Clinical Laboratory DomainNew Integration Profiles

Clinical Laboratory DomainNew Integration Profiles

Charles ParisotCharles ParisotGE HealthcareGE Healthcare

IHE IT Technical Committee Co-chairIHE IT Technical Committee Co-chair

François MacaryFrançois MacaryAGFA Healthcare ITAGFA Healthcare IT

IHE Laboratory Committee Co-chairIHE Laboratory Committee Co-chair

IHE Lab today and to-morrow

• 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-R2– Specimen labels workflow

• Ordering, placing, scheduling and performing clinical laboratory tests both for Hospital and Ambulatory.

• Microbiology included. Anatomic pathology and blood bank excluded

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

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 ReconciliationUse 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.

5. Clinical lab tests performed on laboratory automation before creation of the order. The order is created automatically from the results.

The order is created afterwards at Order Filler and matched to the results.

Laboratory Information ReconciliationUse Case 5

LIR also covers the scenario of tests performed before the order is entered, no matter the patient is identified or not.

IHE Lab today and to-morrow

• 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-R2– Specimen labels workflow

• Ordering, placing, scheduling and performing clinical laboratory tests both for Hospital and Ambulatory.

• Microbiology included. Anatomic pathology and blood bank excluded

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

Automation Manager

Clinical Laboratory

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

Automation Manager

Robotic Specimen Transportation System

decapper

Step 2: decap Chemistry Analyzer

Step 3: Convey to chemistry analyzer

centrifuging

Test Na, K, Cl

Perform electrolye Work Order for serum n° 123

Step 4: Query for test?

Schedules steps 1 to 6

Downloads steps 1, 2, 3, 5, 6

Schedules steps 1 to 6

Downloads steps 1, 2, 3, 5, 6

Send the results

Step 1: Convey to decapper

recapper

Step 6: recap

Step 5: Convey to recapper

Blood specimen

Serum

LAB-22 Query for

WOS

LAB-26 SWOS status

change

LAB-21 WOS

download

LAB-22 Query

for WOS

LAB-23 AWOS status

change

LAB-21 WOS

download

Pre/Post-processor Analyzer

Automation Manager

LDA: Actors & Transactions

• 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 Transactions Opt HL7 2.5 messagesAutomationManager

LAB-21 : WOS Download R OML^O33 / ORL^O34

LAB-22 : WOS Query R QBP^Q11 / RSP^K11

LAB-23 : AWOS Status Change

R OUL^R22 / ACK^R22

LAB-26 : SWOS Status Change O SSU^U03 / ACK^U03

Analyzer LAB-21 : WOS Download O OML^O33 / ORL^O34

LAB-22 : WOS Query O QBP^Q11 / RSP^K11

LAB-23 : AWOS Status Change R OUL^R22 / ACK^R22

Pre/PostProcessor

LAB-21 : WOS Download O OML^O33 / ORL^O34

LAB-22 : WOS Query O QBP^Q11 / RSP^K11

LAB-26 : SWOS Status Change R SSU^U03 / ACK^U03

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

• 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-R2– Specimen labels workflow

• Ordering, placing, scheduling and performing clinical laboratory tests both for Hospital and Ambulatory.

• Microbiology included. Anatomic pathology and blood bank excluded

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 benefitsof 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 entryPoint 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 FillerRecipient of POCT results

• Stores the results within matched or generated orders

• Performs the clinical validation

Ward

Clinical laboratory

LPOCT: Actors and Transactions

Point Of Care Result Generator

Point Of Care Data Manager

Order Filler

Lab-32:

Accepted observation set

Lab-31:

Performed observation set

Lab-30: (option persistent cnx)

Initiate testing on a specimen

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.

Transactions and optionsActors Transactions Optionality

Order Filler Transaction LAB-32 R

Point Of Care Data Manager

Transaction LAB-30 O

Transaction LAB-31 R

Transaction LAB-32 R

Point Of Care Result Generator

Transaction LAB-30 O

Transaction LAB-31 R

Transaction LAB-30 is required with option “Patient Identity Checking”

Selected standards

POCRG POCDM Order Filler

Based on HL7 v2.5

Based on HL7 early v3

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

IHE Lab today and to-morrow

• 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-R2– Specimen labels workflow

• Ordering, placing, scheduling and performing clinical laboratory tests both for Hospital and Ambulatory.

• Microbiology included. Anatomic pathology and blood bank excluded

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

Laboratory Code Set Master

LAB-51: Laboratory Code Set Management

Laboratory Code Set Consumer

Grouped with: Order FillerEnterprise Common Repository…

Grouped with: Order PlacerOrder Result TrackerAutomation ManagerOrder Filler…

Replaces Observation/Test/Battery Code SetsReplaces 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 Use Case 1

Laboratory Code Set Master

Laboratory Code Set Consumer

Creates observation-test -battery codes

Laboratory Code Set Management (REP)

Laboratory Code Set Distribution Standard

Interactions based on HL7 V2.5, Master Files (chapter 8).

Advantages of using HL7 V2.5:

• HL7 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

HL7 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