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==1. Proposed Workitem: Contrast Administration Monitoring==
==1. Proposed Workitem: Contrast Administration Management==


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


=== Summary ===


== Summary ==
DICOM Imaging Agent Administration Structured Reports (IAASR - Sup164) provide a standardized way to '''capture and record information associated with administration of imaging agents'''.


The DICOM Sup164 is developed to record information associated with administration of imaging agent. The information is expressed as Planned and Performed Imaging Agent Administration Structured Report (IAA SR) and is stored in the IM/IA for later retrieval to meet various needs. Work flow, Contrast Agent Administration Reporting (CAAR), to support handling of selection of imaging agent, its use according to usage protocol, record of adverse event and infusion related events, generation and storage of IAA SR, and retrieval of reports is developed.
IAASR supports both '''performed''' administrations (analogous to IHE REM) and '''planned''' administrations (analogous to IHE MAP).


Automating these processes would improve the quality and efficiency of care and reduce management costs for the institution.


[[Category:RAD]]
[[Category:RAD]]
Line 18: Line 20:
==2. The Problem==
==2. The Problem==


Administration of contrast is often requested and performed in imaging studies. Information generated during the administration usually is recorded manually because IHE integration profile and a base standard for this purpose is lacking, which makes important medical records prone to be missed.
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'''.  They should be an essential part of the medical record.


Now DICOM Supplement 164 is published, it becomes possible to automatically report and store information regarding imaging agent administration in an integrated workflow.
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 as well as support medicolegal activities.  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 to '''minimize patient risk''' and '''maximize image quality'''.


''<Now describe the Value Statement: what is the underlying cost incurred by the problem, what is to be gained by solving it>''
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 contrast administration protocol executed in conjunction with the imaging procedure order.  Today this process is often manual and imperfect.  Poor management, selection, and modification of contrast protocols has a great impact on the image quality, potentially disrupting the accuracy of the diagnosis. In the extreme, poor contrast protocol usage can be a direct risk to the health of the patient.
 
The two problem areas will be described in this proposal as Profile work in two phases.  Specifically, '''This proposal is for Phase 1 only''' to minimize effort & complexity.  Phase 2 is shown for context and may be proposed in a subsequent year.


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


:* An order for imaging study is placed by a clinician and transmitted to DSS/OF via Placer Order Management [RAD-2].
A CAM Profile can reduce the work burden of medical professionals in creating detailed, precise, and high-quality records.  
:* 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>
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.


== General use case ==
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.  
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 ==
===Phase 1 (Storage and Retrieval)===
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 ==
* The technologist confirms the end of the procedure to the infusion manager
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 infusion manager sends the contrast administration record (IAASR) to the IM/IA
* At reporting time, the Report Creator could retrieve the IAASR and populate fields in the report
* The Charge Poster could retrieve the IAASR and populate billing fields
* The Dose Reporter? could retrieve the IAASR to investigate adverse events or create departmental reports


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
Note: not clear there is currently an interest in an IAASR registry so that could potentially be omitted


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.
===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. There are several approaches to synchronization that could be considered.
* 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


==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
Phase 1
:* 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
:* '''IHE REM/REM-NM''' Profiles - framework for this profile and example transactions
:* New transactions for Infusion Manager
:* '''DICOM IAASR''' (Sup 164) - format for contrast administration data
:** To retrieve a worklist from DSS.
 
:*** Modality can retrieve a worklist by Query Modality Worklist [RAD-5]. Infusion Manager also needs this function.
Phase 2 (Not currently proposed)
:** New Transaction from DSS to Infusion Manager notifying start of the procedure.
:* IHE SWF.b - provides the context and several useful transactions
:*** DSS can receive this information by Modality Procedure Step In Progress [RAD-6].
:* DICOM, HL7, etc.
:*** 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:  
==5. Technical Approach==
:** 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
The profile would be patterned after IHE REM with a different SR payload.
:** 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
Since it is not part of the current proposal, Phase 2 is not described here.
:** DICOM 2011 PS 3.16: Planned Imaging Agent Administration SR IOD Templates
 
:** DICOM 2011 PS 3.16: Performed Imaging Agent Administration SR IOD Templates
===Actors===
:** DICOM 2011 PS 3.4: Storage Service Class
* (NEW) '''Infusion Manager'''
:** DICOM 2011 PS 3.4: Structured Reporting Storage SOP Classes
: Generates contrast information objects for the injector/infusion pump and sends them for storage.  
:* Expand Storage Commitment [RAD-10] to include Infusion Manager:
* (NEW) '''Contrast Information Consumer'''
:** DICOM 2011 PS 3.4: Storage Commitment Push Model SOP Class
: Query/retrieves contrast information objects
:* Modify Retrieve Dose Information [RAD-64] to derive new transaction Retrieve Imaging Agent Administration SR [RAD-YY]
: No specific usage requirements, could include radiology report creators, dept contrast reporters, billing/inventory systems, etc
:** DICOM 2011 PS 3.4: Query/Retrieve Service Class
* IM/IA
:** DICOM 2011 PS 3.4: Structured Reporting Storage SOP Classes
: Usual behaviors.
:* DICOM 2011 PS 3.3 Suppl. 164: A.35.X4.2 Performed Imaging Agent Administration SR IOD
 
===Transactions===
* (NEW) '''Store injection record'''
: Clone Store RDSR (RAD-62) and modify payload reference and details
: EP 1 – simple store, maybe CP 1 to do some constraints on Sup164, note national variations (Japan, Europe, etc)
* (NEW) '''Query injection record'''
: Clone Query RDSR (RAD-64) and modify payload reference
: EP 1 CP 0 – maybe address injection start time?
* (NEW) '''Retrieve injection record'''
: Clone Retrieve RDSR (RAD-65) and modify payload reference
: EP 1 CP 0
* Storage Commitment (RAD-10)
: No change. Might decide not to include.
 
EP 1 CP 1 for using DICOMweb if we switch (Not Min)
 
Note scope is focused INJECTED. Other administration paths like inhaled or swallowed are not prohibited but not directly discussed.
 
NM injections/administrations are out of scope since already in REM-NM
 
===Profile===
(NEW) '''Contrast Administration Management (CAM) Profile'''
* Clone IHE REM-NM and modify
: EP 2 normal size, CP 1 new domain (contrast agent)
* Document CAM use case
: EP 1
 
''Q. Any existing profiles that might need to be modified? SWF.b?''
 
===Decisions/Topics/Uncertainties===
* UP 1 Should we use DIMSE or DICOMweb - injectors being small, new implementations
* Consider injectors as new players, consult with IHE DEV?
* Generation of Planned IAASR left for Phase 2
* Should Storage Commitment [RAD-10] be required, optional, or ignored? 
* How would you investigate a bad contrast lot? If we can’t query by lot number, describe using time range to get initial objects then examine the lot number values inside.
 
===Out of Scope===
No interest/need today but might add during Phase 2
* Registry Submission
* DICOMweb transport?
 
==6. Support & Resources==
JIRA and several Japanese vendors have been interested in this for several years.
* Try to invite additional domain experts (vendors and clinicians).
:* Maybe check RSNA abstracts on the topic of contrast administration QA (operational topic) for additional players and inputs
 
A couple Japanese vendors may be interested in prototyping/implementing the Profile if it is published this cycle.
 
==7. Risks==
The Phase 2 workflow represents a common contrast protocolling workflow in Japan. North American & European workflow differ.
* Plan: If/when we do Phase-2, confirm common workflow patterns in North America, Europe, and elsewhere, which might change some of the interactions with the RIS, Order Placer, etc.
 
==8. Tech Cmte Evaluation==
Point Tally
* EP 6 CP 2 UP 1 = 9 (MUE)
* EP +1 CP +1 UP = 11 (Full)
 
Effort Evaluation (as a % of Tech Cmte Bandwidth):
:* xx% for MUE
:* yy% for MUE + optional


==5. Discussion==
Editor:
: Araki/Kevin


''<Include additional discussion or consider a few details which might be useful for the detailed proposal>''
SME/Champion:
:''<Why IHE would be a good venue to solve the problem and what you think IHE should do to solve it.>''
: TBA ''<typically with a technical editor, the Subject Matter Expert will bring clinical expertise; in the (unusual) case of a clinical editor, the SME will bring technical expertise>''
:''<What might the IHE technical approach be? Existing Actors? New Transactions? Additional Profiles?>''
:''<What are some of the risks or open issues to be addressed?>''

Latest revision as of 16:45, 16 September 2020

1. Proposed Workitem: Contrast Administration Management

  • 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 agents.

IAASR supports both performed administrations (analogous to IHE REM) and planned administrations (analogous to IHE MAP).

Automating these 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. They should be an essential part of the medical record.

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 as well as support medicolegal activities. 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 to minimize patient risk and maximize image quality.

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 contrast administration protocol executed in conjunction with the imaging procedure order. Today this process is often manual and imperfect. Poor management, selection, and modification of contrast protocols has a great impact on the image quality, potentially disrupting the accuracy of the diagnosis. In the extreme, poor contrast protocol usage can be a direct risk to the health of the patient.

The two problem areas will be described in this proposal as Profile work in two phases. Specifically, This proposal is for Phase 1 only to minimize effort & complexity. Phase 2 is shown for context and may be proposed in a subsequent year.

3. Key Use Case

A CAM Profile can reduce the work burden of medical professionals in creating detailed, precise, and high-quality records.

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 could retrieve the IAASR and populate fields in the report
  • The Charge Poster could retrieve the IAASR and populate billing fields
  • The Dose Reporter? could retrieve the IAASR to investigate adverse events or create departmental reports

Note: not clear there is currently an interest in an IAASR registry so that could potentially be omitted

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. There are several approaches to synchronization that could be considered.
  • 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

4. Standards and Systems

Phase 1

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

Phase 2 (Not currently proposed)

  • IHE SWF.b - provides the context and several useful transactions
  • DICOM, HL7, etc.

5. Technical Approach

The profile would be patterned after IHE REM with a different SR payload.

Since it is not part of the current proposal, Phase 2 is not described here.

Actors

  • (NEW) Infusion Manager
Generates contrast information objects for the injector/infusion pump and sends them for storage.
  • (NEW) Contrast Information Consumer
Query/retrieves contrast information objects
No specific usage requirements, could include radiology report creators, dept contrast reporters, billing/inventory systems, etc
  • IM/IA
Usual behaviors.

Transactions

  • (NEW) Store injection record
Clone Store RDSR (RAD-62) and modify payload reference and details
EP 1 – simple store, maybe CP 1 to do some constraints on Sup164, note national variations (Japan, Europe, etc)
  • (NEW) Query injection record
Clone Query RDSR (RAD-64) and modify payload reference
EP 1 CP 0 – maybe address injection start time?
  • (NEW) Retrieve injection record
Clone Retrieve RDSR (RAD-65) and modify payload reference
EP 1 CP 0
  • Storage Commitment (RAD-10)
No change. Might decide not to include.

EP 1 CP 1 for using DICOMweb if we switch (Not Min)

Note scope is focused INJECTED. Other administration paths like inhaled or swallowed are not prohibited but not directly discussed.

NM injections/administrations are out of scope since already in REM-NM

Profile

(NEW) Contrast Administration Management (CAM) Profile

  • Clone IHE REM-NM and modify
EP 2 normal size, CP 1 new domain (contrast agent)
  • Document CAM use case
EP 1

Q. Any existing profiles that might need to be modified? SWF.b?

Decisions/Topics/Uncertainties

  • UP 1 Should we use DIMSE or DICOMweb - injectors being small, new implementations
  • Consider injectors as new players, consult with IHE DEV?
  • Generation of Planned IAASR left for Phase 2
  • Should Storage Commitment [RAD-10] be required, optional, or ignored?
  • How would you investigate a bad contrast lot? If we can’t query by lot number, describe using time range to get initial objects then examine the lot number values inside.

Out of Scope

No interest/need today but might add during Phase 2

  • Registry Submission
  • DICOMweb transport?

6. Support & Resources

JIRA and several Japanese vendors have been interested in this for several years.

  • Try to invite additional domain experts (vendors and clinicians).
  • Maybe check RSNA abstracts on the topic of contrast administration QA (operational topic) for additional players and inputs

A couple Japanese vendors may be interested in prototyping/implementing the Profile if it is published this cycle.

7. Risks

The Phase 2 workflow represents a common contrast protocolling workflow in Japan. North American & European workflow differ.

  • Plan: If/when we do Phase-2, confirm common workflow patterns in North America, Europe, and elsewhere, which might change some of the interactions with the RIS, Order Placer, etc.

8. Tech Cmte Evaluation

Point Tally

  • EP 6 CP 2 UP 1 = 9 (MUE)
  • EP +1 CP +1 UP = 11 (Full)

Effort Evaluation (as a % of Tech Cmte Bandwidth):

  • xx% for MUE
  • yy% for MUE + optional

Editor:

Araki/Kevin

SME/Champion:

TBA <typically with a technical editor, the Subject Matter Expert will bring clinical expertise; in the (unusual) case of a clinical editor, the SME will bring technical expertise>
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