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 its level of complexity, scope, global differences, as well as technical challenges in 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. Despite a valiant effort, the FUNC profile itself remains incomplete, but the problem it addresses is no less relevant or important than it was when the profile was originally introduced.

Current state of FUNC supplement: The scope of the FUNC profile itself was nearly halved in terms of length (i.e., number of pages) when the Results Distribution profile was spun off. The FUNC supplement text is currently ~100 pages in length with RD removed. More recently, 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 developed and have been reviewed several times by the IHE Rad Technical Committee. These will need to be re-reviewed in light of RD having been separated, but should ultimately be decreased rather than increased.

FUNC Volume 2:

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

The exact FHIR resources continue to evolve for two of the transactions, in part because FHIR is still evolving, and 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 on 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 and exchange of patient information. This profile is not intended to cover the situation where a notification has to be sent between entirely distinct and unaffiliated facilities,.

Specifically, FUNC addresses communication and feedback for ACR Category 3 findings, or "non-critical actionable findings". 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.

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 of follow-up within a 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, using standards in the real world today.

The FUNC supplement link Volume 2 has extensive additional detail.

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

5. Discussion

We estimate that FUNC Volume 1 development (writing) is 80% complete to get to Public Comment.

We estimate that FUNC Volume 2 development (writing) is 50% complete to get to Public Comment. In particular, the FHIR resource definitions are still under development.

Estimates for additional time and effort required to complete FUNC include:

• TC: 6 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: 12 h of PC comment review (qty 6 - 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

Summarized TC committee efforts:

• To get to publish for Public Comment: 12 hours
• To get to publish for Trial Implementation after Public Comment period: 12 hours

5. Technical Approach

See current supplement at: FUNC Profile

Existing actors

• See Volume 1: Report Manager

New actors

• See Volume 1:

• Follow up Source
• Alert Reporter
• Alert Aggregator

Existing transactions

• See Volume 1:

• RD RAD-Y1 (Send Imaging Results)

New transactions (standards used)

• See Volume 1:

• 6 new FHIR transactions, however 3 of them are "acks"
• 1 new HL7 v2 ORM transaction, including ack

Impact on existing integration profiles

• Need to complete RD

New integration profiles needed

<Indicate what new profile(s) might need to be created.>

Breakdown of tasks

See work break down above.

6. Support & Resources

• Need to continue to have support from FHIR knowledgeable developers (i.e., Elliot Silver).

7. Risks

• Scope creep beyond current A/T diagram
• FHIR STU-3 changes dramatically again. STU-3 is currently frozen. FHIR DSTU-4 is approximately a year out.
• FHIR Communication and Communication Request is a FHIR Maturity Level 2.
• Current existing products do not use FHIR.
• Need to get RD out the door and to TI to be able to focus on FUNC.
• Disagreement on FHIR Resources selected during Public Comment period. (ie., Communication and Communication Request)
• Very specific technical issues such as differences of agreement on Contained Resources.
• IHE TC availability for conference calls to get to Public Comment

8. Open Issues

• profile is off cycle from Radiology TC now
• IHE Documentation staff availability
• profile does not get to TI by November

9. Tech Cmte Evaluation

Technical Evaluation:

• No unsolvable hurdles foreseen

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

• 20% to complete through Trial Implementation publication for FUNC
• MUE 10% - 3 hours at each of 3 TC meetings

• get to Public Comment version ready for publication (but not Public Comment review)

Candidate Editor:

Teri Sippel Schmidt