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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. Five profiles: Laboratory Scheduled Workflow (LSWF) Laboratory Information Reconciliation (LIR)

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Clinical Laboratory Domain New Integration Profiles

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  1. 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. 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 IHE Lab today and to-morrow • Ordering, placing, scheduling and performing clinical laboratory tests both for Hospital and Ambulatory. • Microbiology included. Anatomic pathology and blood bank excluded

  3. Match clinical lab observations produced on specimens collected from misidentified or unidentified patient with the patient’s 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 Laboratory Information Reconciliation

  4. Unidentified Patient registered at ADT. Clinical lab tests ordered at Order Placer level. Unidentified Patient registered at ADT . Clinical lab tests ordered at Order Filler level. Unidentified Patient registered at Order Placer. Clinical lab tests ordered at Order Placer level. Unidentified Patient registered at Order Filler. Clinical lab tests ordered at Order Filler level. Laboratory Information ReconciliationUse 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. 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 ReconciliationUse Case 5 LIR also covers the scenario of tests performed before the order is entered, no matter the patient is identified or not.

  6. 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 IHE Lab today and to-morrow • Ordering, placing, scheduling and performing clinical laboratory tests both for Hospital and Ambulatory. • Microbiology included. Anatomic pathology and blood bank excluded

  7. Work Order Steps LDA Laboratory Device Automation (LDA) Demographics Demographics ADT Clinical Laboratory Placer order Order Placer Order Filler Filler order Work order Results Results Order Result Tracker Automation Manager LSWF

  8. 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 Scope of LDA Integration Profile

  9. 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). Fulfillment of a Work Order

  10. 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 6: recap Step 2: decap centrifuging Step 5: Convey to recapper Step 3: Convey to chemistry analyzer Serum Example of workflow Schedules steps 1 to 6 Downloads steps 1, 2, 3, 5, 6 Automation Manager Chemistry Analyzer decapper recapper Robotic Specimen Transportation System

  11. WOS = Work Order Step AWOS = Analytical Work Order Step: Produces observations SWOS = Specimen processing Work Order Step. Does not produce any observation LDA: Actors & Transactions Automation Manager 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-processor Analyzer

  12. LDA: Actors and transactions

  13. LDA: Options

  14. 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 IHE Lab today and to-morrow • Ordering, placing, scheduling and performing clinical laboratory tests both for Hospital and Ambulatory. • Microbiology included. Anatomic pathology and blood bank excluded

  15. 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 Scope of LPOCT

  16. 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. Contraints and benefitsof point of care testing

  17. 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. Examples of LPOCT

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

  20. LPOCT: Actors and Transactions Ward Clinical laboratory Lab-30: (option persistent cnx) Initiate testing on a specimen Point Of Care Result Generator Point Of Care Data Manager Lab-31: Performed observation set Lab-32: Accepted observation set Order Filler 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 Transaction LAB-30 is required with option “Patient Identity Checking”

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

  23. 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 IHE Lab today and to-morrow • Ordering, placing, scheduling and performing clinical laboratory tests both for Hospital and Ambulatory. • Microbiology included. Anatomic pathology and blood bank excluded

  24. 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 … Laboratory Code Set Distribution

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

  26. 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.

  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. 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 HL7 Master Files

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