Contrast Administration Management - Proposal

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

• Open Issue: Is it worthwhile to mandate Storage Commitment here?

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

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

• IM/IA

New transactions (standards used)

TODO: Need to revise to reflect two phases.

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

TODO: Need to merge two cycles of detailed review.

Profiles

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

Transactions

• Store injection record (cloned and modified from Store Dose Information RAD-62)
  • SP: 1 effort, 0 complexity
• Query injection record (cloned and modified from Query Dose Information RAD-64)
  • SP: 1 effort, 0 complexity
• Retrieve injection record (cloned and modified from Retrieve Dose Information 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

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.

8. Effort Estimates

• MaxUE:
• MinUE:

2 points added for editing assistance of the profile.