1. September, 2005What IHE Delivers 1 HIMSS 2006 – Interoperability Showcase François Macary, AGFA HCES IHE Lab Committee co-chair IHE Clinical Laboratory Update

2. 2 Agenda Lab domain: Scope and Work Reminder of Lab Scheduled Workflow Lab Device Automation Lab Information Reconciliation Lab Point Of Care Testing Lab Code Set Distribution

3. 3 Laboratory Technical Framework General scope: Ordering, placing, scheduling and performing clinical laboratory tests within acute care settings. Bound to in vitro testing Microbiology included. Pathology and blood banks excluded. The first profile LSWF addresses acute care settings

4. 4 The major problems to solve Reduce over-ordering and over blood-drawing By consolidating the lab results in a common repository shared by all wards in charge with the patient By sharing the opened orders Bring the accurate lab results to the clinician, in time for clinical decision Without flooding the ward with paper reports Without flooding the lab with phone calls

5. 5 The IHE Laboratory Committee Contributing countries France Japan Germany Italy The Netherlands UK US (1 from CLSI) Development started in 2003 1st profile in November 2003 10 systems validated in 2004 12 systems validated in 2005 4 new profiles for connectathon 2006 Cochairs: Yoshimitsu Takagi - Hitachi Francois Macary - Agfa Healthcare IT

6. 6 Laboratory Scheduled WorkFlow Externally placed order with identified specimens Specimens identified on the container with a barcode label Externally placed order with specimens unidentified or to be collected by the laboratory The specimens unidentified in the message placing the order Filler order with specimens identified by the laboratory Order created in lab. Order number allocated afterwards Three major use cases:

7. 7 Patient Administration Clinical Laboratory Ward or EHR Lab-1: Placer order Lab-2: Filler order Rad1, Rad-12 Patient demographics & visit Lab-5: Results Rad-1, Rad-12 Lab-3: Results Lab-4: Work order Order Result Tracker ADT Automation Manager Order Placer Order Filler IHE Laboratory: LSWF

8. 8 Laboratory Device Automation (LDA) Order FillerOrder Placer Order Result Tracker ADT Placer order Filler order Demographics Results Demographics Results Work order LSWF LDA Work Order Steps AnalyzerPre/post processor Automation Manager

9. 9 Scope of LDA Workflow between an Automation Manager and its set of automated devices. Each Work Order is split into a sequence of steps, each of which uses a specimen on a device. Scope limited to devices operated by the lab staff.

10. 10 No candidate for year 2006? AutomationManager LIS vendors Small companies with specialized software …Sometimes bought by devices manufacturers Analyzers Pre/post analytic devices Manufacturers No standard available One standard available: ASTM E1394 + one future ISO standard IHE proposed one common standard: HL7 2.5 – chap 13

11. 11 Laboratory Information Reconciliation (LIR) Reconcile clinical lab observations produced on specimens collected from misidentified or unidentified patient. (Same thing as PIR in Radio land) Reconcile clinical lab observations produced on specimens before the orders are created: Results for unknown orders. (Different from PIR) LIR profile depends upon LSWF and LDA profiles No added transactions

12. 12 LIR: one example of process flow

13. 13 Laboratory Point Of Care Testing In vitro tests performed on point of care or patient bedside specimen collected, tested at once and eliminated No pre or post-processing Results used immediately by the care provider Supervision by a clinical laboratory of the hospital Training provided to the ward staff Provision of reagent Supervision of quality control Clinical validation a posteriori Scope:

14. 14 Benefits of LPOCT Results obtained at once increases the efficiency of clinical decisions Minimizes the blood quantity drawn from the patient, because of the immediate use of the specimen. E.g. Two drops are enough to test blood gas, electrolyte and hematocrit of a new-born baby. Preserving a high level of quality of the POCT process through its supervision by a clinical laboratory.

15. 15 Examples of LPOCT Portable blood gaz and chemistry analyzer used by the nurse in a neonatology ward Blood gas analyzer permanently installed in the surgery theater Glucometer used by the patient in home care Workstation on which the nurse manually enters the results of pregnancy stick tests.

16. 16 The Actors of LPOCT Point Of Care Result Generator (POCRG) Produces the results from a specimen by testing on a specimen, or calculation or manual entry Point Of Care Data Manager (POCDM) Administers a set of POCRG, controls their process. Collects the patient and QC results. Forwards the patient results to the Order Filler Order Filler Recipient of POCT results. Stores the results within orders. Performs a posteriori clinical validation Point of care results Point of care patient results

17. 17 Ward Clinical laboratory LPOCT: Actors and Transactions Point Of Care Result Generator Point Of Care Data Manager Order Filler Lab-32: Accepted observation set (patient results) Lab-31: Performed observation set (patient or QC results) Lab-30: Initiate testing on a specimen POCDM and Order Filler are assumed to be provided with up-to-date patient demographic data (for instance by PAM or PDQ)

18. 18 Five major use cases 1. Observations to match with an existing order, real-time patient identity checking 2. Unordered observations, real-time patient identity checking 3. Unordered observations on a POCRG with an intermittent link (no patient identity check) 4. Manual entry of unordered observations 5. QC results

19. 19 Selected standard POCRGPOCDMOrder Filler HL7 v2.5 Based on HL7 early v3 in XML POCT 1-A, published by CLSI (ex NCCLS)

20. 20 Laboratory Code Set Distribution The goal of this profile is to simplify the configuration of the systems involved in the Laboratory Scheduled Workflow. The Laboratory Code Set Distribution Profile offers the means to share the same set of test/observation codes between different actors. Other information can be also exchanged like presentation of results, laboratory codes (in which lab a test is performed), units …

21. 21 Replaces Observation/Test/Battery Code Sets All Observation, Test and Battery code sets of the Consumer are replaced by the code sets sent by the Master. This Use Case is used both for initialization as well as periodic (weekly, monthly) update. LCSD: Use Case 1 Laboratory Code Set Consumer Creates observation, test, battery codes LAB-51: Laboratory Code Set Management (REP) Laboratory Code Set Master

22. 22 LCSD - Standard used HL7 V2.5: Master Files Messages rich enough to transport other information than just observation/test/battery codes : presentation of the results Units of measure Laboratories fulfilling this test

23. 23 Next Steps for IHE Lab in 2006 CDA rel 2 Lab Report Beyond need to request/receive results, also need to share/distribute complete validated lab reports with structured tests results as one object. Laboratory results communicated via messaging are point-to-point (request/result) and not human readable Laboratory results can only be shared when approved for release by an authorized source: a document oriented laboratory report is needed. Human readable and structured coded lab reports are necessary in a wide variety of Patient Care Coordination use cases

24. 24 As a Provider or Vendor Contributor Offer Clinical Use Case Input to Drive IHE Profile Development Become a member of relevant domains Planning or Technical Committees Become a member of relevant Regional/National Committees Help to shape IHEs future direction As a Vendor Participant Respond to Public Comments of Domain Supplements Attend the June Educational Workshop Participate in Connect-a-thons and Demonstrations As a Provider/Consultant Participant Respond to Public Comments of Domain Supplements Attend the June Educational Workshop Attend Demonstrations and include IHE Integration Profiles in your RFPs and Integration Projects. How can I participate?

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26. 26 IHE Web site: www.IHE.net Frequently Asked Questions Integration Profiles in Technical Frameworks: See Volume 1 of each TF for Use cases Cardiology IT Infrastructure Laboratory Patient Care Coordination Radiology Connectathon Result: www.ihe.net/Events/connectathon_results.cfm Vendor Products Integration Statements Participation in Committees & Connectathons