Laboratory Device Automation: Difference between revisions

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'''Laboratory Device Automation(LDA)''' Integration Profile supports the workflow on the automated technical section of the clinical laboratory. The automated section of a laboratory can be handled by the Laboratory Information System ('''LIS''') or by one or more Laboratory Automation Systems ('''LAS''').
{| style="color: blue;"
| '''This profile is part of the Pathology and Laboratory Medicine (PaLM) domain, which merged the former AP and LAB domains since 2016, January 4th.'''
|}
'''Laboratory Device Automation (LDA)''' supports workflow in the automated technical section of the clinical laboratory, also known as the "work area".  


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==Summary==
==Summary==


The Laboratory Device Automation (LDA) Integration Profile supports the workflow on the automated technical section of the clinical laboratory. It covers the exchanges between an Automation Manager (e.g. a LAS or a LIS) and a set of automated Laboratory Devices (LD) to process a Work Order, perform the tests on the related specimens and retrieve their results. This processing includes the pre-analytical process of the specimen (sorting, centrifugation, aliquoting, transportation, decapping) the analytical process itself (run of the ordered tests on the specimen) and the post-analytical process (recapping, transportation, rerun, dilution, storage and retrieval).
The Laboratory Device Automation (LDA) Integration Profile covers the exchanges between an Automation Manager (Actor played by a Laboratory Information System '''LIS''' or by a Laboratory Automation System '''LAS''') and a set of automated Laboratory Devices (LD) to process a Work Order, perform the tests on the related specimens and retrieve their results. This processing includes the pre-analytical process of the specimen (sorting, centrifugation, aliquoting, transportation, decapping) the analytical process itself (run of the ordered tests on the specimen) and the post-analytical process (recapping, transportation, rerun, storage and retrieval).
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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 LPOCT profile.
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.
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The input of the workflow is a '''Work Order''': A set of tests requested on one or more specimens, to be fulfilled by the Automation Manager. This Actor splits the Work Order into a sequence of one or more '''Work Order Steps (WOS)'''.  
The input of the workflow is a '''Work Order''': A set of tests requested on one or more specimens, to be fulfilled by the Automation Manager. This Actor splits the Work Order into a sequence of one or more '''Work Order Steps (WOS)'''.  
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'''Improves efficiency of the clinical laboratory'''
'''Improves efficiency of the clinical laboratory'''
* Stremalines specimen process in the work area of the clinical laboratory.
* Streamlines specimen processing in the work area of the clinical laboratory.
* Reduces the processing time and accelerates the delivery of test results.
* Reduces the processing time and accelerates the delivery of test results.
'''Favors independence of laboratories from their automated devices'''
'''Favors independence of laboratories from their automated devices'''
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==Details==
==Details==


The '''''Laboratory Testing Workflow (LTW) Integration Profile''''' establishes the continuity and integrity of in vitro diagnostic test orders placed towards clinical laboratories for a patient, and of the results produced for these orders, inside the healthcare institution.<br/>
The '''''Laboratory Device Automation (LDA) Integration Profile''''' covers six major use cases:
This Integration Profile is bound to in vitro diagnostic testing (tests performed on in vitro specimen). It supports all laboratory specialties but anatomic pathology.<br/>
* WOS downloaded on the device before specimen arrival
The LTW Integration Profile covers three major use cases:
* Query for the WOS at specimen arrival on the device
* Order placed with specimens collected and identified by the orderer
* Manual entry of the WOS on the LD
* Order placed with specimens collected by a third party, then identified and labeled by the laboratory information system
* Rerun on the Analyzer, automatically launched by the analyzer or requested by the LAS at technical validation time.
* Order generated by the laboratory and notified to the ordering system to obtain an order number.
* Quality Control order downloaded by the LAS
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.<br/>
* 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.<br/>


==Systems Affected==
==Systems Affected==
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Systems involved in this profile are:
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.
* 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.
* 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 worklists, result manual entry for non connected-tests, clinical validation and interpretation of results, result reporting. Each LIS implements an Order Filler Actor.
* This profile distinguishes two categories of automated devices:
* 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 WSork Order on its set of devices, to eventually get the test results, perform the technical validation thereof, and upload them back to the LIS.<br/>
:* The pre/pos-analytical devices (centrifuge, robotic specimen conveyer, decapper, robotized specimen storage, aliquoter...
A laboratory request ordered by a physician for a patient is frequently composed of multiple tests and panels placed to a laboratory. Such a '''laboratory request''' containing several orders is called an '''Order Group''' in the HL7 standard, and uniquely identified by the ordering CIS with a '''Placer Group Number'''. Each of the orders is in turn uniquely identified by the CIS with a '''Placer Order Number'''. Each order accepted by the laboratory as well as each reflex order generated by the laboratory is uniquely identified by the LIS with a '''Filler Order Number'''.<br/>
:* The analyzer, which performs tests and produces observations related to a specimen.
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'''Actors & Transactions:'''
'''Actors & Transactions:'''


<center>[[Image:ltw-actor-transaction.JPG]]</center>
<center>[[Image:lda-actor-transaction.JPG]]</center>
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'''Other requirements for systems implementing LTW (dependencies towards IT Infrastructure Profiles):'''
* An application implementing one of the Actors Order Placer, Order Result Tracker, Order Filler shall also implement the Actors Patient Demographics Consumer and Patient Encounter Consumer from either '''PAM''' or '''PDQ''' Profile or both.
* An application implementing one of the Actors Order Placer, Order Result Tracker, Order Filler shall also implement the Actor Secure Node from the '''ATNA''' Profile, as well as the Actor Time Client from the '''CT''' Profile.


==Specification==
==Specification==


'''Profile Status:''' [[Comments| Trial Implementation]]   
'''Profile Status:''' [[Comments| Final Text]]   
 
'''Documents:''' [https://www.ihe.net/resources/technical_frameworks/#PaLM IHE Pathology and Laboratory Medicine Technical Framework:]


'''Documents:'''
:* [http://www.ihe.net/Technical_Framework/index.cfm#laboratory IHE Laboratory Technical Framework:]
'''Underlying Standards:'''
'''Underlying Standards:'''
:* [http://www.hl7.org HL7]
:* [http://www.hl7.org HL7]
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'''Related Profiles'''
'''Related Profiles'''


* '''Integration Profiles LTW depends on'''
* '''Integration Profiles LDA depends on'''
:* [[Patient_Administration_Management]] (PAM) or [[Patient_Demographics_Query]] (PDQ) from ITI Technical Framework: The Actors Order Placer, Order Filler, Order Result Tracker shall be grouped with Actors from PAM or PDQ or both.
:* [[Laboratory Testing Workflow]] (LTW): The Actor Automation Manager shall also be an Automation Manager in the LTW profile. Thus, it will fulfill Work Order, received in the LTW profile, handling each Work Order as a sequence of Work Order Steps performed in the LDA profile
:* [[Audit_Trail_and_Node_Authentication]] (ATNA) and [[Consistent_Time]] (CT) from ITI Technical Framework: The Actors Order Placer, Order Filler, Order Result Tracker shall be grouped with the Actors "Secure Node" from ATNA and "Time Client" from ATNA.
 
* '''Integration Profiles depending upon LTW'''
:* [[Laboratory_Device_Automation]] (LDA) from the Laboratory Technical Framework: The Actor Automation Manager from the LDA Profile must also be an Automation Manager in the LTW Profile.
:* [[Laboratory_Point_Of_Care_Testing]] (LPOCT) from the Laboratory Technical Framework: The Actor Order Filler from the Laboratory LPOCT Profile must also be an Order Filler in the LTW Profile.
:* [[Laboratory_Specimen_Barcode_Labeling]] (LBL) from the Laboratory Technical Framework: The Label Information Provider Actor of the LBL profile shall be grouped with either the Order Filler or the Order Placer from the LTW profile.


'''Consumer Information'''
'''Consumer Information'''
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[[Category:Profiles]]
[[Category:Profiles]]
[[Category:PaLM Profile]]
[[Category:HL7v2]]

Latest revision as of 14:34, 17 November 2022

This profile is part of the Pathology and Laboratory Medicine (PaLM) domain, which merged the former AP and LAB domains since 2016, January 4th.

Laboratory Device Automation (LDA) supports workflow in the automated technical section of the clinical laboratory, also known as the "work area".


Summary

The Laboratory Device Automation (LDA) Integration Profile covers the exchanges between an Automation Manager (Actor played by a Laboratory Information System LIS or by a Laboratory Automation System LAS) and a set of automated Laboratory Devices (LD) to process a Work Order, perform the tests on the related specimens and retrieve their results. This processing includes the pre-analytical process of the specimen (sorting, centrifugation, aliquoting, transportation, decapping) the analytical process itself (run of the ordered tests on the specimen) and the post-analytical process (recapping, transportation, rerun, storage and retrieval).
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 input of the workflow is a Work Order: A set of tests requested on one or more specimens, to be fulfilled by the Automation Manager. This Actor splits the Work Order into a sequence of one or more Work Order Steps (WOS).
Each WOS represents one action to be performed by one device on one specimen.


Benefits

Improves efficiency of the clinical laboratory

  • Streamlines specimen processing in the work area of the clinical laboratory.
  • Reduces the processing time and accelerates the delivery of test results.

Favors independence of laboratories from their automated devices

  • By providing clear specifications of interfaces between Laboratory Automation System (LAS), and the various types of automated devices this profile enables a laboratory to replace a device by a new one without breaking the existing workflow in the work area.

Details

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.

Systems Affected

Systems involved in this profile are:

  • 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.


Actors & Transactions:


Specification

Profile Status: Final Text

Documents: IHE Pathology and Laboratory Medicine Technical Framework:

Underlying Standards:

See Also

Related Profiles

  • Integration Profiles LDA depends on
  • Laboratory Testing Workflow (LTW): The Actor Automation Manager shall also be an Automation Manager in the LTW profile. Thus, it will fulfill Work Order, received in the LTW profile, handling each Work Order as a sequence of Work Order Steps performed in the LDA profile


Consumer Information

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