IHE Laboratory ProfilesReference: IHE_LAB_TF_Vol2a Section 3.2 Order Results Management (LAB-3):...
Transcript of IHE Laboratory ProfilesReference: IHE_LAB_TF_Vol2a Section 3.2 Order Results Management (LAB-3):...
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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.
http://wiki.ihe.net/index.php?title=Laboratory_Testing_Workflow
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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