Clinical Laboratory Domain New Integration Profiles Charles Parisot

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

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 • 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-R 2 – Specimen labels workflow

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

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 • 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-R 2 – Specimen labels workflow

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

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

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).

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

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

LDA: Actors and transactions Actors Automation Manager Transactions LAB-21 : WOS Download LAB-22 : WOS Query LAB-23 : AWOS Status Change LAB-26 : SWOS Status Change Analyzer LAB-21 : WOS Download LAB-22 : WOS Query LAB-23 : AWOS Status Change Pre/Post LAB-21 : WOS Download Processor LAB-22 : WOS Query LAB-26 : SWOS Status Change Opt R R R HL 7 2. 5 messages O O O R SSU^U 03 / ACK^U 03 OML^O 33 / ORL^O 34 QBP^Q 11 / RSP^K 11 OUL^R 22 / ACK^R 22 OML^O 33 / ORL^O 34 QBP^Q 11 / RSP^K 11 SSU^U 03 / ACK^U 03

LDA: Options Actor Options Automation Manager Management of Pre/Post-processor Analyzer Query mode WOS Download mode WOS Pre/Post-processor Query mode WOS Download mode WOS

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 • 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-R 2 – Specimen labels workflow

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

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.

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.

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

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

LPOCT: Actors and Transactions Ward Point Of Care Result Generator Lab-30: (option persistent cnx) Initiate testing on a specimen Lab-31: Point Of Care Data Manager Performed observation set Lab-32: Accepted observation set 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. Order Filler Clinical laboratory

Transactions and options Actors Order Filler Transactions Transaction LAB-32 Point Of Care Data Manager Transaction LAB-30 O Transaction LAB-31 R Transaction LAB-32 R Transaction LAB-30 O Transaction LAB-31 R Point Of Care Result Generator Optionality R Transaction LAB-30 is required with option “Patient Identity Checking”

Selected standards POCT 1 -A, published by CLSI (ex NCCLS) Based on HL 7 early v 3 POCRG Based on HL 7 v 2. 5 POCDM Order Filler

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 • 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-R 2 – Specimen labels workflow

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 Grouped with: Order Filler Laboratory Code Set Enterprise Common Master Repository … LAB-51: Laboratory Code Set Management Laboratory Code Set Consumer Grouped with: Order Placer Order Result Tracker Automation Manager Order Filler …

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.

Laboratory Code Set Distribution Standard Interactions based on HL 7 V 2. 5, Master Files (chapter 8). Advantages of using HL 7 V 2. 5: • HL 7 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

HL 7 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