1. February 7-10, 2005Noordwijkerhout IHE Workshop 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

2. February 7-10, 2005Noordwijkerhout 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

3. February 7-10, 2005Noordwijkerhout 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)

4. February 7-10, 2005Noordwijkerhout 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.

5. February 7-10, 2005Noordwijkerhout 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

6. February 7-10, 2005Noordwijkerhout 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

7. February 7-10, 2005Noordwijkerhout 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

8. February 7-10, 2005Noordwijkerhout IHE Workshop 8 LPOCT Actors and transactions POCRG LAB-31: Raw observation set LAB-33: Remote steering of POCRG LAB-32: Accepted Observation Set Clinical laboratory POCDM LAB-30: Initiate patient specimen testing Order Filler PDS ITI-22 : Patient Demographics and Visit Query PDC Tecnical validation Clinical validation Clinical ward ADT RAD-1, RAD-12: Patient demographics dowload. One or the other

9. February 7-10, 2005Noordwijkerhout IHE Workshop 9 Workflow using the query method PDS POCRG 3) PDC queries PDS with the patient ID 7) POCRG sends the results 8) POCDM accepts the results, stores them, and forwards them to the Order Filler POCDM 2) POCRG sends this data PDC 1) : The nurse identifies herself, scans the patient ID and selects the tests to perform 4) PDS sends the patient identity and location 5) POCDM sends back the patient identity 6) : The nurse checks the patient identity, perforrms the tests and uses the results 9) Order Filler matches an existing order or creates a new one, and stores the results within 10) Clinical expert validates the results Order Filler

10. February 7-10, 2005Noordwijkerhout IHE Workshop 10 Device without persistent link (query) PDS POCRG 8) POCDM accepts the results, stores them, and forwards them to the Order Filler POCDM PDC 2) Later on, when the device establishes a connection to the network, POCRG sends all its accumulated results 3) PDC queries PDS with the patient ID 1) : The nurse identifies herself, scans the patient ID, performs the tests, and uses the results 4) PDS sends the patient identity and location 9) Order Filler matches an existing order or creates a new one, and stores the results within Order Filler

11. February 7-10, 2005Noordwijkerhout IHE Workshop 11 Device without persistent link (download) ADT POCRG 8) POCDM accepts the results, stores them, and forwards them to the Order Filler POCDM 2) Later on, when the device establishes a connection to the network, POCRG sends all its accumulated results 1) : The nurse identifies herself, scans the patient ID, performs the tests, and uses the results ADT provides patient demobgraphics and visit up to date information 9) Order Filler matches an existing order or creates a new one, and stores the results within Order Filler

12. February 7-10, 2005Noordwijkerhout IHE Workshop 12 LPOCT coupled with LSWF ADT POCRG LAB-31: Raw observation set LAB-32: Accepted Observation Set Clinical laboratory POCDM LAB-30: Initiate patient specimen testing Order Filler Clinical validation Order Placer LAB-2: Generate placer order from filler order Order Result Tracker LAB-3: Results RAD-1, RAD-12

13. February 7-10, 2005Noordwijkerhout IHE Workshop 13 Selected standards 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 POCRGPOCDMOrder Filler Based on HL7 v2.5 Based on HL7 early v3 POCT 1-A, published by NCCLS

14. February 7-10, 2005Noordwijkerhout IHE Workshop 14 Thank you for your attention…