Clinical Laboratory Domain Update. Presented by François Macary ASIP Santé LAB planning committee cochair

Transcription

1 Clinical Laboratory Domain Update Presented by François Macary ASIP Santé LAB planning committee cochair

2 Agenda 1. IHE, an organization and a process 2. The Laboratory domain: history, scope, contributors, systems 3. Laboratory integration profiles 4. Focus on Laboratory Analytical Workflow 5. How to participate 2

3 Base Standards Why IHE? International standards represent usually the state-of-theart and the best-of-bread building blocks to build safe interoperable solutions in healthcare. However They often carry a big number of options to accommodate various situations in the World. They hardly say how one should combine them into an e-health solution involving multiple systems exchanging information with one another. IHTSDO IETF ehealth Projects 3

4 Base Standards IHE combines established standards and guides their implementation to cover a set of use cases. An implementation guide of a set of standards solving the needs for information exchange of a set of use cases, is called an Integration Profile. IHTSDO Use case IETF An Integration Profile ehealth Projects IHE is not a Standard Development Organization. IHE promotes the coordinated use of established standards 4

5 IHE basic terms An integration profile does not impose any particular architecture of systems, nor does it constrain the applications granularity. It identifies functional roles with precise information exchanges responsibilities assigned to them. These functional & interoperable roles are called Actors. A functionally homogenous flow of information between two Actors is called a Transaction. Example: Order Result Tracker Transaction [LAB-3] Order Results Management Na + level = 138 meq/l, in serum 07/24 7:30 am, from John Doe Order Filler This Actor could be played by: - a computerized physician order entry (CPOE) system - an integrated Hospital Information System (HIS) - an enterprise repository of diagnostic results 5

6 IHE International joins healthcare professionals and IT vendors to build robust and relevant interoperability specifications. IHE is organized per domains. The integration profiles of a domain are assembled into the domain Technical Framework. Each domain has a planning committee and a technical committee, or a single committee combining the two roles. 6

7 Connectathons Week-long testing sessions organized annually per continent (Japan, North- America, Europe ). Enable IT vendors to test the interoperability of their solutions with their peers. Accelerate the refinement of the specifications (integration profiles). Once finalized, the status of an Integration Profile changes from "Trial Implementation" to "Final Text", and the specification is then integrated into the domain Technical Framework. 7

8 The Laboratory domain Domain launched in First profile published and tested in General scope = in vitro diagnostic testing. Anatomic Pathology excluded (a separate domain: ANAPATH) Non invasive patient-performed tests excluded (PCD domain) Three sponsors spread on three continents: o JAHIS (Japan) o CAP (US) o ASIP Santé (France) Contributing countries: France, Japan, US, Italy, UK, NL, Germany, Belgium, Spain, Austria 8

9 IT Systems interested by IHE LAB integration profiles Electronic Healthcare Record Systems (EHR-S) in hospital and ambulatory care settings. Clinical lab and public health lab information systems (LIS) Electronic healthcare record shared infrastructures (PHR, HIE ) Robotic specimen container distributers and barcode labelers Automated devices in the laboratory work area (robotic transport systems, diluters, decappers ) IVD analyzers in laboratory or on the point of care Middleware systems handling a set of analyzers, in laboratory or on points of care. 9

10 The LAB domain integration profiles IHE Laboratory Technical Framework (IHE LAB TF) Volume 1: Profiles & Use Cases (user view) Volumes 2a, 2b: Transactions (implementer view) Volume 2x: Appendices - common material for Transactions Volume 3: Content Modules Supplements for Trial Implementation Inter-Laboratory Workflow (ILW) Profile TRIAL FINAL Laboratory Analytical Workflow (LAW) Profile "Graphics and simple Images in Results (GIR)" option on LTW Profile "Labels and Containers Delivered" option on LBL Profile Brief Description of Profiles developed by the Laboratory Domain 10

11 IT infrastructure profiles security ATNA CT patient administration PAM PDQ < Laboratory Integration Profiles > Blood specimen collection rooms Care providers (care settings, ambulatory providers) Clinical Laboratories Management LCSD: sharing lab tests code set LTW: tests performed in hospital lab LPOCT: point of care testing LBL: robotized distribution &labeling of specimen containers FINAL FINAL Automation FINAL FINAL LDA: laboratory automation document sharing XDS XDM XDR ILW: lab to lab XD-LAB: clinical or public health laboratory digital report FINAL TRIAL LAW: laboratory analytical workflow FINAL TRIAL 11

12 Established Profiles: The intra-hospital workflow Laboratory Testing Workflow (LTW) FINAL Ordering, scheduling, processing, and result reporting associated with IVD tests performed by clinical labs in healthcare institutions. 3 major use cases: Specimen collected by orderer Specimen collected by lab staff Specimen collected by 3rd party Systems involved: HIS/EMR, LIS, LAS/middlewares Value proposition: Enhances quality of care (reduces manual copy, redundant orders, orphan or lost specimens, transcription errors). Improves throughput (saves phone calls and paper reports, streamlines tests scheduling, processing, reporting). Standard: HL

13 Example of a set of systems implementing LTW 13

14 Established Profiles: Point of care testing Laboratory Point Of Care Testing (LPOCT) FINAL IVD tests performed on the point of care or on patient bedside by caregivers, under the supervision of a clinical laboratory of the institution. Systems involved: HIS/EMR, LIS, point of care devices and data managers Value proposition: Shortcut for clinicians who produce and use their results at once for a limited panel of tests. Minimizes patient blood collection. The supervision by a clinical lab ensures a stable level of quality of thr point of care testing process. Combined with the LTW profile and with PAM or PDQ profiles. Standard: POCT1-A from CLSI (which includes HL ORU) 14

15 LPOCT in combination with LTW and [PAM / PDQ] Clinical wards Option patient identity checking 15

16 Established Profiles: Robotization Lab Barcode Labeling (LBL) Robotized delivery and labeling of containers at blood sample collection. Systems involved: HIS/EMR, LIS, Robotic container selector & barcode printer. Value proposition: Avoids selection of inadequate containers and prevents misidentification. Streamlines specimen collection. May be combined with LTW to let the LIS steer the printing of barcode labels performed by the CIS. Lab Device Automation (LDA) Automation of pre and postanalytical steps, such as specimen transportation, centrifugation, aliquoting, decapping, storage... Systems involved: middleware, pre/post-analytical devices. Value proposition: Streamlines the operations in the lab work area. Combined with LTW with the middleware playing a pivot role. 16

17 Established Profiles: synchronize the test dictionaries Laboratory Code Set Distribution (LCSD) Enables an application (e.g.; a LIS) owning a code set (batteries, tests and observations) to share it with other applications to further support data exchange between them. Systems: LIS, HIS/EMR, middleware, Value proposition Reduces time of configuration of the interfaces between applications. Smoothes the maintenance of the interfaces over time. FINAL Standard: HL7 2.5 Chapt. 8 (master files) 17

18 Established Profiles: Sharing electronic lab reports Sharing Laboratory Report (XD-LAB) FINAL A unique electronic format for the exchange/sharing of lab reports. Systems: LIS as content creator, HIS/EMR/EHR as content consumer, HIE/PHR as document registry/repository Value proposition Both human-readable and machine-processable: The narrative text of each section is derived from the entry of structured data, carried below it. May carry reportable conditions or outbreak identification, as structured data, therefore also usable in public health. Standards: HL7 v3 CDA R2 LOINC, UCUM 18

19 IVD analyzers connectivity Laboratory Analytical Workflow (LAW) TRIAL A multi-year joint effort of the IHE LAB Committee and the IVD Industry Connectivity Consortium (IICC) Purpose: exchange of information related to patient and QC test orders & their results between IVD testing systems and health informatics systems (LIS, middleware, ) Analytical Work Order Step: A panel or test to be performed on a specimen in a container, assigned to an analyzer 19

20 LAW profile TRIAL Value proposition: Reduces complexity and variability of data exchange with IVD testing systems. Simplifies installations and maintenance of connections LIS or middleware Query for AWOS [LAB-27] Analyzer Manager AWOS Broadcast [LAB-28] AWOS Status Change [LAB-29] Standards: HL pre-adoptions from 2.8 & 2.9 LOINC recommended UCUM IVD testing system Analyzer Release 1 was tested at Europe 2012 connectathon (Bern, Switzerland) 7 systems (4 Analyzers, 3 AM) passed successfully 20

21 LAW profile release 2 to be published on early September Brings clarifications on: Observation identification Orders and results vocabularies Error handling Enhancements: Possibility to use an external storage for bulk data associated with results Transmission of supplemental results (e.g.; graphs, images, raw values) Retransmission Handling of multiple runs Microbiology AWOS and results, representation of an isolate Parent results & child orders AWOS update IICC member vendors coming to next North-American connectathon, to test this release 2. Rendez-vous in Chicago next January! 21

22 A future profile in construction: Laboratory Clinical Communication (LCC) This new profile will enable rapid, standardized, automated capture of and response to problems related to orders and questions about results, between clinician and lab staff. It will allow this information to be logged, tracked, and included in QA studies and process improvement projects. Systems: LIS HIS/EMR/EHR Profile dependencies: Combined with LTW profile 22

23 LCC raises the questions LTW carries the responses LCC Transaction LTW Transaction Ordering physician Laboratory staff Order Placer Q R [LAB-6] Proposal for replacement of an order [LAB-1] Order replacement Order Filler Order Result Tracker Q R [LAB-7] Request for verification of a result [LAB-3] Result correction or confirmation 23

24 If you want to contribute Apply for IHE International Organizational Membership it s Free Visit: (note IP Policy) Approved monthly by IHE International Board Review IHE's 600+ Organizational Members: Join IHE Laboratory Planning & Technical Committees contact: lab@ihe.net Mailing list: Non-members can also participate: Review & comment during Supplement Public Comment period Implement IHE Profiles and test them at connectathons 24

25 Thank you The complete program of educational webinars IHE International IHE Europe () provides the connectathon results matrix Overview of the 135 existing integration profiles 25