Difference between revisions of "Specimen Event Tracking"

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Specimen Event Tracking (SET) profile is a project of the IHE PaLM Technical committee that was started in 2016. The purpose of this new profile of the PaLM domain is to define a series of use cases and all related events relevant to be tracked, when one or more macro operations involving a specimen occur (i.e., container preparation, collection, movement from one facility to another one, archiving, and so on).  
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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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|}
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'''Specimen Event Tracking (SET)''' profile is a project of the IHE PaLM Technical committee that was started in 2016. The purpose of this new profile of the PaLM domain is to define a series of use cases and all related events relevant to be tracked, when one or more macro operations involving a specimen occur (i.e., container preparation, collection, movement from one facility to another one, archiving, and so on).  
  
 
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The Specimen Event Tracking (SET) profile covers use cases and transactions related to the tracking of biological specimens in vitro collected for the purpose of diagnostic testing, during their entire lifecycle, from creation to storage inside a laboratory specimen archive or a biobank for future usage, and to final disposal. Specimen workflows can involve a ward and a laboratory in the same hospital, different laboratory facilities inside the same institution, or across different institutions. In the latter case, specimens need to be transferred by a courier service from the sending institution to the receiving institution. Another important use case to be tracked is the specimen creation for the specific purpose of becoming part of a biobank for a research institution or program.
 
The Specimen Event Tracking (SET) profile covers use cases and transactions related to the tracking of biological specimens in vitro collected for the purpose of diagnostic testing, during their entire lifecycle, from creation to storage inside a laboratory specimen archive or a biobank for future usage, and to final disposal. Specimen workflows can involve a ward and a laboratory in the same hospital, different laboratory facilities inside the same institution, or across different institutions. In the latter case, specimens need to be transferred by a courier service from the sending institution to the receiving institution. Another important use case to be tracked is the specimen creation for the specific purpose of becoming part of a biobank for a research institution or program.
 
The SET profile tracks macro activities related to specimens, such as collecting, shipping, receiving, accepting... Micro operations part of a macro activity (e.g. decapping a tube) are out of scope of the profile.
 
The SET profile tracks macro activities related to specimens, such as collecting, shipping, receiving, accepting... Micro operations part of a macro activity (e.g. decapping a tube) are out of scope of the profile.
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<br/>
 
For most recent information on the SET please see:  http://wiki.ihe.net/index.php/Pathology_and_Laboratory_Medicine_(PaLM)#Current_Activity.
 
For most recent information on the SET please see:  http://wiki.ihe.net/index.php/Pathology_and_Laboratory_Medicine_(PaLM)#Current_Activity.
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<br/>
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<br/>
 
   
 
   
[[File:SET_main_profile_image.jpg|frame|1024px]]
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[[File:SET_main_profile_image.jpg|center|]]
  
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''Figure 1 - Some of the main events that might occur to a Specimen during its overall lifecycle, and that the SET profile aims to track. Traceability messages are collected at each step by an Informer entity and sent to a tracker entity (repository). Notice that, according to the use case, the trackers may be more than one, if the Collecting Facility and the Laboratory have independent tracking environments.
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''
  
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==Benefits==
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* Keep under control the chain-of-custody of the specimen, when operation addressed by all the other profiles occur to the specimen
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* Prevent specimen loss, opportunity to raise alerts if some exceptions occurs to the process (i.e., broken container, specimen collection unavailable)
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* All events might be collected in a single place and use to improve the overall process
  
  
  
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==Details==
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Four main use cases have been identified for the SET profile, according to the main operation that might be tracked for a specimen, in different contexts:
  
Higher level use case categories are:
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# Container Delivery and Specimen Collection Tracking
1) Specimen collecting tracking: this is the starting link of the specimen tracking chain for every SET profile use case.
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# Specimen Inter and Intra organization transfer
2) Specimen Inter-Organization transfer: these use cases cover scenarios where specimens have to be transported from an institution to another.
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# Specimen tracking within the Laboratory
3) Intra-organization testing workflow specimen transfer: this use case analyzes some workflows occurring inside the same institution, where the involved facilities can be physically located in the same building, or physically separated, with an intra-organization inter-facilities transfer.
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# Biobank Specimen Tracking
4) Intra-laboratory IVD testing specimen tracking: this use case is focused on the main tracking events happening during all In Vitro Diagnostics (IVD) testing operations performed on a specimen
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5) Specimen biobank transfer: these use cases are related to the transfer of a specimen to a biobank and its future retrieval for further analysis. See also 2.7.
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6) Pathology specimen tracking: this class of use cases addresses the tracking of specimens related to Anatomic Pathology testing workflow.
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1) A new message type will be proposed for implementation. The main purpose for this message type is that of carrying specimen events tracking information, during all the phases of its clinical lifecycle, as: labeled containers production, collection, movement intra or inter organization/facilities, movement in an analyzer chain, biobanks, and so on.
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Each of these use cases describes a scenario where one or more macro-operations might occur to the specimen. For each operation, a correspondent event is tracked by the SET profile. An event is composed of common attributes and specific attributes. For example, all events carry the specimen identifier and the timestamp of occurrence, while only “movement related” events carry information about the departure and the arrival facilities.  
2) The proposed structure for the new message type shall be able to carry all needed information for all the different types of events. Some of the segments/blocks will be mandatory or not, according to the different types of events that the new message is tracking. All these restricting rules could be directly addressed in IHE Specimen Event Tracking (SET) profile Volume 2 implementation.  
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The SET Profile defines a total of 15 different types of events, which in turn are divided into 4 macro-categories, as shown in the following table:
3) For tracking purposes, some of the tracking events defined inside the SET profile require a reference to the order (i.e., Placer Order Number) that originated the request for specimens production (Transactions LAB-1 and LAB-2). In order to avoid to add into the new message structure both ORC and OBR segments only for this reason, a field inside the SPM segment has to be found, in order to fulfill these requirement. For this reason, the proposed new message structure will not consider the presence of an ORDER block section.
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{| class="wikitable" style="margin: auto;"
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!colspan="2"|SET Events List
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|-
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|rowspan="3"|Tracking specimen container preparation and specimen collection events
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|Containers Prepared For Specimen Collection
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|-
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|Specimen Collection Succeeded
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|-
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|Specimen Collection Failed
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|-
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|rowspan="7"|Tracking specimen movements events
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|Specimen Departed
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|-
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|Specimen Arrived
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|-
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|Specimen Accepted
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|-
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|Specimen Rejected
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|-
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|Specimen Archived
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|-
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|Specimen Retrieved from Archive
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|-
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|Specimen Disposed Of
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|-
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|Tracking specimen identification events
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|Specimen Identifier Changed
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|-
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|rowspan="3"|Tracking specimen processing events
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|Specimen Procedure Step Successfully Produced a Derived Specimen
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|-
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|Specimen Procedure Step Succeeded (with no derived specimen)
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|-
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|Specimen Procedure Step Failed
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|}
  
''<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.>''
 
 
==Benefits==
 
''<If the profile can improve Cost, Safety, Quality or Efficiency then list the specific examples of that benefit (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.  Such benefits help users and vendors make the business case for the profile.  If the profile does not improve any aspect of Cost, Safety, Quality or Efficiency feel free to talk about something else here.>''
 
 
==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.>''
 
 
''<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.>''
 
 
''<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.>''
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All systems where an operation to a Specimen occurs are expected to implement this profile.  
* EHR-S
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* LIS
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* Lab automation manager
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* ...
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'''Actors & Transactions:'''
 
'''Actors & Transactions:'''
[[File:SET.jpg]]
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From a point of view of the Actors diagram, a Specimen Event Informer (SEI) actor is defined. This actor is paired with the system where the specimen operation occurs. For example, if the operation is related to the production of the labelled containers for the specimen, the SEI will be paired with a labeling machine.
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The Actors and the Interactions diagrams are depicted in Fig. 2:
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<br/>
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<br/>
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[[File:Actors_and_transactions_SET_diagrams.jpg|center ]]
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''Figure 2 - Actors (on the left) and Interactions (on the right) diagrams for the SET Profile
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''
  
''<Insert an actor-transaction diagram, and or list of Content Definitions>''
 
  
 
==Specification==
 
==Specification==
  
'''Profile Status:''' [[Comments| Final Text]]
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*'''Profile Status:''' Published for public comment in the period from August 27 through September 27, 2021
''<Replace "Final Text" with "Trial Implementation" or "Public Comment" as appropriate.>''
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*'''Documents:''' [https://www.ihe.net/uploadedFiles/Documents/PaLM/IHE_PaLM_Suppl_SET_Rev1-0_PC_2021-08-27.pdf SET profile proposal (Public comment version)]
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*'''Important Note:''' HL7 v2 has been identified as the underlying standard to use. The tracking event information that the HL7v2 message shall carry on strictly depends on the related event type: for example, tracking container preparation for a specimen needs different information than tracking specimen movements or specimen identification. The HL7 v2 messaging standard does not provide a message type that satisfies the needs of all SET event types. For this reason, a CR proposal has been submitted to the HL7 Orders and Observation group, defining a new set of HL7 v2 messages that are specific for Specimen traceability. The last version of the CR proposal is available [https://drive.google.com/file/d/16xqPCiuQem4uJnr-qy6Q9W0vOz8lbyhk/view?usp=sharing here]
  
'''Documents:'''
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<!--Link to SET matrix with collection of all data elements per use case: https://wiki.ihe.net/index.php/File:2019_01_SET_new_mapping_structure_pre_HL7_call.xlsx
Link to current draft document: [https://docs.google.com/viewer?a=v&pid=forums&srcid=MDQ3NDcyMTUyODAxMzMyMzAzNTQBMTY0MjQ4ODk4Njk5ODUzMTMzNTQBd1UtbVFHMHhDUUFKATAuMQFpaGUubmV0AXYy&authuser=0]
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Link to SET matrix with collection of all data elements per use case: https://wiki.ihe.net/index.php/File:2019_01_SET_new_mapping_structure_pre_HL7_call.xlsx
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'''Underlying Standards:'''
 
'''Underlying Standards:'''
  
:* HL7 v2 - chapters 7 (for OSM^R26) and 13 (for SSU^U03) [http://www.hl7.org HL7]
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:* HL7 v2 - (New messages proposed) [http://www.hl7.org HL7]
 
:* ...
 
:* ...
  
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[[Category:HL7v2]]
 
[[Category:HL7v2]]
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Latest revision as of 08:53, 8 September 2021

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

Specimen Event Tracking (SET) profile is a project of the IHE PaLM Technical committee that was started in 2016. The purpose of this new profile of the PaLM domain is to define a series of use cases and all related events relevant to be tracked, when one or more macro operations involving a specimen occur (i.e., container preparation, collection, movement from one facility to another one, archiving, and so on).

Summary

The Specimen Event Tracking (SET) profile covers use cases and transactions related to the tracking of biological specimens in vitro collected for the purpose of diagnostic testing, during their entire lifecycle, from creation to storage inside a laboratory specimen archive or a biobank for future usage, and to final disposal. Specimen workflows can involve a ward and a laboratory in the same hospital, different laboratory facilities inside the same institution, or across different institutions. In the latter case, specimens need to be transferred by a courier service from the sending institution to the receiving institution. Another important use case to be tracked is the specimen creation for the specific purpose of becoming part of a biobank for a research institution or program. The SET profile tracks macro activities related to specimens, such as collecting, shipping, receiving, accepting... Micro operations part of a macro activity (e.g. decapping a tube) are out of scope of the profile.
For most recent information on the SET please see: http://wiki.ihe.net/index.php/Pathology_and_Laboratory_Medicine_(PaLM)#Current_Activity.

SET main profile image.jpg

Figure 1 - Some of the main events that might occur to a Specimen during its overall lifecycle, and that the SET profile aims to track. Traceability messages are collected at each step by an Informer entity and sent to a tracker entity (repository). Notice that, according to the use case, the trackers may be more than one, if the Collecting Facility and the Laboratory have independent tracking environments.

Benefits

  • Keep under control the chain-of-custody of the specimen, when operation addressed by all the other profiles occur to the specimen
  • Prevent specimen loss, opportunity to raise alerts if some exceptions occurs to the process (i.e., broken container, specimen collection unavailable)
  • All events might be collected in a single place and use to improve the overall process


Details

Four main use cases have been identified for the SET profile, according to the main operation that might be tracked for a specimen, in different contexts:

  1. Container Delivery and Specimen Collection Tracking
  2. Specimen Inter and Intra organization transfer
  3. Specimen tracking within the Laboratory
  4. Biobank Specimen Tracking

Each of these use cases describes a scenario where one or more macro-operations might occur to the specimen. For each operation, a correspondent event is tracked by the SET profile. An event is composed of common attributes and specific attributes. For example, all events carry the specimen identifier and the timestamp of occurrence, while only “movement related” events carry information about the departure and the arrival facilities. The SET Profile defines a total of 15 different types of events, which in turn are divided into 4 macro-categories, as shown in the following table:


SET Events List
Tracking specimen container preparation and specimen collection events Containers Prepared For Specimen Collection
Specimen Collection Succeeded
Specimen Collection Failed
Tracking specimen movements events Specimen Departed
Specimen Arrived
Specimen Accepted
Specimen Rejected
Specimen Archived
Specimen Retrieved from Archive
Specimen Disposed Of
Tracking specimen identification events Specimen Identifier Changed
Tracking specimen processing events Specimen Procedure Step Successfully Produced a Derived Specimen
Specimen Procedure Step Succeeded (with no derived specimen)
Specimen Procedure Step Failed


Systems Affected

All systems where an operation to a Specimen occurs are expected to implement this profile.

Actors & Transactions: From a point of view of the Actors diagram, a Specimen Event Informer (SEI) actor is defined. This actor is paired with the system where the specimen operation occurs. For example, if the operation is related to the production of the labelled containers for the specimen, the SEI will be paired with a labeling machine. The Actors and the Interactions diagrams are depicted in Fig. 2:

Actors and transactions SET diagrams.jpg

Figure 2 - Actors (on the left) and Interactions (on the right) diagrams for the SET Profile


Specification

  • Profile Status: Published for public comment in the period from August 27 through September 27, 2021
  • Documents: SET profile proposal (Public comment version)
  • Important Note: HL7 v2 has been identified as the underlying standard to use. The tracking event information that the HL7v2 message shall carry on strictly depends on the related event type: for example, tracking container preparation for a specimen needs different information than tracking specimen movements or specimen identification. The HL7 v2 messaging standard does not provide a message type that satisfies the needs of all SET event types. For this reason, a CR proposal has been submitted to the HL7 Orders and Observation group, defining a new set of HL7 v2 messages that are specific for Specimen traceability. The last version of the CR proposal is available here