Difference between revisions of "Laboratory Analytical Workflow Profile"

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The LAW profile addresses the exchange of information related to patient and QC test orders & results between IVD testing systems and health informatics systems.  
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{| style="color: blue;"
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| '''This profile is part of the Pathology and Laboratory Medicine (PaLM) domain, which merged the former AP and LAB domains since 2016, January 4th.'''
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The '''Laboratory Analytical Workflow (LAW) profile''' addresses the exchange of information related to patient and QC test orders & results between IVD testing systems and health informatics systems.  
  
 
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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 middlewares.
 
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 middlewares.
  
''<Insert a simple graphic that, at a glance, visually summarizes what the profile is about.  Do not use an actor/transaction diagram here.  Show your graphic to someone for 5 seconds (literally) and ask them what it's about.  If what they say hits the main points in your summary paragraph, you have succeeded.  E.g. a graphic of a hospital, a clinic, and a lab with patient records moving between them.  .>''
 
  
''<See [[Help:Contents#Tips_.26_Tricks| Help - Tips and Tricks]] for details on inserting an image/graphic.>''
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[[Image:Law_purpose.jpg]]
  
 
==Benefits==
 
==Benefits==
  
''<List the key benefits the profile provides (e.g. error reduction, increased throughput) and how they come about (e.g. SWF reduces patient errors due to mistyped demographics at the modality by transfering demographics electronically from the Order Filler).  Consider using a bullet list for readability.  If possible, identify benefits that help users and vendors make the business case for the profile.  More specifically, which of Cost, Safety, Quality or Efficiency is improved by the use of this profile.>''
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The LAW profile represents a big step forward to meet the clinical laboratory’s need for stable interoperability of IVD analyzers, by providing IVD analyzer and software vendors with a reproducible and maintainable implementation framework.
  
 
==Details==
 
==Details==
  
''<A few paragraphs, if appropriate, providing more details (mostly in user-speak, not tech-speak) on what the profile does and how it works.>''
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This LAW Profile covers the workflow of “Analytical Work Order Steps” (AWOS) between an Analyzer Manager application (e.g., a LAS or a LIS) and an Analyzer (an IVD device). This workflow handles the processing of IVD tests by the Analyzer, on specimen materials. Both
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patient and quality control (QC) specimens are in scope.
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All specialties of clinical laboratories (including blood bank testing) are in scope.
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Tests performed on the point of care by the ward staff or the patient are out of scope of this profile, and addressed by the LPOCT profile instead.
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An AWOS is an analytical service to be performed by an analyzer on a specimen. The AWOS is ordered by means of a code representing this analytical service. The code may represent an elementary test (e.g., “measure the glucose level of the specimen”) or a panel of several
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elementary tests. In all cases the analytical service is expected to produce observations on the specimen that will be reported back by the Analyzer. The AWOS does not say how to perform the analytical service. The electromechanical handling of an analyzer is out of scope of this profile.
  
''<If the user might be familiar with the mechanisms used by the profile, you can mention them here.  E.g. Evidence Documents is based on DICOM Structured Report (SR) Templates.>''
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The use cases related to patient specimens are summarized on this diagram:
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[[File:LAWUSECASES.jpg]]
  
''<If the user might have an appreciation for the problems addressed in the profile, you can mention them here, but keep it short.  E.g. Mapping HL7 Order fields to DICOM Modality Worklist attributes can be inconsistent in the marketplace, so Scheduled Workflow provides vendors with more detailed instructions.>''
 
 
 
==Systems Affected==
 
==Systems Affected==
''<List (in user terms) the types of systems they might expect to have implemented actors from this profile, e.g. RIS, PACS, HIS, CAD Workstation, etc. and for each, how it would participate.>''
 
  
* ''PACS systems may store, manage, and/or display Evidence Documents.''
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* In vitro diagnostic devices usually implement the Analyzer Actor of the profile. They obtain analytical work order steps (AWOS) related to a specimen-in-container and perform the requested tests and send back the results.
* ''Display systems may query, retrieve and display Evidence Documents.''
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* A middleware or a LIS may implement the Analyzer Manager Actor. It will provide the AWOS to the intended Analyzer and collect the results from those AWOS.
* ''Reporting workstations may retrieve, process and include details from Evidence Documents in reports
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'''Actors & Transactions:'''
 
'''Actors & Transactions:'''
  
''<Insert an actor-transaction diagram, and or list of Content Definitions>''
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[[File:LAW_ActorsTransac.jpg]]
  
 
==Specification==
 
==Specification==
  
'''Profile Status:''' [[Comments| Final Text]]   
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'''Profile Status:''' [[Comments| Trial Implementation]]   
''<Replace "Final Text" with "Trial Implementation" or "Public Comment" as appropriate.>''
 
  
 
'''Documents:'''  
 
'''Documents:'''  
  
''<Provide direct links to the specific volumes or supplements, and list the volume sections relevant to this profile. This is a simple inventory of official normative and informative text. If you would like to provide a reading guide or walkthrough of what is in each of the different sections for implementers or users, do that in the Profile FAQ or the Profile Implementation Page linked below. If the profile uses transactions from multiple Tech. Frameworks, repeat the structure below.>''
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''[http://www.ihe.net/Technical_Framework/upload/IHE_Lab_Suppl_LAW.pdf last revision from October 2, 2012]''
  
[http://www.ihe.net/Technical_Framework/index.cfm#radiology IHE Radiology Technical Framework:]
 
:* [http://www.ihe.net/Technical_Framework/upload/ihe_tf_rev8.pdf Vol. 1] - Section 5 (SWF Profile)
 
:* [http://www.ihe.net/Technical_Framework/upload/ihe_tf_rev8-2.pdf Vol. 2] - Sections 4.8 to 4.10, 4.14 to 4.19, and 4.23
 
:* [http://www.ihe.net/Technical_Framework/upload/ihe_tf_rev8-3.pdf Vol. 3] - Appendix E
 
  
 
'''Underlying Standards:'''
 
'''Underlying Standards:'''
  
''<list all the standards on which the profile is based; if possible with links to sources>''
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:* [http://www.hl7.org HL7 2.5.1 + some pre-adopted features of 2.8 & 2.9]
:* [http://dicom.nema.org DICOM]
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:* [http://loinc.org/ Logical Observations Identifiers Names and Codes (LOINC) from Regenstrief]
:* [http://www.hl7.org HL7]
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:* [http://unitsofmeasure.org/ the Unified Code for Units of Measure (UCUM)]
:* ...
 
  
 
==See Also==
 
==See Also==
  
''<The following sections can be left out if there is nothing to point to. This is just to show where such information can go.>''
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'''Related Profiles'''
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No profile depends upon LAW.
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However it is important to stress the repartition between LAW and LDA:
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LDA covers laboratory devices involved in the pre-analytical and post-analytical workflows.
  
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LAW covers laboratory IVD devices involved in the analytical workflow.
  
'''Related Profiles'''
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A middleware system in a laboratory typically plays the role of Automation Manager in LTW and LDA and the role of Analyzer Manager in LAW.
  
''<List profiles this one depends on, profiles that depend on this one, profiles that are synergistic with this one.  Start with the name of the other profile as a link and then explain the relationship.>''
 
  
* ''[[Reporting Workflow]] [RWF] may use Evidence Documents as inputs to the reporting process.''
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''<The following sections can be left out if there is nothing to point to. This is just to show where such information can go.>''
* ''[[Simple Image & Numeric Reports]] [SINR] may include data copied from Evidence Documents.''
 
* ''[[Cross-enterprise Document Sharing for Imaging]] [XDS-I] can be used to share Evidence Documents between sites over a network.''
 
* ''[[Portable Data for Imaging]] [PDI] can store Evidence Documents on media such as CDs.''
 
* ''[[Import Reconciliation Workflow]] [IRWF] can fix patient ids, etc. of Evidence Documents when importing.''
 
  
  
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[[Category:Profiles]]
 
[[Category:Profiles]]
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[[Category:PaLM Profile]]
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[[Category:HL7v2]]

Latest revision as of 05:32, 1 August 2017

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

The Laboratory Analytical Workflow (LAW) profile addresses the exchange of information related to patient and QC test orders & results between IVD testing systems and health informatics systems.

Summary

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 middlewares.


Law purpose.jpg

Benefits

The LAW profile represents a big step forward to meet the clinical laboratory’s need for stable interoperability of IVD analyzers, by providing IVD analyzer and software vendors with a reproducible and maintainable implementation framework.

Details

This LAW Profile covers the workflow of “Analytical Work Order Steps” (AWOS) between an Analyzer Manager application (e.g., a LAS or a LIS) and an Analyzer (an IVD device). This workflow handles the processing of IVD tests by the Analyzer, on specimen materials. Both patient and quality control (QC) specimens are in scope.

All specialties of clinical laboratories (including blood bank testing) are in scope.

Tests performed on the point of care by the ward staff or the patient are out of scope of this profile, and addressed by the LPOCT profile instead.

An AWOS is an analytical service to be performed by an analyzer on a specimen. The AWOS is ordered by means of a code representing this analytical service. The code may represent an elementary test (e.g., “measure the glucose level of the specimen”) or a panel of several elementary tests. In all cases the analytical service is expected to produce observations on the specimen that will be reported back by the Analyzer. The AWOS does not say how to perform the analytical service. The electromechanical handling of an analyzer is out of scope of this profile.

The use cases related to patient specimens are summarized on this diagram:

LAWUSECASES.jpg

Systems Affected

  • In vitro diagnostic devices usually implement the Analyzer Actor of the profile. They obtain analytical work order steps (AWOS) related to a specimen-in-container and perform the requested tests and send back the results.
  • A middleware or a LIS may implement the Analyzer Manager Actor. It will provide the AWOS to the intended Analyzer and collect the results from those AWOS.


Actors & Transactions:

LAW ActorsTransac.jpg

Specification

Profile Status: Trial Implementation

Documents:

last revision from October 2, 2012


Underlying Standards:

See Also

Related Profiles

No profile depends upon LAW. However it is important to stress the repartition between LAW and LDA: LDA covers laboratory devices involved in the pre-analytical and post-analytical workflows.

LAW covers laboratory IVD devices involved in the analytical workflow.

A middleware system in a laboratory typically plays the role of Automation Manager in LTW and LDA and the role of Analyzer Manager in LAW.


<The following sections can be left out if there is nothing to point to. This is just to show where such information can go.>


Consumer Information

The Profile FAQ Template answers typical questions about what the Profile does. <Replace the link with a link to the actual FAQ page for the Profile>

The Profile Purchasing Template describes considerations when purchasing equipment to deploy this Profile. <Replace the link with a link to the actual Purchasing page for the Profile>

Implementer Information

The Profile Implementation Template provides additional information about implementing this Profile in software. <Replace the link with a link to the actual Implementation page for the Profile>

Reference Articles

<List References (good and bad) (with link if possible) to Journal Articles that mention IHE's work (and hopefully include some analysis). Go ahead, Google: IHE <Profile Name> abstract or Google: IHE <Profile Name> and under the "more" select "Scholar". You might be surprised. >


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