Contrast Administration Management - Proposal: Difference between revisions

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* Contributors:   
* Contributors:   
* Domain: Radiology
* Domain: Radiology


== Summary ==
== Summary ==
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A second problem area is that the order from the radiologist to use contrast for a given imaging procedure needs to be translated into an appropriate administration protocol executed in conjunction with the imaging procedure order.  Today this process is often manual and imperfect.
A second problem area is that the order from the radiologist to use contrast for a given imaging procedure needs to be translated into an appropriate administration protocol executed in conjunction with the imaging procedure order.  Today this process is often manual and imperfect.


The two problem areas will be described here as related work in two parts.
The two problem areas will be described in this proposal as related Profile work in two phases.


==3. Key Use Case==
==3. Key Use Case==


Now DICOM Supplement 164 is published, i.e., Imaging Agent Administration Structured Report (IAASR), it becomes possible to automatically report and store information regarding imaging agent administration in an integrated workflow.
The two phases are presented in the order they should likely be worked on
Phase 1 addresses storage and retrieval of performed administration details.  Because the mechanics are straightforward with few unknowns, it is presented first even though the steps in Phase 2 precede the steps in Phase 1 in terms of the workflow.
 
The infusion manager here refers to the combination of the power injector and its associated IT components to manage and select user-defined injection protocols and interact with the modality and hospital infrastructure.  
 
===Phase 1 (Storage and Retrieval)===
 
:* The technologist confirms the end of the procedure to the infusion manager
:* The infusion manager sends the contrast administration record (IAASR) to the IM/IA
:* (At reporting time, the Report Creator retrieves the IAASR and populates fields in the report)
:* (The Charge Poster retrieves the IAASR and populates billing fields)
:* (The Dose Reporter? retrieves the IAASR to investigate adverse events or create departmental reports)
 
===Phase 2 (Protocol Management and Selection)===
 
:* A clinician places an order for imaging study (sent to DSS/OF via Placer Order Management [RAD-2])
:* The radiologist reviews the order, decides whether contrast is appropriate, and if so selects a contrast administration protocol that corresponds to the image acquisition protocol
:* The RIS records the selected imaging protocol and the contrast protocol in the worklist entry
:* The technologist selects and reviews the worklist entry for the current procedure (Query Modality Worklist [RAD-5])
:* The technologist selects a protocol from those stored in the infusion manager that corresponds to the ordered contrast protocol
:* The technologist makes appropriate changes to the contrast protocol, if needed, and confirms the protocol on the injector console
::* Open Issue: the technologist is responsible for mapping and modifying the contrast protocol on the infusion manager, and the imaging protocol on the acquisition modality.  This could be done as two separate sequences of steps, or with integration they might be combined or synchronized.
:* The technologist starts both the imaging and contrast protocols
::* Open Issue: CAN protocol allows modalities to trigger injectors and synchronize imaging with contrast appropriately. Some contrast protocols include manual injection triggers.  Need to consider various cases and if the profile should address.
:* The technologist ends the study
:* <See Phase 1>
:* In addition to the performed IAASR, the infusion manager also stores the planned IAASR
::* Open Issue: Is it worthwhile to mandate Storage Commitment here?


Thus, detailed record of the imaging agent use should be documented in medical record. The Contrast Administration Management (CAM) Integration Profile aims automatic creation and storage of the record contributing to reduction in work burden, while it helps healthcare professionals make the record detailed and precise.
<center>[[Image:CAM-Actor_Diagram.jpg|800px]]</center>


:* An order for imaging study is placed by a clinician and transmitted to DSS/OF via Placer Order Management [RAD-2].
<center>[[Image:CAM-Diagram.png|800px]]</center>
:* A radiologist checks the order to select an imaging protocol that fits the order. When the protocol includes contrast, he determines whether to modify it or not.
:* The imaging protocol and the resultant contrast usage protocol is recorded in the RIS.
:* A radiologic technologist uses Query Modality Worklist [RAD-5] to select the order to process.
:* A power injector, which is composed of grouped Infusion Manager and Infusion Pump, has stored user-defined contrast usage protocols in it.
:* The radiologic technologist selects one protocol from the stored protocols in the injector that corresponds to the ordered usage protocol. If the contrast usage is modified from the pre-defined protocol, the radiologic technologist makes appropriate changes and confirms the protocol on the injector console. 
:* After finishing the injection, a contrast SR is sent to the IM/IA triggered by receipt of end signal of the administration by the infusion manager.


<center>[[Image:CAM-Diagram.png]]</center>
<center>[[Image:CAM actor transaction diagram.png|800px]]</center>


'''General use case'''
<center>[[Image:CAM actor transaction diagram2.png|800px]]</center>
Selection of the contrast usage protocol by a human operator on the injector:  
The radiology technician knows the contrast usage protocol determined by the radiologist on display of a RIS terminal. She (He) selects one from the stored protocols in the injector that corresponds to the ordered usage protocol. If the usage is modified from the pre-defined protocol, she makes appropriate changes and confirms the protocol on the injector console, which triggers generation of a planned IAA SR.
During the imaging study the imaging agent is infused according the protocol followed by image acquisition. The radiology technician signals the end of the injection by pressing end button on the injector console. This triggers creation of performed Imaging Agent Administration SRs (reinjection may be needed such as cases of extravasation), which is followed by transmission of the planned and performed Imaging Agent Administration SRs to IM/IA.


'''Acquisition method of the Worklist'''
'''Acquisition method of the Worklist'''
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'''Decision of the contrast protocol'''
'''Decision of the contrast protocol'''
Automatic selection of the contrast usage protocol on the Infusion Manager: Selection of the procedure from the worklist is synchronized as in Use Case with the synchronized selection of the procedure. The Infusion Manager receives the contrast usage protocol as ID in the fourth component of IPC segment of HL7 OMI message sent from the DSS to the Infusion Manager. The infusion manager displays the infusion protocol on its display reflecting the modification done on the pre-defined protocol, if any.
Automatic selection of the contrast usage protocol on the Infusion Manager: Selection of the procedure from the worklist is synchronized as in Use Case with the synchronized selection of the procedure. The Infusion Manager receives the contrast usage protocol as ID in the fourth component of IPC segment of HL7 OMI message sent from the DSS to the Infusion Manager. The infusion manager displays the infusion protocol on its display reflecting the modification done on the pre-defined protocol, if any.
The Radiology technician confirms the protocol to accept it by pressing OK button of the Infusion Manager. The procedure is processed same as the Use Case thereafter to result in issue of the planned and performed Imaging Agent Administration SRs to IM/IA
Storage commitment is sent to the IM/IA,  and if its response shows the commitment by IM/IA, the stored SRs in the Infusion Manager are removed from it.
<center>[[Image:CAM actor transaction diagram.png]]</center>


==4. Standards and Systems==
==4. Standards and Systems==
General
:* IHE REM/REM-NM Profiles - provide a framework for this profile and example transactions
:* DICOM Sup 164 (expect Final Text in October) - provides format for contrast administration data
Specific
:* IPC-4: Scheduled Procedure Step ID (RAD TF-2:4.4.4.1.2.2.8) to convey a contrast usage protocol as a protocol ID
:* New transactions for Infusion Manager
:** To retrieve a worklist from DSS.
:*** Modality can retrieve a worklist by Query Modality Worklist [RAD-5]. Infusion Manager also needs this function.
:** New Transaction from DSS to Infusion Manager notifying start of the procedure.
:*** DSS can receive this information by Modality Procedure Step In Progress [RAD-6].
:*** Order status change conveyed this transaction needs to be transmitted to Infusion Manager.
:* Modify Store Dose Information [RAD-62] to derive new transaction Store Imaging Agent Administration SR [RAD-XX]. Following standards may be utilized:
:** DICOM 2011 PS 3.3 Suppl. 164: A.35.X3.2 Planned Imaging Agent Administration SR IOD
:** DICOM 2011 PS 3.3 Suppl. 164: A.35.X4.2 Performed Imaging Agent Administration SR IOD
:** DICOM 2011 PS 3.3 Suppl. 164:  Planned Imaging Agent Administration SR Storage SOP Class
:** DICOM 2011 PS 3.3 Suppl. 164:  Performed Imaging Agent Administration SR Storage SOP Class
:** DICOM 2011 PS 3.16: Planned Imaging Agent Administration SR IOD Templates
:** DICOM 2011 PS 3.16: Performed Imaging Agent Administration SR IOD Templates
:** DICOM 2011 PS 3.4: Storage Service Class
:** DICOM 2011 PS 3.4: Structured Reporting Storage SOP Classes
:* Expand Storage Commitment [RAD-10] to include Infusion Manager:
:** DICOM 2011 PS 3.4: Storage Commitment Push Model SOP Class
:* Modify Retrieve Dose Information [RAD-64] to derive new transaction Retrieve Imaging Agent Administration SR [RAD-YY]
:** DICOM 2011 PS 3.4: Query/Retrieve Service Class
:** DICOM 2011 PS 3.4: Structured Reporting Storage SOP Classes
:* DICOM 2011 PS 3.3 Suppl. 164: A.35.X4.2 Performed Imaging Agent Administration SR IOD


<center>[[Image:CAM actor transaction diagram2.png]]</center>
:* IHE REM/REM-NM Profiles - framework for this profile and example transactions
:* DICOM IAASR (Sup 164) - format for contrast administration data


==5. Technical Approach==
==5. Technical Approach==
Development of new transactions is required.  See  new transactions  below. 


'''New actors'''
'''New actors'''


Infusion manager grouped with Infusion Pump:  This actor is for setting contrast usage, generating planned and performed IAA SR, sending the reports to IM/IA.   
Infusion Manager: Grouped with Infusion Pump. Sets contrast usage, generates planned and performed IAASR, sends to IM/IA.   
Imaging Agent Administration SR Consumer:This actor is for retrieving IAA SR to analyze the repots such as frequency of adverse reaction in relation to imaging agent etc. This actor will not be discussed further in this proposal
IAASR Consumer:Retrieves IAASR for various purposes.


'''Existing actors'''
'''Existing actors'''


Order Placer, DSS/OF, IM/IA, and Acquisition Modality participate in the proposed integration profile.
Order Placer, DSS/OF, IM/IA, Acquisition Modality


'''New transactions (standards used)'''
'''New transactions (standards used)'''
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'''Impact on existing integration profiles'''
'''Impact on existing integration profiles'''
Interaction, or, integration with SWF.b may be useful
Interaction, or, integration with SWF.b may be useful


'''New integration profile needed'''
'''New integration profile'''




Breakdown of tasks that need to be accomplished
Breakdown of tasks


'''Transactions'''
'''Transactions'''
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'''Profiles'''
'''Profiles'''
:* Clone REM-NM
:* Phase 1: Clone REM-NM
:** SP: 2 - normal size, 1 - new domain (contrast agent), 1 - new use case
:** SP: 2 - normal size, 1 - new domain (contrast agent), 1 - new use case
:* Phase 2:


'''Debates / Discussions'''
'''Debates / Discussions'''
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===6. Risks===
===6. Risks===
Because transactions needed are all within the boundary of Radiology Information System, risks are minimal. 
:* Phase 1 is pretty straightforward
:* Depends on DICOM Supp164
:* Phase 2 depends on workflows that may differ between sites and needs more new transaction work.
:** Scheduled to be final text by late September (tentatively)
:** New DICOM SR object with new IOD
:** Currently it is quite stable, not expecting major changes
:* Not expecting any patent issue
:** Check with Bayer


===7. Open Issues===
===7. Open Issues===
Any vendors already planned to support similar effort?


===8. Effort Estimates===
===8. Effort Estimates===
:* MaxUE: 14 points
:* MaxUE:  
:* MinUE: No Submit transaction – 13 points
:* MinUE:  


2 points added for editing assistance of the profile.
2 points added for editing assistance of the profile.

Revision as of 20:24, 13 August 2020

1. Proposed Workitem: Contrast Administration Monitoring

  • Proposal Editor: Norinari Honda (IHE-J)
  • Proposal Contributors: Araki (Nemoto-Kyorindo), Shiokawa, O'Donnell (Canon)
  • Editor: Tentative: Araki / Salt / O'Donnell
  • Contributors:
  • Domain: Radiology

Summary

DICOM Imaging Agent Administration Structured Reports (IAASR - Sup164) provide a standardized way to capture and record information associated with administration of imaging agent. IAASR supports both performed administrations (analogous to IHE REM) and planned administrations (analogous to IHE MAP). Automating the two processes would improve the quality and efficiency of care and reduce management costs for the institution.

2. The Problem

Contrast agents, usually injected, are commonly used in imaging studies for many different modalities. However, capturing the details of each performed contrast administration is typically done manually or using proprietary methods. The result is that the recorded details are sparse, poorly integrated, and sometimes either inaccurate or missing entirely.

This is a problem because there is a potential for serious adverse reactions, and when those occur, a detailed record is central to investigating and reducing the likelihood of future problems. Lack of a reliable stored record increases the cost and decreases the quality of efforts to incorporate the information in radiology reports, handle charging and management of drugs and consumables, evaluate clinical practice, and track conformance to guidelines for imaging agent use.

A second problem area is that the order from the radiologist to use contrast for a given imaging procedure needs to be translated into an appropriate administration protocol executed in conjunction with the imaging procedure order. Today this process is often manual and imperfect.

The two problem areas will be described in this proposal as related Profile work in two phases.

3. Key Use Case

The two phases are presented in the order they should likely be worked on Phase 1 addresses storage and retrieval of performed administration details. Because the mechanics are straightforward with few unknowns, it is presented first even though the steps in Phase 2 precede the steps in Phase 1 in terms of the workflow.

The infusion manager here refers to the combination of the power injector and its associated IT components to manage and select user-defined injection protocols and interact with the modality and hospital infrastructure.

Phase 1 (Storage and Retrieval)

  • The technologist confirms the end of the procedure to the infusion manager
  • The infusion manager sends the contrast administration record (IAASR) to the IM/IA
  • (At reporting time, the Report Creator retrieves the IAASR and populates fields in the report)
  • (The Charge Poster retrieves the IAASR and populates billing fields)
  • (The Dose Reporter? retrieves the IAASR to investigate adverse events or create departmental reports)

Phase 2 (Protocol Management and Selection)

  • A clinician places an order for imaging study (sent to DSS/OF via Placer Order Management [RAD-2])
  • The radiologist reviews the order, decides whether contrast is appropriate, and if so selects a contrast administration protocol that corresponds to the image acquisition protocol
  • The RIS records the selected imaging protocol and the contrast protocol in the worklist entry
  • The technologist selects and reviews the worklist entry for the current procedure (Query Modality Worklist [RAD-5])
  • The technologist selects a protocol from those stored in the infusion manager that corresponds to the ordered contrast protocol
  • The technologist makes appropriate changes to the contrast protocol, if needed, and confirms the protocol on the injector console
  • Open Issue: the technologist is responsible for mapping and modifying the contrast protocol on the infusion manager, and the imaging protocol on the acquisition modality. This could be done as two separate sequences of steps, or with integration they might be combined or synchronized.
  • The technologist starts both the imaging and contrast protocols
  • Open Issue: CAN protocol allows modalities to trigger injectors and synchronize imaging with contrast appropriately. Some contrast protocols include manual injection triggers. Need to consider various cases and if the profile should address.
  • The technologist ends the study
  • <See Phase 1>
  • In addition to the performed IAASR, the infusion manager also stores the planned IAASR
  • Open Issue: Is it worthwhile to mandate Storage Commitment here?

Acquisition method of the Worklist Synchronized selection of the procedure from the worklist on Modality and Infusion Manager: The radiology technician selects the procedure to start from the modality worklist. This caused the Modality to send performed procedure step in progress to PPSM via RAD-6. The PPSM delivers this to DSS ([RAD-6] transaction). DSS informs the order status change (Scheduled to In Progress) to the Infusion Manager, which triggers selection of the corresponding procedure from the Infusion Manager’s worklist. Thus, synchronization of the procedure between the modality and the Infusion Manage is attained. The procedure is processed same as the Use Case 1 thereafter to result in issue of the planned and performed Imaging Agent Administration SRs to IM/IA

Decision of the contrast protocol Automatic selection of the contrast usage protocol on the Infusion Manager: Selection of the procedure from the worklist is synchronized as in Use Case with the synchronized selection of the procedure. The Infusion Manager receives the contrast usage protocol as ID in the fourth component of IPC segment of HL7 OMI message sent from the DSS to the Infusion Manager. The infusion manager displays the infusion protocol on its display reflecting the modification done on the pre-defined protocol, if any.

4. Standards and Systems

  • IHE REM/REM-NM Profiles - framework for this profile and example transactions
  • DICOM IAASR (Sup 164) - format for contrast administration data

5. Technical Approach

New actors

Infusion Manager: Grouped with Infusion Pump. Sets contrast usage, generates planned and performed IAASR, sends to IM/IA. IAASR Consumer:Retrieves IAASR for various purposes.

Existing actors

Order Placer, DSS/OF, IM/IA, Acquisition Modality

New transactions (standards used)

A transaction for infusion Manager to retrieve worklist from DSS is needed. The transaction should have filtering capability to retrieve only procedure scheduled at particular location where an acquisition modality and a grouped infusion manager with infusion pump is installed. Infusion Manager must be able to suppress display on the worklist of procedures that are not planned for imaging agent administration. But use of imaging agent may be determined on site for procedure not planned for administration of imaging agent, Infusion manager must be able to show the hidden procedure on demand.

The second new transaction is necessary to inform the Infusion Manager of a start of the procedure that is contained in the worklist of the Infusion Manger. This function is necessary to synchronize procedure selection between Infusion Manager and Modality.

The final new transaction is to store IAA SR to IM/IM.

Impact on existing integration profiles

Interaction, or, integration with SWF.b may be useful

New integration profile


Breakdown of tasks

Transactions

  • Store injection record (cloned and modified from Store RDSR RAD-62)
    • SP: 1 effort, 0 complexity
  • Query injection record (cloned and modified from Store RDSR RAD-64)
    • SP: 1 effort, 0 complexity
  • Retrieve injection record (cloned and modified from Store RDSR RAD-65)
    • SP: 1 effort, 0 complexity
  • Notify worklist to Infusion Manager (new, model based on Query Modality Worklist: trigger by MPPS In Progress from modality)
    • SP: 1 effort, 1 complexity
  • Submit to Registry (cloned and modified from Submit RDSR RAD-63)
    • MaxUE
    • SP: 1 effort, 0 complexity

Profiles

  • Phase 1: Clone REM-NM
    • SP: 2 - normal size, 1 - new domain (contrast agent), 1 - new use case
  • Phase 2:

Debates / Discussions

  • Should the synchronization and injection protocol selection to the Infusion Manager be push or pull?
    • The notification needs to be sent early before the modality injects radiation. This may argue for pull workflow.
    • SP: 1 uncertainty
  • This profile follows a similar pattern as REM and REM has a Registry actor. Should this profile also include a Registry actor? May be interested to have a public registry to collect data for analysis.
    • May be beneficial as a named option (may be a MaxUE item)
    • The consumer is responsible for de-identification. This means a higher load on the consumer.
    • SP: 1 discussion

6. Risks

  • Phase 1 is pretty straightforward
  • Phase 2 depends on workflows that may differ between sites and needs more new transaction work.

7. Open Issues

8. Effort Estimates

  • MaxUE:
  • MinUE:

2 points added for editing assistance of the profile.