Coordinated Registry Network (CRN) HL7 Implementation Guide (IG) Workgroup (WG)

Meeting Date & Time

Tuesday, March 5, 2019 at 2:00 pm ET

Attendees

Attendees

Present/Absent

Attendees

Present/Absent

Becky Angeles

P

Behnaz  Minaei

P

Nagesh Bashyam (Dragon)

P

JaWanna Henry

P

Gayathri Jayawardena

P

Myron Finseth

P

Richard Ballew

P

Vaishnavi Rao

 

Rob Samples

 

Ioana Singureanu

 

Terrie Reed

P

Marti Velezis

P

Lisa Lang

P

Patrick McLaughlin

P

Abdullah Rafiqi

P

Robin Taylor

P

Christina Nguyen

P

Lindsey Hoggle

P

Discussion                                                                    

CRN Implementation Guide (IG) Updates

  • Latest CDE spreadsheet was provided by on 14-FEB-2019. Thank you to everyone who worked on putting this together for the CRN Implementation Guide (IG)
  • CRN IG has been updated to align with the FHIR v4
    • Most of the IG build will be complete by the last week of February, including the tracker and ballot comments
  • Updates to STU IG can be accessed here: http://build.fhir.org/ig/HL7/coordinated-registry-network/ , final content which includes the completion of QA, minor edits, and minor adjustments to profiles will be complete by March 24 and the final STU IG will be submitted
     

CRN HL7 May 2019 Ballot Cycle Consensus Group Sign-Up Now Open

CRN FHIR Tracker #19720

  • The UDI needs to be "must support" and "1…1" instead of "1…*"    
  • There should not be multiple UDIs for a single device instance.        
  • The UDI constraint should be inherited from the US Core Device profile.    
  • This IG needs to be aligned with US Core and FHIR R4, as much as possible
    • Existing Wording : This profile builds on Device
    • Proposed Wording : This profile builds on US Core Device profile
      • Disposition: Persuasive with Mod
      • Disposition Comment: Revise wording to read “This profile builds on US Core Device profile”
      • Substantive Change (Y/N): Y

 

CRN Core Minimum dataset

  • UDI Representation
    • udiCarrier - Marti noted if provided, carrierAIDC or carrierHRF should be entered.  These are both 0..1 which is correct.  One of these values and an entrytype are needed.  Dragon confirmed entrytype is mandatory.  He will add the appropriate constraint.
    • Expansion List - Dragon noted that the current FHIR spec has a value set using SNOMED.  Dragon asked if this value set of all codes where root is device is appropriate for inclusion in the IG.
      • AI: Marti and Behnaz will confirm the root is correct.
  • Mandatory Data Elements and Terminology: Device Identifier (DI) - Dragon asked if the following elements are mandatory if the DI is available: Manufacturer, Device Name, Model Number. 
    • Marti suggested if the DI is available, this data is available through the GUDID.  The goal is that this data would always be populated.  If the device is outside US, you would have a DI, but not necessarily present in US database.  Dragon will add language to indicate that whenever DI is populated, the Device Name and Model Number must be populated.  Manufacturer is already required.
      • Marti suggested Dragon add language to the description to indicate that the Manufacturer Name can be pulled from the GUDID.
  • CDE Repository
    • Dragon added the latest spreadsheet of date elements and added links to the CDE repository and the questionnaire representation of the CDE provided by NLM. 
    • Dragon also populated the mapping between CDEs and FHIR data elements as well as the specific profiles for use. 
  • Question for NLM Team
    • Is the harmonized value set (e.g., procedures, conditions) published anywhere on the NLM website or VSAC?
    • Richard noted all value sets have OIDs and a URL can be provided for these.
      • AI: NLM Team to provide URLs and Dragon to add links.
  • Policy questions posed by Lisa
    • Data Capture and Reuse - Lisa suggested that the IG implies that data capture is for the purpose of reuse by registries and third parties and it would be nice to have agreement on this point.
    • Comment Process: What is the timing and format for the next round of data element revisions?  How should the Working Groups develop a common set of comments that can be incorporated into the next version of the IG so that it is in better shape for pilots? 
      • The ESAC Team will work on common set of comments.  Any comments submitted by April 18 th can be submitted for the ballot cycle. 
      • Dragon suggested any further revisions of the data elements can be submitted as comments to the ballot.  Individual comments can be reconciled and incorporated in the IG published after the ballot.  A QA period goes through March 24 th and any minor changes can be made up until this point. 
      • Given the data elements are inserted in the IG as link, will any changes made automatically show or is there a process to update?
        • Richard suggested that by using the grouping OID, if there are changes to membership in the value set, these will be reflected through the same OID.  There are versions within VSAC and can refer to a specific version through the API.
      • Lisa suggested the Leadership Committee will want to know the difference between kinds of changes which should be made between now and March 24 th and kinds of substantive changes that need to be made through comment process during March 28 - April 28 as well as the process for incorporating these changes. 
        • AI: Team to clarify process from ONC perspective in advance of tomorrow’s call with the Leadership Committee.
      • Dragon noted in terms of value set, will need specific version link for the ballot.  He suggested a note be included to indicate this is a dynamic value set/minimum version and be aware that newer versions exist and pilots are encouraged to download newer versions.   
      • What can NLM Team and clinical workgroups provide as changes during QA period?  Dragon responded that he will stop making changes at the end of this week and beginning Monday, March 11 th , begin a one-week period to review and provide feedback.  These corrections can be made prior to March 24 th
      • If changes are substantive, are these better suited for ballot comment?  Dragon agreed.  Once at ballot, what changes are possible to reconcile?  And what changes might affect the pilot process? 
        • Dragon noted that the FHIR spec cannot be changed through the ballot process, but there are no specific constraints to making updates to the IG.  We will try to address anything substantive during reconciliation process.  Any comment to the FHIR base spec should still be submitted through the ballot process and these comments can then be converted into a tracker item assigned to FHIR.
      • Comments on data elements not addressed in a FHIR profile.  For example, a ballot comment to say we didn’t use US Core for devices.  We would make this a future consideration because it is not available through FHIR profiles and could not be adopted at the time.  This sort of suggestion would need to be deferred.
        • Dragon agreed.  Noted specific codes adopted through harmonization process and if these do not match up to what FHIR recommends through other FHIR profiles, could receive a comment.  Could make conscious decision to use our value sets, knowing these are not in sync with FHIR value sets, due to requirement of our use case specific to women’s health CRN work.  These sorts of ballot comments would not be persuasive.
      • IG Review Period - March 11 th - 15 th .  Dragon will try to address all feedback prior to March 24 th .  Any feedback we cannot accommodate will make ballot comment.  Dragon will let anyone know if comment should be ballot comment.
    • Use of Repository for the IG - Dragon incorporated into the IG.
    • Technical presentation of the data elements and how to represent intentional value sets - there is a way to represent Intentional value sets.  Dragon would like to incorporate existing VSAC link where possible. 
    • Rendering of questionnaire - This will be dictated by pilots as we go forward.  The FHIR spec is flexible. 

 

 

Next Steps

  • NLM to send links for value sets.
  • ESAC Team will provide link on Monday, March 11 th to IG for all to review and provide feedback.
  • Dragon will incorporate feedback as possible and submit IG on March 24 th .