IHE: Clinical Laboratory Domain

1. IHE: Clinical Laboratory Domain François Macary AGFA Healthcare IT IHE Laboratory Committee Co-chair IHE-NL Conferentie

2. IHE Clinical Laboratory Domain • Introduction • Established profiles • Laboratory Scheduled WorkFlow • New profiles for 2006 connectathon • Laboratory Point Of Care Testing (LPOCT) • Laboratory Device Automation (LDA) • Laboratory Code Set Distribution (LCSD) • Laboratory Information Reconciliation (LIR) • Future plans IHE-NL Conferentie

3. IHE Clinical Laboratory Domain • Introduction • Established profiles • Laboratory Scheduled WorkFlow • New profiles for 2006 connectathon • Laboratory Point Of Care Testing (LPOCT) • Laboratory Device Automation (LDA) • Laboratory Code Set Distribution (LCSD) • Laboratory Information Reconciliation (LIR) • Future plans IHE-NL Conferentie

4. Contributing countries France Japan Germany Italy The Netherlands UK US (NCCLS) The IHE Laboratory Committee Cochairs: Yoshimitsu Takagi - Hitachi Francois Macary - Agfa Healthcare IT 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 IHE-NL Conferentie

5. Laboratory Technical Framework General scope: • Ordering, placing, scheduling and performing clinical laboratory tests within acute care settings. • In vitro testing • Microbiology included. • Anatomic pathology and blood bank excluded. IHE-NL Conferentie

6. 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 IHE-NL Conferentie

7. IHE Clinical Laboratory Domain • Introduction • Established profiles • Laboratory Scheduled WorkFlow • New profiles for 2006 connectathon • Laboratory Device Automation (LDA) • Laboratory Point Of Care Testing (LPOCT) • Laboratory Code Set Distribution (LCSD) • Laboratory Information Reconciliation (LIR) • Future plans IHE-NL Conferentie

8. Scope of LSWF profile • Integrate the clinical laboratory in the care setting • Ordering, scheduling, performing clinical laboratory tests • Delivering the results accurately • In vitro testing: All specialties working on specimen • Bound to clinical biology (pathology excluded) IHE-NL Conferentie

9. Added value in order management • Two parallel flows synchronized • The electronic order • The specimen(s) required to perform the order • A dynamic process • Specimen added by the placer to a running time study • Specimen rejected by the filler (damaged or spoiled), tests held in wait for a new specimen • Unordered test added by the filler (e.g. antibiogram in microbiology) IHE-NL Conferentie

10. Added value in results management • Results transmitted at various steps of completeness depending upon the analyte, the ordering ward, the clinical state of the patient, the treatment • Management of corrections, cancellations, • Flagging non validated results • Presentation to the clinician in the appropriate sorting order IHE-NL Conferentie

11. LSWF: Three major use cases • 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 IHE-NL Conferentie

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

13. Choice of the standard • Need for an international standard, fully implementable with guides and tools ready for use • Supporting specimen and container management  HL7 v2.5 IHE-NL Conferentie

14. IHE Clinical Laboratory Domain • Introduction • Established profiles • Laboratory Scheduled WorkFlow • New profiles for 2006 connectathon • Laboratory Device Automation (LDA) • Laboratory Point Of Care Testing (LPOCT) • Laboratory Code Set Distribution (LCSD) • Laboratory Information Reconciliation (LIR) • Future plans IHE-NL Conferentie

15. Laboratory Device Automation (LDA) Work Order Steps LDA Demographics Demographics ADT Clinical Laboratory Placer order Order Placer Order Filler Filler order Work order Results Results Order Result Tracker Automation Manager LSWF IHE-NL Conferentie

16. 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. IHE-NL Conferentie

17. Example of workflow Perform electrolye Work Order for serum n° 123 Blood specimen Step 1: Convey to decapper Step 4: Query for test? Test Na, K, Cl Send the results Step 2: decap centrifuging Step 3: Convey to chemistry analyzer Schedules steps 1 to 4 Downloads steps 1, 2, 3 Automation Manager Chemistry Analyzer decapper Robotic Specimen Transportation System Serum IHE-NL Conferentie

18. IHE Clinical Laboratory Domain • Introduction • Established profiles • Laboratory Scheduled WorkFlow • New profiles for 2006 connectathon • Laboratory Device Automation (LDA) • Laboratory Point Of Care Testing (LPOCT) • Laboratory Code Set Distribution (LCSD) • Laboratory Information Reconciliation (LIR) • Future plans IHE-NL Conferentie

19. Scope of LPOCT • 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 IHE-NL Conferentie

20. 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 requires its supervision by a clinical laboratory. IHE-NL Conferentie

21. 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. IHE-NL Conferentie

22. The IHE 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 IHE-NL Conferentie

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

24. Five major use cases • Observations to match with an existing order, real-time patient identity checking • Unordered observations, real-time patient identity checking • Unordered observations on a POCRG with an intermitent link (no patient identity check) • Manual entry of unordered observations • QC results IHE-NL Conferentie

25. Use case 1: LPOCT /LSWF Order Result Tracker Order Placer Order Filler POCDM POCRG LAB-1: New POCT order Specimen to test for a patient Order entered LAB-30: Check patient identity Test performed, LAB-31: Produced observations set LAB-32 Accepted observations set LAB-1: Order Results received clinical validation LAB-1: Order completed LAB-3: Results validated IHE-NL Conferentie

26. Selected standard POCT 1-A by NCCLS (now called CLSI) Based on HL7 standards: • Early V3 between the device and the POCDM • V2.5 between the POCDM and the LIS (Order Filler IHE-NL Conferentie

27. IHE Clinical Laboratory Domain • Introduction • Established profiles • Laboratory Scheduled WorkFlow • New profiles for 2006 connectathon • Laboratory Device Automation (LDA) • Laboratory Point Of Care Testing (LPOCT) • Laboratory Code Set Distribution (LCSD) • Laboratory Information Reconciliation (LIR) • Future plans IHE-NL Conferentie

28. 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 … IHE-NL Conferentie

29. Laboratory Code Set Distribution Actors/Transaction Laboratory Code Set Master Grouped with: Order Filler, Enterprise Common Repository … LAB-51: Laboratory Code Set Management Grouped with: Order Placer, Order Result Tracker, Order Filler, … Laboratory Code Set Consumer IHE-NL Conferentie

30. Laboratory Code Set Distribution Use Case 1 Laboratory Code Set Master Laboratory Code Set Consumer Creates observation-test -battery codes Laboratory Code Set Management (REP) 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. IHE-NL Conferentie

31. 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 IHE-NL Conferentie

32. IHE Clinical Laboratory Domain • Introduction • Established profiles • Laboratory Scheduled WorkFlow • New profiles for 2006 connectathon • Laboratory Device Automation (LDA) • Laboratory Point Of Care Testing (LPOCT) • Laboratory Code Set Distribution (LCSD) • Laboratory Information Reconciliation (LIR) • Future plans IHE-NL Conferentie

33. Laboratory Information Reconciliation (LIR) • Reconcile clinical lab observations produced on specimens collected from misidentified or unidentified patient. • Reconcile clinical lab observations produced on specimens before the orders be created. • LIR profile depends upon LSWF and LDA profiles IHE-NL Conferentie

34. Future plans • Incorporate analyzer images in the result workflow • Cross-enterprise sharing of lab reports, using Clinical Document Architecture • Specimen labels workflow • IHE documentation available on www.ihe.net • & www.ihe-europe.org • & www.gmsih.fr/IHE • Thank you for your attention… IHE-NL Conferentie