Point-of-Care Overview Gliwice November 1 7 th , 200 8

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

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

POS Basics • Whatis 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, physician’s-office testing, and patient self testing.

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

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

Connectivity System Components • 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 • 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 • DeviceInterface • Governs the flow of information between devices and Observation Reviewers • ObservationReportingInterface (EDI interface) • Describes messaging between Observation Reviewers and Observation Recipients

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

POS Interfaces • The DML allows bidirectional data exchange concerning the following topics: • Device Status • Observations • Patient Tests • Calibration Tests • Quality Tests • Liquid QC • Electronic QC • Calibration Verification • Proficiency Test • Device Events • Update Lists • Operator List • Patient List • Directives • Basic (e.g., Lockout, Goto Standby) • Complex (e.g., Set Time) • Vendor-specific • Vendor-specific Data

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

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

POS Interfaces • 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

Device Messaging Layer • MessageFlow • 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 • MessageEncoding • POC Device Messaging Layer’s messages leverage the XML encoding rules defined in HL7 version 3 • Example: Simple Glucose Messages

Device Messaging Layer MessageEncoding

Observation Reporting Interface • 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 • 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 • MessageExample • 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 • 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 • 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 • 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 doesn’t support that input capability or the accession number isn’t 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

Many thanks for your attention! Iwona Machowska Marketing & New Business ManagerTel. +48 600 375 376Email: iwona.machowska@codeconcept.pl Ul. Toszecka 101/22244-100 Gliwice, PolandTel. 48 32 23 00 290www.codeconcept.pl

Point-of-Care Overview Gliwice November 1 7 th , 200 8