Follow-up of Non-critical Actionable Findings (FUNC) profile completion- Proposal

1. Proposed Workitem: Completion of Follow-up of Non-critical Actionable Findings (FUNC) supplement

• Proposal Editor: Teri Sippel Schmidt/Vital Images, Steve Langer/ Mayo Clinic, Tessa Cook, MD PhD/ Univ of Pennsylvania
• Editor: Teri Sippel Schmidt/Vital Images
• Date: N/A (Wiki keeps history)
• Version: N/A (Wiki keeps history)
• Domain: Radiology

2. The Problem

The IHE TC problem: The possibility exists that the Follow-up of Non-Critical Actionable Findings (FUNC) profile was underestimated in 2016 for level of complexity, scope, global differences, as well as technical challenges adopting a new and evolving technology (FHIR). As a result, the Results Distribution (RD- HL7 v2.5.1 ORU message) was separated from the FUNC profile and went to public comment in June, 2017. In spite of valiant efforts, the FUNC profile itself remains incomplete but is no less relevant or important than it was during last year's review cycle.

Current state of FUNC supplement: The scope of the FUNC profile itself was cut almost in half, in terms of # of pages, when the Results Distribution profile was separated it. As an example, the FUNC supplement text is currently ~100 pages in length with RD removed. In the short term, however, focus and resources were redirected from FUNC to focus on actual completion of RD.

FUNC Volume 1:

The use cases and background material in Volume 1 are fairly well thought through and have been reviewed several times by the IHE Rad Tech Committee. These will need to be re-reviewed in light of RD being removed, but should be reduced, not expanded.

FUNC Volume 2:

The basic architecture has been determined, after quite intense and lengthy discussions, the "Alert Reporter" actor is effectively a "FHIR server" also.

The exact FHIR resources continue to evolve for two of the transactions, in part because FHIR is still evolving, in larger part because of the IHE Rad TC learning curve.

The FUNC clinical problem statement:

Taken from Volume 1:

In a University of Pennsylvania (HUP) two-year study presented at RSNA 2016 looking at recommendations for follow-up based on abdominal imaging, researchers found that 14% of such exams recommended follow-up imaging for non-critical, actionable findings (Cook2016). A substudy looking at six months of these recommendations noted that there was a 4:1 ratio of in-system to out-of-system physicians ordering abdominal imaging performed at this large academic medical center. Combining these results, it is estimated that, at least for abdominal imaging, approximately 3% of exams contain non-critical, actionable findings that need to be communicated outside a single health system. As such, these patients are automatically at a much higher risk of not having their findings communicated (because the communication may currently rely on faxing printed results or calling ordering physicians’ offices). Using the large, academic center in the study above as an example, this translates to approximately 30,000 at-risk patients every year at HUP.

The original FUNC 2016 Profile Proposal can be found here: Critical_Finding_Follow-up_and_Communication

The current FUNC supplement under development can be found here: Draft of FUNC Supplement for Public Comment

3. Key Use Case

This profile focuses alert notifications within affiliated facilities, for example from a hospital to a referring provider group or within a Canadian provincial healthcare domain, and between known enterprises, for example from the Medical College of Wisconsin and the University of Wisconsin, where there is significant patient population overlap. This profile is not intended to cover every possible situation (e.g., patient from another country).

Specifically, FUNC addresses ACR Category 3 findings, or "non-critical actionable finding" communication and feedback. ACR Category 1 and 2 (urgent and emergent) findings require immediate human intervention (i.e., a phone call to the physician caring for the patient) and are therefore not covered in or addressed by this profile.

Specifically, the six use cases currently defined in Volume 1 are:

X.4.2 Use Cases: Follow-up Alerts of Non-critical Actionable Findings

X.4.2.1 Use Case 1: Simple Case- Single healthcare system

X.4.2.2 Use Case 2: Multiple providers to be notified

X.4.2.3 Use Case 3: Affiliated healthcare systems

X.4.2.4 Use Case 4: Multiple alerts within a plan

X.4.2.5 Use Case 5: Follow up Rejected by provider

X.4.2.6 Use Case 6: Expiration of Follow-up Alert Plan

4. Standards and Systems

The transaction within the Radiology Department, to set up the alert notification, is an HL7 v2.5.1. order message (ORM).

The transactions to communicate this alert throughout the enterprise are FHIR CommunicationRequest and Communication Resources.

The Alert Report actor does not yet exist, at least en masse, in the real world today using standards.

Also see the FUNC supplement link Volume 2 for all details.

The FUNC Actor Transaction diagram is as follows. The Report Manager and RAD-Y1 transaction have been moved to the RD profile.

5. Discussion

A ballpark estimate is that FUNC Volume 1 development (writing) is 80% complete.

A ballpark estimate is that that FUNC Volume 2 development (writing) is 50% complete, specifically the FHIR resource definitions are still being worked upon.

Estimates to complete FUNC include:

• TC: 4 more TC conference calls 2h each to complete transactions (1- ORM, 3- FHIR); vote for PC
• editor: 10 h to clean up Volume 1 and re-align
• editor: 20 h to clean up Volume 2 and re-align
• doc specialist: 5 h to publish for Public Comment
• TC: 6 h each member to review independently and submit comments for PC
• editor: 3 h to clean up and organize PC comments
• TC: 8 h of PC comment review (qty 4 - 2h conference calls); vote for approval to TI
• editor: 20 h of PC comment clean up
• doc specialist: 5 h to to publish for Trial Implementation