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Clinical Laboratory Domain. François Macary AGFA Healthcare IT IHE Laboratory Committee Co-chair. Contributing countries France Japan Germany Italy The Netherlands UK US (CLSI - ex NCCLS). Development started in 2003 First profile published in November 2003

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Clinical Laboratory Domain


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

    2. Contributing countries France Japan Germany Italy The Netherlands UK US (CLSI - ex NCCLS) Development started in 2003 First profile published in November 2003 10 systems validated in 2004 12 systems validated in 2005 Four new profiles currently published for public comment The IHE Laboratory Committee Cochairs: Francois Macary - Agfa Healthcare IT Yoshimitsu Takagi - Hitachi

    3. General scope: Ordering, placing, scheduling and performing clinical laboratory tests both for Hospital and Ambulatory. Microbiology included. Anatomic pathology and blood bank excluded. Five profiles: Laboratory Scheduled Workflow (LSWF) Laboratory Point Of Care Testing (LPOCT) Laboratory Device Automation (LDA) Laboratory Code Set Distribution (LCSD) Laboratory Information Reconciliation (LIR) Future plans IHE Lab today and to-morrow

    4. Volume 1

    5. Integrate the clinical laboratory in the healthcare enterprise Workflow: Ordering, placing, scheduling, performing clinical laboratory tests, and delivering the results. In vitro testing: All specialties working on specimen, not on the patient itself. Bound to clinical biology (anatomic pathology excluded) Scope of LSWF profile

    6. Externally placed order with identified specimens The ordering provider collects the specimens and uniquely identifies them (in the message placing the order as well as on the container with a barcode label) Externally placed order with specimens unidentified or to be collected by the laboratory The specimens are unidentified within the message placing the order Filler order with specimens identified by the laboratory The order is created in the laboratory, and afterwards a number is assigned to it in the placer application. LSWF: Three major use cases

    7. 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

    8. Two parallel flows to keep synchronized Electronic: The order Material: 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) Order management in LSWF profile Order Placer and Order Filler must keep the same vision of the order (content and status) all along the process

    9. Results can be transmitted at various steps After technical validation (by the lab technician) After clinical validation (by the clinical expert) Requirement to keep Order Result Tracker informed with all changes occurred to results previously sent Send corrections Send validation or un-validation Send cancellation Other characteristics Result type: Numeric, coded, textual, graphical (electrophoresis) Results are sent in recapitulative mode, appropriately sorted Results management in LSWF profile

    10. Laboratory Technical Framework Volume 2

    11. Need for an international standard, fully implementable with guides and tools ready for use Excluded HL7 v3 Supporting specimen and container management Excluded v2.3.1 and v2.4 Choice of HL7 v2.5, released just before IHE Lab TF (end 2003) Choice of the standard See Vol 2 section 1.1 HL7 v2.5 Transactions LAB-1, LAB-2, LAB-3, LAB-4, LAB-5 HL7 v2.3.1 Transactions RAD-1, RAD-12 Vertical bar encoding shall be supported. XML encoding may be supported

    12. Static definition: Usage of segments and fields R: Required RE: Required but may be empty O: Optional = Usage not defined yet C: Conditional (condition predicate in the textual description) X: Not supported. Must not be sent. For a better readability: Segments with usage X do not appear in message tables Fields with usage O do not appear in segment tables Cardinalities of segments, segment groups and fields: Min and max between square brackets: [0..*] * stands for “no upper limit” HL7 v2.5 profiling conventions See Vol 2 section 2.2

    13. Specimen Segment group Example of message static definition

    14. Filler Order Number (accepted battery) F101 F102 F103 Laboratory request 123 ordered battery 12347 accepted battery F103 Vocabulary & tracking orders The physician places a lab request. The Order Placer allocates the unique Id “123” to this request consisting of: Order Placer allocates an Identifier to each ordered battery Order Filler allocates an Identifier to each accepted battery • a CBC (complete blood count) • an electrolyte (Na, K, Cl) • a creatinine clearance

    15. Each example is using the same layout: Storyboard List of human actors and organizations Ids and numbers List of interactions Interaction diagram Messages with key information highlighted. Watch the 4 examples of section 9 For implementers: One of the most helpful parts of Laboratory Technical Framework.

    16. 1st example: Two hematology batteries

    17. 1st example: Two hematology batteries

    18. Two hematology batteries: One message

    19. Application-level acknowledgements (i.e. not transport acknowledgements). They must be generated by the receiving application after it has processed the message semantic content, according to its own business rules. Intermediate message brokers do not have this capacity and therefore shall not be used to generate the contents of application acknowledgements. The receiving application shall automatically generate the application-level acknowledgement messages without waiting for human approval of the contents of the message that was received Acknowledgements rules See Vol 2 section 2.3

    20. 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) IHE Lab today and to-morrow

    21. 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 Laboratory Information Reconciliation (LIR)

    22. 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) IHE Lab today and to-morrow

    23. 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

    24. Workflow between an Automation Manager and its set of automated devices. A sequence of steps, each of which uses a specimen on a device. Scope limited to devices operated by the lab staff. 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

    25. 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) IHE Lab today and to-morrow

    26. 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 (unlike 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 Provision of reagent Supervision of quality control Clinical validation a posteriori Scope of LPOCT

    27. 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 benefits of POCT

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

    29. Point Of Care Result Generator (POCRG) Produces the results from a specimen by testing on a specimen, or calculation or manual entry The IHE actors of LPOCT 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

    30. 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) IHE Lab today and to-morrow

    31. 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

    32. 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 …

    33. Future plans Incorporate analyzer images in the result workflow Cross-enterprise sharing of lab reports, using CDA-R2 Specimen labels workflow • IHE documentation available on www.ihe.net • Thank you for your attention…