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

Meeting Date & Time

Tuesday, July 2, 2019 at 2:00 pm ET

Attendees

Attendees

Present/Absent

Attendees

Present/Absent

Becky Angeles

 

Behnaz  Minaei

 

Nagesh Bashyam (Dragon)

P

JaWanna Henry

 

Gayathri Jayawardena

P

Myron Finseth

P

Richard Ballew

P

Vaishnavi Rao

P

Rob Samples

 

Ioana Singureanu

 

Terrie Reed

P

Marti Velezis

 

Lisa Lang

 

Patrick McLaughlin

P

Abdullah Rafiqi

P

Robin Taylor

 

Christina Nguyen

 

Lindsey Hoggle

 

Craig Newman

P

Mary Ann Hantakas

 

Yanyan Hu

 

Mike Flanigan

P

Liz Amos

 

Clem McDonald

 

Discussion                                                                    

CRN Implementation Guide (IG) Ballot Comment Reconciliation

  • Comments Requiring Follow-up
    • The Support Team reached out to the appropriate stakeholders regarding comments which required follow-up for additional input.  This process is ongoing and 7-8 comments are not yet resolved.
    • Craig’s comment pertained to adverse events (AEs).  The Support Team reached out to the FDA Informatics Team for clarification on what is required for AE reporting.  The team is awaiting their feedback. 
      • Kathleen’s response indicated that they planned to collect complications or AEs that occur during and following surgery.  They developed a list of specific complications they were interested in during the Delphi process.
      • Dragon suggested need to inquire about specific complications they want to capture.
      • Richard noted there was discussion about the desire to capture device-related AEs.  He was not aware of any more specific discussion. 
      • Terrie noted there are existing codes used for device AEs.  She will provide Dragon with this form and link to these codes.  She noted this reporting applies to the medical device industry who must report AEs to the FDA.  Registries do not fall into this category, but she suggested there is no reason they cannot use the same.
      • Craig noted the definition of the AE resource is strict and pertains to risk management control.  He suggested in compiling this list it is important to consider whether it is an AE, condition or observation.  The Patient Care Workgroup may be able to assist with this.

 

Next Steps

  • Support Team to collect AE information as discussed and determine the most appropriate resolution.