1. Point-of-Care Overview Gliwice November 17 th, 2008

2. POC Basics Connectivity System Components POC Interfaces Device Messaging Layer Observation Reporting Interface Agenda

3. What is POS? Point-of-Care testing is defined as various testing conducted near the site of patient care. It incorporates different environments, including hospital based testing, near-patient testing, physicians-office testing, and patient self testing. POS Basics

4. POC Connectivity Allow seamless multi-vendor interoperability and communication between point-of-care devices, data concentrators, and clinical information systems. Provide framework for engineers to design devices, workstations and interface for multiple types and brands of POC devices to communicate bi- directionally with access points, data concentrators, and laboratory information systems from variety of vendors. POS Basics

5. What is POC Standard? The core of the standard is a group of specifications developed by the Connectivity Industry Consortium (CIC). Describes the attributes of an access point; the communication protocols between the device and access point; communication between a data manager and clinical information system. POS Basics

6. Evolution of POC standards Cooperative effort of: providers, manufacturers, representatives of: CIC NCCLS HL7 IEEE CAP FDA JCCLS IFCC POS Basics

7. POC Basics Connectivity System Components POC Interfaces Device Messaging Layer Observation Reporting Interface Agenda

8. Point-of-Care Device Hand-held devices; test modules that are part of the other instrumentation (patient monitor, for example); or small, bench-top analyzers Connectivity System Components

9. Access Point Allow to communicate with an Observation Reviewer to report results and exchange information Connectivity System Components

10. The Observation Reviewer (POC Data Manager) The primary role of an Observation Reviewer is to host one or more services to which point-of-care diagnostic devices connect. Services hosted by an Observation Reviewer may exchange data with existing information systems that already exist in the hospital laboratory Connectivity System Components

11. The Observation Recipient (LIS, CDR, or EMR) In many cases, the final resting place of a point-of-care diagnostic test observation is inside an Observation Recipient system Typically, LIS or Clinical Data Repository (CDR) systems fill the role of Observation Recipient Connectivity System Components

12. Device Interface Governs the flow of information between devices and Observation Reviewers Observation Reporting Interface (EDI interface) Describes messaging between Observation Reviewers and Observation Recipients Connectivity System Components

13. POC Basics Connectivity System Components POC Interfaces Device Messaging Layer Observation Reporting Interface Agenda

14. DML Device Messaging Layer specification describes the dialog between a device and Observation Reviewer POS Interfaces

15. The DML allows bidirectional data exchange concerning the following topics: I.Device Status II.Observations 1.Patient Tests 2.Calibration Tests 3.Quality Tests i.Liquid QC ii.Electronic QC iii.Calibration Verification iv.Proficiency Test III.Device Events IV.Update Lists 1.Operator List 2.Patient List V.Directives 1.Basic (e.g., Lockout, Goto Standby) 2.Complex (e.g., Set Time) 3.Vendor-specific VI.Vendor-specific Data POS Interfaces

16. DAP Device Access Point specification defines a law cost, flexible means to reliably communicate messages between POC Device and Observation Reviewer POS Interfaces

17. DAP and DML interfaces are layered on top one another in the OSI model POS Interfaces DML DAP

18. Observation Reporting Interface – facilities the communication of test results and orders information between Observation Reviewers and Observation Recipients The interface provides bidirectional flow between these services POS Interfaces

19. POC Basics Connectivity System Components POC Interfaces Device Messaging Layer Observation Reporting Interface Agenda

20. Message Flow In general, the communication between the Device and Observation Reviewer can be described at a high – level in terms of dialog between two actors Example: Scheme of base profile message flow Device Messaging Layer

21. Message Encoding POC Device Messaging Layers messages leverage the XML encoding rules defined in HL7 version 3 Example: Simple Glucose Messages Device Messaging Layer

22. Message Encoding Device Messaging Layer

23. POC Basics Connectivity System Components POC Interfaces Device Messaging Layer Observation Reporting Interface Agenda

24. EDI employs existing HL7 messages, segments, and fields in order to communicate test results and ordering information Four new triggers (as compared to HL7 v2.4) are defined for HL7 ORU message As long as the final implementation uses the messages and fields defined in POCT1 specification ( ORU^R30, ORU^R31, ORU^R32, ACK^R33 ), the resulting interface is compliant with the POCT1 Observation Reporting Interface specification Observation Reporting Interface

25. Individual institutions or deployments may have additional requirements beyond addressed by POCT1 specification Message fields not defined for use by POCT1 specification may be used to support these site-specific requirements Observation Reporting Interface

26. Message Example Sample message exchange, preordered test with single- valued result ORU^32 – Observation result message from POCT1DMS- OBSREV to POCT1LIS-OBSRCPT sent 6/10/00 1:03:55 Observation Reporting Interface

27. ORU^30 Unordered Observation – Place Order One example of this use case occurs when a doctor verbally instructs a nurse to perform a test To allow the Observation Reviewers correlate every result with its associated order, the Observation Recipient will return the newly created Order ID in the application-level acknowledgement to this ORU^30 message Observation Reporting Interface

28. ORU^31 New Observation – Search for an Order In this case, the Observation Reviewers does not know if an order has been placed This trigger instructs the Observation Recipient to search for an existing order for the associated results Observation Reporting Interface

29. ORU^32 Preordered Observation In this case order information is provided by either of the following schemes: The user enters an accession number at the POC Device when performing test If the Device doesnt support that input capability or the accession number isnt known at the point-of-care, the Observation Reviewer (e.g., POC Data Manager) retrospectively determines the appropriate order to match to the test result Observation Reporting Interface

30. Many thanks for your attention! Iwona Machowska Marketing & New Business Manager Tel. +48 600 375 376 Email: iwona.machowska@codeconcept.pl Ul. Toszecka 101/222 44-100 Gliwice, Poland Tel. 48 32 23 00 290 www.codeconcept.pl