier and patient
Enable healthcare processes to be compatible with supply solutions and best practices
Integrate supply of medical products with the rest of enterprise interoperability

23. Integration with a clinical process (example)
Clinical path
Order
Processing
/ validation
Preparation
Administration
Transport,
inventory mgmt,
product identification
Besides supporting the procurement, purchase, labelling, distribution and preparation…
We can also integrate these concerns into the “clinical” process.
Purchasing…
Purchasing…
Materials path

24. Inside / outside logistics
For IHE, focus on the enterprise (institution, or group of institutions).
Articulate with – not redo – the supply mechanisms outside the institution

25. Scope Supply (e.g. of medication) Supply of Healthcare products
Supporting all expected distribution rules
Nominal/bulk dispense, consignment, ordered or ad-hoc
Supply of Healthcare products
Medication (obvious need)
Supporting / Extendable to all expected product types
Medical devices
Nutrition products
Other consumables
Non-traceable, batch- or serial-traceable.
Support other products and flows beyond “order” or “prescription”
Articulate with formulary / catalog; articulate with billing
Analyse (keeping flexibility) product coding, barcoding, RFID…
Enable best practices, not depend on them
Gather much existing knowledge into applicable guidance

26. Scope exclusions
Should not define rules like “How to calculate ideal stock levels”
=> concepts like “refill when stock reaches minimum” are use cases, not design constraints. Assuming them as universal would harm the model
Should not hardcode other business rules that may change with
Location
Regulation
Product type
Defining a business model is out of scope. We should provide support for communication.
“Anchor” or limit any freedom from supply chain or data is not good for interoperability - innovative models or views will exist and should be supported.
Should not replace formulary or catalog of items/services.
Must not enforce or block any billing options

27. Use Cases “Simple” order – supply (e.g. medication)
Forward and reverse traceability
Extra: support product recall
Internal redistribution (inventory balancing)
Product replacement
In daily operations due to shortage
After new purchase contract
Give the prescriber visibility about supply
Determine whether supply is limited
(easy for medication, more complex for long lead time products, or perishable items)

28. Business Vision Full bidirectional traceability
Identify shortage before ordering
Predict shortages before they happen
Review purchasing based on actual consumption
Allowing finer-grained forecasts?
Easy and safer identification of the right product

29. Changing the Way Healthcare CONNECTS