Contrast Administration Management - Proposal

1. Proposed Workitem: Contrast Administration Monitoring

Proposal Editor: IHE-J/Tomoyuki Araki/Nemoto-Kyorindo
Proposal Contributors: Shiokawa, O'Donnell
Editor: Tentative: Tomoyuki Araki / Salt
Contributors:
Domain: Radiology

Summary

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.

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.

Now DICOM Supplement 164 is published, it becomes possible to automatically report and store information regarding imaging agent administration in an integrated workflow.

<Now describe the Value Statement: what is the underlying cost incurred by the problem, what is to be gained by solving it>

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 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.

General use case 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 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.

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.

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

5. Technical Approach

Development of new transactions is required. See new transactions below.

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. 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

Existing actors

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

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 needed

Breakdown of tasks that need to be accomplished

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

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

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

Because transactions needed are all within the boundary of Radiology Information System, risks are minimal.

Depends on DICOM Supp164
- 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

Any vendors already planned to support similar effort?

8. Effort Estimates

MaxUE: 14 points
MinUE: No Submit transaction – 13 points

2 points added for editing assistance of the profile.