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

Meeting Date & Time

Tuesday, March 12, 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                                                                    

BR&R WG

  • The final CRN tracker item was closed out during today’s call.
  • Dragon provided a walkthrough of the IG.
    • The IG was not voted on; co-chairs to check on process of approval and get back to us.  Gayathri will make the group aware of any updates.

 

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

  • The sign-up is open through March 28 th
  • All are encouraged to sign-up.  Non-HL7 members may still sign up as non-members.
  • For those unable to sign-up or meet the deadline, ESAC can submit comments on your behalf.

 

CRN Implementation Guide (IG) Updates

  • The latest IG can be accessed here: http://build.fhir.org/ig/HL7/coordinated-registry-network/
  • Device Profile
    • Marti suggested adding a note for the udiCarrier to indicate that if the udiCarrier is present, the udiCarrier must contain at least one carrierAIDC or carrierHRF.  If both are provided two udiCarriers will be entered. 
    • Additional Profile Specific implementation guidance - ‘None’ is misleading.  Instead of ‘none’, this should refer to the appropriate restrictions and constraints.   
    • Device Definition profile
      • Additional Profile Specific implementation guidance - Should indicate that if the manufacturer, name, model and type values are not available on the label, they should be pulled from the GUDID database using the UDI deviceIdentifier.
      • Device name, model number and type are required elements in GUDID.  Marti noted this was left open to allow extensibility with US Core, but suggested noting in the additional guidance that they should pull from GUDID.  Marti and Behnaz agreed to add the following: If the device identifier is available and found in the GUDID database, then device name, model number and type should be populated. 
  • Terminology - Value Sets and Code Systems
    • Marti asked if the SNOMED codes for device type are included.   Dragon noted this is in the FHIR specification and can be referenced.  It is in the base resource.
    • Marti asked if the change to the US Core Profile has a different constraint.  Dragon explained it does not as it is pulled from the base resource.  Currently, it is an example, Dragon will make it bound.
  • Implementation Guidance - APIs
    • GUDID is publically available.  Should indicate this is “active GUDID”.  Suggested a note be added to the device profile to indicate that this API is available.  Marti will send Device Lookup and parsed UDI in email to Dragon.  Parsed UDI API is used on Device profile and lookup is used on Device Definition Profile. 
      • Action Item: Marti to draft instructions regarding use of parsed UDI and forward this along with APIs to Dragon for inclusion.
    • Non-implant devices - Behnaz asked if the same information applies to non-implant devices.  Marti suggested no differentiation is needed. 
  • National Drug Codes (NDC) - Behnaz asked about combination devices which may have an NDC code rather than UDI, or both UDI and NDC.  Marti noted that there is no constraint on UDI Carrier as to what is put in it, but did not think users would think to put the NDC code in it. 
    • Richard recalled from a previous discussion that the NDC would not be part of the UDI.  The Women’s Health Initiative had no example.  Marti suggested as we progress in pilot, if there are requirements we cannot address, we can include this in a future update.  Marti noted the GUDID will take NDC as a secondary device identifier and suggested that opening up to allow a device that was previously assigned an NDC would do the effort a disservice.  NDCs assigned to a medication are a separate issue and the group will address if requirements for this arise.
    • Behnaz noted it may be too disruptive to ignore the NDC for devices in use that are combination products. 
      • Action Item: Behnaz to send these examples to Marti.

 

Next Steps

  •   All to review IG and provide feedback by Tuesday, March 19 th .