1. Presented by Jose Costa TeixeiraJanuary 2015 Healthcare Product Supply Interoperability Challenges and first steps

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 Related preparation work: DICOM supplement (Contrast administration, WIP) Findings: Interest in the topic Big scope Very big variance of adoption of standards. No clear guidance. IHE can provide guidance, but we are finding gaps

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 OrderingConsumptions Operational support (e.g. Billing) AIDC With semantics, international Barcodes (e.g. GTIN) RFIDs... Without semantics Barcodes (proprietary / internal numbering) RFIDs... 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

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

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 results 1 (WIP) TransactionName GS1 XML v3.1HL7 v2.8 2 CAT-1 Catalog update request 33 CAT-2 Catalog update Item Data NotificationMFN? SUP-1 Supply Order OrderRDE / OMS? SUP-2 Order response Order ResponseWIP SUP-3 Dispense notice Dispatch AdviceRDS? SUP-4 Reception notice Receiving AdviceWIP SUP-5 Consumption report Consumption ReportRDS? (WIP) INV-1 Refill request Replenishment requestOMS? INV-2 Stock refill proposal Replenishment proposalN/A INV-3 Inventory query 3 MFN? (WIP) INV-4 Inventory update INVRPT MFN? (WIP) 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 3 Profiling work in progress or needs to start

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 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. Proposed Process 1.Collect known needs from use cases Delivery: White papers (IHE Pharmacy) Supply (Order and Inventory management) Catalog 2.Create backlog of open issues for discussion 1.Where to place our common backlog of things to discuss/change? Wiki (so far: google drive + wiki)? 3.Define standards (SDOs) and profile them (IHE) 1.IHE profiling choices will be reviewed by HL7 and GS1. 2.Proposals/gaps in standards will be reviewed by all and traced from the common requirement set

17. (Probable) items in the backlog Catalog Update Request + Catalog Update Request and Send the list of products available for ordering Dispense Order The same as prescription? If not, which message/event/resource? Receipt Notice V2 implementation? Which message/event/resource? Is there a difference between “reception of an item” and “tracking of an item”?...

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