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.

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

Estimates for additional time and effort required 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

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)

<Describe possible new transactions (indicating what standards might be used for each).>

<Transaction diagrams are very helpful here. Go into as much detail as seems useful.>

Impact on existing integration profiles

<Indicate how existing profiles might need to be modified.>

New integration profiles needed

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

Breakdown of tasks

<As the basis for the effort estimation, enumerate the tasks to develop the Profile text. E.g.>

• <Discuss/Confirm use case list (currently 5) to decide in/out of scope and details>
• <Analyze/choose which report guidelines to use>
• <Resolve open issue on the degree of computer parsability>
• <Draft/Review content definition for Oncology Report (profile use of CCDA)>
• <Draft/Review transaction for Retrieve Report>

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 DSTU-3 changes dramatically again.
• 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.

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

<The technical committee will use this area to record details of the effort estimation, etc.>

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

• xx% for ...

Candidate Editor:

Teri Sippel Schmidt, until Nov 2017