1. Clinical Laboratory Domain New Integration Profiles Clinical Laboratory Domain New Integration Profiles Charles Parisot GE Healthcare IHE IT Technical Committee Co-chair François Macary AGFA Healthcare IT IHE Laboratory Committee Co-chair

2. IHE Lab today and to-morrow Five profiles: –Laboratory Scheduled Workflow (LSWF) –Laboratory Information Reconciliation (LIR) –Laboratory Point Of Care Testing (LPOCT) –Laboratory Device Automation (LDA) –Laboratory Code Set Distribution (LCSD) Future plans –Incorporate analyzer images in the result workflow –Cross-enterprise sharing of lab reports, using CDA-R2 –Specimen labels workflow Ordering, placing, scheduling and performing clinical laboratory tests both for Hospital and Ambulatory. Microbiology included. Anatomic pathology and blood bank excluded

3. Laboratory Information Reconciliation Match clinical lab observations produced on specimens collected from misidentified or unidentified patient with the patients record. Match clinical lab observations produced on specimens with orders created afterwards, either in the Order Placer or in the Order Filler application. LIR profile depends upon LSWF and LDA profiles

4. 1.Unidentified Patient registered at ADT. Clinical lab tests ordered at Order Placer level. 2.Unidentified Patient registered at ADT. Clinical lab tests ordered at Order Filler level. 3.Unidentified Patient registered at Order Placer. Clinical lab tests ordered at Order Placer level. 4.Unidentified Patient registered at Order Filler. Clinical lab tests ordered at Order Filler level. Laboratory Information Reconciliation Use Cases 1, 2, 3, 4 The Unidentified Patient cases cover scenarios in which the care situation requires that tests be ordered immediately, even before proper Patient registration. It also covers the scenario of tests performed before the order is entered, whether the patient is identified or not.

5. 5.Clinical lab tests performed on laboratory automation before creation of the order. The order is created automatically from the results. The order is created afterwards at Order Filler and matched to the results. Laboratory Information Reconciliation Use Case 5 LIR also covers the scenario of tests performed before the order is entered, no matter the patient is identified or not.

6. IHE Lab today and to-morrow Five profiles: –Laboratory Scheduled Workflow (LSWF) –Laboratory Information Reconciliation (LIR) –Laboratory Device Automation (LDA) –Laboratory Point Of Care Testing (LPOCT) –Laboratory Code Set Distribution (LCSD) Future plans –Incorporate analyzer images in the result workflow –Cross-enterprise sharing of lab reports, using CDA-R2 –Specimen labels workflow Ordering, placing, scheduling and performing clinical laboratory tests both for Hospital and Ambulatory. Microbiology included. Anatomic pathology and blood bank excluded

7. 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 Automation Manager Clinical Laboratory

8. Scope of LDA Integration Profile Workflow between an Automation Manager and the automated devices that it handles. Workflow specimen based: A sequence of steps, each of which uses a specimen on a device. Scope limited to devices operated by the lab staff. Goal: To fulfill a Work Order and its clinical tests on the related specimens, using the various devices connected to the Automation Manager. Except for the robotic transportation of the specimen, this profile does not address electromechanical command interface. Its transactions carry the needed or produced specimen related data back and forth between Automation Manager and Devices

9. Fulfillment of a Work Order A Work Order is split into a sequence of steps according to the devices involved in its process. This sequence of steps includes three main phases: –the pre-analytical process of the specimens (sorting, centrifugation, aliquoting, transportation, decapping) –the analytical process (run of the clinical tests on the specimen) –the post-analytical process (recapping, transportation, rerun, dilution, storage and retrieval).

10. Example of workflow Automation Manager Robotic Specimen Transportation System decapper Step 2: decap Chemistry Analyzer Step 3: Convey to chemistry analyzer centrifuging Test Na, K, Cl Perform electrolye Work Order for serum n° 123 Step 4: Query for test? Schedules steps 1 to 6 Downloads steps 1, 2, 3, 5, 6 Schedules steps 1 to 6 Downloads steps 1, 2, 3, 5, 6 Send the results Step 1: Convey to decapper recapper Step 6: recap Step 5: Convey to recapper Blood specimen Serum

11. LAB-22 Query for WOS LAB-26 SWOS status change LAB-21 WOS download LAB-22 Query for WOS LAB-23 AWOS status change LAB-21 WOS download Pre/Post-processorAnalyzer Automation Manager LDA: Actors & Transactions WOS = Work Order Step –AWOS = Analytical Work Order Step: Produces observations –SWOS = Specimen processing Work Order Step. Does not produce any observation

12. LDA: Actors and transactions ActorsTransactionsOptHL7 2.5 messages Automation Manager LAB-21 : WOS DownloadR OML^O33 / ORL^O34 LAB-22 : WOS QueryR QBP^Q11 / RSP^K11 LAB-23 : AWOS Status Change R OUL^R22 / ACK^R22 LAB-26 : SWOS Status Change O SSU^U03 / ACK^U03 AnalyzerLAB-21 : WOS DownloadO OML^O33 / ORL^O34 LAB-22 : WOS QueryO QBP^Q11 / RSP^K11 LAB-23 : AWOS Status Change R OUL^R22 / ACK^R22 Pre/Post Processor LAB-21 : WOS DownloadO OML^O33 / ORL^O34 LAB-22 : WOS QueryO QBP^Q11 / RSP^K11 LAB-26 : SWOS Status Change R SSU^U03 / ACK^U03

13. LDA: Options ActorOptions Automation ManagerManagement of Pre/Post-processor AnalyzerQuery mode WOS Download mode WOS Pre/Post-processorQuery mode WOS Download mode WOS

14. IHE Lab today and to-morrow Five profiles: –Laboratory Scheduled Workflow (LSWF) –Laboratory Information Reconciliation (LIR) –Laboratory Device Automation (LDA) –Laboratory Point Of Care Testing (LPOCT) –Laboratory Code Set Distribution (LCSD) Future plans –Incorporate analyzer images in the result workflow –Cross-enterprise sharing of lab reports, using CDA-R2 –Specimen labels workflow Ordering, placing, scheduling and performing clinical laboratory tests both for Hospital and Ambulatory. Microbiology included. Anatomic pathology and blood bank excluded

15. Scope of LPOCT Tests of clinical biology, performed on point of care or patient bedside –In vitro tests: performed on a specimen, not on the patient itself –Usually quick tests, specimen collected, tested at once and eliminated –No pre or post-processing (like in LDA) –Results used immediately by the care provider in its clinical decisions Supervision by a clinical laboratory of the healthcare enterprise –Training provided to the ward staff good practices on specimen and analyzer –Provision of reagent –Supervision of quality control –Clinical validation a posteriori

16. Contraints and benefits of point of care testing 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.

17. Examples of LPOCT Portable blood gaz and chemistry analyzer used by the nurse on patient bedside Blood gas analyzer permanently installed in a surgery theater Coagulation analyzer in acute care ward Glucometer used by the patient in home care Work station on which the nurse manually enters the results of pregnancy stick tests.

18. The IHE actors of LPOCT Point Of Care Result Generator (POCRG) Produces the results from a specimen By measurement of an analyte on a specimen By calculation By manual entry Point Of Care Data Manager (POCDM) Handles and administers a set of POCRG Controls the process, checks the patient identity and location Collects the patient results Collects and manages the QC results Forwards the patient results to the Order Filler

19. The IHE actors of LPOCT Order Filler Recipient of POCT results Stores the results within matched or generated orders Performs the clinical validation

20. Ward Clinical laboratory LPOCT: Actors and Transactions Point Of Care Result Generator Point Of Care Data Manager Order Filler Lab-32: Accepted observation set Lab-31: Performed observation set Lab-30: (option persistent cnx) Initiate testing on a specimen POCDM is assumed to be provided with up-to-date patient demographics and visit data, using an appropriate profile (PAM or PDQ) LPOCT depends upon LSWF: The Order Filler is also involved in LSWF profile.

21. Transactions and options ActorsTransactionsOptionality Order FillerTransaction LAB-32R Point Of Care Data Manager Transaction LAB-30O Transaction LAB-31R Transaction LAB-32R Point Of Care Result Generator Transaction LAB-30O Transaction LAB-31R Transaction LAB-30 is required with option Patient Identity Checking

22. Selected standards POCRGPOCDMOrder Filler Based on HL7 v2.5 Based on HL7 early v3 POCT 1-A, published by CLSI (ex NCCLS)

23. IHE Lab today and to-morrow Five profiles: –Laboratory Scheduled Workflow (LSWF) –Laboratory Information Reconciliation (LIR) –Laboratory Device Automation (LDA) –Laboratory Point Of Care Testing (LPOCT) –Laboratory Code Set Distribution (LCSD) Future plans –Incorporate analyzer images in the result workflow –Cross-enterprise sharing of lab reports, using CDA-R2 –Specimen labels workflow Ordering, placing, scheduling and performing clinical laboratory tests both for Hospital and Ambulatory. Microbiology included. Anatomic pathology and blood bank excluded

24. 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 …

25. Laboratory Code Set Distribution Actors/Transaction Laboratory Code Set Master LAB-51: Laboratory Code Set Management Laboratory Code Set Consumer Grouped with: Order Filler Enterprise Common Repository … Grouped with: Order Placer Order Result Tracker Automation Manager Order Filler …

26. 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. 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)

27. Laboratory Code Set Distribution Standard Interactions based on HL7 V2.5, Master Files (chapter 8). Advantages of using HL7 V2.5: HL7 is already implemented on laboratory systems; no need to implement a new protocol Master Files are already adopted by some vendors. Messages are rich enough to transport other information than just observation/test/battery codes : presentation of the results laboratory codes units of measure

28. HL7 Master Files Master files are a set of common reference files used by one or more application systems. Some common examples of master files in the healthcare environment include: staff and health practitioner master file location (census and clinic) master file lab test definition file exam code (lab, radiology) definition file