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February 7-10, 2005 Noordwijkerhout IHE Workshop1

Integrating the Healthcare EnterpriseIntegrating the Healthcare Enterprise

A new Profile for the Laboratory Domain:

Laboratory Point Of Care Testing

Francois Macary GWI Medica FranceCochair IHE Laboratory Committee

February 7-10, 2005 Noordwijkerhout IHE Workshop2

Scope of LPOCTScope 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

February 7-10, 2005 Noordwijkerhout IHE Workshop3

Contraints and benefits Contraints and benefits of point of care testingof 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)

February 7-10, 2005 Noordwijkerhout IHE Workshop4

Examples of LPOCTExamples 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.

February 7-10, 2005 Noordwijkerhout IHE Workshop5

The IHE actors of LPOCTThe 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

February 7-10, 2005 Noordwijkerhout IHE Workshop6

The IHE actors of LPOCTThe 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

February 7-10, 2005 Noordwijkerhout IHE Workshop7

The POCDM has the choice between dowwnload The POCDM has the choice between dowwnload and query to obtain patient informationand 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

February 7-10, 2005 Noordwijkerhout IHE Workshop8

LPOCT Actors and transactionsLPOCT Actors and transactions

POCRG LAB-31: Raw observation set

LAB-33: Remote steering of POCRG

LAB-32: Accepted Observation Set

Clinical laboratory

POCDMLAB-30: Initiate patient specimen testing

Order Filler

PDS

ITI-22 : Patient Demographics and Visit Query

PDC

Tecnicalvalidation

Clinicalvalidation

Clinical ward

ADT

RAD-1 , RAD-12: Patient demographics dowload

.

One or the other

February 7-10, 2005 Noordwijkerhout IHE Workshop9

Workflow using the query methodWorkflow 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

POCDM2) 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

February 7-10, 2005 Noordwijkerhout IHE Workshop10

Device without persistent link (query)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

February 7-10, 2005 Noordwijkerhout IHE Workshop11

Device without persistent link (download)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

February 7-10, 2005 Noordwijkerhout IHE Workshop12

LPOCT coupled with LSWFLPOCT coupled with LSWFADT

POCRGLAB-31: Raw observation set LAB-32:

Accepted Observation

Set

Clinical laboratory

POCDMLAB-30: Initiate patient specimen testing

Order Filler

Clinicalvalidation

Order Placer

LAB-2: Generate placer order from filler order

Order Result TrackerLAB-3: Results

RAD-1, RAD-12

February 7-10, 2005 Noordwijkerhout IHE Workshop13

Selected standardsSelected 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

POCRG POCDM Order Filler

Based on HL7 v2.5

Based on HL7 early v3

POCT 1-A, published by NCCLS

February 7-10, 2005 Noordwijkerhout IHE Workshop14

Thank you for your attention…

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