Franois Macary, AGFA HCES

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Clinical Laboratory

• François Macary, AGFA HCES
• IHE Lab Committee cochair

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Agenda

• Lab domain Scope and Work
• Reminder of LSWF
• LDA
• LIR
• LPOCT
• LCSD

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Laboratory 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

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The 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

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The IHE Laboratory Committee
Cochairs Yoshimitsu Takagi - Hitachi Francois
Macary - Agfa Healthcare IT

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

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
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Laboratory Scheduled WorkFlow
Three major use cases

• 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

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IHE Laboratory LSWF
Patient Administration
Rad-1, Rad-12
Rad1, Rad-12 Patient demographics visit
ADT
Clinical Laboratory
Ward or EHR
Lab-1 Placer order
Order Placer
Order Filler
Lab-2 Filler order
Lab-5 Results
Lab-4 Work order
Lab-3 Results
Order Result Tracker
Automation Manager
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Laboratory Device Automation (LDA)
Demographics
Demographics
ADT
Placer order
Order Filler
Order Placer
Filler order
Results
Work order
Results
Order Result Tracker
Automation Manager
LSWF
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Scope 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.

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No candidate for year 2006?
LIS vendors Small companies with specialized
software Sometimes bought by devices
manufacturers
No standard available
Automation Manager
One standard available ASTM E1394 one future
ISO standard
IHE proposed one common standard HL7 2.5 chap
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Analyzers
Pre/post analytic devices
Manufacturers
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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

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LIR one example of process flow
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Laboratory Point Of Care Testing
Scope

• 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

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Benefits 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.

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Examples 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.

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The Actors of LPOCT

• Point 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
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LPOCT Actors and Transactions
Ward
Clinical laboratory
Lab-30 Initiate testing on a specimen
Point Of Care Result Generator
Point Of Care Data Manager
Lab-31 Performed observation set (patient or QC
results)
Lab-32 Accepted observation set (patient
results)
Order Filler
POCDM and Order Filler are assumed to be
provided with up-to-date patient demographic data
(for instance by PAM or PDQ)
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Five major use cases

• Observations to match with an existing order,
  real-time patient identity checking
• Unordered observations, real-time patient
  identity checking
• Unordered observations on a POCRG with an
  intermittent link (no patient identity check)
• Manual entry of unordered observations
• QC results

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Use case 1 LPOCT LSWF
Order Result Tracker
Order Filler
POCDM
POCRG
Order Placer
LAB-1 New POCT order
Specimen to test for a patient
Order entered
LAB-30 Check patient identity
Test performed,
LAB-31 Produced observations set
LAB-32 Accepted observations set
LAB-1 Order Results received
clinical validation
LAB-1 Order completed
LAB-3 Results validated
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Selected standard
POCT 1-A, published by CLSI (ex NCCLS)
Based on HL7 early v3 in XML
HL7 v2.5
POCRG
POCDM
Order Filler
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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

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LCSD Actors/Transaction
Grouped with Order Filler, Enterprise Common
Repository
Laboratory Code Set Master
LAB-51 Laboratory Code Set Management
Grouped with Order Placer, Order Result
Tracker, Order Filler,
Laboratory Code Set Consumer
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LCSD Use Case 1
Laboratory Code Set Consumer
Laboratory Code Set Master
Creates observation, test, battery codes
LAB-51 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.
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LCSD - 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

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LCSD Messages
Code Set Master
Code Set Consumer
MFNM08 Numeric tests
MFKM08 Acknowledgement
MFNM09 Categorical tests
MFKM09 Acknowledgement
MFNM10 Batteries
MFKM10 Acknowledgement
MFNM11 Calculated tests
MFKM11 Acknowledgement
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