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

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

IHE Lab today and to-morrow 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

Volume 1

Scope of LSWF profile 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)

LSWF: Three major use cases 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.

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 Clinical validation Technical validation

Order management in LSWF profile 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 Placer and Order Filler must keep the same vision of the order (content and status) all along the process

Results management in LSWF profile 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

Laboratory Technical Framework Volume 2

Choice of the standard 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) 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 See Vol 2 section 1.1

HL7 v2.5 profiling conventions 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 See Vol 2 section 2.2

Example of message static definition Specimen Segment group

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

Watch the 4 examples of section 9 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. For implementers: One of the most helpful parts of Laboratory Technical Framework.

1st example: Two hematology batteries

Two hematology batteries: One message

Acknowledgements rules 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 See Vol 2 section 2.3

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)

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 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)

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

Scope of LDA Integration Profile 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

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)

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 (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

Contraints and benefits of POCT 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.

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 Glucometer used by the patient in home care Workstation on which the nurse manually enters the results of pregnancy stick tests.

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

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)

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 …

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 …

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