1September, 2005 What IHE Delivers

HIMSS 2006 – Interoperability ShowcaseHIMSS 2006 – Interoperability Showcase

François Macary, AGFA HCESFrançois Macary, AGFA HCESIHE Lab Committee co-chairIHE Lab Committee co-chair

IHE Clinical Laboratory IHE Clinical Laboratory UpdateUpdate

2

AgendaAgenda

Lab domain: Scope and Work

Reminder of Lab Scheduled Workflow

Lab Device Automation

Lab Information Reconciliation

Lab Point Of Care Testing

Lab Code Set Distribution

3

Laboratory Technical FrameworkLaboratory Technical Framework

General scope:

Ordering, placing, scheduling and performing clinical

laboratory tests within acute care settings.

Bound to in vitro testing

Microbiology included.

Pathology and blood banks excluded.

The first profile LSWF addresses acute care settings

4

The major problems to solveThe major problems to solve

Reduce over-ordering and over “blood-drawing”

By consolidating the lab results in a common repository shared by all wards in charge with the patient

By sharing the opened orders

Bring the accurate lab results to the clinician, in time for clinical decision

Without flooding the ward with paper reports Without flooding the lab with phone calls

5

The IHE Laboratory CommitteeThe IHE Laboratory Committee

Contributing countries France Japan Germany Italy The Netherlands UK US (1 from CLSI)

Development started in 2003

1st profile in November 2003

10 systems validated in 2004

12 systems validated in 2005

4 new profiles for connectathon 2006

Cochairs: Yoshimitsu Takagi - Hitachi

Francois Macary - Agfa Healthcare IT

6

Laboratory Scheduled WorkFlowLaboratory Scheduled WorkFlow

Externally placed order with identified specimens Specimens identified on the container with a barcode label

Externally placed order with specimens unidentified or to be collected by the laboratory The specimens unidentified in the message placing the order

Filler order with specimens identified by the laboratory Order created in lab. Order number allocated afterwards

Three major use cases:Three major use cases:

7

Patient Administration

Clinical LaboratoryWard 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: LSWFIHE Laboratory: LSWF

8

Laboratory Device Automation (LDA)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

AnalyzerPre/post processor

Automation Manager

9

Scope of LDAScope of LDA

Workflow between an Automation Manager and its set

of automated devices.

Each Work Order is split into a sequence of steps, each

of which uses a specimen on a device.

Scope limited to devices operated by the lab staff.

10

No candidate for year 2006?No candidate for year 2006?

Automation Automation ManagerManager

LIS vendorsLIS vendors

Small companies with Small companies with specialized softwarespecialized software

……Sometimes bought by Sometimes bought by devices manufacturersdevices manufacturers

AnalyzersAnalyzersPre/post Pre/post analytic analytic devicesdevices

ManufacturersManufacturers

No No standard standard availableavailable

One standard One standard available: available:

ASTM E1394ASTM E1394+ one future + one future ISO standardISO standard

IHE proposed one IHE proposed one common standard: common standard: HL7 2.5 – chap 13HL7 2.5 – chap 13

11

Laboratory Information Reconciliation (LIR)Laboratory Information Reconciliation (LIR)

Reconcile clinical lab observations produced on specimens collected from misidentified or unidentified patient. (Same thing as PIR in Radio land)

Reconcile clinical lab observations produced on specimens before the orders are created: Results for unknown orders. (Different from PIR)

LIR profile depends upon LSWF and LDA profiles

No added transactions

12

LIR: one example of process flowLIR: one example of process flow

13

Laboratory Point Of Care TestingLaboratory Point Of Care Testing

In vitro tests performed on point of care or patient bedside

specimen collected, tested at once and eliminated

No pre or post-processing

Results used immediately by the care provider

Supervision by a clinical laboratory of the hospital

Training provided to the ward staff

Provision of reagent

Supervision of quality control

Clinical validation a posteriori

Scope:Scope:

14

Benefits of LPOCTBenefits of LPOCT

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 through its supervision by a clinical laboratory.

15

Examples of LPOCTExamples of LPOCT

Portable blood gaz and chemistry analyzer used by the nurse in a neonatology ward

Blood gas analyzer permanently installed in the surgery theater

Glucometer used by the patient in home care

Workstation on which the nurse manually enters the results of pregnancy stick tests.

16

The Actors of LPOCTThe Actors of LPOCTPoint 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

Point of care results

Point of care patient results

17

Ward

Clinical laboratory

LPOCT: Actors and TransactionsLPOCT: Actors and Transactions

Point Of Care Result Generator

Point Of Care Data Manager

Order Filler

Lab-32:

Accepted observation set

(patient results)

Lab-31:

Performed observation set

(patient or QC results)

Lab-30:

Initiate testing on a specimen

POCDM and Order Filler are assumed to be provided with up-to-date patient demographic data

(for instance by PAM or PDQ)

18

Five major use casesFive major use cases

1. Observations to match with an existing order, real-time patient identity checking

2. Unordered observations, real-time patient identity checking

3. Unordered observations on a POCRG with an intermittent link (no patient identity check)

4. Manual entry of unordered observations

5. QC results

19

Selected standardSelected standard

POCRG POCDM Order Filler

HL7 v2.5Based on HL7 early v3 in XML

POCT 1-A, published by CLSI (ex NCCLS)

20

Laboratory Code Set DistributionLaboratory 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 …

21

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.

LCSD: Use Case 1LCSD: Use Case 1

Laboratory Code Set Consumer

Creates observation, test, battery

codes

LAB-51: Laboratory Code Set Management (REP)

Laboratory Code Set Master

22

LCSD - Standard usedLCSD - Standard used

HL7 V2.5: Master Files

Messages rich enough to transport other information than just observation/test/battery codes : presentation of the results Units of measure Laboratories fulfilling this test

23

Next Steps for IHE Lab in 2006Next Steps for IHE Lab in 2006

CDA rel 2 Lab ReportCDA rel 2 Lab ReportBeyond need to request/receive results, also need to share/distribute complete validated lab reports with structured tests results as one object.

Laboratory results communicated via messaging are point-to-point (request/result) and not human readable

Laboratory results can only be shared when “approved” for release by an authorized source: a document oriented laboratory report is needed.

Human readable and structured coded lab reports are necessary in a wide variety of Patient Care Coordination use cases

24

As a Provider or Vendor ContributorAs a Provider or Vendor Contributor

Offer Clinical Use Case Input to Drive IHE Profile DevelopmentOffer Clinical Use Case Input to Drive IHE Profile Development

Become a member of relevant domain’s Planning or Technical Become a member of relevant domain’s Planning or Technical CommitteesCommittees

Become a member of relevant Regional/National CommitteesBecome a member of relevant Regional/National Committees

Help to shape IHE’s future directionHelp to shape IHE’s future direction

As a Vendor ParticipantAs a Vendor Participant

Respond to Public Comments of Domain SupplementsRespond to Public Comments of Domain Supplements

Attend the June Educational WorkshopAttend the June Educational Workshop

Participate in Connect-a-thons and DemonstrationsParticipate in Connect-a-thons and Demonstrations

As a Provider/Consultant ParticipantAs a Provider/Consultant Participant

Respond to Public Comments of Domain SupplementsRespond to Public Comments of Domain Supplements

Attend the June Educational Workshop Attend the June Educational Workshop

Attend Demonstrations and include IHE Integration Profiles in your RFPs Attend Demonstrations and include IHE Integration Profiles in your RFPs and Integration Projects.and Integration Projects.

How can I participate?How can I participate?

25

26

IHE Web site:IHE Web site: www.IHE .netwww.IHE .net Frequently AskedFrequently Asked QuestionsQuestions

Integration Profiles in Technical Frameworks: Integration Profiles in Technical Frameworks: See Volume 1 of each TF for Use casesSee Volume 1 of each TF for Use cases

Cardiology IT Infrastructure Laboratory Patient Care Coordination Radiology

Connectathon Result: Connectathon Result: www.ihe.net/Events/connectathon_results.cfmwww.ihe.net/Events/connectathon_results.cfm

Vendor Products Integration StatementsVendor Products Integration Statements

Participation in Committees & ConnectathonsParticipation in Committees & Connectathons