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Agenda:


10:00am ET

  1. Call to order 
    1. 10:04am ET 
    2. Call for Attendance


      1. Please click the "Sign In" button at the top of the Agenda Page for today's meeting. Once you have signed in, it will indicate you have already signed in and place your name in the Attendees drop down list.




  2. Business Updates (10 min)
    1. Additions/modifications to the agenda
    2. Approve minutes from

      This is to approve minutes via general consent. "You have received the minutes. Are there any corrections to the minutes? (pause) Hearing none, if there are no objections, the minutes are approved as printed."

      2020-09-03 Agenda and Minutes

    3. HL7
  3. Review Project Proposals
    1. Project Proposals Home
  4. External Updates - ONC and others
  5. Project Updates
    1.  

  6. Additional Items
    1. Sept Work Group Agenda: 2020 September SDWG WGM Agenda 
    2. Extensions
  7. STU Comments
    1. HL7 CDA® R2 IG: C-CDA Templates for Clinical Notes DSTU Release 2.1 - US Realm


      1. STU

        Last Updated

        Commenter

        Issue

        2021

         

        Priyaranjan TokachichuThe schematron rule considers "assignedPerson or representedOrganizaton" logic, but not "assignedPerson or (assignedAuthoringDevice and representedOrganization)". This results in schematron failure of "author/assignedAuthor" in the header that has "assignedPerson" and "representedOrganization" (which is valid based on implied meaning of (CONF:1198-8457)).
        2016

         

        The Planned Intervention Act (V2) contains text in the template description that is logically correct due to the intent of the section to contain only planned events: “All interventions referenced in a Planned Intervention Act must have moodCodes indicating that that are planned (have not yet occurred).”
        So, any moodCode OTHER THAN "EVN".
        2007

         

        The current Payer Section "REQUIRES" (SHALL 1..*) a prior authorization. There will not always be an authorization every time coverage is used/communicated in the Payer Section.
        1945

         

        Encounter Diagnosis (V3)
        [act: identifier urn:hl7ii:2.16.840.1.113883.10.20.22.4.80:2015-08-01 (open)]

        This template wraps relevant problems or diagnoses at the close of a visit or that need to be followed after the visit. If the encounter is associated with a Hospital Discharge, the Hospital Discharge Diagnosis must be used. This entry requires at least one Problem Observation entry.
        1885

         

        @sueann svabySHALL contain exactly one [1..1] code, which SHOULD be selected from ValueSet Social History Type urn:oid:2.16.840.1.113883.3.88.12.80.60 DYNAMIC (CONF:1198-8558).
        a. If @codeSystem is not LOINC, then this code SHALL contain at least one [1..*] translation, which SHOULD be selected from CodeSystem LOINC (urn:oid:2.16.840.1.113883.6.1) (CONF:1198-32951).
        1873

         

        Encounter Diagnosis (V3)
        [act: identifier urn:hl7ii:2.16.840.1.113883.10.20.22.4.80:2015-08-01 (open)]

        The template is missing a binding for statusCode.

        Figure 144 shows a statusCode of "active". This provides the wrong guidance.
        1859

         

        Please REMOVE/DEPRECATE this commentIn the errata release from June 2019,Figure 162 is wrong and needs to be updated to use the correct Code System OID for CVX 2.16.840.1.113762.1.4.1010.6. It currently shows as 2.16.840.1.113762.12.292

         

        Care Plan (V2)
        [ClinicalDocument: identifier urn:hl7ii:2.16.840.1.113883.10.20.22.1.15:2015-08-01 (open)]

        The CDA Care Plan represents an instance of this dynamic Care Plan at a point in time. The CDA document itself is NOT dynamic.
        Key differentiators between a Care Plan CDA and CCD (another “snapshot in time” document): There are 2 required sections:
        o Health Concerns o Interventions
        There are 2 optional sections:
        o Goals o Outcomes

        • Provides the ability to identify patient and provider priorities with each act • Provides a header participant to indicate occurrences of Care Plan review A care plan document can include entry references from the information in these sections to the information (entries) in other sections.
        Please see Volume 1 of this guide to view a Care Plan Relationship diagram and story board.
        1802

         

        Smoking Status - Meaningful Use (V2) (urn:hl7ii:2.16.840.1.113883.10.20.22.4.78:2014-06-09)

        . This value SHALL contain exactly one [1..1] @code, which SHALL be selected from ValueSet Smoking Status urn:oid:2.16.840.1.113883.11.20.9.38 DYNAMIC (CONF:1098-14817).

        1800 

        1801

         

        We have trouble adding new Social History Observations when the US Gov't identifies the observation using LOINC. We really should be using LOINC in the code ("the question").

        I recommend creating a Grouping Value Set that combines the original set of concepts using SNOMEDCT (Social History Type (SNOMEDCT)) and then agree to put all new/additional social history observation codes in the Social History Type (LOINC) value set. Use the existing OID for the new Grouping VS and make two new value sets for the parts of the grouping VS.
        1798

         

        On page 392, Section 3.61.1, the last three sentences of the text read as follows:

        "Procedure act is for procedures that alter the physical condition of a patient (e.g., splenectomy). Observation act is for procedures that result in new information about a patient but do not cause physical alteration (e.g., EEG). Act is for all other types of procedures (e.g., dressing change)."

        This is different from the wording on page 390, Section 3.61 Procedures Section (entries optional) (V2). Updated language is in the proposed section below.
        1793

        3.41 Immunization Medication Information (V2) includes SHALL have a manufactureMaterial where this code MAY contain zero or more [0..*] translation, which MAY be selected from ValueSet Vaccine Clinical Drug urn:oid:2.16.840.1.113762.1.4.1010.8 DYNAMIC (CONF:1098-31543).

         

        3.41 Immunization Medication Information (V2) includes SHALL have a manufactureMaterial where this code MAY contain zero or more [0..*] translation, which MAY be selected from ValueSet Vaccine Clinical Drug urn:oid:2.16.840.1.113762.1.4.1010.8 DYNAMIC (CONF:1098-31543).
        1790

         

        SHOULD contain exactly one [1..1] effectiveTime (CONF:1098-32943) such that it
        a. SHALL contain exactly one [1..1] @operator="A" (CONF:1098-32945).
        b. SHALL contain exactly one [1..1] @xsi:type="PIVL_TS" or "EIVL_TS" (CONF:1098-32946).

         

        We have seen real-world implementation defects where planned future encounters appear in the Encounters section rather than the Plan of Treatment section where they should be. I think some developers are just querying their database encounter tables for all encounters for a particular patient and sticking everything in the Encounters section regardless of whether they are past or future. Let's introduce a new conformance rule to ensure each Encounter activity ends before the document header effectiveTime.

         

        In section 3.81 Procedure Activity Procedure (V2) the Procedure.code (CONF:1098-7656) doesn't mention HCPCS as a possible code system. I think that code system should be explicitly listed because it is in common use in the US realm along with CPT-4. There are many procedures which are in HCPCS but not in CPT-4.

        This @code SHOULD be selected from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96), and MAY be selected from CPT-4 (CodeSystem: 2.16.840.1.113883.6.12) or ICD10 PCS (CodeSystem: 2.16.840.1.113883.6.4) or CDT-2 (Code System: 2.16.840.1.113883.6.13) (CONF:1098-19207).
        1777

         

        The value set for statusCode for Medication Supply Order (v2) include several codes that are incompatible with the equivalent statusCodes in the FHIR US Core profile for MedicationRequest (http://hl7.org/fhir/STU3/valueset-medication-request-status.html).
        1776

         

        The statusCode for Immunizations in the Immunization Activity (v3) allows for all values in the ActStatus urn:oid:2.16.840.1.113883.1.11.15933:
        1775

         

        The value set for status of Result Observation (V3) [Result Status urn:oid:2.16.840.1.113883.11.20.9.39 STATIC] is broadly incompatible with the FHIR US Core value sets for Observation status (http://hl7.org/fhir/valueset-observation-status.html) and DiagnosticReport status (http://hl7.org/fhir/valueset-diagnostic-report-status.html). Here are the values for reference:
        1774

         

        The ProcedureAct statusCode urn:oid:2.16.840.1.113883.11.20.9.22 STATIC 2014-04-23 used for statusCode in the Procedure Activity Procedure (V2) template currently has 4 values:
        1773

         

        In the Goal Observation template, the status is currently hardcoded to "active":
        1772

         

        The C-CDA 2.1 Problem Value Set (urn:oid:2.16.840.1.113883.3.88.12.3221.7.4) allows only terms descending from the Clinical Findings (404684003) or Situation with Explicit Context (243796009) hierarchies.
        1768

         

        Currently the Personal and Legal Relationship Role Type Value set (2.16.840.1.113883.11.20.12.1) is missing some (about 10) concepts needed to align with the corresponding Value set used in FHIR RelatedPerson.Relationship.
        1765

         

        Template Improvement Request:
        1764

         

        New feature request
        1762

        SHALL contain exactly one [1..1] componentOf (CONF:1198-8386).
        a. This componentOf SHALL contain exactly one [1..1] encompassingEncounter (CONF:1198-8387).
        1760

         

        Smoking Status - Meaningful Use (V2)
        [observation: identifier urn:hl7ii:2.16.840.1.113883.10.20.22.4.78:2014-06-09 (open)]
        1758

         

        Immunizations Section (entries required) (V3)
        [section: identifier urn:hl7ii:2.16.840.1.113883.10.20.22.2.2.1:2015-08-01 (open)]
        1757

        In order to stay aligned with FHIR, the Birth Sex entry template needs to be modified to use the same value set for birth sex.

        The value set is being established now in VSAC. We believe the OID will be OID: 2.16.840.1.113762.1.4.1021.24.
        1752

         

        Page 85-86: "There are 2 required sections: Health Concerns and Interventions
        There are 2 optional sections: Goals and Outcomes"
        1693

         

        Interventions Section (V3)
        [section: identifier urn:hl7ii:2.16.840.1.113883.10.20.21.2.3:2015-08-01 (open)]
        1691

         

        Currently the infulfillmentOF/order in the header doesn't seem to allow for the semantics to indicate when the document contains information about the initiation of an order. It only seems to permit indicating when a document contains information about the fulfillment of an order. Where would I index in the header information about evidence within the document indicating an order was placed?
        1642

         

        This template represents the patient's home environment including, but not limited to, type of residence (trailer, single family home, assisted living), living arrangement (e.g., alone, with parents), and housing status (e.g., evicted, homeless, home owner).
        1638

         

        This sdtc:dischargeDispositionCode SHOULD contain exactly [0..1] codeSystem, which SHOULD be either CodeSystem: NUBC 2.16.840.1.113883.6.301.5 OR CodeSystem: HL7 Discharge Disposition 2.16.840.1.113883.12.112 (CONF:1198-32377).
        1626

         

        Because LOINC has deprecated the code 52521-1 the examples for Care Plan document should use the replacement code of 18776-5, and the sample code in the value set should be fixed to use 18776-5.

        Duplicate to 1625 - made this by mistake and couldn't figure out how to delete it.
        1625

         

        Because LOINC has deprecated the code 52521-2 the examples for Care Plan document should use the replacement code of 18776-5, and the sample code in the value set should be fixed to use 18776-5.
        1623

         

        Health Status Evaluations and Outcomes Section
        [section: identifier urn:oid:2.16.840.1.113883.10.20.22.2.61 (open)]

        This template represents observations regarding the outcome of care from the interventions used to treat the patient. These observations represent status, at points in time, related to established care plan goals and/or interventions.
        1611

         

        There is a general need to do an overall clean-up the C-CDA IG to go through all value set definitions and make sure that the source information is correct.

        As we have improved the availability of value set definitions and expansions in VSAC, the source may have changed from PHINVADS or some other organization.
        1607

         

        @Eric ParapiniIn the template Immunization Activity Act (V3) (TemplateId: 2.16.840.1.113883.10.20.22.4.52:2015-08-01) there is an entryRelationship to the Instruction (V2) template (TemplateId: 2.16.840.1.113883.10.20.22.4.20:2014-06-09).     
        1606

         

        @Eric ParapiniI would like to request the LOINC code "80791-7" Nutrition and dietetics Plan of care note be added to the Care Plan Document Type value set (urn:oid:2.16.840.1.113762.1.4.1099.10)
        1605

         

        In the latest errata version (CDAR2_IG_CCDA_CLINNOTES_R1_DSTU2.1_2015AUG_Vol2_2018MAYwith_errata.pdf) on page128 (2.1.8 above number 4) that "Preferred code is 18748-4 LOINC Diagnostic Imaging Report" but per LOINC, that code will be deprecated in December 2018
        1603

         

        From the C-CDA Companion Guide Note Activity Template (Page 92 - 9(c)(ii)(1)):

        The playingEntity, if present, SHALL contain zero or more [0..*] US Realm Person Name (PN.US.FIELDED) (identifier: urn:oid:2.16.840.1.113883.10.20.22.5.1.1) (CONF:3250-16929).
        1602

         

        Allergy & intolerance template (2.16.840.1.113883.10.20.22.4.7), substance reactant binding (CONF:1098-7419)
        The bound value set is very large, making it difficult to support for both entry and validation.
        1525

        SHOULD contain zero or one [0..1] performer="PRF" Performer (CodeSystem: HL7ParticipationType urn:oid:2.16.840.1.113883.5.90 STATIC) (CONF:1198-8961) such that it
        1516

         

        Number of Pressure Ulcers Observation (V3)
        [observation: identifier urn:hl7ii:2.16.840.1.113883.10.20.22.4.76:2015-08-01 (open)]
        This template represents the number of pressure ulcers observed at a particular stage.
        1515

         

        @George DixonClinical Documentation Request we are unable to support. Medication Administration- Ability to display an administered dose with a cumulative dose. Use Case - For a given treatment timeframe when ordering and administering chemotherapy medications related to their toxicity it is important to know the patient's running dosage received. Depending on the clinical environments management of visits (acute versus repeat outpatient treatments) this may be within an encounter or across encounters for a given period of time. Need communicate most recent dose(s), Cumulative interval (low/high) and cumulative dose.
        1513

         

        Table 400: Health Insurance Type

        Code System OID is wrong


        ALSO WRONG IN THE LIST OF CODES SYSTEMS USED IN THE IG
        1510

         

        Value Set: HealthcareServiceLocation urn:oid:2.16.840.1.113883.1.11.20275
        A comprehensive classification of locations and settings where healthcare services are provided. This value set is based on the National Healthcare Safety Network (NHSN) location code system that has been developed over a number of years through CDC's interaction with a variety of healthcare facilities and is intended to serve a variety of reporting needs where coding of healthcare service locations is required.
        1505

         

        Currently in the Patient Generated Document Header

        13. MAY contain zero or more [0..*] documentationOf (CONF:1198-28710).
        The code should be selected from a value set established by the document-level template for a specific type of Patient Generated Document.
        1502

         

        @Berge,RuthThe link in section 1.1.17 Progress Note (v3) in Table 49 (Progress Note (V3) Context) for " Allergies and Intolerances Section (entries optional) (V3) " goes to 2.4.1 Allergies and Intolerances Section (entries required) (V3). This is also true for the link in Table 53: Referral Note (V2) Constraints Overview . In Table 53 the Allergies section is assigned CONF# 1198- 30625. On page 195, in the details for Allergies there is another link that also goes to the wrong Allergies and Intolerance Section.
        1470

         

        This comment refers back to decisions made in Errata 1338.

        Given a proposed alternative constraint was not provided/proposed by Regenstrief in time to be included in the September errata update for C-CDA R2.1, I supported leaving the errata change as had been proposed and implemented in the US Realm header template draft C-CDA R2.1 errata release (shown below):
        1452

         

        Value Set X_ActRelationshipDocument is a new value set that came into existence during the C-CDA R2.1 Errata Update. It needs to be added to the CCDA Value Set Summary sheet maintained in the HL7 SDWG Workgroup Documents area.
        1430

         

        SHALL contain exactly one [1..1] templateId (CONF:81-8531) such that it
        a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.6.1.2"
        1429

         

        3.34 Goal Observation
        ...
        MAY contain zero or one [0..1] value (CONF:1098-32743).

         

        Section 3.23, page 483:

        Table 272: EncounterTypeCode
        Value Set: EncounterTypeCode urn:oid:2.16.840.1.113883.3.88.12.80.32
        This value set includes only the codes of the Current Procedure and Terminology designated for Evaluation and Management (99200 – 99607) (subscription to AMA Required
        Value Set Source: http://www.amacodingonline.com/
        1425

         

        @Hyde,LindaValue Set Links in IG
        A number of the links for value sets in the IG either no long work or point to the wrong location. For example several value set links send you to the VTSL Browser (veterinary service extension); the link for the country value set is no longer valid.
        1424

         

        @Hyde,LindaWound Measurements Value set 2.16.840.1.113883.1.11.20.2.5 (dynamic)
        IG table says 'A value set of SNOMED-CT codes to capture the dimensions of a wound' but the value set is using LOINC codes.
        1422

         

        @Hyde,LindaProcedure Value set 2.16.840.1.113883.3.88.12.80.28 (dynamic)
        This value set is referenced in the IG but does not appear in the list of value sets in the appendix or as it's own table. It appears in the section for 'performer for the value of service event code' pg 169,182. Value set covers all values under the 71388002 Procedure. It is in VSAC and in the R2.1 Value Set Download from VSAC.
        1421

         

        @Hyde,LindaPressure Point Value Set 2.16.840.1.113883.11.20.9.36 (static)
        VSAC and Trifolia only have one code in common. Trifolia codes are for the site 'structure' and VSAC for 'skin structure of'. The IG value set table contains the same codes as Trifolia. The purpose of this value set is to identify the areas of the body generally associated with pressure ulcers so it would seem that 'skin structure of' would be the more appropriate concepts to use.
        1420

         

        @Hyde,LindaPlanned moodcode (Observation)Value set 2.16.840.1.113883.11.20.9.25 (static)
        VSAC contains code for GOL (goal). This code is not in the IG table. It is in the ActMood table.
        1419

         

        @Hyde,LindaParticipationFunction Value set 2.16.840.1.113883.1.11.10267 (static)
        There are new codes in the ParticipationFunction code system that are not in VSAC.
        1418

         

        @Hyde,LindaObservation Interpretation (HL7)Value set 2.16.840.1.113883.1.11.78 (static)
        1. There is a new version of ObservationInterpretation with additional codes that are not in VSAC and several codes in VSAC that are now deprecated.
        2. Code system name in IG is HITSP-CS-83 but in VSAC it is ObservationInterpretation. IG should be updated
        1417

         

        @Hyde,LindaINDRoleClassCodes Value set. 2.16.840.1.113883.11.20.9.33
        The implementation contains references to both static and dynamic for this value set. Pages 62,97,144,157 refer to this value set as STATIC, however on page 204 it is listed as DYNAMIC.
        1416

         

        @Hyde,LindaEntityPersonNamePartQualifier Value Set 2.16.840.1.113883.11.20.9.26(static)
        LS legal status)code is not in VSAC. In the original version of the code system it was include but in a separate level. All the codes under _ PersonNamePartQualifier are in VSAC.
        1415

         

        @Hyde,LindaEntity Name Use Value Set 2.16.840.1.113883.1.11.15913 (static)
        All values of the EntityNameUse code system are in VSAC except OR (official registry).This code was not in the original code system but is in V3.
        1414

         

        @Hyde,LindaAllergy and Intolerance Type Value Set 2.16.840.1.113883.3.88.12.3221.6.2 (dynamic)

         

        <!-- ************************ ENCOUNTERS *********************** -->
        <component>
        <section>
        <!-- *** Encounters section (entries required) (V3) *** -->
        <templateId root="2.16.840.1.113883.10.20.22.2.22.1" extension="2015-08-01"/>
        <templateId root="2.16.840.1.113883.10.20.22.2.22.1"/>

        I think there is a problem with the sample CCD file C-CDA_R2-1_CCD.xml included in this package.

        1381

         

        doseQuanity/@unit and administrationUnitCode/@code are a confusing set of elements, but I will do my best pulling from the base definitions:
        1370

         

        In the Comment Activity template (2.16.840.1.113883.10.20.22.4.64):

        5. SHALL contain exactly one [1..1] text (CONF:81-9430).
        a. This text SHALL contain exactly one [1..1] reference (CONF:81-15967).



    2. (expand HL7 CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes Companion Guide, Release 2 STU - US Realm )


      1. STU

        Last Update

        Commenter

        Comment

        2014

         

        The Note Types Value Set (urn:oid:2.16.840.1.113883.11.20.9.68) version 20191017 is missing three note types specific in USCDI v1:
        1996

         

        In Appendix C, I read the Provenance - Author Participation template as saying you can use the same trick as in the standard C-CDA Author Participation template to reference an author already defined elsewhere in the document:

        The assignedAuthor/id may be set equal to (a pointer to) an id on a participant elsewhere in the document (header or entries) or a new author participant can be described here.

         

        (Vocab issue)
        Table 9 of the Companion Guide recommends the LOINC codes 11502-2 for Laboratory Narrative notes and 11526-1 for Pathology Narrative notes. However, these codes aren't actually included in the Note Types value set (urn:oid:2.16.840.1.113883.11.20.9.68) as required by the Notes Section and Note Activity templates in Appendix A. Likewise, although no specific LOINC code is recommended for Imaging Narrative notes, the value set doesn't include any codes from the value set recommended for imaging notes in Table 8 (urn:oid:1.3.6.1.4.1.12009.10.2.5).

         

        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?

         

        Appendix B UDI
        1.1 UDI Organizer 

        Figure 1: Unique Device Identifier (UDI) Organizer Template ID root is incorrect



11:00am ET

  1. Value Set Updates- Rob McClure
  2. Adjournment


Notes/Minutes:


10:00am ET

  1. Call to order 
    1. 10:04am ET 
    2. Call for Attendance


      1. Please click the "Sign In" button at the top of the Agenda Page for today's meeting. Once you have signed in, it will indicate you have already signed in and place your name in the Attendees drop down list.




  2. Business Updates (10 min)
    1. Additions/modifications to the agenda
    2. Approve minutes from

      This is to approve minutes via general consent. "You have received the minutes. Are there any corrections to the minutes? (pause) Hearing none, if there are no objections, the minutes are approved as printed."

      2020-09-03 Agenda and Minutes

    3. HL7
  3. Review Project Proposals
    1. Project Proposals Home
      1. Only one project - the Codex - they are looking for a home.
  4. External Updates - ONC and others
    1. No external updates.
  5. Project Updates
    1. HAI 3 has been approved by TSC and is being submitted to ANSI for a public comment period with ANSI.

    2. Request that SDWG approve an errata request to get that updated.


    3. TypeMotion
      Motion

      Motion to link schema files

      By
      Second
      Date

       

      Ref #Links to STU Comments, Documents, Tracker items, or other relevant content.
      For24
      Neg00
      Abs00
      Status

      Tally24-00-00
      Discussion

      The next time a dot release comes out, it may be more appropriate to fix that.

      Are these files under source control? The original files were under source control.

      Is there a github repo that we could go to? It is probably appropriate to make sure these are in the correct place.

      We should make sure those files are in the gitHub? Calvin may need to check with someone that has some operational experience with gitHub to see where those are. Calvin will work with Sean McIlvenna to see if we can get those in the correct place in GitHub.

      Calvin is thinking of putting a comment line in to include a reference line to the GitHub repo. A readme or a comment reference to know where it is stored for updates.

      ActionWho and What Follow up items need to take place after the vote?



  6. Additional Items
    1. Sept Work Group Agenda: 2020 September SDWG WGM Agenda 
      1. updated the agenda
    2. Extensions
      1. What is our current resourcing ability? Who can apply extensions? Does Ben or Alex Henket know how to do this besides Sarah? There are resources at MaxMD that are willing to learn. Additional id's. Schema from the entire from the entire CDAr3 that can be included in this. It is mostly known. It is all stored somewhere. Austin recovered it from his hard drive. He recovered it from his hard drive. It could be stored in GitHub. He pulled it from a Draft for Comment ballot that was submitted many years ago. Lisa could work with Ben, Alex, and others to scheduled some time to record and document how to do this using the new tooling. Phase 1 is to get the modeling right and Phase 2 is to get the process. Ben is open to that.
  7. STU Comments
    1. HL7 CDA® R2 IG: C-CDA Templates for Clinical Notes DSTU Release 2.1 - US Realm
      1. 2033

      2. This is a technical issue in Trifolia. There are two tables that this references. This is a Trifolia artifact. Table 424 on pg 739. 


      3. TypeMotion
        Motion

        Motion to approve this as disposed

        By
        Second
        Date

         

        Ref #2033
        For24
        Neg00
        Abs00
        Status

        Tally24-00-00
        Discussion

        Any additional discussion after the motion has been made?

        Action

        Make technical corrections in Trifolia. Lisa R. Nelsonand Natasha Kreisle will get the updates in Trifolia.





      4. TypeMotion
        Motion

        Motion to approve as disposed

        By
        Second
        Date

         

        Ref #2026
        For22
        Neg00
        Abs00
        Status

        Tally22-00-00 
        Discussion

        Any additional discussion after the motion has been made?

        Action

        Matt Szczepankiewiczwill follow up with Sean McIlvenna to get this updated into the Trifolia tool.





      5. STU

        Last Updated

        Commenter

        Issue

        2021

         

        Priyaranjan TokachichuThe schematron rule considers "assignedPerson or representedOrganizaton" logic, but not "assignedPerson or (assignedAuthoringDevice and representedOrganization)". This results in schematron failure of "author/assignedAuthor" in the header that has "assignedPerson" and "representedOrganization" (which is valid based on implied meaning of (CONF:1198-8457)).
        2016

         

        The Planned Intervention Act (V2) contains text in the template description that is logically correct due to the intent of the section to contain only planned events: “All interventions referenced in a Planned Intervention Act must have moodCodes indicating that that are planned (have not yet occurred).”
        So, any moodCode OTHER THAN "EVN".
        2007

         

        The current Payer Section "REQUIRES" (SHALL 1..*) a prior authorization. There will not always be an authorization every time coverage is used/communicated in the Payer Section.
        1945

         

        Encounter Diagnosis (V3)
        [act: identifier urn:hl7ii:2.16.840.1.113883.10.20.22.4.80:2015-08-01 (open)]

        This template wraps relevant problems or diagnoses at the close of a visit or that need to be followed after the visit. If the encounter is associated with a Hospital Discharge, the Hospital Discharge Diagnosis must be used. This entry requires at least one Problem Observation entry.
        1885

         

        @sueann svabySHALL contain exactly one [1..1] code, which SHOULD be selected from ValueSet Social History Type urn:oid:2.16.840.1.113883.3.88.12.80.60 DYNAMIC (CONF:1198-8558).
        a. If @codeSystem is not LOINC, then this code SHALL contain at least one [1..*] translation, which SHOULD be selected from CodeSystem LOINC (urn:oid:2.16.840.1.113883.6.1) (CONF:1198-32951).
        1873

         

        Encounter Diagnosis (V3)
        [act: identifier urn:hl7ii:2.16.840.1.113883.10.20.22.4.80:2015-08-01 (open)]

        The template is missing a binding for statusCode.

        Figure 144 shows a statusCode of "active". This provides the wrong guidance.
        1859

         

        Please REMOVE/DEPRECATE this commentIn the errata release from June 2019,Figure 162 is wrong and needs to be updated to use the correct Code System OID for CVX 2.16.840.1.113762.1.4.1010.6. It currently shows as 2.16.840.1.113762.12.292

         

        Care Plan (V2)
        [ClinicalDocument: identifier urn:hl7ii:2.16.840.1.113883.10.20.22.1.15:2015-08-01 (open)]

        The CDA Care Plan represents an instance of this dynamic Care Plan at a point in time. The CDA document itself is NOT dynamic.
        Key differentiators between a Care Plan CDA and CCD (another “snapshot in time” document): There are 2 required sections:
        o Health Concerns o Interventions
        There are 2 optional sections:
        o Goals o Outcomes

        • Provides the ability to identify patient and provider priorities with each act • Provides a header participant to indicate occurrences of Care Plan review A care plan document can include entry references from the information in these sections to the information (entries) in other sections.
        Please see Volume 1 of this guide to view a Care Plan Relationship diagram and story board.
        1802

         

        Smoking Status - Meaningful Use (V2) (urn:hl7ii:2.16.840.1.113883.10.20.22.4.78:2014-06-09)

        . This value SHALL contain exactly one [1..1] @code, which SHALL be selected from ValueSet Smoking Status urn:oid:2.16.840.1.113883.11.20.9.38 DYNAMIC (CONF:1098-14817).

        1800 

        1801

         

        We have trouble adding new Social History Observations when the US Gov't identifies the observation using LOINC. We really should be using LOINC in the code ("the question").

        I recommend creating a Grouping Value Set that combines the original set of concepts using SNOMEDCT (Social History Type (SNOMEDCT)) and then agree to put all new/additional social history observation codes in the Social History Type (LOINC) value set. Use the existing OID for the new Grouping VS and make two new value sets for the parts of the grouping VS.
        1798

         

        On page 392, Section 3.61.1, the last three sentences of the text read as follows:

        "Procedure act is for procedures that alter the physical condition of a patient (e.g., splenectomy). Observation act is for procedures that result in new information about a patient but do not cause physical alteration (e.g., EEG). Act is for all other types of procedures (e.g., dressing change)."

        This is different from the wording on page 390, Section 3.61 Procedures Section (entries optional) (V2). Updated language is in the proposed section below.
        1793

        3.41 Immunization Medication Information (V2) includes SHALL have a manufactureMaterial where this code MAY contain zero or more [0..*] translation, which MAY be selected from ValueSet Vaccine Clinical Drug urn:oid:2.16.840.1.113762.1.4.1010.8 DYNAMIC (CONF:1098-31543).

         

        3.41 Immunization Medication Information (V2) includes SHALL have a manufactureMaterial where this code MAY contain zero or more [0..*] translation, which MAY be selected from ValueSet Vaccine Clinical Drug urn:oid:2.16.840.1.113762.1.4.1010.8 DYNAMIC (CONF:1098-31543).
        1790

         

        SHOULD contain exactly one [1..1] effectiveTime (CONF:1098-32943) such that it
        a. SHALL contain exactly one [1..1] @operator="A" (CONF:1098-32945).
        b. SHALL contain exactly one [1..1] @xsi:type="PIVL_TS" or "EIVL_TS" (CONF:1098-32946).

         

        We have seen real-world implementation defects where planned future encounters appear in the Encounters section rather than the Plan of Treatment section where they should be. I think some developers are just querying their database encounter tables for all encounters for a particular patient and sticking everything in the Encounters section regardless of whether they are past or future. Let's introduce a new conformance rule to ensure each Encounter activity ends before the document header effectiveTime.

         

        In section 3.81 Procedure Activity Procedure (V2) the Procedure.code (CONF:1098-7656) doesn't mention HCPCS as a possible code system. I think that code system should be explicitly listed because it is in common use in the US realm along with CPT-4. There are many procedures which are in HCPCS but not in CPT-4.

        This @code SHOULD be selected from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96), and MAY be selected from CPT-4 (CodeSystem: 2.16.840.1.113883.6.12) or ICD10 PCS (CodeSystem: 2.16.840.1.113883.6.4) or CDT-2 (Code System: 2.16.840.1.113883.6.13) (CONF:1098-19207).
        1777

         

        The value set for statusCode for Medication Supply Order (v2) include several codes that are incompatible with the equivalent statusCodes in the FHIR US Core profile for MedicationRequest (http://hl7.org/fhir/STU3/valueset-medication-request-status.html).
        1776

         

        The statusCode for Immunizations in the Immunization Activity (v3) allows for all values in the ActStatus urn:oid:2.16.840.1.113883.1.11.15933:
        1775

         

        The value set for status of Result Observation (V3) [Result Status urn:oid:2.16.840.1.113883.11.20.9.39 STATIC] is broadly incompatible with the FHIR US Core value sets for Observation status (http://hl7.org/fhir/valueset-observation-status.html) and DiagnosticReport status (http://hl7.org/fhir/valueset-diagnostic-report-status.html). Here are the values for reference:
        1774

         

        The ProcedureAct statusCode urn:oid:2.16.840.1.113883.11.20.9.22 STATIC 2014-04-23 used for statusCode in the Procedure Activity Procedure (V2) template currently has 4 values:
        1773

         

        In the Goal Observation template, the status is currently hardcoded to "active":
        1772

         

        The C-CDA 2.1 Problem Value Set (urn:oid:2.16.840.1.113883.3.88.12.3221.7.4) allows only terms descending from the Clinical Findings (404684003) or Situation with Explicit Context (243796009) hierarchies.
        1768

         

        Currently the Personal and Legal Relationship Role Type Value set (2.16.840.1.113883.11.20.12.1) is missing some (about 10) concepts needed to align with the corresponding Value set used in FHIR RelatedPerson.Relationship.
        1765

         

        Template Improvement Request:
        1764

         

        New feature request
        1762

        SHALL contain exactly one [1..1] componentOf (CONF:1198-8386).
        a. This componentOf SHALL contain exactly one [1..1] encompassingEncounter (CONF:1198-8387).
        1760

         

        Smoking Status - Meaningful Use (V2)
        [observation: identifier urn:hl7ii:2.16.840.1.113883.10.20.22.4.78:2014-06-09 (open)]
        1758

         

        Immunizations Section (entries required) (V3)
        [section: identifier urn:hl7ii:2.16.840.1.113883.10.20.22.2.2.1:2015-08-01 (open)]
        1757

        In order to stay aligned with FHIR, the Birth Sex entry template needs to be modified to use the same value set for birth sex.

        The value set is being established now in VSAC. We believe the OID will be OID: 2.16.840.1.113762.1.4.1021.24.
        1752

         

        Page 85-86: "There are 2 required sections: Health Concerns and Interventions
        There are 2 optional sections: Goals and Outcomes"
        1693

         

        Interventions Section (V3)
        [section: identifier urn:hl7ii:2.16.840.1.113883.10.20.21.2.3:2015-08-01 (open)]
        1691

         

        Currently the infulfillmentOF/order in the header doesn't seem to allow for the semantics to indicate when the document contains information about the initiation of an order. It only seems to permit indicating when a document contains information about the fulfillment of an order. Where would I index in the header information about evidence within the document indicating an order was placed?
        1642

         

        This template represents the patient's home environment including, but not limited to, type of residence (trailer, single family home, assisted living), living arrangement (e.g., alone, with parents), and housing status (e.g., evicted, homeless, home owner).
        1638

         

        This sdtc:dischargeDispositionCode SHOULD contain exactly [0..1] codeSystem, which SHOULD be either CodeSystem: NUBC 2.16.840.1.113883.6.301.5 OR CodeSystem: HL7 Discharge Disposition 2.16.840.1.113883.12.112 (CONF:1198-32377).
        1626

         

        Because LOINC has deprecated the code 52521-1 the examples for Care Plan document should use the replacement code of 18776-5, and the sample code in the value set should be fixed to use 18776-5.

        Duplicate to 1625 - made this by mistake and couldn't figure out how to delete it.
        1625

         

        Because LOINC has deprecated the code 52521-2 the examples for Care Plan document should use the replacement code of 18776-5, and the sample code in the value set should be fixed to use 18776-5.
        1623

         

        Health Status Evaluations and Outcomes Section
        [section: identifier urn:oid:2.16.840.1.113883.10.20.22.2.61 (open)]

        This template represents observations regarding the outcome of care from the interventions used to treat the patient. These observations represent status, at points in time, related to established care plan goals and/or interventions.
        1611

         

        There is a general need to do an overall clean-up the C-CDA IG to go through all value set definitions and make sure that the source information is correct.

        As we have improved the availability of value set definitions and expansions in VSAC, the source may have changed from PHINVADS or some other organization.
        1607

         

        @Eric ParapiniIn the template Immunization Activity Act (V3) (TemplateId: 2.16.840.1.113883.10.20.22.4.52:2015-08-01) there is an entryRelationship to the Instruction (V2) template (TemplateId: 2.16.840.1.113883.10.20.22.4.20:2014-06-09).     
        1606

         

        @Eric ParapiniI would like to request the LOINC code "80791-7" Nutrition and dietetics Plan of care note be added to the Care Plan Document Type value set (urn:oid:2.16.840.1.113762.1.4.1099.10)
        1605

         

        In the latest errata version (CDAR2_IG_CCDA_CLINNOTES_R1_DSTU2.1_2015AUG_Vol2_2018MAYwith_errata.pdf) on page128 (2.1.8 above number 4) that "Preferred code is 18748-4 LOINC Diagnostic Imaging Report" but per LOINC, that code will be deprecated in December 2018
        1603

         

        From the C-CDA Companion Guide Note Activity Template (Page 92 - 9(c)(ii)(1)):

        The playingEntity, if present, SHALL contain zero or more [0..*] US Realm Person Name (PN.US.FIELDED) (identifier: urn:oid:2.16.840.1.113883.10.20.22.5.1.1) (CONF:3250-16929).
        1602

         

        Allergy & intolerance template (2.16.840.1.113883.10.20.22.4.7), substance reactant binding (CONF:1098-7419)
        The bound value set is very large, making it difficult to support for both entry and validation.
        1525

        SHOULD contain zero or one [0..1] performer="PRF" Performer (CodeSystem: HL7ParticipationType urn:oid:2.16.840.1.113883.5.90 STATIC) (CONF:1198-8961) such that it
        1516

         

        Number of Pressure Ulcers Observation (V3)
        [observation: identifier urn:hl7ii:2.16.840.1.113883.10.20.22.4.76:2015-08-01 (open)]
        This template represents the number of pressure ulcers observed at a particular stage.
        1515

         

        @George DixonClinical Documentation Request we are unable to support. Medication Administration- Ability to display an administered dose with a cumulative dose. Use Case - For a given treatment timeframe when ordering and administering chemotherapy medications related to their toxicity it is important to know the patient's running dosage received. Depending on the clinical environments management of visits (acute versus repeat outpatient treatments) this may be within an encounter or across encounters for a given period of time. Need communicate most recent dose(s), Cumulative interval (low/high) and cumulative dose.
        1513

         

        Table 400: Health Insurance Type

        Code System OID is wrong


        ALSO WRONG IN THE LIST OF CODES SYSTEMS USED IN THE IG
        1510

         

        Value Set: HealthcareServiceLocation urn:oid:2.16.840.1.113883.1.11.20275
        A comprehensive classification of locations and settings where healthcare services are provided. This value set is based on the National Healthcare Safety Network (NHSN) location code system that has been developed over a number of years through CDC's interaction with a variety of healthcare facilities and is intended to serve a variety of reporting needs where coding of healthcare service locations is required.
        1505

         

        Currently in the Patient Generated Document Header

        13. MAY contain zero or more [0..*] documentationOf (CONF:1198-28710).
        The code should be selected from a value set established by the document-level template for a specific type of Patient Generated Document.
        1502

         

        @Berge,RuthThe link in section 1.1.17 Progress Note (v3) in Table 49 (Progress Note (V3) Context) for " Allergies and Intolerances Section (entries optional) (V3) " goes to 2.4.1 Allergies and Intolerances Section (entries required) (V3). This is also true for the link in Table 53: Referral Note (V2) Constraints Overview . In Table 53 the Allergies section is assigned CONF# 1198- 30625. On page 195, in the details for Allergies there is another link that also goes to the wrong Allergies and Intolerance Section.
        1470

         

        This comment refers back to decisions made in Errata 1338.

        Given a proposed alternative constraint was not provided/proposed by Regenstrief in time to be included in the September errata update for C-CDA R2.1, I supported leaving the errata change as had been proposed and implemented in the US Realm header template draft C-CDA R2.1 errata release (shown below):
        1452

         

        Value Set X_ActRelationshipDocument is a new value set that came into existence during the C-CDA R2.1 Errata Update. It needs to be added to the CCDA Value Set Summary sheet maintained in the HL7 SDWG Workgroup Documents area.
        1430

         

        SHALL contain exactly one [1..1] templateId (CONF:81-8531) such that it
        a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.6.1.2"
        1429

         

        3.34 Goal Observation
        ...
        MAY contain zero or one [0..1] value (CONF:1098-32743).

         

        Section 3.23, page 483:

        Table 272: EncounterTypeCode
        Value Set: EncounterTypeCode urn:oid:2.16.840.1.113883.3.88.12.80.32
        This value set includes only the codes of the Current Procedure and Terminology designated for Evaluation and Management (99200 – 99607) (subscription to AMA Required
        Value Set Source: http://www.amacodingonline.com/
        1425

         

        @Hyde,LindaValue Set Links in IG
        A number of the links for value sets in the IG either no long work or point to the wrong location. For example several value set links send you to the VTSL Browser (veterinary service extension); the link for the country value set is no longer valid.
        1424

         

        @Hyde,LindaWound Measurements Value set 2.16.840.1.113883.1.11.20.2.5 (dynamic)
        IG table says 'A value set of SNOMED-CT codes to capture the dimensions of a wound' but the value set is using LOINC codes.
        1422

         

        @Hyde,LindaProcedure Value set 2.16.840.1.113883.3.88.12.80.28 (dynamic)
        This value set is referenced in the IG but does not appear in the list of value sets in the appendix or as it's own table. It appears in the section for 'performer for the value of service event code' pg 169,182. Value set covers all values under the 71388002 Procedure. It is in VSAC and in the R2.1 Value Set Download from VSAC.
        1421

         

        @Hyde,LindaPressure Point Value Set 2.16.840.1.113883.11.20.9.36 (static)
        VSAC and Trifolia only have one code in common. Trifolia codes are for the site 'structure' and VSAC for 'skin structure of'. The IG value set table contains the same codes as Trifolia. The purpose of this value set is to identify the areas of the body generally associated with pressure ulcers so it would seem that 'skin structure of' would be the more appropriate concepts to use.
        1420

         

        @Hyde,LindaPlanned moodcode (Observation)Value set 2.16.840.1.113883.11.20.9.25 (static)
        VSAC contains code for GOL (goal). This code is not in the IG table. It is in the ActMood table.
        1419

         

        @Hyde,LindaParticipationFunction Value set 2.16.840.1.113883.1.11.10267 (static)
        There are new codes in the ParticipationFunction code system that are not in VSAC.
        1418

         

        @Hyde,LindaObservation Interpretation (HL7)Value set 2.16.840.1.113883.1.11.78 (static)
        1. There is a new version of ObservationInterpretation with additional codes that are not in VSAC and several codes in VSAC that are now deprecated.
        2. Code system name in IG is HITSP-CS-83 but in VSAC it is ObservationInterpretation. IG should be updated
        1417

         

        @Hyde,LindaINDRoleClassCodes Value set. 2.16.840.1.113883.11.20.9.33
        The implementation contains references to both static and dynamic for this value set. Pages 62,97,144,157 refer to this value set as STATIC, however on page 204 it is listed as DYNAMIC.
        1416

         

        @Hyde,LindaEntityPersonNamePartQualifier Value Set 2.16.840.1.113883.11.20.9.26(static)
        LS legal status)code is not in VSAC. In the original version of the code system it was include but in a separate level. All the codes under _ PersonNamePartQualifier are in VSAC.
        1415

         

        @Hyde,LindaEntity Name Use Value Set 2.16.840.1.113883.1.11.15913 (static)
        All values of the EntityNameUse code system are in VSAC except OR (official registry).This code was not in the original code system but is in V3.
        1414

         

        @Hyde,LindaAllergy and Intolerance Type Value Set 2.16.840.1.113883.3.88.12.3221.6.2 (dynamic)

         

        <!-- ************************ ENCOUNTERS *********************** -->
        <component>
        <section>
        <!-- *** Encounters section (entries required) (V3) *** -->
        <templateId root="2.16.840.1.113883.10.20.22.2.22.1" extension="2015-08-01"/>
        <templateId root="2.16.840.1.113883.10.20.22.2.22.1"/>

        I think there is a problem with the sample CCD file C-CDA_R2-1_CCD.xml included in this package.

        1381

         

        doseQuanity/@unit and administrationUnitCode/@code are a confusing set of elements, but I will do my best pulling from the base definitions:
        1370

         

        In the Comment Activity template (2.16.840.1.113883.10.20.22.4.64):

        5. SHALL contain exactly one [1..1] text (CONF:81-9430).
        a. This text SHALL contain exactly one [1..1] reference (CONF:81-15967).



    2. (expand HL7 CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes Companion Guide, Release 2 STU - US Realm )


      1. STU

        Last Update

        Commenter

        Comment

        2014

         

        The Note Types Value Set (urn:oid:2.16.840.1.113883.11.20.9.68) version 20191017 is missing three note types specific in USCDI v1:
        1996

         

        In Appendix C, I read the Provenance - Author Participation template as saying you can use the same trick as in the standard C-CDA Author Participation template to reference an author already defined elsewhere in the document:

        The assignedAuthor/id may be set equal to (a pointer to) an id on a participant elsewhere in the document (header or entries) or a new author participant can be described here.

         

        (Vocab issue)
        Table 9 of the Companion Guide recommends the LOINC codes 11502-2 for Laboratory Narrative notes and 11526-1 for Pathology Narrative notes. However, these codes aren't actually included in the Note Types value set (urn:oid:2.16.840.1.113883.11.20.9.68) as required by the Notes Section and Note Activity templates in Appendix A. Likewise, although no specific LOINC code is recommended for Imaging Narrative notes, the value set doesn't include any codes from the value set recommended for imaging notes in Table 8 (urn:oid:1.3.6.1.4.1.12009.10.2.5).

         

        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?

         

        Appendix B UDI
        1.1 UDI Organizer 

        Figure 1: Unique Device Identifier (UDI) Organizer Template ID root is incorrect



11:00am ET

  1. Linda Michaelsen has an STU comment that she would like to discuss next week during the PIE session. She will add that tracker item to the agenda for that session.
  2. Marti Velezis will find the UDI tracker items to be discussed and will identify times that they might be discussed during the WGM next week.
  3. Adjournment
    1. motion to adjourn by Calvin E. Beebe accepted by Gay Dolin Adjourned at 12:00pm ET

 


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