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

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>