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

Meeting Date & Time

Tuesday, June 18, 2019 at 2:00 pm ET

Attendees

Attendees

Present/Absent

Attendees

Present/Absent

Becky Angeles

P

Behnaz  Minaei

 

Nagesh Bashyam (Dragon)

P

JaWanna Henry

 

Gayathri Jayawardena

P

Myron Finseth

P

Richard Ballew

P

Vaishnavi Rao

 

Rob Samples

 

Ioana Singureanu

 

Terrie Reed

P

Marti Velezis

P

Lisa Lang

 

Patrick McLaughlin

P

Abdullah Rafiqi

P

Robin Taylor

P

Christina Nguyen

 

Lindsey Hoggle

P

Craig Newman

 

Mary Ann Hantakas

 

Yanyan Hu

 

Mike Flanigan

P

Liz Amos

 

Clem McDonald

 

Discussion                                                                    

CRN Implementation Guide (IG) Ballot Comment Reconciliation

  • Comment resolutions from last week’s call were added to the tracker.
  • Block voting will occur during the bi-weekly BR&R WG calls.
  • Comment Review
    • 21305 - Submitter suggests identifying the specific version of the Structured Data Capture (SDC) FHIR Implementation Guide (IG) being referenced.
      • Resolution: Add the specific SDC FHIR IG version on which the CRN IG depends as part of the history of different versions.
    • 21307 - Submitter posed a question regarding whether patient direct entry is a component of the data collection workflow. 
      • Dragon suggested there is ability to use PRO instruments to collect specific information.  At this point, we have not specified whether patient direct entry is excluded.  He suggested the IG could indicate that the technical solution allows patient direct entry; however individual registry policy will determine whether data is collected from patients directly and validated prior to inclusion in the registry.
      • Resolution: Add clarification to indicate that the technical capabilities allow data entry by a patient directly if necessary; however the policy framework of the registry will determine whether to collect data from patients directly.
    • 21309 - Submitter asked if specific questionnaires will be created and standardized for specific categories of information.
      • Robin Taylor noted that she did not have knowledge regarding creating specific standardized questionnaires. 
      • Terrie Reed wondered whether the question refers to putting the data elements in VSAC.  She noted when UDI was included in CCDA, it was requested that device identifier and production identifier be entered into a valid code set in VSAC.  Dragon noted with regard to the common data elements (CDEs), the vocabulary bindings are also created.  This is documented in the CDE spreadsheet which will be included as part of the IG.  There is a tracker item to ensure every value set required by the IG is in VSAC.
      • It was noted that the FHIR value sets are likely not registered in VSAC.  Dragon noted that for those not in VSAC, it is acceptable to point to the FHIR value set.  Others suggested these might need to be included in VSAC.  Dragon will follow-up regarding this requirement.
      • Richard Ballew noted that there is not a complete set of questions for any form with the core minimum set.  There is potential to do this.  Some data elements would be part of core data set, others would be domain-specific; but this goes beyond the delivery of the core minimum set which was the focus of this project.
      • Resolution: For the scope of this project, the core minimum data elements have been standardized; however the questionnaires that use these data elements are not standardized and will be created by the registries as needed as each registry typically has additional data elements that they use as part of the forms. 
        • AI: Follow-up to determine requirement for storing value sets in VSAC.
    • 21311 - Identify and discuss limiting increase in provider burden by supporting data collection.  The ability to map the data elements to existing workflow and to questionnaires will be critical to reducing provider burden and increasing data collection compliance.
      • Dragon noted that the IG offers the concept of auto-population from an EHR or EMR to reduce data entry and provider burden.  No further analysis of provider burden was performed.
      • Richard noted it is possible the submitter is assuming the overall core minimum set form is intended to be used as a data collection form.  This does not include the context for which the information is to be collected.  He noted there was some discussion which indicated that the direct capture from an EHR was viewed as a bridge too far for this stage, but the consensus on the call was that it is important to look towards this as means to reduce clinician burden. 
      • Resolution: Dragon to follow-up with George and capture any additional ideas he may have regarding provider burden.   
    • 21313 - Depersonalization of patient data and whether this should be addressed in the IG.
      • Dragon suggested it is up to each registry to determine how they choose to expose the data. 
      • Richard noted no conversations regarding how to use the data have occurred; however it would be beneficial to start these discussions.
      • Dragon suggested resolving the ticket by indicating that de-identification was not discussed yet and out of scope for this version of the IG; however this might be a future consideration.
      • Terrie suggested depersonalization is not out of scope, but rather a good question to consider.  She suggested Dragon take this question to Art for data governance perspective.
      • Resolution: Follow-up with Art and bring response back to this group.

 

Next Steps

  • Dragon to follow-up on comments as discussed in this meeting.
  • Block voting to occur on 16 comments at the next BR&R WG call.