GMSIH, HL7 France H’, HL7 Germany, IHE-J, JAHIS, SFIL, IHE Italy

Integrating the Healthcare Enterprise

IHE Laboratory Technical Framework
Supplement 2004-2005

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Laboratory Device Automation(LDA)

Public Comment Version
June 15, 2005
Comments due July 15, 2005

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IHE Technical Framework Supplement - Profile Draft______________________________________________________________________________

Foreword
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Integrating the Healthcare Enterprise (IHE) is an initiative designed to stimulate the integrationof the information systems which support modern healthcare institutions. Its fundamental
objective is to ensure that in the care of patients all required information for medical decisions isboth correct and available to healthcare professionals. The IHE initiative is both a process and aforum for encouraging integration efforts. It defines a technical framework for the
implementation of established messaging standards to achieve specific clinical goals. It includes
a rigorous testing process for the implementation of this framework. And it organizes
educational sessions and exhibits at major meetings of medical professionals to demonstrate thebenefits of this framework and encourage its adoption by industry and users.
The approach employed in the IHE initiative is not to define new integration standards, but rather

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to support the use of existing standards, HL7, DICOM, IETF, and others, as appropriate in theirrespective domains in an integrated manner, defining configuration choices when necessary.
IHE maintain formal relationships with several standards bodies including HL7, DICOM andrefers recommendations to them when clarifications or extensions to existing standards arenecessary.
This initiative has numerous sponsors and supporting organizations in different medical specialty
domains and geographical regions. In North America the primary sponsors are the American
College of Cardiology (ACC), the Healthcare Information and Management Systems Society(HIMSS) and the Radiological Society of North America (RSNA). IHE Canada has also been
formed. IHE Europe (IHE-EUR) is supported by a large coalition of organizations including theEuropean Association of Radiology (EAR) and European Congress of Radiologists (ECR), theCoordination Committee of the Radiological and Electromedical Industries (COCIR), Deutsche
Röntgengesellschaft (DRG), the EuroPACS Association, Groupement pour la Modernisation duSystème d'Information Hospitalier (GMSIH), Société Francaise de Radiologie (SFR), Società
Italiana di Radiologia Medica (SIRM), the European Institute for health Records (EuroRec), andthe European Society of Cardiology (ESC). In Japan IHE-J is sponsored by the Ministry of
Economy, Trade, and Industry (METI); the Ministry of Health, Labor, and Welfare; and MEDISDC; cooperating organizations include the Japan Industries Association of Radiological Systems(JIRA), the Japan Association of Healthcare Information Systems Industry (JAHIS), Japan
Radiological Society (JRS), Japan Society of Radiological Technology (JSRT), and the Japan
Association of Medical Informatics (JAMI). Other organizations representing healthcare
professionals are invited to join in the expansion of the IHE process across disciplinary andgeographic boundaries.
The IHE Technical Frameworks for the various domains (IT Infrastructure, Cardiology,
Laboratory, Radiology, etc.) defines specific implementations of established standards to achieve
integration goals that promote appropriate sharing of medical information to support optimal
patient care. It is expanded annually, after a period of public review, and maintained regularly__________________________________________________________________________
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IHE Technical Framework Supplement - Profile Draft______________________________________________________________________________
through the identification and correction of errata. The current version for these Technical
Frameworks may be found at www.rsna.org/IHE or http://www.gmsih.fr/IHE.
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The IHE Technical Framework identifies a subset of the functional components of the healthcare
enterprise, called IHE Actors, and specifies their interactions in terms of a set of coordinated,
standards-based transactions. It describes this body of transactions in progressively greater
depth. The volume I provides a high-level view of IHE functionality, showing the transactionsorganized into functional units called Integration Profiles which highlight their capacity toaddress specific clinical needs. The subsequent volumes provide detailed technical descriptionsof each IHE transaction.
This supplement to the IHE Laboratory Technical Framework V1.2.1 is submitted for
Public Comment between June 15, 2005 and July 15, 2005, per the schedule announced in
February 2005.

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Comments shall be submitted before July 15, 2005 on the “Public Comment
Lab Supplement” sheet, addressed by email to:
francois.macary@gwi-medica.fr
takagi-yoshimitsu@naka.hitachi-hitec.com
karima.bourqard@gmsih.fr
eric.poiseau@univ-rennes1.fr
The IHE Laboratory Technical Committee will address these comments and publish the
Trial Implementation version in November 2005.

Document production
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Principal editor:
Last update:

Yoshimitsu Takagi – Hitachi
June 15, 2005

Introduction
Version 1 of Laboratory Technical Framework considered the automation within the laboratory
as a grouped actor named Automation Manager, receiving Work Orders from the Order Filler,
using various automated devices to fulfill the observations for these orders, and sending back the__________________________________________________________________________
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results. Laboratory Technical Framework version 1 did not describe the workflow between theautomation manager and the automated device involved in this process.
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This new Integration Profile, Laboratory Device Automation (LDA) adds the description of thisworkflow, involving three new actors and four new transactions. This new Integration Profile
will be added to Volume I of the IHE Laboratory Technical Framework version 2. The four new
transactions will be added to Volume II of the IHE Laboratory Technical Framework version 2.

Profile Abstract

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The Laboratory Device Automation Integration Profile describes the workflow between the
Automation Manager and two new actors (Pre/Post-processor and Analyzer) to support theprocessing of Work Orders and fulfill their embedded clinical tests on the related specimen. This
processing includes the pre-analytical process of the specimen (sorting, centrifugation,aliquoting, transportation, decapping) the analytical process itself (run of the ordered clinicaltests on the specimen) and the post-analytical process (recapping, transportation, rerun, dilution,
storage and retrieval).
The Automation Manager receives a Work Order from the Order Filler, splits it into a sequenceof one or more Work Order Steps (WOS), each of which is entrusted to an automated device
implementing an actor (Pre/Post-processor , Analyzer). This profile assumes that each LD
performs at most one WOS for a specimen.
This profile covers various situations such as: Work Order Step downloaded before specimen
arrival, Work Order Step obtained by query after specimen recognition on the device, Work
Order Step manually entered on the automated device.

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Except for the robotic transportation of the specimen, this profile does not address the handlingof an automated device through an electromechanical interface. It only carries the Work Order
Steps related information, the status of these Work Order Steps, and the results obtained.

GlossaryAM

Automation Manager

LD

Laboratory Device : A category of actors in LDA profile. A LD actor iseither an Analyzer actor or a Pre/Post processor actor.

LAS

Laboratory Automation System: A system which handles a set ofLaboratory Devices (LD). This system implements the Automation
Manager actor.

WOS

Work Order Step: A step of a Work Order performed on one specimen__________________________________________________________________________
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by one LD.
AWOS

Analytical Work Order Step: A WOS performed by an Analyzer actor.

SWOS

Specimen Wok Order Step: A WOS performed by a Pre/Post Processor
actor.

QC

Quality Control performed by Analyzer actor on a quality control
specimen.

Analyzer

An actor which is an automated device which fulfills clinical tests on
biologic specimen. An Analyzer performs analyzing for a specimen
according to AWOS, and return the result to the AM.

Pre/Postprocessor

An actor which provides some pre- and post- processes to thespecimen. This actor is categorized to two sub categories, one is preprocessor and the other one is post-processor. A Pre/Post-processor
processes a specimen according to SWOS, and return the result to theAM.

Pre-processor

An automated device which provides some preparation (decapping,aliquoting, centrifugation, transportation, …) of the specimen before
the clinical testing.

Post-processor

An automated device which deals with the specimen after clinical tests
have been performed on it, making it ready for rerun or for storage, orthat conveys it to another automated device.

Centrifuge

An automated device which divides the blood into a serum ingredientand a blood cell ingredient by centrifugal separation.

DecapperAn automated device which takes off the cap of the specimen
container.

Aliquoter

An automated device which aliquots a parent specimen into one ormore child specimen.

Labeler

An automated device which affixes the bar code label to the specimen
container.

Conveyor

An automated device which transports specimen to the appropriate
devices.

Sorter

An automated device which sorts the specimen according to theirprocess type.

Dilution System

An automated device which dilutes a specimen by mixing a diluent.

RecapperAn automated device which re-caps a specimen container.

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Specimen Storage
SystemAn automated storage device which saves and manages processed
specimen.

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Volume I – Integration Profiles
X Laboratory Device Automation Integration Profile
X.1 Scope of LDA Integration Profile120

The LDA Integration Profile supports the workflow for the automated technical section of theclinical laboratory. It provides the transactions between the actors of this section (Automation
Managers, Pre/Post-processors, Analyzers) to fulfill the Work Orders sent by the Order Filler,and send back the results produced for these Work Orders.
This LDA profile strictly addresses the workflow between Automation Managers and Laboratory
Devices (LD) operated by the clinical laboratory staff. Devices operated by the clinical ward
staff, are supported by another profile: LPOCT, and are therefore out of scope of LDA.
The input to the LDA workflow is a Work Order generated by the Order Filler. The Automation
Manager splits this Wok Order into a sequence of one or more Work Order Steps (WOS),
sending each one to a particular automated device.

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Among this sequence, the particular WOS that instructs the Analyzer to fulfill the clinical tests iscalled the Analytical Work Order Step (AWOS). The transaction carrying this AWOS instructs
the analyzer to perform a list of tests on a particular specimen. It does not say how to perform
them: The electromechanical handling of an analyzer is out of scope of this profile.
The tests are performed on specimen collected from the patients. The specimen may arrive on an
automated device before or after the WOS referring to it has been delivered. In both cases, thespecimen and the WOS (instruction) must be both present on the device in order for the step tobe performed

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This LDA profile also addresses the testing of QC specimen on an Analyzer, and the upload of
QC results from the Analyzer to the AM. An Analyzer can fulfill both patient specimen AWOS
and QC specimen AWOS. The LSWF profile supports the upload of QC results from the AM to
the Order Filler. Thus the combination of both profiles enables the centralization of QC results ofall the Analyzers of the clinical laboratory, on the Laboratory Information System.
In some situations, the recognition of the specimen (by its ID or position) or the WOS content
can be entered manually on the LD user interface.
For the purpose of messaging, the identification of specimen is essential.
The primary specimen ID is provided either by the Order Placer or by the Order Filler. In case a
Specimen Work Order Step (SWOS) instructs an aliquoter to prepare aliquot specimen, a new ID
coded on a new barcode label will be required for each aliquot produced. These IDs and labels__________________________________________________________________________
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may be provided by the Automation Manager or by the aliquoter or by a third party. The
organizational details of the labeling process are out of the scope of this profile, which only
recommends that barcode labels be readable (e.g. format and length of the barcode, label format)
by all the LD that will perform a WOS on this specimen.
The profile includes the LD’s ability to accept or reject a WOS, with the notice of specimen
arrival to the Automation Manager. It also includes the ability of an Analyzer to modify thecontent of an AWOS, for instance adding automatically a new test, depending on the results
obtained on the original tests.
The ability to automatically create modification of the work order at the AM may be constrainedby regulatory requirement.
The exchange of code sets and associated rules is supported by another profile: LCSD.

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Observation results tracking implies the ability of each actor (Analyzer, Automation Manager)
to store the raw results, before refining or translating them, automatically or interactively (e.g.
during the technical validation). This safe storage is out of the scope of this profile.
This LDA profile may enrich its specifications in order to integrate specific types of pre or postprocessing laboratory devices. The manufacturers of laboratory devices are invited by the IHE
Laboratory Committee to bring their contributions to these specifications.

X.2 Use cases

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All the use cases for patient specimen testing defined in this section start with a Work Order sentby the Order Filler to the Automation Manager. The Automation Manager splits this Work Order
into a sequence of Work Order Steps, and schedules each step on a LD (aliquoter, robotic
conveyer, analyzer…) according to the organization of the laboratory automation.
Each WOS contains all the information required by the target device to perform it: container
identification, specimen information, target ID, operation to perform, scheduled time…)
The Analytical Work Order Step (AWOS) also contains the list of clinical tests to perform, thepatient identification, admission and clinical information, the order information…The specimen
information may include the ID, position, specimen type, volume, date and time of collection, IDof collector, specimen pre-analytical status (e.g. “centrifuged”, “decapped”…).
For some Analyzers which perform single test (e.g. HbA1c), or a constant panel (Blood culture,
Blood cells count…), the AWOS need not mention the tests to be performed.

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By definition, a Work Order Step is related to a single specimen. The specimen (primary or
aliquot) is usually identified with a unique ID printed on a barcode label stuck to the specimen
container.
The laboratory technical staff supervise the various WOS using the Automation Manager andoperating all necessary LD. The technical staff perform the technical validation of the results on
the Automation Manager, which then, sends these results back to the Order Filler.
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Should a specimen be damaged or lost, the Automation Manager will suspend or cancel its Work
Order until the replacement specimen arrives. This section also provides two use cases for QC
testing.
X.2.1 WOS downloaded on the LD before specimen arrival
Initial part of the scenario:
190a) The Automation Manager sends the scheduled WOS to the LD. For some LD, many
WOS may be grouped into a single work list, which is downloaded within a single
message sent to the LD. But still in that case, each WOS part of the work list, is related toa single specimen.
b) The LD recognizes the specimen (though barcode ID scanning, position identification on
the carrier, or manual entry) and selects the related WOS from its memory.
c) Optionally, the LD may then send a “specimen arrived” notification to the Automation
Manager.
Final part of the scenario:r) The LD performs the ordered step on that specimen.

200s) The LD notifies the Automation Manager, with the status of the performed step. In thecase where the LD is an Analyzer and the WOS is an AWOS, this notification message
contains the results and status of the performed clinical tests
Exceptions handling:
In the case where the WOS has not been downloaded yet by the time the specimen isrecognized, then several events may occur depending upon the LD own capabilities andupon the operator’s actions: Either the LD skips this specimen or it suspends its process,waiting for the download of the missing WOS, or the LD queries the Automation
Manager with the specimen ID (shift to second use case) or the operator manually enters
the WOS (shift to third use case).

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In the time between the WOS first download and the specimen recognition by the LD, thecontent of the parent order and Work Order may be modified (suppressing some tests,
adding some others, shifting the target LD with another LD) or even canceled. Such
events will result into the cancellation or the modification of the WOS on the Automation
Manager, and therefore, SHALL trigger a message from the Automation Manager to the
LD carrying this modification or cancellation.
X.2.2 Query for the WOS after specimen arrival on the LD
Initial part of the scenario:a) The Automation Manager schedules the WOS but does not send it to the LD.
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220b) In the case where the Automation Manager receives a Work Order update or cancellation,
it updates or cancels the related WOS appropriately, and creates new ones if needed.
c) The LD recognizes the specimen (barcode scanning, or manual entry), and queries theAutomation Manager with the specimen ID.
d) The Automation Manager replies to the query with the WOS to perform.
Final part of the scenario: same as in use case X.2.1
Exceptions handling:
In this use case, the step to perform is sent by the Automation Manager just in time, whenthe LD is ready to perform it on the specimen. Thus there is no need for “update WOS”
and “cancel WOS” messages.

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The specimen may be placed on the LD, before the Order Filler has sent the Work Orderto the Automation Manager, and before the WOS exist on the latter. In that case the queryin step c) is unsuccessful. The answer sent in step d) will be “unknown specimen, no
pending WOS for it”. Then, either the LD skips this specimen and will try a new query
later, or (especially in case of an urgent order) the operator manually enters the WOS on
the LD(shift to third use case).
X.2.3 Manual entry of the WOS on the LDa) The Automation Manager schedules the WOS and prints it on a sheet of paper, with all
related information which will be required by the LD.
b) The laboratory technical staff enter the WOS manually on the LD, from the paper sheet.
c) At specimen recognition, the LD picks up the related WOS.

240d) Optionally, the LD may then send a “specimen arrived” notification to the Automation
Manager.
Final part of the scenario: same as in use case X.2.1
Exceptions handling:
In the case where the WOS has not been entered by the time the specimen is recognized,then several events may occur: Either the LD skips this specimen or it suspends its
process, waiting for the manual entry of the WOS by the operator, or the LD performs a
default WOS. If the LD is an Analyzer, the default AWOS may be a panel of emergency
tests which can be performed and reported quickly.

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In the time between the WOS printing by the Automation Manager and its fulfillment on
the LD, the content of the parent order and Work Order may be modified (suppressing
some tests, adding some others, shifting the target LD with another LD) or even canceled.
Such events will result in the cancellation or the modification of the WOS on the__________________________________________________________________________
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Automation Manager, which must inform the operator of those changes (on its userinterface or by printing a new corrected WOS sheet). The operator must then, manuallycorrect the WOS on the LD.
X.2.4 Rerun on the Analyzer
An AWOS usually needs one analytic run on the Analyzer (see Data Model in section 3.4). In
some circumstances the results obtained from this first run need to be controlled by a second run
or “rerun”.
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The need for a rerun may be decided-

either immediately after the first run on the LD, before uploading the results to the
Automation Manager-

or during the technical validation of the Work Order with the first run results, on the
Automation Manager application.

-or later, during the clinical validation of the order with the first run results, on the Order
Filler application

Thus, three sub cases are to be considered:
X.2.4.1 Rerun decided on the Analyzer immediately after the first run
The rerun is decided automatically or manually, at the end of the first run. The reason may be:
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Results could not be obtained, due to a flaw on the Analyzer: reagent shortage, needle
blocked up, calibration failure…

-

Results out of range, triggering a rerun with automatic dilution of the specimen.

This rerun happens before the results upload to the Automation Manager. The results of the firstrun either does not exist or are improper.
The Automation Manager should be notified of this status change of the AWOS (“First run
failed, second run scheduled”), in order to track the LD operations, and to register the reagent
consumption.
The common final part of the three preceding scenarios is presented in the following sub-case:
Final part of the scenario:
280r) The LD (Analyzer) performs the ordered step on that specimen (first run).
s) Considering the results obtained, a second run is scheduled. The Analyzer notifies the
AWOS status change to the Automation Manager: “First run failed, second runscheduled”.

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IHE Technical Framework Supplement - Profile Draft______________________________________________________________________________t) After the appropriate fix (dilution, reagent refill, needle wash, calibration…) the Analyzer
performs the second run.
u) The Analyzer notifies the Automation Manager, with the results and status of the secondrun.
X.2.4.2 Rerun decided during technical validation on the Automation Manager
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The control (rerun) is decided during the technical validation of the results of the first run,compared with normal ranges, patient’s prior results, and other clinical information, or technicalinformation such as drifting or out of range quality control detected. This decision is taken by thetechnical staff, or automatically by the Automation Manager application.
The common final part of the three preceding scenarios is presented in the following sub-case:
Final part of the scenario:r) The Analyzer performs the ordered step on that specimen (first run).
s) The Analyzer notifies the Automation Manager, with the results and status of the first run
for this AWOS.

300t) The technical validation of the results is performed on the Automation Manager, resulting
in a new run requested with the same tests on the same specimen. This new run may berequested on the same analyzer or on another one (to confirm the results obtained on thefirst one).
The rerun picks up the scenario appropriate to the working mode of the Analyzer chosen for thesecond run:If the Analyzer targeted for the rerun is working in download mode (at least for reruns) the
Automation Manager sends a new AWOS to it, for the same specimen and the same tests.
This starts a new X.2.1. scenario (step a).
If the Analyzer is working in query mode, the Automation Manager schedules the new
AWOS and waits for the query from the Analyzer. This starts a new X.2.2. scenario (step a)

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If the Analyzer only supports manual entry, the Automation Manager prints out thescheduled rerun. This starts a new X.2.3. scenario (step a)
In addition, the rerun may generate new SWOS entrusted on LDs other than the targeted
Analyzer. Here are some examples:-

The rerun is scheduled on a new aliquot that needs to be produced by an aliquoter (PreAnalyzer LD), using a new container.

-

The rerun needs the transportation of the specimen to a different Analyzer. This involves
the Post-Analyzer robotic conveyer.

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X.2.4.3 Rerun decided during clinical validation on the Order Filler

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The control (rerun) is decided during the clinical validation of the results of the whole ordergroup, considering the clinical consistency of this whole set of results, together with normal
ranges, patient’s prior results, and other clinical and technical information, or technicalinformation such as drifting or out of range quality control detected. This decision is taken by thelaboratory clinical expert, or by an automated expert system assisting the clinical expert.
In this situation, the final part of the first three scenarios ends normally. After the clinicalvalidation the Order Filler generates a new Work Order for the same patient, same specimen,
requesting the Automation Manager to schedule the tests anew, on one of its Analyzers. This
new Work Order may carry some additional tests ordered in the meantime. It may possibly
require a new aliquot.
This kind of rerun is supported and described by the first three scenarios.

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X2.5 QC performed on an analyzer
In the following use cases, in all exchanged messages, the specimen is playing the role of a “QC
specimen”.
X2.5.1 QC downloaded by the Automation Managera)
The Automation Manager schedules (automatically or interactively by the technician) a
new QC AWOS to be performed by an Analyzer, for a set of tests on a QC specimen. The
AWOS (with the specimen/container ID or specific position, and the tests to perform) is
downloaded to the analyzerb)
The analyzer recognizes the specimen (scanning the bar-coded ID, or by position) finds
the related AWOS and performs the tests.

340

c)

The analyzer sends the results obtained for the AWOS to the AM.

d)
The AM applies its evaluation rules to these QC results (result accepted or out of control,or warning of deviation trend) and stores them into its QC data base.
e)
Conditionally, the AM may forward the QC results to the Order Filler, using LAB-5transaction and a reflex QC Work Order.

X2.5.2 QC scheduled by the Automation Manager, queried by the Analyzera)
The Automation Manager schedules (automatically or interactively by the technician) a
new QC AWOS to be performed by an Analyzer, for a set of tests on a QC specimen. The
AWOS (with the specimen/container ID and the tests to perform) is prepared for the analyzer__________________________________________________________________________
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350b)
The analyzer recognizes the specimen (scanning the bar-coded ID) and queries the AMwith the specimen/container ID. The AM replies with the appropriate AWOS for this “QC
specimen”.
c)

The analyzer performs the tests and sends the results obtained for the AWOS to the AM.

d)
The AM applies its evaluation rules to these QC results (result accepted or out of control,or warning of deviation trend) and stores them into its QC data base.
e)
Conditionally, the AM may forward the QC results to the Order Filler, using LAB-5transaction and a reflex QC Work Order.
X2.5.3 Unsolicited QC results uploaded to the Automation Manager
360a)
The analyzer recognizes a QC specimen (by position, and/or manual entry of the required
information) and performs a pre-configured or manually entered list of tests on this specimen.
b)

The analyzer sends the results to the AM within a reflex AWOS.

c)
The AM applies its evaluation rules to these unsolicited QC results (result accepted or outof control, or warning of deviation trend) and stores them into its QC data base.
d)
Conditionally, the AM may forward the QC results to the Order Filler, using LAB-5transaction and a reflex QC Work Order.
At the end of section X.6 of volume 1, add the following workflows, related to the three above
use cases:
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X.3 Systems interconnection in the laboratory
As formerly stated, a clinical laboratory uses an Order Filler (OF) application to manage its
orders. It handles its technical automation with the help of one or more Automation Managers(AM), each of which may manage one or more Laboratory Devices (LD). The systems:
Laboratory Information System (LIS), Laboratory Automation System (LAS), Devices (Dev)that support the IHE actors, may be interconnected in various ways:__________________________________________________________________________
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LIS

LIS

LAS

LAS

LIS

LAS

Dev

Dev

LAS

Dev

LAS

Dev

Dev

Dev

Dev

Dev

Two levels of LAS andsingle path

One level of LAS
380

LAS

Dev

Dev

Dev

Dev

Two levels of LAS andmulti-path

Each of these architectures of interconnection is valid provided the systems implement theappropriate actors. That is:
OF

AM

LD

OF

OF

AM

AM
LD
AM

AM

LD

LD

One level of LAS

LD

LD

LD

LD

LD AM

LD

Two levels of LAS andsingle path

LD

LD

LD

LD

Two levels of LAS andmulti-path

The management of multi-path Work Orders is an internal matter of the Order Filler application.
These management rules are not part of the scope of IHE profiles.

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X.4 Actors/ Transactions
X.4.1 Workflow Diagram

Automation Manager
LAB-22
Query
for
WOS

LAB-26
SWOS
statuschangeLAB-21
WOS
download

Pre/Post-processor

LAB-21
WOS
download

LAB-22Query
for WOSLAB-23AWOS
statuschangeAnalyzer

Figure X.4-1. Laboratory Device Automation Diagram390

X.4.2 Transactions
LAB-21 – WOS Download: This transaction contains the messages used to download a Work
Order Step (WOS) from the Automation Manager to the Analyzer or Pre/Post-processor,
according to a “push method”. It includes “new WOS”, “update WOS”, “cancel WOS” and therelated applicative acknowledgements. This transaction is used with Analyzers and Pre/Postprocessor which work in download mode.
LAB-22: WOS Query: This transaction contains the message used by the Analyzer or Pre/Postprocessor to query the Automation Manager with one or more specimen (or location) identifiers,
and the reply message from the Automation Manager delivering one or more WOS dedicated toeach of these specimen. This transaction implements the “pull method” for requesting WOS.
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400

LAB-23: AWOS Status Change: This transaction contains the messages used by the Analyzer
to report the status of an AWOS (such as “specimen arrived”, “first run failed”, “second run
started”, “AWOS complete”…) and to send the tests results when the AWOS is complete. It also
includes the related applicative acknowledgements from the Automation Manager.
LAB-26: SWOS Status Change: This transaction contains the messages used by the Pre or
Post-Processor to report all the status changes of the SWOS, and the related applicative
acknowledgements. Status changes include: “specimen arrived”, “SWOS complete”, “SWOS
failed”…

410

Table X.4-1 lists the transactions for each actor involved in the LDA Profile. To claim support ofthis Integration Profile, an implementation of an actor must perform the required transactions(labeled “R”). Transactions labeled “O” are optional and define the profile options explained in
the X.5 section below.
Table X.4-1. LDA Integration Profile - Actors and Transactions
ActorsTransactions

Automation Manager

LAB-21 : WOS Download

R

LAB-22 : WOS QueryR

LAB-23 : AWOS Status Change

R

LAB-26 : SWOS Status ChangeO

LAB-21 : WOS DownloadO

LAB-22 : WOS QueryO

Analyzer

Pre/Post-processor

Optionality

LAB-23 : AWOS Status Change

R

LAB-21 : WOS DownloadO

LAB-22 : WOS QueryO

LAB-26 : SWOS Status Change

R

Section in
Vol. 2

X.5 LDA Integration Profile Options
Options which may be selected for this Integration Profile are listed in the table X.5-1 along with
the Actors to which they apply.
Table X.5-1 Laboratory Device Automation - Actors and Options
Actor

Options

Automation Manager

Management of Pre/Post-processor

Analyzer

Vol & Section

Query mode WOS
Download mode WOS__________________________________________________________________________
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Actor
Pre/Post-processor

Options

Vol & Section

Query mode WOS
Download mode WOS

420

Management of Pre/Post-processor : A product may implement an Automation Manager which
manages only AWOS on Analyzers, and therefore supports only transactions LAB-21, LAB-22
and LAB-23. If a product supports the Management of Pre/Post-processor option, then it mustalso manages SWOS and it must support transactions LAB-26 with Pre/Post-processors.
Query mode WOS: An Analyzer implementing this option must support transaction LAB-22.
Download mode WOS: An Analyzer implementing this option must support transaction LAB21.
Query mode WOS: A Pre/Post-processor implementing this option must support transaction
LAB-22.

430

Download mode WOS: A Pre/Post-processor implementing this option must support transaction
LAB-21.
Note:

A product implementing an Analyzer which supports neither transaction LAB-21 nor transaction LAB-22 canstill claim for the LDA Integration Profile conformance: It is a one way Analyzer, only able to report its results
using transaction LAB-23.

Note:

To claim for the LDA Integration Profile conformance, a product implementing a Pre/Post-processor must
support at least one of the two transactions LAB-21 and LAB-22, together with the mandatory transaction LAB26.

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X.6 LDA Integration Profile Process Flow
440

These UML sequence diagrams present a high-level view of the process flow: Each transaction isrepresented by a single arrow with the initial triggering event, but without any detail on thevarious messages which compose the transaction. The message flow of each transaction and thedescription of each of its individual messages can be found in volume 2.
X.6.1 Normal process of a specimen with all LD working in downloLD modeThis process flow is based on use case X.2.1, with all LD working in download mode.
Pre/Postprocessor

Automation
ManagerWork Order
receivedfrom Order
Filler

Pre/Postprocessor

Analyzer(acting as Pre-Processor)(acting as Post-Processor)

LAB-21 – WOS Download
LAB-21 – WOS Download
LAB-21 – WOS Download
LAB-26 – SWOS Status Change(specimen arrived)

Specimen
recognized
SWOS
complete

LAB-26 – SWOS Status Change(SWOS complete)
LAB-23 – AWOS
Status Change
LAB-23 – AWOS Status
Change with results

Specimen
recognizedTests
performed

Specimen
recognized

LAB-26 – SWOS Status Change (specimen arrived)
SWOS
complete
LAB-26 – SWOS Status Change (SWOS complete)Figure X.6.1-1. Normal process in download mode

In this example, all LD support the optional message WOS Status Change triggered by the event“Specimen recognized on the LD carrier”.

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450

This diagram shows a situation with one pre-processing device, one analyzer and one postprocessing device. In the situation where the three LDs are combined in a single physical device,
duplicate messages shall not be sent.
X.6.2 WOS Update with all LD working in download modeThis process flow based on use case X.2.1, shows the handling of the exception “Work Order
updated” after download and before fulfillment of some of its WOS.
Automation
ManagerWork Order
receivedfrom Order
Filler

Pre/Postprocessor

Pre/Postprocessor

Analyzer(acting as Pre-Processor)(acting as Post-Processor)

LAB-21 – WOS Download
LAB-21 – WOS Download

LAB-21 – WOS Download
SWOS
complete
LAB-26 – SWOS Status Change (SWOS complete)
Updatereceivedfrom Order
Filler

LAB-21 – WOS Update
LAB-21 – WOS Update

LAB-23 – AWOS Status
Change with results

Tests
performed

SWOS
complete
LAB-26 – SWOS Status Change (SWOS complete)Figure X.6.2-1. WOS Update, in download mode

In this example, the LD do not use the optional message “WOS status change” triggered by theevent “specimen recognized on the LD carrier”.
460

When the Automation Manager receives the update from the Order Filler, it forwards this update
only to those LDs which have not completed their Work Order Step yet, and which areconcerned with this update.

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X.6.3 Normal process with AWOS manual entry and SWOS download
This process flow is based on use case X.2.1, for SWOS, and use case X.2.3 for AWOS:
Pre/Post-processors are working in download mode, whilst the Analyzer, has a one-way interface
supporting only transaction LAB-23 to report its results, and therefore needs the manual entry of
its worklist of AWOS.

Automation
ManagerWork Order
receivedfrom Order
Filler

Pre/Postprocessor

Pre/Postprocessor

Analyzer(acting as Pre-Processor)(acting as Post-Processor)

LAB-21 – SWOS Download
LAB-21 – SWOS Download

SWOS
complete

LAB-26 – SWOS Status Change (SWOS complete)
AWOS
worklist
printed out
AWOS worklist

LAB-23 – AWOS Status
Change with results

AWOS worklist
manually enteredTests
performed
SWOS
complete

LAB-26 – SWOS Status Change (SWOS complete)

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X.6.4 Normal process of a specimen with all LD working in query modeThis process flow is based on use case X.2.2, with all LD working in query mode.
Automation
ManagerWork Order
receivedfrom Order
Filler

Pre/Postprocessor

Analyzer(acting as Pre-Processor)

LAB-22 – WOS query

Pre/Postprocessor(acting as Post-Processor)

Specimen
recognized

LAB-26 – SWOS Status Change (SWOS complete)
SWOS
complete

LAB-22 – WOS query

LAB-23 – AWOS Status
Change with results

Specimen
recognizedTests
performed
Specimen
recognized

LAB-22 – WOS query
SWOS
complete
LAB-26 – SWOS Status Change (SWOS complete)Figure X.6.4-1. Normal process in query mode__________________________________________________________________________
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X.6.5 Automatic rerun on the Analyzer, triggered by out of range results
This process flow is based on sub-use case X.2.4.1.

Automation
ManagerWork Order
receivedfrom Order
Filler

Pre/Postprocessor

Analyzer(acting as Pre-Processor)
LAB-21 – WOS Download

Pre/Postprocessor(acting as Post-Processor)

LAB-21 – WOS Download
LAB-21 – WOS Download
SWOS
complete
LAB-26 – SWOS Status Change (SWOS complete)
LAB-23 – AWOS Status
Change « First run failed »LAB-23 – AWOS Status
Change « AWOS complete
after 2nd run », with results

1st run performed,
results out of range
trigger 2nd run with
automatic dilution

2nd run performed,
results correct

SWOS
complete
LAB-26 – SWOS Status Change (SWOS complete)Figure X.6.5-1. Rerun decided on the Analyzer immediately after first run__________________________________________________________________________
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X.6.6 Rerun requested by the Automation Manager during technical validation
This process flow is based on sub-use case X.2.4.2.

Automation
Manager

Pre/Postprocessor

Analyzer(acting as Pre-Processor)
Work Order
receivedfrom Order
Filler

Pre/Postprocessor(acting as Post-Processor)

LAB-21 – WOS Download

LAB-21 – WOS Download
LAB-21 – WOS Download

LAB-26 – SWOS Status Change (SWOS complete)
SWOS
complete

LAB-23 – AWOS Status Change«AWOS complete» with results

1st run performed,
results reported

LAB-26 – SWOS Status Change (SWOS complete)
Technical
validation
requests
for a 2nd run

SWOScomplete

LAB-21 – new WOS Download

LAB-21 – WOS Download(prepare specimen for rerun)

LAB-26 – SWOS Status Change (SWOS complete)

LAB-23 – AWOS Status
Change « AWOS complete »,with results

SWOS
complete

2nd run performed,
results reported

Figure X.6.6-1. Rerun decided on the Automation Manager at technical validation

The request for a second run generates a new AWOS for the same specimen on the Analyzer. In
this example it also generates a new SWOS to the Post-processor, requesting it to prepare thespecimen for the second run (aliquoting, retrieval, transportation to the analyzer…)__________________________________________________________________________
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X.6.7 Urgent tests performed before the arrival of the Work Order
This process flow is based on use case X.2.2 linked with use case X.2.3

Automation
Manager

Analyzer

LAB-22 – WOS query (specimen ID)

Specimen
recognized

Reply: Unknown specimen. No pending AWOS for it
Manual entryof the WOS:
urgent tests
to perform

LAB-23 – manual AWOS complete with results (specimen ID)
results stored withspecimen ID
Work Order
received from
Order Filler
LAB-4

Tests
performed
results reported
manually to theclinical department

Matching with the manual AWOS,
based on the specimen ID
Technical validationof the urgent results

LAB-5

490

results sent to
the Order Filler

Figure X.6.7-1. Manual urgent AWOS performed and used before arrival of Work Order__________________________________________________________________________
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X6.8 QC downloaded by the Automation Manager
The following diagram illustrates use case X.2.5.1
Automation Manager
AWOS
scheduled for
QC specimen

Analyzer

LAB-21 – AWOS Download(Specimen role = QC)

Specimen ID
recognized

QC results produced

LAB-23 – AWOS Status Change(AWOS complete with results)(Specimen role = QC)__________________________________________________________________________
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X6.9 QC scheduled by the Automation Manager, queried by the Analyzer
The following diagram illustrates use case X.2.5.2
Automation Manager

Analyzer

AWOS
scheduled for
QC specimen
Specimen ID
recognized

LAB-22 –WOS Query(The reply says « Specimen role = QC »)QC results produced

LAB-23 – AWOS Status Change(AWOS complete with results)(Specimen role = QC)__________________________________________________________________________
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X6.10 Unsolicited QC results uploaded to the Automation Manager
500

The following diagram illustrates use case X.2.5.3
Automation Manager

Analyzer

QC specimen
recognized, wih
tests to perform

QC results produced

LAB-23 –AWOS Status Change(reflex AWOS complete with results)(Specimen role = QC)__________________________________________________________________________
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Volume 2 - Transactions
IHE Transactions
X.8 Transaction LAB-21: Work Order Step, Downloaded to LD
This section corresponds to Transaction LAB-21 of the IHE Technical Framework. Transaction
LAB-21 is used by the Automation Manager and LD actors.
X.8.1 Scope
This transaction is used if the Automation Manager issues a new WOS to the LD.
510

In addition, this transaction is used to cancel and/or modify a WOS which was previously sent to
the LD.
It is also possible to cancel a previous WOS and send a new WOS to modify it.
X.Y.2 Use Case Roles
Automation
ManagerLD(Analyzer,
Pre/Post Processor)

WOS Mgt

Actor: Automation Manager
Role: Manages the pre-processing, analysis, post-processing to fulfill the Work Order. Receives
the Process Result from the Pre/Post Processor and (if necessary) performs the technicalvalidation on it and (if necessary) sends the validated Process Result to the Order Filler.
Actor: (LD) Pre/Post-processor, Analyzer

520

Role: Analyzes the specimen, perform the ordered tests and generates the test results, orManages the Pre/Post-process on the specimen and generates a Process Result.

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X.8.3 Referenced Standard

HL7 v2.5, Chapter 4
X.8.4 Interaction Diagram

LD

Automation
Manager

OML^O33
New Order (ORC-1: NW)
ORL^O34
Order accepted (ORC-1: OK)
Unable to accept (ORC-1: UA)OML^O33
Order Modify (ORC-1: RP)
ORL^O34
Order modified(ORC-1:RQ)

OML^O33
Order Cancel (ORC-1: CA)ORL^O34
Order cancelled(ORC-1:CR)

X.8.4.1 Laboratory Order Message (OML^O33, ORL^O34)

530

This transaction contains the messages used to download a Work Order Step (WOS) from theAutomation Manager to the Analyzer or Pre/Post-processor. It includes “new WOS”, “update
WOS”, “cancel WOS” and the related application acknowledgements.
X.8.4.1.1 Trigger Events

OML (O33): WOS sent by the Automation Manager.
ORL (O34): Acknowledgement of the WOS sent by the LD.
X.8.4.1.2 Message Semantics

Refer to the HL7 standard for the OML, ORL message of HL7 2.5 Chapter 4 and the generalmessage semantics.
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Table : OML^O33
Segment

Meaning

Usage

Card.

HL7 chapter
2

MSH

Message Header

R[1..1][--- PATIENT begin

O[0..1]

PID

Patient IdentificationR[1..1]

3

RE[0..1]

3[ PV1 ]

Patient Visit]--- PATIENT end{--- SPECIMEN beginR[1..1]

SPM

SpecimenR[1..1]

7[{SAC}]

Specimen ContainerO[0..1]{--- ORDER beginR[1..1]

ORC

Common Order (for one battery)R[1..1]

4
4[{TQ1}]

Timing Quantity

RE[0..1][--- OBSERVATION REQUEST beginR[1..1]

OBR

Observation Request

R[1..1][TCD]

4

Test Code Details

O[0..1]

13

Observation Result

C[0..*]

7{--- PRIOR RESULT startO[0..*][ORC]

Common order – prior resultO[0..1]

4

OBR

Order detail – prior resultR[1..1]

4{OBX}

Observation/Result – prior result

R[1..*][{NTE}]

Comment of the result

C[0..*][{OBX}]}--- PRIOR RESULT end]--- OBSERVATION REQUEST end}--- ORDER end}--- SPECIMEN end

2

MSH-9 - Message Type (MSG) shall have its three components respectively valued to540"OML", "O33" and “OML_O33”
SPM-11 Specimen Role (CWE) in SPM segment shall be coded“ Q” (Control specimen) in thecase of a QC AWOS.

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Table : ORL^O34

Segment

Meaning

Usage

Card.

HL7 chapter

MSH

Message header

R[1..1]

2

MSA

Message AcknowledgementR[1..1]

2[{ERR}]

Error

O[0..*]

2[PID]

Patient IdentificationO[0..1]

3{--- SPECIMEN beginR[1..*]

SpecimenR[1..1]

7
13

SPM[{SAC}]

Specimen ContainerO[0..*][{--- ORDER begin

O[0..*]

ORC

Common OrderR[1..1]

4[{TQ1}]

Timing/Quantity

RE[0..1]

4[OBR]

Observation Request

R[1..1]

4}]--- ORDER end}--- SPECIMEN end

MSH-9 - Message Type (MSG) shall have its three components respectively valued to"ORL", "O34" and “ORL_O34”.
550
OBR segment

All fields are optional except those listed in table below.
Table : OBR Segment
SEQ

LEN

DT

Usage

Card.

TBL#

ITEM#

Element name

2

22

EI

R

[1..1]

00216

Placer Order Number

3

22

EI

RE

[0..1]

00217

Filler Order Number

4

250

CE

R

[1..1]

00238

Universal Service Identifier

5

2

ID

X

[0..0]

00239

Priority – OBR

6

26

TS

X

[0..0]

00240

Requested Date/Time

7

26

TS

X

[0..0]

00241

Observation Date/Time #

8

26

TS

X

[0..0]

00242

Observation End Date/Time #__________________________________________________________________________
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SEQ

LEN

DT

Usage

Card.

TBL#

ITEM#

9

20

CQ

X

[0..0]

11

1

ID

RE

[0..1]

00245

Specimen Action Code *

12

250

CE

X

[0..0]

00246

Danger Code

13

300

ST

X

[0..0]

00247

Relevant Clinical Information

14

26

TS

X

[0..0]

00248

Specimen Received Date/Time *

15

300

SPS

X

[0..0]

00249

Specimen Source

16

250

XCN

R

[1..1]

00226

Ordering Provider

17

250

XTN

RE

[0..2]

00250

Order Callback Phone Number

18

60

ST

X

[0..0]

00251

Placer Field 1

19

60

ST

X

[0..0]

00252

Placer Field 2

20

60

ST

X

[0..0]

00253

Filler Field 1 +

21

60

ST

X

[0..0]

00254

Filler Field 2 +

22

26

TS

X

[0..0]

00255

Results Rpt/Status Chng - Date/Time +

23

40

MOC

X

[0..0]

00256

Charge to Practice +

24

10

ID

C

[0..1]

0074

00257

Diagnostic Serv Sect ID

25

1

ID

X

[0..0]

0123

00258

Result Status +

26

400

PRL

X

[0..0]

00259

Parent Result +

27

200

TQ

X

[0..0]

00221

Quantity/Timing

29

200

EIP

X

[0..0]

00261

Parent

30

20

ID

X

[0..0]

00262

Transportation Mode

40

250

CE

X

[0..0]

01031

Transport Arrangement Responsibility

41

30

ID

X

[0..0]

0224

01032

Transport Arranged

42

1

ID

X

[0..0]

0225

43

250

CE

X

[0..0]

48

250

CWE

X

[0..0]

00243
0065

0124

0476

Element nameCollection Volume *01033

Escort Required

01034

Planned Patient Transport Comment

01646

Medically Necessary Duplicate Procedure
Reason.

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IHE Technical Framework Supplement - Profile Draft______________________________________________________________________________TCD segment
Table : TCD Segment
SEQ

LEN

DT

Usage

Card.

TBL#

ITEM#

Element name

1

250

CE

R

[1..1]

00238

Universal Service Identifier

2

20

SN

O

[0..1]

01420

Auto-Dilution Factor

3

20

SN

O

[0..1]

01421

Rerun Dilution Factor

4

20

SN

O

[0..1]

01422

Pre-Dilution Factor

5

20

SN

O

[0..1]

01413

Endogenous Content of Pre-Dilution Diluent

6

1

ID

O

[0..1]

0136

01416

Automatic Repeat Allowed

7

1

ID

O

[0..1]

0136

01424

Reflex Allowed

8

250

CE

O

[0..1]

0389

01425

Analyte Repeat Status

560
Note:
The usage of this segment needs to be considered between AM and LD.
Universal Service Identifier is a copy of OBR-4.
X.8.4.1.3 Expected Actions

If the OML message of the Order Control Code NW is received from Automation Manager, theLD will receive and register the order information, then it will transmit the result either “Accept”
or “Reject” to Automation Manager by the ORL message.

X.9 Transaction LAB-22: WOS Query
570

This section corresponds to Transaction LAB-22 of the IHE Technical Framework. Transaction
LAB-22 is used by the Automation Manager and the Pre/Post-processor, Analyzer(LD) actors.
This transaction is used by the LD to get the WOS to perform for each specimen from theAutomation Manager by querying after the specimen arrives. The transaction provides a query
for multiple specimen and the reply will carry zero or one container and one WOS for eachspecimen. The Automation Manager and the LD preserve the conformity between the specimen
and the WOS by checking the Specimen Information (Specimen ID and the like) within themessage.

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X.9.1 Scope

580

This transaction is used by the general use case “Query for the WOS after specimen arrival on
the LD” described in the Volume 1 of this LDA Technical Framework. It is used by the
Automation Manager (Laboratory Automation System) and the LD which supports "QueryMode".
X.9.2 Use Case Roles
Automation
ManagerLD(Analyzer,
Pre/Post Processor)

WOS Mgt

Actor: Automation Manager
Role: Manages the Work Orders and WOS. Returns the appropriate WOS to the query from theLD.
Actor: (LD) Pre/Post-processor, Analyzer

590

Role: Queries the WOS to the Automation Manager when a specimen arrives, and receives the
WOS as the response.
X.9.3 Referenced Standard

HL7 version 2.5:
• Chapter5: "Query" --> QBP and RSP messages• Chapter5: "Query" --> QPD, RCP and QAK segments
X.9.4 Interaction Diagram__________________________________________________________________________
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LD(in query mode)

Automation
Manager

QBP^WOS^QBP_Q11 (Query for WOS)

Specimen
recognized

RSP^WOS^RSP_K11(Response including WOS)

X.9.4.1 WOS Query Message (QBP^WOS^QBP_Q11, RSP^WOS^RSP_K11)

600

After the LD working in query mode recognizes one or more specimen arrival, the LD sends"WOS Query Message"(QBP^WOS^QBP_Q11) with one or more Specimen IDs or other IDs to
the Automation Manager.
The Automation Manager replies with the response message (RSP^WOS^RSP_K11) containing
one or more WOS for each specimen identified in the query.
X.9.4.1.1 Trigger Events

QBP(Q11) : Query for the WOS sent by the LD.
RSP(K11) : Response including the WOS sent by the Automation Manager.
X.9.4.1.2 Message Semantics

Refer to the HL7 standard for the QBP message of HL7 2.5 Chapter 5 and the general message
semantics.
610

Table : QBP^WOS^QBP_Q11
Segment

Meaning

Usage

Card.

HL7 chapter

MSH

Message header

R[1..1]

2[{SFT}]

Software Segment

O[0..*]2

QPD

Query Parameter DefinitionR[1..1]

5

RCP

Response Control ParameterR[1..1]

5[DSC]

Continuation PointerO[0..1]

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MSH-9 - Message Type (MSG) shall have its two first components respectively valued to "QBP"and "Q11".

Table : RSP^WOS^RSP_K11
Segment

Meaning

Usage

Card.

HL7 chapter

MSH

Message header

R[1..1]

2[{SFT}]

Software Segment

O[0..*]

2

MSA

Message AcknowledgementR[1..1]

2

[ERR]

Error

O

[0..1]

2

QAK

Query AcknowledgementR[1..1]

5

QPD

Query Parameter DefinitionR[1..1]

5{--- SPECIMEN beginR[1..*]

SPM

SpecimenR[1..1]

7[{OBX}]

Observation related to specimen

O[0..*]

7[{SAC}]

Specimen ContainerRE[0..1]

13[--- PATIENT begin

O[0..1]

PID

Patient IdentificationR[1..1]

3[{OBX}]

Observation related to the patientO[0..*]

7]--- PATIENT end{--- ORDER beginR[1..1]

ORC

Common OrderR[1..1]

4[{TQ1}]

Timing/Quantity

RE[0..1]

4[--- OBSERVATION REQUEST begin

O[0..1]

OBR

Observation Request

R[1..1]

4[ TCD ]

Test Code Details

O[0..1]

13]--- OBSERVATION REQUEST end}}--- ORDER end--- SPECIMEN end

MSH-9 - Message Type (MSG) shall have its two first components respectively valued to "RSP"and "K11".
SPM-11 Specimen Role (CWE) in SPM segment shall be coded “Q” (Control specimen) in thecase of a QC AWOS.
620

If the query was not based on the specimen ID, the response shall contain SAC.
QPD segment
Table : QPD segment__________________________________________________________________________
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SEQ

LEN

1

60

DT
CE

Usage

Card.

R

[1..1]

TBL#

ITEM#
01375

Element nameMessage Query Name

2

32

ST

R

[1..1]

00696

Query Tag

3

80

EIP

C

[0..*]

01756

SPM-2:Specimen Identification

4

80

EI

C

[0..*]

01331

SAC-3:Container Identification

5

80

EI

C

[0..1]

01337

SAC-10:Carrier Identification

6

80

NA

C

[0..1]

01338

SAC-11:Position in Carrier

7

80

EI

C

[0..1]

01340

SAC-13:Tray Identification

8

80

NA

C

[0..1]

01341

SAC-14:Position in Tray

9

250

CE

C

[0..*]

01342

SAC-15:Location

QPD-1 Message Query Name (CE), requiredMust be valued "WOS^Work Order Step^IHE_LABTF"
QPD-2 Query Tag (ST), required
Unique to each query message instance.

630

QPD-3 Specimen Identification (EIP), conditional
As for the 1st component "Placer Assigned Identifier"(EI), contains the placer assigned identifier
and its assigning authority.
As for the 2nd component "Filler Assigned Identifier"(EI), contains the filler assigned identifier
and its assigning authority.
If this field is valued all other query fields shall be empty.
QPD-4 Container Identification (EI), conditional
Contains the identification of the container.
QPD-5 Carrier Identification (EI), conditional
Contains the identification of the carrier (also known as Rack).
If this field is valued, then the field "QPD-6:Position in Carrier" shall also be valued.
If these 2 fields(QPD-5,6) are valued all other query fields shall be empty, with the possible
exception of the Location field(QPD-9).

640

QPD-6 Position in Carrier (NA), conditional
Contains the positions of the specimen/aliquot on the carrier (rack).
If this field is valued, then the field "QPD-5: Carrier Identification" shall also be valued.
QPD-7 Tray Identification (EI), conditional
Contains the identification of the Tray.
QPD-8 Position in Tray (NA), conditional
Contains the position of the carrier on the tray.
QPD-9 Location (CE), conditional
Contains the physical location of the specimen.

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650

This field cannot be valued in isolation, it must always be combined with the physicallocation/position of the specimen on either a carrier or a tray.
This field shall never be used in combination with either the specimen identification or thecontainer identification fields.
RCP segment
Table : RCP segment
SEQ

LEN

1

1

2

10

DT

Usage

Card.

TBL#

ITEM#

Element nameID

O

[0..1]

0091

00027

Query Priority

CQ

O[0..1]

0126

00031

Quantity Limited Request

0394

01440

Response Modality

01594

Segment group inclusion

NM
CE
3

60

CE

O

[0..1]

7

256

ID

O

[0..*]

RCP-1 Query Priority(ID), optional

Fixed to "I" (=Immediate). If no value is given, the default is "I".
RCP-2 Quantity Limited Request(CQ), optional660

As for the 1st component "Quantity"(NM), Number of Records which will be returned in eachincrement of the response. If no value is given, the entire response will be returned in a single
increment.
As for the 2nd component "Units"(CE), "RD"(=Records) is always set. If no value is given, thedefault is RD.
RCP-3 Response Modality(CE), optional

Fixed to "R" (=Realtime). If no value is given, the default is "R".
RCP-7 Segment group inclusion(ID), optional

Specifies those optional segment groups which are to be included in the response. If this field is
not valued, all segment groups will be included.
Note: The usage of this segment needs to be considered between AM and LD.
670
X.9.4.1.3 Expected Actions

When specimen arrives on the LD which supports "Query Mode", the LD sends a QBP message
to the Automation Manager to get WOS. This QBP message may have one or more Specimen
IDs/Container IDs.
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IHE Technical Framework Supplement - Profile Draft______________________________________________________________________________The Automation Manager receives the QBP message and prepares the appropriate WOS bychecking IDs contained in the QBP message. The Automation Manager returns the RSP message
with WOS to the LD immediately. The LD receives WOS and performs processing for the
specimen.
680

Even if the Automation Manager could not prepare WOS for one or more IDs, the RSP message
must have SPM segments of the same number as IDs contained in the QBP message. OBR/TCD
segments can be omitted.

X.10 Transaction LAB-23: AWOS Performed, Analysis Results
This section corresponds to transaction LAB-23 of IHE Laboratory Technical Framework. The
actors using this transaction are the Automation Manager and the Analyzer.
X.10.1 Scope

This transaction is used if the Analyzer sends test results to the Automation Manager.
X.Y.2 Use Case Roles
Automation
Manager

Analyzer

AWOS Mgt

Actor: Automation Manager

690

Role:

Manages Analyzer in order to implement the AWOS.
Receives the test results from Analyzer, performs technical validation, then sends the validated
results to Order filler
Actor: Analyzer
Role:

Analyzes the specimen and outputs the test results.

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X.10.3 Referenced Standard

HL7 Version 2.5--mainly referred to in Chapter 7.
700

X.10.4 Interaction Diagram

Automation
Manager

Analyzer

OUL^ R22(Test Result)
ACK^ R22(Result Accepted)

X.10.4.1 Analysis Results Upload (OUL^R22, ACK^R22)

This transaction contains the messages used by the Analyzer to report the status of an AWOS
(such as “specimen arrived”, “first run failed”, “second run started”, “AWOS complete”…) andto send the tests results when the AWOS is complete. It also includes the related applicative
acknowledgements from the Automation Manager.
X.10.4.1.1 Trigger Events

Analyzer sends test results.
710

Automation Manager returns acknowledgement.
Notes HL7 V2.5 Chapter 7 has no description of ACK message. However, ACK message isnecessary to exchange the messages on the HL7.
X.10.4.1.2 Message Semantics

Refer to the HL7 standard for the OUL message of HL7 2.5 Chapter 7 and the general message
semantics.

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Table : OUL^R22
Segment

Meaning

MSH

Usage

Card.

HL7 chapter

Message header

R[1..1]

2[PID]

Patient Identification

RE[0..1]

3[PV1]

Patient VisitO[0..1]

3{--- SPECIMEN beginR[1..1]

SPM

Specimen informationR[1..1]

7[{ OBX }]Observation Result (for Specimen)O[0..*]

7[{--- CONTAINER begin

0[0..1]

SAC

Container informationR[1..1]

13[INV]

Detailed Substance information (e.g., id, lot,O

[0..1]

13

manufacturer, … of QC specimen)}]--- CONTAINER end{--- ORDER beginR[1..1]

OBR

Observation OrderR[1..1]

7[ORC]

Common OrderO[0..1]

4[{--- RESULT begin

O[0..*]

OBX

Observation ResultR[1..1]7[TCD]

Test Code DetailC*1[0..1]

13[{SID}]

Substance Identifier (e.g., reagents used for testing)C*1[0..*]

13[{NTE}]

Notes and commentsO[0..*]}]--- RESULT end}--- ORDER end}--- SPECIMEN end

Table ACK^R22
Segment*1

Meaning

Usage

Card.

HL7 chapter

MSH

Message header

R[1..1]

2

MSA

Message AcknowledgementR[1..1]

2

[ERR]

Error

O

[0..1]

2

If it is patient sample, this is Optional. If it is a QC sample it is Mandatory if it is available.

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720
MSH-9 - Message Type (MSG) shall have its three components respectively valued to"OUL", "R22" and “OUL_R22”.
SPM-11 Specimen Role (CWE) in SPM segment shall be coded “Q” (Control specimen) in thecase of a QC AWOS.

OBR segment

All fields are optional except those listed in table below.
730

Table: OBR segment
SEQ

LEN

DT

Usage

Card.

TBL#

2

22

EI

RE

[0..1]

00216

Placer Order Number

3

22

EI

RE

[0..1]

00217

Filler Order Number

4

250

CE

R

[1..1]

00238

Universal Service Identifier

5

2

ID

X

[0..0]

00239

Priority – OBR

6

26

TS

X

[0..0]

00240

Requested Date/Time

7

26

TS

RE

[0..1]

00241

Observation Date/Time #

8

26

TS

RE

[0..1]

00242

Observation End Date/Time #

11

1

ID

RE

[0..1]

00245

Specimen Action Code *

12

250

CE

X

[0..0]

00246

Danger Code

0065

ITEM#

Element name

13

300

ST

X

[0..0]

00247

Relevant Clinical Information

14

26

TS

X

[0..0]

00248

Specimen Received Date/Time *

15

300

SPS

X

[0..0]

00249

Specimen Source

16

250

XCN

R

[1..1]

00226

Ordering Provider

17

250

XTN

RE

[0..2]

00250

Order Callback Phone Number

18

60

ST

X

[0..0]

00251

Placer Field 1

19

60

ST

X

[0..0]

00252

Placer Field 2

20

60

ST

X

[0..0]

00253

Filler Field 1 +

21

60

ST

X

[0..0]

00254

Filler Field 2 +

22

26

TS

C

[0..1]

00255

Results Rpt/Status Chng - Date/Time +

23

40

MOC

X

[0..0]

00256

Charge to Practice +

24

10

ID

C

[0..1]

0074

00257

Diagnostic Serv Sect ID

25

1

ID

R

[1..1]

0123

00258

Result Status +__________________________________________________________________________
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SEQ

LEN

DT

Usage

Card.

27

200

TQ

X

[0..0]

30

20

ID

X

[0..0]

40

250

CE

X

[0..0]

41

30

ID

X

[0..0]

42

1

ID

X

[0..0]

43

250

CE

X

[0..0]

48

250

CWE

X

[0..0]

TBL#

ITEM#
00221

0124

Element name
Quantity/Timing

00262

Transportation Mode

01031

Transport Arrangement Responsibility

0224

01032

Transport Arranged

0225

01033

Escort Required

0476

01034

Planned Patient Transport Comment

01646

Medically Necessary Duplicate Procedure
Reason.

All field data should reflect LAB-21,22 transaction’s OBR.

TCD segment

All fields are optional except those listed in table below.
Table : TCD segment
SEQ

LEN

DT

Usage

Card.

1

250

CE

R

[1..1]

TBL#

ITEM#

Element name00238

Universal Service Identifier

X.10.4.1.3 Expected Actions

740

Analyzer notifies Automation Manager of the test results using the OUL message . Automation
Manager accepts and registers information, and responds to the Analyzer with the ACK message.

X.11 Transaction LAB-26: Sending Process Result/Specimen Status
Update Message
This section corresponds to Transaction LAB-26 of the IHE Laboratory Technical Framework. It
is used by the Automation Manager and the Pre/Post Processor.
X.11.1 Scope

This transaction is used when the Pre/Post Processor transmits a Process Results to the
Automation Manager.

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X.11.2 Use Case Roles
Automation
Manager(LD)Pre/PostAnalyzer

SWOS Mgt

750
Actor: Automation Manager
Role: Manages the preprocessing, analysis, post-processing to fulfill the Work Order. Receives
the Test Result from the Pre/Post Processor and (if necessary) performs the technical validation
on it and (if necessary) sends the validated Result to the Order Filler.
Actor: (LD)Pre/Post Processor
Role: Manages the Pre/Post-analysis process on the specimen and generates a Process Result orSpecimen Status Message.

X.11.3 Referenced Standard

760

HL7 Version 2.5--mainly referred to in Chapter 7 and Chapter13.
X.11.4 Interaction Diagram(LD)Pre/Post
processor

Automation
Manager

SSU^ U03 (Specimen Status Message)
ACK^U03 (General Acknowledgment )Figure 2-2 : Unsolicited Specimen Status Update Message from Pre/Post
Processor (SSU/ACK)__________________________________________________________________________
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X.11.4.1 Process Result Upload (SSU^U03, ACK^U03)

This transaction contains the messages used by the Pre or Post-Processor to report all the statuschanges of the SWOS, and the related application acknowledgements. Status changes include:“specimen arrived”, “SWOS complete”, “SWOS failed”…
770

X.11.4.1.1 Trigger Events

SSU (U03): Pre/Post Processor transmits a Specimen Status Update Message.
ACK (U03): Automation Manager sends the affirmative response.

X.11.4.1.2 Message Semantics

Refer to the HL7 standard for the SSU message in HL7 2.5 Chapter 13.

Table 2-5: SSU^U03
Segment

Meaning

Usage

Card.

HL7
chapterR[1..1]

2
13

MSH

Message header

EQU

Equipment DetailR[1..1]{--- SPECIMEN_CONTAINER beginR[1..1]

SAC

Specimen Container DetailR[1..1]

13

Additional specimen characteristics

O[0..*]

7--- SPECIMEN beginR[1..1]

SPM

Specimen informationO[1..1]

7{[ OBX ]

Observation Result (for Specimen)O[0..*]

7}]--- SPECIMEN end{[ OBX ]}[ {}--- SPECIMEN_CONTAINER end}

780
Table 2-6: ACK^U03
Segment
MSH

Meaning
Message header

Usage

Card.

HL7 chapter

R[1..1]

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MSA

Message AcknowledgementR[1..1]

2

[ERR]

Error

O

[0..1]

2

X.11.4.1.3 Expected Actions

The Pre/Post Processor sends a Process Result using the SSU message to the Automation
Manager. The Automation Manager accepts and registers the Process Result, and responds to the
Pre/Post Processor using the ACK message.

790

Note: The SSU message might appear too restrictive to meet future needs for carrying the output
data of a SWOS, brought along by specific pre or post processing devices. If such a use caseappears in the future for a specific device, alternative messages will be studied to extend thisprofile.

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X.12 Real world use cases
X.12.1 Guideline

Each of the use cases in this section are to be considered as a template for handling aworkflow of automated clinical laboratory through all the transactions of the LDA technicalframework. Only major steps and interactions are described.

800

Each use case is described by a storyboard which describes the complete workflow inchronological order, completed by an interaction diagram, and illustrated by the mostsignificant messages of the workflow. The message descriptions are abbreviated, to focus on
the main points of interest.
OP : Order Placer
OF : Order Filler
AM : Automation Manager
ORT: Order Result Tracker
LD : Laboratory Device
WOS: Work Order Step
SWOS: Specimen Work Order Step
AWOS: Analytical Work Order Step810

LIS: Laboratory Information System

X.12.2 Assumed in use case820This use case is in the context given where the following conditions are satisfied: The orderis sent to the automation manager (AM) from the order entry system (OP) according to theworkflow indicated in the LSWF technical framework. The patient ID is confirmed with thespecimen container with appropriate label affixed according to the procedure specified byeach facility, and then the sample is obtained appropriately. The filled specimen container issent to the laboratory according to the procedure specified by the facility. The sample isprocessed in the Pre-processor immediately prior to or following the sample arrival checking
on the Order Filler (OF). The sample is transferred to the Pre-processor, the Analyzer, andthen the Post-processor in this order. The measurement data is transmitted to ORT via OF
after approval by AM.

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IHE Technical Framework Supplement - Profile Draft______________________________________________________________________________An example of use cases is described in this section, however a hybrid use case may be
applicable in the field.
For instance, either of the Pre- or the Post-processor may be used or neither of them may be
used. Therefore it is suggested that the uses case should be used to compare with real life
scenarios evidenced in specific facilities.
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X.12.3 Typical specimen testing
X.12.3.1 Case Flow

This example corresponds to the use case described in Volume 1 as "Externally placed orderwith unidentified specimen or to be collected by the laboratory". AM schedules orders to be
performed and transmits WOS for LDs (Analyzer, Pre/Post-processor) requiring WOS.
Notifying AM of the sample arrival, LD processed the downloaded WOS whose result istransmitted to AM.
X.12.3.2 Storyboard

840

Dr. Smith orders five chemistry tests (TP, T-Bil, AST, ALT and LDH) on the patient (ID:1111222) through the order entry system terminal. Ann Norman, technician sets the received
sample onto the Laboratory Automation System (LAS) wherein the sample is treated bycentrifugation, de-capping, aliquoting as well as labeling. However, if the sample process
information has not arrived at the Pre-processor, it may have to wait for a while to receive
the sample process information before processing..
The sample whose pre-processing is appropriately completed is measured in the analyzer.
After measurement, the measurement result is transmitted to Laboratory Information System(LIS) where the approved sample is capped and unloaded.

850

Human actors and organizations participating to the process:

Assigning authority:

Marrione hospital

Placer:

Urology department

Filler:

Cytology laboratory

Ordering facility:

Urology

Patient:

Josie Macneal, Patient hospital identifier:1111222, Patient visit number: 3333444,
class = inpatient

Orderer:

Dr Smith. ID number 14789

Placer order enterer:

Tom Nurse. ID number 66623

Specimen collector:

Janet Kerry. ID number 48484

Technician:Paul Stedt. ID number 99992__________________________________________________________________________
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Clinical expert:

David Zhen 55565

ID numbers used by the workflow:
IDnumber

Value

Assigned by

Patient hospital ID

1111222

Admission office (ADT)Patient visit number

3333444

Admission office (ADT)

Care unit order group555

Enter-gastric department (OP)

Observation Order Code（TP）

1234561

Enter-gastric department (OP)

Observation Order Code（T-Bil） 1234562

Enter-gastric department (OP)

Observation Order Code（AST）

1234563

Enter-gastric department (OP)

Observation Order Code（ALT）

1234564

Enter-gastric department (OP)

Observation Order Code（LDH） 1234565

Enter-gastric department (OP)Work Order Code (TP)456

Bio-chemistry laboratory (OF)Work Order Code (T-Bil)457

Bio-chemistry laboratory (OF)Work Order Code (AST)458

Bio-chemistry laboratory (OF)Work Order Code (ALT)459

Bio-chemistry laboratory (OF)Work Order Code (LDH)460

Bio-chemistry laboratory (OF)Work Order Step Code (TP)456

Bio-chemistry laboratory (AM)Work Order Step Code (T-Bil)457

Bio-chemistry laboratory (AM)Work Order Step Code (AST)458

Bio-chemistry laboratory (AM)Work Order Step Code (ALT)459

Bio-chemistry laboratory (AM)Work Order Step Code (LDH)460

Bio-chemistry laboratory (AM)Specimen ID

101_1

Bio-chemistry laboratory (AM)

LAB-21 interaction: AM transmits "new order" (NW) to LD (Analyzer, Pre/Post-processor).
LAB-23 interaction: The Analyzer transmits the sample arrival notice to AM by reading its
ID label. After measurement completes, the measurement result is transmitted.

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LAB-26 interaction: The Pre/Post-processor transmits the sample arrival notice and theprocess result to AM by reading its ID label.

X.12.3.3 Interaction diagram
Automation
Manager

Receive
Work Orderfrom OF

Pre-Processor

Post-Processor

Analyzer

OML^O33（NW）

ORL^O34

OML^O33（NW）
ORL^O34

OML^O33（NW）
ORL ^ O34

SSU^U03（
Speciemen
Status Change)

Specimens checked

ACK^U03(ACK)SSU^U03（
Speciemen
Status Change)
ACK^U03(ACK)SWOS
Complete

Specimens checked

OUL^R22(Specimen Status Change)

ACK^R22(ACK)OUL^R22(Specimen Status Change with Results)

AWOS
Complete

Specimens
checked

ACK^R22(ACK)SSU^U03（
Speciemen Status Change)
ACK^U03(ACK)SWOS
Complete

SSU^U03（
Speciemen Status Change)
ACK^U03(ACK)860

X.12.3.4 Message

LAB-21（AM→LD）： New WOS transmitted to LD
LAB-23（Analyzer→AM）： Performed AWOS transmitted to AM and measurement result
LAB-26（Pre/Post-processor→ AM）： Performed SWOS transmitted to AM__________________________________________________________________________
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X.12.4 Test with dedicated device for fixed items such as an urine qualitative
device870

X.12.4.1 Case flow

The Post-processor performs downloading of orders. Not receiving an order, the Analyzer
transmits results of a predetermined item to AM. The sample ID is automatically (ormanually) entered with the barcode label affixed to the sample container.

X.12.4.2 Storyboard

Dr. Thomas orders a battery of urine qualitative test on the patient (ID: 2222111) with acomment "urgent" through the order entry system terminal.
The battery consists of five urine qualitative tests (pH, protein, sugar, occult blood andketone body).
880

Anne Norman, technician sets the sample arriving at the Emergency Laboratory onto theAnalyzer, which automatically reads barcode info and sends measurement result to LIS after
measurement completion. The measured sample is unloaded according to its sample
processing info.
Urine qualitative tests are performed in an independent single analyzer.
Human actors and organizations participating to the process:

Assigning authority:

Marrione hospital

Placer:Emergency Ward

Filler:Emergency Laboratory

Ordering facility:

Emergency Ward

Patient:

Henry Schneider. account number 2222111 Patient visit
number 050228011 class = outpatient.

Orderer:Dr. Thomas, phone number 7999 ID number 99999

Placer order enterer:

Dr. Thomas, phone number 7999 ID number 99999

Specimen collector:

John nurse, ID number 99991

Technician:Karen nurse, ID number 99992

Clinical expert:

Ema Scott, ID number 55565__________________________________________________________________________
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ID numbers used by the workflow

ID number

Value

Assigned by

Patient hospital ID

2222111

Admission office (ADT)Patient visit number

050228011 Admission office (ADT)

Care unit order group

999

Emergency ward (OP)

Care unit order comment (Stat)

Q

Emergency ward (OP)

Observation Order Code (Urine
qualitative)

1234561

Emergency ward (OP)Word Order Code (Urine
qualitative)

45600

Emergency laboratory (OF)Work Order Step Code (pH)45601

Emergency laboratory (AM)Work Order Step Code (Protein)

45602

Emergency laboratory (AM)Work Order Step Code (Glucose)

45603

Emergency laboratory (AM)Work Order Step Code (Occult
Blood)

45604

Emergency laboratory (AM)Work Order Step Code (Ketone
Object)45605

Emergency laboratory (AM)Specimen ID

156

Emergency laboratory (AM)890
LAB-21 interaction: As soon as AM receives Work order, it transmits NW to the Postprocessor.
LAB-23 interaction: The Analyzer transmits the sample arrival notice to AM by reading its
ID label. When measurement is completed, measurement result is transmitted.
LAB-26 interaction: The Post-processor transmits the sample arrival notice and sample
processing results to AM by reading its ID label.

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X.12.4.3 Interaction diagram
Automation
Manager

Post-Processor

Analyzer

Recieve
Work Orderfrom OFOML^O33（NW）
ORL ^ O34
Specimens checked

OUL^R22(Specimen Status
Change)ACK^R22(ACK)
Analyze start

OUL^R22(Specimen Status
Change with Results)

ACK^R22(ACK)Specimens
checkedSSU^U03（
Speciemen Status Change)
ACK^U03(ACK)SSU^U03（
Speciemen Status Change)

SWOS
Complete

ACK^U03(ACK)900

X.12.4.4 Message

LAB-21（AM→ Post-processor）: New SWOS transmitted to Post-processor
LAB-23（Analyzer→ AM）: Performed AWOS to be transmitted to AM and measurement
result
LAB-26（Post-processor→ AM）: Performed SWOS transmitted to AM__________________________________________________________________________
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X.12.5 Setting of sample without pre-post processor
X.12.5.1 Case flow910

A sample is set onto the Analyzer directly with no Pre/Post-processor. AM downloads
AWOS to the Analyzer beforehand. The Analyzer identifies sample by reading its ID label
and measures the sample according to AWOS, then transmits results to AM.
X.12.5.2 Storyboard

Dr. Smith orders an HbA1c test on the patient (ID: 2222333) from the order entry systemterminal. The specimen, which arrived to the biochemistry laboratory, is placed to theanalyzer by the technician Paul Stedt and analyzed.
After completing the measurement by the analyzer, the test result is transferred fromanalyzer to the LIS.

920

Human actors and organizations participating to the process:

Assigning authority:

Marrione hospital

Placer:Internal department

Filler:Biochemistry laboratory

Ordering facility:

Internal secretion department

Patient:

Josie Macneal, Patient hospital identifier: 2222333,
Patient visit number: 050228022, class = outpatient

Orderer:

Dr Smith. ID number 77777

Placer order enterer:

Dr Smith. ID number 77777

Specimen collector:

Janet Kerry. ID number 99991

Technician:Paul Stedt. ID number 99992

Clinical expert:

David Zhen 55565

ID numbers used by the workflow

ID number

Value

Assigned by

Patient hospital ID

2222333

Admission office (ADT)Patient visit number

050228022

Admission office (ADT)__________________________________________________________________________
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Care unit order group

333

Internal department (OP)

Observation Order Code (HbA1c)

1234567Internal department (OP)Work Order Code (HbA1c)

45678

Bio-chemistry laboratory (OF)Work Order Step Code (HbA1c)

45678

Bio-chemistry laboratory (AM)Specimen ID

147

Bio-chemistry laboratory (AM)

LAB-21 interaction: As soon as AM receives Work order, it transmits NW to the Postprocessor.
LAB-23 interaction: The Analyzer transmits the sample arrival notice to AM by reading its
ID label. When measurement is completed, measurement result is transmitted.

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X.12.5.3 Interaction diagram

Automation
Manager

Analyzer

Pre-Post
Processor

Receive
Word Orderfrom OFOML^O33（NW）
ORL ^ O34

OUL^R22(Specimen Status
Change)ACK^R22(ACK)OUL^R22(Specimen Status
Change with Results)

Specimens
checked

AWOS
CompletACK^R22(ACK)930

X.12.5.4 Message

LAB-21（AM→ Analyzer）：New AWOS transmitted to Analyzer
LAB-23（Analyzer→ AM）：Performed AWOS to be transmitted to AM and measurement
result__________________________________________________________________________
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X.12.6 Manual ordering to the analyzer
X.12.6.1 Case flow

940

This use case is the one example of Volume1 “X.2.3. Manual entry of the WOS on the LD”.
AM schedules the Work Order and transmit the WOS to the Pre-processor. A technician
manually order test into the analyzer according to the worksheet, which is output from AM.
Pre-processor and Analyzer inform the sample arrival status to the AM, process WOS thentransmit the result to AM.
X.12.6.2 Storyboard

Dr. Smith orders a Cyclosporin test on the patient (ID: 4444333) from the order entry systemterminal. Technician Paul Stedt set a specimen onto the Laboratory automation system, thenthe specimen is treated by centrifugation, de-capping, aliquoting as well as labeling. Afterthese pre-processes, Paul Stedt prints out the worksheet from LIS then input the test ordermanually to the analyzer.
950

Analyzer detects the specimen ID barcode and process measurement. After completing themeasurement by the analyzer, the test result is transferred from analyzer to the LIS.
Human actors and organizations participating to the process:

Assigning authority:

Marrione hospital

Placer:

Urology department

Filler:Biochemistry laboratory

Ordering facility:

Urology department

Patient:

Josie Macneal, Patient hospital identifier: 4444333,
Patient visit number: 050228033, class = outpatient

Orderer:

Dr Smith. ID number 77777

Placer order enterer:

Dr Smith. ID number 77777

Specimen collector:

Janet Kerry. ID number 99991

Technician:Paul Stedt. ID number 99992

Clinical expert:

David Zhen 55565__________________________________________________________________________
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ID numbers used by the workflow

ID numbervalue

Patient hospital ID

4444333

Assigned by
Admission office (ADT)Patient visit number

050228033

Admission office (ADT)

Care unit order group

555

Urology department (OP)

Observation Order Code (Cyclosporin)

234567

Urology department (OP)Work Order Code (Cyclosporin)

54321

Bio-chemistry laboratory (OF)Work Order Step Code
(Cyclosporin)

54321

Bio-chemistry laboratory (AM)Specimen ID

258

Bio-chemistry laboratory (AM)

LAB-21 interaction: As soon as AM receives Work order, it transmits NW to the Preprocessor.

960

LAB-23 interaction: The Analyzer transmits the sample arrival notice to AM by reading its
ID label. When measurement is completed, measurement result is transmitted.
LAB-26 interaction: The Pre-processor transmits the sample arrival notice and sample
processing results to AM by reading its ID label.

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X.12.6.3 Interaction diagram
Automation
Manager

Pre-Processor

Anlyzer

OML^O33（
NW）

Receive
Work Orderfrom OFORL^O34
SSU^U03（
Speciemen Status Change)

Specimens
checked

ACK^U03(ACK)SSU^U03（
Speciemen Status Change)

SWOS
Complete

ACK^U03(ACK)AWOS
Worksheet
PrintsAWOS Worksheet
manually input

OUL^R22(Specimen Status Change with Results)

AWOS
Complete

ACK^R22(ACK)

X.12.6.4 Message

970

LAB-21（AM→ Pre-processor）：New SWOS transmitted to Pre-processor
LAB-26（Preprocessor→ AM）：Perform SWOS transmitted to AM
LAB-23（Analyzer→ AM）：Perform AWOS to be transmitted to AM and measurement result__________________________________________________________________________
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X.12.7 Analyzer queries the test order
X.12.7.1 Case flow

This use case is one example of Volume 1 “X.2.2.Query for the WOS after specimen arrivalon the LD”.

980

AM schedules the Work Order and creates WOS. All LDs inform the sample arrival status to
the AM, then query WOS. AM replies to the query from LD. LD processes WOS thentransmit the result to AM.

X.12.7.2 Storyboard

Dr. Smith orders three tests (Uric acid, BUN and Creatinine) on the Plasma specimen of thepatient ( ID: 4444555) from the order entry system terminal. Technician Paul Stedt set a
specimen onto the Laboratory automation system. Pre/Post-processor detects the specimen
ID barcode and queries sample processing info to the LIS.
The specimen is treated by centrifugation, de-capping, aliquoting as well as labelingaccording to the reply of the query. The specimen, which is successfully processed by Preprocessor, transferred to the analyzer and measured.
990

The measurement result is transferred from analyzer to the LIS, then the specimen istransferred to the Post-processor. At the Post-processor, the specimen is re-capped andstored to the storage unit.
Human actors and organizations participating to the process:

Assigning authority:

Marrione hospital

Placer:

Urology department

Filler:Biochemistry laboratory

Ordering facility:

Urology department

Patient:

Josie Macneal, Patient hospital identifier: 4444555,
Patient visit number: 050228066, class = outpatient

Orderer:

Dr Smith. ID number 77777

Placer order enterer:

Dr Smith. ID number 77777

Specimen collector:

Janet Kerry. ID number 99991

Technician:Paul Stedt. ID number 99992__________________________________________________________________________
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Clinical expert:

David Zhen 55565

ID numbers used by the workflow

ID number

Value

Assigned byCare unit order group

333

Internal department (OP)

Observation Order Code (Uricacid)

1234567Internal department (OP)

Observation Order Code (BUN)
Observation Order Code(Creatinine)

2345678

Internal department (OP)3456789

Internal department (OP)Work Order Code (Uric acid)34567

Bio-chemistry laboratory (OF)Work Order Code (BUN)

45678

Bio-chemistry laboratory (OF)Work Order Code (Creatinine)

56789

Bio-chemistry laboratory (OF)Work Order Step Code (Urine
acid)

34567

Bio-chemistry laboratory (AM)Work Order Step Code (BUN)

45678

Bio-chemistry laboratory (AM)Work Order Step Code(Creatinine)

56789

Bio-chemistry laboratory (AM)Specimen ID

151

Bio-chemistry laboratory (AM)

LAB-22 interaction: LD queries WOS to AM. AM replies WOS to the LD.
LAB-23 interaction: The Analyzer transmits AWOS result to AM.

1000

LAB-26 interaction: The Pre/Post-processor transmits SWOS results to AM.

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X.12.7.3 Interaction diagram
Automation
Manager

Receive
Work Orderfrom OF

Pre-Processor

QBP^WOS^QBP_Q11(Query for SWOS)

Analyzer

Post-Processor

Specimens
checked

RSP^WOS^RSP_K11(Response including SWOS)
SSU^U03（
Speciemen Status Change)

SWOS
Complete

ACK^U03(ACK)QBP^WOS^QBP_Q11(Query for AWOS)

Specimens
checked

RSP^WOS^RSP_K11(Response including AWOS)OUL^R22(Specimen Status Change with Results)

AWOS
Complete

ACK^R22(ACK)QBP^WOS^QBP_Q11(Query for SWOS)
RSP^WOS^RSP_K11(Response including SWOS)
SSU^U03（
Speciemen Status Change)

Specimens
checkedSWOS
Complete

ACK^U03(ACK)

X.12.7.4 Message

LAB-22（LD→ AM→ LD）： Query of test order. WOS transferred from AM to LD
LAB-23（Analyzer→ AM）： Performed AWOS and measurement result transmitted to AM
LAB-26（Pre/Post-processor→ AM）： Performed SWOS transmitted to AM
1010__________________________________________________________________________
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X.12.8 Two Hematology batteries on a blood specimen

This use case is the continuation in LDA profile, of the “real world example” presented in
section 9.2 of the Laboratory Technical Framework.
X.12.8.1 Case Flow

1020

This example corresponds to the use case described in Volume 1 as "Externally placed orderwith unidentified specimen or to be collected by the laboratory". This example continues thefirst real word use case described in Volume 2 of the Laboratory Scheduled Workflow
profile. The Automation Manager schedules orders to be performed and transmits WOS for
the Laboratory Device specialized in blood analysis. The LD combines the three functions(pre-processor, analyzer and post-processor) in one device. Notifying AM of the sample
arrival, LD processed the downloaded WOS whose result is transmitted to AM.
X.12.8.2 Storyboard

Dr. Physician orders two batteries of tests on the same specimen: blood count anddifferential blood count. Technician Ann Norman sets the received sample onto the
Laboratory Automation System (LAS). The sample is pre-processed and analyzed by thesame device. After measurement, results are transmitted to Laboratory Information System(LIS).
Human actors and organizations participating to the process:

Assigning authority:

Abbeville hospital

Placer:

Urology department

Filler:

Cytology laboratory

Ordering facility:

Urology

Patient:

John Ill, Patient hospital identifier: 6543210,
Patient visit number: 9998888, class =inpatient

Orderer:Dr Uro, ID number 14788

Placer order enterer:

Janet Nurse, ID number 66622

Specimen collector:

John Collect, ID number 48483

Technician:Marc Techos, ID number 99991

Clinical expert:

Jane Cyto, ID number 55564__________________________________________________________________________
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1030
ID numbers used by the workflow:

ID number

Value

Assigned by

Patient hospital ID

6543210

Admission office (ADT)Patient visit number

9998888

Admission office (ADT)

Care unit order group

555

Urology department (OP)

Observation Order Code（1st9876543

Urology department (OP)9876544

Urology department (OP)456

Cytology laboratory (OF)457

Cytology laboratory (OF)Work Order Step Code (1 battery) 456

Cytology laboratory (AM)battery）
Observation Order Code（2ndbattery）
Work Order Code (1st battery)nd

Work Order Code (2 battery)stndWork Order Step Code (2battery)

457

Cytology laboratory (AM)Specimen ID

456_1

Cytology laboratory (AM)

LAB-21 interaction: AM transmits "new order" (NW) to LD. An identifier is alreadyassigned to the specimen by the Order Filler.
LAB-23 interaction: the Analyzer transmits the sample arrival notice to AM by reading its
ID label. After measurement completes, result are transmitted.

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X.12.8.3 Interaction diagram

Automation
Manager

Receive
Work Orderfrom OF

Analyzer

OML^O33（NW）
ORL^O34
Specimens checked
OUL^R22(Specimen Status Change)
ACK^R22(ACK)OUL^R22(Specimen Status Change with Results)

AWOS
Complete

ACK^R22(ACK)1040

X.12.8.4 Message
LAB-21（AM→LD： New WOS transmitted to the LD

1050

MSH|^~\&|AM|Cytology|LD|Cytology|200506121348||OML^O33^OML_O33|001|T|2.5|||||USA||EN
PID|1||6543210^^^Abbeville Hospital^PI||ILL^JOHN^^^^^L|19810101|M
PV1|1|I||||||||||||||||9998888
SPM|1|456_1||BLD|||||||P||||||200506121330|||||||||1
ORC|NW|9876543^Urology|||||||200506121315|66622^NURSE^JANET|||||||||||Urology
TQ1|||||||||R
OBR||9876543||85027^Hemogram and platelet count, automated^CPT4||||||||||||14788^URO
ORC|NW|9876544^Urology|||||||200506121315|66622^NURSE^JANET|||||||||||Urology
TQ1|||||||||R
OBR||9876544||85009^Differential WBC count, buffy coat^CPT4||||||||||||14788^URO__________________________________________________________________________
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Acknowledgement sent by the LD:

1060

MSH|^~\&|LD|Cytology|AM|Cytology|200506121349||OML^O34^OML_O34|101|T|2.5|||||USA||EN
MSA|AA|001
PID|1||6543210^^^Abbeville Hospital^PI||ILL^JOHN^^^^^L|19810101|M
PV1|1|I||||||||||||||||9998888
SPM|1|456_1||BLD
ORC|OK|9876543^Urology|||||||200506121349
OBR||9876543||85027^Hemogram and platelet count, automated^CPT4
ORC|OK|9876544^Urology|||||||200506121349
OBR||9876544||85009^Differential WBC count, buffy coat^CPT4

LAB-23（LD→AM)： Specimen arrived on the LD

1070

MSH|^~\&|LD|Cytology|AM|Cytology|200506121400||OUL^R22^OUL_R22|102|T|2.5|||||USA||EN
PID|1||6543210^^^Abbeville Hospital^PI||ILL^JOHN^^^^^L|19810101|M
PV1|1|I||||||||||||||||9998888
SPM|1|456_1||BLD
ORC|SC|9876543^Urology|||||||200506121400
OBR||9876543||85027^Hemogram and platelet count, automated^CPT4|||||||||||||||||||||I
ORC|SC|9876544^Urology|||||||200506121400
OBR||9876544||85009^Differential WBC count, buffy coat^CPT4|||||||||||||||||||||I

Acknowledgement sent by the AM: ACK (not described in this example)
LAB-23（LD→AM)： Performed AWOS transmitted to AM and measurement result

1080

1090

1100

MSH|^~\&|LD|Cytology|AM|Cytology|200506121410||OUL^R22^OUL_R22|102|T|2.5|||||USA||EN
PID|1||6543210^^^Abbeville Hospital^PI||ILL^JOHN^^^^^L|19810101|M
PV1|1|I||||||||||||||||9998888
SPM|1|456_1||BLD
ORC|SC|9876543^Urology|||||||200506121410
OBR||9876543||85027^Hemogram and platelet count, automated^CPT4|||||||||||||||||||||R
OBX|1|NM|11156-7^LEUKOCYTES^LN||8.2|10*3/mm3|||||R|||200506121410
OBX|2|NM|11273-0^ERYTHROCYTES^LN||4.08|10*3/mm3|||||R|||200506121410
OBX|3|NM|20509-6^HEMOGLOBIN^LN||13.4|10*3/mm3|||||R|||200506121410
OBX|4|NM|20570-8^HEMATOCRIT^LN||39.7|10*3/mm3|||||R|||200506121410
OBX|5|NM|30428-7^MVC^LN||97|10*3/mm3|||||R|||200506121410
OBX|6|NM|28539-5^MCH^LN||33.0|10*3/mm3|||||R|||200506121410
OBX|7|NM|28540-3^MCHC^LN||33.8|10*3/mm3|||||R|||200506121410
OBX|8|NM|11125-2^PLATELETS^LN||220|10*3/mm3|||||R|||200506121410
ORC|SC|9876544^Urology|||||||200506121410
OBR||9876544||85009^Differential WBC count, buffy coat^CPT4|||||||||||||||||||||R
OBX|1|NM|23761-0^NEUTROPHILS/100 LEUKOCYTES^LN||72|%|||||R|||200506121410
OBX|2|NM|26450-7^EOSINOPHILS/100 LEUKOCYTES ^LN||2|%|||||R|||200506121410
OBX|3|NM|26478-8^LYMPHOCYTES/100 LEUKOCYTES ^LN||20|%|||||R|||200506121410
OBX|4|NM|26485-3^MONOCYTES/100 LEUKOCYTES ^LN||6|%|||||R|||200506121410
OBX|5|NM|30180-4^BASOPHILS/100 LEUKOCYTES ^LN||0|%|||||R|||200506121410

Acknowledgement sent by the AM: ACK (not described in this example)__________________________________________________________________________
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Note: Some Considerations for Pre/Post-processor
Since some arguments arose while this document is being made, we describe these here as futureissues.
As the Pre-processors we are assuming these followings:
1110

zCentrifugezDecapperz

Aliquoterz

Sorterand as the Post-processors, we are assuming these followings:

1120

z

RecapperzSpecimen storage system

However, it seems among these devices, the Aliquoter is the only device that can implement
HL7. Since other devices will be under control of the Automation Manager as a precondition,otherwise standalone without the need for communicating, we may have to discuss thesignificance of defining their transactions.
On a practical basis, it may be more realistic that the AM spontaneously transmits the Process
Result to the Order Filler or the other by using a message such as SSU.
In addition, if HL7 is implemented in these preprocessing devices, the installation of EAC
messages may be required to conduct the specimen handling and execute Start/Stop.
On the Centrifuge:

1130

One of our members commented “it would be useful if it could receive centrifugal conditions(time, acceleration and the like)”. However it seems the existing HL7 has no appropriate
message/segment/field to contain those centrifugal conditions.
Moreover, it has no data area to indicate that centrifugation is needed/unneeded, completed,successful/unsuccessful.
On the Decapper:__________________________________________________________________________
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It has no data area to indicate decapping is needed/not needed, completed,successful/unsuccessful.

1140

However, because SAC-26 for example is Cap-type, it can contain values such as SCR (screwcap), PSH (push cap), FOIL (foil). Therefore, we think it is possible for the segment to contain
indications such as “Decapped”, ”Fail” or the like.
On the Aliquoter:
Generally the Aliquoter set multiple items “to be dispensed in a specified area”. Therefore it will
be necessary to devise a way to define a work order when using OML messages.
In addition, HL7 has no data area to indicate explicitly the Label Printing Information of “theAliquoter with label-issuing capability”.
Moreover, an aliquoter/analyzer expert pointed out that the container information SAC-16-21 in
the current SAC segment is inadequate. He insisted especially the need for a more detailed
description of its bottom surface form.

1150
16

20

NM

O

01343

Container Height

17

20

NM

O

01344

Container Diameter

18

20

NM

O

01345

Barrier Delta

19

20

NM

O

01346

Bottom Delta

20

250

CE

O

01347

Container Height/Diameter/Delta Units

21

20

NM

O

00644

Container Volume

On the Recapper:
As same as Decapper, it has no data area to indicate recapping is needed/not needed, completed,successful/unsuccessful.
However, because SAC-26 for example is Cap-type, it can contain values such as SCR (screwcap), PSH (push cap), FOIL (foil). Therefore, we think it is possible for the segment to contain
indications such as “Recapped”, ”Fail” or the like.

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1160

MEMO (2004/09/23)•

For QC result upload, “Specimen Role (SPM-11)” is used to distinguish QC sample orPatient sample. So it is “mandatory” if this is QC sample.

•

OUL message for status change (specimen arrival) will be added in LAB-5. (CP is required)•

Need to add Use Cases for unsolicited analyzed results like QC.

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