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IVD Industry Connectivity Consortium (IICC) Introducing the IVD Industry Connectivity Consortium Ed Heierman CTO, IVD Industry Connectivity Consortium.

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Presentation on theme: "IVD Industry Connectivity Consortium (IICC) Introducing the IVD Industry Connectivity Consortium Ed Heierman CTO, IVD Industry Connectivity Consortium."— Presentation transcript:

1 IVD Industry Connectivity Consortium (IICC) Introducing the IVD Industry Connectivity Consortium Ed Heierman CTO, IVD Industry Connectivity Consortium March 2011

2 IVD Industry Connectivity Consortium (IICC) Target outcomes for the clinical laboratory industry4 Collaborations with leading standards organizations3 Foundation of IVD Industry Connectivity Consortium2 Why we need to modernize analyzer connectivity1 Agenda Next Steps5

3 IVD Industry Connectivity Consortium (IICC) How does connectivity work today? LIS, Middleware HIS, EMR Analyzer Standards for Orders & Results: CLSI LIS-1 / LIS-2 (ASTM) HL7 2.x, HL7 3.x IHE Lab LDA (based on HL7 2.5, 2.51) Standards for Orders & Results: HL7 2.x, HL7 3 HITSP C163 (built on HL ) ELINCS (built on HL7 2.4) IHE Lab LTW (built on HL7 2.5, 2.5.1) Others (e.g. LIDDEx)

4 IVD Industry Connectivity Consortium (IICC) How does connectivity work today? LIS, Middleware Analyzer 2. IT vendor develops driver based on interface spec for analyzer 1. Analyzer vendor develops custom ASTM interface for analyzer 3. Laboratory and vendors configure driver based on local lab configuration 4. Laboratory and vendors validate connectivity $

5 IVD Industry Connectivity Consortium (IICC) How does connectivity work today? LIS, Middleware Analyzer 2. IT vendor develops driver based on interface spec for analyzer 1. Analyzer vendor develops custom ASTM interface for analyzer 3. Laboratory and vendors configure driver based on local lab configuration 4. Laboratory and vendors validate connectivity Repeat for each new analyzer $

6 IVD Industry Connectivity Consortium (IICC) How does connectivity work today? LIS, Middleware Analyzer 2. IT vendor develops driver based on interface spec for analyzer 1. Analyzer vendor develops custom ASTM interface for analyzer 3. Laboratory and vendors configure driver based on local lab configuration 4. Laboratory and vendors validate connectivity Repeat for new analyzer feature $

7 IVD Industry Connectivity Consortium (IICC) How does connectivity work today? LIS, Middleware Analyzer 2. IT vendor develops driver based on interface spec for analyzer 1. Analyzer vendor develops custom ASTM interface for analyzer 3. Laboratory and vendors configure driver based on local lab configuration 4. Laboratory and vendors validate connectivity Repeat per analyzer installation $

8 IVD Industry Connectivity Consortium (IICC) Reducing complexity will reduce time and cost Time and money spent on interfacing should be spent elsewhere The ideal endpoint is plug and play interoperability Complexity can be reduced via elimination of variability in standards implementation at three layers: Use Case Layer (major variation) Messaging Layer (major variation) Low Level Layer (minor variation)

9 IVD Industry Connectivity Consortium (IICC) Target outcomes for the clinical laboratory industry4 Collaborations with leading standards organizations3 Foundation of IVD Industry Connectivity Consortium2 Why we need to modernize analyzer connectivity1 Agenda Next Steps5

10 IVD Industry Connectivity Consortium (IICC) Mission To create and ensure adoption of an interoperable connectivity paradigm to reduce the complexity and variability of data exchange between IVD testing systems and healthcare informatics systems reduce the complexity and variability of data exchange 1

11 IVD Industry Connectivity Consortium (IICC) Mission To create and ensure adoption of an interoperable connectivity paradigm to reduce the complexity and variability of data exchange between IVD testing systems and healthcare informatics systems interoperable connectivity paradigm 2

12 IVD Industry Connectivity Consortium (IICC) Mission To create and ensure adoption of an interoperable connectivity paradigm to reduce the complexity and variability of data exchange between IVD testing systems and healthcare informatics systems create and ensure adoption 3

13 IVD Industry Connectivity Consortium (IICC) Mission To create and ensure adoption of an interoperable connectivity paradigm to reduce the complexity and variability of data exchange between IVD testing systems and healthcare informatics systems between IVD testing systems and healthcare informatics systems 4

14 IVD Industry Connectivity Consortium (IICC) Scope: Absolutely Global Most labs may be country-oriented, but most IVD products are sold globally We have to balance differences between Europe, US, Japan, and others We have to ensure that national efforts keep globalization in mind (e.g. HITSP)

15 IVD Industry Connectivity Consortium (IICC) Scope: Types of data flows In Scope: IVD Test Orders (Patient & Quality Control) IVD Test Results (Patient & Quality Control) Out of Scope (Potential Future Effort): Calibration Data Configuration Information Process Status Monitoring

16 IVD Industry Connectivity Consortium (IICC) Scope: Types of IVD testing In Scope (Priority Order): 1.Clinical Chemistry 2.Immunoassay 3.Hematology 4.Hemostasis 5.Microbiology 6.Molecular Out of Scope: Point of Care Anatomic Pathology Imaging

17 IVD Industry Connectivity Consortium (IICC) Scope: Types of IT systems In Scope: IICC will cover the transmission of orders and results between IT systems and IVD analyzers IICC will not attempt to distinguish the roles of different types of IT systems (e.g. LIS, middleware, automation manager) Out of Scope: IICC will not attempt to standardize the features of IT systems – only their external connectivity IICC is not specifically focused on middleware

18 IVD Industry Connectivity Consortium (IICC) Board of Directors: Eric Olson (Siemens), Jay Jones (Geisinger), Jean-Claude Lugeon (Roche), Carl Murray (Beckman Coulter) Eric Olson (Siemens) President Scott Goss (Abbott) Treasurer & Secretary Ed Heierman (Abbott) Chief Technology Officer Jean Rhame (AACC) Chief Marketing Officer Jay Jones (Geisinger) Provider Review Chair Provider Review Committee Dr. Jay Jones (Geisinger) Dr. Ken Blick (U. Oklahoma) Dr. Anand Dighe (Mass General) Dr. Jan Dols (U. van Amsterdam) Dr. Ralf Englert (MVZ Clotten) Dr. Alfredo Enguix (U. Virgen de la Victoria) Dr. William Neeley (Detroit Medical) Leo Serrano (Avera McKennan) Technical Leadership Team Rob Bush (Orchard) Andrzej Knafel (Roche) Andrea Pitkus (CAP) Christophe Reynaud (bioMerieux) Marketing Team Vesna Swartz (Siemens) Lena Chow (City of Paris) Member Organizations: Abbott Diagnostics, Beckman Coulter, Becton Dickinson, bioMerieux, Data Innovations, Orchard Software, Ortho Clinical Diagnostics, Roche Diagnostics, Siemens Healthcare, Systelab Technical Team Members: Jean Benech (bioMerieux), Christophe Delpy (bioMerieux), David Fallas (Sysmex), Oday Hameed (Abbott), Ed Harshberger (bioMerieux), Jean-Christophe Hurpeau (bioMerieux), Marta Jaremek (Siemens), Steward Macis (Antek), Daniel Moncusi (Systelab), Jon Morris (Siemens), Bill Ormerod (Siemens), Dan Roberts (Siemens), Butch Schleicher (bioMerieux), Jordi Treserres (Systelab), Andy Weyl (Siemens), Bill Williams (Abbott), Andrew Young (Beckman Coulter) Effective Jun 1, 2011

19 IVD Industry Connectivity Consortium (IICC) Target outcomes for the clinical laboratory industry4 Collaborations with leading standards organizations3 Foundation of IVD Industry Connectivity Consortium2 Why we need to modernize analyzer connectivity1 Agenda Next Steps5

20 IVD Industry Connectivity Consortium (IICC) IICC has partnered with CLSI, IHE, and HL7 Use Case Layer Partner with IHE Build on the work of IHEs LDA (Lab Device Automation) Message Layer Partner with HL7 Build on the work of HL7s v2.x Standard Low Level Layer Partner with HL7 Build on the work of HL7s MLLP (Minimal Low Level Protocol) Technology Adoption Partner with CLSI Laboratory standards publication, e.g. a new LIS standard

21 IVD Industry Connectivity Consortium (IICC) Partnership with IHE LAB Leverage the talents of the active members of IHE LAB Build from LDA profile that is the closest our industry has come to achieving interoperability Utilize IHEs approach to constraining standards Utilize IHEs approach to demonstrating conformance Connectathons Showcases

22 IVD Industry Connectivity Consortium (IICC) Target outcomes for the clinical laboratory industry4 Collaborations with leading standards organizations3 Foundation of IVD Industry Connectivity Consortium2 Why we need to modernize analyzer connectivity1 Agenda Next Steps5

23 IVD Industry Connectivity Consortium (IICC) Development of new IHE Laboratory Profile Split LDA (Laboratory Device Automation) into two profiles LDA Automation Manager Pre/post processor LAW (Laboratory Analytical Workflow) Analyzer Manager Analyzer Create international implementation guide that defines the minimum set of interactions required for plug-n-play Provides basic functionality Optional interactions can be supported though configuration changes

24 IVD Industry Connectivity Consortium (IICC) Extend IHE Use Cases Providing Partial Coverage Unsolicited new Work Order Step (WOS) download Unsolicited WOS update or cancel LD query for WOS for specific specimen(s) WOS manually entered at LD Upload to AM final results generated on LD Rerun decided on LD Rerun decided on AM

25 IVD Industry Connectivity Consortium (IICC) Incorporate Additional Use Cases into the LAW Profile LD query for WOS for all specimens LD informs AM about WOS validity status Upload to AM preliminary results generated on LD Retransmit results to AM AM informs LD about observation validity status Pooling of patient specimens Reflex test decided on LD Reflex test decided on AM

26 IVD Industry Connectivity Consortium (IICC) Summary of Baseline Standard Selection Considered ASTM, HL7 v2.x, and HL7 v3 Basic Messaging Requirements: Evaluated standards against basic messaging requirements Reviewed with domain experts HL7 v3 (89%) > HL7 v2.x (83%) > ASTM (37%) Use Case Considerations: Developed IICC Use Cases using IHE as a starting point Evaluated standards support for use cases HL7 v3 (91%) = HL7 v2.x (91%) > ASTM (59%) Low Level Considerations: Established low level scope and requirements Evaluated standards support for low level recommendations HL7 v3 (68%) > HL7 v2.x (62%) > ASTM (55%) Evaluated Nontechnical Considerations

27 IVD Industry Connectivity Consortium (IICC) Baseline Standard Selection Status Calculate the scores and combine it in the standard evaluation matrix with the analysis by Use Cases, Messaging, and Low Level Protocol teams. Evaluation input by technical teams Resulting score

28 IVD Industry Connectivity Consortium (IICC) Evaluation Score Summary HL7 v2.x:69.2 HL7 v3:50.4 ASTM 1394 / CLSI LIS-2:56.2

29 IVD Industry Connectivity Consortium (IICC) Target outcomes for the clinical laboratory industry4 Collaborations with leading standards organizations3 Foundation of IVD Industry Connectivity Consortium2 Why we need to modernize analyzer connectivity1 Agenda 5Next Steps

30 IVD Industry Connectivity Consortium (IICC) Next Steps Leverage expertise of HL7 Orders and Observations Working Group Answer questions on usage of HL7 v2.x Review HL7 v2.8 change proposals IICC/IHE will submit topics for weekly teleconference calls Finalize Selection of HL7 v2.x Standard Initial target is v2.5.1 Wide spread usage Currently used by IHE Lab profiles Analysis indicates nearly 100% coverage Will re-evaluate based on change proposals Test Interface at a 2012 IHE Connectathon Trial implementation ready by November 2011 Sign-up vendors for participation IVD testing systems Healthcare informatics systems Demonstrate connectivity at various events (HIMSS, etc.) following connectathon

31 IVD Industry Connectivity Consortium (IICC) Milestones Complete Draft LAW Vol 1 Profile (Use Case Definitions) May 2011 Submit CLSI Project Proposal for New Standard Based on LAW Profile Jun 2011 CLSI Consensus Committee EndorsementJul 2011 Complete Draft LAW Vol 2 Transactions (HL7 Message Definitions) Sep 2011 Public Comment Period for LAW ProfileOct 2011 Publish Trial Implementation of LAW ProfileNov 2011 Initiate CLSI Document Development Committee Activities Dec 2011 IHE-Europe Connectathon Testing for LAW Profile Apr 2012 Publish CLSI Standard (15-month, Track 1 Document) Mar 2013


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