IHE Laboratory ProfilesReference: IHE_LAB_TF_Vol2a Section 3.2 Order Results Management (LAB-3): This transaction notifies the Order Result Tracker of requested tests upon creation

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LAB DOMAIN

IHE Profiles describe specific solutions to integration problems. A profile documents how standards will be

used by each system's Actors to cooperate to address the problem.

Referencing IHE Integration and Content Profiles lets implementers and users be sure they're talking about

the same solution without having to restate the many technical details that ensure actual interoperability.

IHE Laboratory Profiles

[LTW] - Laboratory Testing Workflow integrates ordering and performance of in-vitro diagnostic tests by

a clinical laboratory inside a healthcare institution.

[LAW] - Laboratory Analytical Workflow Profile supports the workflow of test orders and results with IVD

specimens on Analyzers.

[LDA] - Laboratory Device Automation integrates an Automation Manager and robotic laboratory

equipment (pre-analytical devices, analyzers, post-analytical devices) in a clinical lab.

[LBL] - Laboratory Barcode Labeling integrates robotic specimen container labeling systems with

sources of order-related labelling information.

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Laboratory Testing Workflow (LTW): The Laboratory Testing Workflow Profile covers the workflow related to tests performed on in vitro

specimens by a clinical laboratory inside a healthcare institution, for both existing and pending orders,

related to identified patients and unidentified or misidentified patients. It maintains the consistency of

patient and order information from registration through ordering, scheduling, pre-analytical processing,

testing, technical and clinical validation, to results reporting and usage of laboratory observations and

comments by the care providers.

Use cases:

The LTW Integration Profile covers three major use cases:

Order placed with specimens collected and identified by the orderer

Order placed with specimens collected by a third party, then identified and labeled by the laboratory

information system

Order generated by the laboratory and notified to the ordering system to obtain an order number.

Transactions:

LTW Integration Profile defines 5 Transactions, all of which based on HL7 release 2.5 or 2.5.1 messaging

standard. Each transaction selects a subset of HL7 message structures (based on OML, ORL, ORU and

OUL) and specifies a set of constraints applying to each message structure, as well as the responsibilities

of the sender and receiver.

This profile leverages IT Infrastructure profiles [PAM] or [PDQ] for up to date patient and encounter data,

and IT Infrastructure profiles [ATNA] and [CT] for security.

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Systems involved in this profile are:

One or more Clinical Information Systems (CIS). Each of these systems is operated by a clinical facility

and provides a number of features such as order entry, order placing, placer order management and

follow-up, order result tracking, management of patient biologic history, specimen calculation,

specimen identification... A CIS usually implements the Actors Order Placer and Order Result Tracker.

One or more Laboratory Information Systems (LIS). Each of these systems is operated by a number of

clinical laboratories inside the institution. The LIS offers features such as order reception, specimen

calculation, specimen identification or specimen acceptance, order check, scheduling, filler order

management, production of work lists, result manual entry for non-connected tests, clinical validation

and interpretation of results, result reporting. Each LIS implements an Order Filler Actor.

One or more Laboratory Automation Systems (LAS) operated in each laboratory. A LAS manages a

set of automated laboratory devices (pre-analytical devices, analyzers, post-analytical devices). The

LAS receives Work Orders related to a specimen and processes the various steps of a Work Order on

its set of devices, to eventually get the test results, perform the technical validation thereof, and upload

them back to the LIS.

Actors & Transactions:

Table lists the transactions for each actor directly involved in the Laboratory Testing 785 Workflow

Integration Profile and the relevant transactions between them. Other actors that may be indirectly

involved due to their participation in Laboratory Point of Care Testing or in Laboratory Specimen

Barcode Labeling are not necessarily shown.

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Represents the basic process flow:

Reference: IHE WIKI, IHE_LAB_TF_Vol1 section 4,

Order Placer: The Actor played by the HIS or the CIS to generate, place and manage orders.

Order Filler: The Actor played by the LIS which manages Orders on the laboratory side.

Order Result Tracker: The Actor tracking the results produced by laboratories.

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Placer Order Management (LAB-1): This transaction is used by the Order Placer to place an Order Group (i.e., a set of Orders to be

tested together for a patient) or a standalone Order to the Order Filler. The transaction enables both

Order Placer and Order Filler to notify all subsequent changes of status and/or content of each Order

to the other side.

Actor: Order Placer

Roles: Places orders. Updates orders. Cancels orders. Nullifies orders. Receives acceptance or

rejection from the Order Filler. Receives Order content and status changes from the Order Filler.

Actor: Order Filler

Roles: Receives orders. Checks the specimens required, and notifies the Order Placer of acceptance

or refusal. Receives Order content changes from the Order Placer. Notifies content updates

(removed batteries/tests) to the Order Placer. Notifies status changes (scheduled, started, 690

cancelled, completed) to the Order Placer.

Interaction Diagrams:

Trigger events: In all interactions below, the initiator chooses the best OML message structure

appropriate to its orders. The responder SHALL respond with the related ORL message structure:

OML^O21 ORL^O22

OML^O33 ORL^O34

OML^O35 ORL^O36

An OML message shall be responded to with exactly one ORL message.

Normal Process of a Placer Order:

The figure below shows the flow of messages in the normal process of a placer order, from placing of

the order by the Order Placer, to the "order completed" event notified by the Order Filler.

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Cancellation of an Order by the Order Placer:

Cancellation of an Order Initiated by the Order Filler:

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Reference: IHE_LAB_TF_Vol2a section 3.1

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Filler Order Management (LAB-2): This transaction is used by the Order Filler to inform the Order Placer that a new Order, standalone

or embedded in an existing Order Group, has been generated on the laboratory side. By this

transaction, the Order Filler Actor requests the Order Placer to assign a unique Placer Order Number

to this new Order. The Order contains a battery or a test to be performed by the laboratory, using

biological specimens collected from the subject.

Actor: Order Placer

Roles: Receives filler orders. Notifies the Order Filler of acceptance or refusal. Notifies the Order

Filler of the placer order number if the filler order was accepted.

Actor: Order Filler

Roles: Notifies filler orders to the Order Placer. Receives acceptance or rejection from the Order

Placer. Receives the Placer Order Number from the Order Placer if the Order was accepted.

Reference: IHE_LAB_TF_Vol2a Section 3.2

Order Results Management (LAB-3): This transaction notifies the Order Result Tracker of requested tests upon creation of an order or

reception of a specimen in the laboratory. It transmits the observation results from the Order Filler

to the Order Result Tracker, when a result is acquired, clinically validated, modified or deleted at the

Order Filler level. Another goal of this transaction is to provide the Order Result Tracker with the

complete sorted set of results related to an Order Group or to an Order. The Order Result Tracker

shall store these results in the sorting order given by the Order Filler. In addition, if the “Report

Facsimile For Order Group” Option is activated, this transaction MAY provide in the results messages

related to an Order Group a PDF report built by the OF presenting the releasable results of this

Order Group.

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Actor: Order Filler

Roles: Provides notification to the Order Result Tracker for specimen arrival, acquisition of

technically validated results, clinical validation of results, modification/cancellation of results and

deletion of tests. Provides the complete sorted set of results related to an Order Group or to 1080

an Order. In case the “Report Facsimile For Order Group” Option is in use, upon request from the OP

the OF complements its results messages related to an Order Group and carrying some clinically

validated results, with a link to the PDF report recapitulating the set of clinically validated results

completed for this Order Group.

Actor: Order Result Tracker

Roles: Receives test order and results from the Order Filler, gives access to this order and results to

the healthcare enterprise, respects the sorting order of the results as received from the Order Filler.

In case the “Report Facsimile For Order Group” Option is in use, when receiving a result message

related to an Order Group providing a link to the PDF report, the ORT imports this PDF file

immediately, and integrates it with the set of results received.

Normal process for management of results of a filler order:

Deletion of Test in a Filler Order:

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At any time during the process, an ordered test/battery of the order can be deleted from the filler

order by the laboratory, which should trigger a message to the Order Result Tracker, with OBR- 25

“Result Status” set to “X” for this particular Order, as shown below.

Reference: IHE_LAB_TF_Vol2a Section 3.3

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Automation Manager: This section corresponds to transaction LAB-5 of IHE Laboratory Technical Framework. The actors

using this transaction are the Order Filler and the Automation Manager.

Scope:

This transaction is used when Automation Manager transmits test results to Order Filler.

Actor: Order Filler

Role: The Order Filler manages the test results notified by the Automation Manager.

Actor: Automation Manager

Role: Handles the preprocessing and the analysis processing to fulfill the Work Order, performs the

technical validation and sends the results technically validated to the Order Filler.

Interaction Diagrams:

Reference: IHE_LAB_TF_Vol2a Section 3.5

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Laboratory Analytical Workflow Profile

The purpose of the LAW profile is to improve interoperability between IVD testing systems and health

informatics systems by reducing complexity and variability in the exchange of information related to patient

and QC test orders and to the result thereof. This profile is thus focused on the analytical workflow in the

work area of a clinical laboratory. Its Transactions streamline the scheduling, performance and result

reporting of Analytical Work Order Steps (AWOS) between IVD testing systems and healthcare IT systems

(LIS or middleware.

Actors & Transactions Diagram:

The Laboratory Analytical Workflow (LAW) integration profile supports the analytical workflow of

IVD test work order steps and their results between IVD analyzers and the systems driving their work

(LIS or LAS).

Reference: IHE WIKI LAW

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Laboratory Device Automation: The Laboratory Device Automation (LDA) Integration Profile describes the workflow between the

Automation Manager and a set of laboratory equipment (pre-analytical devices, analyzers, post-

analytical devices) involved in the testing process.

The scope of this LDA profile is strictly restricted to automated devices operated inside a clinical

laboratory. Whenever the same devices are used on the point of care and operated by the ward

staff, they are taken care of by the Laboratory Point Of Care Testing Profile.

The Laboratory

Device Automation (LDA) Integration Profile covers six major use cases:

WOS downloaded on the device before specimen arrival

Query for the WOS at specimen arrival on the device

Manual entry of the WOS on the LD

Rerun on the Analyzer, automatically launched by the analyzer or requested by the LAS at technical

validation time.

Quality Control order downloaded by the LAS

Quality Control order queried by the device

Unsolicited QC results sent by the device.

The LDA Integration Profile defines 4 Transactions, all of which based on HL7 release 2.5 or 2.5.1

messaging standard:

LAB-21 WOS download to automated device

LAB-22 WOS queried by automated device

LAB-23 Status change of an analytical WOS, and upload of the results produced

LAB-26: Stautus change of a pre-analytical or post-analytical WOS

Each of these transaction selects a subset of HL7 message structures (based on OML, ORL and OUL) and

specifies a set of constraints applying to each message structure, as well as the responsibilities of the

sender and receiver.

Actors & Transactions:

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The Actor Automation Manager can be played either by a Laboratory Automation System (LAS), which

is a system dedicated to the work area of the laboratory, or by the Laboratory Information System

(LIS), which usually supports the capacity to connect some if not all the automated devices of the work

area. In frequent organizations a laboratory may combine a LIS and one or more LAS, each system

handling a subset of devices.

This profile distinguishes two categories of automated devices:

The pre/pos-analytical devices (centrifuge, robotic specimen conveyer, decapper, robotized

specimen storage, aliquoter...

The analyzer, which performs tests and produces observations related to a specimen.

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Process Flow:

Reference: IHE_LAB_TF_Vol2a section 5.6

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Laboratory Barcode Labeling The Laboratory Barcode Labeling Integration Profile supports this workflow: A robotic system

delivers specimen containers pre-identified with a bar coded label, for the specimen collection

related to a laboratory test order. This robotic system receives patient, test order and specimen data

from another system (HIS, CIS, LIS), and issues a label for each (specimen, container) needed, with

the specimen identifier bar coded on the label, and possibly other information printed on this label.

Improves integrity and efficiency of in vitro diagnostic testing in healthcare institutions

Identifies the specimen container at blood sample collection time, with an identifier tightly coupled to

the laboratory request this specimen is for, and to the patient subject of the request.

Robotizes and accelerates blood sample collection process.

Reduces patient waiting time in the blood sample collection room.

Avoids barcode reading problems on downstream analyzers.

The Laboratory Specimen Barcode Labeling (LBL) Integration Profile covers 5 use cases reflecting

five possible organizations:

Specimen container identification and delivery process driven by the clinical ordering system

(HIS/CIS/EMR), in push mode.

Specimen container identification and delivery process driven by the laboratory information system

(LIS), in push mode.

Specimen container identification and delivery process driven by HIS/CIS/EMR, from specimen data

provided by LIS, in push mode.

Specimen container identification and delivery process driven by HIS/CIS/EMR, in pull mode.

Specimen container identification and delivery process driven by LIS, in pull mode.

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The LIS or HIS or CIS/EMR, which will request the specimen provision, depending upon the enterprise

organization. This system will be the Label Information Provider Actor.

The specimen containers provider, which is a robotic system managing containers, a barcode printer

and stickers automatically stuck to containers. This system will be the Label broker Actor.

Actors & Transactions:

Actor: Label Broker

Role: The Label Broker receives labeling instructions to issue the specimen container labels and stick

them on the appropriate containers.

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Actor: Label Information Provider

Role: The Label Information Provider transmits the labeling instructions to the Label Broker.

Interaction Diagram:

Reference: IHE_LAB_TF_Vol2 section 16-17