Integrating the Healthcare Enterprise

1. Integrating the Healthcare Enterprise A new Profile for the Laboratory Domain: Laboratory Point Of Care Testing Francois Macary GWI Medica France Cochair IHE Laboratory Committee Noordwijkerhout IHE Workshop

2. 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 healthcase enterprise • Training provided to the ward staff  good practices on specimen and analyzer • Provision of reagent • Supervision of quality control • Clinical validation a posteriori Noordwijkerhout IHE Workshop

3. 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 gaz, 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. (This is at least agreed upon in US and Europe) Noordwijkerhout IHE Workshop

4. Examples of LPOCT • Portable blood gaz and chemistry analyzer used by the nurse on patient bedside • Blood gaz 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. Noordwijkerhout IHE Workshop

5. 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 enter 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 results to the Order Filler Noordwijkerhout IHE Workshop

6. The IHE actors of LPOCT Order Filler Recipient of POCT results • Stores the results within matched or generated orders • Performs the clinical validation • Optionnaly, centralizes the QC results Noordwijkerhout IHE Workshop

7. The POCDM has the choice between dowwnload and query to obtain patient information ADT • Downloads tp POCDM patient demographics and visit data Patient Demographics Consumer (PDC) • Grouped with POCDM, queries for patient and visit data Patient Demographics Supplier (PDS) • Responds to queries from PDC grouped with POCDM Noordwijkerhout IHE Workshop

8. LPOCT Actors and transactions PDS ADT ITI-22 : Patient Demographics and Visit Query RAD-1 , RAD-12: Patient demographics dowload PDC One or the other LAB-30: Initiate patient specimen testing POCDM . LAB-32: Accepted Observation Set Tecnical validation POCRG LAB-31: Raw observation set LAB-33: Remote steering of POCRG Clinical validation Order Filler Clinical laboratory Clinical ward Noordwijkerhout IHE Workshop

9. Workflow using the query method PDS 4) PDS sends the patient identity and location 3) PDC queries PDS with the patient ID 8) POCDM accepts the results, stores them, and forwards them to the Order Filler PDC 2) POCRG sends this data POCDM 5) POCDM sends back the patient identity POCRG 7) POCRG sends the results 9) Order Filler matches an existing order or creates a new one, and stores the results within 1) : The nurse identifies herself, scans the patient ID and selects the tests to perform 6) : The nurse checks the patient identity, perforrms the tests and uses the results Order Filler 10) Clinical expert validates the results Noordwijkerhout IHE Workshop

10. Device without persistent link (query) 4) PDS sends the patient identity and location 3) PDC queries PDS with the patient ID 2) Later on, when the device establishes a connection to the network, POCRG sends all its accumulated results PDS 8) POCDM accepts the results, stores them, and forwards them to the Order Filler PDC POCDM POCRG 9) Order Filler matches an existing order or creates a new one, and stores the results within 1) : The nurse identifies herself, scans the patient ID, performs the tests, and uses the results Order Filler Noordwijkerhout IHE Workshop

11. Device without persistent link (download) 2) Later on, when the device establishes a connection to the network, POCRG sends all its accumulated results ADT ADT provides patient demobgraphics and visit up to date information 8) POCDM accepts the results, stores them, and forwards them to the Order Filler POCDM POCRG 9) Order Filler matches an existing order or creates a new one, and stores the results within 1) : The nurse identifies herself, scans the patient ID, performs the tests, and uses the results Order Filler Noordwijkerhout IHE Workshop

12. LPOCT coupled with LSWF ADT RAD-1, RAD-12 LAB-30: Initiate patient specimen testing POCDM POCRG LAB-32: Accepted Observation Set LAB-31: Raw observation set LAB-2: Generate placer order from filler order Order Placer Order Filler Clinical validation Order Result Tracker LAB-3: Results Clinical laboratory Noordwijkerhout IHE Workshop

13. Selected standards • POCT 1-A, published by NCCLS • ITI-22 (patient demographics and visit query) based on HL7 v2.5 • RAD-1 and RAD-12 (patient download) based on HL7 v2.3.1 Based on HL7 early v3 Based on HL7 v2.5 POCRG POCDM Order Filler Noordwijkerhout IHE Workshop

14. Thank you for your attention… Noordwijkerhout IHE Workshop