Clinical Laboratory Domain

New Integration Profiles

Charles Parisot
GE Healthcare
IHE IT Technical Committee Co-chair
François Macary
AGFA Healthcare IT
IHE Laboratory Committee Co-chair
 IHE Lab today and to-morrow
• Ordering, placing, scheduling and performing clinical
laboratory tests both for Hospital and Ambulatory.
• Microbiology included. Anatomic pathology and blood bank
excluded
• 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
 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
 Laboratory Information Reconciliation
Use 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.
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 Reconciliation
Use Case 5

LIR also covers the scenario of tests performed

before the order is entered, no matter 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.
 IHE Lab today and to-morrow
• Ordering, placing, scheduling and performing clinical
laboratory tests both for Hospital and Ambulatory.
• Microbiology included. Anatomic pathology and blood bank
excluded
• 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
Laboratory Device Automation (LDA)

Demographics Demographics
ADT

Clinical Laboratory
Placer order
Order Placer Order Filler
Filler order

Results Work order Results

Order Result Automation

Tracker Manager
Work
Order
Steps

LSWF LDA
 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
Schedules steps 1 to 6
Perform electrolye Work Order
for serum n° 123 Downloads steps 1, 2, 3, 5, 6

Automation Manager
Blood Step 1: Step 4:
specimen Test Send
Convey to Query
Na, the
decapper for test?
K, Cl results Step 6:
Step 2:
recap
decap Chemistry Analyzer

centrifuging decapper Step 5: recapper

Step 3:
Convey to Convey to
chemistry recapper
analyzer
Robotic Specimen Transportation System
Serum
 LDA: Actors & Transactions
Automation Manager
LAB-22 LAB-26
Query for SWOS status LAB-21
WOS change WOS
download
LAB-22 LAB-23
LAB-21 Query AWOS status
WOS for WOS change
download

Pre/Post-processor Analyzer
• 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 messages
Automation LAB-21 : WOS Download R OML^O33 / ORL^O34
Manager
LAB-22 : WOS Query R QBP^Q11 / RSP^K11

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

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

Processor 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
• Ordering, placing, scheduling and performing clinical
laboratory tests both for Hospital and Ambulatory.
• Microbiology included. Anatomic pathology and blood bank
excluded
• 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
 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 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 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 entry
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 patient results to the Order Filler
 The IHE actors of LPOCT

Order Filler
Recipient of POCT results
• Stores the results within matched or generated
orders
• Performs the clinical validation
 LPOCT: Actors and Transactions

Ward Lab-30: (option persistent cnx)

Initiate testing on a specimen
Point Of Care Point Of Care
Result Generator Data Manager
Lab-31:
Performed observation set
Lab-32:
Accepted
observation
set

POCDM is assumed to be provided with Order Filler

up-to-date patient demographics and visit
data, using an appropriate profile (PAM or Clinical
PDQ) laboratory
LPOCT depends upon LSWF: The Order
Filler is also involved in LSWF profile.
 Transactions and options
Actors Transactions Optionality
Order Filler Transaction LAB-32 R
Point Of Care Data Transaction LAB-30 O
Manager Transaction LAB-31 R
Transaction LAB-32 R
Point Of Care Result Transaction LAB-30 O
Generator Transaction LAB-31 R

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

 Selected standards

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

Based on HL7 Based on

early v3 HL7 v2.5

POCRG POCDM Order

Filler
 IHE Lab today and to-morrow
• Ordering, placing, scheduling and performing clinical
laboratory tests both for Hospital and Ambulatory.
• Microbiology included. Anatomic pathology and blood bank
excluded
• 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
 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

Grouped with: Order Filler

Laboratory Code Set Enterprise Common
Master Repository
…
LAB-51: Laboratory Code Set Management

Laboratory Code Set Grouped with: Order Placer

Consumer Order Result Tracker
Automation Manager
Order Filler
…
 Laboratory Code Set Distribution
Use Case 1

Laboratory Code Set Laboratory Code Set

Master Consumer

Creates observation-test -
battery codes
Laboratory Code Set
Management (REP)

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.
 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