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Facilitator:

Austin Kreisler


Date:


Call Details:


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Agenda:


10:00am ET

  1. Call to order 
    1. Call for Attendance


  2. Business Updates (10 min)
    1. Additions/modifications to the agenda
    2. Approve minutes from 2020-08-13 Agenda and Minutes

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

  5. Additional Items
    1. Extensions
  6. STU Comments
    1. Nick Radov(Expand C-CDA Templates for Clinical Notes DSTU Release 2.1 - US Realm to find Nick's issues)
      1. HL7 CDA® R2 IG: C-CDA Templates for Clinical Notes DSTU Release 2.1 - US Realm
      2.  Click here to expand...

        STU

        Last Updated

        Commenter

        Issue

         

        Figure 161: Immunization Activity (V3) Example
        (page 550)

        <code code="33" codeSystem="2.16.840.1.113883.6.59" displayName="Pneumococcal polysaccharide vaccine" codeSystemName="CVX">

        Figure 224: Substance Administered Act Example
        (page 846)

        <code code="43" codeSystem="2.16.840.1.113883.6.59" displayName="Hepatitis B Vaccine" codeSystemName="CVX" />
        1946

         

        Table 6 found on page 63 in CDAR2_IG_CCDA_CLINNOTES_R1_DSTU2.1_2015AUG_Vol2_2019JUNwith_errata.pdf has the following text:

        Table 6: Language Value Set: Language urn:oid:2.16.840.1.113883.1.11.11526

        A value set of codes defined by Internet RFC 5646. Use 2 character code if one exists. Use 3 character code if a 2 character code does not exist. Including type = region is allowed

        See http://www.iana.org/assignments/language-subtag-registry/language-subtag-registry
        Value Set Source: http://www.loc.gov/standards/iso639-2/php/code_list.php

        While the table states Including type = region is allowed - the value set source does not list any valid regions. Also, the two sample provided as follows need to be corrected:

        The Figure 1: US Realm Header (V3) Example shows <languageCode code="en-US" />
        which SHOULD be <languageCode code="en" />

        The Figure 2: recordTarget Example shows <languageCommunication> <languageCode code="eng" />
        which SHOULD be <languageCommunication> <languageCode code="en" /> because Table 6 (Page 63) states to use the 2 digit code if there is one.

        Lastly, this value set is not included in VSAC. Should it be?
        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).

         

        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).

         

        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/

         

        <!-- ************************ 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.

    2. Matt Szczepankiewicz (expand HL7 CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes Companion Guide, Release 2 STU - US Realm )
      1.   

         Click here to expand...

        STU

        Last Update

        Commenter

        Comment

         

        Appendix C has a constraint with root, extension and NULL of UNK

         

        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.

         

        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

         

        (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).

         

        The following unimplemented constraints use the expression "not(.)" throughout the main Companion Guide schematron file:

        CONF:3250-16902
        CONF:3250-16912
        CONF:3250-16914
        CONF:4435-133
        CONF:3250-16942

        Typically unimplemented constraints use a dummy expression like "not(tested)" that always returns false (since the current element doesn't have a child named "tested"), but in this case, we're asserting that the current node is null, which returns false, makes the assertion fail, and triggers a false positive schematron error.
      2.  

11:00am ET

  1. Value Set Updates
  2. Value Set STU Comments
    1. #nnnn
  3. Adjournment

Notes/Minutes:


10:00am ET

  1. Call to order 
    1. Meeting was started at 10:05am ET 
    2. Call for Attendance


  2. Business Updates (10 min)
    1. Additions/modifications to the agenda
    2. Approve minutes from 2020-08-13 Agenda and Minutes

      1. minutes were approved by consensus
    3. HL7
  3. External Updates - ONC and others
    1. USCDI - this is going thru another cycle. Soliciting comments for this and there are not any other ballots at the moment and this may add a new requirement for balloting. A good topic for the Working Group Meeting. Good topic for the CDA Management Workgroup
  4. Project Updates
    1.  No project updates

  5. Additional Items
    1. Extensions - 
      1. Andrew didn't get the extensions pages merged for today.
      2. Lisa R. Nelson will reach out to Russell Ott , Linda Michaelsen to identify if there are others who can help own the new extension work
  6. STU Comments
    1. Nick Radov(Expand C-CDA Templates for Clinical Notes DSTU Release 2.1 - US Realm to find Nick's issues)
      1. HL7 CDA® R2 IG: C-CDA Templates for Clinical Notes DSTU Release 2.1 - US Realm
      2.  Click here to expand...

        STU

        Last Updated

        Commenter

        Issue

         

        Figure 161: Immunization Activity (V3) Example
        (page 550)

        <code code="33" codeSystem="2.16.840.1.113883.6.59" displayName="Pneumococcal polysaccharide vaccine" codeSystemName="CVX">

        Figure 224: Substance Administered Act Example
        (page 846)

        <code code="43" codeSystem="2.16.840.1.113883.6.59" displayName="Hepatitis B Vaccine" codeSystemName="CVX" />
        1946

         

        Table 6 found on page 63 in CDAR2_IG_CCDA_CLINNOTES_R1_DSTU2.1_2015AUG_Vol2_2019JUNwith_errata.pdf has the following text:

        Table 6: Language Value Set: Language urn:oid:2.16.840.1.113883.1.11.11526

        A value set of codes defined by Internet RFC 5646. Use 2 character code if one exists. Use 3 character code if a 2 character code does not exist. Including type = region is allowed

        See http://www.iana.org/assignments/language-subtag-registry/language-subtag-registry
        Value Set Source: http://www.loc.gov/standards/iso639-2/php/code_list.php

        While the table states Including type = region is allowed - the value set source does not list any valid regions. Also, the two sample provided as follows need to be corrected:

        The Figure 1: US Realm Header (V3) Example shows <languageCode code="en-US" />
        which SHOULD be <languageCode code="en" />

        The Figure 2: recordTarget Example shows <languageCommunication> <languageCode code="eng" />
        which SHOULD be <languageCommunication> <languageCode code="en" /> because Table 6 (Page 63) states to use the 2 digit code if there is one.

        Lastly, this value set is not included in VSAC. Should it be?
        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).

         

        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).

         

        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/

         

        <!-- ************************ 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.

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

         Click here to expand...

        STU

        Last Update

        Commenter

        Comment

         

        Appendix C has a constraint with root, extension and NULL of UNK

         

        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.

         

        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

         

        (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).

         

        The following unimplemented constraints use the expression "not(.)" throughout the main Companion Guide schematron file:

        CONF:3250-16902
        CONF:3250-16912
        CONF:3250-16914
        CONF:4435-133
        CONF:3250-16942

        Typically unimplemented constraints use a dummy expression like "not(tested)" that always returns false (since the current element doesn't have a child named "tested"), but in this case, we're asserting that the current node is null, which returns false, makes the assertion fail, and triggers a false positive schematron error.
      •  1984
      • TypeMotion
        Motion

        Motion to approve Motion as disposed

        By
        Second
        Date

         

        Ref #1984
        For17
        Neg0
        Abs0
        Status

        APPROVED

        Tally17-00-00 
        Discussion

        Action
        TypeMotion
        Motion

        Motion to remove the schematron file, stylesheet, anything consider executable from the publication package to avoid security issues, and the fact that these files need to evolve over time. The download package should contain a reference to these files which reside elsewhere.

        By
        Second
        Date

         

        Ref #
        For18
        Neg00
        Abs00
        Status

        APPROVED

        Tally18-00-00 
        Discussion

        Action
      • https://gist.github.com/mjszczep/c815a16c788eba587f7fff414519cc42
      • 2008 
        • We could make this a change
        • TypeMotion
          Motion

          Motion to approve as disposed with mod

          By
          Second
          Date

           

          Ref #2008
          For19
          Neg00
          Abs01
          Status

          APPROVED

          Tally19-00-01 
          Discussion

          Action
          TypeMotion
          Motion

          Motion to approve clarification on 2008

          By
          Second
          Date

           

          Ref #2008
          For19
          Neg00
          Abs00
          Status

          APPROVED

          Tally00-00-00 
          Discussion

          Action

11:00am ET

  1. Adjournment
    1. 11:58 am ET

 


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