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Facilitator:

Austin Kreisler


Date:


Call Details:


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Agenda:


10:00am EST

  1. Call to order 
    1. Call for Attendance


  2. Business Updates (10 min)
    1. Additions/modifications to the agenda
    2. Approve minutes from 2020-06-11 Agenda and Minutes

    3. HL7
  3. External Updates - ONC and others
  4. Project Updates
    1. Value Set Issues

      1. see 11:00am
    2. Provenance
    3. Other Project Updates
  5. Additional Items
    1. Structural Review of Payor Section Wireframes with Linda Michaelsen (continuation of discussion from  
    2. HAI CDA IG Ballot Recon Sarah Gaunt
    3. Expiring STU's
      1. STUs Expiring in Next 6 Months (carried over from  Agenda)
    4. As a point of order, officially in today’s SDWG call (so it appears in the minutes) I would like to request a status update on the C-CDA on FHIR IG for FHIR R4.0.  I believe publication was approved by SDWG, but I could be wrong about this. I am asking for a confirmation of that and a pointer to the minutes/date where that decision was approved by SDWG (if it was). [Does SDWG keep a decision log that makes searching for information like this easier?] (Lisa R. Nelson)

    5. Also, I am asking for a clarification of when it can be expected that an IG approved for publishing by SDWG would then be published?  What is an expected turnaround time from Publication Approved in SDWG to the rest of the approval process running, to an officially published IG? What is an reasonable expectation, i.e. if you don’t see the IG published in X weeks, then you know something has gone wrong in the process. (Lisa R. Nelson)

  6. STU Comments
    1. #1971 - Name field vs US Realm Name
      1. This needed additional discussion that we didn't have time for during the last call.
    2. #1981 - Lot or Batch Number type of ED vs ST
      1. Marti Velezis to bring some research on the history of this.
    3. #1982 - Manufacturing date observations in Appendix B which is an optional template are imposing constraints that should be removed.
      1. Marti Velezis to bring some research on the history of this.
    4. #1983 - Order fulfillment conformance statement that are contradictory
    5. #1984 - Appendix C has a constraint with root, extension and NULL of UNK
    6. #1985 - The Provenance entry in the Appendix C is inconsistent with the author entry in the C-CDAr2.1 IG in terms of allowable values and it is misleading.
    7. #1986 - For the UDI information, can we get clarification on whether it is possible to send other information when we do not have the DI information?

11:00am EST

  1. Value Set Updates
  2. Value Set STU Comments
    1. #nnnn
  3. Adjournment
    1. Next meeting 2020-06-25 Agenda and Minutes

Notes/Minutes:


  1. Business Updates (10 min)
    1. Additions/modifications to the agenda
    2. Approve minutes from 2020-06-11 Agenda and Minutes - Minutes Approved

    3. HL7
  2. External Updates - ONC and others
  3. Project Updates
    1. Value Set Issues

      1. see 11:00am
    2. Provenance
    3. Other Project Updates
  4. Additional Items
    1. HAI CDA IG Ballot Recon Sarah Gaunt
      1. TypeMotion
        Motion

        Motion to approve the block vote of CDAR2_IG_HAIRPT_R3_N1_2020MAY_AMALGAMATED.xls 1-39

        By
        Second
        Date

         

        Ref #CDAR2_IG_HAIRPT_R3_N1_2020MAY_AMALGAMATED.xls
        For18
        Neg00
        Abs00
        Status

        APPROVED

        Tally18-00-00 
        Discussion

        This is the third time that HAI has gone Normative.

        There are 39 comments, one has been withdrawn in the list.

        Action
        • Sarah Gauntwill send out the spreadsheet with all the changes.

        Separate vote to accept the amalgamated sheet as complete. (see below)

        TypeMotion
        Motion

        Motion to approve a ballot reconciliation package for CDAR2_IG_HAIRPT_R3_N1_2020MAY

        By
        Second
        Date

         

        Ref #http://www.hl7.org/documentcenter/public/ballots/2020MAY/reconciliation/recon_cdar2_ig_hairpt_r3_n1_2020may.xls
        For18
        Neg00
        Abs00
        Status

        APPROVED

        Tally18-00-00 
        Discussion

        We can't get the publication request until those negatives are withdrawn.

        Action

        Over 8692 hospitals have implemented this. 25million since 2008. 7.5 million since 2019 alone.

    2. Expiring STU's
      1. STUs Expiring in Next 6 Months (carried over from  Agenda)
        1. Will hold for next meeting.  
    3. As a point of order, officially in today’s SDWG call (so it appears in the minutes) I would like to request a status update on the C-CDA on FHIR IG for FHIR R4.0.  I believe publication was approved by SDWG, but I could be wrong about this. I am asking for a confirmation of that and a pointer to the minutes/date where that decision was approved by SDWG (if it was). [Does SDWG keep a decision log that makes searching for information like this easier?] (Lisa R. Nelson)

      1. There was an approval in 2019-07-25 Agenda and Minutes where the WG approved a version of the C-CDA on FHIR IG Publication Request
      2. Then in 2020-02-27 Agenda and Minutes the WG approved a Publication Request: HL7 FHIR® Implementation Guide: C-CDA on FHIR, Release 2
      3. FHIR Management Group never did approve this Publication Request according to the document.
      4. Will invite Rick Geimerto attend next week to provide an update.
      5. Seems like when the process breaks down, it really goes off the rails.
      6. It wasn't that long ago that Rick took this to the FHIR Management Group.
    4. Also, I am asking for a clarification of when it can be expected that an IG approved for publishing by SDWG would then be published?  What is an expected turnaround time from Publication Approved in SDWG to the rest of the approval process running, to an officially published IG? What is an reasonable expectation, i.e. if you don’t see the IG published in X weeks, then you know something has gone wrong in the process. (Lisa R. Nelson)

      1. There is no visibility right now to spot when things are stuck. Lisa R. Nelson is interested in creating a dashboard or a process that will keep things from falling off the radar.
      2. Austin Kreislerpointed out that this is a volunteer organization and sometimes things have to progress at the speed of the volunteers. We could re-direct the volunteers to work on dashboards and tools for tracking progress of deliverables or we could continue to focus on making progress on deliverables.
  5. STU Comments
    1. #1971 - Name field vs US Realm Name
      1. This needed additional discussion that we didn't have time for during the last call.
        1. Will need to roll this over again until Brett Marquardcan attend
    2. #1981 - Lot or Batch Number type of ED vs ST
      1. Marti Velezis to bring some research on the history of this.
        1. Everywhere else the example is a string. We would like the example to be a string.
        2. Does changing from Narrative to string prevent us from using narrative text linking? Yes

          TypeMotion
          Motion

          Motion to dispose STU Comment 1981 as Not Persuasive with Mod and revise the sample to use the ST data type instead of ED, and not make the change to the constraint, leaving it as ST.

          By
          Second
          Date

           

          Ref #STU Comment 1981 
          For18
          Neg00
          Abs01
          Status

          APPROVED

          Tally18-00-01
          Discussion


          Action
    3. #1982 - Manufacturing date observations in Appendix B which is an optional template are imposing constraints that should be removed.
      1. Marti Velezis to bring some research on the history of this.
        1. FDA is open to the idea of Null flavors. All of these components are 0..1. It is required as 0.1. The cardinality is 0..1. Null flavors give you another way to address the requirement. Two of the 5 identifiers fit in the same category. Two of them would require more than one. Two of the 5 flavors could be masked because of PII.
        2. Matt is uncomfortable with restricting the Null flavors.
        3. Marti states that not all Null flavors are acceptable.
        4. Matt states that is always true with Null flavors. Matt doesn't feel very strongly about this one in either direction. Feels very inconsistent with how C-CDA deals with Null flavors in other situations.
        5. Austin has marked this as a design change.
        6. Substantive changes. - For those observations, it would stay a SHALL, regardless of whether it has a Null flavor. In the organizer, the value is not required.
        7. Matt was envisioning getting rid of the two conformance statements. We don't want people to not send UDI data. This Companion Guide allows them to not send UDI data. If you don't have anything to add value, then you leave out the observation.
        8. Marti says you don't need to make a change at all, you just need to send the observation.
        9. Marti - if we are not forcing the UDI to be sent, then we need to enforce it to be quality values.
        10. If the value is a Null flavor, then they want to constrain it.
        11. Not persuasive? The current design allows you to not send it.
        12. Matt: can't think of any reason why Epic is invested in this in actuality. Was thinking about the consistency in the way C-CDA behaves and giving senders flexibility.
        13. Marti - the reason for sending with Null flavors is for masking for PII. If we need to get to serial number or other component, then we need to know that it is there.
        14. Matt agrees that not all Null Flavors are appropriate here, but because consistency sake, we would like this to be the same as for other areas of C-CDA.
        15. TypeMotion
          Motion

          Motion to dispose of STU Comment 1982 as Not Persuasive.

          By
          Second
          Date

           

          Ref #STU Comment 1982
          For18
          Neg00
          Abs00
          Status

          APPROVED

          Tally18-00-00 
          Discussion


          ActionNo further action required.

          What is the relationship between the Supplemental IG and the Companion Guide Appendix with UDI Templates. 

        16. Marti Velezis will take the Supplemental IG question back to the FDA and see what they want to do with it (Renew, Retire?)
    4. Will move the following items to a future agenda:
      1. #1983 - Order fulfillment conformance statement that are contradictory
      2. #1984 - Appendix C has a constraint with root, extension and NULL of UNK
      3. #1985 - The Provenance entry in the Appendix C is inconsistent with the author entry in the C-CDAr2.1 IG in terms of allowable values and it is misleading.
      4. #1986 - For the UDI information, can we get clarification on whether it is possible to send other information when we do not have the DI information?

11:00am EST

  1. Structural Review of Payor Section Wireframes with Linda Michaelsen (continuation of discussion from  
    1. ParticipantRole (Group, RXBIN, RXPCN, RXGroup, RXID)
    2. RXBIN is assigned by ANSI
    3. Group, RXPCN, RXGroup, RXID are all assigned by the Payer.
    4. The big payers all use NAIC - that is incorporated on the card in some form. It is thinking it will have the national plan identifier. That work was debated and shut down towards the end of last year. Linda worked out to the Architect for Humana and at FHIR Dev Days yesterday she talked to Stephan ? and some Task Force is working on it. 
    5. Whatever identifier is there - A Role based identifier. Still going to need OIDs. Will be able to convey the type. Will need to be able to identify the Payer. An OID for the Payer itself.
    6. For the people using NAIC - two OIDs for NAIC - one for ValueSet and one for CodeSet. the NAIC appears on quite a few of the cards. Sometimes it is in the magnetic street so you don't see it printed. The other thing is the Medicaid OID. HIC OID is antoher.
    7. OID Registry - look up NAIC
    8. FHIR would not consider this a codesystem buy a naming system.
    9. An instance of all these companies and they are all in a ValueSet structure.
    10. Austin states that they don't fit in an extension. We need the code to convey the type of the identifier.
    11. There isn't formal structure and may just need a collection of strings.
    12. One other capability - the ability to attach an authorization
    13. A single C-CDA for a single encounter. No way to identify that the C-CDA aligns with a specific encounter. 
    14. Guarantor - the payer
    15. Need to create the relationship to the encounter
    16. Will build these templates and then take these to Financial Management. Will need to have combined discussions.
    17. Lisa R. Nelson suggested to start conversation with FM by agreeing on common language/terminology. Comparison of C-CDA terms to FHIR terms.
    18. Linda Michaelsen will send a message out to the co-chairs of both Structured Documents and Financial Management to introduce the concept of a combined meeting to review the Payer Section templates for C-CDA and get alignment between C-CDA and FHIR on insurance profiles.
  2. Lisa R. Nelson asked to put extensions on next week's agenda
  3. Nick Radov asked to put his STU Comments on next week's agenda
  4. Robert Dieterle has a topic regarding Clinical Data Exchange PSS for DaVinci and making changes, but only for FHIR R4
    1. This has been approved by the other sponsors/co-sponsors for the PSS. Structured Documents is the last Workgroup that is needed to approve this. 
    2. TypeMotion
      Motion

      Motion to accept the proposal that we will only accept the DaVinci updates in FHIR R4 for the Clinical Data Exchange (CDex) Update 1 PSS.

      By
      Second
      Date

       

      Ref #PSS for Clinical Data Exchange (CDex) Update 1
      For19
      Neg00
      Abs00
      Status

      APPROVED

      Tally19-00-00 
      Discussion


      Action
      • Robert Dieterlewill update the PSS to reflect that Structured Documents has approved this motion
  5. Adjournment
    1. Next meeting 2020-06-25 Agenda and Minutes
    2. Austin Kreisler adjourned the meeting at 11:59am EST

 

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